[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR410.29]



[Page 326]

 

                         TITLE 42--PUBLIC HEALTH

 

                    CHAPTER IV--CENTERS FOR MEDICARE

                          & MEDICAID SERVICES,

                        DEPARTMENT OF HEALTH AND

                             HUMAN SERVICES

 

PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of Contents

 

               Subpart B_Medical and Other Health Services

 

Sec. 410.29  Limitations on drugs and biologicals.



    Medicare part B does not pay for the following:

    (a) Except as provided in Sec. 410.28(a) for outpatient diagnostic 

services and Sec. 410.63(b) for blood clotting factors, and except for 

EPO, any drug or biological that can be self-administered.

    (b) Any drug product that meets all of the following conditions:

    (1) The drug product was approved by the Food and Drug 

Administration (FDA) before October 10, 1962.

    (2) The drug product is available only through prescription.

    (3) The drug product is the subject of a notice of opportunity for 

hearing issued under section 505(e) of the Federal Food, Drug, and 

Cosmetic Act and published in the Federal Register on a proposed order 

of FDA to withdraw its approval for the drug product because it has 

determined that the product is less than effective for all its labeled 

indications.

    (4) The drug product is presently not subject to a determination by 

FDA, made under its efficacy review program, that there is a compelling 

justification of the drug product's medical need. (21 CFR 310.6 contains 

an explanation of the efficacy review program.)

    (c) Any drug product that is identical, related, or similar, as 

defined in 21 CFR 310.6, to a drug product that meets the conditions of 

paragraph (b) of this section.



[51 FR 41339, Nov. 14, 1986, as amended at 55 FR 22790, June 4, 1990; 56 

FR 43709, Sept. 4, 1991]