[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6092 Introduced in House (IH)]

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116th CONGRESS
  2d Session
                                H. R. 6092

  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.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             March 5, 2020

  Mr. Dunn (for himself and Mr. Cunningham) introduced the following 
     bill; which was 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, access to life-saving extending 
    precision clinical trials and research, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Veteran's Prostate Cancer Treatment 
and Research Act''.

SEC. 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.

SEC. 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 in the National Surgery Office of the 
        Department of Veterans Affairs a national clinical pathway for 
        all stages of prostate cancer, from early detection to end-of-
        life care including recommendations regarding the use of 
        transformative innovations, research, and uniform clinical 
        data.
            (2) Elements.--The national clinical pathway established 
        under this subsection shall include the following elements:
                    (A) A multi-disciplinary plan for the early 
                detection, diagnosis, and treatment of prostate cancer 
                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.
                    (B) A suggested, but not mandatory, protocol for 
                screening, diagnosis, and treatment or care for 
                subpopulations with evidence-based risk factors 
                (including race, ethnicity, socioeconomic status, 
                geographic location, exposure risks, and genetic risks, 
                including family history).
                    (C) A suggested treatment protocol timeframe for 
                each point of care based on severity and stage of 
                cancer.
            (3) Public comment period.--Upon the establishment of a 
        proposed clinical pathway as required under this subsection, 
        the Secretary shall publish the proposed clinical pathway in 
        the Federal Register and provide for a 45-day period for public 
        comments. The Secretary--
                    (A) may make any such public comments publicly 
                available; and
                    (B) make changes to the proposed clinical pathway 
                in response to any such comments received using the 
                same process and criteria used to establish the 
                proposed clinical pathway.
            (4) Collaboration and coordination.--In establishing the 
        clinical pathway required under this section, the Secretary 
        shall--
                    (A) provide for consideration of other clinical 
                pathways and research findings of other departments and 
                agencies, including guidelines that are widely 
                recognized and guidelines that are used as the standard 
                for clinical policy in oncology care, such as National 
                Comprehensive Cancer Network guidelines; and
                    (B) collaborate and coordinate with--
                            (i) the National Institutes of Health;
                            (ii) the National Cancer Institute;
                            (iii) the National Institute on Minority 
                        Health and Health Disparities;
                            (iv) other Institutes and Centers as the 
                        Secretary determines necessary;
                            (v) the Centers for Disease Control and 
                        Prevention;
                            (vi) the Department of Defense;
                            (vii) the Centers for Medicare and Medicaid 
                        Services;
                            (viii) the Patient-Centered Outcomes 
                        Research Institute; and
                            (ix) the Food and Drug Administration.
            (5) Publication.--The Secretary shall--
                    (A) publish the clinical pathway established under 
                this subsection on a publicly available Department 
                website; and
                    (B) regularly 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 National Cancer of the Prostate Clinical Care 
Implementation Program.--
            (1) Establishment.--Not later than 90 days after the date 
        of the enactment of this Act, the Secretary shall submit to 
        Congress a plan to establish a comprehensive prostate cancer 
        program.
            (2) Program requirements.--The comprehensive prostate 
        cancer program shall--
                    (A) be multidisciplinary and include the authority 
                to work across clinical care lines, specialties, and 
                the organizational divisions of the Veterans Health 
                Administration;
                    (B) receive direct oversight from the Deputy 
                Undersecretary for Health of the Department of Veterans 
                Affairs;
                    (C) include a yearly program implementation 
                evaluation to facilitate replication for other disease 
                states or in other healthcare institutions;
                    (D) be metric driven and include the development of 
                quarterly 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;
                    (E) made available as national decision support 
                tools in the electronic medical record;
                    (F) include an education plan for patients and 
                providers; and
                    (G) be funded appropriately to accomplish the 
                objectives of this Act.
            (3) Program implementation evaluation.--The Secretary shall 
        establish a program evaluation tool as an integral component to 
        learn best practices of multidisciplinary disease-based 
        implementation 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 Affairs for supporting prostate cancer research 
        designed to position the Department as a national resource for 
        quality reporting metrics, practice-based evidence, comparative 
        effectiveness, precision oncology, and clinical trials in 
        prostate cancer.
            (5) Prostate cancer real time registry program.--The 
        Secretary, in collaboration with data stewards of the 
        Department of Veterans Affairs, scientists, and the heads of 
        other Departments, agencies, and non-governmental 
        organizations, such as foundations and non-profit organizations 
        focused on prostate cancer research and care, shall establish a 
        real-time, actionable, national prostate cancer registry. Such 
        registry shall be designed--
                    (A) to establish a systematic and standardized 
                database that enables intra-agency collaboration by 
                which to track veteran patient progress, enable 
                population management programs, facilitate best 
                outcomes, and encourage future research and further 
                development of clinical pathways, including patient 
                access to precision resources and treatments and access 
                to life-extending precision clinical trials;
                    (B) to employ novel methods of structuring data, 
                including natural language processing, artificial 
                intelligence, structured data clinical notes, patient 
                reported outcome instruments, and other tools, to 
                ensure that all clinically meaningful data is included; 
                and
                    (C) to be accessible to--
                            (i) clinicians treating veterans diagnosed 
                        with prostate cancer and being treated for 
                        prostate cancer in conjunction with Department 
                        medical facilities; and
                            (ii) researchers.
    (c) Clinical Pathway Defined.--In this section, 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.
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