pleted any of the following education 
requirements: 
‘‘(aa) A bachelor’s degree or 
master’s degree in prosthetics as 
offered by educational institu-
tions accredited by the Commis-
sion on Accreditation of Allied 
Health Education Programs. 
‘‘(bb) A bachelor’s degree, 
plus a certificate in prosthetics as 
offered by educational institu-
tions accredited by the Commis-
sion on Accreditation of Allied 
Health Education Programs. 
‘‘(cc) A foreign degree deter-
mined by the World Education 
Service to be equivalent to an 
educational program in pros-
thetics accredited by the Com-
mission on Accreditation of Allied 
Health Education Programs. 
‘‘(ii) 
CUSTOM
FABRICATED 
ORTHOTICS
CATEGORY.—The category of 
orthotics and prosthetics care described in 
this clause is a category for custom fab-
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ricated orthotics that are made from de-
tailed measurements, images, or models in 
accordance with a prescription and that 
can only be utilized by a specific intended 
patient. The provider qualification designa-
tion for the category shall reflect the fol-
lowing, in accordance with subparagraph 
(D): 
‘‘(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 satisfies any 
of the education requirements de-
scribed in clause (i)(III) (except that 
for purposes of this subclause such 
clause shall be applied by substituting 
the term ‘orthotics’ each place the 
term ‘prosthetics’ is used), has com-
pleted an orthotic residency accredited 
by 
the 
National 
Commission 
on 
Orthotic and Prosthetic Education, 
and is certified or licensed in orthotics 
to ensure the appropriate provision of 
orthotic care. 
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‘‘(iii) 
CUSTOM
FITTED
HIGH 
ORTHOTICS
CATEGORY.—The category of 
orthotic care described in this clause is a 
category for prefabricated orthotics 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-
tion. The provider qualification designation 
for the category shall reflect the following, 
in accordance with subparagraph (D): 
‘‘(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 either— 
‘‘(aa) satisfies any of the 
education requirements described 
in clause (i)(III), except that for 
purposes of this subclause such 
clause shall be applied by sub-
stituting the term ‘orthotics’ each 
place the term ‘prosthetics’ is 
used; or 
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‘‘(bb) is certified or licensed 
in orthotics to ensure the appro-
priate provision of orthotic care 
within the practitioner’s normal 
scope of practice. 
‘‘(iv) 
CUSTOM
FITTED
LOW 
ORTHOTICS
CATEGORY.—The category of 
orthotics and prosthetics care described in 
this clause is a category for prefabricated 
orthotics that are manufactured with no 
specific patient in mind, but that are ap-
propriately sized and adjusted to a specific 
patient in accordance with a prescription. 
The provider qualification designation for 
the category shall reflect 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 certified or li-
censed within a limited scope of prac-
tice to ensure appropriate provision of 
orthotic care. The supplier’s education 
and training shall ensure that basic 
clinical knowledge and technical ex-
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pertise is available to confirm success-
ful fit and device compliance with the 
prescription. 
‘‘(v) OFF-THE-SHELF.—The category 
of orthotic care described in this clause is 
a category for prefabricated orthotics that 
require minimal self adjustment for appro-
priate use. The provider qualification des-
ignation for the category shall reflect that 
such orthotics do not require expertise in 
trimming, bending, molding, assembling, or 
customizing to fit the patient and that no 
formal credentialing, clinical education, or 
technical training is required to dispense 
such items. 
‘‘(D) CARE
BASED
ON
SOUND
CLINICAL 
JUDGMENT AND TECHNICAL EXPERTISE.—Care 
described in clauses (i), (ii), and (iii) of sub-
paragraph (C) shall be based on sound clinical 
judgment and technical expertise based on the 
practitioner’s education and clinical training, in 
order to allow the practitioner to determine— 
‘‘(i) with respect to care described in 
clause (i) and (ii) of subparagraph (C), the 
device parameters and design, fabrication 
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