REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING INFORMATION WITH RESPECT TO DRUGS UNDER THE MEDICARE PROGRAM.

SEC. 401. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING INFORMATION WITH RESPECT TO DRUGS UNDER THE MEDICARE PROGRAM. (a) In General.—Section 1847A of the Social Security Act (42 U.S.C. 1395w-3a) is amended— (1) in subsection (b)— (A) in paragraph (2)(A), by inserting “or subsection (f)(2), as applicable” before the period at the end; (B) in paragraph (3), in the matter preceding subparagraph (A), by inserting “or subsection (f)(2), as applicable,” before “determined by”; and (C) in paragraph (6)(A), in the matter preceding clause (i), by inserting “or subsection (f)(2), as applicable,” before “determined by”; and (2) in subsection (f)— (A) by striking “For requirements” and inserting the following: “(1) In general.—For requirements” ; and (B) by adding at the end the following new paragraph: “(2) Manufacturers without a rebate agreement under title xix.— “(A) In general.—If the manufacturer of a drug or biological described in subparagraph (C), (E), or (G) of section 1842(o)(1) or in section 1881(b)(14)(B) that is payable under this part has not entered into and does not have in effect a rebate agreement described in subsection (b) of section 1927, for calendar quarters beginning on January 1, 2022, such manufacturer shall report to the Secretary the information described in subsection (b)(3)(A)(iii) of such section 1927 with respect to such drug or biological in a time and manner specified by the Secretary. For purposes of applying this paragraph, a drug or biological described in the previous sentence includes items, services, supplies, and products that are payable under this part as a drug or biological. “(B) Audit.—Information reported under subparagraph (A) is subject to audit by the Inspector General of the Department of Health and Human Services. “(C) Verification.—The Secretary may survey wholesalers and manufacturers that directly distribute drugs or biologicals described in subparagraph (A), when necessary, to verify manufacturer prices and manufacturer’s average sales prices (including wholesale acquisition cost) if required to make payment reported under subparagraph (A). The Secretary may impose a civil monetary penalty in an amount not to exceed $100,000 on a wholesaler, manufacturer, or direct seller, if the wholesaler, manufacturer, or direct seller of such a drug or biological refuses a request for information about charges or prices by the Secretary in connection with a survey under this subparagraph or knowingly provides false information. The provisions of section 1128A (other than subsections (a) (with respect to amounts of penalties or additional assessments) and (b)) shall apply to a civil money penalty under this subparagraph in the same manner as such provisions apply to a penalty or proceeding under section 1128A(a). “(D) Confidentiality.—Notwithstanding any other provision of law, information disclosed by manufacturers or wholesalers under this paragraph (other than the wholesale acquisition cost for purposes of carrying out this section) is confidential and shall not be disclosed by the Secretary in a form which discloses the identity of a specific manufacturer or wholesaler or prices charged for drugs or biologicals by such manufacturer or wholesaler, except— “(i) as the Secretary determines to be necessary to carry out this section (including the determination and implementation of the payment amount), or to carry out section 1847B; “(ii) to permit the Comptroller General of the United States to review the information provided; “(iii) to permit the Director of the Congressional Budget Office to review the information provided; “(iv) to permit the Medicare Payment Advisory Commission to review the information provided; and “(v) to permit the Medicaid and CHIP Payment and Access Commission to review the information provided.” . (b) Enforcement.—Section 1847A of such Act (42 U.S.C. 1395w-3a) is further amended— (1) in subsection (d)(4)— (A) in subparagraph (A), by striking “In general” and inserting “Misrepresentation”; (B) in subparagraph (B), by striking “subparagraph (B)” and inserting “subparagraph (A), (B), or (C)”; (C) by redesignating subparagraph (B) as subparagraph (E); and (D) by inserting after subparagraph (A) the following new subparagraphs: “(B) Failure to provide timely information.—If the Secretary determines that a manufacturer described in subsection (f)(2) has failed to report on information described in section 1927(b)(3)(A)(iii) with respect to a drug or biological in accordance with such subsection, the Secretary shall apply a civil money penalty in an amount of $10,000 for each day the manufacturer has failed to report such information and such amount shall be paid to the Treasury. “(C) False information.—Any manufacturer required to submit information under subsection (f)(2) that knowingly provides false information is subject to a civil money penalty in an amount not to exceed $100,000 for each item of false information. Such civil money penalties are in addition to other penalties as may be prescribed by law. “(D) Increasing oversight and enforcement.—For calendar quarters beginning on or after January 1, 2022, section 1927(b)(3)(C)(iv) shall be applied as if— “(i) each reference to ‘under this subparagraph and subsection (c)(4)(B)(ii)(III)’ were a reference to ‘under this subparagraph, subsection (c)(4)(B)(ii)(III), and subparagraphs (A), (B), and (C) of section 1847A(d)(4)’; and “(ii) the reference to ‘activities related to the oversight and enforcement of this section and agreements under this section’ were a reference to ‘activities related to the oversight and enforcement of this section and under subsection (f)(2) of section 1847A and subparagraphs (A), (B), and (C) of section 1847A(d)(4) and, if applicable, agreements under this section’.” ; and (2) in subsection (c)(6)(A), by striking the period at the end and inserting “, except that, for purposes of subsection (f)(2), the Secretary may, if the Secretary determines appropriate, exclude repackagers of a drug or biological from such term.”. (c) Manufacturers With a Rebate Agreement.— (1) In general.—Section 1927(b)(3)(A) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by adding at the end the following new sentence: “ForTime period.Effective date. purposes of applying clause (iii), for calendar quarters beginning on or after January 1, 2022, a drug or biological described in the flush matter following such clause includes items, services, supplies, and products that are payable under part B of title XVIII as a drug or biological.”. (2) Technical amendment.—Section 1927(b)(3)(A)(iii) of the Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is amended by striking “section 1881(b)(13)(A)(ii)” and inserting “section 1881(b)(14)(B)”. (d) Report.—Not later than January 1, 2023, the Inspector General of the Department of Health and Human Services shall assess and submit to Congress a report on the accuracy of average sales price information submitted by manufacturers under section 1847A of the Social Security Act (42 U.S.C. 1395w-3a), including the extent to which manufacturers provide false information, misclassify drug products, or misreport information. Such report shall include any recommendations on how to improve the accuracy of such information.