,,ii #aadth ,,congress #b;d ,session ,s4 #biih ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #bf1 #bjaf,mr4 ,coats 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 ensure prompt coverage of breakthrough devices under the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,ensuring ,patient ,access to ,critical ,breakthrough ,products ,act of #bjaf4 #b4 ,coverage and payment for breakthrough devices under the ,medicare program 7a7 ,in general ,part ,e of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex et seq47 is amended by adding at the end the following new section3 #ahii;,c4 ,coverage of breakthrough devices 7a7 ,breakthrough devices 7#a7 ,in general ,for purposes of this section1 the term breakthrough device means a medical device that is a device 7as defined in section #bja of the ,federal ,food1 ,drug1 and ,cosmetic ,act7 and that either-- 7,a7 is-- 7i7 provided with review priority by the ,secretary under subsection 7d77#e7 of section #eae of such ,act2 and 7ii7 approved under such section for use in treating an indication2 or 7,b7 subject to paragraph 7#b71 is cleared under section #eaj7k7 of such ,act for use in treating an indication4 7#b7 ,limitation on number of #eaj7k7 devices ,with respect to a #e-year period1 in no case may more than five medical devices described in paragraph 7#a77;,b7 be covered and paid for under this title by reason of this section during each such #e-year period4 7b7 ,coverage 7#a7 ,transitional coverage 7,a7 ,in general ,during the transitional coverage period 7as defined in subparagraph 7,b77 a breakthrough device shall be-- 7i7 deemed to be reasonable and necessary for purposes of section #ahfb7;a77#a77;,a72 7ii7 deemed to be approved for an additional payment under section #ahhf7;d77#e77,k72 7iii7 deemed to be approved for pass-through payment under section #ahcc7t77#f7 and section #ahcc7;i72 and 7iv7 insofar as such breakthrough device may be furnished in a setting for which payment is made under an applicable payment system described in subparagraphs 7,d7 through 7,i7 of subsection 7c77#d71 deemed eligible for an additional payment pursuant to subsection 7d77#c7 when furnished in a setting for which payment is made under such an applicable payment system during such transitional coverage period4 7,b7 ,transitional coverage period defined ,as used in this section1 the term transitional coverage period means1 with respect to a breakthrough device1 the period that-- 7i7 begins on the date of the approval under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or of the clearance under section #eaj7k7 of such ,act1 as applicable1 of such device by the ,secretary for the indication described in subparagraph 7,a77ii7 or 7,b7 of subsection 7a77#a71 respectively2 and 7ii7 ends on the last day of the #c-year period that begins on the date that the ,secretary1 pursuant to subsection 7c77#b71 updates the relevant applicable payment system 7as defined in subsection 7c77#d77 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such breakthrough device1 except as provided in subsections 7d77#a77;,b7 and 7d77#b77;,b74 7#b7 ,process for regular coverage ,for purposes of the application of section #ahfb7;a77#a77;,a7 to a breakthrough device furnished after the transitional coverage period 7as defined in paragraph 7#a77;,b77 for such device1 the ,secretary1 acting through the ,council for ,technology and ,innovation 7established under section #ahfh7;b77 in conjunction with the ,coverage and ,analysis ,group of the ,centers for ,medicare ,medicaid ,services1 shall establish a process for the coverage of such breakthrough devices under this title after such period as follows3 7,a7 ,identification of additional evidence 7i7 ,in general ,with respect to a breakthrough device1 not later than #a year after the date of the approval of such device under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or of the clearance of such device under section #eaj7k7 of such ,act1 as applicable1 the ,secretary shall identify whether any additional data or evidence is required with respect to any indications for such device for purposes of the application of such section #ahfb7;a77#a77;,a7 to such device for such indications4 7ii7 ,non-duplication of data requests ,in carrying out clause 7i7 with respect to a breakthrough device1 the ,secretary shall ensure that data or evidence identified-- 7,i7 does not duplicate data required to be collected by the ,food and ,drug ,administration with respect to such breakthrough device2 7,,ii7 minimizes the administrative burdens of data collection and reporting on providers of services1 suppliers1 and manufacturers of breakthrough devices2 and 7,,iii7 is not otherwise unnecessary or redundant4 7,b7 ,proposal for coverage after the transitional coverage period ,not later than #b years after the date of the approval or clearance of a breakthrough device by the ,food and ,drug ,administration1 the ,secretary shall develop a proposal for coverage under this title of such breakthrough device for such indications as the ,secretary determines to be appropriate1 based on the data and evidence collected under subparagraph 7,a71 for such devices furnished after the transitional coverage period under paragraph 7#a7 for such device4 ,if the ,secretary does not1 on a date that is before the end of such two-year period1 take action to modify the indications for which coverage of a breakthrough device may be provided under this title after such period1 for purposes of section #ahfb7;a77#a77;,a7 coverage under this title of such breakthrough device shall be made for all indications for which such device is approved under section #eae of the ,federal ,food1 ,drug1 and ,cosmetic ,act or cleared under section #eaj7k7 of such ,act4 7#c7 ,rules of construction ,nothing in this section shall be construed to-- 7,a7 affect the ability of the manufacturer of a breakthrough device to seek approval for pass-through payment status under section #ahcc7t77#f7 or to seek approval for an additional payment under section #ahhf7;d77#e77,k7 insofar as such breakthrough device does not qualify for transitional coverage under paragraph 7#a72 or 7,b7 affect the application and approval process for pass-through payment status under section #ahcc7t77#f7 or for an additional payment under section #ahhf7;d77#e77,k7 in the case of a medical device that is not approved by the ,food and ,drug ,administration as a breakthrough device4 7c7 ,coding 7#a7 ,prompt assignment ,not later than three months after the date of approval or clearance of a breakthrough device by the ,food and ,drug ,administration1 subject to subparagraph 7,b71 the ,secretary shall assign a unique temporary or permanent code or codes for purposes of coverage and payment for such breakthrough device under the applicable payment systems 7described in paragraph 7#d774 7#b7 ,updates 7,a7 ,,ipps ,the ,secretary shall provide for semiannual updates under the applicable payment system described in paragraph 7#d77;,a7 7relating to the inpatient hospital prospective payment system7 to recognize the code or codes assigned under paragraph 7#a74 7,b7 ,,opps ,the ,secretary shall provide for quarterly updates under the applicable payment system described in paragraph 7#d77;,b7 7relating to the outpatient hospital prospective payment system7 to recognize the code or codes assigned under paragraph 7#a74 7#c7 ,transparency ,the process for the assignment of a code or codes under this subsection shall provide for public notice and a meaningful opportunity for public comment from affected parties4 7#d7 ,applicable payment systems described ,for purposes of this subsection1 the term applicable payment systems means-- 7,a7 with respect to inpatient hospital services1 the prospective payment system for inpatient hospital services established under section #ahhf7;d72 7,b7 with respect to outpatient hospital services1 the prospective payment system for covered ,,opd services established under section #ahcc7t72 7,c7 with respect to ambulatory surgical center services1 the fee schedule for such services established under #ahcc7;i72 7,d7 with respect to physicians' services1 the physician fee schedules established under section #ahdh2 7,e7 with respect to covered items of durable medical equipment1 the applicable fee schedules established under section #ahcd2 7,f7 with respect to diagnostic laboratory tests1 the fee schedule established under section #ahcd7;h71 the payment amounts under section #ahcd;,a1 and the fee schedules establish under section #ahdh1 as the case may be2 7,g7 with respect to inpatient hospital services furnished by rehabilitation facilities1 the prospective payment system established under section #ahhf7;j72 7,h7 with respect to inpatient hospital services furnished by long-term care hospitals1 the prospective payment system under section #ahhf7m72 and 7,i7 with respect to inpatient hospital services furnished by psychiatric hospitals and psychiatric units1 the prospective payment system under section #ahhf7s74 7d7 ,payment 7#a7 ,inpatient hospital prospective payment system3 deemed eligibility for breakthrough payment ,the ,secretary shall deem each breakthrough device as approved for an additional payment under section #ahhf7;d77#e77,k7 for the #c-year period that begins-- 7,a7 except as provided in subparagraph 7,b71 on the date that the ,secretary1 pursuant to subsection 7c77#b77;,a71 updates the payment system under section #ahhf7;d7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such breakthrough device2 or 7,b7 in the case of a device that has not received approval or clearance as a breakthrough device by the ,food and ,drug ,administration before such payment system is updated under subsection 7c77#b77;,a7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such device1 on the date of such approval or clearance4 ,nothing in this paragraph shall be construed to affect the authority of the ,secretary to use claims data to establish new diagnosis or procedure codes for breakthrough devices or to identify appropriate diagnosis-related groups for the assignment of breakthrough devices under annual rulemaking to carry out section #ahhf7;d77#e77,k74 7#b7 ,outpatient prospective payment system3 deemed eligibility for pass-through payment ,the ,secretary shall deem each breakthrough device as approved for pass-through payment under section #ahcc7t77#f7 7including for purposes of section #ahcc7;i77#b77;,d77 during the #c-year period that begins-- 7,a7 except as provided in subparagraph 7,b71 on the date that the ,secretary1 pursuant to subsection 7c77#b77;,b71 updates the payment system under section #ahcc7t7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such breakthrough device2 or 7,b7 in the case of a device that has not received approval or clearance as a breakthrough device by the ,food and ,drug ,administration before such payment system is updated under subsection 7c77#b77;,b7 to recognize the unique temporary or permanent code or codes assigned under subsection 7c77#a7 to such device1 on the date of such approval or clearance4 ,nothing in this paragraph shall be construed to affect the authority of the ,secretary to use claims data to establish new ambulatory payment classification groups for breakthrough devices or to revise such groups to take into account breakthrough devices under annual rulemaking to carry out section #ahcc7t74 7#c7 ,other payment systems 7,a7 ,in general ,in the case of breakthrough device that is furnished and for which payment may be made under the payment system established under sections #ahcd1 #ahcd;,a1 #ahdh1 #ahhf7;j71 #ahhf7m71 #ahhf7s71 or any other relevant provision of this title 7other than sections #ahcc7;i71 #ahcc7t71 and #ahhf7;d771 the ,secretary shall provide for an additional payment for such breakthrough device under such payment systems in an amount equal to #hj percent of the costs of such breakthrough device4 7,b7 ,rule of construction ,nothing in this paragraph shall be construed to affect the authority of the ,secretary to use claims data to establish new or modify existing ambulatory payment classification groups1 diagnosis-related groups1 level ,,ii ,,hcpcs codes or such other groups or codes as the ,secretary may establish under the annual rulemaking authority under the provisions referred to in subparagraph 7,a74 7#d7 ,payment for breakthrough devices after the transitional coverage period ,payment for a breakthrough device that is furnished after the conclusion of the transitional coverage period under subsection 7b77#a7 for such device shall be made pursuant to the applicable payment system involved1 taking into account the additional evidence and data collected under subsection 7b77#b74 7e7 ,treatment of breakthrough devices under pay-for-,performance programs 7#a7 ,pay-for-performance programs defined ,in this subsection1 the term pay-for-performance programs means1 with respect to items and services for which payment is made under the applicable payment systems under this title1 payment initiatives designed to improve the quality1 efficiency1 and overall value of health care furnished to individuals entitled to benefits under part ,a or enrolled under part ,b through financial incentives to providers of services and suppliers for meeting or exceeding certain quality or performance measures or through financial penalties on providers that fail to achieve specified goals or cost savings1 or both4 ,such term includes-- 7,a7 the ,medicare shared savings program under established section #ahii2 7,b7 shared savings programs tested by the ,center for ,medicare and ,medicaid ,innovation under section #aaae;,a1 including the ,pioneer ,,aco program2 7,c7 the ,national ,pilot ,program on ,payment ,bundling under section #ahff;,d2 7,d7 bundled payment programs tested by the ,center for ,medicare and ,medicaid ,innovation under section #aaae;,a2 and 7,e7 any other similar program conducted under this title or under applicable authorities under title ,,xi4 7#b7 ,exclusion of additional costs of breakthrough devices ,insofar as the amount of payment for a breakthrough device exceeds the amount of payment that the item or service would otherwise receive under a pay-for-performance program for which shared savings or shared losses are calculated1 the ,secretary shall exclude from the calculation of such shared savings or losses under such program for such period the amount by which the payment for the breakthrough device involved exceeds the payment amount for such other item or service that would have been made but for the use of the breakthrough device4 7#c7 ,adjustment to quality process measures for breakthrough devices 7,a7 ,in general ,in the case that the furnishing by a provider of services or supplier participating in a pay-for-performance program of a breakthrough device to an individual entitled to benefits under part ,a or enrolled under part ,b and participating in such program would result in such provider or supplier1 with respect to the condition and episode of care for which such device is furnished1 receiving a poor or failing score for a quality measure under such program that measures whether such provider or supplier gave the treatment known to give the best results for most patients with a particular condition 7commonly known as a clinical process of care measure71 the ,secretary shall exclude such quality measure from any determination of whether such provider or supplier met applicable quality performance thresholds under such program with respect to such condition and episode of care of such individual4 7,b7 ,inapplicability to clinical outcomes measures ,nothing in subparagraph 7,a7 may be construed to allow for the exclusion1 with respect to a breakthrough device furnished to an individual by a provider or supplier under a pay-for-performance program1 of any quality measure designed to reflect the results of care furnished to such individual by such provider or supplier 7commonly known as a clinical outcome measure7 from a determination described in such subparagraph4 4 7b7 ,study on limit of #eaj7k7 breakthrough devices 7#a7 ,study ,the ,secretary of ,health and ,human ,services shall conduct a study on the effect of the limit 7under section #ahii;,c7a77#b7 of the ,social ,security ,act1 as added by subsection 7a77 on the number of devices cleared under section #eaj7k7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cfj7k77 that are breakthrough devices for purposes of such section #ahii;,c4 7#b7 ,matters examined ,in conducting the study described in paragraph 7#a71 the ,secretary shall-- 7,a7 determine the number of medical devices cleared under such section #eaj7k7 during the #e-year period beginning on the date of the enactment of this ,act2 7,b7 determine the number of such devices that were not breakthrough devices for purposes of such section #ahii;,c by reason of the limitation under subsection 7a77#b7 of such section2 and 7,c7 examine the impact of such limitation on access to such devices for individuals entitled to benefits under part ,a or enrolled in part ,b of title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq474 7#c7 ,report ,not later than #f years after the date of the enactment of this ,act1 the ,secretary shall submit to ,congress a report on the study conducted under this subsection and shall include such recommendations for legislative or administrative changes as the ,secretary determines to be appropriate4 7c7 ,modifications to the council for technology and innovation 7#a7 ,expansion of duties ,paragraph 7#c7 of section #ahfh7;b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acie;ee7b77 is amended by adding at the end the following3 ,the ,council shall also coordinate activities of the ,secretary for the implementation of section #ahii;,c 7relating to breakthrough devices71 especially with respect to timely coverage1 coding1 evidence-gathering1 and payment for such devices44 7#b7 ,reorganization within the ,,cmmi ,such section is further amended-- 7,a7 in paragraph 7#a71 by striking within the ,centers and all that follows through the end and inserting within the ,center for ,medicare and ,medicaid ,innovation established under section #aaae;,a 7in this subsection referred to as ,,cmmi742 and 7,b7 in paragraph 7#d71 by striking the ,administrator of ,,cms and inserting the ,director of the ,,cmmi4 7d7 ,improvements to ,,ntap payment adjustment under the inpatient prospective payment system 7#a7 ,payment for costs of new technologies ,with respect to hospital discharges for which payment is made under section #ahhf7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77 occurring on or after ,october #a1 #bjaf1 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 ,regulations1 as if the reference to #ej percent each place it appears in such section were a reference to #hj percent4 7#b7 ,clarification regarding payments for new technologies 7,a7 ,,ipps new technology payment ,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 ,during the period with respect to which a new medical service or technology is eligible for an additional payment under this subsection by reason of this subparagraph1 any local coverage determination 7as defined in section #ahfi7;f77#b77;,b77 that would affect the coverage of1 or the additional payment under this subsection for1 such new medical service or technology shall have no force or effect in law or regulation4 4 7,b7 ,conforming amendment for opps pass-through payment ,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,g7 ,prohibition on use of local coverage determinations to affect coverage of and payment for pass-through devices ,during the period with respect to which a drug1 biological1 or medical device is eligible for an additional payment under this paragraph1 any local coverage determination 7as defined in section #ahfi7;f77#b77;,b77 that would affect the coverage of1 or the additional payment under this paragraph for1 such drug1 biological1 or medical device shall have no force or effect in law or regulation4 4 7,c7 ,effective date ,this paragraph1 and the amendments made by this paragraph1 shall apply with respect to items and services furnished on or after the date of the enactment of this ,act1 including any such item or service that is eligible on such date for an additional payment under section #ahcc7t77#f7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7t77#f77 or under section #ahhf7;d7 of such ,act 7#db ,u4,s4,c4 #acieww7d77 by reason of paragraph 7#e77,k7 of such section1 or that would have been so eligible on such date but for a local coverage determination that limits or denies coverage of and such additional payment for the item or service4 7#c7 ,revision to the cost threshold 7,a7 ,in general ,section #ahhf7;d77#e77,k77ii77,i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77ii77,i77 is amended by striking #ge percent each place it appears and inserting #ej percent4 7,b7 ,effective date ,the amendment made by subparagraph 7,a7 shall take effect on the date of the enactment of this ,act4 7#d7 ,use of best available cost data for ,,ms-,,drg classification 7,a7 ,in general ,section #ahhf7;d77#e77,k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k771 as amended by paragraph 7#b77;,a71 is further amended by adding at the end the following new clause3 7xi7 ,in carrying out the requirement under clause 7ii77,,iv7 for classification of a new medical service or technology to a new or existing diagnosis-related group after the close of the period under clause 7ii77,,ii71 the ,secretary shall use the most recently available data and information on the costs of such service or technology in making such a classification for the service or technology1 including data and information from surveys of providers of services and suppliers conducted by the ,secretary1 private payers1 health plans1 physician specialty societies1 or manufacturers as well as commercial price data and data from manufacturer invoices4 4 7,b7 ,effective date ,the amendment made by subparagraph 7,a7 shall take effect on the date of the enactment of this ,act4 7#e7 ,criteria applied in making substantial improvement determinations 7,a7 ,in general ,section #ahhf7;d77#e77,k7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k771 as amended by paragraphs 7#b77;,a7 and 7#d77;,a71 is further amended by adding at the end the following new clause3 7xii7 7,i7 ,in making a determination under this subparagraph whether a new medical service or technology represents an advance in medical technology that substantially improves the diagnosis or treatment of ,medicare beneficiaries relative to a medical service or technology that was previously available1 the ,secretary shall also consider whether such new medical service or technology meets one or more of the following criteria3 7aa7 ,the use of the new medical service or technology can result in a reduction of the length of a hospital stay4 7bb7 ,the use of the new medical service or technology can improve patient quality of life4 7cc7 ,the use of the new medical service or technology can create long-term clinical efficiencies in treatment4 7dd7 ,the use of the new medical service or technology can address patient-centered objectives 7as defined by the ,secretary74 7ee7 ,the use of the new medical service or technology can meet such other criteria as the ,secretary may specify4 7,,ii7 ,in considering whether a new medical service or technology potentially meets the criteria under subclause 7,i71 the ,secretary shall consider the following forms of evidence3 7aa7 ,evidence described in well-documented case histories1 including registry data4 7bb7 ,studies published in peer-reviewed journals4 7cc7 ,data collected in countries other than the ,united ,states so long as such data otherwise meet the criteria specified in this clause4 4 7,b7 ,effective date ,the amendment made by subparagraph 7,a7 shall take effect on the date of the enactment of this ,act4 7#f7 ,revision to the newness criterion 7,a7 ,in general ,section #ahhf7;d77#e77,k77vi7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77vi77 is amended-- 7i7 by inserting 7,i7 after 7vi72 and 7ii7 by adding at the end the following new subclauses3 7,,ii7 ,under the criteria established under this clause with respect to the determination of whether a medical service or technology is considered new for purposes of this subparagraph and subparagraph 7,l71 the ,secretary shall include devices that involve a significant technological change that do not raise different questions of safety and effectiveness 7in a comparison to the predicate device7 and result in enhanced clinical advantages or reduced cost1 even though they use the same or similar mechanism of action or are assigned to the same diagnosis-related group4 7,,iii7 ,under the criteria established under this clause with respect to the determination of whether a medical service or technology is considered new for purposes of this subparagraph and subparagraph 7,l71 the ,secretary shall not disqualify a new medical service or technology as not meeting the newness criterion solely on the basis of a finding of a de minimis number of claims for such medical service or technology in ,medicare claims data4 ,for purposes of this subclause1 the term de minimis means1 with respect to claims1 an amount that is fewer than #ej4 4 7,b7 ,effective date ,the amendment made by subparagraph 7,a7 shall take effect on the date of the enactment of this ,act4 7#g7 ,revision to the commencement of the period for collection of cost data for new technologies 7,a7 ,in general ,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,b7 ,effective date ,the amendment made by subparagraph 7,a7 shall take effect on the date of the enactment of this ,act1 and shall apply with respect to hospital discharges for inpatient hospital services for which payment is made under section #ahhf7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 occurring on or after ,october #a1 #bjaf4 7#h7 ,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,k771 as amended by paragraphs 7#b77;,a71 7#d77;,a71 and 7#e77;,a71 is further amended by adding at the end the following new clause3 7xiii7 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 an official of the ,department of ,health and ,human ,services 7other than an official of the ,centers for ,medicare ,medicaid ,services74 ,under such process1 the ,department official involved shall complete administrative review within #ij days of receipt of a request for such review4 7,,iii7 ,in the case of an application for additional payment under this subparagraph for a new technology that is approved under administrative review1 the ,secretary shall provide for such additional payment for such new technology during the period that-- 7aa7 begins on the date that is the first day of the first calendar quarter that begins after the date of the completion of such administrative review2 and 7bb7 ends on the date that is not less than #b years and not more than #c years after the date referred to in item 7aa74 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 with respect to a discharge occurring on or after the date of the date of the enactment of the ,ensuring ,patient ,access to ,critical ,breakthrough ,products ,act of #bjaf after paragraph 7#d77;,d74 7,c7 ,effective date ,the amendments made by this paragraph shall take effect on the date of the enactment of this ,act1 and shall apply with respect to hospital discharges for inpatient hospital services for which payment is made under section #ahhf7;d7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7 occurring on or after ,october #a1 #bjaf4 7e7 ,conforming amendments 7#a7 ,inpatient prospective payment system ,section #ahhf7;d77#e77,k77i7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acieww7d77#e77,k77i77 is amended by adding at the end the following new sentence3 ,effective for discharges occurring on or after ,october #a1 #bjaf1 in the case of a new medical service or technology that is a breakthrough device 7as defined in section #ahii;,c7a77 payment for such breakthrough device shall be made for the #c-year period applicable to such breakthrough device under section #ahii;,c7d77#a744 7#b7 ,outpatient prospective payment system ,section #ahcc7t77#f77;,c7 of such ,act 7#db ,u4,s4,c4 #aciel7t77#f77;,c77 is amended by adding at the end the following new clause3 7iii7 ,special rule for breakthrough devices ,notwithstanding clause 7i7 or 7ii71 or any other provision of this paragraph to the contrary1 in the case of a breakthrough device 7as defined in section #ahii;,c7a77 that is furnished on or after ,january #a1 #bjag1 payment under this paragraph for such breakthrough device shall be made for the #c-year period applicable to such breakthrough device under section #ahii;,c7d77#b74 ,the provisions of this clause shall also apply for purposes of transitional pass-through payment under section #ahcc7;i77#b77;,d74 4 7f7 ,effective date ,this section and the amendments made by this section shall take effect on the date of the enactment of this ,act and1 unless otherwise specified in this section 7or in an amendment made by this section71 shall apply to breakthrough devices 7as defined in section #ahii;,c7a71 as added by subsection 7a77 approved on or after ,january #a1 #bjag4