I 

113TH CONGRESS 

1ST SESSION H. R. 3112 

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, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

SEPTEMBER 17, 2013 

Mr. THOMPSON of Pennsylvania (for himself and Mr. THOMPSON of California) 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, and for other 

purposes. 


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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 2013’’. 

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 ‘‘ORGANIZATIONS.—Not later 

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

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

16 (ii), not later than’’; and 

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

18 paragraph (1), the following new 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, 2014, 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, 2014, 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)’’; 

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))’’; and 


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

2 clause: 

3 ‘‘(v) EXEMPTION OF OFF-THE-SHELF

4 ORTHOTICS INCLUDED IN A COMPETITIVE

5 ACQUISITION PROGRAM.—This subpara6 graph shall not apply to an item of 

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

8 section 1847(a) furnished on or after Jan9 uary 1, 2014, that is included in a com10 petitive acquisition program in a competi11 tive acquisition area under such section.’’. 

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

13 subsection (a) shall apply to orthotics and prosthetics fur14 nished on or after January 1, 2014. 

15 SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR 

16 ORTHOTICS AND PROSTHETICS BASED ON 

17 SUPPLIER QUALIFICATIONS AND COM18 PLEXITY OF CARE. 

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

20 1395m(h)) is amended— 

21 (1) in paragraph (1)(F)(iii), in the matter pre22 ceding subclause (I), by striking ‘‘other individual 

23 who’’ and inserting ‘‘other individual who, with re24 spect to a category of orthotics and prosthetics care 

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1 graph (5)(C) furnished on or after January 1, 2014, 

2 and subject to paragraph (5)(A), satisfies all appli3 cable criteria of the supplier qualification designa4 tion for such category described in the respective 

5 clause, and who’’; 

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

7 the period the following: ‘‘and, with respect to a cat8 egory of orthotics and prosthetics care described in 

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

10 furnished on or after January 1, 2014, and subject 

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

12 of the provider qualification designation for such 

13 category described in the respective clause’’; and 

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

15 paragraph: 

16 ‘‘(5) ELIGIBILITY FOR PAYMENT BASED ON

17 SUPPLIER QUALIFICATIONS AND COMPLEXITY OF

18 CARE.— 

19 ‘‘(A) CONSIDERATIONS FOR ELIGIBILITY

20 FOR PAYMENTS.— 

21 ‘‘(i) IN GENERAL.—In applying 

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

23 for purposes of determining whether pay24 ment may be made under this subsection 

25 for orthotics and prosthetics furnished on 


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1 or after January 1, 2014, the Secretary 

2 shall take into account the complexity of 

3 the respective item and, subject to clauses 

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

5 individual or entity furnishing and fabri6 cating such respective item in accordance 

7 with this paragraph. 

8 ‘‘(ii) INDIVIDUAL AND ENTITIES EX9 EMPTED FROM SUPPLIER QUALIFICATION

10 DESIGNATION CRITERIA.—With respect to 

11 an item of orthotics or prosthetics de12 scribed in clause (ii), (iii), (iv) or (v) of 

13 subparagraph (C), any criteria for the sup14 plier qualification designations under such 

15 respective clause, including application of 

16 subparagraph (D), shall not apply to phy17 sicians, occupational therapists, or physical 

18 therapists who are licensed or otherwise 

19 regulated by the State in which they are 

20 practicing and who receive payment under 

21 this title, including regulations promul22 gated pursuant to this subsection, for the 

23 provision of orthotics and prosthetics. 

24 ‘‘(iii) SUPPLIERS MEDICARE-ELIGIBLE

25 PRIOR TO JANUARY 1, 2014, EXEMPTED.— 


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1 In the case of a qualified supplier who is 

2 eligible to receive payment under this title 

3 before January 1, 2014— 

4 ‘‘(I) with respect to an item of 

5 orthotics or prosthetics described in 

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

7 criteria for the provider qualification 

8 designations under such clause, in9 cluding application of subparagraph 

10 (D), shall not apply to such supplier, 

11 respectively, for the furnishing or fab12 rication of such an item so described; 

13 and 

14 ‘‘(II) with respect to an item of 

15 orthotics or prosthetics described in 

16 clause (ii), (iii), or (iv) of subpara17 graph (C), any criteria for the sup18 plier qualification designations under 

19 the respective clause (or a subsequent 

20 clause of such subparagraph), includ21 ing application of subparagraph (D), 

22 shall not apply to such supplier, re23 spectively, for the furnishing or fab24 rication of such an item described in 


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1 such respective (or such subsequent) 

2 clause. 

3 ‘‘(iv) DELAYED APPLICATION OF CER4 TAIN SUPPLIER QUALIFICATION DESIGNA5 TION CRITERIA.—The supplier qualifica6 tion designations under clauses (i), (ii), 

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

8 the application of subparagraph (D) to 

9 such clauses, shall not be taken into ac10 count with respect to payment made under 

11 this subsection for orthotics and pros12 thetics furnished before January 1, 2015. 

13 ‘‘(v) MODIFICATIONS.—The Secretary 

14 shall, in consultation with the Boards and 

15 programs described in paragraph 

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

17 for the supplier qualification designation 

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

19 implement by regulation any modifications 

20 to such criteria, as determined appropriate 

21 in accordance with such consultation. Any 

22 such modification shall take effect no ear23 lier than January 1, 2016. 

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

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1 retary, in consultation with representatives of 

2 the fields of occupational therapy, physical ther3 apy, orthotics, and prosthetics shall utilize and 

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

5 date of the enactment of this paragraph, in the 

6 Centers for Medicare & Medicaid Services docu7 ment entitled Transmittal 656 (CMS Pub. 100– 

8 04, Change Request 3959, August 19, 2005). 

9 Transmittal 656 shall be the controlling source 

10 of category, product, and code assignments for 

11 the orthotics and prosthetics care described in 

12 each of clauses (i) through (v) of subparagraph 

13 (C) using the supplier qualification designation 

14 for each HCPCS code as stated in such docu15 ment. In the case that Transmittal 656 is up16 dated, reissued, or replaced by a subsequent 

17 document, the previous sentence shall be ap18 plied with respect to the most recent update, 

19 reissuance, or replacement of such document. 

20 ‘‘(C) CATEGORIES OF ORTHOTIC AND

21 PROSTHETIC CARE DESCRIBED.— 

22 ‘‘(i) CUSTOM-FABRICATED LIMB PROS23 THETICS CATEGORY.—The category of 

24 orthotic and prosthetic care described in 

25 this clause is a category for artificial legs 


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1 and arms, including replacements (as de2 scribed in section 1861(s)(9)) that are 

3 made from detailed measurements, images, 

4 or models in accordance with a prescrip5 tion and that can only be utilized by a spe6 cific intended patient and for which pay7 ment is made under this part. The supplier 

8 qualification designation for the category 

9 shall reflect each of the following, in ac10 cordance with subparagraph (D): 

11 ‘‘(I) The category of care involves 

12 the highest level of complexity with 

13 substantial clinical risk. 

14 ‘‘(II) The category of care re15 quires a supplier who satisfies any of 

16 the education requirements described 

17 in subclause (III), has completed a 

18 prosthetic residency accredited by the 

19 National Commission on Orthotic and 

20 Prosthetic Education (‘NCOPE’), and 

21 is certified or licensed in prosthetics 

22 to ensure the comprehensive provision 

23 of prosthetic care. 

24 ‘‘(III) The category of care re25 quires a supplier who has completed 


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1 any of the following education require2 ments: 

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 supplier 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 supplier who satisfies any of 

14 the education requirements described 

15 in clause (i)(III) (except that for pur16 poses of this subclause such clause 

17 shall be applied by substituting the 

18 term ‘orthotics’ each place the term 

19 ‘prosthetics’ is used), has completed 

20 an orthotic residency accredited by 

21 the National Commission on Orthotic 

22 and Prosthetic Education, and is cer23 tified or licensed in orthotics to ensure 

24 the appropriate provision of orthotic 

25 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 supplier 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 supplier 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 described in section 1847(a)(2)(C). The 

7 supplier qualification designation for the 

8 category shall reflect that no formal 

9 credentialing, clinical education, or tech10 nical training is required to dispense such 

11 items. 

12 ‘‘(D) CARE BASED ON SOUND CLINICAL

13 JUDGMENT AND TECHNICAL EXPERTISE.—Care 

14 described in clauses (i), (ii), and (iii) of sub15 paragraph (C) shall be based on sound clinical 

16 judgment and technical expertise based on the 

17 supplier’s education and clinical training, in 

18 order to allow the practitioner to determine— 

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

20 clause (i) or (ii) of subparagraph (C), the 

21 device parameters and design, fabrication 

22 process, and functional purpose specific to 

23 the needs of the patient to maximize opti24 mal clinical outcomes; and 


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

2 clause (iii) of such subparagraph, the ap3 propriate device relative to the diagnosis 

4 and specific to the needs of the patient to 

5 maximize optimal clinical outcomes.’’. 

6 SEC. 5. CONSULTATION. 

7 In implementing the provisions of, and amendments 

8 made by, this Act, the Secretary of Health and Human 

9 Services shall consult with appropriate experts in orthotics 

10 and prosthetics, including suppliers that furnish items 

11 within the categories of orthotic and prosthetic care de12 scribed in paragraph (5)(C) of section 1834(h) of the So13 cial Security Act (42 U.S.C. 1395m(h)), as added by sec14 tion 4. 

15 SEC. 6. 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 (42 U.S.C. 

24 1395m(h)(1)(F)), as amended by section 3, are enforced. 

25 Such report shall include a determination of the extent 


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1 to which payments for orthotics and prosthetics under the 

2 Medicare program under title XVIII of such Act are made 

3 only to those suppliers that meet the relevant accreditation 

4 and licensure requirements under such section and 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. 7. REDUCTION IN MEDICARE SPENDING. 

18 (a) PROJECTION OF CUMULATIVE EFFECT ON

19 SPENDING.—Not later than December 31, 2014, the Sec20 retary of Health and Human Services (in this section re21 ferred to as the ‘‘Secretary’’), acting through the Chief 

22 Actuary of the Centers for Medicare & Medicaid Services 

23 (in this section referred to as the ‘‘Chief Actuary’’), shall 

24 submit to Congress, and have published in the Federal 

25 Register, a projection of the effect on cumulative Federal 


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1 spending under part B of title XVIII of the Social Security 

2 Act for the period of years 2014 through 2018 as a result 

3 of the implementation of the provisions of, and amend4 ments made by, this Act. 

5 (b) STRENGTHENING STANDARDS APPLICABLE IF

6 SAVINGS NOT ACHIEVED.— 

7 (1) IN GENERAL.—Subject to paragraph (2), if 

8 the Chief Actuary projects under subsection (a) that 

9 the implementation of the provisions of, and amend10 ments made by, this Act will not result in a cumu11 lative reduction in spending under such part of at 

12 least $250,000,000 for the period of years 2014 

13 through 2018 (using a 2013 baseline), the Secretary 

14 shall, in accordance with the Chief Actuary’s projec15 tion, issue an interim final regulation (to take effect 

16 for 2015 and subsequent years) with a period for 

17 public comment on such regulation after the date of 

18 publication to strengthen the licensure, accredita19 tion, and quality standards applicable to suppliers of 

20 orthotics and prosthetics under title XVIII of the 

21 Social Security Act, including such standards de22 scribed in subsections (a)(20) and (h)(1)(F) of sec23 tion 1834 of such Act (42 U.S.C. 1395m), as 

24 amended by this Act, in order to produce such cu25 mulative reduction by December 31, 2018. 


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1 (2) EXCEPTION.—The interim final regulation 

2 issued under paragraph (1) shall not apply to a 

3 qualified physical therapist or qualified occupational 

4 therapist (as described in section 1834(h)(1)(F)(iii) 

5 of the Social Security Act (42 U.S.C. 

6 1395m(h)(1)(F)(iii))). 

7 SEC. 8. NO EFFECT ON PAYMENT BASIS FOR ORTHOTICS 

8 AND PROSTHETICS OR COMPETITIVE BID9 DING PROGRAMS. 

10 Nothing in the provisions of, or amendments made 

11 by, this Act shall have any effect on— 

12 (1) the determination of the payment basis for 

13 orthotics and prosthetics under section 1834(h) of 

14 the Social Security Act (42 U.S.C. 1395m(h)); or 

15 (2) the implementation of competitive acquisi16 tion programs under section 1847 of such Act (42 

17 U.S.C. 1395w–3), including such implementation 

18 with respect to off-the-shelf orthotics described in 

19 subsection (a)(2)(C) of that section, that are in20 cluded in a competitive acquisition program in a 

21 competitive acquisition area under that section. 

Æ 


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