[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5239 Introduced in House (IH)]
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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 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. In the case
of a price change report required under subsection (b), the
Secretary shall make publicly available a notice of the price
change contained in such report on the day such change takes
effect.
(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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