42 C.F.R. § 414.701

Purpose

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This subpart implements section 1842(o) of the Act by specifying the methodology for determining the payment allowance limit for drugs and biologicals covered under Part B of Title XVIII of the Act (hereafter in this subpart referred to as the “program”) that are not paid on a cost or prospective payment system basis. Examples of drugs that are subject to the rules contained in this subpart are: Drugs furnished incident to a physician's service; durable medical equipment (DME) drugs; separately billable drugs at independent dialysis facilities not under the ESRD composite rate; statutorily covered drugs, for example, influenza, pneumococcal, hepatitis, and COVID-19 vaccines, antigens, hemophilia blood clotting factor, immunosuppressive drugs and certain oral anti-cancer drugs.

[85 FR 71197, Nov. 6, 2020]
Notes of Decisions
Cited in 1 case, 2012–2012 · leading case: Elec. Workers Ins. Fund v. Sebelius, 906 F. Supp. 2d 707 (E.D. Mich. 2012).
Elec. Workers Ins. Fund v. Sebelius, 906 F. Supp. 2d 707 (E.D. Mich. 2012). · cites it 4× “at §§ 1395k(a)(l), 1395x(s); 42 C.F.R. § 414.701 . See also 42 C.F.R. Part 410 (scope of Part B benefits).”
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