I 117th CONGRESS 2d Session H. R. 9310 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.

1. Short title This Act may be cited as the Preventive Services Early Action Act . 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). .