,,ii #aacth ,,congress #ast ,session ,s4 #eaf ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,march #aa1 #bjac ,mr4 ,tester 7for himself and ,mr4 ,blunt7 introduced the following bill2 which was read twice and referred to the ,committee on ,health1 ,education1 ,labor1 and ,pensions ,a ,,bill ,to reduce disparities and improve access to effective and cost efficient diagnosis and treatment of prostate cancer through advances in testing1 research1 and education1 including through telehealth1 comparative effectiveness research1 and identification of best practices in patient education and outreach particularly with respect to underserved racial1 ethnic and rural populations and men with a family history of prostate cancer1 to establish a directive on what constitutes clinically appropriate prostate cancer imaging1 and to create a prostate cancer scientific advisory board for the ,office of the ,chief ,scientist at the ,food and ,drug ,administration to accelerate real-time sharing of the latest research and accelerate movement of new medicines to patients4 #a4 ,short ,title ,this ,act may be cited as the ,prostate ,research1 ,outreach1 ,screening1 ,testing1 ,access1 and ,treatment ,effectiveness ,act of #bjac or the ,,prostate ,act4 #b4 ,findings ,congress makes the following findings3 7#a7 ,prostate cancer is the second leading cause of cancer death among men4 7#b7 ,in #bjaj1 more than #bag1gcj new patients were diagnosed with prostate cancer and more than #cb1jjj men died from this disease4 7#c7 ,roughly #b1jjj1jjj ,americans are living with a diagnosis of prostate cancer and its consequences4 7#d7 ,while prostate cancer generally affects older individuals1 younger men are also at risk for the disease1 and when prostate cancer appears in early middle age it frequently takes on a more aggressive form4 7#e7 ,there are significant racial and ethnic disparities that demand attention1 namely ,african-,americans have prostate cancer mortality rates that are more than double those in the ,white population4 7#f7 ,underserved rural populations have higher rates of mortality compared to their urban counterparts1 and innovative and cost-efficient methods to improve rural access to high quality care should take advantage of advances in telehealth to diagnose and treat prostate cancer when appropriate4 7#g7 ,certain veterans populations may have nearly twice the incidence of prostate cancer as the general population of the ,united ,states4 7#h7 ,urologists may constitute the specialists who diagnose and treat the vast majority of prostate cancer patients4 7#i7 ,although much basic and translational research has been completed and much is currently known1 there are still many unanswered questions4 ,for example1 it is not fully understood how much of known disparities are attributable to disease etiology1 access to care1 or education and awareness in the community4 7#aj7 ,causes of prostate cancer are not known4 ,there is not good information regarding how to differentiate accurately1 early on1 between aggressive and indolent forms of the disease4 ,as a result1 there is significant overtreatment in prostate cancer4 ,there are no treatments that can durably arrest growth or cure prostate cancer once it has metastasized4 7#aa7 ,a significant proportion 7roughly #bc to #ed percent7 of cases may be clinically indolent and overdiagnosed1 resulting in significant overtreatment4 ,more accurate tests will allow men and their families to face less physical1 psychological1 financial1 and emotional trauma and billions of dollars could be saved in private and public health care systems in an area that has been identified by the ,medicare program as one of eight high volume1 high cost areas in the ,resource ,utilization ,report program authorized by ,congress under the ,medicare ,improvements for ,patients and ,providers ,act of #bjjh4 7#ab7 ,prostate cancer research and health care programs across ,federal agencies should be coordinated to improve accountability and actively encourage the translation of research into practice1 to identify and implement best practices1 in order to foster an integrated and consistent focus on effective prevention1 diagnosis1 and treatment of this disease4 #c4 ,prostate cancer coordination and education 7a7 ,interagency prostate cancer coordination and education task force ,not later than #ahj days after the date of the enactment of this section1 the ,secretary of ,veterans ,affairs1 in cooperation with the ,secretary of ,defense and the ,secretary of ,health and ,human ,services1 shall establish an ,interagency ,prostate ,cancer ,coordination and ,education ,task ,force 7in this section referred to as the ,prostate ,cancer ,task ,force74 7b7 ,duties ,the ,prostate ,cancer ,task ,force shall-- 7#a7 develop a summary of advances in prostate cancer research supported or conducted by ,federal agencies relevant to the diagnosis1 prevention1 and treatment of prostate cancer1 including psychosocial impairments related to prostate cancer treatment1 and compile a list of best practices that warrant broader adoption in health care programs2 7#b7 consider establishing1 and advocating for1 a guidance to enable physicians to allow screening of men who are over age #gd1 on a case-by-case basis1 taking into account quality of life and family history of prostate cancer2 7#c7 share and coordinate information on ,federal research and health care program activities1 including activities related to-- 7,a7 determining how to improve research and health care programs1 including psychosocial impairments related to prostate cancer treatment2 7,b7 identifying any gaps in the overall research inventory and in health care programs2 7,c7 identifying opportunities to promote translation of research into practice2 and 7,d7 maximizing the effects of ,federal efforts by identifying opportunities for collaboration and leveraging of resources in research and health care programs that serve those susceptible to or diagnosed with prostate cancer2 7#d7 develop a comprehensive interagency strategy and advise relevant ,federal agencies in the solicitation of proposals for collaborative1 multidisciplinary research and health care programs1 including proposals to evaluate factors that may be related to the etiology of prostate cancer1 that would-- 7,a7 result in innovative approaches to study emerging scientific opportunities or eliminate knowledge gaps in research to improve the prostate cancer research portfolio of the ,federal ,government2 7,b7 outline key research questions1 methodologies1 and knowledge gaps2 and 7,c7 ensure consistent action1 as outlined by section #djb7;b7 of the ,public ,health ,service ,act2 7#e7 develop a coordinated message related to screening and treatment for prostate cancer to be reflected in educational and beneficiary materials for ,federal health programs as such documents are updated2 and 7#f7 not later than two years after the date of the establishment of the ,prostate ,cancer ,task ,force1 submit to the ,expert ,advisory ,panel to be reviewed and returned within #cj days1 and then within #ij days submitted to ,congress recommendations-- 7,a7 regarding any appropriate changes to research and health care programs1 including recommendations to improve the research portfolio of the ,department of ,veterans ,affairs1 ,department of ,defense1 ,national ,institutes of ,health1 and other ,federal agencies to ensure that scientifically based strategic planning is implemented in support of research and health care program priorities2 7,b7 designed to ensure that the research and health care programs and activities of the ,department of ,veterans ,affairs1 the ,department of ,defense1 the ,department of ,health and ,human ,services1 and other ,federal agencies are free of unnecessary duplication2 7,c7 regarding public participation in decisions relating to prostate cancer research and health care programs to increase the involvement of patient advocates1 community organizations1 and medical associations representing a broad geographical area2 7,d7 on how to best disseminate information on prostate cancer research and progress achieved by health care programs2 7,e7 about how to expand partnerships between public entities1 including ,federal agencies1 and private entities to encourage collaborative1 cross-cutting research and health care delivery2 7,f7 assessing any cost savings and efficiencies realized through the efforts identified and supported in this ,act and recommending expansion of those efforts that have proved most promising while also ensuring against any conflicts in directives from other congressional or statutory mandates or enabling statutes2 7,g7 identifying key priority action items from among the recommendations2 and 7,h7 with respect to the level of funding needed by each agency to implement the recommendations contained in the report4 7c7 ,members of the ,prostate ,cancer ,task ,force ,the ,prostate ,cancer ,task ,force described in subsection 7a7 shall be composed of representatives from such ,federal agencies1 as each ,secretary determines necessary1 to coordinate a uniform message relating to prostate cancer screening and treatment where appropriate1 including representatives of the following3 7#a7 ,the ,department of ,veterans ,affairs1 including representatives of each relevant program areas of the ,department of ,veterans ,affairs4 7#b7 ,the ,prostate ,cancer ,research ,program of the ,congressionally ,directed ,medical ,research ,program of the ,department of ,defense4 7#c7 ,the ,department of ,health and ,human ,services1 including at a minimum representatives of the following3 7,a7 ,the ,national ,institutes of ,health4 7,b7 ,national research institutes and centers1 including the ,national ,cancer ,institute1 the ,national ,institute of ,allergy and ,infectious ,diseases1 and the ,office of ,minority ,health4 7,c7 ,the ,centers for ,medicare ,medicaid ,services4 7,d7 ,the ,food and ,drug ,administration4 7,e7 ,the ,centers for ,disease ,control and ,prevention4 7,f7 ,the ,agency for ,healthcare ,research and ,quality4 7,g7 ,the ,health ,resources and ,services ,administration4 7d7 ,appointing expert advisory panels ,the ,prostate ,cancer ,task ,force shall appoint expert advisory panels1 as determined appropriate1 to provide input and concurrence from individuals and organizations from the medical1 prostate cancer patient and advocate1 research1 and delivery communities with expertise in prostate cancer diagnosis1 treatment1 and research1 including practicing urologists1 primary care providers1 and others and individuals with expertise in education and outreach to underserved populations affected by prostate cancer4 7e7 ,meetings ,the ,prostate ,cancer ,task ,force shall convene not less than twice a year1 or more frequently as the ,secretary determines to be appropriate4 7f7 ,submittal of recommendations to ,congress ,the ,secretary of ,veterans ,affairs shall submit to ,congress any recommendations submitted to the ,secretary under subsection 7b77#e74 7g7 ,federal ,advisory ,committee ,act 7#a7 ,in general ,except as provided in paragraph 7#b71 the ,federal ,advisory ,committee ,act 7#e ,u4,s4,c4 ,app47 shall apply to the ,prostate ,cancer ,task ,force4 7#b7 ,exception ,section #ad7;a77#b77;,b7 of such ,act 7relating to the termination of advisory committees7 shall not apply to the ,prostate ,cancer ,task ,force4 7h7 ,sunset ,date ,the ,prostate ,cancer ,task ,force shall terminate at the end of fiscal year #bjaf4 #d4 ,prostate cancer research 7a7 ,research coordination ,the ,secretary of ,veterans ,affairs1 in coordination with the ,secretaries of ,defense and of ,health and ,human ,services1 shall establish and carry out a program to coordinate and intensify prostate cancer research as needed4 ,specifically1 such research program shall-- 7#a7 develop advances in diagnostic and prognostic methods and tests1 including biomarkers and an improved prostate cancer screening blood test1 including improvements or alternatives to the prostate specific antigen test and additional tests to distinguish indolent from aggressive disease2 7#b7 better understand the etiology of the disease 7including an analysis of life style factors proven to be involved in higher rates of prostate cancer1 such as obesity and diet1 and in different ethnic1 racial1 and socioeconomic groups1 such as the ,african-,american1 ,latin ,american1 and ,american ,indian populations and men with a family history of prostate cancer7 to improve prevention efforts2 7#c7 expand basic research into prostate cancer1 including studies of fundamental molecular and cellular mechanisms2 7#d7 identify and provide clinical testing of novel agents for the prevention and treatment of prostate cancer2 7#e7 establish clinical registries for prostate cancer2 7#f7 use the ,national ,institute of ,biomedical ,imaging and ,bioengineering and the ,national ,cancer ,institute for assessment of appropriate imaging modalities2 and 7#g7 address such other matters relating to prostate cancer research as may be identified by the ,federal agencies participating in the program under this section4 7b7 ,prostate ,cancer ,advisory ,board ,there is established in the ,office of the ,chief ,scientist of the ,food and ,drug ,administration a ,prostate ,cancer ,scientific ,advisory ,board4 ,such board shall be responsible for accelerating real-time sharing of the latest research data and accelerating movement of new medicines to patients4 7c7 ,underserved minority grant program ,in carrying out such program1 the ,secretary shall-- 7#a7 award grants to eligible entities to carry out components of the research outlined in subsection 7a72 7#b7 integrate and build upon existing knowledge gained from comparative effectiveness research2 and 7#c7 recognize and address-- 7,a7 the racial and ethnic disparities in the incidence and mortality rates of prostate cancer and men with a family history of prostate cancer2 7,b7 any barriers in access to care and participation in clinical trials that are specific to racial1 ethnic1 and other underserved minorities and men with a family history of prostate cancer2 7,c7 needed outreach and educational efforts to raise awareness in these communities2 and 7,d7 appropriate access and utilization of imaging modalities4 #e4 ,telehealth and rural access pilot project 7a7 ,in general ,the ,secretary of ,veterans ,affairs1 the ,secretary of ,defense1 and the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretaries7 shall establish #d-year telehealth pilot projects for the purpose of analyzing the clinical outcomes and cost effectiveness associated with telehealth services in a variety of geographic areas that contain high proportions of medically underserved populations1 including ,african-,americans1 ,latin ,americans1 ,american ,indians1 and those in rural areas4 ,such projects shall promote efficient use of specialist care through better coordination of primary care and physician extender teams in underserved areas and more effectively employ tumor boards to better counsel patients4 7b7 ,eligible entities 7#a7 ,in general ,the ,secretaries shall select eligible entities to participate in the pilot projects under this section4 7#b7 ,priority ,in selecting eligible entities to participate in the pilot projects under this section1 the ,secretaries shall give priority to such entities located in medically underserved areas1 particularly those that include ,african-,americans1 ,latin ,americans1 and facilities of the ,indian ,health ,service1 and those in rural areas4 7c7 ,evaluation ,the ,secretaries shall1 through the pilot projects1 evaluate-- 7#a7 the effective and economic delivery of care in diagnosing and treating prostate cancer with the use of telehealth services in medically underserved and tribal areas including collaborative uses of health professionals and integration of the range of telehealth and other technologies2 7#b7 the effectiveness of improving the capacity of nonmedical providers and nonspecialized medical providers to provide health services for prostate cancer in medically underserved and tribal areas1 including the exploration of innovative medical home models with collaboration between urologists1 other relevant medical specialists1 including oncologists1 radiologists1 and primary care teams and coordination of care through the efficient use of primary care teams and physician extenders2 and 7#c7 the effectiveness of using telehealth services to provide prostate cancer treatment in medically underserved areas1 including the use of tumor boards to facilitate better patient counseling4 7d7 ,report ,not later than #ab months after the completion of the pilot projects under this subsection1 the ,secretaries shall submit to ,congress a report describing the outcomes of such pilot projects1 including any cost savings and efficiencies realized1 and providing recommendations1 if any1 for expanding the use of telehealth services4 #f4 ,education and awareness 7a7 ,in general ,the ,secretary of ,veterans ,affairs shall develop a national education campaign for prostate cancer4 ,such campaign shall involve the use of written educational materials and public service announcements consistent with the findings of the ,prostate ,cancer ,task ,force under section #c1 that are intended to encourage men to seek prostate cancer screening when appropriate4 7b7 ,racial disparities and the population of men with a family history of prostate cancer ,in developing the national campaign under subsection 7a71 the ,secretary shall ensure that such educational materials and public service announcements are more readily available in communities experiencing racial disparities in the incidence and mortality rates of prostate cancer and by men of any race classification with a family history of prostate cancer4 7c7 ,grants ,in carrying out the national campaign under this section1 the ,secretary shall award grants to nonprofit private entities to enable such entities to test alternative outreach and education strategies4 #g4 ,authorization of appropriations 7a7 ,in general ,there is authorized to be appropriated to carry out this ,act for the period of fiscal years #bjad through #bjah an amount equal to the savings described in subsection 7b74 7b7 ,corresponding reduction ,the amount authorized to be appropriated by provisions of law other than this ,act for the period of fiscal years #bjad through #bjah for ,federal research and health care program activities related to prostate cancer is reduced by the amount of ,federal savings projected to be achieved over such period by implementation of section #c7;b77#c7 of this ,act4