,,ii ,calendar ,no4 #ahd #aadth ,,congress #ast ,session ,s4 #abec ,report ,no4 #aad-aje ,,in ,,the ,,senate ,,of ,,the ,,united ,,states ,may #g1 #bjae,mr4 ,burr 7for himself1 ,mr4 ,bennet1 and ,mr4 ,alexander7 introduced the following bill2 which was read twice and referred to the ,committee on ,finance ,july #cj1 #bjae,reported by ,mr4 ,hatch1 with an amendment and an amendment to the title,strike out all after the enacting clause and insert the part printed in italic ,a ,,bill ,to amend title ,,xviii of the ,social ,security ,act to provide coverage of certain disposable medical technologies under the ,medicare program1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,patient ,access to ,disposable ,medical ,technology ,act of #bjae4 #b4 ,coverage of certain disposable medical technologies under the ,medicare program 7a7 ,coverage ,section #ahfa of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7 is amended-- 7#a7 in subsection 7n7-- 7,a7 by inserting substitute disposable medical technologies 7as defined in subsection 7iii77 and services and supplies used in conjunction with such technologies1 after hospital beds12 and 7,b7 by inserting 7unless such equipment is a substitute disposable medical technology or a service or supply used in conjunction with such a technology7 after rental basis2 and 7#b7 by adding at the end the following new subsection3 7iii7 ,substitute disposable medical technology ,the term substitute disposable medical technology means medical equipment that-- 7#a7 is primarily and customarily used to serve a medical purpose2 7#b7 would otherwise be covered as durable medical equipment under this title but for the fact that such equipment is not durable 7as defined by the ,secretary for purposes of coverage of durable medical equipment under this title72 and 7#c7 the ,secretary determines substitutes for durable medical equipment4 ,in making the determination under paragraph 7#c71 the ,secretary shall consult with medical specialty societies1 medical device manufacturers1 patient groups1 and other stakeholders as part of the annual rulemaking process for durable medical equipment under this title4 4 7b7 ,payment provisions ,section #ahcd7;a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7a77 is amended by adding at the end the following new paragraph3 7#bc7 ,special payment rule for substitute disposable medical technologies ,notwithstanding the preceding provisions of this subsection1 the ,secretary shall determine the payment amount under this subsection for a substitute disposable medical technology 7as defined in section #ahfa7;iii771 and for any related supplies and service fees incurred in conjunction with the use and maintenance of such technology1 in accordance with the following3 7,a7 ,single payment amount ,the ,secretary shall determine a single payment amount that shall be paid for a substitute disposable medical technology and for any related supplies and service fees incurred in conjunction with the use and maintenance of such technology4 ,a payment for such a technology and for any such related supplies and service fees made in the amount of such single payment amount shall constitute full payment under this title for such technology and such related supplies and service fees4 7,b7 ,calculation of payment amount ,the single payment amount described in subparagraph 7,a7 for a substitute disposable medical technology and for any related supplies and service fees incurred in conjunction with the use and maintenance of such technology shall be calculated by-- 7i7 calculating the sum of the amounts of payment that otherwise would be made under this section for-- 7,i7 the item of durable medical equipment for which the ,secretary determines1 pursuant to section #ahfa7;iii77#c71 that such substitute disposable medical technology substitutes2 and 7,,ii7 all related supplies and service fees incurred in conjunction with the use and maintenance of such item of durable medical equipment2 7ii7 calculating the amount that is #ie percent of the sum calculated under clause 7i72 and 7iii7 calculating the single payment amount for the substitute disposable medical technology and for any related supplies and service fees incurred in conjunction with the use and maintenance of such technology such that the sum of the payments under this subsection for-- 7,i7 all substitute disposable medical technologies that the ,secretary determines1 pursuant to section #ahfa7;iii77#c71 will be necessary to provide a substitute for the item of durable medical equipment described in clause 7i77,i72 and 7,,ii7 any related supplies and service fees incurred in conjunction with the use and maintenance of such technologies1 and is equal to the amount calculated under clause 7ii74 ,in making such calculation1 the ,secretary shall consult with medical specialty societies1 medical device manufacturers1 patient groups1 and other stakeholders to ensure that an appropriate comparison is made that captures use of the various technologies 7including related supplies1 if any7 over an average course of therapy for a typical patient4 7,c7 ,lump-sum payment ,the single payment amount described in subparagraph 7,a7 for a substitute disposable medical technology and for any related supplies and service fees incurred in conjunction with the use and maintenance of such technology shall be made in a lump-sum amount4 7,d7 ,payment for physicians' and hospital outpatient department services ,nothing in this paragraph should be construed as limiting or changing payment for items or services for which payment is made under section #ahdh or section #ahcc7t74 4 7c7 ,conforming amendment ,section #ahdg7;a77#g77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c7;a77#g77;,b77 is amended-- 7#a7 in clause 7i71 by striking and at the end2 7#b7 in clause 7ii71 by striking the period at the end and inserting 2 and2 and 7#c7 by adding at the end the following new clause3 7iii7 that are substitute disposable medical technologies 7as defined in section #ahfa7;iii774 4 7d7 ,effective date ,the provisions of1 and amendments made by1 this section shall apply with respect to items and services furnished on or after ,january #a1 #bjaf4 7e7 ,rule of construction2 implementation 7#a7 ,rule of construction ,nothing in this section or the amendments made by this section shall be construed as-- 7,a7 affecting the ability of a physician 7or any other prescribing practitioner7 to exercise their judgment in prescribing or ordering for a ,medicare beneficiary appropriate durable medical equipment or other medical device or technology for the treatment of an illness1 injury1 or condition of the ,medicare beneficiary2 or 7,b7 affecting the ability of the ,medicare beneficiary to access appropriate durable medical equipment or other appropriate medical device or technology for such treatment4 7#b7 ,implementation ,the ,secretary shall implement the provisions of1 and amendments made by1 this section in a manner such that the methodologies for determining coverage of an item of durable medical equipment 7as defined in section #ahfa7n7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7n777 7other than such an item that is a substitute disposable medical technology 7as defined in section #ahfa7;iii777 and the payment amount for the item of durable medical equipment 7other than such an item that is a substitute disposable medical technology 7as so defined77 under section #ahcd or #ahdg of such ,act 7#db ,u4,s4,c4 #aciem1 #aciew-#c71 as the case may be1 is not affected by the coverage of and payment amount for a substitute disposable medical technology under sections #ahfa7;iii7 and #ahcd7;a77#bc7 of such ,act1 respectively1 as added by subsections 7a7 and 7b71 respectively4 #a4 ,short title ,this ,act may be cited as the ,patient ,access to ,disposable ,medical ,technology ,act of #bjae4 #b4 ,treatment of disposable devices 7a7 ,in general ,section #ahcd of the ,social ,security ,act 7#db ,u4,s4,c4 #aciem7 is amended by adding at the end the following new subsection3 7s7 ,payment for applicable disposable devices 7#a7 ,separate payment ,the ,secretary shall make a payment 7separate from the payments otherwise made under section #ahie7 in the amount established under paragraph 7#c7 to a home health agency for an applicable disposable device 7as defined in paragraph 7#b77 when furnished on or after ,january #a1 #bjag1 to an individual who receives home health services for which payment is made under section #ahie7;b74 7#b7 ,applicable disposable device ,in this subsection1 the term applicable disposable device means a disposable device that1 as determined by the ,secretary1 is-- 7,a7 a disposable negative pressure wound therapy device that is an integrated system comprised of a non-manual vacuum pump1 a receptacle for collecting exudate1 and dressings for the purposes of wound therapy2 and 7,b7 a substitute for1 and used in lieu of1 a negative pressure wound therapy durable medical equipment item that is an integrated system of a negative pressure vacuum pump1 a separate exudate collection canister1 and dressings that would otherwise be covered for individuals for such wound therapy4 7#c7 ,payment amount ,the ,secretary shall establish the separate payment amount for an applicable disposable device such that such amount is equal to-- 7,a7 for #bjag1 #bjah1 and #bjai1 the greater of-- 7i7 the payment that would be made under section #ahcc7t7 7relating to payment for covered ,,opd services7 for the year for the ,level ,i ,healthcare ,common ,procedure ,coding ,system 7,,hcpcs7 code for which the description for a professional service includes the furnishing of such device2 or 7ii7 an amount equal to #aej percent of the payment that applied under such section #ahcc7t7 for #bjae for such ,,hcpcs code2 and 7,b7 for #bjbj and each subsequent year1 the payment that would be made under such section #ahcc7t7 for the year for such ,,hcpcs code4 4 7b7 ,conforming amendments 7#a7 ,coinsurance ,section #ahcc7;a77#a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciel7a77#a77 is amended-- 7,a7 by striking and before 7,z72 and 7,b7 by inserting before the semicolon at the end the following3 1 and 7,,aa7 with respect to an applicable disposable device 7as defined in paragraph 7#b7 of section #ahcd7s77 furnished to an individual pursuant to paragraph 7#a7 of such section1 the amount paid shall be equal to #hj percent of the lesser of the actual charge or the amount determined under paragraph 7#c7 of such section4 7#b7 ,home health ,section #ahfa7m77#e7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciex7m77#e77 is amended by inserting and applicable disposable devices 7as defined in section #ahcd7s77#b77 after durable medical equipment4 7c7 ,reports 7#a7 ,,gao study and report on disposable devices 7,a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the value of disposable devices to the ,medicare program and ,medicare beneficiaries and the role of disposable devices as substitutes for durable medical equipment4 ,such study shall address the following3 7i7 ,the types of disposable devices that could potentially qualify as being substitutes for durable medical equipment under the ,medicare program1 the similarities and differences between such disposable devices and the durable medical equipment for which they would be a substitute1 and the extent to which other payers1 including the ,medicaid program and private payers1 cover such disposable devices4 7ii7 ,views of1 and information from1 medical device manufacturers1 providers of services1 and suppliers on the incentives and disincentives under current ,medicare coverage and payment policies for disposable devices that are substitutes for durable medical equipment and how such policies affect manufacturers' decisions to develop innovative products and providers' and suppliers' decisions to use such products4 7iii7 ,implications of expanding coverage under the ,medicare program to include additional disposable devices that are substitutes for durable medical equipment4 7iv7 ,payment methodologies that could be used to pay for disposable devices that are substitutes for durable medical equipment other than applicable disposable devices pursuant to the amendments made by subsections 7a7 and 7b74 7v7 ,other applicable areas determined appropriate by the ,comptroller ,general4 7,b7 ,report ,not later than #ah months after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress and the ,secretary of ,health and ,human ,services a report on the study conducted under subparagraph 7,a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines to be appropriate4 7#b7 ,,gao study and report on the impact of the payment of applicable disposable devices 7,a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on the impact of the payment for applicable disposable devices 7as defined in section #ahcd7s77#b7 of the ,social ,security ,act7 under the provisions of1 and amendments made by1 subsections 7a7 and 7b74 ,such study shall address the following3 7i7 ,the impact on utilization and ,medicare program and beneficiary spending as a result of such provisions and amendments4 7ii7 ,the type of ,medicare beneficiaries who1 under the home health benefit1 use the applicable disposable device and the period of use of the applicable disposable devices compared to the beneficiaries who use the substitute durable medical equipment and their period of use4 7iii7 ,how payment rates of other payers1 including the ,medicaid program and private payers1 for applicable disposable devices compare to the payment rates for such devices under such provisions and amendments4 7iv7 ,other applicable areas determined appropriate by the ,comptroller ,general4 7,b7 ,report ,not later than #d years after the date of the enactment of this ,act1 the ,comptroller ,general of the ,united ,states shall submit to ,congress and the ,secretary of ,health and ,human ,services a report on the study conducted under subparagraph 7,a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines to be appropriate4 7d7 ,effective date ,the amendments made by this section shall apply to items furnished on or after ,january #a1 #bjag4 ,amend the title so as to read3 ,a bill to amend title ,,xviii of the ,social ,security ,act to provide for the treatment of certain disposable medical technologies under the ,medicare program44 ,july #cj1 #bjae,reported with an amendment and an amendment to the title