USPSTF Transparency and Accountability Act of 2019

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 re- ferred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently de- termined 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 Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘USPSTF Trans- 4 parency and Accountability Act of 2019’’. 5 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 2 •HR 3534 IH SEC. 2. CHANGES TO UNITED STATES PREVENTIVE SERV- 1 ICES TASK FORCE. 2 (a) IN GENERAL.—Subsection (a) of section 915 of 3 the Public Health Service Act (42 U.S.C. 299b–4) is 4 amended— 5 (1) by amending the heading to read as follows: 6 ‘‘UNITED STATES PREVENTIVE SERVICES TASK 7 FORCE’’; 8 (2) by amending paragraph (1) to read as fol- 9 lows: 10 ‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di- 11 rector may establish and periodically convene the 12 United States Preventive Services Task Force (in 13 this section referred to as the ‘Task Force’). The 14 Task Force shall review the scientific evidence and 15 new science related to the effectiveness and appro- 16 priateness of clinical preventive services for the pur- 17 pose of developing recommendations for primary 18 care clinicians and the health care community and 19 updating previous clinical preventive recommenda- 20 tions.’’; 21 (3) by striking paragraph (3); 22 (4) by redesignating paragraphs (4) through 23 (7) as paragraphs (9) through (12), respectively; 24 (5) by inserting after paragraph (2) the fol- 25 lowing new paragraphs: 26 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 3 •HR 3534 IH ‘‘(3) COMPOSITION.— 1 ‘‘(A) IN GENERAL.—The Task Force shall 2 be composed of individuals that collectively have 3 appropriate scientific expertise, including in 4 fields of health sciences research, health eco- 5 nomics, health promotion, disease prevention, 6 and clinical care. The Task Force shall include 7 a balanced representation of practicing primary 8 and specialty care providers (including in the 9 fields of health services research, health eco- 10 nomics, and clinical care), patients, and health 11 care consumers. 12 ‘‘(B) NOTICE.—Before appointing mem- 13 bers to the Task Force, the Director shall pro- 14 vide notice in the Federal Register to give per- 15 sons an opportunity to nominate potential mem- 16 bers. 17 ‘‘(4) REVIEW AND CONSULTATION.— 18 ‘‘(A) RESEARCH PLANS.— 19 ‘‘(i) IN GENERAL.—In conducting its 20 reviews under paragraph (1), the Task 21 Force shall publish one or more proposed 22 research plans (in this subsection referred 23 to as a ‘research plan’) to guide the Task 24 Force’s systematic review of the evidence 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 4 •HR 3534 IH referred to in such paragraph. Each such 1 plan shall include an analytic framework, 2 key questions, and a literature search 3 strategy or research approach, and shall 4 incorporate the methodological guidelines 5 developed under clause (iii). 6 ‘‘(ii) PUBLICATION; PUBLIC COMMENT 7 PERIOD.—The Task Force shall provide 8 for the publication in the Federal Register 9 of a request for public comments on each 10 research plan and shall accept comments 11 on such plan during a period of not less 12 than 45 days. The Director shall make 13 publicly available comments submitted in 14 response to a request for public comments. 15 Any final research plan shall be made 16 available to the public and include a dis- 17 cussion of the comments received with re- 18 spect to such plan and responses to such 19 comments. The Task Force, with the con- 20 currence of the Director, may change such 21 a research plan through the same process 22 as applied to the initial adoption of such 23 plan. 24 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 5 •HR 3534 IH ‘‘(iii) CRITERIA.—The Director shall 1 design and regularly update guidelines for 2 proper methodological standards for incor- 3 poration into such research plans. Such 4 guidelines shall include measures for ap- 5 propriate validity, for risk adjustment, for 6 timeliness, for input from relevant experts 7 and peers in the respective communities, 8 for accounting for all relevant subpopula- 9 tions (including disparities by gender, race, 10 ethnicity, socioeconomic status, and geo- 11 graphic location), and for other health out- 12 come measurements. Such guidelines and 13 methodological standards shall ensure the 14 consideration of any evidence concerning 15 any relevant subpopulations (including dis- 16 parities by gender, race, ethnicity, genetic 17 predisposition, socioeconomic status, and 18 geographic location), any real world evi- 19 dence, any recent evidence, and any United 20 States-based studies. 21 ‘‘(iv) CONSULTATION ON RESEARCH 22 PLANS.—The Director shall facilitate co- 23 ordination and interaction with other agen- 24 cies and departments in the preparation 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 6 •HR 3534 IH and publication of research plans (taking 1 into consideration research and findings by 2 other agencies and departments) and 3 methodological standards under clause 4 (iii), including with the National Institutes 5 of Health, the National Cancer Institute, 6 the National Institute on Minority Health 7 and Health Disparities, the Centers for 8 Disease Control and Prevention, the De- 9 partment of Defense, the Department of 10 Veterans Affairs, the Centers for Medicare 11 & Medicaid Services, and the Patient-Cen- 12 tered Outcomes Research Institute. 13 ‘‘(B) EVIDENCE REPORTS.— 14 ‘‘(i) INITIAL PUBLICATION.—The Di- 15 rector shall make publicly available each 16 systematic evidence review and any related 17 reports that serve as the foundation for 18 any recommendation of the Task Force 19 and publish in the Federal Register a re- 20 quest for public comments on such review 21 or related reports. 22 ‘‘(ii) PUBLIC COMMENT PERIOD.—The 23 Director shall accept comments on any 24 draft evidence report published under 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 7 •HR 3534 IH clause (i) during a period of at least 45 1 days. The Director shall make publicly 2 available comments submitted in response 3 to a request for public comment. Each 4 final evidence review shall include a de- 5 scription of comments submitted on the 6 draft evidence review and the response of 7 the Task Force to such comments. 8 ‘‘(iii) REVIEW BY EXTERNAL EX- 9 PERTS.—No such evidence report shall be 10 published prior to it being reviewed by a 11 panel of external subject matter experts 12 that includes provider and patient rep- 13 resentatives. Each such report shall in- 14 clude a description of the panel that con- 15 ducted such review. Such description shall 16 include information on each panel member, 17 including name, academic degree (or de- 18 grees), affiliations, and related expertise. 19 ‘‘(C) RECOMMENDATION STATEMENTS.— 20 ‘‘(i) PUBLICATION OF DRAFT REC- 21 OMMENDATIONS.—The Director shall make 22 publicly available each draft recommenda- 23 tion statement (as that term is used for 24 purposes of section 7 of the U.S. Preven- 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 8 •HR 3534 IH tive Services Task Force Procedure Man- 1 ual, as in effect on April 1, 2019) and 2 shall provide for the publication in the 3 Federal Register of a request for com- 4 ments and accept comments during a pe- 5 riod of not less than 45 days. 6 ‘‘(ii) CONSULTATION ON REC- 7 OMMENDATIONS.—Before voting on a draft 8 or final recommendation statement (as 9 that term is used for purposes of section 7 10 of the procedure manual referred to in 11 clause (i)), the Task Force shall— 12 ‘‘(I) consult with relevant stake- 13 holders, including provider groups, 14 practicing specialists that treat the 15 specific disease under review, and rel- 16 evant patient and disease advocacy or- 17 ganizations; and 18 ‘‘(II) take into account the feed- 19 back provided by the board. 20 ‘‘(iii) PUBLIC AVAILABILITY OF COM- 21 MENTS AND INCLUSION OF DESCRIPTION 22 OF COMMENTS IN FINAL STATEMENT.— 23 The Director shall make comments re- 24 ceived pursuant to clause (i) publicly avail- 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 9 •HR 3534 IH able. Any final recommendation statement 1 shall include a description of comments re- 2 ceived on the draft recommendation state- 3 ment and recommendations of other Fed- 4 eral agencies or organizations relating to 5 the topic of the statement. The Director 6 shall make final recommendation state- 7 ments publicly available, including through 8 publication in the Federal Register. 9 ‘‘(iv) CONSIDERATION.—In publishing 10 draft or final recommendation statements 11 (as those terms are used for purposes of 12 section 7 of the procedure manual referred 13 to in clause (i)), the Task Force shall con- 14 sider— 15 ‘‘(I) the impact of its rec- 16 ommendations on the health care 17 community; 18 ‘‘(II) whether a preventive service 19 is beneficial for some individuals and 20 the need to encourage a discussion of 21 benefits and risks for those individ- 22 uals; and 23 ‘‘(III) how its specific assignment 24 of a grade to a product or service may 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 10 •HR 3534 IH affect coverage and access to such 1 product or service under Federal pro- 2 grams and private health insurance 3 coverage. 4 ‘‘(v) DISSEMINATION OF EVIDENCE- 5 BASED RECOMMENDATIONS.—The Task 6 Force shall publish and disseminate the 7 evidence-based recommendations after con- 8 sultation with the following: 9 ‘‘(I) Relevant patient organiza- 10 tions. 11 ‘‘(II) Providers of clinical serv- 12 ices, including community-based pro- 13 viders and specialty physicians. 14 ‘‘(III) The Department of Vet- 15 erans Affairs, the Centers for Medi- 16 care & Medicaid Services, and the 17 Centers for Disease Control and Pre- 18 vention. 19 ‘‘(D) GRADING SYSTEM.—Subject to sub- 20 paragraph (E), in publishing recommendation 21 statements (as that term is used for purposes 22 of section 7 of the procedure manual referred to 23 in clause (i)), the Task Force shall grade prod- 24 ucts and services consistent with the following: 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 11 •HR 3534 IH ‘‘(i) GRADE A.—The Task Force shall 1 assign a product or service Grade A if the 2 Task Force concludes that the current evi- 3 dence is sufficient to assess the balance of 4 benefits and risks of the product or service, 5 and, on the basis of such evidence, rec- 6 ommends the product or service and deter- 7 mines that there is high certainty that the 8 net benefit from the product or service is 9 substantial. 10 ‘‘(ii) GRADE B.—The Task Force 11 shall assign a product or service Grade B 12 if the Task Force concludes that the cur- 13 rent evidence is sufficient to assess the bal- 14 ance of benefits and risks of the product or 15 service, and, on the basis of such evidence, 16 recommends the product or service and de- 17 termines that there is high certainty that 18 the net benefit of the product or service is 19 moderate or there is moderate certainty 20 that the net benefit of the product or serv- 21 ice is moderate to substantial. 22 ‘‘(iii) GRADE C.—The Task Force 23 shall assign a product or service Grade C 24 if the Task Force concludes that— 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 12 •HR 3534 IH ‘‘(I) the current evidence is suffi- 1 cient to assess the balance of benefits 2 and risks of the product or service; 3 ‘‘(II) on the basis of such evi- 4 dence, does not make a recommenda- 5 tion of the product or service and cli- 6 nicians may provide this product or 7 service to selected patients depending 8 on individual circumstances; and 9 ‘‘(III) for most individuals with- 10 out signs or symptoms of a particular 11 disease or condition there is at least 12 moderate certainty that the net ben- 13 efit is small. 14 ‘‘(iv) GRADE D.—The Task Force 15 shall assign a product or service Grade D 16 if the Task Force concludes that the cur- 17 rent evidence is sufficient to assess the bal- 18 ance of benefits and risks of the product or 19 service, and, on the basis of such evidence, 20 recommends against the product or service 21 and determines that there is moderate or 22 high certainty that the product or service 23 has no net benefit or that the harm of the 24 product or service outweighs the benefits. 25 VerDate Sep 11 2014 02:37 Jul 09, 2019 Jkt 034408 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\H3534.IH H3534 pbinns on DSK79D2C42PROD with BILLS 13 •HR 3534 IH ‘‘(v) GRADE I.—The Task Force shall 1 assign a product or service Grade I if the 2 Task Force concludes that the current evi- 3 dence is not sufficient to assess the bal- 4 ance of benefits and risks of the product or 5 service. 6 ‘‘(E) CHANGES IN GRADING SYSTEM.— 7 ‘‘(i) IN GENERAL.—The Director may 8 provide, by regulation, for changes in the 9 grading system described in subparagraph 10 (D). 11 ‘‘(ii) IMPACT OF CHANGES.—If the 12 Director makes a change in the grad [Text truncated for display. 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