[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Proposed Rules]
[Pages 48018-48030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22358]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AP46
Prosthetic and Rehabilitative Items and Services
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to revise its
medical regulations related to providing prosthetic and rehabilitative
items as medical services to veterans. These revisions would reorganize
and update the current regulations related to prosthetic and
rehabilitative items, primarily to clarify eligibility for prosthetic
and other rehabilitative items and services, and to define the types of
items and services available to eligible veterans.
DATES: Comments must be received by VA on or before December 15, 2017.
ADDRESSES: Written comments may be submitted by email through http://www.regulations.gov; by mail or hand delivery to Director, Regulations
Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue
NW., Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026.
Comments should indicate that they are submitted in response to ``RIN
2900-AP46, Prosthetic and rehabilitative items and services.'' Copies
of comments received will be available for public inspection in the
Office of Regulation Policy and Management, Room 1063B, between the
hours of 8:00 a.m. and 4:30 p.m. Monday through Friday (except
holidays). Please call (202) 461-4902 for an appointment. (This is not
a toll-free number.) In addition, during the comment period, comments
may be viewed online through the Federal Docket Management System
(FDMS) at http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Penny Nechanicky, National Program
Director for Prosthetic and Sensory Aids Service (10P4RK), Department
of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420;
(202) 461-0337. (This is not a toll-free number.)
[email protected].
SUPPLEMENTARY INFORMATION: Section 1710 of title 38, United States Code
(U.S.C.), authorizes VA to provide veterans with, among other things,
``medical services'' when VA determines that they are ``needed.''
``Medical services'' is further defined in 38 U.S.C. 1701(6)(F) to
include the following items and services, for veterans who are
otherwise receiving care or services under chapter 17 of title 38
U.S.C.: Wheelchairs, artificial limbs, trusses, and similar appliances;
special clothing made necessary by the wearing of prosthetic
appliances; and such other supplies or services as the Secretary
determines to be reasonable and necessary. 38 U.S.C. 1701(6)(F)(i)-
(iii). The language in clauses (i) through (iii) of section 1701(6)(F)
is the source of
[[Page 48019]]
VA's authority to provide prosthetic and rehabilitative items and
related services to veterans as necessary items and services (i.e.,
``medical services''). Historically, we have interpreted section
1701(6)(F)(iii) to authorize VA to provide other supplies and services
only to the extent that they are similar or related to the expressly
listed items in sections 1701(6)(F)(i) and (ii), i.e., wheelchairs,
artificial limbs, trusses or similar appliances, and special clothing
made necessary by the wearing of prosthetic appliances. We base this
interpretation on tenets of statutory construction and opinions of VA's
Office of General Counsel. See 2A Norman J. Singer, Statutes and
Statutory Construction Sec. 47.17 (6th ed. 2000) (explaining that as a
matter of statutory interpretation, where general words follow specific
words, ``the general words are construed to embrace only objects
similar in nature to those objects enumerated by the preceding specific
words''). See also VAOPGCADV 7-2009, VAOPGCADV 9-2005, VAOPGCCONCL-8-
98.
VA has considered those items expressly listed in section
1701(6)(F)(i) and (ii) as medically necessary because such items assist
a veteran in compensating for the loss of mobility or loss of other
functional abilities. Thus for a supply (i.e., hereafter referred to as
an item) or service to be similar in nature to what is enumerated in
section 1701(6)(F)(i) and (ii), it must assist a veteran to compensate
for loss of mobility or loss of other functional abilities. For such
items and services to be provided pursuant to section 1701(6)(F)(iii),
the Secretary must first determine that the item or service could
assist veterans to compensate for loss of mobility or loss of other
functional abilities. Next, under that provision, the Secretary must
determine that they are ``reasonable and necessary.'' Once the
Secretary makes these two determinations regarding an item or service
under 1701(6)(F)(iii), VA may include them in the medical benefits
package and provide them to individual eligible veterans as medical
services if they are determined to be ``needed'' as required by section
1710(a) as implemented by 38 CFR 17.38(b).
VA's authority as described above to provide medically needed
prosthetic and similar items to all veterans who are otherwise
receiving care or services under chapter 17 of title 38 U.S.C. was
established by section 103(a) of Public Law 104-262, The Veterans'
Health Care Eligibility Reform Act of 1996, which amended the
definition of medical services in 38 U.S.C. 1701(6). Prior to the
enactment of Public Law 104-262, VA was effectively prohibited from
providing prosthetic and similar items to most nonservice-connected
veterans except in preparation for a hospital admission or to obviate
the need for hospital admission. Section 103(b) of Public Law 104-262
further directed VA to prescribe guidelines for the expanded
prosthetics eligibility in section 103(a). These guidelines were issued
through national Veterans Health Administration (VHA) policies
beginning with VHA Directive 96-069 (as published November 7, 1996),
culminating in VHA Handbook 1173.1 (as last published November 2,
2000). VA has further expressly listed ``durable medical equipment and
prosthetic and orthotic devices'' as medical services available to
eligible veterans as part of VA's medical benefits package in 38 CFR
17.38(a)(1)(viii). Although VA administers its prosthetics program with
the support of Sec. 17.38(a)(1)(viii) as well as multiple VHA
policies, neither Sec. 17.38 (except for Sec. 17.38(c)) nor these
policies are appropriately descriptive of VA's current practices in
providing prosthetic and similar items. For instance, 17.38(a)(1)(viii)
provides that eligible veterans may receive prosthetic and similar
items as medical services, and Sec. 17.38(b) further provides that
such items may be considered medically necessary if they are
``determined by appropriate healthcare professionals that the care is
needed to promote, preserve, or restore the health'' of eligible
veterans; however, the ``promote, preserve, or restore'' criteria in
Sec. 17.38(b) are not specific enough to properly articulate the
concept of medical necessity in the context of prosthetic and similar
items and services, versus for medical services more generally. VA
finds it necessary now to clarify its current practices and to propose
certain changes with regard to the provision of prosthetic and similar
items and services, and such clarification and proposed changes are
appropriate for a rulemaking because they would affect VA's provision
of prosthetic and similar items and services. We would not seek to
substantively revise Sec. 17.38 in this manner, however, as it would
be cumbersome and potentially confusing to establish additional
eligibility and other administrative criteria for prosthetic and
similar items and services as a specific type of medical service. We
would seek instead to establish new regulations in proposed Sec. Sec.
17.3200-.3250, and would remove a current but defunct regulation
specifically related to the provision of prosthetic and similar items,
38 CFR 17.150. Section 17.150 was first promulgated in 1967 and was
never substantively revised to reflect eligibility for prosthetic and
similar items as provided in section 103(a) of Public Law 104-262 and
Sec. 17.38(a)(1)(viii). Although Sec. 17.150 does establish that
there must be a VA determination of ``feasibility and medical need''
prior to the provision of prosthetic and rehabilitative items and
services to veterans, the phrase ``feasibility and medical need'' does
not properly articulate the concept of medical necessity in a manner
that is consistent with current VA practices. Further, Sec. 17.150
only provides a limited list of examples of prosthetic items and
services that are provided to eligible veterans, which could be
misinterpreted to be an exhaustive list. Removing Sec. 17.150 and
establishing proposed Sec. Sec. 17.3200-.3250 would, among other
things as described throughout this rulemaking, articulate the concept
of medical necessity for these items and services in a manner
consistent with current VA authority and practice, would provide a
broader and expressly non-exhaustive list as well as definitions for
items and services that may be provided, and would update veteran
eligibility for these items and services in a manner consistent with
section 103(a) of Public Law 104-262 and with Sec. 17.38(a)(1)(viii).
The changes proposed in this rulemaking would also clarify the
provision of prosthetic and rehabilitative items and services that VA
provides as ``medical services'' under sections 1701 and 1710, versus
other similar items and services that VA provides under other
authorities. Congress has enacted specific statutory provisions other
than sections 1701 and 1710 to authorize VA to furnish veterans with
particular items and services in connection with a disability or to
assist veterans in overcoming a disability. For example, sections
1714(b) and 1717(c) authorize VA to furnish devices to blind and deaf
veterans, respectively, for the broad purpose of ``overcoming the
disability'' of blindness or deafness, without the criterion that such
devices be considered medically necessary. This is not to say that such
items and services could not be interpreted as being medically
necessary. Rather, the enactment of statutes other than sections
1701(6)(F) and 1710(a) demonstrates Congressional intent that the items
and services provided under these other statutes are to be provided in
accordance with the criteria in those statutes and their implementing
[[Page 48020]]
regulations. VA has established different regulatory criteria
implementing these other statutes to control the provision of these
other items (see, for instance, 38 CFR 17.3100 et seq., which controls
the provision of home improvements and structural alterations permitted
by 38 U.S.C. 1717(a)(2)). We propose to establish this distinction
between sections 1701(6)(F) and 1710(a), and other statutes that
control the provision of certain items and services, more clearly in
proposed section 17.3200; specifically, we would provide a table of the
statutory and regulatory authorities for items and services provided
outside of sections 1701(6)(F) and 1710(a). This table would include
authorities for items and services provided to veterans, but would not
include authorities for items and services provided to non-veteran
beneficiaries (such as the authorities to provide items necessary for
care of a newborn as permitted by 38 U.S.C. 1786, or items necessary
for care of certain dependents as permitted by 38 U.S.C. 1781). We do
not believe it is necessary to include authorities related to non-
veterans in the proposed table, as proposed sections 17.3200 through
17.3250 only address the provision of these items and services to
veterans.
17.3200. Purpose and Scope
Proposed Sec. 17.3200 would establish a clearer purpose and scope
for the provision of prosthetic and rehabilitative items and services
as ``medical services'' than what is articulated in current Sec.
17.150, to distinguish VA's provision of prosthetic and rehabilitative
items and services as medical services under sections 1701(6)(F) and
1710 from VA's provision of other items and services under other
authorities. Proposed Sec. 17.3200(a) would state that the purpose of
proposed Sec. Sec. 17.3200 through 17.3250 would be to establish
eligibility and other criteria for the provision of prosthetic and
rehabilitative items and services to veterans as medical services under
sections 1701(6)(F) and 1710(a). These items and services would be
listed in proposed Sec. 17.3230, and we would reference that section
for ease of use.
Proposed Sec. 17.3200(b) would establish that the scope of
proposed Sec. Sec. 17.3200 through 17.3250 would be limited to those
prosthetic or rehabilitative items and services provided by VA as
medical services under sections 1701(6)(F) and 1710(a), and would
identify in a table other items or services controlled by other
statutes and regulations. We propose to include this table because
these items and services have different criteria (related to
eligibility, restrictions, etc.) in accordance with distinct legal
authorities other than sections 1701(6)(F) and 1710(a). The proposed
rule would help reduce confusion by telling users where to find the
other statutes and regulations relevant to these other items and
services.
17.3210. Definitions
Proposed Sec. 17.3210 would establish definitions relevant to the
prosthetic and rehabilitative items and services to be provided by VA
as medical services under sections 1701(6)(F) and 1710(a). The items
and services that would be defined in this section are either expressly
listed as medical services under section 1701(6)(F)(i) and (ii), or are
similar or related to such expressly listed items and services because
they are similarly deemed ``needed'' (as required by section 1710(a)),
because they may be medically necessary to assist a veteran to
compensate for loss of mobility or loss of other functional abilities
as explained previously in this rulemaking. We note that some of the
definitions below would propose additional qualifying criteria related
to the items or services themselves. These additional qualifying
criteria would be related to accomplishing specific tasks associated
with the veteran's rehabilitation plan in addition to the general
requirement that the item be deemed medically necessary for the
veteran.
``Activities of daily living (ADL)'' would be defined as specific
personal care activities that are required for basic daily maintenance
and sustenance, to include eating, toileting, bathing, grooming,
dressing and undressing, and mobility. This definition of ADLs is
consistent with other VA regulatory definitions or uses of the term.
See Sec. Sec. 17.36, 51.120, 52.2, and 61.1.
``Adaptive household item'' would be defined as a durable household
item that has been adapted to compensate for, or that by design
compensates for, loss of physical, sensory, or cognitive function and
is necessary to complete one or more ADLs in the home or other
residential setting. We believe this definition captures the common
meaning and understanding of the word ``adaptive'' as something that
compensates for loss of function, and we believe the further
restrictions in this definition as explained below better explain the
scope of items that would be considered covered. For instance, we would
require that the adaptive household item must be ``necessary'' to
complete one or more ADLs, because we believe this is a reasonable
restriction for equipment that would be used in an individual's home or
other residential setting, and would ensure that common household items
are not provided except in narrow circumstances when a veteran cannot
complete an ADL without such an item due to the veteran's loss of
function. The definition of ``adaptive household item'' would further
provide examples of such items, to include adaptive eating utensils,
shower stools or chairs, hooks to assist in buttoning clothing, or shoe
horns. The definition of ``adaptive household item'' would exclude
household furniture or furnishing (which, as discussed later in this
proposed rule, we would define as an item commonly used to make a home
habitable or otherwise used to ornament a home, including but not
limited to tables, chairs, desks, lamps, cabinets, non-hospital beds,
curtains, carpet(s), etc.) because we do not find that common household
furniture or furnishings are generally necessary to complete an ADL.
For instance, a dining table is associated with the ADL of eating, but
is distinguishable from an adaptive utensil that may be required to
complete the ADL of eating. We further clarify that certain specialized
items that may be medically necessary and that could be interpreted as
furniture (such as hospital beds) would be expressly included under the
proposed definition of ``home medical equipment'' as explained later in
this proposed rule. The definition of ``adaptive household item'' would
also expressly exclude an ``improvement or structural alteration''
which we would define in this section the same as it is defined in 38
CFR 17.3101 (i.e., a modification to a home or to an existing feature
or fixture of a home, including repairs to or replacement of previously
improved or altered features or fixtures) because such improvements or
alterations are authorized by section 1717(a)(2) and 38 CFR 17.3100 et
seq., and are not within the scope of these proposed regulations, as
stated in the table in proposed Sec. 17.3200(b). The definition of
``adaptive household item'' would further exclude household appliances
(which, as discussed later in this proposed rule, we would define as
equipment for use in the home for performance of domestic chores or
other domestic tasks, including but not limited to a refrigerator,
stove, washing machine, and vacuum cleaner), except as necessary to
complete an ADL, because generally most household appliances cannot be
adapted to compensate, or by design do not compensate for, functional
loss in such a manner as to be considered necessary to complete
[[Page 48021]]
ADLs as defined above. An exception to this general exclusion would be
permitted when the appliance would be necessary to complete an ADL,
such as the provision of a blender or other food processing device to a
veteran with a diagnosed swallowing disorder who must have all food
pureed in order to complete the ADL of eating. In contrast, appliances
that are commonly related to eating but not necessary to complete the
ADL of eating, such as stoves or microwaves, would not be provided. We
further would clarify that the definition of ``adaptive household
item'' would exclude any requirement that VA furnish such items in such
a manner as to relieve any other person or entity of a contractual
obligation to furnish these items to the veteran. This is because such
items would not be needed as they have otherwise been provided for. For
example, a veteran may have contracted with a residence or residential
setting to furnish adaptive household items to the veteran.
``Adaptive recreation equipment'' would be defined as an item that
is designed to compensate for, or that by design compensates for, loss
of physical, sensory, or cognitive function and is necessary for the
veteran to actively and regularly participate in a sport, recreation,
or leisure activity to achieve the veteran's rehabilitation goals. The
additional requirement that these items be deemed necessary for active
and regular participation in an activity to achieve the veteran's
rehabilitation goals, which would be documented in the veteran's
medical record, ensures that items are only provided when their regular
use is specifically tied to a medical goal, and not provided merely to
support a veteran's participation in an activity only for personal
enjoyment. Examples of such equipment VA could provide to veterans
include mono-skis and specially designed wheelchairs to play sports
such as basketball.
``Cognitive device'' would be defined as an item that compensates
for a cognitive impairment and that is used to maintain or improve a
veteran's functional capabilities. Examples of such equipment VA could
provide to veterans include tablets and smart phones, as well as
associated technological equipment, applications, and/or software, that
can assist a veteran in maintaining daily scheduling of important tasks
or navigating their surroundings (e.g., global positioning system or
GPS).
``Communication device'' would be defined as an item that
compensates for a communication deficiency and allows participation in
daily communication activities. Examples of such equipment VA could
provide to veterans include augmentation and alternative communication
devices such as picture or symbol communication boards, or an electro
larynx.
``Durable'' would be defined to mean capable of, and intended for,
repeat use. We believe this definition captures the common meaning and
understanding of the term ``durable.''
``Home exercise equipment'' would be defined as an item used in a
home or residential setting that compensates for a loss of physical,
sensory, or cognitive function and is necessary for the veteran to
actively and regularly participate in aerobic, fitness, strength, or
flexibility activities to achieve the veteran's rehabilitation goals.
As with the definition of ``adaptive recreation equipment,'' the
additional criteria in the definition that items are necessary for
active and regular participation in an activity to achieve the
veteran's rehabilitation goals, which would be documented in the
veteran's medical record, ensures that items are only provided when
their regular use is specifically tied to a medical goal, and not
provided merely to support a veteran's participation in an activity
only for personal enjoyment. This criterion would also ensure that this
equipment is only provided when there is no other means for the veteran
to exercise to achieve the rehabilitation goal. Such ``home exercise
equipment'' would only be provided for one location, the veteran's
primary residence, which is defined in this rulemaking (as discussed
below) under proposed Sec. 17.3210 as ``the personal domicile or
residential setting in which the veteran resides the majority of the
year,'' and this additional criterion would be stated in proposed Sec.
17.3230 as discussed later in this rulemaking. In identifying the
veteran's primary residence, we would typically rely upon the veteran's
record with VA, as well as the veteran's declared residence. The
additional criterion that such equipment would only be provided for one
location, the primary residence, is current VA practice, and VA has
authority to determine that it is reasonable pursuant to 38 U.S.C.
1701(6)(F)(iii). In this case, VA has determined this criterion to be
reasonable because it may not be cost effective to provide multiple
sets of the same equipment for multiple locations. Because we will
provide one set of equipment, we believe it is adequate to provide this
equipment where it is used the most routinely and regularly, i.e., the
veteran's primary residence. While we generally would provide home
exercise equipment to the veteran's primary residence, there may be
instances when it may be provided to a veteran's non-primary residence.
For example, if a veteran's medical treatment or rehabilitation plan
requires access to home exercise equipment and the veteran has access
to a gym near his or her primary residence, but has another residence
in a rural area in which the veteran does not have access to a gym, the
equipment may be provided to the veteran at his or her non-primary
residence based on a clinical determination that providing such
equipment at the veteran's non-primary residence would be necessary as
a direct and active component of the veteran's medical treatment and
rehabilitation. We further would state that prior to any installation
of ``home exercise equipment'', the owner of the residence would agree
to the installation. We also note that to the extent the equipment is
portable, an individual would be free to move it to another location
where the veteran may temporarily reside, such as another residence
during an extended seasonal stay. Examples of such equipment VA could
provide to veterans include an upper body ergometer and a functional
electrical stimulation cycle.
``Home medical equipment'' would be defined as movable and durable
medical devices used in a home or residential setting to treat or
support treatment of specific medical conditions and would include
hospital beds, portable patient lifts (such as porch lifts or stair
glides), portable ramps, ventilators, home dialysis equipment, and
infusion, feeding, or wound therapy pumps. This definition is intended
to encompass those medical devices typically found in a medical
facility setting (e.g., hospital beds and infusion pumps), but that
must be used in a home or residential setting for specific medical
treatment (most typically, for continuation of treatment initially
received in a medical facility setting). The definition of ``home
medical equipment'' would specifically exclude household furniture or
furnishings, improvements or structural alterations, or any household
appliances for the same reasons as stated in the definition of
``adaptive household item,'' because such items could not reasonably be
considered to be medical devices. For instance, a hospital bed could be
provided as ``home medical equipment,'' whereas a common bed frame and
mattress could not. As proposed in Sec. 17.3230 (later in this
rulemaking) ``home medical equipment'' would only be provided for one
residential setting, the veteran's primary residence, for the same
reasons as stated
[[Page 48022]]
for ``home exercise equipment'' above. In the instance that at-home
installation or delivery is required and the veteran has more than one
residence, the Department will deliver the equipment to the veteran's
primary residence. We note that to the extent the equipment is
portable, an individual would be free to move it to another location
where the veteran may temporarily reside, such as another residence
during an extended seasonal stay. We will provide such equipment at the
veteran's primary residence, as the veteran is usually also receiving
professional care or assistance from a caregiver who must be at the
residence at specific times, and which would involve use of the
provided ``home medical equipment.'' While we generally would provide
``home medical equipment'' to the veteran's primary residence, there
may be instances when it may be provided to a veteran's non-primary
residence, as is similar to the provision of ``home exercise
equipment.'' For example, a veteran may be authorized for a stair
glider; however, his or her primary residence may be a single floor
residence. The veteran may have another residence that has more than
one floor, and it may be clinically determined that the provision of
the stair glider at the non-primary residence is necessary as an active
and direct component of the veteran's medical treatment or
rehabilitation. We also would clarify that prior to any installation of
``home medical equipment'', the owner of the residence must agree to
the installation of the equipment. We further would clarify that the
definition of ``home medical equipment'' would exclude any requirement
that VA will furnish such items in such a manner as to relieve any
other person or entity of a contractual obligation to furnish these
items or services to the veteran. This is because such items would not
be needed as they have otherwise been provided for. For example, a
veteran may have contracted with a residence or residential setting to
furnish home medical equipment to the veteran.
The definition of ``home medical equipment'' would also exclude
``medical alert devices,'' which, as discussed later in this proposed
rule, we would define as devices designed to summon general safety
assistance for a veteran, e.g. a device worn by an individual to summon
medical assistance in the event of a fall or other incident, or to
provide a veteran's general medical information to others, e.g.,
medical identification bracelets. While we currently provide both
medical alert devices and medical identification bracelets, those would
not be provided under these proposed rules as these items would not be
an active and direct component of a veteran's medical treatment or
rehabilitation pursuant to proposed Sec. 17.3230, described later in
this rulemaking. Medical alert devices are passive and purely
communicative devices, similar to cell phones, which are not used for
specific medical treatment or rehabilitation and do not contribute
directly to a veteran's medical treatment or rehabilitation and would
therefore not be provided under this authority. Their purpose is to
communicate about an unforeseeable future event, and they do not
actively communicate clinical or medical information about a veteran
nor do they communicate information that contributes directly to a
veteran's medical treatment or rehabilitation pursuant to proposed
Sec. 17.3230, described later in this rulemaking. Although these may
be used during an unforeseeable emergency to convey information about a
veteran, they do not actively or directly medically treat or
rehabilitate a veteran and any limitations the veteran may have, and
thus are not ``necessary'' under this authority. Medical alert devices
are also programmable to alert whomever the veteran chooses, and do not
necessarily result in an alert or communication to a medical
professional. These devices also do not necessarily result in an alert
that the veteran is in need of medical assistance, as these devices can
be used to alert an individual or entity of a general need for
assistance. With the prevalence of, and access to, cell phones and
other similar technologies that serve a similar function as medical
alert devices in this context, we believe that most, if not all,
veterans have access to the technology necessary to alert individuals
and/or entities when medical assistance is needed. Thus, while these
devices could be considered beneficial to a veteran's treatment in
limited circumstances, we do not consider the provision of these under
this authority as reasonable. The definition of ``medical alert
devices'' would not apply to alarms or other safety indicators on home
medical equipment, such as an alarm to alert an individual if a
ventilator is unplugged. Such alarms and indicators, therefore, could
be provided as part of home medical equipment. These alarms and
indicators that are part of medical equipment (such as a ventilator) do
contribute directly to a veteran's treatment as part of the total
function of the piece of medical equipment, unlike devices that serve a
purely communicative function.
Similarly, medical identification bracelets would be excluded under
this regulation as they are not a direct and active component of a
veteran's medical treatment or rehabilitation, and therefore are not
reasonable and necessary under this authority. Medical identification
bracelets are entirely passive, do not actively communicate any
information about a veteran, and merely provide information about the
existence of a condition of a veteran. Although these may be used
during an unforeseeable emergency to convey information about a
veteran, they do not actively or directly medically treat or
rehabilitate a veteran and any limitations the veteran may have, and
thus are not ``necessary'' under this authority. While these devices
could be considered beneficial to a veteran's treatment in limited
circumstances, we do not consider the provision of these under this
authority as reasonable for the same reasons stated above. We note that
we currently provide these medical identification bracelets, however
for the reasons discussed, they would be outside the scope of this
authority and would not be authorized to be provided pursuant to these
proposed regulations. We further note that after the publication of the
final rulemaking, we would rescind VHA Directive 2009-007, Provision of
Medical Identification (ID) Bracelets and Pendants, to ensure VA policy
is consistent with the published final rules.
Lastly, we clarify that although certain home medical equipment
might need to be installed in a home to ensure its proper functioning,
such as a portable ramp or a hospital bed, such equipment must not
amount to an improvement or structural alteration to a veteran's
residence. Such improvements or alterations to homes are authorized by
section 1717(a)(2) and 38 CFR 17.3100 et seq., and are not within the
scope of these proposed regulations, as stated in the table in proposed
Sec. 17.3200(b). This clarification related to installation would be
established in proposed Sec. 17.3230 as discussed later in this
rulemaking.
``Home respiratory equipment'' would be defined as an item used to
provide oxygen therapy or to support or enhance respiratory function.
We note that home respiratory equipment would be distinguished from
home medical equipment because we would permit the provision of
additional pieces of respiratory equipment as medically necessary
outside of a single home or residential setting, such as additional
portable oxygen tanks when a veteran
[[Page 48023]]
might need to travel. Examples of such equipment VA would provide to
veterans include compressed oxygen, oxygen concentrators, and
continuous positive airway pressure machines.
``Household appliances'' would be defined as equipment for use in
the home for performance of domestic chores or other domestic tasks,
including but not limited to a refrigerator, stove, washing machine,
and vacuum cleaner. We believe this definition captures the common
meaning and understanding of this term.
``Household furniture or furnishing'' would be defined as an item
commonly used to make a home habitable or otherwise used to ornament a
home, including but not limited to tables, chairs, desks, lamps,
cabinets, non-hospital beds, curtains, and carpet(s). We believe this
definition captures the common meaning and understanding of this term.
``Implant'' would be defined as any biological or non-biological
material that is manufactured or processed to be placed into a
surgically or naturally formed cavity on the human body; is covered
with tissue, has the potential to be covered with tissue, or is
permanently embedded in tissue; does not dissolve or dissipate within
the body; and is not a living organ, embryonic tissue, blood, or blood
product. VA provides implants as part of the prosthetics program, and
this definition characterizes such implants consistently with VA's
current provision of implants, and to that extent would not reflect a
change in the scope of benefits available to eligible veterans.
``Improvements or structural alterations'' means a modification to
a home or to an existing feature or fixture of a home, including
repairs to or replacement of previously improved or altered features or
fixtures. This term would be defined the same as it is defined in 38
CFR 17.3101 (i.e., a modification to a home or to an existing feature
or fixture of a home, including repairs to or replacement of previously
improved or altered features or fixtures). Such improvements or
structural alterations are authorized by section 1717(a)(2) and 38 CFR
17.3100 et seq., and are not within the scope of these proposed
regulations, as stated in the table in proposed Sec. 17.3200(b).
``Medical alert device'' would mean an item designed to summon
general safety assistance for a veteran, or that provides a veteran's
general medical information to others. This definition would not
include alarms or other safety indicators for home medical equipment.
As previously discussed, this definition is necessary because ``medical
alert device'' would be excluded from the term ``home medical
equipment.''
``Mobility aid'' would be defined as an item that compensates for a
mobility impairment and that is used to maintain or improve a veteran's
functional capabilities to be mobile. Examples of such equipment VA
would provide to veterans include manual and motorized wheelchairs,
canes, walkers, and equipment to assist veterans with reaching for or
grasping items. We would exclude a service or guide dog from this
definition because the provision of certain benefits for service or
guide dogs is not within the scope of these proposed regulations as
stated in the table in proposed Sec. 17.3200(b). VA has published
regulations concerning benefits for service and guide dogs at 38 CFR
17.148.
``Orthotic device'' would be defined as an item fitted externally
to the body that is used to support, align, prevent, or correct
deformities or to improve the function of movable parts of the body. We
believe this definition captures the common meaning and understanding
of this term as well as its common meaning and use in the health care
industry. Examples of such items VA would provide to veterans include
leg braces, upper extremity splints and braces, and functional
electrical stimulation devices such as Bioness[supreg] or
WalkAide[supreg].
``Primary residence'' would be defined as the personal domicile or
residential setting in which the veteran resides the majority of the
year. We believe this definition captures the common meaning and
understanding of this term. While a person may maintain more than one
residence, they may only have one primary residence at a time. This
would include any residential setting the veteran owns, rents, or in
which the veteran otherwise resides.
``Prosthetic device'' would be defined as an item that replaces a
missing or defective body part. We believe this definition captures the
common meaning and understanding of this term as well as its common
meaning and use in the health care industry. Examples of such items VA
would provide to veterans include artificial limbs and artificial eyes.
We note that certain prosthetic devices may not have mechanical or
other functionality, but nonetheless could be considered medically
necessary and not merely cosmetic in nature. For instance, certain
artificial hands may not have mechanical functions to grasp objects,
but the use of such devices equalizes weight distribution in the arm
and across the body. As another example, artificial eyes would not
function to restore or improve sight, but would provide necessary shape
to an eye socket and prevent objects from entering the eye socket.
``Replacement item'' would be defined as an item that is similar or
identical to an item provided under proposed Sec. 17.3230(a), and that
takes the place of such an item. We believe this definition captures
the common meaning and understanding of this term.
``VA-authorized vendor'' would be defined as a vendor that has been
authorized by VA to provide items and services under Sec. 17.3230. We
believe this definition is self-explanatory. This definition would be
relevant to the discussion later in this proposed rule regarding the
furnishing of items and services in proposed Sec. 17.3240.
17.38. Medical Benefits Package and 17.3220. Eligibility
Proposed Sec. 17.3220 would clarify veteran eligibility for
prosthetic and rehabilitative items and services provided under
sections 1701(6)(F) and 1710(a). As explained previously in this
rulemaking, VA is authorized under sections 1701(6)(F)(iii) and 1710(a)
to provide those prosthetic and rehabilitative items and services that
VA determines are medically necessary to assist a veteran to compensate
for loss of mobility or loss of other functional abilities, where the
veteran is otherwise receiving care or services under chapter 17 of
title 38 U.S.C. Section 17.38(a)(1)(viii), in turn includes the
provision of ``durable medical equipment and prosthetic and orthotic
devices'' as part of VA's ``medical benefits package.'' We would first
revise Sec. 17.38(a)(1)(viii) to use the term ``prosthetic and
rehabilitative items and services'' as proposed in these regulations,
and would cross reference this term with citations to the proposed
regulations in this rulemaking so it is clear that such items and
services under Sec. 17.38(a)(1)(viii) are provided in accordance with
proposed Sec. Sec. 17.3200 through 17.3250.
We would also revise Sec. 17.38(b) to reflect that prosthetic and
rehabilitative items and services authorized in Sec. 17.38(a)(1)(viii)
are excluded from the ``promote, preserve, or restore'' standard under
Sec. 17.38(b). As previously discussed in this rulemaking, the
standard of ``promote, preserve, or restore'' under Sec. 17.38(b) is
not specific enough to distinguish when prosthetic and rehabilitative
items should be provided because they are medically necessary, versus
when an item or service would not be provided because
[[Page 48024]]
it is only desired. Using a standard other than that of ``promote,
preserve, or restore'' would also be consistent with the authorizing
statutes, sections 1701(6)(F) and 1710(a), requiring that VA provide
those items and services that are necessary and reasonable. However, in
a note to proposed Sec. 17.3230, we would state that the exclusions in
Sec. 17.38(c) apply to the provision of items and services pursuant to
Sec. 17.3230.
Proposed Sec. 17.3220 would then establish eligibility for
prosthetic and rehabilitative items and services by requiring that
veterans be enrolled in VA's enrollment system under Sec. 17.36 or
exempt from such enrollment under Sec. 17.37, and requiring that such
veterans are otherwise receiving care under chapter 17 of title 38
U.S.C. These two eligibility criteria would be in proposed Sec.
17.3220(a)-(b), respectively. Proposed Sec. 17.3220(b) would further
describe the concept of ``otherwise receiving care'' to include where a
veteran is prescribed a prosthetic or rehabilitative item or service by
a VA provider or an authorized non-Department provider. We believe that
by receiving a prescription the veteran would be receiving care under
chapter 17.
17.3230. Authorized Items and Services
Proposed Sec. 17.3230(a) would state that VA would provide
veterans who are eligible under Sec. 17.3220 with items and services
that would be listed in proposed Sec. 17.3230(a)(1)-(15) as described
below. Proposed Sec. 17.3230(a) would further state that VA will
provide items and services listed in proposed Sec. 17.3230(a)(1)-(15),
if VA determines that the items or services serve as a direct and
active component of the veteran's medical treatment or rehabilitation,
and do not merely support the comfort or convenience of the veteran.
The statement in proposed Sec. 17.3230(a) that items and services need
to be a direct and active component of the veteran's medical treatment
or rehabilitation and not merely for the comfort or convenience of the
veteran is consistent with VA practice. As stated previously in this
rulemaking, the more specific criteria related to medical necessity in
proposed Sec. 17.3230(a) are needed because the ``promote, preserve,
or restore'' criteria in Sec. 17.38(b) may be appropriate in terms of
medical services generally, but are not specific enough to distinguish
when prosthetic and rehabilitative items and services should be
provided because they are medically necessary, versus when an item or
service would not be provided because it is only desired. The items and
services provided are intended to be limited to those that accommodate
a veteran's medical treatment or rehabilitation. This would also be
consistent with the authorizing statutes, sections 1701(6)(F) and
1710(a), requiring that VA provide those items and services that are
necessary and reasonable. Proposed Sec. 17.3230(a)(1) through (a)(15)
would list the categories of items and services that have been and
would continue to be provided by VA as prosthetic or rehabilitative
items or services. Definitions of the items and services to be provided
in proposed Sec. 17.3230(a)(1) through (a)(15), as well as examples of
such items, are provided in the discussion of proposed Sec. 17.3210,
and we do not reiterate that information generally below. We propose,
however, additional criteria that must be met in proposed Sec.
17.3230(a)(5) and (a)(6) for ``home exercise equipment'' and ``home
medical equipment,'' respectively. We reiterate from the discussion of
the proposed definitions earlier in this rulemaking that proposed Sec.
17.3230(a)(5) and (a)(6) would establish a restriction that both ``home
exercise equipment'' and ``home medical equipment'' would only be
provided for one location, generally the veteran's primary residence.
This additional criterion that such equipment would only be provided
for one location is current VA practice and is reasonable because we
believe it is adequate in most cases to provide this equipment at the
veteran's primary residence, a term which is previously defined and
discussed in this rulemaking. Relatedly, it is current VA practice to
provide one piece of equipment; therefore, we believe it is also
reasonable to provide that equipment to the veteran's primary
residence, as that is the personal domicile or residential setting in
which the veteran resides the majority of the year, and is where we
believe the equipment will likely be used most routinely and regularly.
If the veteran has more than one residence, the Department will provide
the equipment to the veteran's primary residence. We note that to the
extent the equipment is portable, an individual would be free to move
it to another location where the veteran may temporarily reside, such
as another residence during an extended seasonal stay. As indicated
previously, there may be limited instances when ``home exercise
equipment'' or ``home medical equipment'' may be provided at a non-
primary residence based on a clinical determination. Prior to any
installation of such equipment in the residence, the owner of the
residence would have to agree to the installation of the equipment.
Additionally, proposed Sec. 17.3230(a)(6) would establish that home
medical equipment must not require installation that amounts to a home
improvement or structural alteration to a veteran's primary residence.
Such improvements and alterations to homes are authorized by 38 U.S.C.
1717(a)(2) and controlled by other implementing regulations, as
referenced in the table in proposed Sec. 17.3200(b). Lastly, we would
require an additional restriction in proposed Sec. 17.3230(a)(2) and
(a)(5) that ``adaptive recreation equipment'' and ``home exercise
equipment'' be provided when such equipment would achieve the veteran's
rehabilitation goals as documented in the veteran's medical record.
This is because these types of equipment are generally provided to
achieve specific rehabilitation goals, while the other items and
services provided under this section are not.
Proposed Sec. 17.3230(a)(12) would authorize the repair of any
item provided under proposed Sec. 17.3230(a), unless cost or clinical
reasons favor replacing the item. Even if not initially prescribed by
VA, an item under proposed Sec. 17.3230(a) could be repaired if the VA
provider or authorized non-Department provider determines that the item
is still medically necessary and writes an authorized prescription for
the veteran. This is consistent with current VA practice, and is
reasonable to ensure that veterans have necessary and properly
functioning items.
Proposed Sec. 17.3230(a)(13) would authorize the replacement of
items provided under proposed Sec. 17.3230 if the original items have
been damaged, destroyed, lost, or stolen, or if replacement is
clinically indicated. Proposed paragraph (a)(13) would establish that
if items are serviceable and still meet the veteran's need, VA will not
replace such items for the sole purpose of obtaining a newer model of
the same or similar item. Proposed Sec. 17.3230(a)(13) sets forth a
reasonable restriction that would allow VA to provide replacement items
as clinically indicated, for the benefit of all veterans to whom VA
must provide these items and services.
We note that generally we would provide veterans with one item or
service under this proposed rule. However, there may be instances when
we would provide a veteran with a spare item. The provision of spare
items would be authorized if it is clinically determined that a veteran
would immediately require another identical or similar item. For
example, the provision of a spare item may be clinically determined to
be immediately required
[[Page 48025]]
if an item provided under the proposed regulations were to fail or
require rotation (e.g., routine cleaning) as a component of proper use.
VA may also provide an identical or similar item in the event of a
failure of an item provided under these regulations if it is determined
that it would otherwise be detrimental to the veteran's medical
treatment or rehabilitation to not provide a spare item. This is
current VA practice and is reasonable to ensure that veterans would
have access to items that are necessary on a continuous basis if the
veteran could not wait for repair or replacement, such as a spare
wheelchair or spare prosthetic limb. VA's provision of items as
explained above attempts to ensure that veterans have working, usable
equipment when needed. We discuss the provision of spare items in a
note at the end of proposed Sec. 17.3230.
Additionally, VA's reimbursement of emergency care under 38 U.S.C.
1725 and 1728 ensures that VA may reimburse some veterans for needed
repairs to equipment if such repairs cannot wait for prior VA
authorization. For these reasons, and to be consistent with section
1728, we propose removing Sec. 17.122, which authorizes the repair of
prosthetic and similar items without prior authorization from VA if the
expenses were incurred in the care of an adjudicated service-connected
disability. Section 17.122 is not needed, as sections 1725 and 1728
would provide for VA payment of repairs without prior VA authorization
as described above, and the other VA regulations that currently
implement these sections (sections 17.120 et seq. and 17.1000 et seq.)
are sufficient to authorize payment. Further, we find no basis for
treating reimbursement of the expenses of prosthetic repairs
differently from the expenses of other types of ``emergency care''. In
addition to removing Sec. 17.122, we propose deleting from Sec.
17.120 the following language, ``(except prosthetic appliances, similar
devices, and repairs),'' because we do not see a need to treat the
provision of these appliances, devices and repairs any differently from
other emergency care provided under this section. Removing Sec. 17.122
is needed as described above, and would clarify that the access to
prosthetic repair services without prior authorization in medical
emergencies for veterans would be authorized under sections 1725 and
1728 and their implementing regulations.
Proposed Sec. 17.3230(a)(14) would authorize the provision of
specialized clothing made necessary by the wearing of a prosthetic
device. The provision of specialized clothing made necessary by the
wearing of a prosthetic device is specifically identified as a medical
service under section 1701(6)(F)(ii), and we would therefore include it
in this proposed rule. We contrast this with the clothing allowance
provided under Sec. 3.810 and authorized by 38 U.S.C. 1162, which is
intended to provide a clothing allowance only to veterans with certain
service-connected disabilities, apart from the provision of medical
services under section 1710. See 118 Cong. Rec. S. 20748, 20751 (1972)
(legislative history related to the bill that would enact section 1162,
explaining that a new clothing allowance would assist veterans to
purchase non-specialized, regular clothing that may experience wear and
tear due to use of a wheelchair or prosthetic device, separate from the
benefit for specialized clothing due to the wearing of a prosthetic
device that VA provided as a medical service).
Proposed Sec. 17.3230(a)(15) would authorize training with and
fitting of items as considered necessary. Training and fitting of
prosthetic appliances is required by 38 U.S.C. 1714(a), is current VA
practice, and is reasonable to ensure, to the extent practicable, that
veterans safely operate items and that items are properly maintained to
promote their longevity. We would additionally remove current Sec.
17.153 related to training and fitting of prosthetic and similar items,
as it would be duplicative of proposed Sec. 17.3230(a)(15).
Proposed Sec. 17.3230(b) would establish that unless items
provided under proposed Sec. 17.3230(a) are loaned to a veteran, based
on a clinical determination, such items become the property of the
veteran once the veteran takes possession of those items. This would
ensure that veterans have full use of, and responsibility for, items
provided by VA, and will use them in the manner in which they are
prescribed. If items will be loaned, a written agreement (which would
include roles and responsibilities for the duration of the loan) with
the veteran would be entered into to ensure that it is clear the
veteran does not own the item, and that the veteran fully understands
and agrees to the terms of the loan.
17.3240. Furnishing Authorized Items and Services
Proposed Sec. 17.3240(a) would establish that VA will determine
whether VA or a VA-authorized vendor will furnish authorized items and
services under Sec. 17.3230 to eligible veterans. When VA has the
capacity or inventory, VA directly provides items and services to
veterans. However, VA also may use, on a case-by case basis, VA-
authorized vendors to provide greater access, lower cost, and/or a
wider range of items and services. We would clarify in regulation that
this administrative business decision is made solely by VA to eliminate
any possible confusion as to whether a veteran has a right to request
items or services generally, or to request specific items or services
from a provider other than VA, and to clarify for the benefit of VA-
authorized vendors that VA retains this discretion as part of our duty
to administer this program in a legally sufficient, fiscally
responsible manner.
Proposed Sec. 17.3240(b) would establish that, except for
emergency treatment reimbursable under 38 CFR 17.120 et. seq or 17.1000
et seq., prior authorization is required from VA for VA-authorized
vendors to obtain reimbursement for furnishing items or services under
Sec. 17.3230 to veterans. Prior authorization may be obtained by
contacting VA. Paragraph (b) will help ensure that the highest quality
and most clinically appropriate device is provided, as prescribed by VA
providers, and that items or services are not subject to potential
alterations or substitutions by VA-authorized vendors without VA
oversight.
17.3250. Veteran Responsibilities
Proposed Sec. 17.3250 would establish responsibilities of veterans
who are provided prosthetic and rehabilitative items and services.
Proposed Sec. 17.3250(a) would establish that veterans must use items
provided under proposed Sec. 17.3230(a) in the manner for which they
are prescribed, and consistent with the manufacturer's instructions and
any training provided. This would ensure, to the extent practicable,
veteran safety in using the item as well as the longevity of the item.
Proposed Sec. 17.3250(b) would establish that, except for
emergency care under 38 CFR 17.120 et. seq. or 38 CFR 17.1000 et seq.,
veterans must obtain prior authorization from VA if they want VA to
reimburse a VA-authorized vendor for such items and services provided
under Sec. 17.3230. This would reinforce general VA oversight
requirements already proposed in these regulations to ensure the
highest quality and most appropriate item or service is provided, and
would distinctly provide notice to veterans and vendors that VA will
not be responsible for the cost of items and services provided to
veterans who are not preauthorized by VA or otherwise covered as
emergency care.
[[Page 48026]]
Rescission of Use of Prosthetic Service Card and Related VA Policy
We note that after the publication of this rulemaking is final, we
would rescind, in their entirety, VHA Handbooks 1173.06, 1173.1.
1173.10, 1173.2, 1173.3, VA Forms 10-2501 and 10-2520, and VA Form
Letter 10-55; and develop new VHA policy to ensure VA's provision of
prosthetics is consistent with the published final rules. Any
references to the prosthetic service card would be excluded from future
VHA policies and forms implementing these rules as further explained
below.
As part of this plan, we specifically note that future VA policy
would not include portions of existing VA policy that reference
``prosthetic service cards'' and establish limits on reimbursement or
payment amounts for emergency repairs of prosthetic items through the
use of a ``prosthetic service card'' to obtain repairs from VA-
authorized vendors without prior authorization from VA. A ``prosthetic
service card'' is a piece of paper (VA Form 10-2501) that VA has issued
to veterans in the past for the purpose of providing a third party
vendor with notice that VA would reimburse such vendor for the
provision of certain repairs, up to certain amounts. VA Form 2520 in
the past has been the invoice used by vendors to submit to VA requests
for payment for repairs performed under the prosthetic service card.
This prosthetic service card was intended to allow third party vendors
to forego the normal process of contacting VA first for authorization,
and instead submit an invoice to VA for the cost of repairs after they
were completed. The card was intended to be used if it was not feasible
for a VA-authorized vendor to contact VA for authorization and the
repair was immediately necessary, such as when a repair was needed
after VA office hours. However, these prosthetic service cards have not
been widely or consistently used by veterans or vendors for the purpose
of obtaining VA approval of emergency repairs. First, veterans in many
instances have lost their prosthetic service cards or have not carried
the card on their person to be able to present to third party vendors.
Second, even when presented with the card, many third party vendors
have nonetheless contacted VA for authorization prior to providing
repairs. The card itself is merely a piece of paper that provides
notice that VA will reimburse a vendor for certain repairs up to
certain amounts--it is not a pre-paid credit card or other means of
providing immediate payment to a VA-authorized vendor (despite the
description of the card as a ``debit'' card in VHA Handbook 1173.1).
Even when the card has been used, third party vendors have still had to
submit an invoice and other documentation to VA to get reimbursed for
the repair. Therefore, use of the prosthetic service card has not
typically been any less burdensome for third party vendors to receive
payment from VA than if such vendors had contacted VA for authorization
prior to the repair. The intent of the card was to decrease the burden
for both veterans and third party vendors, but it has not functioned
consistently in this manner. Additionally, the card does not
appropriately reference sections 1725 and 1728 as the authorities to
provide repairs without prior authorization, which creates problems
where the card either does not recognize the applicable criteria in
sections 1725 and 1728 (for instance, related to eligibility under
sections 1725 and 1728), or establishes criteria that may be
inconsistent with 1725 and 1728 (for instance, the prosthetic service
card contains a space for VA to set a limit on any repair costs).
Currently, references to the prosthetic service card (PSC) are
located in paragraphs 3.tt, 8.a, 9.i, 9.h, 9.m of VHA Handbook 1173.1;
paragraphs 4.a.(2)-a.(7), 4.b., 4.c.(1)-c.(7), and 6.c.(4) of VHA
Handbook 1173.2; paragraphs 10.a.(1) and 10.c of VHA Handbook 1173.3;
paragraphs 7.a. and 7.e. of VHA Handbook 1173.06; and paragraphs
3.i.(9) and 4.c. in VHA Handbook 1173.10. Paragraphs 3.tt and 9.h in
VHA Handbook 1173.1 both define ``VA Form 10-2501, Prosthetic Service
Card (PSC).'' Paragraph 8.a. in VHA Handbook 1173.1 references requests
for payment of PSC (i.e. prosthetic service card) repairs. Paragraph
9.i in VHA Handbook 1173.1 defines ``VA Form 10-2520, Prosthetic
Service Card Invoice'', and paragraph 9.m. defines ``VA Form Letter 10-
55, Authority to Exceed Repair Costs of Prosthetic Appliances'' as a
letter of authorization forwarded to a provider of PSC (i.e. prosthetic
service card) repairs when the cost of that repair exceeds the limit
authorized by the PSC (i.e. prosthetic service card). In VHA Handbook
1173.2, paragraph 4.a.(2) requires that repairs be obtained by use of
the prosthetic service card; paragraphs 4.a.(3)-a.(7) detail
requirements that PSCs be provided by all prosthetic programs at field
facilities, authority for equipment repairs and services using
prosthetic service cards, monetary limits for prosthetic service cards,
responsibility for payment of prosthetic service card invoices, and
payment for repairs made without prior approval; paragraph 4.b. sets
forth VA, vendor, and veteran responsibilities related to the
administration of prosthetic service cards; paragraphs 4.c.(1)-c.(7)
include prosthetic service card benefits limits, and the processes for
prosthetic service card preparation and issuance, prosthetic service
card invoice preparation and issues, repairs authorization, and
prosthetic service card revocation or cancellation; and paragraph
6.c.(4) requires repairs of artificial limbs, braces, wheelchairs, and
other appliances on presentation by the veteran of a valid prosthetic
service card.
Paragraph 10.a.(1) of VHA Handbook 1173.3 states that repairs may
be obtained through commercial sources using VA Form 10-2501, and
paragraph 10.c. of VHA Handbook 1173.3 encourages the use of prosthetic
service cards for those veterans eligible for a prosthetic service
card.
Paragraphs 7.a. and 7.e. of VHA Handbook 1173.06 authorize the use
of prosthetic service cards for repairs to wheelchairs. Paragraphs
3.i.(9) and 4.c. in VHA Handbook 1173.10 authorize the use of
prosthetic service cards for repairs to orthotic devices.
Lastly, VA Form 10-2501, VA Form 10-2520, and VA Form Letter 10-55
also reference prosthetic service cards. Currently, VA Form 10-2520 is
an approved information collection under OMB Control Number 2900-0188,
which is set to expire on October 31, 2017. On August 22, 2017, we
issued a Federal Register (FR) Notice informing the public of the
opportunity to comment on the proposed renewal of that information
collection. 82 FR 39951. While we are requesting renewal of that
collection, we now propose to eliminate VA Form 10-2520 under that
existing collection for the reasons explained above as part of this
proposed rule. Public comments on the discontinuance of VA Form 10-2520
should be submitted as part of this rulemaking for consideration by VA.
While related, VA Form 10-2015 and VA Form Letter 10-55 are not
information collections, did not require OMB approval prior to
issuance, and thus are not part of that Federal Register Notice.
As previously stated, to ensure consistency with the published
final regulations, we would rescind all relevant and applicable
handbooks, and develop a new VHA policy document or documents. Any
references to prosthetic service cards in existing policies would be
excluded from that future policy document or documents for the reasons
mentioned above. We would also discontinue the use of the related forms
[[Page 48027]]
and letters previously identified in this section. As part of this
rulemaking, we welcome any public comments on these efforts as they
relate to this rulemaking.
Although we would rescind the prosthetic service card and the
policies and forms governing its use, there would remain, as explained
previously, statutory and regulatory authority (38 U.S.C. 1725 and
1728, 38 CFR 17.120 et seq. and 17.1000 et seq.) to reimburse some
vendors or veterans for the cost of some emergency, unauthorized
repairs. VA could also obviate the need for veterans to obtain
emergency repairs from vendors by providing spares for prosthetic and
rehabilitative items under Sec. 17.3230, as clinically appropriate.
Effect of Rulemaking
The Code of Federal Regulations, as proposed to be revised by this
proposed rulemaking, would represent the exclusive legal authority on
this subject. No contrary guidance or procedures would be authorized.
All VA guidance would be read to conform with this proposed rulemaking
if possible or, if not possible, such guidance would be superseded by
this rulemaking.
Paperwork Reduction Act
This proposed rule contains no provisions constituting a collection
of information under the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3521).
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act, 5
U.S.C. 601-612. Therefore, pursuant to 5 U.S.C. 605(b), these
amendments would be exempt from the initial and final regulatory
flexibility analysis requirements of 5 U.S.C. 603 and 604.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' requiring review by the Office of
Management and Budget (OMB) as ``any regulatory action that is likely
to result in a rule that may: (1) Have an annual effect on the economy
of $100 million or more or adversely affect in a material way the
economy, a sector of the economy, productivity, competition, jobs, the
environment, public health or safety, or State, local, or tribal
governments or communities; (2) Create a serious inconsistency or
otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user
fees, or loan programs or the rights and obligations of recipients
thereof; or (4) Raise novel legal or policy issues arising out of legal
mandates, the President's priorities, or the principles set forth in
this Executive Order.''
The economic, interagency, budgetary, legal, and policy
implications of this regulatory action have been examined, and it has
been determined not to be a significant regulatory action under
Executive Order 12866. VA's impact analysis can be found as a
supporting document at http://www.regulations.gov, usually within 48
hours after the rulemaking document is published. Additionally, a copy
of the rulemaking and its impact analysis are available on VA's Web
site at http://www1.va.gov/orpm/, by following the link for ``VA
Regulations Published.''
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This proposed rule would have no such
effect on State, local, and tribal governments, or on the private
sector.
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance numbers and titles for
the programs affected by this document are 64.009, Veterans Medical
Care Benefits; 64.013, Veterans Prosthetic Appliances.
Signing Authority
The Secretary of Veterans Affairs, or designee, approved this
document and authorized the undersigned to sign and submit the document
to the Office of the Federal Register for publication electronically as
an official document of the Department of Veterans Affairs. Gina S.
Farrisee, Deputy Chief of Staff, approved this document on October 11,
2017, for publication.
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Government contracts, Health
care, Health facilities, Health professions, Medical devices, Veterans.
Dated: October 11, 2017.
Janet Coleman,
Chief, Office of Regulation Policy & Management, Office of the
Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, we propose to amend 38
CFR part 17 as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 continues to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
0
2. Amend Sec. 17.38 by revising paragraph (a)(1)(viii) and revising
paragraph (b). The revisions read as follows:
Sec. 17.38. Medical Benefits Package.
(a) * * *
(1) * * *
(viii) Prosthetic and rehabilitative items and services as
authorized under Sec. Sec. 17.3200-.3250, and eyeglasses and hearing
aids as authorized under Sec. 17.149.
* * * * *
(b) Provision of the ``medical benefits package''. Care referred to
in the ``medical benefits package'' (except for prosthetics and
rehabilitative items and services authorized in paragraph (a)(1)(viii)
of this section) will be provided to individuals only if it is
determined by appropriate healthcare professionals that the care is
needed to promote, preserve, or restore the health of the individual
and is in accord with generally accepted standards of medical practice.
* * * * *
Sec. 17.120 [Amended].
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3. Amend the introductory text of Sec. 17.120 by removing ``(except
prosthetic appliances, similar devices, and repairs)''.
Sec. 17.122 [Removed].
0
4. Remove Sec. 17.122.
0
5. Revise the undesignated center heading that precedes Sec. 17.148 to
read as follows:
[[Page 48028]]
Sensory and Other Rehabilitative Aids
Sec. Sec. 17.150 [Removed and reserved]
Sec. Sec. 17.153 [Removed and reserved]
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6. Remove and reserve Sec. Sec. 17.150 and 17.153.
0
7. Add an undesignated center heading and Sec. Sec. 17.3200 through
17.3250, to read as follows:
Prosthetic and Rehabilitative Items And Services
Sec. 17.3200 Purpose and scope.
(a) Purpose. The purpose of Sec. Sec. 17.3200 through 17.3250 is
to establish eligibility and other criteria for the provision to
veterans of the prosthetic and rehabilitative items and services,
listed in Sec. 17.3230, authorized as medical services under 38 U.S.C.
1701(6)(F) and 38 U.S.C. 1710(a).
(b) Scope. Sections 17.3200 through 17.3250 apply only to items and
services listed in Sec. 17.3230(a) and authorized as medical services
under 38 U.S.C. 1701(6)(F) and 38 U.S.C. 1710(a). The provision of the
items or services and payments in the table below are authorized in
whole or in part by separate statutes and controlled by other
implementing regulations:
------------------------------------------------------------------------
Item or service Statute Regulation(s)
------------------------------------------------------------------------
Clothing allowance............ 38 U.S.C. 1162........ 38 CFR 3.810.
Service and guide dog benefits 38 U.S.C. 1714(b) & 38 CFR 17.148.
(c).
Sensori-neural aids........... 38 U.S.C. 1707(b)..... 38 CFR 17.149.
Patient lifts and other 38 U.S.C. 1717(b)..... 38 CFR 17.151.
rehabilitative devices.
Devices for deaf veterans..... 38 U.S.C. 1717(c)..... 38 CFR 17.152.
Equipment for blind veterans.. 38 U.S.C. 1714(b)..... 38 CFR 17.154.
Automobile adaptive equipment. 38 U.S.C. 3901 et seq. 38 CFR 17.155 et
seq.
Home improvements and 38 U.S.C. 1717(a)(2).. 38 CFR 17.3100
structural alterations. et seq.
------------------------------------------------------------------------
(Authority: 38 U.S.C. 501, 1162, 1701, 1707, 1710, 1714, 1717, 3901)
Sec. 17.3210 Definitions.
For the purposes of Sec. Sec. 17.3200 through 17.3250:
Activities of daily living (ADLs) means specific personal care
activities that are required for basic daily maintenance and
sustenance, to include eating, toileting, bathing, grooming, dressing
and undressing, and mobility.
Adaptive household item means a durable household item that has
been adapted to compensate for, or that by design compensates for, loss
of physical, sensory, or cognitive function and is necessary to
complete one or more ADLs in the home or other residential setting.
Adaptive household items include but are not limited to adaptive eating
utensils, shower stools or chairs, hooks to assist in buttoning
clothing, or shoe horns. This definition does not include household
furniture or furnishings, improvements or structural alterations, or
household appliances, unless a household appliance is necessary to
complete an ADL in the home or other residential setting. VA will not
furnish such items or services in such a manner as to relieve any other
person or entity of a contractual obligation to furnish these items or
services to the veteran.
Adaptive recreation equipment means an item that is designed to
compensate for, or that by design compensates for, loss of physical,
sensory, or cognitive function and is necessary for the veteran to
actively and regularly participate in a sport, recreation, or leisure
activity to achieve the veteran's rehabilitation goals as documented in
the veteran's medical record.
Cognitive device means an item that compensates for a cognitive
impairment and that is used to maintain or improve a veteran's
functional capabilities, including but not limited to technological
equipment such as tablets and smart phones, and associated
technological equipment, applications or software that can assist a
veteran in maintaining daily scheduling of important tasks or
navigating their surroundings (e.g., global positioning system, or GPS)
.
Communication device means an item that compensates for a
communication deficiency and allows participation in daily
communication activities, including but not limited to picture or
symbol communication boards and an electro larynx.
Durable means capable of, and intended for, repeat use.
Home exercise equipment means an item used in a home or residential
setting that compensates for a loss of physical, sensory, or cognitive
function and that is necessary for the veteran to actively and
regularly participate in aerobic, fitness, strength, or flexibility
activities to achieve the veteran's rehabilitation goals as documented
in the veteran's medical record, when there is no other means for the
veteran to exercise to achieve the veteran's rehabilitation goals. Such
equipment includes but is not limited to an upper body ergometer and a
functional electrical stimulation cycle.
Home medical equipment means an item that is a movable and durable
medical device that is used in a home or residential setting to treat
or support treatment of specific medical conditions. Such equipment
includes but is not limited to hospital beds, portable patient lifts,
portable ramps, ventilators, home dialysis equipment, and infusion,
feeding, or wound therapy pumps. This definition does not include
household furniture or furnishings, improvements or structural
alterations, household appliances, or medical alert devices. VA will
not furnish home medical equipment in such a manner as to relieve any
other person or entity of a contractual obligation to furnish these
items or services to the veteran.
Home respiratory equipment means an item used to provide oxygen
therapy or to support or enhance respiratory function, including but
not limited to compressed oxygen, oxygen concentrators, and continuous
positive airway pressure machines.
Household appliance means an item used in the home for performance
of domestic chores or other domestic tasks, including but not limited
to a refrigerator, stove, washing machine, and vacuum cleaner.
Household furniture or furnishing means an item commonly used to
make a home habitable or otherwise used to ornament a home, including
but not limited to tables, chairs, desks, lamps, cabinets, non-hospital
beds, curtains, and carpet(s).
Implant means any biological or non-biological material that:
(1) Is manufactured or processed to be placed into a surgically or
naturally formed cavity on the human body;
(2) Is covered with tissue, has the potential to be covered with
tissue, or is permanently embedded in tissue;
(3) Does not dissolve or dissipate within the body; and
(4) Is not a living organ, embryonic tissue, blood, or blood
product.
[[Page 48029]]
Improvements or structural alterations means a modification to a
home or to an existing feature or fixture of a home, including repairs
to or replacement of previously improved or altered features or
fixtures.
Medical alert device means an item designed to summon general
safety assistance for a veteran, or provides a veteran's general
medical information to others. This definition does not include alarms
or other safety indicators for home medical equipment.
Mobility aid means an item that compensates for a mobility
impairment and that is used to maintain or improve a veteran's
functional capabilities to be mobile. Mobility aids include but are not
limited to manual and motorized wheelchairs, canes, walkers, and
equipment to assist a veteran to reach for or grasp items This
definition does not include a service or guide dog.
Orthotic device means an item fitted externally to the body that is
used to support, align, prevent, or correct deformities or to improve
the function of movable parts of the body. Orthotic devices include but
are not limited to leg braces, upper extremity splints and braces, and
functional stimulation devices.
Primary residence means the personal domicile or residential
setting in which the veteran resides the majority of the year.
Prosthetic device means an item that replaces a missing or
defective body part. Prosthetic devices include but are not limited to
artificial limbs and artificial eyes.
Replacement item means an item that is similar or identical to an
item provided under Sec. 17.3230(a), and that takes the place of such
an item.
VA-authorized vendor means a vendor that has been authorized by VA
to provide items and services under Sec. 17.3230.
(Authority: 38 U.S.C. 501, 1701, 1710)
Sec. 17.3220 Eligibility.
A veteran is eligible to receive items and services described in
Sec. 17.3230 if:
(a) The veteran is enrolled under Sec. 17.36 or exempt from
enrollment under Sec. 17.37; and
(b) The veteran is otherwise receiving care or services under
chapter 17 of title 38 U.S.C. If a VA provider or an authorized non-
Department provider prescribes an item or service for the veteran, the
veteran is considered to otherwise be receiving care or services under
chapter 17 of title 38 U.S.C.
(Authority: 38 U.S.C. 501, 1701(6)(F), 1710)
Sec. 17.3230 Authorized items and services.
(a) VA will provide veterans eligible under Sec. 17.3220 with the
following items and services, if VA determines that such items and
services serve as a direct and active component of the veteran's
medical treatment and rehabilitation and do not merely support the
comfort or convenience of the veteran:
(1) Adaptive household items.
(2) Adaptive recreation equipment, when such equipment would
achieve the veteran's rehabilitation goals as documented in the
veteran's medical record.
(3) Cognitive devices.
(4) Communication devices.
(5) Home exercise equipment, where such equipment will only be
provided for one location, the veteran's primary residence, unless it
is clinically determined that the equipment should be provided at the
veteran's non-primary residence instead of the veteran's primary
residence. Prior to any installation of home exercise equipment, the
owner of the residence must agree to the installation. Such equipment
will only be provided to achieve the veteran's rehabilitation goals as
documented in the veteran's medical record.
(6) Home medical equipment, and if required, installation that does
not amount to an improvement or structural alteration to a veteran's
residence. Such equipment will only be provided for one location, the
veteran's primary residence, unless it is clinically determined that
the equipment should be provided at the veteran's non-primary residence
instead of the veteran's primary residence. Prior to any installation
of home medical equipment, the owner of the residence must agree to the
installation.
(7) Home respiratory equipment.
(8) Implants.
(9) Mobility aids.
(10) Orthotic devices.
(11) Prosthetic devices.
(12) Repairs to items provided under paragraph (a) of this section,
even if the item was not initially prescribed by VA, but VA determines
the repair to be necessary, unless VA determines to replace the item
for cost or clinical reasons.
(13) Replacement items, if items provided under this section have
been damaged, destroyed, lost, or stolen, or if replacement is
clinically indicated, subject to the following: Items that are
serviceable, and that still meet the veteran's need, will not be
replaced for the sole purpose of obtaining a newer model of the same or
similar item.
(14) Specialized clothing made necessary by the wearing of a
prosthetic device; and
(15) Training with and fitting of prescribed items as considered
necessary.
(b) Unless an item provided under Sec. 17.3230(a) is loaned to the
veteran based on a clinical determination that a loan is more
beneficial for the veteran, such items become the property of the
veteran once the veteran takes possession of those items. If the
determination is that the item will be loaned to a veteran, the veteran
must agree to the terms of the loan in order to receive the item.
Note to Section Sec. 17.3230: Even though the items and services
listed in this provision are included in the medical benefits package,
this section governs determinations of need for them and not 38 CFR
17.38(b). The exclusions under 38 CFR 17.38(c) will apply to the items
and services provided under this section. While VA will generally
provide only one item under this section, the provision of spare items
may be authorized based on a clinical determination of need using the
criteria set forth in this section.
(Authority: 38 U.S.C. 501, 1701(6)(F), 1710, 1714(a))
Sec. 17.3240 Furnishing authorized items and services.
(a) VA will determine whether VA or a VA-authorized vendor will
furnish authorized items and services under Sec. 17.3230 to veterans
eligible for such items and services under Sec. 17.3210.
(b) Except for emergency care reimbursable under 38 CFR 17.120 et
seq. or 38 CFR 17.1000 et seq., prior authorization is required for VA
to reimburse VA-authorized vendors for furnishing items or services
under Sec. 17.3230 to veterans. Prior authorization must be obtained
from VA by contacting any VA medical facility.
Sec. 17.3250. Veteran responsibilities.
(a) Veterans must use items provided under Sec. 17.3230 in the
manner for which they are prescribed, and consistent with the
manufacturer's instructions and any training provided. Failure to do so
may result in the item not being replaced under Sec. 17.3230(a)(13).
(b) Except for emergency care under 38 CFR 17.120 et seq. or
17.1000 et seq., veterans obtaining items and services provided under
Sec. 17.3230 must obtain prior authorization from VA in order to
obtain VA reimbursement for such items and services obtained from a VA-
authorized vendor. VA will not be responsible for the cost of items and
[[Page 48030]]
services provided that are not preauthorized by VA or that otherwise
are not covered as emergency care under 38 CFR 17.120 et. seq. or
17.1000 et seq.
(Authority: 38 U.S.C. 501, 1701, 1710, 1725, 1728)
[FR Doc. 2017-22358 Filed 10-13-17; 8:45 am]
BILLING CODE 8320-01-P