,,ii #aaith ,,congress #b;d ,session ,s4 #diic ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,july #ae1 #bjbf,mr4 ,moran introduced the following bill2 which was read twice and referred to the ,committee on ,veterans' ,affairs ,a ,,bill ,to direct the ,secretary of ,veterans ,affairs to establish a precision oncology program for cancer of the prostate at the ,department of ,veterans ,affairs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,precision ,oncology ,program for ,cancer of the ,prostate ,authorization ,act of #bjbf or the ,p,o,p,ca,p ,act of #bjbf4 #b4 ,establishment of precision oncology program for cancer of the prostate 7a7 ,establishment of program 7#a7 ,in general ,subchapter ,,ii of chapter #gc of title #ch1 ,united ,states ,code1 is amended by adding at the end the following new section3 #gccj;,e4 ,precision oncology program for cancer of the prostate 7a7 ,establishment ,the ,secretary shall establish within the ,department a precision oncology program for cancer of the prostate in accordance with this section 7in this section referred to as the ,program74 7b7 ,eligibility ,a veteran is eligible to participate in the ,program if the veteran has a diagnosis of prostate cancer4 7c7 ,centers of excellence 7#a7 ,designation of centers ,effective on the date of the enactment of this section1 the ,secretary shall designate the following medical facilities of the ,department as provisional centers of excellence for the ,program3 7,a7 ,the ,seattle ,,va ,medical ,center1 ,seattle1 ,washington4 7,b7 ,the ,james ,j4 ,peters ,,va ,medical ,center1 ,bronx1 ,new ,york4 7,c7 ,the ,lieutenant ,colonel ,charles ,s4 ,kettles ,,va ,medical ,center1 ,ann ,arbor1 ,michigan4 7,d7 ,the ,margaret ,cochran ,corbin ,manhattan ,,va ,medical ,center1 ,manhattan1 ,new ,york4 7,e7 ,the ,jesse ,brown ,department of ,veterans ,affairs ,medical ,center1 ,chicago1 ,illinois4 7,f7 ,the ,west ,los ,angeles ,,va ,medical ,center1 ,los ,angeles1 ,california4 7,g7 ,the ,corporal ,michael ,j4 ,crescenz ,,va ,medical ,center1 ,philadelphia1 ,pennsylvania4 7,h7 ,the ,durham ,,va ,medical ,center1 ,durham1 ,north ,carolina4 7,i7 ,the ,washington ,,dc ,,va ,medical ,center1 ,washington1 ,district of ,columbia4 7,j7 ,the ,james ,a4 ,haley ,veterans ,hospital1 ,tampa1 ,florida4 7,k7 ,the ,portland ,,va ,medical ,center1 ,portland1 ,oregon4 7,l7 ,the ,jamaica ,plain ,,va ,medical ,center1 ,boston1 ,massachusetts4 7,m7 ,the ,san ,francisco ,,va ,medical ,center1 ,san ,francisco1 ,california4 7,n7 ,the ,michael ,e4 ,de,bakey ,department of ,veterans ,affairs ,medical ,center1 ,houston1 ,texas4 7,o7 ,the ,rocky ,mountain ,regional ,,va ,medical ,center1 ,aurora1 ,colorado4 7,p7 ,the ,john ,j4 ,cochran ,veterans ,hospital1 ,st4 ,louis1 ,missouri4 7,q7 ,the ,kansas ,city ,,va ,medical ,center1 ,kansas ,city1 ,missouri4 7,r7 ,the ,joseph ,maxwell ,cleland ,atlanta ,,va ,medical ,center1 ,decatur1 ,georgia4 7,s7 ,the ,ralph ,h4 ,johnson ,,va ,medical ,center1 ,charleston1 ,south ,carolina4 7,t7 ,the ,orlando ,,va ,medical ,center1 ,orlando1 ,florida4 7,u7 ,the ,baltimore ,,va ,medical ,center1 ,baltimore1 ,maryland4 7,v7 ,the ,john ,l4 ,mc,clellan ,memorial ,veterans' ,hospital1 ,little ,rock1 ,arkansas4 7,w7 ,the ,william ,s4 ,middleton ,memorial ,veterans ,hospital1 ,madison1 ,wisconsin4 7,x7 ,the ,minneapolis ,,va ,medical ,center1 ,minneapolis1 ,minnesota4 7,y7 ,the ,george ,e4 ,wahlen ,department of ,veterans ,affairs ,medical ,center1 ,salt ,lake ,city1 ,utah4 7,z7 ,the ,carl ,t4 ,hayden ,veterans' ,administration ,medical ,center1 ,phoenix1 ,arizona4 7,,aa7 ,the ,dallas ,,va ,medical ,center1 ,dallas1 ,texas4 7,,bb7 ,the ,malcom ,randall ,department of ,veterans ,affairs ,medical ,center1 ,gainesville1 ,florida4 7#b7 ,operational requirements 7,a7 ,minimum number of centers ,the ,secretary shall ensure that1 at all times1 not fewer than #ba medical facilities of the ,department are designated and operating as centers of excellence under the ,program1 with not fewer than one center maintained in each ,veterans ,integrated ,service ,network4 7,b7 ,duration of secretarial designation ,subject to paragraph 7#c71 each center designated under this section shall be so designated for a period of not less than five years4 7#c7 ,additional designations 7,a7 ,in general ,the ,secretary may designate medical facilities as centers of excellence in addition to those designated under paragraph 7#a74 7,b7 ,protection of initial centers ,for purposes of complying with the minimum number of designated centers of excellence requirement under paragraph 7#b71 the ,secretary shall count toward such minimum number any medical facilities designated pursuant to paragraph 7#a7 and not terminated under paragraph 7#d74 7#d7 ,termination of designation 7,a7 ,in general ,beginning not earlier than ,january #a1 #bjcj1 the ,secretary may terminate the designation of a medical facility as a center of excellence under the ,program if the ,secretary determines the facility is failing to serve the purposes of the ,program required by this section4 7,b7 ,process ,the ,secretary-- 7i7 before terminating a designation under subparagraph 7,a71 shall submit to the ,committee on ,veterans' ,affairs and the ,committee on ,appropriations of the ,senate and the ,committee on ,veterans' ,affairs and the ,committee on ,appropriations of the ,house of ,representatives a notice of the intent to terminate the designation2 and 7ii7 may not terminate the designation until the date that is #fj days after the date of the submission of such notice4 7#e7 ,performance reviews 7,a7 ,in general ,beginning in #bjcj1 the ,secretary shall conduct reviews of the performance of the centers of excellence designated under the ,program4 7,b7 ,rolling cycle ,in carrying out subparagraph 7,a71 the ,secretary shall ensure that-- 7i7 in #bjcj and each year thereafter1 the ,secretary reviews and makes a determination on not more than seven centers2 7ii7 the centers selected for review in any given year constitute a class of centers distinct from the classes reviewed in the preceding four years2 and 7iii7 not later than the date of the submission of the fifth annual report under subsection 7f7 following the initial conduct of reviews under this paragraph1 and not later than every fifth year thereafter1 every center operating under the ,program has been reviewed4 7,c7 ,scope of review ,each review of a center under this paragraph shall assess whether the performance of the center in providing the services required under this section is adequate to justify the continued designation of the center as a center of excellence under the ,program4 7d7 ,activities and staffing of centers 7#a7 ,activities ,each center designated under subsection 7c7 shall carry out the following activities3 7,a7 ,establishing a program of genetic sequencing for veterans with advanced prostate cancer4 7,b7 ,instituting a uniform genetic sequencing platform to allow for coordination across all centers4 7,c7 ,participating in the telemedicine tumor board of the ,program4 7,d7 ,participating in the registry study of the ,program to track mutations4 7,e7 ,providing travel support to veterans with mutations to facilitate access to studies4 7,f7 ,developing clinical trials that are biomarker specific4 7,g7 ,participating in industry-sponsored precision oncology studies4 7,h7 ,participating in monthly calls and not less than three in-person meetings per year with the ,program ,leadership team established under subsection 7e7 to assess progress4 7,i7 ,providing ongoing reporting to the ,program ,leadership team regarding trial accruals and research conducted by investigators of the ,department with limited experience who are undergoing mentorship4 7,j7 ,establishing metastasis biopsy capability4 7,k7 ,extending resources to affiliated centers in the ,veterans ,integrated ,service ,network in which the center is located4 7#b7 ,staffing ,the ,secretary shall ensure that each center designated under subsection 7c7 employs1 at a minimum-- 7,a7 a medical oncologist2 7,b7 an interventional radiologist2 7,c7 a urologist2 7,d7 a radiation oncologist2 7,e7 a pathologist2 and 7,f7 two full-time equivalent research staff members4 7e7 ,program leadership 7#a7 ,in general ,the ,secretary shall establish a ,program ,leadership team located at the medical facility designated under subsection 7c77#a77;,a7 7in this section referred to as the ,program ,leadership team74 7#b7 ,composition ,the ,program ,leadership team shall include1 at a minimum1 an ,executive ,director1 a ,clinical ,director1 and a ,research ,director4 7#c7 ,duties ,the ,program ,leadership team shall be responsible for-- 7,a7 providing strategic liaison services with industry to ensure engagement by the ,department with study design and participation2 7,b7 coordinating participation by the ,department in prostate cancer group studies sponsored by the ,national ,cancer ,institute2 7,c7 facilitating the development of study concepts1 design1 and start-up with investigators of the ,department with limited experience who are undergoing mentorship2 7,d7 creating and executing a model for hybrid decentralized clinical trials1 including remote research coordination1 regulatory start-up and maintenance1 data management1 and approval by an institutional review board2 7,e7 creating and maintaining a prostate cancer registry and data repository of the ,department2 and 7,f7 maintaining relevant working groups to bring together expertise of the ,department from across the country4 7#d7 ,specific responsibilities 7,a7 ,executive director ,the ,executive ,director of the ,program ,leadership team shall-- 7i7 provide administrative leadership to the ,program network in partnership with the ,clinical ,director2 7ii7 maintain responsibility for the development1 execution1 and monitoring of the national strategic plan of the ,program2 and 7iii7 serve as the liaison to the executive steering committee and other leadership of the ,department and centers of excellence4 7,b7 ,clinical director ,the ,clinical ,director of the ,program ,leadership team shall-- 7i7 oversee the ,program network to ensure eligible veterans receive access to care based on the latest research2 7ii7 maintain responsibility for the development and implementation of strategies for program growth1 quality improvement1 and patient satisfaction2 7iii7 serve on the review committee of the ,program for clinical trials to ensure studies are conducted ethically and efficiently2 and 7iv7 serve as the liaison with stakeholders to integrate clinical services and research4 7,c7 ,research director ,the ,research ,director of the ,program ,leadership team shall-- 7i7 provide leadership on national research objectives2 7ii7 serve on committees to review new research concepts and projects in the ,program network2 7iii7 maintain a deep understanding of current research and emerging technologies in prostate cancer2 and 7iv7 interact with stakeholders1 including regulatory agencies1 industry partners1 and research institutions1 to improve prostate cancer research within the ,department4 7f7 ,annual report 7#a7 ,in general ,not later than ,march #a of each year1 the ,secretary shall submit to the ,committee on ,veterans' ,affairs and the ,committee on ,appropriations of the ,senate and the ,committee on ,veterans' ,affairs and the ,committee on ,appropriations of the ,house of ,representatives a report on the ,program4 7#b7 ,elements ,each report submitted under paragraph 7#a7 shall include1 with respect to the period covered by the report1 the following3 7,a7 ,the funding levels for each center of excellent designated under the ,program2 7,b7 ,the number of veterans served by the ,program2 7,c7 ,the number of investigators and providers participating in the ,program network2 7,d7 ,the number of publications by providers of the ,department relating to prostate cancer2 7,e7 ,the number of clinical research studies supported by the network2 7,f7 ,the number of veterans enrolled in such clinical research studies2 7,g7 ,the five-year survival rate of veterans enrolled in clinical research studies of the ,program compared to other veterans and civilians with prostate cancer2 and 7,h7 ,the outcomes and survival data for veterans served at dedicated genitourinary centers under the ,program compared to that of other veterans and civilians served at other centers of excellence under the ,program4 7#c7 ,comprehensive plan ,the ,secretary shall include in the report submitted under paragraph 7#a7 in #bjbi1 a comprehensive plan for the designation and operation of the centers of excellence under subsection 7c77#b77;,a71 including a timeline for center evaluations1 performance criteria to be utilized in evaluations1 and center selection process4 7#d7 ,performance review findings ,beginning with the report submitted under paragraph 7#a7 in #bjca1 and all subsequent such reports1 the ,secretary shall include results of the performance reviews conducted pursuant to subsection 7c77#e71 including a determination by the ,secretary regarding whether the results of such review for each center justifies continued designation as a center of excellence4 7#e7 ,forecast ,each report submitted under paragraph 7#a7 shall include forecasts of the matter described in paragraph 7#a77;,a7 for the upcoming review period4 4 7#b7 ,clerical amendment ,the table of sections at the beginning of such chapter is amended by inserting after the item relating to section #gccj;,d the following new item3 #gccj;,e4 ,precision oncology program for cancer of the prostate4 4 7b7 ,establishment1 designation1 and operation 7#a7 ,in general ,the ,secretary of ,veterans ,affairs shall establish the program required under section #gccj;,e of title #ch1 ,united ,states ,code1 as added by subsection 7a77#a71 including the designation of program leadership under subsection 7e7 of such section and the designation and operation of the centers of excellence under subsection 7c7 of such section1 by not later than ,january #a1 #bjbg4 7#b7 ,terms and conditions ,the designation and operation of the centers of excellence described in paragraph 7#a7 shall be conducted under the same terms and conditions and in the same manner as those centers were designated and operated on ,january #a1 #bjbc4 7c7 ,implementation plan 7#a7 ,in general ,not later than #ahj days after the date of the enactment of this ,act1 the ,secretary of ,veterans ,affairs shall submit to the ,committee on ,veterans' ,affairs and the ,committee on ,appropriations of the ,senate and the ,committee on ,veterans' ,affairs and the ,committee on ,appropriations of the ,house of ,representatives a plan for the implementation of section #gccj;,e of title #ch1 ,united ,states ,code1 as added by subsection 7a77#a74 7#b7 ,elements ,the plan required by paragraph 7#a7 shall include-- 7,a7 an assessment of staffing required at each center of excellence designated under section #gccj;,e7c7 of title #ch1 ,united ,states ,code1 as added by subsection 7a77#a72 7,b7 an identification of contracting requirements2 7,c7 a plan for sequencing platform selection2 7,d7 a plan for registry creation2 7,e7 a plan for coordination with a central institutional review board2 and 7,f7 an identification of anticipated funding levels for the #aj-year period beginning on the date of the submittal of the plan4 7d7 ,authorization of appropriations ,there is authorized to be appropriated to the ,secretary of ,veterans ,affairs to carry out section #gccj;,e of title #ch1 ,united ,states ,code1 as added by subsection 7a77#a71 #ae1ejj1jjj for each of fiscal years #bjbg through #bjbi4