Sec. 4. Payment rules
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Section 1834 of the Social Security Act ( 42 U.S.C. 1395m ) is amended by adding at the end the following: 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— with HCPCS codes that were assigned to the item under section 1861(iii)(2)(C)(i)(II); for which no HCPCS code was assigned prior to such date; or which, prior to such date, was classified under a miscellaneous HCPCS code. In determining the payment system under subparagraph
(A), the Secretary— 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 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— the unique needs of qualified individuals for access to CRT items; the unique complexity of CRT items; and the resources and staff needed to provide appropriate customization of CRT items for a qualified individual. 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. No payment shall be made under this subsection for a CRT item unless such CRT item— is provided to a qualified individual; meets the clinical conditions for coverage established under paragraph
(2); and is furnished by a supplier accredited pursuant to paragraph
(3). The Secretary shall establish standards for clinical conditions for payment for CRT items under this subsection. The standards established under subparagraph
(A)shall require the following: 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. 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. 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— 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 evidence of any CRT evaluation required under clause (i)(II) . 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. In developing the standards under subparagraph
(A), the coverage of CRT items with respect to an individual shall be based on— the specific medical, physical, and functional needs of the individual; 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 the individual’s expected progression of such needs and capacities. 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. 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. In establishing the quality standards under subparagraph
(A), the Secretary shall consult with relevant parties (including clinicians, consumer groups, suppliers, and manufacturers). In establishing the quality standards under subparagraph
(A), the Secretary shall require that the suppliers of CRT items meet the following requirements: 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). The supplier of a CRT item makes available, in each service area served by such supplier, at least one qualified CRT professional to— analyze the needs and capacities of individuals for a CRT item in collaboration with the clinical team; assist in selecting an appropriate CRT item for such individual, given such needs and capacities; and provide technology-related training to such individual in the proper use and maintenance of the CRT items. 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. 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. The supplier of a CRT item— makes available, in each service area served by such supplier, at least one qualified CRT service technician to service and repair CRT items that— are furnished by such supplier; and at the time of the need for repair, are located in a service area of the supplier; or 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. 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. 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). 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). 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— to comply with such standards; and 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. 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— are approved under subsection (a)(20)(B); and the Secretary has determined have the capability to assess whether suppliers of CRT items meet the quality standards established under paragraph
(3). 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. 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). 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. 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— no changes have been made to the code definitions, required code characteristics or test requirements; and the item was previously verified to meet the code requirements. The Secretary shall, in consultation with suppliers and manufacturers of CRT items— remove from the coding subset for durable medical equipment any CRT items that are included in the coding subset under subparagraph
(A); and assign new codes to such CRT items for purposes of including such items in the subset under subparagraph
(A). 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— if the product is novel; the clinical application of the product; and the ability of the product to address the unique needs and capacities of a qualified individual. The Secretary shall include the codes established in clause
(i)in the list under section 1861(iii)(2)(F). The coding subset established under subparagraph
(A)shall include at least one miscellaneous code for items not otherwise classified. 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— there was a change in the physiological condition of the qualified individual to whom such item was provided; 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 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. 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). 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. 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. Payment permitted under subparagraph
(A)shall be made on a monthly basis, and the period of rental may not exceed two months. 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. For purposes of this subsection: The term HCPCS refers to the Health Care Procedure Coding System. The term qualified CRT professional means an individual who— 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 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. 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). For purposes of this subparagraph, the term relevant parties includes clinicians, consumer groups, CRT suppliers, and CRT manufacturers. The term qualified CRT service technician means an individual who— is factory-trained by the manufacturers of the CRT items being offered by the suppler of such items; is trained and educated (including through on the job training) to assemble, fit, program, service, and repair CRT items; and on an annual basis, completes at least 10 hours of continuing education specific to the assembly, fitting, programming, service, and repair of CRT items. The term qualified individual has the meaning given such term in section 1861(iii)(3)(E). 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)). .
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