Subpart A - General Provisions

§ 423.1 - Basis and scope.

§ 423.4 - Definitions.

§ 423.6 - Cost-sharing in beneficiary education and enrollment-related costs.

Subpart B - Eligibility and Enrollment

§ 423.30 - Eligibility and enrollment.

§ 423.32 - Enrollment process.

§ 423.34 - Enrollment of low-income subsidy eligible individuals.

§ 423.36 - Disenrollment process.

§ 423.38 - Enrollment periods.

§ 423.40 - Effective dates.

§ 423.44 - Involuntary disenrollment from Part D coverage.

§ 423.46 - Late enrollment penalty.

§ 423.48 - Information about Part D.

§ 423.50 - Approval of marketing materials and enrollment forms.

§ 423.56 - Procedures to determine and document creditable status of prescription drug coverage.

Subpart C - Benefits and Beneficiary Protections

§ 423.100 - Definitions.

§ 423.104 - Requirements related to qualified prescription drug coverage.

§ 423.112 - Establishment of prescription drug plan service areas.

§ 423.120 - Access to covered Part D drugs.

§ 423.124 - Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.

§ 423.128 - Dissemination of Part D plan information.

§ 423.129 - Resolution of complaints in complaints tracking module.

§ 423.132 - Public disclosure of pharmaceutical prices for equivalent drugs.

§ 423.136 - Privacy, confidentiality, and accuracy of enrollee records.

Subpart D - Cost Control and Quality Improvement Requirements

§ 423.150 - Scope.

§ 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.

§ 423.154 - Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA–PD plans.

§ 423.156 - Consumer satisfaction surveys.

§ 423.159 - Electronic prescription drug program.

§ 423.160 - Standards for electronic prescribing.

§ 423.162 - Quality improvement organization activities.

§ 423.165 - Compliance deemed on the basis of accreditation.

§ 423.168 - Accreditation organizations.

§ 423.171 - Procedures for approval of accreditation as a basis for deeming compliance.

§ 423.180 - xxx

§ 423.182 - Part D Prescription Drug Plan Quality Rating System.

§ 423.184 - Adding, updating, and removing measures.

§ 423.186 - Calculation of Star Ratings.

Subpart E - XXX

Subpart F - Submission of Bids and Monthly Beneficiary Premiums; Plan Approval

§ 423.251 - Scope.

§ 423.258 - Definitions.

§ 423.265 - Submission of bids and related information.

§ 423.272 - Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.

§ 423.279 - National average monthly bid amount.

§ 423.286 - Rules regarding premiums.

§ 423.293 - Collection of monthly beneficiary premium.

§ 423.294 - Failure to collect and incorrect collections of premiums and cost sharing.

Subpart G - Payments to Part D Plan Sponsors For Qualified Prescription Drug Coverage

§ 423.301 - Scope.

§ 423.308 - Definitions and terminology.

§ 423.315 - General payment provisions.

§ 423.322 - Requirement for disclosure of information.

§ 423.329 - Determination of payments.

§ 423.336 - Risk-sharing arrangements.

§ 423.343 - Retroactive adjustments and reconciliations.

§ 423.346 - Reopening.

§ 423.350 - Payment appeals.

§ 423.352 - CMS-identified overpayments associated with payment data submitted by Part D sponsors.

§ 423.360 - Reporting and returning of overpayments.

Subpart H - XXX

Subpart I - Organization Compliance with State Law and Preemption by Federal Law

§ 423.401 - General requirements for PDP sponsors.

§ 423.410 - Waiver of certain requirements to expand choice.

§ 423.415 - Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region

§ 423.420 - Solvency standards for non-licensed entities.

§ 423.425 - Licensure does not substitute for or constitute certification.

§ 423.440 - Prohibition of State imposition of premium taxes; relation to State laws.

Subpart J - Coordination of Part D Plans With Other Prescription Drug Coverage

§ 423.452 - Scope.

§ 423.454 - Definitions.

§ 423.458 - Application of Part D rules to certain Part D plans on and after January 1, 2006.

§ 423.462 - Medicare secondary payer procedures.

§ 423.464 - Coordination of benefits with other providers of prescription drug coverage.

§ 423.466 - Timeframes for coordination of benefits and claims adjustments.

Subpart K - Application Procedures and Contracts with Part D plan sponsors

§ 423.500 - Scope.

§ 423.501 - Definitions

§ 423.502 - Application requirements.

§ 423.503 - Evaluation and determination procedures.

§ 423.504 - General provisions.

§ 423.505 - Contract provisions.

§ 423.506 - Effective date and term of contract.

§ 423.507 - Nonrenewal of contract.

§ 423.508 - Modification or termination of contract by mutual consent.

§ 423.509 - Termination of contract by CMS.

§ 423.510 - Termination of contract by the Part D sponsor.

§ 423.512 - Minimum enrollment requirements.

§ 423.514 - Validation of Part D reporting requirements.

§ 423.516 - Prohibition of midyear implementation of significant new regulatory requirements.

§ 423.520 - Prompt payment by Part D sponsors.

§ 423.521 - Final settlement process and payment.

§ 423.522 - Requesting an appeal of the final settlement amount.

§ 423.530 - Plan crosswalks.

Subpart L - Effect of Change of Ownership or Leasing of Facilities During Term of Contract

§ 423.551 - General provisions.

§ 423.552 - Novation agreement requirements.

§ 423.553 - Effect of leasing of a PDP sponsor's facilities.

Subpart M - Grievances, Coverage Determinations, Redeterminations, and Reconsiderations

§ 423.558 - Scope.

§ 423.560 - Definitions.

§ 423.562 - General provisions.

§ 423.564 - Grievance procedures.

§ 423.566 - Coverage determinations.

§ 423.568 - Standard timeframe and notice requirements for coverage determinations.

§ 423.570 - Expediting certain coverage determinations.

§ 423.572 - Timeframes and notice requirements for expedited coverage determinations.

§ 423.576 - Effect of a coverage determination.

§ 423.578 - Exceptions process.

§ 423.580 - Right to a redetermination.

§ 423.582 - Request for a standard redetermination.

§ 423.584 - Expediting certain redeterminations.

§ 423.586 - Opportunity to submit evidence.

§ 423.590 - Timeframes and responsibility for making redeterminations.

§ 423.600 - Reconsideration by an independent review entity (IRE).

§ 423.602 - Notice of reconsideration determination by the independent review entity.

§ 423.604 - Effect of a reconsideration determination.

§ 423.610 - Right to an ALJ hearing.

§ 423.612 - Request for an ALJ hearing.

§ 423.620 - Medicare Appeals Council (MAC) review.

§ 423.630 - Judicial review.

§§ 423.610--423.634 - [Reserved]

§ 423.634 - Reopening and revising determinations and decisions.

§ 423.636 - How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.

§ 423.638 - How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.

Subpart N - Medicare Contract Determinations and Appeals

§ 423.641 - Contract determinations.

§ 423.642 - Notice of contract determination.

§ 423.643 - Effect of contract determination.

§ 423.644 - Reconsideration: Applicability.

§ 423.645 - Request for reconsideration.

§ 423.646 - Opportunity to submit evidence.

§ 423.647 - Reconsidered determination.

§ 423.648 - Notice of reconsidered determination.

§ 423.649 - Effect of reconsidered determination.

§ 423.650 - Right to a hearing, burden of proof, standard of proof, and standards of review.

§ 423.651 - Request for hearing.

§ 423.652 - Postponement of effective date of a contract determination when a request for a hearing is filed timely.

§ 423.653 - Designation of hearing officer.

§ 423.654 - Disqualification of hearing officer.

§ 423.655 - Time and place of hearing.

§ 423.656 - Appointment of representatives.

§ 423.657 - Authority of representatives.

§ 423.658 - Conduct of hearing.

§ 423.659 - Evidence.

§ 423.660 - Witnesses.

§ 423.661 - Witnesses lists and documents.

§ 423.662 - Prehearing and summary judgment.

§ 423.663 - Record of hearing.

§ 423.664 - Authority of hearing officer.

§ 423.665 - Notice and effect of hearing decision.

§ 423.666 - Review by the Administrator.

§ 423.667 - Effect of Administrator's decision.

§ 423.668 - Reopening of a contract determination or decision of a hearing officer or the Administrator.

§ 423.669 - Effect of revised determination.

Subpart O - Intermediate Sanctions

§ 423.750 - Types of intermediate sanctions and civil money penalties.

§ 423.752 - Basis for imposing intermediate sanctions and civil money penalties.

§ 423.756 - Procedures for imposing intermediate sanctions and civil money penalties.

§ 423.758 - Collection of civil money penalties imposed by CMS.

§ 423.760 - Determinations regarding the amount of civil money penalties and assessment imposed by CMS.

§ 423.762 - Settlement of penalties.

§ 423.764 - Other applicable provisions.

Subpart P - Premiums and Cost-Sharing Subsidies for Low-Income Individuals

§ 423.771 - Basis and scope.

§ 423.772 - Definitions.

§ 423.773 - Requirements for eligibility.

§ 423.774 - Eligibility determinations, redeterminations, and applications.

§ 423.780 - Premium subsidy.

§ 423.782 - Cost-sharing subsidy.

§ 423.800 - Administration of subsidy program.

Subpart Q - Guaranteeing Access to a Choice of Coverage (Fallback Prescription Drug Plans)

§ 423.851 - Scope.

§ 423.855 - Definitions.

§ 423.859 - Assuring access to a choice of coverage.

§ 423.863 - Submission and approval of bids.

§ 423.867 - Rules regarding premiums.

§ 423.871 - Contract terms and conditions.

§ 423.875 - Payment to fallback plans.

Subpart R - Payments to Sponsors of Retiree Prescription Drug Plans

§ 423.880 - Basis and scope.

§ 423.882 - Definitions.

§ 423.884 - Requirements for qualified retiree prescription drug plans.

§ 423.886 - Retiree drug subsidy amounts.

§ 423.888 - Payment methods, including provision of necessary information.

§ 423.890 - Appeals.

§ 423.892 - Change of ownership.

§ 423.894 - Construction.

Subpart S - Special Rules for States-Eligibility Determinations for Subsidies and General Payment Provisions

§ 423.900 - Basis and scope.

§ 423.902 - Definitions.

§ 423.904 - Eligibility determinations for low-income subsidies.

§ 423.906 - General payment provisions.

§ 423.907 - Treatment of territories.

§ 423.908 - Phased-down State contribution to drug benefit costs assumed by Medicare.

§ 423.910 - Requirements.

Subpart T - Appeal Procedures for Civil Money Penalties

§ 423.1000 - Basis and scope.

§ 423.1002 - Definitions.

§ 423.1004 - Scope and applicability.

§ 423.1006 - Appeal rights.

§ 423.1008 - Appointment of representatives.

§ 423.1010 - Authority of representatives.

§ 423.1012 - Fees for services of representatives.

§ 423.1014 - Charge for transcripts.

§ 423.1016 - Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.

§ 423.1018 - Notice and effect of initial determinations.

§ 423.1020 - Request for hearing.

§ 423.1022 - Parties to the hearing.

§ 423.1024 - Designation of hearing official.

§ 423.1026 - Disqualification of Administrative Law Judge.

§ 423.1028 - Prehearing conference.

§ 423.1030 - Notice of prehearing conference.

§ 423.1032 - Conduct of prehearing conference.

§ 423.1034 - Record, order, and effect of prehearing conference.

§ 423.1036 - Time and place of hearing.

§ 423.1038 - Change in time and place of hearing.

§ 423.1040 - Joint hearings.

§ 423.1042 - Hearing on new issues.

§ 423.1044 - Subpoenas.

§ 423.1046 - Conduct of hearing.

§ 423.1048 - Evidence.

§ 423.1050 - Witnesses.

§ 423.1052 - Oral and written summation.

§ 423.1054 - Record of hearing.

§ 423.1056 - Waiver of right to appear and present evidence.

§ 423.1058 - Dismissal of request for hearing.

§ 423.1060 - Dismissal for abandonment.

§ 423.1062 - Dismissal for cause.

§ 423.1064 - Notice and effect of dismissal and right to request review.

§ 423.1066 - Vacating a dismissal of request for hearing.

§ 423.1068 - Administrative Law Judge's decision.

§ 423.1070 - Removal of hearing to Departmental Appeals Board.

§ 423.1072 - Remand by the Administrative Law Judge.

§ 423.1074 - Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.

§ 423.1076 - Request for Departmental Appeals Board review.

§ 423.1078 - Departmental Appeals Board action on request for review.

§ 423.1080 - Procedures before the Departmental Appeals Board on review.

§ 423.1082 - Evidence admissible on review.

§ 423.1084 - Decision or remand by the Departmental Appeals Board.

§ 423.1086 - Effect of Departmental Appeals Board Decision.

§ 423.1088 - Extension of time for seeking judicial review.

§ 423.1090 - Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.

§ 423.1092 - Revision of reopened decision.

§ 423.1094 - Notice and effect of revised decision.

Subpart U - Reopening, ALJ Hearings and ALJ and Attorney Adjudicator Decisions, Council Review, and Judicial Review

§ 423.1968 - Scope.

§ 423.1970 - Right to an ALJ hearing.

§ 423.1972 - Request for an ALJ hearing.

§ 423.1974 - Council review.

§§ 423.1970--423.1976 - [Reserved]

§ 423.1976 - Judicial review.

§ 423.1978 - Reopening determinations and decisions.

§ 423.1980 - Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews.

§ 423.1982 - Notice of a revised determination or decision.

§ 423.1984 - Effect of a revised determination or decision.

§ 423.1986 - Good cause for reopening.

§ 423.1990 - Expedited access to judicial review.

§ 423.2000 - Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.

§ 423.2002 - Right to an ALJ hearing.

§ 423.2004 - Right to a review of IRE notice of dismissal.

§ 423.2006 - xxx

§ 423.2008 - Parties to the proceedings on a request for an ALJ hearing.

§ 423.2010 - When CMS, the IRE, or Part D plan sponsors may participate in the proceedings on a request for an ALJ hearing.

§ 423.2014 - Request for an ALJ hearing or a review of an IRE dismissal.

§ 423.2016 - Timeframes for deciding an appeal of an IRE reconsideration.

§ 423.2018 - Submitting evidence.

§ 423.2020 - Time and place for a hearing before an ALJ.

§ 423.2022 - Notice of a hearing before an ALJ.

§ 423.2024 - Objections to the issues.

§ 423.2026 - Disqualification of the ALJ or attorney adjudicator.

§ 423.2030 - ALJ hearing procedures.

§ 423.2032 - Issues before an ALJ or attorney adjudicator.

§ 423.2034 - Requesting information from the IRE.

§ 423.2036 - Description of an ALJ hearing process.

§ 423.2038 - Deciding a case without a hearing before an ALJ.

§ 423.2040 - Prehearing and posthearing conferences.

§ 423.2042 - The administrative record.

§ 423.2044 - Consolidated proceedings.

§ 423.2046 - Notice of an ALJ or attorney adjudicator decision.

§ 423.2048 - The effect of an ALJ's or attorney adjudicator's decision.

§ 423.2050 - Removal of a hearing request from OMHA to the Council.

§ 423.2052 - Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal.

§ 423.2054 - Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal.

§ 423.2056 - xxx

§ 423.2058 - xxx

§ 423.2062 - Applicability of policies not binding on the ALJ and Council.

§ 423.2063 - Applicability of laws, regulations, CMS Rulings, and precedential decisions.

§ 423.2100 - Medicare appeals council review: general.

§ 423.2102 - Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.

§ 423.2106 - Where a request for review may be filed.

§ 423.2108 - Council Actions when request for review is filed.

§ 423.2110 - Council reviews on its own motion.

§ 423.2112 - Content of request for review.

§ 423.2114 - Dismissal of request for review.

§ 423.2116 - Effect of dismissal of request for Council review or request for hearing.

§ 423.2118 - Obtaining evidence from the Council.

§ 423.2120 - Filing briefs with the Council.

§ 423.2122 - What evidence may be submitted to the Council.

§ 423.2124 - Oral argument.

§ 423.2126 - Case remanded by the Council.

§ 423.2128 - Action of the Council.

§ 423.2130 - Effect of the Council's decision.

§ 423.2134 - Extension of time to file action in Federal District Court.

§ 423.2136 - Judicial review.

§ 423.2138 - Case remanded by a Federal District Court.

§ 423.2140 - Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court.

Subpart V - Part D Communication Requirements

§ 423.2260 - Definitions.

§ 423.2261 - Submission, review, and distribution of materials.

§ 423.2262 - General communications materials and activity requirements.

§ 423.2263 - General marketing requirements.

§ 423.2264 - Beneficiary contact.

§ 423.2265 - xxx

§ 423.2266 - Activities with healthcare providers or in the healthcare setting.

§ 423.2267 - Required materials and content.

§ 423.2268 - Standards for Part D Sponsor communications and marketing.

§ 423.2272 - Licensing of marketing representatives and confirmation of marketing resources.

§ 423.2274 - Agent, broker, and other third-party requirements.

§ 423.2276 - Employer group retiree marketing.

Subpart W - Medicare Coverage Gap Discount Program

§ 423.2300 - Scope.

§ 423.2305 - Definitions.

§ 423.2310 - Condition for coverage of drugs under Part D.

§ 423.2315 - Medicare Coverage Gap Discount Program Agreement.

§ 423.2320 - Payment processes for Part D sponsors.

§ 423.2325 - Provision of applicable discounts.

§ 423.2330 - Manufacturer discount payment audit and dispute resolution.

§ 423.2335 - Beneficiary dispute resolution.

§ 423.2340 - Compliance monitoring and civil money penalties.

§ 423.2345 - Termination of Discount Program Agreement.

Subpart X - Requirements for a Minimum Medical Loss Ratio

§ 423.2400 - Basis and scope.

§ 423.2401 - Definitions.

§ 423.2410 - General requirements.

§ 423.2420 - Calculation of medical loss ratio.

§ 423.2430 - Activities that improve health care quality.

§ 423.2440 - Credibility adjustment.

§ 423.2450 - [Reserved]

§ 423.2460 - Reporting requirements.

§ 423.2470 - Remittance to CMS if the applicable MLR requirement is not met.

§ 423.2480 - MLR review and non-compliance.

§ 423.2490 - Release of Part D MLR data.

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

§ 423.2500 - Basis and scope.

§ 423.2504 - LI NET eligibility and enrollment.

§ 423.2508 - LI NET benefits and beneficiary protections.

§ 423.2512 - LI NET sponsor requirements.

§ 423.2516 - Selection of LI NET sponsor and contracting provisions.

§ 423.2518 - Intermediate sanctions for the LI NET sponsor.

§ 423.2520 - Non-renewal or termination of appointment.

§ 423.2524 - Bidding and payments to LI NET sponsor.

§ 423.2536 - Waiver of Part D program requirements.

Subpart Z - Recovery Audit Contractor Part C Appeals Process

§ 423.2600 - Payment appeals.

§ 423.2605 - Request for reconsideration.

§ 423.2610 - Hearing official review.

§ 423.2615 - Review by the Administrator.