retary, in consultation with representatives of 
the fields of occupational therapy, physical ther-
apy, orthotics, and prosthetics shall utilize and 
incorporate the set of L-codes listed, as of the 
date of the enactment of this paragraph, in the 
Centers for Medicare & Medicaid Services docu-
ment entitled Transmittal 656 (CMS Pub. 100– 
04, Change Request 3959, August 19, 2005). 
Transmittal 656 shall be the controlling source 
of category, product, and code assignments for 
the orthotics and prosthetics care described in 
each of clauses (i) through (v) of subparagraph 
(C) using the supplier qualification designation 
for each HCPCS code as stated in such docu-
ment. In the case that Transmittal 656 is up-
dated, reissued, or replaced by a subsequent 
document, the previous sentence shall be ap-
plied with respect to the most recent update, 
reissuance, or replacement of such document. 
‘‘(C) CATEGORIES
OF
ORTHOTIC
AND 
PROSTHETIC CARE DESCRIBED.— 
‘‘(i) CUSTOM-FABRICATED LIMB PROS-
THETICS
CATEGORY.—The category of 
orthotic and prosthetic care described in 
this clause is a category for artificial legs 
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and arms, including replacements (as de-
scribed in section 1861(s)(9)) that are 
made from detailed measurements, images, 
or models in accordance with a prescrip-
tion and that can only be utilized by a spe-
cific intended patient and for which pay-
ment is made under this part. The supplier 
qualification designation for the category 
shall reflect each of the following, in ac-
cordance 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 supplier who satisfies any of 
the education requirements described 
in subclause (III), has completed a 
prosthetic residency accredited by the 
National Commission on Orthotic and 
Prosthetic Education (‘NCOPE’), and 
is certified or licensed in prosthetics 
to ensure the comprehensive provision 
of prosthetic care. 
‘‘(III) The category of care re-
quires a supplier who has completed 
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any of the following education require-
ments: 
‘‘(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 supplier 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 supplier who satisfies any of 
the education requirements described 
in clause (i)(III) (except that for pur-
poses of this subclause such clause 
shall be applied by substituting the 
term ‘orthotics’ each place the term 
‘prosthetics’ is used), has completed 
an orthotic residency accredited by 
the National Commission on Orthotic 
and Prosthetic Education, and is cer-
tified 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 supplier 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 supplier 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 
described in section 1847(a)(2)(C). The 
supplier qualification designation for the 
category shall reflect that no formal 
credentialing, clinical education, or tech-
nical 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 
supplier’s education and clinical training, in 
order to allow the practitioner to determine— 
‘‘(i) with respect to care described in 
clause (i) or (ii) of subparagraph (C), the 
device parameters and design, fabrication 
process, and functional purpose specific to 
the needs of the patient to maximize opti-
mal clinical outcomes; and 
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‘‘(ii) with respect to care described in 
clause (iii) of such subparagraph, the ap-
propriate device relative to the diagnosis 
and specific to the needs of the patient to 
maximize optimal clinical outcomes.’’. 
SEC. 5. CONSULTATION. 
In implementing the provisions of, and amendments 
made by, this Act, the Secretary of Health and Human 
Services shall consult with appropriate experts in orthotics 
and prosthetics, including suppliers that furnish items 
within the categories of orthotic and prosthetic care de-
scribed in paragraph (5)(C) of section 1834(h) of the So-
cial Security Act (42 U.S.C. 1395m(h)), as added by sec-
tion 4. 
SEC. 6. 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 
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 (42 U.S.C. 
1395m(h)(1)(F)), as amended by section 3, are enforced. 
Such report shall include a determination of the extent 
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to which payments for orthotics and prosthetics under the 
Medicare program under title XVIII of such Act are made 
only to those suppliers that meet the relevant accreditation 
and licensure requirements under such section and a de-
termination 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 orthotics and prosthetics for which payment is 
made under such program. 
SEC. 7. REDUCTION IN MEDICARE SPENDING. 
(a) PROJECTION
OF
CUMULATIVE
EFFECT
ON 
SPENDING.—Not later than December 31, 2014, the Sec-
retary of Health and Human Services (in this section re-
ferred to as the ‘‘Secretary’’), acting through the Chief 
Actuary of the Centers for Medicare & Medicaid Services 
(in this section referred to as the ‘‘Chief Actuary’’), shall 
submit to Congress, and have published in the Federal 
Register, a projection of the effect on cumulative Federal 
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spending under part B of title XVIII of the Social Security 
Act for the period of years 2014 through 2018 as a result 
of the implementation of the provisions of, and amend-
ments made by, this Act. 
(b) STRENGTHENING STANDARDS APPLICABLE
IF 
SAVINGS NOT ACHIEVED.— 
(1) IN GENERAL.—Subject to paragraph (2), if 
the Chief Actuary projects under subsection (a) that 
the implementation of the provisions of, and amend-
ments made by, this Act will not result in a cumu-
lative reduction in spending under such part of at 
least $250,000,000 for the period of years 2014 
through 2018 (using a 2013 baseline), the Secretary 
shall, in accordance with the Chief Actuary’s projec-
tion, issue an interim final regulation (to take effect 
for 2015 and subsequent years) with a period for 
public comment on such regulation after the date of 
publication to strengthen the licensure, accredita-
tion, and quality standards applicable to suppliers of 
orthotics and prosthetics under title XVIII of the 
Social Security Act, including such standards de-
scribed in subsections (a)(20) and (h)(1)(F) of sec-
tion 1834 of such Act (42 U.S.C. 1395m), as 
amended by this Act, in order to produce such cu-
mulative reduction by December 31, 2018. 
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(2) EXCEPTION.—The interim final regulation 
issued under paragraph (1) shall not apply to a 
qualified physical therapist or qualified occupational 
therapist (as described in section 1834(h)(1)(F)(iii) 
of 
the 
Social 
Security 
Act 
(42 
U.S.C. 
1395m(h)(1)(F)(iii))). 
SEC. 8. NO EFFECT ON PAYMENT BASIS FOR ORTHOTICS 
AND PROSTHETICS OR COMPETITIVE BID-
DING PROGRAMS. 
Nothing in the provisions of, or amendments made 
by, this Act shall have any effect on— 
(1) the determination of the payment basis for 
orthotics and prosthetics under section 1834(h) of 
the Social Security Act (42 U.S.C. 1395m(h)); or 
(2) the implementation of competitive acquisi-
tion programs under section 1847 of such Act (42 
U.S.C. 1395w–3), including such implementation 
with respect to off-the-shelf orthotics described in 
subsection (a)(2)(C) of that section, that are in-
cluded in a competitive acquisition program in a 
competitive acquisition area under that section. 
Æ 
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