Prescription Drug Price Reporting Act

II 116TH CONGRESS 1ST SESSION S. 1664 To require reporting on prescription drug expenditures under group health plans and on prescription drug price changes, and for other purposes. IN THE SENATE OF THE UNITED STATES MAY 23 (legislative day, MAY 22), 2019 Mr. SCOTT of Florida (for himself, Ms. COLLINS, and Mr. GARDNER) intro- duced the following bill; which was read twice and referred to the Com- mittee on Health, Education, Labor, and Pensions 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 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 2 •S 1664 IS (1) IN GENERAL.—Each manufacturer of a pre- 1 scription drug shall submit to the Secretary, elec- 2 tronically, in such manner as the Secretary may re- 3 quire, by April 1 of each year, a list of each such 4 drug that is marketed in the United States and, 5 with respect to each such drug, all of the following 6 information with respect to the previous year: 7 (A) Each applicable National Drug Code 8 (or J-Code). 9 (B) Brand name. 10 (C) Generic name and chemical name, as 11 applicable. 12 (D) Therapeutic class or classes, as appli- 13 cable. 14 (E) Current wholesale acquisition cost per 15 30-day supply or typical course of treatment. 16 (F) Average wholesale acquisition cost for 17 the drug per 30-day supply or typical course of 18 treatment during the previous calendar year, or, 19 in the case of a drug that has been marketed 20 for only a portion of such year, during the por- 21 tion of time in such year that the drug was 22 marketed. 23 (G) Average net price per 30-day supply or 24 typical course of treatment, during the previous 25 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 3 •S 1664 IS calendar year, or, in the case of a drug that has 1 been marketed for only a portion of such year, 2 during the portion of time in such year that the 3 drug was marketed, taking into account all dis- 4 counts, rebates, and other fees or payments to 5 health insurance plans or pharmacy benefit 6 managers with respect to sales of the drug to 7 individuals covered by such a plan. 8 (H) Total rebates and other payments to 9 health insurance plans or pharmacy benefit 10 managers, per 30-day supply or typical course 11 of treatment, with respect to individuals covered 12 by such a plan, during the previous calendar 13 year, or, in the case of a drug that has been 14 marketed for only a portion of such calendar 15 year, during the portion of time in such cal- 16 endar year that the drug was marketed. 17 (2) TIMELINE FOR INITIAL SUBMISSION.— 18 (A) DRUGS MARKETED BEFORE DECEM- 19 BER 31, 2020.—Each manufacturer of a pre- 20 scription drug that is marketed at any time 21 during calendar year 2020, shall submit to the 22 Secretary, not later than April 1, 2021— 23 (i) the information required under 24 paragraph (1); and 25 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 4 •S 1664 IS (ii) in addition to the information re- 1 quired under subparagraphs (F), (G), and 2 (H) of paragraph (1), such average whole- 3 sale acquisition cost, average net price, and 4 total rebates and other payments, de- 5 scribed in each of such subparagraphs, re- 6 spectively, with respect to the calendar 7 year immediately preceding the calendar 8 year for which such information is required 9 to be reported under such subparagraphs 10 (F), (G), and (H). 11 (B) SUBSEQUENTLY MARKETED DRUGS.— 12 With respect to a prescription drug that is first 13 marketed after December 31, 2020, each manu- 14 facturer of such a drug shall submit the infor- 15 mation required under subparagraphs (A) 16 through (E) of paragraph (1) not later than 60 17 days after the date on which the drug is first 18 marketed, and shall submit annual reports of 19 all of the information required under paragraph 20 (1) beginning on the first annual reporting date 21 that is more than 30 days after the date on 22 which the drug is first marketed. 23 (b) ADVANCE NOTIFICATION OF PRESCRIPTION 24 DRUG PRICING CHANGES.— 25 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 5 •S 1664 IS (1) IN GENERAL.—Each manufacturer of a pre- 1 scription drug shall report to the Secretary, elec- 2 tronically, in such manner as the Secretary may re- 3 quire, any increase or decrease in the wholesale ac- 4 quisition cost of a prescription drug not later than 5 30 days prior to the date on which the price change 6 takes effect. 7 (2) CONTENT.—A price change report under 8 paragraph (1) shall include— 9 (A) the information required under sub- 10 paragraphs (A), (B), (C), (D), and (F) of sub- 11 section (a)(1); 12 (B) the wholesale acquisition cost per 30- 13 day supply or typical course of treatment imme- 14 diately prior to the price change; 15 (C) the new wholesale acquisition cost per 16 30-day supply or typical course of treatment, 17 when the change takes effect; and 18 (D) financial and non-financial factors the 19 manufacturer took into consideration when 20 making the price change, including any changes 21 or improvements to the drug. 22 (c) PUBLIC DATABASE.— 23 (1) IN GENERAL.—The Secretary shall establish 24 an internet-based system to post prescription drug 25 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 6 •S 1664 IS information reported under subsection (a) and price 1 change reports required under subsection (b). 2 (2) CONSUMER SUBSCRIPTION OPTIONS.—The 3 system established under paragraph (1) shall enable 4 consumers to subscribe to price change notifica- 5 tions— 6 (A) for— 7 (i) all drugs; 8 (ii) a particular drug; or 9 (iii) a particular therapeutic class of 10 drugs; and 11 (B) that are limited to price changes that 12 are at or over a specified amount. 13 (3) TIMING.—The prescription drug informa- 14 tion reported under subsection (a) shall be made 15 publicly available not later than 30 days after being 16 reported to the Secretary. Price change reports re- 17 quired under subsection (b) shall be made publically 18 available no later than 5 business days after submis- 19 sion to the Secretary. 20 (d) PRIVACY PROTECTIONS.—The information sub- 21 mitted under subparagraphs (A) through (F) of subsection 22 (a)(1) and paragraph (2)(A)(ii) shall be publicly available 23 through the database established under subsection (c). No 24 other information submitted to the Secretary pursuant to 25 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 7 •S 1664 IS subsection (a) or (b) that is proprietary, confidential, or 1 trade secret information shall be included in such data- 2 base. 3 (e) DEFINITIONS.—For purposes of this section— 4 (1) the term ‘‘manufacturer’’ has the meaning 5 given such term in section 581 of the Federal Food, 6 Drug, and Cosmetic Act (21 U.S.C. 360eee); 7 (2) the term ‘‘prescription drug’’ means a drug 8 approved section 505 of the Federal Food, Drug, 9 and Cosmetic Act (21 U.S.C. 355) or a biological 10 product licensed under section 351 of the Public 11 Health Service Act (42 U.S.C. 262) that is subject 12 to section 503(b)(1) of the Federal Food, Drug, and 13 Cosmetic Act (21 U.S.C. 353(b)(1)); 14 (3) the term ‘‘Secretary’’ means the Secretary 15 of Health and Human Services; and 16 (4) the term ‘‘wholesale acquisition cost’’ has 17 the meaning given such term in section 18 1847A(c)(6)(B) of the Social Security Act (42 19 U.S.C. 1395w–3a (c)(6)(B)). 20 (f) PREEMPTION.—Effective on the date that the 21 public database under subsection (b)(3) first becomes 22 operational, no State or political subdivision of a State 23 may establish or continue in effect any law requiring the 24 VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS 8 •S 1664 IS manufacturer to report or make public prescription drug 1 pricing information. 2 Æ VerDate Sep 11 2014 04:38 Jun 01, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6301 E:\BILLS\S1664.IS S1664 kjohnson on DSK79L0C42 with BILLS