I 

111TH CONGRESS 

1ST SESSION H. R. 2479 

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

of accreditation organizations for prosthetic devices and orthotics and 

prosthetics, to apply accreditation and licensure requirements to 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 19, 2009 

Ms. BERKLEY 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 prosthetic devices and orthotics and prosthetics, to apply 

accreditation and licensure requirements to 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 2009’’. 

4 SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE 

5 UNDER MEDICARE TO DESIGNATION OF AC6 CREDITATION ORGANIZATIONS FOR SUP7 PLIERS OF PROSTHETIC DEVICES AND 

8 ORTHOTICS AND PROSTHETICS. 

9 (a) IN GENERAL.—Section 1834(a)(20)(B) of the So10 cial Security Act (42 U.S.C. 1395m(a)(20)(B)) is amend11 ed— 

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

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

14 than’’ with the same indentation as the clause added 

15 by paragraph (2); and 

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

17 clause: 

18 ‘‘(ii) SPECIAL REQUIREMENTS FOR

19 ACCREDITATION OF PROSTHETIC DEVICES

20 AND ORTHOTICS AND PROSTHETICS.—For 

21 purposes of applying quality standards 

22 under subparagraph (A) for suppliers of 

23 items and services described in subpara24 graph (D)(ii), the Secretary shall designate 

25 and approve an independent accreditation 

26 organization under clause (i) only if such 


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1 organization is a Board or program de2 scribed in subsection (h)(1)(F)(iv). Not 

3 later than January 1, 2010, the Secretary 

4 shall ensure that at least one independent 

5 accreditation organization is designated 

6 and approved in accordance with this 

7 clause.’’. 

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

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

10 by subsection (a)(2), not later than January 1, 2010, re11 gardless of whether such organization is designated or ap12 proved as an independent accreditation organization be13 fore, on, or after the date of the enactment of this Act. 

14 SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND 

15 LICENSURE REQUIREMENTS FOR CERTAIN 

16 PROSTHETICS AND CUSTOM-FABRICATED 

17 ORTHOTICS TO PROSTHETIC DEVICES AND 

18 ORTHOTICS AND PROSTHETICS. 

19 (a) IN GENERAL.—Section 1834(h)(1)(F) of the So20 cial Security Act (42 U.S.C. 1395m(h)(1)(F)) is amend21 ed— 

22 (1) in the heading, by striking ‘‘SPECIAL PAY23 MENT RULES FOR CERTAIN PROSTHETICS AND CUS24 TOM-FABRICATED ORTHOTICS’’ and inserting ‘‘PAY25 MENT RULES’’; 


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1 (2) in clause (i), by striking ‘‘an item of cus2 tom-fabricated orthotics described in clause (ii) or 

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

4 inserting ‘‘a prosthetic device or an item of orthotics 

5 or prosthetics, including an item of custom-fab6 ricated orthotics described in clause (ii), unless such 

7 device or item, respectively, is’’; 

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

9 to which this subparagraph applies’’ and inserting 

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

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

12 or manage the provision of prosthetics and custom13 designed or -fabricated orthotics’’ and inserting ‘‘to 

14 provide or manage the provision of prosthetics and 

15 orthotics (and custom-designed or -fabricated 

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

17 (ii))’’. 

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

19 subsection (a) shall apply to devices and items furnished 

20 on or after January 1, 2010. 


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1 SEC. 4. MEDICARE PAYMENT RULES FOR PROSTHETIC DE2 VICES AND ORTHOTICS AND PROSTHETICS 

3 TO ACCOUNT FOR PRACTITIONER QUALI4 FICATIONS AND COMPLEXITY OF CARE. 

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

6 1395m(h)) is amended— 

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

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

9 with respect to a category of orthotics and pros10 thetics care described in clause (i), (ii), (iii), (iv), or 

11 (v) of paragraph (5)(C) furnished on or after Janu12 ary 1, 2010, satisfies all applicable criteria of the 

13 provider qualification designation for such category 

14 described in the respective clause, and who’’; 

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

16 the period the following: ‘‘and, with respect to a cat17 egory of orthotics and prosthetics care described in 

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

19 and furnished on or after January 1, 2010, satisfies 

20 all applicable criteria of the provider qualification 

21 designation for such category described in the re22 spective clause’’; and 

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

24 paragraph: 


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1 ‘‘(5) PAYMENT RULES TO ACCOUNT FOR PRAC2 TITIONER QUALIFICATIONS AND COMPLEXITY OF

3 CARE.— 

4 ‘‘(A) IN GENERAL.—In applying clauses 

5 (iii) and (iv) of paragraph (1)(F) for purposes 

6 of determining whether payment may be made 

7 under this subsection for prosthetic devices and 

8 orthotics and prosthetics furnished on or after 

9 January 1, 2010, the Secretary shall take into 

10 account the complexity of the respective item 

11 and the qualifications of the individual or entity 

12 furnishing and fabricating such respective item 

13 in accordance with this paragraph. 

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

15 For purposes of subparagraph (A), the Sec16 retary shall utilize and incorporate the set of L17 codes listed, as of the date of the enactment of 

18 this paragraph, in the ‘2008 Orthotics and 

19 Prosthetics Tripartite Document’, a multi-orga20 nization compilation of HCPCS codes, to assign 

21 specific billing codes to the category of orthotics 

22 and prosthetics care described in each of 

23 clauses (i) through (v) of subparagraph (C) 

24 using the provider qualification designation for 

25 each HCPCS code as stated in such document. 


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1 In the case that such document is updated or 

2 reissued, the previous sentence shall be applied 

3 with respect to the most recent update or 

4 reissuance of such document. 

5 ‘‘(C) CATEGORIES OF ORTHOTICS AND

6 PROSTHETICS CARE DESCRIBED.— 

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

9 orthotics and prosthetics care described in 

10 this clause is a category for custom fab11 ricated prosthetics devices that are made 

12 from detailed measurements, images, or 

13 models in accordance with a prescription 

14 and that can only be utilized by a specific 

15 intended patient. The provider qualifica16 tion designation for the category shall re17 flect the following: 

18 ‘‘(I) The category of care involves 

19 the highest level of complexity with 

20 substantial clinical risk. 

21 ‘‘(II) The category of care re22 quires a practitioner who is educated 

23 and trained with a course of study 

24 specific to and is credentialed, cer25 tified, or licensed in prosthetics to enVerDate Nov 24 2008 02:33 May 20, 2009 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2479.IH H2479

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1 sure the comprehensive provision of 

2 prosthetic care. Such care shall be 

3 based on sound clinical judgment and 

4 technical expertise based on the prac5 titioner’s education and clinical train6 ing, in order to allow the practitioner 

7 to determine the device parameters 

8 and design, fabrication process, and 

9 functional purpose specific to the 

10 needs of the patient to maximize opti11 mal clinical outcomes. 

12 ‘‘(ii) CUSTOM FABRICATED

13 ORTHOTICS CATEGORY.—The category of 

14 orthotics and prosthetics care described in 

15 this clause is a category for custom fab16 ricated orthotics devices that are made 

17 from detailed measurements, images, or 

18 models in accordance with a prescription 

19 and that can only be utilized by a specific 

20 intended patient. The provider qualifica21 tion designation for the category shall re22 flect the following: 

23 ‘‘(I) The category of care involves 

24 the highest level of complexity with 

25 substantial clinical risk. 


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1 ‘‘(II) The category of care re2 quires a practitioner who is educated 

3 and trained with a course of study 

4 specific to orthotics and is 

5 credentialed, certified, or licensed in 

6 orthotics to ensure the appropriate 

7 provision of orthotic care. Such care 

8 shall be based on sound clinical judg9 ment and technical expertise based on 

10 the practitioner’s education and clin11 ical training, in order to allow the 

12 practitioner to determine the device 

13 parameters and design, fabrication 

14 process, and functional purpose spe15 cific to the needs of the patient to 

16 maximize optimal clinical outcomes. 

17 ‘‘(iii) CUSTOM FITTED HIGH.—The 

18 category of orthotics and prosthetics care 

19 described in this clause is a category for 

20 prefabricated orthotics devices that are 

21 manufactured with no specific patient in 

22 mind, but that are appropriately sized, 

23 adapted, modified, and configured (with 

24 the required tools and equipment) to a spe25 cific patient in accordance with a prescripVerDate Nov 24 2008 02:33 May 20, 2009 Jkt 079200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\H2479.IH H2479

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1 tion. The provider qualification designation 

2 for the category shall reflect the following: 

3 ‘‘(I) The category of care involves 

4 moderate to high complexity with sub5 stantial clinical risk. 

6 ‘‘(II) The category of care re7 quires a practitioner who is educated 

8 and trained with a course of study 

9 specific to orthotics and is 

10 credentialed, certified, or licensed in 

11 orthotics to ensure the appropriate 

12 provision of orthotic care. Such care 

13 shall be based on sound clinical judg14 ment and technical expertise based on 

15 the practitioner’s education and clin16 ical training, in order to allow the 

17 practitioner to determine the appro18 priate device relative to the diagnosis 

19 and specific to the needs of the pa20 tient to maximize optimal clinical out21 comes. 

22 ‘‘(iv) CUSTOM FITTED LOW.—The cat23 egory of orthotics and prosthetics care de24 scribed in this clause is a category for pre25 fabricated orthotics devices that are manuVerDate Nov 24 2008 02:33 May 20, 2009 Jkt 079200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\H2479.IH H2479

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1 factured with no specific patient in mind, 

2 but that are appropriately sized and ad3 justed to a specific patient in accordance 

4 with a prescription. The provider qualifica5 tion designation for the category shall re6 flect the following: 

7 ‘‘(I) The category of care involves 

8 a low level of complexity and low clin9 ical risk. 

10 ‘‘(II) The category of care re11 quires a supplier that is credentialed, 

12 certified, or licensed within a limited 

13 scope of practice to ensure appro14 priate provision of orthotic care. The 

15 supplier’s education and training shall 

16 insure that basic clinical knowledge 

17 and technical expertise is available to 

18 confirm successful fit and device com19 pliance with the prescription. 

20 ‘‘(v) OFF-THE-SHELF.—The category 

21 of orthotics and prosthetics care described 

22 in this clause is a category for prefab23 ricated devices that require minimal self 

24 adjustment for appropriate use. The pro25 vider qualification designation for the catVerDate Nov 24 2008 02:33 May 20, 2009 Jkt 079200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\H2479.IH H2479

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1 egory shall reflect that such devices do not 

2 require expertise in trimming, bending, 

3 molding, assembling, or customizing to fit 

4 the patient and that no formal 

5 credentialing, clinical education, or tech6 nical training is required to dispense such 

7 devices. 

8 ‘‘(D) CONSULTATION.—In modifying the 

9 payment basis, the Secretary shall consult with 

10 appropriate experts in orthotics and prosthetics, 

11 including practitioners that furnish devices and 

12 items within the categories of prosthetics and 

13 orthotics care described in subparagraph (C). 

14 ‘‘(E) BUDGET NEUTRALITY.—This para15 graph shall be applied in a manner to result in 

16 the same aggregate amount of expenditures for 

17 prosthetic devices and orthotics and prosthetics 

18 under this section for a year as would be made 

19 if this paragraph did not apply, as estimated by 

20 the Secretary.’’. 

21 SEC. 5. REPORTS. 

22 (a) REPORT ON ENFORCING NEW LICENSING AND

23 ACCREDITATION REQUIREMENTS.—Not later than 18 

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

25 Secretary of Health and Human Services shall submit to 


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1 Congress a report on the steps taken by the Department 

2 of Health and Human Services to ensure that the State 

3 licensure and accreditation requirements under section 

4 1834(h)(1)(F) of the Social Security Act, as amended by 

5 section 3, are enforced. Such report shall include a deter6 mination of the extent to which payments for prosthetic 

7 devices and orthotics and prosthetics under the Medicare 

8 program under title XVIII of such Act are made only to 

9 those providers of services and suppliers that meet the rel10 evant accreditation and licensure requirements under such 

11 section, as well as a determination of whether additional 

12 steps are needed. 

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

14 30 months after the date of the enactment of this Act, 

15 the Secretary of Health and Human Services shall submit 

16 to Congress a report on the effect of the requirements 

17 under subsection (a)(20)(B)(ii) of section 1834 of the So18 cial Security Act (42 U.S.C. 1395m), as added by section 

19 2, and subsection (h)(1)(F) of such section, as amended 

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

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

22 respect to prosthetic devices and orthotics and prosthetics 

23 for which payment is made under such program. 


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1 SEC. 6. RULES OF CONSTRUCTION. 

2 (a) SCOPE OF PRACTICE.—Nothing in this Act shall 

3 be construed as superceding or otherwise affecting a provi4 sion of State law insofar as such law relates to the scope 

5 of practice for occupational therapists, physical therapists, 

6 or both. 

7 (b) NO EFFECT ON OTHER SERVICES.—Nothing in 

8 this Act shall be construed as modifying the ability, in ex9 istence as of the date of the enactment of this Act, of a 

10 physical therapist or occupational therapist to provide 

11 services for which payment may be made under title XVIII 

12 of the Social Security Act if such services are completely 

13 distinct from the fabrication and sale of prosthetic devices 

14 and orthotics and prosthetics described in section 

15 1834(h)(4) of the Social Security Act (42 U.S.C. 

16 1395m(h)(4)), such as assisting in adapting or using such 

17 devices, gate training, or other equivalent services. 

Æ 


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