Section 414.900 - Basis and scope(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- (ii) Pneumococcal, Hepatitis B, and COVID-19 vaccines.(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