#aaeth ,,congress #ast ,session ,h4 ,r4 #cagh ,,an ,,act ,to amend title ,,xviii of the ,social ,security ,act to improve the delivery of home infusion therapy and dialysis and the application of the ,stark rule under the ,medicare program1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,medicare ,part ,b ,improvement ,act of #bjag4 7b7 ,table of contents ,the table of contents of this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,title ,i--,improvements in ,provision of ,home ,infusion ,therapy ,sec4 #aja4 ,home infusion therapy services temporary transitional payment4 ,sec4 #ajb4 ,extension of ,medicare ,patient ,,ivig ,access ,demonstration ,project4 ,sec4 #ajc4 ,orthotist's and prosthetist's clinical notes as part of the patient's medical record4 ,title ,,ii--,improvements in ,dialysis ,services ,sec4 #bja4 ,independent accreditation for dialysis facilities and assurance of high quality surveys4 ,sec4 #bjb4 ,expanding access to home dialysis therapy4 ,title ,,iii--,improvements in ,application of ,stark ,rule ,sec4 #cja4 ,modernizing the application of the ,stark rule under ,medicare4 ,sec4 #cjb4 ,funds from the ,medicare ,improvement ,fund4 ,i ,improvements in ,provision of ,home ,infusion ,therapy #aja4 ,home infusion therapy services temporary transitional payment 7a7 ,in general ,section #ahcd7u7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7u77 is amended1 by adding at the end the following new paragraph3 7#g7 ,home infusion therapy services temporary transitional payment 7,a7 ,temporary transitional payment 7i7 ,in general ,the ,secretary shall1 in accordance with the payment methodology described in subparagraph 7,b7 and subject to the provisions of this paragraph1 provide a home infusion therapy services temporary transitional payment under this part to an eligible home infusion supplier 7as defined in subparagraph 7,f77 for items and services described in subparagraphs 7,a7 and 7,b7 of section #ahfa7;iii77#b77 furnished during the period specified in clause 7ii7 by such supplier in coordination with the furnishing of transitional home infusion drugs 7as defined in clause 7iii774 7ii7 ,period specified ,for purposes of clause 7i71 the period specified in this clause is the period beginning on ,january #a1 #bjai1 and ending on the day before the date of the implementation of the payment system under paragraph 7#a77;,a74 7iii7 ,transitional home infusion drug defined ,for purposes of this paragraph1 the term transitional home infusion drug has the meaning given to the term home infusion drug under section #ahfa7;iii77#c77;,c771 except that clause 7ii7 of such section shall not apply if a drug described in such clause is identified in clauses 7i71 7ii71 7iii7 or 7iv7 of subparagraph 7,c7 as of the date of the enactment of this paragraph4 7,b7 ,payment methodology ,for purposes of this paragraph1 the ,secretary shall establish a payment methodology1 with respect to items and services described in subparagraph 7,a77i74 ,under such payment methodology the ,secretary shall-- 7i7 create the three payment categories described in clauses 7i71 7ii71 and 7iii7 of subparagraph 7,c72 7ii7 assign drugs to such categories1 in accordance with such clauses2 7iii7 assign appropriate ,healthcare ,common ,procedure ,coding ,system 7,,hcpcs7 codes to each payment category2 and 7iv7 establish a single payment amount for each such payment category1 in accordance with subparagraph 7,d71 for each infusion drug administration calendar day in the individual's home for drugs assigned to such category4 7,c7 ,payment categories 7i7 ,payment category #a ,the ,secretary shall create a payment category #a and assign to such category drugs which are covered under the ,local ,coverage ,determination on ,external ,infusion ,pumps 7,,lcd number ,l#ccgid7 and billed with the following ,,hcpcs codes 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary73 ,j#jacc1 ,j#jbhe1 ,j#jbhg1 ,j#jbhh1 ,j#jbhi1 ,j#jhie1 ,j#aagj1 ,j#abej1 ,j#abfe1 ,j#acbe1 ,j#adee1 ,j#adeg1 ,j#aegj1 ,j#bage1 ,j#bbfj1 ,j#bbgj1 ,j#bbgd1 ,j#bbgh1 ,j#cjaj1 or ,j#cbhe4 7ii7 ,payment category #b ,the ,secretary shall create a payment category #b and assign to such category drugs which are covered under such local coverage determination and billed with the following ,,hcpcs codes 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary73 ,j#aeei ,,jb1 ,j#aefa ,,jb1 ,j#aefb ,,jb1 ,j#aefi ,,jb1 or ,j#aege ,,jb4 7iii7 ,payment category #c ,the ,secretary shall create a payment category #c and assign to such category drugs which are covered under such local coverage determination and billed with the following ,,hcpcs codes 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary73 ,j#ijjj1 ,j#ijci1 ,j#ijdj1 ,j#ijfe1 ,j#iajj1 ,j#iaij1 ,j#ibjj1 ,j#icfj1 or ,j#icgj4 7iv7 ,infusion drugs not otherwise included ,with respect to drugs that are not included in payment category #a1 #b1 or #c under clause 7i71 7ii71 or 7iii71 respectively1 the ,secretary shall assign to the most appropriate of such categories1 as determined by the ,secretary1 drugs which are-- 7,i7 covered under such local coverage determination and billed under ,,hcpcs codes ,j#ggii or ,j#giii 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary72 or 7,,ii7 billed under any code that is implemented after the date of the enactment of this paragraph and included in such local coverage determination or included in subregulatory guidance as a home infusion drug described in subparagraph 7,a77i74 7,d7 ,payment amounts 7i7 ,in general ,under the payment methodology1 the ,secretary shall pay eligible home infusion suppliers1 with respect to items and services described in subparagraph 7,a77i7 furnished during the period described in subparagraph 7,a77ii7 by such supplier to an individual1 at amounts equal to the amounts determined under the physician fee schedule established under section #ahdh for services furnished during the year for codes and units of such codes described in clauses 7ii71 7iii71 and 7iv7 with respect to drugs included in the payment category under subparagraph 7,c7 specified in the respective clause1 determined without application of the geographic adjustment under subsection 7e7 of such section4 7ii7 ,payment amount for category #a ,for purposes of clause 7i71 the codes and units described in this clause1 with respect to drugs included in payment category #a described in subparagraph 7,c77i71 are one unit of ,,hcpcs code #ifcfe plus four units of ,,hcpcs code #ifcff 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary74 7iii7 ,payment amount for category #b ,for purposes of clause 7i71 the codes and units described in this clause1 with respect to drugs included in payment category #b described in subparagraph 7,c77i71 are one unit of ,,hcpcs code #ifcfi plus four units of ,,hcpcs code #ifcgj 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary74 7iv7 ,payment amount for category #c ,for purposes of clause 7i71 the codes and units described in this clause1 with respect to drugs included in payment category #c described in subparagraph 7,c77i71 are one unit of ,,hcpcs code #ifdac plus four units of ,,hcpcs code #ifdae 7as identified as of ,july #a1 #bjag1 and as subsequently modified by the ,secretary74 7,e7 ,clarifications 7i7 ,infusion drug administration day ,for purposes of this subsection1 a reference1 with respect to the furnishing of transitional home infusion drugs or home infusion drugs to an individual by an eligible home infusion supplier1 to payment to such supplier for an infusion drug administration calendar day in the individual's home shall refer to payment only for the date on which professional services 7as described in section #ahfa7;iii77#b77;,a77 were furnished to administer such drugs to such individual4 ,for purposes of the previous sentence1 an infusion drug administration calendar day shall include all such drugs administered to such individual on such day4 7ii7 ,treatment of multiple drugs administered on same infusion drug administration day ,in the case that an eligible home infusion supplier1 with respect to an infusion drug administration calendar day in an individual's home1 furnishes to such individual transitional home infusion drugs which are not all assigned to the same payment category under subparagraph 7,c71 payment to such supplier for such infusion drug administration calendar day in the individual's home shall be a single payment equal to the amount of payment under this paragraph for the drug1 among all such drugs so furnished to such individual during such calendar day1 for which the highest payment would be made under this paragraph4 7,f7 ,eligible home infusion suppliers ,in this paragraph1 the term eligible home infusion supplier means a supplier that is enrolled under this part as a pharmacy that provides external infusion pumps and external infusion pump supplies and that maintains all pharmacy licensure requirements in the ,state in which the applicable infusion drugs are administered4 7,g7 ,implementation ,notwithstanding any other provision of law1 the ,secretary may implement this paragraph by program instruction or otherwise4 4 7b7 ,conforming amendment ,section #ahdb7;b77#f77;,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieu7b77#f77;,i77 is amended by inserting or1 in the case of items and services described in clause 7i7 of section #ahcd7u77#g77;,a7 furnished to an individual during the period described in clause 7ii7 of such section1 payment shall be made to the eligible home infusion therapy supplier after payment shall be made to the qualified home infusion therapy supplier4 #ajb4 ,extension of ,medicare ,patient ,,ivig ,access ,demonstration ,project ,section #aja7;b7 of the ,medicare ,,ivig ,access and ,strengthening ,medicare and ,repaying ,taxpayers ,act of #bjab 7#db ,u4,s4,c4 #aciel note7 is amended-- 7#a7 in paragraph 7#a71 by inserting after for a period of #c years the following3 and1 subject to the availability of funds under subsection 7g7-- 7,a7 if the date of enactment of the ,medicare ,part ,b ,improvement ,act of #bjag is on or before ,september #cj1 #bjag1 for the period beginning on ,october #a1 #bjag1 and ending on ,december #ca1 #bjbj2 and 7,b7 if the date of enactment of such ,act is after ,september #cj1 #bjag1 for the period beginning on the date of enactment of such ,act and ending on ,december #ca1 #bjbj0 2 and 7#b7 in paragraph 7#b71 by adding at the end the following new sentences3 ,subject to the preceding sentence1 a ,medicare beneficiary enrolled in the demonstration project on ,september #cj1 #bjag1 shall be automatically enrolled during the period beginning on the date of the enactment of the ,medicare ,part ,b ,improvement ,act of #bjag and ending on ,december #ca1 #bjbj1 without submission of another application4 ,chapter #ce of title #dd1 ,united ,states ,code1 shall not apply to any application form used for a ,medicare beneficiary who enrolls in the demonstration project on or after such date of enactment44 #ajc4 ,orthotist's and prosthetist's clinical notes as part of the patient's medical record ,section #ahcd7;h7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7h77 is amended by adding at the end the following new paragraph3 7#e7 ,documentation created by orthotists and prosthetists ,for purposes of determining the reasonableness and medical necessity of orthotics and prosthetics1 documentation created by an orthotist or prosthetist shall be considered part of the individual's medical record to support documentation created by eligible professionals described in section #ahdh7k77#c77;,b74 4 ,,ii ,improvements in ,dialysis ,services #bja4 ,independent accreditation for dialysis facilities and assurance of high quality surveys 7a7 ,accreditation and surveys 7#a7 ,in general ,section #ahfe of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;bb7 is amended-- 7,a7 in subsection 7a7-- 7i7 in paragraph 7#a71 in the matter preceding subparagraph 7,a71 by striking or the conditions and requirements under section #ahha7;b72 and 7ii7 in paragraph 7#d71 by inserting 7including a renal dialysis facility7 after facility2 and 7,b7 by adding at the end the following new subsection3 7e7 ,with respect to an accreditation body that has received approval from the ,secretary under subsection 7a77#c77;,a7 for accreditation of provider entities that are required to meet the conditions and requirements under section #ahha7;b71 in addition to review and oversight authorities otherwise applicable under this title1 the ,secretary shall 7as the ,secretary determines appropriate7 conduct1 with respect to such accreditation body and provider entities1 any or all of the following as frequently as is otherwise required to be conducted under this title with respect to other accreditation bodies or other provider entities3 7#a7 ,validation surveys referred to in subsection 7d74 7#b7 ,accreditation program reviews 7as defined in section #dhh4h7;c7 of title #db of the ,code of ,federal ,regulations1 or a successor regulation74 7#c7 ,performance reviews 7as defined in section #dhh4h7;a7 of title #db of the ,code of ,federal ,regulations1 or a successor regulation74 4 7#b7 ,timing for acceptance of requests from accreditation organizations ,not later than #ij days after the date of enactment of this ,act1 the ,secretary of ,health and ,human ,services shall begin accepting requests from national accreditation bodies for a finding described in section #ahfe7;a77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;bb7a77#c77;,a77 for purposes of accrediting provider entities that are required to meet the conditions and requirements under section #ahha7;b7 of such ,act 7#db ,u4,s4,c4 #acierr7b774 7b7 ,requirement for timing of surveys of new dialysis facilities ,section #ahha7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77#a77 is amended by adding at the end the following new sentence3 ,beginning #ahj days after the date of the enactment of this sentence1 an initial survey of a provider of services or a renal dialysis facility to determine if the conditions and requirements under this paragraph are met shall be initiated not later than #ij days after such date on which both the provider enrollment form 7without regard to whether such form is submitted prior to or after such date of enactment7 has been determined by the ,secretary to be complete and the provider's enrollment status indicates approval is pending the results of such survey44 #bjb4 ,expanding access to home dialysis therapy 7a7 ,allowing use of telehealth for monthly end stage renal disease-,related visits 7#a7 ,in general ,paragraph 7#c7 of section #ahha7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acierr7b77 is amended-- 7,a7 by redesignating subparagraphs 7,a7 and 7,b7 as clauses 7i7 and 7ii71 respectively2 7,b7 in clause 7i71 as redesignated by subparagraph 7,a71 by striking under this subparagraph and inserting under this clause2 7,c7 in clause 7ii71 as redesignated by subparagraph 7,a71 by inserting subject to subparagraph 7,b71 before on a comprehensive2 7,d7 by striking ,with respect to and inserting 7,a7 ,with respect to2 and 7,e7 by adding at the end the following new subparagraph3 7,b7 7i7 ,subject to clause 7ii71 an individual who is determined to have end stage renal disease and who is receiving home dialysis may choose to receive monthly end stage renal disease-related visits1 furnished on or after ,january #a1 #bjai1 via telehealth4 7ii7 ,clause 7i7 shall apply to an individual only if the individual receives a face-to-face visit1 without the use of telehealth-- 7,i7 in the case of the initial #c months of home dialysis of such individual1 at least monthly2 and 7,,ii7 after such initial #c months1 at least once every #c consecutive months4 4 7#b7 ,conforming amendment ,paragraph 7#a7 of such section is amended by striking paragraph 7#c77;,a7 and inserting paragraph 7#c77;,a77i74 7b7 ,expanding originating sites for telehealth ,to include renal dialysis facilities and the home for purposes of monthly end stage renal disease-,related visits 7#a7 ,in general ,section #ahcd7m7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7m77 is amended-- 7,a7 in paragraph 7#d77;,c77ii71 by adding at the end the following new subclauses3 7,,ix7 ,a renal dialysis facility1 but only for purposes of section #ahha7;b77#c77;,b74 7,x7 ,the home of an individual1 but only for purposes of section #ahha7;b77#c77;,b74 2 and 7,b7 by adding at the end the following new paragraph3 7#e7 ,treatment of home dialysis monthly ,,esrd-related visit ,the geographic requirements described in paragraph 7#d77;,c77i7 shall not apply with respect to telehealth services furnished on or after ,january #a1 #bjai1 for purposes of section #ahha7;b77#c77;,b71 at an originating site described in subclause 7,,vi71 7,,ix71 or 7,x7 of paragraph 7#d77;,c77ii771 subject to applicable ,state law requirements1 including ,state licensure requirements4 4 7#b7 ,no facility fee if originating site for home dialysis therapy is the home ,section #ahcd7m77#b77;,b7 of the ,social ,security 7#db ,u4,s4,c4 #aciem7m77#b77;,b77 is amended-- 7,a7 by redesignating clauses 7i7 and 7ii7 as subclauses 7,i7 and 7,,ii71 respectively1 and by indenting each of such subclauses #b ems to the right2 7,b7 in subclause 7,,ii71 as redesignated by subparagraph 7,a71 by striking clause 7i7 or this clause and inserting subclause 7,i7 or this subclause2 7,c7 by striking site4--,with respect to and inserting 8site4-- 7i7 ,in general ,subject to clause 7ii71 with respect to 2 and 7,d7 by adding at the end the following new clause3 7ii7 ,no facility fee if originating site for home dialysis therapy is the home ,no facility fee shall be paid under this subparagraph to an originating site described in subclause 7,x7 of paragraph 7#d77;,c77ii74 4 7c7 ,clarification regarding telehealth provided to beneficiaries ,section #aabh;,a7i77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;a7i77#f77 is amended-- 7#a7 in subparagraph 7,h71 by striking 2 or and inserting a semicolon2 7#b7 in subparagraph 7,i71 by striking the period at the end and inserting 2 or2 and 7#c7 by adding at the end the following new subparagraph3 7,j7 the provision of telehealth technologies on or after ,january #a1 #bjai1 to individuals with end stage renal disease under title ,,xviii by a health care provider for the purpose of furnishing of telehealth4 4 7d7 ,study and report on further expansion 7#a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study to examine the feasibility1 benefits1 and drawbacks of expanding the use of telehealth and store-and-forward technologies under the ,medicare program under title ,,xviii of the ,social ,security ,act for items and services included in renal dialysis services1 as such term is defined in section #ahha7;b77#ad77;,b7 of such ,act 7#db ,u4,s4,c4 #acierr7b77#ad77;,b774 7#b7 ,report ,not later than #b years after the date of the enactment of this ,act1 the ,comptroller ,general shall submit to ,congress a report on the results of the study conducted under paragraph 7#a74 ,,iii ,improvements in ,application of ,stark ,rule #cja4 ,modernizing the application of the ,stark rule under ,medicare 7a7 ,clarification of the writing requirement and signature requirement for arrangements pursuant to the ,stark rule 7#a7 ,writing requirement ,section #ahgg7;h77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7h77#a77 is amended by adding at the end the following new subparagraph3 7,d7 ,written requirement clarified ,in the case of any requirement pursuant to this section for a compensation arrangement to be in writing1 such requirement shall be satisfied by such means as determined by the ,secretary1 including by a collection of documents1 including contemporaneous documents evidencing the course of conduct between the parties involved4 4 7#b7 ,signature requirement ,section #ahgg7;h77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7h77#a771 as amended by paragraph 7#a71 is further amended by adding at the end the following new subparagraph3 7,e7 ,special rule for signature requirements ,in the case of any requirement pursuant to this section for a compensation arrangement to be in writing and signed by the parties1 such signature requirement shall be met if-- 7i7 not later than #ij consecutive calendar days immediately following the date on which the compensation arrangement became noncompliant1 the parties obtain the required signatures2 and 7ii7 the compensation arrangement otherwise complies with all criteria of the applicable exception4 4 7b7 ,indefinite holdover for lease arrangements and personal services arrangements pursuant to the ,stark rule ,section #ahgg7;e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acienn7e77 is amended-- 7#a7 in paragraph 7#a71 by adding at the end the following new subparagraph3 7,c7 ,holdover lease arrangements ,in the case of a holdover lease arrangement for the lease of office space or equipment1 which immediately follows a lease arrangement described in subparagraph 7,a7 for the use of such office space or subparagraph 7,b7 for the use of such equipment and that expired after a term of at least #a year1 payments made by the lessee to the lessor pursuant to such holdover lease arrangement1 if-- 7i7 the lease arrangement met the conditions of subparagraph 7,a7 for the lease of office space or subparagraph 7,b7 for the use of equipment when the arrangement expired2 7ii7 the holdover lease arrangement is on the same terms and conditions as the immediately preceding arrangement2 and 7iii7 the holdover arrangement continues to satisfy the conditions of subparagraph 7,a7 for the lease of office space or subparagraph 7,b7 for the use of equipment4 2 and 7#b7 in paragraph 7#c71 by adding at the end the following new subparagraph3 7,c7 ,holdover personal service arrangement ,in the case of a holdover personal service arrangement1 which immediately follows an arrangement described in subparagraph 7,a7 that expired after a term of at least #a year1 remuneration from an entity pursuant to such holdover personal service arrangement1 if-- 7i7 the personal service arrangement met the conditions of subparagraph 7,a7 when the arrangement expired2 7ii7 the holdover personal service arrangement is on the same terms and conditions as the immediately preceding arrangement2 and 7iii7 the holdover arrangement continues to satisfy the conditions of subparagraph 7,a74 4 #cjb4 ,funds from the ,medicare ,improvement ,fund ,section #ahih7;b77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;iii7b77#a77 is amended by striking during and after fiscal year #bjba1 #bgj1jjj1jjj and inserting during and after fiscal year #bjba1 #bde1jjj1jjj4 ,passed the ,house of ,representatives ,july #be1 #bjag4;,clerk4