,i #aafth ,,congress #ast ,session ,h4 ,r4 #cecd ,,in ,,the ,,house ,,of ,,representatives ,june #bg1 #bjai ,mr4 ,rush 7for himself1 ,mr4 ,david ,p4 ,roe of ,tennessee1 ,ms4 ,judy ,chu of ,california1 and ,mr4 ,dunn7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committee on ,ways and ,means1 for a period to be subsequently determined by the ,speaker1 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 ,force1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,,uspstf ,transparency and ,accountability ,act of #bjai4 #b4 ,changes to ,united ,states ,preventive ,services ,task ,force 7a7 ,in general ,subsection 7a7 of section #iae of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bii;b-#d7 is amended-- 7#a7 by amending the heading to read as follows3 ,united ,states ,preventive ,services ,task ,force2 7#b7 by amending paragraph 7#a7 to read as follows3 7#a7 ,establishment and purpose ,the ,director may establish and periodically convene the ,united ,states ,preventive ,services ,task ,force 7in this section referred to as the ,task ,force74 ,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 recommendations4 2 7#c7 by striking paragraph 7#c72 7#d7 by redesignating paragraphs 7#d7 through 7#g7 as paragraphs 7#i7 through 7#ab71 respectively2 7#e7 by inserting after paragraph 7#b7 the following new paragraphs3 7#c7 ,composition 7,a7 ,in general ,the ,task ,force shall be composed of individuals that collectively have appropriate scientific expertise1 including in fields of health sciences research1 health economics1 health promotion1 disease prevention1 and clinical care4 ,the ,task ,force shall include a balanced representation of practicing primary and specialty care providers 7including in the fields of health services research1 health economics1 and clinical care71 patients1 and health care consumers4 7,b7 ,notice ,before appointing members to the ,task ,force1 the ,director shall provide notice in the ,federal ,register to give persons an opportunity to nominate potential members4 7#d7 ,review and consultation 7,a7 ,research plans 7i7 ,in general ,in conducting its reviews under paragraph 7#a71 the ,task ,force shall publish one or more proposed research plans 7in this subsection referred to as a research plan7 to guide the ,task ,force's systematic review of the evidence referred to in such paragraph4 ,each such plan shall include an analytic framework1 key questions1 and a literature search strategy or research approach1 and shall incorporate the methodological guidelines developed under clause 7iii74 7ii7 ,publication2 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 #de days4 ,the ,director shall make publicly available comments submitted in response to a request for public comments4 ,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 comments4 ,the ,task ,force1 with the concurrence of the ,director1 may change such a research plan through the same process as applied to the initial adoption of such plan4 7iii7 ,criteria ,the ,director shall design and regularly update guidelines for proper methodological standards for incorporation into such research plans4 ,such guidelines shall include measures for appropriate validity1 for risk adjustment1 for timeliness1 for input from relevant experts and peers in the respective communities1 for accounting for all relevant subpopulations 7including disparities by gender1 race1 ethnicity1 socioeconomic status1 and geographic location71 and for other health outcome measurements4 ,such guidelines and methodological standards shall ensure the consideration of any evidence concerning any relevant subpopulations 7including disparities by gender1 race1 ethnicity1 genetic predisposition1 socioeconomic status1 and geographic location71 any real world evidence1 any recent evidence1 and any ,united ,states-based studies4 7iv7 ,consultation on research plans ,the ,director shall facilitate coordination and interaction with other agencies and departments in the preparation and publication of research plans 7taking into consideration research and findings by other agencies and departments7 and methodological standards under clause 7iii71 including with the ,national ,institutes of ,health1 the ,national ,cancer ,institute1 the ,national ,institute on ,minority ,health and ,health ,disparities1 the ,centers for ,disease ,control and ,prevention1 the ,department of ,defense1 the ,department of ,veterans ,affairs1 the ,centers for ,medicare ,medicaid ,services1 and the ,patient-,centered ,outcomes ,research ,institute4 7,b7 ,evidence reports 7i7 ,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 reports4 7ii7 ,public comment period ,the ,director shall accept comments on any draft evidence report published under clause 7i7 during a period of at least #de days4 ,the ,director shall make publicly available comments submitted in response to a request for public comment4 ,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 comments4 7iii7 ,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 representatives4 ,each such report shall include a description of the panel that conducted such review4 ,such description shall include information on each panel member1 including name1 academic degree 7or degrees71 affiliations1 and related expertise4 7,c7 ,recommendation statements 7i7 ,publication of draft recommendations ,the ,director shall make publicly available each draft recommendation statement 7as that term is used for purposes of section #g of the ,u4,s4 ,preventive ,services ,task ,force ,procedure ,manual1 as in effect on ,april #a1 #bjai7 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 #de days4 7ii7 ,consultation on recommendations ,before voting on a draft or final recommendation statement 7as that term is used for purposes of section #g of the procedure manual referred to in clause 7i771 the ,task ,force shall-- 7,i7 consult with relevant stakeholders1 including provider groups1 practicing specialists that treat the specific disease under review1 and relevant patient and disease advocacy organizations2 and 7,,ii7 take into account the feedback provided by the board4 7iii7 ,public availability of comments and inclusion of description of comments in final statement ,the ,director shall make comments received pursuant to clause 7i7 publicly available4 ,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 statement4 ,the ,director shall make final recommendation statements publicly available1 including through publication in the ,federal ,register4 7iv7 ,consideration ,in publishing draft or final recommendation statements 7as those terms are used for purposes of section #g of the procedure manual referred to in clause 7i771 the ,task ,force shall consider-- 7,i7 the impact of its recommendations on the health care community2 7,,ii7 whether a preventive service is beneficial for some individuals and the need to encourage a discussion of benefits and risks for those individuals2 and 7,,iii7 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 coverage4 7v7 ,dissemination of evidence-based recommendations ,the ,task ,force shall publish and disseminate the evidence-based recommendations after consultation with the following3 7,i7 ,relevant patient organizations4 7,,ii7 ,providers of clinical services1 including community-based providers and specialty physicians4 7,,iii7 ,the ,department of ,veterans ,affairs1 the ,centers for ,medicare ,medicaid ,services1 and the ,centers for ,disease ,control and ,prevention4 7,d7 ,grading system ,subject to subparagraph 7,e71 in publishing recommendation statements 7as that term is used for purposes of section #g of the procedure manual referred to in clause 7i771 the ,task ,force shall grade products and services consistent with the following3 7i7 ,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 service1 and1 on the basis of such evidence1 recommends the product or service and determines that there is high certainty that the net benefit from the product or service is substantial4 7ii7 ,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 service1 and1 on the basis of such evidence1 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 substantial4 7iii7 ,grade ,c ,the ,task ,force shall assign a product or service ,grade ,c if the ,task ,force concludes that-- 7,i7 the current evidence is sufficient to assess the balance of benefits and risks of the product or service2 7,,ii7 on the basis of such evidence1 does not make a recommendation of the product or service and clinicians may provide this product or service to selected patients depending on individual circumstances2 and 7,,iii7 for most individuals without signs or symptoms of a particular disease or condition there is at least moderate certainty that the net benefit is small4 7iv7 ,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 service1 and1 on the basis of such evidence1 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 benefits4 7v7 ,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 service4 7,e7 ,changes in grading system 7i7 ,in general ,the ,director may provide1 by regulation1 for changes in the grading system described in subparagraph 7,d74 7ii7 ,impact of changes ,if the ,director makes a change in the grading system under clause 7i7 for a particular grade1 the ,task ,force shall review and re-grade the products or services previously classified within that grade4 ,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 completed4 7#e7 ,role of agency ,the ,agency shall provide ongoing administrative1 research1 and technical support for the operations of the ,task ,force1 including coordinating and supporting the dissemination of its recommendation statements1 ensuring adequate staff resources1 and assistance to those organizations requesting it for implementation of the recommendations of the ,task ,force4 7#f7 ,preventive services advisory board 7,a7 ,in general ,the ,task ,force shall convene a preventive services advisory board 7in this subsection referred to as the board7 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 services4 7,b7 ,membership ,the members of the board shall include representatives of the following3 7i7 ,patient groups4 7ii7 ,providers of clinical services1 including community-based providers and specialty physicians4 7iii7 ,federal departments and agencies that have expertise in the clinical preventive service being reviewed4 7,c7 ,responsibilities ,the board shall-- 7i7 recommend clinical preventive services for review by the ,task ,force2 7ii7 suggest scientific evidence for consideration by the ,task ,force related to reviews undertaken by the ,task ,force2 7iii7 provide feedback regarding the research plan1 the evidence report1 and draft recommendations by the ,task ,force2 and 7iv7 assist with efforts regarding dissemination of recommendations by the ,director4 7,d7 ,meetings ,the board shall meet as the chair of the board determines to be appropriate to fulfill the responsibilities described in paragraph 7,c71 but not fewer than #b times each year4 7#g7 ,disclosure and conflicts of interest ,prior to participating in a meeting of the ,task ,force or board1 each member of the ,task ,force or board1 respectively1 shall disclose to the ,director any potential1 relevant financial interests in the same manner and to the same extent as an employee of the executive branch of the ,united ,states1 if the employee were participating in such meeting1 would be required to disclose such interests under section #bjh of title #ah1 ,united ,states ,code4 7#h7 ,no pay2 receipt of travel expenses ,members of the ,task ,force or the board shall not receive any pay for service on the ,task ,force or board1 but may receive travel expenses1 including a per diem1 in accordance with applicable provisions of subchapter ,i of chapter #eg of title #e1 ,united ,states ,code4 2 and 7#f7 by amending paragraph 7#aj71 as redesignated by paragraph 7#d71 to read as follows3 7#aj7 ,application of ,,faca ,the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,task ,force except that section #ad of such ,act 7relating to termination of advisory committees7 shall not apply to the ,task ,force4 4 7b7 ,effective date2 transition 7#a7 ,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 amendments4 7#b7 ,reconstitution of ,task ,force ,not later than #ahj days after the date of the enactment of this ,act1 the ,director of the ,agency for ,healthcare ,research and ,quality shall take steps to reconstitute the membership of the ,task ,force consistent with section #iae7;a77#c7 of the ,public ,health ,service ,act1 as amended by subsection 7a74 7#c7 ,previously published recommendations ,with respect to recommendations or guidelines published by such ,task ,force before the date of the enactment of this ,act1 under procedures established by the ,director of the ,agency for ,healthcare ,research and ,quality1 the reconstituted ,task ,force shall undertake a review process consistent with the following3 7,a7 ,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 guideline4 7,b7 ,based upon such requests1 the ,task ,force shall establish a process for the review of previous recommendations or guidelines4 7,c7 ,such process shall include public notice through the ,federal ,register and opportunity for comment and a determination to confirm or modify such recommendations or guidelines4 7,d7 ,the process shall1 to the extent feasible1 be consistent with the procedures applied under the amendments made by subsection 7a7 for the promulgation of new recommendations4 7c7 ,elimination of ,secretarial discretion ,to remove certain preventive services under the ,medicare program ,section #ahcd7n7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7n77 is amended-- 7#a7 by striking paragraph 7#b72 7#b7 by striking 2 and at the end of paragraph 7#a77;,b7 and inserting a period2 7#c7 by redesignating subparagraphs 7,a7 and 7,b7 of paragraph 7#a7 as paragraphs 7#a7 and 7#b71 respectively1 and moving their margins #b ems to the left2 and 7#d7 by striking may and all that follows through modify and inserting may modify4 7d7 ,application to secretarial discretion ,to remove certain preventive services under the ,medicare program ,section #ahcd7n7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7n771 as amended by subsection 7c71 is further amended by adding at the end the following flush sentence3 ,effective on the date of enactment of the ,,uspstf ,transparency and ,accountability ,act of #bjai1 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 #b7;a7 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 groups44 7e7 ,application to physician quality measures under the ,medicare program ,section #ahdh of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#d7 is amended by adding at the end the following new subsection3 7t7 ,measures related to ,,uspstf recommendations ,effective on the date of enactment of the ,,uspstf ,transparency and ,accountability ,act of #bjai1 notwithstanding any other provision of this title1 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 #b7;a7 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 groups4 4