Home/CFR/Title 42/Part 423
FEDERAL · 42 CFR

Part 423 — Voluntary Medicare Prescription Drug Benefit

337 sections · Title 42: Public Health

§ 423.1Basis and scope.
§ 423.4Definitions.
§ 423.6Cost-sharing in beneficiary education and enrollment-related costs.
§ 423.30Eligibility and enrollment.
§ 423.32Enrollment process.
§ 423.34Enrollment of low-income subsidy eligible individuals.
§ 423.36Disenrollment process.
§ 423.38Enrollment periods.
§ 423.40Effective dates.
§ 423.44Involuntary disenrollment from Part D coverage.
§ 423.46Late enrollment penalty.
§ 423.48Information about Part D.
§ 423.56Procedures to determine and document creditable status of prescription drug coverage.
§ 423.100Definitions.
§ 423.104Requirements related to qualified prescription drug coverage.
§ 423.112Establishment of prescription drug plan service areas.
§ 423.120Access to covered Part D drugs.
§ 423.124Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.
§ 423.128Dissemination of Part D plan information.
§ 423.129Resolution of complaints in complaints tracking module.
§ 423.132Public disclosure of pharmaceutical prices for equivalent drugs.
§ 423.136Privacy, confidentiality, and accuracy of enrollee records.
§ 423.137Medicare Prescription Payment Plan.
§ 423.150Scope.
§ 423.153Drug utilization management, quality assurance, medication therapy management (MTM) programs, drug management programs, and access to Medicare Parts A and B claims data extracts.
§ 423.154Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans.
§ 423.156Consumer satisfaction surveys.
§ 423.159Electronic prescription drug program.
§ 423.160Standards for electronic prescribing.
§ 423.162Quality improvement organization activities.
§ 423.165Compliance deemed on the basis of accreditation.
§ 423.168Accreditation organizations.
§ 423.171Procedures for approval of accreditation as a basis for deeming compliance.
§ 423.180Basis and scope of the Part D Prescription Drug Plan Quality Rating System.
§ 423.182Part D Prescription Drug Plan Quality Rating System.
§ 423.184Adding, updating, and removing measures.
§ 423.186Calculation of Star Ratings.
§ 423.251Scope.
§ 423.258Definitions.
§ 423.265Submission of bids and related information.
§ 423.272Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.
§ 423.279National average monthly bid amount.
§ 423.286Rules regarding premiums.
§ 423.293Collection of monthly beneficiary premium.
§ 423.294Failure to collect and incorrect collections of premiums and cost sharing.
§ 423.301Scope.
§ 423.308Definitions and terminology.
§ 423.315General payment provisions.
§ 423.322Requirement for disclosure of information.
§ 423.325PDE submission timeliness requirements.
§ 423.329Determination of payments.
§ 423.336Risk-sharing arrangements.
§ 423.343Retroactive adjustments and reconciliations.
§ 423.346Reopening.
§ 423.350Payment appeals.
§ 423.352CMS-identified overpayments associated with payment data submitted by Part D sponsors.
§ 423.360Reporting and returning of overpayments.
§ 423.401General requirements for PDP sponsors.
§ 423.410Waiver of certain requirements to expand choice.
§ 423.415Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region.
§ 423.420Solvency standards for non-licensed entities.
§ 423.425Licensure does not substitute for or constitute certification.
§ 423.440Prohibition of State imposition of premium taxes; relation to State laws.
§ 423.452Scope.
§ 423.454Definitions.
§ 423.458Application of Part D rules to certain Part D plans on and after January 1, 2006.
§ 423.462Medicare secondary payer procedures.
§ 423.464Coordination of benefits with other providers of prescription drug coverage.
§ 423.466Timeframes for coordination of benefits and claims adjustments.
§ 423.500Scope.
§ 423.501Definitions
§ 423.502Application requirements.
§ 423.503Evaluation and determination procedures.
§ 423.504General provisions.
§ 423.505Contract provisions.
§ 423.506Effective date and term of contract.
§ 423.507Nonrenewal of contract.
§ 423.508Modification or termination of contract by mutual consent.
§ 423.509Termination of contract by CMS.
§ 423.510Termination of contract by the Part D sponsor.
§ 423.512Minimum enrollment requirements.
§ 423.514Validation of Part D reporting requirements.
§ 423.516Prohibition of midyear implementation of significant new regulatory requirements.
§ 423.520Prompt payment by Part D sponsors.
§ 423.521Final settlement process and payment.
§ 423.522Requesting an appeal of the final settlement amount.
§ 423.530Plan crosswalks.
§ 423.551General provisions.
§ 423.552Novation agreement requirements.
§ 423.553Effect of leasing of a PDP sponsor's facilities.
§ 423.558Scope.
§ 423.560Definitions.
§ 423.562General provisions.
§ 423.564Grievance procedures.
§ 423.566Coverage determinations.
§ 423.568Standard timeframe and notice requirements for coverage determinations.
§ 423.570Expediting certain coverage determinations.
§ 423.572Timeframes and notice requirements for expedited coverage determinations.
§ 423.576Effect of a coverage determination.
§ 423.578Exceptions process.
§ 423.580Right to a redetermination.
§ 423.582Request for a standard redetermination.
§ 423.584Expediting certain redeterminations.
§ 423.586Opportunity to submit evidence.
§ 423.590Timeframes and responsibility for making redeterminations.
§ 423.600Reconsideration by an independent review entity (IRE).
§ 423.602Notice of reconsideration determination by the independent review entity.
§ 423.604Effect of a reconsideration determination.
§ 423.610-423.634§§ 423.610-423.634 [Reserved]
§ 423.636How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.
§ 423.638How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.
§ 423.641Contract determinations.
§ 423.642Notice of contract determination.
§ 423.643Effect of contract determination.
§ 423.650Right to a hearing, burden of proof, standard of proof, and standards of review.
§ 423.651Request for hearing.
§ 423.652Postponement of effective date of a contract determination when a request for a hearing is filed timely.
§ 423.653Designation of hearing officer.
§ 423.654Disqualification of hearing officer.
§ 423.655Time and place of hearing.
§ 423.656Appointment of representatives.
§ 423.657Authority of representatives.
§ 423.658Conduct of hearing.
§ 423.659Evidence.
§ 423.660Witnesses.
§ 423.661Witnesses lists and documents.
§ 423.662Prehearing and summary judgment.
§ 423.663Record of hearing.
§ 423.664Authority of hearing officer.
§ 423.665Notice and effect of hearing decision.
§ 423.666Review by the Administrator.
§ 423.667Effect of Administrator's decision.
§ 423.668Reopening of a contract determination or decision of a hearing officer or the Administrator.
§ 423.750Types of intermediate sanctions and civil money penalties.
§ 423.752Basis for imposing intermediate sanctions and civil money penalties.
§ 423.756Procedures for imposing intermediate sanctions and civil money penalties.
§ 423.758Collection of civil money penalties imposed by CMS.
§ 423.760Determinations regarding the amount of civil money penalties and assessment imposed by CMS.
§ 423.762Settlement of penalties.
§ 423.764Other applicable provisions.
§ 423.771Basis and scope.
§ 423.772Definitions.
§ 423.773Requirements for eligibility.
§ 423.774Eligibility determinations, redeterminations, and applications.
§ 423.780Premium subsidy.
§ 423.782Cost-sharing subsidy.
§ 423.800Administration of subsidy program.
§ 423.851Scope.
§ 423.855Definitions.
§ 423.859Assuring access to a choice of coverage.
§ 423.863Submission and approval of bids.
§ 423.867Rules regarding premiums.
§ 423.871Contract terms and conditions.
§ 423.875Payment to fallback plans.
§ 423.880Basis and scope.
§ 423.882Definitions.
§ 423.884Requirements for qualified retiree prescription drug plans.
§ 423.886Retiree drug subsidy amounts.
§ 423.888Payment methods, including provision of necessary information.
§ 423.890Appeals.
§ 423.892Change of ownership.
§ 423.894Construction.
§ 423.900Basis and scope.
§ 423.902Definitions.
§ 423.904Eligibility determinations for low-income subsidies.
§ 423.906General payment provisions.
§ 423.907Treatment of territories.
§ 423.908Phased-down State contribution to drug benefit costs assumed by Medicare.
§ 423.910Requirements.
§ 423.1000Basis and scope.
§ 423.1002Definitions.
§ 423.1004Scope and applicability.
§ 423.1006Appeal rights.
§ 423.1008Appointment of representatives.
§ 423.1010Authority of representatives.
§ 423.1012Fees for services of representatives.
§ 423.1014Charge for transcripts.
§ 423.1016Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.
§ 423.1018Notice and effect of initial determinations.
§ 423.1020Request for hearing.
§ 423.1022Parties to the hearing.
§ 423.1024Designation of hearing official.
§ 423.1026Disqualification of Administrative Law Judge.
§ 423.1028Prehearing conference.
§ 423.1030Notice of prehearing conference.
§ 423.1032Conduct of prehearing conference.
§ 423.1034Record, order, and effect of prehearing conference.
§ 423.1036Time and place of hearing.
§ 423.1038Change in time and place of hearing.
§ 423.1040Joint hearings.
§ 423.1042Hearing on new issues.
§ 423.1044Subpoenas.
§ 423.1046Conduct of hearing.
§ 423.1048Evidence.
§ 423.1050Witnesses.
§ 423.1052Oral and written summation.
§ 423.1054Record of hearing.
§ 423.1056Waiver of right to appear and present evidence.
§ 423.1058Dismissal of request for hearing.
§ 423.1060Dismissal for abandonment.
§ 423.1062Dismissal for cause.
§ 423.1064Notice and effect of dismissal and right to request review.
§ 423.1066Vacating a dismissal of request for hearing.
§ 423.1068Administrative Law Judge's decision.
§ 423.1070Removal of hearing to Departmental Appeals Board.
§ 423.1072Remand by the Administrative Law Judge.
§ 423.1074Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.
§ 423.1076Request for Departmental Appeals Board review.
§ 423.1078Departmental Appeals Board action on request for review.
§ 423.1080Procedures before the Departmental Appeals Board on review.
§ 423.1082Evidence admissible on review.
§ 423.1084Decision or remand by the Departmental Appeals Board.
§ 423.1086Effect of Departmental Appeals Board Decision.
§ 423.1088Extension of time for seeking judicial review.
§ 423.1090Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.
§ 423.1092Revision of reopened decision.
§ 423.1094Notice and effect of revised decision.
§ 423.1968Scope.
§ 423.1970-423.1976§§ 423.1970-423.1976 [Reserved]
§ 423.1978Reopening determinations and decisions.
§ 423.1980Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews.
§ 423.1982Notice of a revised determination or decision.
§ 423.1984Effect of a revised determination or decision.
§ 423.1986Good cause for reopening.
§ 423.1990Expedited access to judicial review.
§ 423.2000Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.
§ 423.2002Right to an ALJ hearing.
§ 423.2004Right to a review of IRE notice of dismissal.
§ 423.2006Amount in controversy required for an ALJ hearing and judicial review.
§ 423.2008Parties to the proceedings on a request for an ALJ hearing.
§ 423.2010When CMS, the IRE, or Part D plan sponsors may participate in the proceedings on a request for an ALJ hearing.
§ 423.2014Request for an ALJ hearing or a review of an IRE dismissal.
§ 423.2016Timeframes for deciding an appeal of an IRE reconsideration.
§ 423.2018Submitting evidence.
§ 423.2020Time and place for a hearing before an ALJ.
§ 423.2022Notice of a hearing before an ALJ.
§ 423.2024Objections to the issues.
§ 423.2026Disqualification of the ALJ or attorney adjudicator.
§ 423.2030ALJ hearing procedures.
§ 423.2032Issues before an ALJ or attorney adjudicator.
§ 423.2034Requesting information from the IRE.
§ 423.2036Description of an ALJ hearing process.
§ 423.2038Deciding a case without a hearing before an ALJ.
§ 423.2040Prehearing and posthearing conferences.
§ 423.2042The administrative record.
§ 423.2044Consolidated proceedings.
§ 423.2046Notice of an ALJ or attorney adjudicator decision.
§ 423.2048The effect of an ALJ's or attorney adjudicator's decision.
§ 423.2050Removal of a hearing request from OMHA to the Council.
§ 423.2052Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal.
§ 423.2054Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal.
§ 423.2056Remands of requests for hearing and requests for review.
§ 423.2058Effect of a remand.
§ 423.2062Applicability of policies not binding on the ALJ and Council.
§ 423.2063Applicability of laws, regulations, CMS Rulings, and precedential decisions.
§ 423.2100Medicare Appeals Council review: general.
§ 423.2102Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.
§ 423.2106Where a request for review may be filed.
§ 423.2108Council Actions when request for review is filed.
§ 423.2110Council reviews on its own motion.
§ 423.2112Content of request for review.
§ 423.2114Dismissal of request for review.
§ 423.2116Effect of dismissal of request for Council review or request for hearing.
§ 423.2118Obtaining evidence from the Council.
§ 423.2120Filing briefs with the Council.
§ 423.2122What evidence may be submitted to the Council.
§ 423.2124Oral argument.
§ 423.2126Case remanded by the Council.
§ 423.2128Action of the Council.
§ 423.2130Effect of the Council's decision.
§ 423.2134Extension of time to file action in Federal District Court.
§ 423.2136Judicial review.
§ 423.2138Case remanded by a Federal District Court.
§ 423.2140Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court.
§ 423.2260Definitions.
§ 423.2261Submission, review, and distribution of materials.
§ 423.2262General communications materials and activity requirements.
§ 423.2263General marketing requirements.
§ 423.2264Beneficiary contact.
§ 423.2265Websites.
§ 423.2266Activities with healthcare providers or in the healthcare setting.
§ 423.2267Required materials and content.
§ 423.2272Licensing of marketing representatives and confirmation of marketing resources.
§ 423.2274Agent, broker, and other third-party requirements.
§ 423.2276Employer group retiree marketing.
§ 423.2300Scope.
§ 423.2305Definitions.
§ 423.2310Condition for coverage of drugs under Part D.
§ 423.2315Medicare Coverage Gap Discount Program Agreement.
§ 423.2320Payment processes for Part D sponsors.
§ 423.2325Provision of applicable discounts.
§ 423.2330Manufacturer discount payment audit and dispute resolution.
§ 423.2335Beneficiary dispute resolution.
§ 423.2340Compliance monitoring and civil money penalties.
§ 423.2345Termination of Coverage Gap Discount Program Agreement.
§ 423.2400Basis and scope.
§ 423.2401Definitions.
§ 423.2410General requirements.
§ 423.2420Calculation of medical loss ratio.
§ 423.2430Activities that improve health care quality.
§ 423.2440Credibility adjustment.
§ 423.2450§ 423.2450 [Reserved]
§ 423.2460Reporting requirements.
§ 423.2470Remittance to CMS if the applicable MLR requirement is not met.
§ 423.2480MLR review and non-compliance.
§ 423.2490Release of Part D MLR data.
§ 423.2500Basis and scope.
§ 423.2504LI NET eligibility and enrollment.
§ 423.2508LI NET benefits and beneficiary protections.
§ 423.2512LI NET sponsor requirements.
§ 423.2516Selection of LI NET sponsor and contracting provisions.
§ 423.2518Intermediate sanctions for the LI NET sponsor.
§ 423.2520Non-renewal or termination of appointment.
§ 423.2524Bidding and payments to LI NET sponsor.
§ 423.2536Waiver of Part D program requirements.
§ 423.2600Payment appeals.
§ 423.2605Request for reconsideration.
§ 423.2610Hearing official review.
§ 423.2615Review by the Administrator.
§ 423.2700Basis and scope.
§ 423.2704Definitions.
§ 423.2708Conditions for coverage of drugs under Part D.
§ 423.2712Applicable discounts.
§ 423.2716Phase-in of applicable discount for certain manufacturers.
§ 423.2720Determination of phase-in eligibility.
§ 423.2724Effect of manufacturer acquisition on phase-in eligibility.
§ 423.2728Recalculation of phase-in eligibility determination.
§ 423.2732Use of third party administrator.
§ 423.2736Requirement for point-of-sale discounts.
§ 423.2740Negative invoice payment process for Part D sponsors.
§ 423.2744Prospective payments to Part D sponsors.
§ 423.2748Requirement to use the Health Plan Management System.
§ 423.2752Manufacturer Discount Program agreement.
§ 423.2756Manufacturer requirements.
§ 423.2760Audits.
§ 423.2764Dispute resolution.
§ 423.2768Civil money penalties.