,i #aaeth ,,congress #ast ,session ,h4 ,r4 #dfgi ,,in ,,the ,,house ,,of ,,representatives ,december #ah1 #bjag,mr4 ,reed 7for himself and ,mr4 ,reichert7 introduced the following bill2 which was referred to the ,committee on ,ways and ,means1 and in addition to the ,committee on ,energy and ,commerce1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to provide for improvements to coverage and payment under the ,medicare program for new drugs1 devices1 and technology4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,equal ,access to ,treatments ,act of #bjag4 #b4 ,coverage and payment for new drugs1 devices1 and technology under the ,medicare program 7a7 ,improvements to ,,ntap payment adjustment under the inpatient prospective payment system 7#a7 ,payment for costs of new technologies ,with respect to hospital discharges occurring on or after ,october #a1 #bjah1 for which payment is made under section #ahhf7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d771 in calculating the amount of the additional payment for a new medical service or technology under paragraph 7#e77,k7 of such section with respect to such a discharge1 the ,secretary of ,health and ,human ,services shall apply section #dab4hh of title #db1 ,code of ,federal ,regulations-- 7,a7 as if the reference to #ej percent each place it appears in such section were a reference to #ge percent2 and 7,b7 as if paragraph 7b7 of such section did not include ,unless a discharge case qualifies for outlier payment under #dab4hd44 7#b7 ,revision to the cost threshold ,section #ahhf7;d77#e77,k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77 is amended-- 7,a7 in clause 7ii7-- 7i7 in subclause 7,i71 by striking #ge percent each place it appears and inserting #ej percent2 and 7ii7 in subclause 7,,ii71 by striking not less than two years and not more than three years and inserting five years2 and 7,b7 in clause 7iii71 by striking ,international ,classification of ,diseases1 #ith ,revision1 ,clinical ,modification 7#8#8,,icd-#i-;,,cm''7 and inserting ,international ,classification of ,diseases1 #ajth ,revision1 ,clinical ,modification 7#8#8,,icd-#aj-;,,cm''74 7#c7 ,revision to the commencement of the period for collection of cost data for new technologies ,section #ahhf7;d77#e77,k77ii77,,ii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77ii77,,ii77 is amended by inserting the later of the date that is the date of the clearance or approval by the ,commissioner of ,food and ,drugs of the service or technology or after beginning on4 7#d7 ,permitting appeals of ntap determinations 7,a7 ,in general ,section #ahhf7;d77#e77,k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77 is amended by adding at the end the following new clause3 7x7 7,i7 ,an individual or entity that submits an application for additional payment under this subparagraph for a new technology shall be entitled to administrative review of an adverse determination by the ,secretary with respect to such application4 7,,ii7 ,the ,secretary shall establish a process for administrative review for purposes of subclause 7,i74 ,under such process1 administrative review shall be conducted by the ,departmental ,appeals ,board of the ,department of ,health and ,human ,services4 ,under such process1 the ,departmental ,appeals ,board shall complete administrative review within #ij days of the date of receipt of the request for such review4 4 7,b7 ,conforming amendment ,section #ahhf7;d77#g77;,b7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#g77;,b77 is amended by inserting but not including a denial by the ,secretary of an application for additional payment under paragraph 7#e77,k7 after paragraph 7#d77;,d74 7#e7 ,requiring new ,,drg codes for new technologies coming off of new technology add-on ,section #ahhf7;d77#e77,k77ii77,,iv7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77ii77,,iv77 is amended by striking or existing4 7#f7 ,limit on aggregate annual adjustment ,section #ahhf7;d77#e7 of such ,act 7#db ,u4,s4,c4 #acieww7d77#e77 is amended by adding at the end the following new subparagraph3 7,m7 ,limit on aggregate annual adjustment 7i7 ,in general ,the total of the additional payments made under subparagraphs 7,k7 and 7,l7 for covered services furnished for discharges in a fiscal year 7as estimated by the ,secretary before the beginning of the fiscal year7 may not exceed the applicable percentage 7specified in clause 7ii77 of the total program payments estimated to be made under this subsection for all covered services furnished for discharges in that fiscal year4 ,if this clause is first applied to less than a full fiscal year1 the previous sentence shall apply only to the portion of such fiscal year4 7ii7 ,applicable percentage ,for purposes of clause 7i71 the term #8applicable percentage' for fiscal year #bjai and each subsequent fiscal year1 is a percentage specified by the ,secretary up to 7but not to exceed7 #b4j percent4 7iii7 ,uniform prospective reduction if aggregate limit projected to be exceeded ,if the ,secretary estimates before the beginning of a fiscal year that the amount of the additional payments under subparagraphs 7,k7 and 7,l7 for the fiscal year 7or portion thereof7 as determined under clause 7i7 without regard to this clause will exceed the limit established under such clause 7i71 the ,secretary shall reduce pro rata the amount of each of the additional payments under this paragraph for that fiscal year 7or portion thereof7 in order to ensure that the aggregate additional payments under subparagraphs 7,k7 and 7,l7 7as so estimated7 do not exceed such limit4 4 7#g7 ,effective date ,the amendments made by paragraphs 7#b71 7#c71 7#d71 7#e71 and 7#f7 shall take effect on the date of the enactment of this ,act and shall apply with respect to hospital discharges occurring on or after ,october #a1 #bjah1 for inpatient hospital services for which payment is made under section #ahhf7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww74 7b7 ,improvements to payment adjustment under the ,medicare outpatient prospective payment system for certain drugs and devices eligible or previously eligible for pass-,through 7#a7 ,requiring separate ambulatory payment classification for certain drugs and devices previously eligible for pass-through payments ,section #ahcc7t7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77 is amended-- 7,a7 in paragraph 7#b7-- 7i7 in subparagraph 7,g71 by striking and at the end2 7ii7 in subparagraph 7,h71 by striking the period at the end and inserting 2 and2 and 7iii7 by adding at the end the following new subparagraph3 7,i7 the ,secretary shall create additional groups of covered ,,opd services that classify separately procedures and services that employ medical devices and drugs described in a subparagraph of paragraph 7#bb71 in accordance with such paragraph4 2 and 7,b7 by adding at the end the following new paragraph3 7#bb7 ,separate additional payment groups for certain drugs and devices previously eligible for pass-through payments ,for purposes of paragraph 7#b77;,i71 the following shall apply3 7,a7 ,in general ,for payments under this subsection for services furnished on or after ,january #a1 #bjbj1 the ,secretary shall1 in accordance with subparagraph 7,b71 create additional groups of covered ,,opd services to classify separately from other covered ,,opd services the following3 7i7 ,existing pass-through drugs and devices ,medical devices and drugs that met the requirements of paragraph 7#f77;,a77iv7 and were receiving payment under paragraph 7#f7 by reason of satisfying such requirements beginning on or after the date of enactment of this paragraph4 7ii7 ,retired pass-through drugs and devices ,medical devices and drugs that had met the requirements of paragraph 7#f77;,a77iv7 and were receiving payment under paragraph 7#f7 by reason of satisfying such requirements before the date of enactment of this paragraph but after ,january #a1 #bjaj4 7,b7 ,considerations ,in carrying out subparagraph 7,a71 the ,secretary shall-- 7i7 bundle procedures and services that employ a device to which such subparagraph applies with all relevant diagnostic tests and surgical procedures1 as applicable2 7ii7 bundle procedures and services that employ a drug1 with respect to which payment is not made on or after the date specified in subparagraph 7,a7 in accordance with the methodology under section #ahdg;,a and to which such subparagraph applies1 with all relevant diagnostic tests and surgical procedures1 as applicable2 and 7iii7 include such relevant diagnostic tests and surgical procedures in more than one group created under such subparagraph1 as necessary4 4 7#b7 ,revision to pass-through period under ,,opps ,section #ahcc7t77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 is amended-- 7,a7 in subparagraph 7,b77iii71 by striking at least #b years1 but not more than #c years and inserting #e years2 and 7,b7 in subparagraph 7,c77i71 by striking at least #b years1 but not more than #c years and inserting #e years4 7#c7 ,appeals process ,section #ahcc7t77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 is amended by adding at the end the following new subparagraph3 7,f7 ,appeals process 7i7 ,in general ,an individual or entity that submits an application for additional payment under this paragraph for a new technology shall be entitled to administrative review of an adverse determination by the ,secretary with respect to such application4 7ii7 ,process ,the ,secretary shall establish a process for administrative review for purposes of clause 7i74 ,under such process1 administrative review shall be conducted by the ,departmental ,appeals ,board of the ,department of ,health and ,human ,services4 ,under such process1 the ,department official involved shall complete administrative review within #ij days of receipt of a request for such review4 4 7#d7 ,effective date ,the amendments made by paragraphs 7#b7 and 7#c7 shall take effect on the date of enactment of this ,act and shall apply with respect to items and services furnished on or after ,january #a1 #bjbj4