Veteran’s Prostate Cancer Treatment and Research Act

IIB 116TH CONGRESS 2D SESSION H. R. 6092 IN THE SENATE OF THE UNITED STATES SEPTEMBER 23, 2020 Received; read twice and referred to the Committee on Veterans’ Affairs AN ACT To direct the Secretary of Veterans Affairs to establish a national clinical pathway for prostate cancer, access to life-saving extending precision clinical trials and research, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 2 HR 6092 RFS SECTION 1. SHORT TITLE. 1 This Act may be cited as the ‘‘Veteran’s Prostate 2 Cancer Treatment and Research Act’’. 3 SEC. 2. FINDINGS. 4 Congress makes the following findings: 5 (1) Prostate cancer is the number one cancer 6 diagnosed in the Veterans Health Administration. 7 (2) A 1996 report published by the National 8 Academy of Sciences, Engineering, and Medicine es- 9 tablished a link between prostate cancer and expo- 10 sure to herbicides, such as Agent Orange. 11 (3) It is essential to acknowledge that due to 12 these circumstances, certain veterans are made 13 aware that they are high-risk individuals when it 14 comes to the potential to develop prostate cancer. 15 (4) In being designated as ‘‘high risk’’, it is es- 16 sential that veterans are proactive in seeking earlier 17 preventative clinical services for the early detection 18 and successful treatment of prostate cancer, whether 19 that be through the Veterans Health Administration 20 or through a community provider. 21 (5) Clinical preventative services and initial de- 22 tection are some of the most important components 23 in the early detection of prostate cancer for veterans 24 at high risk of prostate cancer. 25 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 3 HR 6092 RFS (6) For veterans with prostate cancer, including 1 prostate cancer that has metastasized, precision on- 2 cology, including biomarker-driven clinical trials and 3 innovations underway through the Prostate Cancer 4 Foundation and Department of Veterans Affairs 5 partnership, represents one of the most promising 6 areas of interventions, treatments, and cures for 7 such veterans and their families. 8 SEC. 3. DEPARTMENT OF VETERANS AFFAIRS TREATMENT 9 AND RESEARCH OF PROSTATE CANCER. 10 (a) ESTABLISHMENT OF CLINICAL PATHWAY.— 11 (1) IN GENERAL.—Not later than 365 days 12 after the date of the enactment of this Act, the Sec- 13 retary of Veterans Affairs shall establish in the Na- 14 tional Surgery Office of the Department of Veterans 15 Affairs a national clinical pathway for all stages of 16 prostate cancer, from early detection to end-of-life 17 care including recommendations regarding the use of 18 transformative innovations, research, and uniform 19 clinical data. 20 (2) ELEMENTS.—The national clinical pathway 21 established under this subsection shall include the 22 following elements: 23 (A) A multi-disciplinary plan for the early 24 detection, diagnosis, and treatment of prostate 25 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 4 HR 6092 RFS cancer that includes, as appropriate, both De- 1 partment medical facilities and community- 2 based partners and providers and research cen- 3 ters specializing in prostate cancer, especially 4 such centers that have entered into partner- 5 ships with the Department. 6 (B) A suggested, but not mandatory, pro- 7 tocol for screening, diagnosis, and treatment or 8 care for subpopulations with evidence-based risk 9 factors (including race, ethnicity, socioeconomic 10 status, geographic location, exposure risks, and 11 genetic risks, including family history). 12 (C) A suggested treatment protocol time- 13 frame for each point of care based on severity 14 and stage of cancer. 15 (3) PUBLIC COMMENT PERIOD.—Upon the es- 16 tablishment of a proposed clinical pathway as re- 17 quired under this subsection, the Secretary shall 18 publish the proposed clinical pathway in the Federal 19 Register and provide for a 45-day period for public 20 comments. The Secretary— 21 (A) may make any such public comments 22 publicly available; and 23 (B) make changes to the proposed clinical 24 pathway in response to any such comments re- 25 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 5 HR 6092 RFS ceived using the same process and criteria used 1 to establish the proposed clinical pathway. 2 (4) COLLABORATION AND COORDINATION.—In 3 establishing the clinical pathway required under this 4 section, the Secretary shall— 5 (A) provide for consideration of other clin- 6 ical pathways and research findings of other de- 7 partments and agencies, including guidelines 8 that are widely recognized and guidelines that 9 are used as the standard for clinical policy in 10 oncology care, such as National Comprehensive 11 Cancer Network guidelines; and 12 (B) collaborate and coordinate with— 13 (i) the National Institutes of Health; 14 (ii) the National Cancer Institute; 15 (iii) the National Institute on Minor- 16 ity Health and Health Disparities; 17 (iv) other Institutes and Centers as 18 the Secretary determines necessary; 19 (v) the Centers for Disease Control 20 and Prevention; 21 (vi) the Department of Defense; 22 (vii) the Centers for Medicare and 23 Medicaid Services; 24 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 6 HR 6092 RFS (viii) the Patient-Centered Outcomes 1 Research Institute; and 2 (ix) the Food and Drug Administra- 3 tion. 4 (5) PUBLICATION.—The Secretary shall— 5 (A) publish the clinical pathway estab- 6 lished under this subsection on a publicly avail- 7 able Department website; and 8 (B) regularly update the clinical pathway 9 as needed by review of the medical literature 10 and available evidence-based guidelines at least 11 annually, in accordance with the criteria under 12 paragraph (2). 13 (b) DEVELOPMENT OF NATIONAL CANCER OF THE 14 PROSTATE CLINICAL CARE IMPLEMENTATION PRO- 15 GRAM.— 16 (1) ESTABLISHMENT.—Not later than 90 days 17 after the date of the enactment of this Act, the Sec- 18 retary shall submit to Congress a plan to establish 19 a comprehensive prostate cancer program. 20 (2) PROGRAM REQUIREMENTS.—The compre- 21 hensive prostate cancer program shall— 22 (A) be multidisciplinary and include the 23 authority to work across clinical care lines, spe- 24 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 7 HR 6092 RFS cialties, and the organizational divisions of the 1 Veterans Health Administration; 2 (B) receive direct oversight from the Dep- 3 uty Undersecretary for Health of the Depart- 4 ment of Veterans Affairs; 5 (C) include a yearly program implementa- 6 tion evaluation to facilitate replication for other 7 disease states or in other healthcare institu- 8 tions; 9 (D) be metric driven and include the devel- 10 opment of quarterly reports on the quality of 11 prostate cancer care, which shall be provided to 12 the leadership of the Department, medical cen- 13 ters, and providers and made publicly available 14 in an electronic form; 15 (E) made available as national decision 16 support tools in the electronic medical record; 17 and 18 (F) include an education plan for patients 19 and providers. 20 (3) PROGRAM IMPLEMENTATION EVALUA- 21 TION.—The Secretary shall establish a program 22 evaluation tool as an integral component to learn 23 best practices of multidisciplinary disease-based im- 24 plementation and to inform the Department and 25 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 8 HR 6092 RFS Congress regarding further use of the disease spe- 1 cific model of care delivery. 2 (4) PROSTATE CANCER RESEARCH.—The Sec- 3 retary shall submit to Congress a plan that provides 4 for continual funding through the Office of Research 5 and Development of the Department of Veterans Af- 6 fairs for supporting prostate cancer research de- 7 signed to position the Department as a national re- 8 source for quality reporting metrics, practice-based 9 evidence, comparative effectiveness, precision oncol- 10 ogy, and clinical trials in prostate cancer. 11 (5) PROSTATE CANCER REAL TIME REGISTRY 12 PROGRAM.—The Secretary, in collaboration with 13 data stewards of the Department of Veterans Af- 14 fairs, scientists, and the heads of other Depart- 15 ments, agencies, and non-governmental organiza- 16 tions, such as foundations and non-profit organiza- 17 tions focused on prostate cancer research and care, 18 shall establish a real-time, actionable, national pros- 19 tate cancer registry. Such registry shall be de- 20 signed— 21 (A) to establish a systematic and standard- 22 ized database that enables intra-agency collabo- 23 ration by which to track veteran patient 24 progress, enable population management pro- 25 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 9 HR 6092 RFS grams, facilitate best outcomes, and encourage 1 future research and further development of clin- 2 ical pathways, including patient access to preci- 3 sion resources and treatments and access to 4 life-extending precision clinical trials; 5 (B) to employ novel methods of structuring 6 data, including natural language processing, ar- 7 tificial intelligence, structured data clinical 8 notes, patient reported outcome instruments, 9 and other tools, to ensure that all clinically 10 meaningful data is included; and 11 (C) to be accessible to— 12 (i) clinicians treating veterans diag- 13 nosed with prostate cancer and being 14 treated for prostate cancer in conjunction 15 with Department medical facilities; and 16 (ii) researchers. 17 (c) CLINICAL PATHWAY DEFINED.—In this section, 18 the term ‘‘clinical pathway’’ means a health care manage- 19 ment tool designed around research and evidence-backed 20 VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS 10 HR 6092 RFS practices that provides direction for the clinical care and 1 treatment of a specific episode of a condition or ailment. 2 Passed the House of Representatives September 22, 2020. Attest: CHERYL L. JOHNSON, Clerk. VerDate Sep 11 2014 18:09 Sep 24, 2020 Jkt 099200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H6092.RFS H6092 pamtmann on DSKBC07HB2PROD with BILLS