42 CFR Part 423
PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
- PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
- Chapter IV—Centers for Medicare & Medicaid Services, Department of Health and Human Services › Subchapter B—Medicare Program
- 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.
- § 423.56 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 E [Reserved]
- 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 H [Reserved]
- 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.
- §§ 423.610-423.634 [Reserved]
- § 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
- § 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.
- §§ 423.1970-423.1976 [Reserved]
- § 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 Coverage Gap 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—Appeals Process for Part D Program Integrity Prescription Drug Event Record Review Audits
- § 423.2600 Payment appeals.
- § 423.2605 Request for reconsideration.
- § 423.2610 Hearing official review.
- § 423.2615 Review by the Administrator.
- Subpart AA—Medicare Part D Manufacturer Discount Program
- § 423.2700 Basis and scope.
- § 423.2704 Definitions.
- § 423.2708 Conditions for coverage of drugs under Part D.
- § 423.2712 Applicable discounts.
- § 423.2716 Phase-in of applicable discount for certain manufacturers.
- § 423.2720 Determination of phase-in eligibility.
- § 423.2724 Effect of manufacturer acquisition on phase-in eligibility.
- § 423.2728 Recalculation of phase-in eligibility determination.
- § 423.2732 Use of third party administrator.
- § 423.2736 Requirement for point-of-sale discounts.
- § 423.2740 Negative invoice payment process for Part D sponsors.
- § 423.2744 Prospective payments to Part D sponsors.
- § 423.2748 Requirement to use the Health Plan Management System.
- § 423.2752 Manufacturer Discount Program agreement.
- § 423.2756 Manufacturer requirements.
- § 423.2760 Audits.
- § 423.2764 Dispute resolution.
- § 423.2768 Civil money penalties.
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