II 117th CONGRESS 1st Session S. 2720 IN THE SENATE OF THE UNITED STATES September 13, 2021 Mr. Moran (for himself and Mr. Tester ) introduced the following bill; which was read twice and referred to the Committee on Veterans' Affairs A BILL To direct the Secretary of Veterans Affairs to establish a national clinical pathway for prostate cancer, and for other purposes.

1. Short title This Act may be cited as the Veterans’ Prostate Cancer Treatment and Research Act . 2. Findings Congress makes the following findings: (1) Prostate cancer is the number one cancer diagnosed in the Veterans Health Administration. (2) A 1996 report published by the National Academy of Sciences, Engineering, and Medicine established a link between prostate cancer and exposure to herbicides, such as Agent Orange. (3) It is essential to acknowledge that due to these circumstances, certain veterans are made aware that they are high-risk individuals when it comes to the potential to develop prostate cancer. (4) In being designated as high risk , it is essential that veterans are proactive in seeking earlier preventative clinical services for the early detection and successful treatment of prostate cancer, whether that be through the Veterans Health Administration or through a community provider. (5) Clinical preventative services and initial detection are some of the most important components in the early detection of prostate cancer for veterans at high risk of prostate cancer. (6) For veterans with prostate cancer, including prostate cancer that has metastasized, precision oncology, including biomarker-driven clinical trials and innovations underway through the Prostate Cancer Foundation and Department of Veterans Affairs partnership, represents one of the most promising areas of interventions, treatments, and cures for such veterans and their families. 3. Department of Veterans Affairs treatment and research of prostate cancer (a) Establishment of clinical pathway (1) In general Not later than 365 days after the date of the enactment of this Act, the Secretary of Veterans Affairs shall establish an interdisciplinary clinical pathway for all stages of prostate cancer, from early detection to end of life care. The clinical pathway shall be established in the National Surgery Office of the Department of Veterans Affairs in close collaboration with the National Program Office of Oncology, the Office of Research and Development, and other relevant entities of the Department, including Primary Care. (2) Elements The national clinical pathway established under this subsection shall include the following elements: (A) A diagnosis pathway for prostate cancer that includes early screening and diagnosis protocol, including screening recommendations for veterans with evidence-based risk factors. (B) A treatment pathway that details the respective roles of each office of the Department that will interact with veterans receiving prostate cancer care, including treatment protocol recommendations for veterans with evidence-based risk factors. (C) Treatment recommendations for all stages of prostate cancer that reflect nationally recognized standards for oncology, including National Comprehensive Cancer Network guidelines. (D) A suggested protocol timeframe for each point of care, from early screening to treatment and end-of-life care, based on severity and stage of cancer. (E) A plan that includes, as appropriate, both Department medical facilities and community-based partners and providers and research centers specializing in prostate cancer, especially such centers that have entered into partnerships with the Department. (3) Collaboration and coordination In establishing the clinical pathway required under this section, the Secretary may collaborate and coordinate with— (A) the National Institutes of Health; (B) the National Cancer Institute; (C) the National Institute on Minority Health and Health Disparities; (D) the Centers for Disease Control and Prevention; (E) the Centers for Medicare and Medicaid Services; (F) the Patient-Centered Outcomes Research Institute; (G) the Food and Drug Administration; (H) the Department of Defense; and (I) other Institutes and Centers as the Secretary determines necessary. (4) Consultation requirement In establishing the clinical pathway required under this section, the Secretary shall consult with, and incorporate feedback from, veterans who have received prostate cancer care at Department medical facilities as well as experts in multi-disciplinary cancer care and clinical research. (5) Publication The Secretary shall— (A) publish the clinical pathway established under this subsection on a publicly available Department website; and (B) update the clinical pathway as needed by review of the medical literature and available evidence-based guidelines at least annually, in accordance with the criteria under paragraph (2). (b) Development of Comprehensive Prostate Cancer Program and Implementation of the Prostate Cancer Clinical Pathway (1) Establishment Not later than 180 days after the date of the enactment of this Act, the Secretary shall submit to Congress a plan to establish a prostate cancer program using the comprehensive prostate cancer clinical pathway developed under subsection (a). (2) Program requirements The comprehensive prostate cancer program shall— (A) receive direct oversight from the Deputy Undersecretary for Health of the Department of Veterans Affairs; (B) include a yearly program implementation evaluation to facilitate replication for other disease states or in other healthcare institutions; (C) be metric driven and include the development of biannual reports on the quality of prostate cancer care, which shall be provided to the leadership of the Department, medical centers, and providers and made publicly available in an electronic form; and (D) include an education plan for patients and providers. (3) Program implementation evaluation The Secretary shall establish a program evaluation tool to learn best practices and to inform the Department and Congress regarding further use of the disease specific model of care delivery. (4) Prostate cancer research The Secretary shall submit to Congress a plan that provides for continual funding through the Office of Research and Development of the Department of Veterans for supporting prostate cancer research designed to position the Department as a national resource for prostate cancer detection and treatment. Such plan shall— (A) include details regarding the funding of and coordination between the National Precision Oncology Program of the Department and the PCF–VA Precision Oncology Centers of Excellence as related to the requirements of this Act; and (B) affirm that no funding included in such funding plan is duplicative in nature. (c) Report on national registry The Secretary of Veterans Affairs shall submit to Congress a report on the barriers and challenges associated with creating a national prostate cancer registry. Such report shall include recommendations for centralizing data about veterans with prostate cancer for the purpose of improving outcomes and serving as a resource for providers. (d) Definitions In this section: (1) The term clinical pathway means a health care management tool designed around research and evidence-backed practices that provides direction for the clinical care and treatment of a specific episode of a condition or ailment. (2) The term evidence-based risk factors includes race, ethnicity, socioeconomic status, geographic location, exposure risks, genetic risks, including family history, and such other factors as the Secretary determines appropriate.