I 

112TH CONGRESS 

1ST SESSION H. R. 1958 

To amend title XVIII of the Social Security Act to modify the designation 

of accreditation organizations for orthotics and prosthetics, to apply 

accreditation and licensure requirements to suppliers of such devices 

and items for purposes of payment under the Medicare program, and 

to modify the payment rules for such devices and items under such 

program to account for practitioner qualifications and complexity of 

care. 

IN THE HOUSE OF REPRESENTATIVES 

MAY 24, 2011 

Ms. BERKLEY (for herself, Mr. THOMPSON of Pennsylvania, Mr. 

RUPPERSBERGER, Mr. GUTHRIE, and Mr. NEAL) 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 modify 

the designation of accreditation organizations for 

orthotics and prosthetics, to apply accreditation and licensure requirements to suppliers of such devices and 

items for purposes of payment under the Medicare program, and to modify the payment rules for such devices 

and items under such program to account for practitioner qualifications and complexity of care. 


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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 Improvement Act of 2011’’. 

6 SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE 

7 UNDER MEDICARE TO DESIGNATION OF AC8 CREDITATION ORGANIZATIONS FOR SUP9 PLIERS OF ORTHOTICS AND PROSTHETICS. 

10 (a) IN GENERAL.—Section 1834(a)(20)(B) of the So11 cial Security Act (42 U.S.C. 1395m(a)(20)(B)) is amend12 ed— 

13 (1) by striking ‘‘Not later than’’ and inserting 

14 ‘‘(i) IN GENERAL.—Subject to clause (ii), not later 

15 than’’ with the same indentation as the clauses 

16 added by paragraph (2); and 

17 (2) by adding at the end the following new 

18 clauses: 

19 ‘‘(ii) SPECIAL REQUIREMENTS FOR

20 ACCREDITATION OF SUPPLIERS OF

21 ORTHOTICS AND PROSTHETICS.—For pur22 poses of applying quality standards under 

23 subparagraph (A) for suppliers (other than 

24 suppliers described in clause (iii)) of items 

25 and services described in subparagraph 


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

2 approve an independent accreditation orga3 nization under clause (i) only if such orga4 nization is a Board or program described 

5 in subsection (h)(1)(F)(iv). Not later than 

6 January 1, 2012, the Secretary shall en7 sure that at least one independent accredi8 tation organization is designated and ap9 proved in accordance with this clause. 

10 ‘‘(iii) EXCEPTION.—Suppliers de11 scribed in this clause are physicians, occu12 pational therapists, or physical therapists 

13 who are licensed or otherwise regulated by 

14 the State in which they are practicing and 

15 who receive payment under this title, in16 cluding regulations promulgated pursuant 

17 to this subsection.’’. 

18 (b) EFFECTIVE DATE.—An organization must satisfy 

19 the requirement of section 1834(a)(20)(B)(ii), as added 

20 by subsection (a)(2), not later than January 1, 2012, re21 gardless of whether such organization is designated or ap22 proved as an independent accreditation organization be23 fore, on, or after the date of the enactment of this Act. 


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1 SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND 

2 LICENSURE REQUIREMENTS TO CERTAIN 

3 PROSTHETICS AND CUSTOM-FABRICATED OR 

4 CUSTOM-FITTED ORTHOTICS. 

5 (a) IN GENERAL.—Section 1834(h)(1)(F) of the So6 cial Security Act (42 U.S.C. 1395m(h)(1)(F)) is amend7 ed— 

8 (1) in the heading, by inserting ‘‘OR CUSTOM9 FITTED’’ after ‘‘CUSTOM-FABRICATED’’; 

10 (2) in clause (i), by striking ‘‘an item of cus11 tom-fabricated orthotics described in clause (ii) or 

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

13 inserting ‘‘an item of orthotics or prosthetics, includ14 ing an item of custom-fabricated orthotics described 

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

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

17 to which this subparagraph applies’’ and inserting 

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

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

20 or manage the provision of prosthetics and custom21 designed or -fabricated orthotics’’ and inserting ‘‘to 

22 provide or manage the provision of orthotics and 

23 prosthetics (and custom-designed or -fabricated 

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

25 (ii))’’. 


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

2 subsection (a) shall apply to orthotics and prosthetics fur3 nished on or after January 1, 2012. 

4 SEC. 4. MEDICARE PAYMENT RULES FOR ORTHOTICS AND 

5 PROSTHETICS TO ACCOUNT FOR PRACTI6 TIONER QUALIFICATIONS AND COMPLEXITY 

7 OF CARE. 

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

9 1395m(h)) is amended— 

10 (1) in paragraph (1)(F)(iii), by striking ‘‘other 

11 individual who’’ and inserting ‘‘other individual who, 

12 with respect to a category of orthotics and pros13 thetics care described in clause (i), (ii), (iii), (iv), or 

14 (v) of paragraph (5)(C) furnished on or after Janu15 ary 1, 2012, and subject to paragraph (5)(A), satis16 fies all applicable criteria of the provider qualifica17 tion designation for such category described in the 

18 respective clause, and who’’; 

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

20 the period the following: ‘‘and, with respect to a cat21 egory of orthotics and prosthetics care described in 

22 clause (i), (ii), (iii), (iv), or (v) of paragraph (5)(C) 

23 furnished on or after January 1, 2012, and subject 

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


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1 of the provider qualification designation for such 

2 category described in the respective clause’’; and 

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

4 paragraph: 

5 ‘‘(5) PAYMENT RULES TO ACCOUNT FOR PRAC6 TITIONER QUALIFICATIONS AND COMPLEXITY OF

7 CARE.— 

8 ‘‘(A) CONSIDERATIONS FOR PAYMENTS.— 

9 ‘‘(i) IN GENERAL.—In applying 

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

11 for purposes of determining whether pay12 ment may be made under this subsection 

13 for orthotics and prosthetics furnished on 

14 or after January 1, 2012, the Secretary 

15 shall take into account the complexity of 

16 the respective item and, subject to clauses 

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

18 individual or entity furnishing and fabri19 cating such respective item in accordance 

20 with this paragraph. 

21 ‘‘(ii) INDIVIDUAL AND ENTITIES EX22 EMPTED FROM PROVIDER QUALIFICATION

23 DESIGNATION CRITERIA.—With respect to 

24 an item of orthotics or prosthetics de25 scribed in clause (ii), (iii), (iv) or (v) of 


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1 subparagraph (C), any criteria for the pro2 vider qualification designations under such 

3 respective clause, including application of 

4 subparagraph (D), shall not apply to phy5 sicians, occupational therapists, or physical 

6 therapists who are licensed or otherwise 

7 regulated by the State in which they are 

8 practicing and who receive payment under 

9 this title, including regulations promul10 gated pursuant to this subsection, for the 

11 provision of orthotics and prosthetics. 

12 ‘‘(iii) PRACTITIONERS MEDICARE-ELI13 GIBLE PRIOR TO JANUARY 1, 2013 EXEMPT14 ED.—In the case of a qualified practitioner 

15 or qualified supplier who is eligible to re16 ceive payment under this title before Janu17 ary 1, 2013— 

18 ‘‘(I) with respect to an item of 

19 orthotics or prosthetics described in 

20 clause (i) of subparagraph (C), any 

21 criteria for the provider qualification 

22 designations under such clause, in23 cluding application of subparagraph 

24 (D), shall not apply to such practi25 tioner or supplier, respectively, for the 


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1 furnishing or fabrication of such an 

2 item so described; and 

3 ‘‘(II) with respect to an item of 

4 orthotics or prosthetics described in 

5 clause (ii), (iii), or (iv) of subpara6 graph (C), any criteria for the pro7 vider qualification designations under 

8 the respective clause (or a subsequent 

9 clause of such subparagraph), includ10 ing application of subparagraph (D), 

11 shall not apply to such practitioner or 

12 supplier, respectively, for the fur13 nishing or fabrication of such an item 

14 described in such respective (or such 

15 subsequent) clause. 

16 ‘‘(iv) DELAYED APPLICATION OF CER17 TAIN PROVIDER QUALIFICATION DESIGNA18 TION CRITERIA.—The provider qualifica19 tion designations under clauses (i), (ii), 

20 and (iii) of subparagraph (C), including 

21 the application of subparagraph (D) to 

22 such clauses, shall not be taken into ac23 count with respect to payment made under 

24 this subsection for orthotics and pros25 thetics furnished before January 1, 2013. 


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1 ‘‘(v) MODIFICATIONS.—The Secretary 

2 shall, in consultation with the boards and 

3 programs described in paragraph 

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

5 for the provider qualification designation 

6 under subparagraph (C)(i)(III) and may 

7 implement by regulation any modifications 

8 to such criteria, as determined appropriate 

9 in accordance with such consultation. Any 

10 such modification shall take effect no ear11 lier than January 1, 2014. 

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

13 For purposes of subparagraph (A), the Sec14 retary, in consultation with representatives of 

15 the fields of occupational therapy, physical ther16 apy, orthotics, and prosthetics shall utilize and 

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

18 date of the enactment of this paragraph, in the 

19 Centers for Medicare & Medicaid Services docu20 ment entitled Transmittal 656 (CMS Pub. 100– 

21 04, Change Request 3959, August 19, 2005) 

22 and the 2008 Orthotics and Prosthetics Tri23 partite Document, a multi-organization com24 pilation of HCPCS codes. Transmittal 656 shall 

25 be the controlling source of category, product, 


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1 and code assignments for the orthotics and 

2 prosthetics care described in each of clauses (i) 

3 through (v) of subparagraph (C) using the pro4 vider qualification designation for each HCPCS 

5 code as stated in such document and, in cases 

6 in which Transmittal 656 does not include a 

7 particular item of orthotics or prosthetics or a 

8 related code or in cases in which Transmittal 

9 656 is revoked or abridged, the 2008 Orthotics 

10 and Prosthetics Tripartite Document shall be 

11 the secondary source for such category, prod12 uct, and code assignments. In the case that ei13 ther of the documents described in the previous 

14 sentence is updated or reissued, the previous 

15 sentence shall be applied with respect to the 

16 most recent update or reissuance of such docu17 ment. 

18 ‘‘(C) CATEGORIES OF ORTHOTIC AND

19 PROSTHETIC CARE DESCRIBED.— 

20 ‘‘(i) CUSTOM FABRICATED LIMB PROS21 THETICS CATEGORY.—The category of 

22 orthotic and prosthetic care described in 

23 this clause is a category for artificial legs 

24 and arms, including replacements (as de25 scribed in section 1861(s)(9)) that are 


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1 made from detailed measurements, images, 

2 or models in accordance with a prescrip3 tion and that can only be utilized by a spe4 cific intended patient and for which pay5 ment is made under this part. The pro6 vider qualification designation for the cat7 egory shall reflect each of the following, in 

8 accordance with subparagraph (D): 

9 ‘‘(I) The category of care involves 

10 the highest level of complexity with 

11 substantial clinical risk. 

12 ‘‘(II) The category of care re13 quires a practitioner who satisfies any 

14 of the education requirements de15 scribed in subclause (III), has com16 pleted a prosthetic residency accred17 ited by the National Commission on 

18 Orthotic and Prosthetic Education 

19 (‘NCOPE’), and is certified or li20 censed in prosthetics to ensure the 

21 comprehensive provision of prosthetic 

22 care. 

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1 pleted any of the following education 

2 requirements: 

3 ‘‘(aa) A bachelor’s degree or 

4 master’s degree in prosthetics as 

5 offered by educational institu6 tions accredited by the Commis7 sion on Accreditation of Allied 

8 Health Education Programs. 

9 ‘‘(bb) A bachelor’s degree, 

10 plus a certificate in prosthetics as 

11 offered by educational institu12 tions accredited by the Commis13 sion on Accreditation of Allied 

14 Health Education Programs. 

15 ‘‘(cc) A foreign degree deter16 mined by the World Education 

17 Service to be equivalent to an 

18 educational program in pros19 thetics accredited by the Com20 mission on Accreditation of Allied 

21 Health Education Programs. 

22 ‘‘(ii) CUSTOM FABRICATED

23 ORTHOTICS CATEGORY.—The category of 

24 orthotics and prosthetics care described in 

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1 ricated orthotics that are made from de2 tailed measurements, images, or models in 

3 accordance with a prescription and that 

4 can only be utilized by a specific intended 

5 patient. The provider qualification designa6 tion for the category shall reflect the fol7 lowing, in accordance with subparagraph 

8 (D): 

9 ‘‘(I) The category of care involves 

10 the highest level of complexity with 

11 substantial clinical risk. 

12 ‘‘(II) The category of care re13 quires a practitioner who satisfies any 

14 of the education requirements de15 scribed in clause (i)(III) (except that 

16 for purposes of this subclause such 

17 clause shall be applied by substituting 

18 the term ‘orthotics’ each place the 

19 term ‘prosthetics’ is used), has com20 pleted an orthotic residency accredited 

21 by the National Commission on 

22 Orthotic and Prosthetic Education, 

23 and is certified or licensed in orthotics 

24 to ensure the appropriate provision of 

25 orthotic care. 


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1 ‘‘(iii) CUSTOM FITTED HIGH

2 ORTHOTICS CATEGORY.—The category of 

3 orthotic care described in this clause is a 

4 category for prefabricated orthotics that 

5 are manufactured with no specific patient 

6 in mind, but that are appropriately sized, 

7 adapted, modified, and configured (with 

8 the required tools and equipment) to a spe9 cific patient in accordance with a prescrip10 tion. The provider qualification designation 

11 for the category shall reflect the following, 

12 in accordance with subparagraph (D): 

13 ‘‘(I) The category of care involves 

14 moderate to high complexity with sub15 stantial clinical risk. 

16 ‘‘(II) The category of care re17 quires a practitioner who either— 

18 ‘‘(aa) satisfies any of the 

19 education requirements described 

20 in clause (i)(III), except that for 

21 purposes of this subclause such 

22 clause shall be applied by sub23 stituting the term ‘orthotics’ each 

24 place the term ‘prosthetics’ is 

25 used; or 


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1 ‘‘(bb) is certified or licensed 

2 in orthotics to ensure the appro3 priate provision of orthotic care 

4 within the practitioner’s normal 

5 scope of practice. 

6 ‘‘(iv) CUSTOM FITTED LOW

7 ORTHOTICS CATEGORY.—The category of 

8 orthotics and prosthetics care described in 

9 this clause is a category for prefabricated 

10 orthotics that are manufactured with no 

11 specific patient in mind, but that are ap12 propriately sized and adjusted to a specific 

13 patient in accordance with a prescription. 

14 The provider qualification designation for 

15 the category shall reflect the following: 

16 ‘‘(I) The category of care involves 

17 a low level of complexity and low clin18 ical risk. 

19 ‘‘(II) The category of care re20 quires a supplier that is certified or li21 censed within a limited scope of prac22 tice to ensure appropriate provision of 

23 orthotic care. The supplier’s education 

24 and training shall ensure that basic 

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1 pertise is available to confirm success2 ful fit and device compliance with the 

3 prescription. 

4 ‘‘(v) OFF-THE-SHELF.—The category 

5 of orthotic care described in this clause is 

6 a category for prefabricated orthotics that 

7 require minimal self adjustment for appro8 priate use. The provider qualification des9 ignation for the category shall reflect that 

10 such orthotics do not require expertise in 

11 trimming, bending, molding, assembling, or 

12 customizing to fit the patient and that no 

13 formal credentialing, clinical education, or 

14 technical training is required to dispense 

15 such items. 

16 ‘‘(D) CARE BASED ON SOUND CLINICAL

17 JUDGMENT AND TECHNICAL EXPERTISE.—Care 

18 described in clauses (i), (ii), and (iii) of sub19 paragraph (C) shall be based on sound clinical 

20 judgment and technical expertise based on the 

21 practitioner’s education and clinical training, in 

22 order to allow the practitioner to determine— 

23 ‘‘(i) with respect to care described in 

24 clause (i) and (ii) of subparagraph (C), the 

25 device parameters and design, fabrication 


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1 process, and functional purpose specific to 

2 the needs of the patient to maximize opti3 mal clinical outcomes; and 

4 ‘‘(ii) with respect to care described in 

5 subparagraph (C)(iii), the appropriate de6 vice relative to the diagnosis and specific to 

7 the needs of the patient to maximize opti8 mal clinical outcomes. 

9 ‘‘(E) CONSULTATION.—In modifying the 

10 payment basis, the Secretary shall consult with 

11 appropriate experts in orthotics and prosthetics, 

12 including practitioners that furnish items within 

13 the categories of prosthetics and orthotics care 

14 described in subparagraph (C).’’. 

15 SEC. 5. REPORTS. 

16 (a) REPORT ON ENFORCING NEW LICENSING AND

17 ACCREDITATION REQUIREMENTS.—Not later than 18 

18 months after the date of the enactment of this Act, the 

19 Secretary of Health and Human Services shall submit to 

20 Congress a report on the steps taken by the Department 

21 of Health and Human Services to ensure that the State 

22 licensure and accreditation requirements under section 

23 1834(h)(1)(F) of the Social Security Act, as amended by 

24 section 3, are enforced. Such report shall include a deter25 mination of the extent to which payments for orthotics and 


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1 prosthetics under the Medicare program under title XVIII 

2 of such Act are made only to those providers of services 

3 and suppliers that meet the relevant accreditation and li4 censure requirements under such section, as well as a de5 termination of whether additional steps are needed. 

6 (b) REPORT ON FRAUD AND ABUSE.—Not later than 

7 30 months after the date of the enactment of this Act, 

8 the Secretary of Health and Human Services shall submit 

9 to Congress a report on the effect of the requirements 

10 under subsection (a)(20)(B)(ii) of section 1834 of the So11 cial Security Act (42 U.S.C. 1395m), as added by section 

12 2, and subsection (h)(1)(F) of such section, as amended 

13 by section 3, on the occurrence of fraud and abuse under 

14 the Medicare program under title XVIII of such Act, with 

15 respect to orthotics and prosthetics for which payment is 

16 made under such program. 

17 SEC. 6. REDUCTION IN MEDICARE SPENDING. 

18 Not later than December 31, 2012, the Secretary of 

19 Health and Human Services, acting through the Chief Ac20 tuary of the Centers for Medicare & Medicaid Services, 

21 shall submit to Congress, and have published in the Fed22 eral Register, a projection of the effect on cumulative Fed23 eral spending under part B of title XVIII of the Social 

24 Security Act for the period of years 2012 through 2016 

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1 cluding the amendments made by this Act. If the Chief 

2 Actuary projects that the implementation of the amend3 ments made by this Act will not result in a cumulative 

4 reduction in spending under such part of at least 

5 $250,000,000 for the period of years 2012 through 2016 

6 (using a 2011 baseline), the Secretary shall, in accordance 

7 with the Actuary’s projection, issue an interim final regu8 lation (to take effect for 2014 and subsequent years) with 

9 comment period to strengthen the licensure, accreditation, 

10 and quality standards applicable to suppliers of orthotics 

11 and prosthetics, as described in this Act (and amendments 

12 made by this Act), in order to produce such cumulative 

13 reduction by the end of 2016, except that such regulation 

14 shall not apply to a qualified physical therapist or qualified 

15 occupational therapist (as described in section 

16 1834(h)(1)(F)(iii) of the Social Security Act (42 U.S.C. 

17 1395m(h)(1)(F)(iii)). 

Æ 


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