1. CHAPTER I PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
2. SUBCHAPTER A GENERAL PROVISIONS
3. PART 2 CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS
4. Subpart A Introduction
5. § 2.1 Statutory authority for confidentiality of substance use disorder patient records.
6. § 2.2 Purpose and effect.
7. § 2.3 Civil and criminal penalties for violations.
8. § 2.4 Complaints of noncompliance.
9. Subpart B General Provisions
10. § 2.11 Definitions.
11. § 2.12 Applicability.
12. § 2.13 Confidentiality restrictions and safeguards.
13. § 2.14 Minor patients.
14. § 2.15 Patients who lack capacity and deceased patients.
15. § 2.16 Security for records and notification of breaches.
16. § 2.17 Undercover agents and informants.
17. § 2.18 Restrictions on the use of identification cards.
18. § 2.19 Disposition of records by discontinued programs.
19. § 2.20 Relationship to state laws.
20. § 2.21 Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity.
21. § 2.22 Notice to patients of Federal confidentiality requirements.
22. § 2.23 Patient access and restrictions on use and disclosure.
23. § 2.24 Requirements for intermediaries.
24. § 2.25 Accounting of disclosures.
25. § 2.26 Right to request privacy protection for records.
26. Subpart C Uses and Disclosures With Patient Consent
27. § 2.31 Consent requirements.
28. § 2.32 Notice and copy of consent to accompany disclosure.
29. § 2.33 Uses and disclosures permitted with written consent.
30. § 2.34 Uses and Disclosures to prevent multiple enrollments.
31. § 2.35 Disclosures to elements of the criminal justice system which have referred patients.
32. § 2.36 Disclosures to prescription drug monitoring programs.
33. Subpart D Uses and Disclosures Without Patient Consent
34. § 2.51 Medical emergencies.
35. § 2.52 Scientific research.
36. § 2.53 Management audits, financial audits, and program evaluation.
37. § 2.54 Disclosures for public health.
38. Subpart E Court Orders Authorizing Use and Disclosure
39. § 2.61 Legal effect of order.
40. § 2.62 Order not applicable to records disclosed without consent to researchers, auditors, and evaluators.
41. § 2.63 Confidential communications.
42. § 2.64 Procedures and criteria for orders authorizing uses and disclosures for noncriminal purposes.
43. § 2.65 Procedures and criteria for orders authorizing use and disclosure of records to criminally investigate or prosecute patients.
44. § 2.66 Procedures and criteria for orders authorizing use and disclosure of records to investigate or prosecute a part 2 program or the person holding the records.
45. § 2.67 Orders authorizing the use of undercover agents and informants to investigate employees or agents of a part 2 program in connection with a criminal matter.
46. § 2.68 Report to the Secretary.
47. PART 2a PROTECTION OF IDENTITY—RESEARCH SUBJECTS
48. § 2a.1 Applicability.
49. § 2a.2 Definitions.
50. § 2a.3 Application; coordination.
51. § 2a.4 Contents of application; in general.
52. § 2a.5 Contents of application; research projects in which drugs will be administered.
53. § 2a.6 Issuance of Confidentiality Certificates; single project limitation.
54. § 2a.7 Effect of Confidentiality Certificate.
55. § 2a.8 Termination.
56. PART 3 PATIENT SAFETY ORGANIZATIONS AND PATIENT SAFETY WORK PRODUCT
57. Subpart A General Provisions
58. § 3.10 Purpose.
59. § 3.20 Definitions.
60. Subpart B PSO Requirements and Agency Procedures
61. § 3.102 Process and requirements for initial and continued listing of PSOs.
62. § 3.104 Secretarial actions.
63. § 3.106 Security requirements.
64. § 3.108 Correction of deficiencies, revocation, and voluntary relinquishment.
65. § 3.110 Assessment of PSO compliance.
66. § 3.112 Submissions and forms.
67. Subpart C Confidentiality and Privilege Protections of Patient Safety Work Product
68. § 3.204 Privilege of patient safety work product.
69. § 3.206 Confidentiality of patient safety work product.
70. § 3.208 Continued protection of patient safety work product.
71. § 3.210 Required disclosure of patient safety work product to the Secretary.
72. § 3.212 Nonidentification of patient safety work product.
73. Subpart D Enforcement Program
74. § 3.304 Principles for achieving compliance.
75. § 3.306 Complaints to the Secretary.
76. § 3.308 Compliance reviews.
77. § 3.310 Responsibilities of respondents.
78. § 3.312 Secretarial action regarding complaints and compliance reviews.
79. § 3.314 Investigational subpoenas and inquiries.
80. § 3.402 Basis for a civil money penalty.
81. § 3.404 Amount of a civil money penalty.
82. § 3.408 Factors considered in determining the amount of a civil money penalty.
83. § 3.414 Limitations.
84. § 3.416 Authority to settle.
85. § 3.418 Exclusivity of penalty.
86. § 3.420 Notice of proposed determination.
87. § 3.422 Failure to request a hearing.
88. § 3.424 Collection of penalty.
89. § 3.426 Notification of the public and other agencies.
90. § 3.504 Hearings before an ALJ.
91. § 3.506 Rights of the parties.
92. § 3.508 Authority of the ALJ.
93. § 3.510 Ex parte contacts.
94. § 3.512 Prehearing conferences.
95. § 3.514 Authority to settle.
96. § 3.516 Discovery.
97. § 3.518 Exchange of witness lists, witness statements, and exhibits.
98. § 3.520 Subpoenas for attendance at hearing.
99. § 3.522 Fees.
100. § 3.524 Form, filing, and service of papers.
101. § 3.526 Computation of time.
102. § 3.528 Motions.
103. § 3.530 Sanctions.
104. § 3.532 Collateral estoppel.
105. § 3.534 The hearing.
106. § 3.538 Witnesses.
107. § 3.540 Evidence.
108. § 3.542 The record.
109. § 3.544 Post hearing briefs.
110. § 3.546 ALJ's decision.
111. § 3.548 Appeal of the ALJ's decision.
112. § 3.550 Stay of the Secretary's decision.
113. § 3.552 Harmless error.
114. PART 4 NATIONAL LIBRARY OF MEDICINE
115. § 4.1 Programs to which these regulations apply.
116. § 4.2 Definitions.
117. § 4.3 Purpose of the Library.
118. § 4.4 Use of Library facilities.
119. § 4.5 Use of materials from the collections.
120. § 4.6 Reference, bibliographic, reproduction, and consultation services.
121. § 4.7 Fees.
122. § 4.8 Publication of the Library and information about the Library.
123. PART 5 DESIGNATION OF HEALTH PROFESSIONAL(S) SHORTAGE AREAS
124. § 5.1 Purpose.
125. § 5.2 Definitions.
126. § 5.3 Procedures for designation of health professional(s) shortage areas.
127. § 5.4 Notification and publication of designations and withdrawals.
128. Appendix A to Part 5 Criteria for Designation of Areas Having Shortages of Primary Medical Care Professional(s)
129. Appendix B to Part 5 Criteria for Designation of Areas Having Shortages of Dental Professional(s)
130. Appendix C to Part 5 Criteria for Designation of Areas Having Shortages of Mental Health Professionals
131. Appendix D to Part 5 Criteria for Designation of Areas Having Shortages of Vision Care Professional(s)
132. Appendix E to Part 5 Criteria for Designation of Areas Having Shortages of Podiatric Professional(s)
133. Appendix F to Part 5 Criteria for Designation of Areas Having Shortages of Pharmacy Professional(s)
134. Appendix G to Part 5 Criteria for Designation of Areas Having Shortages of Veterinary Professional(s)
135. PART 6 FEDERAL TORT CLAIMS ACT COVERAGE OF CERTAIN GRANTEES AND INDIVIDUALS
136. § 6.1 Applicability.
137. § 6.2 Definitions.
138. § 6.3 Eligible entities.
139. § 6.4 Covered individuals.
140. § 6.5 Deeming process for eligible entities.
141. § 6.6 Covered acts and omissions.
142. PART 7 DISTRIBUTION OF REFERENCE BIOLOGICAL STANDARDS AND BIOLOGICAL PREPARATIONS
143. § 7.1 Applicability.
144. § 7.2 Establishment of a user charge.
145. § 7.3 Definitions.
146. § 7.4 Schedule of charges.
147. § 7.5 Payment procedures.
148. § 7.6 Exemptions.
149. PART 8 MEDICATIONS FOR THE TREATMENT OF OPIOID USE DISORDER
150. Subpart A General Provisions
151. § 8.1 Scope.
152. §thnsp;8.2 Definitions.
153. Subpart B Accreditation of Opioid Treatment Programs
154. § 8.3 Application for approval as an Accreditation Body.
155. § 8.4 Accreditation Body responsibilities.
156. § 8.5 Periodic evaluation of Accreditation Bodies.
157. § 8.6 Withdrawal of approval of Accreditation Bodies.
158. Subpart C Certification and Treatment Standards for Opioid Treatment Programs
159. § 8.11 Opioid Treatment Program certification.
160. § 8.12 Federal Opioid Use Disorder treatment standards.
161. § 8.13 Revocation of accreditation and Accreditation Body approval.
162. § 8.14 Suspension or revocation of certification.
163. § 8.15 Forms.
164. Subpart D Procedures for Informal Review of Suspension or Proposed Revocation of OTP Certification, and of Adverse Action Regarding Withdrawal of Approval of an Accreditation Body
165. § 8.21 Applicability.
166. § 8.22 Definitions.
167. § 8.23 Limitation on issues subject to review.
168. § 8.24 Specifying who represents the parties.
169. § 8.25 Informal review and the reviewing official's response.
170. § 8.26 Preparation of the review file and written arguments.
171. § 8.27 Opportunity for oral presentation.
172. § 8.28 Expedited procedures for review of immediate suspension.
173. § 8.29 Ex parte communications.
174. § 8.30 Transmission of written communications by reviewing official and calculation of deadlines.
175. § 8.31 Authority and responsibilities of the reviewing official.
176. § 8.32 Administrative record.
177. § 8.33 Written decision.
178. § 8.34 Court review of final administrative action; exhaustion of administrative remedies.
179. E Subpart E [Reserved]
180. PART 9 STANDARDS OF CARE FOR CHIMPANZEES HELD IN THE FEDERALLY SUPPORTED SANCTUARY SYSTEM
181. § 9.1 Applicability and purpose.
182. § 9.2 Definitions.
183. § 9.3 Sanctuary policies and responsibilities.
184. § 9.4 Physical facility policies and design.
185. § 9.5 Chimpanzee ownership, fees, and studies.
186. § 9.6 Animal care, well-being, husbandry, veterinary care, and euthanasia.
187. § 9.7 Reproduction.
188. § 9.8 Animal records.
189. § 9.9 Facility staffing.
190. § 9.10 Occupational Health and Safety Program (OHSP) and biosafety requirements.
191. § 9.11 Animal transport.
192. § 9.12 Compliance with the Standards of Care, and USDA and PHS policies and regulations.
193. § 9.13 Other federal laws, regulations, and statutes that apply to the sanctuary.
194. PART 10 340B DRUG PRICING PROGRAM
195. Subpart A General Provisions
196. § 10.1 Purpose.
197. § 10.2 Summary of 340B Drug Pricing Program.
198. § 10.3 Definitions.
199. Subpart B 340B Ceiling Price
200. § 10.10 Ceiling price for a covered outpatient drug.
201. § 10.11 Manufacturer civil monetary penalties.
202. Subpart C Administrative Dispute Resolution
203. § 10.20 340B Administrative Dispute Resolution Panel.
204. § 10.21 Claims.
205. § 10.22 Covered entity information and document requests.
206. § 10.23 340B ADR Panel decision process.
207. § 10.24 340B ADR Panel decision reconsideration process.
208. § 10.25 Severability.
209. PART 11 CLINICAL TRIALS REGISTRATION AND RESULTS INFORMATION SUBMISSION
210. Subpart A General Provisions
211. § 11.2 What is the purpose of this part?
212. § 11.4 To whom does this part apply?
213. § 11.6 What are the requirements for the submission of truthful information?
214. § 11.8 In what format must clinical trial information be submitted?
215. § 11.10 What definitions apply to this part?
216. Subpart B Registration
217. § 11.20 Who must submit clinical trial registration information?
218. § 11.22 Which applicable clinical trials must be registered?
219. § 11.24 When must clinical trial registration information be submitted?
220. § 11.28 What constitutes clinical trial registration information?
221. § 11.35 By when will the NIH Director post clinical trial registration information submitted under § 11.28?
222. Subpart C Results Information Submission
223. § 11.40 Who must submit clinical trial results information?
224. § 11.42 For which applicable clinical trials must clinical trial results information be submitted?
225. § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?
226. § 11.48 What constitutes clinical trial results information?
227. § 11.52 By when will the NIH Director post submitted clinical trial results information?
228. § 11.54 What are the procedures for requesting and obtaining a waiver of the requirements for clinical trial results information submission?
229. Subpart D Additional Submission of Clinical Trial Information
230. § 11.60 What requirements apply to the voluntary submission of clinical trial information for clinical trials of FDA-regulated drug products (including biological products) and device products?
231. § 11.62 What requirements apply to applicable clinical trials for which submission of clinical trial information has been determined by the Director to be necessary to protect the public health?
232. § 11.64 When must clinical trial information submitted to ClinicalTrials.gov be updated or corrected?
233. Subpart E Potential Legal Consequences of Non-Compliance
234. § 11.66 What are potential legal consequences of not complying with the requirements of this part?
235. PART 12 TELEMEDICINE FLEXIBILITIES
236. Subpart A Special Exceptions Related to Telemedicine
237. § 12.1 Temporary extension of certain COVID-19 telemedicine flexibilities for prescription of controlled medications.
238. § 12.2 [Reserved]
239. Subpart B Telemedicine Prescribing
240. § 12.3 Telemedicine prescribing of schedule III-V medications for the treatment of Opioid Use Disorder.
241. § 12.4 Telemedicine prescribing of schedule II-V medications by the Department of Veterans Affairs practitioners.
242. SUBCHAPTER B PERSONNEL
243. PART 21 COMMISSIONED OFFICERS
244. Subpart A Definitions
245. § 21.1 Meaning of terms.
246. Subpart B Appointment
247. § 21.21 Meaning of terms.
248. § 21.22 Submission of application and evidence of qualifications.
249. § 21.23 False statements as disqualification.
250. § 21.24 Physical examinations.
251. § 21.25 Eligibility; junior assistant grade.
252. § 21.26 Eligibility; assistant grade.
253. § 21.27 Eligibility; senior assistant grade.
254. § 21.28 Age requirements, Regular Corps, senior assistant grade and below.
255. § 21.29 Eligibility; grades above senior assistant grade.
256. § 21.30 Determination of creditable years of educational and professional training and experience.
257. § 21.31 Eligibility; all grades; academic and professional education and professional training and experience.
258. § 21.32 Boards; appointment of; powers and duties.
259. § 21.33 General service.
260. § 21.34 Certification by candidate; requirement of new physical examination.
261. § 21.41 Professional examinations, holding of; subjects to be included.
262. § 21.42 Examinations; junior assistant, assistant, or senior assistant grade.
263. § 21.43 Examination; full grade and above.
264. § 21.44 Clinical or other practical demonstration.
265. § 21.45 Rating values.
266. § 21.46 Merit roll.
267. § 21.47 Examination; anticipation of meeting qualifications.
268. § 21.51 Appointment of officers having specialized training or experience in administration and management.
269. § 21.52 Waiver of entrance qualifications for original appointment in time of war or national emergency.
270. § 21.53 Examination.
271. § 21.54 Students.
272. § 21.55 Appointment to higher grades; candidates exceptionally qualified in specialized fields.
273. § 21.56 Reappointment.
274. § 21.57 Examination for reappointment.
275. § 21.58 Physical examination for reappointment.
276. Subpart C Involuntary Child and Spousal Support Allotments
277. § 21.70 Purpose.
278. § 21.71 Applicability and scope.
279. § 21.72 Definitions.
280. § 21.73 Policy.
281. § 21.74 Responsibilities.
282. § 21.75 Procedures.
283. PART 22 PERSONNEL OTHER THAN COMMISSIONED OFFICERS
284. 4 Hansen's Disease Duty by Personnel Other Than Commissioned Officers
285. 5 Special Consultants
286. § 22.3 Appointment of special consultants.
287. § 22.5 Leave without pay while on detail.
288. PART 23 NATIONAL HEALTH SERVICE CORPS
289. Subpart A Assignment of National Health Service Corps Personnel
290. § 23.1 To what entities does this regulation apply?
291. § 23.2 Definitions.
292. § 23.3 What entities are eligible to apply for assignment?
293. § 23.4 How must an entity apply for assignment?
294. § 23.5 What are the criteria for deciding which applications for assignment will be approved?
295. § 23.6 What are the criteria for determining the entities to which National Health Service Corps personnel will be assigned?
296. § 23.7 What must an entity agree to do before the assignment is made?
297. § 23.8 What operational requirements apply to an entity to which National Health Service Corps personnel are assigned?
298. § 23.9 What must an entity to which National Health Service Corps personnel are assigned (i.e., a National Health Service Corps site) charge for the provision of health services by assigned personnel?
299. § 23.10 Under what circumstances may a National Health Service Corps site's reimbursement obligation to the Federal Government be waived?
300. § 23.11 Under what circumstances may the Secretary sell equipment or other property of the United States used by the National Health Service Corps site?
301. § 23.12 Who will supervise and control the assigned personnel?
302. § 23.13 What nondiscrimination requirements apply to National Health Service Corps sites?
303. PART 24 SENIOR BIOMEDICAL RESEARCH AND BIOMEDICAL PRODUCT ASSESSMENT SERVICE
304. § 24.1 Establishment, number of members, and purpose.
305. § 24.2 Allocation.
306. § 24.3 Policy Board.
307. § 24.4 Eligibility.
308. § 24.5 Pay and compensation.
309. § 24.6 Performance appraisal system.
310. § 24.7 Inapplicability of provisions regarding appointments.
311. § 24.8 Removal from the Service.
312. § 24.9 Reporting.
313. SUBCHAPTER C MEDICAL CARE AND EXAMINATIONS
314. PART 31 MEDICAL CARE FOR CERTAIN PERSONNEL OF THE COAST GUARD, NATIONAL OCEAN SURVEY, PUBLIC HEALTH SERVICE, AND FORMER LIGHTHOUSE SERVICE
315. 6 Definitions
316. § 31.1 Meaning of terms.
317. 7 Provisions Applicable to Coast Guard, National Ocean Survey and Public Health Service
318. § 31.2 Persons entitled to treatment.
319. § 31.3 Use of Service facilities.
320. § 31.4 Use of other than Service facilities.
321. § 31.5 Application for treatment; active duty personnel.
322. § 31.6 Personnel absent without leave.
323. § 31.7 Continuance of medical relief after loss of status.
324. § 31.8 Retired personnel; extent of treatment.
325. § 31.9 Dependent members of families; treatment.
326. § 31.10 Dependent members of families; use of Service facilities.
327. 8 Provisions Applicable to Personnel of Former Lighthouse Service
328. § 31.11 Persons entitled to treatment.
329. § 31.12 Use of Service facilities.
330. § 31.13 Use of other than Service facilities.
331. § 31.14 Application for treatment; active duty personnel.
332. § 31.15 Continuance of medical relief after loss of status.
333. § 31.16 Retired personnel; extent of treatment.
334. PART 34 MEDICAL EXAMINATION OF ALIENS
335. § 34.1 Applicability.
336. § 34.2 Definitions.
337. § 34.3 Scope of examinations.
338. § 34.4 Medical notifications.
339. § 34.5 Postponement of medical examination.
340. § 34.6 Applicability of foreign quarantine regulations.
341. § 34.7 Medical and other care; death.
342. § 34.8 Reexamination; convening of review boards; expert witnesses; reports.
343. PART 35 HOSPITAL AND STATION MANAGEMENT
344. Subpart A General
345. § 35.1 Hospital and station rules.
346. § 35.2 Compliance with hospital rules.
347. § 35.3 Noncompliance; deprivation of privileges.
348. § 35.4 Noncompliance; discharge or transfer.
349. § 35.5 Entitlement to care after discharge or transfer by reason of noncompliance.
350. § 35.6 Admissions; determination of eligibility for care.
351. § 35.7 Admissions; designation of person to be notified.
352. § 35.8 Safekeeping of money and effects; withdrawals.
353. § 35.9 Disposition of money and effects left by other than deceased patients.
354. § 35.10 Destruction of effects dangerous to health.
355. § 35.11 Clinical records; confidential.
356. § 35.12 Solicitation of legal business prohibited.
357. § 35.13 Entry for negotiation of release or settlement.
358. § 35.14 Solicitation of legal business; negotiation of release or settlement; assistance prohibited.
359. § 35.15 Consent to operative procedures.
360. § 35.16 Autopsies and other post-mortem operations.
361. § 35.17 Fees and charges for copying, certification, search of records and related services.
362. Subpart B Transfer of Patients
363. § 35.21 Authorization of transfer.
364. § 35.22 Attendants.
365. Subpart C Disposition of Articles Produced by Patients
366. § 35.31 Retention by patients.
367. § 35.32 Board of appraisers.
368. § 35.33 Sale; prices; deposit of proceeds.
369. § 35.34 Resale.
370. § 35.35 Unsalable articles.
371. Subpart D Disposal of Money and Effects of Deceased Patients
372. § 35.41 Inventory.
373. § 35.42 Notice upon death.
374. § 35.43 Delivery only upon filing claim; forms; procedure.
375. § 35.44 Delivery to legal representative; to other claimants if value is $1,000 or less.
376. § 35.45 Disposition of effects; exceptions.
377. § 35.46 Conflicting claims.
378. § 35.47 Disposition of Government checks.
379. § 35.48 Deposit of unclaimed money; sale of unclaimed effects and deposit of proceeds.
380. § 35.49 Sale of unclaimed effects; procedures.
381. § 35.50 Disposition of unsold effects.
382. § 35.51 Manner of delivery; costs, receipts.
383. § 35.52 Delivery of possession only; title unaffected.
384. Subpart E Contributions for the Benefit of Patients
385. § 35.61 Applicability.
386. § 35.62 Acceptance of contributions.
387. § 35.63 Report of and accounting for contributions.
388. § 35.64 Donors.
389. § 35.65 Acceptable personal property.
390. § 35.66 Expenditure of cash contributions.
391. PART 37 SPECIFICATIONS FOR MEDICAL EXAMINATIONS OF COAL MINERS
392. Subpart Chest Radiographic Examinations
393. § 37.1 Scope.
394. § 37.2 Definitions.
395. § 37.3 Chest radiographs required for miners.
396. § 37.4 Chest radiographic examinations conducted by the Secretary.
397. § 37.10 Standards incorporated by reference.
398. § 37.20 Miner identification document.
399. 12 Specifications for Performing Chest Radiographic Examinations
400. § 37.40 General provisions.
401. § 37.41 Chest radiograph specifications—film.
402. § 37.42 Chest radiograph specifications—digital radiography systems.
403. § 37.43 Approval of radiographic facilities that use film radiography systems.
404. § 37.44 Approval of radiographic facilities that use digital radiography systems.
405. § 37.45 Protection against radiation emitted by radiographic equipment.
406. 13 Specifications for Interpretation, Classification, and Submission of Chest Radiographs
407. § 37.50 Interpreting and classifying chest radiographs—film radiography systems.
408. § 37.51 Interpreting and classifying chest radiographs—digital radiography systems.
409. § 37.52 Proficiency in the use of systems for classifying the pneumoconioses.
410. § 37.53 Method of obtaining definitive chest radiograph classifications.
411. § 37.54 Notification of abnormal radiographic findings.
412. § 37.60 Submitting required chest radiograph classification and miner identification documents.
413. 14 Review and Availability of Records
414. § 37.70 Review of classifications.
415. § 37.80 Availability of records for radiographs.
416. Subpart Spirometry Testing
417. § 37.90 Scope.
418. § 37.91 Definitions.
419. § 37.92 Spirometry testing required for miners.
420. § 37.93 Approval of spirometry facilities.
421. § 37.94 Respiratory assessment form.
422. § 37.95 Specifications for performing spirometry tests.
423. § 37.96 Spirometry interpretations, reports, and submission.
424. § 37.97 Notification of spirometry results.
425. § 37.98 Standards incorporated by reference.
426. Subpart General Requirements
427. § 37.100 Coal mine operator plan for medical examinations.
428. § 37.101 Approval of plans.
429. § 37.102 Transfer of affected miner to less dusty area.
430. § 37.103 Medical examination at miner's expense.
431. Subpart Autopsies
432. § 37.200 Scope.
433. § 37.201 Definitions.
434. § 37.202 Payment for autopsy.
435. § 37.203 Autopsy specifications.
436. § 37.204 Procedure for obtaining payment.
437. PART 38 DISASTER ASSISTANCE FOR CRISIS COUNSELING AND TRAINING
438. § 38.1 Purpose; coordination.
439. § 38.2 Definitions.
440. § 38.3 Assistance; procedures, limitations.
441. § 38.4 Contracts.
442. § 38.5 Grant assistance.
443. § 38.6 Nondiscrimination.
444. § 38.7 Nonliability.
445. § 38.8 Criminal and civil penalties.
446. § 38.9 Federal audits.
447. SUBCHAPTER D GRANTS
448. PART 50 POLICIES OF GENERAL APPLICABILITY
449. A Subpart A [Reserved]
450. Subpart B Sterilization of Persons in Federally Assisted Family Planning Projects
451. § 50.201 Applicability.
452. § 50.202 Definitions.
453. § 50.203 Sterilization of a mentally competent individual aged 21 or older.
454. § 50.204 Informed consent requirement.
455. § 50.205 Consent form requirements.
456. § 50.206 Sterilization of a mentally incompetent individual or of an institutionalized individual.
457. § 50.207 Sterilization by hysterectomy.
458. § 50.208 Program or project requirements.
459. § 50.209 Use of Federal financial assistance.
460. § 50.210 Review of regulation.
461. Appendix to Subpart B of Part 50 Required Consent Form
462. Subpart C Abortions and Related Medical Services in Federally Assisted Programs of the Public Health Service
463. § 50.301 Applicability.
464. § 50.302 Definitions.
465. § 50.303 General rule.
466. § 50.304 Life of the mother would be endangered.
467. § 50.305 [Reserved]
468. § 50.306 Rape and incest.
469. § 50.307 Documentation needed by programs or projects.
470. § 50.308 Drugs and devices and termination of ectopic pregnancies.
471. § 50.309 Recordkeeping requirements.
472. § 50.310 Confidentiality.
473. Subpart D Public Health Service Grant Appeals Procedure
474. § 50.401 What is the purpose of this subpart?
475. § 50.402 To what program do these regulations apply?
476. § 50.403 What is the policy basis for these procedures?
477. § 50.404 What disputes are covered by these procedures?
478. § 50.405 What is the structure of review committees?
479. § 50.406 What are the steps in the process?
480. Subpart E Maximum Allowable Cost for Drugs
481. § 50.501 Applicability.
482. § 50.502 Definitions.
483. § 50.503 Policy.
484. § 50.504 Allowable cost of drugs.
485. Subpart F Promoting Objectivity in Research
486. § 50.601 Purpose.
487. § 50.602 Applicability.
488. § 50.603 Definitions.
489. § 50.604 Responsibilities of Institutions regarding Investigator financial conflicts of interest.
490. § 50.605 Management and reporting of financial conflicts of interest.
491. § 50.606 Remedies.
492. § 50.607 Other HHS regulations that apply.
493. PART 51 REQUIREMENTS APPLICABLE TO THE PROTECTION AND ADVOCACY FOR INDIVIDUALS WITH MENTAL ILLNESS PROGRAM
494. § 51.1 Scope.
495. § 51.2 Definitions.
496. Subpart A Basic Requirements
497. § 51.3 Formula for determining allotments.
498. § 51.4 Grants administration requirements.
499. § 51.5 Eligibility for allotment.
500. § 51.6 Use of allotments.
501. § 51.7 Eligibility for protection and advocacy services.
502. § 51.8 Annual reports.
503. § 51.9 [Reserved]
504. § 51.10 Remedial actions.
505. §§ 51.11-51.20 [Reserved]
506. Subpart B Program Administration and Priorities
507. § 51.21 Contracts for program operations.
508. § 51.22 Governing authority.
509. § 51.23 Advisory council.
510. § 51.24 Program priorities.
511. § 51.25 Grievance procedure.
512. § 51.26 Conflicts of interest.
513. § 51.27 Training.
514. §§ 51.28-51.30 [Reserved]
515. Subpart C Protection and Advocacy Services
516. § 51.31 Conduct of protection and advocacy activities.
517. § 51.32 Resolving disputes.
518. §§ 51.33-51.40 [Reserved]
519. Subpart D Access to Records, Facilities and Individuals
520. § 51.41 Access to records.
521. § 51.42 Access to facilities and residents.
522. § 51.43 Denial or delay of access.
523. § 51.44 [Reserved]
524. § 51.45 Confidentiality of protection and advocacy system records.
525. § 51.46 Disclosing information obtained from a provider of mental health services.
526. PART 51a PROJECT GRANTS FOR MATERNAL AND CHILD HEALTH
527. § 51a.1 To which programs does this regulation apply?
528. § 51a.2 Definitions.
529. § 51a.3 Who is eligible to apply for Federal funding?
530. § 51a.4 How is application made for Federal funding?
531. § 51a.5 What criteria will DHHS use to decide which projects to fund?
532. § 51a.6 What confidentiality requirements must be met?
533. § 51a.7 What other DHHS regulations apply?
534. § 51a.8 What other conditions apply to these grants?
535. PART 51b PROJECT GRANTS FOR PREVENTIVE HEALTH SERVICES
536. Subpart A General Provisions
537. § 51b.101 To which programs do these regulations apply?
538. § 51b.102 Definitions.
539. § 51b.103 What are the general application requirements?
540. § 51b.104 Can personnel, supplies, and related items be provided in lieu of cash?
541. § 51b.105 Which other HHS regulations apply to these grants?
542. § 51b.106 What other conditions apply to these grants?
543. § 51b.107 Is participation in preventive health service programs required by these regulations?
544. Subpart B Grants for Childhood Immunization Programs
545. § 51b.201 To which programs does this subpart apply?
546. § 51b.202 Definitions.
547. § 51b.203 Who is eligible for a grant under this subpart?
548. § 51b.204 What information is required in the application?
549. § 51b.205 How will grant applications be evaluated and the grants awarded?
550. § 51b.206 How can grant funds be used?
551. C Subpart C [Reserved]
552. Subpart D Grants for Venereal Disease Control Programs
553. § 51b.401 To which programs does this subpart apply?
554. § 51b.402 Definitions.
555. § 51b.403 Who is eligible for a grant under this subpart?
556. § 51b.404 What are the confidentiality requirements?
557. § 51b.405 What information is required in the application?
558. § 51b.406 How will grant applications be evaluated and the grants awarded?
559. § 51b.407 How can grant funds be used?
560. E Subpart E [Reserved]
561. Subpart F Grants for Research, Demonstrations, and Public Information and Education for the Prevention and Control of Venereal Disease
562. § 51b.601 To which programs does this subpart apply?
563. § 51b.602 Who is eligible for a grant under this subpart?
564. § 51b.603 What are the confidentiality requirements?
565. § 51b.604 What information is required in the application?
566. § 51b.605 How will grant applications be evaluated and the grants awarded?
567. § 51b.606 How can grant funds be used?
568. PART 51c GRANTS FOR COMMUNITY HEALTH SERVICES
569. Subpart A General Provisions
570. § 51c.101 Applicability.
571. § 51c.102 Definitions.
572. § 51c.103 Eligibility.
573. § 51c.104 Application.
574. § 51c.105 Accord with health planning.
575. § 51c.106 Amount of grant.
576. § 51c.107 Use of project funds.
577. § 51c.108 Grant payments.
578. § 51c.109 Nondiscrimination.
579. § 51c.110 Confidentiality.
580. § 51c.111 Publications and copyright.
581. § 51c.112 Grantee accountability.
582. § 51c.113 Applicability of 2 CFR parts 200 and 300.
583. Subpart B Grants for Planning and Developing Community Health Centers
584. § 51c.201 Applicability.
585. § 51c.202 Application.
586. § 51c.203 Project elements.
587. § 51c.204 Grant evaluation and award.
588. Subpart C Grants for Operating Community Health Centers
589. § 51c.301 Applicability.
590. § 51c.302 Application.
591. § 51c.303 Project elements.
592. § 51c.304 Governing board.
593. § 51c.305 Grant evaluation and award.
594. Subpart D Grants for Operating Community Health Projects
595. § 51c.401 Applicability.
596. § 51c.402 Application.
597. § 51c.403 Project elements.
598. § 51c.404 Grant evaluation and award.
599. Subpart E Acquisition and Modernization of Existing Buildings
600. § 51c.501 Applicability.
601. § 51c.502 Definitions.
602. § 51c.503 Application.
603. § 51c.504 Project elements.
604. § 51c.505 Determination of cost.
605. § 51c.506 Use of grant funds.
606. § 51c.507 Facility which has previously received Federal grant.
607. PART 51d MENTAL HEALTH AND SUBSTANCE ABUSE EMERGENCY RESPONSE PROCEDURES
608. § 51d.1 To what does this subpart apply?
609. § 51d.2 Definitions.
610. § 51d.3 Who is eligible for an award under this subpart?
611. § 51d.4 What information is required in the application?
612. § 51d.5 How is an emergency determined to exist?
613. § 51d.6 How will applications be evaluated and awarded?
614. § 51d.7 What are the limitations on how award funds may be used?
615. § 51d.8 Which other HHS regulations apply to these awards?
616. § 51d.9 What other conditions apply to these awards?
617. § 51d.10 What are the reporting requirements?
618. 51e-51g PARTS 51e-51g [RESERVED]
619. PART 52 GRANTS FOR RESEARCH PROJECTS
620. § 52.1 To which programs do these regulations apply?
621. § 52.2 Definitions.
622. § 52.3 Who is eligible to apply for a grant?
623. § 52.4 How to apply for a grant.
624. § 52.5 Evaluation and disposition of applications.
625. § 52.6 Grant awards.
626. § 52.7 Use of funds; changes.
627. § 52.8 Other HHS regulations and policies that apply.
628. § 52.9 Additional conditions.
629. PART 52a NATIONAL INSTITUTES OF HEALTH CENTER GRANTS
630. § 52a.1 To which programs do these regulations apply?
631. § 52a.2 Definitions.
632. § 52a.3 Who is eligible to apply?
633. § 52a.4 What information must each application contain?
634. § 52a.5 How will NIH evaluate applications?
635. § 52a.6 Information about grant awards.
636. § 52a.7 For what purposes may a grantee spend grant funds?
637. § 52a.8 Other HHS regulations and policies that apply.
638. § 52a.9 Additional conditions.
639. PART 52b NATIONAL INSTITUTES OF HEALTH CONSTRUCTION GRANTS
640. § 52b.1 To what programs do these regulations apply?
641. § 52b.2 Definitions.
642. § 52b.3 Who is eligible to apply?
643. § 52b.4 How to apply.
644. § 52b.5 How will NIH evaluate applications?
645. § 52b.6 What is the rate of federal financial participation?
646. § 52b.7 How is the grantee obligated to use the facility?
647. § 52b.8 How will NIH monitor the use of facilities constructed with federal funds?
648. § 52b.9 What is the right of the United States to recover Federal funds when facilities are not used for research or are transferred?
649. § 52b.10 What are the terms and conditions of awards?
650. § 52b.11 What are the requirements for acquisition and modernization of existing facilities?
651. § 52b.12 What are the minimum requirements of construction and equipment?
652. § 52b.13 Additional conditions.
653. § 52b.14 Other Federal laws, regulations, Executive orders, and policies that apply.
654. PART 52d NATIONAL CANCER INSTITUTE CLINICAL CANCER EDUCATION PROGRAM
655. § 52d.1 Applicability.
656. § 52d.2 Definitions.
657. § 52d.3 Eligibility.
658. § 52d.4 Application.
659. § 52d.5 Program requirements.
660. § 52d.6 Grant awards.
661. § 52d.7 Expenditure of grant funds.
662. § 52d.8 Other HHS regulations that apply.
663. § 52d.9 Additional conditions.
664. PART 52e NATIONAL HEART, LUNG, AND BLOOD INSTITUTE GRANTS FOR PREVENTION AND CONTROL PROJECTS
665. § 52e.1 To what programs do these regulations apply?
666. § 52e.2 Definitions.
667. § 52e.3 Who is eligible to apply?
668. § 52e.4 How to apply.
669. § 52e.5 What are the project requirements?
670. § 52e.6 How will NIH evaluate applications?
671. § 52e.7 What are the terms and conditions of awards?
672. § 52e.8 Other HHS regulations and policies that apply.
673. § 52e.9 Additional conditions.
674. PART 52h SCIENTIFIC PEER REVIEW OF RESEARCH GRANT APPLICATIONS AND RESEARCH AND DEVELOPMENT CONTRACT PROJECTS
675. § 52h.1 Applicability.
676. § 52h.2 Definitions.
677. § 52h.3 Establishment and operation of peer review groups.
678. § 52h.4 Composition of peer review groups.
679. § 52h.5 Conflict of interest.
680. § 52h.6 Availability of information.
681. § 52h.7 What matters must be reviewed for grants?
682. § 52h.8 What are the review criteria for grants?
683. § 52h.9 What matters must be reviewed for unsolicited contract proposals?
684. § 52h.10 What matters must be reviewed for solicited contract proposals?
685. § 52h.11 What are the review criteria for contract projects and proposals?
686. § 52h.12 Other regulations that apply.
687. PART 52i JOHN LEWIS NIMHD RESEARCH ENDOWMENT PROGRAM
688. § 52i.1 To what program does this part apply?
689. § 52i.2 Definitions.
690. § 52i.3 Who is eligible to apply?
691. § 52i.4 Under what conditions may an eligible institution designate a foundation as the recipient of a research endowment grant?
692. § 52i.5 How to apply for a grant.
693. § 52i.6 Evaluation and award of research endowment grant applications.
694. § 52i.7 Grant awards.
695. § 52i.8 When and for what purposes may a grantee spend the endowment fund corpus?
696. § 52i.9 How much endowment fund income may a grantee spend and for what purposes?
697. § 52i.10 How shall a grantee calculate the amount of endowment fund income that it may withdraw and spend?
698. § 52i.11 What shall a grantee record and report?
699. § 52i.12 What happens if a grantee fails to administer the research endowment grant in accordance with applicable regulations?
700. § 52i.13 Other HHS policies and regulations that apply.
701. § 52i.14 Additional conditions.
702. PART 53 GRANTS, LOANS AND LOAN GUARANTEES FOR CONSTRUCTION AND MODERNIZATION OF HOSPITALS AND MEDICAL FACILITIES
703. A Subparts A-K [Reserved]
704. Subpart L Services for Persons Unable To Pay; Community Service; Nondiscrimination
705. § 53.111 Services for persons unable to pay.
706. § 53.112 Nondiscrimination.
707. § 53.113 Community service.
708. M Subpart M [Reserved]
709. Subpart N Loan Guarantees and Direct Loans
710. § 53.154 Waiver of right of recovery.
711. § 53.155 Modification of loans.
712. § 53.156 Fees for modification requests.
713. PART 54 CHARITABLE CHOICE REGULATIONS APPLICABLE TO STATES RECEIVING SUBSTANCE ABUSE PREVENTION AND TREATMENT BLOCK GRANTS AND/OR PROJECTS FOR ASSISTANCE IN TRANSITION FROM HOMELESSNESS GRANTS
714. § 54.1 Scope.
715. § 54.2 Definitions.
716. § 54.3 Nondiscrimination against religious organizations.
717. § 54.4 Religious activities.
718. § 54.5 Religious character and independence.
719. § 54.6 Employment practices.
720. § 54.7 Nondiscrimination requirement.
721. § 54.8 Right to services from an alternative provider.
722. § 54.9 Assurances and State oversight of the Charitable Choice requirements.
723. § 54.10 Fiscal accountability.
724. § 54.11 Effects on State and local funds.
725. § 54.12 Treatment of intermediate organizations.
726. § 54.13 Educational requirements for personnel in drug treatment programs.
727. PART 54a CHARITABLE CHOICE REGULATIONS APPLICABLE TO STATES, LOCAL GOVERNMENTS AND RELIGIOUS ORGANIZATIONS RECEIVING DISCRETIONARY FUNDING UNDER TITLE V OF THE PUBLIC HEALTH SERVICE ACT, 42 U.S.C. 290aa, et seq., FOR SUBSTANCE ABUSE PREVENTION AND TREATMENT SERVICES
728. § 54a.1 Scope.
729. § 54a.2 Definitions.
730. § 54a.3 Nondiscrimination against religious organizations.
731. § 54a.4 Religious activities.
732. § 54a.5 Religious character and independence.
733. § 54a.6 Employment practices.
734. § 54a.7 Nondiscrimination requirement.
735. § 54a.8 Right to services from an alternative provider.
736. § 54a.9 Oversight of the Charitable Choice requirements.
737. § 54a.10 Fiscal accountability.
738. § 54a.11 Effect on State and local funds.
739. § 54a.12 Treatment of intermediate organizations.
740. § 54a.13 Educational requirements for personnel in drug treatment programs.
741. § 54a.14 Determination of nonprofit status.
742. Appendix to Part 54a Model Notice of Individuals Receiving Substance Abuse Services
743. PART 55a PROGRAM GRANTS FOR BLACK LUNG CLINICS
744. Subpart A General Provisions
745. § 55a.101 Definitions.
746. § 55a.102 Who is eligible to apply for a Black Lung clinics grant?
747. § 55a.103 What criteria has HHS established for deciding which grant application to fund?
748. § 55a.104 What confidentiality requirements must be met?
749. § 55a.105 How must grantees carry out their projects?
750. § 55a.106 Provision for waiver by the Secretary.
751. § 55a.107 What other regulations apply?
752. Subpart B Grants to States
753. § 55a.201 What is required for a State application?
754. Subpart C Grants to Entities Other Than States
755. § 55a.301 What is required for an application from an entity other than a State?
756. PART 56 GRANTS FOR MIGRANT HEALTH SERVICES
757. Subpart A General Provisions
758. § 56.101 Applicability.
759. § 56.102 Definitions.
760. § 56.103 Eligibility.
761. § 56.104 Application.
762. § 56.105 Accord with health planning.
763. § 56.106 Amount of grant.
764. § 56.107 Priorities for grants.
765. § 56.108 Use of grant funds.
766. § 56.109 Grant payments.
767. § 56.110 Nondiscrimination.
768. § 56.111 Confidentiality.
769. § 56.112 Publications and copyright.
770. § 56.113 Grantee accountability.
771. § 56.114 Applicability of 2 CFR parts 200 and 300.
772. Subpart B Grants for Planning and Developing Migrant Health Centers
773. § 56.201 Applicability.
774. § 56.202 Application.
775. § 56.203 Project elements.
776. § 56.204 Grant evaluation and award.
777. Subpart C Grants for Operating Migrant Health Centers
778. § 56.301 Applicability.
779. § 56.302 Application.
780. § 56.303 Project elements.
781. § 56.304 Governing board.
782. § 56.305 Grant evaluation and award.
783. Subpart D Grants for Operating Migrant Health Entities
784. § 56.401 Applicability.
785. § 56.402 Application.
786. § 56.403 Project elements.
787. § 56.404 Grant evaluation and award.
788. Subpart E Grants for Planning and Developing Migrant Health Programs
789. § 56.501 Applicability.
790. § 56.502 Application.
791. § 56.503 Project elements.
792. § 56.504 Grant evaluation and award.
793. Subpart F Grants for Operating Migrant Health Programs
794. § 56.601 Applicability.
795. § 56.602 Application.
796. § 56.603 Project elements.
797. § 56.604 Grant evaluation and award.
798. Subpart G Grants for Technical Assistance
799. § 56.701 Applicability.
800. § 56.702 Application.
801. § 56.703 Project elements.
802. § 56.704 Grant evaluation and award.
803. Subpart H Acquisition and Modernization of Existing Buildings
804. § 56.801 Applicability of 42 CFR part 51c, subpart E.
805. PART 57 GRANTS FOR CONSTRUCTION OF TEACHING FACILITIES, EDUCATIONAL IMPROVEMENTS, SCHOLARSHIPS AND STUDENT LOANS
806. A Subparts A-B [Reserved]
807. Subpart C Health Professions Student Loans
808. § 57.201 Applicability.
809. § 57.202 Definitions.
810. § 57.203 Application by school.
811. § 57.204 Payment of Federal capital contributions and reallocation of funds remitted to the Secretary.
812. § 57.205 Health professions student loan funds.
813. § 57.206 Eligibility and selection of health professions student loan applicants.
814. § 57.207 Maximum amount of health professions student loans.
815. § 57.208 Health professions student loan promissory note and disclosure requirements.
816. § 57.209 Payment of health professions student loans.
817. § 57.210 Repayment and collection of health professions student loans.
818. § 57.211 Cancellation of health professions students loans for disability or death.
819. § 57.212 [Reserved]
820. § 57.213 Continuation of provisions for cancellation of loans made prior to November 18, 1971.
821. § 57.213a Loan cancellation reimbursement.
822. § 57.214 Repayment of loans made after November 17, 1971, for failure to complete a program of study.
823. § 57.215 Records, reports, inspection, and audit.
824. § 57.216 What additional Department regulations apply to schools?
825. § 57.216a Performance standard.
826. § 57.217 Additional conditions.
827. § 57.218 Noncompliance.
828. Subpart D Nursing Student Loans
829. § 57.301 Applicability.
830. § 57.302 Definitions.
831. § 57.303 Application by school.
832. § 57.304 Payment of Federal capital contributions and reallocation of funds remitted to the Secretary.
833. § 57.305 Nursing student loan funds.
834. § 57.306 Eligibility and selection of nursing student loan applicants.
835. § 57.307 Maximum amount of nursing student loans.
836. § 57.308 Nursing student loan promissory note.
837. § 57.309 Payment of nursing student loans.
838. § 57.310 Repayment and collection of nursing student loans.
839. § 57.311 Cancellation of nursing student loans for disability or death.
840. § 57.312 Repayment of loans for service in a shortage area.
841. § 57.313 Loan cancellation for full-time employment as a registered nurse.
842. § 57.313a Loan cancellation reimbursement.
843. § 57.314 Repayment of loans made after November 17, 1971, for failure to complete a program of study. 2
844. § 57.315 Records, reports, inspection, and audit.
845. § 57.316 What additional Department regulations apply to schools?
846. § 57.316a Performance standard.
847. § 57.317 Additional conditions.
848. § 57.318 Noncompliance.
849. Subpart E Grants for Construction of Nurse Training Facilities
850. § 57.409 Good cause for other use of completed facility.
851. F Subparts F-O [Reserved]
852. Subpart P Loan Guarantees and Interest Subsidies to Assist in Construction of Teaching Facilities for Health Profession Personnel
853. § 57.1501 Applicability.
854. § 57.1502 Definitions.
855. § 57.1503 Eligibility.
856. § 57.1504 Application.
857. § 57.1505 Approval of applications.
858. § 57.1506 Priority.
859. § 57.1507 Limitations applicable to loan guarantee.
860. § 57.1508 Amount of interest subsidy payments; limitations.
861. § 57.1509 Forms of credit and security instruments.
862. § 57.1510 Security for loans.
863. § 57.1511 Opinion of legal counsel.
864. § 57.1512 Length and maturity of loans.
865. § 57.1513 Repayment.
866. § 57.1514 Loan guarantee and interest subsidy agreements.
867. § 57.1515 Loan closing.
868. § 57.1516 Right of recovery-subordination.
869. § 57.1517 Waiver of right of recovery.
870. § 57.1518 Modification of loans.
871. Q Subparts Q-T [Reserved]
872. Subpart U Armed Forces Health Professions Scholarship Program
873. § 57.2001 Applicability.
874. § 57.2002 Definitions.
875. § 57.2003 Determinations of increased enrollment solely for the program.
876. V Subpart V [Reserved]
877. Subpart W Physician Shortage Area Scholarship Grants
878. § 57.2201 Applicability.
879. § 57.2202 Definitions.
880. § 57.2203 Eligibility.
881. § 57.2204 Application.
882. § 57.2205 Priority for selection of scholarship recipients.
883. § 57.2206 Grant award.
884. § 57.2207 Amount of scholarship grant.
885. § 57.2208 Payment of scholarship grant.
886. § 57.2209 Conditions of scholarship grant.
887. § 57.2210 Failure to comply.
888. § 57.2211 Waiver or suspension.
889. AA Subparts AA-FF [Reserved]
890. Subpart GG Payment for Tuition and Other Educational Costs
891. § 57.3201 To which programs do these regulations apply?
892. § 57.3202 How will allowable increases be determined?
893. HH Subparts HH-PP [Reserved]
894. PART 58 GRANTS FOR TRAINING OF PUBLIC HEALTH AND ALLIED HEALTH PERSONNEL
895. A Subparts A-F [Reserved]
896. PART 59 GRANTS FOR FAMILY PLANNING SERVICES
897. Subpart A Project Grants for Family Planning Services
898. § 59.1 To what programs do these regulations apply?
899. § 59.2 Definitions.
900. § 59.3 Who is eligible to apply for a family planning services grant?
901. § 59.4 How does one apply for a family planning services grant?
902. § 59.5 What requirements must be met by a family planning project?
903. § 59.6 What procedures apply to assure the suitability of informational and educational material (print and electronic)?
904. § 59.7 What criteria will the Department of Health and Human Services use to decide which family planning services projects to fund and in what amount?
905. § 59.8 How is a grant awarded?
906. § 59.9 For what purpose may grant funds be used?
907. § 59.10 Confidentiality.
908. § 59.11 Additional conditions.
909. B Subpart B [Reserved]
910. Subpart C Grants for Family Planning Service Training
911. § 59.201 Applicability.
912. § 59.202 Definitions.
913. § 59.203 Eligibility.
914. § 59.204 Application for a grant.
915. § 59.205 Project requirements.
916. § 59.206 Evaluation and grant award.
917. § 59.207 Payments.
918. § 59.208 Use of project funds.
919. § 59.209 Civil rights.
920. § 59.210 Inventions or discoveries.
921. § 59.211 Publications and copyright.
922. § 59.212 Grantee accountability.
923. § 59.213 [Reserved]
924. § 59.214 Additional conditions.
925. § 59.215 Applicability of 2 CFR parts 200 and 300.
926. PART 59a NATIONAL LIBRARY OF MEDICINE GRANTS
927. Subpart A Grants for Establishing, Expanding, and Improving Basic Resources
928. § 59a.1 Programs to which these regulations apply.
929. § 59a.2 Definitions.
930. § 59a.3 Who is eligible for a grant?
931. § 59a.4 How are grant applications evaluated?
932. § 59a.5 Awards.
933. § 59a.6 How may funds or materials be used?
934. § 59a.7 Other HHS regulations that apply.
935. Subpart B Establishment of Regional Medical Libraries
936. § 59a.11 Programs to which these regulations apply.
937. § 59a.12 Definitions.
938. § 59a.13 Who is eligible for a grant?
939. § 59a.14 How to apply.
940. § 59a.15 Awards.
941. § 59a.16 What other conditions apply?
942. § 59a.17 Other HHS regulations that apply.
943. SUBCHAPTER E FELLOWSHIPS, INTERNSHIPS, TRAINING
944. PART 61 FELLOWSHIPS
945. Subpart A Regular Fellowships
946. § 61.1 Definitions.
947. § 61.2 Applicability.
948. § 61.3 Purpose of regular fellowships.
949. § 61.4 Establishment and conditions.
950. § 61.5 Qualifications.
951. § 61.6 Method of application.
952. § 61.7 Review of applications; committees; awards.
953. § 61.8 Benefits: Stipends; dependency allowances; travel allowances; vacation.
954. § 61.9 Payments: Stipends; dependency allowances; travel allowances.
955. § 61.10 Benefits: Tuition and other expenses.
956. § 61.11 Payments: Tuition and other expenses.
957. § 61.12 Accountability.
958. § 61.13 Duration and continuation.
959. § 61.14 Separate consideration of information concerning moral character or loyalty.
960. § 61.15 Moral character or loyalty; reference to Special Review Committee; review and recommendation.
961. § 61.16 Termination of or refusal to continue award on grounds relating to moral character or loyalty; hearing.
962. § 61.17 Termination on grounds other than those relating to moral character or loyalty.
963. § 61.18 Publications.
964. § 61.19 Copyright and reproduction.
965. § 61.20 Inventions or discoveries.
966. § 61.21 Interest.
967. § 61.22 Nondiscrimination.
968. Subpart B Service Fellowships
969. § 61.30 Definitions.
970. § 61.31 Applicability.
971. § 61.32 Purpose of service fellowships.
972. § 61.33 Establishment of service fellowships.
973. § 61.34 Qualifications.
974. § 61.35 Method of application.
975. § 61.36 Selection and appointment of service fellows.
976. § 61.37 Stipends, allowances, and benefits.
977. § 61.38 Duration of service fellowships.
978. PART 62 NATIONAL HEALTH SERVICE CORPS SCHOLARSHIP AND LOAN REPAYMENT PROGRAMS
979. Subpart A National Health Service Corps Scholarship Program
980. § 62.1 What is the scope and purpose of the National Health Service Corps scholarship program?
981. § 62.2 Definitions.
982. § 62.3 Who is eligible to apply for a scholarship program award?
983. § 62.4 To whom will scholarship program awards be available in addition to those individuals pursuing courses of study leading to degrees in medicine, osteopathy, or dentistry?
984. § 62.5 How is application made for a scholarship program award?
985. § 62.6 How will individuals be selected to participate in the scholarship program?
986. § 62.7 What will an individual be awarded for participating in the scholarship program?
987. § 62.8 What does an individual have to do in return for the scholarship program award?
988. § 62.9 Under what circumstances can the period of obligated service be deferred to complete approved graduate training?
989. § 62.10 What will happen if an individual does not comply with the terms and conditions of participating in the scholarship program?
990. § 62.11 When can a scholarship program payment obligation be discharged in bankruptcy?
991. § 62.12 Under what circumstances can the service or payment obligation be canceled, waived or suspended?
992. § 62.13 What are the limitations on the receipt of concurrent benefits?
993. § 62.14 What are the special provisions relating to recipients of awards under the PH/NHSC scholarship training program who will also receive awards under the scholarship program?
994. Subpart B National Health Service Corps Loan Repayment Program
995. § 62.21 What is the scope and purpose of the National Health Service Corps Loan Repayment Program?
996. § 62.22 Definitions.
997. § 62.23 How will individuals be selected to participate in the Loan Repayment Program?
998. § 62.24 Who is eligible to apply for the Loan Repayment Program?
999. § 62.25 What does the Loan Repayment Program provide?
1000. § 62.26 What does an individual have to do in return for loan repayments received under the Loan Repayment Program?
1001. § 62.27 What will happen if an individual does not comply with the terms and conditions of participation in the Loan Repayment Program?
1002. § 62.28 Under what circumstances can the service or payment obligation be canceled, waived or suspended?
1003. § 62.29 Under what circumstances can the Loan Repayment Program obligation be discharged in bankruptcy?
1004. § 62.30 What other regulations and statutes apply?
1005. Subpart C Grants for State Loan Repayment Programs
1006. § 62.51 What is the scope and purpose of the State Loan Repayment Program?
1007. § 62.52 Definitions.
1008. § 62.53 Who is eligible for this program?
1009. § 62.54 What must applications for the State Loan Repayment Program contain?
1010. § 62.55 What State Program Elements are required to ensure similarity with the NHSC Loan Repayment Program?
1011. § 62.56 How are the Federal grant funds and State matching funds to be used under this program?
1012. § 62.57 How will States be selected to participate in this program?
1013. § 62.58 What other regulations apply?
1014. Subpart D Special Repayment Program
1015. § 62.71 What is the scope and purpose of the Special Repayment Program?
1016. § 62.72 Definitions.
1017. § 62.73 What are the procedures for participation in the Special Repayment Program?
1018. § 62.74 How much credit will a Program participant receive for monetary repayments made, or for approved service performed, before beginning service under the Special Repayment Program?
1019. § 62.75 Will individuals serving under the Special Repayment Program receive credit for partial service?
1020. § 62.76 How will amounts of money due under the option under section 204(c)(1) of Public Law 100-177 be required to be repaid?
1021. PART 63 TRAINEESHIPS
1022. § 63.1 To what programs do these regulations apply?
1023. § 63.2 Definitions.
1024. § 63.3 What is the purpose of traineeships?
1025. § 63.4 What are the minimum qualifications for awards?
1026. § 63.5 How will NIH make awards?
1027. § 63.6 How to apply.
1028. § 63.7 What are the benefits of awards?
1029. § 63.8 What are the terms and conditions of awards?
1030. § 63.9 How may NIH terminate awards?
1031. § 63.10 Other HHS regulations and policies that apply.
1032. PART 63a NATIONAL INSTITUTES OF HEALTH TRAINING GRANTS
1033. § 63a.1 To what programs do these regulations apply?
1034. § 63a.2 Definitions.
1035. § 63a.3 What is the purpose of training grants?
1036. § 63a.4 Who is eligible for a training grant?
1037. § 63a.5 How to apply for a training grant.
1038. § 63a.6 How are training grant applications evaluated?
1039. § 63a.7 Awards.
1040. § 63a.8 How long does grant support last?
1041. § 63a.9 What are the terms and conditions of awards?
1042. § 63a.10 How may training grant funds be spent?
1043. § 63a.11 Other HHS regulations and policies that apply.
1044. PART 64 NATIONAL LIBRARY OF MEDICINE TRAINING GRANTS
1045. § 64.1 Programs to which these regulations apply.
1046. § 64.2 Definitions.
1047. § 64.3 Who is eligible for a grant?
1048. § 64.4 How to apply for a grant.
1049. § 64.5 How are grant applications evaluated?
1050. § 64.6 Awards.
1051. § 64.7 What other conditions apply?
1052. § 64.8 How may funds be used?
1053. § 64.9 Other HHS regulations that apply.
1054. PART 64a OBLIGATED SERVICE FOR MENTAL HEALTH TRAINEESHIPS
1055. § 64a.101 Purpose.
1056. § 64a.102 To whom do these regulations apply?
1057. § 64a.103 Definitions.
1058. § 64a.104 What requirements are imposed upon grantees?
1059. § 64a.105 What are the conditions of obligated service?
1060. PART 65 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS WASTE WORKER TRAINING
1061. § 65.1 To what projects do these regulations apply?
1062. § 65.2 Definitions.
1063. § 65.3 Who is eligible to apply for a grant?
1064. § 65.4 Project requirements.
1065. § 65.5 How will applications be evaluated?
1066. § 65.6 How long does grant support last?
1067. § 65.7 For what purposes may grant funds be spent?
1068. § 65.8 What additional Department regulations apply to grantees?
1069. § 65.9 Additional conditions.
1070. PART 65a NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES HAZARDOUS SUBSTANCES BASIC RESEARCH AND TRAINING GRANTS
1071. § 65a.1 To what programs do these regulations apply?
1072. § 65a.2 Definitions.
1073. § 65a.3 Who is eligible to apply for a grant?
1074. § 65a.4 What are the program requirements?
1075. § 65a.5 How to apply.
1076. § 65a.6 How will applications be evaluated?
1077. § 65a.7 Awards.
1078. § 65a.8 How long does grant support last?
1079. § 65a.9 What are the terms and conditions of awards?
1080. § 65a.10 For what purposes may grant funds be spent?
1081. § 65a.11 Other HHS regulations and policies that apply.
1082. PART 66 NATIONAL RESEARCH SERVICE AWARDS
1083. Subpart A Direct Awards
1084. § 66.101 Applicability.
1085. § 66.102 Definitions.
1086. § 66.103 Eligibility.
1087. § 66.104 Application.
1088. § 66.105 Requirements.
1089. § 66.106 Awards.
1090. § 66.107 Payments to awardees.
1091. § 66.108 Payments to institutions.
1092. § 66.109 Termination.
1093. § 66.110 Service, payback, and recovery requirements.
1094. § 66.111 Suspension, waiver, and cancellation.
1095. § 66.112 Other HHS regulations and policies that apply.
1096. § 66.113 Publications.
1097. § 66.114 Copyright.
1098. § 66.115 Additional conditions.
1099. Subpart B Institutional Grants
1100. § 66.201 Applicability.
1101. § 66.202 Definitions.
1102. § 66.203 Eligibility.
1103. § 66.204 Application.
1104. § 66.205 Requirements.
1105. § 66.206 Grant awards.
1106. § 66.207 Other HHS regulations and policies that apply.
1107. § 66.208 Additional conditions.
1108. PART 67 AGENCY FOR HEALTH CARE POLICY AND RESEARCH GRANTS AND CONTRACTS
1109. Subpart A Research Grants for Health Services Research, Evaluation, Demonstration, and Dissemination Projects
1110. § 67.10 Purpose and scope.
1111. § 67.11 Definitions.
1112. § 67.12 Eligible applicants.
1113. § 67.13 Eligible projects.
1114. § 67.14 Application.
1115. § 67.15 Peer review of applications.
1116. § 67.16 Evaluation and disposition of application.
1117. § 67.17 Grant award.
1118. § 67.18 Use of project funds.
1119. § 67.19 Other applicable regulations.
1120. § 67.20 Confidentiality.
1121. § 67.21 Control of data and availability of publications.
1122. § 67.22 Additional conditions.
1123. Subpart B Peer Review of Contracts for Health Services Research, Evaluation, Demonstration, and Dissemination Projects
1124. § 67.101 Purpose and scope.
1125. § 67.102 Definitions.
1126. § 67.103 Peer review of contract proposals.
1127. § 67.104 Confidentiality.
1128. § 67.105 Control of data and availability of publications.
1129. PART 68 NATIONAL INSTITUTES OF HEALTH (NIH) LOAN REPAYMENT PROGRAMS (LRPs)
1130. § 68.1 What are the scope and purpose of the NIH LRPs?
1131. § 68.2 Definitions.
1132. § 68.3 Who is eligible to apply?
1133. § 68.4 Who is eligible to participate?
1134. § 68.5 Who is ineligible to participate?
1135. § 68.6 How do individuals apply to participate in the NIH LRPs?
1136. § 68.7 How are applicants selected to participate in the NIH LRPs?
1137. § 68.8 What do the NIH LRPs provide to participants?
1138. § 68.9 What loans qualify for repayment?
1139. § 68.10 What loans are ineligible for repayment?
1140. § 68.11 What does an individual have to do in return for loan repayments received under the NIH LRPs?
1141. § 68.12 How does an individual receive loan repayments beyond the initial applicable contract period?
1142. § 68.13 What will happen if an individual does not comply with the terms and conditions of participation in the NIH LRPs?
1143. § 68.14 Under what circumstances can the service or payment obligation be canceled, waived, or suspended?
1144. § 68.15 When can an NIH LRP payment obligation be discharged in bankruptcy?
1145. § 68.16 Additional conditions.
1146. § 68.17 What other regulations and statutes apply?
1147. PART 68b NATIONAL INSTITUTES OF HEALTH (NIH) UNDERGRADUATE SCHOLARSHIP PROGRAM REGARDING PROFESSIONS NEEDED BY NATIONAL RESEARCH INSTITUTES (UGSP)
1148. § 68b.1 What is the scope and purpose of the National Institutes of Health Undergraduate Scholarship Program Regarding Professions Needed by National Research Institutes?
1149. § 68b.2 Definitions.
1150. § 68b.3 Who is eligible to apply for a Scholarship Program award?
1151. § 68b.4 How is an application made for a Scholarship Program award?
1152. § 68b.5 How will applicants be selected to participate in the Scholarship Program?
1153. § 68b.6 What will an individual be awarded for participating in the Scholarship Program?
1154. § 68b.7 What does an individual have to do in return for the Scholarship Program award?
1155. § 68b.8 Under what circumstances can the period of obligated service be deferred to complete approved graduate training?
1156. § 68b.9 What will happen if an individual does not comply with the terms and conditions of participating in the Scholarship Program?
1157. § 68b.10 When can a Scholarship Program payment obligation be discharged in bankruptcy?
1158. § 68b.11 Under what circumstances can the service or payment obligation be canceled, waived, or suspended?
1159. § 68b.12 What other regulations and statutes apply?
1160. SUBCHAPTER F QUARANTINE, INSPECTION, LICENSING
1161. PART 70 INTERSTATE QUARANTINE
1162. § 70.1 General definitions.
1163. § 70.2 Measures in the event of inadequate local control.
1164. § 70.3 All communicable diseases.
1165. § 70.4 Report of disease.
1166. § 70.5 Requirements relating to travelers under a Federal order of isolation, quarantine, or conditional release.
1167. § 70.6 Apprehension and detention of persons with quarantinable communicable diseases.
1168. § 70.7 Responsibility with respect to minors, wards, and patients.
1169. § 70.8 Members of military and naval forces.
1170. § 70.9 Vaccination clinics.
1171. § 70.10 Public health prevention measures to detect communicable disease.
1172. § 70.11 Report of death or illness onboard aircraft operated by an airline.
1173. § 70.12 Medical examinations.
1174. § 70.13 Payment for care and treatment.
1175. § 70.14 Requirements relating to the issuance of a Federal order for quarantine, isolation, or conditional release.
1176. § 70.15 Mandatory reassessment of a Federal order for quarantine, isolation, or conditional release.
1177. § 70.16 Medical review of a Federal order for quarantine, isolation, or conditional release.
1178. § 70.17 Administrative records relating to Federal quarantine, isolation, or conditional release.
1179. § 70.18 Penalties.
1180. PART 71 FOREIGN QUARANTINE
1181. Subpart A Definitions and General Provisions
1182. § 71.1 Scope and definitions.
1183. § 71.2 Penalties.
1184. § 71.3 Designation of yellow fever vaccination centers; Validation stamps.
1185. § 71.4 Requirements relating to the transmission of airline passenger, crew, and flight information for public health purposes.
1186. § 71.5 Requirements relating to the transmission of vessel passenger, crew, and voyage information for public health purposes.
1187. Subpart B Measures at Foreign Ports
1188. § 71.11 Bills of health.
1189. Subpart C Notice of Communicable Disease Prior to Arrival
1190. § 71.20 Public health prevention measures to detect communicable disease.
1191. § 71.21 Report of death or illness.
1192. Subpart D Health Measures at U.S. Ports: Communicable Diseases
1193. § 71.29 Administrative records relating to quarantine, isolation, or conditional release.
1194. § 71.30 Payment for care and treatment.
1195. § 71.31 General provisions.
1196. § 71.32 Persons, carriers, and things.
1197. § 71.33 Persons: Isolation and surveillance.
1198. § 71.34 Carriers of U.S. military services.
1199. § 71.35 Report of death or illness on carrier during stay in port.
1200. § 71.36 Medical examinations.
1201. § 71.37 Requirements relating to the issuance of a Federal order for quarantine, isolation, or conditional release.
1202. § 71.38 Mandatory reassessment of a Federal order for quarantine, isolation, or conditional release (surveillance).
1203. § 71.39 Medical review of a Federal order for quarantine, isolation, or conditional release.
1204. § 71.40 Suspension of the right to introduce and prohibition of the introduction of persons into the United States from designated foreign countries or places for public health purposes.
1205. Subpart E Requirements Upon Arrival at U.S. Ports: Sanitary Inspection
1206. § 71.41 General provisions.
1207. § 71.42 Disinfection of imports.
1208. § 71.43 Exemption for mails.
1209. § 71.44 Disinsection of aircraft.
1210. § 71.45 Food, potable water, and waste: U.S. seaports and airports.
1211. § 71.46 Issuance of Deratting Certificates and Deratting Exemption Certificates.
1212. § 71.47 Special provisions relating to airports: Office and isolation facilities.
1213. § 71.48 Carriers in intercoastal and interstate traffic.
1214. Subpart F Importations
1215. § 71.50 Scope and definitions.
1216. § 71.51 Dogs and cats.
1217. § 71.52 Turtles, tortoises, and terrapins.
1218. § 71.53 Requirements for importers of nonhuman primates.
1219. § 71.54 Import regulations for infectious biological agents, infectious substances, and vectors.
1220. § 71.55 Importation of human remains.
1221. § 71.56 African rodents and other animals that may carry the monkeypox virus.
1222. § 71.63 Suspension of entry of animals, articles, or things from designated foreign countries and places into the United States.
1223. 72 PART 72 [RESERVED]
1224. PART 73 SELECT AGENTS AND TOXINS
1225. § 73.0 Applicability and related requirements.
1226. § 73.1 Definitions.
1227. § 73.2 Purpose and scope.
1228. § 73.3 HHS select agents and toxins.
1229. § 73.4 Overlap select agents and toxins.
1230. § 73.5 Exemptions for HHS select agents and toxins.
1231. § 73.6 Exemptions for overlap select agents and toxins.
1232. § 73.7 Registration and related security risk assessments.
1233. § 73.8 Denial, revocation, or suspension of registration.
1234. § 73.9 Responsible Official.
1235. § 73.10 Restricting access to select agents and toxins; security risk assessments.
1236. § 73.11 Security.
1237. § 73.12 Biosafety.
1238. § 73.13 Restricted experiments.
1239. § 73.14 Incident response.
1240. § 73.15 Training.
1241. § 73.16 Transfers.
1242. § 73.17 Records.
1243. § 73.18 Inspections.
1244. § 73.19 Notification of theft, loss, or release.
1245. § 73.20 Administrative review.
1246. § 73.21 Civil money penalties.
1247. PART 75 STANDARDS FOR THE ACCREDITATION OF EDUCATIONAL PROGRAMS FOR AND THE CREDENTIALING OF RADIOLOGIC PERSONNEL
1248. § 75.1 Background and purpose.
1249. § 75.2 Definitions.
1250. § 75.3 Applicability.
1251. Appendix A to Part 75 Standards for Accreditation of Educational Programs for Radiographers
1252. Appendix B to Part 75 Standards for Accreditation of Dental Radiography Training for Dental Hygienists
1253. Appendix C to Part 75 Standards for Accreditation of Dental Radiography Training for Dental Assistants
1254. Appendix D to Part 75 Standards for Accreditation of Educational Programs for Nuclear Medicine Technologists
1255. Appendix E to Part 75 Standards for Accreditation of Educational Programs for Radiation Therapy Technologists
1256. Appendix F to Part 75 Standards for Licensing Radiographers, Nuclear Medicine Technologists, and Radiation Therapy Technologists
1257. Appendix G to Part 75 Standards for Licensing Dental Hygienists and Dental Assistants in Dental Radiography
1258. SUBCHAPTER G OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES
1259. 80 PART 80 [RESERVED]
1260. PART 81 GUIDELINES FOR DETERMINING PROBABILITY OF CAUSATION UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
1261. Subpart A Introduction
1262. § 81.0 Background.
1263. § 81.1 Purpose and Authority.
1264. § 81.2 Provisions of EEOICPA concerning this part.
1265. Subpart B Definitions
1266. § 81.4 Definition of terms used in this part.
1267. Subpart C Data Required To Estimate Probability of Causation
1268. § 81.5 Use of personal and medical information.
1269. § 81.6 Use of radiation dose information.
1270. Subpart D Requirements for Risk Models Used To Estimate Probability of Causation
1271. § 81.10 Use of cancer risk assessment models in NIOSH IREP.
1272. § 81.11 Use of uncertainty analysis in NIOSH-IREP.
1273. § 81.12 Procedure to update NIOSH-IREP.
1274. Subpart E Guidelines To Estimate Probability of Causation
1275. § 81.20 Required use of NIOSH-IREP.
1276. § 81.21 Cancers requiring the use of NIOSH-IREP.
1277. § 81.22 General guidelines for use of NIOSH-IREP.
1278. § 81.23 Guidelines for cancers for which primary site is unknown.
1279. § 81.24 Guidelines for leukemia.
1280. § 81.25 Guidelines for claims including two or more primary cancers.
1281. PART 82 METHODS FOR CONDUCTING DOSE RECONSTRUCTION UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
1282. Subpart A Introduction
1283. § 82.0 Background information on this part.
1284. § 82.1 What is the purpose of this part?
1285. § 82.2 What are the basics of dose reconstruction?
1286. § 82.3 What Are the Requirements for Dose Reconstruction Under EEOICPA?
1287. § 82.4 How Will DOL Use the Results of the NIOSH Dose Reconstructions?
1288. Subpart B Definitions
1289. § 82.5 Definition of terms used in this part.
1290. Subpart C Dose Reconstruction Process
1291. § 82.10 Overview of the dose reconstruction process.
1292. § 82.11 For which claims under EEOICPA will NIOSH conduct a dose reconstruction?
1293. § 82.12 Will it be possible to conduct dose reconstructions for all claims?
1294. § 82.13 What sources of information may be used for dose reconstructions?
1295. § 82.14 What types of information could be used in dose reconstructions?
1296. § 82.15 How will NIOSH evaluate the completeness and adequacy of individual monitoring data?
1297. § 82.16 How will NIOSH add to monitoring data to remedy limitations of individual monitoring and missed dose?
1298. § 82.17 What types of information could be used to supplement or substitute for individual monitoring data?
1299. § 82.18 How will NIOSH calculate internal dose to the primary cancer site(s)?
1300. § 82.19 How will NIOSH address uncertainty about dose levels?
1301. Subpart D Reporting and Review of Dose Reconstruction Results
1302. § 82.25 When will NIOSH report dose reconstruction results, and to whom?
1303. § 82.26 How will NIOSH report dose reconstruction results?
1304. § 82.27 How can claimants obtain reviews of their NIOSH dose reconstruction results by NIOSH?
1305. § 82.28 Who can review NIOSH dose reconstruction files on individual claimants?
1306. Subpart E Updating the Scientific Elements Underlying Dose Reconstructions
1307. § 82.30 How will NIOSH inform the public of any plans to change scientific elements underlying the dose reconstruction process to maintain methods reasonably current with scientific progress?
1308. § 82.31 How can the public recommend changes to scientific elements underlying the dose reconstruction process?
1309. § 82.32 How will NIOSH make changes in scientific elements underlying the dose reconstruction process, based on scientific progress?
1310. § 82.33 How will NIOSH inform the public of changes to the scientific elements underlying the dose reconstruction process?
1311. PART 83 PROCEDURES FOR DESIGNATING CLASSES OF EMPLOYEES AS MEMBERS OF THE SPECIAL EXPOSURE COHORT UNDER THE ENERGY EMPLOYEES OCCUPATIONAL ILLNESS COMPENSATION PROGRAM ACT OF 2000
1312. Subpart A Introduction
1313. § 83.0 Background information on the procedures in this part.
1314. § 83.1 What is the purpose of the procedures in this part?
1315. § 83.2 How will DOL use the designations established under the procedures in this part?
1316. Subpart B Definitions
1317. § 83.5 Definitions of terms used in the procedures in this part.
1318. Subpart C Procedures for Adding Classes of Employees to the Cohort
1319. § 83.6 Overview of the procedures in this part.
1320. § 83.7 Who can submit a petition on behalf of a class of employees?
1321. § 83.8 How is a petition submitted?
1322. § 83.9 What information must a petition include?
1323. § 83.10 If a petition satisfies all relevant requirements under § 83.9, does this mean the class will be added to the Cohort?
1324. § 83.11 What happens to petitions that do not satisfy all relevant requirements under §§ 83.7 through 83.9?
1325. § 83.12 How will NIOSH notify petitioners, the Board, and the public of petitions that have been selected for evaluation?
1326. § 83.13 How will NIOSH evaluate petitions, other than petitions by claimants covered under § 83.14?
1327. § 83.14 How will NIOSH evaluate a petition by a claimant whose dose reconstruction NIOSH could not complete under 42 CFR part 82?
1328. § 83.15 How will the Board consider and advise the Secretary on a petition?
1329. § 83.16 How will the Secretary decide the outcome(s) of a petition?
1330. § 83.17 How will the Secretary report a final decision to add a class of employees to the Cohort and any action of Congress concerning the effect of the final decision?
1331. § 83.18 How can petitioners obtain an administrative review of a final decision by the Secretary?
1332. § 83.19 How can the Secretary cancel or modify a final decision to add a class of employees to the Cohort?
1333. PART 84 APPROVAL OF RESPIRATORY PROTECTIVE DEVICES
1334. Subpart A General Provisions
1335. § 84.1 Purpose.
1336. § 84.2 Definitions.
1337. § 84.3 Respirators for mine rescue or other emergency use in mines.
1338. Subpart B Application for Approval
1339. § 84.10 Application procedures.
1340. § 84.11 Contents of application.
1341. § 84.12 Delivery of respirators and components by applicant; requirements.
1342. Subpart C Fees
1343. § 84.20 Establishment of fees.
1344. § 84.21 Fee calculation.
1345. § 84.22 Fee administration.
1346. § 84.23 Fee revision.
1347. § 84.24 Authorization for additional examinations, inspections, tests, and fees.
1348. Subpart D Approval and Disapproval
1349. § 84.30 Certificates of approval; scope of approval.
1350. § 84.31 Certificates of approval; contents.
1351. § 84.32 Notice of disapproval.
1352. § 84.33 Approval labels and markings; approval of contents; use.
1353. § 84.34 Revocation of certificates of approval.
1354. § 84.35 Changes or modifications of approved respirators; issuance of modification of certificate of approval.
1355. § 84.36 Delivery of changed or modified approved respirator.
1356. Subpart E Quality Control
1357. § 84.40 Quality control plans; filing requirements.
1358. § 84.41 Quality control plans; contents.
1359. § 84.42 Proposed quality control plans; approval by the Institute.
1360. § 84.43 Quality control records; review by the Institute; revocation of approval.
1361. Subpart F Classification of Approved Respirators; Scope of Approval; Atmospheric Hazards; Service Time
1362. § 84.50 Types of respirators to be approved; scope of approval.
1363. § 84.51 Entry and escape, or escape only; classification.
1364. § 84.52 Respiratory hazards; classification.
1365. § 84.53 Service time; classification.
1366. Subpart G General Construction and Performance Requirements
1367. § 84.60 Construction and performance requirements; general.
1368. § 84.61 General construction requirements.
1369. § 84.62 Component parts; minimum requirements.
1370. § 84.63 Test requirements; general.
1371. § 84.64 Pretesting by applicant; approval of test methods.
1372. § 84.65 Conduct of examinations, inspections, and tests by the Institute; assistance by applicant; observers; recorded data; public demonstrations.
1373. § 84.66 Withdrawal of applications.
1374. Subpart H Self-Contained Breathing Apparatus
1375. § 84.70 Self-contained breathing apparatus; description.
1376. § 84.71 Self-contained breathing apparatus; required components.
1377. § 84.72 Breathing tubes; minimum requirements.
1378. § 84.73 Harnesses; installation and construction; minimum requirements.
1379. § 84.74 Apparatus containers; minimum requirements.
1380. § 84.75 Half-mask facepieces, full facepieces, mouthpieces; fit; minimum requirements.
1381. § 84.76 Facepieces; eyepieces; minimum requirements.
1382. § 84.77 Inhalation and exhalation valves; minimum requirements.
1383. § 84.78 Head harnesses; minimum requirements.
1384. § 84.79 Breathing gas; minimum requirements.
1385. § 84.80 Interchangeability of oxygen and air prohibited.
1386. § 84.81 Compressed breathing gas and liquefied breathing gas containers; minimum requirements.
1387. § 84.82 Gas pressure gages; minimum requirements.
1388. § 84.83 Timers; elapsed time indicators; remaining service life indicators; minimum requirements.
1389. § 84.84 Hand-operated valves; minimum requirements.
1390. § 84.85 Breathing bags; minimum requirements.
1391. § 84.86 Component parts exposed to oxygen pressures; minimum requirements.
1392. § 84.87 Compressed gas filters; minimum requirements.
1393. § 84.88 Breathing bag test.
1394. § 84.89 Weight requirement.
1395. § 84.90 Breathing resistance test; inhalation.
1396. § 84.91 Breathing resistance test; exhalation.
1397. § 84.92 Exhalation valve leakage test.
1398. § 84.93 Gas flow test; open-circuit apparatus.
1399. § 84.94 Gas flow test; closed-circuit apparatus.
1400. § 84.95 Service time test; open-circuit apparatus.
1401. § 84.96 Service time test; closed-circuit apparatus.
1402. § 84.97 Test for carbon dioxide in inspired gas; open- and closed-circuit apparatus; maximum allowable limits.
1403. § 84.98 Tests during low temperature operation.
1404. § 84.99 Man tests; testing conditions; general requirements.
1405. § 84.100 Man tests 1, 2, 3, and 4; requirements.
1406. § 84.101 Man test 5; requirements.
1407. § 84.102 Man test 6; requirements.
1408. § 84.103 Man tests; performance requirements.
1409. § 84.104 Gas tightness test; minimum requirements.
1410. 0
1411. Tables to Subpart H of Part 84
1412. Subpart I Gas Masks
1413. § 84.110 Gas masks; description.
1414. § 84.111 Gas masks; required components.
1415. § 84.112 Canisters and cartridges in parallel; resistance requirements.
1416. § 84.113 Canisters and cartridges; color and markings; requirements.
1417. § 84.114 Filters used with canisters and cartridges; location; replacement.
1418. § 84.115 Breathing tubes; minimum requirements.
1419. § 84.116 Harnesses; installation and construction; minimum requirements.
1420. § 84.117 Gas mask containers; minimum requirements.
1421. § 84.118 Half-mask facepieces, full facepieces, and mouthpieces; fit; minimum requirements.
1422. § 84.119 Facepieces; eyepieces; minimum requirements.
1423. § 84.120 Inhalation and exhalation valves; minimum requirements.
1424. § 84.121 Head harnesses; minimum requirements.
1425. § 84.122 Breathing resistance test; minimum requirements.
1426. § 84.123 Exhalation valve leakage test.
1427. § 84.124 Facepiece tests; minimum requirements.
1428. § 84.125 Particulate tests; canisters containing particulate filters; minimum requirements.
1429. § 84.126 Canister bench tests; minimum requirements.
1430. Tables to Subpart I of Part 84
1431. Subpart J Supplied-Air Respirators
1432. § 84.130 Supplied-air respirators; description.
1433. § 84.131 Supplied-air respirators; required components.
1434. § 84.132 Breathing tubes; minimum requirements.
1435. § 84.133 Harnesses; installation and construction; minimum requirements.
1436. § 84.134 Respirator containers; minimum requirements.
1437. § 84.135 Half-mask facepieces, full facepieces, hoods, and helmets; fit; minimum requirements.
1438. § 84.136 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
1439. § 84.137 Inhalation and exhalation valves; check valves; minimum requirements.
1440. § 84.138 Head harnesses; minimum requirements.
1441. § 84.139 Head and neck protection; supplied-air respirators; minimum requirements.
1442. § 84.140 Air velocity and noise levels; hoods and helmets; minimum requirements.
1443. § 84.141 Breathing gas; minimum requirements.
1444. § 84.142 Air supply source; hand-operated or motor driven air blowers; Type A supplied-air respirators; minimum requirements.
1445. § 84.143 Terminal fittings or chambers; Type B supplied-air respirators; minimum requirements.
1446. § 84.144 Hand-operated blower test; minimum requirements.
1447. § 84.145 Motor-operated blower test; minimum requirements.
1448. § 84.146 Method of measuring the power and torque required to operate blowers.
1449. § 84.147 Type B supplied-air respirator; minimum requirements.
1450. § 84.148 Type C supplied-air respirator, continuous flow class; minimum requirements.
1451. § 84.149 Type C supplied-air respirator, demand and pressure demand class; minimum requirements.
1452. § 84.150 Air-supply line tests; minimum requirements.
1453. § 84.151 Harness test; minimum requirements.
1454. § 84.152 Breathing tube test; minimum requirements.
1455. § 84.153 Airflow resistance test, Type A and Type AE supplied-air respirators; minimum requirements.
1456. § 84.154 Airflow resistance test; Type B and Type BE supplied-air respirators; minimum requirements.
1457. § 84.155 Airflow resistance test; Type C supplied-air respirator, continuous flow class and Type CE supplied-air respirator; minimum requirements.
1458. § 84.156 Airflow resistance test; Type C supplied-air respirator, demand class; minimum requirements.
1459. § 84.157 Airflow resistance test; Type C supplied-air respirator, pressure-demand class; minimum requirements.
1460. § 84.158 Exhalation valve leakage test.
1461. § 84.159 Man tests for gases and vapors; supplied-air respirators; general performance requirements.
1462. § 84.160 Man test for gases and vapors; Type A and Type AE respirators; test requirements.
1463. § 84.161 Man test for gases and vapors; Type B and Type BE respirators; test requirements.
1464. § 84.162 Man test for gases and vapors; Type C respirators, continuous-flow class and Type CE supplied-air respirators; test requirements.
1465. § 84.163 Man test for gases and vapors; Type C supplied-air respirators, demand and pressure-demand classes; test requirements.
1466. Table to Subpart J of Part 84
1467. Subpart K Air-Purifying Particulate Respirators
1468. § 84.170 Air-purifying particulate respirators; description.
1469. § 84.171 Required components and attributes.
1470. § 84.172 Airflow resistance test.
1471. § 84.173 Exhalation valve leakage test.
1472. § 84.174 Filter efficiency level determination test—non-powered series N, R, and P filtration.
1473. § 84.175 Instantaneous filter efficiency level determination test—PAPR series HE, PAPR100-N, and PAPR100-P filtration.
1474. § 84.176 Fit test—PAPR classes HE and PAPR100.
1475. § 84.177 Total noise level test—PAPR classes HE and PAPR100.
1476. § 84.178 Breath response type, airflow resistance test—PAPR classes HE and PAPR100.
1477. § 84.179 Silica dust loading test—PAPR series HE filtration.
1478. § 84.180 Particulate loading test—PAPR series PAPR100-N and PAPR100-P filtration.
1479. § 84.181 Communication performance test—PAPR class PAPR100.
1480. Subpart L Chemical Cartridge Respirators
1481. § 84.190 Chemical cartridge respirators: description.
1482. § 84.191 Chemical cartridge respirators; required components.
1483. § 84.192 Cartridges in parallel; resistance requirements.
1484. § 84.193 Cartridges; color and markings; requirements.
1485. § 84.194 Filters used with chemical cartridges; location; replacement.
1486. § 84.195 Breathing tubes; minimum requirements.
1487. § 84.196 Harnesses; installation and construction; minimum requirements.
1488. § 84.197 Respirator containers; minimum requirements.
1489. § 84.198 Half-mask facepieces, full facepieces, mouthpieces, hoods, and helmets; fit; minimum requirements.
1490. § 84.199 Facepieces, hoods, and helmets; eyepieces; minimum requirements.
1491. § 84.200 Inhalation and exhalation valves; minimum requirements.
1492. § 84.201 Head harnesses; minimum requirements.
1493. § 84.202 Air velocity and noise levels; hoods and helmets; minimum requirements.
1494. § 84.203 Breathing resistance test; minimum requirements.
1495. § 84.204 Exhalation valve leakage test; minimum requirements.
1496. § 84.205 Facepiece test; minimum requirements.
1497. § 84.206 Particulate tests; respirators with filters; minimum requirements; general.
1498. § 84.207 Bench tests; gas and vapor tests; minimum requirements; general.
1499. Tables to Subpart L of Part 84
1500. M Subpart M [Reserved]
1501. Subpart N Special Use Respirators
1502. § 84.250 Vinyl chloride respirators; description.
1503. § 84.251 Required components.
1504. § 84.252 Gas masks; requirements and tests.
1505. § 84.253 Chemical-cartridge respirators; requirements and tests.
1506. § 84.254 Powered air-purifying respirators; requirements and tests.
1507. § 84.255 Requirements for end-of-service-life indicator.
1508. § 84.256 Quality control requirements.
1509. § 84.257 Labeling requirements.
1510. Subpart O Closed-Circuit Escape Respirators
1511. § 84.300 Closed-circuit escape respirator; description.
1512. § 84.301 Applicability to new and previously approved CCERs.
1513. § 84.302 Required components, attributes, and instructions.
1514. § 84.303 General testing conditions and requirements.
1515. § 84.304 Capacity test requirements.
1516. § 84.305 Performance test requirements.
1517. § 84.306 Wearability test requirements.
1518. § 84.307 Environmental treatments.
1519. § 84.308 Additional testing.
1520. § 84.309 Additional testing and requirements for dockable CCERs.
1521. § 84.310 Post-approval testing.
1522. § 84.311 Registration of CCER units upon purchase.
1523. P Subparts P-JJ [Reserved]
1524. Appendix A to Part 84 Annual (Fixed) Respirator Certification Fees
1525. Appendix B to Part 84 Application-Based Respirator Certification Fees
1526. PART 85 REQUESTS FOR HEALTH HAZARD EVALUATIONS
1527. § 85.1 Applicability.
1528. § 85.2 Definitions.
1529. § 85.3 Procedures for requesting health hazard evaluations.
1530. § 85.3-1 Contents of a request for health hazard evaluation.
1531. § 85.4 Acting on requests.
1532. § 85.5 Authority for investigations.
1533. § 85.6 Advance notice of visits.
1534. § 85.7 Conduct of investigations.
1535. § 85.8 Provision of suitable space for employee interviews and examinations; identification of employees.
1536. § 85.9 Representatives of employers and employees; employee requests.
1537. § 85.10 Imminent dangers.
1538. § 85.11 Notification of determination to employers, affected employees and Department of Labor.
1539. § 85.12 Subsequent requests for health hazard evaluations.
1540. PART 85a OCCUPATIONAL SAFETY AND HEALTH INVESTIGATIONS OF PLACES OF EMPLOYMENT
1541. § 85a.1 Applicability.
1542. § 85a.2 Definitions.
1543. § 85a.3 Authority for investigations of places of employment.
1544. § 85a.4 Procedures for initiating investigations of places of employment.
1545. § 85a.5 Conduct of investigations of places of employment.
1546. § 85a.6 Provision of suitable space for employee interviews and examinations.
1547. § 85a.7 Imminent dangers.
1548. § 85a.8 Reporting of results of investigations of places of employment.
1549. PART 86 GRANTS FOR EDUCATION PROGRAMS IN OCCUPATIONAL SAFETY AND HEALTH
1550. Subpart A General
1551. § 86.1 Applicability.
1552. § 86.2 Definitions.
1553. § 86.3 Inventions and discoveries.
1554. § 86.4 Publications and copyrights.
1555. § 86.5 Grant appeals procedure.
1556. Subpart B Occupational Safety and Health Training Grants
1557. § 86.10 Nature and purpose of training grants.
1558. § 86.11 Eligibility.
1559. § 86.12 Application for a grant.
1560. § 86.13 Project requirements.
1561. § 86.14 Evaluation and grant award.
1562. § 86.15 Payments.
1563. § 86.16 Use of project funds.
1564. § 86.17 Nondiscrimination.
1565. § 86.18 Grantee accountability.
1566. § 86.19 Human subjects; animal welfare.
1567. § 86.20 Additional conditions.
1568. § 86.21 Applicability of 45 CFR part 74.
1569. Subpart C Occupational Safety and Health Direct Traineeships
1570. § 86.30 Nature and purpose of direct traineeships.
1571. § 86.31 Eligibility; minimum requirements.
1572. § 86.32 Application for direct traineeship.
1573. § 86.33 Human subjects; animal welfare.
1574. § 86.34 Evaluation and award of direct traineeships.
1575. § 86.35 Payments.
1576. § 86.36 Duration and continuation.
1577. § 86.37 Terms and conditions.
1578. § 86.38 Accountability.
1579. § 86.39 Termination of direct traineeship.
1580. PART 87 NATIONAL INSTITUTE FOR OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND DEMONSTRATION GRANTS
1581. § 87.1 To which programs does this regulation apply?
1582. § 87.2 Definitions.
1583. § 87.3 Who is eligible to apply for a grant under this part?
1584. § 87.4 For what purposes may grants be awarded?
1585. § 87.5 What information must be included in the grant application?
1586. § 87.6 How will grant applications be evaluated and the grants awarded?
1587. § 87.7 For what period of time will grants be awarded?
1588. § 87.8 How may a grantee use grant funds?
1589. § 87.9 Which other HHS regulations apply?
1590. PART 88 WORLD TRADE CENTER HEALTH PROGRAM
1591. § 88.1 Definitions.
1592. § 88.2 General provisions.
1593. § 88.3 Eligibility—currently identified responders.
1594. § 88.4 Eligibility criteria—WTC responders.
1595. § 88.5 Application process—WTC responders.
1596. § 88.6 Enrollment decision—WTC responders.
1597. § 88.7 Eligibility—currently identified survivors.
1598. § 88.8 Eligibility criteria—WTC survivors.
1599. § 88.9 Application process—WTC survivors.
1600. § 88.10 Enrollment decision—screening-eligible survivors.
1601. § 88.11 Initial health evaluation for screening-eligible survivors.
1602. § 88.12 Enrollment decision—certified-eligible survivors.
1603. § 88.13 Disenrollment.
1604. § 88.14 Appeal of enrollment or disenrollment decision.
1605. § 88.15 List of WTC-Related Health Conditions.
1606. § 88.16 Addition of health conditions to the List of WTC-Related Health Conditions.
1607. § 88.17 Physician's determination of WTC-related health conditions.
1608. § 88.18 Certification.
1609. § 88.19 Decertification.
1610. § 88.20 Authorization of treatment.
1611. § 88.21 Appeal of certification, decertification, or treatment authorization decision.
1612. § 88.22 Reimbursement for medical treatment and services.
1613. § 88.23 Appeal of reimbursement denial.
1614. § 88.24 Coordination of benefits and recoupment.
1615. § 88.25 Reopening of WTC Health Program final decisions.
1616. SUBCHAPTER H HEALTH ASSESSMENTS AND HEALTH EFFECTS STUDIES OF HAZARDOUS SUBSTANCES RELEASES AND FACILITIES
1617. PART 90 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
1618. § 90.1 Purpose and applicability.
1619. § 90.2 Definitions.
1620. § 90.3 Procedures for requesting health assessments.
1621. § 90.4 Contents of requests for health assessments.
1622. § 90.5 Acting on requests.
1623. § 90.6 Notification of determination to conduct a health assessment in response to a request from the public.
1624. § 90.7 Decision to conduct health effects study.
1625. § 90.8 Conduct of health assessments and health effects studies.
1626. § 90.9 Public health advisory.
1627. § 90.10 Notice and comment period.
1628. § 90.11 Reporting of results of health assessments and health effects studies.
1629. § 90.12 Confidentiality of information.
1630. § 90.13 Recordkeeping requirements.
1631. § 90.14 Documentation and cost recovery.
1632. PART 93 PUBLIC HEALTH SERVICE POLICIES ON RESEARCH MISCONDUCT
1633. § 93.25 Organization of this part.
1634. § 93.50 Special terms.
1635. § 93.75 Application of effective date to research misconduct proceedings.
1636. Subpart A General
1637. § 93.100 General policy.
1638. § 93.101 Purpose.
1639. § 93.102 Applicability.
1640. § 93.103 Requirements for findings of research misconduct.
1641. § 93.104 Time limitations.
1642. § 93.105 Evidentiary standards.
1643. § 93.106 Confidentiality.
1644. § 93.107 Coordination with other agencies.
1645. Subpart B Definitions
1646. § 93.200 Accepted practices of the relevant research community.
1647. § 93.201 Administrative action.
1648. § 93.202 Administrative record.
1649. § 93.203 Allegation.
1650. § 93.204 Assessment.
1651. § 93.205 Charge letter.
1652. § 93.206 Complainant.
1653. § 93.207 Contract.
1654. § 93.208 Day.
1655. § 93.209 Departmental Appeals Board or DAB.
1656. § 93.210 Evidence.
1657. § 93.211 Fabrication.
1658. § 93.212 Falsification.
1659. § 93.213 Funding component.
1660. § 93.214 Good faith.
1661. § 93.215 Inquiry.
1662. § 93.216 Institution.
1663. § 93.217 Institutional Certifying Official.
1664. § 93.218 Institutional Deciding Official.
1665. § 93.219 Institutional member.
1666. § 93.220 Institutional record.
1667. § 93.221 Intentionally.
1668. § 93.222 Investigation.
1669. § 93.223 Knowingly.
1670. § 93.224 Notice.
1671. § 93.225 Office of Research Integrity or ORI.
1672. § 93.226 Person.
1673. § 93.227 Plagiarism.
1674. § 93.228 Preponderance of the evidence.
1675. § 93.229 Public Health Service or PHS.
1676. § 93.230 PHS support.
1677. § 93.231 Recklessly.
1678. § 93.232 Research.
1679. § 93.233 Research Integrity Officer or RIO.
1680. § 93.234 Research misconduct.
1681. § 93.235 Research misconduct proceeding.
1682. § 93.236 Research record.
1683. § 93.237 Respondent.
1684. § 93.238 Retaliation.
1685. § 93.239 Secretary or HHS.
1686. § 93.240 Small institution.
1687. § 93.241 Suspension and Debarment Official or SDO.
1688. Subpart C Responsibilities of Institutions
1689. 26 Compliance and Assurances
1690. § 93.300 General responsibilities for compliance.
1691. § 93.301 Research integrity assurances.
1692. § 93.302 Maintaining active research integrity assurances.
1693. § 93.303 Research integrity assurances for small institutions.
1694. § 93.304 Institutional policies and procedures.
1695. § 93.305 General conduct of research misconduct proceedings.
1696. 27 The Institutional Assessment
1697. § 93.306 Institutional assessment.
1698. 28 The Institutional Inquiry
1699. § 93.307 Institutional inquiry.
1700. § 93.308 Notice of the results of the inquiry.
1701. § 93.309 Reporting to ORI on the decision to initiate an investigation.
1702. 29 The Institutional Investigation
1703. § 93.310 Institutional investigation.
1704. § 93.311 Investigation time limits.
1705. § 93.312 Opportunity to comment on the draft investigation report.
1706. § 93.313 Investigation report.
1707. § 93.314 Decision by the Institutional Deciding Official.
1708. § 93.315 Institutional appeals.
1709. § 93.316 Transmittal of the institutional record to ORI.
1710. § 93.317 Completing the research misconduct process.
1711. 30 Other Institutional Responsibilities
1712. § 93.318 Retention and custody of the institutional record and all sequestered evidence.
1713. § 93.319 Institutional standards of conduct.
1714. Subpart D Responsibilities of the U.S. Department of Health and Human Services
1715. 31 General Information
1716. § 93.400 General statement of ORI authority.
1717. § 93.401 Interaction with other entities and interim actions.
1718. 32 Research Misconduct Issues
1719. § 93.402 ORI allegation assessments.
1720. § 93.403 ORI review of research misconduct proceedings.
1721. § 93.404 Findings of research misconduct and proposed HHS administrative actions.
1722. § 93.405 Notifying the respondent of findings of research misconduct and proposed HHS administrative actions.
1723. § 93.406 Final HHS actions.
1724. § 93.407 HHS administrative actions.
1725. § 93.408 Mitigating and aggravating factors in HHS administrative actions.
1726. § 93.409 Settlement of research misconduct proceedings.
1727. § 93.410 Final HHS action with no settlement or finding of research misconduct.
1728. § 93.411 Final HHS action with a settlement or finding of research misconduct.
1729. 33 Institutional Compliance Issues
1730. § 93.412 Making decisions on institutional noncompliance.
1731. § 93.413 ORI compliance actions.
1732. 34 Disclosure of Information
1733. § 93.414 Notice.
1734. Subpart E Opportunity To Contest ORI Findings of Research Misconduct and Proposed HHS Administrative Actions
1735. 35 General Information
1736. § 93.500 General policy.
1737. 36 Process for Contesting Research Misconduct Findings and/or Proposed HHS Administrative Actions
1738. § 93.501 Notice of appeal.
1739. § 93.502 Appointment of the Administrative Law Judge.
1740. § 93.503 Filing of the administrative record.
1741. § 93.504 Standard of review.
1742. § 93.505 Rights of the parties.
1743. § 93.506 Authority of the Administrative Law Judge.
1744. § 93.507 Ex parte communications.
1745. § 93.508 Filing, format, and service.
1746. § 93.509 Filing motions.
1747. § 93.510 Conferences.
1748. § 93.511 The Administrative Law Judge's ruling.
1749. I [RESERVED] SUBCHAPTER I [RESERVED]
1750. SUBCHAPTER J VACCINES
1751. PART 100 VACCINE INJURY COMPENSATION
1752. § 100.1 Applicability.
1753. § 100.2 Average cost of a health insurance policy.
1754. § 100.3 Vaccine injury table.
1755. PART 110 COUNTERMEASURES INJURY COMPENSATION PROGRAM
1756. Subpart A General Provisions
1757. § 110.1 Purpose.
1758. § 110.2 Summary of available benefits.
1759. § 110.3 Definitions.
1760. Subpart B Persons Eligible To Receive Benefits
1761. § 110.10 Eligible requesters.
1762. § 110.11 Survivors.
1763. Subpart C Covered Injuries
1764. § 110.20 How to establish a covered injury.
1765. Subpart D Available Benefits
1766. § 110.30 Benefits available to different categories of requesters under this Program.
1767. § 110.31 Medical benefits.
1768. § 110.32 Benefits for lost employment income.
1769. § 110.33 Death benefits.
1770. Subpart E Procedures for Filing Request Packages
1771. § 110.40 How to obtain forms and instructions.
1772. § 110.41 How to file a Request Package.
1773. § 110.42 Deadlines for filing Request Forms.
1774. § 110.43 Deadlines for submitting documentation.
1775. § 110.44 Legal or personal representatives of requesters.
1776. § 110.45 Multiple survivors.
1777. § 110.46 Amending a Request Package.
1778. Subpart F Documentation Required for the Secretary To Determine Eligibility
1779. § 110.50 Medical records necessary for the Secretary to determine whether a covered injury was sustained.
1780. § 110.51 Documentation an injured countermeasure recipient must submit for the Secretary to make a determination of eligibility for Program benefits.
1781. § 110.52 Documentation a survivor must submit for the Secretary to make a determination of eligibility for death benefits.
1782. § 110.53 Documentation the executor or administrator of the estate of a deceased injured countermeasure recipient must submit for the Secretary to make a determination of eligibility for benefits to the estate.
1783. Subpart G Documentation Required for the Secretary To Determine Program Benefits
1784. § 110.60 Documentation a requester who is determined to be eligible must submit for the Secretary to make a determination of medical benefits.
1785. § 110.61 Documentation a requester who is determined to be eligible must submit for the Secretary to make a determination of lost employment income benefits.
1786. § 110.62 Documentation a requester who is determined to be an eligible survivor must submit for the Secretary to make a determination of death benefits.
1787. § 110.63 Documentation a legal or personal representative must submit when filing on behalf of a minor or on behalf of an adult who lacks legal capacity to receive payment of benefits.
1788. Subpart H Secretarial Determinations
1789. § 110.70 Determinations the Secretary must make before benefits can be paid.
1790. § 110.71 Insufficient documentation for eligibility and benefits determinations.
1791. § 110.72 Sufficient documentation for eligibility and benefits determinations.
1792. § 110.73 Approval of benefits.
1793. § 110.74 Disapproval of benefits.
1794. Subpart I Calculation and Payment of Benefits
1795. § 110.80 Calculation of medical benefits.
1796. § 110.81 Calculation of benefits for lost employment income.
1797. § 110.82 Calculation of death benefits.
1798. § 110.83 Payment of all benefits.
1799. § 110.84 The Secretary's right to recover benefits paid under this Program from third-party payers.
1800. Subpart J Reconsideration of the Secretary's Determinations
1801. § 110.90 Reconsideration of the Secretary's eligibility and benefits determinations.
1802. § 110.91 Secretary's review authority.
1803. § 110.92 No additional judicial or administrative review of determinations made under this part.
1804. Subpart K Covered Countermeasures Injury Tables
1805. § 110.100 Injury Tables.
1806. SUBCHAPTER K HEALTH RESOURCES DEVELOPMENT
1807. PART 121 ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK
1808. § 121.1 Applicability.
1809. § 121.2 Definitions.
1810. § 121.3 The OPTN.
1811. § 121.4 OPTN policies: Secretarial review and appeals.
1812. § 121.5 Listing requirements.
1813. § 121.6 Organ procurement.
1814. § 121.7 Identification of organ recipient.
1815. § 121.8 Allocation of organs.
1816. § 121.9 Designated transplant program requirements.
1817. § 121.10 Reviews, evaluation, and enforcement.
1818. § 121.11 Record maintenance and reporting requirements.
1819. § 121.12 Advisory Committee on Organ Transplantation.
1820. § 121.13 Definition of human organ under section 301 of the National Organ Transplant Act of 1984, as amended.
1821. § 121.14 Reimbursement for living organ donors: incidental non-medical expenses.
1822. PART 124 MEDICAL FACILITY CONSTRUCTION AND MODERNIZATION
1823. Subpart A Project Grants for Public Medical Facility Construction and Modernization
1824. § 124.1 Applicability.
1825. § 124.2 Definitions.
1826. § 124.3 Eligibility.
1827. § 124.4 Application.
1828. § 124.5 Grant evaluation and award.
1829. § 124.6 Grant payments.
1830. § 124.7 Use of grant funds.
1831. § 124.8 Grantee accountability.
1832. § 124.9 Nondiscrimination.
1833. § 124.10 Additional conditions.
1834. § 124.11 Applicability of 2 CFR parts 200 and 300.
1835. B Subparts B-E [Reserved]
1836. Subpart F Reasonable Volume of Uncompensated Services to Persons Unable To Pay
1837. § 124.501 Applicability.
1838. § 124.502 Definitions.
1839. § 124.503 Compliance level.
1840. § 124.504 Notice of availability of uncompensated services.
1841. § 124.505 Eligibility criteria.
1842. § 124.506 Allocation of services; plan requirement.
1843. § 124.507 Written determinations of eligibility.
1844. § 124.508 Cessation of uncompensated services.
1845. § 124.509 Reporting requirements.
1846. § 124.510 Record maintenance requirements.
1847. § 124.511 Investigation and determination of compliance.
1848. § 124.512 Enforcement.
1849. § 124.513 Public facility compliance alternative.
1850. § 124.514 Compliance alternative for facilities with small annual obligations.
1851. § 124.515 Compliance alternative for community health centers, migrant health centers and certain National Health Service Corps sites.
1852. § 124.516 Charitable facility compliance alternative.
1853. § 124.517 Unrestricted availability compliance alternative for Title VI-assisted facilities.
1854. § 124.518 Agreements with State agencies.
1855. Subpart G Community Service
1856. § 124.601 Applicability.
1857. § 124.602 Definitions.
1858. § 124.603 Provision of services.
1859. § 124.604 Posted notice.
1860. § 124.605 Reporting and record maintenance requirements.
1861. § 124.606 Investigation and enforcement.
1862. § 124.607 Agreements with State agencies.
1863. Appendix to Subpart G of Part 124 Interim Procedures and Criteria for Review by Health Systems Agencies of Applications Under Section 1625 of the Public Health Service Act
1864. Subpart H Recovery of Grant Funds
1865. § 124.701 Applicability.
1866. § 124.702 Definitions.
1867. § 124.703 Federal right of recovery.
1868. § 124.704 Notification of sale, transfer, or change of use.
1869. § 124.705 Amount of recovery.
1870. § 124.706 Calculation of interest.
1871. § 124.707 Waiver of recovery where facility is sold or transferred to a proprietary entity.
1872. § 124.708 Waiver of recovery—good cause for other use of facility.
1873. § 124.709 Withdrawal of waiver.
1874. 125-129 PARTS 125-129 [RESERVED]
1875. SUBCHAPTER L COMPASSIONATE PAYMENTS
1876. 131-135 PARTS 131-135 [RESERVED]
1877. SUBCHAPTER M INDIAN HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
1878. PART 136 INDIAN HEALTH
1879. Subpart A Purpose and Definitions
1880. § 136.1 Definitions.
1881. § 136.2 Purpose of the regulations.
1882. § 136.3 Administrative instructions.
1883. Subpart B What Services Are Available and Who Is Eligible To Receive Care?
1884. § 136.11 Services available.
1885. § 136.12 Persons to whom services will be provided.
1886. § 136.13 [Reserved]
1887. § 136.14 Care and treatment of ineligible individuals.
1888. Subpart C Contract Health Services
1889. § 136.21 Definitions.
1890. § 136.22 Establishment of contract health service delivery areas.
1891. § 136.23 Persons to whom contract health services will be provided.
1892. § 136.24 Authorization for contract health services.
1893. § 136.25 Reconsideration and appeals.
1894. Subpart D Limitation on Charges for Services Furnished by Medicare-Participating Hospitals to Indians
1895. § 136.30 Payment to Medicare-participating hospitals for authorized Contract Health Services.
1896. § 136.31 Authorization by urban Indian organization.
1897. § 136.32 Disallowance.
1898. Subpart E Preference in Employment
1899. § 136.41 Definitions.
1900. § 136.42 Appointment actions.
1901. § 136.43 Application procedure for preference eligibility.
1902. F Subpart F [Reserved]
1903. Subpart G Residual Status
1904. § 136.61 Payor of last resort.
1905. Subpart H Grants for Development, Construction, and Operation of Facilities and Services
1906. § 136.101 Applicability.
1907. § 136.102 Definitions.
1908. § 136.103 Eligibility.
1909. § 136.104 Application.
1910. § 136.105 Project elements.
1911. § 136.106 Grant award and evaluation.
1912. § 136.107 Use of project funds.
1913. § 136.108 [Reserved]
1914. § 136.109 Availability of appropriations.
1915. § 136.110 Facilities construction.
1916. § 136.111 Interest.
1917. § 136.112 Additional conditions.
1918. § 136.113 Fair and uniform provision of services.
1919. § 136.114 Applicability of other Department regulations.
1920. § 136.115 Rescission of grants.
1921. § 136.116 Reports.
1922. § 136.117 Amendment of regulations.
1923. § 136.118 Effect on existing rights.
1924. § 136.119 Penalties.
1925. § 136.120 Use of Indian business concerns.
1926. § 136.121 Indian preference in training and employment.
1927. Subpart I Limitation on Charges for Health Care Professional Services and Non-Hospital-Based Care
1928. § 136.201 Applicability.
1929. § 136.202 Definitions.
1930. § 136.203 Payment for provider and supplier services purchased by Indian health programs.
1931. § 136.204 Authorization by an urban Indian organization.
1932. Subpart J Indian Health Care Improvement Act Programs
1933. Subdivision J-1 Provisions of General and Special Applicability
1934. § 136.301 Policy and applicability.
1935. § 136.302 Definitions.
1936. § 136.303 Indians applying for scholarships.
1937. § 136.304 Publication of a list of allied health professions.
1938. § 136.305 Additional conditions.
1939. Subdivision J-2 Health Professions Recruitment Program for Indians
1940. § 136.310 Health professions recruitment grants.
1941. § 136.311 Eligibility.
1942. § 136.312 Application.
1943. § 136.313 Evaluation and grant awards.
1944. § 136.314 Use of funds.
1945. § 136.315 Publication of list of grantees and projects.
1946. § 136.316 Other HHS regulations that apply.
1947. Subdivision J-3 Health Professions Preparatory Scholarship Program for Indians
1948. § 136.320 Preparatory scholarship grants.
1949. § 136.321 Eligibility.
1950. § 136.322 Application and selection.
1951. § 136.323 Scholarship and tuition.
1952. § 136.324 Availability of list of recipients.
1953. Subdivision J-4 Indian Health Scholarship Program
1954. § 136.330 Indian health scholarships.
1955. § 136.331 Selection.
1956. § 136.332 Service obligation.
1957. § 136.333 Distribution of scholarships.
1958. § 136.334 Publication of a list of recipients.
1959. Subdivision J-5 Continuing Education Allowances
1960. § 136.340 Provision of continuing education allowances.
1961. Subdivision J-6 Contracts With Urban Indian Organizations
1962. § 136.350 Contracts with Urban Indian organizations.
1963. § 136.351 Application and selection.
1964. § 136.352 Fair and uniform provision of services.
1965. § 136.353 Reports and records.
1966. Subdivision J-7 Leases With Indian Tribes
1967. § 136.360 Leases with Indian tribes.
1968. Subdivision J-8 Health Professions Pregraduate Scholarship Program for Indians
1969. § 136.370 Pregraduate scholarship grants.
1970. § 136.371 Eligibility.
1971. § 136.372 Application and selection.
1972. § 136.373 Scholarship and tuition.
1973. § 136.374 Availability of list of recipients.
1974. Subpart K Indian Child Protection and Family Violence Prevention
1975. § 136.401 Purpose.
1976. § 136.402 Policy.
1977. § 136.403 Definitions.
1978. § 136.404 What does the Indian Child Protection and Family Violence Prevention Act require of the IHS and Indian Tribes or Tribal organizations receiving funds under the ISDEA?
1979. § 136.405 What are the minimum standards of character for individuals placed in, or applying for, a position that involves regular contact with or control over Indian children?
1980. § 136.406 Under what circumstances will the minimum standards of character be considered to be met?
1981. § 136.407 Under what circumstances should a conviction, or plea of nolo contendere or guilty to, be considered if there has been a pardon, expungement, set aside, or other court order of the conviction or plea?
1982. § 136.408 What are other factors, in addition to the minimum standards of character, that may be considered in determining placement of an individual in a position that involves regular contact with or control over Indian children?
1983. § 136.409 What positions require a background investigation and determination of eligibility for employment or retention?
1984. § 136.410 Who conducts the background investigation and prepares determinations of eligibility for employment?
1985. § 136.411 Are the requirements for IHS adjudication different from the requirements for Indian Tribes and Tribal organizations?
1986. § 136.412 What questions must the IHS ask as part of the background investigation?
1987. § 136.413 What protections must the IHS and Tribes or Tribal organizations provide to individuals undergoing a background investigation?
1988. § 136.414 How does the IHS determine eligibility for placement or retention of individuals in positions involving regular contact with Indian children?
1989. § 136.415 What rights does an individual have during this process?
1990. § 136.416 When should the IHS deny employment or dismiss an employee?
1991. § 136.417 May the IHS hire individuals pending completion of a background investigation?
1992. § 136.418 What should the IHS do if an individual has been charged with an offense but the charge is pending or no disposition has been made by a court?
1993. Subpart L Indian Catastrophic Health Emergency Fund
1994. § 136.501 Definitions.
1995. § 136.502 Purpose of this subpart.
1996. § 136.503 Threshold cost.
1997. § 136.504 Reimbursement procedure.
1998. § 136.505 Reimbursable services.
1999. § 136.506 Alternate resources.
2000. § 136.507 Program integrity.
2001. § 136.508 Recovery of reimbursement funds.
2002. § 136.509 Reconsideration and appeals.
2003. § 136.510 Severability.
2004. PART 136a INDIAN HEALTH
2005. Subpart A Purpose
2006. § 136a.1 Purpose of the regulations.
2007. § 136a.2 Administrative instructions.
2008. Subpart B What Services Are Available and Who Is Eligible To Receive Care?
2009. § 136a.10 Definitions.
2010. § 136a.11 Services available.
2011. § 136a.12 Persons to whom health services will be provided.
2012. § 136a.13 Authorization for contract health services.
2013. § 136a.14 Reconsideration and appeals.
2014. § 136a.15 Health Service Delivery Areas.
2015. § 136a.16 Beneficiary Identification Cards and verification of tribal membership.
2016. C Subpart C [Reserved]
2017. Subpart D Transition Provisions
2018. § 136a.31 Transition period.
2019. § 136a.32 Delayed implementation.
2020. § 136a.33 Grace period.
2021. § 136a.34 Care and treatment of people losing eligibility.
2022. Subpart E Preference in Employment
2023. § 136a.41 Definitions.
2024. § 136a.42 Appointment actions.
2025. § 136a.43 Application procedure for preference eligibility.
2026. Subpart F Abortions and Related Medical Services in Indian Health Service Facilities and Indian Health Service Programs
2027. § 136a.51 Applicability.
2028. § 136a.52 Definitions.
2029. § 136a.53 General rule.
2030. § 136a.54 Life of the mother would be endangered.
2031. § 136a.55 Drugs and devices and termination of ectopic pregnancies.
2032. § 136a.56 Recordkeeping requirements.
2033. § 136a.57 Confidentiality.
2034. Subpart G Residual Status
2035. § 136a.61 Payor of last resort.
2036. PART 137 TRIBAL SELF-GOVERNANCE
2037. Subpart A General Provisions
2038. § 137.1 Authority, purpose and scope
2039. § 137.2 Congressional policy.
2040. § 137.3 Effect on existing Tribal rights.
2041. § 137.4 May Title V be construed to limit or reduce in any way the funding for any program, project, or activity serving an Indian Tribe under this or other applicable Federal law?
2042. § 137.5 Effect of these regulations on Federal program guidelines, manual, or policy directives.
2043. § 137.6 Secretarial policy.
2044. Subpart B Definitions
2045. § 137.10 Definitions.
2046. Subpart C Selection of Indian Tribes for Participation in Self-Governance
2047. § 137.15 Who may participate in Tribal Self-Governance?
2048. § 137.16 What if more than 50 Indian Tribes apply to participate in self-governance?
2049. § 137.17 May more than one Indian Tribe participate in the same compact and/or funding agreement?
2050. § 137.18 What criteria must an Indian Tribe satisfy to be eligible to participate in self-governance?
2051. 91 Planning Phase
2052. § 137.20 What is required during the planning phase?
2053. § 137.21 How does an Indian Tribe demonstrate financial stability and financial management capacity?
2054. § 137.22 May the Secretary consider uncorrected significant and material audit exceptions identified regarding centralized financial and administrative functions?
2055. § 137.23 For purposes of determining eligibility for participation in self-governance, may the Secretary consider any other information regarding the Indian Tribe's financial stability and financial management capacity?
2056. § 137.24 Are there grants available to assist the Indian Tribe to meet the requirements to participate in self-governance?
2057. § 137.25 Are planning and negotiation grants available?
2058. § 137.26 Must an Indian Tribe receive a planning or negotiation grant to be eligible to participate in self-governance?
2059. Subpart D Self-Governance compact
2060. § 137.30 What is a self-governance compact?
2061. § 137.31 What is included in a compact?
2062. § 137.32 Is a compact required to participate in self-governance?
2063. § 137.33 May an Indian Tribe negotiate a funding agreement at the same time it is negotiating a compact?
2064. § 137.34 May a funding agreement be executed without negotiating a compact?
2065. § 137.35 What is the term of a self-governance compact?
2066. Subpart E Funding Agreements
2067. § 137.40 What is a funding agreement?
2068. § 137.41 What PSFAs must be included in a funding agreement?
2069. § 137.42 What Tribal shares may be included in a funding agreement?
2070. § 137.43 May a Tribe negotiate and leave funds with IHS for retained services?
2071. 92 Terms in a Funding Agreement
2072. § 137.45 What terms must be included in a funding agreement?
2073. § 137.46 May additional terms be included in a funding agreement?
2074. § 137.47 Do any provisions of Title I apply to compacts, funding agreements, and construction project agreements negotiated under Title V of the Act?
2075. § 137.48 What is the effect of incorporating a Title I provision into a compact or funding agreement?
2076. § 137.49 What if a Self-Governance Tribe requests such incorporation at the negotiation stage of a compact or funding agreement?
2077. 93 Term of a Funding Agreement
2078. § 137.55 What is the term of a funding agreement?
2079. § 137.56 Does a funding agreement remain in effect after the end of its term?
2080. § 137.57 How is a funding agreement amended during the effective period of the funding agreement?
2081. Subpart F Statutorily Mandated Grants
2082. § 137.60 May a statutorily mandated grant be added to a funding agreement?
2083. § 137.65 May a Self-Governance Tribe receive statutorily mandated grant funding in an annual lump sum advance payment?
2084. § 137.66 May a Self-Governance Tribe keep interest earned on statutorily mandated grant funds?
2085. § 137.67 How may a Self-Governance Tribe use interest earned on statutorily mandated grant funds?
2086. § 137.68 May funds from a statutorily mandated grant added to a funding agreement be reallocated?
2087. § 137.69 May a statutorily mandated grant program added to a funding agreement be redesigned?
2088. § 137.70 Are the reporting requirements different for a statutorily mandated grant program added to a funding agreement?
2089. § 137.71 May the Secretary and the Self-Governance Tribe develop separate programmatic reporting requirements for statutorily mandated grants?
2090. § 137.72 Are Self-Governance Tribes and their employees carrying out statutorily mandated grant programs added to a funding agreement covered by the Federal Tort Claims Act (FTCA)?
2091. § 137.73 What provisions of Title V apply to statutorily mandated grants added to the funding agreement?
2092. Subpart G Funding
2093. 94 General
2094. § 137.75 What funds must the Secretary transfer to a Self-Governance Tribe in a funding agreement?
2095. § 137.76 When must the Secretary transfer to a Self-Governance Tribe funds identified in a funding agreement?
2096. § 137.77 When must the Secretary transfer funds that were not paid as part of the initial lump sum payment?
2097. § 137.78 May a Self-Governance Tribe negotiate a funding agreement for a term longer or shorter than one year?
2098. § 137.79 What funds must the Secretary include in a funding agreement?
2099. 95 Prohibitions
2100. § 137.85 Is the Secretary prohibited from failing or refusing to transfer funds that are due to a Self-Governance Tribe under Title V?
2101. § 137.86 Is the Secretary prohibited from reducing the amount of funds required under Title V to make funding available for self-governance monitoring or administration by the Secretary?
2102. § 137.87 May the Secretary reduce the amount of funds due under Title V in subsequent years?
2103. § 137.88 May the Secretary reduce the amount of funds required under Title V to pay for Federal functions, including Federal pay costs, Federal employee retirement benefits, automated data processing, technical assistance, and monitoring of activities under the Act?
2104. § 137.89 May the Secretary reduce the amount of funds required under Title V to pay for costs of Federal personnel displaced by contracts under Title I or Self-Governance under Title V?
2105. § 137.90 May the Secretary increase the funds required under the funding agreement?
2106. 96 Acquisition of Goods and Services From the IHS
2107. § 137.95 May a Self-Governance Tribe purchase goods and services from the IHS on a reimbursable basis?
2108. 97 Prompt Payment Act
2109. § 137.96 Does the Prompt Payment Act apply to funds transferred to a Self-Governance Tribe in a compact or funding agreement?
2110. 98 Interest or Other Income on Transfers
2111. § 137.100 May a Self-Governance Tribe retain and spend interest earned on any funds paid under a compact or funding agreement?
2112. § 137.101 What standard applies to a Self-Governance Tribe's management of funds paid under a compact or funding agreement?
2113. 99 Carryover of Funds
2114. § 137.105 May a Self-Governance Tribe carryover from one year to the next any funds that remain at the end of the funding agreement?
2115. 100 Program Income
2116. § 137.110 May a Self-Governance Tribe retain and expend any program income earned pursuant to a compact and funding agreement?
2117. 101 Limitation of Costs
2118. § 137.115 Is a Self-Governance Tribe obligated to continue performance under a compact or funding agreement if the Secretary does not transfer sufficient funds?
2119. 102 Stable Base Budget
2120. § 137.120 May a Self-Governance Tribe's funding agreement provide for a stable base budget?
2121. § 137.121 What funds may be included in a stable base budget amount?
2122. § 137.122 May a Self-Governance Tribe with a stable base budget receive other funding under its funding agreement?
2123. § 137.123 Once stable base funding is negotiated, do funding amounts change from year to year?
2124. § 137.124 Does the effective period of a stable base budget have to be the same as the term of the funding agreement?
2125. Subpart H Final Offer
2126. § 137.130 What is covered by this subpart?
2127. § 137.131 When should a final offer be submitted?
2128. § 137.132 How does the Indian Tribe submit a final offer?
2129. § 137.133 What does a final offer contain?
2130. § 137.134 When does the 45 day review period begin?
2131. § 137.135 May the Secretary request and obtain an extension of time of the 45 day review period?
2132. § 137.136 What happens if the agency takes no action within the 45 day review period (or any extensions thereof)?
2133. § 137.137 If the 45 day review period or extension thereto, has expired, and the Tribes offer is deemed accepted by operation of law, are there any exceptions to this rule?
2134. § 137.138 Once the Indian Tribe's final offer has been accepted or deemed accepted by operation of law, what is the next step?
2135. 103 Rejection of Final Offers
2136. § 137.140 On what basis may the Secretary reject an Indian Tribe's final offer?
2137. § 137.141 How does the Secretary reject a final offer?
2138. § 137.142 What is a “significant danger” or “risk” to the public health?
2139. § 137.143 How is the funding level to which the Indian Tribe is entitled determined?
2140. § 137.144 Is technical assistance available to an Indian Tribe to avoid rejection of a final offer?
2141. § 137.145 If the Secretary rejects a final offer, is the Secretary required to provide the Indian Tribe with technical assistance?
2142. § 137.146 If the Secretary rejects all or part of a final offer, is the Indian Tribe entitled to an appeal?
2143. § 137.147 Do those portions of the compact, funding agreement, or amendment not in dispute go into effect?
2144. § 137.148 Does appealing the decision of the Secretary prevent entering into the compact, funding agreement, or amendment?
2145. 104 Burden of Proof
2146. § 137.150 What is the burden of proof in an appeal from rejection of a final offer?
2147. 105 Decision Maker
2148. § 137.155 What constitutes a final agency action?
2149. Subpart I Operational Provisions
2150. 106 Conflicts of Interest
2151. § 137.160 Are Self-Governance Tribes required to address potential conflicts of interest?
2152. 107 Audits and Cost Principles
2153. § 137.165 Are Self-Governance Tribes required to undertake annual audits?
2154. § 137.166 Are there exceptions to the annual audit requirements?
2155. § 137.167 What cost principles must a Self-Governance Tribe follow when participating in self-governance under Title V?
2156. § 137.168 May the Secretary require audit or accounting standards other than those specified in § 137.167?
2157. § 137.169 How much time does the Federal Government have to make a claim against a Self-Governance Tribe relating to any disallowance of costs, based on an audit conducted under § 137.165?
2158. § 137.170 When does the 365 day period commence?
2159. § 137.171 Where do Self-Governance Tribes send their audit reports?
2160. § 137.172 Should the audit report be sent anywhere else to ensure receipt by the Secretary?
2161. § 137.173 Does a Self-Governance Tribe have a right of appeal from a disallowance?
2162. 108 Records
2163. § 137.175 Is a Self-Governance Tribe required to maintain a recordkeeping system?
2164. § 137.176 Are Tribal records subject to the Freedom of Information Act and Federal Privacy Act?
2165. § 137.177 Is the Self-Governance Tribe required to make its records available to the Secretary?
2166. § 137.178 May Self-Governance Tribes store patient records at the Federal Records Centers?
2167. § 137.179 May a Self-Governance Tribe make agreements with the Federal Records Centers regarding disclosure and release of the patient records stored pursuant to § 137.178?
2168. § 137.180 Are there other laws that govern access to patient records?
2169. 109 Redesign
2170. § 137.185 May a Self-Governance Tribe redesign or consolidate the PSFAs that are included in a funding agreement and reallocate or redirect funds for such PSFAs?
2171. 110 Non-Duplication
2172. § 137.190 Is a Self-Governance Tribe that receives funds under Title V also entitled to contract under section 102 of the Act [25 U.S.C. 450(f)] for such funds?
2173. 111 Health Status Reports
2174. § 137.200 Are there reporting requirements for Self-Governance Tribes under Title V?
2175. § 137.201 What are the purposes of the Tribal reporting requirements?
2176. § 137.202 What types of information will Self-Governance Tribes be expected to include in the reports?
2177. § 137.203 May a Self-Governance Tribe participate in a voluntary national uniform data collection effort with the IHS?
2178. § 137.204 How will this voluntary national uniform data set be developed?
2179. § 137.205 Will this voluntary uniform data set reporting activity be required of all Self-Governance Tribes entering into a compact with the IHS under Title V?
2180. § 137.206 Why does the IHS need this information?
2181. § 137.207 Will funding be provided to the Self-Governance Tribe to compensate for the costs of reporting?
2182. 112 Savings
2183. § 137.210 What happens if self-governance activities under Title V reduce the administrative or other responsibilities of the Secretary with respect to the operation of Indian programs and result in savings?
2184. § 137.211 How does a Self-Governance Tribe learn whether self-governance activities have resulted in savings as described in § 137.210.
2185. 113 Access to Government Furnished Property
2186. § 137.215 How does a Self-Governance Tribe obtain title to real and personal property furnished by the Federal Government for use in the performance of a compact, funding agreement, construction project agreement, or grant agreement pursuant to section 512(c) of the Act [25 U.S.C. 458aaa-11(c)]?
2187. 114 Matching and Cost Participation Requirements
2188. § 137.217 May funds provided under compacts, funding agreements, or grants made pursuant to Title V be treated as non-Federal funds for purposes of meeting matching or cost participation requirements under any other Federal or non-Federal program?
2189. 115 Federal Tort Claims Act (FTCA)
2190. § 137.220 Do section 314 of Public Law 101-512 [25 U.S.C. 450f note] and section 102(d) of the Act [25 U.S.C. 450f(d)] (regarding, in part, FTCA coverage) apply to compacts, funding agreements and construction project agreements?
2191. Subpart J Regulation Waiver
2192. § 137.225 What regulations may be waived under Title V?
2193. § 137.226 How does a Self-Governance Tribe request a waiver?
2194. § 137.227 How much time does the Secretary have to act on a waiver request?
2195. § 137.228 Upon what basis may the waiver request be denied?
2196. § 137.229 What happens if the Secretary neither approves or denies a waiver request within the time specified in § 137.227?
2197. § 137.230 Is the Secretary's decision on a waiver request final for the Department?
2198. § 137.231 May a Self-Governance Tribe appeal the Secretary's decision to deny its request for a waiver of a regulation promulgated under section 517 of the Act [25 U.S.C. 458aaa-16]?
2199. Subpart K Withdrawal
2200. § 137.235 May an Indian Tribe withdraw from a participating inter-Tribal consortium or Tribal organization?
2201. § 137.236 When does a withdrawal become effective?
2202. § 137.237 How are funds redistributed when an Indian Tribe fully or partially withdraws from a compact or funding agreement and elects to enter a contract or compact?
2203. § 137.238 How are funds distributed when an Indian Tribe fully or partially withdraws from a compact or funding agreement administered by an inter-Tribal consortium or Tribal organization serving more than one Indian Tribe and the withdrawing Indian Tribe elects not to enter a contract or compact?
2204. § 137.239 If the withdrawing Indian Tribe elects to operate PSFAs carried out under a compact or funding agreement under Title V through a contract under Title I, is the resulting contract considered a mature contract under section 4(h) of the Act [25 U.S.C. 450b(h)]?
2205. Subpart L Retrocession
2206. § 137.245 What is retrocession?
2207. § 137.246 How does a Self-Governance Tribe retrocede a PSFA?
2208. § 137.247 What is the effective date of a retrocession?
2209. § 137.248 What effect will a retrocession have on a retroceding Self-Governance Tribe's rights to contract or compact under the Act?
2210. § 137.249 Will retrocession adversely affect funding available for the retroceded program?
2211. § 137.250 How are funds distributed when a Self-Governance Tribe fully or partially retrocedes from its compact or funding agreement?
2212. § 137.251 What obligation does the retroceding Self-Governance Tribe have with respect to returning property that was provided by the Secretary under the compact or funding agreement and that was used in the operation of the retroceded program?
2213. Subpart M Reassumption
2214. § 137.255 What does reassumption mean?
2215. § 137.256 Under what circumstances may the Secretary reassume a program, service, function, or activity (or portion thereof)?
2216. § 137.257 What steps must the Secretary take prior to reassumption becoming effective?
2217. § 137.258 Does the Self-Governance Tribe have a right to a hearing prior to a non-immediate reassumption becoming effective?
2218. § 137.259 What happens if the Secretary determines that the Self-Governance Tribe has not corrected the conditions that the Secretary identified in the notice?
2219. § 137.260 What is the earliest date on which a reassumption can be effective?
2220. § 137.261 Does the Secretary have the authority to immediately reassume a PSFA?
2221. § 137.262 If the Secretary reassumes a PSFA immediately, when must the Secretary provide the Self-Governance Tribe with a hearing?
2222. § 137.263 May the Secretary provide a grant to a Self-Governance Tribe for technical assistance to overcome conditions identified under § 137.257?
2223. § 137.264 To what extent may the Secretary require the Self-Governance Tribe to return property that was provided by the Secretary under the compact or funding agreement and used in the operation of the reassumed program?
2224. § 137.265 May a Tribe be reimbursed for actual and reasonable close out costs incurred after the effective date of reassumption?
2225. Subpart N Construction
2226. 116 Purpose and Scope
2227. § 137.270 What is covered by this subpart?
2228. § 137.271 Why is there a separate subpart in these regulations for construction project agreements?
2229. § 137.272 What other alternatives are available for Self-Governance Tribes to perform construction projects?
2230. § 137.273 What are IHS construction PSFAs?
2231. § 137.274 Does this subpart cover construction programs?
2232. § 137.275 May Self-Governance Tribes include IHS construction programs in a construction project agreement or in a funding agreement?
2233. 117 Construction Definitions
2234. § 137.280 Construction Definitions.
2235. 118 NEPA Process
2236. § 137.285 Are Self-Governance Tribes required to accept Federal environmental responsibilities to enter into a construction project agreement?
2237. § 137.286 Do Self-Governance Tribes become Federal agencies when they assume these Federal environmental responsibilities?
2238. § 137.287 What is the National Environmental Policy Act (NEPA)?
2239. § 137.288 What is the National Historic Preservation Act (NHPA)?
2240. § 137.289 What is a Federal undertaking under NHPA?
2241. § 137.290 What additional provisions of law are related to NEPA and NHPA?
2242. § 137.291 May Self-Governance Tribes carry out construction projects without assuming these Federal environmental responsibilities?
2243. § 137.292 How do Self-Governance Tribes assume environmental responsibilities for construction projects under section 509 of the Act [25 U.S.C. 458aaa-8]?
2244. § 137.293 Are Self-Governance Tribes required to adopt a separate resolution or take equivalent Tribal action to assume environmental responsibilities for each construction project agreement?
2245. § 137.294 What is the typical IHS environmental review process for construction projects?
2246. § 137.295 May Self-Governance Tribes elect to develop their own environmental review process?
2247. § 137.296 How does a Self-Governance Tribe comply with NEPA and NHPA?
2248. § 137.297 If the environmental review procedures of a Federal agency are adopted by a Self-Governance Tribe, is the Self-Governance Tribe responsible for ensuring the agency's policies and procedures meet the requirements of NEPA, NHPA, and related environmental laws?
2249. § 137.298 Are Self-Governance Tribes required to comply with Executive Orders to fulfill their environmental responsibilities under section 509 of the Act [25 U.S.C. 458aaa-8]?
2250. § 137.299 Are Federal funds available to cover the cost of Self-Governance Tribes carrying out environmental responsibilities?
2251. § 137.300 Since Federal environmental responsibilities are new responsibilities, which may be assumed by Tribes under section 509 of the Act [25 U.S.C. 458aaa-8], are there additional funds available to Self-Governance Tribes to carry out these formerly inherently Federal responsibilities?
2252. § 137.301 How are project and program environmental review costs identified?
2253. § 137.302 Are Federal funds available to cover start-up costs associated with initial Tribal assumption of environmental responsibilities?
2254. § 137.303 Are Federal or other funds available for training associated with Tribal assumption of environmental responsibilities?
2255. § 137.304 May Self-Governance Tribes buy back environmental services from the IHS?
2256. § 137.305 May Self-Governance Tribes act as lead, cooperating, or joint lead agencies for environmental review purposes?
2257. § 137.306 How are Self-Governance Tribes recognized as having lead, cooperating, or joint lead agency status?
2258. § 137.307 What Federal environmental responsibilities remain with the Secretary when a Self-Governance Tribe assumes Federal environmental responsibilities for construction projects under section 509 of the Act [25 U.S.C. 458aaa-8]?
2259. § 137.308 Does the Secretary have any enforcement authority for Federal environmental responsibilities assumed by Tribes under section 509 of the Act [25 U.S.C. 458aaa-8]?
2260. § 137.309 How are NEPA and NHPA obligations typically enforced?
2261. § 137.310 Are Self-Governance Tribes required to grant a limited waiver of their sovereign immunity to assume Federal environmental responsibilities under section 509 of the Act [25 U.S.C. 458aaa-8]?
2262. § 137.311 Are Self-Governance Tribes entitled to determine the nature and scope of the limited immunity waiver required under section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)]?
2263. § 137.312 Who is the proper defendant in a civil enforcement action under section 509(a)(2) of the Act [25 U.S.C. 458aaa-8(a)(2)]?
2264. 119 Notification (Prioritization Process, Planning, Development and Construction)
2265. § 137.320 Is the Secretary required to consult with affected Indian Tribes concerning construction projects and programs?
2266. § 137.321 How do Indian Tribes and the Secretary identify and request funds for needed construction projects?
2267. § 137.322 Is the Secretary required to notify an Indian Tribe that funds are available for a construction project or a phase of a project?
2268. 120 Project Assumption Process
2269. § 137.325 What does a Self-Governance Tribe do if it wants to perform a construction project under section 509 of the Act [25 U.S.C. 458aaa-8]?
2270. § 137.326 What must a Tribal proposal for a construction project agreement contain?
2271. § 137.327 May multiple projects be included in a single construction project agreement?
2272. § 137.328 Must a construction project proposal incorporate provisions of Federal construction guidelines and manuals?
2273. § 137.329 What environmental considerations must be included in the construction project agreement?
2274. § 137.330 What happens if the Self-Governance Tribe and the Secretary cannot develop a mutually agreeable construction project agreement?
2275. § 137.331 May the Secretary reject a final construction project proposal based on a determination of Tribal capacity or capability?
2276. § 137.332 On what basis may the Secretary reject a final construction project proposal?
2277. § 137.333 What procedures must the Secretary follow if the Secretary rejects a final construction project proposal, in whole or in part?
2278. § 137.334 What happens if the Secretary fails to notify the Self-Governance Tribe of a decision to approve or reject a final construction project proposal within the time period allowed?
2279. § 137.335 What costs may be included in the budget for a construction agreement?
2280. § 137.336 What is the difference between fixed-price and cost-reimbursement agreements?
2281. § 137.337 What funding must the Secretary provide in a construction project agreement?
2282. § 137.338 Must funds from other sources be incorporated into a construction project agreement?
2283. § 137.339 May a Self-Governance Tribe use project funds for matching or cost participation requirements under other Federal and non-Federal programs?
2284. § 137.340 May a Self-Governance Tribe contribute funding to a project?
2285. § 137.341 How will a Self-Governance Tribe receive payment under a construction project agreement?
2286. § 137.342 What happens to funds remaining at the conclusion of a cost reimbursement construction project?
2287. § 137.343 What happens to funds remaining at the conclusion of a fixed price construction project?
2288. § 137.344 May a Self-Governance Tribe reallocate funds among construction project agreements?
2289. 121 Roles of Self-Governance Tribe in Establishing and Implementing Construction Project Agreements
2290. § 137.350 Is a Self-Governance Tribe responsible for completing a construction project in accordance with the negotiated construction project agreement?
2291. § 137.351 Is a Self-Governance Tribe required to submit construction project progress and financial reports for construction project agreements?
2292. § 137.352 What is contained in a construction project progress report?
2293. § 137.353 What is contained in a construction project financial report?
2294. 122 Roles of the Secretary in Establishing and Implementing Construction Project Agreements
2295. § 137.360 Does the Secretary approve project planning and design documents prepared by the Self-Governance Tribe?
2296. § 137.361 Does the Secretary have any other opportunities to approve planning or design documents prepared by the Self-Governance Tribe?
2297. § 137.362 May construction project agreements be amended?
2298. § 137.363 What is the procedure for the Secretary's review and approval of amendments?
2299. § 137.364 What constitutes a significant change in the original scope of work?
2300. § 137.365 What is the procedure for the Secretary's review and approval of project planning and design documents submitted by the Self-Governance Tribe?
2301. § 137.366 May the Secretary conduct onsite project oversight visits?
2302. § 137.367 May the Secretary issue a stop work order under a construction project agreement?
2303. § 137.368 Is the Secretary responsible for oversight and compliance of health and safety codes during construction projects being performed by a Self-Governance Tribe under section 509 of the Act [25 U.S.C. 488aaa-8]?
2304. 123 Other
2305. § 137.370 Do all provisions of this part apply to construction project agreements under this subpart?
2306. § 137.371 Who takes title to real property purchased with funds provided under a construction project agreement?
2307. § 137.372 Does the Secretary have a role in the fee-to-trust process when real property is purchased with construction project agreement funds?
2308. § 137.373 Do Federal real property laws, regulations and procedures that apply to the Secretary also apply to Self-Governance Tribes that purchase real property with funds provided under a construction project agreement?
2309. § 137.374 Does the Secretary have a role in reviewing or monitoring a Self-Governance Tribe's actions in acquiring or leasing real property with funds provided under a construction project agreement?
2310. § 137.375 Are Tribally-owned facilities constructed under section 509 of the Act [25 U.S.C. 458aaa-8] eligible for replacement, maintenance, and improvement funds on the same basis as if title to such property were vested in the United States?
2311. § 137.376 Are design and construction projects performed by Self-Governance Tribes under section 509 of the Act [25 U.S.C. 458aaa-8] subject to Federal metric requirements?
2312. § 137.377 Do Federal procurement laws and regulations apply to construction project agreements performed under section 509 of the Act [25 U.S.C. 458aaa-8]?
2313. § 137.378 Do the Federal Davis-Bacon Act and wage rates apply to construction projects performed by Self-Governance Tribes using their own funds or other non-Federal funds?
2314. § 137.379 Do Davis-Bacon wage rates apply to construction projects performed by Self-Governance Tribes using Federal funds?
2315. Subpart O Secretarial Responsibilities
2316. 124 Budget Request
2317. § 137.401 What role does Tribal consultation play in the IHS annual budget request process?
2318. 125 Reports
2319. § 137.405 Is the Secretary required to report to Congress on administration of Title V and the funding requirements presently funded or unfunded?
2320. § 137.406 In compiling reports pursuant to this section, may the Secretary impose any reporting requirements on Self-Governance Tribes, not otherwise provided in Title V?
2321. § 137.407 What guidelines will be used by the Secretary to compile information required for the report?
2322. Subpart P Appeals
2323. § 137.410 For the purposes of section 110 of the Act [25 U.S.C. 450m-1] does the term contract include compacts, funding agreements, and construction project agreements entered into under Title V?
2324. 126 Post-Award Disputes
2325. § 137.412 Do the regulations at 25 CFR Part 900, Subpart N apply to compacts, funding agreements, and construction project agreements entered into under Title V?
2326. 127 Pre-Award Disputes
2327. § 137.415 What decisions may an Indian Tribe appeal under § 137.415 through 137.436?
2328. § 137.416 Do §§ 137.415 through 137.436 apply to any other disputes?
2329. § 137.417 What procedures apply to Interior Board of Indian Appeals (IBIA) proceedings?
2330. § 137.418 How does an Indian Tribe know where and when to file its appeal from decisions made by IHS?
2331. § 137.419 What authority does the IBIA have under §§ 137.415 through 137.436?
2332. § 137.420 Does an Indian Tribe have any options besides an appeal?
2333. § 137.421 How does an Indian Tribe request an informal conference?
2334. § 137.422 How is an informal conference held?
2335. § 137.423 What happens after the informal conference?
2336. § 137.424 Is the recommended decision from the informal conference final for the Secretary?
2337. § 137.425 How does an Indian Tribe appeal the initial decision if it does not request an informal conference or if it does not agree with the recommended decision resulting from the informal conference?
2338. § 137.426 May an Indian Tribe get an extension of time to file a notice of appeal?
2339. § 137.427 What happens after an Indian Tribe files an appeal?
2340. § 137.428 How is a hearing arranged?
2341. § 137.429 What happens when a hearing is necessary?
2342. § 137.430 What is the Secretary's burden of proof for appeals covered by § 137.415?
2343. § 137.431 What rights do Indian Tribes and the Secretary have during the appeal process?
2344. § 137.432 What happens after the hearing?
2345. § 137.433 Is the recommended decision always final?
2346. § 137.434 If an Indian Tribe objects to the recommended decision, what will the Secretary do?
2347. § 137.435 Will an appeal adversely affect the Indian Tribe's rights in other compact, funding negotiations, or construction project agreement?
2348. § 137.436 Will the decisions on appeal be available for the public to review?
2349. 128 Appeals of an Immediate Reassumption of a Self-Governance Program
2350. § 137.440 What happens in the case of an immediate reassumption under section 507(a)(2)(C) of the Act [25 U.S.C. 458aaa-6(a)(2)(C)]?
2351. § 137.441 Will there be a hearing?
2352. § 137.442 What happens after the hearing?
2353. § 137.443 Is the recommended decision always final?
2354. § 137.444 If a Self-Governance Tribe objects to the recommended decision, what action will the Secretary take?
2355. § 137.445 Will an immediate reassumption appeal adversely affect the Self-Governance Tribe's rights in other self-governance negotiations?
2356. 129 Equal Access to Justice Act Fees
2357. § 137.450 Does the Equal Access to Justice Act (EAJA) apply to appeals under this subpart?
2358. 138-199 PARTS 138-199 [RESERVED]
2359. 0 CHAPTERS II-III [RESERVED]
2360. CHAPTER IV CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
2361. SUBCHAPTER A GENERAL PROVISIONS
2362. PART 400 INTRODUCTION; DEFINITIONS
2363. A Subpart A [Reserved]
2364. Subpart B Definitions
2365. § 400.200 General definitions.
2366. § 400.202 Definitions specific to Medicare.
2367. § 400.203 Definitions specific to Medicaid.
2368. C Subpart C [Reserved]
2369. PART 401 GENERAL ADMINISTRATIVE REQUIREMENTS
2370. A Subpart A [Reserved]
2371. Subpart B Confidentiality and Disclosure
2372. § 401.101 Purpose and scope.
2373. § 401.102 Definitions.
2374. § 401.105 Rules for disclosure.
2375. § 401.106 Publication.
2376. § 401.108 CMS rulings.
2377. § 401.109 Precedential Final Decisions of the Secretary.
2378. § 401.110 Publications for sale.
2379. § 401.112 Availability of administrative staff manuals.
2380. § 401.116 Availability of records upon request.
2381. § 401.118 Deletion of identifying details.
2382. § 401.120 Creation of records.
2383. § 401.126 Information or records that are not available.
2384. § 401.128 Where requests for records may be made.
2385. § 401.130 Materials available at social security district offices and branch offices.
2386. § 401.132 Materials in field offices of the Office of Hearings and Appeals, SSA.
2387. § 401.133 Availability of official reports on providers and suppliers of services, State agencies, intermediaries, and carriers under Medicare.
2388. § 401.134 Release of Medicare information to State and Federal agencies.
2389. § 401.135 Release of Medicare information to the public.
2390. § 401.136 Requests for information or records.
2391. § 401.140 Fees and charges.
2392. § 401.144 Denial of requests.
2393. § 401.148 Administrative review.
2394. § 401.152 Court review.
2395. C Subpart C [Reserved]
2396. Subpart D Reporting and Returning of Overpayments
2397. § 401.301 Basis and scope.
2398. § 401.303 Definitions.
2399. § 401.305 Requirements for reporting and returning of overpayments.
2400. E Subpart E [Reserved]
2401. Subpart F Claims Collection and Compromise
2402. § 401.601 Basis and scope.
2403. § 401.603 Definitions.
2404. § 401.605 Omissions not a defense.
2405. § 401.607 Claims collection.
2406. § 401.613 Compromise of claims.
2407. § 401.615 Payment of compromise amount.
2408. § 401.617 Suspension of collection action.
2409. § 401.621 Termination of collection action.
2410. § 401.623 Joint and several liability.
2411. § 401.625 Effect of CMS claims collection decisions on appeals.
2412. Subpart G Availability of Medicare Data for Performance Measurement
2413. § 401.701 Purpose and scope.
2414. § 401.703 Definitions.
2415. § 401.705 Eligibility criteria for qualified entities.
2416. § 401.707 Operating and governance requirements for qualified entities.
2417. § 401.709 The application process and requirements.
2418. § 401.711 Updates to plans submitted as part of the application process.
2419. § 401.713 Ensuring the privacy and security of data.
2420. § 401.715 Selection and use of performance measures.
2421. § 401.716 Non-public analyses.
2422. § 401.717 Provider and supplier requests for error correction.
2423. § 401.718 Dissemination of data.
2424. § 401.719 Monitoring and sanctioning of qualified entities.
2425. § 401.721 Terminating an agreement with a qualified entity.
2426. § 401.722 Qualified clinical data registries.
2427. PART 402 CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS
2428. Subpart A General Provisions
2429. § 402.1 Basis and scope.
2430. § 402.3 Definitions.
2431. § 402.5 Right to a hearing before the final determination.
2432. § 402.7 Notice of proposed determination.
2433. § 402.9 Failure to request a hearing.
2434. § 402.11 Notice to other agencies and other entities.
2435. § 402.13 Penalty, assessment, and exclusion not exclusive.
2436. § 402.15 Collateral estoppel.
2437. § 402.17 Settlement.
2438. § 402.19 Hearings and appeals.
2439. § 402.21 Judicial review.
2440. Subpart B Civil Money Penalties and Assessments
2441. § 402.105 Amount of penalty.
2442. § 402.107 Amount of assessment.
2443. § 402.109 Statistical sampling.
2444. § 402.111 Factors considered in determinations regarding the amount of penalties and assessments.
2445. § 402.113 When a penalty and assessment are collectible.
2446. § 402.115 Collection of penalty or assessment.
2447. Subpart C Exclusions
2448. § 402.200 Basis and purpose.
2449. § 402.205 Length of exclusion.
2450. § 402.208 Factors considered in determining whether to exclude, and the length of exclusion.
2451. § 402.209 Scope and effect of exclusion.
2452. § 402.210 Notices.
2453. § 402.212 Response to notice of proposed determination to exclude.
2454. § 402.214 Appeal of exclusion.
2455. § 402.300 Request for reinstatement.
2456. § 402.302 Basis for reinstatement.
2457. § 402.304 Approval of request for reinstatement.
2458. § 402.306 Denial of request for reinstatement.
2459. § 402.308 Waivers of exclusions.
2460. PART 403 SPECIAL PROGRAMS AND PROJECTS
2461. A Subpart A [Reserved]
2462. Subpart B Medicare Supplemental Policies
2463. § 403.200 Basis and scope.
2464. 5 General Provisions
2465. § 403.201 State regulation of insurance policies.
2466. § 403.205 Medicare supplemental policy.
2467. § 403.206 General standards for Medicare supplemental policies.
2468. § 403.210 NAIC model standards.
2469. § 403.215 Loss ratio standards.
2470. 6 State Regulatory Programs
2471. § 403.220 Supplemental Health Insurance Panel.
2472. § 403.222 State with an approved regulatory program.
2473. 7 Voluntary Certification Program: General Provisions
2474. § 403.231 Emblem.
2475. § 403.232 Requirements and procedures for obtaining certification.
2476. § 403.235 Review and certification of policies.
2477. § 403.239 Submittal of material to retain certification.
2478. § 403.245 Loss of certification.
2479. § 403.248 Administrative review of CMS determinations.
2480. 8 Voluntary Certification Program: Loss Ratio Provisions
2481. § 403.250 Loss ratio calculations: General provisions.
2482. § 403.251 Loss ratio date and time frame provisions.
2483. § 403.253 Calculation of benefits.
2484. § 403.254 Calculation of premiums.
2485. § 403.256 Loss ratio supporting data.
2486. § 403.258 Statement of actuarial opinion.
2487. Subpart C Recognition of State Reimbursement Control Systems
2488. § 403.300 Basis and purpose.
2489. § 403.302 Definitions.
2490. § 403.304 Minimum requirements for State systems—discretionary approval.
2491. § 403.306 Additional requirements for State systems—mandatory approval.
2492. § 403.308 State systems under demonstration projects—mandatory approval.
2493. § 403.310 Reduction in payments.
2494. § 403.312 Submittal of application.
2495. § 403.314 Evaluation of State systems.
2496. § 403.316 Reconsideration of certain denied applications.
2497. § 403.318 Approval of State systems.
2498. § 403.320 CMS review and monitoring of State systems.
2499. § 403.321 State systems for hospital outpatient services.
2500. § 403.322 Termination of agreements for Medicare recognition of State systems.
2501. Subparts D F [Reserved]
2502. Subpart G Religious Nonmedical Health Care Institutions—Benefits, Conditions of Participation, and Payment
2503. § 403.700 Basis and purpose.
2504. § 403.702 Definitions and terms.
2505. § 403.720 Conditions for coverage.
2506. § 403.724 Valid election requirements.
2507. § 403.730 Condition of participation: Patient rights.
2508. § 403.732 Condition of participation: Quality assessment and performance improvement.
2509. § 403.734 Condition of participation: Food services.
2510. § 403.736 Condition of participation: Discharge planning.
2511. § 403.738 Condition of participation: Administration.
2512. § 403.740 Condition of participation: Staffing.
2513. § 403.742 Condition of participation: Physical environment.
2514. § 403.744 Condition of participation: Life safety from fire.
2515. § 403.745 Condition of participation: Building safety.
2516. § 403.746 Condition of participation: Utilization review.
2517. § 403.748 Condition of participation: Emergency preparedness.
2518. § 403.750 Estimate of expenditures and adjustments.
2519. § 403.752 Payment provisions.
2520. § 403.754 Monitoring expenditure level.
2521. § 403.756 Sunset provision.
2522. § 403.764 Basis and purpose of religious nonmedical health care institutions providing home service.
2523. § 403.766 Requirements for coverage and payment of RNHCI home services.
2524. § 403.768 Excluded services.
2525. § 403.770 Payments for home services.
2526. Subpart H Medicare Prescription Drug Discount Card and Transitional Assistance Program
2527. § 403.800 Basis and scope.
2528. § 403.802 Definitions.
2529. § 403.804 General rules for solicitation, application and Medicare endorsement period.
2530. § 403.806 Sponsor requirements for eligibility for endorsement.
2531. § 403.808 Use of transitional assistance funds.
2532. § 403.810 Eligibility and reconsiderations.
2533. § 403.811 Enrollment and disenrollment and associated endorsed sponsor requirements.
2534. § 403.812 HIPAA privacy, security, administrative data standards, and national identifiers.
2535. § 403.813 Marketing limitations and record retention requirements.
2536. § 403.814 Special rules concerning Part C organizations and Medicare cost plans and their enrollees.
2537. § 403.815 Special rules concerning States.
2538. § 403.816 Special rules concerning long-term care and I/T/U pharmacies.
2539. § 403.817 Special rules concerning the territories.
2540. § 403.820 Sanctions, penalties, and termination.
2541. § 403.822 Reimbursement of transitional assistance and associated sponsor requirements.
2542. Subpart I Transparency Reports and Reporting of Physician Ownership or Investment Interests
2543. § 403.900 Purpose and scope.
2544. § 403.902 Definitions.
2545. § 403.904 Reports of payments or other transfers of value to covered recipients.
2546. § 403.906 Reports of physician ownership and investment interests.
2547. § 403.908 Procedures for electronic submission of reports.
2548. § 403.910 Delayed publication for payments made under product research or development agreements and clinical investigations.
2549. § 403.912 Penalties for failure to report.
2550. § 403.914 Preemption of State laws.
2551. Subpart K Access to Identifiable Data for the Center for Medicare and Medicaid Models
2552. § 403.1100 Purpose and scope.
2553. § 403.1105 Definitions.
2554. § 403.1110 Evaluation of models.
2555. Subpart L Requirements for Direct-to-Consumer Television Advertisements of Drugs and Biological Products To Include the List Price of That Advertised Product
2556. § 403.1200 Scope.
2557. § 403.1201 Definitions.
2558. § 403.1202 Pricing information.
2559. § 403.1203 Specific presentation requirements.
2560. § 403.1204 Compliance.
2561. SUBCHAPTER B MEDICARE PROGRAM
2562. PART 405 FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED
2563. A Subpart A [Reserved]
2564. Subpart B Medical Services Coverage Decisions That Relate to Health Care Technology
2565. § 405.201 Scope of subpart and definitions.
2566. § 405.203 FDA categorization of investigational devices.
2567. § 405.205 Coverage of a Category B (Nonexperimental/investigational) device.
2568. § 405.207 Services related to a noncovered device.
2569. § 405.209 Payment for a Category B (Nonexperimental/investigational) device.
2570. § 405.211 Coverage of items and services in FDA-approved IDE studies.
2571. § 405.212 Medicare Coverage IDE study criteria.
2572. § 405.213 Re-evaluation of a device categorization.
2573. § 405.215 Confidential commercial and trade secret information.
2574. Subpart C Suspension of Payment, Recovery of Overpayments, and Repayment of Scholarships and Loans
2575. 22 General Provisions
2576. § 405.301 Scope of subpart.
2577. 23 Liability for Payments To Providers or Suppliers and Handling of Incorrect Payments
2578. § 405.350 Individual's liability for payments made to providers and other persons for items and services furnished the individual.
2579. § 405.351 Incorrect payments for which the individual is not liable.
2580. § 405.352 Adjustment of title XVIII incorrect payments.
2581. § 405.353 Certification of amount that will be adjusted against individual title II or railroad retirement benefits.
2582. § 405.354 Procedures for adjustment or recovery—title II beneficiary.
2583. § 405.355 Waiver of adjustment or recovery.
2584. § 405.356 Principles applied in waiver of adjustment or recovery.
2585. § 405.357 Notice of right to waiver consideration.
2586. § 405.358 When waiver of adjustment or recovery may be applied.
2587. § 405.359 Liability of certifying or disbursing officer.
2588. 24 Suspension and Recoupment of Payment to Providers and Suppliers and Collection and Compromise of Overpayments
2589. § 405.370 Definitions.
2590. § 405.371 Suspension, offset, and recoupment of Medicare payments to providers and suppliers of services.
2591. § 405.372 Proceeding for suspension of payment.
2592. § 405.373 Proceeding for offset or recoupment.
2593. § 405.374 Opportunity for rebuttal.
2594. § 405.375 Time limits for, and notification of, administrative determination after receipt of rebuttal statement.
2595. § 405.376 Suspension and termination of collection action and compromise of claims for overpayment.
2596. § 405.377 Withholding Medicare payments to recover Medicaid overpayments.
2597. § 405.378 Interest charges on overpayment and underpayments to providers, suppliers, and other entities.
2598. § 405.379 Limitation on recoupment of provider and supplier overpayments.
2599. 25 Repayment of Scholarships and Loans
2600. § 405.380 Collection of past-due amounts on scholarship and loan programs.
2601. Subpart D Private Contracts
2602. § 405.400 Definitions.
2603. § 405.405 General rules.
2604. § 405.410 Conditions for properly opting-out of Medicare.
2605. § 405.415 Requirements of the private contract.
2606. § 405.420 Requirements of the opt-out affidavit.
2607. § 405.425 Effects of opting-out of Medicare.
2608. § 405.430 Failure to properly opt-out.
2609. § 405.435 Failure to maintain opt-out.
2610. § 405.440 Emergency and urgent care services.
2611. § 405.445 Cancellation of opt-out and early termination of opt-out.
2612. § 405.450 Appeals.
2613. § 405.455 Application to Medicare Advantage contracts.
2614. Subpart E Criteria for Determining Reasonable Charges
2615. § 405.500 Basis.
2616. § 405.501 Determination of reasonable charges.
2617. § 405.502 Criteria for determining reasonable charges.
2618. § 405.503 Determining customary charges.
2619. § 405.504 Determining prevailing charges.
2620. § 405.505 Determination of locality.
2621. § 405.506 Charges higher than customary or prevailing charges or lowest charge levels.
2622. § 405.507 Illustrations of the application of the criteria for determining reasonable charges.
2623. § 405.508 Determination of comparable circumstances; limitation.
2624. § 405.509 Determining the inflation-indexed charge.
2625. § 405.511 Reasonable charges for medical services, supplies, and equipment.
2626. § 405.512 Carriers' procedural terminology and coding systems.
2627. § 405.515 Reimbursement for clinical laboratory services billed by physicians.
2628. § 405.517 Payment for drugs and biologicals that are not paid on a cost or prospective payment basis.
2629. § 405.520 Payment for a physician assistant's, nurse practitioner's, and clinical nurse specialists' services and services furnished incident to their professional services.
2630. § 405.534 Limitation on payment for screening mammography services.
2631. § 405.535 Special rule for nonparticipating physicians and suppliers furnishing screening mammography services before January 1, 2002.
2632. F Subparts F- G [Reserved]
2633. Subpart H Appeals Under the Medicare Part B Program
2634. § 405.800 Appeals of CMS or a CMS contractor.
2635. § 405.803 Appeals rights.
2636. § 405.806 Impact of reversal of contractor determinations on claims processing.
2637. § 405.809 Reinstatement of provider or supplier billing privileges following corrective action.
2638. § 405.812 Effective date for DMEPOS supplier's billing privileges.
2639. § 405.815 Submission of claims.
2640. § 405.818 Deadline for processing provider enrollment initial determinations.
2641. Subpart I Determinations, Redeterminations, Reconsiderations, and Appeals Under Original Medicare (Part A and Part B)
2642. § 405.900 Basis and scope.
2643. § 405.902 Definitions.
2644. § 405.903 Prepayment review.
2645. § 405.904 Medicare initial determinations, redeterminations and appeals: General description.
2646. § 405.906 Parties to the initial determinations, redeterminations, reconsiderations, hearings, and reviews.
2647. § 405.908 Medicaid State agencies.
2648. § 405.910 Appointed representatives.
2649. § 405.912 Assignment of appeal rights.
2650. 26 Initial Determinations
2651. § 405.920 Initial determinations.
2652. § 405.921 Notice of initial determination.
2653. § 405.922 Time frame for processing initial determinations.
2654. § 405.924 Actions that are initial determinations.
2655. § 405.925 Decisions of utilization review committees.
2656. § 405.926 Actions that are not initial determinations.
2657. § 405.927 Initial determinations subject to the reopenings process.
2658. § 405.928 Effect of the initial determination.
2659. § 405.929 Post-payment review.
2660. § 405.930 Failure to respond to additional documentation request.
2661. 27 Retrospective Appeals for Changes in Patient Status That Resulted in Denial of Part A Coverage for Hospital Services
2662. § 405.931 Scope, basis, and definitions.
2663. § 405.932 Right to appeal a denial of Part A coverage resulting from a change in patient status.
2664. § 405.934 Reconsideration.
2665. § 405.936 Hearings before an ALJ and decisions by an ALJ or Attorney Adjudicator.
2666. § 405.938 Review by the Medicare Appeals Council and judicial review.
2667. 28 Redeterminations
2668. § 405.940 Right to a redetermination.
2669. § 405.942 Time frame for filing a request for a redetermination.
2670. § 405.944 Place and method of filing a request for a redetermination.
2671. § 405.946 Evidence to be submitted with the redetermination request.
2672. § 405.947 Notice to the beneficiary of applicable plan's request for a redetermination.
2673. § 405.948 Conduct of a redetermination.
2674. § 405.950 Time frame for making a redetermination.
2675. § 405.952 Withdrawal or dismissal of a request for a redetermination.
2676. § 405.954 Redetermination.
2677. § 405.956 Notice of a redetermination.
2678. § 405.958 Effect of a redetermination.
2679. 29 Reconsideration
2680. § 405.960 Right to a reconsideration.
2681. § 405.962 Timeframe for filing a request for a reconsideration.
2682. § 405.964 Place and method of filing a request for a reconsideration.
2683. § 405.966 Evidence to be submitted with the reconsideration request.
2684. § 405.968 Conduct of a reconsideration.
2685. § 405.970 Timeframe for making a reconsideration following a contractor redetermination.
2686. § 405.972 Withdrawal or dismissal of a request for reconsideration or review of a contractor's dismissal of a request for redetermination.
2687. § 405.974 Reconsideration and review of a contractor's dismissal of a request for redetermination.
2688. § 405.976 Notice of a reconsideration.
2689. § 405.978 Effect of a reconsideration.
2690. 30 Reopenings
2691. § 405.980 Reopening of initial determinations, redeterminations, reconsiderations, decisions, and reviews.
2692. § 405.982 Notice of a revised determination or decision.
2693. § 405.984 Effect of a revised determination or decision.
2694. § 405.986 Good cause for reopening.
2695. 31 Expedited Access to Judicial Review
2696. § 405.990 Expedited access to judicial review.
2697. 32 ALJ Hearings
2698. § 405.1000 Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.
2699. § 405.1002 Right to an ALJ hearing.
2700. § 405.1004 Right to a review of QIC notice of dismissal.
2701. § 405.1006 Amount in controversy required for an ALJ hearing and judicial review.
2702. § 405.1008 Parties to the proceedings on a request for an ALJ hearing.
2703. § 405.1010 When CMS or its contractors may participate in the proceedings on a request for an ALJ hearing.
2704. § 405.1012 When CMS or its contractors may be a party to a hearing.
2705. § 405.1014 Request for an ALJ hearing or a review of a QIC dismissal.
2706. § 405.1016 Time frames for deciding an appeal of a QIC reconsideration or escalated request for a QIC reconsideration.
2707. § 405.1018 Submitting evidence.
2708. § 405.1020 Time and place for a hearing before an ALJ.
2709. § 405.1022 Notice of a hearing before an ALJ.
2710. § 405.1024 Objections to the issues.
2711. § 405.1026 Disqualification of the ALJ or attorney adjudicator.
2712. § 405.1028 Review of evidence submitted by parties.
2713. § 405.1030 ALJ hearing procedures.
2714. § 405.1032 Issues before an ALJ or attorney adjudicator.
2715. § 405.1034 Requesting information from the QIC.
2716. § 405.1036 Description of an ALJ hearing process.
2717. § 405.1037 Discovery.
2718. § 405.1038 Deciding a case without a hearing before an ALJ.
2719. § 405.1040 Prehearing and posthearing conferences.
2720. § 405.1042 The administrative record.
2721. § 405.1044 Consolidated proceedings.
2722. § 405.1046 Notice of an ALJ or attorney adjudicator decision.
2723. § 405.1048 The effect of an ALJ's or attorney adjudicator's decision.
2724. § 405.1050 Removal of a hearing request from OMHA to the Council.
2725. § 405.1052 Dismissal of a request for a hearing before an ALJ or request for review of a QIC dismissal.
2726. § 405.1054 Effect of dismissal of a request for a hearing or request for review of QIC dismissal.
2727. § 405.1056 Remands of requests for hearing and requests for review.
2728. § 405.1058 Effect of a remand.
2729. 33 Applicability of Medicare Coverage Policies
2730. § 405.1060 Applicability of national coverage determinations (NCDs).
2731. § 405.1062 Applicability of local coverage determinations and other policies not binding on the ALJ or attorney adjudicator and Council.
2732. § 405.1063 Applicability of laws, regulations, CMS Rulings, and precedential decisions.
2733. 34 Medicare Appeals Council Review
2734. § 405.1100 Medicare Appeals Council review: General.
2735. § 405.1102 Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.
2736. § 405.1106 Where a request for review or escalation may be filed.
2737. § 405.1108 Council actions when request for review or escalation is filed.
2738. § 405.1110 Council reviews on its own motion.
2739. § 405.1112 Content of request for review.
2740. § 405.1114 Dismissal of request for review.
2741. § 405.1116 Effect of dismissal of request for Council review or request for hearing.
2742. § 405.1118 Obtaining evidence from the Council.
2743. § 405.1120 Filing briefs with the Council.
2744. § 405.1122 What evidence may be submitted to the Council.
2745. § 405.1124 Oral argument.
2746. § 405.1126 Case remanded by the Council.
2747. § 405.1128 Action of the Council.
2748. § 405.1130 Effect of the Council's decision.
2749. § 405.1132 Request for escalation to Federal court.
2750. § 405.1134 Extension of time to file action in Federal district court.
2751. § 405.1136 Judicial review.
2752. § 405.1138 Case remanded by a Federal district court.
2753. § 405.1140 Council review of ALJ decision in a case remanded by a Federal district court.
2754. Subpart J Procedures and Beneficiary Rights for Expedited Determinations and Reconsiderations When Coverage is Changed or Terminated
2755. § 405.1200 Notifying beneficiaries of provider service terminations.
2756. § 405.1202 Expedited determination procedures.
2757. § 405.1204 Expedited reconsiderations.
2758. § 405.1205 Notifying beneficiaries of hospital discharge appeal rights.
2759. § 405.1206 Expedited determination procedures for inpatient hospital care.
2760. § 405.1208 Hospital requests expedited QIO review.
2761. § 405.1210 Notifying eligible beneficiaries of appeal rights when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
2762. § 405.1211 Expedited determination procedures when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
2763. § 405.1212 Expedited reconsideration procedures regarding Part A coverage when a beneficiary is reclassified from an inpatient to an outpatient receiving observation services.
2764. K Subparts K-Q [Reserved]
2765. Subpart R Provider Reimbursement Determinations and Appeals
2766. § 405.1801 Introduction.
2767. § 405.1803 Contractor determination and notice of amount of program reimbursement.
2768. § 405.1804 Matters not subject to administrative and judicial review under prospective payment.
2769. § 405.1805 Parties to contractor determination.
2770. § 405.1807 Effect of contractor determination.
2771. § 405.1809 Contractor hearing procedures.
2772. § 405.1811 Right to contractor hearing; contents of, and adding issues to, hearing request.
2773. § 405.1813 Good cause extension of time limit for requesting a contractor hearing.
2774. § 405.1814 Contractor hearing officer jurisdiction.
2775. § 405.1815 Parties to proceedings before the contractor hearing officer(s).
2776. § 405.1817 Hearing officer or panel of hearing officers authorized to conduct contractor hearing; disqualification of officers.
2777. § 405.1819 Conduct of contractor hearing.
2778. § 405.1821 Prehearing discovery and other proceedings prior to the contractor hearing.
2779. § 405.1823 Evidence at contractor hearing.
2780. § 405.1825 Witnesses at contractor hearing.
2781. § 405.1827 Record of proceedings before the contractor hearing officer(s).
2782. § 405.1829 Scope of authority of contractor hearing officer(s).
2783. § 405.1831 Contractor hearing decision.
2784. § 405.1832 Contractor hearing officer review of compliance with the substantive reimbursement requirement of an appropriate cost report claim.
2785. § 405.1833 Effect of contractor hearing decision.
2786. § 405.1834 CMS reviewing official procedure and Administrator review.
2787. § 405.1835 Right to Board hearing; contents of, and adding issues to, hearing request.
2788. § 405.1836 Good cause extension of time limit for requesting a Board hearing.
2789. § 405.1837 Group appeals.
2790. § 405.1839 Amount in controversy.
2791. § 405.1840 Board jurisdiction.
2792. § 405.1842 Expedited judicial review.
2793. § 405.1843 Parties to proceedings in a Board appeal.
2794. § 405.1845 Composition of Board; hearings, decisions, and remands.
2795. § 405.1847 Disqualification of Board members.
2796. § 405.1849 Establishment of time and place of hearing by the Board.
2797. § 405.1851 Conduct of Board hearing.
2798. § 405.1853 Board proceedings prior to any hearing; discovery.
2799. § 405.1855 Evidence at Board hearing.
2800. § 405.1857 Subpoenas.
2801. § 405.1859 Witnesses.
2802. § 405.1861 Oral argument and written allegations.
2803. § 405.1863 Administrative policy at issue.
2804. § 405.1865 Record of administrative proceedings.
2805. § 405.1867 Scope of Board's legal authority.
2806. § 405.1868 Board actions in response to failure to follow Board rules.
2807. § 405.1869 Scope of Board's authority in a hearing decision.
2808. § 405.1871 Board hearing decision.
2809. § 405.1873 Board review of compliance with the reimbursement requirement of an appropriate cost report claim.
2810. § 405.1875 Administrator review.
2811. § 405.1877 Judicial review.
2812. § 405.1881 Appointment of representative.
2813. § 405.1883 Authority of representative.
2814. § 405.1885 Reopening a contractor determination or reviewing entity decision.
2815. § 405.1887 Notice of reopening; effect of reopening.
2816. § 405.1889 Effect of a revision; issue-specific nature of appeals of revised determinations and decisions.
2817. S Subparts S-T [Reserved]
2818. Subpart U Conditions for Coverage of Suppliers of End-Stage Renal Disease (ESRD) Services
2819. §§ 405.2100-405.2101 [Reserved]
2820. § 405.2102 Definitions.
2821. § 405.2110 Designation of ESRD networks.
2822. § 405.2111 [Reserved]
2823. § 405.2112 ESRD network organizations.
2824. § 405.2113 Medical review board.
2825. § 405.2114 [Reserved]
2826. §§ 405.2131-405.2184 [Reserved]
2827. V Subparts V-W [Reserved]
2828. Subpart X Rural Health Clinic and Federally Qualified Health Center Services
2829. § 405.2400 Basis.
2830. § 405.2401 Scope and definitions.
2831. § 405.2402 Rural health clinic basic requirements.
2832. § 405.2403 Rural health clinic content and terms of the agreement with the Secretary.
2833. § 405.2404 Termination of rural health clinic agreements.
2834. § 405.2410 Application of Part B deductible and coinsurance.
2835. § 405.2411 Scope of benefits.
2836. § 405.2412 Physicians' services.
2837. § 405.2413 Services and supplies incident to a physician's services.
2838. § 405.2414 Nurse practitioner, physician assistant, and certified nurse midwife services.
2839. § 405.2415 Incident to services and direct supervision.
2840. § 405.2416 Visiting nurse services.
2841. § 405.2417 Visiting nurse services: Determination of shortage of agencies.
2842. 35 Federally Qualified Health Center Services
2843. § 405.2430 Basic requirements.
2844. § 405.2434 Content and terms of the agreement.
2845. § 405.2436 Termination of agreement.
2846. § 405.2440 Conditions for reinstatement after termination by CMS.
2847. § 405.2442 Notice to the public.
2848. § 405.2444 Change of ownership.
2849. § 405.2446 Scope of services.
2850. § 405.2448 Preventive primary services.
2851. § 405.2449 Preventive services.
2852. § 405.2450 Clinical psychologist, clinical social worker, marriage and family therapist, and mental health counselor services.
2853. § 405.2452 Services and supplies incident to clinical psychologist, clinical social worker, marriage and family therapist, and mental health counselor services.
2854. 36 Payment for Rural Health Clinic and Federally Qualified Health Center Services
2855. § 405.2460 Applicability of general payment exclusions.
2856. § 405.2462 Payment for RHC and FQHC services.
2857. § 405.2463 What constitutes a visit.
2858. § 405.2464 Payment rate.
2859. § 405.2466 Annual reconciliation.
2860. § 405.2467 Requirements of the FQHC PPS.
2861. § 405.2468 Allowable costs.
2862. § 405.2469 FQHC supplemental payments.
2863. § 405.2470 Reports and maintenance of records.
2864. § 405.2472 Beneficiary appeals.
2865. PART 406 HOSPITAL INSURANCE ELIGIBILITY AND ENTITLEMENT
2866. Subpart A General Provisions
2867. § 406.1 Statutory basis.
2868. § 406.2 Scope.
2869. § 406.3 Definitions.
2870. § 406.5 Basis of eligibility and entitlement.
2871. § 406.6 Application or enrollment for hospital insurance.
2872. § 406.7 Forms to apply for entitlement under Medicare Part A.
2873. Subpart B Hospital Insurance Without Monthly Premiums
2874. § 406.10 Individual age 65 or over who is entitled to social security or railroad retirement benefits, or who is eligible for social security benefits.
2875. § 406.11 Individual age 65 or over who is not eligible as a social security or railroad retirement benefits beneficiary, or on the basis of government employment.
2876. § 406.12 Individual under age 65 who is entitled to social security or railroad retirement disability benefits.
2877. § 406.13 Individual who has end-stage renal disease.
2878. § 406.15 Special provisions applicable to Medicare qualified government employment.
2879. Subpart C Premium Hospital Insurance
2880. § 406.20 Basic requirements.
2881. § 406.21 Individual enrollment.
2882. § 406.22 Effect of month of enrollment on entitlement.
2883. § 406.24 Special enrollment period related to coverage under group health plans.
2884. § 406.25 Special enrollment period for volunteers outside the United States.
2885. § 406.26 Enrollment under State buy-in.
2886. § 406.27 Special enrollment periods for exceptional conditions.
2887. § 406.28 End of entitlement.
2888. § 406.32 Monthly premiums.
2889. § 406.33 Determination of months to be counted for premium increase: Enrollment.
2890. § 406.34 Determination of months to be counted for premium increase: Reenrollment.
2891. § 406.38 Prejudice to enrollment rights because of Federal Government error.
2892. Subpart D Special Circumstances That Affect Entitlement to Hospital Insurance
2893. § 406.50 Nonpayment of benefits on behalf of certain aliens.
2894. § 406.52 Conviction of certain offenses.
2895. PART 407 SUPPLEMENTARY MEDICAL INSURANCE (SMI) ENROLLMENT AND ENTITLEMENT
2896. Subpart A General Provisions
2897. § 407.1 Basis and scope.
2898. § 407.2 General description of program.
2899. § 407.4 Basic requirements for entitlement.
2900. Subpart B Individual Enrollment and Entitlement for SMI
2901. § 407.10 Eligibility to enroll.
2902. § 407.11 Forms used to apply for enrollment under Medicare Part B.
2903. § 407.12 General enrollment provisions.
2904. § 407.14 Initial enrollment period.
2905. § 407.15 General enrollment period.
2906. § 407.17 Automatic enrollment.
2907. § 407.18 Determining month of automatic enrollment.
2908. § 407.20 Special enrollment period related to coverage under group health plans.
2909. § 407.21 Special enrollment period for volunteers outside the United States.
2910. § 407.22 Request for individual enrollment.
2911. § 407.23 Special enrollment periods for exceptional conditions.
2912. § 407.25 Beginning of entitlement: Individual enrollment.
2913. § 407.27 Termination of entitlement: Individual enrollment.
2914. § 407.30 Limitations on enrollment.
2915. § 407.32 Prejudice to enrollment rights because of Federal Government misrepresentation, inaction, or error.
2916. Subpart C State Buy-In Agreements
2917. § 407.40 Enrollment under a State buy-in agreement.
2918. § 407.42 Buy-in groups available to the 50 States, the District of Columbia, and the Northern Mariana Islands.
2919. § 407.43 Buy-in groups available to Puerto Rico, Guam, the Virgin Islands, and American Samoa.
2920. § 407.47 Beginning of coverage under a State buy-in agreement.
2921. § 407.48 Termination of coverage under a State buy-in agreement.
2922. § 407.50 Continuation of coverage: Individual enrollment following end of coverage under a State buy-in agreement.
2923. Subpart D Part B Immunosuppressive Drug Benefit
2924. § 407.55 Eligibility to enroll.
2925. § 407.57 Part B-ID benefit enrollment.
2926. § 407.59 Attestation.
2927. § 407.62 Termination of coverage.
2928. PART 408 PREMIUMS FOR SUPPLEMENTARY MEDICAL INSURANCE
2929. Subpart A General Provisions
2930. § 408.1 Statutory basis.
2931. § 408.2 Scope and purpose.
2932. § 408.3 Definitions.
2933. § 408.4 Payment obligations.
2934. § 408.6 Methods and priorities for payment.
2935. § 408.8 Grace period and termination date.
2936. § 408.10 Claim for monthly benefits pending concurrently with request for SMI enrollment.
2937. Subpart B Amount of Monthly Premiums
2938. § 408.20 Monthly premiums.
2939. § 408.21 Reduction in Medicare Part B premium as an additional benefit under Medicare + Choice plans.
2940. § 408.22 Increased premiums for late enrollment and for reenrollment.
2941. § 408.24 Individuals who enrolled or reenrolled before April 1, 1981 or after September 30, 1981.
2942. § 408.25 Individuals who enrolled or reenrolled between April 1 and September 30, 1981.
2943. § 408.26 Examples.
2944. § 408.27 Rounding the monthly premium.
2945. § 408.28 Increased premiums due to the income-related monthly adjustment amount (IRMAA).
2946. Subpart C Deduction From Monthly Benefits
2947. § 408.40 Deduction from monthly benefits: Basic rules.
2948. § 408.42 Deduction from railroad retirement benefits.
2949. § 408.43 Deduction from social security benefits.
2950. § 408.44 Deduction from civil service annuities.
2951. § 408.45 Deduction from age 72 special payments.
2952. § 408.46 Effect of suspension of social security benefits.
2953. § 408.47 [Reserved]
2954. § 408.50 When premiums are considered paid.
2955. § 408.52 Change from direct remittance to deduction.
2956. § 408.53 Change from partial direct remittance to full deduction.
2957. Subpart D Direct Remittance: Individual Payment
2958. § 408.60 Direct remittance: Basic rules.
2959. § 408.62 Initial and subsequent billings.
2960. § 408.63 Billing procedures when monthly benefits are less than monthly premiums.
2961. § 408.65 Payment options.
2962. § 408.68 When premiums are considered paid.
2963. § 408.70 Change from quarterly to monthly payments.
2964. § 408.71 Change from deduction or State payment to direct remittance.
2965. Subpart E Direct Remittance: Group Payment
2966. § 408.80 Basic rules.
2967. § 408.82 Conditions for group billing.
2968. § 408.84 Billing and payment procedures.
2969. § 408.86 Responsibilities under group billing arrangement.
2970. § 408.88 Refund of group payments.
2971. § 408.90 Termination of group billing arrangement.
2972. § 408.92 Change from group payment to deduction or individual payment.
2973. Subpart F Termination and Reinstatement of Coverage
2974. § 408.100 Termination of coverage for nonpayment of premiums.
2975. § 408.102 Reconsideration of termination.
2976. § 408.104 Reinstatement procedures.
2977. Subpart G Collection of Unpaid Premiums; Refund of Excess Premiums After the Death of the Enrollee
2978. § 408.110 Collection of unpaid premiums.
2979. § 408.112 Refund of excess premiums after the enrollee dies.
2980. Subpart H Supplementary Medical Insurance Premium Surcharge Agreements
2981. § 408.200 Statutory basis.
2982. § 408.201 Definitions.
2983. § 408.202 Conditions for participation.
2984. § 408.205 Application procedures.
2985. § 408.207 Billing and payment procedures.
2986. § 408.210 Termination of SMI premium surcharge agreement.
2987. PART 409 HOSPITAL INSURANCE BENEFITS
2988. Subpart A Hospital Insurance Benefits: General Provisions
2989. § 409.1 Statutory basis.
2990. § 409.2 Scope.
2991. § 409.3 Definitions.
2992. § 409.5 General description of benefits.
2993. Subpart B Inpatient Hospital Services and Inpatient Critical Access Hospital Services
2994. § 409.10 Included services.
2995. § 409.11 Bed and board.
2996. § 409.12 Nursing and related services, medical social services; use of hospital or CAH facilities.
2997. § 409.13 Drugs and biologicals.
2998. § 409.14 Supplies, appliances, and equipment.
2999. § 409.15 Services furnished by an intern or a resident-in-training.
3000. § 409.16 Other diagnostic or therapeutic services.
3001. § 409.17 Physical therapy, occupational therapy, and speech-language pathology services.
3002. § 409.18 Services related to kidney transplantations.
3003. Subpart C Posthospital SNF Care
3004. § 409.20 Coverage of services.
3005. § 409.21 Nursing care.
3006. § 409.22 Bed and board.
3007. § 409.23 Physical therapy, occupational therapy, and speech-language pathology services.
3008. § 409.24 Medical social services.
3009. § 409.25 Drugs, biologicals, supplies, appliances, and equipment.
3010. § 409.26 Transfer agreement hospital services.
3011. § 409.27 Other services generally provided by (or under arrangements made by) SNFs.
3012. Subpart D Requirements for Coverage of Posthospital SNF Care
3013. § 409.30 Basic requirements.
3014. § 409.31 Level of care requirement.
3015. § 409.32 Criteria for skilled services and the need for skilled services.
3016. § 409.33 Examples of skilled nursing and rehabilitation services.
3017. § 409.34 Criteria for “daily basis”.
3018. § 409.35 Criteria for “practical matter”.
3019. § 409.36 Effect of discharge from posthospital SNF care.
3020. Subpart E Home Health Services Under Hospital Insurance
3021. § 409.40 Basis, purpose, and scope.
3022. § 409.41 Requirement for payment.
3023. § 409.42 Beneficiary qualifications for coverage of services.
3024. § 409.43 Plan of care requirements.
3025. § 409.44 Skilled services requirements.
3026. § 409.45 Dependent services requirements.
3027. § 409.46 Allowable administrative costs.
3028. § 409.47 Place of service requirements.
3029. § 409.48 Visits.
3030. § 409.49 Excluded services.
3031. § 409.50 Coinsurance for durable medical equipment (DME) and applicable disposable devices furnished as a home health service.
3032. Subpart F Scope of Hospital Insurance Benefits
3033. § 409.60 Benefit periods.
3034. § 409.61 General limitations on amount of benefits.
3035. § 409.62 Lifetime maximum on inpatient psychiatric care.
3036. § 409.63 Reduction of inpatient psychiatric benefit days available in the initial benefit period.
3037. § 409.64 Services that are counted toward allowable amounts.
3038. § 409.65 Lifetime reserve days.
3039. § 409.66 Revocation of election not to use lifetime reserve days.
3040. § 409.68 Guarantee of payment for inpatient hospital or inpatient CAH services furnished before notification of exhaustion of benefits.
3041. Subpart G Hospital Insurance Deductibles and Coinsurance
3042. § 409.80 Inpatient deductible and coinsurance: General provisions.
3043. § 409.82 Inpatient hospital deductible.
3044. § 409.83 Inpatient hospital coinsurance.
3045. § 409.85 Skilled nursing facility (SNF) care coinsurance.
3046. § 409.87 Blood deductible.
3047. § 409.89 Exemption of kidney donors from deductible and coinsurance requirements.
3048. Subpart H Payment of Hospital Insurance Benefits
3049. § 409.100 To whom payment is made.
3050. § 409.102 Amounts of payment.
3051. PART 410 SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS
3052. Subpart A General Provisions
3053. § 410.1 Basis and scope.
3054. § 410.2 Definitions.
3055. § 410.3 Scope of benefits.
3056. § 410.5 Other applicable rules.
3057. Subpart B Medical and Other Health Services
3058. § 410.10 Medical and other health services: Included services.
3059. § 410.12 Medical and other health services: Basic conditions and limitations.
3060. § 410.14 Special requirements for services furnished outside the United States.
3061. § 410.15 Annual wellness visits providing Personalized Prevention Plan Services: Conditions for and limitations on coverage.
3062. § 410.16 Initial preventive physical examination: Conditions for and limitations on coverage.
3063. § 410.17 Cardiovascular disease screening tests.
3064. § 410.18 Diabetes screening tests.
3065. § 410.19 Ultrasound screening for abdominal aortic aneurysms: Condition for and limitation on coverage.
3066. § 410.20 Physicians' services.
3067. § 410.21 Limitations on services of a chiropractor.
3068. § 410.22 Limitations on services of an optometrist.
3069. § 410.23 Screening for glaucoma: Conditions for and limitations on coverage.
3070. § 410.24 Limitations on services of a doctor of dental surgery or dental medicine.
3071. § 410.25 Limitations on services of a podiatrist.
3072. § 410.26 Services and supplies incident to a physician's professional services: Conditions.
3073. § 410.27 Therapeutic outpatient hospital or CAH services and supplies incident to a physician's or nonphysician practitioner's service: Conditions.
3074. § 410.28 Hospital or CAH diagnostic services furnished to outpatients: Conditions.
3075. § 410.29 Limitations on drugs and biologicals.
3076. § 410.30 Prescription drugs used in immunosuppressive therapy.
3077. § 410.31 Bone mass measurement: Conditions for coverage and frequency standards.
3078. § 410.32 Diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests: Conditions.
3079. § 410.33 Independent diagnostic testing facility.
3080. § 410.34 Mammography services: Conditions for and limitations on coverage.
3081. § 410.35 X-ray therapy and other radiation therapy services: Scope.
3082. § 410.36 Medical supplies, appliances, and devices: Scope.
3083. § 410.37 Colorectal cancer screening tests: Conditions for and limitations on coverage.
3084. § 410.38 Durable medical equipment, prosthetics, orthotics and supplies (DMEPOS): Scope and conditions.
3085. § 410.39 Prostate cancer screening tests: Conditions for and limitations on coverage.
3086. § 410.40 Coverage of ambulance services.
3087. § 410.41 Requirements for ambulance providers and suppliers.
3088. § 410.42 Limitations on coverage of certain services furnished to hospital outpatients.
3089. § 410.43 Partial hospitalization services: Conditions and exclusions.
3090. § 410.44 Intensive outpatient services: Conditions and exclusions.
3091. § 410.45 Rural health clinic services: Scope and conditions.
3092. § 410.46 Physician and other practitioner services furnished in or at the direction of an IHS or Indian tribal hospital or clinic: Scope and conditions.
3093. § 410.47 Pulmonary rehabilitation program: Conditions for coverage.
3094. § 410.48 Kidney disease education services.
3095. § 410.49 Cardiac rehabilitation program and intensive cardiac rehabilitation program: Conditions of coverage.
3096. § 410.50 Institutional dialysis services and supplies: Scope and conditions.
3097. § 410.52 Home dialysis services, supplies, and equipment: Scope and conditions.
3098. § 410.53 Marriage and family therapist services.
3099. § 410.54 Mental health counselor services.
3100. § 410.55 Services related to kidney donations: Conditions.
3101. § 410.56 Screening pelvic examinations.
3102. § 410.57 Preventive vaccines.
3103. § 410.58 Additional services to HMO and CMP enrollees.
3104. § 410.59 Outpatient occupational therapy services: Conditions.
3105. § 410.60 Outpatient physical therapy services: Conditions.
3106. § 410.61 Plan of treatment requirements for outpatient rehabilitation services.
3107. § 410.62 Outpatient speech-language pathology services: Conditions and exclusions.
3108. § 410.63 Hepatitis B vaccine and blood clotting factors: Conditions.
3109. § 410.64 Additional preventive services.
3110. § 410.66 Emergency outpatient services furnished by a nonparticipating hospital and services furnished in a foreign country.
3111. § 410.67 Medicare coverage and payment of Opioid use disorder treatment services furnished by Opioid treatment programs.
3112. § 410.68 Antigens: Scope and conditions.
3113. § 410.69 Services of a certified registered nurse anesthetist or an anesthesiologist's assistant: Basic rule and definitions.
3114. § 410.71 Clinical psychologist services and services and supplies incident to clinical psychologist services.
3115. § 410.72 Registered dietitians' and nutrition professionals' services.
3116. § 410.73 Clinical social worker services.
3117. § 410.74 Physician assistants' services.
3118. § 410.75 Nurse practitioners' services.
3119. § 410.76 Clinical nurse specialists' services.
3120. § 410.77 Certified nurse-midwives' services: Qualifications and conditions.
3121. § 410.78 Telehealth services.
3122. § 410.79 Medicare Diabetes Prevention Program expanded model: Conditions of coverage.
3123. Subpart C Home Health Services Under SMI
3124. § 410.80 Applicable rules.
3125. Subpart D Comprehensive Outpatient Rehabilitation Facility (CORF) Services
3126. § 410.100 Included services.
3127. § 410.102 Excluded services.
3128. § 410.105 Requirements for coverage of CORF services.
3129. Subpart E Community Mental Health Centers (CMHCs) Providing Partial Hospitalization Services and Intensive Outpatient Services
3130. § 410.110 Requirements for coverage of partial hospitalization services by CMHCs.
3131. § 410.111 Requirements for coverage of intensive outpatient services in CMHCs.
3132. F Subpart F [Reserved]
3133. Subpart G Medical Nutrition Therapy
3134. § 410.130 Definitions.
3135. § 410.132 Medical nutrition therapy.
3136. § 410.134 Provider qualifications.
3137. Subpart H Outpatient Diabetes Self-Management Training and Diabetes Outcome Measurements
3138. § 410.140 Definitions.
3139. § 410.141 Outpatient diabetes self-management training.
3140. § 410.142 CMS process for approving national accreditation organizations.
3141. § 410.143 Requirements for approved accreditation organizations.
3142. § 410.144 Quality standards for deemed entities.
3143. § 410.145 Requirements for entities.
3144. § 410.146 Diabetes outcome measurements.
3145. Subpart I Payment of SMI Benefits
3146. § 410.150 To whom payment is made.
3147. § 410.152 Amounts of payment.
3148. § 410.155 Outpatient mental health treatment limitation.
3149. § 410.160 Part B annual deductible.
3150. § 410.161 Part B blood deductible.
3151. § 410.163 Payment for services furnished to kidney donors.
3152. § 410.165 Payment for rural health clinic services and ambulatory surgical center services: Conditions.
3153. § 410.170 Payment for home health services, for medical and other health services furnished by a provider or an approved ESRD facility, and for comprehensive outpatient rehabilitation facility (CORF) services: Conditions.
3154. § 410.172 Payment for partial hospitalization services in CMHCs: Conditions.
3155. § 410.173 Payment for intensive outpatient services in CMHCs: Conditions.
3156. § 410.175 Alien absent from the United States.
3157. PART 411 EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE PAYMENT
3158. Subpart A General Exclusions and Exclusion of Particular Services
3159. § 411.1 Basis and scope.
3160. § 411.2 Conclusive effect of QIO determinations on payment of claims.
3161. § 411.4 Items and services for which neither the beneficiary nor any other person is legally obligated to pay.
3162. § 411.6 Services furnished by a Federal provider of services or other Federal agency.
3163. § 411.7 Services that must be furnished at public expense under a Federal law or Federal Government contract.
3164. § 411.8 Services paid for by a Government entity.
3165. § 411.9 Services furnished outside the United States.
3166. § 411.10 Services required as a result of war.
3167. § 411.12 Charges imposed by an immediate relative or member of the beneficiary's household.
3168. § 411.15 Particular services excluded from coverage.
3169. Subpart B Insurance Coverage That Limits Medicare Payment: General Provisions
3170. § 411.20 Basis and scope.
3171. § 411.21 Definitions.
3172. § 411.22 Reimbursement obligations of primary payers and entities that received payment from primary payers.
3173. § 411.23 Beneficiary's cooperation.
3174. § 411.24 Recovery of conditional payments.
3175. § 411.25 Primary payer's notice of primary payment responsibility.
3176. § 411.26 Subrogation and right to intervene.
3177. § 411.28 Waiver of recovery and compromise of claims.
3178. § 411.30 Effect of primary payment on benefit utilization and deductibles.
3179. § 411.31 Authority to bill primary payers for full charges.
3180. § 411.32 Basis for Medicare secondary payments.
3181. § 411.33 Amount of Medicare secondary payment.
3182. § 411.35 Limitations on charges to a beneficiary or other party when a workers' compensation plan, a no-fault insurer, or an employer group health plan is primary payer.
3183. § 411.37 Amount of Medicare recovery when a primary payment is made as a result of a judgment or settlement.
3184. § 411.39 Automobile and liability insurance (including self-insurance), no-fault insurance, and workers' compensation: Final conditional payment amounts via Web portal.
3185. Subpart C Limitations on Medicare Payment for Services Covered Under Workers' Compensation
3186. § 411.40 General provisions.
3187. § 411.43 Beneficiary's responsibility with respect to workers' compensation.
3188. § 411.45 Basis for conditional Medicare payment in workers' compensation cases.
3189. § 411.46 Lump-sum payments.
3190. § 411.47 Apportionment of a lump-sum compromise settlement of a workers' compensation claim.
3191. Subpart D Limitations on Medicare Payment for Services Covered Under Liability or No-Fault Insurance
3192. § 411.50 General provisions.
3193. § 411.51 Beneficiary's responsibility with respect to no-fault insurance.
3194. § 411.52 Basis for conditional Medicare payment in liability cases.
3195. § 411.53 Basis for conditional Medicare payment in no-fault cases.
3196. § 411.54 Limitation on charges when a beneficiary has received a liability insurance payment or has a claim pending against a liability insurer.
3197. Subpart E Limitations on Payment for Services Covered Under Group Health Plans: General Provisions
3198. § 411.100 Basis and scope.
3199. § 411.101 Definitions.
3200. § 411.102 Basic prohibitions and requirements.
3201. § 411.103 Prohibition against financial and other incentives.
3202. § 411.104 Current employment status.
3203. § 411.106 Aggregation rules.
3204. § 411.108 Taking into account entitlement to Medicare.
3205. § 411.110 Basis for determination of nonconformance.
3206. § 411.112 Documentation of conformance.
3207. § 411.114 Determination of nonconformance.
3208. § 411.115 Notice of determination of nonconformance.
3209. § 411.120 Appeals.
3210. § 411.121 Hearing procedures.
3211. § 411.122 Hearing officer's decision.
3212. § 411.124 Administrator's review of hearing decision.
3213. § 411.126 Reopening of determinations and decisions.
3214. § 411.130 Referral to Internal Revenue Service (IRS).
3215. Subpart F Special Rules: Individuals Eligible or Entitled on the Basis of ESRD, Who Are Also Covered Under Group Health Plans
3216. § 411.160 Scope.
3217. § 411.161 Prohibition against taking into account Medicare eligibility or entitlement or differentiating benefits.
3218. § 411.162 Medicare benefits secondary to group health plan benefits.
3219. § 411.163 Coordination of benefits: Dual entitlement situations.
3220. § 411.165 Basis for conditional Medicare payments.
3221. Subpart G Special Rules: Aged Beneficiaries and Spouses Who Are Also Covered Under Group Health Plans
3222. § 411.170 General provisions.
3223. § 411.172 Medicare benefits secondary to group health plan benefits.
3224. § 411.175 Basis for Medicare primary payments.
3225. Subpart H Special Rules: Disabled Beneficiaries Who Are Also Covered Under Large Group Health Plans
3226. § 411.200 Basis.
3227. § 411.201 Definitions.
3228. § 411.204 Medicare benefits secondary to LGHP benefits.
3229. § 411.206 Basis for Medicare primary payments and limits on secondary payments.
3230. I Subpart I [Reserved]
3231. Subpart J Financial Relationships Between Physicians and Entities Furnishing Designated Health Services
3232. § 411.350 Scope of subpart.
3233. § 411.351 Definitions.
3234. § 411.352 Group practice.
3235. § 411.353 Prohibition on certain referrals by physicians and limitations on billing.
3236. § 411.354 Financial relationship, compensation, and ownership or investment interest.
3237. § 411.355 General exceptions to the referral prohibition related to both ownership/investment and compensation.
3238. § 411.356 Exceptions to the referral prohibition related to ownership or investment interests.
3239. § 411.357 Exceptions to the referral prohibition related to compensation arrangements.
3240. § 411.361 Reporting requirements.
3241. § 411.362 Additional requirements concerning physician ownership and investment in hospitals.
3242. § 411.363 Process for requesting an exception from the prohibition on facility expansion.
3243. § 411.370 Advisory opinions relating to physician referrals.
3244. § 411.372 Procedure for submitting a request.
3245. § 411.373 Certification.
3246. § 411.375 Fees for the cost of advisory opinions.
3247. § 411.377 Expert opinions from outside sources.
3248. § 411.378 Withdrawing a request.
3249. § 411.379 When CMS accepts a request.
3250. § 411.380 When CMS issues a formal advisory opinion.
3251. § 411.382 CMS' right to rescind advisory opinions.
3252. § 411.384 Disclosing advisory opinions and supporting information.
3253. § 411.386 CMS's advisory opinions as exclusive.
3254. § 411.387 Effect of an advisory opinion.
3255. § 411.388 When advisory opinions are not admissible evidence.
3256. § 411.389 Range of the advisory opinion.
3257. Subpart K Payment for Certain Excluded Services
3258. § 411.400 Payment for custodial care and services not reasonable and necessary.
3259. § 411.402 Indemnification of beneficiary.
3260. § 411.404 Criteria for determining that a beneficiary knew that services were excluded from coverage as custodial care or as not reasonable and necessary.
3261. § 411.406 Criteria for determining that a provider, practitioner, or supplier knew that services were excluded from coverage as custodial care or as not reasonable and necessary.
3262. § 411.408 Refunds of amounts collected for physician services not reasonable and necessary, payment not accepted on an assignment-related basis.
3263. PART 412 PROSPECTIVE PAYMENT SYSTEMS FOR INPATIENT HOSPITAL SERVICES
3264. Subpart A General Provisions
3265. § 412.1 Scope of part.
3266. § 412.2 Basis of payment.
3267. § 412.3 Admissions.
3268. § 412.4 Discharges and transfers.
3269. § 412.6 Cost reporting periods subject to the prospective payment systems.
3270. § 412.8 Publication of schedules for determining prospective payment rates.
3271. § 412.10 Changes in the DRG classification system.
3272. Subpart B Hospital Services Subject to and Excluded From the Prospective Payment Systems for Inpatient Operating Costs and Inpatient Capital-Related Costs
3273. § 412.20 Hospital services subject to the prospective payment systems.
3274. § 412.22 Excluded hospitals and hospital units: General rules.
3275. § 412.23 Excluded hospitals: Classifications.
3276. § 412.24 Requirements under the PPS-Exempt Cancer Hospital Quality Reporting (PCHQR) Program.
3277. § 412.25 Excluded hospital units: Common requirements.
3278. § 412.27 Excluded psychiatric units: Additional requirements.
3279. § 412.29 Classification criteria for payment under the inpatient rehabilitation facility prospective payment system.
3280. § 412.30 [Reserved]
3281. Subpart C Conditions for Payment Under the Prospective Payment Systems for Inpatient Operating Costs and Inpatient Capital-Related Costs
3282. § 412.40 General requirements.
3283. § 412.42 Limitations on charges to beneficiaries.
3284. § 412.44 Medical review requirements: Admissions and quality review.
3285. § 412.46 Medical review requirements.
3286. § 412.48 Denial of payment as a result of admissions and quality review.
3287. § 412.50 Furnishing of inpatient hospital services directly or under arrangements.
3288. § 412.52 Reporting and recordkeeping requirements.
3289. Subpart D Basic Methodology for Determining Prospective Payment Federal Rates for Inpatient Operating Costs
3290. § 412.60 DRG classification and weighting factors.
3291. § 412.62 Federal rates for inpatient operating costs for fiscal year 1984.
3292. § 412.63 Federal rates for inpatient operating costs for Federal fiscal years 1984 through 2004.
3293. § 412.64 Federal rates for inpatient operating costs for Federal fiscal year 2005 and subsequent fiscal years.
3294. Subpart E Determination of Transition Period Payment Rates for the Prospective Payment System for Inpatient Operating Costs
3295. § 412.70 General description.
3296. § 412.71 Determination of base-year inpatient operating costs.
3297. § 412.72 Modification of base-year costs.
3298. § 412.73 Determination of the hospital-specific rate based on a Federal fiscal year 1982 base period.
3299. § 412.75 Determination of the hospital-specific rate for inpatient operating costs based on a Federal fiscal year 1987 base period.
3300. § 412.76 Recovery of excess transition period payment amounts resulting from unlawful claims.
3301. § 412.77 Determination of the hospital-specific rate for inpatient operating costs for sole community hospitals based on a Federal fiscal year 1996 base period.
3302. § 412.78 Determination of the hospital-specific rate for inpatient operating costs for sole community hospitals based on a Federal fiscal year 2006 base period.
3303. § 412.79 Determination of the hospital-specific rate for inpatient operating costs for Medicare-dependent, small rural hospitals based on a Federal fiscal year 2002 base period.
3304. Subpart F Payments for Outlier Cases, Special Treatment Payment for New Technology, and Payment Adjustment for Certain Replaced Devices
3305. 50 Payment for Outlier Cases
3306. § 412.80 Outlier cases: General provisions.
3307. § 412.82 Payment for extended length-of-stay cases (day outliers).
3308. § 412.84 Payment for extraordinarily high-cost cases (cost outliers).
3309. 51 Payment Adjustment for Certain Clinical Trial Cases and Expanded Access Use Immunotherapy
3310. § 412.85 Payment adjustment for certain immunotherapy cases.
3311. § 412.83 Payment for extraordinarily high-cost day outliers.
3312. § 412.86 412.86 [Reserved]
3313. 52 Additional Special Payment for Certain New Technology
3314. § 412.87 Additional payment for new medical services and technologies: General provisions.
3315. § 412.88 Additional payment for new medical service or technology.
3316. 53 Payment Adjustment for Certain Replaced Devices
3317. § 412.89 Payment adjustment for certain replaced devices.
3318. Subpart G Special Treatment of Certain Facilities Under the Prospective Payment System for Inpatient Operating Costs
3319. § 412.90 General rules.
3320. § 412.92 Special treatment: Sole community hospitals.
3321. § 412.96 Special treatment: Referral centers.
3322. § 412.98 [Reserved]
3323. § 412.100 Special treatment: Kidney transplant programs.
3324. § 412.101 Special treatment: Inpatient hospital payment adjustment for low-volume hospitals.
3325. § 412.102 Special treatment: Hospitals located in areas that are changing from urban to rural as a result of a geographic redesignation.
3326. § 412.103 Special treatment: Hospitals located in urban areas and that apply for reclassification as rural.
3327. § 412.104 Special treatment: Hospitals with high percentage of ESRD discharges.
3328. § 412.105 Special treatment: Hospitals that incur indirect costs for graduate medical education programs.
3329. § 412.106 Special treatment: Hospitals that serve a disproportionate share of low-income patients.
3330. § 412.107 Special treatment: Hospitals that receive an additional update for FYs 1998 and 1999.
3331. § 412.108 Special treatment: Medicare-dependent, small rural hospitals.
3332. § 412.109 Special treatment: Essential access community hospitals (EACHs).
3333. Subpart H Payments to Hospitals Under the Prospective Payment Systems
3334. § 412.110 Total Medicare payment.
3335. § 412.112 Payments determined on a per case basis.
3336. § 412.113 Other payments.
3337. § 412.115 Additional payments.
3338. § 412.116 Method of payment.
3339. § 412.120 Reductions to total payments.
3340. § 412.125 Effect of change of ownership on payments under the prospective payment systems.
3341. § 412.130 Retroactive adjustments for incorrectly excluded hospitals and units.
3342. § 412.140 Participation, data submission, and validation requirements under the Hospital Inpatient Quality Reporting (IQR) Program.
3343. Subpart I Adjustments to the Base Operating DRG Payment Amounts Under the Prospective Payment Systems for Inpatient Operating Costs
3344. § 412.150 Basis and scope of subpart.
3345. 54 Payment Adjustments Under the Hospital Readmissions Reduction Program
3346. § 412.152 Definitions for the Hospital Readmissions Reduction Program.
3347. § 412.154 Payment adjustments under the Hospital Readmissions Reduction Program.
3348. §§ 412.155-412.159 [Reserved]
3349. 55 Incentive Payments Under the Hospital Value-Based Purchasing Program
3350. § 412.160 Definitions for the Hospital Value-Based Purchasing (VBP) Program.
3351. § 412.161 Applicability of the Hospital Value-Based Purchasing (VBP) Program.
3352. § 412.162 Process for reducing the base operating DRG payment amount and applying the value-based incentive payment amount adjustment under the Hospital Value-Based Purchasing (VBP) Program.
3353. § 412.163 Process for making hospital-specific performance information under the Hospital Value-Based Purchasing (VBP) Program available to the public.
3354. § 412.164 Measure selection under the Hospital Value-Based Purchasing (VBP) Program.
3355. § 412.165 Performance scoring under the Hospital Value-Based Purchasing (VBP) Program.
3356. § 412.167 Appeal under the Hospital Value-Based Purchasing (VBP) Program.
3357. § 412.168 Special rules for FY 2022 and FY 2023.
3358. § 412.169 [Reserved]
3359. 56 Payment Adjustments Under the Hospital-Acquired Condition Reduction Program
3360. § 412.170 Definitions for the Hospital-Acquired Condition Reduction Program.
3361. § 412.172 Payment adjustments under the Hospital-Acquired Condition Reduction Program.
3362. § 412.190 Overall Hospital Quality Star Rating.
3363. J Subpart J [Reserved]
3364. Subpart K Prospective Payment System for Inpatient Operating Costs for Hospitals Located in Puerto Rico
3365. § 412.200 General provisions.
3366. § 412.204 Payment to hospitals located in Puerto Rico.
3367. § 412.208 Puerto Rico rates for Federal fiscal year 1988.
3368. § 412.210 Puerto Rico rates for Federal fiscal years 1989 through 2003.
3369. § 412.211 Puerto Rico rates for Federal fiscal year 2004 and subsequent fiscal years.
3370. § 412.212 National rate.
3371. § 412.220 Special treatment of certain hospitals located in Puerto Rico.
3372. Subpart L The Medicare Geographic Classification Review Board
3373. 57 Criteria and Conditions for Redesignation
3374. § 412.230 Criteria for an individual hospital seeking redesignation to another rural area or an urban area.
3375. § 412.232 Criteria for all hospitals in a rural county seeking urban redesignation.
3376. § 412.234 Criteria for all hospitals in an urban county seeking redesignation to another urban area.
3377. § 412.235 Criteria for all hospitals in a State seeking a statewide wage index redesignation.
3378. 58 Composition and Procedures
3379. § 412.246 MGCRB members.
3380. § 412.248 Number of members needed for a decision or a hearing.
3381. § 412.250 Sources of MGCRB's authority.
3382. § 412.252 Applications.
3383. § 412.254 Proceedings before MGCRB.
3384. § 412.256 Application requirements.
3385. § 412.258 Parties to MGCRB proceeding.
3386. § 412.260 Time and place of the oral hearing.
3387. § 412.262 Disqualification of an MGCRB member.
3388. § 412.264 Evidence and comments in MGCRB proceeding.
3389. § 412.266 Availability of wage data.
3390. § 412.268 Subpoenas.
3391. § 412.270 Witnesses.
3392. § 412.272 Record of proceedings before the MGCRB.
3393. § 412.273 Withdrawing an application, terminating an approved 3-year reclassification, or reinstating a previous termination.
3394. § 412.274 Scope and effect of an MGCRB decision.
3395. § 412.276 Timing of MGCRB decision and its appeal.
3396. § 412.278 Administrator's review.
3397. § 412.280 Representation.
3398. Subpart M Prospective Payment System for Inpatient Hospital Capital Costs
3399. 59 General Provisions
3400. § 412.300 Scope of subpart and definition.
3401. § 412.302 Introduction to capital costs.
3402. § 412.304 Implementation of the capital prospective payment system.
3403. 60 Basic Methodology for Determining the Federal Rate for Capital-Related Costs
3404. § 412.308 Determining and updating the Federal rate.
3405. § 412.312 Payment based on the Federal rate.
3406. § 412.316 Geographic adjustment factors.
3407. § 412.320 Disproportionate share adjustment factor.
3408. § 412.322 Indirect medical education adjustment factor.
3409. 61 Determination of Transition Period Payment Rates for Capital-Related Costs
3410. § 412.324 General description.
3411. § 412.328 Determining and updating the hospital-specific rate.
3412. § 412.331 Determining hospital-specific rates in cases of hospital merger, consolidation, or dissolution.
3413. § 412.332 Payment based on the hospital-specific rate.
3414. § 412.336 Transition period payment methodologies.
3415. § 412.340 Fully prospective payment methodology.
3416. § 412.344 Hold-harmless payment methodology.
3417. § 412.348 Exception payments.
3418. § 412.352 Budget neutrality adjustment.
3419. 62 Special Rules for Puerto Rico Hospitals
3420. § 412.370 General provisions for hospitals located in Puerto Rico.
3421. § 412.374 Payments to hospitals located in Puerto Rico.
3422. Subpart N Prospective Payment System for Inpatient Hospital Services of Inpatient Psychiatric Facilities
3423. § 412.400 Basis and scope of subpart.
3424. § 412.402 Definitions.
3425. § 412.404 Conditions for payment under the prospective payment system for inpatient hospital services of psychiatric facilities.
3426. § 412.405 Preadmission services as inpatient operating costs under the inpatient psychiatric facility prospective payment system.
3427. § 412.422 Basis of payment.
3428. § 412.424 Methodology for calculating the Federal per diem payment amount.
3429. § 412.426 Transition period.
3430. § 412.428 Publication of changes to the inpatient psychiatric facility prospective payment system.
3431. § 412.432 Method of payment under the inpatient psychiatric facility prospective payment system.
3432. § 412.433 Procedural requirements under the IPFQR Program.
3433. § 412.434 Reconsideration and appeals procedures of Inpatient Psychiatric Facilities Quality Reporting (IPFQR) Program decisions.
3434. Subpart O Prospective Payment System for Long-Term Care Hospitals
3435. § 412.500 Basis and scope of subpart.
3436. § 412.503 Definitions.
3437. § 412.505 Conditions for payment under the prospective payment system for long-term care hospitals.
3438. § 412.507 Limitation on charges to beneficiaries.
3439. § 412.508 Medical review requirements.
3440. § 412.509 Furnishing of inpatient hospital services directly or under arrangement.
3441. § 412.511 Reporting and recordkeeping requirements.
3442. § 412.513 Patient classification system.
3443. § 412.515 LTC-DRG weighting factors.
3444. § 412.517 Revision of LTC-DRG group classifications and weighting factors.
3445. § 412.521 Basis of payment.
3446. § 412.522 Application of site neutral payment rate.
3447. § 412.523 Methodology for calculating the Federal prospective payment rates.
3448. § 412.525 Adjustments to the Federal prospective payment.
3449. § 412.526 Payment provisions for a “subclause (II)” long-term care hospital.
3450. § 412.529 Special payment provision for short-stay outliers.
3451. § 412.531 Special payment provisions when an interruption of a stay occurs in a long-term care hospital.
3452. § 412.533 Transition payments.
3453. § 412.534 Special payment provisions for long-term care hospitals-within-hospitals and satellites of long-term care hospitals, effective for discharges occurring in cost reporting periods beginning on or before September 30, 2016.
3454. § 412.535 Publication of the Federal prospective payment rates.
3455. § 412.536 Special payment provisions for long-term care hospitals and satellites of long-term care hospitals that discharge Medicare patients admitted from a hospital not located in the same building or on the same campus as the long-term care hospital or satellite of the long-term care hospital, effective for discharges occurring on or before September 30, 2016 or in cost reporting periods beginning on or before June 30, 2016.
3456. § 412.538 [Reserved]
3457. § 412.540 Method of payment for preadmission services under the long-term care hospital prospective payment system.
3458. § 412.541 Method of payment under the long-term care hospital prospective payment system.
3459. § 412.560 Requirements under the Long-Term Care Hospital Quality Reporting Program (LTCH QRP).
3460. Subpart P Prospective Payment for Inpatient Rehabilitation Hospitals and Rehabilitation Units
3461. § 412.600 Basis and scope of subpart.
3462. § 412.602 Definitions.
3463. § 412.604 Conditions for payment under the prospective payment system for inpatient rehabilitation facilities.
3464. § 412.606 Patient assessments.
3465. § 412.608 Patients' rights regarding the collection of patient assessment data.
3466. § 412.610 Assessment schedule.
3467. § 412.612 Coordination of the collection of patient assessment data.
3468. § 412.614 Transmission of patient assessment data.
3469. § 412.616 Release of information collected using the patient assessment instrument.
3470. § 412.618 Assessment process for interrupted stays.
3471. § 412.620 Patient classification system.
3472. § 412.622 Basis of payment.
3473. § 412.624 Methodology for calculating the Federal prospective payment rates.
3474. § 412.626 Transition period.
3475. § 412.628 Publication of the Federal prospective payment rates.
3476. § 412.630 Limitation on review.
3477. § 412.632 Method of payment under the inpatient rehabilitation facility prospective payment system.
3478. § 412.634 Requirements under the Inpatient Rehabilitation Facility (IRF) Quality Reporting Program (QRP).
3479. PART 413 PRINCIPLES OF REASONABLE COST REIMBURSEMENT; PAYMENT FOR END-STAGE RENAL DISEASE SERVICES; PROSPECTIVELY DETERMINED PAYMENT RATES FOR SKILLED NURSING FACILITIES; PAYMENT FOR ACUTE KIDNEY INJURY DIALYSIS
3480. Subpart A Introduction and General Rules
3481. § 413.1 Introduction.
3482. § 413.5 Cost reimbursement: General.
3483. § 413.9 Cost related to patient care.
3484. § 413.13 Amount of payment if customary charges for services furnished are less than reasonable costs.
3485. § 413.17 Cost to related organizations.
3486. Subpart B Accounting Records and Reports
3487. § 413.20 Financial data and reports.
3488. § 413.24 Adequate cost data and cost finding.
3489. Subpart C Limits on Cost Reimbursement
3490. § 413.30 Limitations on payable costs.
3491. § 413.35 Limitations on coverage of costs: Charges to beneficiaries if cost limits are applied to services.
3492. § 413.40 Ceiling on the rate of increase in hospital inpatient costs.
3493. Subpart D Apportionment
3494. § 413.50 Apportionment of allowable costs.
3495. § 413.53 Determination of cost of services to beneficiaries.
3496. § 413.56 [Reserved]
3497. Subpart E Payments to Providers
3498. § 413.60 Payments to providers: General.
3499. § 413.64 Payments to providers: Specific rules.
3500. § 413.65 Requirements for a determination that a facility or an organization has provider-based status.
3501. § 413.70 Payment for services of a CAH.
3502. § 413.74 Payment to a foreign hospital.
3503. Subpart F Specific Categories of Costs
3504. § 413.75 Direct GME payments: General requirements.
3505. § 413.76 Direct GME payments: Calculation of payments for GME costs.
3506. § 413.77 Direct GME payments: Determination of per resident amounts.
3507. § 413.78 Direct GME payments: Determination of the total number of FTE residents.
3508. § 413.79 Direct GME payments: Determination of the weighted number of FTE residents.
3509. § 413.80 Direct GME payments: Determination of weighting factors for foreign medical graduates.
3510. § 413.81 Direct GME payments: Application of community support and redistribution of costs in determining FTE resident counts.
3511. § 413.82 Direct GME payments: Special rules for States that formerly had a waiver from Medicare reimbursement principles.
3512. § 413.83 Direct GME payments: Adjustment of a hospital's target amount or prospective payment hospital-specific rate.
3513. § 413.84 Prohibition against unlawful discrimination.
3514. § 413.85 Cost of approved nursing and allied health education activities.
3515. § 413.87 Payments for Medicare + Choice nursing and allied health education programs.
3516. § 413.88 Incentive payments under plans for voluntary reduction in number of medical residents.
3517. § 413.89 Bad debts, charity, and courtesy allowances.
3518. § 413.90 Research costs.
3519. § 413.92 Costs of surety bonds.
3520. § 413.94 Value of services of nonpaid workers.
3521. § 413.98 Purchase discounts and allowances, and refunds of expenses.
3522. § 413.99 Qualified and Non-Qualified Deferred Compensation Plans.
3523. § 413.100 Special treatment of certain accrued costs.
3524. § 413.102 Compensation of owners.
3525. § 413.106 Reasonable cost of physical and other therapy services furnished under arrangements.
3526. § 413.114 Payment for posthospital SNF care furnished by a swing-bed hospital.
3527. § 413.118 Payment for facility services related to covered ASC surgical procedures performed in hospitals on an outpatient basis.
3528. § 413.122 Payment for hospital outpatient radiology services and other diagnostic procedures.
3529. § 413.123 Payment for screening mammography performed by hospitals on an outpatient basis.
3530. § 413.124 Reduction to hospital outpatient operating costs.
3531. § 413.125 Payment for home health agency services.
3532. Subpart G Capital-Related Costs
3533. § 413.130 Introduction to capital-related costs.
3534. § 413.134 Depreciation: Allowance for depreciation based on asset costs.
3535. § 413.139 Depreciation: Optional allowance for depreciation based on a percentage of operating costs.
3536. § 413.144 Depreciation: Allowance for depreciation on fully depreciated or partially depreciated assets.
3537. § 413.149 Depreciation: Allowance for depreciation on assets financed with Federal or public funds.
3538. § 413.153 Interest expense.
3539. § 413.157 Return on equity capital of proprietary providers.
3540. Subpart H Payment for End-Stage Renal Disease (ESRD) Services
3541. § 413.170 Scope.
3542. § 413.171 Definitions.
3543. § 413.172 Principles of prospective payment.
3544. § 413.174 Prospective rates for hospital-based and independent ESRD facilities.
3545. § 413.176 Amount of payments.
3546. § 413.177 Quality incentive program payment.
3547. § 413.178 ESRD quality incentive program.
3548. § 413.180 Procedures for requesting exceptions to payment rates.
3549. § 413.182 Criteria for approval of exception requests.
3550. § 413.184 Payment exception: Pediatric patient mix.
3551. § 413.186 Payment exception: Self-dialysis training costs in pediatric facilities.
3552. § 413.194 Appeals.
3553. § 413.195 Limitation on Review.
3554. § 413.196 Notification of changes in rate-setting methodologies and payment rates.
3555. § 413.198 Recordkeeping and cost reporting requirements for outpatient maintenance dialysis.
3556. § 413.200 [Reserved]
3557. § 413.202 Organ procurement organization (OPO) cost for kidneys sent to foreign countries or transplanted in patients other than Medicare beneficiaries.
3558. § 413.203 Transplant center costs for organs sent to foreign countries or transplanted in patients other than Medicare beneficiaries.
3559. § 413.210 Conditions for payment under the end-stage renal disease (ESRD) prospective payment system.
3560. § 413.215 Basis of payment.
3561. § 413.217 Items and services included in the ESRD prospective payment system.
3562. § 413.220 Methodology for calculating the per-treatment base rate under the ESRD prospective payment system effective January 1, 2011.
3563. § 413.230 Determining the per treatment payment amount.
3564. § 413.231 Adjustment for wages.
3565. § 413.232 Low-volume adjustment.
3566. § 413.233 Additional facility-level adjustments.
3567. § 413.234 Drug designation process.
3568. § 413.235 Patient-level adjustments.
3569. § 413.236 Transitional add-on payment adjustment for new and innovative equipment and supplies.
3570. § 413.237 Outliers.
3571. § 413.239 Transition period.
3572. § 413.241 Pharmacy arrangements.
3573. Subpart I Prospectively Determined Payment Rates for Low-Volume Skilled Nursing Facilities, for Cost Reporting Periods Beginning Prior to July 1, 1998
3574. § 413.300 Basis and scope.
3575. § 413.302 Definitions.
3576. § 413.304 Eligibility for prospectively determined payment rates.
3577. § 413.308 Rules governing election of prospectively determined payment rates.
3578. § 413.310 Basis of payment.
3579. § 413.312 Methodology for calculating rates.
3580. § 413.314 Determining payment amounts: Routine per diem rate.
3581. § 413.316 Determining payment amounts: Ancillary services.
3582. § 413.320 Publication of prospectively determined payment rates or amounts.
3583. § 413.321 Simplified cost report for SNFs.
3584. Subpart J Prospective Payment for Skilled Nursing Facilities
3585. § 413.330 Basis and scope.
3586. § 413.333 Definitions.
3587. § 413.335 Basis of payment.
3588. § 413.337 Methodology for calculating the prospective payment rates.
3589. § 413.338 Skilled nursing facility value-based purchasing program.
3590. § 413.340 Transition period.
3591. § 413.343 Resident assessment data.
3592. § 413.345 Publication of Federal prospective payment rates.
3593. § 413.348 Limitation on review.
3594. § 413.350 Periodic interim payments for skilled nursing facilities receiving payment under the skilled nursing facility prospective payment system for Part A services.
3595. § 413.355 Additional payment: QIO reimbursement for cost of sending records electronically or by photocopy and mailing.
3596. § 413.360 Requirements under the Skilled Nursing Facility (SNF) Quality Reporting Program (QRP).
3597. Subpart K Payment for Acute Kidney Injury (AKI) Dialysis
3598. § 413.370 Scope.
3599. § 413.371 Definition.
3600. § 413.372 AKI dialysis payment rate.
3601. § 413.373 Other adjustments to the AKI dialysis payment rate.
3602. § 413.374 Renal dialysis services included in the AKI dialysis payment rate.
3603. § 413.375 Notification of changes in rate-setting methodologies and payment rates.
3604. Subpart L Payment of Organ Acquisition Costs for Transplant Hospitals. Organ Procurement Organizations, and Histocompatibility Laboratories
3605. § 413.400 Definitions.
3606. § 413.402 Organ acquisition costs.
3607. § 413.404 Standard acquisition charge.
3608. § 413.406 Acquisition of pancreata for islet cell transplant.
3609. § 413.408 [Reserved]
3610. § 413.410 [Reserved]
3611. § 413.412 Intent to transplant, intent for research, counting en bloc, and unusable organs.
3612. § 413.414 Medicare secondary payer and organ acquisition costs.
3613. § 413.416 Organ acquisition charges for kidney-paired exchanges.
3614. § 413.418 Amounts billed to organ procurement organizations for hospital services provided to deceased donors and included as organ acquisition costs.
3615. § 413.420 Payment to independent organ procurement organizations (IOPOs) and histocompatibility laboratories (HCLs) for organ acquisition costs.
3616. CHAPTER IV CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
3617. SUBCHAPTER B MEDICARE PROGRAM (CONTINUED)
3618. PART 414 PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES
3619. Subpart A General Provisions
3620. § 414.1 Basis and scope.
3621. § 414.2 Definitions.
3622. § 414.4 Fee schedule areas.
3623. § 414.5 Hospital services paid under Medicare Part B when a Part A hospital inpatient claim is denied because the inpatient admission was not reasonable and necessary, but hospital outpatient services would have been reasonable and necessary in treating the beneficiary.
3624. Subpart B Physicians and Other Practitioners
3625. § 414.20 Formula for computing fee schedule amounts.
3626. § 414.21 Medicare payment basis.
3627. § 414.22 Relative value units (RVUs).
3628. § 414.24 Publication of RVUs and direct PE inputs.
3629. § 414.26 Determining the GAF.
3630. § 414.28 Conversion factors.
3631. § 414.30 Conversion factor update.
3632. § 414.34 Payment for services and supplies incident to a physician's service.
3633. § 414.36 Payment for drugs incident to a physician's service.
3634. § 414.39 Special rules for payment of care plan oversight.
3635. § 414.40 Coding and ancillary policies.
3636. § 414.42 Adjustment for first 4 years of practice.
3637. § 414.44 Transition rules.
3638. § 414.46 Additional rules for payment of anesthesia services.
3639. § 414.48 Limits on actual charges of nonparticipating suppliers.
3640. § 414.50 Physician or other supplier billing for diagnostic tests performed or interpreted by a physician who does not share a practice with the billing physician or other supplier.
3641. § 414.52 Payment for physician assistants' services.
3642. § 414.53 Fee schedule for clinical social worker, marriage and family therapist, and mental health counselor services.
3643. § 414.54 Payment for certified nurse-midwives' services.
3644. § 414.56 Payment for nurse practitioners' and clinical nurse specialists' services.
3645. § 414.58 Payment of charges for physician services to patients in providers.
3646. § 414.60 Payment for the services of CRNAs.
3647. § 414.61 Payment for anesthesia services furnished by a teaching CRNA.
3648. § 414.62 Fee schedule for clinical psychologist services.
3649. § 414.63 Payment for outpatient diabetes self-management training.
3650. § 414.64 Payment for medical nutrition therapy.
3651. § 414.65 Payment for telehealth services.
3652. § 414.66 Incentive payments for physician scarcity areas.
3653. § 414.67 Incentive payments for services furnished in Health Professional Shortage Areas.
3654. § 414.68 Imaging accreditation.
3655. § 414.80 Incentive payment for primary care services.
3656. § 414.84 Payment for MDPP services.
3657. § 414.90 Physician Quality Reporting System (PQRS).
3658. § 414.92 Electronic Prescribing Incentive Program.
3659. § 414.94 [Reserved]
3660. Subpart C Fee Schedules for Parenteral and Enteral Nutrition (PEN) Nutrients, Equipment and Supplies, Splints, Casts, and Certain Intraocular Lenses (IOLs)
3661. § 414.100 Purpose.
3662. § 414.102 General payment rules.
3663. § 414.104 PEN Items and Services.
3664. § 414.105 Application of competitive bidding information.
3665. § 414.106 Splints and casts.
3666. § 414.108 IOLs inserted in a physician's office.
3667. § 414.110 Continuity of pricing when HCPCS codes are divided or combined.
3668. § 414.112 Establishing fee schedule amounts for new HCPCS codes for items and services without a fee schedule pricing history.
3669. § 414.114 Procedures for making benefit category determinations and payment determinations for new PEN items and services covered under the prosthetic device benefit; splints and casts; and IOLs inserted in a physician's office covered under the prosthetic device benefit.
3670. Subpart D Payment for Durable Medical Equipment and Prosthetic and Orthotic Devices
3671. § 414.200 Purpose.
3672. § 414.202 Definitions.
3673. § 414.210 General payment rules.
3674. § 414.220 Inexpensive or routinely purchased items.
3675. § 414.222 Items requiring frequent and substantial servicing.
3676. § 414.224 Customized items.
3677. § 414.226 Oxygen and oxygen equipment.
3678. § 414.228 Prosthetic and orthotic devices.
3679. § 414.229 Other durable medical equipment—capped rental items.
3680. § 414.230 Determining a period of continuous use.
3681. § 414.232 Special payment rules for transcutaneous electrical nerve stimulators (TENS).
3682. § 414.234 Prior authorization for items frequently subject to unnecessary utilization.
3683. § 414.236 Continuity of pricing when HCPCS codes are divided or combined.
3684. § 414.238 Establishing fee schedule amounts for new HCPCS codes for items and services without a fee schedule pricing history.
3685. § 414.240 Procedures for making benefit category determinations and payment determinations for new durable medical equipment, prosthetic devices, orthotics and prosthetics, surgical dressings, and therapeutic shoes and inserts.
3686. Subpart E Determination of Reasonable Charges Under the ESRD Program
3687. § 414.300 Scope of subpart.
3688. § 414.310 Determination of reasonable charges for physician services furnished to renal dialysis patients.
3689. § 414.313 Initial method of payment.
3690. § 414.314 Monthly capitation payment method.
3691. § 414.316 Payment for physician services to patients in training for self-dialysis and home dialysis.
3692. § 414.320 Determination of reasonable charges for physician renal transplantation services.
3693. § 414.330 Payment for home dialysis equipment, supplies, and support services.
3694. § 414.335 Payment for EPO furnished to a home dialysis patient for use in the home.
3695. Subpart F Competitive Bidding for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS)
3696. § 414.400 Purpose and basis.
3697. § 414.402 Definitions.
3698. § 414.404 Scope and applicability.
3699. § 414.406 Implementation of programs.
3700. § 414.408 Payment rules.
3701. § 414.409 Special payment rules.
3702. § 414.410 Phased-in implementation of competitive bidding programs.
3703. § 414.411 Special rule in case of competitions for diabetic testing strips conducted on or after January 1, 2011.
3704. § 414.412 Submission of bids under a competitive bidding program.
3705. § 414.414 Conditions for awarding contracts.
3706. § 414.416 Determination of competitive bidding payment amounts.
3707. § 414.418 Opportunity for networks.
3708. § 414.420 Physician or treating practitioner authorization and consideration of clinical efficiency and value of items.
3709. § 414.422 Terms of contracts.
3710. § 414.423 Appeals process for breach of a DMEPOS competitive bidding program contract actions.
3711. § 414.424 Administrative or judicial review.
3712. § 414.425 Claims for damages.
3713. § 414.426 Adjustments to competitively bid payment amounts to reflect changes in the HCPCS.
3714. Subpart G Payment for Clinical Diagnostic Laboratory Tests
3715. § 414.500 Basis and scope.
3716. § 414.502 Definitions.
3717. § 414.504 Data reporting requirements.
3718. § 414.506 Procedures for public consultation for payment for a new clinical diagnostic laboratory test.
3719. § 414.507 Payment for clinical diagnostic laboratory tests.
3720. § 414.508 Payment for a new clinical diagnostic laboratory test.
3721. § 414.509 Reconsideration of basis for and amount of payment for a new clinical diagnostic laboratory test.
3722. § 414.510 Laboratory date of service for clinical laboratory and pathology specimens.
3723. § 414.522 Payment for new advanced diagnostic laboratory tests.
3724. § 414.523 Payment for laboratory specimen collection fee and travel allowance.
3725. Subpart H Fee Schedule for Ambulance Services
3726. § 414.601 Purpose.
3727. § 414.605 Definitions.
3728. § 414.610 Basis of payment.
3729. § 414.615 Transition to the ambulance fee schedule.
3730. § 414.617 Transition from regional to national ambulance fee schedule.
3731. § 414.620 Publication of the ambulance fee schedule.
3732. § 414.625 Limitation on review.
3733. § 414.626 Data reporting by ground ambulance organizations.
3734. Subpart I Payment for Drugs and Biologicals
3735. § 414.701 Purpose.
3736. § 414.704 Definitions.
3737. § 414.707 Basis of payment.
3738. Subpart J Submission of Manufacturer's Average Sales Price Data
3739. § 414.800 Purpose.
3740. § 414.802 Definitions.
3741. § 414.804 Basis of payment.
3742. § 414.806 Penalties associated with misrepresentation and the failure to submit timely and accurate ASP data.
3743. Subpart K Payment for Drugs and Biologicals Under Part B
3744. § 414.900 Basis and scope.
3745. § 414.902 Definitions.
3746. § 414.904 Average sales price as the basis for payment.
3747. § 414.906 Competitive acquisition program as the basis for payment.
3748. § 414.908 Competitive acquisition program.
3749. § 414.910 Bidding process.
3750. § 414.912 Conflicts of interest.
3751. § 414.914 Terms of contract.
3752. § 414.916 Dispute resolution for vendors and beneficiaries.
3753. § 414.917 Dispute resolution and process for suspension or termination of approved CAP contract and termination of physician participation under exigent circumstances.
3754. § 414.918 Assignment.
3755. § 414.920 Judicial review.
3756. § 414.930 Compendia for determination of medically-accepted indications for off-label uses of drugs and biologicals in an anti-cancer chemotherapeutic regimen.
3757. § 414.940 Refund for certain discarded single-dose container or single-use package drugs.
3758. Subpart L Supplying and Dispensing Fees
3759. § 414.1000 Purpose.
3760. § 414.1001 Basis of payment.
3761. Subpart M Payment for Comprehensive Outpatient Rehabilitation Facility (CORF) Services
3762. § 414.1100 Basis and scope.
3763. § 414.1105 Payment for Comprehensive Outpatient Rehabilitation Facility (CORF) services.
3764. Subpart N Value-Based Payment Modifier Under the Physician Fee Schedule
3765. § 414.1200 Basis and scope.
3766. § 414.1205 Definitions.
3767. § 414.1210 Application of the value-based payment modifier.
3768. § 414.1215 Performance and payment adjustment periods for the value-based payment modifier.
3769. § 414.1220 Reporting mechanisms for the value-based payment modifier.
3770. § 414.1225 Alignment of Physician Quality Reporting System quality measures and quality measures for the value-based payment modifier.
3771. § 414.1230 Additional measures for groups and solo practitioners.
3772. § 414.1235 Cost measures.
3773. § 414.1240 Attribution for quality of care and cost measures.
3774. § 414.1245 Scoring methods for the value-based payment modifier using the quality-tiering approach.
3775. § 414.1250 Benchmarks for quality of care measures.
3776. § 414.1255 Benchmarks for cost measures.
3777. § 414.1260 Composite scores.
3778. § 414.1265 Reliability of measures.
3779. § 414.1270 Determination and calculation of Value-Based Payment Modifier adjustments.
3780. § 414.1275 Value-based payment modifier quality-tiering scoring methodology.
3781. § 414.1280 Limitation on review.
3782. § 414.1285 Informal inquiry process.
3783. Subpart O Merit-Based Incentive Payment System and Alternative Payment Model Incentive
3784. § 414.1300 Basis and scope.
3785. § 414.1305 Definitions.
3786. § 414.1310 Applicability.
3787. § 414.1315 Virtual groups.
3788. § 414.1317 APM Entity groups.
3789. § 414.1318 Subgroups.
3790. § 414.1320 MIPS performance period.
3791. § 414.1325 Data submission requirements.
3792. § 414.1330 Quality performance category.
3793. § 414.1335 Data submission criteria for the quality performance category.
3794. § 414.1340 Data completeness criteria for the quality performance category.
3795. § 414.1350 Cost performance category.
3796. § 414.1355 Improvement activities performance category.
3797. § 414.1360 Data submission criteria for the improvement activities performance category.
3798. § 414.1365 MIPS Value Pathways.
3799. § 414.1367 APM performance pathway.
3800. § 414.1370 APM scoring standard under MIPS.
3801. § 414.1375 Promoting Interoperability (PI) performance category.
3802. § 414.1380 Scoring.
3803. § 414.1385 Targeted review and review limitations.
3804. § 414.1390 Data validation and auditing.
3805. § 414.1395 Public reporting.
3806. § 414.1400 Third party intermediaries.
3807. § 414.1405 Payment.
3808. § 414.1410 Advanced APM determination.
3809. § 414.1415 Advanced APM criteria.
3810. § 414.1420 Other payer advanced APM criteria.
3811. § 414.1425 Qualifying APM participant determination: In general.
3812. § 414.1430 Qualifying APM participant determination: QP and partial QP thresholds.
3813. § 414.1435 Qualifying APM participant determination: Medicare option.
3814. § 414.1440 Qualifying APM participant determination: All-payer combination option.
3815. § 414.1445 Determination of other payer advanced APMs.
3816. § 414.1450 APM incentive payment.
3817. § 414.1455 Limitation on review.
3818. § 414.1460 Monitoring and program integrity.
3819. § 414.1465 Physician-focused payment models.
3820. Subpart P Home Infusion Therapy Services Payment
3821. 3 Conditions for Payment
3822. § 414.1500 Basis, purpose, and scope.
3823. § 414.1505 Requirement for payment.
3824. § 414.1510 Beneficiary qualifications for coverage of services.
3825. § 414.1515 Plan of care requirements.
3826. 4 Payment System
3827. § 414.1550 Basis of payment.
3828. Subpart Q Payment for Lymphedema Compression Treatment Items
3829. § 414.1600 Purpose and definitions.
3830. § 414.1650 Payment basis for lymphedema compression treatment items.
3831. § 414.1660 Continuity of pricing when HCPCS codes are divided or combined.
3832. § 414.1670 Procedures for making benefit category determinations and payment determinations for new lymphedema compression treatment items.
3833. § 414.1680 Frequency limitations.
3834. § 414.1690 Application of competitive bidding information.
3835. Subpart R Home Intravenous Immunoglobulin (IVIG) Items and Services Payment
3836. § 414.1700 Basis of payment.
3837. PART 415 SERVICES FURNISHED BY PHYSICIANS IN PROVIDERS, SUPERVISING PHYSICIANS IN TEACHING SETTINGS, AND RESIDENTS IN CERTAIN SETTINGS
3838. Subpart A General Provisions
3839. § 415.1 Basis and scope.
3840. Subpart B Fiscal Intermediary Payments to Providers for Physician Services
3841. § 415.50 Scope.
3842. § 415.55 General payment rules.
3843. § 415.60 Allocation of physician compensation costs.
3844. § 415.70 Limits on compensation for physician services in providers.
3845. Subpart C Part B Carrier Payments for Physician Services to Beneficiaries in Providers
3846. § 415.100 Scope.
3847. § 415.102 Conditions for fee schedule payment for physician services to beneficiaries in providers.
3848. § 415.105 Amounts of payment for physician services to beneficiaries in providers.
3849. § 415.110 Conditions for payment: Medically directed anesthesia services.
3850. § 415.120 Conditions for payment: Radiology services.
3851. § 415.130 Conditions for payment: Physician pathology services.
3852. § 415.140 Conditions for payment: Split (or shared) visits.
3853. Subpart D Physician Services in Teaching Settings
3854. § 415.150 Scope.
3855. § 415.152 Definitions.
3856. § 415.160 Election of reasonable cost payment for direct medical and surgical services of physicians in teaching hospitals: General provisions.
3857. § 415.162 Determining payment for physician services furnished to beneficiaries in teaching hospitals.
3858. § 415.164 Payment to a fund.
3859. § 415.170 Conditions for payment on a fee schedule basis for physician services in a teaching setting.
3860. § 415.172 Physician fee schedule payment for services of teaching physicians.
3861. § 415.174 Exception: Evaluation and management services furnished in certain centers.
3862. § 415.176 Renal dialysis services.
3863. § 415.178 Anesthesia services.
3864. § 415.180 Teaching setting requirements for the interpretation of diagnostic radiology and other diagnostic tests.
3865. § 415.184 Psychiatric services.
3866. § 415.190 Conditions of payment: Assistants at surgery in teaching hospitals.
3867. Subpart E Services of Residents
3868. § 415.200 Services of residents in approved GME programs.
3869. § 415.202 Services of residents not in approved GME programs.
3870. § 415.204 Services of residents in skilled nursing facilities and home health agencies.
3871. § 415.206 Services of residents in nonprovider settings.
3872. § 415.208 Services of moonlighting residents.
3873. PART 416 AMBULATORY SURGICAL SERVICES
3874. Subpart A General Provisions and Definitions
3875. § 416.1 Basis and scope.
3876. § 416.2 Definitions.
3877. Subpart B General Conditions and Requirements
3878. § 416.25 Basic requirements.
3879. § 416.26 Qualifying for an agreement.
3880. § 416.30 Terms of agreement with CMS.
3881. § 416.35 Termination of agreement.
3882. Subpart C Specific Conditions for Coverage
3883. § 416.40 Condition for coverage—Compliance with State licensure law.
3884. § 416.41 Condition for coverage—Governing body and management.
3885. § 416.42 Condition for coverage—Surgical services.
3886. § 416.43 Conditions for coverage—Quality assessment and performance improvement.
3887. § 416.44 Condition for coverage—Environment.
3888. § 416.45 Condition for coverage—Medical staff.
3889. § 416.46 Condition for coverage—Nursing services.
3890. § 416.47 Condition for coverage—Medical records.
3891. § 416.48 Condition for coverage—Pharmaceutical services.
3892. § 416.49 Condition for coverage—Laboratory and radiologic services.
3893. § 416.50 Condition for coverage—Patient rights.
3894. § 416.51 Conditions for coverage—Infection control.
3895. § 416.52 Conditions for coverage—Patient admission, assessment and discharge.
3896. § 416.54 Condition for coverage—Emergency preparedness.
3897. Subpart D Scope of Benefits for Services Furnished Before January 1, 2008
3898. § 416.60 General rules.
3899. § 416.61 Scope of facility services.
3900. § 416.65 Covered surgical procedures.
3901. § 416.75 Performance of listed surgical procedures on an inpatient hospital basis.
3902. § 416.76 Applicability.
3903. Subpart E Prospective Payment System for Facility Services Furnished Before January 1, 2008
3904. § 416.120 Basis for payment.
3905. § 416.121 Applicability.
3906. § 416.125 ASC facility services payment rate.
3907. § 416.130 Publication of revised payment methodologies.
3908. § 416.140 Surveys.
3909. Subpart F Coverage, Scope of ASC Services, and Prospective Payment System for ASC Services Furnished on or After January 1, 2008
3910. § 416.160 Basis and scope.
3911. § 416.161 Applicability of this subpart.
3912. § 416.163 General rules.
3913. § 416.164 Scope of ASC services.
3914. § 416.166 Covered surgical procedures.
3915. § 416.167 Basis of payment.
3916. § 416.171 Determination of payment rates for ASC services.
3917. § 416.172 Adjustments to national payment rates.
3918. § 416.173 Publication of revised payment methodologies and payment rates.
3919. § 416.174 Payment for non-opioid pain management drugs, biologicals, and medical devices.
3920. § 416.178 Limitations on administrative and judicial review.
3921. § 416.179 Payment and coinsurance reduction for devices replaced without cost or when full or partial credit is received.
3922. Subpart G Adjustment in Payment Amounts for New Technology Intraocular Lenses Furnished by Ambulatory Service Centers
3923. § 416.180 Basis and scope.
3924. § 416.185 Process for establishing a new class of new technology IOLs.
3925. § 416.190 Request for review of payment amount.
3926. § 416.195 Determination of membership in new classes of new technology IOLs.
3927. § 416.200 Payment adjustment.
3928. Subpart H Requirements Under the Ambulatory Surgical Center Quality Reporting (ASCQR) Program
3929. § 416.300 Basis and scope of subpart.
3930. § 416.305 Participation and withdrawal requirements under the ASCQR Program.
3931. § 416.310 Data collection and submission requirements under the ASCQR Program.
3932. § 416.315 Public reporting of data under the ASCQR Program.
3933. § 416.320 Retention and removal of quality measures under the ASCQR Program.
3934. § 416.325 Measure maintenance under the ASCQR Program.
3935. § 416.330 Reconsiderations under the ASCQR Program.
3936. PART 417 HEALTH MAINTENANCE ORGANIZATIONS, COMPETITIVE MEDICAL PLANS, AND HEALTH CARE PREPAYMENT PLANS
3937. Subpart A General Provisions
3938. § 417.1 Definitions.
3939. § 417.2 Basis and scope.
3940. Subpart B Qualified Health Maintenance Organizations: Services
3941. § 417.101 Health benefits plan: Basic health services.
3942. § 417.102 Health benefits plan: Supplemental health services.
3943. § 417.103 Providers of basic and supplemental health services.
3944. § 417.104 Payment for basic health services.
3945. § 417.105 Payment for supplemental health services.
3946. § 417.106 Quality assurance program; Availability, accessibility, and continuity of basic and supplemental health services.
3947. Subpart C Qualified Health Maintenance Organizations: Organization and Operation
3948. § 417.120 Fiscally sound operation and assumption of financial risk.
3949. § 417.122 Protection of enrollees.
3950. § 417.124 Administration and management.
3951. § 417.126 Recordkeeping and reporting requirements.
3952. Subpart D Application for Federal Qualification
3953. § 417.140 Scope.
3954. § 417.142 Requirements for qualification.
3955. § 417.143 Application requirements.
3956. § 417.144 Evaluation and determination procedures.
3957. Subpart E Inclusion of Qualified Health Maintenance Organizations in Employee Health Benefits Plans
3958. § 417.150 Definitions.
3959. § 417.151 Applicability.
3960. § 417.153 Offer of HMO alternative.
3961. § 417.155 How the HMO option must be included in the health benefits plan.
3962. § 417.156 When the HMO must be offered to employees.
3963. § 417.157 Contributions for the HMO alternative.
3964. § 417.158 Payroll deductions.
3965. § 417.159 Relationship of section 1310 of the Public Health Service Act to the National Labor Relations Act and the Railway Labor Act.
3966. Subpart F Continued Regulation of Federally Qualified Health Maintenance Organizations
3967. § 417.160 Applicability.
3968. § 417.161 Compliance with assurances.
3969. § 417.162 Reporting requirements.
3970. § 417.163 Enforcement procedures.
3971. § 417.164 Effect of revocation of qualification on inclusion in employee's health benefit plans.
3972. § 417.165 Reapplication for qualification.
3973. § 417.166 Waiver of assurances.
3974. G Subparts G-I [Reserved]
3975. Subpart J Qualifying Conditions for Medicare Contracts
3976. § 417.400 Basis and scope.
3977. § 417.401 Definitions.
3978. § 417.402 Effective date of initial regulations.
3979. § 417.404 General requirements.
3980. § 417.406 Application and determination.
3981. § 417.407 Requirements for a Competitive Medical Plan (CMP).
3982. § 417.408 Contract application process.
3983. § 417.410 Qualifying conditions: General rules.
3984. § 417.412 Qualifying condition: Administration and management.
3985. § 417.413 Qualifying condition: Operating experience and enrollment.
3986. § 417.414 Qualifying condition: Range of services.
3987. § 417.416 Qualifying condition: Furnishing of services.
3988. § 417.418 Qualifying condition: Quality assurance program.
3989. Subpart K Enrollment, Entitlement, and Disenrollment under Medicare Contract
3990. § 417.420 Basic rules on enrollment and entitlement.
3991. § 417.422 Eligibility to enroll in an HMO or CMP.
3992. § 417.423 Special rules: ESRD and hospice patients.
3993. § 417.424 Denial of enrollment.
3994. § 417.426 Open enrollment requirements.
3995. § 417.427 Extending MA and Part D program disclosure requirements to section 1876 cost contract plans.
3996. § 417.428 Marketing activities.
3997. § 417.430 Application procedures.
3998. § 417.432 Conversion of enrollment.
3999. § 417.434 Reenrollment.
4000. § 417.436 Rules for enrollees.
4001. § 417.440 Entitlement to health care services from an HMO or CMP.
4002. § 417.442 Risk HMO's and CMP's: Conditions for provision of additional benefits.
4003. § 417.444 Special rules for certain enrollees of risk HMOs and CMPs.
4004. § 417.446 [Reserved]
4005. § 417.448 Restriction on payments for services received by Medicare enrollees of risk HMOs or CMPs.
4006. § 417.450 Effective date of coverage.
4007. § 417.452 Liability of Medicare enrollees.
4008. § 417.454 Charges to Medicare enrollees.
4009. § 417.456 Refunds to Medicare enrollees.
4010. § 417.458 Recoupment of uncollected deductible and coinsurance amounts.
4011. § 417.460 Disenrollment of beneficiaries by an HMO or CMP.
4012. § 417.461 Disenrollment by the enrollee.
4013. § 417.464 End of CMS's liability for payment: Disenrollment of beneficiaries and termination or default of contract.
4014. Subpart L Medicare Contract Requirements
4015. § 417.470 Basis and scope.
4016. § 417.472 Basic contract requirements.
4017. § 417.474 Effective date and term of contract.
4018. § 417.476 Waived conditions.
4019. § 417.478 Requirements of other laws and regulations.
4020. § 417.479 Requirements for physician incentive plans.
4021. § 417.480 Maintenance of records: Cost HMOs and CMPs.
4022. § 417.481 Maintenance of records: Risk HMOs and CMPs.
4023. § 417.482 Access to facilities and records.
4024. § 417.484 Requirement applicable to related entities.
4025. § 417.486 Disclosure of information and confidentiality.
4026. § 417.488 Notice of termination and of available alternatives: Risk contract.
4027. § 417.490 Renewal of contract.
4028. § 417.492 Nonrenewal of contract.
4029. § 417.494 Modification or termination of contract.
4030. § 417.496 Cost plan crosswalk.
4031. § 417.500 Intermediate sanctions for and civil monetary penalties against HMOs and CMPs.
4032. Subpart M Change of Ownership and Leasing of Facilities: Effect on Medicare Contract
4033. § 417.520 Effect on HMO and CMP contracts.
4034. Subpart N Medicare Payment to HMOs and CMPs: General Rules
4035. § 417.524 Payment to HMOs or CMPs: General.
4036. § 417.526 Payment for covered services.
4037. § 417.528 Payment when Medicare is not primary payer.
4038. Subpart O Medicare Payment: Cost Basis
4039. § 417.530 Basis and scope.
4040. § 417.531 Hospice care services.
4041. § 417.532 General considerations.
4042. § 417.533 Part B carrier responsibilities.
4043. § 417.534 Allowable costs.
4044. § 417.536 Cost payment principles.
4045. § 417.538 Enrollment and marketing costs.
4046. § 417.540 Enrollment costs.
4047. § 417.542 Reinsurance costs.
4048. § 417.544 Physicians' services furnished directly by the HMO or CMP.
4049. § 417.546 Physicians' services and other Part B supplier services furnished under arrangements.
4050. § 417.548 Provider services through arrangements.
4051. § 417.550 Special Medicare program requirements.
4052. § 417.552 Cost apportionment: General provisions.
4053. § 417.554 Apportionment: Provider services furnished directly by the HMO or CMP.
4054. § 417.556 Apportionment: Provider services furnished by the HMO or CMP through arrangements with others.
4055. § 417.558 Emergency, urgently needed, and out-of-area services for which the HMO or CMP accepts responsibility.
4056. § 417.560 Apportionment: Part B physician and supplier services.
4057. § 417.564 Apportionment and allocation of administrative and general costs.
4058. § 417.566 Other methods of allocation and apportionment.
4059. § 417.568 Adequate financial records, statistical data, and cost finding.
4060. § 417.570 Interim per capita payments.
4061. § 417.572 Budget and enrollment forecast and interim reports.
4062. § 417.574 Interim settlement.
4063. § 417.576 Final settlement.
4064. Subpart P Medicare Payment: Risk Basis
4065. § 417.580 Basis and scope.
4066. § 417.582 Definitions.
4067. § 417.584 Payment to HMOs or CMPs with risk contracts.
4068. § 417.585 Special rules: Hospice care.
4069. § 417.588 Computation of adjusted average per capita cost (AAPCC).
4070. § 417.590 Computation of the average of the per capita rates of payment.
4071. § 417.592 Additional benefits requirement.
4072. § 417.594 Computation of adjusted community rate (ACR).
4073. § 417.596 Establishment of a benefit stabilization fund.
4074. § 417.597 Withdrawal from a benefit stabilization fund.
4075. § 417.598 Annual enrollment reconciliation.
4076. Subpart Q Beneficiary Appeals
4077. § 417.600 Basis and scope.
4078. Subpart R Medicare Contract Appeals
4079. § 417.640 Applicability.
4080. S Subparts S-T [Reserved]
4081. Subpart U Health Care Prepayment Plans
4082. § 417.800 Payment to HCPPs: Definitions and basic rules.
4083. § 417.801 Agreements between CMS and health care prepayment plans.
4084. § 417.802 Allowable costs.
4085. § 417.804 Cost apportionment.
4086. § 417.806 Financial records, statistical data, and cost finding.
4087. § 417.808 Interim per capita payments.
4088. § 417.810 Final settlement.
4089. § 417.830 Scope of regulations on beneficiary appeals.
4090. § 417.832 Applicability of requirements and procedures.
4091. § 417.834 Responsibility for establishing administrative review procedures.
4092. § 417.836 Written description of administrative review procedures.
4093. § 417.838 Organization determinations.
4094. § 417.840 Administrative review procedures.
4095. Subpart V Administration of Outstanding Loans and Loan Guarantees
4096. § 417.910 Applicability.
4097. § 417.911 Definitions.
4098. § 417.920 Planning and initial development.
4099. § 417.930 Initial costs of operation.
4100. § 417.931 [Reserved]
4101. § 417.934 Reserve requirement.
4102. § 417.937 Loan and loan guarantee provisions.
4103. § 417.940 Civil action to enforce compliance with assurances.
4104. PART 418 HOSPICE CARE
4105. Subpart A General Provision and Definitions
4106. § 418.1 Statutory basis.
4107. § 418.2 Scope of part.
4108. § 418.3 Definitions.
4109. Subpart B Eligibility, Election and Duration of Benefits
4110. § 418.20 Eligibility requirements.
4111. § 418.21 Duration of hospice care coverage—Election periods.
4112. § 418.22 Certification of terminal illness.
4113. § 418.24 Election of hospice care.
4114. § 418.25 Admission to hospice care.
4115. § 418.26 Discharge from hospice care.
4116. § 418.28 Revoking the election of hospice care.
4117. § 418.30 Change of the designated hospice.
4118. Subpart C Conditions of Participation: Patient Care
4119. § 418.52 Condition of participation: Patient's rights.
4120. § 418.54 Condition of participation: Initial and comprehensive assessment of the patient.
4121. § 418.56 Condition of participation: Interdisciplinary group, care planning, and coordination of services.
4122. § 418.58 Condition of participation: Quality assessment and performance improvement.
4123. § 418.60 Condition of participation: Infection control.
4124. § 418.62 Condition of participation: Licensed professional services.
4125. 7 Core Services
4126. § 418.64 Condition of participation: Core services.
4127. § 418.66 Condition of participation: Nursing services—Waiver of requirement that substantially all nursing services be routinely provided directly by a hospice.
4128. 8 Non-Core Services
4129. § 418.70 Condition of participation: Furnishing of non-core services.
4130. § 418.72 Condition of participation: Physical therapy, occupational therapy, and speech-language pathology.
4131. § 418.74 Waiver of requirement—Physical therapy, occupational therapy, speech-language pathology, and dietary counseling.
4132. § 418.76 Condition of participation: Hospice aide and homemaker services.
4133. § 418.78 Conditions of participation—Volunteers.
4134. Subpart D Conditions of participation: Organizational Environment
4135. § 418.100 Condition of Participation: Organization and administration of services.
4136. § 418.102 Condition of participation: Medical director.
4137. § 418.104 Condition of participation: Clinical records.
4138. § 418.106 Condition of participation: Drugs and biologicals, medical supplies, and durable medical equipment.
4139. § 418.108 Condition of participation: Short-term inpatient care.
4140. § 418.110 Condition of participation: Hospices that provide inpatient care directly.
4141. § 418.112 Condition of participation: Hospices that provide hospice care to residents of a SNF/NF or ICF/IID.
4142. § 418.113 Condition of participation: Emergency preparedness.
4143. § 418.114 Condition of participation: Personnel qualifications.
4144. § 418.116 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients.
4145. E Subpart E [Reserved]
4146. Subpart F Covered Services
4147. § 418.200 Requirements for coverage.
4148. § 418.202 Covered services.
4149. § 418.204 Special coverage requirements.
4150. § 418.205 Special requirements for hospice pre-election evaluation and counseling services.
4151. Subpart G Payment for Hospice Care
4152. § 418.301 Basic rules.
4153. § 418.302 Payment procedures for hospice care.
4154. § 418.304 Payment for physician, and nurse practitioner, and physician assistant services.
4155. § 418.306 Annual update of the payment rates and adjustment for area wage differences.
4156. § 418.307 Periodic interim payments.
4157. § 418.308 Limitation on the amount of hospice payments.
4158. § 418.309 Hospice aggregate cap.
4159. § 418.310 Reporting and recordkeeping requirements.
4160. § 418.311 Administrative appeals.
4161. § 418.312 Data submission requirements under the hospice quality reporting program.
4162. Subpart H Coinsurance
4163. § 418.400 Individual liability for coinsurance for hospice care.
4164. § 418.402 Individual liability for services that are not considered hospice care.
4165. § 418.405 Effect of coinsurance liability on Medicare payment.
4166. PART 419 PROSPECTIVE PAYMENT SYSTEMS FOR HOSPITAL OUTPATIENT DEPARTMENT SERVICES
4167. Subpart A General Provisions
4168. § 419.1 Basis and scope.
4169. § 419.2 Basis of payment.
4170. Subpart B Categories of Hospitals and Services Subject to and Excluded From the Hospital Outpatient Prospective Payment System
4171. § 419.20 Hospitals subject to the hospital outpatient prospective payment system.
4172. § 419.21 Hospital services subject to the outpatient prospective payment system.
4173. § 419.22 Hospital services excluded from payment under the hospital outpatient prospective payment system.
4174. Subpart C Basic Methodology for Determining Prospective Payment Rates for Hospital Outpatient Services
4175. § 419.30 Base expenditure target for calendar year 1999.
4176. § 419.31 Ambulatory payment classification (APC) system and payment weights.
4177. § 419.32 Calculation of prospective payment rates for hospital outpatient services.
4178. Subpart D Payments to Hospitals
4179. § 419.40 Payment concepts.
4180. § 419.41 Calculation of national beneficiary copayment amounts and national Medicare program payment amounts.
4181. § 419.42 Hospital election to reduce coinsurance.
4182. § 419.43 Adjustments to national program payment and beneficiary copayment amounts.
4183. § 419.44 Payment reductions for procedures.
4184. § 419.45 Payment and copayment reduction for devices replaced without cost or when full or partial credit is received.
4185. § 419.46 Requirements under the Hospital Outpatient Quality Reporting (OQR) Program.
4186. § 419.47 Coding and payment for Category B Investigational Device Exemption (IDE) studies.
4187. § 419.48 Definition of excepted items and services.
4188. § 419.49 Additional payment for technetium-99m (Tc-99m) derived from domestically produced molybdenum-99 (Mo-99).
4189. Subpart E Updates
4190. § 419.50 Annual review.
4191. Subpart F Limitations on Review
4192. § 419.60 Limitations on administrative and judicial review.
4193. Subpart G Transitional Pass-through Payments
4194. § 419.62 Transitional pass-through payments: General rules.
4195. § 419.64 Transitional pass-through payments: Drugs and biologicals.
4196. § 419.66 Transitional pass-through payments: Medical devices.
4197. Subpart H Transitional Corridors
4198. § 419.70 Transitional adjustments to limit decline in payments.
4199. § 419.71 Payment reduction for certain X-ray imaging services.
4200. Subpart I Prior Authorization for Outpatient Department Services
4201. § 419.80 Basis and scope of this subpart.
4202. § 419.81 Definitions.
4203. § 419.82 Prior authorization for certain covered hospital outpatient department services.
4204. § 419.83 List of hospital outpatient department services requiring prior authorization.
4205. §§ 419.84-419.89 [Reserved]
4206. Subpart J Payments to Rural Emergency Hospitals (REHs)
4207. § 419.90 Basis and scope of subpart.
4208. § 419.91 Definitions.
4209. § 419.92 Payment to rural emergency hospitals.
4210. § 419.93 Payment for an off-campus provider-based department of a rural emergency hospital.
4211. § 419.94 Preclusion of administrative and judicial review.
4212. § 419.95 Requirements under the Rural Emergency Hospital Quality Reporting (REHQR) Program.
4213. PART 420 PROGRAM INTEGRITY: MEDICARE
4214. Subpart A General Provisions
4215. § 420.1 Scope and purpose.
4216. § 420.3 Other related regulations.
4217. B Subpart B [Reserved]
4218. Subpart C Disclosure of Ownership and Control Information
4219. § 420.200 Purpose.
4220. § 420.201 Definitions.
4221. § 420.202 Determination of ownership or control percentages.
4222. § 420.203 Disclosure of hiring of intermediary's former employees.
4223. § 420.204 Principals convicted of a program-related crime.
4224. § 420.205 Disclosure by providers and part B suppliers of business transaction information.
4225. § 420.206 Disclosure of persons having ownership, financial, or control interest.
4226. Subpart D Access to Books, Documents, and Records of Subcontractors
4227. § 420.300 Basis, purpose, and scope.
4228. § 420.301 Definitions.
4229. § 420.302 Requirement for access clause in contracts.
4230. § 420.303 HHS criteria for requesting books, documents, and records.
4231. § 420.304 Procedures for obtaining access to books, documents, and records.
4232. Subpart E Rewards for Information Relating to Medicare Fraud and Abuse, and Establishment of a Program to Collect Suggestions for Improving Medicare Program Efficiency and to Reward Suggesters for Monetary Savings
4233. § 420.400 Basis and scope.
4234. § 420.405 Rewards for information relating to Medicare fraud and abuse.
4235. § 420.410 Establishment of a program to collect suggestions for improving Medicare program efficiency and to reward suggesters for monetary savings.
4236. PART 421 MEDICARE CONTRACTING
4237. Subpart A Scope, Definitions, and General Provisions
4238. § 421.1 Basis, applicability, and scope.
4239. § 421.3 Definitions.
4240. § 421.5 General provisions.
4241. Subpart B Intermediaries
4242. § 421.100 Intermediary functions.
4243. § 421.103 Payment to providers.
4244. § 421.104 Assignment of providers of services to intermediaries during transition to Medicare Administrative Contractors (MACs).
4245. § 421.110 Requirements for approval of an agreement.
4246. § 421.112 Considerations relating to the effective and efficient administration of the program.
4247. § 421.114 Assignment and reassignment of providers by CMS.
4248. § 421.120 Performance criteria.
4249. § 421.122 Performance standards.
4250. § 421.124 Intermediary's failure to perform efficiently and effectively.
4251. § 421.126 Termination of agreements.
4252. § 421.128 Intermediary's opportunity for hearing and right to judicial review.
4253. Subpart C Carriers
4254. § 421.200 Carrier functions.
4255. § 421.201 Performance criteria and standards.
4256. § 421.202 Requirements and conditions.
4257. § 421.203 Carrier's failure to perform efficiently and effectively.
4258. § 421.205 Termination by the Secretary.
4259. § 421.210 Designations of regional carriers to process claims for durable medical equipment, prosthetics, orthotics and supplies.
4260. § 421.212 Railroad Retirement Board contracts.
4261. § 421.214 Advance payments to suppliers furnishing items or services under Part B.
4262. Subpart D Medicare Integrity Program Contractors
4263. § 421.300 Basis, applicability, and scope.
4264. § 421.302 Eligibility requirements for Medicare integrity program contractors.
4265. § 421.304 Medicare integrity program contractor functions.
4266. § 421.306 Awarding of a contract.
4267. § 421.308 Renewal of a contract.
4268. § 421.310 Conflict of interest requirements.
4269. § 421.312 Conflict of interest resolution.
4270. § 421.316 Limitation on Medicare integrity program contractor liability.
4271. Subpart E Medicare Administrative Contractors (MACs)
4272. § 421.400 Statutory basis and scope.
4273. § 421.401 Definitions.
4274. § 421.404 Assignment of providers and suppliers to MACs.
4275. F Subpart F [Reserved]
4276. PART 422 MEDICARE ADVANTAGE PROGRAM
4277. Subpart A General Provisions
4278. § 422.1 Basis and scope.
4279. § 422.2 Definitions.
4280. § 422.3 MA organizations' use of reinsurance.
4281. § 422.4 Types of MA plans.
4282. § 422.6 Cost-sharing in enrollment-related costs.
4283. Subpart B Eligibility, Election, and Enrollment
4284. § 422.50 Eligibility to elect an MA plan.
4285. § 422.52 Eligibility to elect an MA plan for special needs individuals.
4286. § 422.53 Eligibility to elect an MA plan for senior housing facility residents.
4287. § 422.54 Continuation of enrollment for MA local plans.
4288. § 422.56 Enrollment in an MA MSA plan.
4289. § 422.57 Limited enrollment under MA RFB plans.
4290. § 422.60 Election process.
4291. § 422.62 Election of coverage under an MA plan.
4292. § 422.64 Information about the MA program.
4293. § 422.66 Coordination of enrollment and disenrollment through MA organizations.
4294. § 422.68 Effective dates of coverage and change of coverage.
4295. § 422.74 Disenrollment by the MA organization.
4296. Subpart C Benefits and Beneficiary Protections
4297. § 422.100 General requirements.
4298. § 422.101 Requirements relating to basic benefits.
4299. § 422.102 Supplemental benefits.
4300. § 422.103 Benefits under an MA MSA plan.
4301. § 422.104 Special rules on supplemental benefits for MA MSA plans.
4302. § 422.105 Special rules for self-referral and point of service option.
4303. § 422.106 Coordination of benefits with employer or union group health plans and Medicaid.
4304. § 422.107 Requirements for dual eligible special needs plans.
4305. § 422.108 Medicare secondary payer (MSP) procedures.
4306. § 422.109 Effect of national coverage determinations (NCDs) and legislative changes in benefits; coverage of clinical trials and A and B device trials.
4307. § 422.110 Discrimination against beneficiaries prohibited.
4308. § 422.111 Disclosure requirements.
4309. § 422.112 Access to services.
4310. § 422.113 Special rules for ambulance services, emergency and urgently needed services, and maintenance and post-stabilization care services.
4311. § 422.114 Access to services under an MA private fee-for-service plan.
4312. § 422.116 Network adequacy.
4313. § 422.118 Confidentiality and accuracy of enrollee records.
4314. § 422.119 Access to and exchange of health data and plan information.
4315. § 422.120 Access to published provider directory information.
4316. § 422.121 Access to and exchange of health data for providers and payers.
4317. § 422.122 Prior authorization requirements.
4318. § 422.125 Resolution of complaints in a Complaints Tracking Module.
4319. § 422.128 Information on advance directives.
4320. § 422.132 Protection against liability and loss of benefits.
4321. § 422.133 Return to home skilled nursing facility.
4322. § 422.134 Reward and incentive programs.
4323. § 422.135 Additional telehealth benefits.
4324. § 422.136 Medicare Advantage (MA) and step therapy for Part B drugs.
4325. § 422.137 Medicare Advantage Utilization Management Committee.
4326. § 422.138 Prior authorization.
4327. Subpart D Quality Improvement
4328. § 422.152 Quality improvement program.
4329. § 422.153 Use of quality improvement organization review information.
4330. § 422.156 Compliance deemed on the basis of accreditation.
4331. § 422.157 Accreditation organizations.
4332. § 422.158 Procedures for approval of accreditation as a basis for deeming compliance.
4333. § 422.160 Basis and scope of the Medicare Advantage Quality Rating System.
4334. § 422.162 Medicare Advantage Quality Rating System.
4335. § 422.164 Adding, updating, and removing measures.
4336. § 422.166 Calculation of Star Ratings.
4337. Subpart E Relationships With Providers
4338. § 422.200 Basis and scope.
4339. § 422.202 Participation procedures.
4340. § 422.204 Provider selection and credentialing.
4341. § 422.205 Provider antidiscrimination rules.
4342. § 422.206 Interference with health care professionals' advice to enrollees prohibited.
4343. § 422.208 Physician incentive plans: requirements and limitations.
4344. § 422.210 Assurances to CMS.
4345. § 422.212 Limitations on provider indemnification.
4346. § 422.214 Special rules for services furnished by noncontract providers.
4347. § 422.216 Special rules for MA private fee-for-service plans.
4348. § 422.220 Exclusion of payment for basic benefits furnished under a private contract.
4349. § 422.222 Preclusion list for contracted and non-contracted individuals and entities.
4350. § 422.224 Payment to individuals and entities excluded by the OIG or included on the preclusion list.
4351. Subpart F Submission of Bids, Premiums, and Related Information and Plan Approval
4352. § 422.250 Basis and scope.
4353. § 422.252 Terminology.
4354. § 422.254 Submission of bids.
4355. § 422.256 Review, negotiation, and approval of bids.
4356. § 422.258 Calculation of benchmarks.
4357. § 422.260 Appeals of quality bonus payment determinations.
4358. § 422.262 Beneficiary premiums.
4359. § 422.264 Calculation of savings.
4360. § 422.266 Beneficiary rebates.
4361. § 422.270 Incorrect collections of premiums and cost-sharing.
4362. § 422.272 Release of MA bid pricing data.
4363. Subpart G Payments to Medicare Advantage Organizations
4364. § 422.300 Basis and scope.
4365. § 422.304 Monthly payments.
4366. § 422.306 Annual MA capitation rates.
4367. § 422.308 Adjustments to capitation rates, benchmarks, bids, and payments.
4368. § 422.310 Risk adjustment data.
4369. § 422.311 RADV audit dispute and appeal processes.
4370. § 422.312 Announcement of annual capitation rate, benchmarks, and methodology changes.
4371. § 422.314 Special rules for beneficiaries enrolled in MA MSA plans.
4372. § 422.316 Special rules for payments to Federally qualified health centers.
4373. § 422.318 Special rules for coverage that begins or ends during an inpatient hospital stay.
4374. § 422.320 Special rules for hospice care.
4375. § 422.322 Source of payment and effect of MA plan election on payment.
4376. § 422.324 Payments to MA organizations for graduate medical education costs.
4377. § 422.326 Reporting and returning of overpayments.
4378. § 422.330 CMS-identified overpayments associated with payment data submitted by MA organizations.
4379. Subpart H Provider-Sponsored Organizations
4380. § 422.350 Basis, scope, and definitions.
4381. § 422.352 Basic requirements.
4382. § 422.354 Requirements for affiliated providers.
4383. § 422.356 Determining substantial financial risk and majority financial interest.
4384. § 422.370 Waiver of State licensure.
4385. § 422.372 Basis for waiver of State licensure.
4386. § 422.374 Waiver request and approval process.
4387. § 422.376 Conditions of the waiver.
4388. § 422.378 Relationship to State law.
4389. § 422.380 Solvency standards.
4390. § 422.382 Minimum net worth amount.
4391. § 422.384 Financial plan requirement.
4392. § 422.386 Liquidity.
4393. § 422.388 Deposits.
4394. § 422.390 Guarantees.
4395. Subpart I Organization Compliance With State Law and Preemption by Federal Law
4396. § 422.400 State licensure requirement.
4397. § 422.402 Federal preemption of State law.
4398. § 422.404 State premium taxes prohibited.
4399. Subpart J Special Rules for MA Regional Plans
4400. § 422.451 Moratorium on new local preferred provider organization plans.
4401. § 422.455 Special rules for MA Regional Plans.
4402. § 422.458 Risk sharing with regional MA organizations for 2006 and 2007.
4403. Subpart K Application Procedures and Contracts for Medicare Advantage Organizations
4404. § 422.500 Scope and definitions.
4405. § 422.501 Application requirements.
4406. § 422.502 Evaluation and determination procedures.
4407. § 422.503 General provisions.
4408. § 422.504 Contract provisions.
4409. § 422.505 Effective date and term of contract.
4410. § 422.506 Nonrenewal of contract.
4411. § 422.508 Modification or termination of contract by mutual consent.
4412. § 422.510 Termination of contract by CMS.
4413. § 422.512 Termination of contract by the MA organization.
4414. § 422.514 Enrollment requirements.
4415. § 422.516 Validation of Part C reporting requirements.
4416. § 422.520 Prompt payment by MA organization.
4417. § 422.521 Effective date of new significant regulatory requirements.
4418. § 422.524 Special rules for RFB societies.
4419. § 422.527 Agreements with Federally qualified health centers.
4420. § 422.528 Final settlement process and payment.
4421. § 422.529 Requesting an appeal of the final settlement amount.
4422. § 422.530 Plan crosswalks.
4423. Subpart L Effect of Change of Ownership or Leasing of Facilities During Term of Contract
4424. § 422.550 General provisions.
4425. § 422.552 Novation agreement requirements.
4426. § 422.553 Effect of leasing of an MA organization's facilities.
4427. Subpart M Grievances, Organization Determinations and Appeals
4428. § 422.560 Basis and scope.
4429. § 422.561 Definitions.
4430. § 422.562 General provisions.
4431. § 422.564 Grievance procedures.
4432. § 422.566 Organization determinations.
4433. § 422.568 Standard timeframes and notice requirements for organization determinations.
4434. § 422.570 Expediting certain organization determinations.
4435. § 422.572 Timeframes and notice requirements for expedited organization determinations.
4436. § 422.574 Parties to the organization determination.
4437. § 422.576 Effect of an organization determination.
4438. § 422.578 Right to a reconsideration.
4439. § 422.580 Reconsideration defined.
4440. § 422.582 Request for a standard reconsideration.
4441. § 422.584 Expediting certain reconsiderations.
4442. § 422.586 Opportunity to submit evidence.
4443. § 422.590 Timeframes and responsibility for reconsiderations.
4444. § 422.592 Reconsideration by an independent entity.
4445. § 422.594 Notice of reconsidered determination by the independent entity.
4446. § 422.596 Effect of a reconsidered determination.
4447. § 422.600 Right to a hearing.
4448. § 422.602 Request for an ALJ hearing.
4449. § 422.608 Medicare Appeals Council (Council) review.
4450. § 422.612 Judicial review.
4451. § 422.616 Reopening and revising determinations and decisions.
4452. § 422.618 How an MA organization must effectuate standard reconsidered determinations or decisions.
4453. § 422.619 How an MA organization must effectuate expedited reconsidered determinations.
4454. § 422.620 Notifying enrollees of hospital discharge appeal rights.
4455. § 422.622 Requesting immediate QIO review of the decision to discharge from the inpatient hospital.
4456. § 422.624 Notifying enrollees of termination of provider services.
4457. § 422.626 Fast-track appeals of service terminations to independent review entities (IREs).
4458. 10 Requirements Applicable to Certain Integrated Dual Eligible Special Needs Plans
4459. § 422.629 General requirements for applicable integrated plans.
4460. § 422.630 Integrated grievances.
4461. § 422.631 Integrated organization determinations.
4462. § 422.632 Continuation of benefits while the applicable integrated plan reconsideration is pending.
4463. § 422.633 Integrated reconsiderations.
4464. § 422.634 Effect.
4465. Subpart N Medicare Contract Determinations and Appeals
4466. § 422.641 Contract determinations.
4467. § 422.644 Notice of contract determination.
4468. § 422.646 Effect of contract determination.
4469. § 422.660 Right to a hearing, burden of proof, standard of proof, and standards of review.
4470. § 422.662 Request for hearing.
4471. § 422.664 Postponement of effective date of a contract determination when a request for a hearing is filed timely.
4472. § 422.666 Designation of hearing officer.
4473. § 422.668 Disqualification of hearing officer.
4474. § 422.670 Time and place of hearing.
4475. § 422.672 Appointment of representatives.
4476. § 422.674 Authority of representatives.
4477. § 422.676 Conduct of hearing.
4478. § 422.678 Evidence.
4479. § 422.680 Witnesses.
4480. § 422.682 Witness lists and documents.
4481. § 422.684 Prehearing and summary judgment.
4482. § 422.686 Record of hearing.
4483. § 422.688 Authority of hearing officer.
4484. § 422.690 Notice and effect of hearing decision.
4485. § 422.692 Review by the Administrator.
4486. § 422.694 Effect of Administrator's decision.
4487. § 422.696 Reopening of a contract determination or decision of a hearing officer or the Administrator.
4488. Subpart O Intermediate Sanctions
4489. § 422.750 Types of intermediate sanctions and civil money penalties.
4490. § 422.752 Basis for imposing intermediate sanctions and civil money penalties.
4491. § 422.756 Procedures for imposing intermediate sanctions and civil money penalties.
4492. § 422.758 Collection of civil money penalties imposed by CMS.
4493. § 422.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
4494. § 422.762 Settlement of penalties.
4495. § 422.764 Other applicable provisions.
4496. P Subparts P-S [Reserved]
4497. Subpart T Appeal procedures for Civil Money Penalties
4498. § 422.1000 Basis and scope.
4499. § 422.1002 Definitions.
4500. § 422.1004 Scope and applicability.
4501. § 422.1006 Appeal rights.
4502. § 422.1008 Appointment of representatives.
4503. § 422.1010 Authority of representatives.
4504. § 422.1012 Fees for services of representatives.
4505. § 422.1014 Charge for transcripts.
4506. § 422.1016 Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.
4507. § 422.1018 Notice and effect of initial determinations.
4508. § 422.1020 Request for hearing.
4509. § 422.1022 Parties to the hearing.
4510. § 422.1024 Designation of hearing official.
4511. § 422.1026 Disqualification of Administrative Law Judge.
4512. § 422.1028 Prehearing conference.
4513. § 422.1030 Notice of prehearing conference.
4514. § 422.1032 Conduct of prehearing conference.
4515. § 422.1034 Record, order, and effect of prehearing conference.
4516. § 422.1036 Time and place of hearing.
4517. § 422.1038 Change in time and place of hearing.
4518. § 422.1040 Joint hearings.
4519. § 422.1042 Hearing on new issues.
4520. § 422.1044 Subpoenas.
4521. § 422.1046 Conduct of hearing.
4522. § 422.1048 Evidence.
4523. § 422.1050 Witnesses.
4524. § 422.1052 Oral and written summation.
4525. § 422.1054 Record of hearing.
4526. § 422.1056 Waiver of right to appear and present evidence.
4527. § 422.1058 Dismissal of request for hearing.
4528. § 422.1060 Dismissal for abandonment.
4529. § 422.1062 Dismissal for cause.
4530. § 422.1064 Notice and effect of dismissal and right to request review.
4531. § 422.1066 Vacating a dismissal of request for hearing.
4532. § 422.1068 Administrative Law Judge's decision.
4533. § 422.1070 Removal of hearing to Departmental Appeals Board.
4534. § 422.1072 Remand by the Administrative Law Judge.
4535. § 422.1074 Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
4536. § 422.1076 Request for Departmental Appeals Board review.
4537. § 422.1078 Departmental Appeals Board action on request for review.
4538. § 422.1080 Procedures before the Departmental Appeals Board on review.
4539. § 422.1082 Evidence admissible on review.
4540. § 422.1084 Decision or remand by the Departmental Appeals Board.
4541. § 422.1086 Effect of Departmental Appeals Board Decision.
4542. § 422.1088 Extension of time for seeking judicial review.
4543. § 422.1090 Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.
4544. § 422.1092 Revision of reopened decision.
4545. § 422.1094 Notice and effect of revised decision.
4546. U Subpart U [Reserved]
4547. Subpart V Medicare Advantage Communication Requirements
4548. § 422.2260 Definitions.
4549. § 422.2261 Submission, review, and distribution of materials.
4550. § 422.2262 General communications materials and activities requirements.
4551. § 422.2263 General marketing requirements.
4552. § 422.2264 Beneficiary contact.
4553. § 422.2265 Websites.
4554. § 422.2266 Activities with healthcare providers or in the healthcare setting.
4555. § 422.2267 Required materials and content.
4556. § 422.2272 Licensing of marketing representatives and confirmation of marketing resources.
4557. § 422.2274 Agent, broker, and other third-party requirements.
4558. § 422.2276 Employer group retiree marketing.
4559. W Subpart W [Reserved]
4560. Subpart X Requirements for a Minimum Medical Loss Ratio
4561. § 422.2400 Basis and scope.
4562. § 422.2401 Definitions.
4563. § 422.2410 General requirements.
4564. § 422.2420 Calculation of the medical loss ratio.
4565. § 422.2430 Activities that improve health care quality.
4566. § 422.2440 Credibility adjustment.
4567. § 422.2450 [Reserved]
4568. § 422.2460 Reporting requirements.
4569. § 422.2470 Remittance to CMS if the applicable MLR requirement is not met.
4570. § 422.2480 MLR review and non-compliance.
4571. § 422.2490 Release of Part C MLR data.
4572. Y Subpart Y [Reserved]
4573. Subpart Z Part C Recovery Audit Contractor Appeals Process
4574. § 422.2600 Payment appeals.
4575. § 422.2605 Request for reconsideration.
4576. § 422.2610 Hearing official review.
4577. § 422.2615 Review by the Administrator.
4578. PART 423 VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
4579. Subpart A General Provisions
4580. § 423.1 Basis and scope.
4581. § 423.4 Definitions.
4582. § 423.6 Cost-sharing in beneficiary education and enrollment-related costs.
4583. Subpart B Eligibility and Enrollment
4584. § 423.30 Eligibility and enrollment.
4585. § 423.32 Enrollment process.
4586. § 423.34 Enrollment of low-income subsidy eligible individuals.
4587. § 423.36 Disenrollment process.
4588. § 423.38 Enrollment periods.
4589. § 423.40 Effective dates.
4590. § 423.44 Involuntary disenrollment from Part D coverage.
4591. § 423.46 Late enrollment penalty.
4592. § 423.48 Information about Part D.
4593. § 423.56 Procedures to determine and document creditable status of prescription drug coverage.
4594. Subpart C Benefits and Beneficiary Protections
4595. § 423.100 Definitions.
4596. § 423.104 Requirements related to qualified prescription drug coverage.
4597. § 423.112 Establishment of prescription drug plan service areas.
4598. § 423.120 Access to covered Part D drugs.
4599. § 423.124 Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.
4600. § 423.128 Dissemination of Part D plan information.
4601. § 423.129 Resolution of complaints in complaints tracking module.
4602. § 423.132 Public disclosure of pharmaceutical prices for equivalent drugs.
4603. § 423.136 Privacy, confidentiality, and accuracy of enrollee records.
4604. § 423.137 Medicare Prescription Payment Plan.
4605. Subpart D Cost Control and Quality Improvement Requirements
4606. § 423.150 Scope.
4607. § 423.153 Drug utilization management, quality assurance, medication therapy management (MTM) programs, drug management programs, and access to Medicare Parts A and B claims data extracts.
4608. § 423.154 Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans.
4609. § 423.156 Consumer satisfaction surveys.
4610. § 423.159 Electronic prescription drug program.
4611. § 423.160 Standards for electronic prescribing.
4612. § 423.162 Quality improvement organization activities.
4613. § 423.165 Compliance deemed on the basis of accreditation.
4614. § 423.168 Accreditation organizations.
4615. § 423.171 Procedures for approval of accreditation as a basis for deeming compliance.
4616. § 423.180 Basis and scope of the Part D Prescription Drug Plan Quality Rating System.
4617. § 423.182 Part D Prescription Drug Plan Quality Rating System.
4618. § 423.184 Adding, updating, and removing measures.
4619. § 423.186 Calculation of Star Ratings.
4620. E Subpart E [Reserved]
4621. Subpart F Submission of Bids and Monthly Beneficiary Premiums; Plan Approval
4622. § 423.251 Scope.
4623. § 423.258 Definitions.
4624. § 423.265 Submission of bids and related information.
4625. § 423.272 Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.
4626. § 423.279 National average monthly bid amount.
4627. § 423.286 Rules regarding premiums.
4628. § 423.293 Collection of monthly beneficiary premium.
4629. § 423.294 Failure to collect and incorrect collections of premiums and cost sharing.
4630. Subpart G Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage
4631. § 423.301 Scope.
4632. § 423.308 Definitions and terminology.
4633. § 423.315 General payment provisions.
4634. § 423.322 Requirement for disclosure of information.
4635. § 423.325 PDE submission timeliness requirements.
4636. § 423.329 Determination of payments.
4637. § 423.336 Risk-sharing arrangements.
4638. § 423.343 Retroactive adjustments and reconciliations.
4639. § 423.346 Reopening.
4640. § 423.350 Payment appeals.
4641. § 423.352 CMS-identified overpayments associated with payment data submitted by Part D sponsors.
4642. § 423.360 Reporting and returning of overpayments.
4643. H Subpart H [Reserved]
4644. Subpart I Organization Compliance with State Law and Preemption by Federal Law
4645. § 423.401 General requirements for PDP sponsors.
4646. § 423.410 Waiver of certain requirements to expand choice.
4647. § 423.415 Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region.
4648. § 423.420 Solvency standards for non-licensed entities.
4649. § 423.425 Licensure does not substitute for or constitute certification.
4650. § 423.440 Prohibition of State imposition of premium taxes; relation to State laws.
4651. Subpart J Coordination of Part D Plans With Other Prescription Drug Coverage
4652. § 423.452 Scope.
4653. § 423.454 Definitions.
4654. § 423.458 Application of Part D rules to certain Part D plans on and after January 1, 2006.
4655. § 423.462 Medicare secondary payer procedures.
4656. § 423.464 Coordination of benefits with other providers of prescription drug coverage.
4657. § 423.466 Timeframes for coordination of benefits and claims adjustments.
4658. Subpart K Application Procedures and Contracts with Part D plan sponsors
4659. § 423.500 Scope.
4660. § 423.501 Definitions
4661. § 423.502 Application requirements.
4662. § 423.503 Evaluation and determination procedures.
4663. § 423.504 General provisions.
4664. § 423.505 Contract provisions.
4665. § 423.506 Effective date and term of contract.
4666. § 423.507 Nonrenewal of contract.
4667. § 423.508 Modification or termination of contract by mutual consent.
4668. § 423.509 Termination of contract by CMS.
4669. § 423.510 Termination of contract by the Part D sponsor.
4670. § 423.512 Minimum enrollment requirements.
4671. § 423.514 Validation of Part D reporting requirements.
4672. § 423.516 Prohibition of midyear implementation of significant new regulatory requirements.
4673. § 423.520 Prompt payment by Part D sponsors.
4674. § 423.521 Final settlement process and payment.
4675. § 423.522 Requesting an appeal of the final settlement amount.
4676. § 423.530 Plan crosswalks.
4677. Subpart L Effect of Change of Ownership or Leasing of Facilities During Term of Contract
4678. § 423.551 General provisions.
4679. § 423.552 Novation agreement requirements.
4680. § 423.553 Effect of leasing of a PDP sponsor's facilities.
4681. Subpart M Grievances, Coverage Determinations, Redeterminations, and Reconsiderations
4682. § 423.558 Scope.
4683. § 423.560 Definitions.
4684. § 423.562 General provisions.
4685. § 423.564 Grievance procedures.
4686. § 423.566 Coverage determinations.
4687. § 423.568 Standard timeframe and notice requirements for coverage determinations.
4688. § 423.570 Expediting certain coverage determinations.
4689. § 423.572 Timeframes and notice requirements for expedited coverage determinations.
4690. § 423.576 Effect of a coverage determination.
4691. § 423.578 Exceptions process.
4692. § 423.580 Right to a redetermination.
4693. § 423.582 Request for a standard redetermination.
4694. § 423.584 Expediting certain redeterminations.
4695. § 423.586 Opportunity to submit evidence.
4696. § 423.590 Timeframes and responsibility for making redeterminations.
4697. § 423.600 Reconsideration by an independent review entity (IRE).
4698. § 423.602 Notice of reconsideration determination by the independent review entity.
4699. § 423.604 Effect of a reconsideration determination.
4700. §§ 423.610-423.634 [Reserved]
4701. § 423.636 How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.
4702. § 423.638 How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.
4703. Subpart N Medicare Contract Determinations and Appeals
4704. § 423.641 Contract determinations.
4705. § 423.642 Notice of contract determination.
4706. § 423.643 Effect of contract determination.
4707. § 423.650 Right to a hearing, burden of proof, standard of proof, and standards of review.
4708. § 423.651 Request for hearing.
4709. § 423.652 Postponement of effective date of a contract determination when a request for a hearing is filed timely.
4710. § 423.653 Designation of hearing officer.
4711. § 423.654 Disqualification of hearing officer.
4712. § 423.655 Time and place of hearing.
4713. § 423.656 Appointment of representatives.
4714. § 423.657 Authority of representatives.
4715. § 423.658 Conduct of hearing.
4716. § 423.659 Evidence.
4717. § 423.660 Witnesses.
4718. § 423.661 Witnesses lists and documents.
4719. § 423.662 Prehearing and summary judgment.
4720. § 423.663 Record of hearing.
4721. § 423.664 Authority of hearing officer.
4722. § 423.665 Notice and effect of hearing decision.
4723. § 423.666 Review by the Administrator.
4724. § 423.667 Effect of Administrator's decision.
4725. § 423.668 Reopening of a contract determination or decision of a hearing officer or the Administrator.
4726. Subpart O Intermediate Sanctions
4727. § 423.750 Types of intermediate sanctions and civil money penalties.
4728. § 423.752 Basis for imposing intermediate sanctions and civil money penalties.
4729. § 423.756 Procedures for imposing intermediate sanctions and civil money penalties.
4730. § 423.758 Collection of civil money penalties imposed by CMS.
4731. § 423.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
4732. § 423.762 Settlement of penalties.
4733. § 423.764 Other applicable provisions.
4734. Subpart P Premiums and Cost-Sharing Subsidies for Low-Income Individuals
4735. § 423.771 Basis and scope.
4736. § 423.772 Definitions.
4737. § 423.773 Requirements for eligibility.
4738. § 423.774 Eligibility determinations, redeterminations, and applications.
4739. § 423.780 Premium subsidy.
4740. § 423.782 Cost-sharing subsidy.
4741. § 423.800 Administration of subsidy program.
4742. Subpart Q Guaranteeing Access to a Choice of Coverage (Fallback Prescription Drug Plans)
4743. § 423.851 Scope.
4744. § 423.855 Definitions.
4745. § 423.859 Assuring access to a choice of coverage.
4746. § 423.863 Submission and approval of bids.
4747. § 423.867 Rules regarding premiums.
4748. § 423.871 Contract terms and conditions.
4749. § 423.875 Payment to fallback plans.
4750. Subpart R Payments to Sponsors of Retiree Prescription Drug Plans
4751. § 423.880 Basis and scope.
4752. § 423.882 Definitions.
4753. § 423.884 Requirements for qualified retiree prescription drug plans.
4754. § 423.886 Retiree drug subsidy amounts.
4755. § 423.888 Payment methods, including provision of necessary information.
4756. § 423.890 Appeals.
4757. § 423.892 Change of ownership.
4758. § 423.894 Construction.
4759. Subpart S Special Rules for States-Eligibility Determinations for Subsidies and General Payment Provisions
4760. § 423.900 Basis and scope.
4761. § 423.902 Definitions.
4762. § 423.904 Eligibility determinations for low-income subsidies.
4763. § 423.906 General payment provisions.
4764. § 423.907 Treatment of territories.
4765. § 423.908 Phased-down State contribution to drug benefit costs assumed by Medicare.
4766. § 423.910 Requirements.
4767. Subpart T Appeal Procedures for Civil Money Penalties
4768. § 423.1000 Basis and scope.
4769. § 423.1002 Definitions.
4770. § 423.1004 Scope and applicability.
4771. § 423.1006 Appeal rights.
4772. § 423.1008 Appointment of representatives.
4773. § 423.1010 Authority of representatives.
4774. § 423.1012 Fees for services of representatives.
4775. § 423.1014 Charge for transcripts.
4776. § 423.1016 Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.
4777. § 423.1018 Notice and effect of initial determinations.
4778. § 423.1020 Request for hearing.
4779. § 423.1022 Parties to the hearing.
4780. § 423.1024 Designation of hearing official.
4781. § 423.1026 Disqualification of Administrative Law Judge.
4782. § 423.1028 Prehearing conference.
4783. § 423.1030 Notice of prehearing conference.
4784. § 423.1032 Conduct of prehearing conference.
4785. § 423.1034 Record, order, and effect of prehearing conference.
4786. § 423.1036 Time and place of hearing.
4787. § 423.1038 Change in time and place of hearing.
4788. § 423.1040 Joint hearings.
4789. § 423.1042 Hearing on new issues.
4790. § 423.1044 Subpoenas.
4791. § 423.1046 Conduct of hearing.
4792. § 423.1048 Evidence.
4793. § 423.1050 Witnesses.
4794. § 423.1052 Oral and written summation.
4795. § 423.1054 Record of hearing.
4796. § 423.1056 Waiver of right to appear and present evidence.
4797. § 423.1058 Dismissal of request for hearing.
4798. § 423.1060 Dismissal for abandonment.
4799. § 423.1062 Dismissal for cause.
4800. § 423.1064 Notice and effect of dismissal and right to request review.
4801. § 423.1066 Vacating a dismissal of request for hearing.
4802. § 423.1068 Administrative Law Judge's decision.
4803. § 423.1070 Removal of hearing to Departmental Appeals Board.
4804. § 423.1072 Remand by the Administrative Law Judge.
4805. § 423.1074 Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
4806. § 423.1076 Request for Departmental Appeals Board review.
4807. § 423.1078 Departmental Appeals Board action on request for review.
4808. § 423.1080 Procedures before the Departmental Appeals Board on review.
4809. § 423.1082 Evidence admissible on review.
4810. § 423.1084 Decision or remand by the Departmental Appeals Board.
4811. § 423.1086 Effect of Departmental Appeals Board Decision.
4812. § 423.1088 Extension of time for seeking judicial review.
4813. § 423.1090 Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.
4814. § 423.1092 Revision of reopened decision.
4815. § 423.1094 Notice and effect of revised decision.
4816. Subpart U Reopening, ALJ Hearings and ALJ and Attorney Adjudicator Decisions, Council Review, and Judicial Review
4817. § 423.1968 Scope.
4818. §§ 423.1970-423.1976 [Reserved]
4819. § 423.1978 Reopening determinations and decisions.
4820. § 423.1980 Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews.
4821. § 423.1982 Notice of a revised determination or decision.
4822. § 423.1984 Effect of a revised determination or decision.
4823. § 423.1986 Good cause for reopening.
4824. § 423.1990 Expedited access to judicial review.
4825. § 423.2000 Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.
4826. § 423.2002 Right to an ALJ hearing.
4827. § 423.2004 Right to a review of IRE notice of dismissal.
4828. § 423.2006 Amount in controversy required for an ALJ hearing and judicial review.
4829. § 423.2008 Parties to the proceedings on a request for an ALJ hearing.
4830. § 423.2010 When CMS, the IRE, or Part D plan sponsors may participate in the proceedings on a request for an ALJ hearing.
4831. § 423.2014 Request for an ALJ hearing or a review of an IRE dismissal.
4832. § 423.2016 Timeframes for deciding an appeal of an IRE reconsideration.
4833. § 423.2018 Submitting evidence.
4834. § 423.2020 Time and place for a hearing before an ALJ.
4835. § 423.2022 Notice of a hearing before an ALJ.
4836. § 423.2024 Objections to the issues.
4837. § 423.2026 Disqualification of the ALJ or attorney adjudicator.
4838. § 423.2030 ALJ hearing procedures.
4839. § 423.2032 Issues before an ALJ or attorney adjudicator.
4840. § 423.2034 Requesting information from the IRE.
4841. § 423.2036 Description of an ALJ hearing process.
4842. § 423.2038 Deciding a case without a hearing before an ALJ.
4843. § 423.2040 Prehearing and posthearing conferences.
4844. § 423.2042 The administrative record.
4845. § 423.2044 Consolidated proceedings.
4846. § 423.2046 Notice of an ALJ or attorney adjudicator decision.
4847. § 423.2048 The effect of an ALJ's or attorney adjudicator's decision.
4848. § 423.2050 Removal of a hearing request from OMHA to the Council.
4849. § 423.2052 Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal.
4850. § 423.2054 Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal.
4851. § 423.2056 Remands of requests for hearing and requests for review.
4852. § 423.2058 Effect of a remand.
4853. § 423.2062 Applicability of policies not binding on the ALJ and Council.
4854. § 423.2063 Applicability of laws, regulations, CMS Rulings, and precedential decisions.
4855. § 423.2100 Medicare Appeals Council review: general.
4856. § 423.2102 Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.
4857. § 423.2106 Where a request for review may be filed.
4858. § 423.2108 Council Actions when request for review is filed.
4859. § 423.2110 Council reviews on its own motion.
4860. § 423.2112 Content of request for review.
4861. § 423.2114 Dismissal of request for review.
4862. § 423.2116 Effect of dismissal of request for Council review or request for hearing.
4863. § 423.2118 Obtaining evidence from the Council.
4864. § 423.2120 Filing briefs with the Council.
4865. § 423.2122 What evidence may be submitted to the Council.
4866. § 423.2124 Oral argument.
4867. § 423.2126 Case remanded by the Council.
4868. § 423.2128 Action of the Council.
4869. § 423.2130 Effect of the Council's decision.
4870. § 423.2134 Extension of time to file action in Federal District Court.
4871. § 423.2136 Judicial review.
4872. § 423.2138 Case remanded by a Federal District Court.
4873. § 423.2140 Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court.
4874. Subpart V Part D Communication Requirements
4875. § 423.2260 Definitions.
4876. § 423.2261 Submission, review, and distribution of materials.
4877. § 423.2262 General communications materials and activity requirements.
4878. § 423.2263 General marketing requirements.
4879. § 423.2264 Beneficiary contact.
4880. § 423.2265 Websites.
4881. § 423.2266 Activities with healthcare providers or in the healthcare setting.
4882. § 423.2267 Required materials and content.
4883. § 423.2272 Licensing of marketing representatives and confirmation of marketing resources.
4884. § 423.2274 Agent, broker, and other third-party requirements.
4885. § 423.2276 Employer group retiree marketing.
4886. Subpart W Medicare Coverage Gap Discount Program
4887. § 423.2300 Scope.
4888. § 423.2305 Definitions.
4889. § 423.2310 Condition for coverage of drugs under Part D.
4890. § 423.2315 Medicare Coverage Gap Discount Program Agreement.
4891. § 423.2320 Payment processes for Part D sponsors.
4892. § 423.2325 Provision of applicable discounts.
4893. § 423.2330 Manufacturer discount payment audit and dispute resolution.
4894. § 423.2335 Beneficiary dispute resolution.
4895. § 423.2340 Compliance monitoring and civil money penalties.
4896. § 423.2345 Termination of Coverage Gap Discount Program Agreement.
4897. Subpart X Requirements for a Minimum Medical Loss Ratio
4898. § 423.2400 Basis and scope.
4899. § 423.2401 Definitions.
4900. § 423.2410 General requirements.
4901. § 423.2420 Calculation of medical loss ratio.
4902. § 423.2430 Activities that improve health care quality.
4903. § 423.2440 Credibility adjustment.
4904. § 423.2450 [Reserved]
4905. § 423.2460 Reporting requirements.
4906. § 423.2470 Remittance to CMS if the applicable MLR requirement is not met.
4907. § 423.2480 MLR review and non-compliance.
4908. § 423.2490 Release of Part D MLR data.
4909. Subpart Y Transitional Coverage and Retroactive Medicare Part D Coverage for Certain Low-Income Beneficiaries Through the Limited Income Newly Eligible Transition (LI NET) Program
4910. § 423.2500 Basis and scope.
4911. § 423.2504 LI NET eligibility and enrollment.
4912. § 423.2508 LI NET benefits and beneficiary protections.
4913. § 423.2512 LI NET sponsor requirements.
4914. § 423.2516 Selection of LI NET sponsor and contracting provisions.
4915. § 423.2518 Intermediate sanctions for the LI NET sponsor.
4916. § 423.2520 Non-renewal or termination of appointment.
4917. § 423.2524 Bidding and payments to LI NET sponsor.
4918. § 423.2536 Waiver of Part D program requirements.
4919. Subpart Z Appeals Process for Part D Program Integrity Prescription Drug Event Record Review Audits
4920. § 423.2600 Payment appeals.
4921. § 423.2605 Request for reconsideration.
4922. § 423.2610 Hearing official review.
4923. § 423.2615 Review by the Administrator.
4924. Subpart AA Medicare Part D Manufacturer Discount Program
4925. § 423.2700 Basis and scope.
4926. § 423.2704 Definitions.
4927. § 423.2708 Conditions for coverage of drugs under Part D.
4928. § 423.2712 Applicable discounts.
4929. § 423.2716 Phase-in of applicable discount for certain manufacturers.
4930. § 423.2720 Determination of phase-in eligibility.
4931. § 423.2724 Effect of manufacturer acquisition on phase-in eligibility.
4932. § 423.2728 Recalculation of phase-in eligibility determination.
4933. § 423.2732 Use of third party administrator.
4934. § 423.2736 Requirement for point-of-sale discounts.
4935. § 423.2740 Negative invoice payment process for Part D sponsors.
4936. § 423.2744 Prospective payments to Part D sponsors.
4937. § 423.2748 Requirement to use the Health Plan Management System.
4938. § 423.2752 Manufacturer Discount Program agreement.
4939. § 423.2756 Manufacturer requirements.
4940. § 423.2760 Audits.
4941. § 423.2764 Dispute resolution.
4942. § 423.2768 Civil money penalties.
4943. PART 424 CONDITIONS FOR MEDICARE PAYMENT
4944. Subpart A General Provisions
4945. § 424.1 Basis and scope.
4946. § 424.3 Definitions.
4947. § 424.5 Basic conditions.
4948. § 424.7 General limitations.
4949. Subpart B Certification and Plan Requirements
4950. § 424.10 Purpose and scope.
4951. § 424.11 General procedures.
4952. § 424.13 Requirements for inpatient services of hospitals other than inpatient psychiatric facilities.
4953. § 424.14 Requirements for inpatient services of inpatient psychiatric facilities.
4954. § 424.15 Requirements for inpatient CAH services.
4955. § 424.16 Timing of certification for individual admitted to a hospital before entitlement to Medicare benefits.
4956. § 424.20 Requirements for posthospital SNF care.
4957. § 424.22 Requirements for home health services.
4958. § 424.24 Requirements for medical and other health services furnished by providers under Medicare Part B.
4959. § 424.27 Requirements for comprehensive outpatient rehabilitation facility (CORF) services.
4960. Subpart C Claims for Payment
4961. § 424.30 Scope.
4962. § 424.32 Basic requirements for all claims.
4963. § 424.33 Additional requirements: Claims for services of providers and claims by suppliers and nonparticipating hospitals.
4964. § 424.34 Additional requirements: Beneficiary's claim for direct payment.
4965. § 424.36 Signature requirements.
4966. § 424.37 Evidence of authority to sign on behalf of the beneficiary.
4967. § 424.40 Request for payment effective for more than one claim.
4968. § 424.44 Time limits for filing claims.
4969. Subpart D To Whom Payment Is Ordinarily Made
4970. § 424.50 Scope.
4971. § 424.51 Payment to the provider.
4972. § 424.52 Payment to a nonparticipating hospital.
4973. § 424.53 Payment to the beneficiary.
4974. § 424.54 Payment to the beneficiary's legal guardian or representative payee.
4975. § 424.55 Payment to the supplier.
4976. § 424.56 Payment to a beneficiary and to a supplier.
4977. § 424.57 Special payment rules for items furnished by DMEPOS suppliers and issuance of DMEPOS supplier billing privileges.
4978. § 424.58 Accreditation.
4979. Subpart E To Whom Payment is Made in Special Situations
4980. § 424.60 Scope.
4981. § 424.62 Payment after beneficiary's death: Bill has been paid.
4982. § 424.64 Payment after beneficiary's death: Bill has not been paid.
4983. § 424.66 Payment to entities that provide coverage complementary to Medicare Part B.
4984. § 424.67 Enrollment requirements for opioid treatment programs (OTP).
4985. § 424.68 Enrollment requirements for home infusion therapy suppliers.
4986. Subpart F Limitations on Assignment and Reassignment of Claims
4987. § 424.70 Basis and scope.
4988. § 424.71 Definitions.
4989. § 424.73 Prohibition of assignment of claims by providers.
4990. § 424.74 Termination of provider agreement.
4991. § 424.80 Prohibition of reassignment of claims by suppliers.
4992. § 424.82 Revocation of right to receive assigned benefits.
4993. § 424.83 Hearings on revocation of right to receive assigned benefits.
4994. § 424.84 Final determination on revocation of right to receive assigned benefits.
4995. § 424.86 Prohibition of assignment of claims by beneficiaries.
4996. § 424.90 Court ordered assignments: Conditions and limitations.
4997. Subpart G Special Conditions: Emergency Services Furnished by a Nonparticipating Hospital
4998. § 424.100 Scope.
4999. § 424.101 Definitions.
5000. § 424.102 Situations that do not constitute an emergency.
5001. § 424.103 Conditions for payment for emergency services.
5002. § 424.104 Election to claim payment for emergency services furnished during a calendar year.
5003. § 424.106 Criteria for determining whether the hospital was the most accessible.
5004. § 424.108 Payment to a hospital.
5005. § 424.109 Payment to the beneficiary.
5006. Subpart H Special Conditions: Services Furnished in a Foreign Country
5007. § 424.120 Scope.
5008. § 424.121 Scope of payments.
5009. § 424.122 Conditions for payment for emergency inpatient hospital services.
5010. § 424.123 Conditions for payment for nonemergency inpatient services furnished by a hospital closer to the individual's residence.
5011. § 424.124 Conditions for payment for physician services and ambulance services.
5012. § 424.126 Payment to the hospital.
5013. § 424.127 Payment to the beneficiary.
5014. Subpart I Requirements for Medicare Diabetes Prevention Program Suppliers and Beneficiary Engagement Incentives Under the Medicare Diabetes Prevention Program Expanded Model
5015. § 424.200 Scope.
5016. § 424.205 Requirements for Medicare Diabetes Prevention Program suppliers.
5017. § 424.210 Beneficiary engagement incentives under the Medicare Diabetes Prevention Program expanded model.
5018. J Subparts J-L [Reserved]
5019. Subpart M Replacement and Reclamation of Medicare Payments
5020. § 424.350 Replacement of checks that are lost, stolen, defaced, mutilated, destroyed, or paid on forged endorsements.
5021. § 424.352 Intermediary and carrier checks that are lost, stolen, defaced, mutilated, destroyed or paid on forged endorsements.
5022. N Subparts N-O [Reserved]
5023. Subpart P Requirements for Establishing and Maintaining Medicare Billing Privileges
5024. § 424.500 Scope.
5025. § 424.502 Definitions.
5026. § 424.505 Basic enrollment requirement.
5027. § 424.506 National Provider Identifier (NPI) on all enrollment applications and claims.
5028. § 424.507 Ordering covered items and services for Medicare beneficiaries.
5029. § 424.510 Requirements for enrolling in the Medicare program.
5030. § 424.514 Application fee.
5031. § 424.515 Requirements for reporting changes and updates to, and the periodic revalidation of Medicare enrollment information.
5032. § 424.516 Additional provider and supplier requirements for enrolling and maintaining active enrollment status in the Medicare program.
5033. § 424.517 Onsite review.
5034. § 424.518 Screening levels for Medicare providers and suppliers.
5035. § 424.519 Disclosure of affiliations.
5036. § 424.520 Effective date of Medicare billing privileges.
5037. § 424.521 Request for payment by certain provider and supplier types.
5038. § 424.522 Additional effective dates.
5039. § 424.525 Rejection of a provider's or supplier's application for Medicare enrollment.
5040. § 424.526 Return of a provider's or supplier's enrollment application.
5041. § 424.527 Provisional period of enhanced oversight.
5042. § 424.530 Denial of enrollment in the Medicare program.
5043. § 424.535 Revocation of enrollment in the Medicare program.
5044. § 424.540 Deactivation of Medicare billing privileges.
5045. § 424.541 Stay of enrollment.
5046. § 424.542 Prohibition on ordering, certifying, referring, or prescribing based on felony conviction.
5047. § 424.545 Provider and supplier appeal rights.
5048. § 424.546 Deactivation rebuttals.
5049. § 424.547 Deactivation based on ordering, certifying, or referring services and items.
5050. § 424.550 Prohibitions on the sale or transfer of billing privileges.
5051. § 424.551 DMEPOS supplier changes in majority ownership.
5052. § 424.555 Payment liability.
5053. § 424.565 Overpayment.
5054. § 424.570 Moratoria on newly enrolling Medicare providers and suppliers.
5055. § 424.575 Rural emergency hospitals.
5056. PART 425 MEDICARE SHARED SAVINGS PROGRAM
5057. Subpart A General Provisions
5058. § 425.10 Basis and scope.
5059. § 425.20 Definitions.
5060. Subpart B Shared Savings Program Eligibility Requirements
5061. § 425.100 General.
5062. § 425.102 Eligible providers and suppliers.
5063. § 425.104 Legal entity.
5064. § 425.106 Shared governance.
5065. § 425.108 Leadership and management.
5066. § 425.110 Number of ACO professionals and beneficiaries.
5067. § 425.112 Required processes and patient-centeredness criteria.
5068. § 425.114 Participation in other shared savings initiatives.
5069. § 425.116 Agreements with ACO participants and ACO providers/suppliers.
5070. § 425.118 Required reporting of ACO participants and ACO providers/suppliers.
5071. Subpart C Application Procedures and Participation Agreement
5072. § 425.200 Participation agreement with CMS.
5073. § 425.202 Application procedures.
5074. § 425.204 Content of the application.
5075. § 425.206 Evaluation procedures for applications.
5076. § 425.208 Provisions of participation agreement.
5077. § 425.210 Application of agreement to ACO participants, ACO providers/suppliers, and others.
5078. § 425.212 Changes to program requirements during the agreement period.
5079. § 425.214 Managing changes to the ACO during the agreement period.
5080. § 425.216 Actions prior to termination.
5081. § 425.218 Termination of the participation agreement by CMS.
5082. § 425.220 Termination of the participation agreement by the ACO.
5083. § 425.221 Close-out procedures and payment consequences of early termination.
5084. § 425.222 Eligibility to re-enter the program for agreement periods beginning before July 1, 2019.
5085. § 425.224 Application procedures for renewing ACOs and re-entering ACOs.
5086. § 425.226 Annual participation elections.
5087. Subpart D Program Requirements and Beneficiary Protections
5088. § 425.300 Compliance plan.
5089. § 425.302 Program requirements for data submission and certifications.
5090. § 425.304 Beneficiary incentives.
5091. § 425.305 Other program safeguards.
5092. § 425.306 Participant agreement and exclusivity of ACO participants.
5093. § 425.308 Public reporting and transparency.
5094. § 425.310 Marketing requirements.
5095. § 425.312 Beneficiary notifications.
5096. § 425.314 Audits and record retention.
5097. § 425.315 Reopening determinations of ACO shared savings or shared losses to correct financial reconciliation calculations.
5098. § 425.316 Monitoring of ACOs.
5099. Subpart E Assignment of Beneficiaries
5100. § 425.400 General.
5101. § 425.401 Criteria for a beneficiary to be assigned to an ACO.
5102. § 425.402 Basic assignment methodology.
5103. § 425.404 Special assignment conditions for ACOs including FQHCs and RHCs.
5104. Subpart F Quality Performance Standards and Reporting
5105. § 425.500 Measures to assess the quality of care furnished by an ACO for performance years (or a performance period) beginning on or before January 1, 2020.
5106. § 425.502 Calculating the ACO quality performance score for performance years (or a performance period) beginning on or before January 1, 2020.
5107. § 425.504 Incorporating reporting requirements related to the Physician Quality Reporting System Incentive and Payment Adjustment.
5108. § 425.506 Incorporating reporting requirements related to adoption of certified electronic health record technology.
5109. § 425.507 Incorporating Promoting Interoperability requirements related to the Quality Payment Program for performance years beginning on or after January 1, 2025.
5110. § 425.508 Incorporating quality reporting requirements related to the Quality Payment Program.
5111. § 425.510 Application of the APM Performance Pathway (APP) quality measure set or the APP Plus quality measure set (as applicable) to Shared Savings Program ACOs for performance years beginning on or after January 1, 2021.
5112. § 425.512 Determining the ACO quality performance standard for performance years beginning on or after January 1, 2021.
5113. Subpart G Shared Savings and Losses
5114. § 425.600 Selection of risk model.
5115. § 425.601 Establishing, adjusting, and updating the benchmark for agreement periods beginning on or after July 1, 2019, and before January 1, 2024.
5116. § 425.602 Establishing, adjusting, and updating the benchmark for an ACO's first agreement period beginning on or before January 1, 2018.
5117. § 425.603 Resetting, adjusting, and updating the benchmark for a subsequent agreement period beginning on or before January 1, 2019.
5118. § 425.604 Calculation of savings under the one-sided model.
5119. § 425.605 Calculation of shared savings and losses under the BASIC track.
5120. § 425.606 Calculation of shared savings and losses under Track 2.
5121. § 425.608 Determining first year performance for ACOs beginning April 1 or July 1, 2012.
5122. § 425.609 Determining performance for 6-month performance years during CY 2019.
5123. § 425.610 Calculation of shared savings and losses under the ENHANCED track.
5124. § 425.611 Adjustments to Shared Savings Program calculations to address the COVID-19 pandemic.
5125. § 425.612 Waivers of payment rules or other Medicare requirements.
5126. § 425.613 Telehealth services.
5127. §§ 425.614-425.629 [Reserved]
5128. § 425.630 Option to receive advance investment payments.
5129. §§ 425.631-425.639 [Reserved]
5130. § 425.640 Option to receive prepaid shared savings.
5131. §§ 425.641-425.649 [Reserved]
5132. § 425.650 Benchmarking methodology.
5133. § 425.652 Establishing, adjusting, and updating the benchmark for agreement periods beginning on January 1, 2024, and in subsequent years.
5134. § 425.654 Calculating county expenditures and regional expenditures.
5135. § 425.655 Calculating the regional risk score growth cap adjustment factor.
5136. § 425.656 Calculating the regional adjustment to the historical benchmark.
5137. § 425.658 Calculating the prior savings adjustment to the historical benchmark.
5138. § 425.659 Calculating risk scores used in Shared Savings Program benchmark calculations.
5139. § 425.660 Accountable Care Prospective Trend (ACPT).
5140. § 425.661 [Reserved]
5141. § 425.662 Calculating the population adjustment to the historical benchmark.
5142. § 425.663-425.669 [Reserved]
5143. § 425.670 Adjustments to mitigate the impact of significant, anomalous, and highly suspect billing activity on Shared Savings Program financial calculations involving calendar year 2023.
5144. § 425.672 Adjustments to mitigate the impact of significant, anomalous, and highly suspect billing activity on Shared Savings Program financial calculations involving calendar year 2024 or subsequent calendar years.
5145. § 425.674 Accounting for the impact of improper payments on Shared Savings Program financial calculations.
5146. Subpart H Data Sharing With ACOs
5147. § 425.700 General rules.
5148. § 425.702 Aggregate reports.
5149. § 425.704 Beneficiary-identifiable claims data.
5150. § 425.706 Minimum necessary data.
5151. § 425.708 Beneficiaries may decline claims data sharing.
5152. § 425.710 Data use agreement.
5153. Subpart I Reconsideration Review Process
5154. § 425.800 Preclusion of administrative and judicial review.
5155. § 425.802 Request for review.
5156. § 425.804 Reconsideration review process.
5157. § 425.806 On-the-record review of reconsideration official's recommendation by independent CMS official.
5158. § 425.808 Effect of independent CMS official's decision.
5159. § 425.810 Effective date of decision.
5160. PART 426 REVIEW OF NATIONAL COVERAGE DETERMINATIONS AND LOCAL COVERAGE DETERMINATIONS
5161. Subpart A General Provisions
5162. § 426.100 Basis and scope.
5163. § 426.110 Definitions.
5164. § 426.120 Calculation of deadlines.
5165. § 426.130 Party submissions.
5166. B Subpart B [Reserved]
5167. Subpart C General Provisions for the Review of LCDs and NCDs
5168. § 426.300 Review of LCDs, NCDs, and deemed NCDs.
5169. § 426.310 LCD and NCD reviews and individual claim appeals.
5170. § 426.320 Who may challenge an LCD or NCD.
5171. § 426.325 What may be challenged.
5172. § 426.330 Burden of proof.
5173. § 426.340 Procedures for review of new evidence.
5174. Subpart D Review of an LCD
5175. § 426.400 Procedure for filing an acceptable complaint concerning a provision (or provisions) of an LCD.
5176. § 426.403 Submitting new evidence once an acceptable complaint is filed.
5177. § 426.405 Authority of the ALJ.
5178. § 426.406 Ex parte contacts.
5179. § 426.410 Docketing and evaluating the acceptability of LCD complaints.
5180. § 426.415 CMS' role in the LCD review.
5181. § 426.416 Role of Medicare Managed Care Organizations (MCOs) and State agencies in the LCD review.
5182. § 426.417 Contractor's statement regarding new evidence.
5183. § 426.418 LCD record furnished to aggrieved party.
5184. § 426.419 LCD record furnished to the ALJ.
5185. § 426.420 Retiring or revising an LCD under review.
5186. § 426.423 Withdrawing a complaint regarding an LCD under review.
5187. § 426.425 LCD review.
5188. § 426.431 ALJ's review of the LCD to apply the reasonableness standard.
5189. § 426.432 Discovery.
5190. § 426.435 Subpoenas.
5191. § 426.440 Evidence.
5192. § 426.444 Dismissals for cause.
5193. § 426.445 Witness fees.
5194. § 426.446 Record of hearing.
5195. § 426.447 Issuance and notification of an ALJ's decision.
5196. § 426.450 Mandatory provisions of an ALJ's decision.
5197. § 426.455 Prohibited provisions of an ALJ's decision.
5198. § 426.457 Optional provisions of an ALJ's decision.
5199. § 426.458 ALJ's LCD review record.
5200. § 426.460 Effect of an ALJ's decision.
5201. § 426.462 Notice of an ALJ's decision.
5202. § 426.463 Future new or revised LCDs.
5203. § 426.465 Appealing part or all of an ALJ's decision.
5204. § 426.468 Decision to not appeal an ALJ's decision.
5205. § 426.470 Board's role in docketing and evaluating the acceptability of appeals of ALJ decisions.
5206. § 426.476 Board review of an ALJ's decision.
5207. § 426.478 Retiring or revising an LCD during the Board's review of an ALJ's decision.
5208. § 426.480 Withdrawing an appeal of an ALJ's decision.
5209. § 426.482 Issuance and notification of a Board decision.
5210. § 426.484 Mandatory provisions of a Board decision.
5211. § 426.486 Prohibited provisions of a Board decision.
5212. § 426.487 Board's record on appeal of an ALJ's decision.
5213. § 426.488 Effect of a Board decision.
5214. § 426.489 Board remands.
5215. § 426.490 Board decision.
5216. Subpart E Review of an NCD
5217. § 426.500 Procedure for filing an acceptable complaint concerning a provision (or provisions) of an NCD.
5218. § 426.503 Submitting new evidence once an acceptable complaint has been filed.
5219. § 426.505 Authority of the Board.
5220. § 426.506 Ex parte contacts.
5221. § 426.510 Docketing and evaluating the acceptability of NCD complaints.
5222. § 426.513 Participation as amicus curiae.
5223. § 426.515 CMS' role in making the NCD record available.
5224. § 426.516 Role of Medicare Managed Care Organizations (MCOs) and State agencies in the NCD review process.
5225. § 426.517 CMS' statement regarding new evidence.
5226. § 426.518 NCD record furnished to the aggrieved party.
5227. § 426.519 NCD record furnished to the Board.
5228. § 426.520 Withdrawing an NCD under review or issuing a revised or reconsidered NCD.
5229. § 426.523 Withdrawing a complaint regarding an NCD under review.
5230. § 426.525 NCD review.
5231. § 426.531 Board's review of the NCD to apply the reasonableness standard.
5232. § 426.532 Discovery.
5233. § 426.535 Subpoenas.
5234. § 426.540 Evidence.
5235. § 426.544 Dismissals for cause.
5236. § 426.545 Witness fees.
5237. § 426.546 Record of hearing.
5238. § 426.547 Issuance, notification, and posting of a Board's decision.
5239. § 426.550 Mandatory provisions of the Board's decision.
5240. § 426.555 Prohibited provisions of the Board's decision.
5241. § 426.557 Optional provisions of the Board's decision.
5242. § 426.560 Effect of the Board's decision.
5243. § 426.562 Notice of the Board's decision.
5244. § 426.563 Future new or revised or reconsidered NCDs.
5245. § 426.565 Board's role in making an LCD or NCD review record available.
5246. § 426.566 Board decision.
5247. § 426.587 Record for appeal of a Board NCD decision.
5248. PART 427 MEDICARE PART B DRUG INFLATION REBATE PROGRAM
5249. Subpart A General Provisions
5250. § 427.10 Basis and scope.
5251. § 427.20 Definitions.
5252. Subpart B Determination of Part B Rebatable Drugs
5253. § 427.100 Definitions.
5254. § 427.101 Identification of Part B rebatable drugs.
5255. Subpart C Coinsurance Adjustment and Adjusted Medicare Payment for Part B Rebatable Drugs With Price Increases Faster Than Inflation
5256. § 427.200 Definitions.
5257. § 427.201 Computation of beneficiary coinsurance and adjusted Medicare payment for Part B rebatable drugs with price increases faster than inflation.
5258. Subpart D Determination of the Rebate Amount for Part B Rebatable Drugs
5259. § 427.300 Definitions.
5260. § 427.301 Calculation of the total Part B rebate amount to be paid by manufacturers.
5261. § 427.302 Calculation of the per unit Part B rebate.
5262. § 427.303 Determination of total number of billing units.
5263. § 427.304 Adjustments for changes to billing and payment codes.
5264. Subpart E Reducing the Rebate Amount for Part B Rebatable Drugs in Shortage and When There Is a Severe Supply Chain Disruption
5265. § 427.400 Definitions.
5266. § 427.401 Reducing the rebate amount for Part B rebatable drugs currently in shortage.
5267. § 427.402 Reducing the rebate amount for certain Part B rebatable drugs when there is a severe supply chain disruption.
5268. Subpart F Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments
5269. § 427.500 Definitions.
5270. § 427.501 Rebate Reports and reconciliation.
5271. § 427.502 Rebate Reports for applicable calendar quarters in calendar years 2023 and 2024.
5272. § 427.503 Suggestion of Error.
5273. § 427.504 Manufacturer access to Rebate Reports.
5274. § 427.505 Deadline and process for payment of rebate amount.
5275. Subpart G Enforcement of Manufacturer Payment of Rebate Amounts
5276. § 427.600 Civil money penalty notice and appeals procedures.
5277. PART 428 MEDICARE PART D DRUG INFLATION REBATE PROGRAM
5278. Subpart A General Provisions
5279. § 428.10 Basis and scope.
5280. § 428.20 Definitions.
5281. Subpart B Determination of Part D Rebatable Drugs
5282. § 428.100 Definitions.
5283. § 428.101 Identification of Part D rebatable drugs.
5284. Subpart C Determination of the Rebate Amount for Part D Rebatable Drugs
5285. § 428.200 Definitions.
5286. § 428.201 Calculation of the total rebate amount to be paid by manufacturers.
5287. § 428.202 Calculation of the per unit Part D rebate amount.
5288. § 428.203 Determination of the total number of units dispensed under Part D.
5289. § 428.204 Treatment of new formulations of Part D rebatable drugs.
5290. Subpart D Reducing the Rebate Amount for Part D Rebatable Drugs in Shortage and When There Is a Severe Supply Chain Disruption or Likely Shortage
5291. § 428.300 Definitions.
5292. § 428.301 Reducing the rebate amount for Part D rebatable drugs currently in shortage.
5293. § 428.302 Reducing the rebate amount for certain Part D rebatable drugs when there is a severe supply chain disruption.
5294. § 428.303 Reducing the rebate amount for generic Part D rebatable drugs likely to be in shortage.
5295. Subpart E Reports of Rebate Amounts, Reconciliation, Suggestion of Error, and Payments
5296. § 428.400 Definitions.
5297. § 428.401 Rebate Reports and reconciliation.
5298. § 428.402 Rebate Reports for applicable periods beginning October 1, 2022, and October 1, 2023.
5299. § 428.403 Suggestion of Error.
5300. § 428.404 Manufacturer access to Rebate Reports.
5301. § 428.405 Deadline and process for payment of rebate amount.
5302. Subpart F Enforcement of Manufacturer Payment of Rebate Amounts
5303. § 428.500 Civil money penalty notice and appeals procedures.
5304. 429 PART 429 [RESERVED]
5305. CHAPTER IV CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
5306. SUBCHAPTER C MEDICAL ASSISTANCE PROGRAMS
5307. PART 430 GRANTS TO STATES FOR MEDICAL ASSISTANCE PROGRAMS
5308. Subpart A Introduction; General Provisions
5309. § 430.0 Program description.
5310. § 430.1 Scope of subchapter C.
5311. § 430.2 Other applicable Federal regulations.
5312. § 430.3 Appeals under Medicaid.
5313. § 430.5 Definitions.
5314. Subpart B State Plans
5315. § 430.10 The State plan.
5316. § 430.12 Submittal of State plans and plan amendments.
5317. § 430.14 Review of State plan material.
5318. § 430.15 Basis and authority for action on State plan material.
5319. § 430.16 Timing and notice of action on State plan material.
5320. § 430.18 Administrative review of action on State plan material.
5321. § 430.20 Effective dates of State plans and plan amendments.
5322. § 430.25 Waivers of State plan requirements.
5323. Subpart C Grants; Reviews and Audits; Withholding for Failure To Comply; Deferral and Disallowance of Claims; Reduction of Federal Medicaid Payments
5324. § 430.30 Grants procedures.
5325. § 430.32 Program reviews.
5326. § 430.33 Audits.
5327. § 430.35 Withholding of payment for failure to comply with Federal requirements.
5328. § 430.38 Judicial review.
5329. § 430.40 Deferral of claims for FFP.
5330. § 430.42 Disallowance of claims for FFP.
5331. § 430.45 Reduction of Federal Medicaid payments.
5332. § 430.48 Repayment of Federal funds by installments.
5333. § 430.49 Corrective action plans, suspensions of procedural disenrollments, and civil money penalties.
5334. Subpart D Hearings on Conformity of State Medicaid Plans and Practice to Federal Requirements
5335. § 430.60 Scope.
5336. § 430.62 Records to be public.
5337. § 430.63 Filing and service of papers.
5338. § 430.64 Suspension of rules.
5339. § 430.66 Designation of presiding officer for hearing.
5340. § 430.70 Notice of hearing or opportunity for hearing.
5341. § 430.72 Time and place of hearing.
5342. § 430.74 Issues at hearing.
5343. § 430.76 Parties to the hearing.
5344. § 430.80 Authority of the presiding officer.
5345. § 430.83 Rights of parties.
5346. § 430.86 Discovery.
5347. § 430.88 Evidence.
5348. § 430.90 Exclusion from hearing for misconduct.
5349. § 430.92 Unsponsored written material.
5350. § 430.94 Official transcript.
5351. § 430.96 Record for decision.
5352. § 430.100 Posthearing briefs.
5353. § 430.102 Decisions following hearing.
5354. § 430.104 Decisions that affect FFP.
5355. PART 431 STATE ORGANIZATION AND GENERAL ADMINISTRATION
5356. § 431.1 Purpose.
5357. Subpart A Single State Agency
5358. § 431.10 Single State agency.
5359. § 431.11 Organization for administration.
5360. § 431.12 Medicaid Advisory Committee and Beneficiary Advisory Council.
5361. § 431.15 Methods of administration.
5362. § 431.16 Reports.
5363. § 431.17 Maintenance of records.
5364. § 431.18 Availability of agency program manuals.
5365. § 431.20 Advance directives.
5366. Subpart B General Administrative Requirements
5367. § 431.40 Basis and scope.
5368. § 431.50 Statewide operation.
5369. § 431.51 Free choice of providers.
5370. § 431.52 Payments for services furnished out of State.
5371. § 431.53 Assurance of transportation.
5372. § 431.54 Exceptions to certain State plan requirements.
5373. § 431.55 Waiver of other Medicaid requirements.
5374. § 431.56 Special waiver provisions applicable to American Samoa and the Northern Mariana Islands.
5375. § 431.60 Beneficiary access to and exchange of data.
5376. § 431.61 Access to and exchange of health data for providers and payers.
5377. § 431.70 Access to published provider directory information.
5378. § 431.80 Prior authorization requirements.
5379. Subpart C Administrative Requirements: Provider Relations
5380. § 431.105 Consultation to medical facilities.
5381. § 431.107 Required provider agreement.
5382. § 431.108 Effective date of provider agreements.
5383. § 431.110 Participation by Indian Health Service facilities.
5384. § 431.115 Disclosure of survey information and provider or contractor evaluation.
5385. § 431.120 State requirements with respect to nursing facilities.
5386. Subpart D Appeals Process for NFs and ICFs/IID
5387. § 431.151 Scope and applicability.
5388. § 431.152 State plan requirements.
5389. § 431.153 Evidentiary hearing.
5390. § 431.154 Informal reconsideration for ICFs/IID.
5391. Subpart E Fair Hearings for Applicants and Beneficiaries
5392. 8 General Provisions
5393. § 431.200 Basis and scope.
5394. § 431.201 Definitions.
5395. § 431.202 State plan requirements.
5396. § 431.205 Provision of hearing system.
5397. § 431.206 Informing applicants and beneficiaries.
5398. 9 Notice
5399. § 431.210 Content of notice.
5400. § 431.211 Advance notice.
5401. § 431.213 Exceptions from advance notice.
5402. § 431.214 Notice in cases of probable fraud.
5403. 10 Right to Hearing
5404. § 431.220 When a hearing is required.
5405. § 431.221 Request for hearing.
5406. § 431.222 Group hearings.
5407. § 431.223 Denial or dismissal of request for a hearing.
5408. § 431.224 Expedited appeals.
5409. 11 Procedures
5410. § 431.230 Maintaining services.
5411. § 431.231 Reinstating services.
5412. § 431.232 Adverse decision of local evidentiary hearing.
5413. § 431.233 State agency hearing after adverse decision of local evidentiary hearing.
5414. § 431.240 Conducting the hearing.
5415. § 431.241 Matters to be considered at the hearing.
5416. § 431.242 Procedural rights of the applicant or beneficiary.
5417. § 431.243 Parties in cases involving an eligibility determination.
5418. § 431.244 Hearing decisions.
5419. § 431.245 Notifying the applicant or beneficiary of a State agency decision.
5420. § 431.246 Corrective action.
5421. 12 Federal Financial Participation
5422. § 431.250 Federal financial participation.
5423. Subpart F Safeguarding Information on Applicants and Beneficiaries
5424. § 431.300 Basis and purpose.
5425. § 431.301 State plan requirements.
5426. § 431.302 Purposes directly related to State plan administration.
5427. § 431.303 State authority for safeguarding information.
5428. § 431.304 Publicizing safeguarding requirements.
5429. § 431.305 Types of information to be safeguarded.
5430. § 431.306 Release of information.
5431. § 431.307 Distribution of information materials.
5432. Subpart G Section 1115 Demonstrations
5433. § 431.400 Basis and purpose.
5434. § 431.404 Definitions.
5435. § 431.408 State public notice process.
5436. § 431.412 Application procedures.
5437. § 431.416 Federal public notice and approval process.
5438. § 431.420 Monitoring and compliance.
5439. § 431.424 Evaluation requirements.
5440. § 431.428 Reporting requirements.
5441. H Subparts H-L [Reserved]
5442. Subpart M Relations With Other Agencies
5443. § 431.610 Relations with standard-setting and survey agencies.
5444. § 431.615 Relations with State health and vocational rehabilitation agencies and title V grantees.
5445. § 431.620 Agreement with State mental health authority or mental institutions.
5446. § 431.621 State requirements with respect to nursing facilities.
5447. § 431.625 Coordination of Medicaid with Medicare part B.
5448. § 431.630 Coordination of Medicaid with QIOs.
5449. § 431.635 Coordination of Medicaid with Special Supplemental Food Program for Women, Infants, and Children (WIC).
5450. Subpart N State Programs for Licensing Nursing Home Administrators
5451. § 431.700 Basis and purpose.
5452. § 431.701 Definitions.
5453. § 431.702 State plan requirement.
5454. § 431.703 Licensing requirement.
5455. § 431.704 Nursing homes designated by other terms.
5456. § 431.705 Licensing authority.
5457. § 431.706 Composition of licensing board.
5458. § 431.707 Standards.
5459. § 431.708 Procedures for applying standards.
5460. § 431.709 Issuance and revocation of license.
5461. § 431.710 Provisional licenses.
5462. § 431.711 Compliance with standards.
5463. § 431.712 Failure to comply with standards.
5464. § 431.713 Continuing study and investigation.
5465. § 431.714 Waivers.
5466. § 431.715 Federal financial participation.
5467. O Subpart O [Reserved]
5468. Subpart P Quality Control
5469. 13 Medicaid Eligibility Quality Control (MEQC) Program
5470. § 431.800 Basis and scope.
5471. § 431.804 Definitions.
5472. § 431.806 State requirements.
5473. § 431.808 Protection of beneficiary rights.
5474. § 431.810 Basic elements of the Medicaid Eligibility Quality Control (MEQC) Program.
5475. § 431.812 Review procedures.
5476. § 431.814 Pilot planning document.
5477. § 431.816 Case review completion deadlines and submittal of reports.
5478. § 431.818 Access to records.
5479. § 431.820 Corrective action under the MEQC program.
5480. 14 Medicaid Quality Control (MQC) Claims Processing Assessment System
5481. § 431.830 Basic elements of the Medicaid quality control (MQC) claims processing assessment system.
5482. § 431.832 Reporting requirements for claims processing assessment systems.
5483. § 431.834 Access to records: Claims processing assessment systems.
5484. § 431.836 Corrective action under the MQC claims processing assessment system.
5485. Subpart Q Requirements for Estimating Improper Payments in Medicaid and CHIP
5486. § 431.950 Purpose.
5487. § 431.954 Basis and scope.
5488. § 431.958 Definitions and use of terms.
5489. § 431.960 Types of payment errors.
5490. § 431.970 Information submission and systems access requirements.
5491. § 431.972 Claims sampling procedures.
5492. § 431.992 Corrective action plan.
5493. § 431.998 Difference resolution and appeal process.
5494. § 431.1002 Recoveries.
5495. § 431.1010 Disallowance of Federal financial participation for erroneous State payments (for PERM review years ending after July 1, 2020).
5496. PART 432 STATE PERSONNEL ADMINISTRATION
5497. Subpart A General Provisions
5498. § 432.1 Basis and purpose.
5499. § 432.2 Definitions.
5500. § 432.10 Standards of personnel administration.
5501. Subpart B Training Programs; Subprofessional and Volunteer Programs
5502. § 432.30 Training programs: General requirements.
5503. § 432.31 Training and use of subprofessional staff.
5504. § 432.32 Training and use of volunteers.
5505. Subpart C Staffing and Training Expenditures
5506. § 432.45 Applicability of provisions in subpart.
5507. § 432.50 FFP: Staffing and training costs.
5508. § 432.55 Reporting training and administrative costs.
5509. PART 433 STATE FISCAL ADMINISTRATION
5510. § 433.1 Purpose.
5511. Subpart A Federal Matching and General Administration Provisions
5512. § 433.8 [Reserved]
5513. § 433.10 Rates of FFP for program services.
5514. § 433.11 Enhanced FMAP rate for children.
5515. § 433.15 Rates of FFP for administration.
5516. § 433.32 Fiscal policies and accountability.
5517. § 433.34 Cost allocation.
5518. § 433.35 Equipment—Federal financial participation.
5519. § 433.36 Liens and recoveries.
5520. § 433.37 Reporting provider payments to Internal Revenue Service.
5521. § 433.38 Interest charge on disallowed claims for FFP.
5522. § 433.40 Treatment of uncashed or cancelled (voided) Medicaid checks.
5523. Subpart B General Administrative Requirements State Financial Participation
5524. § 433.50 Basis, scope, and applicability.
5525. § 433.51 Public Funds as the State share of financial participation.
5526. § 433.52 General definitions.
5527. § 433.53 State plan requirements.
5528. § 433.54 Bona fide donations.
5529. § 433.55 Health care-related taxes defined.
5530. § 433.56 Classes of health care services and providers defined.
5531. § 433.57 General rules regarding revenues from provider-related donations and health care-related taxes.
5532. §§ 433.58-433.60 [Reserved]
5533. § 433.66 Permissible provider-related donations.
5534. § 433.67 Limitations on level of FFP for permissible provider-related donations.
5535. § 433.68 Permissible health care-related taxes.
5536. § 433.70 Limitation on level of FFP for revenues from health care-related taxes.
5537. § 433.72 Waiver provisions applicable to health care-related taxes.
5538. § 433.74 Reporting requirements.
5539. Subpart C Mechanized Claims Processing and Information Retrieval Systems
5540. § 433.110 Basis, purpose, and applicability.
5541. § 433.111 Definitions.
5542. § 433.112 FFP for design, development, installation or enhancement of mechanized processing and information retrieval systems.
5543. § 433.114 Procedures for obtaining initial approval; notice of decision.
5544. § 433.116 FFP for operation of mechanized claims processing and information retrieval systems.
5545. § 433.117 Initial approval of replacement systems.
5546. § 433.119 Conditions for reapproval; notice of decision.
5547. § 433.120 Procedures for reduction of FFP after reapproval review.
5548. § 433.121 Reconsideration of the decision to reduce FFP after reapproval review.
5549. § 433.122 Reapproval of a disapproved system.
5550. § 433.123 Notification of changes in system requirements, performance standards or other conditions for approval or reapproval.
5551. § 433.127 Termination of FFP for failure to provide access to claims processing and information retrieval systems.
5552. § 433.131 Waiver for noncompliance with conditions of approval and reapproval.
5553. Subpart D Third Party Liability
5554. § 433.135 Basis and purpose.
5555. § 433.136 Definitions.
5556. § 433.137 State plan requirements.
5557. § 433.138 Identifying liable third parties.
5558. § 433.139 Payment of claims.
5559. § 433.140 FFP and repayment of Federal share.
5560. 17 Assignment of Rights to Benefits
5561. § 433.145 Assignment of rights to benefits—State plan requirements.
5562. § 433.146 Rights assigned; assignment method.
5563. § 433.147 Cooperation in establishing the identity of a child's parents and in obtaining medical support and payments and in identifying and providing information to assist in pursuing third parties who may be liable to pay.
5564. § 433.148 Denial or termination of eligibility.
5565. 18 Cooperative Agreements and Incentive Payments
5566. § 433.151 Cooperative agreements and incentive payments—State plan requirements.
5567. § 433.152 Requirements for cooperative agreements for third party collections.
5568. § 433.153 Incentive payments to States and political subdivisions.
5569. § 433.154 Distribution of collections.
5570. Subpart E Methodologies for Determining Federal Share of Medicaid Expenditures for Adult Eligibility Group
5571. § 433.202 Scope.
5572. § 433.204 Definitions.
5573. § 433.206 Threshold methodology.
5574. Subpart F Refunding of Federal Share of Medicaid Overpayments to Providers
5575. § 433.300 Basis.
5576. § 433.302 Scope of subpart.
5577. § 433.304 Definitions.
5578. § 433.310 Applicability of requirements.
5579. § 433.312 Basic requirements for refunds.
5580. § 433.316 When discovery of overpayment occurs and its significance.
5581. § 433.318 Overpayments involving providers who are bankrupt or out of business.
5582. § 433.320 Procedures for refunds to CMS.
5583. § 433.322 Maintenance of Records.
5584. Subpart G Temporary FMAP Increase During the Public Health Emergency for COVID-19
5585. § 433.400 Continued enrollment for temporary FMAP increase.
5586. PART 434 CONTRACTS
5587. Subpart A General Provisions
5588. § 434.1 Basis and scope.
5589. § 434.2 Definitions.
5590. § 434.4 State plan requirement.
5591. § 434.6 General requirements for all contracts and subcontracts.
5592. Subpart B Contracts with Fiscal Agents and Private Nonmedical Institutions
5593. § 434.10 Contracts with fiscal agents.
5594. § 434.12 Contracts with private nonmedical institutions.
5595. § 434.14 [Reserved]
5596. C Subpart C [Reserved]
5597. Subpart D Contracts With Health Insuring Organizations
5598. § 434.40 Contract requirements.
5599. E Subpart E [Reserved]
5600. Subpart F Federal Financial Participation
5601. § 434.70 Conditions for Federal Financial Participation (FFP).
5602. § 434.76 Costs under fiscal agent contracts.
5603. § 434.78 Right to reconsideration of disallowance.
5604. PART 435 ELIGIBILITY IN THE STATES, DISTRICT OF COLUMBIA, THE NORTHERN MARIANA ISLANDS, AND AMERICAN SAMOA
5605. Subpart A General Provisions and Definitions
5606. § 435.2 Purpose and applicability.
5607. § 435.3 Basis.
5608. § 435.4 Definitions and use of terms.
5609. § 435.10 State plan requirements.
5610. Subpart B Mandatory Coverage
5611. § 435.100 Scope.
5612. 48 Mandatory Coverage of Families and Children
5613. § 435.110 Parents and other caretaker relatives.
5614. § 435.112 Families terminated from AFDC because of increased earnings or hours of employment.
5615. § 435.115 Families with Medicaid eligibility extended because of increased collection of spousal support.
5616. 49 Mandatory Coverage of Pregnant Women, Children Under 19, and Newborn Children
5617. § 435.116 Pregnant women.
5618. § 435.117 Deemed newborn children.
5619. 50 Mandatory Coverage of Qualified Family Members
5620. § 435.118 Infants and children under age 19.
5621. 51 Mandatory Coverage for Individuals Age 19 Through 64
5622. § 435.119 Coverage for individuals age 19 or older and under age 65 at or below 133 percent FPL.
5623. 52 Mandatory Coverage of the Aged, Blind, and Disabled
5624. § 435.120 Individuals receiving SSI.
5625. § 435.121 Individuals in States using more restrictive requirements for Medicaid than the SSI requirements.
5626. § 435.122 Individuals who are ineligible for SSI or optional State supplements because of requirements that do not apply under title XIX of the Act.
5627. § 435.123 Individuals eligible as qualified Medicare beneficiaries.
5628. § 435.124 Individuals eligible as specified low-income Medicare beneficiaries.
5629. § 435.125 Individuals eligible as qualifying individuals.
5630. § 435.126 Individuals eligible as qualified disabled and working individuals.
5631. § 435.130 Individuals receiving mandatory State supplements.
5632. § 435.131 Individuals eligible as essential spouses in December 1973.
5633. § 435.132 Institutionalized individuals who were eligible in December 1973.
5634. § 435.133 Blind and disabled individuals eligible in December 1973.
5635. § 435.134 Individuals who would be eligible except for the increase in OASDI benefits under Pub. L. 92-336 (July 1, 1972).
5636. § 435.135 Individuals who become ineligible for cash assistance as a result of OASDI cost-of-living increases received after April 1977.
5637. § 435.136 State agency implementation requirements for one-time notice and annual review system.
5638. § 435.137 Disabled widows and widowers who would be eligible for SSI except for the increase in disability benefits resulting from elimination of the reduction factor under Pub. L. 98-21.
5639. § 435.138 Disabled widows and widowers aged 60 through 64 who would be eligible for SSI except for early receipt of social security benefits.
5640. 53 Mandatory Coverage of Certain Aliens
5641. § 435.139 Coverage for certain aliens.
5642. 54 Mandatory Coverage of Adoption Assistance and Foster Care Children
5643. § 435.145 Children with adoption assistance, foster care, or guardianship care under title IV-E.
5644. § 435.150 Former foster care children.
5645. 55 Mandatory Coverage of Special Groups
5646. § 435.170 Pregnant women eligible for extended or continuous eligibility.
5647. § 435.172 Continuous eligibility for hospitalized children.
5648. Subpart C Options for Coverage
5649. § 435.200 Scope.
5650. § 435.201 Individuals included in optional groups.
5651. 56 Options for Coverage of Families and Children and the Aged, Blind, and Disabled
5652. § 435.210 Optional eligibility for individuals who meet the income and resource requirements of the cash assistance programs.
5653. § 435.211 Optional eligibility for individuals who would be eligible for cash assistance if they were not in medical institutions.
5654. § 435.212 Individuals who would be ineligible if they were not enrolled in an MCO or PCCM.
5655. § 435.213 Optional eligibility for individuals needing treatment for breast or cervical cancer.
5656. § 435.214 Eligibility for Medicaid limited to family planning and related services.
5657. § 435.215 Individuals infected with tuberculosis.
5658. § 435.217 Individuals receiving home and community-based services.
5659. § 435.218 Individuals with MAGI-based income above 133 percent FPL.
5660. § 435.219 Individuals receiving State plan home and community-based services.
5661. 57 Options for Coverage of Families and Children
5662. § 435.220 Optional eligibility for parents and other caretaker relatives.
5663. § 435.221 [Reserved]
5664. § 435.222 Optional eligibility for reasonable classifications of individuals under age 21 with income below a MAGI-equivalent standard in specified eligibility categories.
5665. § 435.223 Other optional eligibility for reasonable classifications of individuals under age 21.
5666. § 435.225 Individuals under age 19 who would be eligible for Medicaid if they were in a medical institution.
5667. § 435.226 Optional eligibility for independent foster care adolescents.
5668. § 435.227 Optional eligibility for individuals under age 21 who are under State adoption assistance agreements.
5669. § 435.229 Optional targeted low-income children.
5670. 58 Options for Coverage of the Aged, Blind, and Disabled
5671. § 435.230 Aged, blind, and disabled individuals in States that use more restrictive requirements for Medicaid than SSI requirements: Optional coverage.
5672. § 435.232 Individuals receiving only optional State supplements.
5673. § 435.234 Individuals receiving only optional State supplements in States using more restrictive eligibility requirements than SSI and certain States using SSI criteria.
5674. § 435.236 Individuals in institutions who are eligible under a special income level.
5675. Subpart D Optional Coverage of the Medically Needy
5676. § 435.300 Scope.
5677. § 435.301 General rules.
5678. § 435.308 Medically needy coverage of individuals under age 21.
5679. § 435.310 Medically needy coverage of parents and other caretaker relatives.
5680. § 435.320 Medically needy coverage of the aged in States that cover individuals receiving SSI.
5681. § 435.322 Medically needy coverage of the blind in States that cover individuals receiving SSI.
5682. § 435.324 Medically needy coverage of the disabled in States that cover individuals receiving SSI.
5683. § 435.326 Individuals who would be ineligible if they were not enrolled in an MCO or PCCM.
5684. § 435.330 Medically needy coverage of the aged, blind, and disabled in States using more restrictive eligibility requirements for Medicaid than those used under SSI.
5685. § 435.340 Protected medically needy coverage for blind and disabled individuals eligible in December 1973.
5686. § 435.350 Coverage for certain aliens.
5687. Subpart E General Eligibility Requirements
5688. § 435.400 Scope.
5689. § 435.401 General rules.
5690. § 435.402 [Reserved]
5691. § 435.403 State residence.
5692. § 435.404 Applicant's choice of category.
5693. § 435.406 Citizenship and noncitizen eligibility.
5694. § 435.407 Types of acceptable documentary evidence of citizenship.
5695. Subpart F Categorical Requirements for Eligibility
5696. § 435.500 Scope.
5697. 59 Age
5698. § 435.520 Age requirements for the aged.
5699. 60 Blindness
5700. § 435.530 Definition of blindness.
5701. § 435.531 Determinations of blindness.
5702. 61 Disability
5703. § 435.540 Definition of disability.
5704. § 435.541 Determinations of disability.
5705. 62 Community Engagement Requirement
5706. § 435.550 Basis and scope.
5707. § 435.551 Applicable individual.
5708. § 435.552 Demonstrating community engagement.
5709. § 435.553 Mandatory exceptions for certain applicable individuals.
5710. § 435.554 Specified excluded individuals.
5711. § 435.555 Optional exception for short-term hardship events.
5712. § 435.556 Assessing compliance with the community engagement requirement.
5713. § 435.557 Verifying compliance with or exception or exclusion from the community engagement requirement.
5714. § 435.558 Noncompliance procedures.
5715. § 435.559 Implementation timing for the community engagement requirement.
5716. § 435.560 Good faith effort exemption.
5717. § 435.561 State requirements for outreach.
5718. § 435.562 Requirements for States to submit data for monitoring community engagement.
5719. § 435.563 Prohibition of waivers of the community engagement requirement.
5720. Subpart G General Financial Eligibility Requirements and Options
5721. § 435.600 Scope.
5722. § 435.601 Application of financial eligibility methodologies.
5723. § 435.602 Financial responsibility of relatives and other individuals.
5724. § 435.603 Application of modified adjusted gross income (MAGI).
5725. § 435.604 [Reserved]
5726. § 435.606 [Reserved]
5727. § 435.608 [Reserved]
5728. § 435.610 Assignment of rights to benefits.
5729. § 435.622 Individuals in institutions who are eligible under a special income level.
5730. § 435.631 General requirements for determining income eligibility in States using more restrictive requirements for Medicaid than SSI.
5731. § 435.640 Protected Medicaid eligibility for individuals eligible in December 1973.
5732. Subpart H Specific Post-Eligibility Financial Requirements for the Categorically Needy
5733. § 435.700 Scope.
5734. § 435.725 Post-eligibility treatment of income of institutionalized individuals in SSI States: Application of patient income to the cost of care.
5735. § 435.726 Post-eligibility treatment of income of individuals receiving home and community-based services furnished under a waiver: Application of patient income to the cost of care.
5736. § 435.733 Post-eligibility treatment of income of institutionalized individuals in States using more restrictive requirements than SSI: Application of patient income to the cost of care.
5737. § 435.735 Post-eligibility treatment of income and resources of individuals receiving home and community-based services furnished under a waiver: Application of patient income to the cost of care.
5738. Subpart I Specific Eligibility and Post-Eligibility Financial Requirements for the Medically Needy
5739. § 435.800 Scope.
5740. 63 Medically Needy Income Standard
5741. § 435.811 Medically needy income standard: General requirements.
5742. § 435.814 Medically needy income standard: State plan requirements.
5743. 64 Medically Needy Income Eligibility
5744. § 435.831 Income eligibility.
5745. § 435.832 Post-eligibility treatment of income of institutionalized individuals: Application of patient income to the cost of care.
5746. 65 Medically Needy Resource Standard
5747. § 435.840 Medically needy resource standard: General requirements.
5748. § 435.843 Medically needy resource standard: State plan requirements.
5749. 66 Determining Eligibility on the Basis of Resources
5750. § 435.845 Medically needy resource eligibility.
5751. §§ 435.850-435.852 [Reserved]
5752. Subpart J Eligibility in the States and District of Columbia
5753. § 435.900 Scope.
5754. 67 General Methods of Administration
5755. § 435.901 Consistency with objectives and statutes.
5756. § 435.902 Simplicity of administration.
5757. § 435.903 Adherence of local agencies to State plan requirements.
5758. § 435.904 Establishment of outstation locations to process applications for certain low-income eligibility groups.
5759. 68 Applications
5760. § 435.905 Availability and accessibility of program information.
5761. § 435.906 Opportunity to apply.
5762. § 435.907 Application.
5763. § 435.908 Assistance with application and renewal.
5764. § 435.909 Automatic entitlement to Medicaid following a determination of eligibility under other programs.
5765. § 435.910 Use of social security number.
5766. 69 Determination of Medicaid Eligibility
5767. § 435.911 Determination of eligibility.
5768. § 435.912 Timely determination of eligibility.
5769. § 435.914 Case documentation.
5770. § 435.915 Effective date.
5771. 70 Redeterminations of Medicaid Eligibility
5772. § 435.916 Periodic renewal of Medicaid eligibility.
5773. § 435.917 Notice of agency's decision concerning eligibility, benefits, or services.
5774. § 435.918 Use of electronic notices.
5775. § 435.919 [Reserved]
5776. § 435.920 Verification of SSNs.
5777. § 435.923 Authorized representatives.
5778. § 435.926 Continuous eligibility for children.
5779. § 435.927 Requirements for States to submit certain data on redeterminations.
5780. § 435.928 Reduction in FMAP for failure to submit certain data.
5781. 71 Furnishing Medicaid
5782. § 435.930 Furnishing Medicaid.
5783. 72 Income and Eligibility Verification Requirements
5784. § 435.940 Basis and scope.
5785. § 435.945 General requirements.
5786. § 435.948 Verifying financial information.
5787. § 435.949 Verification of information through an electronic service.
5788. § 435.952 Use of information and requests of additional information from individuals.
5789. § 435.956 Verification of other non-financial information.
5790. § 435.960 Standardized formats for furnishing and obtaining information to verifying income and eligibility.
5791. § 435.965 Delay of effective date.
5792. Subpart K Federal Financial Participation
5793. § 435.1000 Scope.
5794. 73 FFP in Expenditures for Determining Eligibility and Providing Services
5795. § 435.1001 FFP for administration.
5796. § 435.1002 FFP for services.
5797. § 435.1003 FFP for redeterminations.
5798. § 435.1004 Beneficiaries overcoming certain conditions of eligibility.
5799. 74 Limitations on FFP
5800. § 435.1005 Beneficiaries in institutions eligible under a special income standard.
5801. § 435.1006 Beneficiaries of optional State supplements only.
5802. § 435.1007 Categorically needy, medically needy, and qualified Medicare beneficiaries.
5803. § 435.1008 FFP in expenditures for medical assistance for individuals who have declared citizenship or nationality or satisfactory immigration status.
5804. § 435.1009 Institutionalized individuals.
5805. § 435.1010 Definitions relating to institutional status.
5806. 75 Requirements for State Supplements
5807. § 435.1011 Requirement for mandatory State supplements.
5808. § 435.1012 Requirement for maintenance of optional State supplement expenditures.
5809. 76 FFP for Premium Assistance
5810. § 435.1015 FFP for premium assistance for plans in the individual market.
5811. Subpart L Options for Coverage of Special Groups under Presumptive Eligibility
5812. § 435.1100 Basis for presumptive eligibility.
5813. § 435.1101 Definitions related to presumptive eligibility.
5814. § 435.1102 Children covered under presumptive eligibility.
5815. § 435.1103 Presumptive eligibility for other individuals.
5816. § 435.1110 Presumptive eligibility determined by hospitals.
5817. Subpart M Coordination of Eligibility and Enrollment Between Medicaid, CHIP, Exchanges and Other Insurance Affordability Programs
5818. § 435.1200 Medicaid agency responsibilities for a coordinated eligibility and enrollment process with other insurance affordability programs.
5819. § 435.1205 Alignment with exchange initial open enrollment period.
5820. PART 436 ELIGIBILITY IN GUAM, PUERTO RICO, AND THE VIRGIN ISLANDS
5821. Subpart A General Provisions and Definitions
5822. § 436.1 Purpose and applicability.
5823. § 436.2 Basis.
5824. § 436.3 Definitions and use of terms.
5825. § 436.10 State plan requirements.
5826. Subpart B Mandatory Coverage of the Categorically Needy
5827. § 436.100 Scope.
5828. § 436.110 Individuals receiving cash assistance.
5829. § 436.111 Individuals who are not eligible for cash assistance because of a requirement not applicable under Medicaid.
5830. § 436.112 Individuals who would be eligible for cash assistance except for increased OASDI under Pub. L. 92-336 (July 1, 1972).
5831. § 436.114 Individuals deemed to be receiving AFDC.
5832. § 436.116 Families terminated from AFDC because of increased earnings or hours of employment.
5833. § 436.118 Children for whom adoption assistance or foster care maintenance payments are made.
5834. § 436.120 Qualified pregnant women and children who are not qualified family members.
5835. § 436.121 Qualified family members.
5836. § 436.122 Pregnant women eligible for extended coverage.
5837. § 436.124 Newborn children.
5838. § 436.128 Coverage for certain qualified aliens.
5839. Subpart C Options for Coverage as Categorically Needy
5840. § 436.200 Scope.
5841. § 436.201 Individuals included in optional groups.
5842. 89 Options for Coverage of Families and Children and Aged, Blind, and Disabled Individuals, Including Pregnant Women
5843. § 436.210 Individuals who meet the income and resource requirements of the cash assistance programs.
5844. § 436.211 Individuals who would be eligible for cash assistance if they were not in medical institutions.
5845. § 436.212 Individuals who would be eligible for cash assistance if the State plan for OAA, AFDC, AB, APTD, or AABD were as broad as allowed under the Act.
5846. § 436.217 Individuals receiving home and community-based services.
5847. § 436.219 Individuals receiving State plan home and community-based services.
5848. § 436.220 Individuals who would meet the income and resource requirements under AFDC if child care costs were paid from earnings.
5849. § 436.222 Individuals under age 21 who meet the income and resource requirements of AFDC.
5850. § 436.224 Individuals under age 21 who are under State adoption assistance agreements.
5851. § 436.229 Optional targeted low-income children.
5852. 90 Options for Coverage of the Aged, Blind, and Disabled
5853. § 436.230 Essential spouses of aged, blind, or disabled individuals receiving cash assistance.
5854. Subpart D Optional Coverage of the Medically Needy
5855. § 436.300 Scope.
5856. § 436.301 General rules.
5857. § 436.308 Medically needy coverage of individuals under age 21.
5858. § 436.310 Medically needy coverage of specified relatives.
5859. § 436.320 Medically needy coverage of the aged.
5860. § 436.321 Medically needy coverage of the blind.
5861. § 436.322 Medically needy coverage of the disabled.
5862. § 436.330 Coverage for certain aliens.
5863. Subpart E General Eligibility Requirements
5864. § 436.400 Scope.
5865. § 436.401 General rules.
5866. § 436.402 [Reserved]
5867. § 436.403 State residence.
5868. § 436.404 Applicant's choice of category.
5869. § 436.406 Citizenship and alienage.
5870. § 436.407 Types of acceptable documentary evidence of citizenship.
5871. § 436.408 [Reserved]
5872. Subpart F Categorical Requirements for Medicaid Eligibility
5873. § 436.500 Scope.
5874. 91 Dependency
5875. § 436.510 Determination of dependency.
5876. 92 Age
5877. § 436.520 Age requirements for the aged.
5878. § 436.522 Determination of age.
5879. 93 Blindness
5880. § 436.530 Definition of blindness.
5881. § 436.531 Determination of blindness.
5882. 94 Disability
5883. § 436.540 Definition of disability.
5884. § 436.541 Determination of disability.
5885. Subpart G General Financial Eligibility Requirements and Options
5886. § 436.600 Scope.
5887. § 436.601 Application of financial eligibility methodologies.
5888. § 436.602 Financial responsibility of relatives and other individuals.
5889. §§ 436.604-436.608 [Reserved]
5890. § 436.610 Assignment of rights to benefits.
5891. H Subpart H [Reserved]
5892. Subpart I Financial Requirements for the Medically Needy
5893. § 436.800 Scope.
5894. 95 Medically Needy Income Standard
5895. § 436.811 Medically needy income standard: General requirements.
5896. § 436.814 Medically needy income standard: State plan requirements.
5897. 96 Medically Needy Income Eligibility and Liability for Payment of Medical Expenses
5898. § 436.831 Income eligibility.
5899. § 436.832 Post-eligibility treatment of income of institutionalized individuals: Application of patient income to the cost of care.
5900. 97 Medically Needy Resource Standard
5901. § 436.840 Medically needy resource standard: General requirements.
5902. § 436.843 Medically needy resource standard: State plan requirements.
5903. 98 Determining Eligibility on the Basis of Resources
5904. § 436.845 Medically needy resource eligibility.
5905. Subpart J Eligibility in Guam, Puerto Rico, and the Virgin Islands
5906. § 436.900 Scope.
5907. § 436.901 General requirements.
5908. § 436.909 Automatic entitlement to Medicaid following a determination of eligibility under other programs.
5909. Subpart K Federal Financial Participation (FFP)
5910. § 436.1000 Scope.
5911. 99 FFP for Expenditures for Determining Eligibility and Providing Services
5912. § 436.1001 FFP for administration.
5913. § 436.1002 FFP for services.
5914. § 436.1003 beneficiaries overcoming certain conditions of eligibility.
5915. § 436.1004 FFP in expenditures for medical assistance for individuals who have declared United States citizenship or nationality under section 1137(d) of the Act and with respect to whom the State has not documented citizenship and identity.
5916. § 436.1005 Institutionalized individuals.
5917. § 436.1006 Definitions relating to institutional status.
5918. Subpart L Option for Coverage of Special Groups
5919. § 436.1100 Basis and scope.
5920. 100 Presumptive Eligibility for Children
5921. § 436.1101 Definitions related to presumptive eligibility period for children.
5922. § 436.1102 General rules.
5923. PART 437 MEDICAID QUALITY
5924. Subpart A Child, Adult, and Health Home Health Care Quality Measures
5925. § 437.1 Basis, scope, purpose, and applicability.
5926. § 437.5 Definitions.
5927. § 437.10 Child, Adult, and Health Home Core Sets.
5928. § 437.15 Annual reporting on the Child, Adult, and Health Home Core Sets.
5929. § 437.20 State plan requirements.
5930. PART 438 MANAGED CARE
5931. Subpart A General Provisions
5932. § 438.1 Basis and scope.
5933. § 438.2 Definitions.
5934. § 438.3 Standard contract requirements.
5935. § 438.4 Actuarial soundness.
5936. § 438.5 Rate development standards.
5937. § 438.6 Special contract provisions related to payment.
5938. § 438.7 Rate certification submission.
5939. § 438.8 Medical loss ratio (MLR) standards.
5940. § 438.9 Provisions that apply to non-emergency medical transportation PAHPs.
5941. § 438.10 Information requirements.
5942. § 438.12 Provider discrimination prohibited.
5943. § 438.14 Requirements that apply to MCO, PIHP, PAHP, PCCM, and PCCM entity contracts involving Indians, Indian health care providers (IHCPs), and Indian managed care entities (IMCEs).
5944. § 438.16 In lieu of services and settings (ILOS) requirements.
5945. Subpart B State Responsibilities
5946. § 438.50 State Plan requirements.
5947. § 438.52 Choice of MCOs, PIHPs, PAHPs, PCCMs, and PCCM entities.
5948. § 438.54 Managed care enrollment.
5949. § 438.56 Disenrollment: Requirements and limitations.
5950. § 438.58 Conflict of interest safeguards.
5951. § 438.60 Prohibition of additional payments for services covered under MCO, PIHP or PAHP contracts.
5952. § 438.62 Continued services to enrollees.
5953. § 438.66 State monitoring requirements.
5954. § 438.68 Network adequacy standards.
5955. § 438.70 Stakeholder engagement when LTSS is delivered through a managed care program.
5956. § 438.71 Beneficiary support system.
5957. § 438.72 Additional requirements for long-term services and supports.
5958. § 438.74 State oversight of the minimum MLR requirement.
5959. Subpart C Enrollee Rights and Protections
5960. § 438.100 Enrollee rights.
5961. § 438.102 Provider-enrollee communications.
5962. § 438.104 Marketing activities.
5963. § 438.106 Liability for payment.
5964. § 438.108 Cost sharing.
5965. § 438.110 Member advisory committee.
5966. § 438.114 Emergency and poststabilization services.
5967. § 438.116 Solvency standards.
5968. Subpart D MCO, PIHP and PAHP Standards
5969. § 438.206 Availability of services.
5970. § 438.207 Assurances of adequate capacity and services.
5971. § 438.208 Coordination and continuity of care.
5972. § 438.210 Coverage and authorization of services.
5973. § 438.214 Provider selection.
5974. § 438.224 Confidentiality.
5975. § 438.228 Grievance and appeal systems.
5976. § 438.230 Subcontractual relationships and delegation.
5977. § 438.236 Practice guidelines.
5978. § 438.242 Health information systems.
5979. Subpart E Quality Measurement and Improvement; External Quality Review
5980. § 438.310 Basis, scope, and applicability.
5981. § 438.320 Definitions.
5982. § 438.330 Quality assessment and performance improvement program.
5983. § 438.332 State review of the accreditation status of MCOs, PIHPs, and PAHPs.
5984. § 438.334 [Reserved]
5985. § 438.340 Managed care State quality strategy.
5986. § 438.350 External quality review.
5987. § 438.352 External quality review protocols.
5988. § 438.354 Qualifications of external quality review organizations.
5989. § 438.356 State contract options for external quality review.
5990. § 438.358 Activities related to external quality review.
5991. § 438.360 Nonduplication of mandatory activities with Medicare or accreditation review.
5992. § 438.362 Exemption from external quality review.
5993. § 438.364 External quality review results.
5994. § 438.370 Federal financial participation (FFP).
5995. Subpart F Grievance and Appeal System
5996. § 438.400 Statutory basis, definitions, and applicability.
5997. § 438.402 General requirements.
5998. § 438.404 Timely and adequate notice of adverse benefit determination.
5999. § 438.406 Handling of grievances and appeals.
6000. § 438.408 Resolution and notification: Grievances and appeals.
6001. § 438.410 Expedited resolution of appeals.
6002. § 438.414 Information about the grievance and appeal system to providers and subcontractors.
6003. § 438.416 Recordkeeping requirements.
6004. § 438.420 Continuation of benefits while the MCO, PIHP, or PAHP appeal and the State fair hearing are pending.
6005. § 438.424 Effectuation of reversed appeal resolutions.
6006. Subpart G Medicaid Managed Care Quality Rating System
6007. § 438.500 Definitions.
6008. § 438.505 General rule and applicability.
6009. § 438.510 Mandatory QRS measure set for Medicaid managed care quality rating system.
6010. § 438.515 Medicaid managed care quality rating system methodology.
6011. § 438.520 website display.
6012. § 438.525 [Reserved]
6013. § 438.530 Annual technical resource manual.
6014. § 438.535 Annual reporting.
6015. Subpart H Additional Program Integrity Safeguards
6016. § 438.600 Statutory basis, basic rule, and applicability.
6017. § 438.602 State responsibilities.
6018. § 438.604 Data, information, and documentation that must be submitted.
6019. § 438.606 Source, content, and timing of certification.
6020. § 438.608 Program integrity requirements under the contract.
6021. § 438.610 Prohibited affiliations.
6022. Subpart I Sanctions
6023. § 438.700 Basis for imposition of sanctions.
6024. § 438.702 Types of intermediate sanctions.
6025. § 438.704 Amounts of civil money penalties.
6026. § 438.706 Special rules for temporary management.
6027. § 438.708 Termination of an MCO, PCCM or PCCM entity contract.
6028. § 438.710 Notice of sanction and pre-termination hearing.
6029. § 438.722 Disenrollment during termination hearing process.
6030. § 438.724 Notice to CMS.
6031. § 438.726 State plan requirement.
6032. § 438.730 Sanction by CMS: Special rules for MCOs.
6033. Subpart J Conditions for Federal Financial Participation (FFP)
6034. § 438.802 Basic requirements.
6035. § 438.806 Prior approval.
6036. § 438.808 Exclusion of entities.
6037. § 438.810 Expenditures for enrollment broker services.
6038. § 438.812 Costs under risk and nonrisk contracts.
6039. § 438.816 Expenditures for the beneficiary support system for enrollees using LTSS.
6040. § 438.818 Enrollee encounter data.
6041. Subpart K Parity in Mental Health and Substance Use Disorder Benefits
6042. § 438.900 Meaning of terms.
6043. § 438.905 Parity requirements for aggregate lifetime and annual dollar limits.
6044. § 438.910 Parity requirements for financial requirements and treatment limitations.
6045. § 438.915 Availability of information.
6046. § 438.920 Applicability.
6047. § 438.930 Compliance dates.
6048. PART 440 SERVICES: GENERAL PROVISIONS
6049. Subpart A Definitions
6050. § 440.1 Basis and purpose.
6051. § 440.2 Specific definitions; definitions of services for FFP purposes.
6052. § 440.10 Inpatient hospital services, other than services in an institution for mental diseases.
6053. § 440.20 Outpatient hospital services and rural health clinic services.
6054. § 440.30 Other laboratory and X-ray services.
6055. § 440.40 Nursing facility services for individuals age 21 or older (other than services in an institution for mental disease), EPSDT, and family planning services and supplies.
6056. § 440.50 Physicians' services and medical and surgical services of a dentist.
6057. § 440.60 Medical or other remedial care provided by licensed practitioners.
6058. § 440.70 Home health services.
6059. § 440.80 Private duty nursing services.
6060. § 440.90 Clinic services.
6061. § 440.100 Dental services.
6062. § 440.110 Physical therapy, occupational therapy, and services for individuals with speech, hearing, and language disorders.
6063. § 440.120 Prescribed drugs, dentures, prosthetic devices, and eyeglasses.
6064. § 440.130 Diagnostic, screening, preventive, and rehabilitative services.
6065. § 440.140 Inpatient hospital services, nursing facility services, and intermediate care facility services for individuals age 65 or older in institutions for mental diseases.
6066. § 440.150 Intermediate care facility (ICF/IID) services.
6067. § 440.155 Nursing facility services, other than in institutions for mental diseases.
6068. § 440.160 Inpatient psychiatric services for individuals under age 21.
6069. § 440.165 Nurse-midwife service.
6070. § 440.166 Nurse practitioner services.
6071. § 440.167 Personal care services.
6072. § 440.168 Primary care case management services.
6073. § 440.169 Case management services.
6074. § 440.170 Any other medical care or remedial care recognized under State law and specified by the Secretary.
6075. § 440.180 Home and community-based waiver services.
6076. § 440.181 Home and community-based services for individuals age 65 or older.
6077. § 440.182 State plan home and community-based services.
6078. § 440.185 Respiratory care for ventilator-dependent individuals.
6079. Subpart B Requirements and Limits Applicable to All Services
6080. § 440.200 Basis, purpose, and scope.
6081. § 440.210 Required services for the categorically needy.
6082. § 440.220 Required services for the medically needy.
6083. § 440.225 Optional services.
6084. § 440.230 Sufficiency of amount, duration, and scope.
6085. § 440.240 Comparability of services for groups.
6086. § 440.250 Limits on comparability of services.
6087. § 440.255 Limited services available to certain aliens.
6088. § 440.260 Methods and standards to assure quality of services.
6089. § 440.262 Access and cultural conditions.
6090. § 440.270 Religious objections.
6091. Subpart C Benchmark Benefit and Benchmark-Equivalent Coverage
6092. § 440.300 Basis.
6093. § 440.305 Scope.
6094. § 440.310 Applicability.
6095. § 440.315 Exempt individuals.
6096. § 440.320 State plan requirements: Optional enrollment for exempt individuals.
6097. § 440.325 State plan requirements: Coverage and benefits.
6098. § 440.330 Benchmark health benefits coverage.
6099. § 440.335 Benchmark-equivalent health benefits coverage.
6100. § 440.340 Actuarial report for benchmark-equivalent coverage.
6101. § 440.345 EPSDT and other required benefits.
6102. § 440.347 Essential health benefits.
6103. § 440.350 Employer-sponsored insurance health plans.
6104. § 440.355 Payment of premiums.
6105. § 440.360 State plan requirements for providing additional services.
6106. § 440.365 Coverage of rural health clinic and federally qualified health center (FQHC) services.
6107. § 440.370 Economy and efficiency.
6108. § 440.375 Comparability.
6109. § 440.380 Statewideness.
6110. § 440.385 Delivery of benchmark and benchmark-equivalent coverage through managed care entities.
6111. § 440.386 Public notice.
6112. § 440.390 Assurance of transportation.
6113. § 440.395 Parity in mental health and substance use disorder benefits.
6114. PART 441 SERVICES: REQUIREMENTS AND LIMITS APPLICABLE TO SPECIFIC SERVICES
6115. § 441.1 Purpose.
6116. Subpart A General Provisions
6117. § 441.10 Basis.
6118. § 441.11 Continuation of FFP for institutional services.
6119. § 441.12 Inpatient hospital tests.
6120. § 441.13 Prohibitions on FFP: Institutionalized individuals.
6121. § 441.15 Home health services.
6122. § 441.16 Home health agency requirements for surety bonds; Prohibition on FFP.
6123. § 441.17 Laboratory services.
6124. § 441.18 Case management services.
6125. § 441.20 Family planning services.
6126. § 441.21 Nurse-midwife services.
6127. § 441.22 Nurse practitioner services.
6128. § 441.25 Prohibition on FFP for certain prescribed drugs.
6129. § 441.30 Optometric services.
6130. § 441.35 Organ transplants.
6131. § 441.40 End-stage renal disease.
6132. Subpart B Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) of Individuals Under Age 21
6133. § 441.50 Basis and purpose.
6134. § 441.55 State plan requirements.
6135. § 441.56 Required activities.
6136. § 441.57 Discretionary services.
6137. § 441.58 Periodicity schedule.
6138. § 441.59 Treatment of requests for EPSDT screening services.
6139. § 441.60 Continuing care.
6140. § 441.61 Utilization of providers and coordination with related programs.
6141. § 441.62 Transportation and scheduling assistance.
6142. Subpart C Medicaid for Individuals Age 65 or Over in Institutions for Mental Diseases
6143. § 441.100 Basis and purpose.
6144. § 441.101 State plan requirements.
6145. § 441.102 Plan of care for institutionalized beneficiaries.
6146. § 441.103 Alternate plans of care.
6147. § 441.105 Methods of administration.
6148. § 441.106 Comprehensive mental health program.
6149. Subpart D Inpatient Psychiatric Services for Individuals Under Age 21 in Psychiatric Facilities or Programs
6150. § 441.150 Basis and purpose.
6151. § 441.151 General requirements.
6152. § 441.152 Certification of need for services.
6153. § 441.153 Team certifying need for services.
6154. § 441.154 Active treatment.
6155. § 441.155 Individual plan of care.
6156. § 441.156 Team developing individual plan of care.
6157. § 441.180 Maintenance of effort: General rule.
6158. § 441.181 Maintenance of effort: Explanation of terms and requirements.
6159. § 441.182 Maintenance of effort: Computation.
6160. § 441.184 Emergency preparedness.
6161. Subpart E Abortions
6162. § 441.200 Basis and purpose.
6163. § 441.201 Definition.
6164. § 441.202 General rule.
6165. § 441.203 Life of the mother would be endangered.
6166. §§ 441.204-441.205 [Reserved]
6167. § 441.206 Documentation needed by the Medicaid agency.
6168. § 441.207 Drugs and devices and termination of ectopic pregnancies.
6169. § 441.208 Recordkeeping requirements.
6170. Subpart F Sterilizations
6171. § 441.250 Applicability.
6172. § 441.251 Definitions.
6173. § 441.252 State plan requirements.
6174. § 441.253 Sterilization of a mentally competent individual aged 21 or older.
6175. § 441.254 Mentally incompetent or institutionalized individuals.
6176. § 441.255 Sterilization by hysterectomy.
6177. § 441.256 Additional condition for Federal financial participation (FFP).
6178. § 441.257 Informed consent.
6179. § 441.258 Consent form requirements.
6180. § 441.259 Review of regulations.
6181. Appendix to Subpart F of Part 441 Required Consent Form
6182. Subpart G Home and Community-Based Services: Waiver Requirements
6183. § 441.300 Basis and purpose.
6184. § 441.301 Contents of request for a waiver.
6185. § 441.302 State assurances.
6186. § 441.303 Supporting documentation required.
6187. § 441.304 Duration, extension, and amendment of a waiver.
6188. § 441.305 Replacement of beneficiaries in approved waiver programs.
6189. § 441.306 Cooperative arrangements with the Maternal and Child Health program.
6190. § 441.307 Notification of a waiver termination.
6191. § 441.308 Hearings procedures for waiver terminations.
6192. § 441.310 Limits on Federal financial participation (FFP).
6193. § 441.311 Reporting requirements.
6194. § 441.312 Home and community-based services quality measure set.
6195. § 441.313 Website transparency.
6196. Subpart H Home and Community-Based Services Waivers for Individuals Age 65 or Older: Waiver Requirements
6197. § 441.350 Basis and purpose.
6198. § 441.351 Contents of a request for a waiver.
6199. § 441.352 State assurances.
6200. § 441.353 Supporting documentation required.
6201. § 441.354 Aggregate projected expenditure limit (APEL).
6202. § 441.355 Duration, extension, and amendment of a waiver.
6203. § 441.356 Waiver termination.
6204. § 441.357 Hearing procedures for waiver denials.
6205. § 441.360 Limits on Federal financial participation (FFP).
6206. § 441.365 Periodic evaluation, assessment, and review.
6207. Subpart I Community Supported Living Arrangements Services
6208. § 441.400 Basis and purpose.
6209. § 441.402 State plan requirements.
6210. § 441.404 Minimum protection requirements.
6211. Subpart J Optional Self-Directed Personal Assistance Services Program
6212. § 441.450 Basis, scope, and definitions.
6213. § 441.452 Self-direction: General.
6214. § 441.454 Use of cash.
6215. § 441.456 Voluntary disenrollment.
6216. § 441.458 Involuntary disenrollment.
6217. § 441.460 Participant living arrangements.
6218. § 441.462 Statewideness, comparability and limitations on number served.
6219. § 441.464 State assurances.
6220. § 441.466 Assessment of need.
6221. § 441.468 Service plan elements.
6222. § 441.470 Service budget elements.
6223. § 441.472 Budget methodology.
6224. § 441.474 Quality assurance and improvement plan.
6225. § 441.476 Risk management.
6226. § 441.478 Qualifications of providers of personal assistance.
6227. § 441.480 Use of a representative.
6228. § 441.482 Permissible purchases.
6229. § 441.484 Financial management services.
6230. § 441.486 Website transparency.
6231. Subpart K Home and Community-Based Attendant Services and Supports State Plan Option (Community First Choice)
6232. § 441.500 Basis and scope.
6233. § 441.505 Definitions.
6234. § 441.510 Eligibility.
6235. § 441.515 Statewideness.
6236. § 441.520 Included services.
6237. § 441.525 Excluded services.
6238. § 441.530 Home and Community-Based Setting.
6239. § 441.535 Assessment of functional need.
6240. § 441.540 Person-centered service plan.
6241. § 441.545 Service models.
6242. § 441.550 Service plan requirements for self-directed model with service budget.
6243. § 441.555 Support system.
6244. § 441.560 Service budget requirements.
6245. § 441.565 Provider qualifications.
6246. § 441.570 State assurances.
6247. § 441.575 Development and Implementation Council.
6248. § 441.580 Data collection.
6249. § 441.585 Quality assurance system.
6250. § 441.590 Increased Federal financial participation.
6251. § 441.595 Website transparency.
6252. Subpart L Vaccines for Children Program
6253. § 441.600 Basis and purpose.
6254. § 441.605 General requirements.
6255. § 441.610 State plan requirements.
6256. § 441.615 Administration fee requirements.
6257. Subpart M State Plan Home and Community-Based Services for the Elderly and Individuals with Disabilities
6258. § 441.700 Basis and purpose.
6259. § 441.705 State plan requirements.
6260. § 441.710 State plan home and community-based services under section 1915(i)(1) of the Act.
6261. § 441.715 Needs-based criteria and evaluation.
6262. § 441.720 Independent assessment.
6263. § 441.725 Person-centered service plan.
6264. § 441.730 Provider qualifications.
6265. § 441.735 Definition of individual's representative.
6266. § 441.740 Self-directed services.
6267. § 441.745 State plan HCBS administration: State responsibilities and quality improvement.
6268. § 441.750 Website transparency.
6269. Subpart N Prohibition on Federal Medicaid Funding for Sex-Rejecting Procedures Furnished to Children
6270. § 441.800 Basis and purpose.
6271. § 441.801 Definitions.
6272. § 441.802 General rules.
6273. PART 442 STANDARDS FOR PAYMENT TO NURSING FACILITIES AND INTERMEDIATE CARE FACILITIES FOR INDIVIDUALS WITH INTELLECTUAL DISABILITIES
6274. Subpart A General Provisions
6275. § 442.1 Basis and purpose.
6276. § 442.2 Terms.
6277. Subpart B Provider Agreements
6278. § 442.10 State plan requirement.
6279. § 442.12 Provider agreement: General requirements.
6280. § 442.13 Effective date of provider agreement.
6281. § 442.14 Effect of change of ownership.
6282. § 442.15 Duration of agreement for ICF/IIDs.
6283. § 442.16 [Reserved]
6284. § 442.30 Agreement as evidence of certification.
6285. § 442.40 Availability of FFP during appeals for ICFs/IID.
6286. § 442.42 FFP under a retroactive provider agreement following appeal.
6287. § 442.43 Payment transparency reporting.
6288. Subpart C Certification of ICFs/IID
6289. § 442.100 State plan requirements.
6290. § 442.101 Obtaining certification.
6291. § 442.105 [Reserved]
6292. § 442.109 Certification period for ICF/IIDs: General provisions.
6293. § 442.110 Certification period for ICF/IID with standard-level deficiencies.
6294. § 442.117 Termination of certification for ICFs/IID whose deficiencies pose immediate jeopardy.
6295. § 442.118 Denial of payments for new admissions to an ICF/IID.
6296. § 442.119 Duration of denial of payments and subsequent termination of an ICF/IID.
6297. D Subparts D-F [Reserved]
6298. PART 447 PAYMENTS FOR SERVICES
6299. Subpart A Payments: General Provisions
6300. § 447.1 Purpose.
6301. § 447.10 Prohibition against reassignment of provider claims.
6302. § 447.15 Acceptance of State payment as payment in full.
6303. § 447.20 Provider restrictions: State plan requirements.
6304. § 447.21 Reduction of payments to providers.
6305. § 447.25 Direct payments to certain beneficiaries for physicians' or dentists' services.
6306. § 447.26 Prohibition on payment for provider-preventable conditions.
6307. § 447.30 Withholding the Federal share of payments to Medicaid providers to recover Medicare overpayments.
6308. § 447.31 Withholding Medicare payments to recover Medicaid overpayments.
6309. § 447.40 Payments for reserving beds in institutions.
6310. § 447.45 Timely claims payment.
6311. § 447.46 Timely claims payment by MCOs.
6312. 110 Medicaid Premiums and Cost Sharing
6313. § 447.50 Premiums and cost sharing: Basis and purpose.
6314. § 447.51 Definitions.
6315. § 447.52 Cost sharing.
6316. § 447.53 Cost sharing for drugs.
6317. § 447.54 Cost sharing for services furnished in a hospital emergency department.
6318. § 447.55 Premiums.
6319. § 447.56 Limitations on premiums and cost sharing.
6320. § 447.57 Beneficiary and public notice requirements.
6321. § 447.88 Options for claiming FFP payment for section 1920A presumptive eligibility medical assistance payments.
6322. § 447.90 FFP: Conditions related to pending investigations of credible allegations of fraud against the Medicaid program.
6323. Subpart B Payment Methods: General Provisions
6324. § 447.200 Basis and purpose.
6325. § 447.201 State plan requirements.
6326. § 447.202 Audits.
6327. § 447.203 Documentation of access to care and service payment rates.
6328. § 447.204 Medicaid provider participation and public process to inform access to care.
6329. § 447.205 Public notice of changes in Statewide methods and standards for setting payment rates.
6330. Subpart C Payment for Inpatient Hospital and Long-Term Care Facility Services
6331. § 447.250 Basis and purpose.
6332. 111 Payment Rates
6333. § 447.251 Definitions.
6334. § 447.252 State plan requirements.
6335. § 447.253 Other requirements.
6336. § 447.255 Related information.
6337. § 447.256 Procedures for CMS action on assurances and State plan amendments.
6338. 112 Federal Financial Participation
6339. § 447.257 FFP: Conditions relating to institutional reimbursement.
6340. 113 Upper Limits
6341. § 447.271 Upper limits based on customary charges.
6342. § 447.272 Inpatient services: Application of upper payment limits.
6343. 114 Swing-Bed Hospitals
6344. § 447.280 Hospital providers of NF services (swing-bed hospitals).
6345. D Subpart D [Reserved]
6346. Subpart E Payment Adjustments for Hospitals That Serve a Disproportionate Number of Low-Income Patients
6347. § 447.294 Medicaid disproportionate share hospital (DSH) allotment reductions.
6348. § 447.295 Hospital-specific disproportionate share hospital payment limit: Determination of individuals without health insurance or other third party coverage.
6349. § 447.296 Limitations on aggregate payments for disproportionate share hospitals for the period January 1, 1992 through September 30, 1992.
6350. § 447.297 Limitations on aggregate payments for disproportionate share hospitals beginning October 1, 1992.
6351. § 447.298 State disproportionate share hospital allotments.
6352. § 447.299 Reporting requirements.
6353. Subpart F Payment Methods for Other Institutional and Noninstitutional Services
6354. § 447.300 Basis and purpose.
6355. § 447.302 State plan requirements.
6356. § 447.304 Adherence to upper limits; FFP.
6357. 115 Outpatient Hospital and Clinic Services
6358. § 447.321 Outpatient hospital and clinic services: Application of upper payment limits.
6359. 116 Other Inpatient and Outpatient Facilities
6360. § 447.325 Other inpatient and outpatient facility services: Upper limits of payment.
6361. § 447.342 [Reserved]
6362. 117 Prepaid Capitation Plans
6363. § 447.362 Upper limits of payment: Nonrisk contract.
6364. 118 Rural Health Clinic Services
6365. § 447.371 Services furnished by rural health clinics.
6366. Subpart G Payments for Primary Care Services Furnished by Physicians
6367. § 447.400 Primary care services furnished by physicians with a specified specialty or subspecialty.
6368. § 447.405 Amount of required minimum payments.
6369. § 447.410 State plan requirements.
6370. § 447.415 Availability of Federal financial participation (FFP).
6371. H Subpart H [Reserved]
6372. Subpart I Payment for Drugs
6373. § 447.500 Basis and purpose.
6374. § 447.502 Definitions.
6375. § 447.504 Determination of average manufacturer price.
6376. § 447.505 Determination of best price.
6377. § 447.506 Authorized generic drugs.
6378. § 447.507 Identification of inhalation, infusion, instilled, implanted, or injectable drugs (5i drugs).
6379. § 447.508 Exclusion from best price of certain sales at a nominal price.
6380. § 447.509 Medicaid drug rebates (MDR).
6381. § 447.510 Requirement and penalties for manufacturers.
6382. § 447.511 Requirements for States.
6383. § 447.512 Drugs: Aggregate upper limits of payment.
6384. § 447.514 Upper limits for multiple source drugs.
6385. § 447.516 Upper limits for drugs furnished as part of services.
6386. § 447.518 State plan requirements, findings, and assurances.
6387. § 447.520 Federal Financial Participation (FFP): Conditions relating to physician-administered drugs.
6388. § 447.522 Optional coverage of investigational drugs and other drugs not subject to rebate.
6389. PART 455 PROGRAM INTEGRITY: MEDICAID
6390. § 455.1 Basis and scope.
6391. § 455.2 Definitions.
6392. § 455.3 Other applicable regulations.
6393. Subpart A Medicaid Agency Fraud Detection and Investigation Program
6394. § 455.12 State plan requirement.
6395. § 455.13 Methods for identification, investigation, and referral.
6396. § 455.14 Preliminary investigation.
6397. § 455.15 Full investigation.
6398. § 455.16 Resolution of full investigation.
6399. § 455.17 Reporting requirements.
6400. § 455.18 Provider's statements on claims forms.
6401. § 455.19 Provider's statement on check.
6402. § 455.20 Beneficiary verification procedure.
6403. § 455.21 Cooperation with State Medicaid fraud control units.
6404. § 455.23 Suspension of payments in cases of fraud.
6405. Subpart B Disclosure of Information by Providers and Fiscal Agents
6406. § 455.100 Purpose.
6407. § 455.101 Definitions.
6408. § 455.102 Determination of ownership or control percentages.
6409. § 455.103 State plan requirement.
6410. § 455.104 Disclosure by Medicaid providers and fiscal agents: Information on ownership and control.
6411. § 455.105 Disclosure by providers: Information related to business transactions.
6412. § 455.106 Disclosure by providers: Information on persons convicted of crimes.
6413. § 455.107 Disclosure of affiliations.
6414. Subpart C Medicaid Integrity Program
6415. § 455.200 Basis and scope.
6416. § 455.202 Limitation on contractor liability.
6417. § 455.230 Eligibility requirements.
6418. § 455.232 Medicaid integrity audit program contractor functions.
6419. § 455.234 Awarding of a contract.
6420. § 455.236 Renewal of a contract.
6421. § 455.238 Conflict of interest.
6422. § 455.240 Conflict of interest resolution.
6423. Subpart D Independent Certified Audit of State Disproportionate Share Hospital Payment Adjustments
6424. § 455.300 Purpose.
6425. § 455.301 Definitions.
6426. § 455.304 Condition for Federal financial participation (FFP).
6427. Subpart E Provider Screening and Enrollment
6428. § 455.400 Purpose.
6429. § 455.405 State plan requirements.
6430. § 455.410 Enrollment and screening of providers.
6431. § 455.412 Verification of provider licenses.
6432. § 455.414 Revalidation of enrollment.
6433. § 455.416 Termination or denial of enrollment.
6434. § 455.417 Termination periods and termination database periods.
6435. § 455.420 Reactivation of provider enrollment.
6436. § 455.422 Appeal rights.
6437. § 455.432 Site visits.
6438. § 455.434 Criminal background checks.
6439. § 455.436 Federal database checks.
6440. § 455.440 National Provider Identifier.
6441. § 455.450 Screening levels for Medicaid providers.
6442. § 455.452 Other State screening methods.
6443. § 455.460 Application fee.
6444. § 455.470 Temporary moratoria.
6445. Subpart F Medicaid Recovery Audit Contractors Program
6446. § 455.500 Purpose.
6447. § 455.502 Establishment of program.
6448. § 455.504 Definitions.
6449. § 455.506 Activities to be conducted by Medicaid RACs and States.
6450. § 455.508 Eligibility requirements for Medicaid RACs.
6451. § 455.510 Payments to RACs.
6452. § 455.512 Medicaid RAC provider appeals.
6453. § 455.514 Federal share of State expense of the Medicaid RAC program.
6454. § 455.516 Exceptions from Medicaid RAC programs.
6455. § 455.518 Applicability to the territories.
6456. PART 456 UTILIZATION CONTROL
6457. Subpart A General Provisions
6458. § 456.1 Basis and purpose of part.
6459. § 456.2 State plan requirements.
6460. § 456.3 Statewide surveillance and utilization control program.
6461. § 456.4 Responsibility for monitoring the utilization control program.
6462. § 456.5 Evaluation criteria.
6463. § 456.6 Review by State medical agency of appropriateness and quality of services.
6464. Subpart B Utilization Control: All Medicaid Services
6465. § 456.21 Scope.
6466. § 456.22 Sample basis evaluation of services.
6467. § 456.23 Post-payment review process.
6468. Subpart C Utilization Control: Hospitals
6469. § 456.50 Scope.
6470. § 456.51 Definitions.
6471. 144 Certification of Need for Care
6472. § 456.60 Certification and recertification of need for inpatient care.
6473. 145 Plan of Care
6474. § 456.80 Individual written plan of care.
6475. 146 Utilization Review (UR) Plan: General Requirement
6476. § 456.100 Scope.
6477. § 456.101 UR plan required for inpatient hospital services.
6478. 147 UR Plan: Administrative Requirements
6479. § 456.105 UR committee required.
6480. § 456.106 Organization and composition of UR committee; disqualification from UR committee membership.
6481. 148 UR Plan: Informational Requirements
6482. § 456.111 Beneficiary information required for UR.
6483. § 456.112 Records and reports.
6484. § 456.113 Confidentiality.
6485. 149 UR Plan: Review of Need for Admission 1
6486. § 456.121 Admission review required.
6487. § 456.122 Evaluation criteria for admission review.
6488. § 456.123 Admission review process.
6489. § 456.124 Notification of adverse decision.
6490. § 456.125 Time limits for admission review.
6491. § 456.126 Time limits for final decision and notification of adverse decision.
6492. § 456.127 Pre-admission review.
6493. § 456.128 Initial continued stay review date.
6494. § 456.129 Description of methods and criteria: Initial continued stay review date; close professional scrutiny; length of stay modification.
6495. 150 UR Plan: Review of Need for Continued Stay
6496. § 456.131 Continued stay review required.
6497. § 456.132 Evaluation criteria for continued stay.
6498. § 456.133 Subsequent continued stay review dates.
6499. § 456.134 Description of methods and criteria: Subsequent continued stay review dates; length of stay modification.
6500. § 456.135 Continued stay review process.
6501. § 456.136 Notification of adverse decision.
6502. § 456.137 Time limits for final decision and notification of adverse decision.
6503. 151 UR Plan: Medical Care Evaluation Studies
6504. § 456.141 Purpose and general description.
6505. § 456.142 UR plan requirements for medical care evaluation studies.
6506. § 456.143 Content of medical care evaluation studies.
6507. § 456.144 Data sources for studies.
6508. § 456.145 Number of studies required to be performed.
6509. Subpart D Utilization Control: Mental Hospitals
6510. § 456.150 Scope.
6511. § 456.151 Definitions.
6512. 152 Certification of Need for Care
6513. § 456.160 Certification and recertification of need for inpatient care.
6514. 153 Medical, Psychiatric, and Social Evaluations and Admission Review
6515. § 456.170 Medical, psychiatric, and social evaluations.
6516. § 456.171 [Reserved]
6517. 154 Plan of Care
6518. § 456.180 Individual written plan of care.
6519. § 456.181 Reports of evaluations and plans of care.
6520. 155 Utilization Review (UR) Plan: General Requirements
6521. § 456.200 Scope.
6522. § 456.201 UR plan required for inpatient mental hospital services.
6523. 156 UR Plan: Administrative Requirements
6524. § 456.205 UR committee required.
6525. § 456.206 Organization and composition of UR committee; disqualification from UR committee membership.
6526. 157 UR Plan: Informational Requirements
6527. § 456.211 Beneficiary information required for UR.
6528. § 456.212 Records and reports.
6529. § 456.213 Confidentiality.
6530. 158 UR Plan: Review of Need for Continued Stay
6531. § 456.231 Continued stay review required.
6532. § 456.232 Evaluation criteria for continued stay.
6533. § 456.233 Initial continued stay review date.
6534. § 456.234 Subsequent continued stay review dates.
6535. § 456.235 Description of methods and criteria: Continued stay review dates; length of stay modification.
6536. § 456.236 Continued stay review process.
6537. § 456.237 Notification of adverse decision.
6538. § 456.238 Time limits for final decision and notification of adverse decision.
6539. 159 UR Plan: Medical Care Evaluation Studies
6540. § 456.241 Purpose and general description.
6541. § 456.242 UR plan requirements for medical care evaluation studies.
6542. § 456.243 Content of medical care evaluation studies.
6543. § 456.244 Data sources for studies.
6544. § 456.245 Number of studies required to be performed.
6545. E Subpart E [Reserved]
6546. Subpart F Utilization Control: Intermediate Care Facilities
6547. § 456.350 Scope.
6548. § 456.351 Definition.
6549. 160 Certification of Need for Care
6550. § 456.360 Certification and recertification of need for inpatient care.
6551. 161 Medical, Psychological, and Social Evaluations and Admission Review
6552. § 456.370 Medical, psychological, and social evaluations.
6553. § 456.371 Exploration of alternative services.
6554. § 456.372 Medicaid agency review of need for admission.
6555. 162 Plan of Care
6556. § 456.380 Individual written plan of care.
6557. § 456.381 Reports of evaluations and plans of care.
6558. 163 Utilization Review (UR) Plan: General Requirement
6559. § 456.400 Scope.
6560. § 456.401 State plan UR requirements and options; UR plan required for intermediate care facility services.
6561. 164 UR Plan: Administrative Requirements
6562. § 456.405 Description of UR review function: How and when.
6563. § 456.406 Description of UR review function: Who performs UR; disqualification from performing UR.
6564. § 456.407 UR responsibilities of administrative staff.
6565. 165 UR Plan: Informational Requirements
6566. § 456.411 Beneficiary information required for UR.
6567. § 456.412 Records and reports.
6568. § 456.413 Confidentiality.
6569. 166 UR Plan: Review of Need for Continued Stay
6570. § 456.431 Continued stay review required.
6571. § 456.432 Evaluation criteria for continued stay.
6572. § 456.433 Initial continued stay review date.
6573. § 456.434 Subsequent continued stay review dates.
6574. § 456.435 Description of methods and criteria: Continued stay review dates.
6575. § 456.436 Continued stay review process.
6576. § 456.437 Notification of adverse decision.
6577. § 456.438 Time limits for notification of adverse decision.
6578. Subpart G Inpatient Psychiatric Services for Individuals Under Age 21: Admission and Plan of Care Requirements
6579. § 456.480 Scope.
6580. § 456.481 Admission certification and plan of care.
6581. § 456.482 Medical, psychiatric, and social evaluations.
6582. Subpart H Utilization Review Plans: FFP, Waivers, and Variances for Hospitals and Mental Hospitals
6583. § 456.500 Purpose.
6584. § 456.501 UR plans as a condition for FFP.
6585. 167 UR Plan: Waiver of Requirements
6586. § 456.505 Applicability of waiver.
6587. § 456.506 Waiver options for Medicaid agency.
6588. § 456.507 Review and granting of waiver requests.
6589. § 456.508 Withdrawal of waiver.
6590. 168 UR Plan: Remote Facility Variances from Time Requirements
6591. § 456.520 Definitions.
6592. § 456.521 Conditions for granting variance requests.
6593. § 456.522 Content of request for variance.
6594. § 456.523 Revised UR plan.
6595. § 456.524 Notification of Administrator's action and duration of variance.
6596. § 456.525 Request for renewal of variance.
6597. Subpart I Inspections of Care in Intermediate Care Facilities and Institutions for Mental Diseases
6598. § 456.600 Purpose.
6599. § 456.601 Definitions.
6600. § 456.602 Inspection team.
6601. § 456.603 Financial interests and employment of team members.
6602. § 456.604 Physician team member inspecting care of beneficiaries.
6603. § 456.605 Number and location of teams.
6604. § 456.606 Frequency of inspections.
6605. § 456.607 Notification before inspection.
6606. § 456.608 Personal contact with and observation of beneficiaries and review of records.
6607. § 456.609 Determinations by team.
6608. § 456.610 Basis for determinations.
6609. § 456.611 Reports on inspections.
6610. § 456.612 Copies of reports.
6611. § 456.613 Action on reports.
6612. § 456.614 Inspections by utilization review committee.
6613. Subpart J Penalty for Failure To Make a Satisfactory Showing of an Effective Institutional Utilization Control Program
6614. § 456.650 Basis, purpose and scope.
6615. § 456.651 Definitions.
6616. § 456.652 Requirements for an effective utilization control program.
6617. § 456.653 Acceptable reasons for not meeting requirements for annual on-site review.
6618. § 456.654 Requirements for content of showings and procedures for submittal.
6619. § 456.655 Validation of showings.
6620. § 456.656 Reductions in FFP.
6621. § 456.657 Computation of reductions in FFP.
6622. Subpart K Drug Use Review (DUR) Program and Electronic Claims Management System for Outpatient Drug Claims
6623. § 456.700 Scope.
6624. § 456.702 Definitions.
6625. § 456.703 Drug use review program.
6626. § 456.705 Prospective drug review.
6627. § 456.709 Retrospective drug use review.
6628. § 456.711 Educational program.
6629. § 456.712 Annual report.
6630. § 456.714 DUR/surveillance and utilization review relationship.
6631. § 456.716 DUR Board.
6632. § 456.719 Funding for DUR program.
6633. § 456.722 Electronic claims management system.
6634. § 456.725 Funding of ECM system.
6635. SUBCHAPTER D STATE CHILDREN'S HEALTH INSURANCE PROGRAMS (SCHIPs)
6636. PART 457 ALLOTMENTS AND GRANTS TO STATES
6637. Subpart A Introduction; State Plans for Child Health Insurance Programs and Outreach Strategies
6638. § 457.1 Program description.
6639. § 457.2 Basis and scope of subchapter D.
6640. § 457.10 Definitions and use of terms.
6641. § 457.30 Basis, scope, and applicability of subpart A.
6642. § 457.40 State program administration.
6643. § 457.50 State plan.
6644. § 457.60 Amendments.
6645. § 457.65 Effective date and duration of State plans and plan amendments.
6646. § 457.70 Program options.
6647. § 457.80 Current State child health insurance coverage and coordination.
6648. § 457.90 Outreach.
6649. § 457.110 Enrollment assistance and information requirements.
6650. § 457.120 Public involvement in program development.
6651. § 457.125 Provision of child health assistance to American Indian and Alaska Native children.
6652. § 457.130 Civil rights assurance.
6653. § 457.135 Assurance of compliance with other provisions.
6654. § 457.140 Budget.
6655. § 457.150 CMS review of State plan material.
6656. § 457.160 Notice and timing of CMS action on State plan material.
6657. § 457.170 Withdrawal process.
6658. Subpart B General Administration—Reviews and Audits; Withholding for Failure to Comply; Deferral and Disallowance of Claims; Reduction of Federal Medical Payments
6659. § 457.200 Program reviews.
6660. § 457.202 Audits.
6661. § 457.203 Administrative and judicial review of action on State plan material.
6662. § 457.204 Withholding of payment for failure to comply with Federal requirements.
6663. § 457.206 Administrative appeals under CHIP.
6664. § 457.208 Judicial review.
6665. § 457.216 Treatment of uncashed or canceled (voided) CHIP checks.
6666. § 457.220 Funds from units of government as the State share of financial participation.
6667. § 457.222 FFP for equipment.
6668. § 457.224 FFP: Conditions relating to cost sharing.
6669. § 457.226 Fiscal policies and accountability.
6670. § 457.228 Cost allocation.
6671. § 457.230 FFP for State ADP expenditures.
6672. § 457.232 Refunding of Federal Share of CHIP overpayments to providers and referral of allegations of waste, fraud or abuse to the Office of Inspector General.
6673. § 457.236 Audits.
6674. § 457.238 Documentation of payment rates.
6675. Subpart C State Plan Requirements: Eligibility, Screening, Applications, and Enrollment
6676. § 457.300 Basis, scope, and applicability.
6677. § 457.301 Definitions and use of terms.
6678. § 457.305 State plan provisions.
6679. § 457.310 Targeted low-income child.
6680. § 457.315 Application of modified adjusted gross income and household definition.
6681. § 457.320 Other eligibility standards.
6682. § 457.330 Application.
6683. § 457.340 Application for and enrollment in CHIP.
6684. § 457.342 Continuous eligibility for children.
6685. § 457.343 Periodic renewal of CHIP eligibility.
6686. § 457.348 Determinations of Children's Health Insurance Program eligibility by other insurance affordability programs.
6687. § 457.350 Eligibility screening and enrollment in other insurance affordability programs.
6688. § 457.351 Coordination involving appeals entities for different insurance affordability programs.
6689. § 457.353 Monitoring and evaluation of screening process.
6690. § 457.355 Presumptive eligibility for children.
6691. § 457.360 Deemed newborn children.
6692. § 457.370 Alignment with Exchange initial open enrollment period.
6693. § 457.380 Eligibility verification.
6694. Subpart D State Plan Requirements: Coverage and Benefits
6695. § 457.401 Basis, scope, and applicability.
6696. § 457.402 Definition of child health assistance.
6697. § 457.410 Health benefits coverage options.
6698. § 457.420 Benchmark health benefits coverage.
6699. § 457.430 Benchmark-equivalent health benefits coverage.
6700. § 457.431 Actuarial report for benchmark-equivalent coverage.
6701. § 457.440 Existing comprehensive State-based coverage.
6702. § 457.450 Secretary-approved coverage.
6703. § 457.470 Prohibited coverage.
6704. § 457.475 Limitations on coverage: Abortions.
6705. § 457.476 Limitations on coverage: Sex-rejecting procedures.
6706. § 457.480 Prohibited coverage limitations, preexisting condition exclusions, and relation to other laws.
6707. § 457.490 Delivery and utilization control systems.
6708. § 457.495 State assurance of access to care and procedures to assure quality and appropriateness of care.
6709. § 457.496 Parity in mental health and substance use disorder benefits.
6710. Subpart E State Plan Requirements: Enrollee Financial Responsibilities
6711. § 457.500 Basis, scope, and applicability.
6712. § 457.505 General State plan requirements.
6713. § 457.510 Premiums, enrollment fees, or similar fees: State plan requirements.
6714. § 457.515 Co-payments, coinsurance, deductibles, or similar cost-sharing charges: State plan requirements.
6715. § 457.520 Cost sharing for well-baby and well-child care services.
6716. § 457.525 Public schedule.
6717. § 457.530 General cost-sharing protection for lower income children.
6718. § 457.535 Cost-sharing protection to ensure enrollment of American Indians and Alaska Natives.
6719. § 457.540 Cost-sharing charges for children in families with incomes at or below 150 percent of the FPL.
6720. § 457.555 Maximum allowable cost-sharing charges on targeted low-income children in families with income from 101 to 150 percent of the FPL.
6721. § 457.560 Cumulative cost-sharing maximum.
6722. § 457.570 Disenrollment protections.
6723. Subpart F Payments to States
6724. § 457.600 Purpose and basis of this subpart.
6725. § 457.602 Applicability.
6726. § 457.606 Conditions for State allotments and Federal payments for a fiscal year.
6727. § 457.608 Process and calculation of State allotments prior to FY 2009.
6728. § 457.609 Process and calculation of State allotments for a fiscal year after FY 2008.
6729. § 457.610 Period of availability for State allotments prior to FY 2009.
6730. § 457.611 Period of availability for State allotments for a fiscal year after FY 2008.
6731. § 457.614 General payment process.
6732. § 457.616 Application and tracking of payments against the fiscal year allotments.
6733. § 457.618 Ten percent limit on certain Children's Health Insurance Program expenditures.
6734. § 457.622 Rate of FFP for State expenditures.
6735. § 457.626 Prevention of duplicate payments.
6736. § 457.628 Other applicable Federal regulations.
6737. § 457.630 Grants procedures.
6738. Subpart G Strategic Planning, Reporting, and Evaluation
6739. § 457.700 Basis, scope, and applicability.
6740. § 457.710 State plan requirements: Strategic objectives and performance goals.
6741. § 457.720 State plan requirement: State assurance regarding data collection, records, and reports.
6742. § 457.730 Beneficiary access to and exchange of data.
6743. § 457.731 Access to and exchange of health data for providers and payers.
6744. § 457.732 Prior authorization requirements.
6745. § 457.740 State expenditures and statistical reports.
6746. § 457.750 Annual report.
6747. § 457.760 Access to published provider directory information.
6748. § 457.770 Reporting on Health Care Quality Measures.
6749. Subpart H Substitution of Coverage
6750. § 457.800 Basis, scope, and applicability.
6751. § 457.805 State plan requirement: Procedures to address substitution under group health plans.
6752. § 457.810 Premium assistance programs: Required protections against substitution.
6753. Subpart I Program Integrity
6754. § 457.900 Basis, scope and applicability.
6755. § 457.910 State program administration.
6756. § 457.915 Fraud detection and investigation.
6757. § 457.925 Preliminary investigation.
6758. § 457.930 Full investigation, resolution, and reporting requirements.
6759. § 457.935 Sanctions and related penalties.
6760. § 457.940 Procurement standards.
6761. § 457.945 Certification for contracts and proposals.
6762. § 457.950 Contract and payment requirements including certification of payment-related information.
6763. § 457.960 Reporting changes in eligibility and redetermining eligibility.
6764. § 457.965 Documentation.
6765. § 457.980 Verification of enrollment and provider services received.
6766. § 457.985 Integrity of professional advice to enrollees.
6767. § 457.990 Provider and supplier screening, oversight, and reporting requirements.
6768. Subpart J Allowable Waivers: General Provisions
6769. § 457.1000 Basis, scope, and applicability.
6770. § 457.1003 CMS review of waiver requests.
6771. § 457.1005 Cost-effective coverage through a community-based health delivery system.
6772. § 457.1010 Purchase of family coverage.
6773. § 457.1015 Cost-effectiveness.
6774. Subpart K State Plan Requirements: Applicant and Enrollee Protections
6775. § 457.1100 Basis, scope and applicability.
6776. § 457.1110 Privacy protections.
6777. § 457.1120 State plan requirement: Description of review process.
6778. § 457.1130 Program specific review process: Matters subject to review.
6779. § 457.1140 Program specific review process: Core elements of review.
6780. § 457.1150 Program specific review process: Impartial review.
6781. § 457.1160 Program specific review process: Time frames.
6782. § 457.1170 Program specific review process: Continuation of enrollment.
6783. § 457.1180 Program specific review process: Notice.
6784. § 457.1190 Application of review procedures when States offer premium assistance for group health plans.
6785. Subpart L Managed Care
6786. 176 General Provisions
6787. § 457.1200 Basis, scope, and applicability.
6788. § 457.1201 Standard contract requirements.
6789. § 457.1203 Rate development standards and medical loss ratio.
6790. § 457.1206 Non-emergency medical transportation PAHPs.
6791. § 457.1207 Information requirements.
6792. § 457.1208 Provider discrimination prohibited.
6793. § 457.1209 Requirements that apply to MCO, PIHP, PAHP, PCCM, and PCCM entity contracts involving Indians, Indian health care provider (IHCP), and Indian managed care entities (IMCE).
6794. 177 State Responsibilities
6795. § 457.1210 Enrollment process.
6796. § 457.1212 Disenrollment.
6797. § 457.1214 Conflict of interest safeguards.
6798. § 457.1216 Continued services to enrollees.
6799. § 457.1218 Network adequacy standards.
6800. 178 Enrollee Rights and Protections
6801. § 457.1220 Enrollee rights.
6802. § 457.1222 Provider-enrollee communication.
6803. § 457.1224 Marketing activities.
6804. § 457.1226 Liability for payment.
6805. § 457.1228 Emergency and poststabilization services.
6806. 179 MCO, PIHP, and PAHP Standards
6807. § 457.1230 Access standards.
6808. § 457.1233 Structure and operation standards.
6809. 180 Quality Measurement and Improvement; External Quality Review
6810. § 457.1240 Quality measurement and improvement.
6811. § 457.1250 External quality review.
6812. 181 Grievance System
6813. § 457.1260 Grievance system.
6814. 182 Sanctions
6815. § 457.1270 Sanctions.
6816. § 457.1280 Conditions necessary to contract as an MCO, PAHP, or PIHP.
6817. § 457.1285 Program integrity safeguards.
6818. SUBCHAPTER E PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
6819. PART 460 PROGRAMS OF ALL-INCLUSIVE CARE FOR THE ELDERLY (PACE)
6820. Subpart A Basis, Scope, and Definitions
6821. § 460.2 Basis.
6822. § 460.3 Part D program requirements.
6823. § 460.4 Scope and purpose.
6824. § 460.6 Definitions.
6825. Subpart B PACE Organization Application and Waiver Process
6826. § 460.10 Purpose.
6827. § 460.12 Application requirements.
6828. § 460.14 [Reserved]
6829. § 460.16 [Reserved]
6830. § 460.18 CMS evaluation of applications.
6831. § 460.19 Issuance of compliance actions for failure to comply with the terms of the PACE program agreement.
6832. § 460.20 Notice of CMS determination.
6833. § 460.24 Limit on number of PACE program agreements.
6834. § 460.26 Submission and evaluation of waiver requests.
6835. § 460.28 Notice of CMS determination on waiver requests.
6836. Subpart C PACE Program Agreement
6837. § 460.30 Program agreement requirement.
6838. § 460.32 Content and terms of PACE program agreement.
6839. § 460.34 Duration of PACE program agreement.
6840. Subpart D Sanctions, Enforcement Actions, and Termination
6841. § 460.40 Violations for which CMS may impose sanctions.
6842. § 460.42 Suspension of enrollment or payment by CMS.
6843. § 460.46 Civil money penalties.
6844. § 460.48 Additional actions by CMS or the State.
6845. § 460.50 Termination of PACE program agreement.
6846. § 460.52 Transitional care during termination.
6847. § 460.54 Termination procedures.
6848. § 460.56 Procedures for imposing sanctions and civil money penalties.
6849. Subpart E PACE Administrative Requirements
6850. § 460.60 PACE organizational structure.
6851. § 460.62 Governing body.
6852. § 460.63 Compliance oversight requirements.
6853. § 460.64 Personnel qualifications for staff with direct participant contact.
6854. § 460.66 Training.
6855. § 460.68 Program integrity.
6856. § 460.70 Contracted services.
6857. § 460.71 Oversight of direct participant care.
6858. § 460.72 Physical environment.
6859. § 460.74 Infection control.
6860. § 460.76 Transportation services.
6861. § 460.78 Dietary services.
6862. § 460.80 Fiscal soundness.
6863. § 460.82 Marketing.
6864. § 460.84 Emergency preparedness.
6865. § 460.86 Payment to individuals and entities excluded by the OIG or included on the preclusion list.
6866. Subpart F PACE Services
6867. § 460.90 PACE benefits under Medicare and Medicaid.
6868. § 460.92 Required services.
6869. § 460.94 Required services for Medicare participants.
6870. § 460.96 Excluded services.
6871. § 460.98 Service delivery.
6872. § 460.100 Emergency care.
6873. § 460.102 Interdisciplinary team.
6874. § 460.104 Participant assessment.
6875. § 460.106 Plan of care.
6876. Subpart G Participant Rights
6877. § 460.110 Bill of rights.
6878. § 460.112 Specific rights to which a participant is entitled.
6879. § 460.114 Restraints.
6880. § 460.116 Explanation of rights.
6881. § 460.118 Violation of rights.
6882. § 460.119 Resolution of complaints in the complaints tracking module.
6883. § 460.120 Grievance process.
6884. § 460.121 Service determination process.
6885. § 460.122 PACE organization's appeals process.
6886. § 460.124 Additional appeal rights under Medicare or Medicaid.
6887. Subpart H Quality Improvement
6888. § 460.130 General rule.
6889. § 460.132 Quality improvement plan.
6890. § 460.134 Minimum requirements for quality improvement program.
6891. § 460.136 Internal quality improvement activities.
6892. § 460.138 Committees with community input.
6893. Subpart I Participant Enrollment and Disenrollment
6894. § 460.150 Eligibility to enroll in a PACE program.
6895. § 460.152 Enrollment process.
6896. § 460.154 Enrollment agreement.
6897. § 460.156 Other enrollment procedures.
6898. § 460.158 Effective date of enrollment.
6899. § 460.160 Continuation of enrollment.
6900. § 460.162 Voluntary disenrollment.
6901. § 460.164 Involuntary disenrollment.
6902. § 460.166 Disenrollment responsibilities.
6903. § 460.168 Reinstatement in other Medicare and Medicaid programs.
6904. § 460.170 Reinstatement in PACE.
6905. § 460.172 Documentation of disenrollment.
6906. Subpart J Payment
6907. § 460.180 Medicare payment to PACE organizations.
6908. § 460.182 Medicaid payment.
6909. § 460.184 Post-eligibility treatment of income.
6910. § 460.186 PACE premiums.
6911. Subpart K Federal/State Monitoring
6912. § 460.190 Monitoring during trial period.
6913. § 460.192 Ongoing monitoring after trial period.
6914. § 460.194 Corrective action.
6915. § 460.196 Disclosure of review results.
6916. § 460.198 Disclosure of compliance deficiencies.
6917. Subpart L Data Collection, Record Maintenance, and Reporting
6918. § 460.200 Maintenance of records and reporting of data.
6919. § 460.202 Participant health outcomes data.
6920. § 460.204 Financial recordkeeping and reporting requirements.
6921. § 460.208 Financial statements.
6922. § 460.210 Medical records.
6923. SUBCHAPTER F QUALITY IMPROVEMENT ORGANIZATIONS
6924. PART 475 QUALITY IMPROVEMENT ORGANIZATIONS
6925. Subpart A General Provisions
6926. § 475.1 Definitions.
6927. B Subpart B [Reserved]
6928. Subpart C Quality Improvement Organizations
6929. § 475.100 Scope and applicability.
6930. § 475.101 Eligibility requirements for QIO contracts.
6931. § 475.102 Requirements for performing case reviews.
6932. § 475.103 Requirements for performing quality improvement initiatives.
6933. § 475.104 [Reserved]
6934. § 475.105 Prohibition against contracting with health care facilities, affiliates, and payor organizations.
6935. § 475.106 [Reserved]
6936. § 475.107 QIO contract awards.
6937. PART 476 QUALITY IMPROVEMENT ORGANIZATION REVIEW
6938. Subpart A General Provisions
6939. § 476.1 Definitions.
6940. B Subpart B [Reserved]
6941. Subpart C Review Responsibilities of Quality Improvement Organizations (QIOs)
6942. 185 General Provisions
6943. § 476.70 Statutory bases and applicability.
6944. § 476.71 QIO review requirements.
6945. § 476.73 Notification of QIO designation and implementation of review.
6946. § 476.74 General requirements for the assumption of review.
6947. § 476.76 Cooperation with health care facilities.
6948. § 476.78 Responsibilities of providers and practitioners.
6949. § 476.80 Coordination with Medicare administrative contractors, fiscal intermediaries, and carriers
6950. § 476.82 Continuation of functions not assumed by QIOs.
6951. 186 QIO Review Functions
6952. § 476.83 Initial denial determinations.
6953. § 476.84 Changes as a result of DRG validation.
6954. § 476.85 Conclusive effect of QIO initial denial determinations and changes as a result of DRG validations.
6955. § 476.86 Correlation of Title XI functions with Title XVIII functions.
6956. § 476.88 Examination of the operations and records of health care facilities and practitioners.
6957. § 476.90 Lack of cooperation by a provider or practitioner.
6958. § 476.93 Opportunity to discuss proposed initial denial determination and changes as a result of a DRG validation.
6959. § 476.94 Notice of QIO initial denial determination and changes as a result of a DRG validation.
6960. § 476.96 Review period and reopening of initial denial determinations and changes as a result of DRG validations.
6961. § 476.98 Reviewer qualifications and participation.
6962. § 476.100 Use of norms and criteria.
6963. § 476.102 Involvement of health care practitioners other than physicians.
6964. § 476.104 Coordination of activities.
6965. § 476.110 Use of immediate advocacy to resolve oral beneficiary complaints.
6966. § 476.120 Submission of written beneficiary complaints.
6967. § 476.130 Beneficiary complaint review procedures.
6968. § 476.140 Beneficiary complaint reconsideration procedures.
6969. § 476.150 Abandoned complaints and reopening rights.
6970. § 476.160 General quality of care review procedures.
6971. § 476.170 General quality of care reconsideration procedures.
6972. PART 478 RECONSIDERATIONS AND APPEALS
6973. A Subpart A [Reserved]
6974. Subpart B Utilization and Quality Control Quality Improvement Organization (QIO) Reconsiderations and Appeals
6975. § 478.10 Scope.
6976. § 478.12 Statutory basis.
6977. § 478.14 Applicability.
6978. § 478.15 QIO review of changes resulting from DRG validation.
6979. § 478.16 Right to reconsideration.
6980. § 478.18 Location for submitting requests for reconsideration.
6981. § 478.20 Time limits for requesting reconsideration.
6982. § 478.22 Good cause for late filing of a request for a reconsideration or hearing.
6983. § 478.24 Opportunity for a party to obtain and submit information.
6984. § 478.26 Delegation of the reconsideration function.
6985. § 478.28 Qualifications of a reconsideration reviewer.
6986. § 478.30 Evidence to be considered by the reconsideration reviewer.
6987. § 478.32 Time limits for issuance of the reconsidered determination.
6988. § 478.34 Notice of a reconsidered determination.
6989. § 478.36 Record of reconsideration.
6990. § 478.38 Effect of a reconsidered determination.
6991. § 478.40 Beneficiary's right to a hearing.
6992. § 478.42 Submitting a request for a hearing.
6993. § 478.44 Determining the amount in controversy for a hearing.
6994. § 478.46 Medicare Appeals Council and judicial review.
6995. § 478.48 Reopening and revision of a reconsidered determination or a decision.
6996. PART 480 ACQUISITION, PROTECTION, AND DISCLOSURE OF QUALITY IMPROVEMENT ORGANIZATION INFORMATION
6997. A Subpart A [Reserved]
6998. Subpart B Utilization and Quality Control Quality Improvement Organizations (QIOs)
6999. 192 General Provisions
7000. § 480.101 Scope and definitions.
7001. § 480.102 Statutory bases for acquisition and maintenance of information.
7002. § 480.103 Statutory bases for disclosure of information.
7003. § 480.104 Procedures for disclosure by a QIO.
7004. § 480.105 Notice of disclosures made by a QIO.
7005. § 480.106 Exceptions to QIO notice requirements.
7006. § 480.107 Limitations on redisclosure.
7007. § 480.108 Penalties for unauthorized disclosure.
7008. § 480.109 Applicability of other statutes and regulations.
7009. 193 QIO Access to Information
7010. § 480.111 QIO access to records and information of institutions and practitioners.
7011. § 480.112 QIO access to records and information of intermediaries and carriers.
7012. § 480.113 QIO access to information collected for QIO purposes.
7013. § 480.114 Limitation on data collection.
7014. 194 QIO Responsibilities
7015. § 480.115 Requirements for maintaining confidentiality.
7016. § 480.116 Notice to individuals and institutions under review.
7017. 195 Disclosure of Nonconfidential Information
7018. § 480.120 Information subject to disclosure.
7019. § 480.121 Optional disclosure of nonconfidential information.
7020. 196 Disclosure of Confidential Information
7021. § 480.130 Disclosure to the Department.
7022. § 480.131 Access to medical records for the monitoring of QIOs.
7023. § 480.132 Disclosure of information about patients.
7024. § 480.133 Disclosure of information about practitioners, reviewers and institutions.
7025. § 480.134 Verification and amendment of QIO information.
7026. § 480.135 Disclosure necessary to perform review responsibilities.
7027. § 480.136 Disclosure to intermediaries and carriers.
7028. § 480.137 Disclosure to Federal and State enforcement agencies responsible for the investigation or identification of fraud or abuse of the Medicare or Medicaid programs.
7029. § 480.138 Disclosure for other specified purposes.
7030. § 480.139 Disclosure of QIO deliberations and decisions.
7031. § 480.140 Disclosure of quality review study information.
7032. § 480.141 Disclosure of QIO interpretations on the quality of health care.
7033. § 480.142 Disclosure of sanction reports.
7034. § 480.143 QIO involvement in shared health data systems.
7035. § 480.144 Access to QIO data and information.
7036. § 480.145 Beneficiary authorization of use of confidential information.
7037. 481 PART 481 [RESERVED]
7038. CHAPTER IV CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
7039. SUBCHAPTER G STANDARDS AND CERTIFICATION
7040. PART 482 CONDITIONS OF PARTICIPATION FOR HOSPITALS
7041. Subpart A General Provisions
7042. § 482.1 Basis and scope.
7043. § 482.2 Provision of emergency services by nonparticipating hospitals.
7044. Subpart B Administration
7045. § 482.11 Condition of participation: Compliance with Federal, State and local laws.
7046. § 482.12 Condition of participation: Governing body.
7047. § 482.13 Condition of participation: Patient's rights.
7048. § 482.15 Condition of participation: Emergency preparedness.
7049. Subpart C Basic Hospital Functions
7050. § 482.21 Condition of participation: Quality assessment and performance improvement program.
7051. § 482.22 Condition of participation: Medical staff.
7052. § 482.23 Condition of participation: Nursing services.
7053. § 482.24 Condition of participation: Medical record services.
7054. § 482.25 Condition of participation: Pharmaceutical services.
7055. § 482.26 Condition of participation: Radiologic services.
7056. § 482.27 Condition of participation: Laboratory services.
7057. § 482.28 Condition of participation: Food and dietetic services.
7058. § 482.30 Condition of participation: Utilization review.
7059. § 482.41 Condition of participation: Physical environment.
7060. § 482.42 Condition of participation: Infection prevention and control and antibiotic stewardship programs.
7061. § 482.43 Condition of participation: Discharge planning.
7062. § 482.45 Condition of participation: Organ, tissue, and eye procurement.
7063. Subpart D Optional Hospital Services
7064. § 482.51 Condition of participation: Surgical services.
7065. § 482.52 Condition of participation: Anesthesia services.
7066. § 482.53 Condition of participation: Nuclear medicine services.
7067. § 482.54 Condition of participation: Outpatient services.
7068. § 482.55 Condition of participation: Emergency services.
7069. § 482.56 Condition of participation: Rehabilitation services.
7070. § 482.57 Condition of participation: Respiratory care services.
7071. § 482.58 Special requirements for hospital providers of long-term care services (“swing-beds”).
7072. § 482.59 Condition of participation: Obstetrical services.
7073. Subpart E Requirements for Specialty Hospitals
7074. § 482.60 Special provisions applying to psychiatric hospitals.
7075. § 482.61 Condition of participation: Special medical record requirements for psychiatric hospitals.
7076. § 482.62 Condition of participation: Special staff requirements for psychiatric hospitals.
7077. § 482.68 Special requirement for transplant programs.
7078. § 482.70 Definitions.
7079. 4 General Requirements for Transplant Centers
7080. § 482.72 Condition of participation: OPTN membership.
7081. § 482.74 Condition of participation: Notification to CMS.
7082. § 482.76 Condition of participation: Pediatric Transplants.
7083. § 482.78 Condition of participation: Emergency preparedness for transplant programs.
7084. 5 Transplant Center Data Submission, Clinical Experience, and Outcome Requirements
7085. § 482.80 Condition of participation: Data submission, clinical experience, and outcome requirements for initial approval of transplant programs.
7086. 6 Transplant Program Process Requirements
7087. § 482.90 Condition of participation: Patient and living donor selection.
7088. § 482.92 Condition of participation: Organ recovery and receipt.
7089. § 482.94 Condition of participation: Patient and living donor management.
7090. § 482.96 Condition of participation: Quality assessment and performance improvement (QAPI).
7091. § 482.98 Condition of participation: Human resources.
7092. § 482.100 Condition of participation: Organ procurement.
7093. § 482.102 Condition of participation: Patient and living donor rights.
7094. § 482.104 Condition of participation: Additional requirements for kidney transplant programs.
7095. PART 483 REQUIREMENTS FOR STATES AND LONG TERM CARE FACILITIES
7096. A Subpart A [Reserved]
7097. Subpart B Requirements for Long Term Care Facilities
7098. § 483.1 Basis and scope.
7099. § 483.5 Definitions.
7100. § 483.10 Resident rights.
7101. § 483.12 Freedom from abuse, neglect, and exploitation.
7102. § 483.15 Admission, transfer, and discharge rights.
7103. § 483.20 Resident assessment.
7104. § 483.21 Comprehensive person-centered care planning.
7105. § 483.24 Quality of life.
7106. § 483.25 Quality of care.
7107. § 483.30 Physician services.
7108. § 483.35 Nursing services.
7109. § 483.40 Behavioral health services.
7110. § 483.45 Pharmacy services.
7111. § 483.50 Laboratory, radiology, and other diagnostic services.
7112. § 483.55 Dental services.
7113. § 483.60 Food and nutrition services.
7114. § 483.65 Specialized rehabilitative services.
7115. § 483.70 Administration.
7116. § 483.71 Facility assessment.
7117. § 483.73 Emergency preparedness.
7118. § 483.75 Quality assurance and performance improvement.
7119. § 483.80 Infection control.
7120. § 483.85 Compliance and ethics program.
7121. § 483.90 Physical environment.
7122. § 483.95 Training requirements.
7123. Subpart C Preadmission Screening and Annual Review of Mentally Ill and Mentally Retarded Individuals
7124. § 483.100 Basis.
7125. § 483.102 Applicability and definitions.
7126. § 483.104 State plan requirement.
7127. § 483.106 Basic rule.
7128. § 483.108 Relationship of PASARR to other Medicaid processes.
7129. § 483.110 Out-of-State arrangements.
7130. § 483.112 Preadmission screening of applicants for admission to NFs.
7131. § 483.114 Annual review of NF residents.
7132. § 483.116 Residents and applicants determined to require NF level of services.
7133. § 483.118 Residents and applicants determined not to require NF level of services.
7134. § 483.120 Specialized services.
7135. § 483.122 FFP for NF services.
7136. § 483.124 FFP for specialized services.
7137. § 483.126 Appropriate placement.
7138. § 483.128 PASARR evaluation criteria.
7139. § 483.130 PASARR determination criteria.
7140. § 483.132 Evaluating the need for NF services and NF level of care (PASARR/NF).
7141. § 483.134 Evaluating whether an individual with mental illness requires specialized services (PASARR/MI).
7142. § 483.136 Evaluating whether an individual with intellectual disability requires specialized services (PASARR/IID).
7143. § 483.138 Maintenance of services and availability of FFP.
7144. Subpart D Requirements That Must Be Met by States and State Agencies: Nurse Aide Training and Competency Evaluation, and Paid Feeding Assistants
7145. § 483.150 Statutory basis; Deemed meeting or waiver of requirements.
7146. § 483.151 State review and approval of nurse aide training and competency evaluation programs.
7147. § 483.152 Requirements for approval of a nurse aide training and competency evaluation program.
7148. § 483.154 Nurse aide competency evaluation.
7149. § 483.156 Registry of nurse aides.
7150. § 483.158 FFP for nurse aide training and competency evaluation.
7151. § 483.160 Requirements for training of paid feeding assistants.
7152. Subpart E Appeals of Discharges, Transfers, and Preadmission Screening and Annual Resident Review (PASARR) Determinations
7153. § 483.200 Statutory basis.
7154. § 483.202 Definitions.
7155. § 483.204 Provision of a hearing and appeal system.
7156. § 483.206 Transfers, discharges and relocations subject to appeal.
7157. Subpart F Requirements That Must be Met by States and State Agencies, Resident Assessment
7158. § 483.315 Specification of resident assessment instrument.
7159. Subpart G Condition of Participation for the Use of Restraint or Seclusion in Psychiatric Residential Treatment Facilities Providing Inpatient Psychiatric Services for Individuals Under Age 21
7160. § 483.350 Basis and scope.
7161. § 483.352 Definitions.
7162. § 483.354 General requirements for psychiatric residential treatment facilities.
7163. § 483.356 Protection of residents.
7164. § 483.358 Orders for the use of restraint or seclusion.
7165. § 483.360 Consultation with treatment team physician.
7166. § 483.362 Monitoring of the resident in and immediately after restraint.
7167. § 483.364 Monitoring of the resident in and immediately after seclusion.
7168. § 483.366 Notification of parent(s) or legal guardian(s).
7169. § 483.368 Application of time out.
7170. § 483.370 Postintervention debriefings.
7171. § 483.372 Medical treatment for injuries resulting from an emergency safety intervention.
7172. § 483.374 Facility reporting.
7173. § 483.376 Education and training.
7174. H Subpart H [Reserved]
7175. Subpart I Conditions of Participation for Intermediate Care Facilities for Individuals with Intellectual Disabilities
7176. § 483.400 Basis and purpose.
7177. § 483.405 Relationship to other HHS regulations.
7178. § 483.410 Condition of participation: Governing body and management.
7179. § 483.420 Condition of participation: Client protections.
7180. § 483.430 Condition of participation: Facility staffing.
7181. § 483.440 Condition of participation: Active treatment services.
7182. § 483.450 Condition of participation: Client behavior and facility practices.
7183. § 483.460 Condition of participation: Health care services.
7184. § 483.470 Condition of participation: Physical environment.
7185. § 483.475 Condition of participation: Emergency preparedness.
7186. § 483.480 Condition of participation: Dietetic services.
7187. PART 484 HOME HEALTH SERVICES
7188. Subpart A General Provisions
7189. § 484.1 Basis and scope.
7190. § 484.2 Definitions.
7191. Subpart B Patient Care
7192. § 484.40 Condition of participation: Release of patient identifiable OASIS information.
7193. § 484.45 Condition of participation: Reporting OASIS information.
7194. § 484.50 Condition of participation: Patient rights.
7195. § 484.55 Condition of participation: Comprehensive assessment of patients.
7196. § 484.58 Condition of participation: Discharge planning.
7197. § 484.60 Condition of participation: Care planning, coordination of services, and quality of care.
7198. § 484.65 Condition of participation: Quality assessment and performance improvement (QAPI).
7199. § 484.70 Condition of participation: Infection prevention and control.
7200. § 484.75 Condition of participation: Skilled professional services.
7201. § 484.80 Condition of participation: Home health aide services.
7202. Subpart C Organizational Environment
7203. § 484.100 Condition of participation: Compliance with Federal, State, and local laws and regulations related to the health and safety of patients.
7204. § 484.102 Condition of participation: Emergency preparedness.
7205. § 484.105 Condition of participation: Organization and administration of services.
7206. § 484.110 Condition of participation: Clinical records.
7207. § 484.115 Condition of participation: Personnel qualifications.
7208. D Subpart D [Reserved]
7209. Subpart E Prospective Payment System for Home Health Agencies
7210. § 484.200 Basis and scope.
7211. § 484.202 Definitions.
7212. § 484.205 Basis of payment.
7213. § 484.215 Initial establishment of the calculation of the national, standardized prospective payment rates.
7214. § 484.220 Calculation of the case-mix and wage area adjusted prospective payment rates.
7215. § 484.225 Annual update of the unadjusted national, standardized prospective payment rates.
7216. § 484.230 Low-utilization payment adjustments.
7217. § 484.235 Partial payment adjustments.
7218. § 484.240 Outlier payments.
7219. § 484.245 Requirements under the Home Health Quality Reporting Program (HH QRP).
7220. § 484.250 OASIS data.
7221. § 484.260 Limitation on review.
7222. § 484.265 Additional payment.
7223. Subpart F Home Health Value-Based Purchasing (HHVBP) Models
7224. 9 HHVBP Model Components for Competing Home Health Agencies Within State Boundaries for the Original HHVBP Model
7225. § 484.300 Basis and scope of subpart.
7226. § 484.305 Definitions.
7227. § 484.310 Applicability of the Home Health Value-Based Purchasing (HHVBP) Model.
7228. § 484.315 Data reporting for measures and evaluation and the public reporting of model data under the Home Health Value-Based Purchasing (HHVBP) Model.
7229. § 484.320 Calculation of the Total Performance Score.
7230. § 484.325 Payments for home health services under Home Health Value-Based Purchasing (HHVBP) Model.
7231. § 484.330 Process for determining and applying the value-based payment adjustment under the Home Health Value-Based Purchasing (HHVBP) Model.
7232. § 484.335 Appeals process for the Home Health Value-Based Purchasing (HHVBP) Model.
7233. 10 HHVBP Model Components for Competing Home Health Agencies (HHAs) for HHVBP Model Expansion—Effective January 1, 2022
7234. § 484.340 Basis and scope of this subpart.
7235. § 484.345 Definitions.
7236. § 484.350 Applicability of the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
7237. § 484.355 Data reporting for measures and evaluation and the public reporting of model data under the expanded Home Health Value-Based Purchasing (HHVBP) Model.
7238. § 484.358 HHVBP Measure removal factors.
7239. § 484.360 Calculation of the Total Performance Score.
7240. § 484.365 Payments for home health services under the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
7241. § 484.370 Process for determining and applying the value-based payment adjustment under the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
7242. § 484.375 Appeals process for the Expanded Home Health Value-Based Purchasing (HHVBP) Model.
7243. PART 485 CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
7244. A Subpart A [Reserved]
7245. Subpart B Conditions of Participation: Comprehensive Outpatient Rehabilitation Facilities
7246. § 485.50 Basis and scope.
7247. § 485.51 Definition.
7248. § 485.54 Condition of participation: Compliance with State and local laws.
7249. § 485.56 Condition of participation: Governing body and administration.
7250. § 485.58 Condition of participation: Comprehensive rehabilitation program.
7251. § 485.60 Condition of participation: Clinical records.
7252. § 485.62 Condition of participation: Physical environment.
7253. § 485.64 [Reserved]
7254. § 485.66 Condition of participation: Utilization review plan.
7255. § 485.68 Condition of participation: Emergency preparedness.
7256. § 485.70 Personnel qualifications.
7257. § 485.74 Appeal rights.
7258. C Subparts C-D [Reserved]
7259. Subpart E Conditions of Participation: Rural Emergency Hospitals (REHs)
7260. § 485.500 Basis and scope.
7261. § 485.502 Definitions.
7262. § 485.504 Basic requirements.
7263. § 485.506 Designation and certification of REHs.
7264. § 485.508 Condition of participation: Compliance with Federal, state, and local laws and regulations.
7265. § 485.510 Condition of participation: Governing body and organizational structure of the REH
7266. § 485.512 Condition of participation: Medical staff.
7267. § 485.514 Condition of participation: Provision of services.
7268. § 485.516 Condition of participation: Emergency services.
7269. § 485.518 Condition of participation: Laboratory services.
7270. § 485.520 Condition of participation: Radiologic services.
7271. § 485.522 Condition of participation: Pharmaceutical services.
7272. § 485.524 Condition of participation: Additional outpatient medical and health services.
7273. § 485.526 Condition of participation: Infection prevention and control and antibiotic stewardship programs.
7274. § 485.528 Condition of participation: Staffing and staff responsibilities.
7275. § 485.530 Condition of participation: Nursing services.
7276. § 485.532 Condition of participation: Discharge planning.
7277. § 485.534 Condition of participation: Patient's rights.
7278. § 485.536 Condition of participation: Quality assessment and performance improvement program.
7279. § 485.538 Condition of participation: Agreements.
7280. § 485.540 Condition of participation: Medical records.
7281. § 485.542 Condition of participation: Emergency preparedness.
7282. § 485.544 Condition of participation: Physical environment.
7283. § 485.546 Condition of participation: Skilled nursing facility distinct part unit.
7284. Subpart F Conditions of Participation: Critical Access Hospitals (CAHs)
7285. § 485.601 Basis and scope.
7286. § 485.603 Rural health network.
7287. § 485.604 Personnel qualifications.
7288. § 485.606 Designation and certification of CAHs.
7289. § 485.608 Condition of participation: Compliance with Federal, State, and local laws and regulations.
7290. § 485.610 Condition of participation: Status and location.
7291. § 485.612 Condition of participation: Compliance with hospital requirements at the time of application.
7292. § 485.614 Condition of participation: Patient's rights.
7293. § 485.616 Condition of participation: Agreements.
7294. § 485.618 Condition of participation: Emergency services.
7295. § 485.620 Condition of participation: Number of beds and length of stay.
7296. § 485.623 Condition of participation: Physical plant and environment.
7297. § 485.625 Condition of participation: Emergency preparedness.
7298. § 485.627 Condition of participation: Organizational structure.
7299. § 485.631 Condition of participation: Staffing and staff responsibilities.
7300. § 485.635 Condition of participation: Provision of services.
7301. § 485.638 Conditions of participation: Clinical records.
7302. § 485.639 Condition of participation: Surgical services.
7303. § 485.640 Condition of participation: Infection prevention and control and antibiotic stewardship programs.
7304. § 485.641 Condition of participation: Quality assessment and performance improvement program.
7305. § 485.642 Condition of participation: Discharge planning.
7306. § 485.643 Condition of participation: Organ, tissue, and eye procurement.
7307. § 485.645 Special requirements for CAH providers of long-term care services (“swing-beds”)
7308. § 485.647 Condition of participation: psychiatric and rehabilitation distinct part units.
7309. § 485.649 Condition of participation: Obstetrical services.
7310. G Subpart G [Reserved]
7311. Subpart H Conditions of Participation for Clinics, Rehabilitation Agencies, and Public Health Agencies as Providers of Outpatient Physical Therapy and Speech-Language Pathology Services
7312. § 485.701 Basis and scope.
7313. § 485.703 Definitions.
7314. § 485.705 Personnel qualifications.
7315. § 485.707 Condition of participation: Compliance with Federal, State, and local laws.
7316. § 485.709 Condition of participation: Administrative management.
7317. § 485.711 Condition of participation: Plan of care and physician involvement.
7318. § 485.713 Condition of participation: Physical therapy services.
7319. § 485.715 Condition of participation: Speech pathology services.
7320. § 485.717 Condition of participation: Rehabilitation program.
7321. § 485.719 Condition of participation: Arrangements for physical therapy and speech pathology services to be performed by other than salaried organization personnel.
7322. § 485.721 Condition of participation: Clinical records.
7323. § 485.723 Condition of participation: Physical environment.
7324. § 485.725 Condition of participation: Infection control.
7325. § 485.727 Condition of participation: Emergency preparedness.
7326. § 485.729 Condition of participation: Program evaluation.
7327. I Subpart I [Reserved]
7328. Subpart J Conditions of Participation: Community Mental Health Centers (CMHCs)
7329. § 485.900 Basis and scope.
7330. § 485.902 Definitions.
7331. § 485.904 Condition of participation: Personnel qualifications.
7332. § 485.910 Condition of participation: Client rights.
7333. § 485.914 Condition of participation: Admission, initial evaluation, comprehensive assessment, and discharge or transfer of the client.
7334. § 485.916 Condition of participation: Treatment team, person-centered active treatment plan, and coordination of services.
7335. § 485.917 Condition of participation: Quality assessment and performance improvement.
7336. § 485.918 Condition of participation: Organization, governance, administration of services, partial hospitalization services, and intensive outpatient services.
7337. § 485.920 Condition of participation: Emergency preparedness.
7338. PART 486 CONDITIONS FOR COVERAGE OF SPECIALIZED SERVICES FURNISHED BY SUPPLIERS
7339. Subpart A General Provisions
7340. § 486.1 Basis and scope.
7341. B Subpart B [Reserved]
7342. Subpart C Conditions for Coverage: Portable X-Ray Services
7343. § 486.100 Condition for coverage: Compliance with Federal, State, and local laws and regulations.
7344. § 486.102 Condition for coverage: Supervision by a qualified physician.
7345. § 486.104 Condition for coverage: Qualifications, orientation and health of technical personnel.
7346. § 486.106 Condition for coverage: Referral for service and preservation of records.
7347. § 486.108 Condition for coverage: Safety standards.
7348. § 486.110 Condition for coverage: Inspection of equipment.
7349. D Subparts D-F [Reserved]
7350. Subpart G Requirements for Certification and Designation and Conditions for Coverage: Organ Procurement Organizations
7351. § 486.301 Basis and scope.
7352. § 486.302 Definitions.
7353. 17 Requirements for Certification and Designation
7354. § 486.303 Requirements for certification.
7355. § 486.304 Requirements for designation.
7356. § 486.306 OPO service area size designation and documentation requirements.
7357. § 486.308 Designation of one OPO for each service area.
7358. § 486.309 Re-certification from August 1, 2006 through July 31, 2010.
7359. § 486.310 Changes in control or ownership or service area.
7360. 18 Re-Certification and De-Certification
7361. § 486.312 De-certification.
7362. § 486.314 Appeals.
7363. § 486.316 Re-certification and competition processes.
7364. 19 Organ Procurement Organization Outcome Requirements
7365. § 486.318 Condition: Outcome measures.
7366. 20 Organ Procurement Organization Process Performance Measures
7367. § 486.320 Condition: Participation in Organ Procurement and Transplantation Network.
7368. § 486.322 Condition: Relationships with hospitals, critical access hospitals, and tissue banks.
7369. § 486.324 Condition: Administration and governing body.
7370. § 486.326 Condition: Human resources.
7371. § 486.328 Condition: Reporting of data.
7372. § 486.330 Condition: Information management.
7373. § 486.342 Condition: Requesting consent.
7374. § 486.344 Condition: Evaluation and management of potential donors and organ placement and recovery.
7375. § 486.346 Condition: Organ preparation and transport.
7376. § 486.348 Condition: Quality assessment and performance improvement (QAPI).
7377. § 486.360 Condition for Coverage: Emergency preparedness.
7378. Subpart H [Reserved]
7379. Subpart I Requirements for Home Infusion Therapy Suppliers
7380. 21 General Provisions
7381. § 486.500 Basis and scope.
7382. § 486.505 Definitions.
7383. 22 Standards for Home Infusion Therapy
7384. § 486.520 Plan of care.
7385. § 486.525 Required services.
7386. PART 488 SURVEY, CERTIFICATION, AND ENFORCEMENT PROCEDURES
7387. Subpart A General Provisions
7388. § 488.1 Definitions.
7389. § 488.2 Statutory basis.
7390. § 488.3 Conditions of participation, conditions for coverage, conditions for certification and long term care requirements.
7391. § 488.4 General rules for a CMS-approved accreditation program for providers and suppliers.
7392. § 488.5 Application and re-application procedures for national accrediting organizations.
7393. § 488.6 Providers or suppliers that participate in the Medicaid program under a CMS-approved accreditation program.
7394. § 488.7 Release and use of accreditation surveys.
7395. § 488.8 Ongoing review of accrediting organizations.
7396. § 488.9 Validation surveys.
7397. § 488.10 State survey agency review: Statutory provisions.
7398. § 488.11 State survey agency functions.
7399. § 488.12 Effect of survey agency certification.
7400. § 488.13 Loss of accreditation.
7401. § 488.14 Effect of QIO review.
7402. § 488.18 Documentation of findings.
7403. § 488.20 Periodic review of compliance and approval.
7404. § 488.24 Certification of noncompliance.
7405. § 488.26 Determining compliance.
7406. § 488.28 Providers or suppliers, other than SNFs, NFs, HHAs, and Hospice programs with deficiencies.
7407. § 488.30 Revisit user fee for revisit surveys.
7408. Subpart B Special Requirements
7409. § 488.52 [Reserved]
7410. § 488.54 Temporary waivers applicable to hospitals.
7411. § 488.56 Temporary waivers applicable to skilled nursing facilities.
7412. § 488.60 Special procedures for approving end stage renal disease facilities.
7413. § 488.61 Special procedures for approval and re-approval of organ transplant programs.
7414. § 488.64 Remote facility variances for utilization review requirements.
7415. § 488.68 State Agency responsibilities for OASIS collection and data base requirements.
7416. § 488.70 Special requirements for rural emergency hospitals (REHs).
7417. Subpart C Survey Forms and Procedures
7418. § 488.100 Long term care survey forms, Part A.
7419. § 488.105 Long term care survey forms, Part B.
7420. § 488.110 Procedural guidelines.
7421. § 488.115 Care guidelines.
7422. Subpart D Reconsideration of Adverse Determinations—Deeming Authority for Accreditation Organizations and CLIA Exemption of Laboratories Under State Programs
7423. § 488.201 Reconsideration.
7424. § 488.203 Withdrawal of request for reconsideration.
7425. § 488.205 Right to informal hearing.
7426. § 488.207 Informal hearing procedures.
7427. § 488.209 Hearing officer's findings.
7428. § 488.211 Final reconsideration determination.
7429. Subpart E Survey and Certification of Long-Term Care Facilities
7430. § 488.300 Statutory basis.
7431. § 488.301 Definitions.
7432. § 488.303 State plan requirement.
7433. § 488.305 Standard surveys.
7434. § 488.307 Unannounced surveys.
7435. § 488.308 Survey frequency.
7436. § 488.310 Extended survey.
7437. § 488.312 Consistency of survey results.
7438. § 488.314 Survey teams.
7439. § 488.318 Inadequate survey performance.
7440. § 488.320 Sanctions for inadequate survey performance.
7441. § 488.325 Disclosure of results of surveys and activities.
7442. § 488.330 Certification of compliance or noncompliance.
7443. § 488.331 Informal dispute resolution.
7444. § 488.332 Investigation of complaints of violations and monitoring of compliance.
7445. § 488.334 Educational programs.
7446. § 488.335 Action on complaints of resident neglect and abuse, and misappropriation of resident property.
7447. Subpart F Enforcement of Compliance for Long-Term Care Facilities with Deficiencies
7448. § 488.400 Statutory basis.
7449. § 488.401 Definitions.
7450. § 488.402 General provisions.
7451. § 488.404 Factors to be considered in selecting remedies.
7452. § 488.406 Available remedies.
7453. § 488.408 Selection of remedies.
7454. § 488.410 Action when there is immediate jeopardy.
7455. § 488.412 Action when there is no immediate jeopardy.
7456. § 488.414 Action when there is repeated substandard quality of care.
7457. § 488.415 Temporary management.
7458. § 488.417 Denial of payment for all new admissions.
7459. § 488.418 Secretarial authority to deny all payments.
7460. § 488.422 State monitoring.
7461. § 488.424 Directed plan of correction.
7462. § 488.425 Directed inservice training.
7463. § 488.426 Transfer of residents, or closure of the facility and transfer of residents.
7464. § 488.430 Civil money penalties: Basis for imposing penalty.
7465. § 488.431 Civil money penalties imposed by CMS and independent informal dispute resolution: for SNFS, dually-participating SNF/NFs, and NF-only facilities.
7466. § 488.432 Civil money penalties imposed by the State: NF-only.
7467. § 488.433 Civil money penalties: Uses and approval of civil money penalties imposed by CMS.
7468. § 488.434 Civil money penalties: Notice of penalty.
7469. § 488.436 Civil money penalties: Waiver of hearing, reduction of penalty amount.
7470. § 488.438 Civil money penalties: Amount of penalty.
7471. § 488.440 Civil money penalties: Effective date and duration of penalty.
7472. § 488.442 Civil money penalties: Due date for payment of penalty.
7473. § 488.444 Civil money penalties: Settlement of penalties.
7474. § 488.446 Administrator sanctions: long-term care facility closures.
7475. § 488.447 Civil Money Penalties imposed for failure to comply with 42 CFR 483.80(g)(1) and (2).
7476. § 488.450 Continuation of payments to a facility with deficiencies.
7477. § 488.452 State and Federal disagreements involving findings not in agreement in non-State operated NFs and dually participating facilities when there is no immediate jeopardy.
7478. § 488.454 Duration of remedies.
7479. § 488.456 Termination of provider agreement.
7480. G Subpart G [Reserved]
7481. Subpart H Termination of Medicare Coverage and Alternative Sanctions for End-Stage Renal Disease (ESRD) Facilities
7482. § 488.604 Termination of Medicare coverage.
7483. § 488.606 Alternative sanctions.
7484. § 488.608 Notice of alternative sanction and appeal rights: Termination of coverage.
7485. § 488.610 Notice of appeal rights: Alternative sanctions.
7486. Subpart I Survey and Certification of Home Health Agencies
7487. § 488.700 Basis and scope.
7488. § 488.705 Definitions.
7489. § 488.710 Standard surveys.
7490. § 488.715 Partial extended surveys.
7491. § 488.720 Extended surveys.
7492. § 488.725 Unannounced surveys.
7493. § 488.730 Survey frequency and content.
7494. § 488.735 Surveyor qualifications.
7495. § 488.740 Certification of compliance or noncompliance.
7496. § 488.745 Informal Dispute Resolution (IDR).
7497. Subpart J Alternative Sanctions for Home Health Agencies With Deficiencies
7498. § 488.800 Statutory basis.
7499. § 488.805 Definitions.
7500. § 488.810 General provisions.
7501. § 488.815 Factors to be considered in selecting sanctions.
7502. § 488.820 Available sanctions.
7503. § 488.825 Action when deficiencies pose immediate jeopardy.
7504. § 488.830 Action when deficiencies are at the condition-level but do not pose immediate jeopardy.
7505. § 488.835 Temporary management.
7506. § 488.840 Suspension of payment for all new patient admissions.
7507. § 488.845 Civil money penalties.
7508. § 488.850 Directed plan of correction.
7509. § 488.855 Directed in-service training.
7510. § 488.860 Continuation of payments to an HHA with deficiencies.
7511. § 488.865 Termination of provider agreement.
7512. Subpart K [Reserved]
7513. Subpart L Accreditation of Home Infusion Therapy Suppliers
7514. 25 General Provisions
7515. § 488.1000 Basis and scope.
7516. § 488.1005 Definitions.
7517. 26 Approval and Oversight of Home Infusion Therapy Supplier Accrediting Organizations
7518. § 488.1010 Application and reapplication procedures for national home infusion therapy accrediting organizations.
7519. § 488.1015 Resubmitting a request for reapproval.
7520. § 488.1020 Public notice and comment.
7521. § 488.1025 Release and use of home infusion therapy accreditation surveys.
7522. § 488.1030 Ongoing review of home infusion therapy accrediting organizations.
7523. § 488.1035 Ongoing responsibilities of a CMS-approved home infusion therapy accrediting organization.
7524. § 488.1040 Onsite observations of home infusion therapy accrediting organization operations.
7525. § 488.1045 Voluntary and involuntary termination.
7526. § 488.1050 Reconsideration.
7527. Subpart M Survey and Certification of Hospice Programs
7528. § 488.1100 Basis and scope.
7529. § 488.1105 Definitions.
7530. § 488.1110 Hospice program: surveys and hotline.
7531. § 488.1115 Surveyor qualifications and prohibition of conflicts of interest.
7532. § 488.1120 Survey teams.
7533. § 488.1125 Consistency of survey results.
7534. § 488.1130 Informal dispute resolution (IDR).
7535. § 488.1135 Hospice Special Focus Program (SFP).
7536. Subpart N Enforcement Remedies for Hospice Programs With Deficiencies
7537. § 488.1200 Statutory basis.
7538. § 488.1205 Definitions.
7539. § 488.1210 General provisions.
7540. § 488.1215 Factors to be considered in selecting remedies.
7541. § 488.1220 Available remedies.
7542. § 488.1225 Action when deficiencies pose immediate jeopardy.
7543. § 488.1230 Action when deficiencies are at the condition-level but do not pose immediate jeopardy.
7544. § 488.1235 Temporary management.
7545. § 488.1240 Suspension of payment for all new patient admissions.
7546. § 488.1245 Civil money penalties.
7547. § 488.1250 Directed plan of correction.
7548. § 488.1255 Directed in-service training.
7549. § 488.1260 Continuation of payments to a hospice program with deficiencies.
7550. § 488.1265 Termination of provider agreement.
7551. PART 489 PROVIDER AGREEMENTS AND SUPPLIER APPROVAL
7552. Subpart A General Provisions
7553. § 489.1 Statutory basis.
7554. § 489.2 Scope of part.
7555. § 489.3 Definitions.
7556. § 489.10 Basic requirements.
7557. § 489.11 Acceptance of a provider as a participant.
7558. § 489.12 Decision to deny an agreement.
7559. § 489.13 Effective date of agreement or approval.
7560. § 489.18 Change of ownership or leasing: Effect on provider agreement.
7561. Subpart B Essentials of Provider Agreements
7562. § 489.20 Basic commitments.
7563. § 489.21 Specific limitations on charges.
7564. § 489.22 Special provisions applicable to prepayment requirements.
7565. § 489.23 Specific limitation on charges for services provided to certain enrollees of fee-for-service FEHB plans.
7566. § 489.24 Special responsibilities of Medicare hospitals in emergency cases.
7567. § 489.25 Special requirements concerning CHAMPUS and CHAMPVA programs.
7568. § 489.26 Special requirements concerning veterans.
7569. § 489.27 Beneficiary notice of discharge or change in status rights.
7570. § 489.28 Special capitalization requirements for HHAs.
7571. § 489.29 Special requirements concerning beneficiaries served by the Indian Health Service, Tribal health programs, and urban Indian organization health programs.
7572. Subpart C Allowable Charges
7573. § 489.30 Allowable charges: Deductibles and coinsurance.
7574. § 489.31 Allowable charges: Blood.
7575. § 489.32 Allowable charges: Noncovered and partially covered services.
7576. § 489.34 Allowable charges: Hospitals participating in State reimbursement control systems or demonstration projects.
7577. § 489.35 Notice to intermediary.
7578. Subpart D Handling of Incorrect Collections
7579. § 489.40 Definition of incorrect collection.
7580. § 489.41 Timing and methods of handling.
7581. § 489.42 Payment of offset amounts to beneficiary or other person.
7582. Subpart E Termination of Agreement and Reinstatement After Termination
7583. § 489.52 Termination by the provider.
7584. § 489.53 Termination by CMS.
7585. § 489.54 Termination by the OIG.
7586. § 489.55 Exceptions to effective date of termination.
7587. § 489.57 Reinstatement after termination.
7588. Subpart F Surety Bond Requirements for HHAs
7589. § 489.60 Definitions.
7590. § 489.61 Basic requirement for surety bonds.
7591. § 489.62 Requirement waived for Government-operated HHAs.
7592. § 489.63 Parties to the bond.
7593. § 489.64 Authorized Surety and exclusion of surety companies.
7594. § 489.65 Amount of the bond.
7595. § 489.66 Additional requirements of the surety bond.
7596. § 489.67 Term and type of bond.
7597. § 489.68 Effect of failure to obtain, maintain, and timely file a surety bond.
7598. § 489.69 Evidence of compliance.
7599. § 489.70 Effect of payment by the Surety.
7600. § 489.71 Surety's standing to appeal Medicare determinations.
7601. § 489.72 Effect of review reversing determination.
7602. § 489.73 Effect of conditions of payment.
7603. § 489.74 Incorporation into existing provider agreements.
7604. G Subparts G-H [Reserved]
7605. Subpart I Advance Directives
7606. § 489.100 Definition.
7607. § 489.102 Requirements for providers.
7608. § 489.104 Effective dates.
7609. PART 491 CERTIFICATION OF CERTAIN HEALTH FACILITIES
7610. Subpart A Rural Health Clinics: Conditions for Certification; and FQHCs Conditions for Coverage
7611. § 491.1 Purpose and scope.
7612. § 491.2 Definitions.
7613. § 491.3 Certification procedures.
7614. § 491.4 Compliance with Federal, State and local laws.
7615. § 491.5 Location of clinic.
7616. § 491.6 Physical plant and environment.
7617. § 491.7 Organizational structure.
7618. § 491.8 Staffing and staff responsibilities.
7619. § 491.9 Provision of services.
7620. § 491.10 Patient health records.
7621. § 491.11 Program evaluation.
7622. § 491.12 Emergency preparedness.
7623. PART 493 LABORATORY REQUIREMENTS
7624. Subpart A General Provisions
7625. § 493.1 Basis and scope.
7626. § 493.2 Definitions.
7627. § 493.3 Applicability.
7628. § 493.5 Categories of tests by complexity.
7629. § 493.15 Laboratories performing waived tests.
7630. § 493.17 Test categorization.
7631. § 493.19 Provider-performed microscopy (PPM) procedures.
7632. § 493.20 Laboratories performing tests of moderate complexity.
7633. § 493.25 Laboratories performing tests of high complexity.
7634. Subpart B Certificate of Waiver
7635. § 493.35 Application for a certificate of waiver.
7636. § 493.37 Requirements for a certificate of waiver.
7637. § 493.39 Notification requirements for laboratories issued a certificate of waiver.
7638. § 493.41 Condition: Reporting of SARS-CoV-2 test results.
7639. Subpart C Registration Certificate, Certificate for Provider-performed Microscopy Procedures, and Certificate of Compliance
7640. § 493.43 Application for registration certificate, certificate for provider-performed microscopy (PPM) procedures, and certificate of compliance.
7641. § 493.45 Requirements for a registration certificate.
7642. § 493.47 Requirements for a certificate for provider-performed microscopy (PPM) procedures.
7643. § 493.49 Requirements for a certificate of compliance.
7644. § 493.51 Notification requirements for laboratories issued a certificate of compliance.
7645. § 493.53 Notification requirements for laboratories issued a certificate for provider-performed microscopy (PPM) procedures.
7646. Subpart D Certificate of Accreditation
7647. § 493.55 Application for registration certificate and certificate of accreditation.
7648. § 493.57 Requirements for a registration certificate.
7649. § 493.61 Requirements for a certificate of accreditation.
7650. § 493.63 Notification requirements for laboratories issued a certificate of accreditation.
7651. Subpart E Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program
7652. § 493.551 General requirements for laboratories.
7653. § 493.553 Approval process (application and reapplication) for accreditation organizations and State licensure programs.
7654. § 493.555 Federal review of laboratory requirements.
7655. § 493.557 Additional submission requirements.
7656. § 493.559 Publication of approval of deeming authority or CLIA exemption.
7657. § 493.561 Denial of application or reapplication.
7658. § 493.563 Validation inspections—Basis and focus.
7659. § 493.565 Selection for validation inspection—laboratory responsibilities.
7660. § 493.567 Refusal to cooperate with validation inspection.
7661. § 493.569 Consequences of a finding of noncompliance as a result of a validation inspection.
7662. § 493.571 Disclosure of accreditation, State and CMS validation inspection results.
7663. § 493.573 Continuing Federal oversight of private nonprofit accreditation organizations and approved State licensure programs.
7664. § 493.575 Removal of deeming authority or CLIA exemption and final determination review.
7665. Subpart F General Administration
7666. § 493.602 Scope of subpart.
7667. § 493.606 Applicability of subpart.
7668. § 493.638 Certificate fees.
7669. § 493.639 Fees for revised and replacement certificates.
7670. § 493.643 Additional fees applicable to laboratories issued a certificate of compliance.
7671. § 493.645 Additional fees applicable to laboratories issued a certificate of accreditation, certificate of waiver, or certificate for PPM procedures.
7672. § 493.649 Additional fees applicable to approved State laboratory programs.
7673. § 493.655 Payment of fees.
7674. § 493.680 Methodology for determining the biennial fee increase.
7675. G Subpart G [Reserved]
7676. Subpart H Participation in Proficiency Testing for Laboratories Performing Nonwaived Testing
7677. § 493.801 Condition: Enrollment and testing of samples.
7678. § 493.803 Condition: Successful participation.
7679. § 493.807 Condition: Reinstatement of laboratories performing nonwaived testing.
7680. 36 Proficiency Testing by Specialty and Subspecialty for Laboratories Performing Tests of Moderate Complexity (Including the Subcategory), High Complexity, or Any Combination of These Tests
7681. § 493.821 Condition: Microbiology.
7682. § 493.823 Standard; Bacteriology.
7683. § 493.825 Standard; Mycobacteriology.
7684. § 493.827 Standard; Mycology.
7685. § 493.829 Standard; Parasitology.
7686. § 493.831 Standard; Virology.
7687. § 493.833 Condition: Diagnostic immunology.
7688. § 493.835 Standard; Syphilis serology.
7689. § 493.837 Standard; General immunology.
7690. § 493.839 Condition: Chemistry.
7691. § 493.841 Standard; Routine chemistry.
7692. § 493.843 Standard; Endocrinology.
7693. § 493.845 Standard; Toxicology.
7694. § 493.849 Condition: Hematology.
7695. § 493.851 Standard; Hematology.
7696. § 493.853 Condition: Pathology.
7697. § 493.855 Standard; Cytology: gynecologic examinations.
7698. § 493.857 Condition: Immunohematology.
7699. § 493.859 Standard; ABO group and D (Rho) typing.
7700. § 493.861 Standard; Unexpected antibody detection.
7701. § 493.863 Standard; Compatibility testing.
7702. § 493.865 Standard; Antibody identification.
7703. Subpart I Proficiency Testing Programs for Nonwaived Testing
7704. § 493.901 Approval of proficiency testing programs.
7705. § 493.903 Administrative responsibilities.
7706. § 493.905 Nonapproved proficiency testing programs.
7707. 37 Proficiency Testing Programs by Specialty and Subspecialty
7708. § 493.909 Microbiology.
7709. § 493.911 Bacteriology.
7710. § 493.913 Mycobacteriology.
7711. § 493.915 Mycology.
7712. § 493.917 Parasitology.
7713. § 493.919 Virology.
7714. § 493.921 Diagnostic immunology.
7715. § 493.923 Syphilis serology.
7716. § 493.927 General immunology.
7717. § 493.929 Chemistry.
7718. § 493.931 Routine chemistry.
7719. § 493.933 Endocrinology.
7720. § 493.937 Toxicology.
7721. § 493.941 Hematology (including routine hematology and coagulation).
7722. § 493.945 Cytology; gynecologic examinations.
7723. § 493.959 Immunohematology.
7724. Subpart J Facility Administration for Nonwaived Testing
7725. § 493.1100 Condition: Facility administration.
7726. § 493.1101 Standard: Facilities.
7727. § 493.1103 Standard: Requirements for transfusion services.
7728. § 493.1105 Standard: Retention requirements.
7729. Subpart K Quality System for Nonwaived Testing
7730. § 493.1200 Introduction.
7731. § 493.1201 Condition: Bacteriology.
7732. § 493.1202 Condition: Mycobacteriology.
7733. § 493.1203 Condition: Mycology.
7734. § 493.1204 Condition: Parasitology.
7735. § 493.1205 Condition: Virology.
7736. § 493.1207 Condition: Syphilis serology.
7737. § 493.1208 Condition: General immunology.
7738. § 493.1210 Condition: Routine chemistry.
7739. § 493.1211 Condition: Urinalysis.
7740. § 493.1212 Condition: Endocrinology.
7741. § 493.1213 Condition: Toxicology.
7742. § 493.1215 Condition: Hematology.
7743. § 493.1217 Condition: Immunohematology.
7744. § 493.1219 Condition: Histopathology.
7745. § 493.1220 Condition: Oral pathology.
7746. § 493.1221 Condition: Cytology.
7747. § 493.1225 Condition: Clinical cytogenetics.
7748. § 493.1226 Condition: Radiobioassay.
7749. § 493.1227 Condition: Histocompatibility.
7750. 38 General Laboratory Systems
7751. § 493.1230 Condition: General laboratory systems.
7752. § 493.1231 Standard: Confidentiality of patient information.
7753. § 493.1232 Standard: Specimen identification and integrity.
7754. § 493.1233 Standard: Complaint investigations.
7755. § 493.1234 Standard: Communications.
7756. § 493.1235 Standard: Personnel competency assessment policies.
7757. § 493.1236 Standard: Evaluation of proficiency testing performance.
7758. § 493.1239 Standard: General laboratory systems quality assessment.
7759. 39 Preanalytic Systems
7760. § 493.1240 Condition: Preanalytic systems.
7761. § 493.1241 Standard: Test request.
7762. § 493.1242 Standard: Specimen submission, handling, and referral.
7763. § 493.1249 Standard: Preanalytic systems quality assessment.
7764. 40 Analytic Systems
7765. § 493.1250 Condition: Analytic systems.
7766. § 493.1251 Standard: Procedure manual.
7767. § 493.1252 Standard: Test systems, equipment, instruments, reagents, materials, and supplies.
7768. § 493.1253 Standard: Establishment and verification of performance specifications.
7769. § 493.1254 Standard: Maintenance and function checks.
7770. § 493.1255 Standard: Calibration and calibration verification procedures.
7771. § 493.1256 Standard: Control procedures.
7772. § 493.1261 Standard: Bacteriology.
7773. § 493.1262 Standard: Mycobacteriology.
7774. § 493.1263 Standard: Mycology.
7775. § 493.1264 Standard: Parasitology.
7776. § 493.1265 Standard: Virology.
7777. § 493.1267 Standard: Routine chemistry.
7778. § 493.1269 Standard: Hematology.
7779. § 493.1271 Standard: Immunohematology.
7780. § 493.1273 Standard: Histopathology.
7781. § 493.1274 Standard: Cytology.
7782. § 493.1276 Standard: Clinical cytogenetics.
7783. § 493.1278 Standard: Histocompatibility.
7784. § 493.1281 Standard: Comparison of test results.
7785. § 493.1282 Standard: Corrective actions.
7786. § 493.1283 Standard: Test records.
7787. § 493.1289 Standard: Analytic systems quality assessment.
7788. 41 Postanalytic Systems
7789. § 493.1290 Condition: Postanalytic systems.
7790. § 493.1291 Standard: Test report.
7791. § 493.1299 Standard: Postanalytic systems quality assessment.
7792. L Subpart L [Reserved]
7793. Subpart M Personnel for Nonwaived Testing
7794. § 493.1351 General.
7795. 42 Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
7796. § 493.1353 Scope.
7797. § 493.1355 Condition: Laboratories performing PPM procedures; laboratory director.
7798. § 493.1357 Standard; laboratory director qualifications.
7799. § 493.1359 Standard; PPM laboratory director responsibilities.
7800. § 493.1361 Condition: Laboratories performing PPM procedures; testing personnel.
7801. § 493.1363 Standard: PPM testing personnel qualifications.
7802. § 493.1365 Standard; PPM testing personnel responsibilities.
7803. 43 Laboratories Performing Moderate Complexity Testing
7804. § 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director.
7805. § 493.1405 Standard; Laboratory director qualifications.
7806. § 493.1407 Standard; Laboratory director responsibilities.
7807. § 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant.
7808. § 493.1411 Standard; Technical consultant qualifications.
7809. § 493.1413 Standard; Technical consultant responsibilities.
7810. § 493.1415 Condition: Laboratories performing moderate complexity testing; clinical consultant.
7811. § 493.1417 Standard; Clinical consultant qualifications.
7812. § 493.1419 Standard; Clinical consultant responsibilities.
7813. § 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel.
7814. § 493.1423 Standard; Testing personnel qualifications.
7815. § 493.1425 Standard; Testing personnel responsibilities.
7816. 44 Laboratories Performing High Complexity Testing
7817. § 493.1441 Condition: Laboratories performing high complexity testing; laboratory director.
7818. § 493.1443 Standard; Laboratory director qualifications.
7819. § 493.1445 Standard; Laboratory director responsibilities.
7820. § 493.1447 Condition: Laboratories performing high complexity testing; technical supervisor.
7821. § 493.1449 Standard; Technical supervisor qualifications.
7822. § 493.1451 Standard: Technical supervisor responsibilities.
7823. § 493.1453 Condition: Laboratories performing high complexity testing; clinical consultant.
7824. § 493.1455 Standard; Clinical consultant qualifications.
7825. § 493.1457 Standard; Clinical consultant responsibilities.
7826. § 493.1459 Condition: Laboratories performing high complexity testing; general supervisor.
7827. § 493.1461 Standard: General supervisor qualifications.
7828. § 493.1463 Standard: General supervisor responsibilities.
7829. § 493.1467 Condition: Laboratories performing high complexity testing; cytology general supervisor.
7830. § 493.1469 Standard: Cytology general supervisor qualifications.
7831. § 493.1471 Standard: Cytology general supervisor responsibilities.
7832. § 493.1481 Condition: Laboratories performing high complexity testing; cytotechnologist.
7833. § 493.1483 Standard: Cytotechnologist qualifications.
7834. § 493.1485 Standard; Cytotechnologist responsibilities.
7835. § 493.1487 Condition: Laboratories performing high complexity testing; testing personnel.
7836. § 493.1489 Standard; Testing personnel qualifications.
7837. § 493.1495 Standard; Testing personnel responsibilities.
7838. N Subparts N-P [Reserved]
7839. Subpart Q Inspection
7840. § 493.1771 Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories.
7841. § 493.1773 Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories.
7842. § 493.1775 Standard: Inspection of laboratories issued a certificate of waiver or a certificate for provider-performed microscopy procedures.
7843. § 493.1777 Standard: Inspection of laboratories that have requested or have been issued a certificate of compliance.
7844. § 493.1780 Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
7845. Subpart R Enforcement Procedures
7846. § 493.1800 Basis and scope.
7847. § 493.1804 General considerations.
7848. § 493.1806 Available sanctions: All laboratories.
7849. § 493.1807 Additional sanctions: Laboratories that participate in Medicare.
7850. § 493.1808 Adverse action on any type of CLIA certificate: Effect on Medicare approval.
7851. § 493.1809 Limitation on Medicaid payment.
7852. § 493.1810 Imposition and lifting of alternative sanctions.
7853. § 493.1812 Action when deficiencies pose immediate jeopardy.
7854. § 493.1814 Action when deficiencies are at the condition level but do not pose immediate jeopardy.
7855. § 493.1816 Action when deficiencies are not at the condition level.
7856. § 493.1820 Ensuring timely correction of deficiencies.
7857. § 493.1826 Suspension of part of Medicare payments.
7858. § 493.1828 Suspension of all Medicare payments.
7859. § 493.1832 Directed plan of correction and directed portion of a plan of correction.
7860. § 493.1834 Civil money penalty.
7861. § 493.1836 State onsite monitoring.
7862. § 493.1838 Training and technical assistance for unsuccessful participation in proficiency testing.
7863. § 493.1840 Suspension, limitation, or revocation of any type of CLIA certificate.
7864. § 493.1842 Cancellation of Medicare approval.
7865. § 493.1844 Appeals procedures.
7866. § 493.1846 Civil action.
7867. § 493.1850 Laboratory registry.
7868. S Subpart S [Reserved]
7869. Subpart T Consultations
7870. § 493.2001 Establishment and function of the Clinical Laboratory Improvement Advisory Committee.
7871. PART 494 CONDITIONS FOR COVERAGE FOR END-STAGE RENAL DISEASE FACILITIES
7872. Subpart A General Provisions
7873. § 494.1 Basis and scope.
7874. § 494.10 Definitions.
7875. § 494.20 Condition: Compliance with Federal, State, and local laws and regulations.
7876. Subpart B Patient Safety
7877. § 494.30 Condition: Infection control.
7878. § 494.40 Condition: Water and dialysate quality.
7879. § 494.50 Condition: Reuse of hemodialyzers and bloodlines.
7880. § 494.60 Condition: Physical environment.
7881. § 494.62 Condition of participation: Emergency preparedness.
7882. Subpart C Patient Care
7883. § 494.70 Condition: Patients' rights.
7884. § 494.80 Condition: Patient assessment.
7885. § 494.90 Condition: Patient plan of care.
7886. § 494.100 Condition: Care at home.
7887. § 494.110 Condition: Quality assessment and performance improvement.
7888. § 494.120 Condition: Special purpose renal dialysis facilities.
7889. § 494.130 Condition: Laboratory services.
7890. Subpart D Administration
7891. § 494.140 Condition: Personnel qualifications.
7892. § 494.150 Condition: Responsibilities of the medical director.
7893. § 494.160 [Reserved]
7894. § 494.170 Condition: Medical records.
7895. § 494.180 Condition: Governance.
7896. PART 495 STANDARDS FOR THE ELECTRONIC HEALTH RECORD TECHNOLOGY INCENTIVE PROGRAM
7897. Subpart A General Provisions
7898. § 495.2 Basis and purpose.
7899. § 495.4 Definitions.
7900. § 495.5 Requirements for EPs seeking to reverse a hospital-based determination under § 495.4.
7901. § 495.20 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs before 2015.
7902. § 495.22 Meaningful use objectives and measures for EPs, eligible hospitals, and CAHs for 2015 through 2018.
7903. § 495.24 Stage 3 meaningful use objectives and measures for EPs, eligible hospitals and CAHs for 2019 and subsequent years.
7904. § 495.40 Demonstration of meaningful use criteria.
7905. § 495.60 Participation requirements for EPs, eligible hospitals, and CAHs.
7906. Subpart B Requirements Specific to the Medicare Program
7907. § 495.100 Definitions.
7908. § 495.102 Incentive payments to EPs.
7909. § 495.104 Incentive payments to eligible hospitals.
7910. § 495.106 Incentive payments to CAHs.
7911. § 495.108 Posting of required information.
7912. § 495.110 Preclusion on administrative and judicial review.
7913. Subpart C Requirements Specific to Medicare Advantage (MA) Organizations
7914. § 495.200 Definitions.
7915. § 495.202 Identification of qualifying MA organizations, MA-EPs and MA-affiliated eligible hospitals.
7916. § 495.204 Incentive payments to qualifying MA organizations for qualifying MA-EPs and qualifying MA-affiliated eligible hospitals.
7917. § 495.206 Timeframe for payment to qualifying MA organizations.
7918. § 495.208 Avoiding duplicate payment.
7919. § 495.210 Meaningful EHR user attestation.
7920. § 495.211 Payment adjustments effective for 2015 and subsequent MA payment years with respect to MA EPs and MA-affiliated eligible hospitals.
7921. § 495.212 Limitation on review.
7922. Subpart D Requirements Specific to the Medicaid Program
7923. § 495.300 Basis and purpose.
7924. § 495.302 Definitions.
7925. § 495.304 Medicaid provider scope and eligibility.
7926. § 495.306 Establishing patient volume.
7927. § 495.308 Net average allowable costs as the basis for determining the incentive payment.
7928. § 495.310 Medicaid provider incentive payments.
7929. § 495.312 Process for payments.
7930. § 495.314 Activities required to receive an incentive payment.
7931. § 495.316 State monitoring and reporting regarding activities required to receive an incentive payment.
7932. § 495.318 State responsibilities for receiving FFP.
7933. § 495.320 FFP for payments to Medicaid providers.
7934. § 495.322 FFP for reasonable administrative expenses.
7935. § 495.324 Prior approval conditions.
7936. § 495.326 Disallowance of FFP.
7937. § 495.328 Request for reconsideration of adverse determination.
7938. § 495.330 Termination of FFP for failure to provide access to information.
7939. § 495.332 State Medicaid health information technology (HIT) plan requirements.
7940. § 495.334 [Reserved]
7941. § 495.336 Health information technology planning advance planning document requirements (HIT PAPD).
7942. § 495.338 Health information technology implementation advance planning document requirements (HIT IAPD).
7943. § 495.340 As-needed HIT PAPD update and as-needed HIT IAPD update requirements.
7944. § 495.342 Annual HIT IAPD requirements.
7945. § 495.344 Approval of the State Medicaid HIT plan, the HIT PAPD and update, the HIT IAPD and update, and the annual HIT IAPD.
7946. § 495.346 Access to systems and records.
7947. § 495.348 Procurement standards.
7948. § 495.350 State Medicaid agency attestations.
7949. § 495.352 Reporting requirements.
7950. § 495.354 Rules for charging equipment.
7951. § 495.356 Nondiscrimination requirements.
7952. § 495.358 Cost allocation plans.
7953. § 495.360 Software and ownership rights.
7954. § 495.362 Retroactive approval of FFP with an effective date of February 18, 2009.
7955. § 495.364 Review and assessment of administrative activities and expenses of Medicaid provider health information technology adoption and operation.
7956. § 495.366 Financial oversight and monitoring of expenditures.
7957. § 495.368 Combating fraud and abuse.
7958. § 495.370 Appeals process for a Medicaid provider receiving electronic health record incentive payments.
7959. PART 498 APPEALS PROCEDURES FOR DETERMINATIONS THAT AFFECT PARTICIPATION IN THE MEDICARE PROGRAM AND FOR DETERMINATIONS THAT AFFECT THE PARTICIPATION OF ICFs/IID AND CERTAIN NFs IN THE MEDICAID PROGRAM
7960. Subpart A General Provisions
7961. § 498.1 Statutory basis.
7962. § 498.2 Definitions.
7963. § 498.3 Scope and applicability.
7964. § 498.4 NFs subject to appeals process in part 498.
7965. § 498.5 Appeal rights.
7966. § 498.10 Appointment of representatives.
7967. § 498.11 Authority of representatives.
7968. § 498.13 Fees for services of representatives.
7969. § 498.15 Charge for transcripts.
7970. § 498.17 Filing of briefs with the ALJ or Departmental Appeals Board, and opportunity for rebuttal.
7971. Subpart B Initial, Reconsidered, and Revised Determinations
7972. § 498.20 Notice and effect of initial determinations.
7973. § 498.22 Reconsideration.
7974. § 498.23 Withdrawal of request for reconsideration.
7975. § 498.24 Reconsidered determination.
7976. § 498.25 Notice and effect of reconsidered determination.
7977. Subpart C Reopening of Initial or Reconsidered Determinations
7978. § 498.30 Limitation on reopening.
7979. § 498.32 Notice and effect of reopening and revision.
7980. Subpart D Hearings
7981. § 498.40 Request for hearing.
7982. § 498.42 Parties to the hearing.
7983. § 498.44 Designation of hearing official.
7984. § 498.45 Disqualification of Administrative Law Judge.
7985. § 498.47 Prehearing conference.
7986. § 498.48 Notice of prehearing conference.
7987. § 498.49 Conduct of prehearing conference.
7988. § 498.50 Record, order, and effect of prehearing conference.
7989. § 498.52 Time and place of hearing.
7990. § 498.53 Change in time and place of hearing.
7991. § 498.54 Joint hearings.
7992. § 498.56 Hearing on new issues.
7993. § 498.58 Subpoenas.
7994. § 498.60 Conduct of hearing.
7995. § 498.61 Evidence.
7996. § 498.62 Witnesses.
7997. § 498.63 Oral and written summation.
7998. § 498.64 Record of hearing.
7999. § 498.66 Waiver of right to appear and present evidence.
8000. § 498.68 Dismissal of request for hearing.
8001. § 498.69 Dismissal for abandonment.
8002. § 498.70 Dismissal for cause.
8003. § 498.71 Notice and effect of dismissal and right to request review.
8004. § 498.72 Vacating a dismissal of request for hearing.
8005. § 498.74 Administrative Law Judge's decision.
8006. § 498.76 Removal of hearing to Departmental Appeals Board.
8007. § 498.78 Remand by the Administrative Law Judge.
8008. § 498.79 Timeframes for deciding an enrollment appeal before an ALJ.
8009. Subpart E Departmental Appeals Board Review
8010. § 498.80 Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
8011. § 498.82 Request for Departmental Appeals Board review.
8012. § 498.83 Departmental Appeals Board action on request for review.
8013. § 498.85 Procedures before the Departmental Appeals Board on review.
8014. § 498.86 Evidence admissible on review.
8015. § 498.88 Decision or remand by the Departmental Appeals Board.
8016. § 498.90 Effect of Departmental Appeals Board decision.
8017. § 498.95 Extension of time for seeking judicial review.
8018. Subpart F Reopening of Decisions Made by Administrative Law Judges or the Departmental Appeals Board
8019. § 498.100 Basis, timing, and authority for reopening an ALJ or Board decision.
8020. § 498.102 Revision of reopened decision.
8021. § 498.103 Notice and effect of revised decision.
8022. SUBCHAPTER H HEALTH CARE INFRASTRUCTURE AND MODEL PROGRAMS
8023. PART 505 ESTABLISHMENT OF THE HEALTH CARE INFRASTRUCTURE IMPROVEMENT PROGRAM
8024. Subpart A Loan Criteria
8025. § 505.1 Basis and scope.
8026. § 505.3 Definitions.
8027. § 505.5 Loan criteria.
8028. § 505.7 Terms of the loan.
8029. § 505.9 State and local permits.
8030. § 505.11 Loan application requirements and procedures.
8031. Subpart B Forgiveness of Indebtedness
8032. § 505.13 Conditions for loan forgiveness.
8033. § 505.15 Plan criteria for meeting the conditions for loan forgiveness.
8034. § 505.17 Reporting requirements for meeting the conditions for loan forgiveness.
8035. § 505.19 Approval or denial of loan forgiveness.
8036. PART 510 COMPREHENSIVE CARE FOR JOINT REPLACEMENT MODEL
8037. Subpart A General Provisions
8038. § 510.1 Basis and scope.
8039. § 510.2 Definitions.
8040. Subpart B Comprehensive Care for Joint Replacement Program Participants
8041. § 510.100 Episodes being tested.
8042. § 510.105 Geographic areas.
8043. § 510.110 Access to records and retention.
8044. § 510.115 Voluntary participation election.
8045. § 510.120 CJR participant hospital CEHRT track requirements.
8046. Subpart C Scope of Episodes
8047. § 510.200 Time periods, included and excluded services, and attribution.
8048. § 510.205 Beneficiary inclusion criteria.
8049. § 510.210 Determination of the episode.
8050. Subpart D Pricing and Payment
8051. § 510.300 Determination of episode quality-adjusted target prices.
8052. § 510.301 Determination of reconciliation target prices.
8053. § 510.305 Determination of the NPRA and reconciliation process.
8054. § 510.310 Appeals process.
8055. § 510.315 Composite quality scores for determining reconciliation payment eligibility and quality incentive payments.
8056. § 510.320 Treatment of incentive programs or add-on payments under existing Medicare payment systems.
8057. § 510.325 Allocation of payments for services that straddle the episode.
8058. Subpart E Quality Measures, Beneficiary Protections, and Compliance Enforcement
8059. § 510.400 Quality measures and reporting.
8060. § 510.405 Beneficiary choice and beneficiary notification.
8061. § 510.410 Compliance enforcement.
8062. Subpart F Financial Arrangements and Beneficiary Incentives
8063. § 510.500 Sharing arrangements under the CJR model.
8064. § 510.505 Distribution arrangements.
8065. § 510.506 Downstream distribution arrangements.
8066. § 510.510 Enforcement authority.
8067. § 510.515 Beneficiary incentives under the CJR model.
8068. Subpart G Waivers
8069. § 510.600 Waiver of direct supervision requirement for certain post-discharge home visits.
8070. § 510.605 Waiver of certain telehealth requirements.
8071. § 510.610 Waiver of SNF 3-day rule.
8072. § 510.615 Waiver of certain post-operative billing restrictions.
8073. § 510.620 Waiver of deductible and coinsurance that otherwise apply to reconciliation payments or repayments.
8074. H Subparts H-J [Reserved]
8075. Subpart K Model Termination
8076. § 510.900 Termination of the CJR model.
8077. PART 512 STANDARD PROVISIONS FOR MANDATORY INNOVATION CENTER MODELS AND SPECIFIC PROVISIONS FOR CERTAIN MODELS
8078. Subpart A Standard Provisions for Mandatory Innovation Center Models
8079. § 512.100 Basis and scope.
8080. § 512.110 Definitions.
8081. § 512.120 Beneficiary protections.
8082. § 512.130 Cooperation in model evaluation and monitoring.
8083. § 512.135 Audits and record retention.
8084. § 512.140 Rights in data and intellectual property.
8085. § 512.150 Monitoring and compliance.
8086. § 512.160 Remedial action.
8087. § 512.165 Innovation center model termination by CMS.
8088. § 512.170 Limitations on review.
8089. § 512.180 Miscellaneous provisions on bankruptcy and other notifications.
8090. § 512.190 Reconsideration review process.
8091. Subpart B Radiation Oncology Model
8092. 88 General
8093. § 512.200 Basis and scope of subpart.
8094. § 512.205 Definitions.
8095. 89 RO Model Participation
8096. § 512.210 RO participants and geographic areas.
8097. § 512.215 Beneficiary population.
8098. § 512.217 Identification of individual practitioners.
8099. § 512.220 RO participant compliance with RO Model requirements.
8100. § 512.225 Beneficiary notification.
8101. 90 Scope of RO Episodes Being Tested
8102. § 512.230 Criteria for determining cancer types.
8103. § 512.235 Included RT services.
8104. § 512.240 Included modalities.
8105. § 512.245 Included RO episodes.
8106. 91 Pricing Methodology
8107. § 512.250 Determination of national base rates.
8108. § 512.255 Determination of participant-specific professional episode payment and participant-specific technical episode payment amounts.
8109. 92 Billing and Payment
8110. § 512.260 Billing.
8111. § 512.265 Payment.
8112. § 512.270 Treatment of add-on payments under existing Medicare payment systems.
8113. 93 Data Reporting
8114. § 512.275 Quality measures, clinical data, and reporting.
8115. 94 Medicare Program Waivers
8116. § 512.280 RO Model Medicare program waivers.
8117. 95 Reconciliation and Review Process
8118. § 512.285 Reconciliation process.
8119. § 512.290 Timely error notice and reconsideration review process.
8120. § 512.292 Overlap with other models tested under Section 1115A and CMS programs.
8121. § 512.294 Extreme and uncontrollable circumstances.
8122. Subpart C ESRD Treatment Choices Model
8123. 96 General
8124. § 512.300 Basis and scope.
8125. § 512.310 Definitions.
8126. 97 ESRD Treatment Choices Model Scope and Participants
8127. § 512.320 Duration.
8128. § 512.325 Participant selection and geographic areas.
8129. § 512.330 Beneficiary notification.
8130. 98 Home Dialysis Payment Adjustment
8131. § 512.340 Payments subject to the Facility HDPA.
8132. § 512.345 Payments subject to the Clinician HDPA.
8133. § 512.350 Schedule of home dialysis payment adjustments.
8134. 99 Performance Payment Adjustment
8135. § 512.355 Schedule of performance assessment and performance payment adjustment.
8136. § 512.360 Beneficiary population and attribution.
8137. § 512.365 Performance assessment.
8138. § 512.370 Benchmarking and scoring.
8139. § 512.375 Payments subject to adjustment.
8140. § 512.380 PPA Amounts and schedules.
8141. § 512.385 PPA exclusions.
8142. § 512.390 Notification, data sharing, and targeted review.
8143. 100 Quality Monitoring
8144. § 512.395 Quality measures.
8145. 101 Medicare Program Waivers
8146. § 512.397 ETC Model Medicare program waivers and additional flexibilities.
8147. Subpart D Increasing Organ Transplant Access (IOTA) Model
8148. § 512.400 Basis and scope.
8149. § 512.402 Definitions.
8150. 102 Increasing Organ Transplant Access Model Scope and Participation
8151. § 512.412 Participant eligibility and selection.
8152. § 512.414 Patient population.
8153. 103 Performance Assessment and Scoring
8154. § 512.422 Overview of performance assessment and scoring.
8155. § 512.424 Achievement domain.
8156. § 512.426 Efficiency domain.
8157. § 512.428 Quality domain.
8158. 104 Payment
8159. § 512.430 Upside risk payment, downside risk payment, and neutral zone.
8160. § 512.434 Targeted review.
8161. § 512.436 Extreme and uncontrollable circumstances.
8162. 105 Data Sharing
8163. § 512.440 Data sharing.
8164. § 512.442 Transparency requirements.
8165. 106 Beneficiary Protections and Financial Arrangements, Beneficiary Incentives, and Compliance
8166. § 512.450 Required beneficiary notifications.
8167. § 512.452 Financial sharing arrangements and attributed patient engagement incentives.
8168. § 512.454 Distribution arrangements.
8169. § 512.455 Enforcement authority.
8170. § 512.456 Beneficiary incentive: Part B and Part D immunosuppressive drug cost sharing support.
8171. § 512.458 Attributed patient engagement incentives.
8172. § 512.459 Application of the CMS-sponsored model arrangements and patient incentives safe harbor.
8173. § 512.460 Audit rights and records retention.
8174. § 512.462 Compliance and monitoring.
8175. § 512.464 Remedial action.
8176. § 512.466 Termination.
8177. § 512.468 Bankruptcy and other notifications.
8178. 107 Waivers
8179. § 512.470 Waivers.
8180. Subpart E Transforming Episode Accountability Model (TEAM)
8181. 108 General
8182. § 512.500 Basis and scope of subpart.
8183. § 512.505 Definitions.
8184. 109 TEAM Participation
8185. § 512.508 Mandatory participation.
8186. § 512.510 Voluntary opt-in participation.
8187. § 512.515 Geographic areas.
8188. § 512.520 Participation tracks.
8189. § 512.522 APM options.
8190. 110 Scope of Episodes Being Tested
8191. § 512.525 Episodes.
8192. § 512.535 Beneficiary inclusion criteria.
8193. § 512.537 Determination of the episode.
8194. 111 Pricing Methodology
8195. § 512.540 Determination of preliminary target prices.
8196. § 512.545 Determination of reconciliation target prices.
8197. 112 Quality Measures and Composite Quality Score
8198. § 512.547 Quality measures, composite quality score, and display of quality measures.
8199. 113 Reconciliation and Review Process
8200. § 512.550 Reconciliation process and determination of the reconciliation payment or repayment amount.
8201. § 512.552 Treatment of incentive programs or add-on payments under existing Medicare payment systems.
8202. § 512.555 Proration of payments for services that extend beyond an episode.
8203. § 512.560 Appeals process.
8204. § 512.561 Reconsideration review processes.
8205. 114 Data Sharing and Other Requirements
8206. § 512.562 Data sharing with TEAM participants.
8207. § 512.563 Health data reporting.
8208. § 512.564 Referral to primary care services.
8209. 115 Financial Arrangements and Beneficiary Incentives
8210. § 512.565 Sharing arrangements.
8211. § 512.568 Distribution arrangements.
8212. § 512.570 Downstream distribution arrangements.
8213. § 512.575 TEAM beneficiary incentives.
8214. § 512.576 Application of the CMS-sponsored model arrangements and patient incentives safe harbor.
8215. 116 Medicare Program Waivers
8216. § 512.580 TEAM Medicare Program Waivers.
8217. 117 General Provisions
8218. § 512.582 Beneficiary protections.
8219. § 512.584 Cooperation in model evaluation and monitoring.
8220. § 512.586 Audits and record retention.
8221. § 512.588 Rights in data and intellectual property.
8222. § 512.590 Monitoring and compliance.
8223. § 512.592 Remedial action.
8224. § 512.594 Limitations on review.
8225. § 512.595 Bankruptcy and other notifications.
8226. § 512.596 Termination of TEAM or TEAM participant from model by CMS.
8227. Subpart F Comprehensive Care For Joint Replacement Expanded (CJR-X) Model
8228. 118 General
8229. § 512.600 Basis and scope of subpart.
8230. § 512.605 Definitions.
8231. 119 CJR-X Participation
8232. § 512.610 Mandatory participation.
8233. § 512.615 CJR-X APM options.
8234. 120 Beneficiary Population
8235. § 512.620 Beneficiary inclusion criteria.
8236. § 512.622 Beneficiary notifications.
8237. 121 Episode of Care
8238. § 512.625 Scope of episode.
8239. § 512.630 Determination of the episode.
8240. 122 Quality Measures and Composite Quality Score
8241. § 512.635 Quality measures, composite quality score, and display of quality measures.
8242. 123 Pricing Methodology
8243. § 512.640 Determination of preliminary target prices.
8244. § 512.645 Determination of reconciliation target prices.
8245. § 512.650 Reconciliation process and determination of the reconciliation payment or repayment amount.
8246. § 512.652 Treatment of incentive programs or add-on payments under existing Medicare payment systems.
8247. § 512.655 Proration of payments for items and services that extend beyond an episode.
8248. § 512.660 Appeals process.
8249. 124 Data Sharing
8250. § 512.665 Data sharing with CJR-X participants.
8251. 125 Financial Arrangements and Beneficiary Incentives
8252. § 512.670 Sharing arrangements.
8253. § 512.675 Distribution arrangements.
8254. § 512.680 Downstream distribution arrangements.
8255. § 512.685 CJR-X beneficiary incentives.
8256. § 512.690 Application of the CMS-sponsored Model Arrangements and Patient Incentives Safe Harbor.
8257. 126 Medicare Program Waivers
8258. § 512.695 CJR-X Medicare Program Waivers.
8259. Subpart G Ambulatory Specialty Model (ASM)
8260. 127 General
8261. § 512.700 Basis and scope of subpart.
8262. § 512.705 Definitions.
8263. § 512.710 Participant eligibility and selection.
8264. 128 Performance Categories and Scoring
8265. § 512.715 Overview of performance assessment.
8266. § 512.720 Data submission requirements.
8267. § 512.725 Quality ASM performance category.
8268. § 512.730 Cost ASM performance category.
8269. § 512.735 Improvement activities ASM performance category.
8270. § 512.740 Promoting Interoperability ASM performance category.
8271. § 512.745 Final scoring.
8272. 129 Payment and Timely Error Notice Process
8273. § 512.750 Payment adjustment.
8274. § 512.755 Timely error notice process.
8275. 130 Data Sharing, Waivers, Safe Harbor, and Compliance
8276. § 512.760 Data sharing with ASM participants.
8277. § 512.765 Application of the CMS-sponsored model arrangements and patient incentives safe harbor.
8278. § 512.770 ASM beneficiary incentives.
8279. § 512.771 Collaborative care arrangements.
8280. § 512.775 Medicare program waivers.
8281. § 512.780 Extreme and uncontrollable circumstances.
8282. PART 513 XXX
8283. SUBCHAPTER I BASIC HEALTH PROGRAM
8284. PART 600 ADMINISTRATION, ELIGIBILITY, ESSENTIAL HEALTH BENEFITS, PERFORMANCE STANDARDS, SERVICE DELIVERY REQUIREMENTS, PREMIUM AND COST SHARING, ALLOTMENTS, AND RECONCILATION
8285. Subpart A General Provisions and Definitions
8286. § 600.1 Scope.
8287. § 600.5 Definitions and use of terms.
8288. Subpart B Establishment and Certification of State Basic Health Programs
8289. § 600.100 Program description.
8290. § 600.105 Basis, scope, and applicability of subpart B.
8291. § 600.110 BHP Blueprint.
8292. § 600.115 Development and submission of the BHP Blueprint.
8293. § 600.120 Certification of a BHP Blueprint.
8294. § 600.125 Revisions to a certified BHP Blueprint.
8295. § 600.130 Withdrawal of a BHP Blueprint prior to implementation.
8296. § 600.135 Notice and timing of HHS action on an initial BHP Blueprint submission.
8297. § 600.140 State termination of a BHP.
8298. § 600.142 HHS withdrawal of certification and termination of a BHP.
8299. § 600.145 State program administration and operation.
8300. § 600.150 Enrollment assistance and information requirements.
8301. § 600.155 Tribal consultation.
8302. § 600.160 Protections for American Indian and Alaska Natives.
8303. § 600.165 Nondiscrimination standards.
8304. § 600.170 Annual report content and timing.
8305. Subpart C Federal Program Administration
8306. § 600.200 Federal program compliance reviews and audits.
8307. Subpart D Eligibility and Enrollment
8308. § 600.300 Basis, scope, and applicability.
8309. § 600.305 Eligible individuals.
8310. § 600.310 Application.
8311. § 600.315 Certified application counselors.
8312. § 600.320 Determination of eligibility for and enrollment in a standard health plan.
8313. § 600.330 Coordination with other insurance affordability programs.
8314. § 600.335 Appeals.
8315. § 600.340 Periodic redetermination and renewal of BHP eligibility.
8316. § 600.345 Eligibility verification.
8317. § 600.350 Privacy and security of information.
8318. Subpart E Standard Health Plan
8319. § 600.400 Basis, scope, and applicability.
8320. § 600.405 Standard health plan coverage.
8321. § 600.410 Competitive contracting process.
8322. § 600.415 Contracting qualifications and requirements.
8323. § 600.420 Enhanced availability of standard health plans.
8324. § 600.425 Coordination with other insurance affordability programs.
8325. Subpart F Enrollee Financial Responsibilities
8326. § 600.500 Basis, scope, and applicability.
8327. § 600.505 Premiums.
8328. § 600.510 Cost-sharing.
8329. § 600.515 Public schedule of enrollee premium and cost sharing.
8330. § 600.520 General cost-sharing protections.
8331. § 600.525 Disenrollment procedures and consequences for nonpayment of premiums.
8332. Subpart G Payment to States
8333. § 600.600 Basis, scope, and applicability.
8334. § 600.605 BHP payment methodology.
8335. § 600.610 Secretarial determination of BHP payment amount.
8336. § 600.615 Deposit of Federal BHP payment.
8337. Subpart H BHP Trust Fund
8338. § 600.700 Basis, scope, and applicability.
8339. § 600.705 BHP trust fund.
8340. § 600.710 Fiscal policies and accountability.
8341. § 600.715 Corrective action, restitution, and disallowance of questioned BHP transactions.
8342. 601-699 PARTS 601-699 [RESERVED]
8343. CHAPTER V OFFICE OF INSPECTOR GENERAL-HEALTH CARE, DEPARTMENT OF HEALTH AND HUMAN SERVICES
8344. SUBCHAPTER A GENERAL PROVISIONS
8345. PART 1000 INTRODUCTION; GENERAL DEFINITIONS
8346. A Subpart A [Reserved]
8347. Subpart B Definitions
8348. § 1000.10 General definitions.
8349. SUBCHAPTER B OIG AUTHORITIES
8350. PART 1001 PROGRAM INTEGRITY—MEDICARE AND STATE HEALTH CARE PROGRAMS
8351. Subpart A General Provisions
8352. § 1001.1 Scope and purpose.
8353. § 1001.2 Definitions.
8354. Subpart B Mandatory Exclusions
8355. § 1001.101 Basis for liability.
8356. § 1001.102 Length of exclusion.
8357. Subpart C Permissive Exclusions
8358. § 1001.201 Conviction relating to program or health care fraud.
8359. § 1001.301 Conviction relating to obstruction of an investigation or audit.
8360. § 1001.401 Conviction relating to controlled substances.
8361. § 1001.501 License revocation or suspension.
8362. § 1001.601 Exclusion or suspension under a Federal or State health care program.
8363. § 1001.701 Excessive claims or furnishing of unnecessary or substandard items and services.
8364. § 1001.801 Failure of HMOs and CMPs to furnish medically necessary items and services.
8365. § 1001.901 False or improper claims.
8366. § 1001.951 Fraud and kickbacks and other prohibited activities.
8367. § 1001.952 Exceptions.
8368. § 1001.1001 Exclusion of entities owned or controlled by a sanctioned person.
8369. § 1001.1101 Failure to disclose certain information.
8370. § 1001.1201 Failure to provide payment information.
8371. § 1001.1301 Failure to grant immediate access.
8372. § 1001.1401 Violations of PPS corrective action.
8373. § 1001.1501 Default of health education loan or scholarship obligations.
8374. § 1001.1551 Exclusion of individuals with ownership or control interest in sanctioned entities.
8375. § 1001.1552 Making false statements or misrepresentation of material facts.
8376. § 1001.1601 Violations of the limitations on physician charges.
8377. § 1001.1701 Billing for services of assistant at surgery during cataract operations.
8378. Appendix A Appendix A to Subpart C of Part 1001
8379. Subpart D Waivers and Effect of Exclusion
8380. § 1001.1801 Waivers of exclusions.
8381. § 1001.1901 Scope and effect of exclusion.
8382. Subpart E Notice and Appeals
8383. § 1001.2001 Notice of intent to exclude.
8384. § 1001.2002 Notice of exclusion.
8385. § 1001.2003 Notice of proposal to exclude.
8386. § 1001.2004 Notice to State agencies.
8387. § 1001.2005 Notice to State licensing agencies.
8388. § 1001.2006 Notice to others regarding exclusion.
8389. § 1001.2007 Appeal of exclusions.
8390. Subpart F Reinstatement into the Programs
8391. § 1001.3001 Timing and method of request for reinstatement.
8392. § 1001.3002 Basis for reinstatement.
8393. § 1001.3003 Approval of request for reinstatement.
8394. § 1001.3004 Denial of request for reinstatement.
8395. § 1001.3005 Withdrawal of exclusion for reversed or vacated decisions.
8396. PART 1002 PROGRAM INTEGRITY—STATE-INITIATED EXCLUSIONS FROM MEDICAID
8397. Subpart A General Provisions
8398. § 1002.1 Basis and scope.
8399. § 1002.2 Other applicable regulations.
8400. § 1002.3 General authority.
8401. § 1002.4 Disclosure by providers and State Medicaid agencies.
8402. § 1002.5 State plan requirement.
8403. § 1002.6 Payment prohibitions.
8404. Subpart B State Exclusion of Certain Managed Care Entities
8405. § 1002.203 State exclusion of certain managed care entities.
8406. Subpart C Procedures for State-Initiated Exclusions
8407. § 1002.210 General authority.
8408. § 1002.211 [Reserved]
8409. § 1002.212 State agency notifications.
8410. § 1002.213 Appeals of exclusions.
8411. § 1002.214 Basis for reinstatement after State agency-initiated exclusion.
8412. § 1002.215 Action on request for reinstatement.
8413. Subpart D Notification to OIG of State or Local Convictions of Crimes Against Medicaid
8414. § 1002.230 Notification of State or local convictions of crimes against Medicaid.
8415. PART 1003 CIVIL MONEY PENALTIES, ASSESSMENTS AND EXCLUSIONS
8416. Subpart A General Provisions
8417. § 1003.100 Basis and purpose.
8418. § 1003.110 Definitions.
8419. § 1003.120 Liability for penalties and assessments.
8420. § 1003.130 Assessments.
8421. § 1003.140 Determinations regarding the amount of penalties and assessments and the period of exclusion.
8422. § 1003.150 Delegation of authority.
8423. § 1003.160 Waiver of exclusion.
8424. Subpart B CMPs, Assessments, and Exclusions for False or Fraudulent Claims and Other Similar Misconduct
8425. § 1003.200 Basis for civil money penalties, assessments, and exclusions.
8426. § 1003.210 Amount of penalties and assessments.
8427. § 1003.220 Determinations regarding the amount of penalties and assessments and the period of exclusion.
8428. Subpart C CMPs, Assessments, and Exclusions for Anti-Kickback and Physician Self-Referral Violations
8429. § 1003.300 Basis for civil money penalties, assessments, and exclusions.
8430. § 1003.310 Amount of penalties and assessments.
8431. § 1003.320 Determinations regarding the amount of penalties and assessments and the period of exclusion.
8432. Subpart D CMPs and Assessments for Contracting Organization Misconduct
8433. § 1003.400 Basis for civil money penalties and assessments.
8434. § 1003.410 Amount of penalties and assessments for Contracting Organization.
8435. § 1003.420 Determinations regarding the amount of penalties and assessments.
8436. Subpart E CMPs and Exclusions for EMTALA Violations
8437. § 1003.500 Basis for civil money penalties and exclusions.
8438. § 1003.510 Amount of penalties.
8439. § 1003.520 Determinations regarding the amount of penalties and the period of exclusion.
8440. Subpart F CMPs for Section 1140 Violations
8441. § 1003.600 Basis for civil money penalties.
8442. § 1003.610 Amount of penalties.
8443. § 1003.620 Determinations regarding the amount of penalties.
8444. Subpart G CMPs, Assessments, and Exclusions for Fraud or False Claims or Similar Conduct Related to Grants, Contracts, and Other Agreements
8445. § 1003.700 Basis for civil money penalties, assessments, and exclusions.
8446. § 1003.710 Amount of penalties and assessments.
8447. § 1003.720 Determinations regarding the amount of penalties and assessments and period of exclusion.
8448. Subpart H CMPs for Adverse Action Reporting and Disclosure Violations
8449. § 1003.800 Basis for civil money penalties.
8450. § 1003.810 Amount of penalties.
8451. § 1003.820 Determinations regarding the amount of penalties.
8452. Subpart I CMPs for Select Agent Program Violations
8453. § 1003.900 Basis for civil money penalties.
8454. § 1003.910 Amount of penalties.
8455. § 1003.920 Determinations regarding the amount of penalties.
8456. Subpart J CMPs, Assessments, and Exclusions for Beneficiary Inducement Violations
8457. § 1003.1000 Basis for civil money penalties, assessments, and exclusions.
8458. § 1003.1010 Amount of penalties and assessments.
8459. § 1003.1020 Determinations regarding the amount of penalties and assessments and the period of exclusion.
8460. Subpart K CMPs for the Sale of Medicare Supplemental Policies
8461. § 1003.1100 Basis for civil money penalties.
8462. § 1003.1110 Amount of penalties.
8463. § 1003.1120 Determinations regarding the amount of penalties.
8464. Subpart L CMPs for Drug Price Reporting
8465. § 1003.1200 Basis for civil money penalties.
8466. § 1003.1210 Amount of penalties.
8467. § 1003.1220 Determinations regarding the amount of penalties.
8468. Subpart M CMPs for Notifying a Skilled Nursing Facility, Nursing Facility, Home Health Agency, or Community Care Setting of a Survey
8469. § 1003.1300 Basis for civil money penalties.
8470. § 1003.1310 Amount of penalties.
8471. § 1003.1320 Determinations regarding the amount of penalties.
8472. Subpart N CMPs for Information Blocking
8473. § 1003.1400 Basis for civil money penalties.
8474. § 1003.1410 Amount of penalties.
8475. § 1003.1420 Determinations regarding the amount of penalties.
8476. Subpart O Procedures for the Imposition of CMPs, Assessments, and Exclusions
8477. § 1003.1500 Notice of proposed determination.
8478. § 1003.1510 Failure to request a hearing.
8479. § 1003.1520 Collateral estoppel.
8480. § 1003.1530 Settlement.
8481. § 1003.1540 Judicial review.
8482. § 1003.1550 Collection of penalties and assessments.
8483. § 1003.1560 Notice to other agencies.
8484. § 1003.1570 Limitations.
8485. § 1003.1580 Statistical sampling.
8486. § 1003.1590 Effect of exclusion.
8487. § 1003.1600 Reinstatement.
8488. PART 1004 IMPOSITION OF SANCTIONS ON HEALTH CARE PRACTITIONERS AND PROVIDERS OF HEALTH CARE SERVICES BY A QUALITY IMPROVEMENT ORGANIZATION
8489. Subpart A General Provisions
8490. § 1004.1 Scope and definitions.
8491. Subpart B Sanctions Under the QIO Program; General Provisions
8492. § 1004.10 Statutory obligations of practitioners and other persons.
8493. § 1004.20 Sanctions.
8494. Subpart C QIO Responsibilities
8495. § 1004.30 Basic responsibilities.
8496. § 1004.40 Action on identification of a violation.
8497. § 1004.50 Meeting with a practitioner or other person.
8498. § 1004.60 QIO finding of a violation.
8499. § 1004.70 QIO action on final finding of a violation.
8500. § 1004.80 QIO report to the OIG.
8501. § 1004.90 Basis for recommended sanction.
8502. Subpart D OIG Responsibilities
8503. § 1004.100 Acknowledgement and review of report.
8504. § 1004.110 Notice of sanction.
8505. Subpart E Effect and Duration of Exclusion
8506. § 1004.120 Effect of an exclusion on program payments and services.
8507. § 1004.130 Reinstatement after exclusion.
8508. Subpart F Appeals
8509. § 1004.140 Appeal rights.
8510. PART 1005 APPEALS OF EXCLUSIONS, CIVIL MONEY PENALTIES AND ASSESSMENTS
8511. § 1005.1 Definitions.
8512. § 1005.2 Hearing before an administrative law judge.
8513. § 1005.3 Rights of parties.
8514. § 1005.4 Authority of the ALJ.
8515. § 1005.5 Ex parte contacts.
8516. § 1005.6 Prehearing conferences.
8517. § 1005.7 Discovery.
8518. § 1005.8 Exchange of witness lists, witness statements and exhibits.
8519. § 1005.9 Subpoenas for attendance at hearing.
8520. § 1005.10 Fees.
8521. § 1005.11 Form, filing and service of papers.
8522. § 1005.12 Computation of time.
8523. § 1005.13 Motions.
8524. § 1005.14 Sanctions.
8525. § 1005.15 The hearing and burden of proof.
8526. § 1005.16 Witnesses.
8527. § 1005.17 Evidence.
8528. § 1005.18 The record.
8529. § 1005.19 Post-hearing briefs.
8530. § 1005.20 Initial decision.
8531. § 1005.21 Appeal to DAB.
8532. § 1005.22 Stay of initial decision.
8533. § 1005.23 Harmless error.
8534. PART 1006 INVESTIGATIONAL INQUIRIES
8535. § 1006.1 Scope.
8536. § 1006.2 Contents of subpoena.
8537. § 1006.3 Service and fees.
8538. § 1006.4 Procedures for investigational inquiries.
8539. § 1006.5 Enforcement of a subpoena.
8540. PART 1007 STATE MEDICAID FRAUD CONTROL UNITS
8541. Subpart A General Provisions and Definitions
8542. § 1007.1 Definitions.
8543. § 1007.3 Statutory basis and organization of rule.
8544. Subpart B Requirements for Certification
8545. § 1007.5 Single, identifiable entity requirements of Unit.
8546. § 1007.7 Prosecutorial authority requirements of Unit.
8547. § 1007.9 Relationship and agreement between Unit and Medicaid agency.
8548. § 1007.11 Duties and responsibilities of Unit.
8549. § 1007.13 Staffing requirements of Unit.
8550. § 1007.15 Establishment and certification of Unit.
8551. § 1007.17 Annual recertification of Unit.
8552. Subpart C Federal Financial Participation (FFP)
8553. § 1007.19 FFP rate and eligible FFP costs.
8554. § 1007.20 Circumstances of permissible data mining.
8555. § 1007.21 Disallowance of claims for FFP.
8556. Subpart D Other Provisions
8557. § 1007.23 Other applicable HHS regulations.
8558. PART 1008 ADVISORY OPINIONS BY THE OIG
8559. Subpart A General Provisions
8560. § 1008.1 Basis and purpose.
8561. § 1008.3 Effective period.
8562. § 1008.5 Matters subject to advisory opinions.
8563. Subpart B Preliminary Obligations and Responsibilities of the Requesting Party
8564. § 1008.11 Who may submit a request.
8565. § 1008.15 Facts subject to advisory opinions.
8566. § 1008.18 Preliminary questions suggested for the requesting party.
8567. Subpart C Advisory Opinion Fees
8568. § 1008.31 OIG fees for the cost of advisory opinions.
8569. § 1008.33 Expert opinions from outside sources.
8570. Subpart D Submission of a Formal Request for an Advisory Opinion
8571. § 1008.36 Submission of a request.
8572. § 1008.37 Disclosure of ownership and related information.
8573. § 1008.38 Signed certifications by the requestor.
8574. § 1008.39 Additional information.
8575. § 1008.40 Withdrawal.
8576. Subpart E Obligations and Responsibilities of the OIG
8577. § 1008.41 OIG acceptance of the request.
8578. § 1008.43 Issuance of a formal advisory opinion.
8579. § 1008.45 Rescission, termination or modification.
8580. § 1008.47 Disclosure.
8581. Subpart F Scope and Effect of OIG Advisory Opinions
8582. § 1008.51 Exclusivity of OIG advisory opinions.
8583. § 1008.53 Affected parties.
8584. § 1008.55 Admissibility of evidence.
8585. § 1008.59 Range of the advisory opinion.
8586. 1009-1099 PARTS 1009-1099 [RESERVED]