2005 CFR Title 42, Volume 3

Title 42--Public Health CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES PART 423--VOLUNTARY MEDICARE PRESCRIPTION DRUG BENEFIT
	423.1	Basis and scope.
	423.4	Definitions.
	423.6	Cost-sharing in beneficiary education and enrollment-related costs.
	423.30	Eligibility and enrollment.
	423.32	Enrollment process.
	423.34	Enrollment of full-benefit dual eligible individuals.
	423.36	Disenrollment process.
	423.38	Enrollment periods.
	423.40	Effective dates.
	423.44	Involuntary disenrollment by the PDP.
	423.46	Late enrollment penalty.
	423.48	Information about Part D.
	423.50	Approval of marketing materials and enrollment forms.
	423.56	Procedures to determine and document creditable status of prescription drug coverage.
	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.
	423.132	Public disclosure of pharmaceutical prices for equivalent drugs.
	423.136	Privacy, confidentiality, and accuracy of enrollee records.
	423.150	Scope.
	423.153	Drug utilization management, quality assurance, and medication therapy management programs (MTMPs).
	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.
	423.251	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.
	423.301	Scope.
	423.308	Definitions and terminology.
	423.315	General payment provisions.
	423.322	Requirement for disclosure of information.
	423.329	Determination of payments.
	423.336	Risk-sharing arrangements.
	423.343	Retroactive adjustments and reconciliations.
	423.346	Reopening.
	423.350	Payment appeals.
	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.
	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.
	423.500	Scope.
	423.501	Definitions
	423.502	Application requirements.
	423.503	Evaluation and determination procedures for applications to be determined qualified to act as a sponsor.
	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	Reporting requirements.
	423.516	Prohibition of midyear implementation of significant new regulatory requirements.
	423.551	General provisions.
	423.552	Novation agreement requirements.
	423.553	Effect of leasing of a PDP sponsor's facilities.
	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	Right to an ALJ hearing.
	423.612	Request for an ALJ hearing.
	423.620	Medicare Appeals Council (MAC) review.
	423.630	Judicial review.
	423.634	Reopening and revising determinations and decisions.
	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.
	423.641	Contract determinations.
	423.642	Notice of contract determination.
	423.643	Effect of contract determination.
	423.644	Reconsideration: Applicability.
	423.645	Request for reconsideration.
	423.646	Opportunity to submit evidence.
	423.647	Reconsidered determination.
	423.648	Notice of reconsidered determination.
	423.649	Effect of reconsidered determination.
	423.650	Right to a hearing.
	423.651	Request for hearing.
	423.652	Postponement of effective date of a contract determination when a request for a hearing for a contract determination 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	Discovery.
	423.662	Prehearing.
	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 contract or reconsidered determination or decision of a hearing officer or the Administrator.
	423.669	Effect of revised determination.
	423.750	Kinds of sanctions.
	423.752	Basis for imposing sanctions.
	423.756	Procedures for imposing sanctions.
	423.758	Maximum amount of civil money penalties imposed by CMS.
	423.760	Other applicable provisions.
	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.
	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.
	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.
	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.