[Federal Register Volume 85, Number 248 (Monday, December 28, 2020)]
[Rules and Regulations]
[Pages 84245-84261]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27014]


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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: Final rule.

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SUMMARY: This rulemaking adopts as final, with changes, proposed 
amendments to VA's regulations governing the provision of prosthetic 
and rehabilitative items and services as medical services to veterans. 
This rulemaking establishes a new section for the provision of 
prosthetic and rehabilitative items and services, clarifies eligibility 
for such items and services, and defines the types of prosthetic and 
rehabilitative items and services available to eligible veterans.

DATES: This rule is effective on January 27, 2021.

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; 
[email protected]; (202) 461-0337. (This is not a toll-free 
number.)

SUPPLEMENTARY INFORMATION:

Background

    On October 16, 2017, VA published a proposed rule in the Federal 
Register (82 FR 48018) to revise VA's regulations governing the 
provision of prosthetic and rehabilitative items and services to 
eligible veterans. The proposed rule set forth revisions to reorganize 
and update

[[Page 84246]]

the regulations on prosthetic and rehabilitative items, and define the 
types of items and services available to eligible veterans. The 
proposed rule also put forward the elimination of existing prosthetics 
regulations at Sec.  17.150 of title 38, Code of Federal Regulations 
(CFR) and the establishment of entirely new sections at Sec. Sec.  
17.3200 through 17.3250. VA provided a 60-day comment period for the 
public to respond to the proposed rule. The comment period for the 
proposed rule ended on December 15, 2017, and VA received 305 comments.
    Based on a review of the public comments received on the proposed 
rule, VA drafted and published a Supplemental Notice of Proposed 
Rulemaking (SNPRM) in the Federal Register (83 FR 61137) on November 
28, 2018. The SNPRM provided clarification about provisions of the 
proposed rulemaking, included additional proposed amendments to Sec.  
17.3240 as proposed, and provided a 30-day comment period for the 
public to respond to the SNPRM and summit comments. The comment period 
for the SNPRM ended on December 28, 2018, and VA received 8 comments on 
the SNPRM. The SNPRM also provided notice regarding certain 
communications between VA and external parties regarding the proposed 
rule, and a summary of those communications were added to the public 
docket of the rulemakings.
    We appreciate the comments we received on the proposed rule and 
SNPRM, and have considered them when adopting this rulemaking as final.
    Several comments commended and supported revisions to the 
regulations identified in the proposed rule and the SNPRM. VA 
appreciates these comments for their support of these rules. All of the 
issues raised by the comments that concerned at least one portion of 
the rule can be grouped together by similar topic, and we have 
organized our discussion of the comments accordingly. For the reasons 
set forth in the proposed rule, in the SNPRM, and in further detail 
below, we are adopting the proposed rule as modified by the SNPRM and 
with additional changes as final.

Medical Alert Devices and Medical Identification Bracelets

    Several comments opposed the proposed elimination of the provision 
of medical alert devices. One comment stated that emergency assistance 
through cell phones is limited among the elderly population, which may 
not have cell phones and may have limited ability in making a cell 
phone call and identifying their location. This comment noted that the 
Freedom Alert device allows for easier and quicker notification of a 
medical emergency to emergency services or a family member than a cell 
phone, in particular because the device can be used to answer a call, 
and would also reduce costs of emergency services. Additionally, this 
comment suggested that the Freedom Alert device would be a small 
investment that would allow many veterans to remain in their homes, 
thus reducing the costs for institutionalized care, home health aide 
care, and assisted living. Another comment also noted that life alerts 
do not directly provide medical information, but rather allow a veteran 
to stay in their home with some safety measure versus having to be 
placed in a facility which is more costly. One comment also opined that 
these devices should not be eliminated as veterans may not have 
alternative technology or financial resources available to them. 
Additional comments noted other benefits of providing these devices, 
including that the device can: Be used to answer phone calls; be 
programmed to contact family first (thus reducing emergency response 
costs); allow those with limited dexterity to push a simple button; 
ensure the well-being of veterans and reduce anxiety; be used as a 
substitute for cell phones in rural areas with unreliable cell service; 
and prevent exacerbation of serious falls or health conditions. 
Comments also noted that eliminating these devices under this 
regulation would reduce quality of life and pose potential risk to 
veterans to everyday hazards, medical complications, and life-
threatening situations; and comments further asserted that if a 
treating physician requests such a device, it should be provided.
    Similarly, some comments opposed elimination of the provision of 
medical identification bracelets pursuant to the proposed rule. A 
comment opined that no longer providing such items would reduce a 
veteran's quality of life and may result in those who need monitoring 
or who have communication limitations being unable to convey medical 
issues. This inability to communicate medical information can affect an 
individual's peace of mind and emotional and mental functioning. 
Additionally, in response to the SNPRM, another comment expressed high 
concern about the elimination of medical identification bracelets, as 
veterans have been provided these bracelets for years, and these 
bracelets help veterans receive better care and better outcomes in 
emergencies when a veteran may not be able to communicate about 
conditions, allergies, etc. This comment also noted that in a survey of 
VA clinicians, 97 percent of them believed VA should continue to 
provide medical identification bracelets to veterans.
    We agree with the comments that medical alert devices as well as 
medical identification bracelets can be an important component of 
ensuring prompt medical response to emergency situations a veteran may 
encounter outside a hospital or clinic environment. However, when such 
devices and bracelets are purely communication devices that do not 
actively or directly treat or rehabilitate a veteran's health condition 
or limitation, they do not meet the direct and active component 
standard as described in the proposed rule. Medical identification 
bracelets particularly are entirely passive and do not actively 
communicate any information about a veteran, but merely provide a 
source of information about the existence of a condition of a veteran. 
Although many of the comments identified general benefits of providing 
medical alert devices and identification bracelets, such comments also 
failed to provide examples of how these devices would meet the direct 
and active component standard, and one comment averred that these 
devices do not contribute directly to an individual's treatment or 
rehabilitation. However, there were also some comments that did provide 
examples of benefits in providing these devices that may, in fact, rise 
to the level of meeting the direct and active component test. For 
example, some comments noted that some individuals need to be safe in 
their homes due to medical conditions, it may be possible for a 
clinician to determine that a medical alert device is the appropriate 
item to directly and actively contribute to the treatment of that 
medical condition. Therefore, in response to comments, we now revise 
the definition of the term home medical equipment in Sec.  17.3210 as 
proposed to remove the restriction on medical alert devices, and we 
further delete the proposed definition of medical alert device as it 
will no longer be needed. This revision will allow the prescribing 
clinician to assess a medical alert device under the same direct and 
active component standard as all other prosthetic and rehabilitative 
items and services. We note that this change will permit a clinician to 
assess clinical needs on a case by case basis as with all other types 
of home medical equipment as provided in the definition under Sec.  
17.3210 as

[[Page 84247]]

revised in this final rule, this change does not ensure that medical 
alert devices will be prescribed merely if they are requested or 
thought needed by a veteran. This change also does not reverse VA's 
rationale as stated in the proposed and supplemental proposed rules for 
not prescribing or approving the furnishing of these items in any case 
in which they serve merely in a monitoring or preventive function, as 
opposed to actively and directly contributing to treatment. When such 
devices and bracelets are purely communication devices that do not 
actively or directly treat or rehabilitate a veteran's health condition 
or limitation, they would not meet the direct and active component 
standard established in this rule and therefore would not be provided.
    As a result of this change, VA will ensure that applicable Veterans 
Health Administration (VHA) policy or guidance is revised or rescinded 
accordingly. For example, VHA Directive 2009-007, Provision of Medical 
Identification (ID) Bracelets and Pendants, provides that medical 
identification bracelets or pendants containing pertinent medical 
information (allergies or diagnoses) must be available, upon 
appropriate request from VA clinicians through VHA's Prosthetics 
Service, for veteran patients whose pertinent medical information would 
be valuable to emergency medical care providers. Although VA's proposed 
rule stated that VA would rescind VHA Directive 2009-007, upon this 
final rule being effective, we will instead revise VHA Directive 2009-
007 to clarify that medical alert devices and medical identification 
bracelets will be made available to veterans under the direct and 
active component standard as with all other prosthetic and 
rehabilitative items and services. We note that the direct and active 
component standard is explained more fully in the next section of this 
final rule that addresses comments on the proposed changes to Sec.  
17.38 and Sec.  17.3230.

Section 17.38, Medical Benefits Package and Sec.  17.3230, Authorized 
Items and Services

    We received multiple comments to the proposed revisions to current 
Sec.  17.38 and criteria in new proposed Sec.  17.3230. To aid in 
summarizing and responding to these comments, we first provide the 
following background and summary of what was proposed. The medical 
benefits package at Sec.  17.38 defines medical services that are 
available from VA to eligible veterans. Paragraph (a) of Sec.  17.38 
addresses the hospital, outpatient, and extended care services that 
constitute the medical benefits package, and prosthetic devices are 
included in the medical benefits package at Sec.  17.38(a)(1)(viii). We 
proposed amending Sec.  17.38(a)(1)(viii) to state that the medical 
benefits package includes prosthetic and rehabilitative items and 
services as authorized under proposed Sec. Sec.  17.3200 through 
17.3250, to reference the new proposed criteria in Sec. Sec.  17.3200 
through 17.3250, versus extensive and likely confusing additional 
revisions to Sec.  17.38 that would apply only to prosthetic and 
rehabilitative items and services. Current Sec.  17.38(b) provides that 
care referred to in the medical benefits package at Sec.  17.38(a) will 
be provided by VA 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. We proposed amending the introductory 
sentence to Sec.  17.38(b) to exclude prosthetics and rehabilitative 
items and services from the requirements in Sec.  17.38(b) 
(specifically, not subject to the promote, preserve, or restore 
standard in Sec.  17.38(b)), and proposed a different standard in 
proposed Sec.  17.3230(a) that VA would provide prosthetic and other 
rehabilitative devices where VA determines that such items and services 
serve as a direct and active component of a veteran's medical treatment 
and rehabilitation and do not merely support the comfort or convenience 
of the veteran.
    In addition to the background above, we will summarize and discuss 
below those comments that related to proposed revisions to Sec.  17.38 
and to Sec.  17.3230(a) as proposed in two general categories: (1) 
Those comments related more directly to VA's standards in determining 
medical necessity for prosthetic and rehabilitative items and services; 
and (2) those comments related more directly to VA's practices and 
continued provision of prosthetic and rehabilitative items and 
services.

Comments Related to VA's Standards in Determining Medical Necessity for 
Prosthetic and Rehabilitative Items and Services

    We received several comments that generally opposed VA's 
consideration of medical necessity in its determination to provide 
prosthetic and rehabilitative items and services, and one comment 
specifically objected to the proposed rule's interpretation of 38 
U.S.C. 1701(6)(F)(i)-(iii) to find that prosthetic and rehabilitative 
items are considered medical services to require VA to consider medical 
necessity. At least one comment also stated that because non-VA 
programs and studies have struggled with defining medical necessity, VA 
should not consider medical necessity in the provision of prosthetic 
and rehabilitative items and services, and further stated that 
considering medical necessity is contrary to VA's policy, mission, and 
public statements.
    We first address those comments that generally opposed VA's 
consideration of medical necessity in its determination to provide 
prosthetic and rehabilitative items and services. We reiterate from the 
proposed rule that VA is required to consider medical necessity in the 
provision of prosthetic and rehabilitative items and services, as 38 
U.S.C. 1710(a) provides that VA shall furnish, or is authorized to 
furnish, hospital care and medical services that the Secretary 
determines to be needed.
    In response to another comment, we note that the term medical 
services is further defined in 38 U.S.C. 1701(6)(F) to include: (i) 
Wheelchairs, artificial limbs, trusses, and similar appliances; (ii) 
special clothing made necessary by the wearing of prosthetic 
appliances; and (iii) such other supplies or services as VA determines 
to be reasonable and necessary, where VA has interpreted section 
1701(6)(F)(i)-(iii) to authorize the provision of prosthetic and 
rehabilitative items generally. To address the comment that objected to 
the proposed rule's interpretation of section 1701(6)(F) to find that 
prosthetic and rehabilitative items are considered medical services to 
require VA to consider medical necessity, we reiterate from the 
proposed rule that VA has interpreted section 1701(6)(F)(iii) to 
authorize the provision of other supplies and services if 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) because such other supplies and services are 
similarly required to assist a veteran to compensate for the loss of 
mobility or loss of other functional abilities. 82 FR 48019. 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

[[Page 84248]]

VAOPGCADV 7-2009, VAOPGCADV 9-2005, VAOPGCCONCL-8-98.
    We next address the comment that asserted VA struggles with 
defining medical necessity and therefore should not consider it when 
determining whether to provide prosthetic or rehabilitative items or 
services, and that further asserted consideration of medical necessity 
is contrary to VA's practice, mission, or messaging. We reiterate from 
the proposed rule that durable medical equipment and prosthetic and 
orthotic devices are expressly listed as medical services available to 
eligible veterans as part of VA's medical benefits package in Sec.  
17.38(a)(1)(viii). When VA promulgated Sec.  17.38, we explained that 
the promote, preserve, or restore standard in Sec.  17.38(b) would be 
used to determine whether health care and services available under 
Sec.  17.38(a) were medically needed for a veteran. See 63 FR 37300. 
VA's assessment of medical need for prosthetic and rehabilitative items 
and services is clearly stated in Sec.  17.38(a)(1)(viii) and (b) and 
is longstanding VA practice.
    We received other comments that did not object to VA's 
consideration of medical necessity per se in providing prosthetic and 
rehabilitative items and services, but that opposed replacement of the 
promote, preserve, or restore standard in current Sec.  17.38(b) with 
the direct and active component standard in Sec.  17.3230(a) as 
proposed. We note that a few of these comments did not indicate an 
understanding that the current promote, preserve, or restore standard 
already required VA to consider medical necessity in the provision of 
medical services generally, so we again clarify that it has been 
longstanding VA practice to use the promote, preserve, or restore 
standard under Sec.  17.38(b) when determining medical necessity for 
care and services provided in the medical benefits package under Sec.  
17.38(a), to include prosthetic and rehabilitative items under Sec.  
17.38(a)(1)(viii). We reiterate from the proposed rule that VA has 
found it necessary, however, to more specifically characterize medical 
necessity in the context of providing prosthetic and rehabilitative 
items and services through establishing the more specific direct and 
active component standard in Sec.  17.3230(a) as proposed. 82 FR 48019. 
The direct and active component standard in Sec.  17.3230(a) as 
proposed is more appropriately descriptive of VA's assessment of 
veterans' medical need for prosthetic and rehabilitative items and 
services because these items and services are durable medical 
equipment, which is a unique category of care under Sec.  17.38(a) that 
functions as an extension of the direct provision of clinical treatment 
from a provider to a veteran. The extended use of reusable, durable 
medical equipment by a veteran as part of their treatment or 
rehabilitation warrants additional considerations on VA's part to 
ensure such equipment is not merely beneficial but is also medically 
necessary.
    Although we believe the direct and active component standard in 
Sec.  17.3230(a) as proposed provides for the appropriate assessment of 
medical necessity in the context of prosthetic and rehabilitative items 
and services, we have reconsidered the exclusion of prosthetic and 
rehabilitative items and services from the requirements in Sec.  
17.38(b) based on public comments. Based on comments, we now find that 
the direct and active component test in Sec.  17.3230(a) as proposed 
should supplement the promote, preserve, and restore standard as well 
as all other requirements in Sec.  17.38(b). We therefore now remove 
the parenthetical exception for prosthetics and rehabilitative items 
and services from Sec.  17.38(b) as proposed, to leave the reading of 
Sec.  17.38(b) as it is in its current state with regard to the 
application of the promote, preserve, or restore standard to all care 
and services available under Sec.  17.38(a), to include prosthetic and 
rehabilitative items and services under Sec.  17.38(a)(1)(viii). To 
further ensure it is clear that VA considers both the promote, 
preserve, and restore standard under Sec.  17.38(b) as well as the 
supplemental direct and active component standard in Sec.  17.3230(a) 
as proposed when assessing medical need, we now revise Sec.  17.3230(a) 
as proposed to clearly reference the assessment of medical need under 
Sec.  17.38(b). Section 17.3230(a) will now state that VA will provide 
veterans with prosthetic and rehabilitative items and services if VA 
determines that such items and services are needed under Sec.  
17.38(b), serve as a direct and active component of the veteran's 
medical treatment and rehabilitation, and do not solely support the 
comfort or convenience of the veteran. We note that revisions to Sec.  
17.38(a)(1)(viii) as proposed indicated that prosthetic and 
rehabilitative items and services will be available as authorized by 
Sec. Sec.  17.3200 through 17.3250, and we are retaining that language 
in this final rule to ensure it is clear that the prescription of 
prosthetic and rehabilitative items is subject not only to the promote, 
preserve, or restore standard in Sec.  17.38(b), but also subject to 
the direct and active component standard in Sec.  17.3230(a) as 
proposed. We additionally revise the reference to ``Sec. Sec.  
17.3200-.3250'' in Sec.  17.38(a)(1)(viii) as proposed, to remove the 
dash and insert the word through, to indicate the range of applicable 
sections from Sec. Sec.  17.3200 through 17.3250. To further ensure 
consistency between the medical necessity standards in Sec. Sec.  
17.38(b) and 17.3230, we are revising and moving the language in the 
note at the end of Sec.  17.3230 as proposed to further clarify that 
Sec.  17.3230 supplements determinations of need for items and services 
listed in Sec.  17.3230(a) in addition to the requirements in Sec.  
17.38(b). The revised language in the former note at the end of Sec.  
17.3230 as proposed will now be lcoated in Sec.  17.3230(a)(2), and we 
will renumber Sec.  17.3230(a) as proposed to Sec.  17.3230(a)(1), and 
renumber Sec.  17.3230(a)(1) through (15) as proposed to Sec.  
17.3230(a)(1)(i) through (xv), respectively. We are also revising Sec.  
17.3240(a)(1) as proposed to remove the phrase that indicated items 
will be prescribed based on the veteran's clinical needs and replace it 
with a clearer reference to the clinical needs assessments in Sec.  
17.3230(a) (which are the needs assessment under both Sec. Sec.  
17.38(b) and 17.3230(a)). Lastly, we are removing extraneous language 
that alludes to a specific item or service listed in Sec.  
17.3230(a)(1) through (15) as being separately or additionally assessed 
for necessity, as this would be duplicative of the clarifications and 
revisions explained above. Specifically, we are revising Sec.  
17.3230(a)(12) and (15) as proposed to remove such extraneous language. 
However, we reiterate from the proposed rule that an item under Sec.  
17.3230(a) could be repaired if it is determined that the item meets 
the needs assessment in Sec.  17.3230(a). 82 FR 48018, 48024. The same 
logic follows for Sec.  17.3230(a)(15) with regards to fitting and 
training, that such fitting and training for an item will be provided 
as long as such item is found to meet the needs assessment under Sec.  
17.3230(a).
    Because the proposed rule did not indicate that the direct and 
active component test in Sec.  17.3230(a) should supplement, versus 
replace, the requirements in Sec.  17.38(b), we now provide an example 
of VA's assessment of both the medical necessity standards under 
Sec. Sec.  17.38(b) and 17.3230(a) as proposed and made final in this 
rulemaking. In this example, a provider who is treating a veteran may 
determine that a number of clinical approaches are medically necessary 
to treat a veteran's sleep apnea by assisting the veteran to

[[Page 84249]]

maintain a less obstructed airway while sleeping, such as lifestyle 
changes (losing weight or quitting smoking), or treatment for nasal 
allergies or other upper respiratory ailments or illnesses. Under the 
medical benefits package in Sec.  17.38(a), the veteran could receive 
weight management and smoking cessation counseling, and could be 
prescribed allergy medications as needed, where all of these care and 
services meet the promote, preserve, or restore standard in Sec.  
17.38(b). None of these care and services would be considered 
prosthetic or rehabilitative items under Sec.  17.38(a)(1)(viii), and 
the assessment of clinical need would be fully met under the Sec.  
17.38(b) promote, preserve, or restore standard. This veteran's 
provider, however, may also determine that a continuous positive airway 
pressure (CPAP) machine would be necessary for the veteran to maintain 
an unobstructed airway while sleeping. A CPAP machine is a durable 
piece of equipment that would be considered a prosthetic or 
rehabilitative item under Sec.  17.38(a)(1)(viii). As such, the 
provider would assess medical need under the requirements in Sec.  
17.38(b) and could specifically find the standard under Sec.  
17.38(b)(3) to be met because the CPAP machine could be found to 
restore the daily functional level of the veteran's airway that has 
been obstructed due to illness or injury. The provider would then also 
assess the CPAP machine under the direct and active component standard 
in Sec.  17.3230(a) as proposed and could find this standard to be met 
because the CPAP machine delivers air pressure through a mask to 
directly and actively assist a veteran to maintain an unobstructed 
airway while sleeping. A CPAP machine would also meet the requirement 
under Sec.  17.3230(a) as proposed as not being solely for the comfort 
or convenience of the veteran.
    We believe the considerations under Sec.  17.3230(a) as proposed 
establish additional context that is necessary when assessing medical 
need for prosthetic and rehabilitative items and services, where the 
promote, preserve, or restore standard in Sec.  17.38(b) by itself may 
not provide adequate context. In the example above of the veteran with 
sleep apnea, for instance, a durable item could be provided under Sec.  
17.38(b)(1) because it promotes health, even if it merely makes the act 
of sleeping seem subjectively easier for a veteran but does not 
directly address the medical issue of an obstructed airway while 
sleeping. A white noise machine is a durable item that may tend to make 
a veteran with sleep apnea feel that it is easier to fall or stay 
asleep, but a white noise machine does not address the medical issue of 
the veteran's obstructed airway while sleeping. Without the additional 
consideration of the direct and active component standard in Sec.  
17.3230(a), it could be possible for a white noise machine to be 
provided under the standard in Sec.  17.38(b)(1) because it promotes 
health by enhancing the quality of life or daily functional level of a 
veteran.
    The additional consideration that prosthetic and rehabilitative 
items and services must be a direct and active component of treatment 
in Sec.  17.3230(a) as proposed helps ensure that VA only furnishes 
durable items that are medically necessary. This is consistent with 
current and longstanding VA practice that requires all prescriptions 
for prosthetic and rehabilitative items to include a medical 
justification that draws a nexus between the item and the function it 
will perform for that condition. As we will respond more directly in 
this rule in relation to the comfort and convenience language from 
Sec.  17.3230(a) as proposed, this nexus between an item and its 
function to medically address a condition does not mean that items may 
not be both beneficial and necessary; but, there must be a medical need 
for an item, and the additional considerations in Sec.  17.3230(a) as 
proposed help ensure that is the case.
    Several comments further opposed elimination of the promote, 
preserve, or restore standard due to concern that the direct and active 
component standard could reduce services to veterans, eliminate most 
quality of life items, and reduce veterans' quality of life. As 
clarified above, the direct and active component standard in Sec.  
17.3230(a) as proposed will supplement and not replace VA's assessment 
of medical need under Sec.  17.38(b). Although it is the case that the 
direct and active component standard will not support VA's provision of 
comfort or convenience items that are not medically required, this 
additional standard should not result in any reduction of medically 
necessary items or services currently being provided to veterans. Most 
items currently provided will continue to be provided so long as they 
are determined by VA health care providers or authorized non-VA 
providers to be medically necessary using both the promote, preserve, 
and restore standard under Sec.  17.38(b) and the direct and active 
component standard in Sec.  17.3230(a) as proposed.
    For the reasons stated in the proposed rule and above, we adopt as 
final the direct and active component standard and other language in 
Sec.  17.3230(a) as proposed with some revisions. We reiterate that 
removing the parenthetical exception from the proposed revision to 
Sec.  17.38(b), as well as the additional revisions to Sec.  17.3230(a) 
and the note at the end of Sec.  17.3230 (to reference Sec.  17.38(b)) 
will clarify that we are supplementing rather than replacing the 
promote, preserve, or restore standard in Sec.  17.38(b).

Comments Related to VA Practices and Continued Provision of Prosthetic 
and Rehabilitative Items and Services

    One comment opined that there is no reason to change the standards 
and criteria for providing prosthetic and rehabilitative items and 
services if we intend to continue current practices. We clarify that we 
are only changing our regulations to conform with current practice; 
these regulations will convey more clearly to the public how we 
administer these benefits and clarify our current practices for the 
public. In those cases where regulatory language does not accurately 
reflect current practice, we should update it to reflect the standard 
we use so that the public is informed of and understands the standards, 
criteria, and requirements that VA uses to provide these benefits.
    Comments also raised concerns that prosthetics representatives 
could deny a prescribed item or service if they determine it to be more 
of a comfort or quality of life item and not a medically necessary 
item. One comment stated that prosthetics representatives may lack 
necessary training, which could result in denial of a physician-
recommended item or service because the item is viewed as convenient 
rather than medically necessary. It was also recommended that we remove 
the language in proposed Sec.  17.3230 that stated that items or 
services must not merely support the comfort or convenience of the 
veteran as this would ensure that veterans are not inappropriately 
denied medically-indicated items because someone not trained in 
prosthetics and rehabilitation may view a prescribed item as convenient 
rather than medically necessary. To address these comments, VA is not 
precluded from providing medically necessary prosthetic and 
rehabilitative items and services that are additionally beneficial to 
the veteran or support the comfort and convenience of the veteran. 
However, VA will not provide prosthetic and rehabilitative items and 
services merely because they support the veteran's comfort or 
convenience only. Prosthetic and rehabilitative services or items may 
be medically necessary, and incidentally or

[[Page 84250]]

directly support the comfort and convenience of the veteran. In 
response to this comment, we have not removed the comfort and 
convenience language as we believe it is important and necessary to 
include in the regulation as it is reflective of our current practices. 
However, we have removed the word merely that was in proposed Sec.  
17.3230(a) and have replaced it with the word solely in order to 
reflect that an item or service will not be provided exclusively for 
comfort or convenience. We believe this addresses any potential 
confusion and more accurately reflects our intent.
    To more specifically address the concern raised in the comment 
related to the input of prosthetic representatives, we note that 
prosthetics representatives give deference to the prescription written 
by a VA health care provider or an authorized non-VA health care 
provider. In the instance that a prosthetic representative may question 
whether a prescribed item or service meets the direct and active 
component standard in Sec.  17.3230(a), the prosthetics representative 
would discuss such concerns with the provider. As long as the item or 
service is prescribed as medically necessary under the standards in 
both Sec. Sec.  17.38(b) and 17.3230(a), it will be provided if it can 
be procured; and it may be the case that in such instances a level of 
comfort and convenience is concomitantly obtained. Indeed, comfort and 
convenience are valid clinical considerations in many decisions about 
which item or service will best meet a veteran's clinical needs.
    In sum, VA will continue to support the holistic care of our 
Veterans. The decision about what item will best meet the Veteran's 
needs will be determined jointly by clinicians and veterans, which will 
result in a prescription for an item. The clinician will continue to 
consider how a specific item may be optimized to meet the veteran's 
unique needs like other diagnosed medical conditions and preserve 
functional independence. For example, VA wheeled mobility clinics will 
continue to partner with veterans, conduct comprehensive evaluations of 
veterans, and consult with clinicians across disciplines to identify 
and prescribe the wheeled mobility device that will best meet a 
veteran's needs. This could be a basic powered wheelchair, one that is 
optimized for transportation in a given urban environment, or an all-
terrain powered wheelchair that could allow the veteran to navigate 
natural obstacles that the veteran encounters on a daily basis. The 
direct and active component standard in Sec.  17.3230(a) will not 
restrict VA's ability to provide this equipment.
    One comment stated that the regulations do not distinguish between 
service-connected versus non service-connected veterans, as the former 
traditionally have been able to choose their provider in limited 
circumstances pursuant to VA policy. While we note that the policy 
documents referred to by the comment do distinguish between service-
connected and non-service connected veterans, the policy documents do 
not provide an all-inclusive list of factors that should be considered 
when providing prosthetic or rehabilitative services, such as the 
veteran's clinical needs, and it was our intent that VA clinical 
providers would be involved in the decision on how the veteran's needs 
can be best met. Authorities such as 38 U.S.C. 1703 previously 
distinguished between these groups of veterans, but this authority was 
amended by the VA Maintaining Internal Systems and Strengthening 
Integrated Outside Networks (MISSION) Act of 2018, Public Law 115-182, 
and as amended, section 1703 no longer recognizes a distinction between 
service-connected and non service-connected care. We see no valid 
reason to continue to distinguish between these groups of veterans with 
regard to the provision of prosthetic and rehabilitative items and 
services, particularly as we believe there are compelling reasons to be 
consistent in how we determine whether VA or an authorized non-VA 
vendor will provide the prescribed item or service, as explained in 
this paragraph and in the SNPRM. See 83 FR 61139-61142.
    One comment raised concerns that proposed Sec.  17.3230(a)(2), 
which would provide that VA furnishes adaptive recreation equipment 
when such equipment would achieve the veteran's rehabilitation goals as 
documented in the veteran's medical record, would limit access to 
rehabilitative items such as sport-specific wheelchairs. The comment 
noted that participation in sports is part of a veteran's 
rehabilitation goals and overall health. We acknowledge that the needs 
of veterans are unique, and the veteran is involved in the decision on 
the appropriate item to be prescribed based on his or her unique needs 
and to ensure his or her clinical needs are met. We specifically note 
that rehabilitation goals, developed jointly by the veteran and 
clinician, will be considered when determining the appropriate item or 
service to be provided to the veteran pursuant to these regulations. As 
long as the sports-related item meets the medical necessity standards 
set forth in Sec. Sec.  17.38(b) and 17.3230(a), we do not believe that 
any additional requirements in Sec.  17.3230(a)(2) such as 
documentation of goals in a medical record will prevent provision of 
such items.
    Another comment supported VA for including adaptive recreation 
equipment in the list of equipment VA will provide under these 
regulations, but suggested VA clarify that the medical need for such 
equipment may be identified within inpatient and outpatient settings. 
We note that there is nothing in the regulation limiting the 
determination of the medical need for prosthetic and rehabilitative 
items and services to inpatient or outpatient care or that the 
determination needs to be made within a certain timeframe. The 
determination that a prosthetic or rehabilitative item or service is 
medically needed can be made at any time by VA. As long as the 
equipment meets the medical necessity standards in Sec. Sec.  17.38(b) 
and 17.3230(a), it will be provided regardless of whether the veteran 
is in an inpatient or outpatient setting. We also note that a veteran's 
medical needs and rehabilitation goals can change over time, and these 
regulations would not limit VA's ability to prescribe a new piece of 
equipment based on a change in the veteran's medical needs.
    Another comment raised concerns that the definition of adaptive 
recreation equipment in Sec.  17.3210 as proposed was too restrictive 
and that it could negatively impact veterans' quality of life. The 
comment referred to the language in the preamble that states that such 
equipment will not be provided merely to support a veteran's 
participation in an activity only for personal enjoyment. This comment 
explained that if a medical professional determines that such equipment 
is needed for medical or therapeutic reasons, prosthetics personnel can 
deny the appliance by determining it is for personal enjoyment. Similar 
to the explanation in prior discussion of this rulemaking on the issue 
of the comfort or convenience language in Sec.  17.3230(a), VA is not 
precluded from providing adaptive recreation equipment if such 
equipment is additionally beneficial to the veteran or supports a 
veteran's participation in an activity for personal enjoyment. VA 
clinicians work closely with veterans to identify recreation activities 
and needed adaptive recreation equipment that are consistent with the 
veteran's individualized rehabilitation goals. While considering 
physical rehabilitation needs, the clinician and veteran simultaneously 
consider quality of life opportunities that are uniquely presented by

[[Page 84251]]

recreation, like personal enjoyment and fulfillment, and socialization 
with friends, family, and fellow veterans. However, VA will not provide 
adaptive recreation equipment solely because the equipment supports the 
veteran's participation in an activity for personal enjoyment. This 
equipment authorized under Sec.  17.3230(a)(2) will be provided only if 
it meets the medical necessity requirements under Sec. Sec.  17.38(b) 
and 17.3230(a).
    We note that the provision of adaptive recreation equipment is one 
component of a comprehensive VA approach to reach out to veterans and 
encourage their participation in recreational and leisure activities, 
led by the VA Recreation Therapy Service. This service embraces a 
philosophy of health promotion and disease prevention facilitated by 
qualified clinicians to enhance physical, cognitive, emotional, social, 
and leisure development that support each veteran's self-directed, 
self-determined, and fully independent participation in their chosen 
life pursuits. The VA recreation therapist's role is not to focus 
solely on the medical diagnosis, but to improve and enrich bio-psycho-
social functioning through active therapy and meaningful therapeutic 
activities to maintain or improve functional independence and life 
quality. VA also regularly conducts National Veteran Sports Programs 
and Special Events, in which we encourage veterans to participate and 
focus on their specific abilities, rather than disabilities. 
Additionally, VA connects veterans to the community of recreational 
resources via the VA Adaptive Sports Grant program to engage in 
activities that promote independent veteran participation in activities 
designed for personal enjoyment.
    We do not make changes to the definition of the term adaptive 
recreation equipment based on the comments above, but we do revise 
Sec.  17.3230(a)(2) to remove all language after the term adaptive 
recreation equipment, as this language is duplicative of the definition 
of adaptive recreation equipment in Sec.  17.3210.
    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. We stated that 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. One comment stated that the 
definition of and references to replacement item should include that 
the item will be of similar value. We address this comment in terms of 
the cost of a replacement item because cost is an objective comparison 
to the item being replaced, versus the subjective and broader 
comparison of value. When considering whether to replace an item, VA 
considers the veteran's clinical needs and whether the replacement item 
would meet the medical necessity standards in Sec. Sec.  17.38(b) and 
17.3230(a). If the replacement item is the same as the previously 
prescribed and provided item, then we would expect the cost of the 
replacement item would be the same or very similar to the original 
item. The focus will be on what replacement item would be most 
appropriate to provide to meet the veteran's clinical needs, and the 
most appropriate item may not be the same item previously prescribed 
and consequently may not be the same cost as the item previously 
prescribed.
    Proposed Sec.  17.3230(a)(14) would authorize the provision of 
specialized clothing made necessary by the wearing of a prosthetic 
device, while paragraph (a)(6) would authorize VA to provide certain 
home medical equipment. One comment suggested that VA not purchase 
items, such as socks, shoes, heating pads, and scales, that can be 
purchased at retail stores. While many of these described items may be 
available for purchase at retail stores, VA will provide those items 
pursuant to this rulemaking as long as the provision of such items 
meets the medical necessity standards under Sec. Sec.  17.38(b) and 
17.3230(a) and the items are one of the types of items expressly 
identified under proposed Sec.  17.3230. That a retail store may carry 
such items would not preclude VA from providing an item to a veteran if 
the criteria and requirements in the regulation are met, similar to 
VA's provision of prescription drugs that are available over the 
counter under Sec.  17.38(a)(1)(iii). The provision of such items would 
be within VA's authority. We further note that eligibility for the 
provision of specialized clothing made necessary by the wearing of a 
prosthetic device is not the same as the clothing allowance provided 
under 38 CFR 3.810 and authorized by 38 U.S.C. 1162, which is intended 
to provide a clothing allowance to veterans with certain service-
connected disabilities.

Section 17.3240 Furnishing Authorized Items and Services

    We proposed in Sec.  17.3240(a) that VA would 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. As stated in the preamble of the proposed rule, 
the intent of the language in Sec.  17.3240(a) as proposed was to 
establish that when VA has the capacity or inventory, VA directly 
provides items and services to veterans, but that 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. The intent of 
Sec.  17.3240(a) as proposed was to clarify in regulation that whether 
VA or a VA-authorized vendor provides a prosthetic item is an 
administrative business decision that 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 its 
duty to administer this program in a legally sufficient, fiscally 
responsible manner.
    We received over 280 comments concerning proposed Sec.  17.3240, 
and the vast majority of these comments (228) addressed the same issues 
in nearly identical language. The main arguments in these comments 
included the following: VA would have sole discretion in determining 
how prosthetic and orthotic care is delivered to veterans; this 
rulemaking would eliminate veterans' choice of provider; it would 
contradict long-standing practice and policy of VA regarding a 
veteran's choice of provider (particularly relating to prosthetic 
limbs); it would disregard the history of cooperation between VA and 
contracted providers as well as veterans' clinical needs; and it would 
directly conflict with public statements made by VA regarding veterans' 
choice in health care. It was also argued that this decision on how to 
provide prosthetic and orthotic care to veterans is not an 
administrative decision, but rather a clinical one. We note that these 
concerns were primarily raised in reference to the provision of 
prosthetic limbs (also referred to as artificial limbs).
    In the SNPRM published on November 28, 2018, we clarified and 
explained our current practices for the general provision of prosthetic 
and rehabilitative items and services, and specifically, the provision 
of prosthetic limbs. See 83 FR 61137. In the SNPRM, we also addressed 
many of the concerns discussed above regarding the comments to the 
proposed rule. We also note that the SNPRM addressed other concerns 
raised in response to the proposed rule. These other concerns

[[Page 84252]]

that the SNPRM addressed included that this proposed rule would be 
inconsistent with the Veterans Access, Choice, and Accountability Act 
of 2014, Public Law 113-146 (Choice Act), with VA policy and with 
current practices; that it would alter current practices; that it may 
implicate other community care authorities (i.e., 38 U.S.C. 1703 and 
8153); and that we did not cite to or reference the authority for Sec.  
17.3240.
    In response to public comments on the proposed rule, the SNPRM 
revised Sec.  17.3240(a) as proposed to state that VA providers will 
prescribe items and services based on the veteran's clinical needs and 
will do so in consultation with the veteran, which we believed was 
responsive to the concerns related to clinical decision making and 
retaining veteran input clarified that this is current VA practice. See 
83 FR 61141. The SNPRM also revised Sec.  17.3240(a) as proposed to 
state that once the prescribed item or service is determined to be 
authorized under Sec.  17.3230, 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.  17.3220, and further that the determination on whether VA or a 
VA-authorized vendor will furnish the authorized item or service under 
Sec.  17.3230 will be based on, but not limited to, such factors as the 
veteran's clinical needs, VA capacity and availability, geographic 
availability, and cost. We believed these additional revisions made in 
the SNPRM to Sec.  17.3240(a) as originally proposed further supported 
and clarified current VA practice concerning how VA makes the 
administrative decision regarding who furnishes a prosthetic item to a 
veteran (i.e., VA or a VA-authorized vendor), for the benefit of both 
veterans and VA-authorized vendors. See 83 FR 61141.
    In response to the SNPRM, we received 8 comments, many of which 
raised the same concerns previously raised in response to the language 
in Sec.  17.3240(a) as originally proposed. In response to these same 
concerns as raised in comments to Sec.  17.3240(a) as originally 
proposed, we reiterate from above that the revisions made in the SNPRM 
clarified that current VA practice does consider clinical need and 
consider veteran input, but also that VA retains control over the 
administrative decision of whether to provide the prosthetic item 
directly to the veteran or have it provided by a VA-authorized vendor. 
See 83 FR 61139-61143. We address below other comments we received to 
the SNPRM.
    In response to the SNPRM, one comment commended VA for the emphasis 
on clinical consultation between the veteran and VA providers in Sec.  
17.3240 and the supporting explanation provided within the SNPRM. One 
comment expressed an expectation that in applying Sec.  17.3240, a 
veteran's prosthetic needs will outweigh any concern with nationwide 
consistency when items are clinically recommended. We acknowledge that 
prosthetic and rehabilitative items and services will be prescribed 
based on a determination that such item or service is medically 
necessary under the direct and active component standard, and that 
medical need will outweigh other concerns such as nationwide 
consistency. This prioritization of medical need is consistent with 
current practice.
    In the SNPRM, we did not specifically address the concern raised in 
the 228 comments that this rulemaking would disregard the history of 
cooperation between VA and contracted providers. Related to this set of 
comments, one comment stated that through these regulations, VA will 
restrict a veteran's ability to receive care from non-VA contractors. 
We now state that this rulemaking does not disregard this history of 
cooperation, as we intend to continue to contract and work with non-VA 
providers to provide the most appropriate and high-quality care, and we 
acknowledge that VA alone cannot meet every veteran's prosthetic and 
rehabilitative needs. VA has over 600 contracts with non-VA providers 
that are utilized to meet the clinical needs of veterans, and we intend 
to continue to utilize such contracts. As explained in the SNPRM, 
veterans will continue to receive care from authorized non-VA 
providers, and this determination is based upon the clinical needs of 
the veteran, as well as additional considerations (e.g., VA capacity 
and availability, geographic availability, cost) which will vary on a 
case by case basis. See 83 FR 61137-61142. These determinations will be 
made for routine, non-urgent, and non-emergent needs for durable 
medical equipment and medical devices. This will ensure that veterans' 
needs are met with the most appropriate and highest quality items and 
services in a consistent manner throughout VA and ensure that VA 
complies with Federal acquisition requirements. Id. As noted in the 
SNPRM revision to Sec.  17.3240(a)(2), we consider veterans' clinical 
needs when determining whether to provide artificial limbs and all 
other items and services under Sec.  17.3230(b) internally or via 
authorized community vendors.
    Several comments raised concerns that Sec.  17.3240 is inconsistent 
with the Choice Act. In the SNPRM, we addressed this concern, and 
incorporate in this final rule our related response from the SNPRM. See 
83 FR 61139-61140. We further note that, effective June 6, 2019, VA was 
no longer authorized to furnish care and services under section 101 of 
the Choice Act. Consequently, we consider these comments to be moot.
    One comment specifically stated that Sec.  17.3240(b) should not 
prevent a provider authorized under the Choice Act to provide care to a 
veteran from providing all items and services related to the care being 
furnished. Similarly, another comment opined that once care is 
authorized in the community, all care should be authorized without 
additional authorization being needed. VA treated prescriptions from 
authorized community providers under the Veterans Choice Program, and 
treats prescriptions under the Veterans Community Care Program, the 
same way that a prescription from an internal VA provider would be 
managed. As explained in the SNPRM, if VA authorized a community 
provider to furnish care to a veteran pursuant to the Choice Act and it 
was determined that a prosthetic or rehabilitative item or service is 
needed, VA would review the prescribed item or service to determine 
whether the prescribed item is within the scope of the authorized 
community care; this requirement applies as well to the Veterans 
Community Care Program. As long as the prescribed item or service meets 
the medical necessity standards in Sec. Sec.  17.38(b) and 17.3230(a) 
and is otherwise authorized pursuant to Sec. Sec.  17.3230 through 
17.3250, then VA will provide the item to the veteran either directly 
or through a VA-authorized vendor. If the prescription is lacking 
sufficient justification, VA will attempt to contact the prescribing 
clinician and may consult with internal VA clinicians with subject 
matter expertise if necessary. If the prescribing clinician or a 
consulted VA clinician is able to provide the needed justification, 
then VA will provide the item to the veteran either directly or through 
a VA-authorized vendor. If the prescribing provider does not respond or 
otherwise provide the necessary justification, then VA is not 
authorized to purchase the item for the veteran. In such an instance, 
VA will ensure that the veteran is seen by a provider who can determine 
whether the initially prescribed item or another item or service is 
needed. We further note that

[[Page 84253]]

in VA's regulations implementing the Veterans Community Care Program, 
VA stated it would pay for prescriptions written by eligible entities 
or providers for covered veterans that have an immediate need for 
durable medical equipment and medical devices that are required for 
urgent or emergent conditions, and that VA would fill prescriptions 
written by such entities and providers for covered veterans for durable 
medical equipment and medical devices that are not required for urgent 
or emergent conditions. See 38 CFR 17.4025(b)(3) and (4). To ensure 
consistency with these community care regulations, we now revise Sec.  
17.3240(a)(1) to similarly state that VA providers or eligible entities 
and providers as defined in 38 CFR 17.4005 will prescribe items and 
services based on the veteran's clinical needs and will do so in 
consultation with the veteran. We further revise Sec.  17.3240(a)(2) 
and (3) to reflect that once an item or service is authorized under 
paragraph (a)(1), VA will either fill a prescription directly or will 
pay for such prescriptions to be furnished through a VA-authorized 
vendor. Lastly, to ensure these regulations are consistent with VA's 
community care regulations, we revise Sec.  17.3240(b) to include 
mention of emergency care available under 38 CFR 17.4020(c) and urgent 
care under 38 CFR 17.4600, and revise Sec.  17.3220(b) to also 
expressly include eligible entities and providers as defined in 38 CFR 
17.4005. We believe these provisions address the issues raised by this 
comment. Incorporating the provisions promulgated separately (RIN 2900-
AQ46, Veterans Community Care Program, and RIN 2900-AQ47, Urgent Care) 
and already subject to public comment will ensure that VA's programs 
are consistently operated.
    The revisions to Sec. Sec.  17.3220 and 17.3240 as proposed and 
described above we believe clarify that VA would determine whether the 
item or service could be provided, and that VA would separately 
determine whether it is furnished by VA or a VA-authorized vendor. If a 
VA provider prescribed an item or service, and VA authorized and 
contracted with a community prosthetist for the item or service, that 
prosthetist would only provide the prescribed item or service. If a 
community prosthetist suggests additional or different items or 
services those items or services must be further reviewed and 
authorized by VA, and VA would additionally determine whether it will 
furnish the item directly or through a VA-authorized vendor. Similarly, 
if a an eligible entity or provider under 38 CFR 17.4005 prescribes 
items or services, because VA will have entered into a contract, 
agreement, or other arrangement for care from such a provider, any 
prescribed items or services would be reviewed and authorized by VA, 
and VA would then determine whether it will furnish the items or 
services directly or through a VA-authorized vendor. This is consistent 
with Federal and VA acquisition requirements, the Veterans Community 
Care Program, and our current business practices to require community 
providers to complete a secondary authorization request or a request 
for service form for additional or continued care to include all 
prosthetic item and service requests (except in the case of items or 
services needed in emergent or urgent circumstances). Because we 
believe that this requirement for VA-authorized vendors to receive 
authorization from VA, prior to such vendors furnishing items or 
services to veterans, is clear within the terms of the contracts, 
agreements, or other arrangements for care VA forms with such vendors, 
we further amend Sec.  17.3240(b) as proposed to remove the last 
sentence that states prior authorization must be obtained from VA by 
contacting any VA medical facility. We believe the revisions to 
Sec. Sec.  17.3220 and 17.3240 described above assist to clarify that 
in all cases, VA either itself furnishes items or services or provides 
them through a VA-authorized vendor as long as VA finds that the 
prescription meets the medical necessity standards in Sec. Sec.  
17.38(b) and 17.3230(a) and otherwise meets the requirements set forth 
in Sec.  17.3200 through 17.3250.
    Comments to both the proposed rule and SNPRM opposed VA retaining 
sole authority in Sec.  17.3240 to determine whether VA or an 
authorized VA vendor will provide the authorized item or service under 
these regulations, and that veterans should maintain this right. As we 
explained in the SNPRM, the veteran will be involved in the decision of 
what item or service will be prescribed in order to meet their needs, 
but VA retains the authority over the determination of how the item or 
service will be provided. This is because VA needs to ensure that 
veterans' needs are met with the most appropriate and highest quality 
items and services in a consistent manner throughout VA, that VA does 
so in a manner that complies with Federal and VA acquisition 
requirements, and that VA is also being fiscally responsible in the 
provision of these items and services. See 83 FR 61138-61142. As 
previously explained, VA has already regulated these general conditions 
in Sec.  17.4025(b)(3) and (4) as part of the Veterans Community Care 
Program.
    One comment stated that Sec.  17.3240 could result in a prosthetics 
representative hundreds of miles away making a decision on how the item 
or service is provided without knowing what is best for the veteran. As 
explained in the SNPRM, the decision regarding what item or service 
will be provided is a clinical decision, and the decision of how that 
item or service is provided is a separate decision that is based on 
clinical and administrative factors. 83 FR 61137, 61138-61142. Both 
decisions take into account the best interests of the veteran, and VA 
clarified the clinical and administrative factors it considers when 
determining how to furnish an item in proposed Sec.  17.3240(a)(2) as 
revised by the SNPRM. 83 FR 61137, 61141. As long as the prescribed 
item or service is authorized pursuant to these regulations and meets 
the medical necessity standards in Sec. Sec.  17.38(b) and 17.3230(a), 
the VA prosthetics representative will honor the prescription and 
procure the prescribed item or service. 83 FR 61137, 61138. This rule 
will not permit a VA decision of how an item or service is furnished 
without considering what is best for a veteran, and we do not make 
changes based on this comment.
    One comment suggested VA revise the regulation as proposed to 
codify VA's consideration of a non-VA provider's input in determining 
what to authorize. We reiterate from the discussion above that VA 
clinicians do consider a non-VA provider's input when VA reviews 
prescriptions from non-VA providers, and that the revision of Sec.  
17.3240 as proposed to specifically reference non-VA eligible entities 
and providers makes this clear without further revisions to the 
regulations as proposed.
    One comment argued that under these regulations, a veteran has no 
role in the decision of who they see or who provides the prescribed 
item. As we explained in the SNPRM, the veteran, in consultation with 
his or her clinician, is directly involved in the decision of what item 
or service is prescribed. See 83 FR 61137-61139. In the SNPRM, we 
modified the language of proposed Sec.  17.3240 to incorporate the 
veteran's input in this decision, and now adopt that language as final 
in this rulemaking. VA retains the authority to make the determination 
of how the item or service is provided in order to ensure that 
veterans' clinical needs are met with the most appropriate and highest 
quality items and services in a consistent manner throughout VA, and 
that we comply with Federal and VA

[[Page 84254]]

acquisition requirements in providing such items and services. See 83 
FR 61138. We further note that in the provision of artificial or 
prosthetic limbs, if VA decides that the veteran should receive the 
item or service from a community prosthetist, the veteran, in 
consultation with his or her VA clinician or amputee clinic (or 
eligible entities and providers as defined in 38 CFR 17.4005), would in 
most cases be able to select a vendor that has an existing agreement 
with VA and is able to meet the veteran's clinical needs.
    At least two comments opined that non-VA providers should be 
utilized to prescribe prosthetic and rehabilitative items and services 
as VA does not have the necessary expertise to meet the needs and 
requirements of veterans to ensure they receive appropriate care. Other 
comments stated that non-VA providers should be utilized to ensure 
appropriate, available, quality, timely, and convenient care. Another 
comment opined that decreased access to non-VA providers would result 
in sub-optimal care, leading to unnecessary pain, less mobility, 
depression, and unemployment among veterans. Comments also noted that 
veterans will have to travel long distances to VA facilities if not 
given a choice to utilize non-VA providers, or claimed VA's historical 
issues with time constraints, availability, and administrative 
deficiencies presented obstacles to justify use of non-VA providers. 
Similar to our response above, we intend to continue to contract and 
work with non-VA providers to enable VA to provide the needed items and 
services in a timely, appropriate, convenient, or quality manner in 
specific cases. As we explained in the proposed rule, VA 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. 82 FR 48025. In 
the SNPRM, we further explained that the determination of whether VA or 
a VA-authorized vendor will furnish authorized items or services will 
be based on, but not limited to, such factors as the veteran's clinical 
needs, VA capacity and availability, geographic availability, and cost. 
83 FR 61141-61143. We clarify here that these determinations are only 
about the furnishing of items or services (such as fitting a 
prosthetic) and not the clinical care that establishes the medical 
necessity of such items and services. The eligibility for receipt of 
that clinical care in the community by covered veterans is controlled 
by the Veterans Community Care Program established in regulation at 38 
CFR 17.4000 through 17.4040. We enter into contracts, agreements, and 
other arrangements with non-VA providers for both clinical care and 
furnishing items and services and will continue to do so on a case-by-
case basis and as clinically needed, to ensure that veterans' clinicals 
needs are met in an appropriate, timely, convenient, and high-quality 
manner.
    We note that VA provides high-quality and timely in-house care in 
the area of artificial limbs. VA has modernized the way that veterans 
access and receive amputation care services. Currently VA offers same-
day service to veterans at all of the 145 sites that offer orthotic and 
prosthetic services. Veterans may also schedule their amputation care 
services directly with the amputee clinics, rather than through a 
referral from another clinical service, facilitating more timely 
provision of care. This ultimately results in the care plan for amputee 
veterans being created on the day that the veteran contacts VA. We also 
note VA has engaged in several activities to ensure that veterans 
receive the best prosthetic care possible from VA. Since 2009, through 
the Extremity Trauma and Amputation Center of Excellence (EACE), we 
have collaborated with the Department of Defense (DoD) to conduct 
research and foster innovation to improve prosthetics for wounded 
servicemembers and veterans. EACE allows VA and DoD to collaborate and 
study extremity trauma care to ensure that prosthetics are made more 
comfortable and better fitting. Since 2008, we also have implemented 
the Amputation System of Care (ASoC) within VA to enhance quality and 
consistency of care provided to veterans with limb loss. ASoC is 
designed to provide the latest practices in medical care, prosthetic 
technology, and rehabilitation management to support veterans in 
reaching the highest level of functional independence. We note that 
ASoC is similar to DoD's amputation care program, which ensures 
consistency during the transition from DoD to VA health care. In 
addition to these systems, we also have prosthetic and orthotic 
laboratories across VA. Prosthetic and orthotic laboratories have 
artificial limb fabrication and repair equipment, and allow for on-site 
evaluation, fitting, maintenance, and long-term care of prosthetic and 
orthotic needs. As of the publication of this final rule, VA currently 
has 84 such laboratories across the country. This allows veterans to 
receive on-site and specialized care at their local facilities in a 
timely manner.
    Similarly, another comment opined that non-VA providers augment VA 
care by providing cutting-edge technology and advanced labs. VA often 
leads in providing such technology when clinically appropriate for 
artificial limbs and any other class of device that may clinically 
benefit veterans, including breakthrough devices newly cleared by the 
United States Food and Drug Administration to be marketed. VA is able 
to provide items that may be unavailable from the private sector due to 
the cost of a given device and limitations of private insurance 
coverage. With regard to artificial limbs and components, VA is a 
leader in clinical research. As mentioned above, we also have 
prosthetic and orthotic labs that allow us to provide timely and 
appropriate care to veterans. Additionally, through EACE, we also 
continue research to find innovative ways to meet the prosthetic needs 
of veterans.
    One comment opined that VA is unable to handle combat amputees and 
is only able to handle amputees due to vascular issues. We acknowledge 
that the vast majority of the amputees we treat are those who had an 
amputation due to disease processes. However, this is reflective of the 
veteran amputee population as only a small percentage of the veteran 
population with amputations has an amputation of traumatic etiology. We 
do provide amputee care to both populations. Webster JB, Poorman CE, 
Cifu DX. Department of Veterans Affairs Amputation System of Care: 5 
years of accomplishments and outcomes. J Rehabil Res Dev. 
2014;51(4):vii-xvi. VA collaborates with DoD via sharing agreements, 
joint education programs, and other initiatives, specifically to 
provide the care for newly-separated reserve and active duty 
servicemembers, as well as veteran combat amputees. A VA Office of 
Inspector General report found that within 5 years of military 
separation, 99 percent of servicemembers with combat-related 
amputations transitioned their care to VA. Health care Inspection: 
Prosthetic limb care in VA facilities, Report No. 11-02138-116. 
Washington, DC, March 8, 2012.
    We note that VA has unique experience in providing care to amputee 
veterans. For example, we have seen over 80,000 veterans with 
amputations for amputee services since 2013. Between 2008 and 2013, VA 
performed an average of 7,669 new amputation procedures annually. See 
Webster JB, et al. Department of Veterans Affairs Amputation System of 
Care: 5 years of accomplishments and outcomes, cited above. In fiscal 
year 2019 VA saw 96,518 veterans with amputations, with

[[Page 84255]]

46,214 of these veterans having at least one major limb amputation 
(i.e., amputation at or proximal to the wrist or ankle). Of those 
96,518 veterans, 39,291 of them were service-connected for an 
amputation-related disability while 2,375 veterans were service-
connected for a combat-related amputation disability. Due to the large 
number of veterans with amputations that we see for care within our 
system, we have unique expertise that allows us to provide specialized 
care to meet these veterans' clinical needs.
    A related comment noted that Sec.  17.3240 as proposed does not 
address the unique clinical needs of veterans, in particular amputees. 
As explained in the SNPRM, we are trying to ensure consistency with the 
provision of all prosthetic and rehabilitative items and services 
across VA, and therefore do not expressly or explicitly distinguish 
between veterans based on their clinical needs in the regulations. 
However, the proposed rules were drafted in a manner to allow 
clinicians to determine, based on each veteran's unique clinical needs, 
those items or services to be provided and how such items or services 
will be provided.
    At least one comment stated that choice of provider is an important 
quality assurance mechanism. The comment noted that veterans can 
determine quality versus VA making that determination. One comment 
additionally noted that the fact that VA contracts with non-VA 
providers indicates that non-VA providers meet or exceed a required 
level of quality. We reiterate from earlier in this rulemaking that 
revisions to Sec.  17.3240(a) as proposed will account for consultation 
with a veteran when VA or non-VA providers prescribe items or services 
for veterans, although this does not necessarily address the issue of a 
veteran's choice of provider. We note that in terms of VA providers, VA 
can address issues of provider choice with veterans internally without 
any changes to these regulations. In terms of non-VA providers (i.e., 
eligible entities and providers as defined in 38 CFR 17.4005, per 
revised Sec.  17.3240(a)(1)), such providers are available to veterans 
to choose from under VA community care regulations at 38 CFR 17.4030, 
to the extent that community providers meet the criteria of Sec.  
17.4030 and to the extent the veteran is a covered veteran and meets 
one or more of the eligibility criteria in Sec.  17.4010. Particularly, 
we note that Sec.  17.4030(c)(2) requires VA to assess the 
qualifications of the community provider to furnish care or services, 
such that a contractual relationship between a community provider and 
VA does not equate with an assumption on VA's part of the quality of 
the provider; VA must still determine whether the community provider 
would be able to provide the services that would meet the veteran's 
unique clinical needs. Thus, even though a veteran may want to choose a 
certain community provider because they have a relationship with that 
community provider or for other reasons, it does not mean that the 
community provider has the specific expertise needed in all instances. 
VA retains ultimate authority to ensure that the veteran's clinical 
needs can be met in an appropriate and high-quality manner.
    Another comment opined that if VA does not allow veterans to choose 
their provider, VA will mass produce prosthetics, and in particular 
will do so using the computer-aided design and manufacturing (CAD-M) 
production method. As a result, this comment explained that veterans 
would receive uncomfortable prosthetics that do not work well. We note 
that VA does not mass produce artificial limbs, and our providers work 
to ensure that the artificial limbs fit each veteran properly. VA also 
has no such plan to mass produce artificial limbs or components using 
any known production method. VA fabricates customized artificial limbs 
based on the individualized needs of each veteran and that veteran's 
personal goals. Most VA prosthetists make the artificial limb by hand 
and make a plaster bandage of the limb shape. We do not generally make 
the limb by CAD-M.
    Another comment asked that VA clarify in the final rule the 
mechanisms it will use to determine and ensure that the clinical needs 
of veterans drive the decision-making of the agency in determining 
whether VA will directly provide the prescribed item or service or 
whether VA will use an authorized vendor. As a general rule, VA 
internal agency processes are not reflected in VA regulations. We will 
develop policies that implement the rule to ensure that clinicians and 
prosthetics representatives make this determination based on the 
veteran's clinical needs, and we do not make changes based on this 
comment.
    A comment also raised a concern that VA may consider cost savings 
ahead of the provision of optimal, timely, efficient care, which would 
harm veterans. This comment requested that we clarify in this final 
rule that when cost is factored into the determination of who will 
provide the authorized item or service, the veteran will receive the 
prescribed item of the same quality, caliber, and effectiveness 
regardless of who furnishes it. This comment also urged VA to afford a 
veteran's preferences greater weight in instances in which cost is the 
sole administrative factor considered and the veteran's preferences do 
not align with VA's determination. We agree with these comments and 
believe that the amendments to Sec.  17.3240 as proposed in the SNPRM 
sufficiently prioritize the clinical needs of each veteran over other 
factors, including cost. We clarify that the clinical needs of the 
veteran are critical to prescribing the correct item. Generally, VA 
will provide the exact item described in the prescription. If the item 
must be procured from a VA-authorized vendor, VA complies with Federal 
acquisition regulations and VA acquisition regulations, which require 
VA to enter into and utilize national and regional contracts when 
appropriate. In the instance that the fabrication of an item like an 
artificial limb requires a skilled clinician to work with the veteran 
on an ongoing basis, then we noted in Sec.  17.3240(a)(2) as proposed 
in the SNPRM that VA will consider the veteran's clinical needs and 
other factors in addition to cost.
    Additionally, a comment requested that as VA develops and 
implements the VA MISSION Act of 2018, it does so in a meaningful way 
that is designed to limit disruption or delay in the delivery of care 
that does not impose undue financial and administrative burdens on VA 
authorized vendors. As we explained in the SNPRM, the VA MISSION Act of 
2018 was enacted on June 6, 2018, and section 101 of this Act revised 
section 1703 of title 38, U.S.C., when VA's implementing regulations 
became effective June 6, 2019. As we have previously discussed, these 
regulations expressly address how VA will pay for or fill prescriptions 
written by eligible entities or providers for covered veterans for 
durable medical equipment and devices at 38 CFR 17.4025(b)(3) and (4); 
similar regulations also apply to the urgent care benefit regulated by 
VA at 38 CFR 17.4600(e)(3). We do not believe that VA-authorized 
vendors will experience any undue financial or administrative burdens 
as a result of VA's implementation of the new Veterans Community Care 
Program or the urgent care benefit, but VA will continue to work to 
ensure that its processes do not cause undue disruption or delay in the 
delivery of care. As previously stated, we have also revised this final 
rule to account for the regulations implementing the changes made by

[[Page 84256]]

section 101 of the VA MISSION Act of 2018.

Section 17.3250 Veteran Responsibilities

    We proposed that 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.
    In proposed Sec.  17.3250(b) we stated that, except for emergency 
care under 38 CFR 17.120 through 17.132 or 38 CFR 17.1000 through 
17.1008, 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 that are not otherwise 
covered as emergency care.
    One comment stated that proposed Sec.  17.3250(b) was too 
restrictive, as veterans should not be required to obtain pre-approval 
on an item or service obtained from a VA-authorized vendor as this 
could cause delays, lead to lapses in care, and be detrimental to 
treatment. This comment and others also raised similar concerns about 
pre-approvals for repairs or replacement services and opposed 
elimination of Sec.  17.122 and the related revision of Sec.  17.120. 
As previously mentioned above, VA may authorize a veteran to receive an 
item or service in the community for numerous reasons. If an item or 
service has been prescribed and VA has authorized a vendor to provide 
that item or service, no further approval is needed unless the vendor 
determines that a different item or service is necessary. This would 
require further VA approval as a new prescription would be needed. This 
would be consistent with our practices and with Federal and VA 
acquisition regulations, as VA has to authorize items and services 
prior to their being provided. We do not find that VA's review and 
approval of prescriptions or review of different requested items or 
services creates undue delay, lapses in care, or is detrimental to a 
veteran's treatment. Absent emergent cases, VA's review and approval of 
prescriptions from non-VA providers, or requests for items or services 
from VA-authorized vendors that differ from what VA providers 
prescribed, is necessary to consider the unique needs of each veteran. 
We note that in emergent cases, VA could reimburse a veteran for 
emergency care pursuant to 38 U.S.C. 1725 or 1728 and 38 CFR 17.120 
through 17.132, or 38 CFR 17.1000 through 17.1008. As previously noted, 
Sec. Sec.  17.4025(b)(3) and 17.4600(e)(3) also authorize payment for 
prescriptions for durable medical equipment and medical devices that 
are required for urgent or emergent conditions. We find that, although 
these other authorities have their own criteria, they would also 
address situations in which a veteran needed an item or service due to 
an emergency.
    Similarly, repairs and replacements by a vendor must also have 
prior authorization from VA before such items and services can be 
provided. When VA contracts for items and services, a scope of work is 
generated, which specifically identifies the items and services for 
which VA is contracting. Prior to performing work for which a vendor 
can be reimbursed, VA must comply with the Federal Acquisition 
Regulation and create a purchase order or establish a contract for such 
work. As a result, VA cannot provide a blanket authorization for a 
vendor to provide any repairs and replacements in addition to the item 
or service prescribed. A new authorization for a vendor to provide 
repairs or replacements would be required. To the extent that there is 
an emergent or urgent situation, prior authorization would not be 
required under one of the authorities described above. We believe that 
these authorities would address the situation in which a veteran needed 
a repair or replacement due to an emergency or urgent situation, and we 
would be able to pay or reimburse for that care consistent with those 
authorities. Thus, VA has determined that Sec.  17.122 is unnecessary, 
although we clarify in this rulemaking that we will remove Sec.  17.122 
but also mark it reserved for future use of the section number as 
needed. VA could also obviate the need for veterans to obtain emergency 
repairs from vendors by providing spare items or devices for prosthetic 
and rehabilitative items under Sec.  17.3230, as clinically 
appropriate.
    One comment stated that moving emergency repairs from under Sec.  
17.120 to Sec.  17.3250 would cause confusion, and that if this change 
is made, outreach and education to veterans on this change should be 
provided. VA believes that consolidating all information on the 
provision of prosthetic and rehabilitative items and services within 
the scope of this rulemaking under one set of regulations, at 
Sec. Sec.  17.3200 through 17.3250, will provide a centralized location 
for veterans to look for information on the provision of these items 
and services. As a result, we believe this will lead to less confusion. 
We will be providing information to veterans once this rulemaking 
becomes final to ensure that veterans are educated and informed on how 
these items and services including emergency repairs will be provided.
    We make no changes to the regulations based on these comments.

Elimination of the Prosthetics Service Card

    We noted in discussion of the proposed rule that VA intended to 
stop use of the prosthetics service card (VA Form 10-2501) when the 
final rule is published. 82 FR 48026. We stated that the prosthetics 
service card is often not used for its intended purpose, is not 
universally utilized by veterans and VA vendors, and would not be 
necessary after publication of the final rule.
    One comment opposed elimination of the prosthetics service card as 
it would result in veterans not being allowed to have immediate non-
emergent repairs completed without prior approval by VA. This comment 
raised concerns that VA would not be able to provide timely pre-
approval and that it is unclear whether an estimate for pre-approval 
would be needed or whether a list of VA authorized vendors would be 
provided. The comment also expressed concern about this adding another 
level of bureaucracy before an item can be repaired. As we explained in 
the preamble of the proposed rule, prosthetics service cards were 
intended to be used in emergency situations. However, these cards have 
not been widely used or consistently used for this purpose. As we 
noted, many veterans have lost these cards or have failed to provide 
them to third party vendors; many vendors still contact VA for 
authorization prior to making repairs; and these cards merely provide 
notice that VA will reimburse repairs up to a certain amount. We have 
found that third party vendors still submit invoices and documentation 
to VA for reimbursement for repairs. As a result, we are eliminating 
use of the prosthetics service card. Non-emergency repairs will be 
authorized pursuant to Sec. Sec.  17.3230 and 17.3240. As we noted 
above, pre-approval is required to

[[Page 84257]]

comply with Federal and VA acquisition regulations. Additionally, as 
explained in Sec.  17.3240(b), prior authorization is not required for 
emergency care under 38 CFR 17.120 through 17.132, 38 CFR 17.1000 
through 17.1008, and 38 CFR 17.4020(c), or urgent care under 38 CFR 
17.4600.
    We make no changes to the regulation based on this comment.

Comments Received on Miscellaneous Issues

    Several comments generally opposed the changes. Some of these 
comments, which included issues with VA leadership, are beyond the 
scope of these regulations, and we are not making any edits based on 
these comments. One comment opined that the drafter of the comment 
should be involved in the development of VA handbooks, directives, and 
other policies that will implement these regulations. We note that this 
comment is outside the scope of these regulations, and we are not 
making any edits based on this comment. In response to the SNPRM, one 
comment raised several other issues, including implementation of the VA 
MISSION Act of 2018, the recommendation that VA consider how to 
incentivize more community-based physical therapists and physical 
therapist assistants to work with VA, and that Veterans Integrated 
Service Networks should include a therapist on the leadership team to 
provide therapy-services relations guidance and expertise. These are 
also outside the scope of these regulations, and we are not making any 
edits based on these comments.
    One comment expressed concerns with veterans' ability to receive 
cochlear implantation through these regulations. While we do reference 
implants in this regulation, hearing aids and other hearing technology, 
including cochlear implants, are outside the scope of these regulations 
as they are covered by a separate regulation, 38 CFR 17.149. 
Additionally, this comment suggested that VA provide training and 
updates on current cochlear implant candidacy practices and outcomes to 
align with best practices. This is also outside the scope of these 
regulations, but we have provided this comment to the appropriate VA 
program office to consider.
    One comment suggested that the clothing allowance should be 
abolished or awarded for artificial limbs only. We note that clothing 
allowance is provided pursuant to separate authorities, 38 U.S.C. 1162 
and 38 CFR 3.810, as explained in proposed Sec.  17.3200, and thus is 
not covered by this rulemaking. This comment is beyond the scope of 
these regulations, and we are not making any edits based on this 
comment.
    One comment opined that the proposed rule may have violated the 
Administrative Procedure Act (APA) due to ambiguities in the discussion 
of the proposed rule concerning the intent of proposed Sec.  17.3240, 
no explanation or citation for the discretionary authority for proposed 
Sec.  17.3240 or on how VA would exercise this authority, the lack of 
discussion in the proposed rule regarding existing law and policy and 
how that will change under Sec.  17.3240, and the failure to address 
non-VA care authorities or prosthetics procurement authority in the 
proposed rulemaking. We note that these issues were addressed in the 
SNPRM, as we explained the intent of proposed Sec.  17.3240; described 
our authority for that section and our exercising of that authority; 
and discussed current laws (including non-VA care authorities such as 
VA MISSION Act of 2018 and Choice Act) as well as VHA policies 
concerning the provision of prosthetic and rehabilitative items and 
services and how these regulations are impacted by the laws and how 
they will impact the referenced policies. See 83 FR 61139-61143. 
Elements of VA's Veterans Community Care Program that affect the 
prescription of prosthetic items and services were subject to notice 
and comment rulemaking (see RIN 2900-AQ46 and RIN 2900-AQ47), and 
elements of those rules are incorporated here for consistency. We are 
not making any edits based on this comment.

Non-Substantive Revisions That Are Not Based on Comments

    We are making certain revisions to provisions from the proposed 
rule that are not based on comments, and that are non-substantive in 
nature.
    We add a section list, immediately following the undesignated 
center heading that reads Prosthetic And Rehability Items and Services, 
to identify each of the Sec. Sec.  17.3200 through 17.3250 with their 
corresponding section header.
    We revise Sec.  17.3200(a) as proposed to add the phrase ``[t]his 
section and Sec. Sec.  17.3210'' through 17.3230 are applicable as 
proposed, to better distinguish reference to Sec.  17.3200.
    We revise Sec.  17.3200(b) as proposed to add the phrase ``[t]his 
section and Sec. Sec.  17.3210'' through 17.3230 are applicable as 
proposed, to better distinguish reference to Sec.  17.3200. We 
additionally revise Sec.  17.3200(b) as proposed to add the phrase ``to 
be provided'' after the first use of the term ``authorized'', so that 
the first sentence of Sec.  17.3200(b) now reads ``[s]ections 17.3200 
through 17.3250 apply only to items and services listed in Sec.  
17.3230(a) and authorized to be provided as medical services under 38 
U.S.C. 1701(6)(F) and 38 U.S.C. 1710(a).'' We lastly revise Sec.  
17.3200(b) to add more specific reference to the accompanying table as 
proposed, to identify the table as table 1, to add to the table a 
corresponding title to read ``Table 1 to Paragraph (b),'' and in table 
1 to correct the ``et seq.'' citation format to include, instead, a 
citation through the end of the applicable section numbers for the 
automobile adaptive equipment and home improvement and structural 
alterations regulatory citations.
    We revise Sec.  17.3220(a) as proposed to remove, from the 
reference to Sec.  17.37, the dash between Sec.  17.37(a) and (c), and 
insert the word ``through'' in its place to better distinguish the 
range of applicable paragraphs. We revise Sec.  17.3220(b) as proposed 
to correct the citation to Sec.  17.4005 with a section symbol versus 
reference to ``38 CFR.''
    We revise Sec.  17.3240(a)(1) as proposed to correct the citation 
to Sec.  17.4005 with a section symbol versus reference to ``38 CFR.'' 
We revise Sec.  17.3240(a)(2) as proposed to correct the reference to 
paragraph (a)(1) of Sec.  17.3240. We revise Sec.  17.3240(a)(3) as 
proposed to correct the reference to paragraph (a)(2) of Sec.  17.3240. 
We revise Sec.  17.3240(b) as proposed to correct citations to 
Sec. Sec.  17.120, 17.1000, 17.4020(c), and 17.4600 with section 
symbols versus reference to ``38 CFR,'' and to correct the ``et seq.'' 
citation format to include, instead, a citation through the end of the 
applicable section numbers for Sec. Sec.  17.120 through 17.132 and 
17.1000 through 17.1008.
    We revise Sec.  17.3250(a) as proposed to add a reference to Sec.  
17.3240, as Sec.  17.3240 also relates to the provision of items and 
services set forth in these regulations. We also revise Sec.  17.3250 
(a) as proposed to replace the phrase ``in the manner for which they 
are prescribed'' with the phrase ``as they are prescribed'', as we 
believe this language is more easily understood.
    We revise Sec.  17.3250(b) to correct citations to Sec. Sec.  
17.120, 17.1000, 17.4020(c), and 17.4600 with section symbols versus 
reference to ``38 CFR,'' and to correct the ``et seq.'' citation format 
to include, instead, a citation through the end of the applicable 
section numbers for Sec. Sec.  17.120 through 17.132 and 17.1000 
through 17.1008. We additionally revise Sec.  17.3250(b) to remove from 
the last sentence the phrase ``that otherwise are'', as this language 
is extraneous and does not add

[[Page 84258]]

to the provisions in Sec.  17.3250(b). We additionally revise the last 
sentence of Sec.  17.3250(b) to reference emergency care under 38 CFR 
17.4020(c) and urgent care under 38 CFR 17.4600, to be consistent with 
the first sentence of Sec.  17.3250(b) and be consistent with Sec.  
17.3240(b) as revised.

External Communications Discussed in SNPRM

    In the SNPRM, we described communications VA had with external 
parties after the comment period for the proposed rule had closed. See 
83 FR 61142. We briefly described a roundtable that was held on July 
25, 2018, which VA attended. We noted that the concerns that were 
raised at the roundtable that related to the proposed rule at RIN 2900-
AP46 were similar to those raised during the public comment period for 
that proposed rule. In the SNPRM, we stated that we addressed these 
concerns within the SNPRM. 83 FR 61142. In response to the SNPRM, at 
least one comment noted that we did not address issues raised 
concerning the proposed rule and medical alert devices and medical 
identification bracelets that were discussed at the roundtable. We 
acknowledge and clarify now that we misstated when we explained that we 
addressed in the SNPRM all the concerns of the roundtable. While we 
addressed, in the SNPRM, some of the concerns that were raised during 
the roundtable, we did not address all of the concerns, such as medical 
alert devices and medical identification bracelets. However, we note 
that in this final rulemaking, we have addressed the remaining concerns 
that were raised during the roundtable. We are not making any edits 
based on this comment.
    We lastly note that we make one technical and nonsubstantive 
revision to Sec.  17.38(b) as proposed, to indicate that the term 
``healthcare'' as proposed will be printed as two words to read 
``health care'', as is consistent with a majority of VA's other medical 
regulations. We also make one technical and nonsubstantive revision to 
Sec.  17.3220(a) as proposed to clarify that veteran eligibility may 
occur if a veteran is exempt from enrollment under Sec.  17.37(a) 
through (c), and not under Sec.  17.37 more generally.
    Based on the rationale set forth in the proposed rule, the SNPRM, 
and in this document, VA is adopting the provisions of the proposed 
rule as a final rule with changes as noted above.

Paperwork Reduction Act

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507) requires that 
VA consider the impact of paperwork and other information collection 
burdens imposed on the public. Under 44 U.S.C. 3507(a), an agency may 
not collect or sponsor the collection of information, nor may it impose 
an information collection requirement unless it displays a currently 
valid Office of Management and Budget (OMB) control number. See also 5 
CFR 1320.8(b)(2)(vi).
    This final rule contains no new and/or revised provisions 
constituting a collection of information under the Paperwork Reduction 
Act of 1995 (44 U.S.C. 3501-3521). However, as stated in the proposed 
rule, we noted that after the final rule is published, VA would request 
to rescind several VHA handbooks and several VA forms, to include VA 
Form 10-2520, which is an approved collection under OMB Control Number 
2900-0188. We proposed to rescind this form, which is an invoice used 
by vendors to submit to VA requests for payment for repairs performed 
pursuant to the prosthetic service cards. Prosthetic service cards have 
not been widely or consistently used by veterans or vendors, these 
cards have typically been lost, and third-party vendors still submit 
separate invoices for reimbursement. We reiterate from earlier in this 
rule that although we received one comment in opposition to rescinding 
this form, we will not keep this form because we find that many vendors 
do not use it as an assurance of pre-approval for emergency repairs. 
Instead, VA-authorized vendors still contact VA for authorization prior 
to making repairs and still submit invoices and documentation to VA for 
reimbursement of repairs, thereby negating the concept that this form 
functions as an emergency approval for repairs. Therefore, upon 
publication of this final rule, VA will request to rescind this form 
through VA's Paperwork Reduction Act Clearance Officer.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will 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. There will be no material changes to the types of items and 
services available to veterans or veteran eligibility for such items 
and services. Therefore, pursuant to 5 U.S.C. 605(b), the initial and 
final regulatory flexibility analysis requirements of 5 U.S.C. 603 and 
604 do not apply.

Executive Orders 12866, 13563, and 13771

    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. 
The Office of Information and Regulatory Affairs has determined that 
this final rule is not a significant regulatory action under Executive 
Order 12866.
    VA's regulatory 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 website at 
http://www.va.gov/orpm by following the link for VA Regulations 
Published from FY 2004 through FYTD.
    This final rule is not an E.O. 13771 regulatory action because this 
rule is not significant under E.O. 12866.

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 final rule will 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; 64.029--Purchase 
Care Program; 64.041--VHA Outpatient Specialty Care.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Government contracts, 
Grant programs--health, Grant programs--

[[Page 84259]]

veterans, Health care, Health facilities, Health professions, Health 
records, Homeless, Medical and Dental schools, Medical devices, Medical 
research, Mental health programs, Nursing homes, Reporting and 
recordkeeping requirements, Travel and transportation expenses, 
Veterans.

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. Brooks D. 
Tucker, Assistant Secretary for Congressional and Legislative Affairs, 
Performing the Delegable Duties of the Chief of Staff, Department of 
Veterans Affairs, approved this document on October 1, 2020, for 
publication.

Luvenia Potts,
Regulation Development Coordinator, Office of Regulation Policy & 
Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons stated in the preamble, we amend 38 CFR part 17 as 
follows:

PART 17--MEDICAL

0
1. The authority citation for part 17 is amended by adding entries for 
Sec. Sec.  17.3200 through 17.3250 in numerical order to read in part 
as follows:

    Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
Section 17.3200 also issued under 38 U.S.C. 1162, 1701, 1707, 1710, 
1714, 1717, 3901.
Section 17.3210 also issued under 38 U.S.C. 1701, 1710.
Section 17.3220 also issued under 38 U.S.C. 1701(6)(F), 1710.
Section 17.3230 also issued under 38 U.S.C. 1701(6)(F), 1710, 
1714(a).
Section 17.3250 also issued under 38 U.S.C. 1701, 1710, 1725, 1728.
* * * * *

0
2. Amend Sec.  17.38, revise paragraph (a)(1)(viii) and in paragraph 
(b) introductory text, remove the word ``healthcare'' and add in its 
place the phrase ``health care'' to 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 through 17.3250, and eyeglasses and 
hearing aids as authorized under Sec.  17.149.
* * * * *


Sec.  17.120  [Amended]

0
3. Amend Sec.  17.120 introductory text by removing ``(except 
prosthetic appliances, similar devices, and repairs)''.


Sec.  17.122  [Removed and Reserved]


0
4. Remove and reserve Sec.  17.122.

0
5. Revise the undesignated center heading that precedes Sec.  17.148 to 
read as follows:

Sensory and Other Rehabilitative Aids


Sec.  Sec.  17.150 and 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.
17.3210 Definitions.
17.3220 Eligibility.
17.3230 Authorized items and services.
17.3240 Furnishing authorized items and services.
17.3250 Veteran responsibilities.


Sec.  17.3200   Purpose and scope.

    (a) Purpose. The purpose of this section and Sec. Sec.  17.3210 
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. This section and Sec. Sec.  17.3210 through 17.3250 
apply only to items and services listed in Sec.  17.3230(a) and 
authorized to be provided 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 table 1 to this paragraph (b) are authorized 
in whole or in part by separate statutes and controlled by other 
implementing regulations:

                        Table 1 to Paragraph (b)
------------------------------------------------------------------------
       Item or service               Statute            Regulation(s)
------------------------------------------------------------------------
Clothing allowance..........  38 U.S.C. 1162......  38 CFR 3.810
Service and guide dog         38 U.S.C. 1714(b) &   38 CFR 17.148
 benefits.                     (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           38 U.S.C. 3901 et     38 CFR 17.155
 equipment.                    seq..                 through 17.159
Home improvements and         38 U.S.C. 1717(a)(2)  38 CFR 17.3100
 structural alterations.                             through 17.3130
------------------------------------------------------------------------

Sec.  17.3210   Definitions.

    For the purposes of Sec. Sec.  17.3200 through 17.3250:
    Activities of daily living (ADL) 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

[[Page 84260]]

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 
veterans 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, or household appliances. 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.
    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.
    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.


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(a) through (c); 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 eligible entity or 
provider as defined in Sec.  17.4005 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.


Sec.  17.3230  Authorized items and services.

    (a)(1) VA will provide veterans eligible under Sec.  17.3220 with 
the following items and services if VA determines that such items and 
services are needed under Sec.  17.38(b), serve as a direct and active 
component of the veteran's medical treatment and rehabilitation, and do 
not solely support the comfort or convenience of the veteran:
    (i) Adaptive household items.
    (ii) Adaptive recreation equipment.
    (iii) Cognitive devices.
    (iv) Communication devices.
    (v) 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.
    (vi) 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.
    (vii) Home respiratory equipment.
    (viii) Implants.
    (ix) Mobility aids.
    (x) Orthotic devices.
    (xi) Prosthetic devices.
    (xii) Repairs to items provided under paragraph (a) of this 
section, even if the item was not initially prescribed by VA, unless VA 
determines to replace the item for cost or clinical reasons.
    (xiii) Replacement items, if items provided under this section have 
been

[[Page 84261]]

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.
    (xiv) Specialized clothing made necessary by the wearing of a 
prosthetic device.
    (xv) Training with and fitting of prescribed items.
    (2) Paragraph (a)(1) of this section supplements the requirement in 
Sec.  17.38(b) for a determination of need but only with respect to the 
provision of items and services listed in paragraph (a)(1) of this 
section. The exclusions under Sec.  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.
    (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.


Sec.  17.3240  Furnishing authorized items and services.

    (a)(1) VA providers, or eligible entities and providers as defined 
in Sec.  17.4005, will prescribe items and services in accordance with 
Sec.  17.3230(a) and will do so in consultation with the veteran.
    (2) Once the item or service is prescribed under paragraph (a)(1) 
of this section, VA will either fill such prescriptions directly or 
will pay for such prescriptions to be furnished through a VA-authorized 
vendor.
    (3) The determination under paragraph (a)(2) of this section of 
whether a prescription will be filled by VA directly or will be 
furnished by a VA-authorized vendor will be based on, but not limited 
to, such factors as the veteran's clinical needs, VA capacity and 
availability, geographic availability, and cost.
    (b) Except for emergency care under Sec. Sec.  17.120 through 
17.132, Sec. Sec.  17.1000 through 17.1008, or Sec.  17.4020(c), or 
urgent care under Sec.  17.4600, prior authorization of items and 
services under Sec.  17.3230 is required for VA to reimburse VA-
authorized vendors for furnishing such items or services to veterans.


Sec.  17.3250  Veteran responsibilities.

    (a) Veterans must use items provided under Sec. Sec.  17.3230 and 
17.3240 as 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 Sec. Sec.  17.120 through 
17.132, Sec. Sec.  17.1000 through 17.1008, or Sec.  17.4020(c), or 
urgent care under Sec.  17.4600, 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 services provided that are not preauthorized by VA or not 
covered as emergency care under Sec. Sec.  17.120 through 17.132, 
Sec. Sec.  17.1000 through 17.1008, or Sec.  17.4020(c), or urgent care 
under Sec.  17.4600.

[FR Doc. 2020-27014 Filed 12-23-20; 8:45 am]
BILLING CODE 8320-01-P