e-CFR data is current as of July 13, 2020
TITLE 42—Public Health
CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) SUBCHAPTER B—MEDICARE PROGRAM (CONTINUED) PART 423—VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
Subpart A—GENERAL PROVISIONS
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| Cost-sharing in beneficiary education and enrollment-related costs. |
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Subpart B—ELIGIBILITY AND ENROLLMENT
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| Eligibility and enrollment. |
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| Enrollment of low-income subsidy eligible individuals. |
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| Involuntary disenrollment from Part D coverage. |
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| Information about Part D. |
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| Procedures to determine and document creditable status of prescription drug coverage. |
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Subpart C—BENEFITS AND BENEFICIARY PROTECTIONS
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| Requirements related to qualified prescription drug coverage. |
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| Establishment of prescription drug plan service areas. |
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| Access to covered Part D drugs. |
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| Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies. |
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| Dissemination of Part D plan information. |
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| Public disclosure of pharmaceutical prices for equivalent drugs. |
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| Privacy, confidentiality, and accuracy of enrollee records. |
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Subpart D—COST CONTROL AND QUALITY IMPROVEMENT REQUIREMENTS
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| Prescription drug plan sponsors' access to Medicare Parts A and B claims data extracts. |
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| Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans. |
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| Consumer satisfaction surveys. |
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| Electronic prescription drug program. |
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| Standards for electronic prescribing. |
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| Quality improvement organization activities. |
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| Compliance deemed on the basis of accreditation. |
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| Accreditation organizations. |
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| Procedures for approval of accreditation as a basis for deeming compliance. |
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| Basis and scope of the Part D Prescription Drug Plan Quality Rating System. |
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| Part D Prescription Drug Plan Quality Rating System. |
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| Adding, updating, and removing measures. |
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| Calculation of Star Ratings. |
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Subpart E—[RESERVED]
Subpart F—SUBMISSION OF BIDS AND MONTHLY BENEFICIARY PREMIUMS; PLAN APPROVAL
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| Submission of bids and related information. |
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| Review and negotiation of bid and approval of plans submitted by potential Part D sponsors. |
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| National average monthly bid amount. |
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| Rules regarding premiums. |
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| Collection of monthly beneficiary premium. |
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Subpart G—PAYMENTS TO PART D PLAN SPONSORS FOR QUALIFIED PRESCRIPTION DRUG COVERAGE
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| Definitions and terminology. |
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| General payment provisions. |
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| Requirement for disclosure of information. |
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| Determination of payments. |
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| Risk-sharing arrangements. |
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| Retroactive adjustments and reconciliations. |
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| CMS-identified overpayments associated with payment data submitted by Part D sponsors. |
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| Reporting and returning of overpayments. |
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Subpart H—[RESERVED]
Subpart I—ORGANIZATION COMPLIANCE WITH STATE LAW AND PREEMPTION BY FEDERAL LAW
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| General requirements for PDP sponsors. |
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| Waiver of certain requirements to expand choice. |
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| Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region |
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| Solvency standards for non-licensed entities. |
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| Licensure does not substitute for or constitute certification. |
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| Prohibition of State imposition of premium taxes; relation to State laws. |
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Subpart J—COORDINATION OF PART D PLANS WITH OTHER PRESCRIPTION DRUG COVERAGE
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| Application of Part D rules to certain Part D plans on and after January 1, 2006. |
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| Medicare secondary payer procedures. |
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| Coordination of benefits with other providers of prescription drug coverage. |
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| Timeframes for coordination of benefits and claims adjustments. |
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Subpart K—APPLICATION PROCEDURES AND CONTRACTS WITH PART D PLAN SPONSORS
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| Application requirements. |
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| Evaluation and determination procedures for applications to be determined qualified to act as a sponsor. |
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| Effective date and term of contract. |
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| Modification or termination of contract by mutual consent. |
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| Termination of contract by CMS. |
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| Termination of contract by the Part D sponsor. |
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| Minimum enrollment requirements. |
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| Validation of Part D reporting requirements. |
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| Prohibition of midyear implementation of significant new regulatory requirements. |
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| Prompt payment by Part D sponsors. |
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Subpart L—EFFECT OF CHANGE OF OWNERSHIP OR LEASING OF FACILITIES DURING TERM OF CONTRACT
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| Novation agreement requirements. |
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| Effect of leasing of a PDP sponsor's facilities. |
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Subpart M—GRIEVANCES, COVERAGE DETERMINATIONS, REDETERMINATIONS, AND RECONSIDERATIONS
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| Standard timeframe and notice requirements for coverage determinations. |
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| Expediting certain coverage determinations. |
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| Timeframes and notice requirements for expedited coverage determinations. |
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| Effect of a coverage determination. |
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| Right to a redetermination. |
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| Request for a standard redetermination. |
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| Expediting certain redeterminations. |
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| Opportunity to submit evidence. |
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| Timeframes and responsibility for making redeterminations. |
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| Reconsideration by an independent review entity (IRE). |
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| Notice of reconsideration determination by the independent review entity. |
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| Effect of a reconsideration determination. |
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| How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions. |
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| How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations. |
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Subpart N—MEDICARE CONTRACT DETERMINATIONS AND APPEALS
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| Notice of contract determination. |
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| Effect of contract determination. |
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| Right to a hearing, burden of proof, standard of proof, and standards of review. |
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| Postponement of effective date of a contract determination when a request for a hearing is filed timely. |
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| Designation of hearing officer. |
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| Disqualification of hearing officer. |
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| Time and place of hearing. |
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| Appointment of representatives. |
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| Authority of representatives. |
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| Witnesses lists and documents. |
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| Prehearing and summary judgment. |
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| Authority of hearing officer. |
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| Notice and effect of hearing decision. |
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| Review by the Administrator. |
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| Effect of Administrator's decision. |
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| Reopening of a contract determination or decision of a hearing officer or the Administrator. |
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Subpart O—INTERMEDIATE SANCTIONS
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| Types of intermediate sanctions and civil money penalties. |
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| Basis for imposing intermediate sanctions and civil money penalties. |
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| Procedures for imposing intermediate sanctions and civil money penalties. |
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| Collection of civil money penalties imposed by CMS. |
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| Determinations regarding the amount of civil money penalties and assessment imposed by CMS. |
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| Other applicable provisions. |
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Subpart P—PREMIUMS AND COST-SHARING SUBSIDIES FOR LOW-INCOME INDIVIDUALS
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| Requirements for eligibility. |
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| Eligibility determinations, redeterminations, and applications. |
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| Administration of subsidy program. |
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Subpart Q—GUARANTEEING ACCESS TO A CHOICE OF COVERAGE (FALLBACK PRESCRIPTION DRUG PLANS)
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| Assuring access to a choice of coverage. |
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| Submission and approval of bids. |
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| Rules regarding premiums. |
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| Contract terms and conditions. |
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| Payment to fallback plans. |
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Subpart R—PAYMENTS TO SPONSORS OF RETIREE PRESCRIPTION DRUG PLANS
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| Requirements for qualified retiree prescription drug plans. |
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| Retiree drug subsidy amounts. |
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| Payment methods, including provision of necessary information. |
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Subpart S—SPECIAL RULES FOR STATES-ELIGIBILITY DETERMINATIONS FOR SUBSIDIES AND GENERAL PAYMENT PROVISIONS
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| Eligibility determinations for low-income subsidies. |
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| General payment provisions. |
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| Treatment of territories. |
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| Phased-down State contribution to drug benefit costs assumed by Medicare. |
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Subpart T—APPEAL PROCEDURES FOR CIVIL MONEY PENALTIES
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| Appointment of representatives. |
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| Authority of representatives. |
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| Fees for services of representatives. |
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| Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal. |
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| Notice and effect of initial determinations. |
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| Designation of hearing official. |
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| Disqualification of Administrative Law Judge. |
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| Notice of prehearing conference. |
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| Conduct of prehearing conference. |
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| Record, order, and effect of prehearing conference. |
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| Time and place of hearing. |
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| Change in time and place of hearing. |
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| Oral and written summation. |
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| Waiver of right to appear and present evidence. |
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| Dismissal of request for hearing. |
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| Dismissal for abandonment. |
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| Notice and effect of dismissal and right to request review. |
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| Vacating a dismissal of request for hearing. |
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| Administrative Law Judge's decision. |
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| Removal of hearing to Departmental Appeals Board. |
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| Remand by the Administrative Law Judge. |
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| Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal. |
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| Request for Departmental Appeals Board review. |
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| Departmental Appeals Board action on request for review. |
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| Procedures before the Departmental Appeals Board on review. |
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| Evidence admissible on review. |
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| Decision or remand by the Departmental Appeals Board. |
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| Effect of Departmental Appeals Board Decision. |
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| Extension of time for seeking judicial review. |
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| Basis, timing, and authority for reopening an Administrative Law Judge or Board decision. |
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| Revision of reopened decision. |
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| Notice and effect of revised decision. |
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Subpart U—REOPENING, ALJ HEARINGS AND ALJ AND ATTORNEY ADJUDICATOR DECISIONS, COUNCIL REVIEW, AND JUDICIAL REVIEW
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| Reopening determinations and decisions. |
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| Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews. |
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| Notice of a revised determination or decision. |
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| Effect of a revised determination or decision. |
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| Good cause for reopening. |
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| Expedited access to judicial review. |
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| Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule. |
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| Right to a review of IRE notice of dismissal. |
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| Amount in controversy required for an ALJ hearing and judicial review. |
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| Parties to the proceedings on a request for an ALJ hearing. |
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| When CMS, the IRE, or Part D plan sponsors may participate in the proceedings on a request for an ALJ hearing. |
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| Request for an ALJ hearing or a review of an IRE dismissal. |
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| Timeframes for deciding an appeal of an IRE reconsideration. |
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| Time and place for a hearing before an ALJ. |
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| Notice of a hearing before an ALJ. |
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| Objections to the issues. |
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| Disqualification of the ALJ or attorney adjudicator. |
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| Issues before an ALJ or attorney adjudicator. |
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| Requesting information from the IRE. |
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| Description of an ALJ hearing process. |
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| Deciding a case without a hearing before an ALJ. |
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| Prehearing and posthearing conferences. |
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| The administrative record. |
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| Consolidated proceedings. |
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| Notice of an ALJ or attorney adjudicator decision. |
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| The effect of an ALJ's or attorney adjudicator's decision. |
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| Removal of a hearing request from OMHA to the Council. |
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| Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal. |
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| Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal. |
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| Remands of requests for hearing and requests for review. |
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| Applicability of policies not binding on the ALJ and Council. |
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| Applicability of laws, regulations, CMS Rulings, and precedential decisions. |
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| Medicare Appeals Council review: general. |
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| Request for Council review when ALJ or attorney adjudicator issues decision or dismissal. |
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| Where a request for review may be filed. |
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| Council Actions when request for review is filed. |
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| Council reviews on its own motion. |
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| Content of request for review. |
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| Dismissal of request for review. |
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| Effect of dismissal of request for Council review or request for hearing. |
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| Obtaining evidence from the Council. |
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| Filing briefs with the Council. |
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| What evidence may be submitted to the Council. |
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| Case remanded by the Council. |
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| Effect of the Council's decision. |
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| Extension of time to file action in Federal District Court. |
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| Case remanded by a Federal District Court. |
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| Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court. |
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Subpart V—PART D COMMUNICATION REQUIREMENTS
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| Review and distribution of marketing materials. |
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| Guidelines for CMS review. |
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| Standards for Part D Sponsor communications and marketing. |
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| Licensing of marketing representatives and confirmation of marketing resources. |
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| Broker and agent requirements. |
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| Employer group retiree marketing. |
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Subpart W—MEDICARE COVERAGE GAP DISCOUNT PROGRAM
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| Condition for coverage of drugs under Part D. |
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| Medicare Coverage Gap Discount Program Agreement. |
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| Payment processes for Part D sponsors. |
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| Provision of applicable discounts. |
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| Manufacturer discount payment audit and dispute resolution. |
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| Beneficiary dispute resolution. |
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| Compliance monitoring and civil money penalties. |
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| Termination of Discount Program Agreement. |
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Subpart X—REQUIREMENTS FOR A MINIMUM MEDICAL LOSS RATIO
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| Calculation of medical loss ratio. |
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| Activities that improve health care quality. |
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| Remittance to CMS if the applicable MLR requirement is not met. |
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| MLR review and non-compliance. |
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| Release of Part D MLR data. |
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Subpart Y—[RESERVED]
Subpart Z—RECOVERY AUDIT CONTRACTOR PART C APPEALS PROCESS
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| Request for reconsideration. |
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| Review by the Administrator. |
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