USPSTF Transparency and Accountability Act of 2013 - Amends the Public Health Service Act to expand the scope and responsibilities of the United States Preventive Services Task Force to require it to: (1) publish research plans to guide its systematic review of evidence and new science relating to the effectiveness of preventive services; (2) make available reports on such evidence and recommendations for public comment; (3) establish a system for grading preventive care products and services (Grades A, B, C, and D and a Grade I for insufficient information); and (4) convene a preventive services stakeholders board to advise it on developing, updating, publishing, and disseminating evidence-based recommendations on the use of clinical preventive services. Provides for the disclosure and management of conflicts of interest by members of the Task Force and the preventive services stakeholders board.
Directs the Government Accountability Office (GAO) to submit a report that: (1) lists current recommendations of the Task Force; (2) compares Task Force recommendations and recommendations of other federal health agencies, national medical professional societies, and patient and disease advocacy organizations; and (3) analyzes the impact of Task Force recommendations on public and private insurance coverage, access, and outcomes, including the impact of morbidity and mortality.
Amends title XVIII (Medicare) of the Social Security Act to eliminate the discretion of the Secretary of Health and Human Services (HHS) to deny payment for a Medicare preventive service that has not received an A, B, C, or I grade by the Task Force.
[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2143 Introduced in House (IH)]
113th CONGRESS
1st Session
H. R. 2143
To amend title IX of the Public Health Service Act to revise the
operations of the United States Preventive Services Task Force.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 23, 2013
Mrs. Blackburn (for herself, Mr. Barrow of Georgia, Mr. Terry, and Mrs.
Christensen) 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.
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 2013''.
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 redesignating paragraph (3) as paragraph (5) and
paragraphs (4) through (7) as paragraphs (9) through (12),
respectively;
(4) 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 balanced representation of practicing
primary and specialty care providers, patient and
health care consumers, and relevant stakeholders from
the medical products manufacturing community.
``(B) Notice.--Before appointing members to the
Task Force, the Director shall give persons an
opportunity to nominate potential members. The Director
shall provide for the publication in the Federal
Register of a request for comments on such members and
shall provide a mechanism for persons to submit such
comments through the official website of the Agency.
The Director shall consider any comments submitted in
selecting the members of the Task Force.
``(4) Review and consultation.--
``(A) Research plans.--
``(i) In general.--In conducting its
reviews under paragraph (1), the Task Force,
with the concurrence of the Director, 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. 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 (ii). The Agency shall provide for the
publication in the Federal Register of a
request for public comments on each plan and
shall accept comments during a period of at
least 60 days. Any final research plan shall be
made available to the public and include a
discussion of the comments received 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.
``(ii) 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 race,
ethnicity, socioeconomic status, and geographic
location), and for other health outcome
measurements.
``(iii) Consultation on research plans.--
The Director shall facilitate coordination and
interaction with other agencies and departments
in the creation of research plans (taking into
consideration research and findings by other
agencies and departments) and methodological
standards under clause (ii), 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.--The Director shall make
publicly available each draft evidence report and
publish in the Federal Register a request for public
comments on such reports. 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
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 60 days.
``(ii) Consultation on draft
recommendations.--Before voting on a draft
recommendation statement, the Task Force shall
consult with relevant stakeholders, including
provider groups, practicing specialists that
treat the specific disease under review, and
relevant patient and disease advocacy
organizations.
``(iii) Public availability of comments and
inclusion of description of comments in final
statement.--The Director shall make such
comments received 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.
``(iv) Consideration.--In publishing
recommendation statements, the Task Force shall
consider the impact of its recommendations on
the health care community, whether a preventive
service is beneficial for some individuals and
the need to encourage a discussion of benefits
and risks for those individuals, and 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.
``(D) Grading system.--In publishing recommendation
statements, the Task Force shall grade products and
services consistent with the following, subject to
subparagraph (E):
``(i) Grade a.--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 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 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, 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. However,
for most individuals without signs or symptoms
there is likely to be only a small benefit from
this product or service.
``(iv) Grade d.--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.
Recommendations against a preventive service
shall only be issued in concurrence with the
Secretary after consultation with other Federal
health agencies and relevant patient and
provider groups.
``(v) Grade i.--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 regrade the services
previously classified within that grade. Such
review and regrade may be done through an
expedited process but any such change in grade
shall not take effect before such review
process is completed.'';
(5) in paragraph (5), as redesignated by paragraph (3)--
(A) by striking ``dissemination of the
recommendations of the Task Force'' and inserting
``dissemination of its recommendation statements''; and
(B) by striking ``Guide's recommendations'' and
inserting ``recommendations of the Task Force'';
(6) by inserting after paragraph (5), as so redesignated,
the following new paragraphs:
``(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 on developing, updating, publishing, and
disseminating 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,
including--
``(I) appropriate health agencies
and offices in the Department,
including 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 Administration on
Aging, the Health Resources and
Services Administration, the Centers
for Medicare & Medicaid Services, the
Office of the Surgeon General of the
Public Health Service, the Department
of Defense, the Department of Veterans
Affairs, the Patient-Centered Outcomes
Research Institute, the Office of
Minority Health, and the Office on
Women's Health; and
``(II) as appropriate, other
Federal departments and agencies the
programs of which have a significant
impact upon health.
``(iv) Private health care payors.
``(C) Responsibilities.--In accordance with
subsection (b)(5), 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 of the Agency for Healthcare Research
and Quality.
``(7) Disclosure and conflicts of interest.--Members of the
Task Force or the board shall not be considered employees of
the Federal Government by reason of service on the Task Force
or the board, except members of the Task Force or the board
shall be considered to be special Government employees within
the meaning of section 107 of the Ethics in Government Act of
1978 (5 U.S.C. App.) and section 208 of title 18, United States
Code, for the purposes of disclosure and management of
conflicts of interest under those sections.
``(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
(7) by amending paragraph (10), as redesignated by
paragraph (3), to read as follows:
``(10) Application of faca.--The Task Force shall conduct
its activities in compliance with the Federal Advisory
Committee Act (5 U.S.C. App.).''.
(b) Effective Date; Transition.--
(1) In general.--Except as otherwise provided, the
amendments made by subsection (a) shall take effect on the date
of the enactment of this Act. 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) Interested parties may request the Task Force
to review such previous recommendations or guidelines.
(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) GAO Evaluation and Report.--Not later than 1 year after the
date of enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report that contains the following:
(1) A listing of the recommendations of the United States
Preventive Services Task Force as of the such date, including
the date final recommendations and any subsequent updates were
posted or published.
(2) A comparison of such recommendations and relevant
recommendations of other Federal health agencies, including the
Centers for Disease Control and Prevention, the Centers for
Medicare & Medicaid Services, the Department of Defense, the
Department of Veterans Affairs, and the Patient-Centered
Outcomes Research Institute, as well as relevant
recommendations from national medical professional societies
and relevant patient and disease advocacy organizations.
(3) An analysis of the impact of the recommendations of the
Task Force on public and private insurance coverage, access,
and outcomes, including impact on morbidity and mortality.
(d) 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)), as added by section 4105(a)
of Public Law 111-148, 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''.
<all>
Introduced in House
Introduced in House
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.
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.
Referred to the Subcommittee on Health.
Referred to the Subcommittee on Health.
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