II 

112TH CONGRESS 

2D SESSION S. 2125 

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 SENATE OF THE UNITED STATES 

FEBRUARY 17, 2012 

Mr. WYDEN (for himself, Ms. SNOWE, and 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 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. 

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 Improvement Act of 2012’’. 

4 SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE 

5 UNDER MEDICARE TO DESIGNATION OF AC6 CREDITATION ORGANIZATIONS FOR SUP7 PLIERS OF ORTHOTICS AND PROSTHETICS. 

8 (a) IN GENERAL.—Section 1834(a)(20)(B) of the So9 cial Security Act (42 U.S.C. 1395m(a)(20)(B)) is amend10 ed— 

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

12 than’’ and inserting ‘‘ORGANIZATIONS.— 

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

14 (ii), not later than’’; and 

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

16 paragraph (1), the following new clauses: 

17 ‘‘(ii) SPECIAL REQUIREMENTS FOR

18 ACCREDITATION OF SUPPLIERS OF

19 ORTHOTICS AND PROSTHETICS.—For pur20 poses of applying quality standards under 

21 subparagraph (A) for suppliers (other than 

22 suppliers described in clause (iii)) of items 

23 and services described in subparagraph 

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

25 approve an independent accreditation orga26 nization under clause (i) only if such orgaVerDate Mar 15 2010 03:12 Feb 18, 2012 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S2125.IS S2125

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1 nization is a Board or program described 

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

3 January 1, 2013, the Secretary shall en4 sure that at least one independent accredi5 tation organization is designated and ap6 proved in accordance with this clause. 

7 ‘‘(iii) EXCEPTION.—Suppliers de8 scribed in this clause are physicians, occu9 pational therapists, or physical therapists 

10 who are licensed or otherwise regulated by 

11 the State in which they are practicing and 

12 who receive payment under this title, in13 cluding regulations promulgated pursuant 

14 to this subsection.’’. 

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

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

17 by subsection (a)(2), not later than January 1, 2013, re18 gardless of whether such organization is designated or ap19 proved as an independent accreditation organization be20 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, 2013, 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, 2013. 

15 SEC. 4. ELIGIBILITY FOR MEDICARE PAYMENT FOR 

16 ORTHOTICS AND PROSTHETICS BASED ON 

17 PRACTITIONER 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 

25 described in clause (i), (ii), (iii), (iv), or (v) of paraVerDate Mar 15 2010 03:12 Feb 18, 2012 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S2125.IS S2125

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1 graph (5)(C) furnished on or after January 1, 2013, 

2 and subject to paragraph (5)(A), satisfies all appli3 cable criteria of the provider 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, 2013, 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 PRACTITIONER QUALIFICATIONS AND COMPLEXITY

18 OF 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, 2013, 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 PROVIDER 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 pro14 vider 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) PRACTITIONERS MEDICARE-ELI25 GIBLE PRIOR TO JANUARY 1, 2013 EXEMPTVerDate Mar 15 2010 03:12 Feb 18, 2012 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S2125.IS S2125

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1 ED.—In the case of a qualified practitioner 

2 or qualified supplier who is eligible to re3 ceive payment under this title before Janu4 ary 1, 2013— 

5 ‘‘(I) with respect to an item of 

6 orthotics or prosthetics described in 

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

8 criteria for the provider qualification 

9 designations under such clause, in10 cluding application of subparagraph 

11 (D), shall not apply to such practi12 tioner or supplier, respectively, for the 

13 furnishing or fabrication of such an 

14 item so described; and 

15 ‘‘(II) with respect to an item of 

16 orthotics or prosthetics described in 

17 clause (ii), (iii), or (iv) of subpara18 graph (C), any criteria for the pro19 vider qualification designations under 

20 the respective clause (or a subsequent 

21 clause of such subparagraph), includ22 ing application of subparagraph (D), 

23 shall not apply to such practitioner or 

24 supplier, respectively, for the fur25 nishing or fabrication of such an item 


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1 described in such respective (or such 

2 subsequent) clause. 

3 ‘‘(iv) DELAYED APPLICATION OF CER4 TAIN PROVIDER QUALIFICATION DESIGNA5 TION CRITERIA.—The provider 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, 2014. 

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 provider 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, 2015. 

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

25 For purposes of subparagraph (A), the SecVerDate Mar 15 2010 03:12 Feb 18, 2012 Jkt 019200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S2125.IS S2125

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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 and the 2008 Orthotics and Prosthetics Tri10 partite Document, a multi-organization com11 pilation of HCPCS codes. Transmittal 656 shall 

12 be the controlling source of category, product, 

13 and code assignments for the orthotics and 

14 prosthetics care described in each of clauses (i) 

15 through (v) of subparagraph (C) using the pro16 vider qualification designation for each HCPCS 

17 code as stated in such document and, in cases 

18 in which Transmittal 656 does not include a 

19 particular item of orthotics or prosthetics or a 

20 related code or in cases in which Transmittal 

21 656 is revoked or abridged, the 2008 Orthotics 

22 and Prosthetics Tripartite Document shall be 

23 the secondary source for such category, prod24 uct, and code assignments. In the case that ei25 ther of the documents described in the previous 


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1 sentence is updated or reissued, the previous 

2 sentence shall be applied with respect to the 

3 most recent update or reissuance of such docu4 ment. 

5 ‘‘(C) CATEGORIES OF ORTHOTIC AND

6 PROSTHETIC CARE DESCRIBED.— 

7 ‘‘(i) CUSTOM FABRICATED LIMB PROS8 THETICS CATEGORY.—The category of 

9 orthotic and prosthetic care described in 

10 this clause is a category for artificial legs 

11 and arms, including replacements (as de12 scribed in section 1861(s)(9)) that are 

13 made from detailed measurements, images, 

14 or models in accordance with a prescrip15 tion and that can only be utilized by a spe16 cific intended patient and for which pay17 ment is made under this part. The pro18 vider qualification designation for the cat19 egory shall reflect each of the following, in 

20 accordance with subparagraph (D): 

21 ‘‘(I) The category of care involves 

22 the highest level of complexity with 

23 substantial clinical risk. 

24 ‘‘(II) The category of care re25 quires a practitioner who satisfies any 


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1 of the education requirements de2 scribed in subclause (III), has com3 pleted a prosthetic residency accred4 ited by the National Commission on 

5 Orthotic and Prosthetic Education 

6 (‘NCOPE’), and is certified or li7 censed in prosthetics to ensure the 

8 comprehensive provision of prosthetic 

9 care. 

10 ‘‘(III) The category of care re11 quires a practitioner who has com12 pleted any of the following education 

13 requirements: 

14 ‘‘(aa) A bachelor’s degree or 

15 master’s degree in prosthetics as 

16 offered by educational institu17 tions accredited by the Commis18 sion on Accreditation of Allied 

19 Health Education Programs. 

20 ‘‘(bb) A bachelor’s degree, 

21 plus a certificate in prosthetics as 

22 offered by educational institu23 tions accredited by the Commis24 sion on Accreditation of Allied 

25 Health Education Programs. 


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1 ‘‘(cc) A foreign degree deter2 mined by the World Education 

3 Service to be equivalent to an 

4 educational program in pros5 thetics accredited by the Com6 mission on Accreditation of Allied 

7 Health Education Programs. 

8 ‘‘(ii) CUSTOM FABRICATED

9 ORTHOTICS CATEGORY.—The category of 

10 orthotics and prosthetics care described in 

11 this clause is a category for custom-fab12 ricated orthotics that are made from de13 tailed measurements, images, or models in 

14 accordance with a prescription and that 

15 can only be utilized by a specific intended 

16 patient. The provider qualification designa17 tion for the category shall reflect the fol18 lowing, in accordance with subparagraph 

19 (D): 

20 ‘‘(I) The category of care involves 

21 the highest level of complexity with 

22 substantial clinical risk. 

23 ‘‘(II) The category of care re24 quires a practitioner who satisfies any 

25 of the education requirements deVerDate Mar 15 2010 03:12 Feb 18, 2012 Jkt 019200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S2125.IS S2125

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1 scribed in clause (i)(III) (except that 

2 for purposes of this subclause such 

3 clause shall be applied by substituting 

4 the term ‘orthotics’ each place the 

5 term ‘prosthetics’ is used), has com6 pleted an orthotic residency accredited 

7 by the National Commission on 

8 Orthotic and Prosthetic Education, 

9 and is certified or licensed in orthotics 

10 to ensure the appropriate provision of 

11 orthotic care. 

12 ‘‘(iii) CUSTOM FITTED HIGH

13 ORTHOTICS CATEGORY.—The category of 

14 orthotic care described in this clause is a 

15 category for prefabricated orthotics that 

16 are manufactured with no specific patient 

17 in mind, but that are appropriately sized, 

18 adapted, modified, and configured (with 

19 the required tools and equipment) to a spe20 cific patient in accordance with a prescrip21 tion. The provider qualification designation 

22 for the category shall reflect the following, 

23 in accordance with subparagraph (D): 


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1 ‘‘(I) The category of care involves 

2 moderate to high complexity with sub3 stantial clinical risk. 

4 ‘‘(II) The category of care re5 quires a practitioner who either— 

6 ‘‘(aa) satisfies any of the 

7 education requirements described 

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

9 purposes of this subclause such 

10 clause shall be applied by sub11 stituting the term ‘orthotics’ each 

12 place the term ‘prosthetics’ is 

13 used; or 

14 ‘‘(bb) is certified or licensed 

15 in orthotics to ensure the appro16 priate provision of orthotic care 

17 within the practitioner’s normal 

18 scope of practice. 

19 ‘‘(iv) CUSTOM FITTED LOW

20 ORTHOTICS CATEGORY.—The category of 

21 orthotics and prosthetics care described in 

22 this clause is a category for prefabricated 

23 orthotics that are manufactured with no 

24 specific patient in mind, but that are ap25 propriately sized and adjusted to a specific 


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1 patient in accordance with a prescription. 

2 The provider qualification designation for 

3 the category shall reflect the following: 

4 ‘‘(I) The category of care involves 

5 a low level of complexity and low clin6 ical risk. 

7 ‘‘(II) The category of care re8 quires a supplier that is certified or li9 censed within a limited scope of prac10 tice to ensure appropriate provision of 

11 orthotic care. The supplier’s education 

12 and training shall ensure that basic 

13 clinical knowledge and technical ex14 pertise is available to confirm success15 ful fit and device compliance with the 

16 prescription. 

17 ‘‘(v) OFF-THE-SHELF.—The category 

18 of orthotic care described in this clause is 

19 described in section 1847(a)(2)(C). The 

20 provider qualification designation for the 

21 category shall reflect that no formal 

22 credentialing, clinical education, or tech23 nical training is required to dispense such 

24 items. 


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1 ‘‘(D) CARE BASED ON SOUND CLINICAL

2 JUDGMENT AND TECHNICAL EXPERTISE.—Care 

3 described in clauses (i), (ii), and (iii) of sub4 paragraph (C) shall be based on sound clinical 

5 judgment and technical expertise based on the 

6 practitioner’s education and clinical training, in 

7 order to allow the practitioner to determine— 

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

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

10 device parameters and design, fabrication 

11 process, and functional purpose specific to 

12 the needs of the patient to maximize opti13 mal clinical outcomes; and 

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

15 clause (iii) of such subparagraph, the ap16 propriate device relative to the diagnosis 

17 and specific to the needs of the patient to 

18 maximize optimal clinical outcomes.’’. 

19 SEC. 5. CONSULTATION. 

20 In implementing the provisions of, and amendments 

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

22 Services shall consult with appropriate experts in orthotics 

23 and prosthetics, including practitioners that furnish items 

24 within the categories of orthotic and prosthetic care deVerDate Mar 15 2010 03:12 Feb 18, 2012 Jkt 019200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S2125.IS S2125

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1 scribed in section 1834(h)(5)(C) of the Social Security 

2 Act, as added by section 4. 

3 SEC. 6. REPORTS. 

4 (a) REPORT ON ENFORCING NEW LICENSING AND

5 ACCREDITATION REQUIREMENTS.—Not later than 18 

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

7 Secretary of Health and Human Services shall submit to 

8 Congress a report on the steps taken by the Department 

9 of Health and Human Services to ensure that the State 

10 licensure and accreditation requirements under section 

11 1834(h)(1)(F) of the Social Security Act, as amended by 

12 section 3, are enforced. Such report shall include a deter13 mination of the extent to which payments for orthotics and 

14 prosthetics under the Medicare program under title XVIII 

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

16 and suppliers that meet the relevant accreditation and li17 censure requirements under such section and a determina18 tion of whether additional steps are needed. 

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

20 30 months after the date of the enactment of this Act, 

21 the Secretary of Health and Human Services shall submit 

22 to Congress a report on the effect of the requirements 

23 under subsection (a)(20)(B)(ii) of section 1834 of the So24 cial Security Act (42 U.S.C. 1395m), as added by section 

25 2, and subsection (h)(1)(F) of such section, as amended 


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

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

3 respect to orthotics and prosthetics for which payment is 

4 made under such program. 

5 SEC. 7. REDUCTION IN MEDICARE SPENDING. 

6 (a) PROJECTION OF CUMULATIVE EFFECT ON

7 SPENDING.—Not later than December 31, 2013, the Sec8 retary of Health and Human Services (in this section re9 ferred to as the ‘‘Secretary’’), acting through the Chief 

10 Actuary of the Centers for Medicare & Medicaid Services 

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

12 submit to Congress, and have published in the Federal 

13 Register, a projection of the effect on cumulative Federal 

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

15 Act for the period of years 2013 through 2017 as a result 

16 of the implementation of the provisions of, and amend17 ments made by, this Act. 

18 (b) STRENGTHENING STANDARDS APPLICABLE IF

19 SAVINGS NOT ACHIEVED.— 

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

21 the Chief Actuary projects under subsection (a) that 

22 the implementation of the provisions of, and amend23 ments made by, this Act will not result in a cumu24 lative reduction in spending under such part of at 

25 least $250,000,000 for the period of years 2013 


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1 through 2017 (using a 2012 baseline), the Secretary 

2 shall, in accordance with the Chief Actuary’s projec3 tion, issue an interim final regulation (to take effect 

4 for 2014 and subsequent years) with a period for 

5 public comment on such regulation after the date of 

6 publication to strengthen the licensure, accredita7 tion, and quality standards applicable to suppliers of 

8 orthotics and prosthetics under title XVIII of the 

9 Social Security Act, including such standards de10 scribed in subsections (a)(20) and (h)(1)(F) of sec11 tion 1834 of such Act (42 U.S.C. 1395m), as 

12 amended by this Act, in order to produce such cu13 mulative reduction by December 31, 2017. 

14 (2) EXCEPTION.—The interim final regulation 

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

16 qualified physical therapist or qualified occupational 

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

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

19 1395m(h)(1)(F)(iii))). 

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

21 AND PROSTHETICS OR COMPETITIVE BID22 DING PROGRAMS. 

23 Nothing in the provisions of, or amendments made 

24 by, this Act shall have any effect on— 


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1 (1) the determination of the payment basis for 

2 orthotics and prosthetics under section 1834(h) of 

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

4 (2) the implementation of competitive acquisi5 tion programs under section 1847 of such Act (42 

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

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

8 subsection (a)(2)(C) of that section, that are in9 cluded in a competitive acquisition program in a 

10 competitive acquisition area under that section. 

Æ 


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