Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015

To amend title XVIII of the Social Security Act to provide for coverage and payment for complex rehabilitation technology items under the Medicare program, and for other purposes. 1. Short title This Act may be cited as the Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 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 (in this Act referred to as CRT items (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. Individually configured CRT items also require more resources in the areas of 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 individual configuration 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 have previously recognized the benefits of a separate classification for unique, individually configured 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. 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 (1) in subsection (s)(2)— (A) in subparagraph (EE), by striking and (B) in subparagraph (FF), by inserting 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 terms complex rehabilitation technology item CRT item (A) is designed or individually configured for a specific qualified individual to meet the individual’s unique— (i) medical, physical, or functional needs related to a medical condition; and (ii) capacities for basic activities of daily living or instrumental activities of daily living; (B) is primarily used to serve a medical or functional 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) (C) (i) The items designated as complex rehabilitation technology items under subparagraph (A)(i) (I) as of January 1, 2015, was classified within the HCPCS codes under clause (ii); and (II) the Secretary, acting in consultation with suppliers and manufacturers of CRT items, determines which items 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, 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) The Secretary shall publish guidelines and implement a process to facilitate the submission of comprehensive coding proposals addressing CRT items to be submitted to the CMS HCPCS Work Group and included in the HCPCS Work Group public meetings. (F) In establishing the eligibility criteria under subparagraph (A)(ii) (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. (G) (i) For 2016, the Secretary shall publish— (I) a list of items designated under subparagraph (A)(i) (II) the eligibility criteria established under subparagraph (A)(ii) (ii) For 2017 and each subsequent year, 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. (H) 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) (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 (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 (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 (D) The term individually-configured (i) the item has features, adjustments, or modifications specific to the individual who uses such item or the item is used in combination with other CRT items specific to the individual's needs; 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(r)(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 (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) . 4. Payment rules Section 1834 of the Social Security Act ( 42 U.S.C. 1395m (r) Coverage and payment for CRT items (1) General rule for payment (A) In general Not later than the date that is one year after the date of the enactment of this subsection, subject to subparagraph (B) (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 date; or (iii) which, prior to such date, was classified under a miscellaneous HCPCS code. (B) Considerations In determining the payment system under subparagraph (A) (i) may disregard the freezes on CPI increases to the payment amounts for durable medical equipment that occurred before the date of the enactment of this subsection, when determining the payment amount for CRT items; (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 individual configuration of CRT items for a qualified individual; and (iii) shall provide that CRT codes will be paid on a purchase basis with a beneficiary rental basis option. (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) (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) (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) subclause (I) (ii) Documentation of medical necessity A qualified ordering practitioner who provides a written order under clause (i) (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) (D) Coverage determinations In developing the standards under subparagraph (A) (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) Contractor individualized consideration The Secretary shall instruct Medicare contractors to provide individual consideration in cases that may lack one of the diagnoses identified, but that exhibit comparable functional presentations or deficits or (or both) and where the need for CRT items has been documented by the qualified clinical professional. (F) 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) (C) Requirements of standards In establishing the quality standards under subparagraph (A) (i) DME standards 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 service and repair The supplier of the CRT item provides the qualified individual with written information on accessing service and repair for the CRT item before the CRT item is ordered for the 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) if the qualified individual lives outside the service area served by such supplier at the time of order of the CRT item, the supplier shall disclose in writing to the qualified individual that the supplier does not provide repair service for such item and provide 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) In general (i) Requirement for provider or supplier number The Secretary shall not provide a supplier of CRT items with a provider or supplier number to submit claims for payment under this title unless the supplier is in compliance with the standards under paragraph (3). (ii) Requirement for payment Payment shall not be made under this part for CRT items furnished by a supplier unless the supplier is in compliance with the standards under paragraph (3). (B) Application of accreditation requirement In implementing quality standards under paragraph (3) (i) to comply with such standards; and (ii) to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under subparagraph (C) (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) (i) are approved under subsection (a)(20)(B); and (ii) 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, establish a formal process to allow submission of CRT code set modification requests by stakeholder groups for comprehensive coding changes related to entire policy groups. This process shall include a specific application, public meeting participation and an appeals process. The Secretary shall then, in consultation with suppliers and manufacturers of CRT items, 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 be 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 amendments made by Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 subparagraph (A) (ii) Updates After the initial assignment under clause (i) (iii) Consultation Before making reassignments of CRT items under clause (ii) Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 subparagraph (A) (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) (ii) assign new codes to such CRT items based on technological differences to support adequate access to meet clinical outcomes and 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) Inclusion of codes in list The Secretary shall include the codes established in clause (i) (E) Miscellaneous code for innovation and local coverage determinations The coding subset established under subparagraph (A) (F) Establishment of adequate HCPCS codes to reflect specialized nature of CRT The Secretary shall ensure that HCPCS codes exist (or are developed) to represent the specialized nature of CRT, including codes to represent custom CRT manual and power wheelchairs and modifications to CRT manual and power wheelchair frames, and miscellaneous codes for CRT manual and power wheelchairs that are 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— (i) there was a change in the physiological condition of the qualified individual to whom such item was provided; (ii) there was 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) (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) (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) (C) Payment amount The amount of payment allowed under subparagraph (A) (8) Definitions For purposes of this subsection: (A) HCPCS The term HCPCS (B) Qualified CRT professional (i) In general The term qualified CRT professional (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) (ii) Establishment Not later than one year after the date of the enactment of this subsection, 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 (C) Qualified CRT service technician The term qualified CRT service technician (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 10 hours of continuing education specific to the assembly, fitting, programming, service, and repair of CRT items. (D) Qualified individual The term qualified individual (E) Qualified ordering practitioner The term qualified ordering practitioner (F) Qualified licensed clinician The term qualified licensed clinician . 5. Conforming amendments (a) Exclusion from the in-Home use limitation for DME Section 1861(n) of the Social Security Act ( 42 U.S.C. 1395x(n) For 2016 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) of the Social Security Act ( 42 U.S.C. 1395w–3(a)(7) (C) CRT items For 2016 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) of the Social Security Act ( 42 U.S.C. 1395yy(e)(2)(A)(iii) (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 ( 42 U.S.C. 1395m(a) (1) in paragraph (4), by adding at the end the following sentence For 2016 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 2016 and subsequent years, the previous sentence shall not apply to power-driven wheelchairs that are designated as CRT items under section 1861(iii). (3) in paragraph (16), by inserting at the end 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 if 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) of the Social Security Act ( 42 U.S.C. 1395m(j)(5) (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)); . 6. Effective date The amendments made by this Act shall apply to items and services furnished on or after January 1, 2016.

Summary: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2015 Amends title XVIII (Medicare) of the Social Security Act to cover, as medical and other health services, complex rehabilitation technology (CRT) items designed or individually configured for a specific qualified individual to meet that individual's unique: (1) medical, physical, or functional needs related to a medical condition; and (2) capacities for basic activities of daily living (ADLs) or instrumental ADLs. Directs the Secretary of Health and Human Services to: (1) designate CRT items (excluding adaptive equipment to operate motor vehicles or certain prosthetic devices and orthotics); and (2) establish eligibility criteria for them. Prescribes requirements for payments for CRT items. Directs the Secretary to establish standards for clinical conditions for CRT item payment as well as quality standards for suppliers of such items. Directs the Secretary to establish a formal process to allow submission of CRT code set modification requests by stakeholder groups for comprehensive coding changes related to entire policy groups. Requires payment for replacement of a CRT item (or any part of one), without regard to certain continuous use or useful lifetime restrictions established for items of durable medical equipment, if a qualified ordering practitioner determines that a replacement item (or part) is necessary.