(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 and Hepatitis B 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]