I 
110TH CONGRESS 
2D SESSION 
H. R. 6878 
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 methodology for such devices and items 
under such program to account for practitioner qualifications and com-
plexity of care. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 11, 2008 
Ms. BERKLEY (for herself and Mr. DAVIS of Alabama) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend title XVIII of the Social Security Act to modify 
the designation of accreditation organizations for pros-
thetic 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 methodology for 
such devices and items under such program to account 
for practitioner qualifications and complexity of care. 
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Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Orthotics and 
Prosthetics Improvement Act of 2008’’. 
SEC. 2. MODIFICATION OF REQUIREMENTS APPLICABLE 
UNDER MEDICARE TO DESIGNATION OF AC-
CREDITATION 
ORGANIZATIONS 
FOR 
SUP-
PLIERS 
OF 
PROSTHETIC 
DEVICES 
AND 
ORTHOTICS AND PROSTHETICS. 
(a) IN GENERAL.—Section 1834(a)(20)(B) of the So-
cial Security Act (42 U.S.C. 1395m(a)(20)(B)) is amend-
ed— 
(1) by striking ‘‘Not later than’’ and inserting 
‘‘(i) IN GENERAL.—Subject to clause (ii), not later 
than’’ with the same indentation as the clause added 
by paragraph (2); and 
(2) by adding at the end the following new 
clause: 
‘‘(ii) SPECIAL
REQUIREMENTS
FOR 
ACCREDITATION OF PROSTHETIC DEVICES 
AND ORTHOTICS AND PROSTHETICS.—For 
purposes of applying quality standards 
under subparagraph (A) for suppliers of 
items and services described in subpara-
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graph (D)(ii), the Secretary shall designate 
and approve an independent accreditation 
organization under clause (i) only if such 
organization is a Board or program de-
scribed in subsection (h)(1)(F)(iv). Not 
later than January 1, 2009, the Secretary 
shall ensure that at least one independent 
accreditation organization is designated 
and approved in accordance with this 
clause.’’. 
(b) EFFECTIVE DATE.—An organization must satisfy 
the requirement of section 1834(a)(20)(B)(ii), as added 
by subsection (a)(2), not later than January 1, 2009, re-
gardless of whether such organization is designated or ap-
proved as an independent accreditation organization be-
fore, on, or after the date of the enactment of this Act. 
SEC. 3. APPLICATION OF EXISTING ACCREDITATION AND 
LICENSURE REQUIREMENTS FOR CERTAIN 
PROSTHETICS 
AND 
CUSTOM-FABRICATED 
ORTHOTICS TO PROSTHETIC DEVICES AND 
ORTHOTICS AND PROSTHETICS. 
(a) IN GENERAL.—Section 1834(h)(1)(F) of the So-
cial Security Act (42 U.S.C. 1395m(h)(1)(F)) is amend-
ed— 
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(1) in the heading, by striking ‘‘SPECIAL PAY-
MENT RULES FOR CERTAIN PROSTHETICS AND CUS-
TOM-FABRICATED ORTHOTICS’’ and inserting ‘‘PAY-
MENT RULES’’; 
(2) in clause (i), by striking ‘‘an item of cus-
tom-fabricated orthotics described in clause (ii) or 
for an item of prosthetics unless such item is’’ and 
inserting ‘‘a prosthetic device or an item of orthotics 
or prosthetics, including an item of custom-fab-
ricated orthotics described in clause (ii), unless such 
device or item, respectively, is’’; 
(3) in clause (ii)(II), by striking ‘‘a list of items 
to which this subparagraph applies’’ and inserting 
‘‘a list of items for purposes of clause (i)’’; and 
(4) in clause (iii)(III), by striking ‘‘to provide 
or manage the provision of prosthetics and custom- 
designed or -fabricated orthotics’’ and inserting ‘‘to 
provide or manage the provision of prosthetics and 
orthotics (and custom-designed or -fabricated orthot-
ics, in the case of an item described in clause (iii))’’. 
(b) EFFECTIVE DATE.—The amendments made by 
subsection (a) shall apply to devices and items furnished 
on or after January 1, 2009. 
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SEC. 4. 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)(I) of the Social Security Act, as added by sec-
tion 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)(I) of such section, as added by 
section 3, on the occurrence of fraud and abuse under the 
Medicare program under title XVIII of such Act, with re-
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spect to prosthetic devices and orthotics and prosthetics 
for which payment is made under such program. 
SEC. 5. MODIFICATION OF MEDICARE PAYMENT METHOD-
OLOGY 
FOR 
PROSTHETIC 
DEVICES 
AND 
ORTHOTICS AND PROSTHETICS. 
Section 1834(h) of the Social Security Act (42 U.S.C. 
1395m(h)) is amended— 
(1) in paragraph (1)(B), by striking ‘‘and 
(H)(i)’’ and inserting ‘‘(H)(i), and paragraph (5)’’; 
and 
(2) by adding at the end the following new 
paragraph: 
‘‘(5) MODIFICATION
OF
PAYMENT
METHOD-
OLOGY TO ACCOUNT FOR PRACTITIONER QUALIFICA-
TIONS AND COMPLEXITY OF CARE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
modify the payment basis under paragraph 
(1)(B) for prosthetic devices and orthotics and 
prosthetics in a manner that links the com-
plexity of the respective item and the qualifica-
tions of the individual or entity furnishing and 
fabricating such respective item in determining 
the payment basis for such item. Such modi-
fications shall be implemented in a manner that 
provides for the application of such modifica-
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tions to items furnished on or after January 1, 
2009. Such modifications shall be designed to 
result in the same aggregate amount of expend-
itures for prosthetic devices and orthotics and 
prosthetics under this section for a year as 
would be made if this subparagraph did not 
apply, as estimated by the Secretary. 
‘‘(B) ASSIGNMENT OF BILLING CODES.— 
For purposes of subparagraph (A), in modifying 
the payment basis under paragraph (1)(B), the 
Secretary shall utilize and incorporate the 
‘2008 Orthotics and Prosthetics Tripartite Doc-
ument’ a multi-organization compilation of 
HCPCS codes to assign specific billing codes to 
the category of orthotics and prosthetics care 
described in each of clauses (i) through (iv) of 
subparagraph (C) using the provider qualifica-
tion designation for each HCPCS code as stat-
ed in such document. 
‘‘(C) CATEGORIES
OF
ORTHOTICS
AND 
PROSTHETICS CARE DESCRIBED.— 
‘‘(i) 
CUSTOM-FABRICATED
CAT-
EGORY.—The category of orthotics and 
prosthetics care described in this clause is 
a category for custom-fabricated devices 
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that are made from detailed measure-
ments, images, or models in accordance 
with a prescription and that can only be 
utilized by a specific intended patient. The 
provider qualification designation for the 
category shall reflect 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 creden-
tialed, certified, or licensed in orthot-
ics or prosthetics, respectively, to in-
sure the comprehensive provision of 
orthotic care or prosthetic care, re-
spectively. Such care 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 de-
termine the device parameters and de-
sign, fabrication process, and func-
tional purpose specific to the needs of 
the patient to maximize optimal clin-
ical outcomes. 
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‘‘(ii) 
CUSTOM-FITTED
HIGH.—The 
category of orthotics and prosthetics care 
described in this clause is a category for 
prefabricated devices that are manufac-
tured with no specific patient in mind, but 
that are appropriately sized, adapted, 
modified, and configured (with the re-
quired tools and equipment) 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 
moderate to high complexity with sub-
stantial clinical risk. 
‘‘(II) The category of care re-
quires a practitioner who is creden-
tialed, certified, or licensed in orthot-
ics or prosthetics or a related field in 
which orthotics or prosthetics is the 
primary focus of the course of study, 
to insure the appropriate provision of 
orthotic care or prosthetic care, re-
spectively. Such care shall be based on 
sound clinical judgment and technical 
expertise based on the practitioner’s 
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education and clinical training, in 
order to allow the practitioner to de-
termine the appropriate device relative 
to the diagnosis and specific to the 
needs of the patient to maximize opti-
mal clinical outcomes. 
‘‘(iii) 
CUSTOM-FITTED
LOW.—The 
category of orthotics and prosthetics care 
described in this clause is a category for 
prefabricated devices that are manufac-
tured with no specific patient in mind, but 
that are appropriately 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 credentialed, 
certified, or licensed within a limited 
scope of practice to insure appropriate 
provision of orthotic care. The sup-
plier’s education and training shall in-
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sure that basic clinical knowledge and 
technical expertise is available to con-
firm successful fit and device compli-
ance with the prescription. 
‘‘(iv) 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-
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 credential-
ing, clinical education, or technical 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).’’. 
Æ 
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