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) introduced the following bill; which was read twice and referred to the Committee 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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Prescription Drug 

5 Price Reporting Act’’. 

6 SEC. 2. PRESCRIPTION DRUG PRICE REPORTING REQUIRE7 MENTS. 

8 (a) SUBMISSION OF DATA.— 


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1 (1) IN GENERAL.—Each manufacturer of a pre2 scription drug shall submit to the Secretary, elec3 tronically, in such manner as the Secretary may re4 quire, by April 1 of each year, a list of each such 

5 drug that is marketed in the United States and, 

6 with respect to each such drug, all of the following 

7 information with respect to the previous year: 

8 (A) Each applicable National Drug Code 

9 (or J-Code). 

10 (B) Brand name. 

11 (C) Generic name and chemical name, as 

12 applicable. 

13 (D) Therapeutic class or classes, as appli14 cable. 

15 (E) Current wholesale acquisition cost per 

16 30-day supply or typical course of treatment. 

17 (F) Average wholesale acquisition cost for 

18 the drug per 30-day supply or typical course of 

19 treatment during the previous calendar year, or, 

20 in the case of a drug that has been marketed 

21 for only a portion of such year, during the por22 tion of time in such year that the drug was 

23 marketed. 

24 (G) Average net price per 30-day supply or 

25 typical course of treatment, during the previous 


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1 calendar year, or, in the case of a drug that has 

2 been marketed for only a portion of such year, 

3 during the portion of time in such year that the 

4 drug was marketed, taking into account all dis5 counts, rebates, and other fees or payments to 

6 health insurance plans or pharmacy benefit 

7 managers with respect to sales of the drug to 

8 individuals covered by such a plan. 

9 (H) Total rebates and other payments to 

10 health insurance plans or pharmacy benefit 

11 managers, per 30-day supply or typical course 

12 of treatment, with respect to individuals covered 

13 by such a plan, during the previous calendar 

14 year, or, in the case of a drug that has been 

15 marketed for only a portion of such calendar 

16 year, during the portion of time in such cal17 endar year that the drug was marketed. 

18 (2) TIMELINE FOR INITIAL SUBMISSION.— 

19 (A) DRUGS MARKETED BEFORE DECEM20 BER 31, 2020.—Each manufacturer of a pre21 scription drug that is marketed at any time 

22 during calendar year 2020, shall submit to the 

23 Secretary, not later than April 1, 2021— 

24 (i) the information required under 

25 paragraph (1); and 


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1 (ii) in addition to the information re2 quired under subparagraphs (F), (G), and 

3 (H) of paragraph (1), such average whole4 sale acquisition cost, average net price, and 

5 total rebates and other payments, de6 scribed in each of such subparagraphs, re7 spectively, with respect to the calendar 

8 year immediately preceding the calendar 

9 year for which such information is required 

10 to be reported under such subparagraphs 

11 (F), (G), and (H). 

12 (B) SUBSEQUENTLY MARKETED DRUGS.— 

13 With respect to a prescription drug that is first 

14 marketed after December 31, 2020, each manu15 facturer of such a drug shall submit the infor16 mation required under subparagraphs (A) 

17 through (E) of paragraph (1) not later than 60 

18 days after the date on which the drug is first 

19 marketed, and shall submit annual reports of 

20 all of the information required under paragraph 

21 (1) beginning on the first annual reporting date 

22 that is more than 30 days after the date on 

23 which the drug is first marketed. 

24 (b) ADVANCE NOTIFICATION OF PRESCRIPTION

25 DRUG PRICING CHANGES.— 


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1 (1) IN GENERAL.—Each manufacturer of a pre2 scription drug shall report to the Secretary, elec3 tronically, in such manner as the Secretary may re4 quire, any increase or decrease in the wholesale ac5 quisition cost of a prescription drug not later than 

6 30 days prior to the date on which the price change 

7 takes effect. 

8 (2) CONTENT.—A price change report under 

9 paragraph (1) shall include— 

10 (A) the information required under sub11 paragraphs (A), (B), (C), (D), and (F) of sub12 section (a)(1); 

13 (B) the wholesale acquisition cost per 30- 

14 day supply or typical course of treatment imme15 diately prior to the price change; 

16 (C) the new wholesale acquisition cost per 

17 30-day supply or typical course of treatment, 

18 when the change takes effect; and 

19 (D) financial and non-financial factors the 

20 manufacturer took into consideration when 

21 making the price change, including any changes 

22 or improvements to the drug. 

23 (c) PUBLIC DATABASE.— 

24 (1) IN GENERAL.—The Secretary shall establish 

25 an internet-based system to post prescription drug 


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1 information reported under subsection (a) and price 

2 change reports required under subsection (b). 

3 (2) CONSUMER SUBSCRIPTION OPTIONS.—The 

4 system established under paragraph (1) shall enable 

5 consumers to subscribe to price change notifica6 tions— 

7 (A) for— 

8 (i) all drugs; 

9 (ii) a particular drug; or 

10 (iii) a particular therapeutic class of 

11 drugs; and 

12 (B) that are limited to price changes that 

13 are at or over a specified amount. 

14 (3) TIMING.—The prescription drug informa15 tion reported under subsection (a) shall be made 

16 publicly available not later than 30 days after being 

17 reported to the Secretary. Price change reports re18 quired under subsection (b) shall be made publically 

19 available no later than 5 business days after submis20 sion to the Secretary. 

21 (d) PRIVACY PROTECTIONS.—The information sub22 mitted under subparagraphs (A) through (F) of subsection 

23 (a)(1) and paragraph (2)(A)(ii) shall be publicly available 

24 through the database established under subsection (c). No 

25 other information submitted to the Secretary pursuant to 


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1 subsection (a) or (b) that is proprietary, confidential, or 

2 trade secret information shall be included in such data3 base. 

4 (e) DEFINITIONS.—For purposes of this section— 

5 (1) the term ‘‘manufacturer’’ has the meaning 

6 given such term in section 581 of the Federal Food, 

7 Drug, and Cosmetic Act (21 U.S.C. 360eee); 

8 (2) the term ‘‘prescription drug’’ means a drug 

9 approved section 505 of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355) or a biological 

11 product licensed under section 351 of the Public 

12 Health Service Act (42 U.S.C. 262) that is subject 

13 to section 503(b)(1) of the Federal Food, Drug, and 

14 Cosmetic Act (21 U.S.C. 353(b)(1)); 

15 (3) the term ‘‘Secretary’’ means the Secretary 

16 of Health and Human Services; and 

17 (4) the term ‘‘wholesale acquisition cost’’ has 

18 the meaning given such term in section 

19 1847A(c)(6)(B) of the Social Security Act (42 

20 U.S.C. 1395w–3a (c)(6)(B)). 

21 (f) PREEMPTION.—Effective on the date that the 

22 public database under subsection (b)(3) first becomes 

23 operational, no State or political subdivision of a State 

24 may establish or continue in effect any law requiring the 


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1 manufacturer to report or make public prescription drug 

2 pricing information. 

Æ 


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