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.