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 Medicare program. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 18, 2012 

Mr. CROWLEY introduced the following bill; which was referred to the Committee 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 technology items under the Medicare program. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Ensuring Access to 

5 Quality Complex Rehabilitation Technology Act of 2012’’. 

6 SEC. 2. FINDINGS. 

7 Congress finds the following: 


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1 (1) Individuals with disabilities and significant 

2 medical conditions such as Cerebral Palsy, Muscular 

3 Dystrophy, Multiple Sclerosis, Spinal Cord Injury, 

4 Amyotrophic Lateral Sclerosis, and Spina Bifida ex5 perience physical, functional, and cognitive chal6 lenges every day. 

7 (2) Complex rehabilitation technology items 

8 (CRT items), including products such as complex re9 habilitation power wheelchairs, highly configurable 

10 manual wheelchairs, adaptive seating and positioning 

11 systems, and other specialized equipment, such as 

12 standing frames and gait trainers, enable individuals 

13 to maximize their function and minimize the extent 

14 and costs of their medical care. 

15 (3) Access to CRT items and related services 

16 can be threatened by inadequate coding, coverage, 

17 and payment policies for such items and services. 

18 These policies have restricted access to existing com19 plex rehabilitation technology and stifled innovation. 

20 Access challenges have increased over the past sev21 eral years and, without meaningful change to these 

22 policies, will only become greater in the future. 

23 (4) Current Medicare policies often fail to ade24 quately address the needs of individuals with disabil25 ities, to consider the range of services furnished by 


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1 complex rehabilitation technology suppliers, and to 

2 recognize and account for the complexity and unique 

3 nature of the equipment itself. 

4 (5) A significant factor responsible for such ac5 cess challenges is that individually-configurable CRT 

6 items do not have a distinct payment category under 

7 the Medicare program, but instead are classified 

8 within the broad category of durable medical equip9 ment (DME). CRT items serve patients with serious 

10 medical conditions that require a broader range of 

11 services and specialized personnel than what is re12 quired for standard DME. Customizable CRT items 

13 also require more resources in the areas configuring, 

14 training, and education to ensure appropriate use 

15 and to optimize results. 

16 (6) Unlike most DME, a medical model incor17 porating an interdisciplinary team approach is nec18 essary to ensure proper customization and use of a 

19 CRT item. This team typically includes a physician, 

20 a licensed physical or licensed occupational therapist 

21 (with no financial relationship with the CRT sup22 plier), a qualified CRT professional, the individual 

23 using such item, and sometimes a caregiver for such 

24 individual. 


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1 (7) The Medicare program should recognize the 

2 specialized nature of the CRT service delivery model, 

3 the required supporting processes and technology-re4 lated CRT services, the credentials and competencies 

5 needed by the providing suppliers and critical staff, 

6 and the related costs involved. A separate benefit 

7 category for CRT items would allow for unique cod8 ing, coverage, and payment rules and policies that 

9 address the unique needs of persons with disabilities 

10 and acknowledge the extensive service component. 

11 (8) Congress and the Centers for Medicare & 

12 Medicaid Services (CMS) have previously recognized 

13 the benefits of a separate classification for unique, 

14 customized products. In 2008, Congress exempted 

15 certain CRT items from inclusion in the Medicare 

16 DME competitive bidding program, and Congress 

17 has created a separate and distinct benefit category 

18 for orthotics and prosthetics (custom braces and ar19 tificial limbs), which have their own medical policies, 

20 accreditation standards, and payment calculations. 

21 SEC. 3. ESTABLISHING SEPARATE BENEFIT CATEGORY FOR 

22 COMPLEX REHABILITATION TECHNOLOGIES 

23 WITHIN MEDICARE. 

24 (a) NEW CATEGORY.—Section 1861 of the Social Se25 curity Act (42 U.S.C. 1395x) is amended— 


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1 (1) in subsection (s)(2)— 

2 (A) in subparagraph (EE), by striking 

3 ‘‘and’’ at the end; 

4 (B) in subparagraph (FF), by inserting 

5 ‘‘and’’ at the end; and 

6 (C) by inserting after subparagraph (FF) 

7 the following new paragraph: 

8 ‘‘(GG) complex rehabilitation technology 

9 items (as defined in subsection (iii));’’; and 

10 (2) by adding at the end the following new sub11 section: 

12 ‘‘(iii) COMPLEX REHABILITATION TECHNOLOGY

13 ITEM.—(1) The term ‘complex rehabilitation technology 

14 item’ or ‘CRT item’ means an item that— 

15 ‘‘(A) is designed and configured for a specific 

16 qualified individual to meet the individual’s unique— 

17 ‘‘(i) medical, physical, and functional needs 

18 related to a medical condition; and 

19 ‘‘(ii) capacities for basic activities of daily 

20 living and instrumental activities of daily living; 

21 ‘‘(B) is primarily used to serve a medical pur22 pose and is generally not useful to a person in the 

23 absence of illness or injury; and 


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1 ‘‘(C) requires certain services to ensure appro2 priate design, configuration, and use of such item, 

3 including— 

4 ‘‘(i) an evaluation of needs and capacities 

5 and matching of the features and functions of 

6 CRT items to the qualified individual who will 

7 use such an item; and 

8 ‘‘(ii) configuring, fitting, programming, ad9 justing, or adapting the particular complex re10 habilitation technology item for use by such in11 dividual. 

12 ‘‘(2)(A) The Secretary, in consultation with the Di13 rector of Office on Disability, the Chairman of the Na14 tional Council on Disability, the Executive Director on the 

15 Interagency Committee on Disability, the Director of the 

16 National Institute on Disability and Rehabilitation Re17 search of the Department of Education, and the Co-Chair18 men of the Senior Oversight Committee’s Care Manage19 ment Reform Team of the Department of Defense and the 

20 Veterans Administration, shall, by regulation— 

21 ‘‘(i) designate items as complex rehabilitation 

22 technology items; and 

23 ‘‘(ii) establish eligibility criteria to determine if 

24 an individual is a qualified individual based on the 

25 level of physical and functional needs and capacities 


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1 related to a medical condition or conditions de2 scribed in subparagraph (E). 

3 ‘‘(B) The items designated as complex rehabilitation 

4 technology items under subparagraph (A)(i) shall include 

5 items which, as of January 1, 2012, were classified within 

6 the following HCPCS codes: E0637, E0638, E0641, 

7 E0642, E0986, E1002, E1003, E1004, E1005, E1006, 

8 E1007, E1008, E1009, E1010, E1011, E1014, E1037, 

9 E1161, E1220, E1228, E1229, E1231, E1232, E1233, 

10 E1234, E1235, E1236, E1237, E1238, E1239 E2209, 

11 E2291, E2292, E2293, E2294, E2295, E2300, E2301, 

12 E2310, E2311, E2312, E2313, E2321, E2322, E2323, 

13 E2324, E2325, E2326, E2327, E2328, E2329, E2330, 

14 E2331, E2351, E2373, E2374, E2376, E2377, E2609, 

15 E2610, E2617, E8000, E8001, E8002, K0005, K0835, 

16 K0836, K0837, K0838, K0839, K0840, K0841, K0842, 

17 K0843, K0848, K0849, K0850, K0851, K0852, K0853, 

18 K0854, K0855, K0856, K0857, K0858, K0859, K0860, 

19 K0861, K0862, K0863, K0864, K0868, K0869, K0870, 

20 K0871, K0877, K0878, K0879, K0880, K0884, K0885, 

21 K0886, K0890, K0891, and K0898. 

22 ‘‘(C)(i) The items designated as complex rehabilita23 tion technology items under subparagraph (A)(i) shall in24 clude items that— 


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1 ‘‘(I) as of January 1, 2012, were classified 

2 within the HCPCS codes under clause (ii); and 

3 ‘‘(II) the Secretary, acting in consultation with 

4 suppliers and manufacturers of, determines should 

5 be removed from such code and assigned a new 

6 HCPCS code because such item is a complex reha7 bilitation technology item. 

8 ‘‘(ii) The HCPCS codes under this clause are the fol9 lowing: E0143, E0950, E0951, E0952, E0955, E0956, 

10 E0957, E0958, E0960, E0967, E0978, E0990, E1015, 

11 E1016, E1028, E01029, E1030, E2205, E2208, E2231, 

12 E2368, E2369, E2370, E2605, E2606, E2607, E2608, 

13 E2613, E2614, E2615, E2616, E2620, E2621, E2624, 

14 E2625, K0004, K0009, K0040, K0108, and K0669. 

15 ‘‘(D) The Secretary may not designate as a complex 

16 rehabilitation technology item— 

17 ‘‘(i) adaptive equipment to operate motor vehi18 cles; 

19 ‘‘(ii) prosthetic devices described in subsection 

20 (s)(8); or 

21 ‘‘(iii) orthotics and prosthetics described in sub22 section (s)(9). 

23 ‘‘(E) In establishing the eligibility criteria under sub24 paragraph (A)(ii), the Secretary shall include appropriate 


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1 physical and functional needs and capacities arising from 

2 any of the following medical conditions: 

3 ‘‘(i) Congenital disorders, progressive or degen4 erative neuromuscular diseases, or injuries or trau5 ma that result in significant physical or functional 

6 needs and capacities. 

7 ‘‘(ii) Spinal cord injury, traumatic brain injury, 

8 cerebral palsy, muscular dystrophy, spina bifida, 

9 osteogenesis imperfecta, arthrogryposis, amyotrophic 

10 lateral sclerosis, multiple sclerosis, demyelinating 

11 disease, myelopathy, myopathy, progressive muscular 

12 atrophy, anterior horn cell disease, post-polio syn13 drome, cerebellar degeneration, dystonia, Hunting14 ton’s disease, or spinocerebellar disease. 

15 ‘‘(iii) Certain types of amputation, paralysis, or 

16 paresis that result in significant physical or func17 tional needs and capacities. 

18 ‘‘(F)(i) For calendar year 2013, the Secretary shall 

19 publish— 

20 ‘‘(I) a list of items designated under subpara21 graph (A)(i) and the HCPCS codes for such items; 

22 and 

23 ‘‘(II) the eligibility criteria established under 

24 subparagraph (A)(ii). 


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1 ‘‘(ii) For calendar year 2014 and subsequent years, 

2 the Secretary shall publish any necessary updates to such 

3 list (including additions of new CRT items and any 

4 changes in applicable HCPCS codes) and to such eligi5 bility criteria. 

6 ‘‘(G) The Secretary shall make available, on a public 

7 Web site, the process by which the Secretary will consider 

8 requests from members of the public that the Secretary— 

9 ‘‘(i) designate an item as a CRT item under 

10 subparagraph (A)(i); or 

11 ‘‘(ii) amend the eligibility criteria established 

12 under subparagraph (A)(ii). 

13 ‘‘(3) For purposes of this subsection: 

14 ‘‘(A) The term ‘capacity for basic activities of 

15 daily living’ means an individual’s capacity to safely 

16 participate in mobility and self-care activities includ17 ing— 

18 ‘‘(i) maintaining and changing body posi19 tion; 

20 ‘‘(ii) transferring to or from one surface to 

21 another; 

22 ‘‘(iii) walking; 

23 ‘‘(iv) moving from place to place using mo24 bility equipment, in a safe and timely manner; 

25 ‘‘(v) washing one’s self; 


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1 ‘‘(vi) caring for the body; 

2 ‘‘(vii) toileting; 

3 ‘‘(viii) dressing; 

4 ‘‘(ix) eating; 

5 ‘‘(x) drinking; 

6 ‘‘(xi) looking after one’s health; and 

7 ‘‘(xii) carrying, moving, and handling ob8 jects to perform and participate in other activi9 ties under this subparagraph and subparagraph 

10 (B). 

11 ‘‘(B) The term ‘capacity for instrumental activi12 ties of daily living’ means an individual’s capacity to 

13 safely participate in life situations in the home and 

14 community, including— 

15 ‘‘(i) communicating; 

16 ‘‘(ii) moving around using transportation; 

17 ‘‘(iii) acquiring necessities, goods, and 

18 services; 

19 ‘‘(iv) performing household tasks; 

20 ‘‘(v) caring for household members and 

21 family members; 

22 ‘‘(vi) caring for household objects; 

23 ‘‘(vii) engaging in education, work, employ24 ment and economic life; and 


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1 ‘‘(viii) participating in community, social, 

2 and civic activities. 

3 ‘‘(C) The term ‘HCPCS’ refers to the Health 

4 Care Procedure Coding System. 

5 ‘‘(D) With respect to an item, the term ‘individ6 ually-configured’ means that— 

7 ‘‘(i) the item has a combination of fea8 tures, adjustments, or modifications that are 

9 specific to the individual who uses such item; 

10 and 

11 ‘‘(ii) the supplier of such item must meas12 ure the individual and configure, fit, program, 

13 adjust, or adapt the item, as appropriate, so 

14 that the item is consistent with— 

15 ‘‘(I) an assessment or evaluation of 

16 the individual by an appropriate licensed 

17 clinician; 

18 ‘‘(II) the written order required under 

19 section 1834(p)(2)(B)(i); and 

20 ‘‘(III) medical condition, physical and 

21 functional needs and capacities, and body 

22 size of the individual who will use the item, 

23 the period for which such individual will 

24 need such item, and the intended use of 

25 such item by such individual. 


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1 ‘‘(E) The term ‘qualified individual’ means an 

2 individual who— 

3 ‘‘(i) is enrolled under Part B; and 

4 ‘‘(ii) has physical and functional needs and 

5 capacities that arise from a medical condition 

6 that meet the eligibility criteria established by 

7 the Secretary under paragraph (2)(A)(ii).’’. 

8 SEC. 4. PAYMENT RULES. 

9 Section 1834 of the Social Security Act (42 U.S.C. 

10 1395m) is amended by adding at the end the following: 

11 ‘‘(p) COVERAGE AND PAYMENT FOR CRT ITEMS.— 

12 ‘‘(1) GENERAL RULE FOR PAYMENT.— 

13 ‘‘(A) IN GENERAL.—Not later than one 

14 year after the date of enactment of the Ensur15 ing Access to Quality Complex Rehabilitation 

16 Technology Act of 2012, subject to subpara17 graph (B), the Secretary shall determine a pay18 ment system that shall apply to CRT items— 

19 ‘‘(i) with HCPCS codes that were as20 signed to the item under section 

21 1861(iii)(2)(C)(i)(II); 

22 ‘‘(ii) for which no HCPCS code was 

23 assigned prior to such data; or 


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1 ‘‘(iii) which, prior to such date, was 

2 classified under a miscellaneous HCPCS 

3 code. 

4 ‘‘(B) CONSIDERATIONS.—In determining 

5 the payment system under subparagraph (A), 

6 the Secretary— 

7 ‘‘(i) may disregard the freezes on CPI 

8 increases to the payment amounts for du9 rable medical equipment that occurred be10 fore the date of enactment of the Ensuring 

11 Access to Quality Complex Rehabilitation 

12 Technology Act of 2012 when determining 

13 the payment amount for CRT items; and 

14 ‘‘(ii) shall ensure that the payment 

15 amounts for CRT items under such system 

16 are adequate to provide qualified individ17 uals with access to such items and to en18 courage innovation, taking into account— 

19 ‘‘(I) the unique needs of qualified 

20 individuals for access to CRT items; 

21 ‘‘(II) the unique complexity of 

22 CRT items; and 

23 ‘‘(III) the resources and staff 

24 needed to provide appropriate 


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1 customization of CRT items for a 

2 qualified individual. 

3 ‘‘(C) EXCLUSIVE PAYMENT RULE.—This 

4 subsection shall constitute the exclusive provi5 sion of this title for payment for CRT items 

6 under this part or under part A to a home 

7 health agency. 

8 ‘‘(D) LIMITATION ON PAYMENT.—No pay9 ment shall be made under this subsection for a 

10 CRT item unless such CRT item— 

11 ‘‘(i) is provided to a qualified indi12 vidual; 

13 ‘‘(ii) meets the clinical conditions for 

14 coverage established under paragraph (2); 

15 and 

16 ‘‘(iii) is furnished by a supplier ac17 credited pursuant to paragraph (3). 

18 ‘‘(2) CLINICAL CONDITIONS FOR COVERAGE.— 

19 ‘‘(A) IN GENERAL.—The Secretary shall 

20 establish standards for clinical conditions for 

21 payment for CRT items under this subsection. 

22 ‘‘(B) REQUIREMENTS.—The standards es23 tablished under subparagraph (A) shall require 

24 the following: 

25 ‘‘(i) WRITTEN ORDER.— 


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1 ‘‘(I) IN GENERAL.—A qualified 

2 ordering practitioner shall provide a 

3 written order for a CRT item for a 

4 qualified individual before the Sec5 retary may provide payment for such 

6 item for such individual under this 

7 subsection. 

8 ‘‘(II) CRT EVALUATION.—In the 

9 case of a CRT item that is cat10 egorized by the Secretary, for pur11 poses of the program under this title, 

12 as a manual wheelchair or a power 

13 wheelchair, and is to be provided to a 

14 qualified individual who has a diag15 nosis specified under subparagraph 

16 (C), the qualified ordering practitioner 

17 may not provide a written order under 

18 subclause (I) unless the qualified indi19 vidual has undergone a CRT evalua20 tion conducted by a licensed physical 

21 therapist or occupational therapist 

22 who has no financial relationship with 

23 the CRT supplier. 

24 ‘‘(ii) DOCUMENTATION OF MEDICAL

25 NECESSITY.—A qualified ordering practiVerDate Mar 15 2010 00:05 Apr 20, 2012 Jkt 019200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\H4378.IH H4378

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1 tioner who provides a written order under 

2 clause (i) shall maintain documentation of 

3 the medical necessity of such order for a 

4 period of seven years and shall make such 

5 documentation available to the Secretary 

6 upon request. The documentation of med7 ical necessity under this clause shall in8 clude— 

9 ‘‘(I) evidence that the individual 

10 for whom the order was written has 

11 physical and functional needs and ca12 pacities related to a medical condition 

13 that meet the eligibility criteria estab14 lished under section 

15 1861(iii)(2)(A)(ii); and 

16 ‘‘(II) evidence of any CRT eval17 uation required under clause (i)(II). 

18 ‘‘(C) SPECIFICATION OF DIAGNOSIS FOR

19 CRT EVALUATION.—The Secretary, in consulta20 tion with relevant parties (including the agen21 cies listed in section 1861(iii)(2)(A), physicians, 

22 licensed physical therapists, licensed occupa23 tional therapists, and suppliers of complex reha24 bilitation technologies) shall specify the diag25 noses and other medical presentations for which 


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1 the requirement for a CRT evaluation under 

2 subparagraph (B)(i)(II) shall apply. 

3 ‘‘(D) COVERAGE DETERMINATIONS.—In 

4 developing the standards under subparagraph 

5 (A), the coverage of CRT items with respect to 

6 an individual shall be based on— 

7 ‘‘(i) the specific medical, physical and 

8 functional needs of the individual; 

9 ‘‘(ii) the individual’s capacities for 

10 safe participation in basic activities of 

11 daily living and instrumental activities of 

12 daily living in all routinely encountered en13 vironments (as such terms are defined in 

14 section 1861(iii)(3)); and 

15 ‘‘(iii) the individual’s expected pro16 gression of such needs and capacities. 

17 ‘‘(E) PAYMENT FOR RESIDENTS OF

18 SKILLED NURSING FACILITIES.—In the case of 

19 a qualified individual who is a resident of a 

20 skilled nursing facility, payment may only be 

21 made under this subsection for a CRT item for 

22 such individual if such CRT item is required as 

23 part of a plan of care to allow the transition of 

24 such individual from the skilled nursing facility 

25 to a home or community setting. 


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1 ‘‘(3) ESTABLISHMENT OF QUALITY STAND2 ARDS.— 

3 ‘‘(A) ESTABLISHMENT.—The Secretary 

4 shall establish, through regulation, quality 

5 standards for suppliers of CRT items. Such 

6 standards shall be applied prospectively and 

7 shall be published on the Internet Web site of 

8 the Centers for Medicare and Medicaid Serv9 ices. 

10 ‘‘(B) CONSULTATION.—In establishing the 

11 quality standards under subparagraph (A), the 

12 Secretary shall consult with relevant parties (in13 cluding clinicians, consumer groups, suppliers, 

14 and manufacturers). 

15 ‘‘(C) REQUIREMENTS OF STANDARDS.—In 

16 establishing the quality standards under sub17 paragraph (A), the Secretary shall require that 

18 the suppliers of CRT items meet the following 

19 requirements: 

20 ‘‘(i) DME STANDARDS AS MINIMUM.— 

21 The supplier complies with all of the 

22 standards that are applicable to suppliers 

23 of durable medical equipment under sub24 section (a)(20) and suppliers of medical 


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1 equipment and supplies under subsection 

2 (j). 

3 ‘‘(ii) QUALIFIED CRT PROFES4 SIONAL.—The supplier of a CRT item 

5 makes available, in each service area 

6 served by such supplier, at least one quali7 fied CRT professional to— 

8 ‘‘(I) analyze the needs and capac9 ities of individuals for a CRT item in 

10 collaboration with the clinical team; 

11 ‘‘(II) assist in selecting an appro12 priate CRT item for such individual, 

13 given such needs and capacities; and 

14 ‘‘(III) provide technology-related 

15 training to such individual in the 

16 proper use and maintenance of the 

17 CRT items. 

18 ‘‘(iii) TRIAL EQUIPMENT.—The sup19 plier of the CRT item provides the quali20 fied individual with appropriate equipment 

21 for trial and simulation, if a physician, li22 censed physical therapist, or licensed occu23 pational therapist determines that the pro24 vision of such equipment is necessary. 


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1 ‘‘(iv) INFORMATION ON REPAIR.—The 

2 supplier of the CRT item provides the 

3 qualified individual with written informa4 tion on the service and repair of the CRT 

5 item provided to such individual. 

6 ‘‘(v) REPAIR.—The supplier of a CRT 

7 item— 

8 ‘‘(I) makes available, in each 

9 service area served by such supplier, 

10 at least one qualified CRT service 

11 technician to service and repair CRT 

12 items that— 

13 ‘‘(aa) are furnished by such 

14 supplier; and 

15 ‘‘(bb) at the time of the 

16 need for repair, are located in a 

17 service area of the supplier; or 

18 ‘‘(II) at the time of sale of the 

19 CRT item, discloses to the qualified 

20 individual that the supplier does not 

21 provide repair service for such item 

22 and provides contact information for 

23 entities that do provide such repair 

24 service. 


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1 ‘‘(vi) RENTAL EQUIPMENT.—If pay2 ment is allowed under paragraph (6), the 

3 supplier of the CRT item provides tem4 porary rental equipment to the qualified 

5 individual when the supplier is repairing a 

6 qualified individual’s CRT item that was 

7 paid for under this subsection. 

8 ‘‘(4) APPLICATION OF STANDARDS AND AC9 CREDITATION PROGRAM FOR SUPPLIERS OF CRT

10 ITEMS.— 

11 ‘‘(A) IMPACT OF STANDARDS.—A supplier 

12 of CRT items may not— 

13 ‘‘(i) furnish any such item for which 

14 payment is made under this part; or 

15 ‘‘(ii) receive or retain a provider or 

16 supplier number used to submit claims for 

17 reimbursement for any such item for which 

18 payment may be made under this title, 

19 unless such supplier is in compliance with the 

20 standards under paragraph (3). 

21 ‘‘(B) APPLICATION OF ACCREDITATION RE22 QUIREMENT.—In implementing quality stand23 ards under paragraph (3), the Secretary shall 

24 require suppliers furnishing CRT items on or 

25 after one year after the standards are published 


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1 under such paragraph, directly or as a subcon2 tractor for another entity— 

3 ‘‘(i) to be compliant with these stand4 ards; and 

5 ‘‘(ii) have submitted to the Secretary 

6 evidence of accreditation by an accredita7 tion organization designated under sub8 paragraph (C) demonstrating that the sup9 plier is compliant with such standards. 

10 ‘‘(C) DESIGNATION OF INDEPENDENT AC11 CREDITATION ORGANIZATIONS.—Not later than 

12 the date that is one year after the date on 

13 which the Secretary implements the quality 

14 standards under paragraph (3), the Secretary 

15 shall designate and approve one or more inde16 pendent accreditation organizations that— 

17 ‘‘(i) are approved under subsection 

18 (a)(20)(B); and 

19 ‘‘(ii) that the Secretary has deter20 mined have the capability to assess wheth21 er suppliers of CRT items meet the quality 

22 standards established under paragraph (3). 

23 ‘‘(5) CODING SYSTEM FOR COMPLEX REHABILI24 TATION TECHNOLOGIES.— 


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1 ‘‘(A) IN GENERAL.—The Secretary shall, 

2 in consultation with suppliers and manufactur3 ers of CRT items, and utilizing existing coding 

4 systems, establish a HCPCS coding subset that 

5 shall utilize and include, HCPCS codes de6 scribed in section 1861(iii)(2) for CRT items 

7 for which payment may made under this sub8 section. 

9 ‘‘(B) TREATMENT OF EXISTING PROD10 UCTS.— 

11 ‘‘(i) IN GENERAL.—With respect to 

12 CRT items for which payment was avail13 able under this title before the effective 

14 date of the Ensuring Access to Quality 

15 Complex Rehabilitation Technology Act of 

16 2012, the Secretary shall assign such items 

17 to a code in the coding subset established 

18 under subparagraph (A). 

19 ‘‘(ii) UPDATES.—After the initial as20 signment under clause (i), the Secretary 

21 may decide to re-assign additional product 

22 categories, or items within those cat23 egories, that exist prior to the date of en24 actment of the Ensuring Access to Quality 


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1 Complex Rehabilitation Technology Act of 

2 2012 to the CRT coding subset. 

3 ‘‘(iii) CONSULTATION.—Before mak4 ing the assignments under clause (ii), the 

5 Secretary shall consult with suppliers and 

6 manufacturers of such CRT items. The 

7 Secretary shall not require manufacturers 

8 of CRT items for which payment was 

9 available under this title before the effec10 tive date of the Ensuring Access to Quality 

11 Complex Rehabilitation Technology Act of 

12 2012 to submit requests for reassignment 

13 of the code for such product to the coding 

14 subset under subparagraph (A) as long 

15 as— 

16 ‘‘(I) no changes have been made 

17 to the code definitions, required code 

18 characteristics or test requirements; 

19 and 

20 ‘‘(II) the item was previously 

21 verified to meet the code require22 ments. 

23 ‘‘(C) REMOVING COMPLEX REHABILITA24 TION TECHNOLOGY FROM DME CODES.—The 


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1 Secretary shall, in consultation with suppliers 

2 and manufacturers of CRT items— 

3 ‘‘(i) remove from the coding subset for 

4 durable medical equipment any CRT items 

5 that are included in the coding subset 

6 under subparagraph (A); and 

7 ‘‘(ii) assign new codes to such CRT 

8 items for purposes of including such items 

9 in the subset under subparagraph (A). 

10 ‘‘(D) NEW TECHNOLOGY.— 

11 ‘‘(i) IN GENERAL.—The Secretary 

12 shall update as needed the HCPCS level II 

13 process used to modify the code set to in14 clude CRT items for the purposes of estab15 lishing new codes and determining prod16 ucts to be classified as CRT items. In de17 termining if a product is a CRT item, the 

18 Secretary shall consider— 

19 ‘‘(I) if the product is novel; 

20 ‘‘(II) the clinical application of 

21 the product; and 

22 ‘‘(III) the ability of the product 

23 to address the unique needs and ca24 pacities of a qualified individual. 


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1 ‘‘(ii) The Secretary shall include the 

2 codes established in clause (i) in the list 

3 under section 1861(iii)(2)(F). 

4 ‘‘(E) MISCELLANEOUS CODE FOR INNOVA5 TION AND LOCAL COVERAGE DETERMINA6 TIONS.—The coding subset established under 

7 subparagraph (A) shall include at least one mis8 cellaneous code for items not otherwise classi9 fied. 

10 ‘‘(6) REPLACEMENT OF CRT ITEMS.— 

11 ‘‘(A) IN GENERAL.—Payment shall be 

12 made for the replacement of a CRT item (or for 

13 the replacement of any part of such item), with14 out regard to continuous use or useful lifetime 

15 restrictions established under section 

16 1834(a)(7)(C) for items of durable medical 

17 equipment if a qualified ordering practitioner 

18 determines that the provision of a replacement 

19 item (or a replacement part of such an item) is 

20 necessary because of any of the following— 

21 ‘‘(i) a change in the physiological con22 dition of the qualified individual to whom 

23 such item was provided; 

24 ‘‘(ii) an irreparable change in the con25 dition of the CRT item (or, in the case of 


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1 the replacement of a part, in the part of 

2 the CRT item); or 

3 ‘‘(iii) the CRT item requires repairs 

4 and the cost of such repairs would be more 

5 than 50 percent of the cost of a replace6 ment of the CRT item. 

7 ‘‘(B) DEFERRAL TO PROVIDERS.— 

8 ‘‘(i) IN GENERAL.—Subject to clause 

9 (ii), if a qualified ordering practitioner de10 termines that a replacement of the CRT 

11 item, or the replacement of a part of a 

12 CRT item, is necessary pursuant to sub13 paragraph (A), the replacement item or 

14 part be deemed to be reasonable and nec15 essary for purposes of section 

16 1862(a)(1)(A). 

17 ‘‘(ii) EXCEPTION FOR ITEMS UNDER 3

18 YEARS OLD.—If the CRT item that is 

19 being replaced (or the part of the CRT 

20 item that is being replaced) under subpara21 graph (A) is less than 3 years old (cal22 culated from the date on which the quali23 fied individual began to use the CRT item 

24 or part), the Secretary may require the 

25 qualified ordering practitioner to provide 


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1 confirmation of necessity of the replace2 ment item or replacement part, as the case 

3 may be. 

4 ‘‘(7) PAYMENT FOR TEMPORARY RENTAL.— 

5 ‘‘(A) IN GENERAL.—If a CRT item owned 

6 by a qualified individual needs to be repaired, 

7 payment may be made under this subsection for 

8 the temporary rental of a CRT item while the 

9 CRT item owned by such individual is being re10 paired. 

11 ‘‘(B) BASIS; LIMITATION.—Payment per12 mitted under subparagraph (A) shall be made 

13 on a monthly basis, and the period of rental 

14 may not exceed two months. 

15 ‘‘(C) PAYMENT AMOUNT.—The amount of 

16 payment allowed under subparagraph (A) for a 

17 month for the rental of a CRT item shall be 10 

18 percent of the purchase price for the CRT item. 

19 ‘‘(8) DEFINITIONS.—For purposes of this sub20 section: 

21 ‘‘(A) CRT ITEM.—The term ‘CRT item’ 

22 has the meaning given such term in section 

23 1861(iii). 

24 ‘‘(B) HCPCS.—The term ‘HCPCS’ refers 

25 to the Health Care Procedure Coding System. 


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1 ‘‘(C) QUALIFIED CRT PROFESSIONAL.— 

2 ‘‘(i) IN GENERAL.—The term ‘quali3 fied CRT professional’ means an individual 

4 who— 

5 ‘‘(I) is certified by the Rehabili6 tation Engineering and Assistive 

7 Technology Society of North America 

8 as an assistive technology professional 

9 or is certified by another organization 

10 designated by the Secretary (acting in 

11 consultation with relevant parties) as 

12 providing a certification that is equiv13 alent to, or more stringent than, the 

14 assistive technology professional cer15 tification; and 

16 ‘‘(II) beginning two years after 

17 the establishment of the designation 

18 under clause (ii), achieves an addi19 tional designation that demonstrates 

20 the individual’s competencies and ex21 perience in supplying CRT items. 

22 ‘‘(ii) ESTABLISHMENT.—Not later 

23 than one year after the date of enactment 

24 of the Ensuring Access to Quality Complex 

25 Rehabilitation Technology Act of 2012, the 


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1 Secretary, acting in consultation with rel2 evant parties, shall establish the additional 

3 designation under clause (i)(II). 

4 ‘‘(iii) RELEVANT PARTIES.—For pur5 poses of this subparagraph, the term ‘rel6 evant parties’ includes clinicians, consumer 

7 groups, CRT suppliers, and CRT manufac8 turers. 

9 ‘‘(D) QUALIFIED CRT SERVICE TECHNI10 CIAN.—The term ‘qualified CRT service techni11 cian’ means an individual who— 

12 ‘‘(i) is factory-trained by the manufac13 turers of the CRT items being offered by 

14 the suppler of such items; 

15 ‘‘(ii) is trained and educated (includ16 ing through on the job training) to assem17 ble, fit, program, service and repair CRT 

18 items; and 

19 ‘‘(iii) on an annual basis, completes at 

20 least ten hours of continuing education 

21 specific to the assembly, fitting, program22 ming, service and repair of CRT items. 

23 ‘‘(E) QUALIFIED INDIVIDUAL.—The term 

24 ‘qualified individual’ has the meaning given 

25 such term in section 1861(iii)(3)(E). 


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1 ‘‘(F) QUALIFIED ORDERING PRACTI2 TIONER.—The term ‘qualified ordering practi3 tioner’ means a physician (as defined in section 

4 1861(r)), a physician assistant, nurse practi5 tioner, or a clinical nurse specialist (as those 

6 terms are defined in section 1861(aa)(5)).’’. 

7 SEC. 5. CONFORMING AMENDMENTS. 

8 (a) EXCLUSION FROM THE IN-HOME USE LIMITA9 TION FOR DME.—Section 1861(n) is amended by adding 

10 at the end the following: ‘‘For 2013 and subsequent years, 

11 such term does not include complex rehabilitation tech12 nologies as defined in subsection (iii)’’. 

13 (b) EXEMPTION FROM COMPETITIVE ACQUISI14 TION.—Section 1847(a)(7) is amended by adding at the 

15 end the following new subparagraph: 

16 ‘‘(C) CRT ITEMS.—For 2013 and subse17 quent years, complex rehabilitation technology 

18 items as defined in section 1861(iii).’’. 

19 (c) EXEMPTION FROM SNF CONSOLIDATED BILL20 ING.—Section 1888(e)(2)(A)(iii) is amended by adding at 

21 the end the following: 

22 ‘‘(VI) Complex rehabilitation 

23 technology items as defined in section 

24 1861(iii) if delivered to an inpatient 

25 for use during the stay in the skilled 


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1 nursing facility as part of the plan of 

2 care to allow the transition of such 

3 qualified individuals from the skilled 

4 nursing facility setting to the home 

5 and community.’’. 

6 (d) PAYMENT EXCLUSIONS.—Section 1834(a) of the 

7 Social Security Act is amended— 

8 (1) in paragraph (4), by adding at the end the 

9 following sentence ‘‘For 2013 and subsequent years, 

10 the items covered by this paragraph shall not include 

11 complex rehabilitation technology items as defined in 

12 section 1861(iii).’’; 

13 (2) in paragraph (7)(A), by adding at the end 

14 the following: ‘‘For fiscal year 2013 and subsequent 

15 years, the previous sentence shall not apply to 

16 power-driven wheelchairs that are designated as 

17 CRT items under section 1861(iii).’’; and 

18 (3) in paragraph (16), by inserting at the end, 

19 after the third sentence, the following: ‘‘The Sec20 retary shall impose (and, may, as allowed by the sec21 ond sentence of this paragraph, waive) the require22 ments of the first sentence of this paragraph to sup23 pliers of complex rehabilitation technology items ex24 cept that, in order to avoid duplicate bonds, the Sec25 retary shall not impose such requirements with reVerDate Mar 15 2010 00:05 Apr 20, 2012 Jkt 019200 PO 00000 Frm 00033 Fmt 6652 Sfmt 6201 E:\BILLS\H4378.IH H4378

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1 spect to suppliers of complex rehabilitation tech2 nology items when such suppliers also participate in 

3 the Medicare program as suppliers of durable med4 ical equipment.’’. 

5 (e) REQUIREMENTS FOR SUPPLIERS OF MEDICAL

6 EQUIPMENT AND SUPPLIES.—Section 1834(j)(5) is 

7 amended— 

8 (1) by redesignating subparagraphs (E) and 

9 (F) as subparagraphs (F) and (G), respectively; 

10 (2) by inserting after subparagraph (D) the fol11 lowing new subparagraph: 

12 ‘‘(E) complex rehabilitation technology 

13 items (as defined in section 1861(iii));’’. 

14 SEC. 6. EFFECTIVE DATE. 

15 The amendments made by this Act shall apply to 

16 items and services furnished on or after January 1, 2013. 

Æ 


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