,,ii #aaith ,,congress #ast ,session ,s4 #bgcj ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,september #h1 #bjbe,mrs4 ,blackburn 7for herself and ,mr4 ,booker7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to improve access to innovative treatment options for end-stage renal disease under the ,medicare program1 and for other purposes4 #a4 ,short title 7a7 ,in general ,this ,act may be cited as the ,kidney ,care ,access ,protection ,act4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title4,,title ,i--,protecting patient access to kidney care innovation,sec4 #aja4 ,refining the end-stage renal disease payment system to improve access to innovative treatment options4,sec4 #ajb4 ,ensuring ,medicare ,advantage supports kidney care innovative therapies4,,title ,,ii--,addressing staffing barriers with ,,esrd market basket labor adjustments,sec4 #bja4 ,ensuring accuracy and stability in kidney care payment4 ,i ,protecting patient access to kidney care innovation #aja4 ,refining the end-stage renal disease payment system to improve access to innovative treatment options 7a7 ,extension of ,transitional ,drug ,add-,on ,payment ,adjustment 7,,tdapa7 period ,the ,secretary of ,health and ,human ,services 7in this section referred to as the ,secretary7 shall pay the transitional drug add-on payment adjustment under section #dac4bcd7;c7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 for not less than #c years for any new renal dialysis drug or biological product-- 7#a7 approved by the ,food and ,drug ,administration on or after ,january #a1 #bjbj1 under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cee7 or section #cea of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bfb72 7#b7 that qualifies for such adjustment under such section2 and 7#c7 that is furnished on or after ,january #a1 #bjbf4 7b7 ,permanent post-,,tdapa adjustment ,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 as defined in section #dac4bcd7;a7 of title #db1 ,code of ,federal ,regulations that received a transitional drug add-on payment adjustment 7referred to in this subparagraph as ,,tdapa7 under section #dac4bcd7;c7 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 #bjbf1 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 7c7 ,clarification to definition of renal dialysis services ,section #ahha7;b77#ad77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77;,b77 is amended-- 7#a7 by redesignating clauses 7i7 through 7iv7 as subclauses 7,i7 through 7,,iv71 respectively2 7#b7 by inserting 7i7 after 7,b72 7#c7 in clause 7i77,,iv71 as added by paragraph 7#b71 by striking clause 7i7 and inserting subclause 7,i72 7#d7 in the flush text at the end1 by striking ,such term does not and inserting the following3 7ii7 ,such term-- 7,i7 does not 2 7#e7 in clause 7ii71 as added by paragraph 7#b7-- 7,a7 in subclause 7,i71 by striking the period at the end and inserting 2 and2 and 7,b7 by adding at the end the following3 7,,ii7 does not include drugs or biological products used to treat a comorbid disease or condition 7including cardiovascular disease1 an inflammatory condition1 cancer1 diabetes1 and obesity7 that may occur in an individual who has been determined to have end-stage renal diseases and is receiving dialysis and-- 7aa7 that have been approved by the ,food and ,drug ,administration after ,december #ca1 #bjbe2 and 7bb7 do not substitute for a drug or biological included in the ,,esrd prospective payment system base rate4 2 and 7#f7 by adding at the end the following new clause3 7iii7 ,implementation ,beginning on the date of enactment of this clause1 for purposes of implementing clause 7ii77,,ii71 the ,secretary shall require that a claim for a drug or biological product described in such clause1 that is payable under this part and is furnished by a provider of services or renal dialysis facility1 contain the ,,ay modifier 7or a successor modifier74 4 7d7 ,revisions to ,transitional ,add-,on ,payment ,adjustment for ,new and ,innovative ,equipment and ,supplies 7,,tpnies7 7#a7 ,extension of period ,the ,secretary shall pay the transitional add-on payment adjustment for new and innovative equipment and supplies under section #dac4bcf of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 for not less than #c years for any new renal dialysis device that-- 7,a7 qualifies for such adjustment2 and 7,b7 is furnished on or after ,january #a1 #bjbf4 7#b7 ,eligibility of breakthrough devices ,beginning ,january #a1 #bjbf1 a device designated for expedited development and priority review under section #eae;,b of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj;e-#c7 shall be eligible for a transitional add-on payment adjustment for new and innovative equipment and supplies under section #dac4bcf of title #db1 ,code of ,federal ,regulations 7or a successor regulation74 7#c7 ,inclusion of capital-related assets in the transitional add-on payment adjustment for new and innovative equipment and supplies and post-,transitional ,add-,on ,payment ,adjustment for ,new and ,innovative ,equipment and ,supplies ,beginning ,january #a1 #bjbf1 the ,secretary shall not apply the criterion described in section #dac4bcf7;b77#f7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 that excludes capital-related assets from the transitional add-on payment adjustment for new and innovative equipment and supplies and shall calculate such adjustment for capital-related assets that are devices that otherwise meet the requirements for the transitional add-on payment adjustment for new and innovative equipment4 7e7 ,effective date ,the amendments made by this section shall take effect on ,january #a1 #bjbf1 and apply to items and services furnished on or after such date4 #ajb4 ,ensuring ,medicare ,advantage supports kidney care innovative therapies 7a7 ,in general ,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 ,beginning ,january #a1 #bjbf1 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 payment 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 7b7 ,conforming amendments ,section #ahea7;i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ba7 is amended-- 7#a7 in paragraph 7#a71 by inserting #ahec7;c77#h71 after #ahhf7;h77#c77;,d712 and 7#b7 in paragraph 7#b71 by inserting #ahec7;c77#h71 after #ahec7;h714 ,,ii ,addressing staffing barriers with ,,esrd market basket labor adjustments #bja4 ,ensuring accuracy and stability in kidney care payment ,section #ahha7;b77#ad77;,f77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#ad77;,f77i77 is amended-- 7#a7 in subclause 7,i71 by striking subclauses 7,,ii7 and 7,,iii7 and inserting subclauses 7,,ii71 7,,iii71 and 7,,iv72 7#b7 in subclause 7,,ii71 by inserting and after application of subclause 7,,iv7 after subclause 7,i72 and 7#c7 by adding at the end the following new subclause3 7,,iv7 ,beginning with #bjbf1 the ,secretary shall compute an adjustment to the increase factor described in subclause 7,i7 for the annual update of the payment amounts established under this paragraph for the previous year to account for forecast error 7referred to in this subclause as the forecast error adjustment74 ,the initial adjustment 7in #bjbf7 to the increase factor shall take into account the cumulative forecast error for #bjba and #bjbb4 ,subsequent adjustments in succeeding years shall take into account the forecast error from the most recently available year for which there is final data4 ,the forecast error adjustment under this subclause shall apply whenever the difference between the forecasted and actual percentage change in the prices of an appropriate mix of goods and services included in renal dialysis services exceeds #j4e percentage points4 4