I 

114TH CONGRESS 

2D SESSION H. R. 5045 

To impose a moratorium on the implementation of a proposed Medicare 

local coverage determination on lower limb prostheses. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 25, 2016 

Mrs. ELLMERS of North Carolina (for herself and Ms. SCHAKOWSKY) introduced the following bill; which was referred to the Committee on Ways 

and Means, and in addition to the Committee on Energy and Commerce, 

for a period to be subsequently determined by the Speaker, in each case 

for consideration of such provisions as fall within the jurisdiction of the 

committee concerned 

A BILL 

To impose a moratorium on the implementation of a proposed Medicare local coverage determination on lower 

limb prostheses. 

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; FINDINGS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘Preserving Access to Modern Prosthetic Limbs Act of 

6 2016’’. 

7 (b) FINDINGS.—Congress finds the following: 


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1 (1) The Medicare program includes coverage for 

2 prosthetic limbs under section 1861(s)(9) of the So3 cial Security Act (42 U.S.C. 1395w(s)(9)). 

4 (2) As a result of significant Federal and pri5 vate investment in research and development over 

6 the past decades, beneficiaries with lower limb pros7 theses are able to maintain optimal function and 

8 lead productive and independent lives. 

9 (3) Federal spending for prosthetic devices in 

10 the Medicare program has decreased by 15 percent 

11 between 2010 and 2014. 

12 (4) The Secretary of Health and Human Serv13 ices, through Medicare contractors known as Dura14 ble Medical Equipment Medicare Administrative 

15 Contractors, released on July 16, 2015, a document 

16 entitled ‘‘Local Coverage Determination (LCD): 

17 Lower Limb Prostheses (DL33787)’’, which applies 

18 to all Medicare beneficiaries across the United 

19 States. 

20 (5) The policies proposed in this document 

21 would comprehensively change the requirements 

22 under which a Medicare beneficiary would qualify for 

23 a lower limb prosthetic device and would seriously 

24 restrict access to modern prosthetic care. 


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1 (6) If finalized, the changes proposed in this 

2 document would create coverage requirements that 

3 are inconsistent with current clinical practice and 

4 would arbitrarily and unreasonably deny Medicare 

5 beneficiaries access to prosthetic limb technologies 

6 considered the current standard of care. 

7 (7) Under these proposed policies, beneficiaries 

8 instead would be eligible for prosthetic devices that 

9 are functionally outdated, less durable, and less safe. 

10 (8) The adverse impact of the Medicare con11 tractors’ proposed policies extend well beyond the 

12 Medicare program and has implications for other 

13 Federal health programs, such as health programs 

14 of the Veterans Administration, and commercial in15 surers. 

16 (9) Given the far reaching effect of these poli17 cies, and the fact that little or no clinical or sci18 entific evidence supported the issuance of these pro19 posals, any changes to prosthetic limb coverage 

20 should be made only after a transparent process in 

21 which evidence is offered to justify coverage modi22 fications, meaningful stakeholder feedback is solic23 ited, and the Secretary and Medicare contractors re24 ceive and respond to this stakeholder feedback in a 

25 public manner. 


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1 (10) A moratorium on the implementation and 

2 enforcement of these proposed policies would enable 

3 the Secretary and the Medicare contractors to en4 gage in such a transparent process. 

5 SEC. 2. MORATORIUM ON IMPLEMENTATION OF PROPOSED 

6 MEDICARE LOCAL COVERAGE DETERMINA7 TION ON LOWER LIMB PROSTHESES. 

8 (a) MORATORIUM.— 

9 (1) IN GENERAL.—The Secretary of Health and 

10 Human Services and any Medicare Administrative 

11 Contractor may not implement and enforce the poli12 cies in the LCD on lower limb prostheses (as defined 

13 in subsection (d)(1)), in whole or in part, during the 

14 period beginning on the date of the enactment of 

15 this Act, and ending on June 30, 2017. 

16 (2) REMOVAL OF POLICY FROM WEBSITES.— 

17 The Secretary of Health and Human Services and 

18 its medicare administrative contractors shall remove 

19 the LCD on lower limb prostheses from the websites 

20 of the Centers for Medicare & Medicaid Services and 

21 its medicare administrative contractors during the 

22 period of the moratorium under paragraph (1). 

23 (b) PROVIDING THE SECRETARY WITH AUTHORITY

24 TO OVERSEE THE DEVELOPMENT OF LOCAL COVERAGE


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1 DETERMINATIONS.—Section 1862(l)(5) of the Social Se2 curity Act (42 U.S.C. 395y(l)(5)) is amended— 

3 (1) by redesignating subparagraph (C) as sub4 paragraph (D); and 

5 (2) by inserting after subparagraph (B) the fol6 lowing new subparagraph: 

7 ‘‘(C) SECRETARY OVERSIGHT AND GUID8 ANCE IN DEVELOPING LOCAL COVERAGE DE9 TERMINATIONS.—The Secretary shall provide 

10 guidance and oversight of any local coverage de11 termination developed by a medicare adminis12 trative contractor to ensure that the local cov13 erage determination is consistent with this 

14 title.’’. 

15 (c) CONSTRUCTION.—Nothing in this section shall be 

16 construed to prevent the Secretary from enforcing existing 

17 statutes, regulations, and local coverage determinations 

18 other than with respect to policies in the LCD on lower 

19 limb prostheses. 

20 (d) DEFINITIONS.—In this section: 

21 (1) LCD ON LOWER LIMB PROSTHESES.—The 

22 term ‘‘LCD on lower limb prostheses’’ means the 

23 local coverage determination on lower limb pros24 theses as proposed by a medicare administrative conVerDate Sep 11 2014 01:18 May 03, 2016 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H5045.IH H5045

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1 tractor in the document (DL33787) released on July 

2 16, 2015, and any successor to such determination. 

3 (2) MEDICARE ADMINISTRATIVE CON4 TRACTOR.—The term ‘‘medicare administrative con5 tractor’’ has the meaning given such term in section 

6 1874A(a)(3)(A) of the Social Security Act (42 

7 U.S.C. 1395kk–1(a)(3)(A)). 

Æ 


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