II 113th CONGRESS 1st Session S. 948 IN THE SENATE OF THE UNITED STATES May 14, 2013 Mr. Schumer (for himself and Mr. Cochran ) introduced the following bill; which was read twice and referred to the Committee on Finance 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. Short title This Act may be cited as the Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 . 2. 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 terms complex rehabilitation technology item and CRT item mean 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, 2013 , 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 each item that— (I) as of January 1, 2013, 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 item 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, E1029, 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 2014, 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 2015 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. (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) The term individually-configured means, with respect to an item, 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) . . 3. 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 the date that is one year after the date of the enactment of this subsection, 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 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) , the Secretary— (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; 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) 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) , 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 comply with such standards; and (ii) to have submitted to the Secretary evidence of accreditation by an accreditation organization designated under subparagraph (C) demonstrating that the supplier is complying 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) 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 amendments made by Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 , 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 reassign additional product categories, or items within those categories, that exist before the date of the enactment of this subsection to the CRT coding subset. (iii) Consultation Before making reassignments of CRT items under clause (ii) , the Secretary shall consult with suppliers and manufacturers of such items. The Secretary shall not require manufacturers of CRT items for which payment was available under this title before the effective date of the amendments made by the Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013 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) Inclusion of codes in list 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— (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) , 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 is 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) HCPCS The term HCPCS refers to the Health Care Procedure Coding System. (B) 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 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 includes clinicians, consumer groups, CRT suppliers, and CRT manufacturers. (C) 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 10 hours of continuing education specific to the assembly, fitting, programming, service, and repair of CRT items. (D) Qualified individual The term qualified individual has the meaning given such term in section 1861(iii)(3)(E). (E) 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)). . 4. 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) ) is amended by adding at the end the following: For 2014 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) ) is amended by adding at the end the following new subparagraph: (C) CRT items For 2014 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) ) 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 (42 U.S.C. 1395m(a)) is amended— (1) in paragraph (4), by adding at the end the following sentence For 2014 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 2014 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 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) ) is amended— (1) by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively; and (2) by inserting after subparagraph (D) the following new subparagraph: (E) complex rehabilitation technology items (as defined in section 1861(iii)); . 5. Effective date The amendments made by this Act shall apply to items and services furnished on or after January 1, 2014.