42 CFR 423.2310 - Condition for coverage of drugs under Part D.

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There are 5 Updates appearing in the Federal Register for 42 CFR Part 423. View below or at eCFR (GPOAccess)
§ 423.2310 Condition for coverage of drugs under Part D.

(a)Covered Part D drug coverage requirement. Except as specified in paragraph (b) of this section, in order for coverage to be available under Medicare Part D for applicable drugs of a manufacturer, the manufacturer must do all of the following:

(1) Participate in the Discount Program.

(2) Have entered into and have in effect an agreement described in § 423.2315(b).

(3) Have entered into and have in effect, under terms and conditions specified by CMS, a contract with the TPA.

(b)Exception to covered drug coverage requirement.Paragraph (a) of this section does not apply to an applicable drug if CMS has made a determination that the availability of the applicable drug is essential to the health of beneficiaries enrolled in Medicare Part D.

Title 42 published on 2015-11-28

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 42 CFR Part 423 after this date.

  • 2017-01-17; vol. 82 # 10 - Tuesday, January 17, 2017
    1. 82 FR 4974 - Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule.
      These regulations are effective on March 20, 2017.
      42 CFR Parts 401, 405, 422, 423, and 478

Title 42 published on 2015-11-28.

The following are only the Rules published in the Federal Register after the published date of Title 42.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2017-01-17; vol. 82 # 10 - Tuesday, January 17, 2017
    1. 82 FR 4974 - Medicare Program: Changes to the Medicare Claims and Entitlement, Medicare Advantage Organization Determination, and Medicare Prescription Drug Coverage Determination Appeals Procedures
      GPO FDSys: XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Final rule.
      These regulations are effective on March 20, 2017.
      42 CFR Parts 401, 405, 422, 423, and 478