Establishment of precision oncology program for cancer of the prostate

(a)

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 a precision oncology program for cancer of the prostate (in this section, referred to as the Program) at the Department in accordance with this section. In carrying out the Program, the Secretary shall— (1) shall designate Centers of Excellence in accordance with subsection (d); and (2) maintain the Program Leadership team under subsection (g). (b)

Eligibility

A veteran is eligible to enroll in additional medical services through the Program if such veteran is enrolled in the patient enrollment system under section 1705 of this title and has a diagnosis of prostate cancer or non-prostate genitourinary cancer. (c)

Requirements of Centers of Excellence

(1) Each Center of Excellence designated under this section shall carry out the following activities: (A) Establishing a program of genetic sequencing for veterans with advanced prostate cancer. (B) Implementing the uniform genetic sequencing platform developed by the Program Leadership under subsection (g)(3)(H) to allow for coordination among Centers. (C) Participating in the Telemedicine Tumor Board of the Program. (D) Participating in the prostate cancer registry maintained by the Program Leadership under subsection (g)(3)(E) to track relevant genetic mutations. (E) Providing travel support to eligible veterans with such mutations to facilitate access to studies. (F) Developing biomarker-specific clinical trials. (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 to assess progress. (I) Providing ongoing reporting to the Program Leadership regarding trial accrual and research conducted by the Center. (J) Establishing metastasis biopsy capability. (K) Extending resources to affiliated medical centers in the Veterans Integrated Service Network in which the Center is located. (2) The Secretary shall ensure that each Center designated under the Program 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. (d)

Designation of Centers of Excellence

(1) The Secretary may designate additional medical facilities as Centers of Excellence. (2) The Secretary shall ensure that not fewer than 21 medical facilities are designated as Centers of Excellence under this section at all times. (3) The Secretary shall ensure that at least one medical facility in each Veterans Integrated Service Network is designated as a Center of Excellence under this section. (4) The Secretary shall ensure that not fewer than seven of the Centers of Excellence designated under this section have a genitourinary program. (5) Effective on the date of the enactment of this section, the following medical facilities shall be designated as Centers of Excellence for the Program: (A) The Seattle VA Medical Center in Seattle, Washington. (B) The James J. Peters VA Medical Center in the Bronx, New York. (C) The Lieutenant Colonel Charles S. Kettles VA Medical Center in Ann Arbor, Michigan. (D) The Margaret Cochran Corbin Manhattan VA Medical Center in Manhattan, New York. (E) The Jesse Brown Department of Veterans Affairs Medical Center in Chicago, Illinois. (F) The West Los Angeles VA Medical Center in Los Angeles, California. (G) The Corporal Michael J. Crescenz VA Medical Center in Philadelphia, Pennsylvania. (H) The Durham VA Medical Center in Durham, North Carolina. (I) The Washington DC VA Medical Center in Washington, District of Columbia. (J) The James A. Haley Veterans Hospital in Tampa, Florida. (K) The Portland VA Medical Center in Portland, Oregon. (L) The Jamaica Plain VA Medical Center in Boston, Massachusetts. (M) The San Francisco VA Medical Center in San Francisco, California. (N) The Michael E. DeBakey Department of Veterans Affairs Medical Center in Houston, Texas. (O) The Rocky Mountain Regional VA Medical Center in Aurora, Colorado. (P) The John J. Cochran Veterans Hospital in St. Louis, Missouri. (Q) The Kansas City VA Medical Center in Kansas City, Missouri. (R) The Joseph Maxwell Cleland Atlanta VA Medical Center in Decatur, Georgia. (S) The Ralph H. Johnson VA Medical Center in Charleston, South Carolina. (T) The Orlando VA Medical Center in Orlando, Florida. (U) The Baltimore VA Medical Center in Baltimore, Maryland. (V) The John L. McClellan Memorial Veterans’ Hospital in Little Rock, Arkansas. (W) The William S. Middleton Memorial Veterans Hospital in Madison, Wisconsin. (X) The Minneapolis VA Medical Center in Minneapolis, Minnesota. (Y) The George E. Wahlen Department of Veterans Affairs Medical Center in Salt Lake City, Utah. (Z) The Carl T. Hayden Veterans’ Administration Medical Center in Phoenix, Arizona. (AA) The Dallas VA Medical Center in Dallas, Texas. (BB) The Malcom Randall Department of Veterans Affairs Medical Center in Gainesville, Florida. (6) For purposes of complying with the minimum number of Centers of Excellence under paragraph (2), the Secretary shall count any towards the minimum number any medical facility designated under paragraph (5) and not terminated under subsection (e). (e)

Termination of Designation

(1) Each Center of Excellence designated under subsection (d) shall remain so designated for not less than five years, unless the Secretary terminates such designation in accordance with this subsection. (2) Not earlier than January 1, 2030, the Secretary may terminate the designation of a medical facility as a Center of Excellence under this section if the Secretary determines the facility is failing to meet the requirements in subsection (c). (3) Before terminating the designation of a medical facility, the Secretary shall— (A) submit to the Committees on Veterans’ Affairs and the Committees on Appropriations of the House of Representatives and the Senate a notice of the intent to terminate such designation; and (B) wait for a period of 60 days following the date of the submission of such notice. (f)

Performance review

(1) In 2030 and each year thereafter, the Secretary shall review the performance of not more than seven Centers of Excellence. (2) The Secretary shall ensure that the performance of each Center of Excellence is reviewed only once in a five year period. (3) By the date of the submission of the annual report described in subsection (f) in 2035 and every fifth year thereafter, the Secretary shall ensure the performance of each Center of Excellence has been reviewed. (4) Each performance review under this subsection shall assess whether the performance of the Center of Excellence in providing the services required under subsection (c) is adequate to justify the continued designation of the facility as a Center of Excellence under this section. (g)

Program Leadership team

(1) The Secretary shall establish a Program Leadership team located at the Seattle VA Medical Center in Seattle, Washington, which shall remain designated as a Center of Excellence until at least 2033. (2) If the Secretary terminates the designation of the Seattle VA Medical Center in Seattle, Washington, as a Center of Excellence under subsection (e), the Secretary shall select another Center to serve as the location of the Program Leadership team. (3) The Program Leadership team shall include, at a minimum, an Executive Director, a Clinical Director, and a Research Director, who shall be employees of the medical center at which the Program Leadership team is located. (4) The Program Leadership team shall— (A) provide strategic liaison services with sponsors and prospective sponsors of clinical trials to ensure engagement by the Department with study design and participation; (B) coordinate participation by the Department in prostate cancer group studies sponsored by the National Cancer Institute; (C) facilitate the development of study concepts, designs, and start-up with researchers of the Department with limited clinical trial experience; (D) create and execute a model for hybrid decentralized clinical trials to be used by Centers of Excellence when conducting trials, including remote research coordination, regulatory start-up and maintenance, data management, and Institutional Review Board approval; (E) create and maintain a publicly available prostate cancer registry and data repository of the Department; (F) establish and maintain relevant working groups of experts of the Department; (G) host at least monthly calls and at least three in-person meetings per year with a representative of each Center for Excellence to assess progress; and (H) develop a uniform genetic sequencing platform to be implemented by each Center of Excellence to allow for coordination among such Centers. (5) The Executive Director shall— (A) provide administrative leadership to the Program in partnership with the Clinical Director; (B) develop, execute, and monitor a national strategic plan for the Program; and (C) serve as the liaison to leadership of the Department and Centers of Excellence. (6) The Clinical Director shall— (A) oversee the Program to ensure eligible veterans receive access to care based on the latest research; (B) develop and implement strategies for Program growth, quality improvement, and patient satisfaction; (C) serve on the review committee of the Program for clinical trials conducted by Centers of Excellence to ensure studies are conducted ethically and efficiently; and (D) serve as the liaison with stakeholders to integrate clinical services and research. (7) The Research Director shall— (A) provide leadership on national research objectives; (B) serve on committees to review new research concepts and projects developed by Centers of Excellence; (C) maintain an understanding of current research and emerging technologies in prostate cancer; and (D) interact with stakeholders, including regulatory agencies, study sponsors, and research institutions, to improve prostate cancer research conducted by the Department. (h)

Annual Report

(1) Not later than March 1 of each year, the Secretary shall submit to the Committees on Veterans’ Affairs and the Committees on Appropriations of the House of Representatives and the Senate a report on the Program. Each such report shall include, for the year covered by the report— (A) the funding levels for each Center of Excellence; (B) the number of veterans participating the Program; (C) the number of researchers and providers participating in the Program; (D) the number of publications relating to prostate cancer by researchers and providers of the Department; (E) the number of clinical research studies supported by the Program; (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; (H) the five-year survival rate of veterans with non-prostate genitourinary cancers enrolled in clinical research studies of the Program at genitourinary centers compared to that of other veterans and civilians with non-prostate genitourinary cancers; and (I) an estimate of (A) through (G) for the upcoming year. (2) In 2029, the report required in this subsection shall include a comprehensive plan for the designation and operation of the Centers of Excellence under this section, including a timeline for the performance evaluations, performance criteria to be used in evaluations, and the process for selecting Centers. (3) In 2031 and each year thereafter, the report required in this subsection shall include, for the year covered by the report, the results of the performance reviews conducted under subsection (f) and a determination by the Secretary regarding whether each Center of Excellence reviewed that year meets the criteria for continued designation as a Center of Excellence. (i)

Authorization of appropriations

There is authorized to be appropriated $15,500,000 for each of fiscal years 2027 through 2029 to the Secretary to carry out this section.

(b)

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.

(c)

Functions and funding of Centers of Excellence

(1)

Functions

The Secretary of Veterans Affairs may not remove from any medical facility designated as a Center of Excellence under section 7330D of title 38, United States Code, any staff, program, or function relating to prostate cancer that was in effect on January 1, 2023, until January 1, 2030. (2)

Funding

The Secretary of Veterans Affairs may not reduce funding provided to such Centers of Excellence below the total amount provided by public and private sources in effect on January 1, 2023, until January 1, 2030. (d)

Deadline

The program required by section 7330E of title 38, United States Code, as added by subsection (a), shall be established by not later than 180 days after the date of the enactment of this Act.