Prescription Drug Price Reporting Act

I 116TH CONGRESS 1ST SESSION H. R. 5239 To require reporting on prescription drug expenditures under group health plans and on prescription drug price changes, and for other purposes. IN THE HOUSE OF REPRESENTATIVES NOVEMBER 21, 2019 Mr. JOYCE of Ohio introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To require reporting on prescription drug expenditures under group health plans and on prescription drug price changes, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Prescription Drug 4 Price Reporting Act’’. 5 SEC. 2. PRESCRIPTION DRUG PRICE REPORTING REQUIRE- 6 MENTS. 7 (a) SUBMISSION OF DATA.— 8 (1) IN GENERAL.—Each manufacturer of a pre- 9 scription drug shall submit to the Secretary, elec- 10 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 2 •HR 5239 IH tronically, in such manner as the Secretary may re- 1 quire, by April 1 of each year, a list of each such 2 drug that is marketed in the United States and, 3 with respect to each such drug, all of the following 4 information with respect to the previous year: 5 (A) Each applicable National Drug Code 6 (or J–Code). 7 (B) Brand name. 8 (C) Generic name and chemical name, as 9 applicable. 10 (D) Therapeutic class or classes, as appli- 11 cable. 12 (E) Current wholesale acquisition cost per 13 30-day supply or typical course of treatment. 14 (F) Average wholesale acquisition cost for 15 the drug per 30-day supply or typical course of 16 treatment during the previous calendar year, or, 17 in the case of a drug that has been marketed 18 for only a portion of such year, during the por- 19 tion of time in such year that the drug was 20 marketed. 21 (G) Average net price per 30-day supply or 22 typical course of treatment, during the previous 23 calendar year, or, in the case of a drug that has 24 been marketed for only a portion of such year, 25 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 3 •HR 5239 IH during the portion of time in such year that the 1 drug was marketed, taking into account all dis- 2 counts, rebates, and other fees or payments to 3 health insurance plans or pharmacy benefit 4 managers with respect to sales of the drug to 5 individuals covered by such a plan. 6 (H) Total rebates and other payments to 7 health insurance plans or pharmacy benefit 8 managers, per 30-day supply or typical course 9 of treatment, with respect to individuals covered 10 by such a plan, during the previous calendar 11 year, or, in the case of a drug that has been 12 marketed for only a portion of such calendar 13 year, during the portion of time in such cal- 14 endar year that the drug was marketed. 15 (2) TIMELINE FOR INITIAL SUBMISSION.— 16 (A) DRUGS MARKETED BEFORE DECEM- 17 BER 31, 2020.—Each manufacturer of a pre- 18 scription drug that is marketed at any time 19 during calendar year 2020, shall submit to the 20 Secretary, not later than April 1, 2021— 21 (i) the information required under 22 paragraph (1); and 23 (ii) in addition to the information re- 24 quired under subparagraphs (F), (G), and 25 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 4 •HR 5239 IH (H) of paragraph (1), such average whole- 1 sale acquisition cost, average net price, and 2 total rebates and other payments, de- 3 scribed in each of such subparagraphs, re- 4 spectively, with respect to the calendar 5 year immediately preceding the calendar 6 year for which such information is required 7 to be reported under such subparagraphs 8 (F), (G), and (H). 9 (B) SUBSEQUENTLY MARKETED DRUGS.— 10 With respect to a prescription drug that is first 11 marketed after December 31, 2020, each manu- 12 facturer of such a drug shall submit the infor- 13 mation required under subparagraphs (A) 14 through (E) of paragraph (1) not later than 60 15 days after the date on which the drug is first 16 marketed, and shall submit annual reports of 17 all of the information required under paragraph 18 (1) beginning on the first annual reporting date 19 that is more than 30 days after the date on 20 which the drug is first marketed. 21 (b) ADVANCE NOTIFICATION OF PRESCRIPTION 22 DRUG PRICING CHANGES.— 23 (1) IN GENERAL.—Each manufacturer of a pre- 24 scription drug shall report to the Secretary, elec- 25 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 5 •HR 5239 IH tronically, in such manner as the Secretary may re- 1 quire, any increase or decrease in the wholesale ac- 2 quisition cost of a prescription drug not later than 3 30 days prior to the date on which the price change 4 takes effect. 5 (2) CONTENT.—A price change report under 6 paragraph (1) shall include— 7 (A) the information required under sub- 8 paragraphs (A), (B), (C), (D), and (F) of sub- 9 section (a)(1); 10 (B) the wholesale acquisition cost per 30- 11 day supply or typical course of treatment imme- 12 diately prior to the price change; 13 (C) the new wholesale acquisition cost per 14 30-day supply or typical course of treatment, 15 when the change takes effect; and 16 (D) financial and non-financial factors the 17 manufacturer took into consideration when 18 making the price change, including any changes 19 or improvements to the drug. 20 (c) PUBLIC DATABASE.— 21 (1) IN GENERAL.—The Secretary shall establish 22 an internet-based system to post prescription drug 23 information reported under subsection (a) and price 24 change reports required under subsection (b). 25 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 6 •HR 5239 IH (2) CONSUMER SUBSCRIPTION OPTIONS.—The 1 system established under paragraph (1) shall enable 2 consumers to subscribe to price change notifica- 3 tions— 4 (A) for— 5 (i) all drugs; 6 (ii) a particular drug; or 7 (iii) a particular therapeutic class of 8 drugs; and 9 (B) that are limited to price changes that 10 are at or over a specified amount. 11 (3) TIMING.—The prescription drug informa- 12 tion reported under subsection (a) shall be made 13 publicly available not later than 30 days after being 14 reported to the Secretary. In the case of a price 15 change report required under subsection (b), the 16 Secretary shall make publicly available a notice of 17 the price change contained in such report on the day 18 such change takes effect. 19 (d) PRIVACY PROTECTIONS.—The information sub- 20 mitted under subparagraphs (A) through (F) of subsection 21 (a)(1) and paragraph (2)(A)(ii) shall be publicly available 22 through the database established under subsection (c). No 23 other information submitted to the Secretary pursuant to 24 subsection (a) or (b) that is proprietary, confidential, or 25 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 7 •HR 5239 IH trade secret information shall be included in such data- 1 base. 2 (e) DEFINITIONS.—For purposes of this section— 3 (1) the term ‘‘manufacturer’’ has the meaning 4 given such term in section 581 of the Federal Food, 5 Drug, and Cosmetic Act (21 U.S.C. 360eee); 6 (2) the term ‘‘prescription drug’’ means a drug 7 approved section 505 of the Federal Food, Drug, 8 and Cosmetic Act (21 U.S.C. 355) or a biological 9 product licensed under section 351 of the Public 10 Health Service Act (42 U.S.C. 262) that is subject 11 to section 503(b)(1) of the Federal Food, Drug, and 12 Cosmetic Act (21 U.S.C. 353(b)(1)); 13 (3) the term ‘‘Secretary’’ means the Secretary 14 of Health and Human Services; and 15 (4) the term ‘‘wholesale acquisition cost’’ has 16 the meaning given such term in section 17 1847A(c)(6)(B) of the Social Security Act (42 18 U.S.C. 1395w–3a (c)(6)(B)). 19 (f) PREEMPTION.—Effective on the date that the 20 public database under subsection (b)(3) first becomes 21 operational, no State or political subdivision of a State 22 may establish or continue in effect any law requiring the 23 VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS 8 •HR 5239 IH manufacturer to report or make public prescription drug 1 pricing information. 2 Æ VerDate Sep 11 2014 03:09 Dec 06, 2019 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\H5239.IH H5239 aiking on DSK30JT082PROD with BILLS