Part 423 — Voluntary Medicare Prescription Drug Benefit
Subpart A — General Provisions
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.
- § 423.56— 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.
- § 423.137— Medicare Prescription Payment Plan.
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— Basis and scope of the Part D Prescription Drug Plan Quality Rating System.
- § 423.182— Part D Prescription Drug Plan Quality Rating System.
- § 423.184— Adding, updating, and removing measures.
- § 423.186— Calculation of Star Ratings.
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.
- § 423.325— PDE submission timeliness requirements.
- § 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 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
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.
- § 423.636— 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.
- § 423.650— 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.
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
Subpart Q — Guaranteeing Access to a Choice of Coverage (Fallback Prescription Drug 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
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.
- § 423.1978— 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— Amount in controversy required for an ALJ hearing and judicial review.
- § 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— Remands of requests for hearing and requests for review.
- § 423.2058— Effect of a remand.
- § 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— Websites.
- § 423.2266— Activities with healthcare providers or in the healthcare setting.
- § 423.2267— Required materials and content.
- § 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.
- § 423.2460— 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.