[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1253 Reported in Senate (RS)]

                                                       Calendar No. 184
114th CONGRESS
  1st Session
                                S. 1253

                          [Report No. 114-105]

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.


_______________________________________________________________________


                   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.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

<DELETED>SECTION 1. SHORT TITLE.</DELETED>

<DELETED>    This Act may be cited as the ``Patient Access to 
Disposable Medical Technology Act of 2015''.</DELETED>

<DELETED>SEC. 2. COVERAGE OF CERTAIN DISPOSABLE MEDICAL TECHNOLOGIES 
              UNDER THE MEDICARE PROGRAM.</DELETED>

<DELETED>    (a) Coverage.--Section 1861 of the Social Security Act (42 
U.S.C. 1395x) is amended--</DELETED>
        <DELETED>    (1) in subsection (n)--</DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (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</DELETED>
        <DELETED>    (2) by adding at the end the following new 
        subsection:</DELETED>

     <DELETED>``Substitute Disposable Medical Technology</DELETED>

<DELETED>    ``(iii) The term `substitute disposable medical 
technology' means medical equipment that--</DELETED>
        <DELETED>    ``(1) is primarily and customarily used to serve a 
        medical purpose;</DELETED>
        <DELETED>    ``(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</DELETED>
        <DELETED>    ``(3) the Secretary determines substitutes for 
        durable medical equipment.</DELETED>
<DELETED>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.''.</DELETED>
<DELETED>    (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:</DELETED>
        <DELETED>    ``(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:</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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--</DELETED>
                        <DELETED>    ``(i) calculating the sum of the 
                        amounts of payment that otherwise would be made 
                        under this section for--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(II) all related 
                                supplies and service fees incurred in 
                                conjunction with the use and 
                                maintenance of such item of durable 
                                medical equipment;</DELETED>
                        <DELETED>    ``(ii) calculating the amount that 
                        is 95 percent of the sum calculated under 
                        clause (i); and</DELETED>
                        <DELETED>    ``(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--</DELETED>
                                <DELETED>    ``(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</DELETED>
                                <DELETED>    ``(II) any related 
                                supplies and service fees incurred in 
                                conjunction with the use and 
                                maintenance of such 
                                technologies,</DELETED>
                        <DELETED>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.</DELETED>
                <DELETED>    ``(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.</DELETED>
                <DELETED>    ``(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).''.</DELETED>
<DELETED>    (c) Conforming Amendment.--Section 1847(a)(7)(B) of the 
Social Security Act (42 U.S.C. 1395w-3(a)(7)(B)) is amended--</DELETED>
        <DELETED>    (1) in clause (i), by striking ``and'' at the 
        end;</DELETED>
        <DELETED>    (2) in clause (ii), by striking the period at the 
        end and inserting ``; and''; and</DELETED>
        <DELETED>    (3) by adding at the end the following new 
        clause:</DELETED>
                        <DELETED>    ``(iii) that are substitute 
                        disposable medical technologies (as defined in 
                        section 1861(iii)).''.</DELETED>
<DELETED>    (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.</DELETED>
<DELETED>    (e) Rule of Construction; Implementation.--</DELETED>
        <DELETED>    (1) Rule of construction.--Nothing in this section 
        or the amendments made by this section shall be construed as--
        </DELETED>
                <DELETED>    (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</DELETED>
                <DELETED>    (B) affecting the ability of the Medicare 
                beneficiary to access appropriate durable medical 
                equipment or other appropriate medical device or 
                technology for such treatment.</DELETED>
        <DELETED>    (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.</DELETED>

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Patient Access to Disposable Medical 
Technology Act of 2015''.

SEC. 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.''.
                                                       Calendar No. 184

114th CONGRESS

  1st Session

                                S. 1253

                          [Report No. 114-105]

_______________________________________________________________________

                                 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.

_______________________________________________________________________

                             July 30, 2015

        Reported with an amendment and an amendment to the title