[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4378 Introduced in House (IH)]

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.

    Be it enacted by the Senate and House of Representatives 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:
            (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 experience physical, functional, and cognitive 
        challenges every day.
            (2) Complex rehabilitation technology items (CRT items), 
        including products such as complex rehabilitation 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 complex rehabilitation technology and 
        stifled innovation. Access challenges have increased over the 
        past several years and, without meaningful change to these 
        policies, will only become greater in the future.
            (4) Current Medicare policies often fail to adequately 
        address the needs of individuals with disabilities, to consider 
        the range of services furnished by 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 access 
        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 equipment (DME). CRT items serve patients with serious 
        medical conditions that require a broader range of services and 
        specialized personnel than what is required 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 incorporating an 
        interdisciplinary team approach is necessary 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 supplier), a qualified CRT professional, the individual 
        using such item, and sometimes a caregiver for such individual.
            (7) The Medicare program should recognize the specialized 
        nature of the CRT service delivery model, the required 
        supporting processes and technology-related 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 coding, 
        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 artificial 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 Security Act (42 
U.S.C. 1395x) is amended--
            (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 subsection:
    ``(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 purpose and is 
        generally not useful to a person in the absence of illness or 
        injury; and
            ``(C) requires certain services to ensure appropriate 
        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, 
                adjusting, or adapting the particular complex 
                rehabilitation technology item for use by such 
                individual.
    ``(2)(A) The Secretary, in consultation with the Director of Office 
on Disability, the Chairman of the National Council on Disability, the 
Executive Director on the Interagency Committee on Disability, the 
Director of the National Institute on Disability and Rehabilitation 
Research of the Department of Education, and the Co-Chairmen of the 
Senior Oversight Committee's Care Management 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 related to a 
        medical condition or conditions described 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 rehabilitation technology 
items under subparagraph (A)(i) shall include items that--
            ``(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 rehabilitation technology item.
    ``(ii) The HCPCS codes under this clause are the following: 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 vehicles;
            ``(ii) prosthetic devices described in subsection (s)(8); 
        or
            ``(iii) orthotics and prosthetics described in subsection 
        (s)(9).
    ``(E) In establishing the eligibility criteria under subparagraph 
(A)(ii), the Secretary shall include appropriate physical and 
functional needs and capacities arising from any of the following 
medical conditions:
            ``(i) Congenital disorders, progressive or degenerative 
        neuromuscular diseases, or injuries or trauma 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 syndrome, cerebellar degeneration, 
        dystonia, Huntington's disease, or spinocerebellar disease.
            ``(iii) Certain types of amputation, paralysis, or paresis 
        that result in significant physical or functional needs and 
        capacities.
    ``(F)(i) For calendar year 2013, the Secretary shall publish--
            ``(I) a list of items designated under subparagraph (A)(i) 
        and the HCPCS codes for such items; and
            ``(II) the eligibility criteria established under 
        subparagraph (A)(ii).
    ``(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 
eligibility 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 including--
                    ``(i) maintaining and changing body position;
                    ``(ii) transferring to or from one surface to 
                another;
                    ``(iii) walking;
                    ``(iv) moving from place to place using mobility 
                equipment, in a safe and timely manner;
                    ``(v) washing one's self;
                    ``(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 objects to 
                perform and participate in other activities under this 
                subparagraph and subparagraph (B).
            ``(B) The term `capacity for instrumental activities 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, employment and 
                economic life; and
                    ``(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 `individually-
        configured' means that--
                    ``(i) the item has a combination of features, 
                adjustments, or modifications that are specific to the 
                individual who uses such item; and
                    ``(ii) the supplier of such item must measure 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.
            ``(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 Ensuring Access to Quality 
                Complex Rehabilitation Technology Act of 2012, subject 
                to subparagraph (B), the Secretary shall determine a 
                payment system that shall apply to CRT items--
                            ``(i) with HCPCS codes that were assigned 
                        to the item under section 
                        1861(iii)(2)(C)(i)(II);
                            ``(ii) for which no HCPCS code was assigned 
                        prior to such data; or
                            ``(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 durable 
                        medical equipment that occurred before 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 individuals with 
                        access to such items and to encourage 
                        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 
                                customization of CRT items for a 
                                qualified individual.
                    ``(C) Exclusive payment rule.--This subsection 
                shall constitute the exclusive provision 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 payment shall be 
                made under this subsection for a CRT item unless such 
                CRT item--
                            ``(i) is provided to a qualified 
                        individual;
                            ``(ii) meets the clinical conditions for 
                        coverage established under paragraph (2); and
                            ``(iii) is furnished by a supplier 
                        accredited 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 established 
                under subparagraph (A) shall require the following:
                            ``(i) Written order.--
                                    ``(I) In general.--A qualified 
                                ordering practitioner shall provide a 
                                written order for a CRT item for a 
                                qualified individual before the 
                                Secretary may provide payment for such 
                                item for such individual under this 
                                subsection.
                                    ``(II) CRT evaluation.--In the case 
                                of a CRT item that is categorized by 
                                the Secretary, for purposes 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 diagnosis 
                                specified under subparagraph (C), the 
                                qualified ordering practitioner may not 
                                provide a written order under subclause 
                                (I) unless the qualified individual has 
                                undergone a CRT evaluation 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 practitioner 
                        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 medical necessity under this 
                        clause shall include--
                                    ``(I) evidence that the individual 
                                for whom the order was written has 
                                physical and functional needs and 
                                capacities related to a medical 
                                condition that meet the eligibility 
                                criteria established under section 
                                1861(iii)(2)(A)(ii); and
                                    ``(II) evidence of any CRT 
                                evaluation required under clause 
                                (i)(II).
                    ``(C) Specification of diagnosis for crt 
                evaluation.--The Secretary, in consultation with 
                relevant parties (including the agencies listed in 
                section 1861(iii)(2)(A), physicians, licensed physical 
                therapists, licensed occupational therapists, and 
                suppliers of complex rehabilitation technologies) shall 
                specify the diagnoses and other medical presentations 
                for which 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 
                        environments (as such terms are defined in 
                        section 1861(iii)(3)); and
                            ``(iii) the individual's expected 
                        progression 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.
            ``(3) Establishment of quality standards.--
                    ``(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 
                Services.
                    ``(B) Consultation.--In establishing the quality 
                standards under subparagraph (A), the Secretary shall 
                consult with relevant parties (including clinicians, 
                consumer groups, suppliers, and manufacturers).
                    ``(C) Requirements of standards.--In establishing 
                the quality standards under subparagraph (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 subsection (a)(20) and 
                        suppliers of medical equipment and supplies 
                        under subsection (j).
                            ``(ii) Qualified crt professional.--The 
                        supplier of a CRT item makes available, in each 
                        service area served by such supplier, at least 
                        one qualified CRT professional to--
                                    ``(I) analyze the needs and 
                                capacities of individuals for a CRT 
                                item in collaboration with the clinical 
                                team;
                                    ``(II) assist in selecting an 
                                appropriate 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 supplier of 
                        the CRT item provides the qualified individual 
                        with appropriate equipment for trial and 
                        simulation, if a physician, licensed physical 
                        therapist, or licensed occupational therapist 
                        determines that the provision of such equipment 
                        is necessary.
                            ``(iv) Information on repair.--The supplier 
                        of the CRT item provides the qualified 
                        individual with written information 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.
                            ``(vi) Rental equipment.--If payment is 
                        allowed under paragraph (6), the supplier of 
                        the CRT item provides temporary 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 accreditation 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 requirement.--In 
                implementing quality standards under paragraph (3), the 
                Secretary shall require suppliers furnishing CRT items 
                on or after one year after the standards are published 
                under such paragraph, directly or as a subcontractor 
                for another entity--
                            ``(i) to be compliant with these standards; 
                        and
                            ``(ii) have submitted to the Secretary 
                        evidence of accreditation by an accreditation 
                        organization designated under subparagraph (C) 
                        demonstrating that the supplier is compliant 
                        with such standards.
                    ``(C) Designation of independent accreditation 
                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 
                independent accreditation organizations that--
                            ``(i) are approved under subsection 
                        (a)(20)(B); and
                            ``(ii) that the Secretary has determined 
                        have the capability to assess whether suppliers 
                        of CRT items meet the quality standards 
                        established under paragraph (3).
            ``(5) Coding system for complex rehabilitation 
        technologies.--
                    ``(A) In general.--The Secretary shall, in 
                consultation with suppliers and manufacturers of CRT 
                items, and utilizing existing coding systems, establish 
                a HCPCS coding subset that shall utilize and include, 
                HCPCS codes described in section 1861(iii)(2) for CRT 
                items for which payment may made under this subsection.
                    ``(B) Treatment of existing products.--
                            ``(i) In general.--With respect to CRT 
                        items for which payment was available 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 
                        assignment under clause (i), the Secretary may 
                        decide to re-assign additional product 
                        categories, or items within those categories, 
                        that exist prior to the date of enactment of 
                        the Ensuring Access to Quality Complex 
                        Rehabilitation Technology Act of 2012 to the 
                        CRT coding subset.
                            ``(iii) Consultation.--Before making 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 effective 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 requirements.
                    ``(C) Removing complex rehabilitation technology 
                from dme codes.--The Secretary shall, in consultation 
                with suppliers and manufacturers of CRT items--
                            ``(i) remove from the coding subset for 
                        durable medical equipment any CRT items that 
                        are included in the coding subset under 
                        subparagraph (A); and
                            ``(ii) assign new codes to such CRT items 
                        for purposes of including such items in the 
                        subset under subparagraph (A).
                    ``(D) New technology.--
                            ``(i) In general.--The Secretary shall 
                        update as needed the HCPCS level II process 
                        used to modify the code set to include CRT 
                        items for the purposes of establishing new 
                        codes and determining products to be classified 
                        as CRT items. In determining if a product is a 
                        CRT item, the Secretary shall consider--
                                    ``(I) if the product is novel;
                                    ``(II) the clinical application of 
                                the product; and
                                    ``(III) the ability of the product 
                                to address the unique needs and 
                                capacities of a qualified individual.
                            ``(ii) The Secretary shall include the 
                        codes established in clause (i) in the list 
                        under section 1861(iii)(2)(F).
                    ``(E) Miscellaneous code for innovation and local 
                coverage determinations.--The coding subset established 
                under subparagraph (A) shall include at least one 
                miscellaneous code for items not otherwise classified.
            ``(6) Replacement of crt items.--
                    ``(A) In general.--Payment shall be made for the 
                replacement of a CRT item (or for the replacement of 
                any part of such item), without regard to continuous 
                use or useful lifetime restrictions established under 
                section 1834(a)(7)(C) for items of durable medical 
                equipment if a qualified ordering practitioner 
                determines that the provision of a replacement item (or 
                a replacement part of such an item) is necessary 
                because of any of the following--
                            ``(i) a change in the physiological 
                        condition of the qualified individual to whom 
                        such item was provided;
                            ``(ii) an irreparable change in the 
                        condition of the CRT item (or, in the case of 
                        the replacement of a part, in the part of the 
                        CRT item); or
                            ``(iii) the CRT item requires repairs and 
                        the cost of such repairs would be more than 50 
                        percent of the cost of a replacement of the CRT 
                        item.
                    ``(B) Deferral to providers.--
                            ``(i) In general.--Subject to clause (ii), 
                        if a qualified ordering practitioner determines 
                        that a replacement of the CRT item, or the 
                        replacement of a part of a CRT item, is 
                        necessary pursuant to subparagraph (A), the 
                        replacement item or part be deemed to be 
                        reasonable and necessary for purposes of 
                        section 1862(a)(1)(A).
                            ``(ii) Exception for items under 3 years 
                        old.--If the CRT item that is being replaced 
                        (or the part of the CRT item that is being 
                        replaced) under subparagraph (A) is less than 3 
                        years old (calculated from the date on which 
                        the qualified individual began to use the CRT 
                        item or part), the Secretary may require the 
                        qualified ordering practitioner to provide 
                        confirmation of necessity of the replacement 
                        item or replacement part, as the case may be.
            ``(7) Payment for temporary rental.--
                    ``(A) In general.--If a CRT item owned by a 
                qualified individual needs to be repaired, payment may 
                be made under this subsection for the temporary rental 
                of a CRT item while the CRT item owned by such 
                individual is being repaired.
                    ``(B) Basis; limitation.--Payment permitted under 
                subparagraph (A) shall be made on a monthly basis, and 
                the period of rental may not exceed two months.
                    ``(C) Payment amount.--The amount of payment 
                allowed under subparagraph (A) for a month for the 
                rental of a CRT item shall be 10 percent of the 
                purchase price for the CRT item.
            ``(8) Definitions.--For purposes of this subsection:
                    ``(A) CRT item.--The term `CRT item' has the 
                meaning given such term in section 1861(iii).
                    ``(B) HCPCS.--The term `HCPCS' refers to the Health 
                Care Procedure Coding System.
                    ``(C) Qualified crt professional.--
                            ``(i) In general.--The term `qualified CRT 
                        professional' means an individual who--
                                    ``(I) is certified by the 
                                Rehabilitation Engineering and 
                                Assistive Technology Society of North 
                                America as an assistive technology 
                                professional or is certified by another 
                                organization designated by the 
                                Secretary (acting in consultation with 
                                relevant parties) as providing a 
                                certification that is equivalent to, or 
                                more stringent than, the assistive 
                                technology professional certification; 
                                and
                                    ``(II) beginning two years after 
                                the establishment of the designation 
                                under clause (ii), achieves an 
                                additional designation that 
                                demonstrates the individual's 
                                competencies and experience in 
                                supplying CRT items.
                            ``(ii) Establishment.--Not later than one 
                        year after the date of enactment of the 
                        Ensuring Access to Quality Complex 
                        Rehabilitation Technology Act of 2012, the 
                        Secretary, acting in consultation with relevant 
                        parties, shall establish the additional 
                        designation under clause (i)(II).
                            ``(iii) Relevant parties.--For purposes of 
                        this subparagraph, the term `relevant parties' 
                        includes clinicians, consumer groups, CRT 
                        suppliers, and CRT manufacturers.
                    ``(D) Qualified crt service technician.--The term 
                `qualified CRT service technician' means an individual 
                who--
                            ``(i) is factory-trained by the 
                        manufacturers of the CRT items being offered by 
                        the suppler of such items;
                            ``(ii) is trained and educated (including 
                        through on the job training) to assemble, fit, 
                        program, service and repair CRT items; and
                            ``(iii) on an annual basis, completes at 
                        least ten hours of continuing education 
                        specific to the assembly, fitting, programming, 
                        service and repair of CRT items.
                    ``(E) Qualified individual.--The term `qualified 
                individual' has the meaning given such term in section 
                1861(iii)(3)(E).
                    ``(F) Qualified ordering practitioner.--The term 
                `qualified ordering practitioner' means a physician (as 
                defined in section 1861(r)), a physician assistant, 
                nurse practitioner, or a clinical nurse specialist (as 
                those terms are defined in section 1861(aa)(5)).''.

SEC. 5. CONFORMING AMENDMENTS.

    (a) Exclusion From the In-Home Use Limitation for DME.--Section 
1861(n) is amended by adding at the end the following: ``For 2013 and 
subsequent years, such term does not include complex rehabilitation 
technologies as defined in subsection (iii)''.
    (b) Exemption From Competitive Acquisition.--Section 1847(a)(7) is 
amended by adding at the end the following new subparagraph:
                    ``(C)  CRT items.--For 2013 and subsequent years, 
                complex rehabilitation technology items as defined in 
                section 1861(iii).''.
    (c) Exemption From SNF Consolidated Billing.--Section 
1888(e)(2)(A)(iii) is amended by adding at the end the following:
                                    ``(VI) Complex rehabilitation 
                                technology items as defined in section 
                                1861(iii) if delivered to an inpatient 
                                for use during the stay in the skilled 
                                nursing facility as part of the plan of 
                                care to allow the transition of such 
                                qualified individuals from the skilled 
                                nursing facility setting to the home 
                                and community.''.
    (d) Payment Exclusions.--Section 1834(a) of the Social Security Act 
is amended--
            (1) in paragraph (4), by adding at the end the following 
        sentence ``For 2013 and subsequent years, the items covered by 
        this paragraph shall not include complex rehabilitation 
        technology items as defined in section 1861(iii).'';
            (2) in paragraph (7)(A), by adding at the end the 
        following: ``For fiscal year 2013 and subsequent years, the 
        previous sentence shall not apply to power-driven wheelchairs 
        that are designated as CRT items under section 1861(iii).''; 
        and
            (3) in paragraph (16), by inserting at the end, after the 
        third sentence, the following: ``The Secretary shall impose 
        (and, may, as allowed by the second sentence of this paragraph, 
        waive) the requirements of the first sentence of this paragraph 
        to suppliers of complex rehabilitation technology items except 
        that, in order to avoid duplicate bonds, the Secretary shall 
        not impose such requirements with respect to suppliers of 
        complex rehabilitation technology items when such suppliers 
        also participate in the Medicare program as suppliers of 
        durable medical equipment.''.
    (e) Requirements for Suppliers of Medical Equipment and Supplies.--
Section 1834(j)(5) is amended--
            (1) by redesignating subparagraphs (E) and (F) as 
        subparagraphs (F) and (G), respectively;
            (2) by inserting after subparagraph (D) the following new 
        subparagraph:
                    ``(E) complex rehabilitation technology items (as 
                defined in section 1861(iii));''.

SEC. 6. EFFECTIVE DATE.

    The amendments made by this Act shall apply to items and services 
furnished on or after January 1, 2013.
                                 <all>