Establishment of precision oncology program for cancer of the prostate

(a)

Establishment of program

(1)

In general

Subchapter II of chapter 73 of title 38, United States Code, is amended by adding at the end the following new section:

7330E.

Precision oncology program for cancer of the prostate

(a)

Establishment

The Secretary shall establish within the Department a precision oncology program for cancer of the prostate in accordance with this section (in this section referred to as the Program).(b)

Eligibility

A veteran is eligible to participate in the Program if the veteran has a diagnosis of prostate cancer.(c)

Centers of excellence

(1)

Designation of centers

Effective on the date of the enactment of this section, the Secretary shall designate the following medical facilities of the Department as provisional centers of excellence for the Program:(A)The Seattle VA Medical Center, Seattle, Washington.(B)The James J. Peters VA Medical Center, Bronx, New York.(C)The Lieutenant Colonel Charles S. Kettles VA Medical Center, Ann Arbor, Michigan.(D)The Margaret Cochran Corbin Manhattan VA Medical Center, Manhattan, New York.(E)The Jesse Brown Department of Veterans Affairs Medical Center, Chicago, Illinois.(F)The West Los Angeles VA Medical Center, Los Angeles, California.(G)The Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.(H)The Durham VA Medical Center, Durham, North Carolina.(I)The Washington DC VA Medical Center, Washington, District of Columbia.(J)The James A. Haley Veterans Hospital, Tampa, Florida.(K)The Portland VA Medical Center, Portland, Oregon.(L)The Jamaica Plain VA Medical Center, Boston, Massachusetts.(M)The San Francisco VA Medical Center, San Francisco, California.(N)The Michael E. DeBakey Department of Veterans Affairs Medical Center, Houston, Texas.(O)The Rocky Mountain Regional VA Medical Center, Aurora, Colorado.(P)The John J. Cochran Veterans Hospital, St. Louis, Missouri.(Q)The Kansas City VA Medical Center, Kansas City, Missouri.(R)The Joseph Maxwell Cleland Atlanta VA Medical Center, Decatur, Georgia.(S)The Ralph H. Johnson VA Medical Center, Charleston, South Carolina.(T)The Orlando VA Medical Center, Orlando, Florida.(U)The Baltimore VA Medical Center, Baltimore, Maryland.(V)The John L. McClellan Memorial Veterans’ Hospital, Little Rock, Arkansas.(W)The William S. Middleton Memorial Veterans Hospital, Madison, Wisconsin.(X)The Minneapolis VA Medical Center, Minneapolis, Minnesota.(Y)The George E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City, Utah.(Z)The Carl T. Hayden Veterans’ Administration Medical Center, Phoenix, Arizona.(AA)The Dallas VA Medical Center, Dallas, Texas.(BB)The Malcom Randall Department of Veterans Affairs Medical Center, Gainesville, Florida.(2)

Operational requirements

(A)

Minimum number of centers

The Secretary shall ensure that, at all times, not fewer than 21 medical facilities of the Department are designated and operating as centers of excellence under the Program, with not fewer than one center maintained in each Veterans Integrated Service Network.(B)

Duration of secretarial designation

Subject to paragraph (3), each center designated under this section shall be so designated for a period of not less than five years.(3)

Additional designations

(A)

In general

The Secretary may designate medical facilities as centers of excellence in addition to those designated under paragraph (1).(B)

Protection of initial centers

For purposes of complying with the minimum number of designated centers of excellence requirement under paragraph (2), the Secretary shall count toward such minimum number any medical facilities designated pursuant to paragraph (1) and not terminated under paragraph (4).(4)

Termination of designation

(A)

In general

Beginning not earlier than January 1, 2030, the Secretary may terminate the designation of a medical facility as a center of excellence under the Program if the Secretary determines the facility is failing to serve the purposes of the Program required by this section.(B)

Process

The Secretary—(i)before terminating a designation under subparagraph (A), shall submit to the Committee on Veterans’ Affairs and the Committee on Appropriations of the Senate and the Committee on Veterans’ Affairs and the Committee on Appropriations of the House of Representatives a notice of the intent to terminate the designation; and(ii)may not terminate the designation until the date that is 60 days after the date of the submission of such notice.(5)

Performance reviews

(A)

In general

Beginning in 2030, the Secretary shall conduct reviews of the performance of the centers of excellence designated under the Program.(B)

Rolling cycle

In carrying out subparagraph (A), the Secretary shall ensure that—(i)in 2030 and each year thereafter, the Secretary reviews and makes a determination on not more than seven centers;(ii)the centers selected for review in any given year constitute a class of centers distinct from the classes reviewed in the preceding four years; and(iii)not later than the date of the submission of the fifth annual report under subsection (f) following the initial conduct of reviews under this paragraph, and not later than every fifth year thereafter, every center operating under the Program has been reviewed.(C)

Scope of review

Each review of a center under this paragraph shall assess whether the performance of the center in providing the services required under this section is adequate to justify the continued designation of the center as a center of excellence under the Program.(d)

Activities and staffing of centers

(1)

Activities

Each center designated under subsection (c) shall carry out the following activities:(A)Establishing a program of genetic sequencing for veterans with advanced prostate cancer.(B)Instituting a uniform genetic sequencing platform to allow for coordination across all centers.(C)Participating in the telemedicine tumor board of the Program.(D)Participating in the registry study of the Program to track mutations.(E)Providing travel support to veterans with mutations to facilitate access to studies.(F)Developing clinical trials that are biomarker specific.(G)Participating in industry-sponsored precision oncology studies.(H)Participating in monthly calls and not less than three in-person meetings per year with the Program Leadership team established under subsection (e) to assess progress.(I)Providing ongoing reporting to the Program Leadership team regarding trial accruals and research conducted by investigators of the Department with limited experience who are undergoing mentorship.(J)Establishing metastasis biopsy capability.(K)Extending resources to affiliated centers in the Veterans Integrated Service Network in which the center is located.(2)

Staffing

The Secretary shall ensure that each center designated under subsection (c) employs, at a minimum—(A)a medical oncologist;(B)an interventional radiologist;(C)a urologist;(D)a radiation oncologist;(E)a pathologist; and(F)two full-time equivalent research staff members.(e)

Program leadership

(1)

In general

The Secretary shall establish a Program Leadership team located at the medical facility designated under subsection (c)(1)(A) (in this section referred to as the Program Leadership team).(2)

Composition

The Program Leadership team shall include, at a minimum, an Executive Director, a Clinical Director, and a Research Director.(3)

Duties

The Program Leadership team shall be responsible for—(A)providing strategic liaison services with industry to ensure engagement by the Department with study design and participation;(B)coordinating participation by the Department in prostate cancer group studies sponsored by the National Cancer Institute;(C)facilitating the development of study concepts, design, and start-up with investigators of the Department with limited experience who are undergoing mentorship;(D)creating and executing a model for hybrid decentralized clinical trials, including remote research coordination, regulatory start-up and maintenance, data management, and approval by an institutional review board;(E)creating and maintaining a prostate cancer registry and data repository of the Department; and(F)maintaining relevant working groups to bring together expertise of the Department from across the country.(4)

Specific responsibilities

(A)

Executive director

The Executive Director of the Program Leadership team shall—(i)provide administrative leadership to the Program network in partnership with the Clinical Director;(ii)maintain responsibility for the development, execution, and monitoring of the national strategic plan of the Program; and(iii)serve as the liaison to the executive steering committee and other leadership of the Department and centers of excellence.(B)

Clinical director

The Clinical Director of the Program Leadership team shall—(i)oversee the Program network to ensure eligible veterans receive access to care based on the latest research;(ii)maintain responsibility for the development and implementation of strategies for program growth, quality improvement, and patient satisfaction;(iii)serve on the review committee of the Program for clinical trials to ensure studies are conducted ethically and efficiently; and(iv)serve as the liaison with stakeholders to integrate clinical services and research.(C)

Research director

The Research Director of the Program Leadership team shall—(i)provide leadership on national research objectives;(ii)serve on committees to review new research concepts and projects in the Program network;(iii)maintain a deep understanding of current research and emerging technologies in prostate cancer; and(iv)interact with stakeholders, including regulatory agencies, industry partners, and research institutions, to improve prostate cancer research within the Department.(f)

Annual report

(1)

In general

Not later than March 1 of each year, the Secretary shall submit to the Committee on Veterans’ Affairs and the Committee on Appropriations of the Senate and the Committee on Veterans’ Affairs and the Committee on Appropriations of the House of Representatives a report on the Program.(2)

Elements

Each report submitted under paragraph (1) shall include, with respect to the period covered by the report, the following:(A)The funding levels for each center of excellent designated under the Program;(B)The number of veterans served by the Program;(C)The number of investigators and providers participating in the Program network;(D)The number of publications by providers of the Department relating to prostate cancer;(E)The number of clinical research studies supported by the network; (F) The number of veterans enrolled in such clinical research studies; (G) The five-year survival rate of veterans enrolled in clinical research studies of the Program compared to other veterans and civilians with prostate cancer; and (H)The outcomes and survival data for veterans served at dedicated genitourinary centers under the Program compared to that of other veterans and civilians served at other centers of excellence under the Program.(3)

Comprehensive plan

The Secretary shall include in the report submitted under paragraph (1) in 2029, a comprehensive plan for the designation and operation of the centers of excellence under subsection (c)(2)(A), including a timeline for center evaluations, performance criteria to be utilized in evaluations, and center selection process.(4)

Performance review findings

Beginning with the report submitted under paragraph (1) in 2031, and all subsequent such reports, the Secretary shall include results of the performance reviews conducted pursuant to subsection (c)(5), including a determination by the Secretary regarding whether the results of such review for each center justifies continued designation as a center of excellence.(5)

Forecast

Each report submitted under paragraph (1) shall include forecasts of the matter described in paragraph (1)(A) for the upcoming review period.

(2)

Clerical amendment

The table of sections at the beginning of such chapter is amended by inserting after the item relating to section 7330D the following new item:

7330E. Precision oncology program for cancer of the prostate.

(b)

Establishment, designation, and operation

(1)

In general

The Secretary of Veterans Affairs shall establish the program required under section 7330E of title 38, United States Code, as added by subsection (a)(1), including the designation of program leadership under subsection (e) of such section and the designation and operation of the centers of excellence under subsection (c) of such section, by not later than January 1, 2027.(2)

Terms and conditions

The designation and operation of the centers of excellence described in paragraph (1) shall be conducted under the same terms and conditions and in the same manner as those centers were designated and operated on January 1, 2023.(c)

Implementation plan

(1)

In general

Not later than 180 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall submit to the Committee on Veterans’ Affairs and the Committee on Appropriations of the Senate and the Committee on Veterans’ Affairs and the Committee on Appropriations of the House of Representatives a plan for the implementation of section 7330E of title 38, United States Code, as added by subsection (a)(1).(2)

Elements

The plan required by paragraph (1) shall include—(A)an assessment of staffing required at each center of excellence designated under section 7330E(c) of title 38, United States Code, as added by subsection (a)(1);(B)an identification of contracting requirements;(C)a plan for sequencing platform selection;(D)a plan for registry creation;(E)a plan for coordination with a central institutional review board; and(F)an identification of anticipated funding levels for the 10-year period beginning on the date of the submittal of the plan.(d)

Authorization of appropriations

There is authorized to be appropriated to the Secretary of Veterans Affairs to carry out section 7330E of title 38, United States Code, as added by subsection (a)(1), $15,500,000 for each of fiscal years 2027 through 2029.