II 

115TH CONGRESS 

1ST SESSION S. 1191 

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 

MAY 22, 2017 

Mr. GRASSLEY 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 2017’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 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, 2018, 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 2018, 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), in the matter preceding sub13 clause (I), by striking ‘‘an item of custom-fabricated 

14 orthotics described in clause (ii) or for an item of 

15 prosthetics unless such item is’’ and inserting ‘‘an 

16 item of orthotics or prosthetics, including an item of 

17 custom-fabricated orthotics described in clause (ii), 

18 unless such item is’’; 

19 (3) in clause (ii)(II), in the first sentence, by 

20 striking ‘‘a list of items to which this subparagraph 

21 applies’’ and inserting ‘‘a list of items for purposes 

22 of clause (i)’’; 

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

24 or manage the provision of prosthetics and custom25 designed or -fabricated orthotics’’ and inserting ‘‘to 


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1 provide or manage the provision of orthotics and 

2 prosthetics (and custom-designed or -fabricated 

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

4 (ii))’’; and 

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

6 clause: 

7 ‘‘(v) EXEMPTION OF OFF-THE-SHELF

8 ORTHOTICS INCLUDED IN A COMPETITIVE

9 ACQUISITION PROGRAM.—This subpara10 graph shall not apply to an item of 

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

12 section 1847(a) furnished on or after Jan13 uary 1, 2018, that is included in a com14 petitive acquisition area under such sec15 tion.’’. 

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

17 subsection (a) shall apply to orthotics and prosthetics fur18 nished on or after January 1, 2018. 

19 SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR 

20 ORTHOTICS AND PROSTHETICS BASED ON 

21 SUPPLIER QUALIFICATIONS AND COM22 PLEXITY OF CARE. 

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

24 1395m(h)) is amended— 


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1 (1) in paragraph (1)(F)(iii), in the matter pre2 ceding subclause (I), by striking ‘‘other individual 

3 who’’ and inserting ‘‘other individual who, with re4 spect to the provision of orthotics and prosthetics 

5 furnished on or after January 1, 2018, and subject 

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

7 of the provider qualification designation for such 

8 orthotic or prosthetic, and who’’; 

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

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

11 provision of orthotics and prosthetics furnished on 

12 or after January 1, 2018, and subject to paragraph 

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

14 qualification designation for such orthotic or pros15 thetic’’; and 

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

17 paragraph: 

18 ‘‘(5) ELIGIBILITY FOR PAYMENT BASED ON

19 SUPPLIER QUALIFICATIONS AND COMPLEXITY OF

20 CARE.— 

21 ‘‘(A) CONSIDERATIONS FOR ELIGIBILITY

22 FOR PAYMENTS.— 

23 ‘‘(i) IN GENERAL.—In applying 

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

25 for purposes of determining whether payVerDate Sep 11 2014 23:24 May 30, 2017 Jkt 069200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1191.IS S1191

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1 ment may be made under this subsection 

2 for orthotics and prosthetics furnished on 

3 or after January 1, 2018, the Secretary 

4 shall take into account the complexity of 

5 the respective item and, subject to clauses 

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

7 individual or entity furnishing and fabri8 cating such respective item in accordance 

9 with this paragraph. 

10 ‘‘(ii) INDIVIDUALS AND ENTITIES EX11 EMPTED FROM SUPPLIER QUALIFICATION

12 CRITERIA.—With respect to the provision 

13 of orthotics or prosthetics, any criteria for 

14 supplier qualifications shall not apply to 

15 physicians, occupational therapists, or 

16 physical therapists who are licensed or oth17 erwise regulated by the State in which they 

18 are practicing and who receive payment 

19 under this title, including regulations pro20 mulgated pursuant to this subsection, for 

21 the provision of orthotics and prosthetics. 

22 ‘‘(iii) SUPPLIERS MEDICARE-ELIGIBLE

23 PRIOR TO JANUARY 1, 2018, EXEMPTED.— 

24 In the case of a qualified supplier who is 

25 eligible to receive payment under this title 


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1 before January 1, 2018, with respect to 

2 the provision of orthotics and prosthetics, 

3 any new criteria for provider qualifications 

4 established after such date shall not apply 

5 to such supplier, for the furnishing or fab6 rication of such an item. 

7 ‘‘(iv) MODIFICATIONS.—The Secretary 

8 shall, in consultation with the Boards and 

9 programs described in paragraph 

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

11 for supplier qualifications and may imple12 ment by regulation any modifications to 

13 such criteria, as determined appropriate in 

14 accordance with such consultation. Any 

15 such modifications shall take effect no ear16 lier than January 1, 2018. 

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

18 For purposes of subparagraph (A), the Sec19 retary, in consultation with representatives of 

20 the fields of occupational therapy, physical ther21 apy, orthotics, and prosthetics, shall utilize and 

22 incorporate the set of L-codes listed, as of the 

23 date of enactment of this paragraph, in the 

24 Centers for Medicare & Medicaid Services docu25 ment entitled ‘Transmittal 656’ (CMS Pub. 


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1 100–04, Change Request 3959, August 19, 

2 2005). Transmittal 656 shall be the controlling 

3 source of category, product, and code assign4 ments for the orthotics and prosthetics care, 

5 using the supplier qualification designation for 

6 each HCPCS code as stated in such document. 

7 In the case that Transmittal 656 is updated, 

8 reissued, or replaced by a subsequent document, 

9 the preceding sentence shall be applied with re10 spect to the most recent update, reissuance, or 

11 replacement of such document.’’. 

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

13 AS PART OF THE PATIENT’S MEDICAL 

14 RECORD. 

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

16 1395m(h)), as amended by section 4, is amended by add17 ing at the end the following new paragraph: 

18 ‘‘(6) DOCUMENTATION CREATED BY

19 ORTHOTISTS AND PROSTHETISTS.—With respect to 

20 claims filed after the date of the enactment of the 

21 Medicare Orthotics and Prosthetics Improvement 

22 Act of 2017, for purposes of determining the reason23 ableness, medical necessity, and functional level (ap24 plicable to prosthetics) of orthotics and prosthetics, 

25 documentation created by an orthotist or prosthetist 


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1 shall be considered part of the patient’s medical 

2 record and, consistent with the treatment of orthotic 

3 and prosthetic patient care delivery stated in the 

4 health care professional exception provided in clause 

5 (ii) of subsection (a)(20)(F), shall be considered 

6 along with documentation created by other health 

7 professionals, including physicians, nurse practi8 tioners, occupational therapists, and physical thera9 pists.’’. 

10 SEC. 6. DISTINGUISHING ORTHOTISTS AND PROSTHETISTS 

11 FROM SUPPLIERS OF DURABLE MEDICAL 

12 EQUIPMENT AND SUPPLIES. 

13 (a) REQUIREMENTS FOR SUPPLIERS OF MEDICAL

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

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

16 by striking subparagraph (C). 

17 (b) REQUIREMENTS FOR ORTHOTISTS AND

18 PROSTHETISTS.— 

19 (1) IN GENERAL.—Section 1834 of the Social 

20 Security Act (42 U.S.C. 1395m) is amended by add21 ing at the end the following new subsection: 

22 ‘‘(v) REQUIREMENTS FOR ORTHOTISTS AND

23 PROSTHETISTS.— 

24 ‘‘(1) ISSUANCE AND RENEWAL OF SUPPLIER

25 NUMBER.— 


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1 ‘‘(A) PAYMENT.— 

2 ‘‘(i) IN GENERAL.—No payment may 

3 be made under this part to an orthotic or 

4 prosthetic supplier unless such orthotic or 

5 prosthetic supplier obtains (and renews at 

6 such intervals as the Secretary may re7 quire) a supplier number. 

8 ‘‘(ii) CLARIFICATION REGARDING PRO9 VIDERS UNDER PART A.—Nothing in 

10 clause (i) shall prohibit a provider other11 wise permitted to receive payment for 

12 orthotics and prosthetics under part A 

13 from continuing to receive payment under 

14 such part without interruption. 

15 ‘‘(B) STANDARDS FOR POSSESSING A SUP16 PLIER NUMBER.—An orthotic or prosthetic sup17 plier may only obtain a supplier number if the 

18 supplier meets standards prescribed by the Sec19 retary that include requirements that the 

20 orthotic or prosthetic supplier (and, where ap21 plicable, the orthotist or prosthetist)— 

22 ‘‘(i) licensure or accreditation— 

23 ‘‘(I) complies with all applicable 

24 State and Federal licensure and regu25 latory requirements; or 


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1 ‘‘(II) acquires accreditation from 

2 the American Board for Certification 

3 in Orthotics, Prosthetics and 

4 Pedorthics, Inc. (ABC) or the Board 

5 of Certification/Accreditation, Inter6 national (BOC), or other accreditation 

7 entity that the Secretary determines 

8 has standards that are essentially 

9 equivalent to the standards of such 

10 Boards; 

11 ‘‘(ii) maintains a physical facility on 

12 an appropriate site; 

13 ‘‘(iii) has proof of appropriate liability 

14 insurance; and 

15 ‘‘(iv) meets such other requirements 

16 as the Secretary shall specify. 

17 ‘‘(C) PROHIBITION AGAINST MULTIPLE

18 SUPPLIER NUMBERS.—The Secretary may not 

19 issue more than one supplier number to any 

20 orthotic or prosthetic supplier unless the Sec21 retary finds that the issuance of more than one 

22 number is appropriate to identify other entities 

23 under the ownership or control of the orthotic 

24 or prosthetic supplier. 


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1 ‘‘(2) ORDER FOR ORTHOTICS OR PROS2 THETICS.— 

3 ‘‘(A) INFORMATION PROVIDED BY

4 ORTHOTISTS AND PROSTHETISTS ON DETAILED

5 WRITTEN ORDERS FOR ORTHOTICS AND PROS6 THETICS.—An orthotist or prosthetist may dis7 tribute to physicians, or to an individual en8 rolled under this part, a detailed written order 

9 for orthotics or prosthetics (as defined in para10 graph (5)) for commercial purposes that con11 tains the following information: 

12 ‘‘(i) The identification of— 

13 ‘‘(I) the orthotic or prosthetic 

14 supplier; and 

15 ‘‘(II) the individual to whom the 

16 orthotics or prosthetics are furnished. 

17 ‘‘(ii) The identification of the treating 

18 physician, including the name, address, 

19 and telephone number of the physician. 

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

21 prosthetics ordered. 

22 ‘‘(iv) Any billing code identifying the 

23 orthotics or prosthetics. 

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

25 the individual’s medical and functional 


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1 condition, and information about the need 

2 for the orthotics or prosthetics. 

3 ‘‘(B) INFORMATION ON CODING AND

4 DESCRIPTORS OF COMPONENTS PROVIDED.—If 

5 an orthotist or prosthetist distributes a detailed 

6 written order for orthotics or prosthetics de7 scribed in subparagraph (A), the orthotist or 

8 prosthetist shall also list on the order the 

9 HCPCS codes and summary descriptors of the 

10 items and services being recommended prior to 

11 submission of the order to the treating physi12 cian for approval. 

13 ‘‘(C) SIGNATURE BY TREATING PHYSI14 CIAN.—A detailed written order for orthotics or 

15 prosthetics described in subparagraph (A) shall 

16 be signed by the treating physician. 

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

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

19 or prosthetist— 

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

21 an individual for which no payment may be 

22 made under this part; or 

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

24 orthosis or prosthesis to an individual for which 

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


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1 any expenses incurred for the orthosis or prosthesis 

2 furnished to an individual by the orthotist or pros3 thetist not on an assigned basis shall be the respon4 sibility of such orthotist or prosthetist. The indi5 vidual shall have no financial responsibility for such 

6 expenses and the orthotist or prosthetist shall refund 

7 on a timely basis to the individual (and shall be lia8 ble to the individual for) any amounts collected from 

9 the individual for such items and services. The pro10 visions of subsection (a)(18) shall apply to refunds 

11 required under the previous sentence in the same 

12 manner as such provisions apply to refunds under 

13 such subsection. 

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

15 prosthetist furnishes an orthosis or prosthesis to an 

16 individual for which payment is denied in advance 

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

18 orthosis or prosthesis furnished to the individual by 

19 the orthotist or prosthetist shall be the responsibility 

20 of the individual. 

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

22 ‘‘(A) DETAILED WRITTEN ORDER FOR

23 ORTHOTICS OR PROSTHETICS.— 

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

25 written order for orthotics or prosthetics’ 


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1 means a form or other document prepared 

2 by an orthotist or prosthetist and signed 

3 by the physician (as defined by section 

4 1861(r)) that contains information re5 quired by the Secretary to be submitted to 

6 show that an orthosis or prosthesis is rea7 sonable and necessary for the treatment of 

8 an illness or injury or to improve the func9 tioning of a malformed body member. 

10 ‘‘(ii) CLARIFICATION.—The detailed 

11 written work order for orthotics or pros12 thetic shall not be considered alone for 

13 purposes of determining the reasonable14 ness, medical necessity, and functional 

15 level (applicable to prosthetics) of pros16 thetic devices and orthotics. 

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

18 term ‘orthotics and prosthetics’ has the mean19 ing given that term in section 1834(h)(4)(C). 

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

21 term ‘orthotist or prosthetist’ means an indi22 vidual who is specifically trained and educated 

23 in the provision of, and patient care manage24 ment related to, prosthetics and custom-fab25 ricated or custom-fit orthotics, and— 


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1 ‘‘(i) in the case of a State that pro2 vides for the licensing of orthotists and 

3 prosthetists, is licensed by the State in 

4 which the orthotics or prosthetics were 

5 supplied; or 

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

7 not provide for the licensing of orthotists 

8 and prosthetists, is certified by the Amer9 ican Board of Certification in Orthotics, 

10 Prosthetics and Pedorthics, Inc. or by the 

11 Board of Certification/Accreditation, Inter12 national, or is certified and approved by an 

13 entity that the Secretary determines has 

14 certification and approval standards that 

15 are essentially equivalent to the certifi16 cation and approval standards of such 

17 Boards.’’. 

18 (2) IMPACT ON DMEPOS BENEFIT.—The 

19 amendment made by paragraph (1)— 

20 (A) shall not be construed to create a sepa21 rate benefit category under title XVIII of the 

22 Social Security Act for orthotic and prosthetic 

23 devices; but 

24 (B) shall be construed as differentiating 

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1 vices and services are provided in contrast to 

2 other durable medical equipment and supplies 

3 services covered under such title. 

4 (c) DEFINITION OF ORTHOTICS AND PROSTHETICS

5 SYNONYMOUS WITH ORTHOSES AND PROSTHESES.—Sec6 tion 1834(h)(4)(C) of the Social Security Act (42 U.S.C. 

7 1395m(h)(4)(C)) is amended by inserting ‘‘(which may 

8 also be referred to without distinction as ‘orthoses and 

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

10 (d) LIMITATION OF COMPETITIVE ACQUISITION FOR

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

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

13 3(a)(7)(A)(i)) is amended— 

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

15 defined in section 1834(v)(5)(C)),’’ after ‘‘by a phy16 sician’’; 

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

18 after ‘‘to the physician’s’’; and 

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

20 after ‘‘of the physician’s’’. 

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

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

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

24 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)’’; 

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 at the end and 

20 inserting ‘‘; 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 The Secretary shall promulgate— 

3 (1) not later than 1 year after the enactment 

4 of this Act, final regulations to implement the provi5 sions of, and amendments made by, this Act; and 

6 (2) not later than 120 days after the enactment 

7 of this Act, final regulations to implement the provi8 sions of, and amendments made by, section 427 of 

9 the Medicare, Medicaid, and SCHIP Benefits Im10 provement and Protections Act of 2000, as enacted 

11 into law by section 1(a)(6) of Public Law 106–554. 

Æ 


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