I 

116TH CONGRESS 

1ST SESSION H. R. 5262 

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 HOUSE OF REPRESENTATIVES 

NOVEMBER 22, 2019 

Mr. THOMPSON of California (for himself, Mr. THOMPSON of Pennsylvania, 

Mr. GUTHRIE, and Mr. BUTTERFIELD) introduced the following bill; 

which was referred to the Committee on Energy and Commerce, and in 

addition to the Committee on Ways and Means, 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 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Medicare Orthotics and 

3 Prosthetics Patient-Centered Care Act’’. 

4 SEC. 2. INCREASING PROTECTIONS FOR BENEFICIARIES 

5 RECEIVING ORTHOTIC AND PROSTHETIC 

6 CARE UNDER THE MEDICARE PROGRAM. 

7 (a) DISTINGUISHING ORTHOTISTS AND

8 PROSTHETISTS FROM SUPPLIERS OF DURABLE MEDICAL

9 EQUIPMENT AND SUPPLIES.—Section 1834 of the Social 

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

11 (1) in subsection (j)(5), by striking subpara12 graph (C) and redesignating the subsequent sub13 paragraphs accordingly; and 

14 (2) by adding at the end the following new sub15 section: 

16 ‘‘(x) REQUIREMENTS FOR ORTHOTISTS AND

17 PROSTHETISTS.— 

18 ‘‘(1) ISSUANCE AND RENEWAL OF SUPPLIER

19 NUMBER.— 

20 ‘‘(A) PAYMENT.— 

21 ‘‘(i) IN GENERAL.—No payment may 

22 be made under this part to an orthotic or 

23 prosthetic supplier unless such orthotic or 

24 prosthetic supplier obtains (and renews at 

25 such intervals as the Secretary may re26 quire) a supplier number. 


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1 ‘‘(ii) CLARIFICATION REGARDING PRO2 VIDERS UNDER PART A.—Nothing in 

3 clause (i) shall prohibit a provider other4 wise permitted to receive payment for 

5 orthotics and prosthetics under part A 

6 from continuing to receive payment under 

7 such part without interruption. 

8 ‘‘(B) STANDARDS FOR POSSESSING A SUP9 PLIER NUMBER.—An orthotic or prosthetic sup10 plier may only obtain a supplier number if the 

11 supplier meets standards prescribed by the Sec12 retary that include requirements that the 

13 orthotic or prosthetic supplier (and, where ap14 plicable, the orthotist or prosthetist)— 

15 ‘‘(i) licensure and accreditation— 

16 ‘‘(I) complies with all applicable 

17 State and Federal licensure and regu18 latory requirements; and 

19 ‘‘(II) acquires accreditation from 

20 the American Board for Certification 

21 in Orthotics, Prosthetics and Pedorth22 ics, Inc. or the Board of Certification/ 

23 Accreditation, International, or other 

24 accreditation entity that the Secretary 

25 determines has standards that are 


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1 equivalent to the standards of such 

2 Boards; 

3 ‘‘(ii) maintains a physical facility on 

4 an appropriate site; 

5 ‘‘(iii) has proof of appropriate liability 

6 insurance; and 

7 ‘‘(iv) meets such other requirements 

8 as the Secretary shall specify. 

9 ‘‘(C) PROHIBITION AGAINST MULTIPLE

10 SUPPLIER NUMBERS.—The Secretary may not 

11 issue more than one supplier number to any 

12 orthotic or prosthetic supplier unless the Sec13 retary finds that the issuance of more than one 

14 number is appropriate to identify other entities 

15 under the ownership or control of the orthotic 

16 or prosthetic supplier. 

17 ‘‘(2) ORDER FOR ORTHOTICS OR PROS18 THETICS.— 

19 ‘‘(A) INFORMATION PROVIDED BY

20 ORTHOTISTS AND PROSTHETISTS ON DETAILED

21 WRITTEN ORDERS FOR ORTHOTICS AND PROS22 THETICS.—An orthotist or prosthetist may dis23 tribute to physicians, physician assistants, 

24 nurse practitioners, clinical nurse specialists, or 

25 individuals entitled to benefits under this part, 


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1 a detailed written order for orthotics or pros2 thetics (as defined in paragraph (5)) for com3 mercial purposes that contains the following in4 formation: 

5 ‘‘(i) The identification of— 

6 ‘‘(I) the orthotic or prosthetic 

7 supplier; and 

8 ‘‘(II) the individual to whom the 

9 orthotics or prosthetics are furnished. 

10 ‘‘(ii) The identification of the treating 

11 physician, physician assistant, nurse prac12 titioner, or clinical nurse specialist. 

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

14 prosthetics ordered. 

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

16 in this subparagraph. 

17 ‘‘(B) INFORMATION ON CODING AND

18 DESCRIPTORS OF COMPONENTS PROVIDED.—If 

19 an orthotist or prosthetist distributes a detailed 

20 written order for orthotics or prosthetics de21 scribed in subparagraph (A), the orthotist or 

22 prosthetist shall also list on the order the sum23 mary descriptors of the items and services being 

24 recommended prior to submission of the order 

25 to the treating physician for approval. 


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1 ‘‘(C) SIGNATURE BY TREATING PHYSI2 CIAN.—A detailed written order for orthotics or 

3 prosthetics described in subparagraph (A) shall 

4 be signed by the treating physician. 

5 ‘‘(3) LIMITATION ON PATIENT LIABILITY.—Ex6 cept as provided in paragraph (4), if an orthotist or 

7 prosthetist— 

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

9 a beneficiary for which no payment may be 

10 made under this part; or 

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

12 orthosis or prosthesis to a beneficiary for which 

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

14 any expenses incurred for the orthosis or prosthesis 

15 furnished to an individual by the orthotist or pros16 thetist not on an assigned basis shall be the respon17 sibility of such orthotist or prosthetist. The indi18 vidual shall have no financial responsibility for such 

19 expenses and the orthotist or prosthetist shall refund 

20 on a timely basis to the individual (and shall be lia21 ble to the individual for) any amounts collected from 

22 the individual for such items and services. The pro23 visions of subsection (a)(18) shall apply to refunds 

24 required under the previous sentence in the same 


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1 manner as such provisions apply to refunds under 

2 such subsection. 

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

4 prosthetist furnishes an orthosis or prosthesis to a 

5 patient for which payment is denied in advance 

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

7 orthosis or prosthesis furnished to the individual by 

8 the orthotist or prosthetist shall be the responsibility 

9 of the individual. 

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

11 ‘‘(A) DETAILED WRITTEN ORDER FOR

12 ORTHOTICS OR PROSTHETICS.— 

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

14 written order for orthotics or prosthetics’ 

15 means a form or other document prepared 

16 by an orthotist or prosthetist and signed 

17 by the physician (as defined by section 

18 1861(r)) that contains information re19 quired by the Secretary to show that an 

20 orthosis or prosthesis is reasonable and 

21 necessary for the treatment of an illness or 

22 injury or to improve the functioning of a 

23 malformed body member. 

24 ‘‘(ii) CLARIFICATION.—The detailed 

25 written order for orthotics or prosthetics 


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1 shall not be considered alone for purposes 

2 of determining the reasonableness, medical 

3 necessity, and functional level (applicable 

4 to prosthetics) of orthotics and prosthetics. 

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

6 term ‘orthotics and prosthetics’ has the mean7 ing given that term in section 1834(h)(4)(C). 

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

9 term ‘orthotist or prosthetist’ means an indi10 vidual who is specifically trained and educated 

11 in the provision of, and patient care manage12 ment related to, prosthetics and custom-fab13 ricated or custom-fit orthotics, and— 

14 ‘‘(i) in the case of a State that pro15 vides for the licensing of orthotists and 

16 prosthetists, is licensed by the State in 

17 which the orthotics or prosthetics were 

18 supplied; or 

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

20 not provide for the licensing of orthotists 

21 and prosthetists, is certified by the Amer22 ican Board for Certification in Orthotics, 

23 Prosthetics and Pedorthics, Inc. or by the 

24 Board of Certification/Accreditation, Inter25 national, or is certified and approved by an 


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1 entity that the Secretary determines has 

2 certification and approval standards that 

3 are essentially equivalent to the certifi4 cation and approval standards of such 

5 Boards.’’. 

6 (b) PROHIBITING PAYMENT FOR CERTAIN

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

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

9 amended by adding at the end the following new subpara10 graph: 

11 ‘‘(I) SPECIAL PAYMENT RULES FOR

12 ORTHOTICS OR PROSTHETICS.— 

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

14 be made under this subsection for— 

15 ‘‘(I) a prosthesis (excluding pros16 thetic supplies) that is delivered by 

17 drop shipment; 

18 ‘‘(II) a custom-fabricated or cus19 tom-fitted orthosis (excluding orthotic 

20 supplies) described in subparagraph 

21 (F)(ii) that is delivered by drop ship22 ment; and 

23 ‘‘(III) an orthotic item that is 

24 not otherwise competitively bid that is 

25 delivered by drop shipment. 


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1 ‘‘(ii) DROP SHIPMENT DEFINED.—In 

2 this subparagraph, the term ‘drop ship3 ment’ means the shipping of an orthosis or 

4 prosthesis to a beneficiary without receiv5 ing from a trained, educated, and certified 

6 or licensed health care practitioner, 

7 orthotist, or prosthetist direct patient care 

8 with respect to assessing, adjusting, and 

9 training in the care and use of the orthosis 

10 or prosthesis.’’. 

11 (c) STANDARDIZING THE DEFINITIONS OF

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

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

14 amended— 

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

16 ‘‘and’’; 

17 (2) in subparagraph (C)— 

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

19 prosthetics’ has the meaning given such term’’ 

20 and inserting ‘‘the terms ‘orthotics and pros21 thetics’ and ‘orthoses and prostheses’ have the 

22 meaning given such terms’’; and 

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

24 inserting ‘‘; and’’; and 


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

2 amended by paragraph (2), the following new sub3 paragraph: 

4 ‘‘(D) the terms ‘prosthetics’ and ‘pros5 theses’ refer to a device (including the clinical 

6 services associated with such device) that re7 places all or part of a limb.’’. 

8 (d) LIMITATION OF COMPETITIVE ACQUISITION FOR

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

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

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

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

13 self-adjustment’’; and 

14 (2) in paragraph (7)(A)(i)— 

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

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

17 ‘‘by a physician’’; 

18 (B) by inserting ‘‘, orthotist’s or prosthet19 ist’s,’’ after ‘‘to the physician’s’’; and 

20 (C) by inserting ‘‘, orthotist’s or prosthet21 ist’s,’’ after ‘‘of the physician’s’’. 

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

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

24 and Human Services shall promulgate final regulations to 


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1 implement the provisions of, and amendments made by, 

2 this Act. 

Æ 


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