Prosthetic and Rehabilitative Items and Services
| Published date | 28 December 2020 |
| Citation | 85 FR 84245 |
| Record Number | 2020-27014 |
| Section | Rules and Regulations |
| Court | Veterans Affairs Department |
Federal Register, Volume 85 Issue 248 (Monday, December 28, 2020)
[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]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
