1. (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.

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

   1. (1) Drugs furnished incident to a physician's service; durable medical equipment (DME) drugs.
   2. (2) Separately billable drugs at independent dialysis facilities not under the ESRD composite rate.

   3. (3) Statutorily covered drugs, for example—

      1. (i) Influenza.
      2. (ii) Pneumococcal, Hepatitis B, and COVID-19 vaccines.
      3. (iii) Antigens.
      4. (iv) Hemophilia blood clotting factor.
      5. (v) Immunosuppressive drugs.
      6. (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]