[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 9310 Introduced in House (IH)]
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117th CONGRESS
2d Session
H. R. 9310
To amend the Public Health Service Act to give the United States
Preventive Services Task Force the authority to take early action based
on scientific evidence, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
November 16, 2022
Ms. Blunt Rochester introduced the following bill; which was referred
to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to give the United States
Preventive Services Task Force the authority to take early action based
on scientific evidence, 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 ``Preventive Services Early Action
Act''.
SEC. 2. CHANGES TO UNITED STATES PREVENTIVE SERVICES TASK FORCE.
Section 915(a) of the Public Health Service Act (42 U.S.C. 299b-
4(a)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (E), by striking ``and'' at the
end;
(B) in subparagraph (F), by striking the period at
the end and inserting ``; and''; and
(C) by adding at the end the following:
``(G) the publication of quarterly reports on the
Task Force's website identifying--
``(i) a list of clinical preventive
recommendations of the Task Force with respect
to the scientific information described in
paragraph (4)(B); and
``(ii) a list of topics that the Scientific
Director determines are appropriate for early
action as described in paragraph (5).'';
(2) by redesignating paragraphs (4), (5), (6), and (7) as
paragraphs (7), (8), (9), and (11), respectively;
(3) after making such redesignations, by inserting after
paragraph (3) the following:
``(4) Ongoing review of scientific evidence and requests
for early action.--For the purpose described in paragraph (1),
the Task Force shall establish and implement a process for the
ongoing review of scientific evidence related to updating
previous clinical preventive recommendations of the Task Force
under paragraph (5) and reviewing new topics for the
development of recommendations for the health care community.
Such scientific evidence shall include--
``(A) information from sources audited under the
LitWatch process described in Appendix III of the
United States Preventive Services Task Force Procedure
Manual (or any successor to such process); and
``(B) information submitted through a public
submission process, which may include evidence--
``(i) of the impact of clinical preventive
services on populations or age groups for which
such clinical preventive services do not have
in effect a rating of A or B;
``(ii) to fill research gaps identified by
the Task Force;
``(iii) of a new, novel screening modality
or technology, preventive medication, or other
preventive service not previously reviewed by
the Task Force;
``(iv) of health outcomes from a clinical
preventive service that was previously
considered but not recommended by the Task
Force; or
``(v) changes in the public health impact
of a specific condition, whether in general or
as such changes relate to a specific
population.
``(5) Early action based on scientific evidence.--
``(A) Determination by scientific director.--Not
less than once per quarter, the Scientific Director
shall determine whether the scientific evidence
reviewed under paragraph (4) supports--
``(i) early review of a previous clinical
preventive recommendation of the Task Force
before the previous recommendation is subject
to full review under the 5-year review period
described in paragraph (2); or
``(ii) modification of a previous clinical
preventive recommendation of the Task Force or
any portion thereof before the previous
recommendation is subject to full review under
the 5-year review period described in paragraph
(2).
``(B) Considerations.--In making a determination
under subparagraph (A), the Scientific Director shall
take into consideration whether the scientific evidence
involved--
``(i) includes information on a new or
novel intervention, modality, technology,
population, or strategy not previously
considered by the Task Force in the development
of the previous clinical preventive
recommendation;
``(ii) helps to address a research gap
identified by the Task Force when developing
the previous recommendation;
``(iii) relates to a previous
recommendation for a preventive service or
treatment of a disease or condition with a high
impact on public health or with disparities in
screening rates, incidence, or health outcomes
linked to socioeconomic status or race;
``(iv) is based on the development of new
technologies or modalities that would allow for
easier disease detection or increase
utilization of recommended clinical
preventative services; or
``(v) is supported by additional sources of
data for any subpopulations (including
subpopulations based on gender, race,
ethnicity, genetic predisposition,
socioeconomic status, geographic location, or
other risk factors) not considered in the
previous recommendation.
``(C) Response by task force.--If the Scientific
Director of the Task Force determines under
subparagraph (A) that the scientific evidence supports
the need for early action, the Task Force shall--
``(i) review the scientific evidence in
support of the determination at the next
meeting of the Task Force, which shall be held
not later than 3 months after the Scientific
Director's determination; and
``(ii) determine that--
``(I) the scientific evidence does
not support the need for early action;
``(II) the scientific evidence
supports the need for an early review
of a previous clinical preventive
recommendation before the previous
recommendation is subject to full
review under the 5-year review period
described in paragraph (2); or
``(III) the scientific evidence
supports the need to modify a previous
clinical preventive recommendation or
any portion thereof before the previous
recommendation is subject to full
review under the 5-year review period
described in paragraph (2), which may
include recommending a new clinical
preventive service, screening test, or
preventive medication without reviewing
or modifying the eligible population in
the previous recommendation.
``(D) Early action.--If the Task Force determines
that the scientific evidence supports the need for an
early review of a previous clinical preventive
recommendation, as described in subparagraph
(C)(ii)(II), the Task Force shall--
``(i) allow for public comment on a draft
recommendation; and
``(ii) not later than 6 months after such
determination, conclude such early review and
make a final recommendation.
``(E) Modification.--If the Task Force determines
that the scientific evidence supports the need to
modify a previous clinical preventive recommendation or
any portion thereof, as described in subparagraph
(C)(ii)(III), the Task Force shall finalize the
modified recommendation not later than 90 days after
such determination. Any modification approved under
this subparagraph shall be in effect until the next
review of such recommendation under the 5-year review
period described in paragraph (2).
``(6) Approval of clearance of certain products.--Not later
than 3 months after the approval or clearance by the Food and
Drug Administration of a screening test or preventive
medication that is a preventive strategy or modality pertaining
to but not included in a previous clinical preventive
recommendation of the Task Force, the Task Force shall
determine that the approval or clearance of the product--
``(A) does not support the need for early action;
``(B) supports the need for an early review of a
previous clinical preventive recommendation before the
previous recommendation is subject to full review under
the 5-year review period described in paragraph (2); or
``(C) supports the need to modify a previous
clinical preventive recommendation or any portion
thereof before the previous recommendation is subject
to full review under the 5-year review period described
in paragraph (2), which may include recommending a new
clinical preventive service, screening test, or
preventive medication without reviewing or modifying
the eligible population in the previous
recommendation.'';
(4) by inserting after paragraph (9), as so redesignated,
the following:
``(10) Definitions.--In this section:
``(A) The term `public submission process' means an
online mechanism that allows any member of the general
public to submit scientific evidence for review by the
Scientific Director and the Task Force staff.
``(B) The term `Scientific Director' means the
chief physician, researcher, and technical advisor for
the Task Force, as determined by the Director.''; and
(5) by amending paragraph (11), as so redesignated, to read
as follows:
``(11) Authorization of appropriations.--There are
authorized to be appropriated such sums as may be necessary for
each fiscal year to carry out the activities of the Task Force,
of which such sums as may be necessary are authorized to be
appropriated for fiscal years 2023 and 2024 to hire additional
staff to carry out paragraphs (4) and (5).''.
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