113 S948 IS: Ensuring Access to Quality Complex Rehabilitation Technology Act of 2013
U.S. Senate
2013-05-14
text/xml
EN
Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.
1.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)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.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)
(A)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)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)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)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)The Secretary shall
establish standards for clinical conditions for payment for CRT items under
this subsection.
(B)The
standards established under
subparagraph (A) shall require the
following:
(i)
(I)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)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 necessityA
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 evaluationThe 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)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 facilitiesIn 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)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)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
standardsIn establishing the
quality standards under
subparagraph (A), the Secretary shall
require that the suppliers of CRT items meet the following requirements:
(i)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
professionalThe 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)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)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)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)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)
(i)Requirement for
provider or supplier numberThe 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)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 requirementIn 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 organizationsNot 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)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)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)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)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 codesThe 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)
(i)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 listThe 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 determinationsThe coding
subset established under
subparagraph (A) shall include at least
one miscellaneous code for items not otherwise classified.
(6)
(A)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)
(i)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 oldIf
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)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)Payment permitted under
subparagraph (A) shall be made on a
monthly basis, and the period of rental may not exceed two months.
(C)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)For
purposes of this subsection:
(A)The
term HCPCS refers to the Health Care Procedure Coding
System.
(B)Qualified CRT
professional
(i)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)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)For purposes of this
subparagraph, the term relevant parties includes clinicians,
consumer groups, CRT suppliers, and CRT manufacturers.
(C)Qualified CRT
service technicianThe 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)The term qualified individual has the
meaning given such term in section 1861(iii)(3)(E).
(E)Qualified
ordering practitionerThe 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.
(a)Exclusion from
the in-Home use limitation for DMESection 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 acquisitionSection 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)For 2014 and subsequent
years, complex rehabilitation technology items (as defined in section
1861(iii)).
.
(c)Exemption from
SNF consolidated billingSection 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)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 suppliesSection 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.The amendments made by
this Act shall apply to items and services furnished on or after January 1,
2014.