I 
112TH CONGRESS 
2D SESSION 
H. R. 4378 
To amend title XVIII of the Social Security Act to provide for coverage 
and payment for complex rehabilitation technology items under the Medi-
care program. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 18, 2012 
Mr. CROWLEY introduced the following bill; which was referred to the Com-
mittee 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 provide 
for coverage and payment for complex rehabilitation tech-
nology items under the Medicare program. 
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 ‘‘Ensuring Access to 
Quality Complex Rehabilitation Technology Act of 2012’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
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(1) Individuals with disabilities and significant 
medical conditions such as Cerebral Palsy, Muscular 
Dystrophy, Multiple Sclerosis, Spinal Cord Injury, 
Amyotrophic Lateral Sclerosis, and Spina Bifida ex-
perience physical, functional, and cognitive chal-
lenges every day. 
(2) Complex rehabilitation technology items 
(CRT items), including products such as complex re-
habilitation power wheelchairs, highly configurable 
manual wheelchairs, adaptive seating and positioning 
systems, and other specialized equipment, such as 
standing frames and gait trainers, enable individuals 
to maximize their function and minimize the extent 
and costs of their medical care. 
(3) Access to CRT items and related services 
can be threatened by inadequate coding, coverage, 
and payment policies for such items and services. 
These policies have restricted access to existing com-
plex rehabilitation technology and stifled innovation. 
Access challenges have increased over the past sev-
eral years and, without meaningful change to these 
policies, will only become greater in the future. 
(4) Current Medicare policies often fail to ade-
quately address the needs of individuals with disabil-
ities, to consider the range of services furnished by 
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complex rehabilitation technology suppliers, and to 
recognize and account for the complexity and unique 
nature of the equipment itself. 
(5) A significant factor responsible for such ac-
cess challenges is that individually-configurable CRT 
items do not have a distinct payment category under 
the Medicare program, but instead are classified 
within the broad category of durable medical equip-
ment (DME). CRT items serve patients with serious 
medical conditions that require a broader range of 
services and specialized personnel than what is re-
quired for standard DME. Customizable CRT items 
also require more resources in the areas configuring, 
training, and education to ensure appropriate use 
and to optimize results. 
(6) Unlike most DME, a medical model incor-
porating an interdisciplinary team approach is nec-
essary to ensure proper customization and use of a 
CRT item. This team typically includes a physician, 
a licensed physical or licensed occupational therapist 
(with no financial relationship with the CRT sup-
plier), a qualified CRT professional, the individual 
using such item, and sometimes a caregiver for such 
individual. 
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(7) The Medicare program should recognize the 
specialized nature of the CRT service delivery model, 
the required supporting processes and technology-re-
lated CRT services, the credentials and competencies 
needed by the providing suppliers and critical staff, 
and the related costs involved. A separate benefit 
category for CRT items would allow for unique cod-
ing, coverage, and payment rules and policies that 
address the unique needs of persons with disabilities 
and acknowledge the extensive service component. 
(8) Congress and the Centers for Medicare & 
Medicaid Services (CMS) have previously recognized 
the benefits of a separate classification for unique, 
customized products. In 2008, Congress exempted 
certain CRT items from inclusion in the Medicare 
DME competitive bidding program, and Congress 
has created a separate and distinct benefit category 
for orthotics and prosthetics (custom braces and ar-
tificial limbs), which have their own medical policies, 
accreditation standards, and payment calculations. 
SEC. 3. ESTABLISHING SEPARATE BENEFIT CATEGORY FOR 
COMPLEX REHABILITATION TECHNOLOGIES 
WITHIN MEDICARE. 
(a) NEW CATEGORY.—Section 1861 of the Social Se-
curity Act (42 U.S.C. 1395x) is amended— 
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(1) in subsection (s)(2)— 
(A) in subparagraph (EE), by striking 
‘‘and’’ at the end; 
(B) in subparagraph (FF), by inserting 
‘‘and’’ at the end; and 
(C) by inserting after subparagraph (FF) 
the following new paragraph: 
‘‘(GG) complex rehabilitation technology 
items (as defined in subsection (iii));’’; and 
(2) by adding at the end the following new sub-
section: 
‘‘(iii) COMPLEX
REHABILITATION
TECHNOLOGY 
ITEM.—(1) The term ‘complex rehabilitation technology 
item’ or ‘CRT item’ means an item that— 
‘‘(A) is designed and configured for a specific 
qualified individual to meet the individual’s unique— 
‘‘(i) medical, physical, and functional needs 
related to a medical condition; and 
‘‘(ii) capacities for basic activities of daily 
living and instrumental activities of daily living; 
‘‘(B) is primarily used to serve a medical pur-
pose and is generally not useful to a person in the 
absence of illness or injury; and 
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‘‘(C) requires certain services to ensure appro-
priate design, configuration, and use of such item, 
including— 
‘‘(i) an evaluation of needs and capacities 
and matching of the features and functions of 
CRT items to the qualified individual who will 
use such an item; and 
‘‘(ii) configuring, fitting, programming, ad-
justing, or adapting the particular complex re-
habilitation technology item for use by such in-
dividual. 
‘‘(2)(A) The Secretary, in consultation with the Di-
rector of Office on Disability, the Chairman of the Na-
tional Council on Disability, the Executive Director on the 
Interagency Committee on Disability, the Director of the 
National Institute on Disability and Rehabilitation Re-
search of the Department of Education, and the Co-Chair-
men of the Senior Oversight Committee’s Care Manage-
ment Reform Team of the Department of Defense and the 
Veterans Administration, shall, by regulation— 
‘‘(i) designate items as complex rehabilitation 
technology items; and 
‘‘(ii) establish eligibility criteria to determine if 
an individual is a qualified individual based on the 
level of physical and functional needs and capacities 
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related to a medical condition or conditions de-
scribed in subparagraph (E). 
‘‘(B) The items designated as complex rehabilitation 
technology items under subparagraph (A)(i) shall include 
items which, as of January 1, 2012, were classified within 
the following HCPCS codes: E0637, E0638, E0641, 
E0642, E0986, E1002, E1003, E1004, E1005, E1006, 
E1007, E1008, E1009, E1010, E1011, E1014, E1037, 
E1161, E1220, E1228, E1229, E1231, E1232, E1233, 
E1234, E1235, E1236, E1237, E1238, E1239 E2209, 
E2291, E2292, E2293, E2294, E2295, E2300, E2301, 
E2310, E2311, E2312, E2313, E2321, E2322, E2323, 
E2324, E2325, E2326, E2327, E2328, E2329, E2330, 
E2331, E2351, E2373, E2374, E2376, E2377, E2609, 
E2610, E2617, E8000, E8001, E8002, K0005, K0835, 
K0836, K0837, K0838, K0839, K0840, K0841, K0842, 
K0843, K0848, K0849, K0850, K0851, K0852, K0853, 
K0854, K0855, K0856, K0857, K0858, K0859, K0860, 
K0861, K0862, K0863, K0864, K0868, K0869, K0870, 
K0871, K0877, K0878, K0879, K0880, K0884, K0885, 
K0886, K0890, K0891, and K0898. 
‘‘(C)(i) The items designated as complex rehabilita-
tion technology items under subparagraph (A)(i) shall in-
clude items that— 
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‘‘(I) as of January 1, 2012, were classified 
within the HCPCS codes under clause (ii); and 
‘‘(II) the Secretary, acting in consultation with 
suppliers and manufacturers of, determines should 
be removed from such code and assigned a new 
HCPCS code because such item is a complex reha-
bilitation technology item. 
‘‘(ii) The HCPCS codes under this clause are the fol-
lowing: E0143, E0950, E0951, E0952, E0955, E0956, 
E0957, E0958, E0960, E0967, E0978, E0990, E1015, 
E1016, E1028, E01029, E1030, E2205, E2208, E2231, 
E2368, E2369, E2370, E2605, E2606, E2607, E2608, 
E2613, E2614, E2615, E2616, E2620, E2621, E2624, 
E2625, K0004, K0009, K0040, K0108, and K0669. 
‘‘(D) The Secretary may not designate as a complex 
rehabilitation technology item— 
‘‘(i) adaptive equipment to operate motor vehi-
cles; 
‘‘(ii) prosthetic devices described in subsection 
(s)(8); or 
‘‘(iii) orthotics and prosthetics described in sub-
section (s)(9). 
‘‘(E) In establishing the eligibility criteria under sub-
paragraph (A)(ii), the Secretary shall include appropriate 
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physical and functional needs and capacities arising from 
any of the following medical conditions: 
‘‘(i) Congenital disorders, progressive or degen-
erative neuromuscular diseases, or injuries or trau-
ma that result in significant physical or functional 
needs and capacities. 
‘‘(ii) Spinal cord injury, traumatic brain injury, 
cerebral palsy, muscular dystrophy, spina bifida, 
osteogenesis imperfecta, arthrogryposis, amyotrophic 
lateral sclerosis, multiple sclerosis, demyelinating 
disease, myelopathy, myopathy, progressive muscular 
atrophy, anterior horn cell disease, post-polio syn-
drome, cerebellar degeneration, dystonia, Hunting-
ton’s disease, or spinocerebellar disease. 
‘‘(iii) Certain types of amputation, paralysis, or 
paresis that result in significant physical or func-
tional needs and capacities. 
‘‘(F)(i) For calendar year 2013, the Secretary shall 
publish— 
‘‘(I) a list of items designated under subpara-
graph (A)(i) and the HCPCS codes for such items; 
and 
‘‘(II) the eligibility criteria established under 
subparagraph (A)(ii). 
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‘‘(ii) For calendar year 2014 and subsequent years, 
the Secretary shall publish any necessary updates to such 
list (including additions of new CRT items and any 
changes in applicable HCPCS codes) and to such eligi-
bility criteria. 
‘‘(G) The Secretary shall make available, on a public 
Web site, the process by which the Secretary will consider 
requests from members of the public that the Secretary— 
‘‘(i) designate an item as a CRT item under 
subparagraph (A)(i); or 
‘‘(ii) amend the eligibility criteria established 
under subparagraph (A)(ii). 
‘‘(3) For purposes of this subsection: 
‘‘(A) The term ‘capacity for basic activities of 
daily living’ means an individual’s capacity to safely 
participate in mobility and self-care activities includ-
ing— 
‘‘(i) maintaining and changing body posi-
tion; 
‘‘(ii) transferring to or from one surface to 
another; 
‘‘(iii) walking; 
‘‘(iv) moving from place to place using mo-
bility equipment, in a safe and timely manner; 
‘‘(v) washing one’s self; 
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‘‘(vi) caring for the body; 
‘‘(vii) toileting; 
‘‘(viii) dressing; 
‘‘(ix) eating; 
‘‘(x) drinking; 
‘‘(xi) looking after one’s health; and 
‘‘(xii) carrying, moving, and handling ob-
jects to perform and participate in other activi-
ties under this subparagraph and subparagraph 
(B). 
‘‘(B) The term ‘capacity for instrumental activi-
ties of daily living’ means an individual’s capacity to 
safely participate in life situations in the home and 
community, including— 
‘‘(i) communicating; 
‘‘(ii) moving around using transportation; 
‘‘(iii) acquiring necessities, goods, and 
services; 
‘‘(iv) performing household tasks; 
‘‘(v) caring for household members and 
family members; 
‘‘(vi) caring for household objects; 
‘‘(vii) engaging in education, work, employ-
ment and economic life; and 
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‘‘(viii) participating in community, social, 
and civic activities. 
‘‘(C) The term ‘HCPCS’ refers to the Health 
Care Procedure Coding System. 
‘‘(D) With respect to an item, the term ‘individ-
ually-configured’ means that— 
‘‘(i) the item has a combination of fea-
tures, adjustments, or modifications that are 
specific to the individual who uses such item; 
and 
‘‘(ii) the supplier of such item must meas-
ure the individual and configure, fit, program, 
adjust, or adapt the item, as appropriate, so 
that the item is consistent with— 
‘‘(I) an assessment or evaluation of 
the individual by an appropriate licensed 
clinician; 
‘‘(II) the written order required under 
section 1834(p)(2)(B)(i); and 
‘‘(III) medical condition, physical and 
functional needs and capacities, and body 
size of the individual who will use the item, 
the period for which such individual will 
need such item, and the intended use of 
such item by such individual. 
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‘‘(E) The term ‘qualified individual’ means an 
individual who— 
‘‘(i) is enrolled under Part B; and 
‘‘(ii) has physical and functional needs and 
capacities that arise from a medical condition 
that meet the eligibility criteria established by 
the Secretary under paragraph (2)(A)(ii).’’. 
SEC. 4. PAYMENT RULES. 
Section 1834 of the Social Security Act (42 U.S.C. 
1395m) is amended by adding at the end the following: 
‘‘(p) COVERAGE AND PAYMENT FOR CRT ITEMS.— 
‘‘(1) GENERAL RULE FOR PAYMENT.— 
‘‘(A) IN
GENERAL.—Not later than one 
year after the date of enactment of the Ensur-
ing Access to Quality Complex Rehabilitation 
Technology Act of 2012, subject to subpara-
graph (B), the Secretary shall determine a pay-
ment system that shall apply to CRT items— 
‘‘(i) with HCPCS codes that were as-
signed 
to 
the 
item 
under 
section 
1861(iii)(2)(C)(i)(II); 
‘‘(ii) for which no HCPCS code was 
assigned prior to such data; or 
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‘‘(iii) which, prior to such date, was 
classified under a miscellaneous HCPCS 
code. 
‘‘(B) CONSIDERATIONS.—In determining 
the payment system under subparagraph (A), 
the Secretary— 
‘‘(i) may disregard the freezes on CPI 
increases to the payment amounts for du-
rable medical equipment that occurred be-
fore the date of enactment of the Ensuring 
Access to Quality Complex Rehabilitation 
Technology Act of 2012 when determining 
the payment amount for CRT items; and 
‘‘(ii) shall ensure that the payment 
amounts for CRT items under such system 
are adequate to provide qualified individ-
uals with access to such items and to en-
courage innovation, taking into account— 
‘‘(I) the unique needs of qualified 
individuals for access to CRT items; 
‘‘(II) the unique complexity of 
CRT items; and 
‘‘(III) the resources and staff 
needed 
to 
provide 
appropriate 
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customization of CRT items for a 
qualified individual. 
‘‘(C) EXCLUSIVE
PAYMENT
RULE.—This 
subsection shall constitute the exclusive provi-
sion of this title for payment for CRT items 
under this part or under part A to a home 
health agency. 
‘‘(D) LIMITATION ON PAYMENT.—No pay-
ment shall be made under this subsection for a 
CRT item unless such CRT item— 
‘‘(i) is provided to a qualified indi-
vidual; 
‘‘(ii) meets the clinical conditions for 
coverage established under paragraph (2); 
and 
‘‘(iii) is furnished by a supplier ac-
credited pursuant to paragraph (3). 
‘‘(2) CLINICAL CONDITIONS FOR COVERAGE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
establish standards for clinical conditions for 
payment for CRT items under this subsection. 
‘‘(B) REQUIREMENTS.—The standards es-
tablished under subparagraph (A) shall require 
the following: 
‘‘(i) WRITTEN ORDER.— 
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‘‘(I) IN
GENERAL.—A qualified 
ordering practitioner shall provide a 
written order for a CRT item for a 
qualified individual before the Sec-
retary may provide payment for such 
item for such individual under this 
subsection. 
‘‘(II) CRT EVALUATION.—In the 
case of a CRT item that is cat-
egorized by the Secretary, for pur-
poses of the program under this title, 
as a manual wheelchair or a power 
wheelchair, and is to be provided to a 
qualified individual who has a diag-
nosis specified under subparagraph 
(C), the qualified ordering practitioner 
may not provide a written order under 
subclause (I) unless the qualified indi-
vidual has undergone a CRT evalua-
tion conducted by a licensed physical 
therapist or occupational therapist 
who has no financial relationship with 
the CRT supplier. 
‘‘(ii) DOCUMENTATION
OF
MEDICAL 
NECESSITY.—A qualified ordering practi-
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tioner who provides a written order under 
clause (i) shall maintain documentation of 
the medical necessity of such order for a 
period of seven years and shall make such 
documentation available to the Secretary 
upon request. The documentation of med-
ical necessity under this clause shall in-
clude— 
‘‘(I) evidence that the individual 
for whom the order was written has 
physical and functional needs and ca-
pacities related to a medical condition 
that meet the eligibility criteria estab-
lished 
under 
section 
1861(iii)(2)(A)(ii); and 
‘‘(II) evidence of any CRT eval-
uation required under clause (i)(II). 
‘‘(C) SPECIFICATION
OF
DIAGNOSIS
FOR 
CRT EVALUATION.—The Secretary, in consulta-
tion with relevant parties (including the agen-
cies listed in section 1861(iii)(2)(A), physicians, 
licensed physical therapists, licensed occupa-
tional therapists, and suppliers of complex reha-
bilitation technologies) shall specify the diag-
noses and other medical presentations for which 
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the requirement for a CRT evaluation under 
subparagraph (B)(i)(II) shall apply. 
‘‘(D) COVERAGE
DETERMINATIONS.—In 
developing the standards under subparagraph 
(A), the coverage of CRT items with respect to 
an individual shall be based on— 
‘‘(i) the specific medical, physical and 
functional needs of the individual; 
‘‘(ii) the individual’s capacities for 
safe participation in basic activities of 
daily living and instrumental activities of 
daily living in all routinely encountered en-
vironments (as such terms are defined in 
section 1861(iii)(3)); and 
‘‘(iii) the individual’s expected pro-
gression of such needs and capacities. 
‘‘(E) 
PAYMENT
FOR
RESIDENTS
OF 
SKILLED NURSING FACILITIES.—In the case of 
a qualified individual who is a resident of a 
skilled nursing facility, payment may only be 
made under this subsection for a CRT item for 
such individual if such CRT item is required as 
part of a plan of care to allow the transition of 
such individual from the skilled nursing facility 
to a home or community setting. 
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‘‘(3) ESTABLISHMENT
OF
QUALITY
STAND-
ARDS.— 
‘‘(A) 
ESTABLISHMENT.—The 
Secretary 
shall establish, through regulation, quality 
standards for suppliers of CRT items. Such 
standards shall be applied prospectively and 
shall be published on the Internet Web site of 
the Centers for Medicare and Medicaid Serv-
ices. 
‘‘(B) CONSULTATION.—In establishing the 
quality standards under subparagraph (A), the 
Secretary shall consult with relevant parties (in-
cluding clinicians, consumer groups, suppliers, 
and manufacturers). 
‘‘(C) REQUIREMENTS OF STANDARDS.—In 
establishing the quality standards under sub-
paragraph (A), the Secretary shall require that 
the suppliers of CRT items meet the following 
requirements: 
‘‘(i) DME STANDARDS AS MINIMUM.— 
The supplier complies with all of the 
standards that are applicable to suppliers 
of durable medical equipment under sub-
section (a)(20) and suppliers of medical 
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equipment and supplies under subsection 
(j). 
‘‘(ii) 
QUALIFIED
CRT
PROFES-
SIONAL.—The supplier of a CRT item 
makes available, in each service area 
served by such supplier, at least one quali-
fied CRT professional to— 
‘‘(I) analyze the needs and capac-
ities of individuals for a CRT item in 
collaboration with the clinical team; 
‘‘(II) assist in selecting an appro-
priate CRT item for such individual, 
given such needs and capacities; and 
‘‘(III) provide technology-related 
training to such individual in the 
proper use and maintenance of the 
CRT items. 
‘‘(iii) TRIAL
EQUIPMENT.—The sup-
plier of the CRT item provides the quali-
fied individual with appropriate equipment 
for trial and simulation, if a physician, li-
censed physical therapist, or licensed occu-
pational therapist determines that the pro-
vision of such equipment is necessary. 
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‘‘(iv) INFORMATION ON REPAIR.—The 
supplier of the CRT item provides the 
qualified individual with written informa-
tion on the service and repair of the CRT 
item provided to such individual. 
‘‘(v) REPAIR.—The supplier of a CRT 
item— 
‘‘(I) makes available, in each 
service area served by such supplier, 
at least one qualified CRT service 
technician to service and repair CRT 
items that— 
‘‘(aa) are furnished by such 
supplier; and 
‘‘(bb) at the time of the 
need for repair, are located in a 
service area of the supplier; or 
‘‘(II) at the time of sale of the 
CRT item, discloses to the qualified 
individual that the supplier does not 
provide repair service for such item 
and provides contact information for 
entities that do provide such repair 
service. 
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‘‘(vi) RENTAL
EQUIPMENT.—If pay-
ment is allowed under paragraph (6), the 
supplier of the CRT item provides tem-
porary rental equipment to the qualified 
individual when the supplier is repairing a 
qualified individual’s CRT item that was 
paid for under this subsection. 
‘‘(4) APPLICATION
OF
STANDARDS
AND
AC-
CREDITATION
PROGRAM
FOR
SUPPLIERS
OF
CRT 
ITEMS.— 
‘‘(A) IMPACT OF STANDARDS.—A supplier 
of CRT items may not— 
‘‘(i) furnish any such item for which 
payment is made under this part; or 
‘‘(ii) receive or retain a provider or 
supplier number used to submit claims for 
reimbursement for any such item for which 
payment may be made under this title, 
unless such supplier is in compliance with the 
standards under paragraph (3). 
‘‘(B) APPLICATION OF ACCREDITATION RE-
QUIREMENT.—In implementing quality stand-
ards under paragraph (3), the Secretary shall 
require suppliers furnishing CRT items on or 
after one year after the standards are published 
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under such paragraph, directly or as a subcon-
tractor for another entity— 
‘‘(i) to be compliant with these stand-
ards; and 
‘‘(ii) have submitted to the Secretary 
evidence of accreditation by an accredita-
tion organization designated under sub-
paragraph (C) demonstrating that the sup-
plier is compliant with such standards. 
‘‘(C) DESIGNATION OF INDEPENDENT AC-
CREDITATION ORGANIZATIONS.—Not later than 
the date that is one year after the date on 
which the Secretary implements the quality 
standards under paragraph (3), the Secretary 
shall designate and approve one or more inde-
pendent accreditation organizations that— 
‘‘(i) are approved under subsection 
(a)(20)(B); and 
‘‘(ii) that the Secretary has deter-
mined have the capability to assess wheth-
er suppliers of CRT items meet the quality 
standards established under paragraph (3). 
‘‘(5) CODING SYSTEM FOR COMPLEX REHABILI-
TATION TECHNOLOGIES.— 
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‘‘(A) IN GENERAL.—The Secretary shall, 
in consultation with suppliers and manufactur-
ers of CRT items, and utilizing existing coding 
systems, establish a HCPCS coding subset that 
shall utilize and include, HCPCS codes de-
scribed in section 1861(iii)(2) for CRT items 
for which payment may made under this sub-
section. 
‘‘(B) TREATMENT
OF
EXISTING
PROD-
UCTS.— 
‘‘(i) IN
GENERAL.—With respect to 
CRT items for which payment was avail-
able under this title before the effective 
date of the Ensuring Access to Quality 
Complex Rehabilitation Technology Act of 
2012, the Secretary shall assign such items 
to a code in the coding subset established 
under subparagraph (A). 
‘‘(ii) UPDATES.—After the initial as-
signment under clause (i), the Secretary 
may decide to re-assign additional product 
categories, or items within those cat-
egories, that exist prior to the date of en-
actment of the Ensuring Access to Quality 
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Complex Rehabilitation Technology Act of 
2012 to the CRT coding subset. 
‘‘(iii) CONSULTATION.—Before mak-
ing the assignments under clause (ii), the 
Secretary shall consult with suppliers and 
manufacturers of such CRT items. The 
Secretary shall not require manufacturers 
of CRT items for which payment was 
available under this title before the effec-
tive date of the Ensuring Access to Quality 
Complex Rehabilitation Technology Act of 
2012 to submit requests for reassignment 
of the code for such product to the coding 
subset under subparagraph (A) as long 
as— 
‘‘(I) no changes have been made 
to the code definitions, required code 
characteristics or test requirements; 
and 
‘‘(II) the item was previously 
verified to meet the code require-
ments. 
‘‘(C) REMOVING
COMPLEX
REHABILITA-
TION
TECHNOLOGY
FROM
DME
CODES.—The 
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