Title 42, Part 423 — Voluntary Medicare Prescription Drug Benefit

Basis and scope.

Definitions.

Cost-sharing in beneficiary education and enrollment-related costs.

Eligibility and enrollment.

Enrollment process.

Enrollment of low-income subsidy eligible individuals.

Disenrollment process.

Enrollment periods.

Effective dates.

Involuntary disenrollment from Part D coverage.

Late enrollment penalty.

Information about Part D.

Procedures to determine and document creditable status of prescription drug coverage.

Definitions.

Requirements related to qualified prescription drug coverage.

Establishment of prescription drug plan service areas.

Access to covered Part D drugs.

Special rules for out-of-network access to covered Part D drugs at out-of-network pharmacies.

Dissemination of Part D plan information.

Resolution of complaints in complaints tracking module.

Public disclosure of pharmaceutical prices for equivalent drugs.

Privacy, confidentiality, and accuracy of enrollee records.

Medicare Prescription Payment Plan.

Scope.

Drug utilization management, quality assurance, medication therapy management (MTM) programs, drug management programs, and access to Medicare Parts A and B claims data extracts.

Appropriate dispensing of prescription drugs in long-term care facilities under PDPs and MA-PD plans.

Consumer satisfaction surveys.

Electronic prescription drug program.

Standards for electronic prescribing.

Quality improvement organization activities.

Compliance deemed on the basis of accreditation.

Accreditation organizations.

Procedures for approval of accreditation as a basis for deeming compliance.

Basis and scope of the Part D Prescription Drug Plan Quality Rating System.

Part D Prescription Drug Plan Quality Rating System.

Adding, updating, and removing measures.

Calculation of Star Ratings.

Scope.

Definitions.

Submission of bids and related information.

Review and negotiation of bid and approval of plans submitted by potential Part D sponsors.

National average monthly bid amount.

Rules regarding premiums.

Collection of monthly beneficiary premium.

Failure to collect and incorrect collections of premiums and cost sharing.

Scope.

Definitions and terminology.

General payment provisions.

Requirement for disclosure of information.

PDE submission timeliness requirements.

Determination of payments.

Risk-sharing arrangements.

Retroactive adjustments and reconciliations.

Reopening.

Payment appeals.

CMS-identified overpayments associated with payment data submitted by Part D sponsors.

Reporting and returning of overpayments.

General requirements for PDP sponsors.

Waiver of certain requirements to expand choice.

Temporary waivers for entities seeking to offer a prescription drug plan in more than one State in a region.

Solvency standards for non-licensed entities.

Licensure does not substitute for or constitute certification.

Prohibition of State imposition of premium taxes; relation to State laws.

Scope.

Definitions.

Application of Part D rules to certain Part D plans on and after January 1, 2006.

Medicare secondary payer procedures.

Coordination of benefits with other providers of prescription drug coverage.

Timeframes for coordination of benefits and claims adjustments.

Scope.

Definitions

Application requirements.

Evaluation and determination procedures.

General provisions.

Contract provisions.

Effective date and term of contract.

Nonrenewal of contract.

Modification or termination of contract by mutual consent.

Termination of contract by CMS.

Termination of contract by the Part D sponsor.

Minimum enrollment requirements.

Validation of Part D reporting requirements.

Prohibition of midyear implementation of significant new regulatory requirements.

Prompt payment by Part D sponsors.

Final settlement process and payment.

Requesting an appeal of the final settlement amount.

Plan crosswalks.

General provisions.

Novation agreement requirements.

Effect of leasing of a PDP sponsor's facilities.

Scope.

Definitions.

General provisions.

Grievance procedures.

Coverage determinations.

Standard timeframe and notice requirements for coverage determinations.

Expediting certain coverage determinations.

Timeframes and notice requirements for expedited coverage determinations.

Effect of a coverage determination.

Exceptions process.

Right to a redetermination.

Request for a standard redetermination.

Expediting certain redeterminations.

Opportunity to submit evidence.

Timeframes and responsibility for making redeterminations.

Reconsideration by an independent review entity (IRE).

Notice of reconsideration determination by the independent review entity.

Effect of a reconsideration determination.

§§ 423.610-423.634 [Reserved]

How a Part D plan sponsor must effectuate standard redeterminations, reconsiderations, or decisions.

How a Part D plan sponsor must effectuate expedited redeterminations or reconsiderations.

Contract determinations.

Notice of contract determination.

Effect of contract determination.

Right to a hearing, burden of proof, standard of proof, and standards of review.

Request for hearing.

Postponement of effective date of a contract determination when a request for a hearing is filed timely.

Designation of hearing officer.

Disqualification of hearing officer.

Time and place of hearing.

Appointment of representatives.

Authority of representatives.

Conduct of hearing.

Evidence.

Witnesses.

Witnesses lists and documents.

Prehearing and summary judgment.

Record of hearing.

Authority of hearing officer.

Notice and effect of hearing decision.

Review by the Administrator.

Effect of Administrator's decision.

Reopening of a contract determination or decision of a hearing officer or the Administrator.

Types of intermediate sanctions and civil money penalties.

Basis for imposing intermediate sanctions and civil money penalties.

Procedures for imposing intermediate sanctions and civil money penalties.

Collection of civil money penalties imposed by CMS.

Determinations regarding the amount of civil money penalties and assessment imposed by CMS.

Settlement of penalties.

Other applicable provisions.

Basis and scope.

Definitions.

Requirements for eligibility.

Eligibility determinations, redeterminations, and applications.

Premium subsidy.

Cost-sharing subsidy.

Administration of subsidy program.

Scope.

Definitions.

Assuring access to a choice of coverage.

Submission and approval of bids.

Rules regarding premiums.

Contract terms and conditions.

Payment to fallback plans.

Basis and scope.

Definitions.

Requirements for qualified retiree prescription drug plans.

Retiree drug subsidy amounts.

Payment methods, including provision of necessary information.

Appeals.

Change of ownership.

Construction.

Basis and scope.

Definitions.

Eligibility determinations for low-income subsidies.

General payment provisions.

Treatment of territories.

Phased-down State contribution to drug benefit costs assumed by Medicare.

Requirements.

Basis and scope.

Definitions.

Scope and applicability.

Appeal rights.

Appointment of representatives.

Authority of representatives.

Fees for services of representatives.

Charge for transcripts.

Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal.

Notice and effect of initial determinations.

Request for hearing.

Parties to the hearing.

Designation of hearing official.

Disqualification of Administrative Law Judge.

Prehearing conference.

Notice of prehearing conference.

Conduct of prehearing conference.

Record, order, and effect of prehearing conference.

Time and place of hearing.

Change in time and place of hearing.

Joint hearings.

Hearing on new issues.

Subpoenas.

Conduct of hearing.

Evidence.

Witnesses.

Oral and written summation.

Record of hearing.

Waiver of right to appear and present evidence.

Dismissal of request for hearing.

Dismissal for abandonment.

Dismissal for cause.

Notice and effect of dismissal and right to request review.

Vacating a dismissal of request for hearing.

Administrative Law Judge's decision.

Removal of hearing to Departmental Appeals Board.

Remand by the Administrative Law Judge.

Right to request Departmental Appeals Board review of Administrative Law Judge's decision or dismissal.

Request for Departmental Appeals Board review.

Departmental Appeals Board action on request for review.

Procedures before the Departmental Appeals Board on review.

Evidence admissible on review.

Decision or remand by the Departmental Appeals Board.

Effect of Departmental Appeals Board Decision.

Extension of time for seeking judicial review.

Basis, timing, and authority for reopening an Administrative Law Judge or Board decision.

Revision of reopened decision.

Notice and effect of revised decision.

Scope.

§§ 423.1970-423.1976 [Reserved]

Reopening determinations and decisions.

Reopening of coverage determinations, redeterminations, reconsiderations, decisions, and reviews.

Notice of a revised determination or decision.

Effect of a revised determination or decision.

Good cause for reopening.

Expedited access to judicial review.

Hearing before an ALJ and decision by an ALJ or attorney adjudicator: General rule.

Right to an ALJ hearing.

Right to a review of IRE notice of dismissal.

Amount in controversy required for an ALJ hearing and judicial review.

Parties to the proceedings on a request for an ALJ hearing.

When CMS, the IRE, or Part D plan sponsors may participate in the proceedings on a request for an ALJ hearing.

Request for an ALJ hearing or a review of an IRE dismissal.

Timeframes for deciding an appeal of an IRE reconsideration.

Submitting evidence.

Time and place for a hearing before an ALJ.

Notice of a hearing before an ALJ.

Objections to the issues.

Disqualification of the ALJ or attorney adjudicator.

ALJ hearing procedures.

Issues before an ALJ or attorney adjudicator.

Requesting information from the IRE.

Description of an ALJ hearing process.

Deciding a case without a hearing before an ALJ.

Prehearing and posthearing conferences.

The administrative record.

Consolidated proceedings.

Notice of an ALJ or attorney adjudicator decision.

The effect of an ALJ's or attorney adjudicator's decision.

Removal of a hearing request from OMHA to the Council.

Dismissal of a request for a hearing before an ALJ or request for review of an IRE dismissal.

Effect of dismissal of a request for a hearing or request for review of an IRE's dismissal.

Remands of requests for hearing and requests for review.

Effect of a remand.

Applicability of policies not binding on the ALJ and Council.

Applicability of laws, regulations, CMS Rulings, and precedential decisions.

Medicare Appeals Council review: general.

Request for Council review when ALJ or attorney adjudicator issues decision or dismissal.

Where a request for review may be filed.

Council Actions when request for review is filed.

Council reviews on its own motion.

Content of request for review.

Dismissal of request for review.

Effect of dismissal of request for Council review or request for hearing.

Obtaining evidence from the Council.

Filing briefs with the Council.

What evidence may be submitted to the Council.

Oral argument.

Case remanded by the Council.

Action of the Council.

Effect of the Council's decision.

Extension of time to file action in Federal District Court.

Judicial review.

Case remanded by a Federal District Court.

Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court.

Definitions.

Submission, review, and distribution of materials.

General communications materials and activity requirements.

General marketing requirements.

Beneficiary contact.

Websites.

Activities with healthcare providers or in the healthcare setting.

Required materials and content.

Licensing of marketing representatives and confirmation of marketing resources.

Agent, broker, and other third-party requirements.

Employer group retiree marketing.

Scope.

Definitions.

Condition for coverage of drugs under Part D.

Medicare Coverage Gap Discount Program Agreement.

Payment processes for Part D sponsors.

Provision of applicable discounts.

Manufacturer discount payment audit and dispute resolution.

Beneficiary dispute resolution.

Compliance monitoring and civil money penalties.

Termination of Discount Program Agreement.

Basis and scope.

Definitions.

General requirements.

Calculation of medical loss ratio.

Activities that improve health care quality.

Credibility adjustment.

[Reserved]

Reporting requirements.

Remittance to CMS if the applicable MLR requirement is not met.

MLR review and non-compliance.

Release of Part D MLR data.

Basis and scope.

LI NET eligibility and enrollment.

LI NET benefits and beneficiary protections.

LI NET sponsor requirements.

Selection of LI NET sponsor and contracting provisions.

Intermediate sanctions for the LI NET sponsor.

Non-renewal or termination of appointment.

Bidding and payments to LI NET sponsor.

Waiver of Part D program requirements.

Payment appeals.

Request for reconsideration.

Hearing official review.

Review by the Administrator.