Title 42

PART 423

Part 423 - Voluntary Medicare Prescription Drug Benefit

PART 423 - VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT Authority:42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh. Source:70 FR 4525, Jan. 28, 2005, unless otherwise noted.

• Authority: 42 U.S.C. 1302, 1306, 1395w-101 through 1395w-152, and 1395hh.
• Source: 70 FR 4525, Jan. 28, 2005, unless otherwise noted.

42:3.0.1.1.10.1	SUBPART A	Subpart A - General Provisions
42:3.0.1.1.10.1.11.1	SECTION 423.1	423.1 Basis and scope.
42:3.0.1.1.10.1.11.2	SECTION 423.4	423.4 Definitions.
42:3.0.1.1.10.1.11.3	SECTION 423.6	423.6 Cost-sharing in beneficiary education and enrollment-related costs.
42:3.0.1.1.10.2	SUBPART B	Subpart B - Eligibility and Enrollment
42:3.0.1.1.10.2.11.1	SECTION 423.30	423.30 Eligibility and enrollment.
42:3.0.1.1.10.2.11.2	SECTION 423.32	423.32 Enrollment process.
42:3.0.1.1.10.2.11.3	SECTION 423.34	423.34 Enrollment of low-income subsidy eligible individuals.
42:3.0.1.1.10.2.11.4	SECTION 423.36	423.36 Disenrollment process.
42:3.0.1.1.10.2.11.5	SECTION 423.38	423.38 Enrollment periods.
42:3.0.1.1.10.2.11.6	SECTION 423.40	423.40 Effective dates.
42:3.0.1.1.10.2.11.7	SECTION 423.44	423.44 Involuntary disenrollment from Part D coverage.
42:3.0.1.1.10.2.11.8	SECTION 423.46	423.46 Late enrollment penalty.
42:3.0.1.1.10.2.11.9	SECTION 423.48	423.48 Information about Part D.
42:3.0.1.1.10.2.11.10	SECTION 423.56	423.56 Procedures to determine and document creditable status of prescription drug coverage.
42:3.0.1.1.10.3	SUBPART C	Subpart C - Benefits and Beneficiary Protections
42:3.0.1.1.10.3.11.1	SECTION 423.100	423.100 Definitions.
42:3.0.1.1.10.3.11.2	SECTION 423.104	423.104 Requirements related to qualified prescription drug coverage.
42:3.0.1.1.10.3.11.3	SECTION 423.112	423.112 Establishment of prescription drug plan service areas.
42:3.0.1.1.10.3.11.4	SECTION 423.120	423.120 Access to covered Part D drugs.
42:3.0.1.1.10.3.11.5	SECTION 423.124	423.124 Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.
42:3.0.1.1.10.3.11.6	SECTION 423.128	423.128 Dissemination of Part D plan information.
42:3.0.1.1.10.3.11.7	SECTION 423.132	423.132 Public disclosure of pharmaceutical prices for equivalent drugs.
42:3.0.1.1.10.3.11.8	SECTION 423.136	423.136 Privacy, confidentiality, and accuracy of enrollee records.
42:3.0.1.1.10.4	SUBPART D	Subpart D - Cost Control and Quality Improvement Requirements
42:3.0.1.1.10.4.11.1	SECTION 423.150	423.150 Scope.
42:3.0.1.1.10.4.11.2	SECTION 423.153	423.153 Prescription drug plan sponsors' access to Medicare Parts A and B claims data extracts.
42:3.0.1.1.10.4.11.3	SECTION 423.154	423.154 Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans.
42:3.0.1.1.10.4.11.4	SECTION 423.156	423.156 Consumer satisfaction surveys.
42:3.0.1.1.10.4.11.5	SECTION 423.159	423.159 Electronic prescription drug program.
42:3.0.1.1.10.4.11.6	SECTION 423.160	423.160 Standards for electronic prescribing.
42:3.0.1.1.10.4.11.7	SECTION 423.162	423.162 Quality improvement organization activities.
42:3.0.1.1.10.4.11.8	SECTION 423.165	423.165 Compliance deemed on the basis of accreditation.
42:3.0.1.1.10.4.11.9	SECTION 423.168	423.168 Accreditation organizations.
42:3.0.1.1.10.4.11.10	SECTION 423.171	423.171 Procedures for approval of accreditation as a basis for deeming compliance.
42:3.0.1.1.10.4.11.11	SECTION 423.180	423.180 Basis and scope of the Part D Prescription Drug Plan Quality Rating System.
42:3.0.1.1.10.4.11.12	SECTION 423.182	423.182 Part D Prescription Drug Plan Quality Rating System.
42:3.0.1.1.10.4.11.13	SECTION 423.184	423.184 Adding, updating, and removing measures.
42:3.0.1.1.10.4.11.14	SECTION 423.186	423.186 Calculation of Star Ratings.
42:3.0.1.1.10.5	SUBPART E	Subpart E [Reserved]
42:3.0.1.1.10.6	SUBPART F	Subpart F - Submission of Bids and Monthly Beneficiary Premiums; Plan Approval
42:3.0.1.1.10.6.11.1	SECTION 423.251	423.251 Scope.
42:3.0.1.1.10.6.11.2	SECTION 423.258	423.258 Definitions.
42:3.0.1.1.10.6.11.3	SECTION 423.265	423.265 Submission of bids and related information.
42:3.0.1.1.10.6.11.4	SECTION 423.272	423.272 Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.
42:3.0.1.1.10.6.11.5	SECTION 423.279	423.279 National average monthly bid amount.
42:3.0.1.1.10.6.11.6	SECTION 423.286	423.286 Rules regarding premiums.
42:3.0.1.1.10.6.11.7	SECTION 423.293	423.293 Collection of monthly beneficiary premium.
42:3.0.1.1.10.7	SUBPART G	Subpart G - Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage
42:3.0.1.1.10.7.11.1	SECTION 423.301	423.301 Scope.
42:3.0.1.1.10.7.11.2	SECTION 423.308	423.308 Definitions and terminology.
42:3.0.1.1.10.7.11.3	SECTION 423.315	423.315 General payment provisions.
42:3.0.1.1.10.7.11.4	SECTION 423.322	423.322 Requirement for disclosure of information.
42:3.0.1.1.10.7.11.5	SECTION 423.329	423.329 Determination of payments.
42:3.0.1.1.10.7.11.6	SECTION 423.336	423.336 Risk-sharing arrangements.
42:3.0.1.1.10.7.11.7	SECTION 423.343	423.343 Retroactive adjustments and reconciliations.
42:3.0.1.1.10.7.11.8	SECTION 423.346	423.346 Reopening.
42:3.0.1.1.10.7.11.9	SECTION 423.350	423.350 Payment appeals.
42:3.0.1.1.10.7.11.10	SECTION 423.352	423.352 CMS-identified overpayments associated with payment data submitted by Part D sponsors.
42:3.0.1.1.10.7.11.11	SECTION 423.360	423.360 Reporting and returning of overpayments.
42:3.0.1.1.10.8	SUBPART H	Subpart H [Reserved]
42:3.0.1.1.10.9	SUBPART I	Subpart I - Organization Compliance with State Law and Preemption by Federal Law
42:3.0.1.1.10.9.11.1	SECTION 423.401	423.401 General requirements for PDP sponsors.
42:3.0.1.1.10.9.11.2	SECTION 423.410	423.410 Waiver of certain requirements to expand choice.
42:3.0.1.1.10.9.11.3	SECTION 423.415	423.415 Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region
42:3.0.1.1.10.9.11.4	SECTION 423.420	423.420 Solvency standards for non-licensed entities.
42:3.0.1.1.10.9.11.5	SECTION 423.425	423.425 Licensure does not substitute for or constitute certification.
42:3.0.1.1.10.9.11.6	SECTION 423.440	423.440 Prohibition of State imposition of premium taxes; relation to State laws.
42:3.0.1.1.10.10	SUBPART J	Subpart J - Coordination of Part D Plans With Other Prescription Drug Coverage
42:3.0.1.1.10.10.11.1	SECTION 423.452	423.452 Scope.
42:3.0.1.1.10.10.11.2	SECTION 423.454	423.454 Definitions.
42:3.0.1.1.10.10.11.3	SECTION 423.458	423.458 Application of Part D rules to certain Part D plans on and after January 1, 2006.
42:3.0.1.1.10.10.11.4	SECTION 423.462	423.462 Medicare secondary payer procedures.
42:3.0.1.1.10.10.11.5	SECTION 423.464	423.464 Coordination of benefits with other providers of prescription drug coverage.
42:3.0.1.1.10.10.11.6	SECTION 423.466	423.466 Timeframes for coordination of benefits and claims adjustments.
42:3.0.1.1.10.11	SUBPART K	Subpart K - Application Procedures and Contracts with Part D plan sponsors
42:3.0.1.1.10.11.11.1	SECTION 423.500	423.500 Scope.
42:3.0.1.1.10.11.11.2	SECTION 423.501	423.501 Definitions
42:3.0.1.1.10.11.11.3	SECTION 423.502	423.502 Application requirements.
42:3.0.1.1.10.11.11.4	SECTION 423.503	423.503 Evaluation and determination procedures for applications to be determined qualified to act as a sponsor.
42:3.0.1.1.10.11.11.5	SECTION 423.504	423.504 General provisions.
42:3.0.1.1.10.11.11.6	SECTION 423.505	423.505 Contract provisions.
42:3.0.1.1.10.11.11.7	SECTION 423.506	423.506 Effective date and term of contract.
42:3.0.1.1.10.11.11.8	SECTION 423.507	423.507 Nonrenewal of contract.
42:3.0.1.1.10.11.11.9	SECTION 423.508	423.508 Modification or termination of contract by mutual consent.
42:3.0.1.1.10.11.11.10	SECTION 423.509	423.509 Termination of contract by CMS.
42:3.0.1.1.10.11.11.11	SECTION 423.510	423.510 Termination of contract by the Part D sponsor.
42:3.0.1.1.10.11.11.12	SECTION 423.512	423.512 Minimum enrollment requirements.
42:3.0.1.1.10.11.11.13	SECTION 423.514	423.514 Validation of Part D reporting requirements.
42:3.0.1.1.10.11.11.14	SECTION 423.516	423.516 Prohibition of midyear implementation of significant new regulatory requirements.
42:3.0.1.1.10.11.11.15	SECTION 423.520	423.520 Prompt payment by Part D sponsors.
42:3.0.1.1.10.12	SUBPART L	Subpart L - Effect of Change of Ownership or Leasing of Facilities During Term of Contract
42:3.0.1.1.10.12.11.1	SECTION 423.551	423.551 General provisions.
42:3.0.1.1.10.12.11.2	SECTION 423.552	423.552 Novation agreement requirements.
42:3.0.1.1.10.12.11.3	SECTION 423.553	423.553 Effect of leasing of a PDP sponsor's facilities.
42:3.0.1.1.10.13	SUBPART M	Subpart M - Grievances, Coverage Determinations, Redeterminations, and Reconsiderations
42:3.0.1.1.10.13.11.1	SECTION 423.558	423.558 Scope.
42:3.0.1.1.10.13.11.2	SECTION 423.560	423.560 Definitions.
42:3.0.1.1.10.13.11.3	SECTION 423.562	423.562 General provisions.
42:3.0.1.1.10.13.11.4	SECTION 423.564	423.564 Grievance procedures.
42:3.0.1.1.10.13.11.5	SECTION 423.566	423.566 Coverage determinations.
42:3.0.1.1.10.13.11.6	SECTION 423.568	423.568 Standard timeframe and notice requirements for coverage determinations.
42:3.0.1.1.10.13.11.7	SECTION 423.570	423.570 Expediting certain coverage determinations.
42:3.0.1.1.10.13.11.8	SECTION 423.572	423.572 Timeframes and notice requirements for expedited coverage determinations.
42:3.0.1.1.10.13.11.9	SECTION 423.576	423.576 Effect of a coverage determination.
42:3.0.1.1.10.13.11.10	SECTION 423.578	423.578 Exceptions process.
42:3.0.1.1.10.13.11.11	SECTION 423.580	423.580 Right to a redetermination.
42:3.0.1.1.10.13.11.12	SECTION 423.582	423.582 Request for a standard redetermination.
42:3.0.1.1.10.13.11.13	SECTION 423.584	423.584 Expediting certain redeterminations.
42:3.0.1.1.10.13.11.14	SECTION 423.586	423.586 Opportunity to submit evidence.
42:3.0.1.1.10.13.11.15	SECTION 423.590	423.590 Timeframes and responsibility for making redeterminations.
42:3.0.1.1.10.13.11.16	SECTION 423.600	423.600 Reconsideration by an independent review entity (IRE).
42:3.0.1.1.10.13.11.17	SECTION 423.602	423.602 Notice of reconsideration determination by the independent review entity.
42:3.0.1.1.10.13.11.18	SECTION 423.604	423.604 Effect of a reconsideration determination.
42:3.0.1.1.10.13.11.19	SECTION 423.610-423.634	423.610-423.634 [Reserved]
42:3.0.1.1.10.13.11.20	SECTION 423.636	423.636 How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.
42:3.0.1.1.10.13.11.21	SECTION 423.638	423.638 How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.
42:3.0.1.1.10.14	SUBPART N	Subpart N - Medicare Contract Determinations and Appeals
42:3.0.1.1.10.14.11.1	SECTION 423.641	423.641 Contract determinations.
42:3.0.1.1.10.14.11.2	SECTION 423.642	423.642 Notice of contract determination.
42:3.0.1.1.10.14.11.3	SECTION 423.643	423.643 Effect of contract determination.
42:3.0.1.1.10.14.11.4	SECTION 423.650	423.650 Right to a hearing, burden of proof, standard of proof, and standards of review.
42:3.0.1.1.10.14.11.5	SECTION 423.651	423.651 Request for hearing.
42:3.0.1.1.10.14.11.6	SECTION 423.652	423.652 Postponement of effective date of a contract determination when a request for a hearing is filed timely.
42:3.0.1.1.10.14.11.7	SECTION 423.653	423.653 Designation of hearing officer.
42:3.0.1.1.10.14.11.8	SECTION 423.654	423.654 Disqualification of hearing officer.
42:3.0.1.1.10.14.11.9	SECTION 423.655	423.655 Time and place of hearing.
42:3.0.1.1.10.14.11.10	SECTION 423.656	423.656 Appointment of representatives.
42:3.0.1.1.10.14.11.11	SECTION 423.657	423.657 Authority of representatives.
42:3.0.1.1.10.14.11.12	SECTION 423.658	423.658 Conduct of hearing.
42:3.0.1.1.10.14.11.13	SECTION 423.659	423.659 Evidence.
42:3.0.1.1.10.14.11.14	SECTION 423.660	423.660 Witnesses.
42:3.0.1.1.10.14.11.15	SECTION 423.661	423.661 Witnesses lists and documents.
42:3.0.1.1.10.14.11.16	SECTION 423.662	423.662 Prehearing and summary judgment.
42:3.0.1.1.10.14.11.17	SECTION 423.663	423.663 Record of hearing.
42:3.0.1.1.10.14.11.18	SECTION 423.664	423.664 Authority of hearing officer.
42:3.0.1.1.10.14.11.19	SECTION 423.665	423.665 Notice and effect of hearing decision.
42:3.0.1.1.10.14.11.20	SECTION 423.666	423.666 Review by the Administrator.
42:3.0.1.1.10.14.11.21	SECTION 423.667	423.667 Effect of Administrator's decision.
42:3.0.1.1.10.14.11.22	SECTION 423.668	423.668 Reopening of a contract determination or decision of a hearing officer or the Administrator.
42:3.0.1.1.10.15	SUBPART O	Subpart O - Intermediate Sanctions
42:3.0.1.1.10.15.11.1	SECTION 423.750	423.750 Types of intermediate sanctions and civil money penalties.
42:3.0.1.1.10.15.11.2	SECTION 423.752	423.752 Basis for imposing intermediate sanctions and civil money penalties.
42:3.0.1.1.10.15.11.3	SECTION 423.756	423.756 Procedures for imposing intermediate sanctions and civil money penalties.
42:3.0.1.1.10.15.11.4	SECTION 423.758	423.758 Collection of civil money penalties imposed by CMS.
42:3.0.1.1.10.15.11.5	SECTION 423.760	423.760 Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
42:3.0.1.1.10.15.11.6	SECTION 423.762	423.762 Settlement of penalties.
42:3.0.1.1.10.15.11.7	SECTION 423.764	423.764 Other applicable provisions.
42:3.0.1.1.10.16	SUBPART P	Subpart P - Premiums and Cost-Sharing Subsidies for Low-Income Individuals
42:3.0.1.1.10.16.11.1	SECTION 423.771	423.771 Basis and scope.
42:3.0.1.1.10.16.11.2	SECTION 423.772	423.772 Definitions.
42:3.0.1.1.10.16.11.3	SECTION 423.773	423.773 Requirements for eligibility.
42:3.0.1.1.10.16.11.4	SECTION 423.774	423.774 Eligibility determinations, redeterminations, and applications.
42:3.0.1.1.10.16.11.5	SECTION 423.780	423.780 Premium subsidy.
42:3.0.1.1.10.16.11.6	SECTION 423.782	423.782 Cost-sharing subsidy.
42:3.0.1.1.10.16.11.7	SECTION 423.800	423.800 Administration of subsidy program.
42:3.0.1.1.10.17	SUBPART Q	Subpart Q - Guaranteeing Access to a Choice of Coverage (Fallback Prescription Drug Plans)
42:3.0.1.1.10.17.11.1	SECTION 423.851	423.851 Scope.
42:3.0.1.1.10.17.11.2	SECTION 423.855	423.855 Definitions.
42:3.0.1.1.10.17.11.3	SECTION 423.859	423.859 Assuring access to a choice of coverage.
42:3.0.1.1.10.17.11.4	SECTION 423.863	423.863 Submission and approval of bids.
42:3.0.1.1.10.17.11.5	SECTION 423.867	423.867 Rules regarding premiums.
42:3.0.1.1.10.17.11.6	SECTION 423.871	423.871 Contract terms and conditions.
42:3.0.1.1.10.17.11.7	SECTION 423.875	423.875 Payment to fallback plans.
42:3.0.1.1.10.18	SUBPART R	Subpart R - Payments to Sponsors of Retiree Prescription Drug Plans
42:3.0.1.1.10.18.11.1	SECTION 423.880	423.880 Basis and scope.
42:3.0.1.1.10.18.11.2	SECTION 423.882	423.882 Definitions.
42:3.0.1.1.10.18.11.3	SECTION 423.884	423.884 Requirements for qualified retiree prescription drug plans.
42:3.0.1.1.10.18.11.4	SECTION 423.886	423.886 Retiree drug subsidy amounts.
42:3.0.1.1.10.18.11.5	SECTION 423.888	423.888 Payment methods, including provision of necessary information.
42:3.0.1.1.10.18.11.6	SECTION 423.890	423.890 Appeals.
42:3.0.1.1.10.18.11.7	SECTION 423.892	423.892 Change of ownership.
42:3.0.1.1.10.18.11.8	SECTION 423.894	423.894 Construction.
42:3.0.1.1.10.19	SUBPART S	Subpart S - Special Rules for States-Eligibility Determinations for Subsidies and General Payment Provisions
42:3.0.1.1.10.19.11.1	SECTION 423.900	423.900 Basis and scope.
42:3.0.1.1.10.19.11.2	SECTION 423.902	423.902 Definitions.
42:3.0.1.1.10.19.11.3	SECTION 423.904	423.904 Eligibility determinations for low-income subsidies.
42:3.0.1.1.10.19.11.4	SECTION 423.906	423.906 General payment provisions.
42:3.0.1.1.10.19.11.5	SECTION 423.907	423.907 Treatment of territories.
42:3.0.1.1.10.19.11.6	SECTION 423.908	423.908 Phased-down State contribution to drug benefit costs assumed by Medicare.
42:3.0.1.1.10.19.11.7	SECTION 423.910	423.910 Requirements.
42:3.0.1.1.10.20	SUBPART T	Subpart T - Appeal Procedures for Civil Money Penalties
42:3.0.1.1.10.20.11.1	SECTION 423.1000	423.1000 Basis and scope.
42:3.0.1.1.10.20.11.2	SECTION 423.1002	423.1002 Definitions.
42:3.0.1.1.10.20.11.3	SECTION 423.1004	423.1004 Scope and applicability.
42:3.0.1.1.10.20.11.4	SECTION 423.1006	423.1006 Appeal rights.
42:3.0.1.1.10.20.11.5	SECTION 423.1008	423.1008 Appointment of representatives.
42:3.0.1.1.10.20.11.6	SECTION 423.1010	423.1010 Authority of representatives.
42:3.0.1.1.10.20.11.7	SECTION 423.1012	423.1012 Fees for services of representatives.
42:3.0.1.1.10.20.11.8	SECTION 423.1014	423.1014 Charge for transcripts.
42:3.0.1.1.10.20.11.9	SECTION 423.1016	423.1016 Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.
42:3.0.1.1.10.20.11.10	SECTION 423.1018	423.1018 Notice and effect of initial determinations.
42:3.0.1.1.10.20.11.11	SECTION 423.1020	423.1020 Request for hearing.
42:3.0.1.1.10.20.11.12	SECTION 423.1022	423.1022 Parties to the hearing.
42:3.0.1.1.10.20.11.13	SECTION 423.1024	423.1024 Designation of hearing official.
42:3.0.1.1.10.20.11.14	SECTION 423.1026	423.1026 Disqualification of Administrative Law Judge.
42:3.0.1.1.10.20.11.15	SECTION 423.1028	423.1028 Prehearing conference.
42:3.0.1.1.10.20.11.16	SECTION 423.1030	423.1030 Notice of prehearing conference.
42:3.0.1.1.10.20.11.17	SECTION 423.1032	423.1032 Conduct of prehearing conference.
42:3.0.1.1.10.20.11.18	SECTION 423.1034	423.1034 Record, order, and effect of prehearing conference.
42:3.0.1.1.10.20.11.19	SECTION 423.1036	423.1036 Time and place of hearing.
42:3.0.1.1.10.20.11.20	SECTION 423.1038	423.1038 Change in time and place of hearing.
42:3.0.1.1.10.20.11.21	SECTION 423.1040	423.1040 Joint hearings.
42:3.0.1.1.10.20.11.22	SECTION 423.1042	423.1042 Hearing on new issues.
42:3.0.1.1.10.20.11.23	SECTION 423.1044	423.1044 Subpoenas.
42:3.0.1.1.10.20.11.24	SECTION 423.1046	423.1046 Conduct of hearing.
42:3.0.1.1.10.20.11.25	SECTION 423.1048	423.1048 Evidence.
42:3.0.1.1.10.20.11.26	SECTION 423.1050	423.1050 Witnesses.
42:3.0.1.1.10.20.11.27	SECTION 423.1052	423.1052 Oral and written summation.
42:3.0.1.1.10.20.11.28	SECTION 423.1054	423.1054 Record of hearing.
42:3.0.1.1.10.20.11.29	SECTION 423.1056	423.1056 Waiver of right to appear and present evidence.
42:3.0.1.1.10.20.11.30	SECTION 423.1058	423.1058 Dismissal of request for hearing.
42:3.0.1.1.10.20.11.31	SECTION 423.1060	423.1060 Dismissal for abandonment.
42:3.0.1.1.10.20.11.32	SECTION 423.1062	423.1062 Dismissal for cause.
42:3.0.1.1.10.20.11.33	SECTION 423.1064	423.1064 Notice and effect of dismissal and right to request review.
42:3.0.1.1.10.20.11.34	SECTION 423.1066	423.1066 Vacating a dismissal of request for hearing.
42:3.0.1.1.10.20.11.35	SECTION 423.1068	423.1068 Administrative Law Judge's decision.
42:3.0.1.1.10.20.11.36	SECTION 423.1070	423.1070 Removal of hearing to Departmental Appeals Board.
42:3.0.1.1.10.20.11.37	SECTION 423.1072	423.1072 Remand by the Administrative Law Judge.
42:3.0.1.1.10.20.11.38	SECTION 423.1074	423.1074 Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
42:3.0.1.1.10.20.11.39	SECTION 423.1076	423.1076 Request for Departmental Appeals Board review.
42:3.0.1.1.10.20.11.40	SECTION 423.1078	423.1078 Departmental Appeals Board action on request for review.
42:3.0.1.1.10.20.11.41	SECTION 423.1080	423.1080 Procedures before the Departmental Appeals Board on review.
42:3.0.1.1.10.20.11.42	SECTION 423.1082	423.1082 Evidence admissible on review.
42:3.0.1.1.10.20.11.43	SECTION 423.1084	423.1084 Decision or remand by the Departmental Appeals Board.
42:3.0.1.1.10.20.11.44	SECTION 423.1086	423.1086 Effect of Departmental Appeals Board Decision.
42:3.0.1.1.10.20.11.45	SECTION 423.1088	423.1088 Extension of time for seeking judicial review.
42:3.0.1.1.10.20.11.46	SECTION 423.1090	423.1090 Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.
42:3.0.1.1.10.20.11.47	SECTION 423.1092	423.1092 Revision of reopened decision.
42:3.0.1.1.10.20.11.48	SECTION 423.1094	423.1094 Notice and effect of revised decision.
42:3.0.1.1.10.21	SUBPART U	Subpart U - Reopening, ALJ Hearings and ALJ and Attorney Adjudicator Decisions, Council Review, and Judicial Review
42:3.0.1.1.10.21.11.1	SECTION 423.1968	423.1968 Scope.
42:3.0.1.1.10.21.11.2	SECTION 423.1970-423.1976	423.1970-423.1976 [Reserved]
42:3.0.1.1.10.21.11.3	SECTION 423.1978	423.1978 Reopening determinations and decisions.
42:3.0.1.1.10.21.11.4	SECTION 423.1980	423.1980 Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews.
42:3.0.1.1.10.21.11.5	SECTION 423.1982	423.1982 Notice of a revised determination or decision.
42:3.0.1.1.10.21.11.6	SECTION 423.1984	423.1984 Effect of a revised determination or decision.
42:3.0.1.1.10.21.11.7	SECTION 423.1986	423.1986 Good cause for reopening.
42:3.0.1.1.10.21.11.8	SECTION 423.1990	423.1990 Expedited access to judicial review.
42:3.0.1.1.10.21.11.9	SECTION 423.2000	423.2000 Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.
42:3.0.1.1.10.21.11.10	SECTION 423.2002	423.2002 Right to an ALJ hearing.
42:3.0.1.1.10.21.11.11	SECTION 423.2004	423.2004 Right to a review of IRE notice of dismissal.
42:3.0.1.1.10.21.11.12	SECTION 423.2006	423.2006 Amount in controversy required for an ALJ hearing and judicial review.
42:3.0.1.1.10.21.11.13	SECTION 423.2008	423.2008 Parties to the proceedings on a request for an ALJ hearing.
42:3.0.1.1.10.21.11.14	SECTION 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.
42:3.0.1.1.10.21.11.15	SECTION 423.2014	423.2014 Request for an ALJ hearing or a review of an IRE dismissal.
42:3.0.1.1.10.21.11.16	SECTION 423.2016	423.2016 Timeframes for deciding an appeal of an IRE reconsideration.
42:3.0.1.1.10.21.11.17	SECTION 423.2018	423.2018 Submitting evidence.
42:3.0.1.1.10.21.11.18	SECTION 423.2020	423.2020 Time and place for a hearing before an ALJ.
42:3.0.1.1.10.21.11.19	SECTION 423.2022	423.2022 Notice of a hearing before an ALJ.
42:3.0.1.1.10.21.11.20	SECTION 423.2024	423.2024 Objections to the issues.
42:3.0.1.1.10.21.11.21	SECTION 423.2026	423.2026 Disqualification of the ALJ or attorney adjudicator.
42:3.0.1.1.10.21.11.22	SECTION 423.2030	423.2030 ALJ hearing procedures.
42:3.0.1.1.10.21.11.23	SECTION 423.2032	423.2032 Issues before an ALJ or attorney adjudicator.
42:3.0.1.1.10.21.11.24	SECTION 423.2034	423.2034 Requesting information from the IRE.
42:3.0.1.1.10.21.11.25	SECTION 423.2036	423.2036 Description of an ALJ hearing process.
42:3.0.1.1.10.21.11.26	SECTION 423.2038	423.2038 Deciding a case without a hearing before an ALJ.
42:3.0.1.1.10.21.11.27	SECTION 423.2040	423.2040 Prehearing and posthearing conferences.
42:3.0.1.1.10.21.11.28	SECTION 423.2042	423.2042 The administrative record.
42:3.0.1.1.10.21.11.29	SECTION 423.2044	423.2044 Consolidated proceedings.
42:3.0.1.1.10.21.11.30	SECTION 423.2046	423.2046 Notice of an ALJ or attorney adjudicator decision.
42:3.0.1.1.10.21.11.31	SECTION 423.2048	423.2048 The effect of an ALJ's or attorney adjudicator's decision.
42:3.0.1.1.10.21.11.32	SECTION 423.2050	423.2050 Removal of a hearing request from OMHA to the Council.
42:3.0.1.1.10.21.11.33	SECTION 423.2052	423.2052 Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal.
42:3.0.1.1.10.21.11.34	SECTION 423.2054	423.2054 Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal.
42:3.0.1.1.10.21.11.35	SECTION 423.2056	423.2056 Remands of requests for hearing and requests for review.
42:3.0.1.1.10.21.11.36	SECTION 423.2058	423.2058 Effect of a remand.
42:3.0.1.1.10.21.11.37	SECTION 423.2062	423.2062 Applicability of policies not binding on the ALJ and Council.
42:3.0.1.1.10.21.11.38	SECTION 423.2063	423.2063 Applicability of laws, regulations, CMS Rulings, and precedential decisions.
42:3.0.1.1.10.21.11.39	SECTION 423.2100	423.2100 Medicare Appeals Council review: general.
42:3.0.1.1.10.21.11.40	SECTION 423.2102	423.2102 Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.
42:3.0.1.1.10.21.11.41	SECTION 423.2106	423.2106 Where a request for review may be filed.
42:3.0.1.1.10.21.11.42	SECTION 423.2108	423.2108 Council Actions when request for review is filed.
42:3.0.1.1.10.21.11.43	SECTION 423.2110	423.2110 Council reviews on its own motion.
42:3.0.1.1.10.21.11.44	SECTION 423.2112	423.2112 Content of request for review.
42:3.0.1.1.10.21.11.45	SECTION 423.2114	423.2114 Dismissal of request for review.
42:3.0.1.1.10.21.11.46	SECTION 423.2116	423.2116 Effect of dismissal of request for Council review or request for hearing.
42:3.0.1.1.10.21.11.47	SECTION 423.2118	423.2118 Obtaining evidence from the Council.
42:3.0.1.1.10.21.11.48	SECTION 423.2120	423.2120 Filing briefs with the Council.
42:3.0.1.1.10.21.11.49	SECTION 423.2122	423.2122 What evidence may be submitted to the Council.
42:3.0.1.1.10.21.11.50	SECTION 423.2124	423.2124 Oral argument.
42:3.0.1.1.10.21.11.51	SECTION 423.2126	423.2126 Case remanded by the Council.
42:3.0.1.1.10.21.11.52	SECTION 423.2128	423.2128 Action of the Council.
42:3.0.1.1.10.21.11.53	SECTION 423.2130	423.2130 Effect of the Council's decision.
42:3.0.1.1.10.21.11.54	SECTION 423.2134	423.2134 Extension of time to file action in Federal District Court.
42:3.0.1.1.10.21.11.55	SECTION 423.2136	423.2136 Judicial review.
42:3.0.1.1.10.21.11.56	SECTION 423.2138	423.2138 Case remanded by a Federal District Court.
42:3.0.1.1.10.21.11.57	SECTION 423.2140	423.2140 Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court.
42:3.0.1.1.10.22	SUBPART V	Subpart V - Part D Communication Requirements
42:3.0.1.1.10.22.11.1	SECTION 423.2260	423.2260 Definitions.
42:3.0.1.1.10.22.11.2	SECTION 423.2261	423.2261 xxx
42:3.0.1.1.10.22.11.3	SECTION 423.2262	423.2262 Review and distribution of marketing materials.
42:3.0.1.1.10.22.11.4	SECTION 423.2263	423.2263 xxx
42:3.0.1.1.10.22.11.5	SECTION 423.2264	423.2264 Guidelines for CMS review.
42:3.0.1.1.10.22.11.6	SECTION 423.2265	423.2265 xxx
42:3.0.1.1.10.22.11.7	SECTION 423.2266	423.2266 xxx
42:3.0.1.1.10.22.11.8	SECTION 423.2267	423.2267 xxx
42:3.0.1.1.10.22.11.9	SECTION 423.2268	423.2268 Standards for Part D Sponsor communications and marketing.
42:3.0.1.1.10.22.11.10	SECTION 423.2272	423.2272 Licensing of marketing representatives and confirmation of marketing resources.
42:3.0.1.1.10.22.11.11	SECTION 423.2274	423.2274 Broker and agent requirements.
42:3.0.1.1.10.22.11.12	SECTION 423.2276	423.2276 Employer group retiree marketing.
42:3.0.1.1.10.23	SUBPART W	Subpart W - Medicare Coverage Gap Discount Program
42:3.0.1.1.10.23.11.1	SECTION 423.2300	423.2300 Scope.
42:3.0.1.1.10.23.11.2	SECTION 423.2305	423.2305 Definitions.
42:3.0.1.1.10.23.11.3	SECTION 423.2310	423.2310 Condition for coverage of drugs under Part D.
42:3.0.1.1.10.23.11.4	SECTION 423.2315	423.2315 Medicare Coverage Gap Discount Program Agreement.
42:3.0.1.1.10.23.11.5	SECTION 423.2320	423.2320 Payment processes for Part D sponsors.
42:3.0.1.1.10.23.11.6	SECTION 423.2325	423.2325 Provision of applicable discounts.
42:3.0.1.1.10.23.11.7	SECTION 423.2330	423.2330 Manufacturer discount payment audit and dispute resolution.
42:3.0.1.1.10.23.11.8	SECTION 423.2335	423.2335 Beneficiary dispute resolution.
42:3.0.1.1.10.23.11.9	SECTION 423.2340	423.2340 Compliance monitoring and civil money penalties.
42:3.0.1.1.10.23.11.10	SECTION 423.2345	423.2345 Termination of Discount Program Agreement.
42:3.0.1.1.10.24	SUBPART X	Subpart X - Requirements for a Minimum Medical Loss Ratio
42:3.0.1.1.10.24.11.1	SECTION 423.2400	423.2400 Basis and scope.
42:3.0.1.1.10.24.11.2	SECTION 423.2401	423.2401 Definitions.
42:3.0.1.1.10.24.11.3	SECTION 423.2410	423.2410 General requirements.
42:3.0.1.1.10.24.11.4	SECTION 423.2420	423.2420 Calculation of medical loss ratio.
42:3.0.1.1.10.24.11.5	SECTION 423.2430	423.2430 Activities that improve health care quality.
42:3.0.1.1.10.24.11.6	SECTION 423.2440	423.2440 Credibility adjustment.
42:3.0.1.1.10.24.11.7	SECTION 423.2450	423.2450 [Reserved]
42:3.0.1.1.10.24.11.8	SECTION 423.2460	423.2460 Reporting requirements.
42:3.0.1.1.10.24.11.9	SECTION 423.2470	423.2470 Remittance to CMS if the applicable MLR requirement is not met.
42:3.0.1.1.10.24.11.10	SECTION 423.2480	423.2480 MLR review and non-compliance.
42:3.0.1.1.10.24.11.11	SECTION 423.2490	423.2490 Release of Part D MLR data.
42:3.0.1.1.10.25	SUBPART Y	Subpart Y [Reserved]
42:3.0.1.1.10.26	SUBPART Z	Subpart Z - Recovery Audit Contractor Part C Appeals Process
42:3.0.1.1.10.26.11.1	SECTION 423.2600	423.2600 Payment appeals.
42:3.0.1.1.10.26.11.2	SECTION 423.2605	423.2605 Request for reconsideration.
42:3.0.1.1.10.26.11.3	SECTION 423.2610	423.2610 Hearing official review.
42:3.0.1.1.10.26.11.4	SECTION 423.2615	423.2615 Review by the Administrator.

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