C.F.R. » Title 42 » CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER B—MEDICARE PROGRAM › PART 414—PAYMENT FOR PART B MEDICAL AND OTHER HEALTH SERVICES › Subpart K—Payment for Drugs and Biologicals Under Part B

42 C.F.R. § 414.900

Basis and scope

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(a) This subpart implements sections 1842(o), 1847A, and 1847B of the Act and outlines two payment methodologies applicable to drugs and biologicals covered under Medicare Part B that are not paid on a cost or prospective payment system basis.

(b) Examples of drugs that are subject to the requirements specified in this subpart are:

(1) Drugs furnished incident to a physician's service; durable medical equipment (DME) drugs.

(2) Separately billable drugs at independent dialysis facilities not under the ESRD composite rate.

(3) Statutorily covered drugs, for example—

(i) Influenza.

(ii) Pneumococcal, Hepatitis B, and COVID-19 vaccines.

(iii) Antigens.

(iv) Hemophilia blood clotting factor.

(v) Immunosuppressive drugs.

(vi) Certain oral anti-cancer drugs.

[69 FR 66424, Nov. 15, 2004, as amended at 70 FR 39093, July 6, 2005; 85 FR 71197, Nov. 6, 2020]
Notes of Decisions
Cited in 2 cases, 2013–2015 · leading case: United States ex rel. Saldivar v. Fresenius Med. Care Holdings, Inc., 972 F. Supp. 2d 1339 (N.D. Ga. 2013).
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United States ex rel. Saldivar v. Fresenius Med. Care Holdings, Inc., 972 F. Supp. 2d 1339 (N.D. Ga. 2013). · cites it 2× “” 42 C.F.R. § 414.900 (a)-(b) (emphasis added).”
United States ex rel. Saldivar v. Fresenius Med. Care Holdings, Inc., 145 F. Supp. 3d 1220 (N.D. Ga. 2015). “See 42 C.F.R. § 414.900 (b) (listing examples of drags subject to the ASP reimbursement methodology).”
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