‘‘(5) PAYMENT RULES TO ACCOUNT FOR PRAC-
TITIONER
QUALIFICATIONS
AND
COMPLEXITY
OF 
CARE.— 
‘‘(A) IN
GENERAL.—In applying clauses 
(iii) and (iv) of paragraph (1)(F) for purposes 
of determining whether payment may be made 
under this subsection for prosthetic devices and 
orthotics and prosthetics furnished on or after 
January 1, 2010, the Secretary shall take into 
account the complexity of the respective item 
and the qualifications of the individual or entity 
furnishing and fabricating such respective item 
in accordance with this paragraph. 
‘‘(B) ASSIGNMENT OF BILLING CODES.— 
For purposes of subparagraph (A), the Sec-
retary shall utilize and incorporate the set of L- 
codes listed, as of the date of the enactment of 
this paragraph, in the ‘2008 Orthotics and 
Prosthetics Tripartite Document’, a multi-orga-
nization compilation of HCPCS codes, to assign 
specific billing codes to the category of orthotics 
and prosthetics care described in each of 
clauses (i) through (v) of subparagraph (C) 
using the provider qualification designation for 
each HCPCS code as stated in such document. 
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In the case that such document is updated or 
reissued, the previous sentence shall be applied 
with respect to the most recent update or 
reissuance of such document. 
‘‘(C) CATEGORIES
OF
ORTHOTICS
AND 
PROSTHETICS CARE DESCRIBED.— 
‘‘(i) 
CUSTOM
FABRICATED
PROS-
THETICS
CATEGORY.—The category of 
orthotics and prosthetics care described in 
this clause is a category for custom fab-
ricated prosthetics devices that are made 
from detailed measurements, images, or 
models in accordance with a prescription 
and that can only be utilized by a specific 
intended patient. The provider qualifica-
tion designation for the category shall re-
flect the following: 
‘‘(I) The category of care involves 
the highest level of complexity with 
substantial clinical risk. 
‘‘(II) The category of care re-
quires a practitioner who is educated 
and trained with a course of study 
specific to and is credentialed, cer-
tified, or licensed in prosthetics to en-
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sure the comprehensive provision of 
prosthetic care. Such care shall be 
based on sound clinical judgment and 
technical expertise based on the prac-
titioner’s education and clinical train-
ing, in order to allow the practitioner 
to determine the device parameters 
and design, fabrication process, and 
functional purpose specific to the 
needs of the patient to maximize opti-
mal clinical outcomes. 
‘‘(ii) 
CUSTOM
FABRICATED 
ORTHOTICS
CATEGORY.—The category of 
orthotics and prosthetics care described in 
this clause is a category for custom fab-
ricated orthotics devices that are made 
from detailed measurements, images, or 
models in accordance with a prescription 
and that can only be utilized by a specific 
intended patient. The provider qualifica-
tion designation for the category shall re-
flect the following: 
‘‘(I) The category of care involves 
the highest level of complexity with 
substantial clinical risk. 
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‘‘(II) The category of care re-
quires a practitioner who is educated 
and trained with a course of study 
specific 
to 
orthotics 
and 
is 
credentialed, certified, or licensed in 
orthotics to ensure the appropriate 
provision of orthotic care. Such care 
shall be based on sound clinical judg-
ment and technical expertise based on 
the practitioner’s education and clin-
ical training, in order to allow the 
practitioner to determine the device 
parameters and design, fabrication 
process, and functional purpose spe-
cific to the needs of the patient to 
maximize optimal clinical outcomes. 
‘‘(iii) CUSTOM
FITTED
HIGH.—The 
category of orthotics and prosthetics care 
described in this clause is a category for 
prefabricated orthotics devices that are 
manufactured with no specific patient in 
mind, but that are appropriately sized, 
adapted, modified, and configured (with 
the required tools and equipment) to a spe-
cific patient in accordance with a prescrip-
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tion. The provider qualification designation 
for the category shall reflect the following: 
‘‘(I) The category of care involves 
moderate to high complexity with sub-
stantial clinical risk. 
‘‘(II) The category of care re-
quires a practitioner who is educated 
and trained with a course of study 
specific 
to 
orthotics 
and 
is 
credentialed, certified, or licensed in 
orthotics to ensure the appropriate 
provision of orthotic care. Such care 
shall be based on sound clinical judg-
ment and technical expertise based on 
the practitioner’s education and clin-
ical training, in order to allow the 
practitioner to determine the appro-
priate device relative to the diagnosis 
and specific to the needs of the pa-
tient to maximize optimal clinical out-
comes. 
‘‘(iv) CUSTOM FITTED LOW.—The cat-
egory of orthotics and prosthetics care de-
scribed in this clause is a category for pre-
fabricated orthotics devices that are manu-
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factured with no specific patient in mind, 
but that are appropriately sized and ad-
justed to a specific patient in accordance 
with a prescription. The provider qualifica-
tion designation for the category shall re-
flect the following: 
‘‘(I) The category of care involves 
a low level of complexity and low clin-
ical risk. 
‘‘(II) The category of care re-
quires a supplier that is credentialed, 
certified, or licensed within a limited 
scope of practice to ensure appro-
priate provision of orthotic care. The 
supplier’s education and training shall 
insure that basic clinical knowledge 
and technical expertise is available to 
confirm successful fit and device com-
pliance with the prescription. 
‘‘(v) OFF-THE-SHELF.—The category 
of orthotics and prosthetics care described 
in this clause is a category for prefab-
ricated devices that require minimal self 
adjustment for appropriate use. The pro-
vider qualification designation for the cat-
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egory shall reflect that such devices do not 
require expertise in trimming, bending, 
molding, assembling, or customizing to fit 
the 
patient 
and 
that 
no 
formal 
credentialing, clinical education, or tech-
nical training is required to dispense such 
devices. 
‘‘(D) CONSULTATION.—In modifying the 
payment basis, the Secretary shall consult with 
appropriate experts in orthotics and prosthetics, 
including practitioners that furnish devices and 
items within the categories of prosthetics and 
orthotics care described in subparagraph (C). 
‘‘(E) BUDGET
NEUTRALITY.—This para-
graph shall be applied in a manner to result in 
the same aggregate amount of expenditures for 
prosthetic devices and orthotics and prosthetics 
under this section for a year as would be made 
if this paragraph did not apply, as estimated by 
the Secretary.’’. 
SEC. 5. REPORTS. 
(a) REPORT ON ENFORCING NEW LICENSING AND 
ACCREDITATION REQUIREMENTS.—Not later than 18 
months after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall submit to 
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Congress a report on the steps taken by the Department 
of Health and Human Services to ensure that the State 
licensure and accreditation requirements under section 
1834(h)(1)(F) of the Social Security Act, as amended by 
section 3, are enforced. Such report shall include a deter-
mination of the extent to which payments for prosthetic 
devices and orthotics and prosthetics under the Medicare 
program under title XVIII of such Act are made only to 
those providers of services and suppliers that meet the rel-
evant accreditation and licensure requirements under such 
section, as well as a determination of whether additional 
steps are needed. 
(b) REPORT ON FRAUD AND ABUSE.—Not later than 
30 months after the date of the enactment of this Act, 
the Secretary of Health and Human Services shall submit 
to Congress a report on the effect of the requirements 
under subsection (a)(20)(B)(ii) of section 1834 of the So-
cial Security Act (42 U.S.C. 1395m), as added by section 
2, and subsection (h)(1)(F) of such section, as amended 
by section 3, on the occurrence of fraud and abuse under 
the Medicare program under title XVIII of such Act, with 
respect to prosthetic devices and orthotics and prosthetics 
for which payment is made under such program. 
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SEC. 6. RULES OF CONSTRUCTION. 
(a) SCOPE OF PRACTICE.—Nothing in this Act shall 
be construed as superceding or otherwise affecting a provi-
sion of State law insofar as such law relates to the scope 
of practice for occupational therapists, physical therapists, 
or both. 
(b) NO EFFECT ON OTHER SERVICES.—Nothing in 
this Act shall be construed as modifying the ability, in ex-
istence as of the date of the enactment of this Act, of a 
physical therapist or occupational therapist to provide 
services for which payment may be made under title XVIII 
of the Social Security Act if such services are completely 
distinct from the fabrication and sale of prosthetic devices 
and orthotics and prosthetics described in section 
1834(h)(4) of the Social Security Act (42 U.S.C. 
1395m(h)(4)), such as assisting in adapting or using such 
devices, gate training, or other equivalent services. 
Æ 
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