,,ii #aaith ,,congress #b;d ,session ,s4 #ebeh ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,august #e1 #bjbf,mr4 ,cassidy 7for himself and ,ms4 ,murkowski7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xi of the ,social ,security ,act to establish a payment model to reimburse providers for furnishing comprehensive breast cancer risk assessments and developing personalized screening and risk-reduction plans1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,personalized ,risk ,evaluation ,for ,effective ,risk ,reduction and ,early ,detection ,screening ,act or the ,,preferred ,screening ,act4 #b4 ,,cmi model to test reimbursing eligible providers for furnishing comprehensive breast cancer risk assessments and developing personalized screening and risk reduction plans ,section #aaae;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acae;a7 is amended-- 7#a7 in subsection 7b77#b77;,a71 by adding at the end the following new sentence3 ,the models selected under this subparagraph shall include the model described in subsection 7h742 and 7#b7 by adding at the end the following new subsection3 7h7 ,testing reimbursing providers for furnishing comprehensive breast cancer risk assessments and developing personalized screening and risk reduction plans 7#a7 ,purpose and establishment 7,a7 ,in general ,not later than #b years after the date of enactment of this subsection1 the ,secretary shall implement a payment model 7referred to in this subsection as the ,model7 to reimburse eligible providers 7as defined in paragraph 7#aa77 for furnishing comprehensive breast cancer risk assessments to eligible individuals 7as defined in such paragraph71 and for developing personalized screening and risk-reduction plans based on such assessments4 7,b7 ,purpose ,the purpose of the ,model is to test whether reimbursing eligible providers for furnishing comprehensive breast cancer risk assessments and developing personalized screening and risk-reduction plans changes the furnishing of breast cancer screening and risk-reduction services to eligible individuals4 7,c7 ,beginning of ,model ,for purposes of this subsection1 the ,model shall be treated as having begun on the date on which the first eligible individual receives a comprehensive breast cancer risk assessment furnished under the ,model4 7,d7 ,notification requirement if there is a delay ,if the ,model has not begun by the date that is #b years after the date of enactment of this subsection1 the ,secretary shall notify the relevant committees of the reasons for the delay and of the expected date on which the ,model will begin4 7,e7 ,rule of construction ,nothing in this subsection shall be construed to require the ,secretary to establish the clinical efficacy of risk-stratified breast cancer screening4 7#b7 ,comprehensive breast cancer risk assessments and personalized screening and risk-reduction plans 7,a7 ,comprehensive breast cancer risk assessments 7i7 ,in general ,a comprehensive breast cancer risk assessment described in paragraph 7#a7 shall-- 7,i7 collect the information described in clause 7ii72 7,,ii7 using a validated risk model1 produce an estimate of an eligible individual's #e-year risk of developing breast cancer1 supplemented by the results of multigene panel testing and a polygenic risk score2 and 7,,iii7 on the basis of such estimate and the results of multigene panel testing1 assign such eligible individual to a risk category4 ,such risk categories shall include at minimum a high-risk category and an elevated-risk category and be established by the ,secretary4 7ii7 ,information collected ,the information described in this clause1 with respect to an eligible individual1 is-- 7,i7 the results of genetic testing1 including multigene panel testing for the ,,brca#a1 ,,brca#b1 ,,palb#b1 ,,cdh#a1 ,,tp#ec1 ,,pten1 ,,stk#aa1 ,,atm1 and ,,chek#b genes and such other breast cancer susceptibility genes as the ,secretary determines appropriate2 7,,ii7 a polygenic risk score2 7,,iii7 the family history of the eligible individual with respect to breast cancer and related cancers2 7,,iv7 breast density1 as determined under mammographic imaging2 7,v7 clinical and lifestyle risk factors2 and 7,,vi7 such other information as the ,secretary determines appropriate4 7,b7 ,personalized screening and risk-reduction plan ,a personalized screening and risk reduction plan described in paragraph 7#a7 shall include-- 7i7 recommendations regarding-- 7,i7 adjusted cancer screening frequency and modality 7such as mammography1 magnetic resonance imaging 7referred to in this subsection as ,,mri71 and ultrasounds7 based on an individual's risk level2 7,,ii7 referrals for enhanced surveillance imaging1 including breast ,m,r,is1 for high-risk individuals 7as defined in paragraph 7#aa772 7,,iii7 risk reduction counseling on modifiable factors1 such as weight management1 physical activity1 and alcohol consumption2 7,,iv7 counseling for a high-risk individual regarding endocrine risk-reducing medications1 such as tamoxifen1 raloxifene1 and aromatase inhibitors2 7,v7 referrals for genetic counseling following pathogenic1 likely pathogenic1 or uncertain significance findings based on test results2 and 7,,vi7 when such individual should be reassessed based on changes in risk factors1 updated risk models1 or reclassification of genetic variants2 7ii7 notifying first-degree relatives who may benefit from genetic testing2 and 7iii7 communicating the personalized screening and risk-reduction plan to the individual's primary care provider and integrating such plan into the individual's medical record4 7#c7 ,delivery approaches ,the ,secretary shall ensure that the ,model allows eligible providers to furnish comprehensive breast cancer risk assessments through-- 7,a7 traditional in-person office visits2 and 7,b7 remote means1 including allowing such providers to collect genetic testing specimens through kits mailed to an eligible individual's home4 7#d7 ,site selection 7,a7 ,in general ,the ,secretary shall ensure that the eligible providers participating in the ,model include a mix of academic medical centers1 community-based practices1 and facilities serving rural populations4 7,b7 ,application ,an eligible provider seeking to enroll in the ,model shall submit to the ,secretary an application for enrollment containing such requirements1 at such time1 and in such manner1 as specified by the ,secretary4 7,c7 ,selection of eligible providers ,in selecting eligible providers to participate in the ,model1 the ,secretary shall prioritize such providers-- 7i7 located in the #aj ,states with the highest breast cancer mortality rate among women2 7ii7 located in an area designated as a health professional shortage area under section #ccb7;a77#a77;,a7 of the ,public ,health ,service ,act2 7iii7 located in a medically underserved area or that serve medically underserved populations 7as defined in section #ccj7;b77#c7 of such ,act72 or 7iv7 located in a rural area 7as defined in section #ahhf7;d77#b77;,d77 whose population has limited access to genetic counseling services or comprehensive breast cancer risk assessments4 7,d7 ,data sharing ,in selecting eligible providers to participate in the ,model1 the ,secretary may give preference to eligible providers who use laboratories that submit de-identified variant data1 including variants of uncertain significance1 to the ,clin,var public database maintained by the ,national ,center for ,biotechnology ,information4 7#e7 ,payment 7,a7 ,in general ,the ,secretary shall establish a payment amount for the furnishing of a comprehensive breast cancer risk assessment and personalized screening and risk reduction plan under the ,model4 7,b7 ,considerations ,in determining the payment amount described in subparagraph 7,a71 the ,secretary shall consider-- 7i7 the clinical time and complexity of the services furnished2 7ii7 the interpretation of genetic testing results1 polygenic risk scores1 and breast density data2 7iii7 the time required for the development of personalized screening and risk reduction plans2 and 7iv7 comparable comprehensive assessment and prevention-planning services under the physician fee schedule under title ,,xviii4 7,c7 ,adjustment ,the ,secretary may adjust the payment amount established under subparagraph 7,a7 during the period of the ,model on the basis of the evaluation described in paragraph 7#f77;,a77vi74 7#f7 ,evaluation ,the ,secretary shall evaluate the ,model from claims data and from the personalized screening and risk-reduction plans developed under the ,model by the following measures that the ,secretary shall stratify by age band3 7,a7 ,primary measures ,the ,secretary shall evaluate-- 7i7 the proportion of eligible individuals who receive a comprehensive breast cancer risk assessment under the ,model2 7ii7 whether the services recommended in an eligible individual's personalized screening and risk-reduction plan have been furnished to such individual2 7iii7 the extent to which screening mammography frequency and modality vary across the risk categories established under paragraph 7#b77;,a77i77,,iii72 7iv7 breast ,,mri utilization among high-risk individuals2 7v7 utilization of endocrine risk-reducing medications1 such as tamoxifen1 raloxifene1 and aromatase inhibitors1 among high-risk individuals and individuals assigned to an elevated risk category2 7vi7 whether the payment amount is sufficient to sustain eligible provider participation in the ,model2 and 7vii7 the number of eligible providers who continue to participate in the ,model4 7,b7 ,secondary measures ,the ,secretary shall evaluate-- 7i7 the total cost of care for breast cancer screening and treatment episodes among participating eligible individuals1 benchmarked against national utilization and spending for individuals comparable to eligible individuals2 7ii7 the projected cost-effectiveness of the ,model over a #aj-year and #bj-year horizon1 including the estimated value of cancers prevented1 cancers detected at earlier stages1 and screening procedures avoided2 7iii7 the proportion of comprehensive breast cancer risk assessments that integrate each item of information described in paragraph 7#b77;,a77ii72 7iv7 the rate at which personalized screening and risk reduction plans are developed and communicated to the primary care providers of eligible individuals2 7v7 the average time from when an eligible individual first receives a comprehensive breast cancer risk assessment to the time such individual receives a personalized screening and risk reduction plan2 7vi7 the rate at which eligible individuals adhere to the recommendations in their personalized screening and risk reduction plan2 7vii7 whether there are any differences in the measures described in this subparagraph between different delivery approaches and eligible providers2 and 7viii7 reported outcomes of eligible individuals1 including the satisfaction of eligible individuals with the personalized screening and risk reduction plan furnished to such individuals1 the understanding of the personal risk level of eligible individuals1 and the anxiety and decisional conflict of eligible individuals1 measured using validated patient-reported outcome instruments4 7,c7 ,exploratory measures ,the ,secretary shall evaluate1 among participating eligible individuals-- 7i7 the rate of-- 7,i7 stage ,,iib or higher breast cancers2 and 7,,ii7 stage ,,iia breast cancers2 7ii7 the rate of ductal carcinoma in situ 7,,dcis7 detection2 and 7iii7 the proportion of breast cancers detected through screening compared to the number of breast cancers detected through symptomatic presentation4 7#g7 ,additional authority ,if the ,secretary determines that additional statutory authority is required to test or expand the ,model1 not later than #ahj days after making such determination1 the ,secretary shall notify the ,committee on ,finance of the ,senate and the ,committee on ,ways and ,means of the ,house of ,representatives4 7#h7 ,termination 7,a7 ,in general ,the ,model shall terminate on the date that is #g years after the date on which the ,model begins1 unless the ,secretary determines that expansion of the ,model is appropriate under subsection 7c74 7,b7 ,authority ,the ,secretary may not terminate the ,model under subsection 7b77#c77;,b7 until after the date on which the ,secretary submits the interim report described in paragraph 7#i77;,a74 7#i7 ,reports 7,a7 ,interim report ,not later than the date that is #c years after the commencement of the ,model1 the ,secretary shall submit to the relevant committees1 the ,director of the ,agency for ,healthcare ,research and ,quality1 and the ,united ,states ,preventive ,services ,task ,force an interim report describing-- 7i7 the measures used to evaluate the ,model under paragraph 7#f72 and 7ii7 the rate of laboratories used by eligible providers that submit de-identified variant data to the ,clin,var public database maintained by the ,national ,center for ,biotechnology ,information4 7,b7 ,final ,report ,not later than the date that is #g years after the commencement of the ,model1 the ,secretary shall submit to the relevant committees1 the ,director of the ,agency for ,healthcare ,research and ,quality1 and the ,united ,states ,preventive ,services ,task ,force a final report-- 7i7 describing the measures used to evaluate the ,model under paragraph 7#f72 7ii7 the rate of laboratories used by eligible providers that submit de-identified variant data to the ,clin,var public database maintained by the ,national ,center for ,biotechnology ,information2 and 7iii7 with recommendations regarding whether the model should be expanded or made permanent1 including whether the ,model should be expanded to individuals enrolled in a ,medicare ,advantage plan under part ,c of title ,,xviii4 7,c7 ,united ,states ,preventive ,services ,task ,force ,if1 after the date of enactment of this ,act1 the ,united ,states ,preventive ,services ,task ,force issues an updated recommendation addressing breast cancer risk assessment or germline genetic testing1 the ,secretary shall-- 7i7 evaluate the effect on such recommendation on the design and evaluation of the ,model1 including whether any modification of the ,model is warranted2 and 7ii7 not later than #ahj days after the ,united ,states ,preventive ,services ,task ,force issues such recommendation1 submit to the relevant committees a report describing such evaluation4 7#aj7 ,funding ,no additional funds are authorized to be appropriated to carry out this subsection4 ,the ,secretary shall carry out the ,model using funds otherwise available under subsection 7f74 7#aa7 ,definitions ,in this subsection3 7,a7 ,eligible individual ,the term eligible individual means an individual-- 7i7 entitled to1 or enrolled for1 benefits under part ,a of title ,,xviii1 or enrolled for benefits under part ,b of such title1 but not enrolled in a plan under part ,c of such title2 7ii7 who has attained #dj years of age but has not attained #ge years of age2 7iii7 who does not have end-stage renal disease2 and 7iv7 who is not receiving hospice care under title ,,xviii4 7,b7 ,eligible provider 7i7 ,in general ,the term eligible provider means-- 7,i7 a physician 7as defined in section #ahfa7r77#a772 7,,ii7 a certified nurse-midwife 7as defined in section #ahfa7;gg772 7,,iii7 a nurse practitioner 7as defined in section #ahfa7;aa77#e77;,a772 7,,iv7 a physician assistant 7as defined in such section72 7,v7 a genetic counselor who is certified by the ,american ,board of ,genetic ,counseling or the ,american ,board of ,medical ,genetics and ,genomics2 or 7,,vi7 any other qualified health professional determined appropriate by the ,secretary4 7ii7 ,clarification ,an individual described in clause 7i7 shall be considered an eligible provider without regard to whether such individual is otherwise recognized as a supplier under title ,,xviii4 7,c7 ,high-penetrance gene ,the term high-penetrance gene means the ,,brca#a1 ,,brca#b1 ,,palb#b1 ,,cdh#a1 ,,tp#ec1 ,,pten1 or ,,stk#aa gene1 and any such other gene as the ,secretary determines to confer comparable risk4 7,d7 ,high-risk individual ,the term high-risk individual means an individual-- 7i7 whose #e-year risk of developing breast cancer1 as estimated by a validated risk model1 is #f percent or greater2 7ii7 who has a pathogenic variant in a high-penetrance gene2 or 7iii7 who possesses such other criteria that the ,secretary determines to be appropriate1 consistent with applicable clinical practice guidelines4 7,e7 ,relevant committees ,the term relevant committees means the ,committee on ,finance and the ,committee on ,health1 ,education1 ,labor1 and ,pensions of the ,senate1 the ,committee on ,ways and ,means and the ,committee on ,energy and ,commerce of the ,house of ,representatives4 7,f7 ,validated risk model ,the term validated risk model means a model that-- 7i7 produces an estimate of an individual's #e-year risk of developing breast cancer2 and 7ii7 the ,secretary determines has been validated in a population comparable to eligible individuals4 4