[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3534 Introduced in House (IH)]
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116th CONGRESS
1st Session
H. R. 3534
To amend title IX of the Public Health Service Act to revise the
operations of the United States Preventive Services Task Force, and for
other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
June 27, 2019
Mr. Rush (for himself, Mr. David P. Roe of Tennessee, Ms. Judy Chu of
California, and Mr. Dunn) introduced the following bill; which was
referred to the Committee on Energy and Commerce, and in addition to
the Committee on Ways and Means, 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 amend title IX of the Public Health Service Act to revise the
operations of the United States Preventive Services Task Force, 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 ``USPSTF Transparency and
Accountability Act of 2019''.
SEC. 2. CHANGES TO UNITED STATES PREVENTIVE SERVICES TASK FORCE.
(a) In General.--Subsection (a) of section 915 of the Public Health
Service Act (42 U.S.C. 299b-4) is amended--
(1) by amending the heading to read as follows: ``United
States Preventive Services Task Force'';
(2) by amending paragraph (1) to read as follows:
``(1) Establishment and purpose.--The Director may
establish and periodically convene the United States Preventive
Services Task Force (in this section referred to as the `Task
Force'). The Task Force shall review the scientific evidence
and new science related to the effectiveness and
appropriateness of clinical preventive services for the purpose
of developing recommendations for primary care clinicians and
the health care community and updating previous clinical
preventive recommendations.'';
(3) by striking paragraph (3);
(4) by redesignating paragraphs (4) through (7) as
paragraphs (9) through (12), respectively;
(5) by inserting after paragraph (2) the following new
paragraphs:
``(3) Composition.--
``(A) In general.--The Task Force shall be composed
of individuals that collectively have appropriate
scientific expertise, including in fields of health
sciences research, health economics, health promotion,
disease prevention, and clinical care. The Task Force
shall include a balanced representation of practicing
primary and specialty care providers (including in the
fields of health services research, health economics,
and clinical care), patients, and health care
consumers.
``(B) Notice.--Before appointing members to the
Task Force, the Director shall provide notice in the
Federal Register to give persons an opportunity to
nominate potential members.
``(4) Review and consultation.--
``(A) Research plans.--
``(i) In general.--In conducting its
reviews under paragraph (1), the Task Force
shall publish one or more proposed research
plans (in this subsection referred to as a
`research plan') to guide the Task Force's
systematic review of the evidence referred to
in such paragraph. Each such plan shall include
an analytic framework, key questions, and a
literature search strategy or research
approach, and shall incorporate the
methodological guidelines developed under
clause (iii).
``(ii) Publication; public comment
period.--The Task Force shall provide for the
publication in the Federal Register of a
request for public comments on each research
plan and shall accept comments on such plan
during a period of not less than 45 days. The
Director shall make publicly available comments
submitted in response to a request for public
comments. Any final research plan shall be made
available to the public and include a
discussion of the comments received with
respect to such plan and responses to such
comments. The Task Force, with the concurrence
of the Director, may change such a research
plan through the same process as applied to the
initial adoption of such plan.
``(iii) Criteria.--The Director shall
design and regularly update guidelines for
proper methodological standards for
incorporation into such research plans. Such
guidelines shall include measures for
appropriate validity, for risk adjustment, for
timeliness, for input from relevant experts and
peers in the respective communities, for
accounting for all relevant subpopulations
(including disparities by gender, race,
ethnicity, socioeconomic status, and geographic
location), and for other health outcome
measurements. Such guidelines and
methodological standards shall ensure the
consideration of any evidence concerning any
relevant subpopulations (including disparities
by gender, race, ethnicity, genetic
predisposition, socioeconomic status, and
geographic location), any real world evidence,
any recent evidence, and any United States-
based studies.
``(iv) Consultation on research plans.--The
Director shall facilitate coordination and
interaction with other agencies and departments
in the preparation and publication of research
plans (taking into consideration research and
findings by other agencies and departments) and
methodological standards under clause (iii),
including with the National Institutes of
Health, the National Cancer Institute, the
National Institute on Minority Health and
Health Disparities, the Centers for Disease
Control and Prevention, the Department of
Defense, the Department of Veterans Affairs,
the Centers for Medicare & Medicaid Services,
and the Patient-Centered Outcomes Research
Institute.
``(B) Evidence reports.--
``(i) Initial publication.--The Director
shall make publicly available each systematic
evidence review and any related reports that
serve as the foundation for any recommendation
of the Task Force and publish in the Federal
Register a request for public comments on such
review or related reports.
``(ii) Public comment period.--The Director
shall accept comments on any draft evidence
report published under clause (i) during a
period of at least 45 days. The Director shall
make publicly available comments submitted in
response to a request for public comment. Each
final evidence review shall include a
description of comments submitted on the draft
evidence review and the response of the Task
Force to such comments.
``(iii) Review by external experts.--No
such evidence report shall be published prior
to it being reviewed by a panel of external
subject matter experts that includes provider
and patient representatives. Each such report
shall include a description of the panel that
conducted such review. Such description shall
include information on each panel member,
including name, academic degree (or degrees),
affiliations, and related expertise.
``(C) Recommendation statements.--
``(i) Publication of draft
recommendations.--The Director shall make
publicly available each draft recommendation
statement (as that term is used for purposes of
section 7 of the U.S. Preventive Services Task
Force Procedure Manual, as in effect on April
1, 2019) and shall provide for the publication
in the Federal Register of a request for
comments and accept comments during a period of
not less than 45 days.
``(ii) Consultation on recommendations.--
Before voting on a draft or final
recommendation statement (as that term is used
for purposes of section 7 of the procedure
manual referred to in clause (i)), the Task
Force shall--
``(I) consult with relevant
stakeholders, including provider
groups, practicing specialists that
treat the specific disease under
review, and relevant patient and
disease advocacy organizations; and
``(II) take into account the
feedback provided by the board.
``(iii) Public availability of comments and
inclusion of description of comments in final
statement.--The Director shall make comments
received pursuant to clause (i) publicly
available. Any final recommendation statement
shall include a description of comments
received on the draft recommendation statement
and recommendations of other Federal agencies
or organizations relating to the topic of the
statement. The Director shall make final
recommendation statements publicly available,
including through publication in the Federal
Register.
``(iv) Consideration.--In publishing draft
or final recommendation statements (as those
terms are used for purposes of section 7 of the
procedure manual referred to in clause (i)),
the Task Force shall consider--
``(I) the impact of its
recommendations on the health care
community;
``(II) whether a preventive service
is beneficial for some individuals and
the need to encourage a discussion of
benefits and risks for those
individuals; and
``(III) how its specific assignment
of a grade to a product or service may
affect coverage and access to such
product or service under Federal
programs and private health insurance
coverage.
``(v) Dissemination of evidence-based
recommendations.--The Task Force shall publish
and disseminate the evidence-based
recommendations after consultation with the
following:
``(I) Relevant patient
organizations.
``(II) Providers of clinical
services, including community-based
providers and specialty physicians.
``(III) The Department of Veterans
Affairs, the Centers for Medicare &
Medicaid Services, and the Centers for
Disease Control and Prevention.
``(D) Grading system.--Subject to subparagraph (E),
in publishing recommendation statements (as that term
is used for purposes of section 7 of the procedure
manual referred to in clause (i)), the Task Force shall
grade products and services consistent with the
following:
``(i) Grade a.--The Task Force shall assign
a product or service Grade A if the Task Force
concludes that the current evidence is
sufficient to assess the balance of benefits
and risks of the product or service, and, on
the basis of such evidence, recommends the
product or service and determines that there is
high certainty that the net benefit from the
product or service is substantial.
``(ii) Grade b.--The Task Force shall
assign a product or service Grade B if the Task
Force concludes that the current evidence is
sufficient to assess the balance of benefits
and risks of the product or service, and, on
the basis of such evidence, recommends the
product or service and determines that there is
high certainty that the net benefit of the
product or service is moderate or there is
moderate certainty that the net benefit of the
product or service is moderate to substantial.
``(iii) Grade c.--The Task Force shall
assign a product or service Grade C if the Task
Force concludes that--
``(I) the current evidence is
sufficient to assess the balance of
benefits and risks of the product or
service;
``(II) on the basis of such
evidence, does not make a
recommendation of the product or
service and clinicians may provide this
product or service to selected patients
depending on individual circumstances;
and
``(III) for most individuals
without signs or symptoms of a
particular disease or condition there
is at least moderate certainty that the
net benefit is small.
``(iv) Grade d.--The Task Force shall
assign a product or service Grade D if the Task
Force concludes that the current evidence is
sufficient to assess the balance of benefits
and risks of the product or service, and, on
the basis of such evidence, recommends against
the product or service and determines that
there is moderate or high certainty that the
product or service has no net benefit or that
the harm of the product or service outweighs
the benefits.
``(v) Grade i.--The Task Force shall assign
a product or service Grade I if the Task Force
concludes that the current evidence is not
sufficient to assess the balance of benefits
and risks of the product or service.
``(E) Changes in grading system.--
``(i) In general.--The Director may
provide, by regulation, for changes in the
grading system described in subparagraph (D).
``(ii) Impact of changes.--If the Director
makes a change in the grading system under
clause (i) for a particular grade, the Task
Force shall review and re-grade the products or
services previously classified within that
grade. Any such review and regrading may be
done through an expedited process so long as
any change in grade does not take effect before
the review of that change in grade is
completed.
``(5) Role of agency.--The Agency shall provide ongoing
administrative, research, and technical support for the
operations of the Task Force, including coordinating and
supporting the dissemination of its recommendation statements,
ensuring adequate staff resources, and assistance to those
organizations requesting it for implementation of the
recommendations of the Task Force.
``(6) Preventive services advisory board.--
``(A) In general.--The Task Force shall convene a
preventive services advisory board (in this subsection
referred to as the `board') composed of representatives
of appropriate public and private entities with an
interest in clinical preventive services to advise the
Task Force throughout the development of evidence-based
recommendations on the use of clinical preventive
services.
``(B) Membership.--The members of the board shall
include representatives of the following:
``(i) Patient groups.
``(ii) Providers of clinical services,
including community-based providers and
specialty physicians.
``(iii) Federal departments and agencies
that have expertise in the clinical preventive
service being reviewed.
``(C) Responsibilities.--The board shall--
``(i) recommend clinical preventive
services for review by the Task Force;
``(ii) suggest scientific evidence for
consideration by the Task Force related to
reviews undertaken by the Task Force;
``(iii) provide feedback regarding the
research plan, the evidence report, and draft
recommendations by the Task Force; and
``(iv) assist with efforts regarding
dissemination of recommendations by the
Director.
``(D) Meetings.--The board shall meet as the chair
of the board determines to be appropriate to fulfill
the responsibilities described in paragraph (C), but
not fewer than 2 times each year.
``(7) Disclosure and conflicts of interest.--Prior to
participating in a meeting of the Task Force or board, each
member of the Task Force or board, respectively, shall disclose
to the Director any potential, relevant financial interests in
the same manner and to the same extent as an employee of the
executive branch of the United States, if the employee were
participating in such meeting, would be required to disclose
such interests under section 208 of title 18, United States
Code.
``(8) No pay; receipt of travel expenses.--Members of the
Task Force or the board shall not receive any pay for service
on the Task Force or board, but may receive travel expenses,
including a per diem, in accordance with applicable provisions
of subchapter I of chapter 57 of title 5, United States
Code.''; and
(6) by amending paragraph (10), as redesignated by
paragraph (4), to read as follows:
``(10) Application of faca.--The Federal Advisory Committee
Act (5 U.S.C. App.) shall apply to the Task Force except that
section 14 of such Act (relating to termination of advisory
committees) shall not apply to the Task Force.''.
(b) Effective Date; Transition.--
(1) In general.--The United States Preventive Services Task
Force shall not publish any draft or final recommendations on
or after such date except in accordance with such amendments.
(2) Reconstitution of task force.--Not later than 180 days
after the date of the enactment of this Act, the Director of
the Agency for Healthcare Research and Quality shall take steps
to reconstitute the membership of the Task Force consistent
with section 915(a)(3) of the Public Health Service Act, as
amended by subsection (a).
(3) Previously published recommendations.--With respect to
recommendations or guidelines published by such Task Force
before the date of the enactment of this Act, under procedures
established by the Director of the Agency for Healthcare
Research and Quality, the reconstituted Task Force shall
undertake a review process consistent with the following:
(A) An organization may request the Task Force to
review any such previous recommendation or guideline if
such organization has additional peer-reviewed
scientific evidence that provides new information
relevant to the previous recommendation or guideline.
(B) Based upon such requests, the Task Force shall
establish a process for the review of previous
recommendations or guidelines.
(C) Such process shall include public notice
through the Federal Register and opportunity for
comment and a determination to confirm or modify such
recommendations or guidelines.
(D) The process shall, to the extent feasible, be
consistent with the procedures applied under the
amendments made by subsection (a) for the promulgation
of new recommendations.
(c) Elimination of Secretarial Discretion To Remove Certain
Preventive Services Under the Medicare Program.--Section 1834(n) of the
Social Security Act (42 U.S.C. 1395m(n)) is amended--
(1) by striking paragraph (2);
(2) by striking ``; and'' at the end of paragraph (1)(B)
and inserting a period;
(3) by redesignating subparagraphs (A) and (B) of paragraph
(1) as paragraphs (1) and (2), respectively, and moving their
margins 2 ems to the left; and
(4) by striking ``may'' and all that follows through
``modify'' and inserting ``may modify''.
(d) Application to Secretarial Discretion To Remove Certain
Preventive Services Under the Medicare Program.--Section 1834(n) of the
Social Security Act (42 U.S.C. 1395m(n)), as amended by subsection (c),
is further amended by adding at the end the following flush sentence:
``Effective on the date of enactment of the USPSTF Transparency and
Accountability Act of 2019, the Secretary may use the authority under
this subsection only to modify coverage of a preventive service based
on the recommendation or grade of the United States Preventive Services
Task Force with respect to the service if such recommendation or grade
was developed or updated in accordance with the amendments made by
section 2(a) of such Act and if the Secretary has concurred with such
recommendation or grade after consultation with other Federal health
agencies and relevant patient and provider groups.''.
(e) Application to Physician Quality Measures Under the Medicare
Program.--Section 1848 of the Social Security Act (42 U.S.C. 1395w-4)
is amended by adding at the end the following new subsection:
``(t) Measures Related to USPSTF Recommendations.--Effective on the
date of enactment of the USPSTF Transparency and Accountability Act of
2019, notwithstanding any other provision of this title, a quality
measure related to a recommendation of the United States Preventive
Services Task Force may be applied under this section only if such
recommendation was developed or updated in accordance with the
amendments made by section 2(a) of such Act and if the Secretary has
concurred with such recommendation or grade after consultation with
other Federal health agencies and relevant patient and provider
groups.''.
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