LIMITATION OF APPLICATION OF FUNCTIONAL EQUIVALENCE STANDARD.

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 117 STAT. 2312 identical to another drug if the 2 products are pharmaceutically equivalent and bioequivalent, as determined by the Commissioner of Food and Drugs.”.