Title: Prescription Drug Price Reporting Act
Policy area: Health

Summary:
Prescription Drug Price Reporting ActThis bill requires that all prescription drug manufacturers submit certain information for every drug marketed in the United States to the Department of Health and Human Services (HHS). Specifically, manufacturers must provide information about cost, pricing, and rebates. Manufacturers are also required to submit any price changes to a prescription drug at least 30 days in advance.HHS must make this information available through a public database that enables consumers to subscribe to price change notifications for different types of prescriptions drugs.

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[S. 1664 Introduced in Senate (IS)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Prescription Drug Price Reporting 
Act''.

SEC. 2. PRESCRIPTION DRUG PRICE REPORTING REQUIREMENTS.

    (a) Submission of Data.--
            (1) In general.--Each manufacturer of a prescription drug 
        shall submit to the Secretary, electronically, in such manner 
        as the Secretary may require, by April 1 of each year, a list 
        of each such drug that is marketed in the United States and, 
        with respect to each such drug, all of the following 
        information with respect to the previous year:
                    (A) Each applicable National Drug Code (or J-Code).
                    (B) Brand name.
                    (C) Generic name and chemical name, as applicable.
                    (D) Therapeutic class or classes, as applicable.
                    (E) Current wholesale acquisition cost per 30-day 
                supply or typical course of treatment.
                    (F) Average wholesale acquisition cost for the drug 
                per 30-day supply or typical course of treatment during 
                the previous calendar year, or, in the case of a drug 
                that has been marketed for only a portion of such year, 
                during the portion of time in such year that the drug 
                was marketed.
                    (G) Average net price per 30-day supply or typical 
                course of treatment, during the previous calendar year, 
                or, in the case of a drug that has been marketed for 
                only a portion of such year, during the portion of time 
                in such year that the drug was marketed, taking into 
                account all discounts, rebates, and other fees or 
                payments to health insurance plans or pharmacy benefit 
                managers with respect to sales of the drug to 
                individuals covered by such a plan.
                    (H) Total rebates and other payments to health 
                insurance plans or pharmacy benefit managers, per 30-
                day supply or typical course of treatment, with respect 
                to individuals covered by such a plan, during the 
                previous calendar year, or, in the case of a drug that 
                has been marketed for only a portion of such calendar 
                year, during the portion of time in such calendar year 
                that the drug was marketed.
            (2) Timeline for initial submission.--
                    (A) Drugs marketed before december 31, 2020.--Each 
                manufacturer of a prescription drug that is marketed at 
                any time during calendar year 2020, shall submit to the 
                Secretary, not later than April 1, 2021--
                            (i) the information required under 
                        paragraph (1); and
                            (ii) in addition to the information 
                        required under subparagraphs (F), (G), and (H) 
                        of paragraph (1), such average wholesale 
                        acquisition cost, average net price, and total 
                        rebates and other payments, described in each 
                        of such subparagraphs, respectively, with 
                        respect to the calendar year immediately 
                        preceding the calendar year for which such 
                        information is required to be reported under 
                        such subparagraphs (F), (G), and (H).
                    (B) Subsequently marketed drugs.--With respect to a 
                prescription drug that is first marketed after December 
                31, 2020, each manufacturer of such a drug shall submit 
                the information required under subparagraphs (A) 
                through (E) of paragraph (1) not later than 60 days 
                after the date on which the drug is first marketed, and 
                shall submit annual reports of all of the information 
                required under paragraph (1) beginning on the first 
                annual reporting date that is more than 30 days after 
                the date on which the drug is first marketed.
    (b) Advance Notification of Prescription Drug Pricing Changes.--
            (1) In general.--Each manufacturer of a prescription drug 
        shall report to the Secretary, electronically, in such manner 
        as the Secretary may require, any increase or decrease in the 
        wholesale acquisition cost of a prescription drug not later 
        than 30 days prior to the date on which the price change takes 
        effect.
            (2) Content.--A price change report under paragraph (1) 
        shall include--
                    (A) the information required under subparagraphs 
                (A), (B), (C), (D), and (F) of subsection (a)(1);
                    (B) the wholesale acquisition cost per 30-day 
                supply or typical course of treatment immediately prior 
                to the price change;
                    (C) the new wholesale acquisition cost per 30-day 
                supply or typical course of treatment, when the change 
                takes effect; and
                    (D) financial and non-financial factors the 
                manufacturer took into consideration when making the 
                price change, including any changes or improvements to 
                the drug.
    (c) Public Database.--
            (1) In general.--The Secretary shall establish an internet-
        based system to post prescription drug information reported 
        under subsection (a) and price change reports required under 
        subsection (b).
            (2) Consumer subscription options.--The system established 
        under paragraph (1) shall enable consumers to subscribe to 
        price change notifications--
                    (A) for--
                            (i) all drugs;
                            (ii) a particular drug; or
                            (iii) a particular therapeutic class of 
                        drugs; and
                    (B) that are limited to price changes that are at 
                or over a specified amount.
            (3) Timing.--The prescription drug information reported 
        under subsection (a) shall be made publicly available not later 
        than 30 days after being reported to the Secretary. Price 
        change reports required under subsection (b) shall be made 
        publically available no later than 5 business days after 
        submission to the Secretary.
    (d) Privacy Protections.--The information submitted under 
subparagraphs (A) through (F) of subsection (a)(1) and paragraph 
(2)(A)(ii) shall be publicly available through the database established 
under subsection (c). No other information submitted to the Secretary 
pursuant to subsection (a) or (b) that is proprietary, confidential, or 
trade secret information shall be included in such database.
    (e) Definitions.--For purposes of this section--
            (1) the term ``manufacturer'' has the meaning given such 
        term in section 581 of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360eee);
            (2) the term ``prescription drug'' means a drug approved 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or a biological product licensed under section 351 
        of the Public Health Service Act (42 U.S.C. 262) that is 
        subject to section 503(b)(1) of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 353(b)(1));
            (3) the term ``Secretary'' means the Secretary of Health 
        and Human Services; and
            (4) the term ``wholesale acquisition cost'' has the meaning 
        given such term in section 1847A(c)(6)(B) of the Social 
        Security Act (42 U.S.C. 1395w-3a (c)(6)(B)).
    (f) Preemption.--Effective on the date that the public database 
under subsection (b)(3) first becomes operational, no State or 
political subdivision of a State may establish or continue in effect 
any law requiring the manufacturer to report or make public 
prescription drug pricing information.
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