42 C.F.R. PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
TITLE 42--Public Health
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--MEDICARE PROGRAM
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 full-benefit dual eligible individuals.
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| Involuntary disenrollment by the PDP.
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| Information about Part D.
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| Approval of marketing materials and enrollment forms.
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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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| Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).
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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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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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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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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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| Prohibition of midyear implementation of significant new regulatory requirements.
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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, AND APPEALS
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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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| Request for an ALJ hearing.
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| Medicare Appeals Council (MAC) review.
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| Reopening and revising determinations and decisions.
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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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| Reconsideration: Applicability.
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| Request for reconsideration.
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| Opportunity to submit evidence.
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| Reconsidered determination.
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| Notice of reconsidered determination.
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| Effect of reconsidered determination.
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| Postponement of effective date of a contract determination when a request for a hearing for a contract determination 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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| 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 contract or reconsidered determination or decision of a hearing officer or the Administrator.
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| Effect of revised determination.
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Subpart O--INTERMEDIATE SANCTIONS
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| Basis for imposing sanctions.
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| Procedures for imposing sanctions.
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| Maximum amount of civil money penalties 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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