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136 STAT. 1851 PUBLIC LAW 117–169—AUG. 16, 2022 by such hospital, physician, or provider or supplier during such year; shall be subject to a civil monetary penalty equal to ten times the amount equal to the product of the number of units of such drug so furnished, dispensed, or administered during such year and the difference between the price for such drug made available for such year by such manufacturer with respect to such individual or hospital, physician, provider of services, or supplier and the maximum fair price for such drug for such year. ‘‘(b) VIOLATIONS OF CERTAIN TERMS OF AGREEMENT.—Any manufacturer of a selected drug that has entered into an agreement under section 1193, with respect to a year during the price applica- bility period with respect to such drug, that is in violation of a requirement imposed pursuant to section 1193(a)(5), including the requirement to submit information pursuant to section 1193(a)(4), shall be subject to a civil monetary penalty equal to $1,000,000 for each day of such violation. ‘‘(c) FALSE INFORMATION.—Any manufacturer that knowingly provides false information pursuant to section 1196(a)(7) shall be subject to a civil monetary penalty equal to $100,000,000 for each item of such false information. ‘‘(d) APPLICATION.—The provisions of section 1128A (other than subsections (a) and (b)) shall apply to a civil monetary penalty under this section in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). ‘‘SEC. 1198. LIMITATION ON ADMINISTRATIVE AND JUDICIAL REVIEW. ‘‘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 1191(c)(6). ‘‘(2) The selection of drugs under section 1192(b), the deter- mination of negotiation-eligible drugs under section 1192(d), and the determination of qualifying single source drugs under section 1192(e). ‘‘(3) The determination of a maximum fair price under subsection (b) or (f) of section 1194. ‘‘(4) The determination of renegotiation-eligible drugs under section 1194(f)(2) and the selection of renegotiation-eligible drugs under section 1194(f)(3).’’. (b) APPLICATION OF MAXIMUM FAIR PRICES AND CONFORMING AMENDMENTS.— (1) UNDER MEDICARE.— (A) APPLICATION TO PAYMENTS UNDER PART B.—Section 1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w– 3a(b)(1)(B)) is amended by inserting ‘‘or in the case of such a drug or biological product that is a selected drug (as referred to in section 1192(c)), with respect to a price applicability period (as defined in section 1191(b)(2)), 106 percent of the maximum fair price (as defined in section 1191(c)(3)) applicable for such drug and a year during such period’’ after ‘‘paragraph (4)’’. (B) APPLICATION UNDER MA OF COST-SHARING FOR PART B DRUGS BASED OFF OF NEGOTIATED PRICE.—Section 1852(a)(1)(B)(iv) of the Social Security Act (42 U.S.C. 1395w–22(a)(1)(B)(iv)) is amended— 42 USC 1320f–7. VerDate Sep 11 2014 13:57 Oct 25, 2022 Jkt 029139 PO 00169 Frm 00035 Fmt 6580 Sfmt 6581 E:\PUBLAW\PUBL169.117 PUBL169 jmbennett on LAP3P8D0R2PROD with Publaw