e-CFR data is current as of October 22, 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
|
| Cost-sharing in beneficiary education and enrollment-related costs. |
|
Subpart B—ELIGIBILITY AND ENROLLMENT
|
| Eligibility and enrollment. |
|
|
| Enrollment of low-income subsidy eligible individuals. |
|
|
| Involuntary disenrollment from Part D coverage. |
|
|
| Information about Part D. |
|
|
| Procedures to determine and document creditable status of prescription drug coverage. |
|
Subpart C—BENEFITS AND BENEFICIARY PROTECTIONS
|
| 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. |
|
|
| Public disclosure of pharmaceutical prices for equivalent drugs. |
|
|
| Privacy, confidentiality, and accuracy of enrollee records. |
|
Subpart D—COST CONTROL AND QUALITY IMPROVEMENT REQUIREMENTS
|
| Prescription drug plan sponsors' 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. |
|
Subpart E—[RESERVED]
Subpart F—SUBMISSION OF BIDS AND MONTHLY BENEFICIARY PREMIUMS; PLAN APPROVAL
|
| 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. |
|
Subpart G—PAYMENTS TO PART D PLAN SPONSORS FOR QUALIFIED PRESCRIPTION DRUG COVERAGE
|
| Definitions and terminology. |
|
|
| General payment provisions. |
|
|
| Requirement for disclosure of information. |
|
|
| Determination of payments. |
|
|
| Risk-sharing arrangements. |
|
|
| Retroactive adjustments and reconciliations. |
|
|
| CMS-identified overpayments associated with payment data submitted by Part D sponsors. |
|
|
| Reporting and returning of overpayments. |
|
Subpart H—[RESERVED]
Subpart I—ORGANIZATION COMPLIANCE WITH STATE LAW AND PREEMPTION BY FEDERAL LAW
|
| 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. |
|
Subpart J—COORDINATION OF PART D PLANS WITH OTHER PRESCRIPTION DRUG COVERAGE
|
| 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. |
|
Subpart K—APPLICATION PROCEDURES AND CONTRACTS WITH PART D PLAN SPONSORS
|
| Application requirements. |
|
|
| Evaluation and determination procedures for applications to be determined qualified to act as a sponsor. |
|
|
| Effective date and term 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. |
|
Subpart L—EFFECT OF CHANGE OF OWNERSHIP OR LEASING OF FACILITIES DURING TERM OF CONTRACT
|
| Novation agreement requirements. |
|
|
| Effect of leasing of a PDP sponsor's facilities. |
|
Subpart M—GRIEVANCES, COVERAGE DETERMINATIONS, REDETERMINATIONS, AND RECONSIDERATIONS
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
Subpart N—MEDICARE CONTRACT DETERMINATIONS AND APPEALS
|
| Notice of contract determination. |
|
|
| Effect of contract determination. |
|
|
| Right to a hearing, burden of proof, standard of proof, and standards of review. |
|
|
| 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. |
|
|
| Witnesses lists and documents. |
|
|
| Prehearing and summary judgment. |
|
|
| 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. |
|
Subpart O—INTERMEDIATE SANCTIONS
|
| 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. |
|
|
| Other applicable provisions. |
|
Subpart P—PREMIUMS AND COST-SHARING SUBSIDIES FOR LOW-INCOME INDIVIDUALS
|
| Requirements for eligibility. |
|
|
| Eligibility determinations, redeterminations, and applications. |
|
|
| Administration of subsidy program. |
|
Subpart Q—GUARANTEEING ACCESS TO A CHOICE OF COVERAGE (FALLBACK PRESCRIPTION DRUG PLANS)
|
| Assuring access to a choice of coverage. |
|
|
| Submission and approval of bids. |
|
|
| Rules regarding premiums. |
|
|
| Contract terms and conditions. |
|
|
| Payment to fallback plans. |
|
Subpart R—PAYMENTS TO SPONSORS OF RETIREE PRESCRIPTION DRUG PLANS
|
| Requirements for qualified retiree prescription drug plans. |
|
|
| Retiree drug subsidy amounts. |
|
|
| Payment methods, including provision of necessary information. |
|
Subpart S—SPECIAL RULES FOR STATES-ELIGIBILITY DETERMINATIONS FOR SUBSIDIES AND GENERAL PAYMENT PROVISIONS
|
| Eligibility determinations for low-income subsidies. |
|
|
| General payment provisions. |
|
|
| Treatment of territories. |
|
|
| Phased-down State contribution to drug benefit costs assumed by Medicare. |
|
Subpart T—APPEAL PROCEDURES FOR CIVIL MONEY PENALTIES
|
| Appointment of representatives. |
|
|
| Authority of representatives. |
|
|
| Fees for services of representatives. |
|
|
| Filing of briefs with the Administrative Law Judge or Departmental Appeals Board, and opportunity for rebuttal. |
|
|
| Notice and effect of initial determinations. |
|
|
| Designation of hearing official. |
|
|
| Disqualification of Administrative Law Judge. |
|
|
| 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. |
|
|
| Oral and written summation. |
|
|
| Waiver of right to appear and present evidence. |
|
|
| Dismissal of request for hearing. |
|
|
| Dismissal for abandonment. |
|
|
| 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. |
|
Subpart U—REOPENING, ALJ HEARINGS AND ALJ AND ATTORNEY ADJUDICATOR DECISIONS, COUNCIL REVIEW, AND JUDICIAL REVIEW
|
| 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 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| Case remanded by the Council. |
|
|
| Effect of the Council's decision. |
|
|
| Extension of time to file action in Federal District Court. |
|
|
| Case remanded by a Federal District Court. |
|
|
| Council Review of ALJ or attorney adjudicator decision in a case remanded by a Federal District Court. |
|
Subpart V—PART D COMMUNICATION REQUIREMENTS
|
| Review and distribution of marketing materials. |
|
|
| Guidelines for CMS review. |
|
|
| Standards for Part D Sponsor communications and marketing. |
|
|
| Licensing of marketing representatives and confirmation of marketing resources. |
|
|
| Broker and agent requirements. |
|
|
| Employer group retiree marketing. |
|
Subpart W—MEDICARE COVERAGE GAP DISCOUNT PROGRAM
|
| 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. |
|
Subpart X—REQUIREMENTS FOR A MINIMUM MEDICAL LOSS RATIO
|
| Calculation of medical loss ratio. |
|
|
| Activities that improve health care quality. |
|
|
| Remittance to CMS if the applicable MLR requirement is not met. |
|
|
| MLR review and non-compliance. |
|
|
| Release of Part D MLR data. |
|
Subpart Y—[RESERVED]
Subpart Z—RECOVERY AUDIT CONTRACTOR PART C APPEALS PROCESS
|
| Request for reconsideration. |
|
|
| Review by the Administrator. |
|
| 