,,ii #aagth ,,congress #ast ,session ,s4 #aiga ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,june #h1 #bjba,mr4 ,cardin 7for himself and ,mr4 ,blunt7 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 #bjba4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4,,title ,i--,increasing awareness1 expanding preventive services1 and improving care coordination,sec4 #aja4 ,expanding ,medicare annual wellness benefit to include kidney disease screening4,sec4 #ajb4 ,increasing access to ,medicare kidney disease education benefit4,sec4 #ajc4 ,improving patient lives and quality of care through research and innovation4,sec4 #ajd4 ,understanding the progression of kidney disease and treatment of kidney failure in minority populations4,,title ,,ii--,creating an economically stable dialysis infrastructure and incentivizing innovation,sec4 #bja4 ,refining the end-stage renal disease payment system to improve accuracy in payment and support therapies4,,title ,,iii--,increasing patient access to quality performance by improving the accuracy and transparency of end-stage renal disease quality programs,sec4 #cja4 ,improving patient decision making and transparency by consolidating and modernizing quality programs4,,title ,,iv--,empowering patients,sec4 #dja4 ,medigap coverage for beneficiaries with end-stage renal disease4,sec4 #djb4 ,network adequacy requirements for dialysis services4 ,i ,increasing awareness1 expanding preventive services1 and improving care coordination #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 redesignating subparagraph 7,o7 as subparagraph 7,p72 and 7#b7 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 #bjbb4 #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 respectively2 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 #bjbb4 #ajc4 ,improving patient lives and quality of care through research and innovation 7a7 ,study ,the ,secretary of ,health and ,human ,services 7in this section referred to 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 that create barriers to kidney transplants and post-transplant care for beneficiaries with end-stage renal disease4 7#b7 ,the practices used by ,states with higher than average donation rates and whether those practices and policies could be successfully utilized in other ,states4 7#c7 ,practices and policies that could increase deceased donation rates of minority populations4 7#d7 ,whether cultural and policy barriers exist to increasing living donation rates1 including an examination of how to better facilitate chained donations4 7#e7 ,other areas determined appropriate by the ,secretary4 7b7 ,report ,not later than #ah months 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 #ajd4 ,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 leading to kidney disease2 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 failure4 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 ,creating an economically stable dialysis infrastructure and incentivizing 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-- 7#a7 in subparagraph 7,d71 in the matter preceding clause 7i71 by striking ,such system and inserting ,subject to subparagraph 7,j71 such system2 and 7#b7 by adding at the end the following new subparagraph3 7,j7 ,for payment for renal dialysis services furnished on or after ,january #a1 #bjbd1 under the system under this paragraph-- 7i7 the payment adjustment described in clause 7i7 of subparagraph 7,d7-- 7,i7 shall not take into account comorbidities2 and 7,,ii7 shall take into account age for purposes of distinguishing between individuals who are under #ah years of age and those who are #ah years of age and older but shall not include any other adjustment for age for patients #ah years of age and older2 7ii7 the ,secretary shall reassess any adjustments related to patient weight under such clause2 7iii7 the payment adjustment described in clause 7ii7 of such subparagraph shall not be included2 and 7iv7 take into account reasonable costs for determining the payment rate consistent with paragraph 7#b77;,b74 4 7b7 ,inclusion of network fee as an allowable cost ,section #ahha7;b77#ad7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad771 as amended by subsection 7a71 is amended by adding at the end the following new subparagraph3 7,k7 ,not later than ,january #a1 #bjbb1 the ,secretary shall amend the ,,esrd facility cost report to include the per treatment network fee 7as described in paragraph 7#g77 as an allowable cost or offset to revenue4 4 7c7 ,determination of productivity adjustment ,section #ahhf7;b77#c77;,b77xi7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#c77;,b77xi77 is amended-- 7#a7 in subclause 7,i71 by striking ,for #bjab and inserting ,subject to subclause 7,,iv71 for #bjab2 and 7#b7 by adding at the end1 the following new subclause3 7,,iv7 ,for each of #bjbb through #bjbe1 the productivity adjustment described in subclause 7,,ii7 shall be zero for a payment system in any year in which the ,medicare ,payment ,advisory ,commission estimates that payments under this title pursuant to such payment system1 on an aggregate national basis1 exceed costs1 on an aggregate national basis1 by #c4j percent or less4 4 7d7 ,payment for new and innovative drugs and biologicals that are renal dialysis services ,section #ahha7;b77#ad7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7b77#ad771 as amended by subsections 7a7 and 7b71 is amended by adding the following new subparagraph-- 7,l7 ,payment for new and innovative drugs1 biologicals1 and devices that are renal dialysis services 7i7 ,in general ,for drugs or biologicals determined to be within a functional category1 the ,secretary1 in consultation with stakeholders1 shall ensure that the single payment amount is adequate to cover the cost of new innovative drugs or biologicals and increase the single payment amount if the ,secretary determines such payment amount is not adequate to cover such cost4 ,in carrying out the preceding sentence1 the ,secretary shall use the cost and utilization data collected during the three-year transitional payment period1 as otherwise described in the final regulation published on ,november #ad1 #bjah 7#hc ,fed4 ,reg4 #efibb et seq474 7ii7 ,money to follow the patient ,the ,secretary1 through notice and comment rulemaking1 shall implement a policy for any drug or biological that is not provided to the average patient that results in the amount by which the single payment amount is increased pursuant to this subparagraph shall be paid only when a provider or renal dialysis facility has demonstrated that it has administered the drug or biological to a patient4 4 7e7 ,new devices and other technologies ,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 #bjbb1 and in consultation with stakeholders1 the ,secretary shall ensure that the single payment amount is adequate to cover the cost of the new innovative device or other technology with substantial clinical improvement and increase the single payment amount if the ,secretary determines such payment amount is not adequate to cover such cost4 ,in carrying out the preceding sentence1 the ,secretary shall use the cost and utilization data collected during a three-year transitional payment period1 as otherwise described in the final regulation published on ,november #i1 #bjbj 7#he ,fed4 ,reg4 #gacih et seq474 ,,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;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7h77#b77;,b77 is amended-- 7#a7 in clause 7ii71 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 endorse42 and 7#b7 by adding at the end the following new clause3 7iii7 ,composite measures ,clauses 7i7 and 7ii7 shall apply to composite measures in the same manner as such clauses apply to individual measures4 4 7c7 ,requirements for dialysis facility compare star rating program ,section #ahha7;h77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7h77#f77 is amended by adding at the end the following new subparagraph3 7,e7 ,requirements for any dialysis facility compare star rating program ,to the extent that the ,secretary maintains a dialysis facility compare star rating program1 under such a program the ,secretary-- 7i7 shall assign stars using the same methodology and total performance score results from the quality incentive program under this subsection2 7ii7 shall determine the stars using the same methodology used under such quality incentive program2 and 7iii7 shall not use a forced bell curve when determining the stars or rebaselining the stars4 4 7d7 ,incentive payments ,section #ahha7;h77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7h77#a77 is amended by adding at the end the following new subparagraph3 7,d7 ,incentive payments 7i7 ,in general ,in the case of a provider of services or a renal dialysis facility that the ,secretary determines exceeds the attainment performance standards under paragraph 7#d7 with respect to a year1 the ,secretary may make a bonus payment to the provider or facility 7pursuant to a process established by the ,secretary74 7ii7 ,funding ,the total amount of bonus payments under clause 7i7 in a year shall be equal to the total amount of reduced payments in a year under subparagraph 7,a74 7iii7 ,no effect in subsequent years ,the provisions of subparagraph 7,c7 shall apply to a bonus payment under this subparagraph in the same manner subparagraph 7,c7 applies to a reduction under such subparagraph4 4 7e7 ,effective date ,the amendments made by this section shall apply to items and services furnished on or after ,january #a1 #bjbb4 ,,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 #bjbb4 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 #bjbc1 and shall end ,june #cj1 #bjbc4 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 #djb4 ,network adequacy standards for dialysis services ,section #aheb7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#bb7;d77 is amended by adding at the end the following new paragraph3 7#g7 ,network adequacy requirements for dialysis services ,for plan year #bjbb and subsequent plan years1 the ,secretary shall apply the network adequacy standards under this subsection with respect to access to dialysis services-- 7,a7 using the time and distance standards in effect for plan year #bjbj2 and 7,b7 without regard to the final rule titled ,medicare ,program2 ,contract ,year #bjba ,policy and ,technical ,changes to the ,medicare ,advantage ,program1 ,medicare ,prescription ,drug ,benefit ,program1 and ,medicare ,cost ,plan ,program 7#he ,fed4 ,reg4 #ccgif74 4