Competition Prescription Act of 2019
This bill revises various requirements related to the development, production, and sale of prescription drugs and biological products.
First, the bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved product if the license holder has declined to make available sufficient quantities of the approved product for the developer's testing.
The bill also requires the Food and Drug Administration (FDA) to establish a process for developers of generic complex drugs to request and receive expedited development and priority review. Further, upon request by a drug sponsor, a drug that treats a life-threatening disease or condition must be designated for expedited review if there are fewer than three drugs currently available for such treatment.
States are prohibited from placing restrictions on dispensing substitute biological products that have been determined to be interchangeable with another product by the FDA.
Additionally, the bill prohibits sponsors of Medicare Part D prescription drug plans from reducing a payment to a pharmacy after a claim without defect has been submitted by such pharmacy. The bill establishes requirements for pricing standards for pharmacy benefits managers under Medicare and other federal prescription drug benefits programs. Starting in 2025, the bill removes the cap on rebates paid by manufacturers of outpatient prescription drugs under Medicaid.
Further, the bill requires the publication of specified information regarding licensed biological products, exempts from antitrust prohibitions specified drug-price negotiation strategies, and establishes a Chief Pharmaceutical Negotiator in the Office of the U.S. Trade Representative.
[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3947 Introduced in House (IH)]
<DOC>
116th CONGRESS
1st Session
H. R. 3947
To lower the cost of prescription drugs, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 24, 2019
Mr. Meadows introduced the following bill; which was referred to the
Committee on Energy and Commerce, and in addition to the Committees on
Ways and Means, the Judiciary, Armed Services, and Oversight and
Reform, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the
jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To lower the cost of prescription drugs, 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; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Competition
Prescription Act of 2019''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--ELIMINATING DELAYS OF GENERIC DRUGS AND BIOSIMILAR PRODUCTS
Sec. 101. Actions for delays of generic drugs and biosimilar biological
products.
Sec. 102. REMS approval process for subsequent filers.
TITLE II--INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS
Sec. 201. Expedited development and priority review for generic complex
drug products.
Sec. 202. Increasing pharmaceutical options to treat an unmet medical
need.
Sec. 203. Preemption of State barriers to the substitution of
biosimilar products.
Sec. 204. Expedited process for biological products authorized for
marketing in European Union.
TITLE III--PRESCRIPTION DRUG PRICING AND COMPETITION
Sec. 301. Medicare drug coverage.
Sec. 302. Fee transparency between pharmacies and PBMs.
Sec. 303. Sunset of limit on maximum rebate amount for single source
drugs and innovator multiple source drugs.
Sec. 304. Regulation of manufacturer-sponsored copay contributions.
TITLE IV--PATENT DISCLOSURE REQUIREMENTS
Sec. 401. Patent disclosure and transparency requirements.
Sec. 402. Antitrust exemption for health insurance issuers to negotiate
wholesale acquisition prices of
prescription drugs purchased from drug
manufacturers.
Sec. 403. Fair treatment of Medicare part B billing codes for the
prescribing of biosimilars.
TITLE V--FIXING GLOBAL FREELOADING
Sec. 501. Chief Pharmaceutical Negotiator in the Office of the United
States Trade Representative.
TITLE I--ELIMINATING DELAYS OF GENERIC DRUGS AND BIOSIMILAR PRODUCTS
SEC. 101. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL
PRODUCTS.
(a) Definitions.--In this section--
(1) the term ``commercially reasonable, market-based
terms'' means--
(A) a nondiscriminatory price for the sale of the
covered product at or below, but not greater than, the
most recent wholesale acquisition cost for the drug, as
defined in section 1847A(c)(6)(B) of the Social
Security Act (42 U.S.C. 1395w-3a(c)(6)(B));
(B) a schedule for delivery that results in the
transfer of the covered product to the eligible product
developer consistent with the timing under subsection
(b)(2)(A)(iv); and
(C) no additional conditions are imposed on the
sale of the covered product;
(2) the term ``covered product''--
(A) means--
(i) any drug approved under subsection (c)
or (j) of section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355) or
biological product licensed under subsection
(a) or (k) of section 351 of the Public Health
Service Act (42 U.S.C. 262);
(ii) any combination of a drug or
biological product described in clause (i); or
(iii) when reasonably necessary to support
approval of an application under section 505 of
the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355), or section 351 of the Public
Health Service Act (42 U.S.C. 262), as
applicable, or otherwise meet the requirements
for approval under either such section, any
product, including any device, that is marketed
or intended for use with such a drug or
biological product; and
(B) does not include any drug or biological product
that appears on the drug shortage list in effect under
section 506E of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 356e), unless--
(i) the drug or biological product has been
on the drug shortage list in effect under such
section 506E continuously for more than 6
months; or
(ii) the Secretary determines that
inclusion of the drug or biological product as
a covered product is likely to contribute to
alleviating or preventing a shortage;
(3) the term ``device'' has the meaning given the term in
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321);
(4) the term ``eligible product developer'' means a person
that seeks to develop a product for approval pursuant to an
application for approval under subsection (b)(2) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) or for licensing pursuant to an application under
section 351(k) of the Public Health Service Act (42 U.S.C.
262(k));
(5) the term ``license holder'' means the holder of an
application approved under subsection (c) or (j) of section 505
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or
the holder of a license under subsection (a) or (k) of section
351 of the Public Health Service Act (42 U.S.C. 262) for a
covered product;
(6) the term ``REMS'' means a risk evaluation and
mitigation strategy under section 505-1 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355-1);
(7) the term ``REMS with ETASU'' means a REMS that contains
elements to assure safe use under section 505-1(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355-1(f));
(8) the term ``Secretary'' means the Secretary of Health
and Human Services;
(9) the term ``single, shared system of elements to assure
safe use'' means a single, shared system of elements to assure
safe use under section 505-1(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355-1(f)); and
(10) the term ``sufficient quantities'' means an amount of
a covered product that the eligible product developer
determines allows it to--
(A) conduct testing to support an application
under--
(i) subsection (b)(2) or (j) of section 505
of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355); or
(ii) section 351(k) of the Public Health
Service Act (42 U.S.C. 262(k)); and
(B) fulfill any regulatory requirements relating to
approval of such an application.
(b) Civil Action for Failure To Provide Sufficient Quantities of a
Covered Product.--
(1) In general.--An eligible product developer may bring a
civil action against the license holder for a covered product
seeking relief under this subsection in an appropriate district
court of the United States alleging that the license holder has
declined to provide sufficient quantities of the covered
product to the eligible product developer on commercially
reasonable, market-based terms.
(2) Elements.--
(A) In general.--To prevail in a civil action
brought under paragraph (1), an eligible product
developer shall prove, by a preponderance of the
evidence--
(i) that--
(I) the covered product is not
subject to a REMS with ETASU; or
(II) if the covered product is
subject to a REMS with ETASU--
(aa) the eligible product
developer has obtained a
covered product authorization
from the Secretary in
accordance with subparagraph
(B); and
(bb) the eligible product
developer has provided a copy
of the covered product
authorization to the license
holder;
(ii) that, as of the date on which the
civil action is filed, the product developer
has not obtained sufficient quantities of the
covered product on commercially reasonable,
market-based terms;
(iii) that the eligible product developer
has requested to purchase sufficient quantities
of the covered product from the license holder;
and
(iv) that the license holder has not
delivered to the eligible product developer
sufficient quantities of the covered product on
commercially reasonable, market-based terms--
(I) for a covered product that is
not subject to a REMS with ETASU, by
the date that is 31 days after the date
on which the license holder received
the request for the covered product;
and
(II) for a covered product that is
subject to a REMS with ETASU, by 31
days after the later of--
(aa) the date on which the
license holder received the
request for the covered
product; or
(bb) the date on which the
license holder received a copy
of the covered product
authorization issued by the
Secretary in accordance with
subparagraph (B).
(B) Authorization for covered product subject to a
rems with etasu.--
(i) Request.--An eligible product developer
may submit to the Secretary a written request
for the eligible product developer to be
authorized to obtain sufficient quantities of
an individual covered product subject to a REMS
with ETASU.
(ii) Authorization.--Not later than 120
days after the date on which a request under
clause (i) is received, the Secretary shall, by
written notice, authorize the eligible product
developer to obtain sufficient quantities of an
individual covered product subject to a REMS
with ETASU for purposes of--
(I) development and testing that
does not involve human clinical trials,
if the eligible product developer has
agreed to comply with any conditions
the Secretary determines necessary; or
(II) development and testing that
involves human clinical trials, if the
eligible product developer has--
(aa)(AA) submitted
protocols, informed consent
documents, and informational
materials for testing that
include protections that
provide safety protections
comparable to those provided by
the REMS for the covered
product; or
(BB) otherwise satisfied
the Secretary that such
protections will be provided;
and
(bb) met any other
requirements the Secretary may
establish.
(iii) Notice.--A covered product
authorization issued under this subparagraph
shall state that the provision of the covered
product by the license holder under the terms
of the authorization will not be a violation of
the REMS for the covered product.
(3) Affirmative defense.--In a civil action brought under
paragraph (1), it shall be an affirmative defense, on which the
defendant has the burden of persuasion by a preponderance of
the evidence--
(A) that, on the date on which the eligible product
developer requested to purchase sufficient quantities
of the covered product from the license holder--
(i) neither the license holder nor any of
its agents, wholesalers, or distributors was
engaged in the manufacturing or commercial
marketing of the covered product; and
(ii) neither the license holder nor any of
its agents, wholesalers, or distributors
otherwise had access to inventory of the
covered product to supply to the eligible
product developer on commercially reasonable,
market-based terms;
(B) that--
(i) the license holder sells the covered
product through agents, distributors, or
wholesalers;
(ii) the license holder has placed no
restrictions, explicit or implicit, on its
agents, distributors, or wholesalers to sell
covered products to eligible product
developers; and
(iii) the covered product can be purchased
by the eligible product developer in sufficient
quantities on commercially reasonable, market-
based terms from the agents, distributors, or
wholesalers of the license holder; or
(C) that the license holder made an offer to sell
sufficient quantities of the covered product to the
eligible product developer at commercially reasonable
market-based terms--
(i) for a covered product that is not
subject to a REMS with ETASU, by the date that
is 14 days after the date on which the license
holder received the request for the covered
product, and the eligible product developer did
not accept such offer by the date that is 7
days after the date on which the eligible
product developer received such offer from the
license holder; or
(ii) for a covered product that is subject
to a REMS with ETASU, by the date that is 20
days after the date on which the license holder
received the request for the covered product,
and the eligible product developer did not
accept such offer by the date that is 10 days
after the date on which the eligible product
developer received such offer from the license
holder.
(4) Methods for transmission of requests for covered
products.--A written request for a covered product, offer to
sell a covered product, or acceptance of such an offer between
the eligible product developer and the license holder shall be
made by--
(A) certified or registered mail with return
receipt requested;
(B) personal delivery; or
(C) electronic means.
(5) Remedies.--
(A) In general.--If an eligible product developer
prevails in a civil action brought under paragraph (1),
the court shall--
(i) order the license holder to provide to
the eligible product developer without delay
sufficient quantities of the covered product on
commercially reasonable, market-based terms;
(ii) award to the eligible product
developer reasonable attorney's fees and costs
of the civil action; and
(iii) award to the eligible product
developer a monetary amount sufficient to deter
the license holder from failing to provide
eligible product developers with sufficient
quantities of a covered product on commercially
reasonable, market-based terms, if the court
finds, by a preponderance of the evidence--
(I) that the license holder delayed
providing sufficient quantities of the
covered product to the eligible product
developer without a legitimate business
justification; or
(II) that the license holder failed
to comply with an order issued under
clause (i).
(B) Maximum monetary amount.--A monetary amount
awarded under subparagraph (A)(iii) shall not be
greater than the revenue that the license holder earned
on the covered product during the period--
(i) beginning on--
(I) for a covered product that is
not subject to a REMS with ETASU, the
date that is 31 days after the date on
which the license holder received the
request; or
(II) for a covered product that is
subject to a REMS with ETASU, the date
that is 31 days after the later of--
(aa) the date on which the
license holder received the
request; or
(bb) the date on which the
license holder received a copy
of the covered product
authorization issued by the
Secretary in accordance with
paragraph (2)(B); and
(ii) ending on the date on which the
eligible product developer received sufficient
quantities of the covered product.
(C) Avoidance of delay.--The court may issue an
order under subparagraph (A)(i) before conducting
further proceedings that may be necessary to determine
whether the eligible product developer is entitled to
an award under clause (ii) or (iii) of subparagraph
(A), or the amount of any such award.
(c) Limitation of Liability.--A license holder for a covered
product shall not be liable for any claim under Federal, State, or
local law arising out of the failure of an eligible product developer
to follow adequate safeguards to assure safe use of the covered product
during development or testing activities described in this section,
including transportation, handling, use, or disposal of the covered
product by the eligible product developer.
(d) No Violation of REMS.--Section 505-1 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355-1) is amended by adding at the end the
following new subsection:
``(l) Provision of Samples Not a Violation of Strategy.--The
provision of samples of a covered product to an eligible product
developer (as those terms are defined in section 2(a) of the Creating
and Restoring Equal Access to Equivalent Samples Act of 2019) shall not
be considered a violation of the requirements of any risk evaluation
and mitigation strategy that may be in place under this section for
such drug.''.
(e) Rule of Construction.--
(1) Definition.--In this subsection, the term ``antitrust
laws''--
(A) has the meaning given the term in subsection
(a) of the first section of the Clayton Act (15 U.S.C.
12); and
(B) includes section 5 of the Federal Trade
Commission Act (15 U.S.C. 45) to the extent that such
section applies to unfair methods of competition.
(2) Antitrust laws.--Nothing in this section shall be
construed to limit the operation of any provision of the
antitrust laws.
SEC. 102. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.
Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355-1), as amended by section 101, is further amended--
(1) in subsection (g)(4)(B)--
(A) in clause (i) by striking ``or'' after the
semicolon;
(B) in clause (ii) by striking the period at the
end and inserting ``; or''; and
(C) by adding at the end the following:
``(iii) accommodate different, comparable
aspects of the elements to assure safe use for
a drug that is the subject of an application
under section 505(j), and the applicable listed
drug.'';
(2) in subsection (i)(1), by striking subparagraph (C) and
inserting the following:
``(C)(i) Elements to assure safe use, if required
under subsection (f) for the listed drug, which,
subject to clause (ii), for a drug that is the subject
of an application under section 505(j) may use--
``(I) a single, shared system with the
listed drug under subsection (f); or
``(II) a different, comparable aspect of
the elements to assure safe use under
subsection (f).
``(ii) The Secretary may require a drug that is the
subject of an application under section 505(j) and the
listed drug to use a single, shared system under
subsection (f), if the Secretary determines that no
different, comparable aspect of the elements to assure
safe use could satisfy the requirements of subsection
(f).'';
(3) in subsection (i), by adding at the end the following:
``(3) Shared rems.--If the Secretary approves, in
accordance with paragraph (1)(C)(i)(II), a different,
comparable aspect of the elements to assure safe use under
subsection (f) for a drug that is the subject of an abbreviated
new drug application under section 505(j), the Secretary may
require that such different comparable aspect of the elements
to assure safe use can be used with respect to any other drug
that is the subject of an application under section 505(j) or
505(b) that references the same listed drug.''; and
(4) by adding at the end the following:
``(m) Separate REMS.--When used in this section, the terms
`different, comparable aspect of the elements to assure safe use' or
`different, comparable approved risk evaluation and mitigation
strategies' means a risk evaluation and mitigation strategy for a drug
that is the subject of an application under section 505(j) that uses
different methods or operational means than the strategy required under
subsection (a) for the applicable listed drug, or other application
under section 505(j) with the same such listed drug, but achieves the
same level of safety as such strategy.''.
TITLE II--INCREASING ACCESS TO DRUGS AND BIOSIMILAR PRODUCTS
SEC. 201. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC COMPLEX
DRUG PRODUCTS.
Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the
following:
``SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC
COMPLEX DRUG PRODUCTS.
``(a) Establishment of Program.--The Secretary shall establish a
program to expedite the development of, and provide priority review
under section 505(j) for, generic complex drug products.
``(b) Request for Designation.--A sponsor of a generic complex drug
product may request that the Secretary designate such product for
expedited development and priority review under this section.
``(c) Designation Process.--
``(1) In general.--Not later than 60 calendar days after
the receipt of a request under subsection (c), the Secretary
shall determine whether the product that is the subject of the
request meets the criteria under subsection (e) to be
considered a generic complex drug product. If the Secretary
determines that the product meets the criteria, the Secretary
shall designate the product for expedited development and
priority review.
``(2) Review.--Review of a request under subsection (b)
shall be undertaken by a team that is composed of experienced
staff and senior managers of the Food and Drug Administration.
``(3) Withdrawal.--The Secretary may not withdraw a
designation granted under this section on the basis of the
criteria under subsection (e) no longer applying because of the
subsequent clearance or approval of any other product.
``(d) Expedited Development and Priority Review Guidance.--
``(1) Content.--Not later than December 31, 2021, the
Secretary shall issue guidance on the implementation of this
section. Such guidance shall--
``(A) set forth the process by which a person may
seek a designation under subsection (c);
``(B) provide a template for requests under
subsection (b);
``(C) identify the criteria the Secretary will use
in evaluating a request for designation under this
section; and
``(D) identify the criteria and processes the
Secretary will use to expedite the development and
review of products designated under this section.
``(2) Process.--Prior to finalizing the guidance under
paragraph (1), the Secretary shall seek public comment on a
draft version of that guidance.
``(e) Generic Complex Drug Product Defined.--In this section, the
term `generic complex drug product' means a product that represents a
complex therapy that consists of or includes a drug for approval under
section 505(j) and that--
``(1)(A) contains complex active ingredients (such as
peptides, polymeric compounds, complex mixtures of active
ingredients, and naturally sourced ingredients);
``(B) is composed of complex formulations (such as
liposomes or colloids);
``(C) requires a complex route of delivery (such as locally
acting drugs such as dermatological products and complex
ophthalmological products and otic dosage forms that are
formulated as suspensions, emulsions, or gels); or
``(D) involves a complex dosage form (such as transdermals,
metered dose inhalers, or extended release injectables);
``(2) presents as a complex drug-device combination product
(such as auto injectors or metered dose inhalers); or
``(3) is a product that would benefit from early scientific
engagement due to complexity or uncertainty concerning the
approval pathway under section 505(j).''.
SEC. 202. INCREASING PHARMACEUTICAL OPTIONS TO TREAT AN UNMET MEDICAL
NEED.
Subsection (b) of section 506 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356) is amended by adding at the end the
following:
``(4) Unmet medical need.--For purposes of paragraph (1), a
drug shall be deemed to address an unmet medical need for a
disease or condition if fewer than 3 available drugs exist for
the treatment of such disease or condition.''.
SEC. 203. PREEMPTION OF STATE BARRIERS TO THE SUBSTITUTION OF
BIOSIMILAR PRODUCTS.
No State, or any political subdivision thereof, may prohibit a
pharmacy or pharmacist from dispensing, in place of a biological
reference product, any product that, pursuant to section 351(k) of the
Public Health Service Act (42 U.S.C. 262(k)), has been determined by
the Secretary of Health and Human Services to be interchangeable with
the reference product in accordance with subsections (a) and (k)(4) of
such Act (42 U.S.C. 262(a), (k)(4)).
SEC. 204. EXPEDITED PROCESS FOR BIOLOGICAL PRODUCTS AUTHORIZED FOR
MARKETING IN EUROPEAN UNION.
Section 351(a) of the Public Health Service Act (42 U.S.C. 262(a))
is amended by adding at the end the following new paragraph:
``(4) Products authorized for marketing in european
union.--In considering whether to license a biological product
under this subsection or subsection (k), the Secretary may
expedite the licensing process if the biological product has
been authorized for marketing by the European Medicines Agency
and such authorization remains in effect.''.
TITLE III--PRESCRIPTION DRUG PRICING AND COMPETITION
SEC. 301. MEDICARE DRUG COVERAGE.
Notwithstanding any other provision of law, the Secretary of Health
and Human Services may alter payments for prescription drugs, including
biologicals, provided through the Medicare part B program by paying at
rates that, based on the average sales price plus 6 percent in the year
of implementation of this Act, grow at the consumer price index (CPI
Prescription Drugs).
SEC. 302. FEE TRANSPARENCY BETWEEN PHARMACIES AND PBMS.
(a) Prohibiting Medicare PDP Sponsors and MA-PD Organizations From
Retroactively Reducing Payment on Clean Claims Submitted by
Pharmacies.--
(1) In general.--Section 1860D-12(b)(4)(A) of the Social
Security Act (42 U.S.C. 1395w-112(b)(4)(A)) is amended by
adding at the end the following new clause:
``(iv) Prohibiting retroactive reductions
in payments on clean claims.--Each contract
entered into with a PDP sponsor under this part
with respect to a prescription drug plan
offered by such sponsor shall provide that
after the date of receipt of a clean claim
submitted by a pharmacy, the PDP sponsor (or an
agent of the PDP sponsor) may not retroactively
reduce payment on such claim directly or
indirectly through aggregated effective rate or
otherwise except in the case such claim is
found to not be a clean claim (such as in the
case of a claim lacking required substantiating
documentation) during the course of a routine
audit as permitted pursuant to written
agreement between the PDP sponsor (or such an
agent) and such pharmacy. The previous sentence
shall not prohibit any retroactive increase in
payment to a pharmacy pursuant to a written
agreement between a PDP sponsor (or an agent of
such sponsor) and such pharmacy.''.
(2) Effective date.--The amendment made by subsection (a)
shall apply with respect to contracts entered into on or after
January 1, 2021.
(b) Elimination of DIR Fees.--
(1) Pharmacy benefits manager standards under the medicare
program for prescription drug plans and ma-pd plans.--
(A) In general.--Section 1860D-12(b) of the Social
Security Act (42 U.S.C. 1395w-112(b)) is amended by
adding at the end the following new paragraph:
``(7) Pharmacy benefits manager transparency
requirements.--Each contract entered into with a PDP sponsor
under this part with respect to a prescription drug plan
offered by such sponsor or with an MA organization offering an
MA-PD plan under part C shall provide that the sponsor or
organization, respectively, may not enter into a contract with
any pharmacy benefits manager (referred to in this paragraph as
a `PBM') to manage the prescription drug coverage provided
under such plan, or to control the costs of the prescription
drug coverage under such plan, unless the PBM adheres to the
following criteria when handling personally identifiable
utilization and claims data or other sensitive patient data:
``(A) The PBM may not transmit any personally
identifiable utilization, protected health information,
or claims data, with respect to a plan enrollee, to a
pharmacy owned by a PBM if the plan enrollee has not
voluntarily elected in writing or via secure electronic
means to fill that particular prescription at the PBM-
owned pharmacy.
``(B) The PBM may not require that a plan enrollee
use a retail pharmacy, mail order pharmacy, specialty
pharmacy, or other pharmacy entity providing pharmacy
services in which the PBM has an ownership interest or
that has an ownership interest in the PBM, or provide
an incentive to a plan enrollee to encourage the
enrollee to use a retail pharmacy, mail order pharmacy,
specialty pharmacy, or other pharmacy entity providing
pharmacy services in which the PBM has an ownership
interest or that has an ownership interest in the PBM,
if the incentive is applicable only to such
pharmacies.''.
(B) Regular update of prescription drug pricing
standard.--Paragraph (6) of section 1860D-12(b) of the
Social Security Act (42 U.S.C. 1395w-112(b)) is amended
to read as follows:
``(6) Regular update of prescription drug pricing
standard.--
``(A) In general.--If the PDP sponsor of a
prescription drug plan (or MA organization offering an
MA-PD plan) uses a standard for reimbursement (as
described in subparagraph (B)) of pharmacies based on
the cost of a drug, each contract entered into with
such sponsor under this part (or organization under
part C) with respect to the plan shall provide that the
sponsor (or organization) shall--
``(i) update such standard not less
frequently than once every 7 days, beginning
with an initial update on January 1 of each
year, to accurately reflect the market price of
acquiring the drug;
``(ii) disclose to applicable pharmacies
and the contracting entities of such pharmacies
the sources used for making any such update
immediately without requirement of request;
``(iii) if the source for such a standard
for reimbursement is not publicly available,
disclose to the applicable pharmacies and the
respective contracting entities of such
pharmacies all individual drug prices to be so
updated in advance of the use of such prices
for the reimbursement of claims;
``(iv) establish a process to appeal,
investigate, and resolve disputes regarding
individual drug prices that are less than the
pharmacy acquisition price for such drug, which
must be adjudicated within 7 days of the
pharmacy filing its appeal; and
``(v) provide all such pricing data in an
.xml spreadsheet format or a comparable easily
accessible and complete spreadsheet format.
``(B) Prescription drug pricing standard defined.--
For purposes of subparagraph (A), a standard for
reimbursement of a pharmacy is any methodology or
formula for varying the pricing of a drug or drugs
during the term of the pharmacy reimbursement contract
that is based on the cost of the drug involved,
including drug pricing references and amounts that are
based upon average wholesale price, wholesale average
cost, average manufacturer price, average sales price,
maximum allowable cost (MAC), or other costs, whether
publicly available or not.''.
(C) Effective date.--The amendments made by this
section shall apply to plan years beginning on or after
January 1, 2020.
(2) Regular update of prescription drug pricing standard
under tricare retail pharmacy program.--Section 1074g(d) of
title 10, United States Code, is amended by adding at the end
the following new paragraph:
``(3) To the extent practicable, with respect to the TRICARE retail
pharmacy program described in subsection (a)(2)(E)(ii), the Secretary
shall ensure that a contract entered into with a TRICARE managed care
support contractor includes requirements described in section 1860D-
12(b)(6) of the Social Security Act (42 U.S.C. 1395w-112(b)(6)) to
ensure the provision of information regarding the pricing standard for
prescription drugs.''.
(3) Prescription drug transparency in the federal employees
health benefits program.--
(A) In general.--Section 8902 of title 5, United
States Code, is amended by adding at the end the
following new subsections:
``(p) A contract may not be made or a plan approved under this
chapter under which a carrier has an agreement with a pharmacy benefits
manager (in this subsection referred to as a `PBM') to manage
prescription drug coverage or to control the costs of the prescription
drug coverage unless the carrier and PBM adhere to the following
criteria:
``(1) The PBM may not transmit any personally identifiable
utilization, protected health information, or claims data with
respect to an individual enrolled under such contract or plan
to a pharmacy owned by the PBM if the individual has not
voluntarily elected in writing or via secure electronic means
to fill that particular prescription at such a pharmacy.
``(2) The PBM may not require that an individual enrolled
under such contract or plan use a retail pharmacy, mail order
pharmacy, specialty pharmacy, or other pharmacy entity
providing pharmacy services in which the PBM has an ownership
interest or that has an ownership interest in the PBM or
provide an incentive to a plan enrollee to encourage the
enrollee to use a retail pharmacy, mail order pharmacy,
specialty pharmacy, or other pharmacy entity providing pharmacy
services in which the PBM has an ownership interest or that has
an ownership interest in the PBM, if the incentive is
applicable only to such pharmacies.
``(q)(1) If a contract made or plan approved under this chapter
provides for a standard for reimbursement (as described in paragraph
(2)) with respect to a prescription drug plan, such contract or plan
shall provide that the applicable carrier--
``(A) update such standard not less frequently than once
every 7 days, beginning with an initial update on January 1 of
each year, to accurately reflect the market price of acquiring
the drug;
``(B) disclose to applicable pharmacies and the contracting
entities of such pharmacies the sources used for making any
such update immediately without requirement of request;
``(C) if the source for such a standard for reimbursement
is not publicly available, disclose to the applicable
pharmacies and contracting entities of such pharmacies all
individual drug prices to be so updated in advance of the use
of such prices for the reimbursement of claims;
``(D) establish a process to appeal, investigate, and
resolve disputes regarding individual drug prices that are less
than the pharmacy acquisition price for such drug, which must
be adjudicated within 7 days of the pharmacy filing its appeal;
and
``(E) provide all such pricing data in an .xml spreadsheet
format or a comparable easily accessible and complete
spreadsheet format.
``(2) For purposes of paragraph (1), a standard for reimbursement
of a pharmacy is any methodology or formula for varying the pricing of
a drug or drugs during the term of the pharmacy reimbursement contract
that is based on the cost of the drug involved, including drug pricing
references and amounts that are based upon average wholesale price,
wholesale average cost, average manufacturer price, average sales
price, maximum allowable cost, or other costs, whether publicly
available or not.''.
(B) Application.--The amendment made by
subparagraph (A) shall apply to any contract entered
into under section 8902 of title 5, United States Code,
on or after the date of enactment of this section.
SEC. 303. SUNSET OF LIMIT ON MAXIMUM REBATE AMOUNT FOR SINGLE SOURCE
DRUGS AND INNOVATOR MULTIPLE SOURCE DRUGS.
Section 1927(c)(2)(D) of the Social Security Act (42 U.S.C. 1396r-
8(c)(2)(D)) is amended by inserting after ``December 31, 2009,'' the
following: ``and before December 31, 2024,''.
SEC. 304. REGULATION OF MANUFACTURER-SPONSORED COPAY CONTRIBUTIONS.
Notwithstanding any other provision of law, the Secretary of Health
and Human Services may establish a mechanism prohibiting drug
manufacturers from contributing financially to patient copays, and
establish a system of penalizing such behavior.
TITLE IV--PATENT DISCLOSURE REQUIREMENTS
SEC. 401. PATENT DISCLOSURE AND TRANSPARENCY REQUIREMENTS.
(a) In General.--
(1) In general.--Section 351 of the Public Health Service
Act (42 U.S.C. 262) is amended by adding at the end the
following:
``(o) Additional Requirements With Respect to Patents.--
``(1) Publication of information.--
``(A) In general.--Within 1 year of the date of
enactment of the Biologic Patent Transparency Act, the
Secretary shall publish and make available to the
public a single, easily searchable list that includes--
``(i) the proper and proprietary name of
each biological product licensed or deemed to
be licensed under subsection (a) or (k);
``(ii) the date of approval and application
number for each such biological product;
``(iii) the marketing status, dosage form,
route of administration, strength, and, if
applicable, reference product, for each such
biological product;
``(iv) the licensure status for each such
biological product, including whether the
license at the time of listing is approved,
withdrawn, or revoked;
``(v) for each such biological product that
is a reference product for which an exclusivity
period applies, and for which the Secretary has
determined the dates of such exclusivity
period, under subsection (k)(7)(A) or
subsection (k)(7)(B) of this section or under
section 527 of the Federal Food, Drug, and
Cosmetic Act, including any extension of such
exclusivity period in accordance with
subsection (m) of this section, the date on
which such exclusivity period expires;
``(vi) any determination of biosimilarity
or interchangeability for each such biological
product; and
``(vii) information regarding approved
indications for each such biological product,
in such manner as the Secretary determines
appropriate.
``(B) Updates.--Every 30 days after the publication
of the first list under subparagraph (A), the Secretary
shall revise the list to include--
``(i)(I) each biological product licensed
under subsection (a) or (k) during the 30-day
period; and
``(II) with respect to each biological
product described in subclause (I), the
information described in clauses (i) through
(vii) of subparagraph (A); and
``(ii) any updates to information
previously published in accordance with
subparagraph (A).''.
(2) Public listing of patent information.--
(A) In general.--The Secretary of Health and Human
Services shall include in the recommendations
transmitted to Congress under section 744I(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
53(f)) recommendations with respect to the collection
and publication of patent information in the list
described in section 351(o) of the Public Health
Service Act (42 U.S.C. 262), as added by paragraph (1).
(B) Development.--In developing recommendations
under subparagraph (A), the Secretary of Health and
Human Services may consult with the Federal Trade
Commission, the Director of the United States Patent
and Trademark Office, and the Federal Trade Commission,
in addition to the entities listed in section
744I(f)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-53(f)(1)).
(b) Rule of Construction.--Nothing in this section, including the
amendment made by this section, shall be construed to require or allow
the Secretary of Health and Human Services to delay the review or
approval of a biologic license application under section 351 of the
Public Health Service Act (42 U.S.C. 262).
SEC. 402. ANTITRUST EXEMPTION FOR HEALTH INSURANCE ISSUERS TO NEGOTIATE
WHOLESALE ACQUISITION PRICES OF PRESCRIPTION DRUGS
PURCHASED FROM DRUG MANUFACTURERS.
(a) Exemption.--It shall not be a violation of the antitrust laws
for one or more health insurance issuers or their designated agents to
jointly negotiate wholesale acquisition prices of a prescription drug
with a manufacturer of a prescription drug with regards to the
reimbursement policies of the insurers of the manufacturer's drugs so
long as no single wholesale acquisition price is jointly determined
between the insurance issuers or their designated agents.
(b) Definitions.--For purposes of this section:
(1) Antitrust laws.--The term ``antitrust laws'' has the
meaning given it in subsection (a) of the 1st section of the
Clayton Act (15 U.S.C. 12(a)), except that such term includes
section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to
the extent such section 5 applies to unfair methods of
competition.
(2) Health insurance issuer.--The term ``health insurance
issuer'' has the meaning given that term in section 2791(b) of
the Public Health Service Act (42 U.S.C. 300gg-91(b)).
(3) Health maintenance organization.--The term ``health
maintenance organization'' means--
(A) a federally qualified health maintenance
organization (as defined in section 300e(a) of title 42
of the Code of Federal Regulations),
(B) an organization recognized under State law as a
health maintenance organization, or
(C) a similar organization regulated under State
law for solvency in the same manner and to the same
extent as such a health maintenance organization.
(4) Manufacturer.--The term ``manufacturer'' means anyone
who is engaged in manufacturing, preparing, propagating,
compounding, processing, packaging, repackaging, or labeling of
a prescription drug.
(5) Prescription drug.--The term ``prescription drug''
means a drug for human use subject to section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)(1)).
(c) Effective Date.--This section shall take effect on the date of
the enactment of this Act but shall not apply with respect to conduct
that occurs before such date.
SEC. 403. FAIR TREATMENT OF MEDICARE PART B BILLING CODES FOR THE
PRESCRIBING OF BIOSIMILARS.
Section 1847A of the Social Security Act (42 U.S.C. 1395w-3a) is
amended by adding at the end the following new subsection:
``(h) Use of Certain Codes.--Notwithstanding any previous provision
of this section, for purposes of payment of biological biosimilar
product the Secretary of Health and Human Services shall assign a
uniform Common Procedure System code to describe all such products that
share a common reference product.''.
TITLE V--FIXING GLOBAL FREELOADING
SEC. 501. CHIEF PHARMACEUTICAL NEGOTIATOR IN THE OFFICE OF THE UNITED
STATES TRADE REPRESENTATIVE.
(a) In General.--Section 141 of the Trade Act of 1974 (19 U.S.C.
2171) is amended--
(1) in subsection (b)(2)--
(A) by striking ``and one Chief Innovation and
Intellectual Property Negotiator'' and inserting ``one
Chief Innovation and Intellectual Property Negotiator,
and one Chief Pharmaceutical Negotiator'';
(B) by striking ``or the Chief Innovation and
Intellectual Property Negotiator'' and inserting ``the
Chief Innovation and Intellectual Property Negotiator,
or the Chief Pharmaceutical Negotiator''; and
(C) by striking ``and the Chief Innovation and
Intellectual Property Negotiator'' and inserting ``the
Chief Innovation and Intellectual Property Negotiator,
and the Chief Pharmaceutical Negotiator''; and
(2) in subsection (c), by adding at the end the following
new paragraph:
``(7) The principal function of the Chief Pharmaceutical
Negotiator shall be to conduct trade negotiations and to
enforce trade agreements relating to United States
pharmaceutical products and services. The Chief Pharmaceutical
Negotiator shall be a vigorous advocate on behalf of United
States pharmaceutical interests, including patients and United
States pharmaceutical workers. The Chief Pharmaceutical
Negotiator shall perform such other functions as the United
States Trade Representative may direct.''.
(b) Compensation.--Section 5314 of title 5, United States Code is
amended by striking ``Chief Innovation and Intellectual Property
Negotiator, Office of the United States Trade Representative.'' and
inserting the following:
``Chief Innovation and Intellectual Property Negotiator, Office of
the United States Trade Representative.
``Chief Pharmaceutical Negotiator, Office of the United States
Trade Representative.''.
(c) Report Required.--Not later than one year after the appointment
of the first Chief Pharmaceutical Negotiator pursuant to paragraph (2)
of section 141(b) of the Trade Act of 1974, as amended by subsection
(a), and annually thereafter, the United States Trade Representative
shall submit to the Committee on Finance of the Senate and the
Committee on Ways and Means of the House of Representatives a report
describing in detail--
(1) enforcement actions taken by the Trade Representative
during the one-year period preceding the submission of the
report to ensure the protection of United States pharmaceutical
products and services; and
(2) other actions taken by the Trade Representative to
advance United States pharmaceutical products and services.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, the Judiciary, Armed Services, and Oversight and Reform, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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Referred to the Subcommittee on Health.
Referred to the Subcommittee on Military Personnel.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Courts, Intellectual Property, and the Internet.
Referred to the Subcommittee on Antitrust, Commercial, and Administrative Law.
Referred to the Subcommittee on the Constitution, Civil Rights, and Civil Liberties.