II 

116TH CONGRESS 

2D SESSION S. 4503 

To amend title XVIII of the Social Security Act to protect beneficiaries 

with limb loss and other orthopedic conditions by providing access to 

appropriate, safe, effective, patient-centered orthotic and prosthetic care, 

to reduce fraud, waste, and abuse with respect to orthotics and prosthetics, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

AUGUST 6, 2020 

Mr. WARNER (for himself, Mr. DAINES, Ms. DUCKWORTH, Mr. CASSIDY, and 

Mr. CORNYN) introduced the following bill; which was read twice and referred to the Committee on Finance 

A BILL 

To amend title XVIII of the Social Security Act to protect 

beneficiaries with limb loss and other orthopedic conditions by providing access to appropriate, safe, effective, 

patient-centered orthotic and prosthetic care, to reduce 

fraud, waste, and abuse with respect to orthotics and 

prosthetics, 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 ‘‘Medicare Orthotics and 

5 Prosthetics Patient-Centered Care Act’’. 


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1 SEC. 2. INCREASING PROTECTIONS FOR BENEFICIARIES 

2 RECEIVING ORTHOTIC AND PROSTHETIC 

3 CARE UNDER THE MEDICARE PROGRAM. 

4 (a) DISTINGUISHING ORTHOTISTS AND

5 PROSTHETISTS FROM SUPPLIERS OF DURABLE MEDICAL

6 EQUIPMENT AND SUPPLIES.—Section 1834 of the Social 

7 Security Act (42 U.S.C. 1395m) is amended— 

8 (1) in subsection (j)(5), by striking subpara9 graph (C) and redesignating the subsequent sub10 paragraphs accordingly; and 

11 (2) by adding at the end the following new sub12 section: 

13 ‘‘(x) REQUIREMENTS FOR ORTHOTISTS AND

14 PROSTHETISTS.— 

15 ‘‘(1) ISSUANCE AND RENEWAL OF SUPPLIER

16 NUMBER.— 

17 ‘‘(A) PAYMENT.— 

18 ‘‘(i) IN GENERAL.—No payment may 

19 be made under this part to an orthotic or 

20 prosthetic supplier unless such orthotic or 

21 prosthetic supplier obtains (and renews at 

22 such intervals as the Secretary may re23 quire) a supplier number. 

24 ‘‘(ii) CLARIFICATION REGARDING PRO25 VIDERS UNDER PART A.—Nothing in 

26 clause (i) shall prohibit a provider otherVerDate Sep 11 2014 18:17 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S4503.IS S4503

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1 wise permitted to receive payment for 

2 orthotics and prosthetics under part A 

3 from continuing to receive payment under 

4 such part without interruption. 

5 ‘‘(B) STANDARDS FOR POSSESSING A SUP6 PLIER NUMBER.—An orthotic or prosthetic sup7 plier may only obtain a supplier number if the 

8 supplier meets standards prescribed by the Sec9 retary that include requirements that the 

10 orthotic or prosthetic supplier (and, where ap11 plicable, the orthotist or prosthetist)— 

12 ‘‘(i) licensure and accreditation— 

13 ‘‘(I) complies with all applicable 

14 State and Federal licensure and regu15 latory requirements; and 

16 ‘‘(II) acquires accreditation from 

17 the American Board for Certification 

18 in Orthotics, Prosthetics and 

19 Pedorthics, Inc. or the Board of Cer20 tification/Accreditation, International, 

21 or other accreditation entity that the 

22 Secretary determines has standards 

23 that are equivalent to the standards of 

24 such Boards; 


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1 ‘‘(ii) maintains a physical facility on 

2 an appropriate site; 

3 ‘‘(iii) has proof of appropriate liability 

4 insurance; and 

5 ‘‘(iv) meets such other requirements 

6 as the Secretary shall specify. 

7 ‘‘(C) PROHIBITION AGAINST MULTIPLE

8 SUPPLIER NUMBERS.—The Secretary may not 

9 issue more than one supplier number to any 

10 orthotic or prosthetic supplier unless the Sec11 retary finds that the issuance of more than one 

12 number is appropriate to identify other entities 

13 under the ownership or control of the orthotic 

14 or prosthetic supplier. 

15 ‘‘(2) ORDER FOR ORTHOTICS OR PROS16 THETICS.— 

17 ‘‘(A) INFORMATION PROVIDED BY

18 ORTHOTISTS AND PROSTHETISTS ON DETAILED

19 WRITTEN ORDERS FOR ORTHOTICS AND PROS20 THETICS.—An orthotist or prosthetist may dis21 tribute to physicians, physician assistants, 

22 nurse practitioners, clinical nurse specialists, or 

23 individuals entitled to benefits under this part, 

24 a detailed written order for orthotics or pros25 thetics (as defined in paragraph (5)) for comVerDate Sep 11 2014 18:17 Aug 27, 2020 Jkt 099200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S4503.IS S4503

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1 mercial purposes that contains the following in2 formation: 

3 ‘‘(i) The identification of— 

4 ‘‘(I) the orthotic or prosthetic 

5 supplier; and 

6 ‘‘(II) the individual to whom the 

7 orthotics or prosthetics are furnished. 

8 ‘‘(ii) The identification of the treating 

9 physician, physician assistant, nurse prac10 titioner, or clinical nurse specialist. 

11 ‘‘(iii) A description of the orthotics or 

12 prosthetics ordered. 

13 ‘‘(iv) The date of the order described 

14 in this subparagraph. 

15 ‘‘(B) INFORMATION ON CODING AND

16 DESCRIPTORS OF COMPONENTS PROVIDED.—If 

17 an orthotist or prosthetist distributes a detailed 

18 written order for orthotics or prosthetics de19 scribed in subparagraph (A), the orthotist or 

20 prosthetist shall also list on the order the sum21 mary descriptors of the items and services being 

22 recommended prior to submission of the order 

23 to the treating physician for approval. 

24 ‘‘(C) SIGNATURE BY TREATING PHYSI25 CIAN.—A detailed written order for orthotics or 


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1 prosthetics described in subparagraph (A) shall 

2 be signed by the treating physician. 

3 ‘‘(3) LIMITATION ON PATIENT LIABILITY.—Ex4 cept as provided in paragraph (4), if an orthotist or 

5 prosthetist— 

6 ‘‘(A) furnishes an orthosis or prosthesis to 

7 a beneficiary for which no payment may be 

8 made under this part; or 

9 ‘‘(B) subject to section 1879, furnishes an 

10 orthosis or prosthesis to a beneficiary for which 

11 payment is denied under section 1862(a)(1), 

12 any expenses incurred for the orthosis or prosthesis 

13 furnished to an individual by the orthotist or pros14 thetist not on an assigned basis shall be the respon15 sibility of such orthotist or prosthetist. The indi16 vidual shall have no financial responsibility for such 

17 expenses and the orthotist or prosthetist shall refund 

18 on a timely basis to the individual (and shall be lia19 ble to the individual for) any amounts collected from 

20 the individual for such items and services. The pro21 visions of subsection (a)(18) shall apply to refunds 

22 required under the previous sentence in the same 

23 manner as such provisions apply to refunds under 

24 such subsection. 


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1 ‘‘(4) PATIENT LIABILITY.—If an orthotist or 

2 prosthetist furnishes an orthosis or prosthesis to a 

3 patient for which payment is denied in advance 

4 under subsection (a)(15), expenses incurred for such 

5 orthosis or prosthesis furnished to the individual by 

6 the orthotist or prosthetist shall be the responsibility 

7 of the individual. 

8 ‘‘(5) DEFINITIONS.—In this subsection: 

9 ‘‘(A) DETAILED WRITTEN ORDER FOR

10 ORTHOTICS OR PROSTHETICS.— 

11 ‘‘(i) IN GENERAL.—The term ‘detailed 

12 written order for orthotics or prosthetics’ 

13 means a form or other document prepared 

14 by an orthotist or prosthetist and signed 

15 by the physician (as defined by section 

16 1861(r)) that contains information re17 quired by the Secretary to show that an 

18 orthosis or prosthesis is reasonable and 

19 necessary for the treatment of an illness or 

20 injury or to improve the functioning of a 

21 malformed body member. 

22 ‘‘(ii) CLARIFICATION.—The detailed 

23 written order for orthotics or prosthetics 

24 shall not be considered alone for purposes 

25 of determining the reasonableness, medical 


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1 necessity, and functional level (applicable 

2 to prosthetics) of orthotics and prosthetics. 

3 ‘‘(B) ORTHOTICS AND PROSTHETICS.—The 

4 term ‘orthotics and prosthetics’ has the mean5 ing given that term in section 1834(h)(4)(C). 

6 ‘‘(C) ORTHOTIST OR PROSTHETIST.—The 

7 term ‘orthotist or prosthetist’ means an indi8 vidual who is specifically trained and educated 

9 in the provision of, and patient care manage10 ment related to, prosthetics and custom-fab11 ricated or custom-fit orthotics, and— 

12 ‘‘(i) in the case of a State that pro13 vides for the licensing of orthotists and 

14 prosthetists, is licensed by the State in 

15 which the orthotics or prosthetics were 

16 supplied; or 

17 ‘‘(ii) in the case of a State that does 

18 not provide for the licensing of orthotists 

19 and prosthetists, is certified by the Amer20 ican Board for Certification in Orthotics, 

21 Prosthetics and Pedorthics, Inc. or by the 

22 Board of Certification/Accreditation, Inter23 national, or is certified and approved by an 

24 entity that the Secretary determines has 

25 certification and approval standards that 


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1 are essentially equivalent to the certifi2 cation and approval standards of such 

3 Boards.’’. 

4 (b) PROHIBITING PAYMENT FOR CERTAIN

5 ORTHOTICS AND PROSTHETICS.—Section 1834(h)(1) of 

6 the Social Security Act (42 U.S.C. 1395m(h)(1)) is 

7 amended by adding at the end the following new subpara8 graph: 

9 ‘‘(I) SPECIAL PAYMENT RULES FOR

10 ORTHOTICS OR PROSTHETICS.— 

11 ‘‘(i) IN GENERAL.—No payment shall 

12 be made under this subsection for— 

13 ‘‘(I) a prosthesis (excluding pros14 thetic supplies) that is delivered by 

15 drop shipment; 

16 ‘‘(II) a custom-fabricated or cus17 tom-fitted orthosis (excluding orthotic 

18 supplies) described in subparagraph 

19 (F)(ii) that is delivered by drop ship20 ment; and 

21 ‘‘(III) an orthotic item that is 

22 not otherwise competitively bid that is 

23 delivered by drop shipment. 

24 ‘‘(ii) DROP SHIPMENT DEFINED.—In 

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1 ment’ means the shipping of an orthosis or 

2 prosthesis to a beneficiary without receiv3 ing from a trained, educated, and certified 

4 or licensed health care practitioner, 

5 orthotist, or prosthetist direct patient care 

6 with respect to assessing, adjusting, and 

7 training in the care and use of the orthosis 

8 or prosthesis.’’. 

9 (c) STANDARDIZING THE DEFINITIONS OF

10 ORTHOTICS AND PROSTHETICS.—Section 1834(h)(4) of 

11 the Social Security Act (42 U.S.C. 1395m(h)(4)) is 

12 amended— 

13 (1) in subparagraph (B), by striking at the end 

14 ‘‘and’’; 

15 (2) in subparagraph (C)— 

16 (A) by striking ‘‘the term ‘orthotics and 

17 prosthetics’ has the meaning given such term’’ 

18 and inserting ‘‘the terms ‘orthotics and pros19 thetics’ and ‘orthoses and prostheses’ have the 

20 meaning given such terms’’; and 

21 (B) by striking the period at the end and 

22 inserting ‘‘; and’’; and 

23 (3) by inserting after subparagraph (C), as 

24 amended by paragraph (2), the following new sub25 paragraph: 


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1 ‘‘(D) the terms ‘prosthetics’ and ‘pros2 theses’ refer to a device (including the clinical 

3 services associated with such device) that re4 places all or part of a limb.’’. 

5 (d) LIMITATION OF COMPETITIVE ACQUISITION FOR

6 OFF-THE-SHELF ORTHOTICS.—Section 1847(a) of the 

7 Social Security Act (42 U.S.C. 1395w–3(a)) is amended— 

8 (1) in paragraph (2)(C), by inserting ‘‘by the 

9 patient (and not by another person)’’ after ‘‘minimal 

10 self-adjustment’’; and 

11 (2) in paragraph (7)(A)(i)— 

12 (A) by inserting ‘‘, orthotist or prosthetist 

13 (as defined in section 1834(x)(5)(C)),’’ after 

14 ‘‘by a physician’’; 

15 (B) by inserting ‘‘, orthotist’s or 

16 prosthetist’s,’’ after ‘‘to the physician’s’’; and 

17 (C) by inserting ‘‘, orthotist’s or 

18 prosthetist’s,’’ after ‘‘of the physician’s’’. 

19 (e) REGULATIONS.—Not later than 1 year after the 

20 date of the enactment of this Act, the Secretary of Health 

21 and Human Services shall promulgate final regulations to 

22 implement the provisions of, and amendments made by, 

23 this Act. 

Æ 


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