Title 42

CHAPTER IV SUBCHAP A

Subchapter A - General Provisions

42:2.0.1.1.1PART 400
PART 400 - INTRODUCTION; DEFINITIONS
42:2.0.1.1.1.1SUBPART A
Subpart A [Reserved]
42:2.0.1.1.1.2SUBPART B
Subpart B - Definitions
42:2.0.1.1.1.2.1.1SECTION 400.200
     400.200 General definitions.
42:2.0.1.1.1.2.1.2SECTION 400.202
     400.202 Definitions specific to Medicare.
42:2.0.1.1.1.2.1.3SECTION 400.203
     400.203 Definitions specific to Medicaid.
42:2.0.1.1.1.3SUBPART C
Subpart C [Reserved]
42:2.0.1.1.2PART 401
PART 401 - GENERAL ADMINISTRATIVE REQUIREMENTS
42:2.0.1.1.2.1SUBPART A
Subpart A [Reserved]
42:2.0.1.1.2.2SUBPART B
Subpart B - Confidentiality and Disclosure
42:2.0.1.1.2.2.1.1SECTION 401.101
     401.101 Purpose and scope.
42:2.0.1.1.2.2.1.2SECTION 401.102
     401.102 Definitions.
42:2.0.1.1.2.2.1.3SECTION 401.105
     401.105 Rules for disclosure.
42:2.0.1.1.2.2.1.4SECTION 401.106
     401.106 Publication.
42:2.0.1.1.2.2.1.5SECTION 401.108
     401.108 CMS rulings.
42:2.0.1.1.2.2.1.6SECTION 401.109
     401.109 Precedential Final Decisions of the Secretary.
42:2.0.1.1.2.2.1.7SECTION 401.110
     401.110 Publications for sale.
42:2.0.1.1.2.2.1.8SECTION 401.112
     401.112 Availability of administrative staff manuals.
42:2.0.1.1.2.2.1.9SECTION 401.116
     401.116 Availability of records upon request.
42:2.0.1.1.2.2.1.10SECTION 401.118
     401.118 Deletion of identifying details.
42:2.0.1.1.2.2.1.11SECTION 401.120
     401.120 Creation of records.
42:2.0.1.1.2.2.1.12SECTION 401.126
     401.126 Information or records that are not available.
42:2.0.1.1.2.2.1.13SECTION 401.128
     401.128 Where requests for records may be made.
42:2.0.1.1.2.2.1.14SECTION 401.130
     401.130 Materials available at social security district offices and branch offices.
42:2.0.1.1.2.2.1.15SECTION 401.132
     401.132 Materials in field offices of the Office of Hearings and Appeals, SSA.
42:2.0.1.1.2.2.1.16SECTION 401.133
     401.133 Availability of official reports on providers and suppliers of services, State agencies, intermediaries, and carriers under Medicare.
42:2.0.1.1.2.2.1.17SECTION 401.134
     401.134 Release of Medicare information to State and Federal agencies.
42:2.0.1.1.2.2.1.18SECTION 401.135
     401.135 Release of Medicare information to the public.
42:2.0.1.1.2.2.1.19SECTION 401.136
     401.136 Requests for information or records.
42:2.0.1.1.2.2.1.20SECTION 401.140
     401.140 Fees and charges.
42:2.0.1.1.2.2.1.21SECTION 401.144
     401.144 Denial of requests.
42:2.0.1.1.2.2.1.22SECTION 401.148
     401.148 Administrative review.
42:2.0.1.1.2.2.1.23SECTION 401.152
     401.152 Court review.
42:2.0.1.1.2.3SUBPART C
Subpart C [Reserved]
42:2.0.1.1.2.4SUBPART D
Subpart D - Reporting and Returning of Overpayments
42:2.0.1.1.2.4.1.1SECTION 401.301
     401.301 Basis and scope.
42:2.0.1.1.2.4.1.2SECTION 401.303
     401.303 Definitions.
42:2.0.1.1.2.4.1.3SECTION 401.305
     401.305 Requirements for reporting and returning of overpayments.
42:2.0.1.1.2.5SUBPART E
Subpart E [Reserved]
42:2.0.1.1.2.6SUBPART F
Subpart F - Claims Collection and Compromise
42:2.0.1.1.2.6.1.1SECTION 401.601
     401.601 Basis and scope.
42:2.0.1.1.2.6.1.2SECTION 401.603
     401.603 Definitions.
42:2.0.1.1.2.6.1.3SECTION 401.605
     401.605 Omissions not a defense.
42:2.0.1.1.2.6.1.4SECTION 401.607
     401.607 Claims collection.
42:2.0.1.1.2.6.1.5SECTION 401.613
     401.613 Compromise of claims.
42:2.0.1.1.2.6.1.6SECTION 401.615
     401.615 Payment of compromise amount.
42:2.0.1.1.2.6.1.7SECTION 401.617
     401.617 Suspension of collection action.
42:2.0.1.1.2.6.1.8SECTION 401.621
     401.621 Termination of collection action.
42:2.0.1.1.2.6.1.9SECTION 401.623
     401.623 Joint and several liability.
42:2.0.1.1.2.6.1.10SECTION 401.625
     401.625 Effect of CMS claims collection decisions on appeals.
42:2.0.1.1.2.7SUBPART G
Subpart G - Availability of Medicare Data for Performance Measurement
42:2.0.1.1.2.7.1.1SECTION 401.701
     401.701 Purpose and scope.
42:2.0.1.1.2.7.1.2SECTION 401.703
     401.703 Definitions.
42:2.0.1.1.2.7.1.3SECTION 401.705
     401.705 Eligibility criteria for qualified entities.
42:2.0.1.1.2.7.1.4SECTION 401.707
     401.707 Operating and governance requirements for qualified entities.
42:2.0.1.1.2.7.1.5SECTION 401.709
     401.709 The application process and requirements.
42:2.0.1.1.2.7.1.6SECTION 401.711
     401.711 Updates to plans submitted as part of the application process.
42:2.0.1.1.2.7.1.7SECTION 401.713
     401.713 Ensuring the privacy and security of data.
42:2.0.1.1.2.7.1.8SECTION 401.715
     401.715 Selection and use of performance measures.
42:2.0.1.1.2.7.1.9SECTION 401.716
     401.716 Non-public analyses.
42:2.0.1.1.2.7.1.10SECTION 401.717
     401.717 Provider and supplier requests for error correction.
42:2.0.1.1.2.7.1.11SECTION 401.718
     401.718 Dissemination of data.
42:2.0.1.1.2.7.1.12SECTION 401.719
     401.719 Monitoring and sanctioning of qualified entities.
42:2.0.1.1.2.7.1.13SECTION 401.721
     401.721 Terminating an agreement with a qualified entity.
42:2.0.1.1.2.7.1.14SECTION 401.722
     401.722 Qualified clinical data registries.
42:2.0.1.1.3PART 402
PART 402 - CIVIL MONEY PENALTIES, ASSESSMENTS, AND EXCLUSIONS
42:2.0.1.1.3.1SUBPART A
Subpart A - General Provisions
42:2.0.1.1.3.1.1.1SECTION 402.1
     402.1 Basis and scope.
42:2.0.1.1.3.1.1.2SECTION 402.3
     402.3 Definitions.
42:2.0.1.1.3.1.1.3SECTION 402.5
     402.5 Right to a hearing before the final determination.
42:2.0.1.1.3.1.1.4SECTION 402.7
     402.7 Notice of proposed determination.
42:2.0.1.1.3.1.1.5SECTION 402.9
     402.9 Failure to request a hearing.
42:2.0.1.1.3.1.1.6SECTION 402.11
     402.11 Notice to other agencies and other entities.
42:2.0.1.1.3.1.1.7SECTION 402.13
     402.13 Penalty, assessment, and exclusion not exclusive.
42:2.0.1.1.3.1.1.8SECTION 402.15
     402.15 Collateral estoppel.
42:2.0.1.1.3.1.1.9SECTION 402.17
     402.17 Settlement.
42:2.0.1.1.3.1.1.10SECTION 402.19
     402.19 Hearings and appeals.
42:2.0.1.1.3.1.1.11SECTION 402.21
     402.21 Judicial review.
42:2.0.1.1.3.2SUBPART B
Subpart B - Civil Money Penalties and Assessments
42:2.0.1.1.3.2.1.1SECTION 402.105
     402.105 Amount of penalty.
42:2.0.1.1.3.2.1.2SECTION 402.107
     402.107 Amount of assessment.
42:2.0.1.1.3.2.1.3SECTION 402.109
     402.109 Statistical sampling.
42:2.0.1.1.3.2.1.4SECTION 402.111
     402.111 Factors considered in determinations regarding the amount of penalties and assessments.
42:2.0.1.1.3.2.1.5SECTION 402.113
     402.113 When a penalty and assessment are collectible.
42:2.0.1.1.3.2.1.6SECTION 402.115
     402.115 Collection of penalty or assessment.
42:2.0.1.1.3.3SUBPART C
Subpart C - Exclusions
42:2.0.1.1.3.3.1.1SECTION 402.200
     402.200 Basis and purpose.
42:2.0.1.1.3.3.1.2SECTION 402.205
     402.205 Length of exclusion.
42:2.0.1.1.3.3.1.3SECTION 402.208
     402.208 Factors considered in determining whether to exclude, and the length of exclusion.
42:2.0.1.1.3.3.1.4SECTION 402.209
     402.209 Scope and effect of exclusion.
42:2.0.1.1.3.3.1.5SECTION 402.210
     402.210 Notices.
42:2.0.1.1.3.3.1.6SECTION 402.212
     402.212 Response to notice of proposed determination to exclude.
42:2.0.1.1.3.3.1.7SECTION 402.214
     402.214 Appeal of exclusion.
42:2.0.1.1.3.3.1.8SECTION 402.300
     402.300 Request for reinstatement.
42:2.0.1.1.3.3.1.9SECTION 402.302
     402.302 Basis for reinstatement.
42:2.0.1.1.3.3.1.10SECTION 402.304
     402.304 Approval of request for reinstatement.
42:2.0.1.1.3.3.1.11SECTION 402.306
     402.306 Denial of request for reinstatement.
42:2.0.1.1.3.3.1.12SECTION 402.308
     402.308 Waivers of exclusions.
42:2.0.1.1.4PART 403
PART 403 - SPECIAL PROGRAMS AND PROJECTS
42:2.0.1.1.4.1SUBPART A
Subpart A [Reserved]
42:2.0.1.1.4.2SUBPART B
Subpart B - Medicare Supplemental Policies
42:2.0.1.1.4.2.5SUBJGRP 5
  General Provisions
42:2.0.1.1.4.2.5.1SECTION 403.200
     403.200 Basis and scope.
42:2.0.1.1.4.2.5.2SECTION 403.201
     403.201 State regulation of insurance policies.
42:2.0.1.1.4.2.5.3SECTION 403.205
     403.205 Medicare supplemental policy.
42:2.0.1.1.4.2.5.4SECTION 403.206
     403.206 General standards for Medicare supplemental policies.
42:2.0.1.1.4.2.5.5SECTION 403.210
     403.210 NAIC model standards.
42:2.0.1.1.4.2.5.6SECTION 403.215
     403.215 Loss ratio standards.
42:2.0.1.1.4.2.6SUBJGRP 6
  State Regulatory Programs
42:2.0.1.1.4.2.6.7SECTION 403.220
     403.220 Supplemental Health Insurance Panel.
42:2.0.1.1.4.2.6.8SECTION 403.222
     403.222 State with an approved regulatory program.
42:2.0.1.1.4.2.7SUBJGRP 7
  Voluntary Certification Program: General Provisions
42:2.0.1.1.4.2.7.9SECTION 403.231
     403.231 Emblem.
42:2.0.1.1.4.2.7.10SECTION 403.232
     403.232 Requirements and procedures for obtaining certification.
42:2.0.1.1.4.2.7.11SECTION 403.235
     403.235 Review and certification of policies.
42:2.0.1.1.4.2.7.12SECTION 403.239
     403.239 Submittal of material to retain certification.
42:2.0.1.1.4.2.7.13SECTION 403.245
     403.245 Loss of certification.
42:2.0.1.1.4.2.7.14SECTION 403.248
     403.248 Administrative review of CMS determinations.
42:2.0.1.1.4.2.8SUBJGRP 8
  Voluntary Certification Program: Loss Ratio Provisions
42:2.0.1.1.4.2.8.15SECTION 403.250
     403.250 Loss ratio calculations: General provisions.
42:2.0.1.1.4.2.8.16SECTION 403.251
     403.251 Loss ratio date and time frame provisions.
42:2.0.1.1.4.2.8.17SECTION 403.253
     403.253 Calculation of benefits.
42:2.0.1.1.4.2.8.18SECTION 403.254
     403.254 Calculation of premiums.
42:2.0.1.1.4.2.8.19SECTION 403.256
     403.256 Loss ratio supporting data.
42:2.0.1.1.4.2.8.20SECTION 403.258
     403.258 Statement of actuarial opinion.
42:2.0.1.1.4.3SUBPART C
Subpart C - Recognition of State Reimbursement Control Systems
42:2.0.1.1.4.3.9.1SECTION 403.300
     403.300 Basis and purpose.
42:2.0.1.1.4.3.9.2SECTION 403.302
     403.302 Definitions.
42:2.0.1.1.4.3.9.3SECTION 403.304
     403.304 Minimum requirements for State systems - discretionary approval.
42:2.0.1.1.4.3.9.4SECTION 403.306
     403.306 Additional requirements for State systems - mandatory approval.
42:2.0.1.1.4.3.9.5SECTION 403.308
     403.308 State systems under demonstration projects - mandatory approval.
42:2.0.1.1.4.3.9.6SECTION 403.310
     403.310 Reduction in payments.
42:2.0.1.1.4.3.9.7SECTION 403.312
     403.312 Submittal of application.
42:2.0.1.1.4.3.9.8SECTION 403.314
     403.314 Evaluation of State systems.
42:2.0.1.1.4.3.9.9SECTION 403.316
     403.316 Reconsideration of certain denied applications.
42:2.0.1.1.4.3.9.10SECTION 403.318
     403.318 Approval of State systems.
42:2.0.1.1.4.3.9.11SECTION 403.320
     403.320 CMS review and monitoring of State systems.
42:2.0.1.1.4.3.9.12SECTION 403.321
     403.321 State systems for hospital outpatient services.
42:2.0.1.1.4.3.9.13SECTION 403.322
     403.322 Termination of agreements for Medicare recognition of State systems.
42:2.0.1.1.4.4SUBPART D
Subparts D - F [Reserved]
42:2.0.1.1.4.5SUBPART G
Subpart G - Religious Nonmedical Health Care Institutions - Benefits, Conditions of Participation, and Payment
42:2.0.1.1.4.5.9.1SECTION 403.700
     403.700 Basis and purpose.
42:2.0.1.1.4.5.9.2SECTION 403.702
     403.702 Definitions and terms.
42:2.0.1.1.4.5.9.3SECTION 403.720
     403.720 Conditions for coverage.
42:2.0.1.1.4.5.9.4SECTION 403.724
     403.724 Valid election requirements.
42:2.0.1.1.4.5.9.5SECTION 403.730
     403.730 Condition of participation: Patient rights.
42:2.0.1.1.4.5.9.6SECTION 403.732
     403.732 Condition of participation: Quality assessment and performance improvement.
42:2.0.1.1.4.5.9.7SECTION 403.734
     403.734 Condition of participation: Food services.
42:2.0.1.1.4.5.9.8SECTION 403.736
     403.736 Condition of participation: Discharge planning.
42:2.0.1.1.4.5.9.9SECTION 403.738
     403.738 Condition of participation: Administration.
42:2.0.1.1.4.5.9.10SECTION 403.740
     403.740 Condition of participation: Staffing.
42:2.0.1.1.4.5.9.11SECTION 403.742
     403.742 Condition of participation: Physical environment.
42:2.0.1.1.4.5.9.12SECTION 403.744
     403.744 Condition of participation: Life safety from fire.
42:2.0.1.1.4.5.9.13SECTION 403.745
     403.745 Condition of participation: Building safety.
42:2.0.1.1.4.5.9.14SECTION 403.746
     403.746 Condition of participation: Utilization review.
42:2.0.1.1.4.5.9.15SECTION 403.748
     403.748 Condition of participation: Emergency preparedness.
42:2.0.1.1.4.5.9.16SECTION 403.750
     403.750 Estimate of expenditures and adjustments.
42:2.0.1.1.4.5.9.17SECTION 403.752
     403.752 Payment provisions.
42:2.0.1.1.4.5.9.18SECTION 403.754
     403.754 Monitoring expenditure level.
42:2.0.1.1.4.5.9.19SECTION 403.756
     403.756 Sunset provision.
42:2.0.1.1.4.5.9.20SECTION 403.764
     403.764 Basis and purpose of religious nonmedical health care institutions providing home service.
42:2.0.1.1.4.5.9.21SECTION 403.766
     403.766 Requirements for coverage and payment of RNHCI home services.
42:2.0.1.1.4.5.9.22SECTION 403.768
     403.768 Excluded services.
42:2.0.1.1.4.5.9.23SECTION 403.770
     403.770 Payments for home services.
42:2.0.1.1.4.6SUBPART H
Subpart H - Medicare Prescription Drug Discount Card and Transitional Assistance Program
42:2.0.1.1.4.6.9.1SECTION 403.800
     403.800 Basis and scope.
42:2.0.1.1.4.6.9.2SECTION 403.802
     403.802 Definitions.
42:2.0.1.1.4.6.9.3SECTION 403.804
     403.804 General rules for solicitation, application and Medicare endorsement period.
42:2.0.1.1.4.6.9.4SECTION 403.806
     403.806 Sponsor requirements for eligibility for endorsement.
42:2.0.1.1.4.6.9.5SECTION 403.808
     403.808 Use of transitional assistance funds.
42:2.0.1.1.4.6.9.6SECTION 403.810
     403.810 Eligibility and reconsiderations.
42:2.0.1.1.4.6.9.7SECTION 403.811
     403.811 Enrollment and disenrollment and associated endorsed sponsor requirements.
42:2.0.1.1.4.6.9.8SECTION 403.812
     403.812 HIPAA privacy, security, administrative data standards, and national identifiers.
42:2.0.1.1.4.6.9.9SECTION 403.813
     403.813 Marketing limitations and record retention requirements.
42:2.0.1.1.4.6.9.10SECTION 403.814
     403.814 Special rules concerning Part C organizations and Medicare cost plans and their enrollees.
42:2.0.1.1.4.6.9.11SECTION 403.815
     403.815 Special rules concerning States.
42:2.0.1.1.4.6.9.12SECTION 403.816
     403.816 Special rules concerning long-term care and I/T/U pharmacies.
42:2.0.1.1.4.6.9.13SECTION 403.817
     403.817 Special rules concerning the territories.
42:2.0.1.1.4.6.9.14SECTION 403.820
     403.820 Sanctions, penalties, and termination.
42:2.0.1.1.4.6.9.15SECTION 403.822
     403.822 Reimbursement of transitional assistance and associated sponsor requirements.
42:2.0.1.1.4.7SUBPART I
Subpart I - Transparency Reports and Reporting of Physician Ownership or Investment Interests
42:2.0.1.1.4.7.9.1SECTION 403.900
     403.900 Purpose and scope.
42:2.0.1.1.4.7.9.2SECTION 403.902
     403.902 Definitions.
42:2.0.1.1.4.7.9.3SECTION 403.904
     403.904 Reports of payments or other transfers of value to covered recipients.
42:2.0.1.1.4.7.9.4SECTION 403.906
     403.906 Reports of physician ownership and investment interests.
42:2.0.1.1.4.7.9.5SECTION 403.908
     403.908 Procedures for electronic submission of reports.
42:2.0.1.1.4.7.9.6SECTION 403.910
     403.910 Delayed publication for payments made under product research or development agreements and clinical investigations.
42:2.0.1.1.4.7.9.7SECTION 403.912
     403.912 Penalties for failure to report.
42:2.0.1.1.4.7.9.8SECTION 403.914
     403.914 Preemption of State laws.
42:2.0.1.1.4.8SUBPART K
Subpart K - Access to Identifiable Data for the Center for Medicare and Medicaid Models
42:2.0.1.1.4.8.9.1SECTION 403.1100
     403.1100 Purpose and scope.
42:2.0.1.1.4.8.9.2SECTION 403.1105
     403.1105 Definitions.
42:2.0.1.1.4.8.9.3SECTION 403.1110
     403.1110 Evaluation of models.
42:2.0.1.1.4.9SUBPART L
Subpart L - Requirements for Direct-to-Consumer Television Advertisements of Drugs and Biological Products To Include the List Price of That Advertised Product
42:2.0.1.1.4.9.9.1SECTION 403.1200
     403.1200 Scope.
42:2.0.1.1.4.9.9.2SECTION 403.1201
     403.1201 Definitions.
42:2.0.1.1.4.9.9.3SECTION 403.1202
     403.1202 Pricing information.
42:2.0.1.1.4.9.9.4SECTION 403.1203
     403.1203 Specific presentation requirements.
42:2.0.1.1.4.9.9.5SECTION 403.1204
     403.1204 Compliance.