42 CFR 447.508 - Exclusion from best price of certain sales at a nominal price.

§ 447.508 Exclusion from best price of certain sales at a nominal price.

(a)Exclusion from best price. Sales of covered outpatient drugs by a manufacturer at nominal prices are excluded from best price when purchased by the following entities:

(1) A covered entity as described in section 340B(a)(4) of the PHSA.

(2) An ICF/IID providing services as set forth in § 440.150 of this chapter.

(3) A State-owned or operated nursing facility providing services as set forth in § 440.155 of this chapter.

(4) A public or non-profit entity, or an entity based at an institution of higher learning whose primary purpose is to provide health care services to students of that institution, that provides family planning services described under section of 1001(a) of PHSA, 42 U.S.C. 300.

(5) An entity that:

(i) Is described in section 501(c)(3) of the Internal Revenue Code of 1986 and exempt from tax under section 501(a) of that Act or is State-owned or operated; and

(ii) Is providing the same services to the same type of population as a covered entity described in section 340B(a)(4) of the PHSA but does not receive funding under a provision of law referred to in such section.

(b)Nonapplication. This restriction does not apply to sales by a manufacturer of covered outpatient drugs that are sold under a master agreement under 38 U.S.C. 8126.

(c)Rule of construction. Nothing in this section is construed to alter any existing statutory or regulatory prohibition on services for an entity described paragraph (a)(5) of this section, including the prohibition set forth in section 1008 of the PHSA.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

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United States Code

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 447 after this date.

  • 2016-11-15; vol. 81 # 220 - Tuesday, November 15, 2016
    1. 81 FR 80003 - Medicaid Program; Covered Outpatient Drug; Delay in Change in Definitions of States and United States
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Centers for Medicare & Medicaid Services
      Interim final rule with comment period.
      Effective date: These regulations are effective on November 15, 2016. Comment date: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on January 17, 2017.
      42 CFR Part 447
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