II 

114TH CONGRESS 

1ST SESSION S. 829 

To amend title XVIII of the Social Security Act to refine how Medicare 

pays for orthotics and prosthetics and to improve beneficiary experience 

and outcomes with orthotic and prosthetic care, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MARCH 23, 2015 

Mr. GRASSLEY (for himself and Mr. WARNER) 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 refine 

how Medicare pays for orthotics and prosthetics and 

to improve beneficiary experience and outcomes with 

orthotic and prosthetic care, 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; TABLE OF CONTENTS. 

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

5 ‘‘Medicare Orthotics and Prosthetics Improvement Act of 

6 2015’’. 

7 (b) TABLE OF CONTENTS.—The Table of Contents 

8 for this Act is as follows: 


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Sec. 1. Short title; table of contents. 

Sec. 2. Modification of requirements applicable under Medicare to the designation of accreditation organizations for suppliers of orthotics 

and prosthetics. 

Sec. 3. Application of existing accreditation and licensure requirements to certain prosthetics and custom-fabricated or custom-fitted 

orthotics. 

Sec. 4. Eligibility for Medicare payment for orthotics and prosthetics based on 

supplier qualifications and complexity of care. 

Sec. 5. Orthotist’s and prosthetist’s clinical notes as part of the patient’s medical record. 

Sec. 6. Distinguishing orthotists and prosthetists from suppliers of durable 

medical equipment and supplies. 

Sec. 7. Clarification about minimal self-adjustment for off-the-shelf orthotics. 

Sec. 8. Regulations. 

1 SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE 

2 UNDER MEDICARE TO THE DESIGNATION OF 

3 ACCREDITATION ORGANIZATIONS FOR SUP4 PLIERS OF ORTHOTICS AND PROSTHETICS. 

5 (a) IN GENERAL.—Section 1834(a)(20)(B) of the So6 cial Security Act (42 U.S.C. 1395m(a)(20)(B)) is amend7 ed— 

8 (1) by striking ‘‘ORGANIZATIONS.—Not later 

9 than’’ and inserting: ‘‘ORGANIZATIONS.— 

10 ‘‘(i) IN GENERAL.—Subject to clause 

11 (ii), not later than’’; and 

12 (2) by adding after clause (i), as added by 

13 paragraph (1), the following new clauses: 

14 ‘‘(ii) SPECIAL REQUIREMENTS FOR

15 ACCREDITATION OF SUPPLIERS OF

16 ORTHOTICS AND PROSTHETICS.—For pur17 poses of applying quality standards under 

18 subparagraph (A) for suppliers (other than 


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1 suppliers described in clause (iii)) of items 

2 and services described in subparagraph 

3 (D)(ii), the Secretary shall designate and 

4 approve independent accreditation organi5 zations under clause (i) only if such orga6 nizations are Boards or programs de7 scribed in subsection (h)(1)(F)(iv). Not 

8 later than January 1, 2016, the Secretary 

9 shall ensure that at least one, and ideally 

10 multiple, independent accreditation organi11 zations are designated and approved in ac12 cordance with this clause. 

13 ‘‘(iii) EXCEPTION.—Suppliers de14 scribed in this clause are physicians, occu15 pational therapists, or physical therapists 

16 who are licensed or otherwise regulated by 

17 the State in which they are practicing and 

18 who receive payment under this title, in19 cluding regulations promulgated pursuant 

20 to this subsection.’’. 

21 (b) EFFECTIVE DATE.—Each organization must sat22 isfy the requirement of section 1834(a)(20)(B)(ii), as 

23 added by subsection (a)(2), not later than January 1, 

24 2016, regardless of whether the organization is designated 


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1 or approved as an independent accreditation organization 

2 before, on, or after the date of the enactment of this Act. 

3 SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND 

4 LICENSURE REQUIREMENTS TO CERTAIN 

5 PROSTHETICS AND CUSTOM-FABRICATED OR 

6 CUSTOM-FITTED ORTHOTICS. 

7 (a) IN GENERAL.—Section 1834(h)(1)(F) of the So8 cial Security Act (42 U.S.C. 1395m(h)(1)(F)) is amend9 ed— 

10 (1) in the heading, by inserting ‘‘OR CUSTOM11 FITTED’’ after ‘‘CUSTOM-FABRICATED’’; 

12 (2) in clause (i), by striking ‘‘an item of cus13 tom-fabricated orthotics described in clause (ii) or 

14 for an item of prosthetics unless such item is’’ and 

15 inserting ‘‘an item of orthotics or prosthetics, includ16 ing an item of custom-fabricated orthotics described 

17 in clause (ii), unless such item is’’; 

18 (3) in clause (ii)(II), by striking ‘‘a list of items 

19 to which this subparagraph applies’’ and inserting 

20 ‘‘a list of items for purposes of clause (i)’’; 

21 (4) in clause (iii)(III), by striking ‘‘to provide 

22 or manage the provision of prosthetics and custom23 designed or -fabricated orthotics’’ and inserting ‘‘to 

24 provide or manage the provision of orthotics and 

25 prosthetics (and custom-designed or -fabricated 


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1 orthotics, in the case of an item described in clause 

2 (ii))’’; and 

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

4 clause: 

5 ‘‘(v) EXEMPTION OF OFF-THE-SHELF

6 ORTHOTICS INCLUDED IN A COMPETITIVE

7 ACQUISITION PROGRAM.—This subpara8 graph shall not apply to an item of 

9 orthotics described in paragraph (2)(C) of 

10 section 1847(a) furnished on or after Jan11 uary 1, 2016, that is included in a com12 petitive acquisition area under such sec13 tion.’’. 

14 (b) EFFECTIVE DATE.—The amendments made by 

15 subsection (a) shall apply to orthotics and prosthetics fur16 nished on or after January 1, 2016. 

17 SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR 

18 ORTHOTICS AND PROSTHETICS BASED ON 

19 SUPPLIER QUALIFICATIONS AND COM20 PLEXITY OF CARE. 

21 Section 1834(h) of the Social Security Act (42 U.S.C. 

22 1395m(h)) is amended— 

23 (1) in paragraph (1)(F)(iii), in the matter pre24 ceding subclause (I), by striking ‘‘other individual 

25 who’’ and inserting ‘‘other individual who, with reVerDate Sep 11 2014 05:13 Mar 28, 2015 Jkt 049200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S829.IS S829

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1 spect to the provision of orthotics and prosthetics 

2 furnished on or after January 1, 2016, and subject 

3 to paragraph (5)(A), satisfies all applicable criteria 

4 of the provider qualification designation for such 

5 orthotic or prosthetic, and who’’; 

6 (2) in paragraph (1)(F)(iv), by inserting before 

7 the period the following: ‘‘and, with respect to the 

8 provision of orthotics and prosthetics furnished on 

9 or after January 1, 2016, and subject to paragraph 

10 (5)(A), satisfies all applicable criteria of the provider 

11 qualification designation for such orthotic or pros12 thetic’’; and 

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

14 paragraph: 

15 ‘‘(5) ELIGIBILITY FOR PAYMENT BASED ON

16 SUPPLIER QUALIFICATIONS AND COMPLEXITY OF

17 CARE.— 

18 ‘‘(A) CONSIDERATIONS FOR ELIGIBILITY

19 FOR PAYMENTS.— 

20 ‘‘(i) IN GENERAL.—In applying 

21 clauses (iii) and (iv) of paragraph (1)(F) 

22 for purposes of determining whether pay23 ment may be made under this subsection 

24 for orthotics and prosthetics furnished on 

25 or after January 1, 2016, the Secretary 


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1 shall take into account the complexity of 

2 the respective item and, subject to clauses 

3 (ii), (iii), and (iv), the qualifications of the 

4 individual or entity furnishing and fabri5 cating such respective item in accordance 

6 with this paragraph. 

7 ‘‘(ii) INDIVIDUALS AND ENTITIES EX8 EMPTED FROM SUPPLIER QUALIFICATION

9 CRITERIA.—With respect to the provision 

10 of orthotics or prosthetics, any criteria for 

11 supplier qualifications shall not apply to 

12 physicians, occupational therapists, or 

13 physical therapists who are licensed or oth14 erwise regulated by the State in which they 

15 are practicing and who receive payment 

16 under this title, including regulations pro17 mulgated pursuant to this subsection, for 

18 the provision of orthotics and prosthetics. 

19 ‘‘(iii) SUPPLIERS MEDICARE-ELIGIBLE

20 PRIOR TO JANUARY 1, 2016, EXEMPTED.— 

21 In the case of a qualified supplier who is 

22 eligible to receive payment under this title 

23 before January 1, 2016, with respect to 

24 the provision of orthotics and prosthetics, 

25 any new criteria for provider qualifications 


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1 established after such date shall not apply 

2 to such supplier, for the furnishing or fab3 rication of such an item. 

4 ‘‘(iv) MODIFICATIONS.—The Secretary 

5 shall, in consultation with the Boards and 

6 programs described in paragraph 

7 (1)(F)(iv), periodically review the criteria 

8 for supplier qualifications and may imple9 ment by regulation any modifications to 

10 such criteria, as determined appropriate in 

11 accordance with such consultation. Any 

12 such modifications shall take effect no ear13 lier than January 1, 2016. 

14 ‘‘(B) ASSIGNMENT OF BILLING CODES.— 

15 For purposes of subparagraph (A), the Sec16 retary, in consultation with representatives of 

17 the fields of occupational therapy, physical ther18 apy, orthotics, and prosthetics, shall utilize and 

19 incorporate the set of L–codes listed, as of the 

20 date of enactment of this paragraph, in the 

21 Centers for Medicare & Medicaid Services docu22 ment entitled ‘Transmittal 656’ (CMS Pub. 

23 100–04, Change Request 3959, August 19, 

24 2005). Transmittal 656 shall be the controlling 

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1 ments for the orthotics and prosthetics care, 

2 using the supplier qualification designation for 

3 each HCPCS code as stated in such document. 

4 In the case that Transmittal 656 is updated, 

5 reissued, or replaced by a subsequent document, 

6 the preceding sentence shall be applied with re7 spect to the most recent update, reissuance, or 

8 replacement of such document.’’. 

9 SEC. 5. ORTHOTIST’S AND PROSTHETIST’S CLINICAL NOTES 

10 AS PART OF THE PATIENT’S MEDICAL 

11 RECORD. 

12 Section 1834(h) of the Social Security Act (42 U.S.C. 

13 1395m(h)), as amended by section 4, is amended by add14 ing at the end the following new paragraph: 

15 ‘‘(6) DOCUMENTATION CREATED BY

16 ORTHOTISTS AND PROSTHETISTS.—With respect to 

17 claims filed after August 11, 2011, for purposes of 

18 determining the reasonableness, medical necessity, 

19 and functional level (applicable to prosthetics) of 

20 prosthetic devices and orthotics and prosthetics, doc21 umentation created by an orthotist or prosthetist 

22 shall be considered part of the patient’s medical 

23 record and, consistent with the treatment of orthotic 

24 and prosthetic patient care delivery stated in the 

25 health care professional exception provided in clause 


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1 (ii) of subsection (a)(20)(F), shall be given the same 

2 consideration as documentation created by other 

3 health professionals, including physicians, nurse 

4 practitioners, occupational therapists, and physical 

5 therapists.’’. 

6 SEC. 6. DISTINGUISHING ORTHOTISTS AND PROSTHETISTS 

7 FROM SUPPLIERS OF DURABLE MEDICAL 

8 EQUIPMENT AND SUPPLIES. 

9 (a) REQUIREMENTS FOR SUPPLIERS OF MEDICAL

10 EQUIPMENT AND SUPPLIES.—Section 1834(j)(5) of the 

11 Social Security Act (42 U.S.C. 1395m(j)(5)) is amended 

12 by striking subparagraph (C). 

13 (b) REQUIREMENTS FOR ORTHOTISTS AND

14 PROSTHETISTS.—Section 1834 of the Social Security Act 

15 (42 U.S.C. 1395m) is amended by adding at the end the 

16 following new subsection: 

17 ‘‘(r) REQUIREMENTS FOR ORTHOTISTS AND

18 PROSTHETISTS.— 

19 ‘‘(1) ISSUANCE AND RENEWAL OF SUPPLIER

20 NUMBER.— 

21 ‘‘(A) PAYMENT.— 

22 ‘‘(i) IN GENERAL.—No payment may 

23 be made under this part to an orthotic or 

24 prosthetic supplier unless such orthotic or 

25 prosthetic supplier obtains (and renews at 


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1 such intervals as the Secretary may re2 quire) a supplier number. 

3 ‘‘(ii) CLARIFICATION REGARDING PRO4 VIDERS UNDER PART A.—Nothing in 

5 clause (i) shall prohibit a provider other6 wise permitted to receive payment for 

7 orthotics and prosthetics under part A 

8 from continuing to receive payment under 

9 such part without interruption. 

10 ‘‘(B) STANDARDS FOR POSSESSING A SUP11 PLIER NUMBER.—An orthotic or prosthetic sup12 plier may only obtain a supplier number if the 

13 supplier meets standards prescribed by the Sec14 retary that include requirements that the 

15 orthotic or prosthetic supplier (and, where ap16 plicable, the orthotist or prosthetist)— 

17 ‘‘(i) complies with all applicable State 

18 and Federal licensure and regulatory re19 quirements; 

20 ‘‘(ii) acquires accreditation from the 

21 American Board for Certification in 

22 Orthotics, Prosthetics and Pedorthics, Inc. 

23 (ABC) or the Board of Certification/Ac24 creditation, International (BOC), or other 

25 accreditation entity that the Secretary deVerDate Sep 11 2014 05:13 Mar 28, 2015 Jkt 049200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S829.IS S829

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1 termines has standards that are essentially 

2 equivalent to the standards of such 

3 Boards; 

4 ‘‘(iii) maintains a physical facility on 

5 an appropriate site; 

6 ‘‘(iv) has proof of appropriate liability 

7 insurance; and 

8 ‘‘(v) meets such other requirements as 

9 the Secretary shall specify. 

10 ‘‘(C) PROHIBITION AGAINST MULTIPLE

11 SUPPLIER NUMBERS.—The Secretary may not 

12 issue more than one supplier number to any 

13 orthotic or prosthetic supplier unless the Sec14 retary finds that the issuance of more than one 

15 number is appropriate to identify other entities 

16 under the ownership or control of the orthotic 

17 or prosthetic supplier. 

18 ‘‘(2) ORDER FOR ORTHOTICS OR PROS19 THETICS.— 

20 ‘‘(A) INFORMATION PROVIDED BY

21 ORTHOTISTS AND PROSTHETISTS ON DETAILED

22 WRITTEN ORDERS FOR ORTHOTICS AND PROS23 THETICS.—An orthotist or prosthetist may dis24 tribute to physicians, or to an individual en25 rolled under this part, a detailed written order 


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1 for orthotics or prosthetics (as defined in para2 graph (5)) for commercial purposes that con3 tains the following information: 

4 ‘‘(i) The identification of— 

5 ‘‘(I) the orthotic or prosthetic 

6 supplier; and 

7 ‘‘(II) the individual to whom the 

8 orthotics or prosthetics are furnished. 

9 ‘‘(ii) The identification of the treating 

10 physician, including the name, address, 

11 and telephone number of the physician. 

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

13 prosthetics ordered. 

14 ‘‘(iv) Any billing code identifying the 

15 orthotics or prosthetics. 

16 ‘‘(v) Diagnosis codes, a description of 

17 the individual’s medical and functional 

18 condition, and information about the need 

19 for the orthotics or prosthetics. 

20 ‘‘(B) INFORMATION ON CODING AND

21 DESCRIPTORS OF COMPONENTS PROVIDED.—If 

22 an orthotist or prosthetist distributes a detailed 

23 written order for orthotics or prosthetics de24 scribed in subparagraph (A), the orthotist or 

25 prosthetist shall also list on the order the 


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1 HCPCS codes and summary descriptors of the 

2 items and services being recommended prior to 

3 submission of the order to the treating physi4 cian for approval. 

5 ‘‘(C) SIGNATURE BY TREATING PHYSI6 CIAN.—A detailed written order for orthotics or 

7 prosthetics described in subparagraph (A) shall 

8 be signed by the treating physician. 

9 ‘‘(3) LIMITATION ON INDIVIDUAL LIABILITY.— 

10 Except as provided in paragraph (4), if an orthotist 

11 or prosthetist— 

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

13 an individual for which no payment may be 

14 made under this part; or 

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

16 orthosis or prosthesis to an individual for which 

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

18 any expenses incurred for the orthosis or prosthesis 

19 furnished to an individual by the orthotist or pros20 thetist not on an assigned basis shall be the respon21 sibility of such orthotist or prosthetist. The indi22 vidual shall have no financial responsibility for such 

23 expenses and the orthotist or prosthetist shall refund 

24 on a timely basis to the individual (and shall be lia25 ble to the individual for) any amounts collected from 


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1 the individual for such items and services. The pro2 visions of subsection (a)(18) shall apply to refunds 

3 required under the previous sentence in the same 

4 manner as such provisions apply to refunds under 

5 such subsection. 

6 ‘‘(4) INDIVIDUAL LIABILITY.—If an orthotist or 

7 prosthetist furnishes an orthosis or prosthesis to an 

8 individual for which payment is denied in advance 

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

10 orthosis or prosthesis furnished to the individual by 

11 the orthotist or prosthetist shall be the responsibility 

12 of the individual. 

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

14 ‘‘(A) DETAILED WRITTEN ORDER FOR

15 ORTHOTICS OR PROSTHETICS.—The term ‘de16 tailed written order for orthotics or prosthetics’ 

17 means a form or other document prepared by 

18 an orthotist or prosthetist and signed by the 

19 physician (as defined by section 1861(r)) that 

20 contains information required by the Secretary 

21 to be submitted to show that an orthosis or 

22 prosthesis is reasonable and necessary for the 

23 treatment of an illness or injury or to improve 

24 the functioning of a malformed body member. 


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

2 term ‘orthotics and prosthetics’ has the mean3 ing given that term in section 1834(h)(4)(C). 

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

5 term ‘orthotist or prosthetist’ means an indi6 vidual who is specifically trained and educated 

7 in the provision of, and patient care manage8 ment related to, prosthetics and custom-fab9 ricated or custom-fit orthotics, and— 

10 ‘‘(i) in the case of a State that pro11 vides for the licensing of orthotists and 

12 prosthetists, is licensed by the State in 

13 which the orthotics or prosthetics were 

14 supplied; or 

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

16 not provide for the licensing of orthotists 

17 and prosthetists, is certified by the Amer18 ican Board of Certification in Orthotics, 

19 Prosthetics and Pedorthics, Inc. or by the 

20 Board of Certification/Accreditation, Inter21 national, or is certified and approved by an 

22 entity that the Secretary determines has 

23 certification and approval standards that 

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1 cation and approval standards of such 

2 Boards.’’. 

3 (c) DEFINITION OF ORTHOTICS AND PROSTHETICS

4 SYNONYMOUS WITH ORTHOSES AND PROSTHESES.—Sec5 tion 1834(h)(4)(C) of the Social Security Act (42 U.S.C. 

6 1395m(h)(4)(C)) is amended by inserting ‘‘(which may 

7 also be referred to without distinction as ‘orthoses and 

8 prostheses’)’’ after ‘‘the term ‘orthotics and prosthetics’ ’’. 

9 (d) LIMITATION OF COMPETITIVE ACQUISITION FOR

10 OFF-THE-SHELF ORTHOTICS.—Section 1847(a)(7)(A)(i) 

11 of the Social Security Act (42 U.S.C. 1395w– 

12 3(a)(7)(A)(i)) is amended— 

13 (1) by inserting ‘‘, orthotist or prosthetist (as 

14 defined in section 1834(r)(5)(C)),’’ after ‘‘by a phy15 sician’’; 

16 (2) by inserting ‘‘, orthotist’s or prosthetist’s,’’ 

17 after ‘‘to the physician’s’’; and 

18 (3) by inserting ‘‘, orthotist’s or prosthetist’s,’’ 

19 after ‘‘of the physician’s’’. 

20 (e) EFFECTIVE DATE.—The amendments made by 

21 this section shall take effect on the date of enactment of 

22 this Act, and apply to items and services furnished on or 

23 after such date. 


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1 SEC. 7. CLARIFICATION ABOUT MINIMAL SELF-ADJUST2 MENT FOR OFF-THE-SHELF ORTHOTICS. 

3 (a) IN GENERAL.—Section 1847(a)(2)(C) of the So4 cial Security Act (42 U.S.C. 1395w–3(a)(2)(C)) is amend5 ed— 

6 (1) by inserting ‘‘furnished to a patient’’ after 

7 ‘‘section 1861(s)(9) of this title’’; 

8 (2) by inserting ‘‘by that patient (and not by 

9 any other person)’’ after ‘‘minimal self-adjustment’’; 

10 and 

11 (3) by striking ‘‘to fit to the individual’’ and in12 serting ‘‘to fit to that patient’’. 

13 (b) INCLUSION IN MEDICAL AND OTHER HEALTH

14 SERVICES.—Section 1861(s)(9) of the Social Security Act 

15 (42 U.S.C. 1395x(s)(9)) is amended— 

16 (1) by striking ‘‘leg, arm’’ and inserting ‘‘(A) 

17 leg, arm’’; 

18 (2) in subparagraph (A), as added by para19 graph (1), by striking the semicolon and inserting ‘‘; 

20 and’’; and 

21 (3) by adding the following new subparagraph: 

22 ‘‘(B) off-the-shelf orthotics (as defined in sec23 tion 1847(a)(2)(C)).’’. 

24 (c) EFFECTIVE DATE.—The amendments made by 

25 this section shall take effect on April 1, 2007, and apply 

26 to items and services furnished on or after such date. 


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1 SEC. 8. REGULATIONS. 

2 Not later than 120 days after the date of enactment 

3 of this Act, the Secretary shall promulgate regulations to 

4 implement— 

5 (1) the provisions of, and amendments made 

6 by, this Act; and 

7 (2) the provisions of, and amendments made 

8 by, section 427 of the Medicare, Medicaid, and 

9 SCHIP Benefits Improvement and Protections Act 

10 of 2000, as enacted into law by section 1(a)(6) of 

11 Public Law 106–554. 

Æ 


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