Prosthetic and Rehabilitative Items and Services, 61137-61143 [2018-24474]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 83, Number 229 (Wednesday, November 28, 2018)]
[Proposed Rules]
[Pages 61137-61143]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24474]


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Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of 
the proposed issuance of rules and regulations. The purpose of these 
notices is to give interested persons an opportunity to participate in 
the rule making prior to the adoption of the final rules.

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Federal Register / Vol. 83, No. 229 / Wednesday, November 28, 2018 / 
Proposed Rules

[[Page 61137]]



DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AP46


Prosthetic and Rehabilitative Items and Services

AGENCY: Department of Veterans Affairs.

ACTION: Supplemental notice of proposed rulemaking.

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SUMMARY: On October 16, 2017, the Department of Veterans Affairs 
published a proposed rulemaking to amend its regulations on the 
provision of prosthetic and rehabilitative items and services. This 
supplemental notice of proposed rulemaking (SNPRM) provides 
clarification about provisions of that proposed rulemaking and seeks 
additional public comments on them. This SNPRM also provides notice 
regarding certain communications between VA and external parties 
regarding the proposed rule, and a summary of these communications has 
been added to the public docket of this rulemaking.

DATES: Comments must be received by VA on or before December 28, 2018.

ADDRESSES: Written comments may be submitted by through https://www.Regulations.gov; by mail or hand-delivery to Director, Regulations 
Management (00REG), Department of Veterans Affairs, 810 Vermont Avenue 
NW, Room 1063B, Washington, DC 20420; or by fax to (202) 273-9026. 
Comments should indicate that they are submitted in response to ``RIN 
2900-AP46, Prosthetic and rehabilitative items and services; 
Supplemental notice of proposed rulemaking''. Copies of comments 
received will be available for public inspection in the Office of 
Regulation Policy and Management, Room 1063B, between the hours of 8:00 
a.m. and 4:30 p.m. Monday through Friday (except holidays). Please call 
(202) 461-4902 for an appointment. (This is not a toll-free number.) In 
addition, during the comment period, comments may be viewed online 
through the Federal Docket Management System (FDMS) at https://www.Regulations.gov.

FOR FURTHER INFORMATION CONTACT: Penny Nechanicky, National Program 
Director for Prosthetic and Sensory Aids Service (10P4RK), Department 
of Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420; (202) 
461-0337. (This is not a toll-free number.)

SUPPLEMENTARY INFORMATION: On October 16, 2017, VA published a proposal 
to amend VA regulations governing the provision of prosthetic and 
rehabilitative items and services to eligible veterans. Federal 
Register (82 FR 48018). That rulemaking proposed to reorganize and 
update the regulations on prosthetic and rehabilitative items and 
define the types of items and services available to eligible veterans. 
That rulemaking also proposed to eliminate the existing prosthetics 
regulations at section 17.150 of title 38, Code of Federal Regulations 
(CFR) and establish entirely new sections at Sec. Sec.  17.3200, et 
seq.
    VA asked for comments on the proposed rule on or before December 
15, 2017, and we received 305 comments. A number of those commenters 
raised concerns about proposed Sec.  17.3240, ``Furnishing Authorized 
Items and Services,'' and whether the proposal would alter VA's current 
practices regarding veterans' choice, particularly with regard to the 
provision of artificial limbs, as reflected, in part, in two Veterans 
Health Administration (VHA) Handbooks. Commenters also raised concerns 
about whether the proposal conflicts with the Veterans Access, Choice, 
and Accountability Act of 2014 (``Choice Act''), which established VA's 
Veterans Choice Program.
    With this SNPRM, we seek to clarify the intended effect of proposed 
Sec.  17.3240, explain our current practices and processes relating to 
that provision, and request additional comments on it. We also propose 
edits to proposed Sec.  17.3240 as explained in more detail below. We 
will address all of the comments that VA received on the proposed rule 
and any comments VA receives on this SNPRM in our final rulemaking.
    We clarify that the proposed rule and this SNPRM would not result 
in a different experience for most veterans receiving prosthetics and 
related care from VA. In proposed Sec.  17.3240, we are codifying our 
current practice of providing all prosthetic and rehabilitative items 
and services under Sec.  17.3230. With regard to the provision of 
artificial limbs under the proposed rule, we propose to revise VHA's 
existing policies that allow veterans to choose the provider of 
artificial limbs in limited circumstances. We also propose to align 
policies and practices to be consistent with the provision of all other 
prosthetic and rehabilitative items and services, with the community 
care authorities (e.g., Choice Act), and with our current national 
preferred process for the provision of artificial limbs (which we 
intend to continue as the national standard pursuant to this 
rulemaking). This current national preferred process would be 
implemented pursuant to this rulemaking as it will provide consistency 
in how artificial limbs are provided throughout VA. In the provision of 
artificial limbs across VHA, medical facilities have not consistently 
applied certain provisions of its current handbooks, specifically 
paragraph 6.c.(1)(b) of VHA Handbook 1173.2 and paragraphs 4.c. and 
7.a. of VHA Handbook 1173.3, as written, and these policies have led to 
ambiguity and misinterpretation within VA and by the public. Pursuant 
to this rulemaking, VA proposes to revise these policies, as following 
them as written in these two handbooks could limit consideration of 
important factors, such as the veteran's clinical needs. It was not our 
intent that VA clinical providers would not be involved in this very 
important decision on how the veteran's needs can be best met. As 
prosthetists have varying levels of expertise and familiarity with 
artificial limbs, if VA followed these policies as written, VA would 
not be able to confirm or validate that the prosthetist chosen by the 
veteran would be the most appropriate prosthetist to provide the 
artificial limb and associated services.
    Following these policies would also not be consistent with our 
contracting authorities, such as the Federal Acquisition Regulations 
(FAR) and VA Acquisition Regulations (VAAR). These policies have been 
left to each medical facility to interpret and apply, which has 
resulted in inconsistent application across the country. In a 2012 
audit of the management and acquisition of

[[Page 61138]]

prosthetic limbs within VHA, VA's Office of the Inspector General (OIG) 
found varying procurement practices among different test regions in VHA 
``[d]ue to the inconsistencies in the available guidance.'' See, 
Veterans Health Administration, Audit of the Management and Acquisition 
of Prosthetic Limbs, Report No. 11-02254-102, VA OIG, Office of Audits 
and Evaluations, March 8, 2012, page 9. The OIG concluded that such 
variability led to ``overlap and gaps in services'' and that 
``contracting staff may be performing unnecessary workload.'' Id. The 
OIG further concluded that ``[i]t is important that VHA monitors 
contract workload and ensures the contracts it awards and administers 
are necessary to support veterans' requirements.'' Id. Through this 
rulemaking, we seek to create a uniform standard and process for the 
provision of artificial limbs to ensure all VA medical facilities are 
in alignment with the current process for the provision of all other 
prosthetic and rehabilitative items and services, and with our current 
national preferred process for the provision of artificial limbs, which 
we intend to continue pursuant to this rulemaking. In the following 
paragraphs, we will explain our processes for the provision of all 
prosthetic and rehabilitative items and services, as well as artificial 
limbs, and address certain public comments regarding proposed Sec.  
17.3240.

General Current Process for the Provision of Prosthetic and 
Rehabilitative Items and Services Other Than Artificial Limbs

    The current decision making process for providing prosthetic and 
rehabilitative items and services starts with a clinical evaluation of 
a veteran's needs by a VA health care provider or authorized community 
(i.e., non-Department) provider. The decision on the prosthetic or 
rehabilitative item or service to be provided to the veteran is a 
clinical decision made by the veteran's health care provider, in 
consultation with the veteran, and results in a prescription for a 
prosthetic or rehabilitative item or service. This ensures that the 
veteran's clinical needs will be met by the item or service prescribed, 
that the item or service prescribed is safe, that the veteran is 
involved in this process because he or she is a necessary member of the 
health care delivery team, and that the item or service will serve as a 
direct and active component of the eligible veteran's medical treatment 
and rehabilitation. A VA prosthetics representative at a VA medical 
facility then determines how best to provide the item or service to the 
veteran. While sections 1701 and 1710 of title 38, United States Code 
(U.S.C.), require VA to furnish medical services, including medically 
necessary prosthetic and rehabilitative items and services to certain 
eligible veterans and authorize VA to provide them to other eligible 
veterans, the decision as to how VA provides such items and services is 
discretionary. As explained at 82 FR 48025, if VA has the capacity or 
inventory to directly provide such item or service, VA will do so. VA 
may use authorized community vendors on a case-by-case basis to provide 
greater access, lower cost, and a wider range of items and services. 
Pursuant to the FAR, VA utilizes national and regional agreements to 
provide prosthetic and rehabilitative items and services and also, on a 
case by case basis, enters into agreements with vendors in the 
community who are not part of these national or regional agreements in 
the instance that VA is unable to provide these items and services 
directly or pursuant to an existing agreement. While VA has general 
authority to provide necessary health care services to eligible 
veterans, VA's authority to provide such services through community 
sources is constrained by statute and regulation. For example, except 
where authorized, VA complies with the FAR and the VAAR, which ensure 
that the prescribed items and services meet the veteran's clinical 
needs and that VA obtains such items and services in a fiscally 
responsible and legally sufficient manner.
    We note that the decision of what prosthetic or rehabilitative item 
or service is to be provided is a clinical decision and results in a 
prescription. The decision of how that prescribed item or service is 
provided is a separate decision, and VA retains the authority to make 
this determination. As long as the prescribed item or service (whether 
prescribed by a VA or an authorized community provider) serves as a 
direct and active component of the veteran's medical treatment and 
rehabilitation, VA prosthetics representatives will honor the 
prescription and procure the prescribed item or service for the 
veteran. While the veteran's clinical needs are always considered in 
the determination of how the item or service is procured, 
administrative factors are also considered on a case by case basis, as 
explained in more detail throughout this SNPRM. Under the proposed 
rulemaking and this SNPRM, we would continue to ensure that the 
veteran's clinical needs drive how the agency determines whether VA can 
directly provide the prescribed item or service, or whether VA will use 
an authorized vendor in the community to provide the item or service. 
VA's procurement practices with respect to prosthetic and 
rehabilitative items and services are aimed at ensuring that veterans' 
needs are met with the most appropriate and highest quality items and 
services in a consistent manner throughout VA and that VA complies with 
Federal and VA acquisition regulations as applicable.

Current National Preferred Process for the Provision of Artificial 
Limbs

    As previously discussed, there is some variation in the provision 
of artificial limbs throughout VHA, specifically with regard to the 
role of the veteran and the clinician in the determination of how 
prescribed items and services are provided. The following is a 
discussion on the current national preferred process for the provision 
of such items and encompasses the process VA intends to continue 
pursuant to proposed Sec.  17.3240. Similar to the provision of other 
prosthetic and rehabilitative items and services under proposed 38 CFR 
17.3230 as explained above, in the instance of the provision of an 
artificial limb, VA first requires an evaluation of a veteran's 
clinical need for such item. This evaluation is typically done by the 
amputee clinic team. If a veteran has been evaluated by an authorized 
community provider, any prescription for an artificial limb and related 
components written by that authorized community provider is referred to 
the amputee clinic team, particularly because the authorized community 
provider may not specialize in artificial limb evaluation. Oftentimes, 
the prescription does not contain sufficient information for VA to 
provide directly or through a VA-authorized prosthetist all the 
components, accessories, supplies, and related services necessary to 
fabricate an artificial limb. Furthermore, agreements with VA-
authorized prosthetists for the artificial limb and related services 
must include Healthcare Common Procedure Coding System (HCPCS) codes, 
which VA determines based on an evaluation of the patient by the 
amputee clinic team. The amputee clinic team conducts an assessment to 
determine the veteran's clinical needs, and along with the veteran, 
identifies the appropriate artificial limb and related components 
needed and makes a determination on how the item(s) will be provided. 
As discussed in the previous section, this decision is in consultation 
with the veteran and prioritizes veterans' clinical needs. Generally, 
if a VA medical

[[Page 61139]]

facility accessible to the veteran offers the orthotic and prosthetic 
services that meet the veteran's clinical needs, then VA provides the 
limb and all associated services (e.g., fitting, minor repairs, routine 
servicing) directly to the veteran. If VA's decision is that the 
veteran should receive the item and services from a community (i.e., 
non-Department) prosthetist, VA utilizes its established orthotic and 
prosthetic agreements in the region to authorize a community 
prosthetist to provide the artificial limb and associated services to 
the veteran. The veteran is able to select, in consultation with his or 
her VA clinician or amputee clinic team, from a list of vendors in the 
geographic area that have an existing agreement with VA and are able to 
meet the veteran's clinical needs. While most facilities have a number 
of established agreements already in place for use, in the instance 
that there is no prosthetist under an established agreement that is 
able to meet the veteran's clinical needs, VA and the veteran will work 
together to identify the appropriate community prosthetist, and VA 
would seek to establish an agreement with that prosthetist for the 
needed artificial limb and related services. In purchasing such items 
and services, VA complies with the FAR and VAAR as applicable. We note 
that some of the above process may vary if the veteran is eligible for 
the Veterans Choice Program, operated pursuant to Sec.  17.1500 et seq. 
Under proposed Sec.  17.3240, we would standardize this process of 
determining whether to directly provide the artificial limb and 
associated services or whether to use a VA-authorized vendor (i.e., a 
community/non-Department prosthetist). This would result in several 
benefits. First, it would ensure VA provides such items and services in 
a consistent and standardized manner throughout VA, which would also be 
consistent with the provision of all other prosthetic and 
rehabilitative items and services. Second, it would be consistent with 
the current national preferred practice, while also ensuring compliance 
with Federal acquisition requirements. Finally, and most importantly, 
this would ensure veterans receive the most appropriate and highest 
quality item or service that meets their clinical needs. We note that 
VA retains authority over this determination to ensure that there is 
consistency across VHA in the provision of these prescribed items and 
services, and for quality control purposes.

Public Comments About Proposed Sec.  17.3240

    Many commenters raised concerns about VA's statement in the 
proposed rule at 82 FR 48025 that the decision as to whether VA or a 
VA-authorized vendor (i.e., community/non-Department vendor) will 
furnish the prescribed item or service to the veteran is an 
administrative business decision; the commenters stated that this is 
instead a clinical issue that should also be based on the veterans' 
preferences. Some commenters were concerned that making this an 
administrative business decision would restrict veterans' choice of 
providers and delay care. We agree and now clarify that our description 
of the proposed rule failed to state that clinical decisions are 
necessary to issue the clinically-appropriate prosthetic or 
rehabilitative item or service to a veteran. Furthermore, as mentioned 
in the discussions above, the decision about what item or service VA 
will provide to the veteran is a clinical decision made by the 
veteran's health care provider, in consultation with the veteran, which 
results in a medical prescription. Additionally, there is a related 
decision about how VA will provide the prescribed items and services 
(whether by VA or by a VA-authorized vendor). The veteran's clinical 
needs will drive this determination. However, while the clinical needs 
are always part of this determination, VA may consider administrative 
factors when making this determination. Such administrative factors 
considered may include, but would not be limited to, VA capacity and 
availability, geographic availability, and cost. We note that VA 
capacity and availability can refer to whether a VA medical facility 
has the resources and equipment to fabricate an authorized item or 
service, and whether VA providers are available and have the skills, 
abilities, and experience to provide an authorized item or service. For 
example, a VA prosthetist may have the ability to fabricate an 
artificial limb, but may not be able to fabricate the limb because of 
his or her workload. In that instance, VA may determine that an 
authorized VA vendor will provide the authorized item or service. If 
the authorized item or service requires certain expertise or experience 
that a VA provider does not have, VA may determine that an authorized 
VA vendor will provide that item or service instead. Relatedly, some VA 
medical facilities have laboratories in which artificial limbs can be 
fabricated while others do not, and this would be a consideration in 
determining whether VA or an authorized VA vendor provides the 
artificial limb. We also note that how geographic availability is 
considered in this determination of whether VA or an authorized VA 
vendor provides the authorized item or service will vary. There would 
be no set distance or mileage that we would define when considering 
geographic availability in this determination, as this can be dependent 
on the health and mobility of the veteran and his or her clinical 
needs. For example, in considering geographic availability, a veteran 
amputee who has no other medical conditions that would limit his or her 
mobility and may have regular access to a vehicle will likely have 
substantially different clinical needs in this regard than a veteran 
amputee with medical conditions that impede his or her mobility and who 
may lack dependable access to a vehicle. For veterans who have mobility 
issues, geographic availability can vary significantly. In such 
situations, it would be appropriate for the provider to consider 
whether a specific limb under consideration can be fabricated, 
serviced, and repaired by a VA or non-VA prosthetist. We further note 
that although cost is not a factor providers consider when determining 
which item or service to prescribe, it may be relevant in determining 
whether VA or an authorized VA vendor provides the prescribed item or 
service. For example, if an authorized vendor sells the authorized item 
at a lower cost than what it would cost VA to provide the item itself, 
then VA may decide to procure the item from the authorized VA vendor 
based on cost.
    While the factors VA considers in making the determination of how 
to provide the authorized item or service will vary, we would continue 
to ensure that the veteran's clinical needs drive how the agency 
determines whether VA can directly provide the prescribed item or 
service, or whether VA will use an authorized vendor in the community 
to provide the item or service, while also ensuring that VA is 
administering these benefits in a fiscally responsible and consistent 
manner.
    Other commenters expressed concern that administrative business 
decisions would not be consistent with other authorities, particularly 
the Choice Act. First, we note that since the publication of the 
proposed rule in October 2017, the President signed into law the VA 
MISSION Act of 2018 (Pub. L. 115-182). Section 143 of this Act provides 
that VA may not use the Choice Act authority to furnish care and 
services after June 6, 2019. While we address, in this SNPRM, the 
concerns regarding the Choice Act that were raised by commenters, we

[[Page 61140]]

realize that these concerns and our responses will become moot once 
VA's authority to furnish care and services pursuant to the Choice Act 
ends. As a result of the VA MISSION Act of 2018, VA is developing new 
regulations for the new Veterans Community Care Program required by 
section 101 of that Act and will also be revising or eliminating the 
regulations implementing the Choice Act; should any further revisions 
to VA's prosthetic regulations be needed as a result of these efforts, 
VA will address those changes through a subsequent rulemaking and 
further explain or modify these regulations as necessary.
    We note that eligibility for the Veterans Choice Program 
implemented pursuant to the Choice Act is dependent on meeting certain 
criteria defined in Sec.  17.1510. In comparison, eligibility for 
prosthetics and rehabilitative items and services is set forth in 
proposed Sec.  17.3220, which would only require that the veteran be 
enrolled in VA health care pursuant to Sec.  17.36 or exempt from 
enrollment under Sec.  17.37, or that the veteran be otherwise 
receiving care or services under chapter 17 of title 38 U.S.C. If the 
veteran meets any of these criteria, he or she would be eligible to 
receive a prosthetic or rehabilitative item or service so long as such 
item or service serves as a direct and active component of the 
veteran's treatment or rehabilitation. Similar to the Choice Program, 
factors such as geographic availability are considered in making the 
determination. However, VA always considers clinical factors in making 
the determination of who will provide the prescribed item or service. 
While the eligibility criteria for when a veteran is able to seek care 
from a community provider under the Veterans Choice Program are 
generally administrative, the determination of who provides the 
prosthetic and rehabilitative item or service under Sec.  17.3240 is 
both administrative and clinical. We note that this latter 
determination is broader and less stringent than the determination 
under the Veterans Choice Program and provides the veteran with input 
into whether VA or an authorized VA vendor provides him or her with the 
prescribed item or service.
    Relatedly, general concerns were raised that proposed Sec.  17.3240 
is inconsistent with the Choice Act. While VA may not use the Choice 
Act to furnish care and services after June 6, 2019, as described 
above, we believe these authorities are consistent with one another, or 
where they are potentially inconsistent, they are so in a way to the 
benefit of the veteran in that this proposed rule is broader and less 
stringent than the eligibility requirements under the Veterans Choice 
Program. We note that the Choice Act requires VA approval prior to 
obtaining care from a community provider, and there are specific 
criteria that veterans and community providers must meet for care to be 
authorized and approved. See Sec. Sec.  17.1500 et seq. If a veteran is 
eligible and approved by VA to seek care outside VA under Sec.  
17.1510, that veteran may obtain care from eligible entities and 
providers under Sec.  17.1530. An agreement must be in place prior to 
the authorized care being furnished, and the agreement or authorization 
for care must be specific as to the care to be provided to the veteran. 
If the authorized entity or provider prescribes a prosthetic or 
rehabilitative item or service, VA would then proceed to procure that 
item or service as long as it is part of the original authorized care 
and serves as a direct and active component of the veteran's treatment 
or rehabilitation. In this context, the proposed rule as modified by 
this SNPRM is consistent with the Choice Act, as the Choice Act 
requires VA to authorize prosthetic and rehabilitative items and 
services from a VA-authorized vendor in the community prior to those 
items or services being provided. See, e.g., Public Law 113-146, sec. 
101(a)(1)(A), (c)(1)(B)(i), (d)(4)(B)(iii), and (h). See also 38 CFR 
17.1505 (the definition of appointment, in particular), 17.1510(d) 
(``prior to obtaining authorization for care''), 17.1515(a), and 
17.1535(c). Thus, proposed Sec.  17.3240 is consistent with, and less 
restrictive than, the Choice Act.
    In addition to the Choice Act, commenters raised concerns about 
whether the proposed rule would implicate other community care 
authorities, such as 38 U.S.C. 8153 and 1703. Sections 8153 and 1703 
are used by VA to obtain medical care in the community; however, we 
note that section 1703 will be revised significantly by 101 of the VA 
MISSION Act of 2018. These changes will become effective when VA 
publishes regulations implementing section 101 of the VA MISSION Act of 
2018. The proposed rule, as amended by this SNPRM, would not limit, 
impact, or be inconsistent with VA's existing or future authorities 
under sections 8153 and 1703. These are not authorities that we have 
used to purchase prescribed prosthetic and rehabilitative items or 
services. Similar to the Choice Program, if the entity or provider 
authorized under sections 1703 and 8153 to provide care to a veteran 
prescribes a prosthetic or rehabilitative item or service, VA would 
then proceed to procure that item or service as long as it is part of 
the original authorized care and serves as a direct and active 
component of the veteran's treatment or rehabilitation. VA would then 
use its prosthetic procurement authorities (i.e., 38 U.S.C. 8123, FAR, 
and VAAR) to obtain the prescribed prosthetic and rehabilitative items 
and services. In this context, the proposed rule as modified by this 
SNPRM is consistent with sections 1703 and 8153. Similar to the Choice 
Act, these authorities have separate eligibility criteria than what is 
in proposed Sec.  17.3220. See 38 U.S.C. 1703, 8153, and 38 CFR 17.52. 
We note that proposed Sec.  17.3220 would be less restrictive than the 
eligibility criteria for these community care programs, as these 
community care authorities require facilities to consider only certain 
factors when determining whether a veteran may obtain care outside VA. 
For example, pursuant to 38 CFR 17.52, in instances when VA facilities 
are incapable of furnishing care due to geographic inaccessibility or 
are not capable of furnishing care or services required, VA may 
contract with non-VA facilities for the care. As the regulations 
implementing these community care authorities are undergoing revision 
due to the enactment of the VA MISSION Act of 2018, should any further 
revisions to VA's prosthetic regulations be needed as a result, VA will 
address those changes through a subsequent rulemaking and further 
explain or modify these regulations as necessary.
    Additionally, we note that 38 U.S.C. 1703 distinguishes between 
veterans with service connected and nonservice connected disabilities 
when determining their eligibility to obtain care outside VA under that 
authority. Section 101 of the VA MISSION Act of 2018 will revise 
section 1703 to remove this distinction, and to the extent necessary, 
such elimination would be reflected under these prosthetics 
regulations. We note that the proposed prosthetics regulations, as 
amended by this SNPRM, do not distinguish between veterans with service 
connected conditions and nonservice connected conditions.
    Commenters also raised concerns about the authority for proposed 
Sec.  17.3240, as VA did not cite to or reference the statutory 
authority for that section. As mentioned previously in this discussion, 
38 U.S.C. 1710, the authorizing statute, requires VA to furnish medical 
services to certain eligible veterans and authorizes VA to provide them 
to other eligible veterans. See also, 38 U.S.C. 1701(6), which defines 
the term ``medical services'' in

[[Page 61141]]

a manner that covers prosthetic and rehabilitative items and services. 
Sections 1701 and 1710 do not, however, mandate how VA provides these 
items and services. In other words, how VA provides them is 
discretionary, and VA proposes Sec.  17.3240 pursuant to this 
authority.
    VA also received many comments stating that the proposed rule 
contradicted existing VHA policies and practices relating to the 
provision of artificial limbs and the veteran's choice of provider. We 
note that VHA Handbooks 1173.2 ``Furnishing Prosthetic Appliances and 
Services'' and 1173.3 ``Amputee Clinic Teams and Artificial Limbs'' 
indicate that a veteran is able to choose his or her prosthetist, 
including community (i.e., non-Department) prosthetists, if the veteran 
has a preexisting relationship with that prosthetist. VHA Handbook 
1173.2 paragraph 6.c.(1)(b) states that, ``Eligible veterans will 
select their provider for artificial limbs from the listing of contract 
vendors, including capable VA Prosthetic and Orthotic Laboratories. 
Service connected veterans who have obtained their most recent limb 
from a non-contract provider will be allowed to have their subsequent 
limb manufactured by the VA non-contract provider as long as the 
prosthetist is willing to accept the geographic VA preferred provider 
payment rate for the State in which the prosthetist performs this 
service.'' Paragraph 4.c. of VHA Handbook 1173.3 states, ``Eligible 
veterans, as identified in VHA Handbook 1173.1, who have previously 
received artificial limbs from commercial sources, will continue to 
have their choice of vendors on contract with VA or their non-contract 
prosthetist, providing the prosthetist accepts the VA preferred 
provider rate for the geographic area.'' Paragraph 7.a. of that same 
Handbook further states, ``Eligible veterans will be permitted to 
obtain authorized artificial limbs and/or terminal devices from any 
commercial artificial limb dealer who is under a current local contract 
to the VA or the veteran's preferred prosthetist who agrees to accept 
the preferred provider rate.''
    As mentioned previously in this document, these provisions in these 
two handbooks have not been consistently applied as written throughout 
VA's medical facilities in the provision of artificial limbs. We 
propose to revise these policies, because following them as written has 
resulted in inconsistent application, and ambiguity and 
misinterpretation within VA and by the public. Additionally, as 
prosthetists have varying levels of expertise and familiarity with 
artificial limbs, if VA followed these policies as written, VA would 
not be able to confirm or validate that the prosthetist chosen by the 
veteran would be the most appropriate prosthetist to provide the 
artificial limb and associated services. It was not our intent that VA 
clinical providers would not be involved in this very important 
decision on how the veteran's needs can be best met. As previously 
mentioned, the veteran and the VA provider would work together to 
determine what item or service is needed to meet the veteran's clinical 
needs, and who may be able to provide such item or service. The 
veteran's preferences will be part of that decision with the VA 
provider. Through this rulemaking, we seek to ensure a standardized and 
consistent process across VA for the provision of artificial limbs that 
is consistent with the current national preferred process and with the 
process for the provision of all other prosthetic and rehabilitative 
items and services.
    After this rulemaking is final, VA will rescind VHA Handbooks 
1173.2 and 1173.3 and develop new policies to update and clarify its 
procedures, consistent with this regulation.

Corrections to Proposed Sec.  17.3240

    Based on these comments received and the discussion above, VA now 
proposes to revise the language of Sec.  17.3240, as proposed in 82 FR 
48018. In revised proposed Sec.  17.3240(a)(1), we would 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. Once 
the prescribed item or service is determined to be authorized under 
Sec.  17.3230, VA will determine whether VA or a VA-authorized vendor 
will furnish authorized items and services under Sec.  17.3230 to 
veterans eligible for such items and services under Sec.  17.3220. We 
would add paragraph (a)(2) to Sec.  17.3240 to state that this 
determination on whether VA or a VA-authorized vendor will furnish the 
authorized item or service under Sec.  17.3230 will be based on, but 
not limited to, such factors as the veteran's clinical needs, VA 
capacity and availability, geographic availability, and cost.
    Revising the language of Sec.  17.3240, as proposed in 82 FR 48018, 
would codify our current practices and the current national preferred 
process for the provision of artificial limbs; it also would clarify 
that the item or service that is authorized is prescribed based on the 
veteran's clinical needs and is done in consultation with the veteran. 
In response to many comments regarding this clinical decision and the 
veteran's involvement in that decision, we explicitly note that the 
prescription is clinical and based on the veteran's clinical needs. For 
similar reasons, we would also clarify that the prescription is 
generated in consultation with the veteran. This would be explained in 
proposed 17.3240(a)(1).
    Additionally, as mentioned, we received comments that the decision 
on how to provide an authorized item or service should not be 
administrative, but rather clinical. Relatedly, at least one commenter 
raised the concern that we did not identify or explain the factors we 
would use in making this determination. In response to the comments 
received, we would revise proposed Sec.  17.3240 to clarify that the 
determination on how the item or service is provided is based on 
clinical and administrative factors. In proposed Sec.  17.3240(a)(2), 
we would list factors that would be considered when procuring and 
providing the authorized item or service. This list of factors is non-
exhaustive. Not all factors would be considered in every instance, as 
the provision of each authorized item or service will vary, and 
additional factors could be considered as needed. For example, a 
specific wheelchair may be prescribed as that may be the only 
wheelchair that would meet the veteran's clinical needs, and there may 
be only one manufacturer of that wheelchair. In that instance, if the 
wheelchair meets the direct and active component standard, it will be 
authorized and VA would proceed to procure that wheelchair directly 
from the manufacturer without consideration of the other factors. 
Additionally, a provider may prescribe diabetic shoes to meet a 
veteran's clinical needs, and if VA has those in its inventory, it will 
provide those to the veteran. If there are none in inventory and VA 
needs to procure the prescribed shoes, then we will look at our 
existing contracts to purchase such items. Additional factors such as 
cost may be considered in that instance to ensure that we are being 
fiscally responsible. As explained previously, VA capacity and 
availability can refer to whether a VA medical facility has the 
resources and equipment to fabricate an authorized item or service, or 
whether VA providers are available or have the skills, abilities, and 
experience to provide an authorized item or service. With regard to 
geographic availability, we note that how this factor may be considered 
would vary. There would be no set distance or mileage that we would 
define when considering geographic

[[Page 61142]]

availability in this determination, as this can be dependent on the 
health and mobility of the veteran and his or her clinical needs. 
Although cost is not a factor providers consider when determining which 
item or service to prescribe, it may be relevant in determining whether 
VA or an authorized VA vendor provides the prescribed item or service, 
as an authorized vendor may sell the authorized item at a lower cost 
than what it would cost VA to provide the item itself.
    How the authorized item or service is obtained and provided to the 
veteran will vary based on each individual case. However, we note that 
the veteran's clinical needs are always prioritized when VA determines 
how to provide the authorized item or service. Proposed Sec.  17.3240 
would ensure that VA is fiscally responsible. VA retains authority over 
this determination of how the authorized item or service is provided to 
ensure that there is consistency across VHA in the provision of 
authorized prosthetic and rehabilitative items and services, and to 
ensure quality control.
    One commenter also noted that we incorrectly referenced proposed 
Sec.  17.3210 in proposed Sec.  17.3240. Proposed Sec.  17.3210 is the 
section on definitions whereas proposed Sec.  17.3220 is the section on 
eligibility. In order to correctly reference the eligibility section, 
we would update proposed Sec.  17.3240 to refer to Sec.  17.3220 
instead of Sec.  17.3210.
    As previously mentioned, since the publication of VA's proposed 
rule in October 2017, the President signed into law the VA MISSION Act 
of 2018 (Pub. L. 115-182). VA is working to implement this new 
authority, and should any further revisions to VA's prosthetic 
regulations be needed as a result of this recently enacted legislation, 
VA will address those changes through subsequent rulemaking related 
specifically to the VA MISSION Act of 2018.

Certain Communications Between VA and External Parties

    The Office of the VA Secretary also received two inquiry letters 
during the public comment period for the proposed rule. One from former 
Senator Bob Dole and the other from Peter Thomas, General Counsel for 
the National Association for the Advancement of Orthotics and 
Prosthetics. Both of these letters were treated as public comments and 
added to docket ID VA-2017-VHA-0023 in regulations.gov. Both of these 
letters raised concerns regarding proposed Sec.  17.3240 and were 
similar to the public comments we received that led to the proposed 
clarification of that section in this SNPRM. The VA Secretary at the 
time and VHA's Executive in Charge, respectively, responded to these 
two inquiries in letters sent to Senator Dole and Mr. Thomas.
    The letters stated the intent and purpose of the proposed rule to 
organize and update the current prosthetic and rehabilitative items and 
services regulations and define the items and services available. These 
letters also explained that these rules were proposed in order to 
ensure standardization and consistency in the provision of such items 
and services throughout VA, while also ensuring that veterans receive 
the most appropriate and highest quality items. The then-Secretary's 
letter to Senator Dole further explained that VA was codifying its 
practice of determining whether VA has the capacity or capability to 
provide items and services directly to veterans, or whether a VA-
authorized vendor may be utilized, which is based on several factors 
including the veteran's clinical needs, costs of items and services, or 
wider selection of items and services. In both letters, VA stated that 
these letters would be treated as public comments and that VA will 
consider and respond to their issues in the final rulemaking. 
Additionally, the Department's letters containing our responses to the 
two letters have been made publicly available in the supplemental 
notice of proposed rulemaking docket.
    On June 14, 2018, VHA met with individuals from McGuire Woods 
Consulting, who represent American Orthotic and Prosthetic Association 
(AOPA), at their request, to discuss several prosthetic issues, 
including the proposed rulemaking at 82 FR 48018 (RIN 2900-AP46). 
During this discussion, VHA was asked the status of RIN 2900-AP46 and 
where VHA thought the policy on veterans being able to see outside 
providers was going. VHA explained that we will continue to provide the 
necessary care inside and outside VA and that reducing the amount of 
care in the community is not our intent. With regard to RIN 2900-AP46, 
VHA conveyed that it received comments, including those of AOPA; is 
considering these comments; and is drafting the final rule, which will 
have to be approved by the Administration, and VHA cannot say when it 
anticipates the final rule to be published. VHA was also asked about 
the impact of the VA MISSION Act of 2018 on RIN 2900-AP46. VHA stated 
that this Act will provide more flexibility to provide care in the 
community and that VHA did not believe the Act would affect the 
provision of prosthetic and rehabilitative items and services. A 
summary of this meeting has been made publicly available in the 
supplemental notice of proposed rulemaking.
    Lastly, the House Veterans' Affairs Committee, Health Subcommittee, 
held a roundtable regarding prosthetics issues on July 25, 2018. VA was 
a participant at this roundtable. During this roundtable, concerns were 
raised about the proposed rule, RIN 2900-AP46, that were similar to 
those concerns raised during the public comment period. Within this 
SNPRM, we have addressed these concerns, which were similar to those 
raised during the public comment period.
    Based on all of the comments received regarding proposed Sec.  
17.3240, we propose to revise the text of proposed Sec.  17.3240 as 
explained previously in this SNPRM.

Effect of Rulemaking

    The Code of Federal Regulations, as proposed to be revised by the 
proposed rulemaking at 82 FR 48018 and this SNPRM, would represent the 
exclusive legal authority on this subject. No contrary guidance or 
procedures would be authorized. All VA guidance would be read to 
conform with the proposed rulemaking at 82 FR 48018 and this SNPRM if 
possible or, if not possible, such guidance would be superseded by this 
SNPRM and the proposed rulemaking at 82 FR 48018.

Paperwork Reduction Act

    This SNPRM contains no provisions constituting a collection of 
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).

Regulatory Flexibility Act

    The Secretary hereby certifies that this SNPRM would not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. Therefore, pursuant to 5 U.S.C. 605(b), these amendments would be 
exempt from the initial and final regulatory flexibility analysis 
requirements of 5 U.S.C. 603 and 604.

Executive Orders 12866, 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

[[Page 61143]]

effects, and other advantages; distributive impacts; and equity). 
Executive Order 13563 (Improving Regulation and Regulatory Review) 
emphasizes the importance of quantifying both costs and benefits, 
reducing costs, harmonizing rules, and promoting flexibility. Executive 
Order 12866 (Regulatory Planning and Review) defines a ``significant 
regulatory action,'' requiring review by the Office of Management and 
Budget (OMB) as ``any regulatory action that is likely to result in a 
rule that may: (1) Have an annual effect on the economy of $100 million 
or more or adversely affect in a material way the economy, a sector of 
the economy, productivity, competition, jobs, the environment, public 
health or safety, or State, local, or tribal governments or 
communities; (2) Create a serious inconsistency or otherwise interfere 
with an action taken or planned by another agency; (3) Materially alter 
the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights and obligations of recipients thereof; or (4) 
Raise novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles set forth in this Executive 
Order.'' The economic, interagency, budgetary, legal, and policy 
implications of this regulatory action have been examined, and it has 
been determined not to be a significant regulatory action under 
Executive Order 12866.
    This rule is not an Executive Order 13771 regulatory action because 
this rule is not significant under Executive Order 12866. VA's impact 
analysis can be found as a supporting document at https://
www.regulations.gov, usually within 48 hours after the rulemaking 
document is published. Additionally, a copy of the rulemaking and its 
impact analysis are available on VA's website at https://www.va.gov/orpm/, by following the link for ``VA Regulations Published.''

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This SNPRM would have no such effect on 
State, local, and tribal governments, or on the private sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance numbers and titles for 
the programs affected by this document are 64.009, Veterans Medical 
Care Benefits; 64.013, Veterans Prosthetic Appliances.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Government contracts, Health 
care, Health facilities, Health professions, Medical devices, Veterans.

Signing Authority

    The Secretary of Veterans Affairs 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. Robert L. 
Wilkie, Secretary, Department of Veterans Affairs, approved this 
document on October 23, 2018, for publication.

    Dated: November 5, 2018.
Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set forth in the preamble, we propose to amend 38 
CFR part 17 as follows:

PART 17--MEDICAL

0
1. The authority citation for part 17 continues to read as follows:

    Authority:  38 U.S.C. 501, and as noted in specific sections.

0
2. Add Sec.  17.3240, to read as follows:


Sec.  17.3240  Furnishing authorized items and services.

    (a)(1) VA providers will prescribe items and services based on the 
veteran's clinical needs and will do so in consultation with the 
veteran. Once the prescribed item or service is determined to be 
authorized under Sec.  17.3230, VA will determine whether VA or a VA-
authorized vendor will furnish authorized items and services under 
Sec.  17.3230 to veterans eligible for such items and services under 
Sec.  17.3220.
    (2) This determination on whether VA or a VA-authorized vendor will 
furnish the authorized item or service under Sec.  17.3230 will be 
based on, but not limited to, such factors as the veteran's clinical 
needs, VA capacity and availability, geographic availability, and cost.
    (b) Except for emergency care reimbursable under 38 CFR 17.120 
through 17.132 or 38 CFR 17.1000 through 17.1008, prior authorization 
of items and services under Sec.  17.3230 is required for VA to 
reimburse VA-authorized vendors for furnishing such items or services 
to veterans. Prior authorization must be obtained from VA by contacting 
any VA medical facility.

[FR Doc. 2018-24474 Filed 11-27-18; 8:45 am]
 BILLING CODE 8320-01-P