[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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