```

[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1151 Introduced in Senate (IS)]

114th CONGRESS
  1st Session
                                S. 1151

   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 SENATE OF THE UNITED STATES

                             April 30, 2015

  Mr. Vitter introduced the following bill; which was read twice and 
                  referred to the Committee on Finance

_______________________________________________________________________

                                 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 2015''.

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 Internet 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 be issued only 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 the recommendation statements of the 
                Task Force''; 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.--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 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)) 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>
```