II Calendar No. 184 114th CONGRESS 1st Session S. 1253 [Report No. 114–105] IN THE SENATE OF THE UNITED STATES May 7, 2015 Mr. Burr (for himself, Mr. Bennet , and Mr. Alexander ) introduced the following bill; which was read twice and referred to the Committee on Finance July 30, 2015 Reported by Mr. Hatch , 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 program, and for other purposes.

1. Short title This Act may be cited as the Patient Access to Disposable Medical Technology Act of 2015 . 2. Coverage of certain disposable medical technologies under the Medicare program (a) Coverage Section 1861 of the Social Security Act ( 42 U.S.C. 1395x ) is amended— (1) in subsection (n)— (A) by inserting substitute disposable medical technologies (as defined in subsection (iii)) and services and supplies used in conjunction with such technologies, after hospital beds, ; and (B) by inserting (unless such equipment is a substitute disposable medical technology or a service or supply used in conjunction with such a technology) after rental basis ; and (2) by adding at the end the following new subsection: (iii) Substitute disposable medical technology The term substitute disposable medical technology means medical equipment that— (1) is primarily and customarily used to serve a medical purpose; (2) would otherwise be covered as durable medical equipment under this title but for the fact that such equipment is not durable (as defined by the Secretary for purposes of coverage of durable medical equipment under this title); and (3) the Secretary determines substitutes for durable medical equipment. In making the determination under paragraph (3), the Secretary shall consult with medical specialty societies, medical device manufacturers, patient groups, and other stakeholders as part of the annual rulemaking process for durable medical equipment under this title. . (b) Payment provisions Section 1834(a) of the Social Security Act ( 42 U.S.C. 1395m(a) ) is amended by adding at the end the following new paragraph: (23) Special payment rule for substitute disposable medical technologies Notwithstanding the preceding provisions of this subsection, the Secretary shall determine the payment amount under this subsection for a substitute disposable medical technology (as defined in section 1861(iii)), and for any related supplies and service fees incurred in conjunction with the use and maintenance of such technology, in accordance with the following: (A) 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 technology. 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 fees. (B) Calculation of payment amount The single payment amount described in subparagraph (A) 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— (i) calculating the sum of the amounts of payment that otherwise would be made under this section for— (I) the item of durable medical equipment for which the Secretary determines, pursuant to section 1861(iii)(3), that such substitute disposable medical technology substitutes; and (II) all related supplies and service fees incurred in conjunction with the use and maintenance of such item of durable medical equipment; (ii) calculating the amount that is 95 percent of the sum calculated under clause (i); and (iii) 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— (I) all substitute disposable medical technologies that the Secretary determines, pursuant to section 1861(iii)(3), will be necessary to provide a substitute for the item of durable medical equipment described in clause (i)(I); and (II) any related supplies and service fees incurred in conjunction with the use and maintenance of such technologies, and is equal to the amount calculated under clause (ii). In making such calculation, the Secretary shall consult with medical specialty societies, medical device manufacturers, patient groups, and other stakeholders to ensure that an appropriate comparison is made that captures use of the various technologies (including related supplies, if any) over an average course of therapy for a typical patient. (C) Lump-sum payment The single payment amount described in subparagraph (A) 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 amount. (D) 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 1848 or section 1833(t). . (c) Conforming amendment Section 1847(a)(7)(B) of the Social Security Act ( 42 U.S.C. 1395w–3(a)(7)(B) ) is amended— (1) in clause (i), by striking and at the end; (2) in clause (ii), by striking the period at the end and inserting ; and ; and (3) by adding at the end the following new clause: (iii) that are substitute disposable medical technologies (as defined in section 1861(iii)). . (d) Effective date The provisions of, and amendments made by, this section shall apply with respect to items and services furnished on or after January 1, 2016. (e) Rule of construction; implementation (1) Rule of construction Nothing in this section or the amendments made by this section shall be construed as— (A) affecting the ability of a physician (or any other prescribing practitioner) 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 illness, injury, or condition of the Medicare beneficiary; or (B) affecting the ability of the Medicare beneficiary to access appropriate durable medical equipment or other appropriate medical device or technology for such treatment. (2) Implementation The Secretary shall implement the provisions of, and amendments made by, this section in a manner such that the methodologies for determining coverage of an item of durable medical equipment (as defined in section 1861(n) of the Social Security Act ( 42 U.S.C. 1395x(n) )) (other than such an item that is a substitute disposable medical technology (as defined in section 1861(iii))) and the payment amount for the item of durable medical equipment (other than such an item that is a substitute disposable medical technology (as so defined)) under section 1834 or 1847 of such Act ( 42 U.S.C. 1395m , 1395w–3), as the case may be, is not affected by the coverage of and payment amount for a substitute disposable medical technology under sections 1861(iii) and 1834(a)(23) of such Act, respectively, as added by subsections (a) and (b), respectively.

1. Short title This Act may be cited as the Patient Access to Disposable Medical Technology Act of 2015 . 2. Treatment of disposable devices (a) In general Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following new subsection: (s) Payment for applicable disposable devices (1) Separate payment The Secretary shall make a payment (separate from the payments otherwise made under section 1895) in the amount established under paragraph (3) to a home health agency for an applicable disposable device (as defined in paragraph (2)) when furnished on or after January 1, 2017, to an individual who receives home health services for which payment is made under section 1895(b). (2) Applicable disposable device In this subsection, the term applicable disposable device means a disposable device that, as determined by the Secretary, is— (A) a disposable negative pressure wound therapy device that is an integrated system comprised of a non-manual vacuum pump, a receptacle for collecting exudate, and dressings for the purposes of wound therapy; and (B) a substitute for, and used in lieu of, a negative pressure wound therapy durable medical equipment item that is an integrated system of a negative pressure vacuum pump, a separate exudate collection canister, and dressings that would otherwise be covered for individuals for such wound therapy. (3) Payment amount The Secretary shall establish the separate payment amount for an applicable disposable device such that such amount is equal to— (A) for 2017, 2018, and 2019, the greater of— (i) the payment that would be made under section 1833(t) (relating to payment for covered OPD services) for the year for the Level I Healthcare Common Procedure Coding System (HCPCS) code for which the description for a professional service includes the furnishing of such device; or (ii) an amount equal to 150 percent of the payment that applied under such section 1833(t) for 2015 for such HCPCS code; and (B) for 2020 and each subsequent year, the payment that would be made under such section 1833(t) for the year for such HCPCS code. . (b) Conforming amendments (1) Coinsurance Section 1833(a)(1) of the Social Security Act ( 42 U.S.C. 1395l(a)(1) ) is amended— (A) by striking and before (Z) ; and (B) by inserting before the semicolon at the end the following: , and (AA) with respect to an applicable disposable device (as defined in paragraph (2) of section 1834(s)) furnished to an individual pursuant to paragraph (1) of such section, the amount paid shall be equal to 80 percent of the lesser of the actual charge or the amount determined under paragraph (3) of such section . (2) Home health Section 1861(m)(5) of the Social Security Act ( 42 U.S.C. 1395x(m)(5) ) is amended by inserting and applicable disposable devices (as defined in section 1834(s)(2)) after durable medical equipment . (c) Reports (1) GAO study and report on disposable devices (A) 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 equipment. Such study shall address the following: (i) The types of disposable devices that could potentially qualify as being substitutes for durable medical equipment under the Medicare program, the similarities and differences between such disposable devices and the durable medical equipment for which they would be a substitute, and the extent to which other payers, including the Medicaid program and private payers, cover such disposable devices. (ii) Views of, and information from, medical device manufacturers, providers of services, 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 products. (iii) Implications of expanding coverage under the Medicare program to include additional disposable devices that are substitutes for durable medical equipment. (iv) 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 (a) and (b). (v) Other applicable areas determined appropriate by the Comptroller General. (B) Report Not later than 18 months after the date of the enactment of this Act, 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 (A), together with recommendations for such legislation and administrative action as the Comptroller General determines to be appropriate. (2) GAO study and report on the impact of the payment of applicable disposable devices (A) Study The Comptroller General of the United States shall conduct a study on the impact of the payment for applicable disposable devices (as defined in section 1834(s)(2) of the Social Security Act) under the provisions of, and amendments made by, subsections (a) and (b). Such study shall address the following: (i) The impact on utilization and Medicare program and beneficiary spending as a result of such provisions and amendments. (ii) The type of Medicare beneficiaries who, under the home health benefit, 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 use. (iii) How payment rates of other payers, including the Medicaid program and private payers, for applicable disposable devices compare to the payment rates for such devices under such provisions and amendments. (iv) Other applicable areas determined appropriate by the Comptroller General. (B) Report Not later than 4 years after the date of the enactment of this Act, 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 (A), together with recommendations for such legislation and administrative action as the Comptroller General determines to be appropriate. (d) Effective date The amendments made by this section shall apply to items furnished on or after January 1, 2017.

Amend the title so as to read: A bill to amend title XVIII of the Social Security Act to provide for the treatment of certain disposable medical technologies under the Medicare program. .

July 30, 2015 Reported with an amendment and an amendment to the title