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-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘USPSTF Trans-
parency and Accountability Act of 2019’’. 
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
SEC. 2. CHANGES TO UNITED STATES PREVENTIVE SERV-
ICES 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 fol-
lows: 
‘‘(1) ESTABLISHMENT AND PURPOSE.—The Di-
rector 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 appro-
priateness of clinical preventive services for the pur-
pose of developing recommendations for primary 
care clinicians and the health care community and 
updating previous clinical preventive recommenda-
tions.’’; 
(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 fol-
lowing new paragraphs: 
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) 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 eco-
nomics, 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 eco-
nomics, and clinical care), patients, and health 
care consumers. 
‘‘(B) NOTICE.—Before appointing mem-
bers to the Task Force, the Director shall pro-
vide notice in the Federal Register to give per-
sons an opportunity to nominate potential mem-
bers. 
‘‘(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 
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
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 dis-
cussion of the comments received with re-
spect to such plan and responses to such 
comments. The Task Force, with the con-
currence of the Director, may change such 
a research plan through the same process 
as applied to the initial adoption of such 
plan. 
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
‘‘(iii) CRITERIA.—The Director shall 
design and regularly update guidelines for 
proper methodological standards for incor-
poration into such research plans. Such 
guidelines shall include measures for ap-
propriate validity, for risk adjustment, for 
timeliness, for input from relevant experts 
and peers in the respective communities, 
for accounting for all relevant subpopula-
tions (including disparities by gender, race, 
ethnicity, socioeconomic status, and geo-
graphic location), and for other health out-
come measurements. Such guidelines and 
methodological standards shall ensure the 
consideration of any evidence concerning 
any relevant subpopulations (including dis-
parities by gender, race, ethnicity, genetic 
predisposition, socioeconomic status, and 
geographic location), any real world evi-
dence, any recent evidence, and any United 
States-based studies. 
‘‘(iv) CONSULTATION
ON
RESEARCH 
PLANS.—The Director shall facilitate co-
ordination and interaction with other agen-
cies and departments in the preparation 
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
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 De-
partment of Defense, the Department of 
Veterans Affairs, the Centers for Medicare 
& Medicaid Services, and the Patient-Cen-
tered Outcomes Research Institute. 
‘‘(B) EVIDENCE REPORTS.— 
‘‘(i) INITIAL PUBLICATION.—The Di-
rector 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 re-
quest 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 
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
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 de-
scription of comments submitted on the 
draft evidence review and the response of 
the Task Force to such comments. 
‘‘(iii) REVIEW
BY
EXTERNAL
EX-
PERTS.—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 rep-
resentatives. Each such report shall in-
clude a description of the panel that con-
ducted such review. Such description shall 
include information on each panel member, 
including name, academic degree (or de-
grees), affiliations, and related expertise. 
‘‘(C) RECOMMENDATION STATEMENTS.— 
‘‘(i) PUBLICATION
OF
DRAFT
REC-
OMMENDATIONS.—The Director shall make 
publicly available each draft recommenda-
tion statement (as that term is used for 
purposes of section 7 of the U.S. Preven-
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
tive Services Task Force Procedure Man-
ual, as in effect on April 1, 2019) and 
shall provide for the publication in the 
Federal Register of a request for com-
ments and accept comments during a pe-
riod of not less than 45 days. 
‘‘(ii) 
CONSULTATION
ON
REC-
OMMENDATIONS.—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 stake-
holders, including provider groups, 
practicing specialists that treat the 
specific disease under review, and rel-
evant patient and disease advocacy or-
ganizations; and 
‘‘(II) take into account the feed-
back provided by the board. 
‘‘(iii) PUBLIC AVAILABILITY OF COM-
MENTS AND INCLUSION OF DESCRIPTION 
OF
COMMENTS
IN
FINAL
STATEMENT.— 
The Director shall make comments re-
ceived pursuant to clause (i) publicly avail-
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
able. Any final recommendation statement 
shall include a description of comments re-
ceived on the draft recommendation state-
ment and recommendations of other Fed-
eral agencies or organizations relating to 
the topic of the statement. The Director 
shall make final recommendation state-
ments 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 con-
sider— 
‘‘(I) the impact of its rec-
ommendations 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 individ-
uals; and 
‘‘(III) how its specific assignment 
of a grade to a product or service may 
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
affect coverage and access to such 
product or service under Federal pro-
grams and private health insurance 
coverage. 
‘‘(v) DISSEMINATION
OF
EVIDENCE- 
BASED
RECOMMENDATIONS.—The 
Task 
Force shall publish and disseminate the 
evidence-based recommendations after con-
sultation with the following: 
‘‘(I) Relevant patient organiza-
tions. 
‘‘(II) Providers of clinical serv-
ices, including community-based pro-
viders and specialty physicians. 
‘‘(III) The Department of Vet-
erans Affairs, the Centers for Medi-
care & Medicaid Services, and the 
Centers for Disease Control and Pre-
vention. 
‘‘(D) GRADING SYSTEM.—Subject to sub-
paragraph (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 prod-
ucts and services consistent with the following: 
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
‘‘(i) GRADE A.—The Task Force shall 
assign a product or service Grade A if the 
Task Force concludes that the current evi-
dence is sufficient to assess the balance of 
benefits and risks of the product or service, 
and, on the basis of such evidence, rec-
ommends the product or service and deter-
mines 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 cur-
rent evidence is sufficient to assess the bal-
ance of benefits and risks of the product or 
service, and, on the basis of such evidence, 
recommends the product or service and de-
termines 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 serv-
ice is moderate to substantial. 
‘‘(iii) GRADE
C.—The Task Force 
shall assign a product or service Grade C 
if the Task Force concludes that— 
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
‘‘(I) the current evidence is suffi-
cient to assess the balance of benefits 
and risks of the product or service; 
‘‘(II) on the basis of such evi-
dence, does not make a recommenda-
tion of the product or service and cli-
nicians may provide this product or 
service to selected patients depending 
on individual circumstances; and 
‘‘(III) for most individuals with-
out signs or symptoms of a particular 
disease or condition there is at least 
moderate certainty that the net ben-
efit is small. 
‘‘(iv) GRADE
D.—The Task Force 
shall assign a product or service Grade D 
if the Task Force concludes that the cur-
rent evidence is sufficient to assess the bal-
ance 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. 
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
‘‘(v) GRADE I.—The Task Force shall 
assign a product or service Grade I if the 
Task Force concludes that the current evi-
dence is not sufficient to assess the bal-
ance 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 re-
view and regrading may be done through 
an expedited process so long as any change 
in grade does not take effect before the re-
view of that change in grade is completed. 
‘‘(5) ROLE OF AGENCY.—The Agency shall pro-
vide ongoing administrative, research, and technical 
support for the operations of the Task Force, includ-
ing coordinating and supporting the dissemination of 
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00013
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
its recommendation statements, ensuring adequate 
staff resources, and assistance to those organizations 
requesting it for implementation of the recommenda-
tions 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’) com-
posed 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 preven-
tive services. 
‘‘(B) MEMBERSHIP.—The members of the 
board shall include representatives of the fol-
lowing: 
‘‘(i) Patient groups. 
‘‘(ii) Providers of clinical services, in-
cluding community-based providers and 
specialty physicians. 
‘‘(iii) Federal departments and agen-
cies that have expertise in the clinical pre-
ventive service being reviewed. 
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00014
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
‘‘(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 dis-
semination of recommendations by the Di-
rector. 
‘‘(D) MEETINGS.—The board shall meet as 
the chair of the board determines to be appro-
priate to fulfill the responsibilities described in 
paragraph (C), but not fewer than 2 times each 
year. 
‘‘(7) DISCLOSURE AND CONFLICTS OF INTER-
EST.—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 Di-
rector any potential, relevant financial interests in 
the same manner and to the same extent as an em-
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00015
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
ployee 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
EX-
PENSES.—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, in-
cluding 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 redesig-
nated 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 Preven-
tive Services Task Force shall not publish any draft 
or final recommendations on or after such date ex-
cept in accordance with such amendments. 
(2) RECONSTITUTION
OF
TASK
FORCE.—Not 
later than 180 days after the date of the enactment 
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00016
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
of this Act, the Director of the Agency for 
Healthcare Research and Quality shall take steps to 
reconstitute the membership of the Task Force con-
sistent with section 915(a)(3) of the Public Health 
Service Act, as amended by subsection (a). 
(3) PREVIOUSLY
PUBLISHED
RECOMMENDA-
TIONS.—With respect to recommendations or guide-
lines published by such Task Force before the date 
of the enactment of this Act, under procedures es-
tablished by the Director of the Agency for 
Healthcare Research and Quality, the reconstituted 
Task Force shall undertake a review process con-
sistent with the following: 
(A) An organization may request the Task 
Force to review any such previous recommenda-
tion or guideline if such organization has addi-
tional peer-reviewed scientific evidence that pro-
vides 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 no-
tice through the Federal Register and oppor-
tunity for comment and a determination to con-
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00017
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
firm or modify such recommendations or guide-
lines. 
(D) The process shall, to the extent fea-
sible, 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 Se-
curity 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), re-
spectively, 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 Se-
curity Act (42 U.S.C. 1395m(n)), as amended by sub-
section (c), is further amended by adding at the end the 
following flush sentence: ‘‘Effective on the date of enact-
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00018
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
ment 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 devel-
oped or updated in accordance with the amendments made 
by section 2(a) of such Act and if the Secretary has con-
curred with such recommendation or grade after consulta-
tion with other Federal health agencies and relevant pa-
tient 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 REC-
OMMENDATIONS.—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 ap-
plied 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 con-
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00019
Fmt 6652
Sfmt 6201
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS
sultation with other Federal health agencies and relevant 
patient and provider groups.’’. 
Æ 
VerDate Sep 11 2014 
02:37 Jul 09, 2019
Jkt 034408
PO 00000
Frm 00020
Fmt 6652
Sfmt 6301
E:\BILLS\H3534.IH
H3534
pbinns on DSK79D2C42PROD with BILLS