Prosthetic and Rehabilitative Items and Services, 48018-48030 [2017-22358]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[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 https://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 https://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.) 
Penny.Nechanicky@va.gov.

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 https://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 https://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].

0
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]

0
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