H. R. 4378
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
To amend title XVIII of the Social Security Act to provide for coverage and payment for complex rehabilitation technology items under the Medicare program.
This Act may be cited as the
Ensuring Access to Quality Complex
Rehabilitation Technology Act of 2012.
Congress finds the following:
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.
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.
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.
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.
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.
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.
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.
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.
Establishing separate benefit category for complex rehabilitation technologies within Medicare
Section 1861 of the Social Security Act (42 U.S.C. 1395x) is amended—
in subsection (s)(2)—
(EE), by striking
and at the end;
(FF), by inserting
and at the end; and
by inserting after subparagraph (FF) the following new paragraph:
complex rehabilitation technology items (as defined in subsection (iii));
by adding at the end the following new subsection:
Complex rehabilitation technology item
The term complex rehabilitation technology item or CRT item means an item that—
is designed and configured for a specific qualified individual to meet the individual’s unique—
medical, physical, and functional needs related to a medical condition; and
capacities for basic activities of daily living and instrumental activities of daily living;
is primarily used to serve a medical purpose and is generally not useful to a person in the absence of illness or injury; and
requires certain services to ensure appropriate design, configuration, and use of such item, including—
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
configuring, fitting, programming, adjusting, or adapting the particular complex rehabilitation technology item for use by such individual.
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—
designate items as complex rehabilitation technology items; and
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).
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.
The items designated as complex rehabilitation technology items under subparagraph (A)(i) shall include items that—
as of January 1, 2012, were classified within the HCPCS codes under clause (ii); and
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.
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.
The Secretary may not designate as a complex rehabilitation technology item—
adaptive equipment to operate motor vehicles;
prosthetic devices described in subsection (s)(8); or
orthotics and prosthetics described in subsection (s)(9).
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:
Congenital disorders, progressive or degenerative neuromuscular diseases, or injuries or trauma that result in significant physical or functional needs and capacities.
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.
Certain types of amputation, paralysis, or paresis that result in significant physical or functional needs and capacities.
For calendar year 2013, the Secretary shall publish—
a list of items designated under subparagraph (A)(i) and the HCPCS codes for such items; and
the eligibility criteria established under subparagraph (A)(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.
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—
designate an item as a CRT item under subparagraph (A)(i); or
amend the eligibility criteria established under subparagraph (A)(ii).
For purposes of this subsection:
The term capacity for basic activities of daily living means an individual’s capacity to safely participate in mobility and self-care activities including—
maintaining and changing body position;
transferring to or from one surface to another;
moving from place to place using mobility equipment, in a safe and timely manner;
washing one’s self;
caring for the body;
looking after one’s health; and
carrying, moving, and handling objects to perform and participate in other activities under this subparagraph and subparagraph (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—
moving around using transportation;
acquiring necessities, goods, and services;
performing household tasks;
caring for household members and family members;
caring for household objects;
engaging in education, work, employment and economic life; and
participating in community, social, and civic activities.
The term HCPCS refers to the Health Care Procedure Coding System.
With respect to an item, the term individually-configured means that—
the item has a combination of features, adjustments, or modifications that are specific to the individual who uses such item; and
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—
an assessment or evaluation of the individual by an appropriate licensed clinician;
the written order required under section 1834(p)(2)(B)(i); and
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.
The term qualified individual means an individual who—
is enrolled under Part B; and
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).
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is amended by adding at the end the following:
Coverage and payment for CRT items
General rule for payment
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—
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 data; 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 enactment of the Ensuring Access to Quality Complex Rehabilitation Technology Act of 2012 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.
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.
Limitation on payment
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).
Clinical conditions for coverage
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.
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—
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).
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.
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.
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.
Establishment of quality standards
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).
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:
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).
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—
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.
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.
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.
Application of standards and accreditation program for suppliers of CRT items
Impact of standards
A supplier of CRT items may not—
furnish any such item for which payment is made under this part; or
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,
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—
to be compliant with these standards; and
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.
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—
are approved under subsection (a)(20)(B); and
that the Secretary has determined have the capability to assess whether suppliers of CRT items meet the quality standards established under paragraph (3).
Coding system for complex rehabilitation technologies
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.Make sure it is clear that payment under this subsection is only for new codes? Or do you cover all three?
Treatment of existing products
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).
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.
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—
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.
Removing complex rehabilitation technology from DME codes
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).
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.
Replacement of CRT items
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—
a change in the physiological condition of the qualified individual to whom such item was provided;
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.
Deferral to providers
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).
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.
Payment for temporary rental
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 CRT item has the meaning given such term in section 1861(iii).
The term HCPCS refers to the Health Care Procedure Coding System.
Qualified CRT professional
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 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).
For purposes of this subparagraph, the term relevant parties includes clinicians, consumer groups, CRT suppliers, and CRT manufacturers.
Qualified CRT service technician
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 ten 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).
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)).
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
Exemption from competitive acquisition
Section 1847(a)(7) is amended by adding at the end the following new subparagraph:
For 2013 and subsequent years, complex rehabilitation technology items as defined in section 1861(iii).
Exemption from SNF consolidated billing
Section 1888(e)(2)(A)(iii) is amended by adding at the end the following:
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.
Section 1834(a) of the Social Security Act is amended—
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
(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).;
in paragraph (16),
by inserting at the end, after the third sentence, the following:
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
Requirements for suppliers of medical equipment and supplies
Section 1834(j)(5) is amended—
by redesignating subparagraphs (E) and (F) as subparagraphs (F) and (G), respectively;
by inserting after subparagraph (D) the following new subparagraph:
complex rehabilitation technology items (as defined in section 1861(iii));
The amendments made by this Act shall apply to items and services furnished on or after January 1, 2013.