I 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘USPSTF Trans5 parency and Accountability Act of 2019’’. 


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1 SEC. 2. CHANGES TO UNITED STATES PREVENTIVE SERV2 ICES TASK FORCE. 

3 (a) IN GENERAL.—Subsection (a) of section 915 of 

4 the Public Health Service Act (42 U.S.C. 299b–4) is 

5 amended— 

6 (1) by amending the heading to read as follows: 

7 ‘‘UNITED STATES PREVENTIVE SERVICES TASK

8 FORCE’’; 

9 (2) by amending paragraph (1) to read as fol10 lows: 

11 ‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di12 rector may establish and periodically convene the 

13 United States Preventive Services Task Force (in 

14 this section referred to as the ‘Task Force’). The 

15 Task Force shall review the scientific evidence and 

16 new science related to the effectiveness and appro17 priateness of clinical preventive services for the pur18 pose of developing recommendations for primary 

19 care clinicians and the health care community and 

20 updating previous clinical preventive recommenda21 tions.’’; 

22 (3) by striking paragraph (3); 

23 (4) by redesignating paragraphs (4) through 

24 (7) as paragraphs (9) through (12), respectively; 

25 (5) by inserting after paragraph (2) the fol26 lowing new paragraphs: 


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1 ‘‘(3) COMPOSITION.— 

2 ‘‘(A) IN GENERAL.—The Task Force shall 

3 be composed of individuals that collectively have 

4 appropriate scientific expertise, including in 

5 fields of health sciences research, health eco6 nomics, health promotion, disease prevention, 

7 and clinical care. The Task Force shall include 

8 a balanced representation of practicing primary 

9 and specialty care providers (including in the 

10 fields of health services research, health eco11 nomics, and clinical care), patients, and health 

12 care consumers. 

13 ‘‘(B) NOTICE.—Before appointing mem14 bers to the Task Force, the Director shall pro15 vide notice in the Federal Register to give per16 sons an opportunity to nominate potential mem17 bers. 

18 ‘‘(4) REVIEW AND CONSULTATION.— 

19 ‘‘(A) RESEARCH PLANS.— 

20 ‘‘(i) IN GENERAL.—In conducting its 

21 reviews under paragraph (1), the Task 

22 Force shall publish one or more proposed 

23 research plans (in this subsection referred 

24 to as a ‘research plan’) to guide the Task 

25 Force’s systematic review of the evidence 


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1 referred to in such paragraph. Each such 

2 plan shall include an analytic framework, 

3 key questions, and a literature search 

4 strategy or research approach, and shall 

5 incorporate the methodological guidelines 

6 developed under clause (iii). 

7 ‘‘(ii) PUBLICATION; PUBLIC COMMENT

8 PERIOD.—The Task Force shall provide 

9 for the publication in the Federal Register 

10 of a request for public comments on each 

11 research plan and shall accept comments 

12 on such plan during a period of not less 

13 than 45 days. The Director shall make 

14 publicly available comments submitted in 

15 response to a request for public comments. 

16 Any final research plan shall be made 

17 available to the public and include a dis18 cussion of the comments received with re19 spect to such plan and responses to such 

20 comments. The Task Force, with the con21 currence of the Director, may change such 

22 a research plan through the same process 

23 as applied to the initial adoption of such 

24 plan. 


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1 ‘‘(iii) CRITERIA.—The Director shall 

2 design and regularly update guidelines for 

3 proper methodological standards for incor4 poration into such research plans. Such 

5 guidelines shall include measures for ap6 propriate validity, for risk adjustment, for 

7 timeliness, for input from relevant experts 

8 and peers in the respective communities, 

9 for accounting for all relevant subpopula10 tions (including disparities by gender, race, 

11 ethnicity, socioeconomic status, and geo12 graphic location), and for other health out13 come measurements. Such guidelines and 

14 methodological standards shall ensure the 

15 consideration of any evidence concerning 

16 any relevant subpopulations (including dis17 parities by gender, race, ethnicity, genetic 

18 predisposition, socioeconomic status, and 

19 geographic location), any real world evi20 dence, any recent evidence, and any United 

21 States-based studies. 

22 ‘‘(iv) CONSULTATION ON RESEARCH

23 PLANS.—The Director shall facilitate co24 ordination and interaction with other agen25 cies and departments in the preparation 


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1 and publication of research plans (taking 

2 into consideration research and findings by 

3 other agencies and departments) and 

4 methodological standards under clause 

5 (iii), including with the National Institutes 

6 of Health, the National Cancer Institute, 

7 the National Institute on Minority Health 

8 and Health Disparities, the Centers for 

9 Disease Control and Prevention, the De10 partment of Defense, the Department of 

11 Veterans Affairs, the Centers for Medicare 

12 & Medicaid Services, and the Patient-Cen13 tered Outcomes Research Institute. 

14 ‘‘(B) EVIDENCE REPORTS.— 

15 ‘‘(i) INITIAL PUBLICATION.—The Di16 rector shall make publicly available each 

17 systematic evidence review and any related 

18 reports that serve as the foundation for 

19 any recommendation of the Task Force 

20 and publish in the Federal Register a re21 quest for public comments on such review 

22 or related reports. 

23 ‘‘(ii) PUBLIC COMMENT PERIOD.—The 

24 Director shall accept comments on any 

25 draft evidence report published under 


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1 clause (i) during a period of at least 45 

2 days. The Director shall make publicly 

3 available comments submitted in response 

4 to a request for public comment. Each 

5 final evidence review shall include a de6 scription of comments submitted on the 

7 draft evidence review and the response of 

8 the Task Force to such comments. 

9 ‘‘(iii) REVIEW BY EXTERNAL EX10 PERTS.—No such evidence report shall be 

11 published prior to it being reviewed by a 

12 panel of external subject matter experts 

13 that includes provider and patient rep14 resentatives. Each such report shall in15 clude a description of the panel that con16 ducted such review. Such description shall 

17 include information on each panel member, 

18 including name, academic degree (or de19 grees), affiliations, and related expertise. 

20 ‘‘(C) RECOMMENDATION STATEMENTS.— 

21 ‘‘(i) PUBLICATION OF DRAFT REC22 OMMENDATIONS.—The Director shall make 

23 publicly available each draft recommenda24 tion statement (as that term is used for 

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1 tive Services Task Force Procedure Man2 ual, as in effect on April 1, 2019) and 

3 shall provide for the publication in the 

4 Federal Register of a request for com5 ments and accept comments during a pe6 riod of not less than 45 days. 

7 ‘‘(ii) CONSULTATION ON REC8 OMMENDATIONS.—Before voting on a draft 

9 or final recommendation statement (as 

10 that term is used for purposes of section 7 

11 of the procedure manual referred to in 

12 clause (i)), the Task Force shall— 

13 ‘‘(I) consult with relevant stake14 holders, including provider groups, 

15 practicing specialists that treat the 

16 specific disease under review, and rel17 evant patient and disease advocacy or18 ganizations; and 

19 ‘‘(II) take into account the feed20 back provided by the board. 

21 ‘‘(iii) PUBLIC AVAILABILITY OF COM22 MENTS AND INCLUSION OF DESCRIPTION

23 OF COMMENTS IN FINAL STATEMENT.— 

24 The Director shall make comments re25 ceived pursuant to clause (i) publicly availVerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534

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1 able. Any final recommendation statement 

2 shall include a description of comments re3 ceived on the draft recommendation state4 ment and recommendations of other Fed5 eral agencies or organizations relating to 

6 the topic of the statement. The Director 

7 shall make final recommendation state8 ments publicly available, including through 

9 publication in the Federal Register. 

10 ‘‘(iv) CONSIDERATION.—In publishing 

11 draft or final recommendation statements 

12 (as those terms are used for purposes of 

13 section 7 of the procedure manual referred 

14 to in clause (i)), the Task Force shall con15 sider— 

16 ‘‘(I) the impact of its rec17 ommendations on the health care 

18 community; 

19 ‘‘(II) whether a preventive service 

20 is beneficial for some individuals and 

21 the need to encourage a discussion of 

22 benefits and risks for those individ23 uals; and 

24 ‘‘(III) how its specific assignment 

25 of a grade to a product or service may 


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1 affect coverage and access to such 

2 product or service under Federal pro3 grams and private health insurance 

4 coverage. 

5 ‘‘(v) DISSEMINATION OF EVIDENCE6 BASED RECOMMENDATIONS.—The Task 

7 Force shall publish and disseminate the 

8 evidence-based recommendations after con9 sultation with the following: 

10 ‘‘(I) Relevant patient organiza11 tions. 

12 ‘‘(II) Providers of clinical serv13 ices, including community-based pro14 viders and specialty physicians. 

15 ‘‘(III) The Department of Vet16 erans Affairs, the Centers for Medi17 care & Medicaid Services, and the 

18 Centers for Disease Control and Pre19 vention. 

20 ‘‘(D) GRADING SYSTEM.—Subject to sub21 paragraph (E), in publishing recommendation 

22 statements (as that term is used for purposes 

23 of section 7 of the procedure manual referred to 

24 in clause (i)), the Task Force shall grade prod25 ucts and services consistent with the following: 


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1 ‘‘(i) GRADE A.—The Task Force shall 

2 assign a product or service Grade A if the 

3 Task Force concludes that the current evi4 dence is sufficient to assess the balance of 

5 benefits and risks of the product or service, 

6 and, on the basis of such evidence, rec7 ommends the product or service and deter8 mines that there is high certainty that the 

9 net benefit from the product or service is 

10 substantial. 

11 ‘‘(ii) GRADE B.—The Task Force 

12 shall assign a product or service Grade B 

13 if the Task Force concludes that the cur14 rent evidence is sufficient to assess the bal15 ance of benefits and risks of the product or 

16 service, and, on the basis of such evidence, 

17 recommends the product or service and de18 termines that there is high certainty that 

19 the net benefit of the product or service is 

20 moderate or there is moderate certainty 

21 that the net benefit of the product or serv22 ice is moderate to substantial. 

23 ‘‘(iii) GRADE C.—The Task Force 

24 shall assign a product or service Grade C 

25 if the Task Force concludes that— 


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1 ‘‘(I) the current evidence is suffi2 cient to assess the balance of benefits 

3 and risks of the product or service; 

4 ‘‘(II) on the basis of such evi5 dence, does not make a recommenda6 tion of the product or service and cli7 nicians may provide this product or 

8 service to selected patients depending 

9 on individual circumstances; and 

10 ‘‘(III) for most individuals with11 out signs or symptoms of a particular 

12 disease or condition there is at least 

13 moderate certainty that the net ben14 efit is small. 

15 ‘‘(iv) GRADE D.—The Task Force 

16 shall assign a product or service Grade D 

17 if the Task Force concludes that the cur18 rent evidence is sufficient to assess the bal19 ance of benefits and risks of the product or 

20 service, and, on the basis of such evidence, 

21 recommends against the product or service 

22 and determines that there is moderate or 

23 high certainty that the product or service 

24 has no net benefit or that the harm of the 

25 product or service outweighs the benefits. 


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1 ‘‘(v) GRADE I.—The Task Force shall 

2 assign a product or service Grade I if the 

3 Task Force concludes that the current evi4 dence is not sufficient to assess the bal5 ance of benefits and risks of the product or 

6 service. 

7 ‘‘(E) CHANGES IN GRADING SYSTEM.— 

8 ‘‘(i) IN GENERAL.—The Director may 

9 provide, by regulation, for changes in the 

10 grading system described in subparagraph 

11 (D). 

12 ‘‘(ii) IMPACT OF CHANGES.—If the 

13 Director makes a change in the grading 

14 system under clause (i) for a particular 

15 grade, the Task Force shall review and re16 grade the products or services previously 

17 classified within that grade. Any such re18 view and regrading may be done through 

19 an expedited process so long as any change 

20 in grade does not take effect before the re21 view of that change in grade is completed. 

22 ‘‘(5) ROLE OF AGENCY.—The Agency shall pro23 vide ongoing administrative, research, and technical 

24 support for the operations of the Task Force, includ25 ing coordinating and supporting the dissemination of 


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1 its recommendation statements, ensuring adequate 

2 staff resources, and assistance to those organizations 

3 requesting it for implementation of the recommenda4 tions of the Task Force. 

5 ‘‘(6) PREVENTIVE SERVICES ADVISORY

6 BOARD.— 

7 ‘‘(A) IN GENERAL.—The Task Force shall 

8 convene a preventive services advisory board (in 

9 this subsection referred to as the ‘board’) com10 posed of representatives of appropriate public 

11 and private entities with an interest in clinical 

12 preventive services to advise the Task Force 

13 throughout the development of evidence-based 

14 recommendations on the use of clinical preven15 tive services. 

16 ‘‘(B) MEMBERSHIP.—The members of the 

17 board shall include representatives of the fol18 lowing: 

19 ‘‘(i) Patient groups. 

20 ‘‘(ii) Providers of clinical services, in21 cluding community-based providers and 

22 specialty physicians. 

23 ‘‘(iii) Federal departments and agen24 cies that have expertise in the clinical pre25 ventive service being reviewed. 


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1 ‘‘(C) RESPONSIBILITIES.—The board 

2 shall— 

3 ‘‘(i) recommend clinical preventive 

4 services for review by the Task Force; 

5 ‘‘(ii) suggest scientific evidence for 

6 consideration by the Task Force related to 

7 reviews undertaken by the Task Force; 

8 ‘‘(iii) provide feedback regarding the 

9 research plan, the evidence report, and 

10 draft recommendations by the Task Force; 

11 and 

12 ‘‘(iv) assist with efforts regarding dis13 semination of recommendations by the Di14 rector. 

15 ‘‘(D) MEETINGS.—The board shall meet as 

16 the chair of the board determines to be appro17 priate to fulfill the responsibilities described in 

18 paragraph (C), but not fewer than 2 times each 

19 year. 

20 ‘‘(7) DISCLOSURE AND CONFLICTS OF INTER21 EST.—Prior to participating in a meeting of the 

22 Task Force or board, each member of the Task 

23 Force or board, respectively, shall disclose to the Di24 rector any potential, relevant financial interests in 

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1 ployee of the executive branch of the United States, 

2 if the employee were participating in such meeting, 

3 would be required to disclose such interests under 

4 section 208 of title 18, United States Code. 

5 ‘‘(8) NO PAY; RECEIPT OF TRAVEL EX6 PENSES.—Members of the Task Force or the board 

7 shall not receive any pay for service on the Task 

8 Force or board, but may receive travel expenses, in9 cluding a per diem, in accordance with applicable 

10 provisions of subchapter I of chapter 57 of title 5, 

11 United States Code.’’; and 

12 (6) by amending paragraph (10), as redesig13 nated by paragraph (4), to read as follows: 

14 ‘‘(10) APPLICATION OF FACA.—The Federal 

15 Advisory Committee Act (5 U.S.C. App.) shall apply 

16 to the Task Force except that section 14 of such Act 

17 (relating to termination of advisory committees) 

18 shall not apply to the Task Force.’’. 

19 (b) EFFECTIVE DATE; TRANSITION.— 

20 (1) IN GENERAL.—The United States Preven21 tive Services Task Force shall not publish any draft 

22 or final recommendations on or after such date ex23 cept in accordance with such amendments. 

24 (2) RECONSTITUTION OF TASK FORCE.—Not 

25 later than 180 days after the date of the enactment 


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1 of this Act, the Director of the Agency for 

2 Healthcare Research and Quality shall take steps to 

3 reconstitute the membership of the Task Force con4 sistent with section 915(a)(3) of the Public Health 

5 Service Act, as amended by subsection (a). 

6 (3) PREVIOUSLY PUBLISHED RECOMMENDA7 TIONS.—With respect to recommendations or guide8 lines published by such Task Force before the date 

9 of the enactment of this Act, under procedures es10 tablished by the Director of the Agency for 

11 Healthcare Research and Quality, the reconstituted 

12 Task Force shall undertake a review process con13 sistent with the following: 

14 (A) An organization may request the Task 

15 Force to review any such previous recommenda16 tion or guideline if such organization has addi17 tional peer-reviewed scientific evidence that pro18 vides new information relevant to the previous 

19 recommendation or guideline. 

20 (B) Based upon such requests, the Task 

21 Force shall establish a process for the review of 

22 previous recommendations or guidelines. 

23 (C) Such process shall include public no24 tice through the Federal Register and oppor25 tunity for comment and a determination to conVerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534

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1 firm or modify such recommendations or guide2 lines. 

3 (D) The process shall, to the extent fea4 sible, be consistent with the procedures applied 

5 under the amendments made by subsection (a) 

6 for the promulgation of new recommendations. 

7 (c) ELIMINATION OF SECRETARIAL DISCRETION TO

8 REMOVE CERTAIN PREVENTIVE SERVICES UNDER THE

9 MEDICARE PROGRAM.—Section 1834(n) of the Social Se10 curity Act (42 U.S.C. 1395m(n)) is amended— 

11 (1) by striking paragraph (2); 

12 (2) by striking ‘‘; and’’ at the end of paragraph 

13 (1)(B) and inserting a period; 

14 (3) by redesignating subparagraphs (A) and 

15 (B) of paragraph (1) as paragraphs (1) and (2), re16 spectively, and moving their margins 2 ems to the 

17 left; and 

18 (4) by striking ‘‘may’’ and all that follows 

19 through ‘‘modify’’ and inserting ‘‘may modify’’. 

20 (d) APPLICATION TO SECRETARIAL DISCRETION TO

21 REMOVE CERTAIN PREVENTIVE SERVICES UNDER THE

22 MEDICARE PROGRAM.—Section 1834(n) of the Social Se23 curity Act (42 U.S.C. 1395m(n)), as amended by sub24 section (c), is further amended by adding at the end the 

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1 ment of the USPSTF Transparency and Accountability 

2 Act of 2019, the Secretary may use the authority under 

3 this subsection only to modify coverage of a preventive 

4 service based on the recommendation or grade of the 

5 United States Preventive Services Task Force with respect 

6 to the service if such recommendation or grade was devel7 oped or updated in accordance with the amendments made 

8 by section 2(a) of such Act and if the Secretary has con9 curred with such recommendation or grade after consulta10 tion with other Federal health agencies and relevant pa11 tient and provider groups.’’. 

12 (e) APPLICATION TO PHYSICIAN QUALITY MEASURES

13 UNDER THE MEDICARE PROGRAM.—Section 1848 of the 

14 Social Security Act (42 U.S.C. 1395w–4) is amended by 

15 adding at the end the following new subsection: 

16 ‘‘(t) MEASURES RELATED TO USPSTF REC17 OMMENDATIONS.—Effective on the date of enactment of 

18 the USPSTF Transparency and Accountability Act of 

19 2019, notwithstanding any other provision of this title, a 

20 quality measure related to a recommendation of the 

21 United States Preventive Services Task Force may be ap22 plied under this section only if such recommendation was 

23 developed or updated in accordance with the amendments 

24 made by section 2(a) of such Act and if the Secretary has 

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1 sultation with other Federal health agencies and relevant 

2 patient and provider groups.’’. 

Æ 


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