Title 42

PART 423

Part 423 - Voluntary Medicare Prescription Drug Benefit

PART 423 - VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Authority:42 U.S.C. 1302, 1395w-101 through 1395w-152, and 1395hh. Link to an amendment published at 85 FR 25634, May 1, 2020. Source:70 FR 4525, Jan. 28, 2005, unless otherwise noted.

42:3.0.1.1.10.1SUBPART A
Subpart A - General Provisions
42:3.0.1.1.10.1.9.1SECTION 423.1
   423.1 Basis and scope.
42:3.0.1.1.10.1.9.2SECTION 423.4
   423.4 Definitions.
42:3.0.1.1.10.1.9.3SECTION 423.6
   423.6 Cost-sharing in beneficiary education and enrollment-related costs.
42:3.0.1.1.10.2SUBPART B
Subpart B - Eligibility and Enrollment
42:3.0.1.1.10.2.9.1SECTION 423.30
   423.30 Eligibility and enrollment.
42:3.0.1.1.10.2.9.2SECTION 423.32
   423.32 Enrollment process.
42:3.0.1.1.10.2.9.3SECTION 423.34
   423.34 Enrollment of low-income subsidy eligible individuals.
42:3.0.1.1.10.2.9.4SECTION 423.36
   423.36 Disenrollment process.
42:3.0.1.1.10.2.9.5SECTION 423.38
   423.38 Enrollment periods.
42:3.0.1.1.10.2.9.6SECTION 423.40
   423.40 Effective dates.
42:3.0.1.1.10.2.9.7SECTION 423.44
   423.44 Involuntary disenrollment from Part D coverage.
42:3.0.1.1.10.2.9.8SECTION 423.46
   423.46 Late enrollment penalty.
42:3.0.1.1.10.2.9.9SECTION 423.48
   423.48 Information about Part D.
42:3.0.1.1.10.2.9.10SECTION 423.56
   423.56 Procedures to determine and document creditable status of prescription drug coverage.
42:3.0.1.1.10.3SUBPART C
Subpart C - Benefits and Beneficiary Protections
42:3.0.1.1.10.3.9.1SECTION 423.100
   423.100 Definitions.
42:3.0.1.1.10.3.9.2SECTION 423.104
   423.104 Requirements related to qualified prescription drug coverage.
42:3.0.1.1.10.3.9.3SECTION 423.112
   423.112 Establishment of prescription drug plan service areas.
42:3.0.1.1.10.3.9.4SECTION 423.120
   423.120 Access to covered Part D drugs.
42:3.0.1.1.10.3.9.5SECTION 423.124
   423.124 Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.
42:3.0.1.1.10.3.9.6SECTION 423.128
   423.128 Dissemination of Part D plan information.
42:3.0.1.1.10.3.9.7SECTION 423.132
   423.132 Public disclosure of pharmaceutical prices for equivalent drugs.
42:3.0.1.1.10.3.9.8SECTION 423.136
   423.136 Privacy, confidentiality, and accuracy of enrollee records.
42:3.0.1.1.10.4SUBPART D
Subpart D - Cost Control and Quality Improvement Requirements
42:3.0.1.1.10.4.9.1SECTION 423.150
   423.150 Scope.
42:3.0.1.1.10.4.9.2SECTION 423.153
   423.153 Prescription drug plan sponsors' access to Medicare Parts A and B claims data extracts.
42:3.0.1.1.10.4.9.3SECTION 423.154
   423.154 Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans.
42:3.0.1.1.10.4.9.4SECTION 423.156
   423.156 Consumer satisfaction surveys.
42:3.0.1.1.10.4.9.5SECTION 423.159
   423.159 Electronic prescription drug program.
42:3.0.1.1.10.4.9.6SECTION 423.160
   423.160 Standards for electronic prescribing.
42:3.0.1.1.10.4.9.7SECTION 423.162
   423.162 Quality improvement organization activities.
42:3.0.1.1.10.4.9.8SECTION 423.165
   423.165 Compliance deemed on the basis of accreditation.
42:3.0.1.1.10.4.9.9SECTION 423.168
   423.168 Accreditation organizations.
42:3.0.1.1.10.4.9.10SECTION 423.171
   423.171 Procedures for approval of accreditation as a basis for deeming compliance.
42:3.0.1.1.10.4.9.11SECTION 423.180
   423.180 Basis and scope of the Part D Prescription Drug Plan Quality Rating System.
42:3.0.1.1.10.4.9.12SECTION 423.182
   423.182 Part D Prescription Drug Plan Quality Rating System.
42:3.0.1.1.10.4.9.13SECTION 423.184
   423.184 Adding, updating, and removing measures.
42:3.0.1.1.10.4.9.14SECTION 423.186
   423.186 Calculation of Star Ratings.
42:3.0.1.1.10.5SUBPART E
Subpart E [Reserved]
42:3.0.1.1.10.6SUBPART F
Subpart F - Submission of Bids and Monthly Beneficiary Premiums; Plan Approval
42:3.0.1.1.10.6.9.1SECTION 423.251
   423.251 Scope.
42:3.0.1.1.10.6.9.2SECTION 423.258
   423.258 Definitions.
42:3.0.1.1.10.6.9.3SECTION 423.265
   423.265 Submission of bids and related information.
42:3.0.1.1.10.6.9.4SECTION 423.272
   423.272 Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.
42:3.0.1.1.10.6.9.5SECTION 423.279
   423.279 National average monthly bid amount.
42:3.0.1.1.10.6.9.6SECTION 423.286
   423.286 Rules regarding premiums.
42:3.0.1.1.10.6.9.7SECTION 423.293
   423.293 Collection of monthly beneficiary premium.
42:3.0.1.1.10.7SUBPART G
Subpart G - Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage
42:3.0.1.1.10.7.9.1SECTION 423.301
   423.301 Scope.
42:3.0.1.1.10.7.9.2SECTION 423.308
   423.308 Definitions and terminology.
42:3.0.1.1.10.7.9.3SECTION 423.315
   423.315 General payment provisions.
42:3.0.1.1.10.7.9.4SECTION 423.322
   423.322 Requirement for disclosure of information.
42:3.0.1.1.10.7.9.5SECTION 423.329
   423.329 Determination of payments.
42:3.0.1.1.10.7.9.6SECTION 423.336
   423.336 Risk-sharing arrangements.
42:3.0.1.1.10.7.9.7SECTION 423.343
   423.343 Retroactive adjustments and reconciliations.
42:3.0.1.1.10.7.9.8SECTION 423.346
   423.346 Reopening.
42:3.0.1.1.10.7.9.9SECTION 423.350
   423.350 Payment appeals.
42:3.0.1.1.10.7.9.10SECTION 423.352
   423.352 CMS-identified overpayments associated with payment data submitted by Part D sponsors.
42:3.0.1.1.10.7.9.11SECTION 423.360
   423.360 Reporting and returning of overpayments.
42:3.0.1.1.10.8SUBPART H
Subpart H [Reserved]
42:3.0.1.1.10.9SUBPART I
Subpart I - Organization Compliance with State Law and Preemption by Federal Law
42:3.0.1.1.10.9.9.1SECTION 423.401
   423.401 General requirements for PDP sponsors.
42:3.0.1.1.10.9.9.2SECTION 423.410
   423.410 Waiver of certain requirements to expand choice.
42:3.0.1.1.10.9.9.3SECTION 423.415
   423.415 Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region
42:3.0.1.1.10.9.9.4SECTION 423.420
   423.420 Solvency standards for non-licensed entities.
42:3.0.1.1.10.9.9.5SECTION 423.425
   423.425 Licensure does not substitute for or constitute certification.
42:3.0.1.1.10.9.9.6SECTION 423.440
   423.440 Prohibition of State imposition of premium taxes; relation to State laws.
42:3.0.1.1.10.10SUBPART J
Subpart J - Coordination of Part D Plans With Other Prescription Drug Coverage
42:3.0.1.1.10.10.9.1SECTION 423.452
   423.452 Scope.
42:3.0.1.1.10.10.9.2SECTION 423.454
   423.454 Definitions.
42:3.0.1.1.10.10.9.3SECTION 423.458
   423.458 Application of Part D rules to certain Part D plans on and after January 1, 2006.
42:3.0.1.1.10.10.9.4SECTION 423.462
   423.462 Medicare secondary payer procedures.
42:3.0.1.1.10.10.9.5SECTION 423.464
   423.464 Coordination of benefits with other providers of prescription drug coverage.
42:3.0.1.1.10.10.9.6SECTION 423.466
   423.466 Timeframes for coordination of benefits and claims adjustments.
42:3.0.1.1.10.11SUBPART K
Subpart K - Application Procedures and Contracts with Part D plan sponsors
42:3.0.1.1.10.11.9.1SECTION 423.500
   423.500 Scope.
42:3.0.1.1.10.11.9.2SECTION 423.501
   423.501 Definitions
42:3.0.1.1.10.11.9.3SECTION 423.502
   423.502 Application requirements.
42:3.0.1.1.10.11.9.4SECTION 423.503
   423.503 Evaluation and determination procedures for applications to be determined qualified to act as a sponsor.
42:3.0.1.1.10.11.9.5SECTION 423.504
   423.504 General provisions.
42:3.0.1.1.10.11.9.6SECTION 423.505
   423.505 Contract provisions.
42:3.0.1.1.10.11.9.7SECTION 423.506
   423.506 Effective date and term of contract.
42:3.0.1.1.10.11.9.8SECTION 423.507
   423.507 Nonrenewal of contract.
42:3.0.1.1.10.11.9.9SECTION 423.508
   423.508 Modification or termination of contract by mutual consent.
42:3.0.1.1.10.11.9.10SECTION 423.509
   423.509 Termination of contract by CMS.
42:3.0.1.1.10.11.9.11SECTION 423.510
   423.510 Termination of contract by the Part D sponsor.
42:3.0.1.1.10.11.9.12SECTION 423.512
   423.512 Minimum enrollment requirements.
42:3.0.1.1.10.11.9.13SECTION 423.514
   423.514 Validation of Part D reporting requirements.
42:3.0.1.1.10.11.9.14SECTION 423.516
   423.516 Prohibition of midyear implementation of significant new regulatory requirements.
42:3.0.1.1.10.11.9.15SECTION 423.520
   423.520 Prompt payment by Part D sponsors.
42:3.0.1.1.10.12SUBPART L
Subpart L - Effect of Change of Ownership or Leasing of Facilities During Term of Contract
42:3.0.1.1.10.12.9.1SECTION 423.551
   423.551 General provisions.
42:3.0.1.1.10.12.9.2SECTION 423.552
   423.552 Novation agreement requirements.
42:3.0.1.1.10.12.9.3SECTION 423.553
   423.553 Effect of leasing of a PDP sponsor's facilities.
42:3.0.1.1.10.13SUBPART M
Subpart M - Grievances, Coverage Determinations, Redeterminations, and Reconsiderations
42:3.0.1.1.10.13.9.1SECTION 423.558
   423.558 Scope.
42:3.0.1.1.10.13.9.2SECTION 423.560
   423.560 Definitions.
42:3.0.1.1.10.13.9.3SECTION 423.562
   423.562 General provisions.
42:3.0.1.1.10.13.9.4SECTION 423.564
   423.564 Grievance procedures.
42:3.0.1.1.10.13.9.5SECTION 423.566
   423.566 Coverage determinations.
42:3.0.1.1.10.13.9.6SECTION 423.568
   423.568 Standard timeframe and notice requirements for coverage determinations.
42:3.0.1.1.10.13.9.7SECTION 423.570
   423.570 Expediting certain coverage determinations.
42:3.0.1.1.10.13.9.8SECTION 423.572
   423.572 Timeframes and notice requirements for expedited coverage determinations.
42:3.0.1.1.10.13.9.9SECTION 423.576
   423.576 Effect of a coverage determination.
42:3.0.1.1.10.13.9.10SECTION 423.578
   423.578 Exceptions process.
42:3.0.1.1.10.13.9.11SECTION 423.580
   423.580 Right to a redetermination.
42:3.0.1.1.10.13.9.12SECTION 423.582
   423.582 Request for a standard redetermination.
42:3.0.1.1.10.13.9.13SECTION 423.584
   423.584 Expediting certain redeterminations.
42:3.0.1.1.10.13.9.14SECTION 423.586
   423.586 Opportunity to submit evidence.
42:3.0.1.1.10.13.9.15SECTION 423.590
   423.590 Timeframes and responsibility for making redeterminations.
42:3.0.1.1.10.13.9.16SECTION 423.600
   423.600 Reconsideration by an independent review entity (IRE).
42:3.0.1.1.10.13.9.17SECTION 423.602
   423.602 Notice of reconsideration determination by the independent review entity.
42:3.0.1.1.10.13.9.18SECTION 423.604
   423.604 Effect of a reconsideration determination.
42:3.0.1.1.10.13.9.19SECTION 423.610-423.634
   423.610-423.634 [Reserved]
42:3.0.1.1.10.13.9.20SECTION 423.636
   423.636 How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.
42:3.0.1.1.10.13.9.21SECTION 423.638
   423.638 How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.
42:3.0.1.1.10.14SUBPART N
Subpart N - Medicare Contract Determinations and Appeals
42:3.0.1.1.10.14.9.1SECTION 423.641
   423.641 Contract determinations.
42:3.0.1.1.10.14.9.2SECTION 423.642
   423.642 Notice of contract determination.
42:3.0.1.1.10.14.9.3SECTION 423.643
   423.643 Effect of contract determination.
42:3.0.1.1.10.14.9.4SECTION 423.650
   423.650 Right to a hearing, burden of proof, standard of proof, and standards of review.
42:3.0.1.1.10.14.9.5SECTION 423.651
   423.651 Request for hearing.
42:3.0.1.1.10.14.9.6SECTION 423.652
   423.652 Postponement of effective date of a contract determination when a request for a hearing is filed timely.
42:3.0.1.1.10.14.9.7SECTION 423.653
   423.653 Designation of hearing officer.
42:3.0.1.1.10.14.9.8SECTION 423.654
   423.654 Disqualification of hearing officer.
42:3.0.1.1.10.14.9.9SECTION 423.655
   423.655 Time and place of hearing.
42:3.0.1.1.10.14.9.10SECTION 423.656
   423.656 Appointment of representatives.
42:3.0.1.1.10.14.9.11SECTION 423.657
   423.657 Authority of representatives.
42:3.0.1.1.10.14.9.12SECTION 423.658
   423.658 Conduct of hearing.
42:3.0.1.1.10.14.9.13SECTION 423.659
   423.659 Evidence.
42:3.0.1.1.10.14.9.14SECTION 423.660
   423.660 Witnesses.
42:3.0.1.1.10.14.9.15SECTION 423.661
   423.661 Witnesses lists and documents.
42:3.0.1.1.10.14.9.16SECTION 423.662
   423.662 Prehearing and summary judgment.
42:3.0.1.1.10.14.9.17SECTION 423.663
   423.663 Record of hearing.
42:3.0.1.1.10.14.9.18SECTION 423.664
   423.664 Authority of hearing officer.
42:3.0.1.1.10.14.9.19SECTION 423.665
   423.665 Notice and effect of hearing decision.
42:3.0.1.1.10.14.9.20SECTION 423.666
   423.666 Review by the Administrator.
42:3.0.1.1.10.14.9.21SECTION 423.667
   423.667 Effect of Administrator's decision.
42:3.0.1.1.10.14.9.22SECTION 423.668
   423.668 Reopening of a contract determination or decision of a hearing officer or the Administrator.
42:3.0.1.1.10.15SUBPART O
Subpart O - Intermediate Sanctions
42:3.0.1.1.10.15.9.1SECTION 423.750
   423.750 Types of intermediate sanctions and civil money penalties.
42:3.0.1.1.10.15.9.2SECTION 423.752
   423.752 Basis for imposing intermediate sanctions and civil money penalties.
42:3.0.1.1.10.15.9.3SECTION 423.756
   423.756 Procedures for imposing intermediate sanctions and civil money penalties.
42:3.0.1.1.10.15.9.4SECTION 423.758
   423.758 Collection of civil money penalties imposed by CMS.
42:3.0.1.1.10.15.9.5SECTION 423.760
   423.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
42:3.0.1.1.10.15.9.6SECTION 423.762
   423.762 Settlement of penalties.
42:3.0.1.1.10.15.9.7SECTION 423.764
   423.764 Other applicable provisions.
42:3.0.1.1.10.16SUBPART P
Subpart P - Premiums and Cost-Sharing Subsidies for Low-Income Individuals
42:3.0.1.1.10.16.9.1SECTION 423.771
   423.771 Basis and scope.
42:3.0.1.1.10.16.9.2SECTION 423.772
   423.772 Definitions.
42:3.0.1.1.10.16.9.3SECTION 423.773
   423.773 Requirements for eligibility.
42:3.0.1.1.10.16.9.4SECTION 423.774
   423.774 Eligibility determinations, redeterminations, and applications.
42:3.0.1.1.10.16.9.5SECTION 423.780
   423.780 Premium subsidy.
42:3.0.1.1.10.16.9.6SECTION 423.782
   423.782 Cost-sharing subsidy.
42:3.0.1.1.10.16.9.7SECTION 423.800
   423.800 Administration of subsidy program.
42:3.0.1.1.10.17SUBPART Q
Subpart Q - Guaranteeing Access to a Choice of Coverage (Fallback Prescription Drug Plans)
42:3.0.1.1.10.17.9.1SECTION 423.851
   423.851 Scope.
42:3.0.1.1.10.17.9.2SECTION 423.855
   423.855 Definitions.
42:3.0.1.1.10.17.9.3SECTION 423.859
   423.859 Assuring access to a choice of coverage.
42:3.0.1.1.10.17.9.4SECTION 423.863
   423.863 Submission and approval of bids.
42:3.0.1.1.10.17.9.5SECTION 423.867
   423.867 Rules regarding premiums.
42:3.0.1.1.10.17.9.6SECTION 423.871
   423.871 Contract terms and conditions.
42:3.0.1.1.10.17.9.7SECTION 423.875
   423.875 Payment to fallback plans.
42:3.0.1.1.10.18SUBPART R
Subpart R - Payments to Sponsors of Retiree Prescription Drug Plans
42:3.0.1.1.10.18.9.1SECTION 423.880
   423.880 Basis and scope.
42:3.0.1.1.10.18.9.2SECTION 423.882
   423.882 Definitions.
42:3.0.1.1.10.18.9.3SECTION 423.884
   423.884 Requirements for qualified retiree prescription drug plans.
42:3.0.1.1.10.18.9.4SECTION 423.886
   423.886 Retiree drug subsidy amounts.
42:3.0.1.1.10.18.9.5SECTION 423.888
   423.888 Payment methods, including provision of necessary information.
42:3.0.1.1.10.18.9.6SECTION 423.890
   423.890 Appeals.
42:3.0.1.1.10.18.9.7SECTION 423.892
   423.892 Change of ownership.
42:3.0.1.1.10.18.9.8SECTION 423.894
   423.894 Construction.
42:3.0.1.1.10.19SUBPART S
Subpart S - Special Rules for States-Eligibility Determinations for Subsidies and General Payment Provisions
42:3.0.1.1.10.19.9.1SECTION 423.900
   423.900 Basis and scope.
42:3.0.1.1.10.19.9.2SECTION 423.902
   423.902 Definitions.
42:3.0.1.1.10.19.9.3SECTION 423.904
   423.904 Eligibility determinations for low-income subsidies.
42:3.0.1.1.10.19.9.4SECTION 423.906
   423.906 General payment provisions.
42:3.0.1.1.10.19.9.5SECTION 423.907
   423.907 Treatment of territories.
42:3.0.1.1.10.19.9.6SECTION 423.908.
   423.908. Phased-down State contribution to drug benefit costs assumed by Medicare.
42:3.0.1.1.10.19.9.7SECTION 423.910
   423.910 Requirements.
42:3.0.1.1.10.20SUBPART T
Subpart T - Appeal Procedures for Civil Money Penalties
42:3.0.1.1.10.20.9.1SECTION 423.1000
   423.1000 Basis and scope.
42:3.0.1.1.10.20.9.2SECTION 423.1002
   423.1002 Definitions.
42:3.0.1.1.10.20.9.3SECTION 423.1004
   423.1004 Scope and applicability.
42:3.0.1.1.10.20.9.4SECTION 423.1006
   423.1006 Appeal rights.
42:3.0.1.1.10.20.9.5SECTION 423.1008
   423.1008 Appointment of representatives.
42:3.0.1.1.10.20.9.6SECTION 423.1010
   423.1010 Authority of representatives.
42:3.0.1.1.10.20.9.7SECTION 423.1012
   423.1012 Fees for services of representatives.
42:3.0.1.1.10.20.9.8SECTION 423.1014
   423.1014 Charge for transcripts.
42:3.0.1.1.10.20.9.9SECTION 423.1016
   423.1016 Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.
42:3.0.1.1.10.20.9.10SECTION 423.1018
   423.1018 Notice and effect of initial determinations.
42:3.0.1.1.10.20.9.11SECTION 423.1020
   423.1020 Request for hearing.
42:3.0.1.1.10.20.9.12SECTION 423.1022
   423.1022 Parties to the hearing.
42:3.0.1.1.10.20.9.13SECTION 423.1024
   423.1024 Designation of hearing official.
42:3.0.1.1.10.20.9.14SECTION 423.1026
   423.1026 Disqualification of Administrative Law Judge.
42:3.0.1.1.10.20.9.15SECTION 423.1028
   423.1028 Prehearing conference.
42:3.0.1.1.10.20.9.16SECTION 423.1030
   423.1030 Notice of prehearing conference.
42:3.0.1.1.10.20.9.17SECTION 423.1032
   423.1032 Conduct of prehearing conference.
42:3.0.1.1.10.20.9.18SECTION 423.1034
   423.1034 Record, order, and effect of prehearing conference.
42:3.0.1.1.10.20.9.19SECTION 423.1036
   423.1036 Time and place of hearing.
42:3.0.1.1.10.20.9.20SECTION 423.1038
   423.1038 Change in time and place of hearing.
42:3.0.1.1.10.20.9.21SECTION 423.1040
   423.1040 Joint hearings.
42:3.0.1.1.10.20.9.22SECTION 423.1042
   423.1042 Hearing on new issues.
42:3.0.1.1.10.20.9.23SECTION 423.1044
   423.1044 Subpoenas.
42:3.0.1.1.10.20.9.24SECTION 423.1046
   423.1046 Conduct of hearing.
42:3.0.1.1.10.20.9.25SECTION 423.1048
   423.1048 Evidence.
42:3.0.1.1.10.20.9.26SECTION 423.1050
   423.1050 Witnesses.
42:3.0.1.1.10.20.9.27SECTION 423.1052
   423.1052 Oral and written summation.
42:3.0.1.1.10.20.9.28SECTION 423.1054
   423.1054 Record of hearing.
42:3.0.1.1.10.20.9.29SECTION 423.1056
   423.1056 Waiver of right to appear and present evidence.
42:3.0.1.1.10.20.9.30SECTION 423.1058
   423.1058 Dismissal of request for hearing.
42:3.0.1.1.10.20.9.31SECTION 423.1060
   423.1060 Dismissal for abandonment.
42:3.0.1.1.10.20.9.32SECTION 423.1062
   423.1062 Dismissal for cause.
42:3.0.1.1.10.20.9.33SECTION 423.1064
   423.1064 Notice and effect of dismissal and right to request review.
42:3.0.1.1.10.20.9.34SECTION 423.1066
   423.1066 Vacating a dismissal of request for hearing.
42:3.0.1.1.10.20.9.35SECTION 423.1068
   423.1068 Administrative Law Judge's decision.
42:3.0.1.1.10.20.9.36SECTION 423.1070
   423.1070 Removal of hearing to Departmental Appeals Board.
42:3.0.1.1.10.20.9.37SECTION 423.1072
   423.1072 Remand by the Administrative Law Judge.
42:3.0.1.1.10.20.9.38SECTION 423.1074
   423.1074 Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
42:3.0.1.1.10.20.9.39SECTION 423.1076
   423.1076 Request for Departmental Appeals Board review.
42:3.0.1.1.10.20.9.40SECTION 423.1078
   423.1078 Departmental Appeals Board action on request for review.
42:3.0.1.1.10.20.9.41SECTION 423.1080
   423.1080 Procedures before the Departmental Appeals Board on review.
42:3.0.1.1.10.20.9.42SECTION 423.1082
   423.1082 Evidence admissible on review.
42:3.0.1.1.10.20.9.43SECTION 423.1084
   423.1084 Decision or remand by the Departmental Appeals Board.
42:3.0.1.1.10.20.9.44SECTION 423.1086
   423.1086 Effect of Departmental Appeals Board Decision.
42:3.0.1.1.10.20.9.45SECTION 423.1088
   423.1088 Extension of time for seeking judicial review.
42:3.0.1.1.10.20.9.46SECTION 423.1090
   423.1090 Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.
42:3.0.1.1.10.20.9.47SECTION 423.1092
   423.1092 Revision of reopened decision.
42:3.0.1.1.10.20.9.48SECTION 423.1094
   423.1094 Notice and effect of revised decision.
42:3.0.1.1.10.21SUBPART U
Subpart U - Reopening, ALJ Hearings and ALJ and Attorney Adjudicator Decisions, Council Review, and Judicial Review
42:3.0.1.1.10.21.9.1SECTION 423.1968
   423.1968 Scope.
42:3.0.1.1.10.21.9.2SECTION 423.1970-423.1976
   423.1970-423.1976 [Reserved]
42:3.0.1.1.10.21.9.3SECTION 423.1978
   423.1978 Reopening determinations and decisions.
42:3.0.1.1.10.21.9.4SECTION 423.1980
   423.1980 Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews.
42:3.0.1.1.10.21.9.5SECTION 423.1982
   423.1982 Notice of a revised determination or decision.
42:3.0.1.1.10.21.9.6SECTION 423.1984
   423.1984 Effect of a revised determination or decision.
42:3.0.1.1.10.21.9.7SECTION 423.1986
   423.1986 Good cause for reopening.
42:3.0.1.1.10.21.9.8SECTION 423.1990
   423.1990 Expedited access to judicial review.
42:3.0.1.1.10.21.9.9SECTION 423.2000
   423.2000 Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.
42:3.0.1.1.10.21.9.10SECTION 423.2002
   423.2002 Right to an ALJ hearing.
42:3.0.1.1.10.21.9.11SECTION 423.2004
   423.2004 Right to a review of IRE notice of dismissal.
42:3.0.1.1.10.21.9.12SECTION 423.2006
   423.2006 Amount in controversy required for an ALJ hearing and judicial review.
42:3.0.1.1.10.21.9.13SECTION 423.2008
   423.2008 Parties to the proceedings on a request for an ALJ hearing.
42:3.0.1.1.10.21.9.14SECTION 423.2010
   423.2010 When CMS, the IRE, or Part D plan sponsors may participate in the proceedings on a request for an ALJ hearing.
42:3.0.1.1.10.21.9.15SECTION 423.2014
   423.2014 Request for an ALJ hearing or a review of an IRE dismissal.
42:3.0.1.1.10.21.9.16SECTION 423.2016
   423.2016 Timeframes for deciding an appeal of an IRE reconsideration.
42:3.0.1.1.10.21.9.17SECTION 423.2018
   423.2018 Submitting evidence.
42:3.0.1.1.10.21.9.18SECTION 423.2020
   423.2020 Time and place for a hearing before an ALJ.
42:3.0.1.1.10.21.9.19SECTION 423.2022
   423.2022 Notice of a hearing before an ALJ.
42:3.0.1.1.10.21.9.20SECTION 423.2024
   423.2024 Objections to the issues.
42:3.0.1.1.10.21.9.21SECTION 423.2026
   423.2026 Disqualification of the ALJ or attorney adjudicator.
42:3.0.1.1.10.21.9.22SECTION 423.2030
   423.2030 ALJ hearing procedures.
42:3.0.1.1.10.21.9.23SECTION 423.2032
   423.2032 Issues before an ALJ or attorney adjudicator.
42:3.0.1.1.10.21.9.24SECTION 423.2034
   423.2034 Requesting information from the IRE.
42:3.0.1.1.10.21.9.25SECTION 423.2036
   423.2036 Description of an ALJ hearing process.
42:3.0.1.1.10.21.9.26SECTION 423.2038
   423.2038 Deciding a case without a hearing before an ALJ.
42:3.0.1.1.10.21.9.27SECTION 423.2040
   423.2040 Prehearing and posthearing conferences.
42:3.0.1.1.10.21.9.28SECTION 423.2042
   423.2042 The administrative record.
42:3.0.1.1.10.21.9.29SECTION 423.2044
   423.2044 Consolidated proceedings.
42:3.0.1.1.10.21.9.30SECTION 423.2046
   423.2046 Notice of an ALJ or attorney adjudicator decision.
42:3.0.1.1.10.21.9.31SECTION 423.2048
   423.2048 The effect of an ALJ's or attorney adjudicator's decision.
42:3.0.1.1.10.21.9.32SECTION 423.2050
   423.2050 Removal of a hearing request from OMHA to the Council.
42:3.0.1.1.10.21.9.33SECTION 423.2052
   423.2052 Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal.
42:3.0.1.1.10.21.9.34SECTION 423.2054
   423.2054 Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal.
42:3.0.1.1.10.21.9.35SECTION 423.2056
   423.2056 Remands of requests for hearing and requests for review.
42:3.0.1.1.10.21.9.36SECTION 423.2058
   423.2058 Effect of a remand.
42:3.0.1.1.10.21.9.37SECTION 423.2062
   423.2062 Applicability of policies not binding on the ALJ and Council.
42:3.0.1.1.10.21.9.38SECTION 423.2063
   423.2063 Applicability of laws, regulations, CMS Rulings, and precedential decisions.
42:3.0.1.1.10.21.9.39SECTION 423.2100
   423.2100 Medicare Appeals Council review: general.
42:3.0.1.1.10.21.9.40SECTION 423.2102
   423.2102 Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.
42:3.0.1.1.10.21.9.41SECTION 423.2106
   423.2106 Where a request for review may be filed.
42:3.0.1.1.10.21.9.42SECTION 423.2108
   423.2108 Council Actions when request for review is filed.
42:3.0.1.1.10.21.9.43SECTION 423.2110
   423.2110 Council reviews on its own motion.
42:3.0.1.1.10.21.9.44SECTION 423.2112
   423.2112 Content of request for review.
42:3.0.1.1.10.21.9.45SECTION 423.2114
   423.2114 Dismissal of request for review.
42:3.0.1.1.10.21.9.46SECTION 423.2116
   423.2116 Effect of dismissal of request for Council review or request for hearing.
42:3.0.1.1.10.21.9.47SECTION 423.2118
   423.2118 Obtaining evidence from the Council.
42:3.0.1.1.10.21.9.48SECTION 423.2120
   423.2120 Filing briefs with the Council.
42:3.0.1.1.10.21.9.49SECTION 423.2122
   423.2122 What evidence may be submitted to the Council.
42:3.0.1.1.10.21.9.50SECTION 423.2124
   423.2124 Oral argument.
42:3.0.1.1.10.21.9.51SECTION 423.2126
   423.2126 Case remanded by the Council.
42:3.0.1.1.10.21.9.52SECTION 423.2128
   423.2128 Action of the Council.
42:3.0.1.1.10.21.9.53SECTION 423.2130
   423.2130 Effect of the Council's decision.
42:3.0.1.1.10.21.9.54SECTION 423.2134
   423.2134 Extension of time to file action in Federal District Court.
42:3.0.1.1.10.21.9.55SECTION 423.2136
   423.2136 Judicial review.
42:3.0.1.1.10.21.9.56SECTION 423.2138
   423.2138 Case remanded by a Federal District Court.
42:3.0.1.1.10.21.9.57SECTION 423.2140
   423.2140 Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court.
42:3.0.1.1.10.22SUBPART V
Subpart V - Part D Communication Requirements
42:3.0.1.1.10.22.9.1SECTION 423.2260
   423.2260 Definitions.
42:3.0.1.1.10.22.9.2SECTION 423.2262
   423.2262 Review and distribution of marketing materials.
42:3.0.1.1.10.22.9.3SECTION 423.2264
   423.2264 Guidelines for CMS review.
42:3.0.1.1.10.22.9.4SECTION 423.2266
   423.2266 [Reserved]
42:3.0.1.1.10.22.9.5SECTION 423.2268
   423.2268 Standards for Part D Sponsor communications and marketing.
42:3.0.1.1.10.22.9.6SECTION 423.2272
   423.2272 Licensing of marketing representatives and confirmation of marketing resources.
42:3.0.1.1.10.22.9.7SECTION 423.2274
   423.2274 Broker and agent requirements.
42:3.0.1.1.10.22.9.8SECTION 423.2276
   423.2276 Employer group retiree marketing.
42:3.0.1.1.10.23SUBPART W
Subpart W - Medicare Coverage Gap Discount Program
42:3.0.1.1.10.23.9.1SECTION 423.2300
   423.2300 Scope.
42:3.0.1.1.10.23.9.2SECTION 423.2305
   423.2305 Definitions.
42:3.0.1.1.10.23.9.3SECTION 423.2310
   423.2310 Condition for coverage of drugs under Part D.
42:3.0.1.1.10.23.9.4SECTION 423.2315
   423.2315 Medicare Coverage Gap Discount Program Agreement.
42:3.0.1.1.10.23.9.5SECTION 423.2320
   423.2320 Payment processes for Part D sponsors.
42:3.0.1.1.10.23.9.6SECTION 423.2325
   423.2325 Provision of applicable discounts.
42:3.0.1.1.10.23.9.7SECTION 423.2330
   423.2330 Manufacturer discount payment audit and dispute resolution.
42:3.0.1.1.10.23.9.8SECTION 423.2335
   423.2335 Beneficiary dispute resolution.
42:3.0.1.1.10.23.9.9SECTION 423.2340
   423.2340 Compliance monitoring and civil money penalties.
42:3.0.1.1.10.23.9.10SECTION 423.2345
   423.2345 Termination of Discount Program Agreement.
42:3.0.1.1.10.24SUBPART X
Subpart X - Requirements for a Minimum Medical Loss Ratio
42:3.0.1.1.10.24.9.1SECTION 423.2400
   423.2400 Basis and scope.
42:3.0.1.1.10.24.9.2SECTION 423.2401
   423.2401 Definitions.
42:3.0.1.1.10.24.9.3SECTION 423.2410
   423.2410 General requirements.
42:3.0.1.1.10.24.9.4SECTION 423.2420
   423.2420 Calculation of medical loss ratio.
42:3.0.1.1.10.24.9.5SECTION 423.2430
   423.2430 Activities that improve health care quality.
42:3.0.1.1.10.24.9.6SECTION 423.2440
   423.2440 Credibility adjustment.
42:3.0.1.1.10.24.9.7SECTION 423.2450
   423.2450 [Reserved]
42:3.0.1.1.10.24.9.8SECTION 423.2460
   423.2460 Reporting requirements.
42:3.0.1.1.10.24.9.9SECTION 423.2470
   423.2470 Remittance to CMS if the applicable MLR requirement is not met.
42:3.0.1.1.10.24.9.10SECTION 423.2480
   423.2480 MLR review and non-compliance.
42:3.0.1.1.10.24.9.11SECTION 423.2490
   423.2490 Release of Part D MLR data.
42:3.0.1.1.10.25SUBPART Y
Subpart Y [Reserved]
42:3.0.1.1.10.26SUBPART Z
Subpart Z - Recovery Audit Contractor Part C Appeals Process
42:3.0.1.1.10.26.9.1SECTION 423.2600
   423.2600 Payment appeals.
42:3.0.1.1.10.26.9.2SECTION 423.2605
   423.2605 Request for reconsideration.
42:3.0.1.1.10.26.9.3SECTION 423.2610
   423.2610 Hearing official review.
42:3.0.1.1.10.26.9.4SECTION 423.2615
   423.2615 Review by the Administrator.