TITLE VI--PROVISIONS RELATING TO PART B
Subtitle C--Other Provisions
SEC. 622. LIMITATION OF APPLICATION OF FUNCTIONAL EQUIVALENCE
STANDARD.
Section 1833(t)(6) (42 U.S.C. 1395l(t)(6)) is amended by adding at the end
the following new subparagraph:
`(F) LIMITATION OF APPLICATION OF FUNCTIONAL EQUIVALENCE
STANDARD-
`(i) IN GENERAL- The Secretary may not publish regulations that
apply a functional equivalence standard to a drug or biological under
this paragraph.
`(ii) APPLICATION- Clause (i) shall apply to the application of a
functional equivalence standard to a drug or biological on or after the
date of enactment of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 unless--
`(I) such application was being made to such drug or biological
prior to such date of enactment; and
`(II) the Secretary applies such standard to such drug or
biological only for the purpose of determining eligibility of such
drug or biological for additional payments under this paragraph and
not for the purpose of any other payments under this
title.
`(iii) RULE OF CONSTRUCTION- Nothing in this subparagraph shall be
construed to effect the Secretary's authority to deem a particular drug
to be identical to another drug if the 2 products are pharmaceutically
equivalent and bioequivalent, as determined by the Commissioner of Food
and Drugs.'.
