Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 84245 

21See DLC & MLC Ex Parte Letter Dec. 9, 2020 

add. B at 2, 3, 10. 

22 17 U.S.C. 115(d)(1)(C). 

U.S.C. 115(d)(1)(C)(i).’’ 21 This proposed 

language seems to suggest that the DLC 

and MLC believe there are types of 

voluntary licenses, authorizing DMPs to 

make and distribute permanent 

downloads, that would not apply to the 

exclusion of the blanket license. It is not 

entirely clear to the Office what is 

meant by this aspect of the proposal, but 

the Office observes that section 

115(d)(1)(C) says ‘‘[a] voluntary license 

for covered activities entered into by or 

under the authority of 1 or more 

copyright owners and 1 or more digital 

music providers, or authority to make 

and distribute permanent downloads of 

a musical work obtained by a digital 

music provider from a sound recording 

copyright owner pursuant to an 

individual download license, shall be 

given effect in lieu of a blanket license 

under this subsection with respect to 

the musical works (or shares thereof) 

covered by such voluntary license or 

individual download authority.’’ 22

Beyond the DLC’s proposal, the Office 

invites comments more generally on 

how to address, or whether the Office 

should address, the pass-through license 

issue that has been raised, including 

whether a different approach should be 

taken. One potential alternative 

approach the Office seeks comment on 

could be for the Office to adopt a rule 

providing that any failure to comply 

with the previously adopted reporting 

requirements in 37 CFR 210.24(b)(8), 

210.25(b)(6), 210.27(c)(5), or 

210.28(c)(5) with respect to individual 

download licenses or voluntary passthrough licenses may not be construed 

as material noncompliance with the 

statute or regulations, but rather would 

be considered to be harmless errors, if 

appropriate alternative information— 

perhaps the information the DLC 

proposed—is timely reported instead. 

This would mean that in such cases, the 

harmless error provisions in place for 

notices of license (§ 210.24(e)), notices 

of nonblanket activity (§ 210.25(e)), and 

SNBL-submitted reports of usage 

(§ 210.28(k)) would apply to protect the 

DMP or SNBL; the statutory default 

provision in 17 U.S.C. 115(d)(4)(E)(i)(III) 

would similarly protect a DMP from 

being in default under the blanket 

license with respect to its reports of 

usage. 

List of Subjects in 37 CFR Part 210 

Copyright, Phonorecords, Recordings. 

Interim Regulations 

For the reasons set forth in the 

preamble, the Copyright Office amends 

37 CFR part 210 as follows: 

PART 210—COMPULSORY LICENSE 

FOR MAKING AND DISTRIBUTING 

PHYSICAL AND DIGITAL 

PHONORECORDS OF NONDRAMATIC 

MUSICAL WORKS 

■ 1. The authority citation for part 210 

continues to read as follows: 

Authority: 17 U.S.C. 115, 702. 

■ 2. Add § 210.30 to read as follows: 

§ 210.30 Temporary exception to certain 

reporting requirements about certain 

permanent download licenses. 

(a) Subject to paragraph (b) of this 

section, where a requirement of 

§ 210.24(b)(8), § 210.25(b)(6), 

§ 210.27(c)(5), or § 210.28(c)(5) has not 

been satisfied with respect to an 

individual download license or 

voluntary pass-through license, such 

failure shall not: 

(1) Render an otherwise compliant 

notice of license, notice of nonblanket 

activity, or report of usage invalid; or 

(2) Provide a basis for the mechanical 

licensing collective to reject an 

otherwise compliant notice of license, 

serve a notice of default on an otherwise 

compliant blanket licensee, terminate an 

otherwise compliant blanket license, or 

engage in legal enforcement efforts 

against an otherwise compliant 

significant nonblanket licensee. 

Note 1 to paragraph (a): Paragraph (a) 

of this section is a transitional exception 

that shall cease to apply in accordance 

with such further regulations as the 

Copyright Office may adopt. 

(b) After paragraph (a) of this section 

is no longer applicable, the mechanical 

licensing collective may take such 

action(s) against a beneficiary of 

paragraph (a) of this section as had been 

prohibited by paragraph (a) when it was 

applicable, if an amendment adopted by 

the Copyright Office to a requirement of 

§ 210.24(b)(8), § 210.25(b)(6), 

§ 210.27(c)(5), or § 210.28(c)(5) with 

respect to individual download licenses 

or voluntary pass-through licenses is not 

complied with by such a beneficiary 

within 45 calendar days after the 

effective date of such an amendment, or 

an alternate date subsequently adopted 

by the Office, whichever is later. Any 

deadline otherwise applicable to any 

such action by the mechanical licensing 

collective shall be tolled with respect to 

a beneficiary of paragraph (a) of this 

section until the conclusion of such 45- 

day or alternate period. 

(c) For purposes of this section, a 

voluntary pass-through license is a 

voluntary license obtained by a licensor 

of sound recordings to make and 

distribute, or authorize the making and 

distribution of, permanent downloads 

embodying musical works through 

which a digital music provider or 

significant nonblanket licensee has 

obtained authority from such licensor of 

sound recordings to make and distribute 

permanent downloads of musical works 

embodied in such sound recordings. 

Dated: December 16, 2020. 

Shira Perlmutter, 

Register of Copyrights and Director of the 

U.S. Copyright Office. 

Approved by: 

Carla D. Hayden, 

Librarian of Congress. 

[FR Doc. 2020–28505 Filed 12–23–20; 8:45 am] 

BILLING CODE 1410–30–P 

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; 

penny.nechanicky@va.gov; (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 


tkelley on DSKBCP9HB2PROD with RULES
84246 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

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 § 17.150 of 

title 38, Code of Federal Regulations 

(CFR) and the establishment of entirely 

new sections at §§ 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 

§ 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 wellbeing 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 

§ 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 § 17.3210 as 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 § 17.38 and 

§ 17.3230. 

Section 17.38, Medical Benefits Package 

and § 17.3230, Authorized Items and 

Services 

We received multiple comments to 

the proposed revisions to current 

§ 17.38 and criteria in new proposed 

§ 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 § 17.38 

defines medical services that are 

available from VA to eligible veterans. 

Paragraph (a) of § 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 § 17.38(a)(1)(viii). We 

proposed amending § 17.38(a)(1)(viii) to 

state that the medical benefits package 

includes prosthetic and rehabilitative 

items and services as authorized under 

proposed §§ 17.3200 through 17.3250, 

to reference the new proposed criteria in 

§§ 17.3200 through 17.3250, versus 

extensive and likely confusing 

additional revisions to § 17.38 that 

would apply only to prosthetic and 

rehabilitative items and services. 

Current § 17.38(b) provides that care 

referred to in the medical benefits 

package at § 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 § 17.38(b) to 

exclude prosthetics and rehabilitative 

items and services from the 

requirements in § 17.38(b) (specifically, 

not subject to the promote, preserve, or 

restore standard in § 17.38(b)), and 

proposed a different standard in 

proposed § 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 § 17.38 and to § 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 nonVA 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 

§ 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 


tkelley on DSKBCP9HB2PROD with RULES
84248 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

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 

§ 17.38(a)(1)(viii). When VA 

promulgated § 17.38, we explained that 

the promote, preserve, or restore 

standard in § 17.38(b) would be used to 

determine whether health care and 

services available under § 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 

§ 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 § 17.38(b) with the 

direct and active component standard in 

§ 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 § 17.38(b) when determining 

medical necessity for care and services 

provided in the medical benefits 

package under § 17.38(a), to include 

prosthetic and rehabilitative items 

under § 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 § 17.3230(a) as proposed. 82 

FR 48019. The direct and active 

component standard in § 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 § 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 

§ 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 

§ 17.38(b) based on public comments. 

Based on comments, we now find that 

the direct and active component test in 

§ 17.3230(a) as proposed should 

supplement the promote, preserve, and 

restore standard as well as all other 

requirements in § 17.38(b). We therefore 

now remove the parenthetical exception 

for prosthetics and rehabilitative items 

and services from § 17.38(b) as 

proposed, to leave the reading of 

§ 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 § 17.38(a), 

to include prosthetic and rehabilitative 

items and services under 

§ 17.38(a)(1)(viii). To further ensure it is 

clear that VA considers both the 

promote, preserve, and restore standard 

under § 17.38(b) as well as the 

supplemental direct and active 

component standard in § 17.3230(a) as 

proposed when assessing medical need, 

we now revise § 17.3230(a) as proposed 

to clearly reference the assessment of 

medical need under § 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 § 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 

§ 17.38(a)(1)(viii) as proposed indicated 

that prosthetic and rehabilitative items 

and services will be available as 

authorized by §§ 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 

§ 17.38(b), but also subject to the direct 

and active component standard in 

§ 17.3230(a) as proposed. We 

additionally revise the reference to 

‘‘§§ 17.3200–.3250’’ in § 17.38(a)(1)(viii) 

as proposed, to remove the dash and 

insert the word through, to indicate the 

range of applicable sections from 

§§ 17.3200 through 17.3250. To further 

ensure consistency between the medical 

necessity standards in §§ 17.38(b) and 

17.3230, we are revising and moving the 

language in the note at the end of 

§ 17.3230 as proposed to further clarify 

that § 17.3230 supplements 

determinations of need for items and 

services listed in § 17.3230(a) in 

addition to the requirements in 

§ 17.38(b). The revised language in the 

former note at the end of § 17.3230 as 

proposed will now be lcoated in 

§ 17.3230(a)(2), and we will renumber 

§ 17.3230(a) as proposed to 

§ 17.3230(a)(1), and renumber 

§ 17.3230(a)(1) through (15) as proposed 

to § 17.3230(a)(1)(i) through (xv), 

respectively. We are also revising 

§ 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 § 17.3230(a) (which are 

the needs assessment under both 

§§ 17.38(b) and 17.3230(a)). Lastly, we 

are removing extraneous language that 

alludes to a specific item or service 

listed in § 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 § 17.3230(a)(12) and (15) 

as proposed to remove such extraneous 

language. However, we reiterate from 

the proposed rule that an item under 

§ 17.3230(a) could be repaired if it is 

determined that the item meets the 

needs assessment in § 17.3230(a). 82 FR 

48018, 48024. The same logic follows 

for § 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 § 17.3230(a). 

Because the proposed rule did not 

indicate that the direct and active 

component test in § 17.3230(a) should 

supplement, versus replace, the 

requirements in § 17.38(b), we now 

provide an example of VA’s assessment 

of both the medical necessity standards 

under §§ 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 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 

§ 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 § 17.38(b). None of 

these care and services would be 

considered prosthetic or rehabilitative 

items under § 17.38(a)(1)(viii), and the 

assessment of clinical need would be 

fully met under the § 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 

§ 17.38(a)(1)(viii). As such, the provider 

would assess medical need under the 

requirements in § 17.38(b) and could 

specifically find the standard under 

§ 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 

§ 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 § 17.3230(a) as 

proposed as not being solely for the 

comfort or convenience of the veteran. 

We believe the considerations under 

§ 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 § 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 § 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 § 17.3230(a), it 

could be possible for a white noise 

machine to be provided under the 

standard in § 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 § 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 

§ 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 

§ 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 § 17.3230(a) as 

proposed will supplement and not 

replace VA’s assessment of medical 

need under § 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 § 17.38(b) and 

the direct and active component 

standard in § 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 § 17.3230(a) as 

proposed with some revisions. We 

reiterate that removing the parenthetical 

exception from the proposed revision to 

§ 17.38(b), as well as the additional 

revisions to § 17.3230(a) and the note at 

the end of § 17.3230 (to reference 

§ 17.38(b)) will clarify that we are 

supplementing rather than replacing the 

promote, preserve, or restore standard in 

§ 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 physicianrecommended 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 § 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 medicallyindicated 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 


tkelley on DSKBCP9HB2PROD with RULES
84250 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

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 

§ 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 § 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 §§ 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 § 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 serviceconnected 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 allinclusive 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 serviceconnected 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 § 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 

§§ 17.38(b) and 17.3230(a), we do not 

believe that any additional requirements 

in § 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 §§ 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 § 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 § 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 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 § 17.3230(a)(2) will be provided 

only if it meets the medical necessity 

requirements under §§ 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 

§ 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 § 17.3210. 

Proposed § 17.3230(a)(13) would 

authorize the replacement of items 

provided under proposed § 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 §§ 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 § 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 §§ 17.38(b) 

and 17.3230(a) and the items are one of 

the types of items expressly identified 

under proposed § 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 § 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 § 17.3240(a) that VA 

would determine whether VA or a VAauthorized vendor will furnish 

authorized items and services under 

§ 17.3230 to veterans eligible for such 

items and services under § 17.3210. As 

stated in the preamble of the proposed 

rule, the intent of the language in 

§ 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 § 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 § 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 


tkelley on DSKBCP9HB2PROD with RULES
84252 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

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 § 17.3240. 

In response to public comments on 

the proposed rule, the SNPRM revised 

§ 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 

§ 17.3240(a) as proposed to state that 

once the prescribed item or service is 

determined to be authorized under 

§ 17.3230, VA will determine whether 

VA or a VA-authorized vendor will 

furnish authorized items and services 

under § 17.3230 to veterans eligible for 

such items and services under 

§ 17.3220, and further that the 

determination on whether VA or a VAauthorized vendor will furnish the 

authorized item or service under 

§ 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 

§ 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 

§ 17.3240(a) as originally proposed. In 

response to these same concerns as 

raised in comments to § 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 § 17.3240 and the supporting 

explanation provided within the 

SNPRM. One comment expressed an 

expectation that in applying § 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 nonVA 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 

§ 17.3240(a)(2), we consider veterans’ 

clinical needs when determining 

whether to provide artificial limbs and 

all other items and services under 

§ 17.3230(b) internally or via authorized 

community vendors. 

Several comments raised concerns 

that § 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 

§ 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 §§ 17.38(b) and 17.3230(a) and is 

otherwise authorized pursuant to 

§§ 17.3230 through 17.3250, then VA 

will provide the item to the veteran 

either directly or through a VAauthorized 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 VAauthorized 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 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 

§ 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 § 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 

§ 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 § 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 §§ 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 

§ 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 §§ 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 §§ 17.38(b) and 17.3230(a) and 

otherwise meets the requirements set 

forth in § 17.3200 through 17.3250. 

Comments to both the proposed rule 

and SNPRM opposed VA retaining sole 

authority in § 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 § 17.4025(b)(3) and (4) as 

part of the Veterans Community Care 

Program. 

One comment stated that § 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 

§ 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 §§ 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 § 17.3240 as 

proposed to specifically reference nonVA 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 

§ 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 


tkelley on DSKBCP9HB2PROD with RULES
84254 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

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 nonVA 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, VAauthorized 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-bycase 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 highquality 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 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 serviceconnected 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 

§ 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 § 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 § 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 § 17.4030 and to the 

extent the veteran is a covered veteran 

and meets one or more of the eligibility 

criteria in § 17.4010. Particularly, we 

note that § 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 § 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 VAauthorized 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 § 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 


tkelley on DSKBCP9HB2PROD with RULES
84256 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

section 101 of the VA MISSION Act of 

2018. 

Section 17.3250 Veteran 

Responsibilities 

We proposed that § 17.3250 would 

establish responsibilities of veterans 

who are provided prosthetic and 

rehabilitative items and services. 

Proposed § 17.3250(a) would establish 

that veterans must use items provided 

under proposed § 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 § 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 VAauthorized vendor for such items and 

services provided under § 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 

§ 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 preapprovals for repairs or replacement 

services and opposed elimination of 

§ 17.122 and the related revision of 

§ 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, §§ 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 § 17.122 is unnecessary, although 

we clarify in this rulemaking that we 

will remove § 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 § 17.3230, as clinically 

appropriate. 

One comment stated that moving 

emergency repairs from under § 17.120 

to § 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 §§ 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 

§§ 17.3230 and 17.3240. As we noted 

above, pre-approval is required to 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 84257 

comply with Federal and VA 

acquisition regulations. Additionally, as 

explained in § 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 therapyservices 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 § 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 § 17.3240, no explanation 

or citation for the discretionary 

authority for proposed § 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 

§ 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 

§ 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 §§ 17.3200 through 

17.3250 with their corresponding 

section header. 

We revise § 17.3200(a) as proposed to 

add the phrase ‘‘[t]his section and 

§§ 17.3210’’ through 17.3230 are 

applicable as proposed, to better 

distinguish reference to § 17.3200. 

We revise § 17.3200(b) as proposed to 

add the phrase ‘‘[t]his section and 

§§ 17.3210’’ through 17.3230 are 

applicable as proposed, to better 

distinguish reference to § 17.3200. We 

additionally revise § 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 § 17.3200(b) now reads ‘‘[s]ections 

17.3200 through 17.3250 apply only to 

items and services listed in § 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 § 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 § 17.3220(a) as proposed to 

remove, from the reference to § 17.37, 

the dash between § 17.37(a) and (c), and 

insert the word ‘‘through’’ in its place to 

better distinguish the range of 

applicable paragraphs. We revise 

§ 17.3220(b) as proposed to correct the 

citation to § 17.4005 with a section 

symbol versus reference to ‘‘38 CFR.’’ 

We revise § 17.3240(a)(1) as proposed 

to correct the citation to § 17.4005 with 

a section symbol versus reference to ‘‘38 

CFR.’’ We revise § 17.3240(a)(2) as 

proposed to correct the reference to 

paragraph (a)(1) of § 17.3240. We revise 

§ 17.3240(a)(3) as proposed to correct 

the reference to paragraph (a)(2) of 

§ 17.3240. We revise § 17.3240(b) as 

proposed to correct citations to 

§§ 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 

§§ 17.120 through 17.132 and 17.1000 

through 17.1008. 

We revise § 17.3250(a) as proposed to 

add a reference to § 17.3240, as 

§ 17.3240 also relates to the provision of 

items and services set forth in these 

regulations. We also revise § 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 § 17.3250(b) to correct 

citations to §§ 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 §§ 17.120 through 

17.132 and 17.1000 through 17.1008. 

We additionally revise § 17.3250(b) to 

remove from the last sentence the 

phrase ‘‘that otherwise are’’, as this 

language is extraneous and does not add 


tkelley on DSKBCP9HB2PROD with RULES
84258 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

to the provisions in § 17.3250(b). We 

additionally revise the last sentence of 

§ 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 

§ 17.3250(b) and be consistent with 

§ 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 

§ 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 § 17.3220(a) as proposed to 

clarify that veteran eligibility may occur 

if a veteran is exempt from enrollment 

under § 17.37(a) through (c), and not 

under § 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— 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 

■ 1. The authority citation for part 17 is 

amended by adding entries for 

§§ 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. 

* * * * * 

■ 2. Amend § 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: 

§ 17.38 Medical Benefits Package. 

(a) * * * 

(1) * * * 

(viii) Prosthetic and rehabilitative 

items and services as authorized under 

§§ 17.3200 through 17.3250, and 

eyeglasses and hearing aids as 

authorized under § 17.149. 

* * * * * 

§ 17.120 [Amended] 

■ 3. Amend § 17.120 introductory text 

by removing ‘‘(except prosthetic 

appliances, similar devices, and 

repairs)’’. 

§ 17.122 [Removed and Reserved] 

■ 4. Remove and reserve § 17.122. 

■ 5. Revise the undesignated center 

heading that precedes § 17.148 to read 

as follows: 

Sensory and Other Rehabilitative Aids 

§ § 17.150 and 17.153 [Removed and 

Reserved] 

■ 6. Remove and reserve §§ 17.150 and 

17.153. 

■ 7. Add an undesignated center 

heading and §§ 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. 

§ 17.3200 Purpose and scope. 

(a) Purpose. The purpose of this 

section and §§ 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 § 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 §§ 17.3210 

through 17.3250 apply only to items and 

services listed in § 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 benefits ......................... 38 U.S.C. 1714(b) & (c) ................................... 38 CFR 17.148 

Sensori-neural aids ............................................ 38 U.S.C. 1707(b) ............................................ 38 CFR 17.149 

Patient lifts and other rehabilitative devices ....... 38 U.S.C. 1717(b) ............................................ 38 CFR 17.151

Devices for deaf veterans .................................. 38 U.S.C. 1717(c) ............................................ 38 CFR 17.152 

Equipment for blind veterans ............................. 38 U.S.C. 1714(b) ............................................ 38 CFR 17.154 

Automobile adaptive equipment ......................... 38 U.S.C. 3901 et seq. .................................... 38 CFR 17.155 through 17.159 

Home improvements and structural alterations 38 U.S.C. 1717(a)(2) ....................................... 38 CFR 17.3100 through 17.3130 

§ 17.3210 Definitions. 

For the purposes of §§ 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 


tkelley on DSKBCP9HB2PROD with RULES
84260 Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 

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 nonbiological 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 § 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 

§ 17.3230. 

§ 17.3220 Eligibility. 

A veteran is eligible to receive items 

and services described in § 17.3230 if: 

(a) The veteran is enrolled under 

§ 17.36 or exempt from enrollment 

under § 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 

§ 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. 

§ 17.3230 Authorized items and services. 

(a)(1) VA will provide veterans 

eligible under § 17.3220 with the 

following items and services if VA 

determines that such items and services 

are needed under § 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 nonprimary 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 nonprimary 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 


tkelley on DSKBCP9HB2PROD with RULES
Federal Register / Vol. 85, No. 248 / Monday, December 28, 2020 / Rules and Regulations 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 

§ 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 § 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 

§ 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. 

§ 17.3240 Furnishing authorized items and 

services. 

(a)(1) VA providers, or eligible entities 

and providers as defined in § 17.4005, 

will prescribe items and services in 

accordance with § 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 

§§ 17.120 through 17.132, §§ 17.1000 

through 17.1008, or § 17.4020(c), or 

urgent care under § 17.4600, prior 

authorization of items and services 

under § 17.3230 is required for VA to 

reimburse VA-authorized vendors for 

furnishing such items or services to 

veterans. 

§ 17.3250 Veteran responsibilities. 

(a) Veterans must use items provided 

under §§ 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 § 17.3230(a)(13). 

(b) Except for emergency care under 

§§ 17.120 through 17.132, §§ 17.1000 

through 17.1008, or § 17.4020(c), or 

urgent care under § 17.4600, veterans 

obtaining items and services provided 

under § 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 

§§ 17.120 through 17.132, §§ 17.1000 

through 17.1008, or § 17.4020(c), or 

urgent care under § 17.4600. 

[FR Doc. 2020–27014 Filed 12–23–20; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 63 

[EPA–HQ–OAR–2019–0282; FRL–10014–50– 

OAR and FRL–10019–02–OAR] 

RIN 2060–AM75 

Reclassification of Major Sources as 

Area Sources Under Section 112 of the 

Clean Air Act; Correction 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule; correction. 

SUMMARY: The U.S. Environmental 

Protection Agency (EPA) is correcting a 

final rule that appeared in the Federal 

Register on November 19, 2020, and 

will become effective on January 19, 

2021. The EPA finalized the 

amendments to the General Provisions 

that apply to National Emission 

Standards for Hazardous Air Pollutants 

(NESHAP). This action corrects 

inadvertent typographical errors and 

redundant text in the Federal Register. 

The corrections described in this action 

do not affect the substantive 

requirements of the final rule 

implementing the plain language 

reading of the ‘‘major source’’ and ‘‘area 

source’’ definitions of section 112 of the 

Clean Air Act. 

DATES: This final rule is effective on 

January 19, 2021. 

FOR FURTHER INFORMATION CONTACT: For 

questions about this final action, contact 

Elineth Torres, Sector Policies and 

Programs Division (D205–02), Office of 

Air Quality Planning and Standards, 

U.S. Environmental Protection Agency, 

Research Triangle Park, North Carolina 

27711; telephone number: (919) 541– 

4347; fax number: (919) 541–4991; and 

email address: torres.elineth@epa.gov. 

SUPPLEMENTARY INFORMATION: The EPA 

is making the following corrections to 

the final rule, Reclassification of Major 

Sources as Area Sources Under Section 

112 of the Clean Air Act (also refered as 

final Major MACT to Area or MM2A 

rule) as published in the Federal 

Register on November 19, 2020 (85 FR 

73854). 

The EPA is correcting inadvertent 

typographical errors and redundant text 

included in the regulatory text of six 

NESHAP subparts amended by the final 

MM2A rule. As described in the 

preamble to the final MM2A rule, the 

EPA finalized amendments to the 

NESHAP General Provision 

applicability tables for most of the 

NESHAP subparts to account for the 

final amendments to the General 

Provisions included in the final MM2A 

rule. 

With this action, the EPA is correcting 

the following errors in FR Document 

Number (FR Doc) 2020–22044 in the 

issue of November 19, 2020. These 

corrections do not change the 

requirements finalized in the MM2A 

rule. 

• At 85 FR 73894, second column, 40 

CFR part 63, subpart EE. The final 

MM2A rule instruction 37 amended 

Table 1 to subpart EE by revising the 

entry for 40 CFR 63.9(b)(2), however, 

there is no such entry on Table 1 to 

subpart EE. In this action, instruction 37 

is corrected to read ‘‘adding in 

numerical order entries for §§ 63.1(c)(6) 

and 63.9(k) . . .’’ and amendatory text 

is corrected by removing the entry for 40 

CFR 63.9(b)(2) from Table 1 to Subpart 

EE of Part 63—Applicability of General 

Provisions to Subpart EE. 

• At 85 FR 73897, third column, 40 

CFR part 63, subpart DDD. The final 

MM2A rule instruction 51 amended 

Table 1 to subpart DDD to add an entry 

for 40 CFR 63.1(c)(6), however this 

addition is unnecessary as Table 1 to 

subpart DDD has another entry 

including that provision. In this action, 

instruction 51 is corrected to read ‘‘. . . 

by adding in numerical order an entry 

for § 63.9(k) . . .’’ and the amendatory 

text is corrected by removing the entry 

for 40 CFR 63.1(c)(6) from Table 1 to 

Subpart DDD of Part 63—Applicability 

of General Provisions (40 CFR part 63, 

subpart A) to Subpart DDD of Part 63. 

• At 85 FR 73899, first column, 40 

CFR part 63, subpart NNN. The final 


tkelley on DSKBCP9HB2PROD with RULES