(a) Basis. This subpart:
(1) Interprets those provisions of section 1927 of the Act that set forth requirements for drug manufacturers' calculating and reporting average manufacturer prices (AMPs) and best prices and that set upper payment limits for covered outpatient drugs.
(2) Implements section 1903(i)(10) of the Act with regard to the denial of Federal financial participation (FFP) in expenditures for certain physician-administered drugs.
(3) Implements section 1902(a)(54) of the Act with regard to a State plan that provides covered outpatient drugs.
(4) Implements section 1903(m)(2)(A)(xiii) of the Act, in part, and section 1927(b) of the Act with regard to rebates for covered outpatient drugs dispensed to individuals eligible for medical assistance who are enrolled in Medicaid managed care organizations (MCOs).
(5) Implements section 1902(a)(30)(A) of the Act with regard to the efficiency, economy, and quality of care in the context of payments for covered outpatient drugs.
(b) Purpose. This subpart specifies certain requirements in the Social Security Act, including changes from the Affordable Care Act and other requirements pertaining to Medicaid payment for drugs.
Notes of Decisions
Starko. Inc. v. N.M. Human Servs. Dep't, 2014 NMSC 33 (N.M. 2014).
“§ 1396r-8 (2012) (providing requirements for prescription drug reimbursements); see also 42 C.F.R. § 447.500 through 447.520 (2012) (providing regulations for payments for prescription drugs).”
Starko, Inc. v. New Mexico Human Servs. Dep't, 2014 NMSC 033 (N.M. 2014).
· cites it 2× “§ 1396r-8 (2012) (providing requirements for prescription drug reimbursements); see also 42 C.F.R. § 447.500 through 447.520 (2012) (providing regulations for payments for prescription drugs).”
Ronald Streck v. Eli Lilly & Co. (7th Cir. 2025).
“39,142 (July 17, 2007) (codified at 42 C.F.R. §447.500 et seq.). Manu- facturers could exclude “fees paid by a manufacturer to an entity” (such as a wholesaler) “for a bona fide, itemized ser- vice actually performed on behalf of the manufacturer that the manufacturer would…”
Ronald Streck v. Eli Lilly & Co. (7th Cir. 2025).
“39,142 (July 17, 2007) (codified at 42 C.F.R. §447.500 et seq.). Manu- facturers could exclude “fees paid by a manufacturer to an entity” (such as a wholesaler) “for a bona fide, itemized ser- vice actually performed on behalf of the manufacturer that the manufacturer would…”
Ronald Streck v. Eli Lilly & Co. (7th Cir. 2025).
“39,142 (July 17, 2007) (codified at 42 C.F.R. §447.500 et seq.). Manu- facturers could exclude “fees paid by a manufacturer to an entity” (such as a wholesaler) “for a bona fide, itemized ser- vice actually performed on behalf of the manufacturer that the manufacturer would…”
Ronald J. Streck v. Eli Lilly & Co. (7th Cir. 2025).
“39,142 (July 17, 2007) (codified at 42 C.F.R. §447.500 et seq.). Manu- facturers could exclude “fees paid by a manufacturer to an entity” (such as a wholesaler) “for a bona fide, itemized ser- vice actually performed on behalf of the manufacturer that the manufacturer would…”
Ronald J. Streck v. Eli Lilly & Co. (7th Cir. 2025).
“39,142 (July 17, 2007) (codified at 42 C.F.R. §447.500 et seq.). Manu- facturers could exclude “fees paid by a manufacturer to an entity” (such as a wholesaler) “for a bona fide, itemized ser- vice actually performed on behalf of the manufacturer that the manufacturer would…”
Ronald J. Streck v. Eli Lilly & Co. (7th Cir. 2025).
“39,142 (July 17, 2007) (codified at 42 C.F.R. §447.500 et seq.). Manu- facturers could exclude “fees paid by a manufacturer to an entity” (such as a wholesaler) “for a bona fide, itemized ser- vice actually performed on behalf of the manufacturer that the manufacturer would…”
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