II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Patient Access to Dis5 posable Medical Technology Act of 2015’’. 


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1 SEC. 2. COVERAGE OF CERTAIN DISPOSABLE MEDICAL 

2 TECHNOLOGIES UNDER THE MEDICARE PRO3 GRAM. 

4 (a) COVERAGE.—Section 1861 of the Social Security 

5 Act (42 U.S.C. 1395x) is amended— 

6 (1) in subsection (n)— 

7 (A) by inserting ‘‘substitute disposable 

8 medical technologies (as defined in subsection 

9 (iii)) and services and supplies used in conjunc10 tion with such technologies,’’ after ‘‘hospital 

11 beds,’’; and 

12 (B) by inserting ‘‘(unless such equipment 

13 is a substitute disposable medical technology or 

14 a service or supply used in conjunction with 

15 such a technology)’’ after ‘‘rental basis’’; and 

16 (2) by adding at the end the following new sub17 section: 

18 ‘‘Substitute Disposable Medical Technology 

19 ‘‘(iii) The term ‘substitute disposable medical tech20 nology’ means medical equipment that— 

21 ‘‘(1) is primarily and customarily used to serve 

22 a medical purpose; 

23 ‘‘(2) would otherwise be covered as durable 

24 medical equipment under this title but for the fact 

25 that such equipment is not durable (as defined by 


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1 the Secretary for purposes of coverage of durable 

2 medical equipment under this title); and 

3 ‘‘(3) the Secretary determines substitutes for 

4 durable medical equipment. 

5 In making the determination under paragraph (3), the 

6 Secretary shall consult with medical specialty societies, 

7 medical device manufacturers, patient groups, and other 

8 stakeholders as part of the annual rulemaking process for 

9 durable medical equipment under this title.’’. 

10 (b) PAYMENT PROVISIONS.—Section 1834(a) of the 

11 Social Security Act (42 U.S.C. 1395m(a)) is amended by 

12 adding at the end the following new paragraph: 

13 ‘‘(23) SPECIAL PAYMENT RULE FOR SUB14 STITUTE DISPOSABLE MEDICAL TECHNOLOGIES.— 

15 Notwithstanding the preceding provisions of this 

16 subsection, the Secretary shall determine the pay17 ment amount under this subsection for a substitute 

18 disposable medical technology (as defined in section 

19 1861(iii)), and for any related supplies and service 

20 fees incurred in conjunction with the use and main21 tenance of such technology, in accordance with the 

22 following: 

23 ‘‘(A) SINGLE PAYMENT AMOUNT.—The 

24 Secretary shall determine a single payment 

25 amount that shall be paid for a substitute disVerDate Sep 11 2014 23:15 Jul 30, 2015 Jkt 049200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6401 E:\BILLS\S1253.RS S1253

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1 posable medical technology and for any related 

2 supplies and service fees incurred in conjunc3 tion with the use and maintenance of such tech4 nology. A payment for such a technology and 

5 for any such related supplies and service fees 

6 made in the amount of such single payment 

7 amount shall constitute full payment under this 

8 title for such technology and such related sup9 plies and service fees. 

10 ‘‘(B) CALCULATION OF PAYMENT

11 AMOUNT.—The single payment amount de12 scribed in subparagraph (A) for a substitute 

13 disposable medical technology and for any re14 lated supplies and service fees incurred in con15 junction with the use and maintenance of such 

16 technology shall be calculated by— 

17 ‘‘(i) calculating the sum of the 

18 amounts of payment that otherwise would 

19 be made under this section for— 

20 ‘‘(I) the item of durable medical 

21 equipment for which the Secretary de22 termines, pursuant to section 

23 1861(iii)(3), that such substitute dis24 posable medical technology sub25 stitutes; and 


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1 ‘‘(II) all related supplies and 

2 service fees incurred in conjunction 

3 with the use and maintenance of such 

4 item of durable medical equipment; 

5 ‘‘(ii) calculating the amount that is 95 

6 percent of the sum calculated under clause 

7 (i); and 

8 ‘‘(iii) calculating the single payment 

9 amount for the substitute disposable med10 ical technology and for any related supplies 

11 and service fees incurred in conjunction 

12 with the use and maintenance of such tech13 nology such that the sum of the payments 

14 under this subsection for— 

15 ‘‘(I) all substitute disposable 

16 medical technologies that the Sec17 retary determines, pursuant to section 

18 1861(iii)(3), will be necessary to pro19 vide a substitute for the item of dura20 ble medical equipment described in 

21 clause (i)(I); and 

22 ‘‘(II) any related supplies and 

23 service fees incurred in conjunction 

24 with the use and maintenance of such 

25 technologies, 


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1 and is equal to the amount calculated 

2 under clause (ii). In making such calcula3 tion, the Secretary shall consult with med4 ical specialty societies, medical device man5 ufacturers, patient groups, and other 

6 stakeholders to ensure that an appropriate 

7 comparison is made that captures use of 

8 the various technologies (including related 

9 supplies, if any) over an average course of 

10 therapy for a typical patient. 

11 ‘‘(C) LUMP-SUM PAYMENT.—The single 

12 payment amount described in subparagraph (A) 

13 for a substitute disposable medical technology 

14 and for any related supplies and service fees in15 curred in conjunction with the use and mainte16 nance of such technology shall be made in a 

17 lump-sum amount. 

18 ‘‘(D) PAYMENT FOR PHYSICIANS’ AND

19 HOSPITAL OUTPATIENT DEPARTMENT SERV20 ICES.—Nothing in this paragraph should be 

21 construed as limiting or changing payment for 

22 items or services for which payment is made 

23 under section 1848 or section 1833(t).’’. 


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1 (c) CONFORMING AMENDMENT.—Section 

2 1847(a)(7)(B) of the Social Security Act (42 U.S.C. 

3 1395w–3(a)(7)(B)) is amended— 

4 (1) in clause (i), by striking ‘‘and’’ at the end; 

5 (2) in clause (ii), by striking the period at the 

6 end and inserting ‘‘; and’’; and 

7 (3) by adding at the end the following new 

8 clause: 

9 ‘‘(iii) that are substitute disposable 

10 medical technologies (as defined in section 

11 1861(iii)).’’. 

12 (d) EFFECTIVE DATE.—The provisions of, and 

13 amendments made by, this section shall apply with respect 

14 to items and services furnished on or after January 1, 

15 2016. 

16 (e) RULE OF CONSTRUCTION; IMPLEMENTATION.— 

17 (1) RULE OF CONSTRUCTION.—Nothing in this 

18 section or the amendments made by this section 

19 shall be construed as— 

20 (A) affecting the ability of a physician (or 

21 any other prescribing practitioner) to exercise 

22 their judgment in prescribing or ordering for a 

23 Medicare beneficiary appropriate durable med24 ical equipment or other medical device or techVerDate Sep 11 2014 23:15 Jul 30, 2015 Jkt 049200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6401 E:\BILLS\S1253.RS S1253

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1 nology for the treatment of an illness, injury, or 

2 condition of the Medicare beneficiary; or 

3 (B) affecting the ability of the Medicare 

4 beneficiary to access appropriate durable med5 ical equipment or other appropriate medical de6 vice or technology for such treatment. 

7 (2) IMPLEMENTATION.—The Secretary shall 

8 implement the provisions of, and amendments made 

9 by, this section in a manner such that the meth10 odologies for determining coverage of an item of du11 rable medical equipment (as defined in section 

12 1861(n) of the Social Security Act (42 U.S.C. 

13 1395x(n))) (other than such an item that is a sub14 stitute disposable medical technology (as defined in 

15 section 1861(iii))) and the payment amount for the 

16 item of durable medical equipment (other than such 

17 an item that is a substitute disposable medical tech18 nology (as so defined)) under section 1834 or 1847 

19 of such Act (42 U.S.C. 1395m, 1395w–3), as the 

20 case may be, is not affected by the coverage of and 

21 payment amount for a substitute disposable medical 

22 technology under sections 1861(iii) and 1834(a)(23) 

23 of such Act, respectively, as added by subsections (a) 

24 and (b), respectively. 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Patient Access to Dispos3 able Medical Technology Act of 2015’’. 

4 SEC. 2. TREATMENT OF DISPOSABLE DEVICES. 

5 (a) IN GENERAL.—Section 1834 of the Social Security 

6 Act (42 U.S.C. 1395m) is amended by adding at the end 

7 the following new subsection: 

8 ‘‘(s) PAYMENT FOR APPLICABLE DISPOSABLE DE9 VICES.— 

10 ‘‘(1) SEPARATE PAYMENT.—The Secretary shall 

11 make a payment (separate from the payments other12 wise made under section 1895) in the amount estab13 lished under paragraph (3) to a home health agency 

14 for an applicable disposable device (as defined in 

15 paragraph (2)) when furnished on or after January 

16 1, 2017, to an individual who receives home health 

17 services for which payment is made under section 

18 1895(b). 

19 ‘‘(2) APPLICABLE DISPOSABLE DEVICE.—In this 

20 subsection, the term ‘applicable disposable device’ 

21 means a disposable device that, as determined by the 

22 Secretary, is— 

23 ‘‘(A) a disposable negative pressure wound 

24 therapy device that is an integrated system com25 prised of a non-manual vacuum pump, a recepVerDate Sep 11 2014 23:15 Jul 30, 2015 Jkt 049200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\S1253.RS S1253

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1 tacle for collecting exudate, and dressings for the 

2 purposes of wound therapy; and 

3 ‘‘(B) a substitute for, and used in lieu of, 

4 a negative pressure wound therapy durable med5 ical equipment item that is an integrated system 

6 of a negative pressure vacuum pump, a separate 

7 exudate collection canister, and dressings that 

8 would otherwise be covered for individuals for 

9 such wound therapy. 

10 ‘‘(3) PAYMENT AMOUNT.—The Secretary shall es11 tablish the separate payment amount for an applica12 ble disposable device such that such amount is equal 

13 to— 

14 ‘‘(A) for 2017, 2018, and 2019, the greater 

15 of— 

16 ‘‘(i) the payment that would be made 

17 under section 1833(t) (relating to payment 

18 for covered OPD services) for the year for 

19 the Level I Healthcare Common Procedure 

20 Coding System (HCPCS) code for which the 

21 description for a professional service in22 cludes the furnishing of such device; or 

23 ‘‘(ii) an amount equal to 150 percent 

24 of the payment that applied under such secVerDate Sep 11 2014 23:15 Jul 30, 2015 Jkt 049200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\S1253.RS S1253

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1 tion 1833(t) for 2015 for such HCPCS code; 

2 and 

3 ‘‘(B) for 2020 and each subsequent year, the 

4 payment that would be made under such section 

5 1833(t) for the year for such HCPCS code.’’. 

6 (b) CONFORMING AMENDMENTS.— 

7 (1) COINSURANCE.—Section 1833(a)(1) of the 

8 Social Security Act (42 U.S.C. 1395l(a)(1)) is 

9 amended— 

10 (A) by striking ‘‘and’’ before ‘‘(Z)’’; and 

11 (B) by inserting before the semicolon at the 

12 end the following: ‘‘, and (AA) with respect to an 

13 applicable disposable device (as defined in para14 graph (2) of section 1834(s)) furnished to an in15 dividual pursuant to paragraph (1) of such sec16 tion, the amount paid shall be equal to 80 per17 cent of the lesser of the actual charge or the 

18 amount determined under paragraph (3) of such 

19 section’’. 

20 (2) HOME HEALTH.—Section 1861(m)(5) of the 

21 Social Security Act (42 U.S.C. 1395x(m)(5)) is 

22 amended by inserting ‘‘and applicable disposable de23 vices (as defined in section 1834(s)(2))’’ after ‘‘dura24 ble medical equipment’’. 

25 (c) REPORTS.— 


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1 (1) GAO STUDY AND REPORT ON DISPOSABLE

2 DEVICES.— 

3 (A) STUDY.—The Comptroller General of 

4 the United States shall conduct a study on the 

5 value of disposable devices to the Medicare pro6 gram and Medicare beneficiaries and the role of 

7 disposable devices as substitutes for durable med8 ical equipment. Such study shall address the fol9 lowing: 

10 (i) The types of disposable devices that 

11 could potentially qualify as being sub12 stitutes for durable medical equipment 

13 under the Medicare program, the similar14 ities and differences between such disposable 

15 devices and the durable medical equipment 

16 for which they would be a substitute, and 

17 the extent to which other payers, including 

18 the Medicaid program and private payers, 

19 cover such disposable devices. 

20 (ii) Views of, and information from, 

21 medical device manufacturers, providers of 

22 services, and suppliers on the incentives and 

23 disincentives under current Medicare cov24 erage and payment policies for disposable 

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1 ical equipment and how such policies affect 

2 manufacturers’ decisions to develop innova3 tive products and providers’ and suppliers’ 

4 decisions to use such products. 

5 (iii) Implications of expanding cov6 erage under the Medicare program to in7 clude additional disposable devices that are 

8 substitutes for durable medical equipment. 

9 (iv) Payment methodologies that could 

10 be used to pay for disposable devices that 

11 are substitutes for durable medical equip12 ment other than applicable disposable de13 vices pursuant to the amendments made by 

14 subsections (a) and (b). 

15 (v) Other applicable areas determined 

16 appropriate by the Comptroller General. 

17 (B) REPORT.—Not later than 18 months 

18 after the date of the enactment of this Act, the 

19 Comptroller General of the United States shall 

20 submit to Congress and the Secretary of Health 

21 and Human Services a report on the study con22 ducted under subparagraph (A), together with 

23 recommendations for such legislation and ad24 ministrative action as the Comptroller General 

25 determines to be appropriate. 


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1 (2) GAO STUDY AND REPORT ON THE IMPACT OF

2 THE PAYMENT OF APPLICABLE DISPOSABLE DE3 VICES.— 

4 (A) STUDY.—The Comptroller General of 

5 the United States shall conduct a study on the 

6 impact of the payment for applicable disposable 

7 devices (as defined in section 1834(s)(2) of the 

8 Social Security Act) under the provisions of, and 

9 amendments made by, subsections (a) and (b). 

10 Such study shall address the following: 

11 (i) The impact on utilization and 

12 Medicare program and beneficiary spending 

13 as a result of such provisions and amend14 ments. 

15 (ii) The type of Medicare beneficiaries 

16 who, under the home health benefit, use the 

17 applicable disposable device and the period 

18 of use of the applicable disposable devices 

19 compared to the beneficiaries who use the 

20 substitute durable medical equipment and 

21 their period of use. 

22 (iii) How payment rates of other pay23 ers, including the Medicaid program and 

24 private payers, for applicable disposable de25 vices compare to the payment rates for such 


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1 devices under such provisions and amend2 ments. 

3 (iv) Other applicable areas determined 

4 appropriate by the Comptroller General. 

5 (B) REPORT.—Not later than 4 years after 

6 the date of the enactment of this Act, the Comp7 troller General of the United States shall submit 

8 to Congress and the Secretary of Health and 

9 Human Services a report on the study conducted 

10 under subparagraph (A), together with rec11 ommendations for such legislation and adminis12 trative action as the Comptroller General deter13 mines to be appropriate. 

14 (d) EFFECTIVE DATE.—The amendments made by this 

15 section shall apply to items furnished on or after January 

16 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.’’. 


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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 

for other purposes. technologies under the Medicare program, and provide coverage of certain disposable medical 

JULY 30, 2015 

Reported with an amendment and an amendment to the 

title 


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