[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2296 Reported in House (RH)]
<DOC>
Union Calendar No. 170
116th CONGRESS
1st Session
H. R. 2296
[Report No. 116-215]
To require reporting regarding certain drug price increases, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 12, 2019
Ms. Schakowsky (for herself and Mr. Rooney of Florida) introduced the
following bill; which was referred to the Committee on Energy and
Commerce
September 24, 2019
Additional sponsors: Mr. Doggett, Mr. Sarbanes, Ms. Underwood, Mr.
Griffith, Mr. Suozzi, Mr. Pocan, and Mr. Carter of Georgia
September 24, 2019
Reported with amendments, committed to the Committee of the Whole House
on the State of the Union, and ordered to be printed
[Strike out all after the enacting clause and insert the part printed
in italic]
[For text of introduced bill, see copy of bill as introduced on April
12, 2019]
_______________________________________________________________________
A BILL
To require reporting regarding certain drug price increases, 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 ``More Efficient
Tools to Realize Information for Consumers Act'' or the ``METRIC Act''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
Sec. 2. Reporting on explanation for drug price increases.
Sec. 3. Public disclosure of drug discounts.
Sec. 4. Study of pharmaceutical supply chain intermediaries and merger
activity.
Sec. 5. Requiring certain manufacturers to report drug pricing
information with respect to drugs under the
Medicare program.
Sec. 6. Making prescription drug marketing sample information reported
by manufacturers available to certain
individuals and entities.
Sec. 7. Requiring prescription drug plan sponsors to include real-time
benefit information as part of such
sponsor's electronic prescription program
under the Medicare program.
Sec. 8. Sense of Congress regarding the need to expand commercially
available drug pricing comparison
platforms.
Sec. 9. Technical corrections.
SEC. 2. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.
(a) In General.--Title III of the Public Health Service Act (42
U.S.C. 241 et seq.) is amended by adding at the end the following:
``PART W--DRUG PRICE REPORTING; DRUG VALUE FUND
``SEC. 399OO. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.
``(a) Definitions.--In this section:
``(1) Manufacturer.--The term `manufacturer' means the
person--
``(A) that holds the application for a drug
approved under section 505 of the Federal Food, Drug,
and Cosmetic Act or licensed under section 351 of this
Act; or
``(B) who is responsible for setting the wholesale
acquisition cost for the drug.
``(2) Qualifying drug.--The term `qualifying drug' means
any drug that is approved under subsection (c) or (j) of
section 505 of the Federal Food, Drug, and Cosmetic Act or
licensed under subsection (a) or (k) of section 351 of this
Act--
``(A) that has a wholesale acquisition cost of $100
or more, adjusted for inflation occurring after the
date of enactment of the More Efficient Tools to
Realize Information for Consumers Act, for a month's
supply or a typical course of treatment that lasts less
than a month, and is--
``(i) subject to section 503(b)(1) of the
Federal Food, Drug, and Cosmetic Act;
``(ii) administered or otherwise dispensed
to treat a disease or condition affecting more
than 200,000 persons in the United States; and
``(iii) not a vaccine; and
``(B) for which, during the previous calendar year,
at least 1 dollar of the total amount of sales were for
individuals enrolled under the Medicare program under
title XVIII of the Social Security Act (42 U.S.C. 1395
et seq.) or under a State Medicaid plan under title XIX
of such Act (42 U.S.C. 1396 et seq.) or under a waiver
of such plan.
``(3) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given that term in section
1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
3a(c)(6)(B)).
``(b) Report.--
``(1) Report required.--The manufacturer of a qualifying
drug shall submit a report to the Secretary for each increase
in the price of a qualifying drug that results in an increase
in the wholesale acquisition cost of that drug that is equal
to--
``(A) 10 percent or more within a single calendar
year beginning on or after January 1, 2019; or
``(B) 25 percent or more within three consecutive
calendar years for which the first such calendar year
begins on or after January 1, 2019.
``(2) Report deadline.--Each report described in paragraph
(1) shall be submitted to the Secretary--
``(A) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
during the period beginning on January 1, 2019, and
ending on the day that is 60 days after the date of the
enactment of the More Efficient Tools to Realize
Information for Consumers Act, not later than 90 days
after such date of enactment; and
``(B) in the case of a report with respect to an
increase in the price of a qualifying drug that occurs
after the period described in subparagraph (A), not
later than 30 days prior to the planned effective date
of such price increase for such qualifying drug.
``(c) Contents.--A report under subsection (b), consistent with the
standard for disclosures described in section 213.3(d) of title 12,
Code of Federal Regulations (as in effect on the date of enactment of
the More Efficient Tools to Realize Information for Consumers Act),
shall, at a minimum, include--
``(1) with respect to the qualifying drug--
``(A) the percentage by which the manufacturer will
raise the wholesale acquisition cost of the drug within
the calendar year or three consecutive calendar years
as described in subsection (b)(1)(A) or (b)(1)(B), and
the effective date of such price increase;
``(B) an explanation for, and description of, each
price increase for such drug that will occur during the
calendar year period described in subsection (b)(1)(A)
or the three consecutive calendar year period described
in subsection (b)(1)(B), as applicable;
``(C) if known and different from the manufacturer
of the qualifying drug, the identity of--
``(i) the sponsor or sponsors of any
investigational new drug applications under
section 505(i) of the Federal Food, Drug, and
Cosmetic Act for clinical investigations with
respect to such drug, for which the full
reports are submitted as part of the
application--
``(I) for approval of the drug
under section 505 of such Act; or
``(II) for licensure of the drug
under section 351 of this Act; and
``(ii) the sponsor of an application for
the drug approved under such section 505 of the
Federal Food, Drug, and Cosmetic Act or
licensed under section 351 of this Act;
``(D) a description of the history of the
manufacturer's price increases for the drug since the
approval of the application for the drug under section
505 of the Federal Food, Drug, and Cosmetic Act or the
issuance of the license for the drug under section 351
of this Act, or since the manufacturer acquired such
approved application or license, if applicable;
``(E) the current wholesale acquisition cost of the
drug;
``(F) the total expenditures of the manufacturer
on--
``(i) materials and manufacturing for such
drug; and
``(ii) acquiring patents and licensing for
such drug;
``(G) the percentage of total expenditures of the
manufacturer on research and development for such drug
that was derived from Federal funds;
``(H) the total expenditures of the manufacturer on
research and development for such drug that is
necessary to demonstrate that it meets applicable
statutory standards for approval under section 505 of
the Federal Food, Drug, and Cosmetic Act or licensure
under section 351 of this Act, as applicable;
``(I) the total expenditures of the manufacturer on
pursuing new or expanded indications or dosage changes
for such drug under section 505 of the Federal Food,
Drug, and Cosmetic Act or section 351 of this Act;
``(J) the total expenditures of the manufacturer on
carrying out postmarket requirements related to such
drug, including under section 505(o)(3) of the Federal
Food, Drug, and Cosmetic Act;
``(K) the total revenue and the net profit
generated from the qualifying drug for each calendar
year since the approval of the application for the drug
under section 505 of the Federal Food, Drug, and
Cosmetic Act or the issuance of the license for the
drug under section 351, or since the manufacturer
acquired such approved application or license; and
``(L) the total costs associated with marketing and
advertising for the qualifying drug;
``(2) with respect to the manufacturer--
``(A) the total revenue and the net profit of the
manufacturer for each of the 1-year period described in
subsection (b)(1)(A) or the 3-year period described in
subsection (b)(1)(B), as applicable;
``(B) all stock-based performance metrics used by
the manufacturer to determine executive compensation
for each of the 1-year period described in subsection
(b)(1)(A) or the 3-year period described in subsection
(b)(1)(B), as applicable; and
``(C) any additional information the manufacturer
chooses to provide related to drug pricing decisions,
such as total expenditures on--
``(i) drug research and development; or
``(ii) clinical trials, including on drugs
that failed to receive approval by the Food and
Drug Administration; and
``(3) such other related information as the Secretary
considers appropriate and as specified by the Secretary through
notice-and-comment rulemaking.
``(d) Information Provided.--The manufacturer of a qualifying drug
that is required to submit a report under subsection (b), shall ensure
that such report and any explanation for, and description of, each
price increase described in subsection (c)(1)(B) shall be truthful, not
misleading, and accurate.
``(e) Civil Monetary Penalty.--Any manufacturer of a qualifying
drug that fails to submit a report for the drug as required by this
section, following notification by the Secretary to the manufacturer
that the manufacturer is not in compliance with this section, shall be
subject to a civil monetary penalty of $75,000 for each day on which
the violation continues.
``(f) False Information.--Any manufacturer that submits a report
for a drug as required by this section that knowingly provides false
information in such report is subject to a civil monetary penalty in an
amount not to exceed $75,000 for each item of false information.
``(g) Public Posting.--
``(1) In general.--Subject to paragraph (3), the Secretary
shall post each report submitted under subsection (b) on the
public website of the Department of Health and Human Services
the day the price increase of a qualifying drug is scheduled to
go into effect.
``(2) Format.--In developing the format in which reports
will be publicly posted under paragraph (1), the Secretary
shall consult with stakeholders, including beneficiary groups,
and shall seek feedback from consumer advocates and readability
experts on the format and presentation of the content of such
reports to ensure that such reports are--
``(A) user-friendly to the public; and
``(B) written in plain language that consumers can
readily understand.
``(3) Protected information.--Nothing in this section shall
be construed to authorize the public disclosure of information
submitted by a manufacturer that is prohibited from disclosure
by applicable laws concerning the protection of trade secrets,
commercial information, and other information covered under
such laws.
``SEC. 399OO-1. ANNUAL REPORT TO CONGRESS.
``(a) In General.--Subject to subsection (b), the Secretary shall
submit to Congress, and post on the public website of the Department of
Health and Human Services in a way that is user-friendly to the public
and written in plain language that consumers can readily understand, an
annual report--
``(1) summarizing the information reported pursuant to
section 399OO;
``(2) including copies of the reports and supporting
detailed economic analyses submitted pursuant to such section;
``(3) detailing the costs and expenditures incurred by the
Department of Health and Human Services in carrying out section
399OO; and
``(4) explaining how the Department of Health and Human
Services is improving consumer and provider information about
drug value and drug price transparency.
``(b) Protected Information.--Nothing in this section shall be
construed to authorize the public disclosure of information submitted
by a manufacturer that is prohibited from disclosure by applicable laws
concerning the protection of trade secrets, commercial information, and
other information covered under such laws.''.
(b) Effective Date.--The amendment made by subsection (a) takes
effect on the date of enactment of this Act.
SEC. 3. PUBLIC DISCLOSURE OF DRUG DISCOUNTS.
Section 1150A of the Social Security Act (42 U.S.C. 1320b-23) is
amended--
(1) in subsection (c), in the matter preceding paragraph
(1), by inserting ``(other than as permitted under subsection
(e))'' after ``disclosed by the Secretary''; and
(2) by adding at the end the following new subsection:
``(e) Public Availability of Certain Information.--
``(1) In general.--In order to allow the comparison of
PBMs' ability to negotiate rebates, discounts, direct and
indirect remuneration fees, administrative fees, and price
concessions and the amount of such rebates, discounts, direct
and indirect remuneration fees, administrative fees, and price
concessions that are passed through to plan sponsors, beginning
January 1, 2020, the Secretary shall make available on the
Internet website of the Department of Health and Human Services
the information with respect to the second preceding calendar
year provided to the Secretary on generic dispensing rates (as
described in paragraph (1) of subsection (b)) and information
provided to the Secretary under paragraphs (2) and (3) of such
subsection that, as determined by the Secretary, is with
respect to each PBM.
``(2) Availability of data.--In carrying out paragraph (1),
the Secretary shall ensure the following:
``(A) Confidentiality.--The information described
in such paragraph is displayed in a manner that
prevents the disclosure of information, with respect to
an individual drug or an individual plan, on rebates,
discounts, direct and indirect remuneration fees,
administrative fees, and price concessions.
``(B) Class of drug.--The information described in
such paragraph is made available by class of drug,
using an existing classification system, but only if
the class contains such number of drugs, as specified
by the Secretary (but not fewer than three drugs), to
ensure confidentiality of proprietary information or
other information that is prevented to be disclosed
under subparagraph (A).''.
SEC. 4. STUDY OF PHARMACEUTICAL SUPPLY CHAIN INTERMEDIARIES AND MERGER
ACTIVITY.
(a) Initial Report.--Not later than 1 year after the date of
enactment of this Act, the Commission shall submit to the appropriate
committees of Congress a report that--
(1) addresses at minimum--
(A) whether pharmacy benefit managers--
(i) charge payers a higher price than the
reimbursement rate at which the pharmacy
benefit managers reimburse competing
pharmacies;
(ii) steer patients for anticompetitive
purposes to any pharmacies, including retail,
mail-order, or any other type of pharmacy, in
which the pharmacy benefit manager has an
ownership interest;
(iii) audit or review proprietary data,
including acquisition costs, patient
information, or dispensing information, of
competing pharmacies that can be used for
anticompetitive purposes; or
(iv) use formulary designs to increase the
market share of higher cost prescription drugs
and depress the market share of lower cost
prescription drugs (each net of rebates and
discounts);
(B) how companies and payers assess the benefits,
costs, and risks of contracting with intermediaries,
including pharmacy services administrative
organizations, and whether more information about the
roles of intermediaries should be available to
consumers and payers; and
(C) whether there are any specific legal or
regulatory obstacles the Commission currently faces in
ensuring a competitive and transparent marketplace in
the pharmaceutical supply chain, including the pharmacy
benefit manager marketplace and pharmacy services
administrative organizations; and
(2) provides--
(A) observations or conclusions drawn from the
November 2017 roundtable entitled ``Understanding
Competition in Prescription Drug Markets: Entry and
Supply Chain Dynamics'', and any similar efforts;
(B) specific actions the Commission intends to take
as a result of the November 2017 roundtable, and any
similar efforts, including a detailed description of
relevant forthcoming actions, additional research or
roundtable discussions, consumer education efforts, or
enforcement actions; and
(C) policy or legislative recommendations to--
(i) improve transparency and competition in
the pharmaceutical supply chain;
(ii) prevent and deter anticompetitive
behavior in the pharmaceutical supply chain;
and
(iii) best ensure that consumers benefit
from any cost savings or efficiencies that may
result from mergers and consolidations.
(b) Interim Report.--Not later than 180 days after the date of
enactment of this Act, the Commission shall submit to the appropriate
committees of Congress an interim report on the progress of the report
required by subsection (a), along with preliminary findings and
conclusions based on information collected to that date.
(c) Definitions.--In this section:
(1) Appropriate committees of congress.--The term
``appropriate committees of Congress'' means--
(A) the Committee on Energy and Commerce of the
House of Representatives;
(B) the Committee on the Judiciary of the Senate;
and
(C) the Committee on the Judiciary of the House of
Representatives.
(2) Commission.--The term ``Commission'' means the Federal
Trade Commission.
SEC. 5. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING
INFORMATION WITH RESPECT TO DRUGS UNDER THE MEDICARE
PROGRAM.
(a) In General.--Section 1847A of the Social Security Act (42
U.S.C. 1395w-3a) is amended--
(1) in subsection (b)--
(A) in paragraph (2)(A), by inserting ``or
subsection (f)(2), as applicable'' before the period at
the end;
(B) in paragraph (3), in the matter preceding
subparagraph (A), by inserting ``or subsection (f)(2),
as applicable,'' before ``determined by''; and
(C) in paragraph (6)(A), in the matter preceding
clause (i), by inserting ``or subsection (f)(2), as
applicable,'' before ``determined by''; and
(2) in subsection (f)--
(A) by striking ``For requirements'' and inserting
the following:
``(1) In general.--For requirements''; and
(B) by adding at the end the following new
paragraph:
``(2) Manufacturers without a rebate agreement under title
xix.--
``(A) In general.--If the manufacturer of a drug or
biological described in subparagraph (C), (E), or (G)
of section 1842(o)(1) or in section 1881(b)(14)(B) that
is payable under this part has not entered into and
does not have in effect a rebate agreement described in
subsection (b) of section 1927, for calendar quarters
beginning on or after January 1, 2020, such
manufacturer shall report to the Secretary the
information described in subsection (b)(3)(A)(iii) of
such section 1927 with respect to such drug or
biological in a time and manner specified by the
Secretary. For purposes of applying this paragraph, a
drug or biological described in the previous sentence
includes items, services, supplies, and products that
are payable under this part as a drug or biological.
``(B) Audit.--Information reported under
subparagraph (A) is subject to audit by the Inspector
General of the Department of Health and Human Services.
``(C) Verification.--The Secretary may survey
wholesalers and manufacturers that directly distribute
drugs described in subparagraph (A), when necessary, to
verify manufacturer prices and manufacturer's average
sales prices (including wholesale acquisition cost) if
required to make payment reported under subparagraph
(A). The Secretary may impose a civil monetary penalty
in an amount not to exceed $100,000 on a wholesaler,
manufacturer, or direct seller, if the wholesaler,
manufacturer, or direct seller of such a drug refuses a
request for information about charges or prices by the
Secretary in connection with a survey under this
subparagraph or knowingly provides false information.
The provisions of section 1128A (other than subsections
(a) (with respect to amounts of penalties or additional
assessments) and (b)) shall apply to a civil money
penalty under this subparagraph in the same manner as
such provisions apply to a penalty or proceeding under
section 1128A(a).
``(D) Confidentiality.--Notwithstanding any other
provision of law, information disclosed by
manufacturers or wholesalers under this paragraph
(other than the wholesale acquisition cost for purposes
of carrying out this section) is confidential and shall
not be disclosed by the Secretary in a form which
discloses the identity of a specific manufacturer or
wholesaler or prices charged for drugs by such
manufacturer or wholesaler, except--
``(i) as the Secretary determines to be
necessary to carry out this section (including
the determination and implementation of the
payment amount), or to carry out section 1847B;
``(ii) to permit the Comptroller General of
the United States to review the information
provided; and
``(iii) to permit the Director of the
Congressional Budget Office to review the
information provided.''.
(b) Enforcement.--Section 1847A of such Act (42 U.S.C. 1395w-3a) is
further amended--
(1) in subsection (d)(4)--
(A) in subparagraph (A), by striking ``In general''
and inserting ``Misrepresentation'';
(B) in subparagraph (B), by striking ``subparagraph
(B)'' and inserting ``subparagraph (A), (B), or (C)'';
(C) by redesignating subparagraph (B) as
subparagraph (D); and
(D) by inserting after subparagraph (A) the
following new subparagraphs:
``(B) Failure to provide timely information.--If
the Secretary determines that a manufacturer described
in subsection (f)(2) has failed to report on
information described in section 1927(b)(3)(A)(iii)
with respect to a drug or biological in accordance with
such subsection, the Secretary shall apply a civil
money penalty in an amount of $10,000 for each day the
manufacturer has failed to report such information and
such amount shall be paid to the Treasury.
``(C) False information.--Any manufacturer required
to submit information under subsection (f)(2) that
knowingly provides false information is subject to a
civil money penalty in an amount not to exceed $100,000
for each item of false information. Such civil money
penalties are in addition to other penalties as may be
prescribed by law.''; and
(2) in subsection (c)(6)(A), by striking the period at the
end and inserting ``, except that, for purposes of subsection
(f)(2), the Secretary may, if the Secretary determines
appropriate, exclude repackagers of a drug or biological from
such term.''.
(c) Manufacturers With a Rebate Agreement.--
(1) In general.--Section 1927(b)(3)(A) of the Social
Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by adding
at the end the following new sentence: ``For purposes of
applying clause (iii), a drug or biological described in the
flush matter following such clause includes items, services,
supplies, and products that are payable under this part as a
drug or biological.''.
(2) Technical amendment.--Section 1927(b)(3)(A)(iii) of the
Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is
amended by striking ``section 1881(b)(13)(A)(ii)'' and
inserting ``section 1881(b)(14)(B)''.
(d) Report.--Not later than January 1, 2021, the Inspector General
of the Department of Health and Human Services shall assess and submit
to Congress a report on the accuracy of average sales price information
submitted by manufacturers under section 1847A of the Social Security
Act (42 U.S.C. 1395w-3a). Such report shall include any recommendations
on how to improve the accuracy of such information.
SEC. 6. MAKING PRESCRIPTION DRUG MARKETING SAMPLE INFORMATION REPORTED
BY MANUFACTURERS AVAILABLE TO CERTAIN INDIVIDUALS AND
ENTITIES.
(a) In General.--Section 1128H of the Social Security Act (42
U.S.C. 1320a-7i) is amended--
(1) by redesignating subsection (b) as subsection (e); and
(2) by inserting after subsection (a) the following new
subsections:
``(b) Data Sharing Agreements.--
``(1) In general.--The Secretary shall enter into
agreements with the specified data sharing individuals and
entities described in paragraph (2) under which--
``(A) upon request of such an individual or entity,
as applicable, the Secretary makes available to such
individual or entity the information submitted under
subsection (a) by manufacturers and authorized
distributors of record; and
``(B) such individual or entity agrees to not
disclose publicly or to another individual or entity
any information that identifies a particular
practitioner or health care facility.
``(2) Specified data sharing individuals and entities.--For
purposes of paragraph (1), the specified data sharing
individuals and entities described in this paragraph are the
following:
``(A) Oversight agencies.--Health oversight
agencies (as defined in section 164.501 of title 45,
Code of Federal Regulations), including the Centers for
Medicare & Medicaid Services, the Office of the
Inspector General of the Department of Health and Human
Services, the Government Accountability Office, the
Congressional Budget Office, the Medicare Payment
Advisory Commission, and the Medicaid and CHIP Payment
and Access Commission.
``(B) Researchers.--Individuals who conduct
scientific research (as defined in section 164.501 of
title 45, Code of Federal Regulations) in relevant
areas as determined by the Secretary.
``(C) Payers.--Private and public health care
payers, including group health plans, health insurance
coverage offered by health insurance issuers, Federal
health programs, and State health programs.
``(3) Exemption from freedom of information act.--Except as
described in paragraph (1), the Secretary may not be compelled
to disclose the information submitted under subsection (a) to
any individual or entity. For purposes of section 552 of title
5, United States Code (commonly referred to as the Freedom of
Information Act), this paragraph shall be considered a statute
described in subsection (b)(3)(B) of such section.
``(c) Penalties.--
``(1) Data sharing agreements.--Subject to paragraph (3),
any specified data sharing individual or entity described in
subsection (b)(2) that violates the terms of a data sharing
agreement the individual or entity has with the Secretary under
subsection (b)(1) shall be subject to a civil money penalty of
not less than $1,000, but not more than $10,000, for each such
violation. Such penalty shall be imposed and collected in the
same manner as civil money penalties under subsection (a) of
section 1128A are imposed and collected under that section.
``(2) Failure to report.--Subject to paragraph (3), any
manufacturer or authorized distributor of record of an
applicable drug under subsection (a) that fails to submit
information required under such subsection in a timely manner
in accordance with rules or regulations promulgated to carry
out such subsection shall be subject to a civil money penalty
of not less than $1,000, but not more than $10,000, for each
such failure. Such penalty shall be imposed and collected in
the same manner as civil money penalties under subsection (a)
of section 1128A are imposed and collected under that section.
``(3) Limitation.--The total amount of civil money
penalties imposed under paragraph (1) or (2) with respect to a
year and an individual or entity described in subparagraph (A)
or a manufacturer or distributor described in subparagraph (B),
respectively, shall not exceed $150,000.
``(d) Drug Sample Distribution Information.--
``(1) In general.--Not later than January 1 of each year
(beginning with 2021), the Secretary shall maintain a list
containing information related to the distribution of samples
of applicable drugs. Such list shall provide the following
information with respect to the preceding year:
``(A) The name of the manufacturer or authorized
distributor of record of an applicable drug for which
samples were requested or distributed under this
section.
``(B) The quantity and class of drug samples
requested.
``(C) The quantity and class of drug samples
distributed.
``(2) Public availability.--The Secretary shall make the
information in such list available to the public on the
Internet Web site of the Food and Drug Administration.''.
(b) FDA Maintenance of Information.--The Food and Drug
Administration shall maintain information available to affected
reporting companies to ensure their ability to fully comply with the
requirements of section 1128H of the Social Security Act.
(c) Prohibition on Distribution of Samples of Opioids.--Section
503(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(d))
is amended--
(1) by moving the margin of paragraph (4) 2 ems to the
left; and
(2) by adding at the end the following:
``(5) No person may distribute a drug sample of a drug that is--
``(A) an applicable drug (as defined in section 1128H(d) of
the Social Security Act);
``(B) a controlled substance (as defined in section 102 of
the Controlled Substances Act) for which the findings required
under section 202(b)(2) of such Act have been made; and
``(C) approved under section 505 for use in the management
or treatment of pain (other than for the management or
treatment of a substance use disorder).''.
(d) MedPAC Report.--Not later than 3 years after the date of the
enactment of this Act, the Medicare Payment Advisory Commission shall
conduct a study on the impact of drug samples on provider prescribing
practices and health care costs and may, as the Commission deems
appropriate, make recommendations on such study.
SEC. 7. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS TO INCLUDE REAL-TIME
BENEFIT INFORMATION AS PART OF SUCH SPONSOR'S ELECTRONIC
PRESCRIPTION PROGRAM UNDER THE MEDICARE PROGRAM.
Section 1860D-4(e)(2) of the Social Security Act (42 U.S.C. 1395w-
104(e)(2)) is amended--
(1) in subparagraph (D), by striking ``To the extent'' and
inserting ``Except as provided in subparagraph (F), to the
extent''; and
(2) by adding at the end the following new subparagraph:
``(F) Real-time benefit information.--
``(i) In general.--Not later than January
1, 2021, the program shall implement real-time
benefit tools that are capable of integrating
with a prescribing health care professional's
electronic prescribing or electronic health
record system for the transmission of formulary
and benefit information in real time to
prescribing health care professionals. With
respect to a covered part D drug, such tools
shall be capable of transmitting such
information specific to an individual enrolled
in a prescription drug plan. Such information
shall include the following:
``(I) A list of any clinically-
appropriate alternatives to such drug
included in the formulary of such plan.
``(II) Cost-sharing information for
such drug and such alternatives,
including a description of any variance
in cost sharing based on the pharmacy
dispensing such drug or such
alternatives.
``(III) Information relating to
whether such drug is included in the
formulary of such plan and any prior
authorization or other utilization
management requirements applicable to
such drug and such alternatives so
included.
``(ii) Electronic transmission.--The
provisions of subclauses (I) and (II) of clause
(ii) of subparagraph (E) shall apply to an
electronic transmission described in clause (i)
in the same manner as such provisions apply
with respect to an electronic transmission
described in clause (i) of such subparagraph.
``(iii) Special rule for 2021.--The program
shall be deemed to be in compliance with clause
(i) for 2021 if the program complies with the
provisions of section 423.160(b)(7) of title
42, Code of Federal Regulations (or a successor
regulation), for such year.
``(iv) Rule of construction.--Nothing in
this subparagraph shall be construed as to
allow a real time benefits tool to steer an
individual, without the consent of the
individual, to a particular pharmacy or
pharmacy setting over their preferred pharmacy
setting nor prohibit the designation of a
preferred pharmacy under such tool.''.
SEC. 8. SENSE OF CONGRESS REGARDING THE NEED TO EXPAND COMMERCIALLY
AVAILABLE DRUG PRICING COMPARISON PLATFORMS.
It is the sense of Congress that--
(1) commercially available drug pricing comparison
platforms can, at no cost, help patients find the lowest price
for their medications at their local pharmacy;
(2) such platforms should be integrated, to the maximum
extent possible, in the health care delivery ecosystem; and
(3) pharmacy benefit managers should work to disclose
generic and brand name drug prices to such platforms to ensure
that--
(A) patients can benefit from the lowest possible
price available to them; and
(B) overall drug prices can be reduced as more
educated purchasing decisions are made based on price
transparency.
SEC. 9. TECHNICAL CORRECTIONS.
(a) In General.--Section 3022(b) of the Public Health Service Act
(42 U.S.C. 300jj-52(b)) is amended by adding at the end the following
new paragraph:
``(4) Application of authorities under inspector general
act of 1978.--In carrying out this subsection, the Inspector
General shall have the same authorities as provided under
section 6 of the Inspector General Act of 1978 (5 U.S.C.
App.).''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect as if included in the enactment of the 21st Century Cures
Act (Public Law 114-255).
Amend the title so as to read: ``A bill to require
reporting for certain drug price information, and for other
purposes.''.
Union Calendar No. 170
116th CONGRESS
1st Session
H. R. 2296
[Report No. 116-215]
_______________________________________________________________________
A BILL
To require reporting regarding certain drug price increases, and for
other purposes.
_______________________________________________________________________
September 24, 2019
Reported with amendments, committed to the Committee of the Whole House
on the State of the Union, and ordered to be printed