§ 1320f–7 - Limitation on administrative and judicial review

CHAPTER 7— SOCIAL SECURITY › SUBCHAPTER XI— GENERAL PROVISIONS, PEER REVIEW, AND ADMINISTRATIVE SIMPLIFICATION

There shall be no administrative or judicial review of any of the following:

(1) The determination of a unit, with respect to a drug or biological product, pursuant to section 1320f(c)(6) of this title.

(2) The selection of drugs under section 1320f–1(b) of this title, the determination of negotiation-eligible drugs under section 1320f–1(d) of this title, and [Fn: So in original. The word “and” probably should not appear.] the determination of qualifying single source drugs under section 1320f–1(e) of this title the [Fn: So in original. Probably should be preceded by “, and”.] application of section 1320f–1(f) of this title,. [Fn: So in original.]

(3) The determination of a maximum fair price under subsection (b) or (f) of section 1320f–3 of this title.

(4) The determination of renegotiation-eligible drugs under section 1320f–3(f)(2) of this title and the selection of renegotiation-eligible drugs under section 1320f–3(f)(3) of this title.

Notes

Editorial Notes

Amendments

2022—Par. (2). Pub. L. 117–169, § 11002(a)(5), which directed the amendment of subsec. (b)(2) of this section by inserting “the application of section 1320f–1(f) of this title,” after “section 1320f–1(e) of this title”, was executed by making the insertion in par. (2) to reflect the probable intent of Congress.