,,ii #aahth ,,congress #b;d ,session ,s4 #ddfi ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #e1 #bjbd,mr4 ,cardin 7for himself and ,mrs4 ,blackburn7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to improve the understanding of1 and promote access to treatment for1 chronic kidney disease1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,chronic ,kidney ,disease ,improvement in ,research and ,treatment ,act of #bjbd4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,preventing kidney disease by expanding education and awareness,sec4 #aja4 ,expanding ,medicare annual wellness benefit to include kidney disease screening4,sec4 #ajb4 ,increasing access to ,medicare kidney disease education benefit4,sec4 #ajc4 ,understanding the progression of kidney disease and treatment of kidney failure in minority populations4,,title ,,ii--,incentivizing kidney care innovation,sec4 #bja4 ,refining the end-stage renal disease payment system to improve accuracy in payment and support therapies4,sec4 #bjb4 ,ensuring ,medicare ,advantage supports kidney care innovative therapies4,sec4 #bjc4 ,improving patient lives and quality of care through research and innovation4,,title ,,iii--,addressing the kidney care workforce crisis4,sec4 #cja4 ,improving patient decision making and transparency by consolidating and modernizing quality programs4,sec4 #cjb4 ,ensuring accuracy and stability in kidney care payment4,,title ,,iv--,expanding patient choice of coverage,sec4 #dja4 ,medigap coverage for beneficiaries with end-stage renal disease4 ,i ,preventing kidney disease by expanding education and awareness #aja4 ,expanding ,medicare annual wellness benefit to include kidney disease screening 7a7 ,in general ,section #ahfa7ww77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ww77#b77 is amended-- 7#a7 by moving subparagraph 7,n7 #b ems to the left2 7#b7 by redesignating subparagraph 7,o7 as subparagraph 7,p72 and 7#c7 by inserting after subparagraph 7,n7 the following new subparagraph3 7,o7 ,chronic kidney disease screening as defined by the ,secretary4 4 7b7 ,effective date ,the amendments made by this section apply to items and services furnished on or after ,january #a1 #bjbe4 #ajb4 ,increasing access to ,medicare kidney disease education benefit 7a7 ,in general ,section #ahfa7;ggg7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7ggg77 is amended-- 7#a7 in paragraph 7#a7-- 7,a7 in subparagraph 7,a71 by inserting or stage ,v after stage ,,iv2 and 7,b7 in subparagraph 7,b71 by inserting or of a physician assistant1 nurse practitioner1 or clinical nurse specialist 7as defined in section #ahfa7;aa77#e77 assisting in the treatment of the individual's kidney condition after kidney condition2 and 7#b7 in paragraph 7#b7-- 7,a7 by striking subparagraph 7,b72 and 7,b7 in subparagraph 7,a7-- 7i7 by striking 7,a7 after 7#b72 7ii7 by striking and at the end of clause 7i72 7iii7 by striking the period at the end of clause 7ii7 and inserting 2 and2 7iv7 by redesignating clauses 7i7 and 7ii7 as subparagraphs 7,a7 and 7,b71 respectively1 and indenting appropriately2 and 7v7 by adding at the end the following3 7,c7 a renal dialysis facility subject to the requirements of section #ahha7;b77#a7 with personnel who-- 7i7 provide the services described in paragraph 7#a72 and 7ii7 is a physician 7as defined in subsection 7r77#a77 or a physician assistant1 nurse practitioner1 or clinical nurse specialist 7as defined in subsection 7aa77#e774 4 7b7 ,payment to renal dialysis facilities ,section #ahha7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77 is amended by adding at the end the following new paragraph3 7#ae7 ,for purposes of paragraph 7#ad71 the single payment for renal dialysis services under such paragraph shall not take into account the amount of payment for kidney disease education services 7as defined in section #ahfa7;ggg774 ,instead1 payment for such services shall be made to the renal dialysis facility on an assignment-related basis under section #ahdh4 4 7c7 ,effective date ,the amendments made by this section apply to kidney disease education services furnished on or after ,january #a1 #bjbe4 #ajc4 ,understanding the progression of kidney disease and treatment of kidney failure in minority populations 7a7 ,study ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall conduct a study on-- 7#a7 the social1 behavioral1 and biological factors associated with kidney disease onset and progression2 7#b7 efforts to slow the progression of kidney disease in minority populations that are disproportionately affected by such disease2 and 7#c7 treatment patterns associated with providing care1 under the ,medicare program under title ,,xviii of the ,social ,security ,act1 the ,medicaid program under title ,,xix of such ,act1 and through private health insurance1 to minority populations that are disproportionately affected by kidney disease4 7b7 ,report ,not later than #a year after the date of the enactment of this ,act1 the ,secretary shall submit to ,congress a report on the study conducted under subsection 7a71 together with such recommendations as the ,secretary determines to be appropriate4 ,,ii ,incentivizing kidney care innovation #bja4 ,refining the end-stage renal disease payment system to improve accuracy in payment and support therapies 7a7 ,in general ,section #ahha7;b77#ad7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77 is amended by adding at the end the following new subparagraph3 7,j7 ,payment for new and innovative drugs1 biologicals1 and devices that are renal dialysis services 7i7 ,in general ,for any new renal dialysis drug or biological product that is used to treat or manage a condition for which there is a functional category as defined in section #dac4bcd7;a7 of title #db1 ,code of ,federal ,regulations that received a transitional drug add-on adjustment 7referred to in this subparagraph as ,,tdapa7 under section #dac4bcd7;c77#b7 of such title1 and was furnished on or after ,january #a1 #bjbd1 the ,secretary shall establish a permanent add-on adjustment to the base rate for claims submitted on or after ,january #a1 #bjbe1 that includes the administration of such drugs or biologicals4 7ii7 ,calculation of the ,post-,,tdapa ,add-on adjustment ,in calculating the add-on adjustment described in clause 7i71 the ,secretary shall-- 7,i7 base the calculation on-- 7aa7 except as provided in items 7bb7 and 7cc71 the most recent #ab-month period of utilization for the new renal dialysis drug or biological product and the most recent available full calendar quarter of average sales price data for such drug or product2 7bb7 if the most recent available full calendar quarter of average sales price data reflects #j or negative sales1 #ajj percent of the wholesale acquisition cost 7as defined in section #ahdg;,a7c77#f77 of such drug or product2 or 7cc7 if the wholesale acquisition cost is not available1 the drug manufacturer's invoice2 7,,ii7 calculate the post-,,tdapa add-on payment adjustment as the expenditures for the new renal dialysis drug or biological product divided by the total number of renal dialysis services during which such drug or biological was administered during the same period2 7,,iii7 set the amount of the add-on adjustment as an amount equal to #fe percent of the amount calculated under subclause 7,,ii72 7,,iv7 update the add-on adjustment annually to account for inflationary changes2 and 7,v7 apply the add-on adjustment amount immediately upon the expiration of the ,,tdapa period and availability of the post-,,tdapa add-on adjustment4 7iii7 ,implementation ,this subparagraph shall not be implemented in a budget neutral manner and shall not be adjusted by any applicable patient-level case-mix adjustments described in section #dac4bce of title #db1 ,code of ,federal ,regulations 7or any successor regulation74 4 7b7 ,extension of transitional drug add-,on adjustment under the drug designation policy ,the ,secretary shall pay the transitional drug add-on adjustment under paragraph 7c7 of section #dac4bcd of title #db1 ,code of ,federal ,regulations 7or a successor regulation7 for a total of #c years for any new renal dialysis drug or biological product that-- 7#a7 is used to treat or manage a condition for which there is a functional category as defined in paragraph 7a7 of such section2 7#b7 qualifies for such adjustment under paragraph 7c77#b7 of such section2 and 7#c7 is furnished on or after ,january #a1 #bjbd4 7c7 ,new devices and other technologies 7#a7 ,in general ,as part of the promulgation of the annual rule for the ,medicare end-stage renal disease prospective payment system under section #ahha7;b77#ad7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77 for calendar year #bjbf1 and in consultation with stakeholders1 the ,secretary of ,health and ,human ,services 7referred to in this subsection as the ,secretary7 shall-- 7,a7 ensure that the single payment amount is adequate to cover the cost of any new innovative device or other technology with substantial clinical improvement2 and 7,b7 increase the single payment amount if the ,secretary determines such payment amount is not adequate to cover such cost4 7#b7 ,cost and utilization data ,in carrying out paragraph 7#a71 the ,secretary shall use the cost and utilization data collected during a #c-year transitional payment period1 as described in the final regulation published on ,november #i1 #bjbj 7#he ,fed4 ,reg4 #gacih74 #bjb4 ,ensuring ,medicare ,advantage supports kidney care innovative therapies ,section #ahec7;c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bc7;c77 is amended by adding at the end the following new paragraph3 7#h7 ,treatment of innovative products for enrollees with end stage renal disease 7,a7 ,in general ,the ,secretary shall make direct payment adjustments to providers of services or renal dialysis facilities for-- 7i7 any new renal dialysis drug or biological product that receives a transitional drug add-on adjustment under section #dac4bcd7;c7 of title #db1 ,code of ,federal ,regulations2 or 7ii7 an item or service that receives a transitional add-on payment adjustment for new and innovative equipment and supplies under section #dac4bcf of such title4 7,b7 ,amount of direct payment ,the amount of the adjustment shall equal the amount determined under the end stage renal disease prospective payment system described in section #ahha7;b77#ad74 7,c7 ,duration of direct payment ,the ,secretary shall make payments under subparagraph 7,a7 for the duration of the transitional payment under the end stage renal disease prospective payment system described in such section4 4 #bjc4 ,improving patient lives and quality of care through research and innovation 7a7 ,study ,the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary7 shall conduct a study on increasing kidney transplantation rates4 ,such study shall include an analysis of each of the following3 7#a7 ,any disincentives in the payment systems under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease4 7#b7 ,the practices used by donation service areas with higher than average donation rates and whether those practices and policies could be successfully utilized in other donation service areas4 7#c7 ,practices and policies that could increase donation rates among minority populations4 7#d7 ,whether cultural and policy barriers exist to increasing living donation rates1 including an examination of how to better facilitate kidney paired donations4 7#e7 ,criteria for transplant recipients for referral and for getting on the waitlist to receive a kidney4 7#f7 ,other areas determined appropriate by the ,secretary4 7b7 ,report ,not later than #ah months after the date of enactment of this ,act1 the ,secretary shall submit to ,congress a report on the study conducted pursuant to subsection 7a71 together with such recommendations as the ,secretary determines to be appropriate4 ,,iii ,increasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs #cja4 ,improving patient decision making and transparency by consolidating and modernizing quality programs 7a7 ,measures ,section #ahha7;h77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7h77#b77 is amended-- 7#a7 by striking subparagraph 7,a7 and inserting the following3 7,a7 ,the measures specified under this paragraph with respect to the year involved shall be selected by the ,secretary in consultation with stakeholders to promote improvement in beneficiary outcomes and shared decision-making with beneficiaries and their caregivers4 ,when selecting measures specified under this paragraph1 the ,secretary shall take into account clinical gaps in care1 underutilization that may lead to beneficiary harm1 patient safety1 and outcomes4 2 7#b7 in subparagraph 7,b77i71 by striking subparagraph 7,a77iv7 and inserting subparagraph 7,a72 7#c7 by striking subparagraph 7,e72 and 7#d7 by adding at the end the following new subparagraphs3 7,e7 ,weighting limitation ,no single measure specified by the ,secretary or individual measure within a composite measure so specified may be weighted less than #aj percent of the total performance score4 7,f7 ,statistically valid and reliable ,in specifying measures under subparagraph 7,a71 the ,secretary shall only specify measures that have been shown to be statistically valid and reliable through testing4 4 7b7 ,endorsement ,section #ahha7;h77#b77;,b77ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7h77#b77;,b77ii77 is amended by adding at the end the following new sentence3 ,the exception under the preceding sentence shall not apply to a measure that the entity with a contract under section #ahij7;a7 7or a similar entity7 considered but failed to endorse44 7e7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after ,january #a1 #bjbe4 ,,iv ,empowering patients #dja4 ,medigap coverage for beneficiaries with end-stage renal disease 7a7 ,guaranteed availability of ,medigap policies to all ,,esrd ,medicare beneficiaries 7#a7 ,in general ,section #ahhb7s7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess7s77 is amended-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,a71 by striking is #fe and all that follows through the period and inserting the following3 8is-- 7i7 #fe years of age or older and is enrolled for benefits under part ,b2 or 7ii7 entitled to benefits under #bbf;,a7b7 and is enrolled for benefits under part ,b4 2 and 7ii7 in subparagraph 7,d71 in the matter preceding clause 7i71 by inserting 7or is entitled to benefits under #bbf;,a7b77 after is #fe years of age or older2 and 7,b7 in paragraph 7#c77;,b7-- 7i7 in clause 7ii71 by inserting 7or is entitled to benefits under #bbf;,a7b77 after is #fe years of age or older2 and 7ii7 in clause 7vi71 by inserting 7or under #bbf;,a7b77 after at age #fe4 7#b7 ,effective date ,the amendments made by paragraph 7#a7 shall apply to ,medicare supplemental policies effective on or after ,january #a1 #bjbf4 7b7 ,additional enrollment period for certain individuals 7#a7 ,one-time enrollment period 7,a7 ,in general ,in the case of an individual described in subparagraph 7,b71 the ,secretary of ,health and ,human ,services shall establish a one-time enrollment period during which such an individual may enroll in any ,medicare supplemental policy under section #ahhb of the ,social ,security ,act 7#db ,u4,s4,c4 #aciess7 of the individual's choosing4 7,b7 ,enrollment period ,the enrollment period established under subparagraph 7,a7 shall begin on ,january #a1 #bjbf1 and shall end ,june #cj1 #bjbf4 7#b7 ,individual described ,an individual described in this paragraph is an individual who-- 7,a7 is entitled to hospital insurance benefits under part ,a of title ,,xviii of the ,social ,security ,act under section #bbf;,a7b7 of such ,act 7#db ,u4,s4,c4 #dbf-a72 7,b7 is enrolled for benefits under part ,b of such title ,,xviii2 and 7,c7 would not1 but for the provisions of1 and amendments made by1 subsection 7a7 be eligible for the guaranteed issue of a ,medicare supplemental policy under paragraph 7#b7 or 7#c7 of section #ahhb7s7 of such ,act 7#db ,u4,s4,c4 #aciess7s774