Veterans Community Care Program, 26278-26310 [2019-11575]
Download as PDF
26278
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AQ46
Veterans Community Care Program
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) adopts as final a proposed
rule amending its regulations that
govern VA health care. This final rule
implements its authority from the VA
MISSION ACT of 2018 for covered
veterans to receive necessary hospital
care, medical services, and extended
care services from non-VA entities or
providers in the community.
DATES: Effective Date: This rule is
effective on June 6, 2019.
FOR FURTHER INFORMATION CONTACT:
Joseph Duran, Office of Community
Care (10D), Veterans Health
Administration, Department of Veterans
Affairs, Ptarmigan at Cherry Creek,
Denver, CO 80209; Joseph.Duran2@
va.gov, (303) 370–1637. (This is not a
toll-free number.)
SUPPLEMENTARY INFORMATION: On June 6,
2018, the President signed into law the
John S. McCain III, Daniel K. Akaka, and
Samuel R. Johnson VA Maintaining
Internal Systems and Strengthening
Integrated Outside Networks (MISSION)
Act of 2018 (hereafter referred to as the
‘‘MISSION Act,’’ Pub. L. 115–182, 132
Stat. 1395, as amended). This final rule
implements section 101 of the MISSION
Act, which requires VA to implement a
Veterans Community Care Program to
furnish required care and services to
covered veterans through eligible
entities and providers. Section 101,
which amends 38 U.S.C. 1703 upon the
effective date of these final regulations,
further establishes the conditions under
which VA determines if covered
veterans are eligible to elect to receive
such care and services through eligible
entities or providers, as well as other
parameters of the Veterans Community
Care Program. This final rule
implements in a regulatory framework
the requirements in amended section
1703, consistent with the mandate in
section 101(c) of the MISSION Act that
VA promulgate regulations to carry out
the Veterans Community Care Program.
For the sake of convenience and
understanding, we will refer to
provisions of section 1703 as it will be
amended on June 6, 2019, the effective
date of this final rule. We additionally
clarify that throughout this final rule,
the abbreviation U.S.C. or the term
jbell on DSK3GLQ082PROD with RULES2
SUMMARY:
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
section will be used to indicate
discussion of or reference to a statutory
provision in the United States Code
(e.g., section 1703) or in another statute,
while the abbreviation CFR or the
section symbol § will be used to indicate
discussion of or reference to an existing
or proposed regulatory provision in the
Code of Federal Regulations (e.g.,
§ 17.4005 as proposed). There may be
instances where the term section rather
than the section symbol must be used at
the beginning of a sentence to discuss or
reference a regulatory provision, but it
should be clear in the sentence that a
regulatory provision is at issue. In
general, any reference to a section that
uses a period in it (e.g., § 17.55) is a
reference to the CFR, while any
reference without such a period (e.g.,
section 1703) is a reference to the U.S.C.
VA published a proposed rule
regarding the criteria for determining
when covered veterans may elect to
receive care and services through
community health care entities or
providers, as well as other parameters of
the program, on February 22, 1019. 84
FR 5629. In response to this proposed
rule, VA received 23,557 comments.
Over 18,000 comments were duplicated
form responses that expressed strong
support for the overall rulemaking, with
some suggestions for substantive
revisions to provisions from the
proposed rule. We received 1,297
comments that were unique in that they
were not duplicated form responses in
support of or in opposition to at least
one portion of the proposed rule,
although VA did consider substantive
issues raised in such duplicated
comments. More than 700 comments
expressed support for the proposed rule,
in whole or in part, without substantive
comment on provisions in the proposed
rule. We appreciate the support of such
comments, and do not address them
below. Other comments expressed
support or disapproval, in whole or in
part, with substantive provisions in the
proposed rule, and we discuss those
comments and applicable revisions from
the proposed rule below. We note that
the discussion below is organized by the
sequential order of the provisions as
presented in the proposed rule, from
§§ 17.4000 through 17.4040. As many of
the comments we received were related
to the access standards as proposed, we
alert readers that the discussion on
access standards can be found under the
last section header § 17.4040 in this
final rule, near the end of the
SUPPLEMENTARY INFORMATION section of
this published document.
We make two technical corrections to
the proposed revisions to §§ 17.46 and
17.55 to clarify the sunset date of these
PO 00000
Frm 00002
Fmt 4701
Sfmt 4700
regulations as they apply to VA’s
community care program such that
these will not apply to care furnished
after June 6, 2019.
§ 17.4000, Purpose and Scope
We received over 200 comments that
did not relate to specific provisions of
the proposed rule, but that related to the
overall effect that implementation of the
Veterans Community Care Program
(VCCP) would have on either: (1) The
care and services that VA directly
furnishes, or (2) the U.S. healthcare
industry at large. We discuss these
comments in the context of § 17.4000(a)
as proposed, because § 17.4000(a)
established that §§ 17.4000 through
17.4040 would generally implement the
VCCP as authorized by 38 U.S.C. 1703.
With regard to the effects on the care
and services that VA directly furnishes,
commenters expressed concern that
implementation of the VCCP would
deplete VA’s allotted budgetary
resources and thereby negatively impact
VA’s ability to directly furnish care and
services to veterans (some comments
referred to this impact as the
‘‘privatization of VA’’). Commenters
offered multiple reasons why
implementation of VCCP would
negatively affect VA’s direct provision
of care, all stemming from the
assumptions that more covered veterans
would choose VA community care if
access to such care were expanded,
which would then create a decreased
need to fund VA’s direct provision of
care (i.e., provision of care in a VA
facility). A few comments further stated
that decreased funding of VA’s direct
provision of care would be unavoidable
unless such care was funded separately
from the VCCP (presumably, separately
funded by Congress specifically through
the Federal appropriation process).
Many of these comments further argued
that, rather than potentially expand the
provision of non-VA care in the
community through implementation of
the VCCP, VA should focus on
improving its own infrastructure, hiring
practices, and quality of care and
services it directly provides. Some of
these comments additionally provided
more specific suggestions for how VA
could use resources required to
implement the VCCP to instead improve
VA’s direct provision of care and
services (e.g., VA could hire additional
specific types of providers or increase
pay scales for its providers generally; or
VA could open additional VA facilities,
expand or improve its existing facilities,
or expand sharing agreements with nonVA facilities).
We do not disagree with portions of
these comments requesting that VA look
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
to improving its direct delivery of care
and services; indeed, a portion of the
proposed rule that was organized under
a header titled improving VA (see 84 FR
5629, 5645–5646) discussed how the
MISSION Act will assist VA in doing so.
We do not, however, make any changes
to § 17.4000 or any other part of the rule
as proposed based on these comments.
Section 1703 requires VA to implement
the VCCP and to establish the
conditions under which VA would
determine if covered veterans are
eligible to elect to receive such care and
services through eligible entities or
providers (see sections 1703(a)(1) and
(d)). Section 1703(a)(1) establishes a
program to furnish hospital care,
medical services, and extended care
services to covered veterans through
eligible entities and providers; it is VA’s
responsibility to implement the VCCP.
Section 1703(d)(3) creates a key
condition on the operation of the VCCP:
that the covered veteran must elect to
receive care in the community, versus
through VA. This election was further
identified and explained in
§§ 17.4000(b), 17.4010, and 17.4020(a)
as proposed. VA’s obligation to
implement the VCCP does not diminish
VA’s obligation to directly provide care
and services to eligible individuals as
otherwise required by title 38 U.S.C,
particularly for covered veterans who
are eligible for but do not elect to
receive care through the VCCP or
veterans who are not eligible to receive
care through the VCCP. As Congress
appropriates funding for VA, VA will
use those resources to implement the
requirements Congress has set forth. The
regulatory impact analysis for this final
rule and VA’s budget requests identify
our anticipated needs, and we will
closely monitor utilization of our
available resources.
With regard to the effects that
implementation of the VCCP would
have on the U.S. healthcare industry at
large, we find such comments generally
beyond the scope of the rule where they
do not relate to VA’s direct provision of
care and services or VA’s ability to
maintain its other core missions. For
instance, some comments asserted that
covered veterans seeking non-VA care
could displace non-veteran patients that
rely on other Federal health care
coverage (i.e., Medicare or Medicaid),
particularly if VA did not consider
potential reductions to other Federal
health care funding in developing the
proposed rule. Conversely, other
comments expressed concern that
implementation of the VCCP could put
covered veterans seeking non-VA care
in the position to compete with non-
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
veteran patients who have private
insurance, because non-VA providers
simply will not have the capacity to
absorb covered veterans as additional
patients. We do not make changes to the
rule based on these comments that
relate to the potential effects that VCCP
implementation may have on capacity
of non-VA providers to see patients,
either to a covered veteran’s advantage
or disadvantage when compared with
other patient cohorts as asserted by the
comments. However, we believe that the
contracts, agreements, or other
arrangements VA enters with eligible
entities and providers will help to
ensure provider availability for covered
veterans who elect to receive care
through the VCCP; we have no reason to
believe that the effect, if any, on nonveteran patients would be significant.
We similarly do not make changes based
on comments that generally argued that
expansion of eligibility for VA
community care could create increased
consolidation of health care markets in
a manner to require VA to pay higher
rates for non-VA care. We do not believe
our actions in implementing the VCCP
will have that significant of an effect on
the health care industry. According to
the National Health Expenditure Data
set, the United States spent $3.5 trillion
on health care in 2017. By comparison,
VA obligated $12.9 billion for
community care in FY 2017 or 17.8
percent of total VA Medical Care
spending. As for other comments that
specifically noted that implementation
of the VCCP could have detrimental
effects on the U.S. health care industry
at large because VA would not be able
to maintain its core missions of research
and health care provider and clinician
training, VA’s obligation to implement
the VCCP does not diminish VA’s
obligation to fulfill any of its core
missions as otherwise required by title
38 U.S.C.
§ 17.4005, Definitions
We received more than ten comments
that either suggested revisions to or
clarification of some terms defined in
the proposed rule, or that requested VA
define additional terms. We address
these comments below as they relate to
the terms in the order they were
presented in § 17.4005 as proposed.
One comment requested revision of
the definition of the term appointment
to expressly include telehealth and
same-day encounters. While we believe
the definition of appointment as
proposed did include telehealth and
same-day encounters (by using the
separately defined term schedule), we
agree with the suggestion to revise the
definition to expressly add these terms.
PO 00000
Frm 00003
Fmt 4701
Sfmt 4700
26279
The definition of appointment is
therefore revised to include telehealth
and same-day encounters.
A few comments requested revisions
to the term covered veteran. The term
covered veteran as proposed is identical
to the statutory definition in section
1703(b), which is limited to veterans.
We reiterate from the proposed rule that
the regulations at §§ 17.4000–17.4040
do not affect other VA authorities to
provide care or services for nonveterans. Therefore, VA’s limited
authority to furnish care or services for
non-veterans is generally not affected by
regulations that implement the VCCP.
Other comments requested that VA add
a regulatory citation to 38 CFR 17.37(c)
to the definition of covered veteran, as
this regulatory citation corresponds to
the statutory citation 38 U.S.C.
1705(c)(2) in the definition that
authorizes eligibility for certain veterans
who do not have to enroll prior to
receiving VA care. We agree with the
commenter that providing a relevant
regulatory citation for these certain
veterans would make the definition
more consistent, as the definition does
include the regulatory citation for
§ 17.36 as it relates to those veterans
who do have an affirmative requirement
to enroll prior to receiving care. We
therefore revise the definition of
covered veteran to reference 38 CFR
17.37(a)–(c), which implement section
1705(c)(2) related to veterans who may
receive VA care without first enrolling
in VA’s system of patient enrollment.
We do not further revise the definition
as requested to require enrollment for
these certain veterans as a condition of
receiving non-VA care under the VCCP,
because that is not a requirement of
section 1703 and believe such a revision
could frustrate efforts to assist veterans
transitioning from service in the Armed
Forces.
One comment requested revision of
the term eligible entity and provider to
expressly include the standards by
which VA will assess these entities and
providers for adequacy, such as
assessment for compliance with VA’s
access standards as proposed, or
compliance with other Federal laws
such as the Americans with Disabilities
Act. We do not make changes to the
definition based on this comment, as the
definition itself references the relevant
section related to entities and providers,
§ 17.4030 as proposed. We will discuss
comments related to entities and
providers in the section of the final rule
related to § 17.4030.
In the definition of episode of care,
VA’s only substantive proposed change
from the definition used in § 17.1505
regarding the Veterans Choice Program
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26280
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
was to remove the qualifying language
that stated the one-year duration for the
episode began from the date of the first
appointment with a non-VA health care
provider. We received one comment
that requested we add this qualifying
language back to the definition, to
ensure it was clear that an episode of
care included follow-up appointments
and ancillary and specialty care as
needed. We do not make any changes
based on this comment, as the definition
as proposed expressly included followup appointments and ancillary and
specialty services.
A few comments requested revisions
to the term extended care services.
Some comments stated that defining the
term extended care services by
referencing its applicable authority at 38
U.S.C. 1710B was insufficient to
indicate what services were covered
under the VCCP, particularly to ensure
coverage of certain extended care
services that comments asserted were
not covered by Medicare (such as adult
day health care). Other comments more
specifically stated that the definition
should expressly list the types of
extended care services that would be
covered, with some comments further
advocating for inclusion of particular
services such as assisted living, or
hourly nursing services provided by
home health agencies. We do not make
changes based on these comments. We
believe the reference in the definition to
section 1710B(a) is sufficient to indicate
the types of extended care services
covered because it does provide a
specific listing of services that
encompasses both institutional and noninstitutional extended care services
(section 1710B(a)(4), for example,
references adult day health care
directly). Moreover, we see two benefits
to referencing the statutory authority
instead of defining it further in this rule.
First, such a change would allow for any
amendments to the law (section 1710B)
to have automatic effect on this rule,
and second, VA’s interpretation of that
provision of law will also automatically
carry over to this rule.
A few comments requested
clarification of or revisions to the
definition of full-service VA medical
facility. One comment requested
clarification of what a full-service VA
medical facility was. We reiterate from
the proposed rule that this term means
a VA medical facility that provides
hospital care, emergency medical
services, and surgical care and having a
surgical complexity designation of at
least standard. This definition includes
a note that states that VA maintains a
website with a list of the facilities that
have been designated with at least a
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
surgical complexity of standard, which
can be accessed on VA’s website. One
commenter indicated that this note was
not adequately specific and should
provide the exact hyperlink where this
information can be found. We do not
make changes based on this comment,
as we do not want to create a gap in our
regulations should VA’s website
locations change in the future. For the
public’s awareness, as of the publication
of this final rule, this information can
currently be found at www.va.gov/
health/surgery. Another commenter
stated that the definition should be
revised to expressly include inpatient
and outpatient mental health services to
ensure that veterans (particularly in
rural and remote areas) have access to
such services. The definition of a fullservice VA medical facility is only
relevant for determinations of veteran
eligibility under § 17.4010(a)(2) as
proposed, which, consistent with
section 1703(d)(1)(B), means that
covered veterans are eligible for VCCP if
they reside in a State where VA does not
operate a full-service VA medical
facility. Therefore, while we understand
the comment’s concern that not
including a specific type of care in the
definition would seem to affect
eligibility for the VCCP, we note that
veterans requiring inpatient or
outpatient mental health services may
be eligible under one of the other five
eligibility criteria in § 17.4010(a)(1) and
(a)(3) through (6) as proposed, should a
facility meet the requirements of this
definition for full-service medical
facility but not have inpatient or
outpatient mental health services. We
also note that the exclusion of a listed
service from the definition of fullservice medical facility is not intended
to indicate that such services are not
available from these facilities—to the
contrary, the existence of services that
are included in the definition, such as
surgical services, tends to indicate that
such facilities are more complex
medical facilities that offer many
services such as mental health, primary
care, and many forms of specialty care,
etc.
One comment requested that VA add
a new definition regarding the best
medical interest of the covered veteran,
to assist in clarifying this concept for
the purposes of determining eligibility
for the VCCP under § 17.4010(a)(5) as
proposed. We do not make changes to
the definitions section based on this
comment, although we will address the
comment’s concern regarding
clarification of the best medical interest
eligibility criterion in our consideration
PO 00000
Frm 00004
Fmt 4701
Sfmt 4700
of comments on § 17.4010, which
discusses eligibility for the VCCP.
One comment requested clarification
of the terms hospital care and medical
services, specifically seeking
clarification of the explanation for the
terms that was provided in the preamble
of the proposed rule. The preamble of
the proposed rule explained these terms
in part by referring to the medical
benefits package at § 17.38(b), where
hospital care and medical services will
be provided only if 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 clarify, as requested by this
comment, that appropriate healthcare
professionals can mean both VA and
non-VA providers but are not making
any revisions to the regulations.
The definition of the term other
health care plan contract as proposed
included language that stated such
contracts did not include a policy,
contract, agreement, or similar
arrangement pursuant to 10 U.S.C.
chapter 55, which is the authority for
the Department of Defense TRICARE
healthcare and insurance program. One
comment requested a revision to this
definition to remove the exclusion
related to 10 U.S.C. chapter 55, to
permit VA to bill TRICARE for non
service-connected care provided under
the VCCP. This comment asserted that
VA was not legally barred from treating
TRICARE as a health care plan contract
for purposes of collecting reasonable
charges for care or services furnished
under 38 U.S.C. 1729. We do not make
changes based on this comment,
because we do not agree that section
1729 permits this practice. The plain
language of the statute does not support
the conclusion that VA may seek
recovery from another Federal entity
under section 1729. Specifically,
TRICARE is another Federal program
and, as such, does not meet the
definition of ‘‘health plan contract’’
under section 1729(i)(1)(A).
Additionally, while the definition of
‘‘third party’’ in section 1729(i)(3)
includes a ‘‘State or political
subdivision of a State[,]’’ it does not
include ‘‘a Federal entity.’’ Moreover,
case law does not support the
conclusion that VA may seek recovery
from another Federal entity under
section 1729. In United States v. Capital
Blue Cross, the United States Court of
Appeals for the Third Circuit found that
by excluding other Federal programs,
such as Medicare, from the reach of
section 1729, Congress avoided the
‘‘inefficient procedure of having one
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
arm of the federal government
reimburse the another.’’ 992 F.2d 1270,
1275 (3d Cir. 1993). Finally, the
legislative history of 38 U.S.C. 1729
does not support the conclusion that VA
may seek recovery from another Federal
entity under section 1729. See, e.g., H.
Rep. 99–300, (finding that no
reimbursement could be obtained from
Medicare or Medicaid by VA). We note
that this discussion of what is
permissible under section 1729 does not
prevent VA from billing DoD under
agreements that control the exchange of
services under 38 U.S.C. 8111.
One comment requested a revision to
the term residence to add language that
would clarify a residence as the place
the covered veteran stays on the date of
the appointment. We do not make
changes based on this comment, as we
believe the definition as proposed,
which defines a residence as where the
covered veteran is staying at the time
they want to receive care or services,
provides for the same outcome without
requiring constant monitoring by VA or
updates by covered veterans. A few
comments communicated that
individuals who maintain more than
one residence (the most common
example provided was maintaining a
different residence in a warmer climate
during winter months, to accommodate
health issues) can experience
difficulties with receiving non-VA care.
These comments did not suggest
changes to any of the criteria or
provisions in the proposed rule, so we
are not making any changes as a result.
We believe it is sufficient to state that
the term residence in § 17.4005 as
proposed does not preclude covered
veterans from maintaining more than
one residence at a time, but a covered
veteran may have one residence at a
time. Such residence is assessed in
accordance with where the individual is
physically staying at the time the care
or services are needed.
A few comments requested that VA
add a definition of unusual or excessive
burden, to clarify how this term is used
in the assessment of whether the best
medical interest eligibility criterion is
met under § 17.4010(a)(5)(vii) as
proposed. We do not make changes
based on these comments. This term has
qualifying language in
§ 17.4010(a)(5)(vii)(A)–(E) that we
believe is sufficient to inform these
determinations, and we will address
this qualifying language as raised by
comments more specifically in the
section of this rule that discusses
eligibility.
One comment requested that VA add
a definition for the term VA care
coordination team to provide examples
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
of VA staff or clinicians who comprise
such a team. This comment requested
this definition be added because it was
used in the preamble of the proposed
rule to provide an example of assessing
when a covered veteran might be
eligible for VCCP under § 17.4010(a)(1)
as proposed, or eligibility when no VA
facility offers the care or services
needed. We do not make changes based
on this comment. This term was used in
the preamble of the proposed rule to
help provide background on the types of
individuals who might assist a covered
veteran with understanding whether VA
facilities at large might not offer certain
services (such as full obstetrics care),
but this term is not material to
determinations of eligibility under
§ 17.4010(a)(1) and is not used in the
regulatory text, so its addition would be
superfluous.
One comment stated that the term VA
facility as defined in the proposed rule
was too broad to be useful for veterans
to distinguish between VA facilities,
and suggested that VA should instead
use: The term center for non-medical
facilities; the term hospital for fullservice facilities; and the term clinic for
all medical service facilities that are not
full-service. We reiterate from the
proposed rule that the term VA facility
references the types of care a facility
provides (i.e., hospital care, medical
services, or extended care services),
rather than designations of VA facilities
(such as a VA medical center, or
community-based outpatient clinic), to
ensure that any future re-designations of
VA facility types would not result in a
gap in our regulations. If the public is
interested in how VA currently defines
the scope of services available at
different facility types, Veterans Health
Administration (VHA) Handbook
1006.02, VHA Site Classifications and
Definitions, should be instructive and is
available online. Additionally, we
clarify that this term is relevant for
determinations of eligibility under
§ 17.4010, and that such determinations
can only be consistently made with a
broad definition that references the
types of care a facility provides rather
than the designation of a facility.
Lastly, one comment requested that
the term VA medical service line be
revised to mean a clinic within a
Department medical center, to ensure
that entire clinics could be designated
as underperforming as needed. While
the commenter’s suggestion would
match the definition in section
1703(o)(2), it would not clarify the
meaning of that phrase for purposes of
this regulation, as we believe the
proposed definition does. The term
clinic, in the context of health care, can
PO 00000
Frm 00005
Fmt 4701
Sfmt 4700
26281
have several different meanings.
Merriam-Webster, for example, defines a
clinic in the context of health care as a
facility (as of a hospital) for diagnosis
and treatment of outpatients, as well as
a group practice in which several
physicians work cooperatively.
Merriam-Webster online, https://
www.merriam-webster.com/dictionary/
clinic. The Cambridge English
Dictionary, alternatively, defines a
clinic as a building or part of a hospital
where people go for medical care or
advice. Cambridge Dictionary online,
https://dictionary.cambridge.org/us/
dictionary/english/clinic. We believe
these definitions reflect the common
understandings of the term clinic, as
well as the ambiguity in that term. In
some contexts, a clinic is a physical
structure, and in others it is an
organizational component of a larger
institution. We believe in the context of
section 1703(o)(2) that the latter
interpretation is more reasonable, as it
would be illogical for Congress to define
the term VA medical service line to
mean a physical structure within a
larger physical structure. The very term
service line also reinforces conceptually
that this authority is limited to a group
practice in which several physicians or
clinicians work cooperatively. VA
policy also repeatedly uses the term
service line to refer to specific practice
areas, such as cardiology, radiology,
oncology, and others. Each service line
has different applicable access
standards or standards for quality for
the purposes of assessing
underperformance under § 17.4015 as
proposed, which could serve as a basis
for eligibility for a covered veteran to
participate in VCCP under
§ 17.4010(a)(6) as proposed. In this
context, the definition of VA medical
service line as proposed, to be limited
to a service or set of services within a
Department medical center, is more
consistent with the general meaning of
the term, provides clarity as to the
intended effect of this provision, and
more appropriately captures those types
of services that are actually
underperforming and not other services
that could in fact be excelling. We note
that it is theoretically possible, however,
for all VA medical service lines within
a clinic to be designated (depending on
the organization of that clinic, and the
assessment of such medical service lines
against VA’s standards, etc.), although
we believe it would be unlikely that this
would actually happen.
§ 17.4010, Veteran Eligibility
We received over 18,000 comments
concerning the criteria under which VA
determines a covered veteran may elect
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26282
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
to receive care and services under the
VCCP. We address these comments
below in the order in which they raise
issues related to provisions in
paragraphs (a)(1) through (6) of
§ 17.4010 as proposed. We note at the
outset that the comments we received
related to eligibility based on designated
access standards in § 17.4010(a)(4) as
proposed we be addressed in the section
of this document that discusses
§ 17.4040 where such comments raised
particular substantive issues related to
the access standards. We will only
discuss access standards in relation to
§ 17.4010 below where comments raised
broad versus specific concerns regarding
VA’s establishment of such standards.
We also note that a majority of these
comments are the result of a duplicated
form letter, within which at least one of
the eligibility criteria from § 17.4010 as
proposed was discussed.
We did not receive any comments that
suggested changes to § 17.4010(a)(1) as
proposed, regarding a covered veteran
being eligible to receive care and
services under the VCCP if no VA
facility offered such care or services.
However, some comments seemed to
assert that this criterion could be
unduly limiting if it was interpreted in
a manner that barred eligibility if a
single VA facility offered such care or
services. One comment further
requested clarification as to whether the
access-related eligibility criterion in
§ 17.4010(a)(4) as proposed would apply
if the criterion in § 17.4010(a)(1) was not
met. We clarify, by reiterating from the
proposed rule, that the criterion in
§ 17.4010(a)(1) will not be used to limit
access to community care in instances
where a single VA facility offers the care
or services required; in such a case,
covered veterans will be assessed under
one of the other five eligibility criteria
in § 17.4010(a)(2) through (6), for
instance, the access-related criterion in
§ 17.4010(a)(4). The criterion in
§ 17.4010(a)(1) will function as a unique
qualifier for covered veterans that need
certain types of care that VA simply
does not provide in any of its facilities
(such as full obstetrics care), and any
covered veteran requiring such care or
services would not have to be assessed
any further under other proposed
eligibility criteria for community care.
We do not make any changes based on
these comments.
We received some comments related
to § 17.4010(a)(2), regarding a covered
veteran being eligible to receive care
and services under the VCCP if there is
not a full-service VA medical facility in
the State in which the veteran resides.
One comment seemed to oppose this
criterion, asserting that this eligibility
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
criterion was inappropriate because it
did not consider full-service facilities
across state lines that may be accessible
to veterans. Another comment seemed
to support this criterion, but also
asserted that it was not appropriate
because it did not consider that in-state
transit times vary by State. We clarify
that the criterion in § 17.4010(a)(2) is an
assessment of VA facility locations
within States, and does not consider
transit times to facilities, in accordance
with section 1703(d)(1)(B). This
criterion is consistent with the statute,
as well as prior VA practice in the
Veterans Choice Program. We do not
make changes based on these comments.
A few comments asserted that VA
should not eliminate the 40-mile
distance eligibility criterion from the
former Veterans Choice Program. We
interpret these comments to be
expressing concern with the limited
grandfathering provision in
§ 17.4010(a)(3)(ii) as proposed, where
the 40-mile criterion will be carried
forward indefinitely for some, but not
all, covered veterans. We reiterate from
the proposed rule that the 40-mile
grandfathering provision is consistent
with 38 U.S.C. 1703(d)(1)(C), where
such eligibility is carried forward
indefinitely for only those covered
veterans that reside in Alaska, Montana,
North Dakota, South Dakota, or
Wyoming and meet additional criteria.
Any covered veterans who do not reside
in one of these States can only be
considered to have grandfathered
eligibility related to the 40-mile
criterion until June 6, 2020. We
therefore do not make any changes
based on these comments, although we
note that other VCCP eligibility criteria
may apply for covered veterans after
June 6, 2020, even if they do not reside
in the States identified for the indefinite
grandfathering provision.
Some comments objected to VA
establishing any eligibility based on
access standards under § 17.4010(a)(4)
as proposed, suggesting instead that VA
community care should not have any
qualifying limitations related to VA’s
assessment of access. We do not make
any changes to § 17.4010(a)(4) based on
these comments. Congress authorized
veterans to elect to receive community
care if VA was unable to furnish care or
services in a manner that complies with
VA’s designated access standards under
section 1703(d)(1)(D). Congress further
authorized the Secretary to establish
access standards under section 1703B.
As explained in the proposed rule, as
well as our report to Congress, the
Secretary is exercising his authority to
establish and designate access standards
for purposes of eligibility. We reiterate
PO 00000
Frm 00006
Fmt 4701
Sfmt 4700
that we will discuss comments related
to the substantive criteria of the access
standards themselves from in the
section related to § 17.4040 later in this
document.
We received many comments related
to the best medical interest criterion in
§ 17.4010(a)(5) as proposed. While some
comments merely sought clarification of
this criterion, others asserted that the
covered veteran and his or her non-VA
provider did not have enough control in
determining when the criterion could be
met, and that a determination by a nonVA provider that the criterion was met
should not be subject to VA’s review or
approval (specifically, over 18,000
comments received were duplicate form
requests that VA should not
administratively or clinically review
such determinations from non-VA
providers). Conversely, other comments
asserted that VA must retain review and
approval for best medical interest
determinations, or even prevent such
determinations from being made by
non-VA providers. Other comments
more specifically suggested that certain
conditions should be found to create
eligibility under this criterion. For
instance, some comments argued
generally that a covered veteran’s
dissatisfaction with care they received
directly from VA in the past should
meet the criterion of best medical
interest. Other comments suggested that
certain conditions or factors should be
considered to constitute an unusual or
excessive burden as assessed under the
best medical interest criterion in
§ 17.4010(a)(5)(vii), such as a veteran
requiring oxygen to travel, or a veteran
having experienced military sexual
trauma.
We first address the issue within the
comments concerning the level of
review or approval that may be required
to find that a determination of best
medical interest has been met for
purposes of eligibility for VCCP. These
comments offered opposing
interpretations of whether VA review or
approval would (or should) be required
to find that a determination of best
medical interest had been met. We
believe these opposing interpretations
in the comments are due to an
inconsistency between the preamble
explanation for § 17.4010(a)(5) as
published in the proposed rule and the
regulation text at § 17.4010(a)(5) as
proposed. The preamble of the proposed
rule contained language that qualified a
determination of best medical interest in
§ 17.4010(a)(5), by stating that such a
determination must be for the purpose
of the veteran achieving improved
clinical outcomes by receiving the care
or services in the community versus
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
from a VA health care provider. In turn,
the preamble of the proposed rule
further explained that the factors in
§ 17.4010(a)(5)(i)–(vii) as proposed
would be considered in the context of
clinical decision making (where the
referring clinician could be either a VA
or a non-VA clinician) to assess whether
improved clinical outcomes would
likely be achieved by receiving care in
the community.
Although the preamble explained that
the qualifying language related to a
veteran’s improved clinical outcomes
would be in § 17.4010(a)(5) as proposed,
it was inadvertently omitted by VA in
the regulation text for § 17.4010(a)(5).
We clarify that VA intended for this
qualifying language to be in
§ 17.4010(a)(5) as proposed to allow VA
to retain the ability to conduct a review
of a best medical interest determination
made by a non-VA or a VA provider if
such determination did not appear to
meet the standard for achieving
improved clinical outcomes. To clarify
this intent, we revise § 17.4010(a)(5) to
add the qualifying language as stated
from the preamble of the proposed rule
that best medical interest
determinations are made for the purpose
of the veteran achieving improved
clinical outcomes. We believe this
revision effectuates VA’s intent as
evidenced in the preamble of the
proposed rule. While we realize that
this revision does not establish an
absolute VA review of best medical
interest determinations, and does not
remove VA’s review of these decisions
as suggested in some comments, we
reiterate from the preamble of the
proposed rule that an assessment of best
medical interest under § 17.4010(a)(5) is
a clinical decision, and as such is made
on a case by case basis depending on the
individual circumstances of a covered
veteran, to be guided by the factors
further established in § 17.4010(a)(5)(i)–
(vii). We believe that it is neither
veteran-centric nor administratively
feasible for VA to regulate an absolute
requirement to review all
determinations of best medical interest
from non-VA or VA providers. We do
not make changes to add certain specific
qualifying conditions to § 17.4010(a)(5)
in response to comments that requested
VA consider specific conditions as
meeting the best medical interest
criterion (as raised earlier, conditions
such as a veteran requiring oxygen to
travel, or a veteran having experienced
military sexual trauma). We believe that
the language in § 17.4010(a)(5)(i)–(vii) is
comprehensive to permit appropriate
clinical decisions on a case by case basis
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
without being overly specific or
restrictive.
We received a few comments that
requested clarification of how VA
would distinguish between a best
medical interest determination that may
simply be for the convenience of the
veteran (which was not permitted under
§ 17.4010(a)(5) as proposed), and a
determination of best medical interest
based on an unusual or excessive travel
burden (which was permitted under
§ 17.4010(a)(5)(vii)). One comment
further requested clarification of
whether the undue or excessive burden
determination was clinical in nature,
and whether it could relate to the drive
time access standard. To address the
request to clarify when the undue or
excessive burden factors in
§ 17.4010(a)(5)(vii)(A)–(E) might be met,
we will not make changes from the
proposed rule, but we clarify that VA
will work to develop guidance for VA
staff (that can be made available to VA
and non-VA providers) regarding how
VA will interpret the factors to ensure
there is a consistent understanding of
how the undue or excessive burden
considerations are assessed and applied.
As a general example, a covered veteran
who requires physical therapy multiple
times a week in relation to a neck injury
might be considered eligible under the
criterion in § 17.4010(a)(5)(vii)(C), if the
veteran’s injured neck is a medical
condition that affects his or her ability
to travel even short distances. In such a
case, it would not be for the mere
convenience of this veteran to be seen
in the community at a location that
would be closer to their residence.
We further clarify, without making
changes to § 17.4010(a)(5)(vii), that the
unusual or excessive burden assessment
would ultimately be a clinical
determination, as we previously
clarified that the overarching best
medical interest criterion is met when it
is clinically determined that a covered
veteran could be expected to experience
improved clinical outcomes. Lastly, we
clarify without changes that the unusual
and excessive burden factors in
§ 17.4010(a)(5)(vii)(A)–(E) are
independent of the access standard
eligibility in § 17.4010(a)(4) and the
standards themselves in § 17.4040; the
undue and excessive burden factors
might qualify a veteran for VCCP, even
if the access standard related to average
drive time might not be met. For
example, a covered veteran could
require daily dialysis care that could be
furnished at a VA facility that is 29
minutes away from the veteran’s
residence by average drive time. If VA
could furnish the care within the waittime standard in § 17.4040, this veteran
PO 00000
Frm 00007
Fmt 4701
Sfmt 4700
26283
would not qualify under § 17.4010(a)(4).
However, given the need for daily travel
and the effect of travel for nearly an
hour in transit every day, the veteran
and the provider could determine it is
in the best medical interest of the
veteran to receive this daily dialysis
care through the VCCP at a non-VA
facility that is only a five-minute
average drive from the veteran’s home.
We received one comment related to
§ 17.4010(a)(6) as proposed, regarding a
covered veteran being eligible to receive
care and services under the VCCP if VA
determined that a VA medical service
line that would furnish the care or
services the veteran requires is not
providing such care or services in a
manner that complies with VA’s
standards for quality. This comment
asserted that VA should revise this
eligibility criterion to be discretionary
and not mandatory, to be consistent
with 38 U.S.C. 1703(e), which is the
statutory provision related to
discretionary eligibility based on a
finding that a VA medical service line
is not providing care that complies with
the standards for quality VA further
establishes under section 1703C. We
agree section 1703(e) authorizes and
does not mandate the furnishing of care
when VA medical service lines are
underperforming, but we do not read
our regulations in §§ 17.4010(a)(6) and
17.4015 as proposed to collectively to
eliminate that discretion. Section
17.4015 permits, but does not require,
the Secretary to identify
underperforming VA medical service
lines. It further permits the Secretary to
establish limitations or conditions on
the ability of veterans to elect to receive
care and services in the community. If
the Secretary makes a determination
under § 17.4015 and identifies
underperforming VA medical service
lines and the conditions under which
covered veterans seeking care or
services from such a medical service
line can elect to receive care in the
community, then § 17.4010(a)(6) would
apply and covered veterans could elect
to receive care or services in the
community consistent with the
Secretary’s determination. Sections
17.4010(a)(6) and 17.4015 therefore
effectively preserve the discretionary
nature of section 1703(e). We will
address comments related to the
establishment of or notice procedures
for VA’s standards for quality in the
portion of the final rule that discusses
§ 17.4015.
We received one comment that
requested clarification of VA’s rationale
to require a covered veteran to submit
to VA information related to a change in
the veteran’s address in § 17.4010(b) as
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26284
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
proposed, and information on any other
health-care plan contract under which
the veteran is covered prior to obtaining
authorization for care and services the
veteran requires. We reiterate from the
proposed rule that this information is
required so that VA may make accurate
eligibility determinations under
§ 17.4010(a)(2)–(6) that rely on a
veteran’s place of residence, and so that
VA can continue to recover or collect
reasonable charges for care and services
furnished in the community for a nonservice connected disability from a
health plan contract, consistent with
section 1703(j). We further note that
veterans are required to submit
information regarding other health
insurance under section 1705A. Related
to this comment concerning the
provision of information by the covered
veteran, one comment asserted that VA
should make VCCP use conditional on
the covered veteran’s acceptance of an
automatic release of their medical
information to non-VA providers. The
commenter asserted that this was
necessary because it was inefficient to
require veterans to authorize individual
releases of their medical information, or
to rely on non-VA providers to attest
that records were received. We do not
make changes based on this comment.
VA currently has the authority to release
veteran medical information for
treatment purposes without the written
consent or authorization of the veteran
under applicable statutes and their
implementing regulations (see 38 U.S.C.
7332(b)(2)(H)). Therefore, there is no
need to require veterans to authorize
individual releases of their medical
information if a veteran is receiving
treatment using VCCP.
Section 17.4010(d) as proposed
established that eligibility
determinations for covered veterans to
receive hospital care, medical services,
or extended care services through the
VCCP would be subject to VA’s clinical
appeals process, and not be appealable
to the Board of Veterans Appeals. We
received some comments that suggested
these eligibility decisions should be
appealable to the Board. We make no
changes based on these comments, as
section 1703(f) expressly provides that
these eligibility decisions be subject to
VA’s clinical appeals process and not be
appealable to the Board of Veterans’
Appeals. Other comments did not
request revisions to § 17.4010(d) per se,
but did suggest that VA’s appeals
process should be comprehensive, and
more specifically that VA should
develop a unique process within its
clinical appeals process, to ensure that
individuals adjudicating the VCCP
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
eligibility determinations are not the
same VA facility or VISN staff that made
the initial eligibility determinations. We
clarify that VA’s current clinical appeals
process can be found in VHA Directive
1041, Appeal of VHA Clinical
Decisions, which can be found on VA’s
website and provides for a
comprehensive process of appealing
clinical decisions that includes
elevating disputes beyond initial stafflevel determinations.
Lastly, one comment raised several
concerns about different provisions
discussed in the proposed rule that
potentially related to eligibility, based
on several assertions: First, the
comment asserted that VA’s proposed
rule would limit eligibility for VA
community care to only certain serviceconnected veterans, or veterans with
only certain discharges from active
service; second, the comment asserted
that the rule would limit eligibility for
care for a recently discharged veteran to
12 months; and third, the comment
asserted that veterans should be treated
for service connected disabilities
regardless of their character of
discharge. All of the provisions cited in
this comment refer to other provisions
of law unaffected by VA’s rule, namely
§ 17.46 (concerning the first issue
identified above), which we are making
no longer effective; section 1705(c)(2),
which authorizes VA to furnish care
notwithstanding a veteran’s failure to
enroll (concerning the second issue
identified above); and section 5303(a),
which statutorily limits VA’s ability to
furnish benefits to certain persons.
Because these authorities are either
being made ineffective through this rule
(in the case of § 17.46) or are statutes
that were unaffected by this rule (in the
case of section 1705(c)(2) and section
5303(a)), we do not make changes based
on this comment.
§ 17.4015, Designated VA Medical
Service Lines
We received over 25 comments
concerning the process by which VA
would designate those VA medical
service lines that were not able to
furnish care or services in a manner that
complied with VA’s standards for
quality, so that covered veterans who
would receive care or services through
such VA medical service lines would be
eligible for the VCCP. We address these
comments below in the order in which
they raise issues related to the
provisions in paragraphs (a)–(e) of
§ 17.4015 as proposed.
As a general matter, one comment
suggested that any proposal to eliminate
entire service lines at VA facilities
should not be implemented. We clarify
PO 00000
Frm 00008
Fmt 4701
Sfmt 4700
that no provision in the proposed rule
sought to eliminate VA medical service
lines at VA facilities. Section 17.4015 as
proposed sought to establish criteria by
which VA would assess VA medical
service lines within its facilities to
determine if they were
underperforming. If such medical
service lines were so identified, then
§ 17.4010(a)(6) as proposed would allow
covered veterans to elect to receive the
care or services they would have
received under those underperforming
VA medical service lines through the
VCCP. We do not make any changes to
the proposed rule based on this
comment. We note that section 1706A,
as added by section 109 of the MISSION
Act, expressly requires remediation of
any VA medical service lines identified
under this criterion, and as we
discussed near the conclusion of the
preamble to the proposed rule, VA’s
remediation efforts will not be limited
to just those medical service lines
designated under § 17.4015. These
remediation efforts are intended to
bolster and support VA’s medical
service lines.
We received multiple comments
related to § 17.4015(a) as proposed,
concerning VA’s basic parameters for
identifying its underperforming medical
service lines. First and most generally,
one comment requested that VA revise
paragraph (a) to make this provision
mandatory by using the word ‘‘shall’’
instead of ‘‘may’’; in the alternative, the
commenter suggested that VA must
otherwise clarify if it interprets the
quality monitoring mandates imposed
by section 1703(e) and 1703C to be
optional. We do not make changes based
on this comment and clarify that not all
provisions in the MISSION Act require
VA to take action. VA used the term
‘‘may’’ in § 17.4015(a) as proposed
because VA is not required, and may be
practically unable, to identify any VA
medical service line as
underperforming, and consequently, it
may be the case that no covered
veterans qualify for community care
under this criterion. We also, as noted
above, allow the Secretary to place
conditions or limitations on the ability
of covered veterans to elect to receive
care under this criterion.
One comment requested that VA
revise § 17.4015(a) to provide for a
comparison of timeliness between VA
and non-VA medical service lines, as
this comparison of timeliness is not
expressly prevented by section 1703 or
1703C. We do not make changes based
on this comment, as the comparison of
timeliness between only VA medical
services lines is consistent with section
1703(e)(1)(B)(i). We further note,
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
however, that § 17.4015(a) identifies
timely care as the first domain of care,
and hence the timeliness of care with
non-VA service lines would be
considered indirectly.
We received multiple comments
related to VA’s standards for quality
themselves, a majority of which we
interpret as beyond the scope of the
proposed rule because such standards
are to be established and announced via
a separate process in the Federal
Register, as stated in the proposed rule.
However, we summarize those
comments here as they could be
interpreted to apply to § 17.4015(a) as
proposed, and that paragraph’s express
statements of using VA’s standards for
quality to determine when VA medical
service line are underperforming.
Multiple comments argued that VA
should not use VA’s standards for
quality, but rather should use existing
industry standards related to quality
monitoring (such as the National
Committee for Quality Assurance’s
Healthcare Effectiveness Data and
Information Set, or Centers for Medicare
and Medicaid Services Merit-Based
Incentive Payment System), versus
developing VA-based quality measures
as indicated in § 17.4015(a) as proposed.
One comment more specifically
requested that VA revise § 17.4015(a)
accordingly to reflect that VA will use
industry standards for quality.
Conversely, other comments suggested
that there seemed to be a deficiency of
reliable data available to VA that is
related to quality measures or metrics
concerning non-VA providers; one
comment further stated that until nonVA providers are able to produce
comparative data to be used in assessing
VA medical service lines, VA should
only use its data to identify and
remediate its medical service lines.
Other comments more specifically
recommended that VA use its existing
tools such as VA’s Strategic Analytics
for Improvement and Learning tool to
identify its underperforming service
lines. Some of these comments further
stated that VA should consider unique
veteran populations when developing
standards, with one comment requesting
that VA require vascular surgery quality
outcomes to be assessed to ensure nonVA outcomes match VA outcomes.
Other comments did not suggest a
particular approach regarding the use of
VA or non-VA quality measures, but
rather requested clarification of what
quality measures or metrics VA would
use. We do not make changes to
§ 17.4015(a) based on these comments,
but we reiterate from the proposed rule
that VA’s standards for quality will be
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
announced through a separate
document published in the Federal
Register as set forth in § 17.4015(c) as
proposed. We do note that VA’s
proposed standards for quality, as
submitted to Congress in a report earlier
this year, focused on the framework for
quality identified by the National
Academy of Medicine.
We did not receive any comments on
§ 17.4015(b) as proposed and are not
making any changes from the language
we proposed.
We received a few comments related
to VA providing notice of its standards
for quality once established, as well as
comments on other provisions set forth
in § 17.4015(c) as proposed. At the
outset, we note that multiple comments
urged VA to publicly release VA’s report
detailing its standards for quality that
was submitted to Congress on March 4,
2019. We do not make changes to
§ 17.4015(c) based on this comment, as
we believe § 17.4015(c) makes adequate
provision for public notice of the
standards of quality.
Section 17.4015(c) as proposed
contained language to establish
potential limitations of when and where
covered veterans could receive
qualifying non-VA care and services at
their election based on VA’s
identification of its underperforming
medical service lines. These possible
limitations on receiving qualifying nonVA care included a limitation by
defined geographic area. We received
one comment that stated this language
implied that VA will interpret its
standards for quality based on a regional
geographic standard versus a national
standard and asked that VA clarify
whether this is the case. We clarify that
while VA will have national standards
for quality, VA’s quality comparisons
will generally be based on care that is
locally available and not on national
averages. It would be of little use to
patients in a particular area or region to
have VA care that is locally available to
them compared to care that is not
locally available. The language in
§ 17.4015(c) related to limitations
(including the limitation based on
geographic area) therefore serves to alert
covered veterans that the qualifying
non-VA care they may elect to receive
may be limited in its location, in the
type of care that may be received, etc.,
as it would be offered as an option to
the specific care that would be
designated in the specific VA medical
service line that VA would have
identified as underperforming. We do
not make changes based on this
comment.
A few comments requested
clarification of whether direct notice to
PO 00000
Frm 00009
Fmt 4701
Sfmt 4700
26285
covered veterans of underperforming
VA medical service lines, as set forth in
§ 17.4015(c) as proposed, would include
other than electronic communication (to
include notification by mail, phone,
etc., as well as a Federal Register
document). A related comment
requested that VA ensure non-VA
providers are provided the direct notice
VA would conduct when making
determinations under § 17.4015(c) on
VA medical service lines. We do not
make changes based on these comments.
We reiterate from the proposed rule that
VA will take reasonable steps to provide
direct notice to covered veterans
affected under this section to include
written correspondence, electronic
messages, or direct contact (in person or
by phone). We do not believe it
necessary to regulate VA’s notice to
community providers.
A few comments requested that VA
revise § 17.4015(d) as proposed to
permit VA to identify more than three
underperforming VA medical service
lines and more than 36 underperforming
VA medical service lines nationally.
One comment stated that there should
be no limit on the number of designated
VA medical service lines per facility or
the total number nationally that could
be designated as underperforming, and
one comment urged VA to seek a
legislative fix to allow VA to designate
more than 36 VA medical service lines
nationally. We do not make changes
based on these comments, as VA is
limited by statute to designating no
more than three service lines per facility
and 36 service lines nationally, in
accordance with section 1703(e)(1)(C).
As the comment indicates, any
resolution to allow more than the
permitted number of VA medical
service lines to be designated would
require Congressional action and
therefore is beyond the scope of the
proposed rule.
Multiple comments raised issues
related to the factors VA would consider
when determining whether its medical
services lines would be identified as
underperforming, as set forth in
§ 17.4015(e) as proposed. One comment
noted that VA should limit comparison
of underperforming VA medical service
lines against only similarly
underperforming non-VA medical
service lines (and further, only those
non-VA underperforming medical
service lines that are accessible to
covered veterans), to ensure that a
covered veteran would not have the
option to choose to receive lower
quality care from a non-VA medical
service line than a VA medical service
line. Another comment asserted that VA
must consider whether non-VA medical
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26286
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
service lines would be able to provide
the same type of care or better care
before designating a VA medical service
line as underperforming. We interpret
these comments to be related to
§ 17.4015(e)(1) as proposed, as the
general paragraph that would establish
whether differences in performance
between VA and non-VA medical
service lines were clinically significant.
We do not make any changes to
§ 17.4015(e)(1) based on these
comments. The language in
§ 17.4015(e)(1) provides that VA will
compare performance of its medical
service lines against the performance of
non-VA medical service lines to identify
VA deficiencies. By the time VA is
determining whether the differences in
performance are clinically significant, it
will have already assessed the quality of
VA’s medical service and non-VA
medical service lines and identified that
there is in fact a difference. We also
reiterate from the proposed rule that the
language related to clinical significance
in § 17.4015(e)(1) would allow VA to
appropriately discern differences in
performance between VA and non-VA
medical service lines to determine if VA
medical service lines were
underperforming. Determinations
regarding performance will be made
locally and should generally result in
veterans being able to access better
quality care in the community than they
would receive from service lines
designated as underperforming.
We received a few comments related
to the factor in § 17.4015(e)(2) as
proposed, that VA would consider the
likelihood and ease of remediation of
the medical service line within a short
timeframe when determining whether it
was underperforming. We reiterate from
the proposed rule that the intent of this
factor is to allow VA to designate as
underperforming those medical service
lines in need of the kind of intensive
remediation envisioned by section
1706A, and not necessarily those
medical services lines where a simple
action (such as the purchase of new
equipment) is likely to occur and would
be sufficient to remediate
underperformance. One comment
requested that VA revise this factor in
§ 17.4015(e)(2) to permit a temporary
designation of a VA medical service
lines that may only require simple
actions likely to occur in a short
timeframe, to prevent scenarios in
which veterans would receive what the
comment asserted would be
substandard care even if on a temporary
basis. We do not make changes based on
this comment. We do not agree with the
comment’s equating of potential
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
temporary underperformance of a VA
medical service line with delivery of
substandard care. Further, we reiterate
from the proposed rule that
§ 17.4015(e)(2) is necessary to allow VA
to be selective in engaging in
remediation that will require allocation
of VA resources. We further note that,
in such temporary situations, covered
veterans might still be eligible to receive
care in the community under the best
medical interest criterion in
§ 17.4010(a)(5), which may provide
more nimble and timely access to care
than the designation of a VA medical
service line under § 17.4015. A related
comment requested clarification of the
effect of the factor in § 17.4015(e)(2),
more specifically whether VA intended
this factor to be used to identify only
those medical service lines that could be
remediated easily. We clarify that this is
not the intent of § 17.4015(e)(2); to the
contrary, we reiterate from above that
this factor should allow VA to designate
as underperforming those VA medical
service lines in need of the kind of
intensive remediation envisioned by
section 1706A, and not necessarily
those services lines where a simple
action is likely to occur and would be
sufficient to remediate
underperformance. As other
commenters noted, VA is limited to the
number of VA medical service lines it
can designate nationally and at any
particular facility. It would be a poor
use of this authority to waste one of
those limited opportunities to designate
a VA medical service line that could be
improved easily and quickly.
We received one comment that
requested VA provide more information
on why data that may be required to
assess the performance of VA and nonVA medical service lines could take as
long as 18–24 months to collect or
analyze, particularly if such data may
already be collected by VA related to the
performance of its medical service lines.
The comment further urged VA to take
steps to shorten this timeframe, to
prevent scenarios where a covered
veteran may receive what the
commenter deemed sub-standard care
for an extended time while VA
determines whether its medical service
lines are underperforming. We believe
this comment is referring to the portion
of the proposed rule that explained
§ 17.4013(e)(3), which is the factor that
would permit VA to consider recent
trends concerning a VA or non-VA
medical service line when determining
if a VA medical service line is
underperforming. The preamble of the
proposed rule provided that the process
to gather, analyze, and verify quality
PO 00000
Frm 00010
Fmt 4701
Sfmt 4700
data could take as long as 18–24
months, and for this reason VA needed
a factor that would permit it to consider
more contemporaneous information to
determine whether one of its medical
service lines was underperforming.
These data are inherently time-lagged,
as much of the data we use is collected
and reported by other entities (such as
Medicare). Moreover, it may take
months to collect enough data to
support valid conclusions; small sample
sizes are inherently unreliable, and if a
particular VA medical service line
simply does not furnish care to that
many patients, it could take some time
to generate enough cases to produce
reliable results that would be actionable.
We again reiterate, though, that covered
veterans could still access care in the
community under any of the five other
eligibility criteria in § 17.4010,
including the best medical interest
criterion under § 17.4010(a)(5). We
believe that § 17.4015(e)(3) as proposed
actually resolves the concern in the
comment, because it expressly allows
VA to consider contemporaneous
information, and we make no changes
based on this comment.
We received one comment that urged
VA to remove the designation factor in
§ 17.4015(e)(6) as proposed, related to
considering the effect that designating a
VA medical service lines would have on
other VA medical service lines. The
comment characterized this factor as a
loophole that would allow
underperforming VA medical service
lines to avoid designation, due to the
negative effects such designation would
have on other medical services lines.
We disagree with the comment’s
characterization of this factor. We do,
however, maintain that this factor is
critical to allow VA to be selective in its
designations, particularly for medical
service lines whose designation may be
more vastly disruptive, both to other VA
medical service lines and other
programs, than we believe is the intent
of identifying any underperforming VA
medical service lines under section
1703(e) generally. We do not make
changes based on this comment.
We received a few comments that did
not seem clearly related to any of the
factors in § 17.4015(e)(1)–(6) as
proposed, but that suggested
clarifications or potential changes to
§ 17.4015(e) based on particular services
or particular veteran populations. One
comment requested that VA clarify to
what extent extended care services
could be an underperforming medical
service line, and another comment
urged VA to consider the unique needs
of women veterans in designating VA
medical service lines as
E:\FR\FM\05JNR2.SGM
05JNR2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES2
underperforming. We do not make
changes to § 17.4015(e) based on these
comments but do clarify that the rule
does not place any limitations on what
type of VA medical service lines may be
designated, so such VA medical service
lines could be those that provide
extended care services (e.g., geriatrics) if
VA finds them to be underperforming.
Additionally, we believe that
§ 17.4015(e) as proposed gives VA the
latitude to consider all veteran
populations, including women veterans,
and we agree that VA should consider
the unique needs of veteran populations
when determining whether its medical
service lines are underperforming.
Lastly, we received a few comments
that urged VA to develop and make
public a dataset that compares
providers, facilities, and practices based
on VA’s standards for quality, to
provide covered veterans with
additional information they may use
when determining whether to elect to
receive care in the community. We do
not make any changes based on these
comments but note that we address
VA’s communication of comparative
information to inform health care
decisions in the portion of this final rule
that discusses miscellaneous comments.
§ 17.4020, Authorized Non-VA Care
We received over 100 comments
concerning the process and
requirements for authorizing non-VA
care under the VCCP. We address these
comments below in the order in which
they raise issues related to the
provisions in paragraphs (a)–(d) of
§ 17.4020 as proposed (including VA’s
supplemental notice of proposed
rulemaking related to transplant care).
We note that some of these comments
did not suggest changes to the
regulation text in § 17.4020 as proposed,
and further raised issues that were
related more to administrative process
rather than the regulatory requirements
under which VA will authorize care. We
will address below only those issues
raised in comments regarding VA’s
requirements and authorities to
authorize non-VA care as proposed and
will address other issues related to
administrative process in another
section of this final rule related to
miscellaneous comments.
We did not receive comments to
revise a covered veteran’s election to
receive care under the VCCP should
they be so eligible, under § 17.4020(a) as
proposed. We do reiterate, however, in
response to many comments that
expressed concerns related to the effects
of expanding non-VA care on VA’s
direct provision of care, that
§ 17.4010(a) requires a veteran’s election
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
to receive non-VA care under the VCCP;
VA does not force covered veterans to
receive non-VA care.
Several comments did request
clarification or revision of VA’s
authorization of care and services to be
furnished through the VCCP if the
covered veteran elects to receive such
care, under § 17.4020(a) as proposed.
Some of these comments broadly
opposed VA’s specific authorization of
care and services, for instance, those
comments that asserted that a veteran’s
VA identification card should be all that
is required to present to obtain care
without further review or authorization
requirements. Other comments were
more specific, for instance, that VA
should reduce or eliminate the
requirement for VA authorization of
care or services from approved non-VA
providers who have a record of effective
and efficient care within the Veterans
Choice program. Still other comments
further advocated that VA should
eliminate the requirements for
additional authorizations that may be
required within an episode of care
(referred to as secondary authorizations)
because they were concerned that these
authorizations could unduly delay the
provision of care or services, such as
additional testing that may be found to
be required. One comment more
specifically requested that any
authorization of an episode of care that
includes a surgical procedure should
automatically cover any other care
furnished during that procedure, and a
related comment even more specifically
requested that VA should require that
follow up care for vascular surgical
procedures (particularly imaging) be
provided by the same non-VA vascular
surgeon who provided the initial care or
services to the covered veteran. We do
not make changes based on these
comments.
We reiterate from the proposed rule
that, in accordance with section
1703(a)(3), VA is required to authorize
care or services that a covered veteran
might elect to receive through the VCCP.
This authorization of care and services
covers an episode of care that may last
up to one year, but only for care and
services that are within the scope of the
care or services initially authorized. VA
has developed a process to facilitate
access to necessary and ancillary
services within an episode of care; we
refer to these authorizations as standard
episodes of care (SEOC). VA uses SEOCs
to bundle services that are necessary
and related so that referrals between
different specialists are more easily
facilitated and so that all specialty and
ancillary services are included within
the episode of care. For example, a
PO 00000
Frm 00011
Fmt 4701
Sfmt 4700
26287
veteran in need of knee replacement
surgery would be authorized through a
SEOC for pre- and post-operative
examinations, the surgery itself, and
physical therapy. The same would
follow for a veteran in need of vascular
surgery, as raised by the comment
described above, for all specialty care
and ancillary services that would
reasonably be expected to be medically
necessary after the surgery itself.
However, the regulation will not
prescribe at so granular a level, for
instance, automatic approvals for
particular follow-up care or for care to
be provided by the same providers that
initially performed surgical procedures.
Requests for authorization of services
outside the SEOC further allow VA to
assess the need for care or services
recommended by a non-VA provider,
and whether these services fall within
the approved episode of care or whether
they constitute a new episode of care.
Several comments asserted that a
covered veteran’s selection of a provider
in § 17.4020(b) as proposed did not
actually ensure that a covered veteran
could see his or her provider of choice.
The primary reasons offered for why
providers of choice were not available
were that delays in VA’s payment of
claims, or other complications
associated with VA’s administration of
its community care programs, created
too many disincentives for non-VA
providers to participate in such
programs. We will address these
comments, as well as other comments
regarding VA’s administration of its
community care programs, in another
section of this final rulemaking related
to miscellaneous comments. However,
we do note that even setting aside these
operational concerns, VA cannot
compel a private provider to furnish
care and services to a covered veteran.
If the covered veteran identifies a
particular entity or provider as his or
her preferred source of care, and if that
provider or entity is within VA’s
network and accessible to the covered
veteran, we would refer the veteran to
that entity or provider. If the identified
provider is not part of VA’s network and
does not wish to become part of VA’s
network (and VA cannot otherwise
secure the care through a sharing
agreement, other arrangement, or
Veterans Care Agreement), VA cannot
compel that provider to treat the
covered veteran. We do not make any
changes to § 17.4020(b) as proposed
based on these comments.
A majority of the comments VA
received related to § 17.4020 as
proposed raised issues related to
emergency care that may be authorized
by VA as set forth in § 17.4020(c) as
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26288
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
proposed. We reiterate that we will
address below only those issues raised
in comments regarding VA’s
requirements and authorities to
authorize emergency care as set forth in
§ 17.4020(c), and we will address issues
related more to administrative process
of VA approving emergency care in
another section of this final rule related
to miscellaneous comments.
We received a few comments that
requested VA clarify any potential
intersection or sharing of assessment
criteria or other standards between
emergency care furnished under the
VCCP and emergency care separately
furnished under 38 U.S.C. 1725 and
1728. We interpret these comments to
be related to § 17.4020(c) as proposed,
as paragraph (c) established that it did
not affect eligibility for, or create any
new rules or conditions affecting,
reimbursement for emergency treatment
under sections 1725 or 1728. These
comments ranged in their primary
concerns for identifying the
relationships between emergency care
offered under different VA authorities.
For instance, one comment wanted
clarification of the reasonableness
standard that would be applied under
the VCCP to determine whether care or
services were emergent in nature, and
further advocated that the prudent
layperson standard should be applied
(specifically, to include poststabilization). Another comment
requested clarification of the
relationship between the varying
emergency care authorities to ensure
that covered veterans would understand
when VA will likely authorize
emergency care and reimburse for such
care, versus the veteran possibly being
liable. We do not make changes based
on these comments.
We believe that § 17.4020(c) is
sufficient to indicate that emergency
care furnished through the VCCP is
distinct from and does not affect
emergency care provided under sections
1725 or 1728. We do clarify, however,
that because paragraph (c)(1) of
§ 17.4020 does reference section
1725(f)(1) to define emergency
treatment, VA will use the prudent
layperson standard as interpreted
through section 1725. We understand
this clarification that VA will use its
section 1725 prudent layperson for
emergency treatment furnished through
the VCCP is not what was requested by
the comment, which asserted that this
very standard permitted VA to review
decisions of reasonableness instead of
VA using what would perhaps be
considered a broader industry standard
(for instance, as referenced by the
comment to a Centers for Medicare and
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
Medicaid Services standard of prudent
layperson in 42 U.S.C. 300gg–
19a(b)(2)(A)). However, we believe VA’s
prudent layperson standard is
reasonable to administer the furnishing
of emergency treatment through the
VCCP. This same comment also
requested that VA revise
§ 17.38(a)(1)(iv) to expressly provide
that emergency care under VCCP is part
of the medical benefits package. We
agree and are revising § 17.38(a)(1)(iv)
accordingly. We believe this change will
assist individuals in understanding that
emergency care provided under the
VCCP is separate from that provided
under sections 1725 and 1728 and is a
covered benefit under the VCCP.
We received a comment that
requested VA clarify that the term
emergency treatment includes mental
health care, which we interpret to be
related to § 17.4020(c)(1) as proposed as
this paragraph referenced the definition
of emergency treatment in 38 U.S.C.
1725(f)(1). We do not make changes
based on this comment, as we believe
the reference to the definition of
emergency treatment in section
1725(f)(1) is sufficient to indicate that
mental health services are considered
within the scope of emergency
treatment. Section 1725(f)(1) refers to
medical care or services furnished in an
emergency. We have interpreted this to
apply to any care or services within
VA’s medical benefits package, which
includes mental health services, as
identified in § 17.38(a)(1)–(2).
Comments generally stated that the
72-hour rule in § 17.4020(c)(2) as
proposed was not reasonable. Primarily,
these comments asserted that the 72hour timeframe was too short or did not
provide exceptions where it may be
exceeded. There were multiple reasons
provided in the comments to support
that the 72-hour rule should have
exceptions, which we summarize and
respond to below. We note that some of
these reasons raise issues related to
requirements in § 17.4020(c)(3) and (4)
as proposed, related to requirements for
approval and notice to VA, respectively.
One comment stated that § 17.4020(c)
as proposed did not reflect what the
comment asserted was the current
regulatory option for an exception to the
72-hour rule, to provide VA notice
within a reasonable amount of time after
the emergency care was furnished. We
note that no such exception exists in
current regulation under § 17.54, and we
see no reason to add such an exception
here, as this rule would only apply to
covered veterans and eligible entities or
providers.
Other comments offered reasons to
establish exceptions to the 72-hour rule
PO 00000
Frm 00012
Fmt 4701
Sfmt 4700
that were related to veterans or non-VA
providers not understanding what VA
facility should receive the notice or who
to contact at such VA facility. Some of
these comments more specifically noted
that neither the appropriate VA official
nor the nearest VA facility in
§ 17.4020(c)(4)(i) as proposed were
clearly defined or characterized,
particularly in instances where a
veteran might be traveling and not be
familiar with VA facility locations, or
non-VA providers may not be familiar
with VA facilities in their area. Some of
these comments further requested
clarification of who is considered an
appropriate VA official, or requested
that VA revise the requirement to allow
notice to be delivered to any VA facility.
As we explained in the proposed rule,
only eligible entities or providers who
have a contract or agreement to furnish
care on VA’s behalf may furnish care
under § 17.4020(c). While veterans who
are traveling may not know the local VA
facility, we are confident that each
community entity or provider in our
network will know the right VA facility
to contact.
Other comments offered reasons to
establish exceptions to the 72-hour rule
that were related to the nature of
receiving emergency care or services.
For instance, these comments asserted
that in many cases a covered veteran
seeking emergency care will be in a
compromised medical state, and
therefore should not be expected to
understand whether they are seeking
care from authorized entities or
providers, or to understand whether all
care offered might be covered by the
medical benefits package.
Still other comments argued that
exceptions are needed due to other
circumstances, such as when the nearest
VA facility might be closed after
business hours or on holidays (to create
delays in meeting the 72-hour rule), or
when 72 hours may simply not be
enough time for a non-VA provider to
have obtained all information required
under § 17.4020(c)(4) (for instance, if a
covered veteran presents for emergency
treatment without identification). One
of these comments further requested
that VA revise the rule so that the 72hour period would not begin until the
later of when the entity or provider
began furnishing the care or the time
when a reasonably diligent non-VA
entity or provider would have the
information necessary to submit a notice
to VA in compliance with
§ 17.4020(c)(4).
We do not make any changes based on
these comments to create exceptions to
the 72-hour rule in § 17.4020(c)(2) as
proposed. We reiterate from the
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
proposed rule that the 72-hour
requirement is consistent with the
window for approval under existing
§ 17.54(a), and we believe the 72-hour
requirement continues to be a
reasonable timeframe to allow
notification upon stabilization of the
patient or upon the next business day in
the overwhelming majority of cases. VA
will work to improve its communication
materials for both veterans and eligible
entities and providers concerning who
may receive the notice and at what VA
facility, without making changes to
§ 17.4020(c)(2) through (4). We believe
this improved communication will
assist with effective and timely
provisions of notice within the 72-hour
requirement. We also clarify that if the
72-hour window is not met, VA will
consider any claims for reimbursement
of the costs of the emergency treatment
under other authorities, specifically
sections 1725 and 1728, which
authorize reimbursement of certain nonVA emergency treatment; there is no 72hour requirement under either of these
other authorities, but we do request
notification under these authorities as
soon as possible in the interest of
coordination of care. We note that a
veteran’s personal financial liability, if
any, could vary depending upon
whether the care is authorized under
section 1703 under the 72-hour rule or
reimbursed under sections 1725 or
1728.
One comment requested that VA
clarify if it will define someone acting
on the covered veteran’s behalf in
§ 17.4020(c)(2), or if VA will provide an
exception to automatically approve care
if a covered veteran is incapacitated (or,
conversely, if VA will apply what the
comment asserted was the current VA
emergency room standard to non-VA
emergency rooms). We do not make any
changes based on this comment, as we
believe the issues raised may be
conflating the concept of a covered
veteran’s consent to receive emergency
treatment with VA’s approval of such
treatment furnished through the VCCP.
One comment requested that VA
revise § 17.4020(c) to permit that two
emergency room visits be permitted
through the VCCP at no charge to
covered veterans. We interpreted this
comment to be raising issues more
related to VA’s administration of its
approval of emergency treatment,
because it relayed concerns that covered
veterans were unduly subject to cost
liabilities for emergency treatment that
the comment asserted VA failed to
approve or pay timely. We will therefore
address this comment in the section of
this final rule that pertains to
miscellaneous comments, although we
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
do clarify here that § 17.4020(c) as
proposed does not limit the number of
visits to an emergency room for a
covered veteran to receive emergency
treatment through the VCCP.
Lastly, one commenter asserted that
VA should add urgent care in addition
to emergency treatment as available care
and services under the VCCP. We do not
make changes based on this comment
but do clarify that VA is promulgating
separate regulations, published
elsewhere in this issue of the Federal
Register, to furnish urgent care through
non-VA providers (see RIN 2900–AQ47,
published as a proposed rule on January
31, 2019 (84 FR 627)).
On April 5, 2019, VA published a
Supplemental Notice of Proposed
Rulemaking (SNPRM) to amend VA’s
proposed rule by proposing a minor
revision to paragraph (a) and a new
paragraph (d) to account for section
1703(l) and its language concerning
organ and bone marrow transplants. 84
FR 13576. VA received 10 comments on
this SNPRM. One comment was a
request for case management assistance,
which VA has addressed but which was
beyond the scope of the rulemaking. We
make no changes based on this
comment. Four comments supported the
changes proposed by the SNPRM. We
make no changes based on these
comments. One comment raised
concerns regarding billing and
payments for community providers. The
commenter stated that clear definitions
of how payments will be processed and
paid between VA and the community
providers is important to minimize any
confusion in the billing process. The
SNPRM did not address claims or
billing issues because these were
separately addressed in § 17.4035 of the
proposed rule. We received comment on
the proposed rule regarding billing and
claims payment, which we address
more fully below. In brief, however, we
do not regulate VA’s process for claims
submissions or billing at this time. VA
contracts and agreements will establish
these requirements between the parties,
and rules of general applicability,
particularly regarding prompt payment,
will be regulated at a later time. We
make no changes based on this
comment.
One commenter requested that VA
provide examples of medically
compelling reason for a veteran to seek
transplant services outside of the Organ
Procurement and Transplantation
Network (OPTN) region in which the
veteran resides. We do not make
changes based on this comment but
clarify that examples of medically
compelling reasons were provided in
§ 17.4020(d)(2)(i) through (iv) as
PO 00000
Frm 00013
Fmt 4701
Sfmt 4700
26289
proposed and were discussed in the
SNPRM. This same commenter
requested for VA to clarify how OPTN
regions and distance considerations in
§ 17.4020(d)(2)(iii) as proposed will
interact in determining whether a
transplant will be authorized. We do not
make changes based on this comment
but clarify that § 17.4020(d)(2)(iii)
provides that VA will consider travel
burden on covered veterans when
deciding to authorize transplantation
care at a transplant center outside the
Veteran’s OPTN region of residence.
Geographical proximity of a qualified
transplant center in an OPTN region
adjacent to the patient’s residence will
be considered when burden of travel is
meaningfully impacted. Availability of
services in consideration for
authorization of care in another OPTN
region is cited in § 17.4020(d)(2)(iv) as
timeliness of transplant center
evaluations and management.
Transplant program qualifications are
further addressed by § 17.4020(d)(2)(i)
and (ii). Transplant programs must meet
standards for quality, and specific
patient factors may include a disease
process or transplantation procedure
that warrants referral to selected
transplantation centers, including those
in a different OPTN region.
One commenter suggested that VA
permit Veterans to be listed on more
than one OPTN regional list if indicated,
to increase their chance of being
matched. We do not make changes
based on this comment but clarify that
the listing of Veterans on more than one
OPTN regional list is not prohibited by
the regulation. Related policy will
specify that such listing is an
appropriate consideration for
authorization of care in an OPTN region
other than that of the Veteran’s
residence.
One commenter asserted that the
SNPRM failed to clarify the differences
between solid organ transplant and bone
marrow transplant. This commenter
more specifically noted that bone
marrow transplant falls outside of the
scope of OPTNs, and that the proposed
rule only indicated how VA Transplant
Programs and VA Transplant Centers
interact with OPTNs; hence, the
commenter indicated that VA should
clarify whether the rule captures bone
marrow transplants. We do not make
any changes based on this comment, as
the MISSION Act includes provisions
for both bone marrow transplantation
and solid organ transplantation. VA
understands that OPTN does not
oversee bone marrow transplantation,
but the rule does cover bone marrow
transplants. This same commenter
further suggested that the four factors in
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26290
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
§ 17.4020(d)(2) to be considered when
determining a medically compelling
reason to travel outside of the OPTN
must be revised to include relevant
details for bone marrow transplant. For
instance, the commenter noted that the
factor related to assessing facilities
outside of an OPTN to determine
whether they meet VA’s standards for
quality in § 17.4020(d)(2)(ii) as proposed
was only explained in the preamble of
the SNPRM in reference to Scientific
Registry of Transplantation Recipients
data, which is only applicable to solid
organ. We do not make changes based
on this further comment. VA
understands that relevant patient factors
may vary based upon the specific
transplant both among solid organ types
and bone marrow transplant, which is
precisely why the SNPRM noted the
four factors in § 17.4020(d)(2)(i)–(iv)
were a non-exhaustive list. The
Scientific Registry of Transplantation
Recipients database is provided only as
an example. Additional standards for
solid organ transplantation programs
and separate standards for bone marrow
transplantation programs will be
developed during policy and
procurement processes.
We received one comment that
requested that VA clarify that it is the
veteran’s choice whether to obtain a VA
or non-VA transplant within the
Veteran’s OPTN (the commenter
essentially asserted that the SNPRM was
unclear that the veteran first has a
choice of a non-VA transplant center
within the OPTN prior to any
consideration of travel outside of an
OPTN). We do not make changes based
on this comment. A covered veteran
who is determined by VA to meet
eligibility criteria for community care in
proposed § 17.4010 has the ability to
decide whether to receive
transplantation care in the community
within the OPTN region of residence.
Veterans who meet eligibility criteria for
community care may elect to receive
care at a VA Transplant Center. This
commenter also asserted that section
1703(l) requires only that a veteran be
a covered veteran to be considered
eligible for this expanded access to
transplant care and does not require
such a covered veteran to be separately
assessed under any other criteria (e.g.,
the criteria to receive community care
generally under section 1703(d) or (e)).
We believe this portion of the comment
was prompted by VA’s clarification in
the SNPRM that this expanded access to
transplant care only applies for a
covered veteran (as defined in
§ 17.4005) who meets one or more of the
eligibility criteria for community care
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
generally under § 17.4010. We do not
make changes based on this comment.
We read section 1703(l) as qualifying
the conditions of eligibility set forth in
section 1703(d) and (e); there is nothing
in section 1703(l) that suggests it is
intended to establish an additional,
independent basis of eligibility for
community care. Moreover, the
expanded access to transplant care
under section 1703(l) is available only if
there is a medically compelling reason
to travel to receive such care. VA cannot
envision any instance in which a
covered veteran would be found to have
a medically compelling reason to justify
travel outside of an OPTN, but not be
found to qualify separately for
community care generally under
§ 17.4010(a), particularly considering
that the factors to determine a medical
compelling reason under
§ 17.4020(d)(2)(i)–(iv) are related to
many of the eligibility factors in
§ 17.4010 (for instance, factors exist
under §§ 17.4010(a) and 17.4020(d) that
relate to the specific medical needs of a
veteran, the travel burden for a veteran,
and the timeliness of care to be
received). This commenter further
asserted that VA should ensure a
veteran’s primary care physician
receives deference over the Secretary in
the determination of whether a veteran
is eligible to travel outside of the OPTN.
We do not make changes based on this
comment. Section 1703(l) requires that
the Secretary make the determination of
whether to authorize community care
for covered veterans requiring an organ
or bone marrow transplant and who
have a medically compelling reason to
travel outside of the OPTN region in
which they reside to receive the
transplant. The Secretary’s
determination is only made when the
primary care provider has opined that
there is a medically compelling reason
to travel outside the OPTN region in
which the veteran resides to receive
such transplant; this opinion is a
threshold question of when the
Secretary makes a determination, and
not a final resolution of the matter.
Lastly, this commenter urged that VA
should include in the final rule a
specific timeframe within which VA is
required to make a decision on requests
to travel outside OPTN for non-VA
transplant, as well as a means for
expedited decision or waiver of such a
decision. We do not make changes
based on this comment. Timeframes
may be influenced by factors such as the
type of transplant, patient disease
process, and patient acuity. It would not
be practicable to define specific
timeframes by regulation, given the
PO 00000
Frm 00014
Fmt 4701
Sfmt 4700
variability of these factors. However, VA
will develop policy that will address
such timeframes.
§ 17.4025, Effect on Other Provisions
We received over 50 comments
concerning the effects of §§ 17.4000
through 17.4040 as proposed upon
provisions of VA law that establish
other criteria for the receipt of care or
services. We address these comments
below in the order in which they raised
issues related to the provisions in
paragraphs (a)–(c) of § 17.4025 as
proposed.
We did not receive any comments that
requested revisions to or clarifications
for § 17.4025(a) as proposed, although as
a general matter we did receive some
comments that seemed to call for
expanding eligibility for certain care
and services under the VCCP beyond
that which is established in other
specifically applicable provisions of VA
law (for instance, multiple comments
called for the expansion of eligibility for
VA dental care). Other comments did
not seek expanded eligibility for certain
care or services under the VCCP but did
assert that the rule as proposed did not
provide adequate explanation of
eligibility for certain benefits such as
dental care. We do not make any
changes based on these comments and
reiterate from the proposed rule that
consistent with section 1703(n)(2), no
provision in the rule may be construed
to alter or modify any other provision of
law establishing specific eligibility
criteria for hospital care, medical
services, or extended care services (such
as for dental care). If specific services
such as dental care under §§ 17.160–
17.169 have unique eligibility
standards, only covered veterans who
are eligible under proposed § 17.4010
and meet such eligibility standards can
elect to receive them through the VCCP.
A majority of the comments we
received on § 17.4025 as proposed
related to § 17.4025(b), regarding VA’s
criteria under the VCCP to fill or pay for
prescriptions issued by non-VA
providers. Some of these comments did
not suggest changes to or clarification of
the regulation text in § 17.4025(b) as
proposed, but rather seemed to present
issues related to administrative process
rather than regulatory requirements
(primarily, VA’s administrative
practices in reviewing prescriptions
issued by non-VA providers). We will
address below only those issues raised
in comments regarding VA’s
requirements in § 17.4025(b) as
proposed, and will address other issues
related to administrative process in
another section of this final rule related
to miscellaneous comments.
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
As proposed, § 17.4025(b)(1)
established the rule that VA would pay
for prescriptions written by eligible
entities and providers for a course of
treatment not to exceed 14 days, and
paragraph (b)(2) established that VA
would fill prescriptions written by
eligible entities and providers without
any accompanying 14-day limitation. As
explained in the preamble of the
proposed rule, the intent of
§ 17.4025(b)(1) and (2) was to establish
in VA regulations the long-standing VA
practice of limiting its payment for
medications written by non-VA
providers and filled through non-VA
pharmacies, rather than limiting VA’s
direct filling of such prescriptions
through VA’s Consolidated Mail Order
Pharmacy (CMOP) system. We first
address a comment that revealed an
inadvertent omission in the regulation
text at § 17.4025(b)(1) as proposed,
related to when VA will pay for non-VA
prescriptions. This comment
specifically urged VA to change its
practice of requiring veterans to pay for
urgent or emergent prescriptions filled
outside of VA’s CMOP and then seek
reimbursement from VA. This comment
correctly summarized VA’s practice at
the time the proposed rule published,
although § 17.4025(b)(1) as proposed
did not contain any qualifying language
related to VA paying for prescriptions
written by non-VA providers only when
they were urgently or emergently
needed. We therefore revise
§ 17.4025(b)(1) to include qualifying
language that VA will pay for
prescriptions no longer than 14 days
written by eligible entities or providers
for covered veterans, including over-thecounter drugs and medical and surgical
supplies, available under the VA
national formulary system to cover a
course of treatment for an urgent or
emergent condition. In response to the
request in this same comment that VA
correct its practice of reimbursing
veterans, to instead pay directly for
prescriptions urgently or emergently
needed for a course of treatment not to
exceed 14 days, we clarify that VA’s use
of the term ‘‘pay’’ versus ‘‘reimburse’’ in
§ 17.4025(b)(1) was intended to and
does create the option for VA to pay
directly for these prescriptions. VA
expects that upon full implementation
of the Community Care Network of
eligible entities and providers, the
pharmacy benefits management options
under those contracts will provide for
VA to pay non-VA pharmacies directly
for prescriptions written by eligible
entities and providers to cover a course
of treatment for an urgent or emergent
condition and not to exceed 14 days.
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
We received multiple comments that
indicated a general dissatisfaction with
VA’s practice of limiting payment for
prescriptions written by non-VA
providers, as well as comments that
more specifically asserted that the 14day limitation in § 17.4025(b)(1) as
proposed was unreasonable because VA
did not establish any exceptions to this
limitation, with one comment
requesting a revision to § 17.4025(b)(1)
to allow for payment of a course of
treatment greater than 14 days if VA is
unable to fill that greater course through
its Consolidated Mail Order Pharmacy
(CMOP) system. Other comments
requested an expansion of the 14-day
limitation, such as a broad expansion of
the limitation to 30 days, with one
comment noting that a 30-day supply of
medication should be approved for
outpatient surgery specifically (to
reduce potential post-surgical injuries or
complications). We received other
comments that did not suggest revisions
or exceptions to the 14-day limitation
per se, but that requested clarifications
regarding its application. For instance,
one comment requested clarification of
VA’s practices in paying for medications
that are prepackaged for durations
exceeding 14 days and that cannot be
divided. We do not make any changes
based on these comments that expressed
general dissatisfaction with the 14-day
limitation, or comments that VA should
establish exceptions to or expand the
14-day limitation. As explained above,
VA’s only pays for non-VA
prescriptions that are filled through
non-VA pharmacies if they are needed
to cover a course of treatment for urgent
or emergent conditions. The 14-day
limitation is a function of the limitation
related to urgent and emergent
conditions, as courses of medication for
longer periods of time are not typically
prescribed to treat urgent or emergent
conditions. VA also has a responsibility
to monitor the prescription of
medications to ensure appropriate
prescribing practices and general patient
care. Using the outpatient surgery
example as provided in one of the
comments, typical medications issued
following surgery such as antibiotics
and pain killers are particularly
important for VA to review and fill via
the CMOP because such medications
create medical concerns (such as
antibiotic resistance, potential opiate
monitoring issues, or other adverse
events) if they were to be issued for and
taken longer than 14 days. We also
reiterate from the proposed rule that the
current practice to limit payment for
non-VA prescriptions allows VA to
ensure that any amount of medication
PO 00000
Frm 00015
Fmt 4701
Sfmt 4700
26291
exceeding 14 days would be filled
through VA’s CMOP system to ensure
cost and quality controls. VA believes
that the economies of scale related to
bulk purchase of medications allow for
the best use of Federal resources.
We received one comment that
asserted non-VA providers must verify
that prescribed medications are
available through VA’s formulary and
comply with VA’s practice guidelines,
to avoid scenarios where covered
veterans might receive prescriptions VA
will not fill. We first note that we do not
have anecdotal knowledge that there are
widespread or recurring issues that nonVA providers are issuing prescriptions
that VA cannot or will not fill because
such medications are not on VA’s
formulary, or because the prescription
contradicts VA’s practices or guidelines.
However, VA will review its
administrative practices in reviewing
and filling prescriptions issued by nonVA providers, to ensure it develops any
necessary education or communication
to non-VA providers to prevent those
scenarios. We do not make any changes
based on this comment but do note that
§ 17.4025(b)(1) and (2) as proposed
generally requires that medications
issued by non-VA providers must be
available under the VA national
formulary system. There are exceptions
where VA may fill non-formulary
prescriptions issued by non-VA
providers, and such requests for
exceptions are reviewed under specific
procedures in VHA Directive 1108.08,
VHA Formulary Management Process,
which can be found on VA’s website.
We received a few comments related
to the prescribing of durable medical
equipment (DME) by non-VA providers
under § 17.4025(b)(3)–(4) as proposed.
Some comments asserted that the rule
should not require VA oversight or
approval of prescriptions from non-VA
providers for durable medical
equipment (DME). Other comments
were more specific, with one comment
requesting clarification of who
determines and what standards are used
to determine when DME is immediately
needed under § 17.4025(b)(3) as
proposed, and further asserting that it
should be determined by the prescribing
clinician. Another comment requested
that VA revise § 17.4025(b)(3) as
proposed to specify that DME is an
immediate need if it is required to safely
discharge a patient from an urgent or
emergent care setting, and that
§ 17.4025(b)(3) and (4) should be revised
to expressly include home oxygen as
covered under DME.
With regard to comments concerning
general VA oversight and approval of
DME that is prescribed by non-VA
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26292
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
providers, we reiterate from the
proposed rule that because DME and
medical devices prescribed by non-VA
health care providers are specific to a
particular clinical need and in most
cases are further specifically tailored to
fit or serve an individual, they require
oversight and approval by VA (except
when urgently or emergently needed) to
ensure clinical appropriateness and the
best use of Federal resources. We
therefore do not make any changes
based on those comments. With regard
to comments concerning who
determines and under what standards
that DME is immediately needed, as
well as the comments concerning the
specific revisions related to immediate
need, we first reiterate that DME to
address an immediate need for urgent or
emergent conditions does not require
VA oversight or approval, and therefore
would be issued by the treating or
prescribing clinician without VA
review. We next reiterate from the
proposed rule that an immediate need
for DME exists when a covered veteran
has a medical condition of acute onset
or exacerbation that manifests itself by
severity of symptoms including pain,
soft tissue symptomatology, bone
injuries, etc. We believe the language in
§ 17.4025(b)(3) as proposed provides
sufficient but non-exhaustive examples
of the types of DME that are typically
necessary to address such immediate
needs (i.e., splints, crutches, manual
wheelchairs), and § 17.4025(b)(3)
otherwise makes clear that urgent and
emergent conditions meet the
immediate need standards. We therefore
do not make changes based on this
comment. With regard to the comment
concerning expressly adding home
oxygen as covered DME, we clarify that
home oxygen is considered DME for
purposes of § 17.4025(b)(3) and (4)
without further revisions to the
proposed rule.
We received comments related to
covered veterans’ possible copayments
in using community care under the
VCCP, which we interpret to be related
to § 17.4025(c) as proposed. Some
comments urged that the rule should
not change anything related to current
copay structures and procedures. One
comment asserted American Indian/
Alaskan Native veterans should not be
charged copayments for care received
under the VCCP, as this was
inconsistent with Federal trust
obligations. We do not make any
changes to the rule based on these
comments and reiterate from the
proposed rule that veterans will
continue to be liable as applicable under
§§ 17.108(b)(4) and (c)(4), 17.110(b)(4),
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
and 17.111(b)(3) for copayments for
community care that is furnished
through the VCCP. The VCCP will not
alter the current treatment of veteran
copayments under VA’s traditional
community care program or the
Veterans Choice Program. We also
reiterate from the proposed rule that
veterans who receive care from the
Indian Health Service (IHS) and Tribal
Health Programs (THP) under a sharing
agreement with VA will not be affected
by regulations that implement the
VCCP; the existing VA reimbursement
agreements between IHS, THPs and VA
control all parameters of how that care
is provided, including whether
copayments are charged.
§ 17.4030, Eligible Entities and
Providers
We received over 200 comments
related to non-VA entities and providers
that may furnish hospital care, medical
services, or extended care services
through the VCCP. We address these
comments below in the order in which
they raised issues related to the
provisions in paragraphs (a)–(c) of
§ 17.4030 as proposed.
A majority of these comments
asserted that VA should ensure non-VA
providers are similarly qualified and
competent as VA providers to furnish
the same levels of care as VA providers.
These comments more specifically
urged that non-VA providers must: Be
properly licensed/credentialed; use
evidence-based treatment; and have
specific training in clinical areas where
VA has developed particular expertise
(e.g., post-traumatic stress disorder,
traumatic brain injury, etc.). Some of
these comments further stated that if
non-VA providers cannot furnish care or
services as well as VA providers, then
those providers should not be an option
that covered veterans may choose to
furnish community care under the
VCCP. Lastly, a few of these comments
also asserted that if non-VA providers
do not submit full medical
documentation for care or services
furnished under the VCCP (and not
mere submission of invoices or bills),
VA must not pay them. We interpret
these comments to be related to
§ 17.4030(a) as proposed, as some of the
comments specifically alluded to VA
establishing more specific requirements
for providers in the contracts,
agreements, or other arrangements the
providers enter into under § 17.4030(a).
Regarding the general need for VA to
establish requirements for non-VA
providers, we agree with the comments
that it is critical for covered veterans to
receive competent care from qualified
non-VA providers should such veterans
PO 00000
Frm 00016
Fmt 4701
Sfmt 4700
elect to receive care under the VCCP.
However, we do not make any changes
to § 17.4030 based on these comments.
The rule at § 17.4030(c)(2) as proposed
requires VA to assess the qualifications
of the entity or provider to furnish the
needed care or services in determining
whether the provider is accessible to the
covered veteran. These assessments can
include licensing and credentialing
information that VA collects under
OMB control number 2900–0823. VA
additionally requires submission of
medical records as part of their claims
for all non-VA care and services
furnished under the rule (also under
OMB control number 2900–0823) and as
required by 38 U.S.C. 1703(a)(2)(A). VA
reviews all licensing and credentialing
information to ensure non-VA providers
meet applicable standards for care
needed, as well as medical records to
ensure care was provided appropriately
and within the scope of authorization.
Although not part of the proposed rule,
VA is establishing competency
standards and requirements for the
provision of care by non-VA providers
in clinical areas where VA has
developed special expertise, in
accordance with section 133 of the
MISSION Act. We are not regulating
these standards to permit flexibility, as
such standards are based on clinical
practice and can be subject to change.
VA’s contracts, agreements, or other
arrangements will impose requirements
to meet these competency standards.
We received some comments that
asserted VA should permit Medicare
providers to participate in VCCP. We do
not make changes based on these
comments, as Medicare providers are a
type of provider permitted under
section 1703(c) to participate in VCCP,
and are otherwise permitted to enter
into contracts, agreements, or other
arrangements with VA to furnish care
and services under § 17.4030(a).
We received a few comments that
requested clarification on whether or to
what extent providers employed by VA
could also participate in VCCP as
eligible entities and providers to furnish
care or services under § 17.4030(b) as
proposed. We reiterate from the
proposed rule, without changes to
§ 17.4030(b) as proposed, that providers
who are employees of VA may not be
acting within the scope of their
employment while providing care or
services through the VCCP. Essentially,
VA providers may participate in VCCP
as long as it is not during their VAemployed work hours.
We received a few comments that
requested clarification of how VA
would assess whether a non-VA
provider is accessible to a covered
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
veteran under § 17.4030(c) as proposed.
These comments generally seemed to
inquire whether § 17.4030(c)(1) and (3)
(related to VA assessing the length of
time the veteran would have to wait to
be seen by the non-VA provider, and the
distance between the veteran’s
residence and that provider,
respectively) were essentially VA’s
application of its access standards to
non-VA providers, as such access
standards were set forth in § 17.4040 as
proposed. Those comments that
assumed § 17.4030(c) did seek to apply
VA’s access standards to non-VA
providers were primarily supportive of
such an assumption. However, a few
comments noted that applying such
standards to non-VA providers was not
feasible or advisable. One comment that
opposed applying VA’s access standards
to non-VA providers more specifically
asserted that non-VA providers would
be discouraged from participating in the
VCCP if they had to comply with VA’s
access standards, as this would amount
to preferred treatment of veteran
patients over non-veteran patients in
terms of timeliness of appointments.
We clarify that VA did not intend for
§ 17.4030(c)(1) and (3) to establish a
regulatory mechanism to apply VA’s
access standards as set forth in
§ 17.4040 to non-VA providers. This
does not mean, however, that VA will
not endeavor to ensure that community
health care providers are able to comply
with the applicable access standards
established by VA, as VA is required to
do so under section 1703B(f). To clarify
VA’s intentions, VA intends to establish
access standards for non-VA providers
in the contracts, agreements, or other
arrangements that eligible entities or
providers enter into under § 17.4030(a)
as proposed, as opposed to establishing
access standards for non-VA providers
in regulation. We do not make changes
to § 17.4030(c) as proposed based on
these comments.
Although we do not make changes to
§ 17.4030(c) as proposed based on these
comments, we do offer the following
clarifications as requested by comments
regarding how VA will use
§ 17.4030(c)(1) and (3) to assess whether
a non-VA provider is accessible. By
considering the length of time a veteran
would have to wait to receive hospital
care or medical services from a non-VA
entity or provider under § 17.4030(c)(1)
as proposed, VA can ensure that
veterans receive care as quickly as
possible. If a veteran selects a non-VA
provider who cannot see the veteran for
several months, VA would probably
determine that provider was
inaccessible, and could then provide the
veteran with other options of non-VA
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
providers to potentially schedule an
appointment sooner. By considering the
distance between the covered veteran’s
residence and the non-VA provider, VA
can ensure that veterans receive care
closer to their residence. If a veteran
resides in New York and selects a
provider in California (to receive care in
California when they otherwise would
not be residing in California at the time
of the appointment), VA would
probably determine that provider was
inaccessible, and could then provide the
veteran with other options of non-VA
providers that would be closer to their
residence at the expected time of the
appointment. In either scenario
(distance or time for an appointment),
VA’s decision regarding accessibility is
not pre-determined; these will be caseby-case decisions. We believe these
factors will be most relevant in
situations where a covered veteran has
not selected a particular non-VA
provider, but is looking for VA to
identify a non-VA provider that can
furnish the care for them. In such cases,
we would use these factors to determine
which providers should be offered as
possible options. If a covered veteran
has selected a particular provider, we
may determine in some cases that the
provider is inaccessible (as in the New
York/California example above), while
in other cases, such cross-country travel
might be approved (if, for example,
there were only one or two providers in
VA’s network that furnished a specific
type of service). In more typical cases,
we anticipate that the veteran’s
selection of a particular provider will
likely be approved, even if a particular
provider might have a slightly longer
wait time or be slightly further away
from the veteran, as this would be the
veteran’s choice.
We also note that § 17.4030(c)(2) as
proposed will consider the
qualifications of the entity or provider
to furnish the hospital care, medical
services, or extended care services the
veteran requires. If an entity or provider
does not have the expertise or
equipment necessary to provide the
required care or services, the needed
care is not accessible from that provider,
and VA may not authorize a patient to
receive care or services from that entity
or provider. We raise this last factor in
§ 17.4030(c)(2) as proposed to reiterate
as stated above that VA will consider
these factors together to make
accessibility determinations on a caseby-case basis, considering each veteran’s
specific needs. Sometimes, there may be
several eligible entities or providers that
could deliver care close to the veteran’s
residence, and in such a scenario,
PO 00000
Frm 00017
Fmt 4701
Sfmt 4700
26293
distance likely will not matter. In other
situations, there may only be one
provider near the veteran’s residence,
but this provider either has extended
wait times or lacks the expertise or
equipment to provide the necessary
care. VA will need to balance these
competing interests and the preference
of the veteran to determine whether an
entity or provider is accessible.
We are making minor changes to
paragraph (c) to use the term covered
veteran in lieu of the term eligible
veteran in several places. The term
eligible veteran is used in § 17.1530
because it is a defined term in § 17.1505.
Under the VCCP regulations, we use the
term covered veteran, as defined in
§ 17.4005. This change simply removes
any ambiguity as to the term and does
not alter the effect or meaning of the
rule.
Lastly, we received a comment that
requested VA specifically include in
these regulations outreach, training, and
other assistance to non-VA providers to
expand the Patient-Centered
Community Care (PC3) network, as the
commenter asserted that such expansion
is particularly critical to deliver
community care in underserved areas.
We do not make changes based on this
comment, as this comment presents an
operational request that is more
appropriately addressed through
contract or policy. We do clarify,
however, efforts on VA’s part to
improve education of providers
regarding the formation of contracts
under section 1703(h) through the
Community Care Network in the portion
of this document that discusses
miscellaneous comments.
§ 17.4035, Payment Rates
We received over 25 comments
concerning the parameters under which
VA establishes payment rates for care
and services furnished through the
VCCP, as set forth in § 17.4035 as
proposed. We address these comments
below in the order in which they raised
issues related to provisions in
paragraphs (a)–(e) of § 17.4035 as
proposed. We note that some comments
we received related more to
administrative processes associated
with payment for care and services (e.g.,
how VA pays non-VA providers), rather
than the regulatory requirements from
the proposed rule; we will address such
administrative comments in the section
of this final rule related to
miscellaneous comments.
We received some comments that
asserted that VA should not pay below
applicable Medicare fee schedules or
prospective payment system amounts,
to ensure non-VA providers are not
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26294
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
discouraged from participating in the
VCCP. One comment was more specific,
noting that VA should pay at full
applicable rates for inpatient care that
go beyond Medicare’s professional fee
schedule, including at academic
hospitals that have both indirect
medical education (IME) and direct
medical education (DME) billing
components. We do not make changes
to § 17.4035(a) as proposed based on
these comments. The limitation of VA’s
payment rates to be no higher than
Medicare, versus being designated the
same as Medicare rates, is consistent
with section 1703(i)(1) that, with
exceptions, the rates VA pays for care
and services may not exceed the
applicable Medicare rate. We clarify,
however, that VA has typically paid at
applicable Medicare rates under the
Veterans Choice Program, to avoid the
scenario raised by comments where
non-VA providers are discouraged from
participating in VA community care
programs. With regard to the specific
concerns in paying IME or DME billing
for academic hospitals, we also do not
make changes to § 17.4035(a) as
proposed but do clarify that VA does
pay adjustments to Medicare costing as
applicable and appropriate.
One comment requested that VA
provide more details on how it will
determine payment rates for inpatient
services provided by critical access
hospitals, as the statutory authority for
setting rates for such hospitals (42
U.S.C. 1395m) was referenced in
§ 17.4035(a) as proposed. This comment
further voiced support for VA using a
cost-based approach to determine rates
for critical access hospitals. We do not
make changes based on this comment.
We believe the language in § 17.4035(a)
and its reference to 42 U.S.C. 1395m is
sufficient to allow VA to calculate
appropriate rates for critical access
hospitals.
One comment requested that VA
confirm that use of the term Medicare
rate in § 17.4035 generally means a rate
unaffected by Federal budget
sequestration. We do not make changes
based on this comment and can only
confirm that to the extent Medicare’s
rates or adjustments are unaffected by
budget sequestration, so too will VA’s
rate setting be unaffected under the
parameters established in § 17.4035.
Similarly, and inversely, if sequestration
did modify the rates paid under the
Medicare program, VA’s rates would
also potentially change. We do not
believe sequestration would change the
Medicare fee schedule, but we
acknowledge that it could affect the
Centers for Medicare and Medicaid
Services’ (CMS) ability to pay. VA’s
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
payment rates for any particular service
to any particular provider will be
established through the terms set forth
in the contract or agreement and may
reference the Medicare fee schedule in
general. If such terms are fixed to a
specific dollar amount, any change in
the Medicare rate will not otherwise
serve to modify the terms of that
contract or agreement. However, if the
terms in the contract or agreement are
relative, such as by referencing the
Medicare fee schedule, then changes to
the Medicare fee schedule would carry
over per the terms of the contract or
agreement.
The parenthetical language in
§ 17.4035(a) as proposed would
establish that VA’s payment rate
adjustments occur only on an annual
basis in line with Medicare’s annual
payment updates. One comment
requested that VA revise this
parenthetical language to require VA to
conform to Medicare’s rate adjustment
approaches in their entirety. This
change would result in changes to VA’s
rates on a much more frequent basis
than the annual payment updates issued
by Medicare that VA presently follows.
We do not make changes based on this
comment. VA does not have access to
the information or systems that
Medicare uses to adjust payments on a
more frequent basis than annually,
based on such factors as quality or
performance, utilization, etc., and as
such, cannot operationalize this aspect
of the Medicare program’s payment
schedule.
We did not receive comments
concerning § 17.4035(b) as proposed,
and therefore do not make any changes.
We received one comment
recommending VA revise § 17.4035(c) as
proposed, to expand the definition of
highly rural area to include rural area.
This comment further stated that VA
should utilize the Rural-Urban
Commuting Areas system, developed by
the Department of Agriculture and the
Department of Health and Human
Services, to define rurality. We do not
make changes based on this comment.
We reiterate from the proposed rule that
use of the term highly rural area is
prescribed by and specifically defined
in statute in section 1703(i)(2)(B).
A few comments requested
clarification as to how VA will
determine that limiting its payment
rates to applicable Medicare rates is not
practicable, as permitted under
§ 17.4035(d) as proposed. Some
comments further requested
clarification of how eligible entities or
providers would be notified of
allowable payment rates in excess of
Medicare rates. One comment
PO 00000
Frm 00018
Fmt 4701
Sfmt 4700
specifically requested that VA should
ensure women veterans’ medical needs
were considered as a factor when
establishing rates in excess of Medicare.
We do not make any changes based on
these comments, although we do
reiterate from the proposed rule that
payment rates are ultimately set forth in
the terms of the contract or agreement
under which the care and services are
furnished. As set forth in § 17.4035(d),
the factors that could prove persuasive
in terms of determining impracticability
as identified in the proposed rule
include patient needs, market analyses,
and provider qualifications, among
others. General market conditions
usually establish that supply and
demand can establish a price
equilibrium, and we believe these
conditions will also inform when it
would be impracticable to pay the
Medicare rate.
A few comments requested
clarification as to how VA will
determine payment rates for nonMedicare services, particularly for
extended care services (e.g., home
health, adult day health care, and
respite care). Some of these comments
further requested that VA be transparent
about establishing and updating these
rates, but not necessarily that VA revise
§ 17.4035 to do so. We do not make
changes based on these comments. As
noted in § 17.4035(a), the rates paid by
VA for hospital care, medical services,
or extended care services furnished
pursuant to procurement contract or an
agreement authorized by §§ 17.4100
through 17.4135, will be the rates set
forth in the terms of such contracts or
agreements. Any services for which
there is no Medicare rate will be
determined in accordance with the
defined terms in the contract or
agreement.
We received one comment related to
the portion of the preamble that
explained § 17.4035(e) as proposed,
which requested that VA explain why
fiscal year (FY) 2003 data is used to
determine amounts under VA’s Alaska
Fee Schedule. We do not make changes
based on this comment but clarify that
the VA Alaska Fee Schedule was
originally introduced following an
actuarial study completed by VA in
2001, in which VA determined that
special circumstances exist in Alaska
that warranted a specific fee schedule be
calculated in order to avoid limitations
on Veteran access to care. Based on this
study, and pursuant to notice-andcomment rulemaking, VA promulgated
a regulation at 38 CFR 17.56(d) to
establish the VA Alaska Fee Schedule
(see 70 FR 5926, February 4, 2005). The
provision in § 17.56(d) as originally
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
promulgated used FY 2003 data and
indicated that VA will increase the
amounts on the VA Alaska Fee
Schedule annually beginning in 2005 in
accordance with the published national
Medicare Economic Index (MEI). VA
has used the MEI to annually update
data from the previous fiscal year’s
Alaska Fee Schedule, since this
schedule was first established. Given
that these updates have occurred
regularly, and that VA’s systems are
built on maintaining this schedule, we
believe it would be administratively
burdensome and likely of little value to
change the baseline reference from FY
2003. We further note that we received
no comments recommending a change
from this baseline; the commenter
simply asked for VA’s rationale for
using this data. We believe this
methodology has proven effective for
providers in Alaska.
We received a few comments that
requested VA clarify or confirm, and
further expressly revise § 17.4035 to
reflect, that VA is always the primary
payer for care and services that covered
veterans receive through the VCCP. A
related comment also requested VA
revise § 17.4035 to indicate that VA’s
payment is payment in full and
extinguishes a covered veteran’s
liability. We do not make any changes
based on this comment but reiterate
from the proposed rule that under
section 1703(j), VA shall recover or
collect reasonable charges for such care
or services from a health plan contract
described in section 1729 in accordance
with such section. These provisions of
law establish VA’s role as the primary
payer. We further note that VA will seek
to ensure that the contracts or
agreements VA enters into with eligible
entities and providers will include
terms that limit their ability to seek
payment from a veteran when VA has
made any payment for care or services
furnished to that veteran on VA’s behalf.
There is no need for regulatory language
to ensure that covered veterans do not
face additional liability (other than
applicable copayments) for using the
VCCP.
Lastly, we received one comment that
urged VA to adopt value-based
reimbursement models, particularly for
mental health care, as permitted under
section 1703(i). This comment further
stated that the ability of VA to use
value-based models should encourage
VA’s development of innovative
payment models, including bundled
payment for certain episodes of care. We
do not make any changes based on this
comment. Again, the contract or
agreement will set forth the terms of
payment, which could include the use
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
of value-based models. To the extent
such value-based models could result in
payment that exceeds the limitation set
forth in § 17.4035(a), VA has the option
of utilizing the exception in § 17.4035(d)
when applicable to permit the use of
such models.
We are making minor changes to this
section to reflect the promulgation of
regulations implementing the Veterans
Care Agreement authority in section
1703A. Specifically, we are replacing
the reference to section 1703A of this
title and referring instead to §§ 17.4100
through 17.4135, as these regulations
were added to the Code of Federal
Regulations through a separate VA
rulemaking published on May 14, 2019
(RIN 2900–AQ45, see 84 FR 21668).
§ 17.4040, Access Standards
We received over 18,000 comments
related to the substantive provisions of
the access standards in § 17.4040 as
proposed. For the sake of clarity, we
have divided the discussion below into
three main sections. The first section
will address the general concerns in
comments that are related to both the
average drive time and wait time
standards as set forth in § 17.4040 as
proposed. The next section will address
more specific substantive issues related
to the average drive time standards, and
the last section will address more
specific substantive issues related to the
wait-time standards. We also clarify that
a majority of these comments were
duplicated form responses, and we
address the access standard issues as
jointly raised below.
Access Standards Generally
We received comments that generally
opposed both the drive-time and wait
time access standards as proposed,
based primarily on assertions that the
access standards were arbitrary because
they were not realistic, feasible, or
sustainable, and VA did not conduct
enough research of all existing access
models to properly propose its own
access standards. Some of these
comments further asserted that VA
should have delayed proposal of access
standards until more research or
analysis could have been completed (to
include VA waiting on the anticipated
results of the market area assessments
required by section 7330C(a) as added
by section 106 of the MISSION Act, and
not before conducting pilot testing as
needed).
Regarding the assertions in comments
that the access standards as proposed by
VA were arbitrary, we reiterate from the
proposed rule that the drive-time
standards were derived from specific
analyses that showed trends of 30-
PO 00000
Frm 00019
Fmt 4701
Sfmt 4700
26295
minute drive times for primary care and
60-minute drive times for specialty care
in TRICARE, State Medicaid plans, State
insurance departments, and commercial
health plans. For instance, TRICARE
Prime (the Department of Defense’s
most comprehensive managed care plan,
uses a 30-minute drive time for primary
care and a 60-minute drive time for
specialty care for non-active duty
beneficiaries. VA also assessed both the
Medicaid Plans and other primary
insurance plans of 14 States, and found
a majority of those States have a 30minute travel time standard for primary
care, and a 60–90-minute travel time
standard for specialty care under State
Medicaid plans and 45–60 minute travel
time standards for other primary State
insurance plans. VA determined that it
would be reasonable to fall in line with
these other network expectations
throughout the industry. VA further
used the results of its access standards
analysis to develop and model several
options using VA’s Enrollee Health Care
Projection Model (EHCPM). VA’s
EHCPM allowed VA to consider best
practices in the industry in its
development of access standards as well
as the financial impact of various access
standard scenarios. After considering
this information from analyses of
similar drive times in other health care
plans as well as from VA’s EHCPM, VA
determined that its access standards
should reflect an average drive timebased criterion that considers the care or
services needed in relation to the
veteran’s residence, which is a similar
approach as TRICARE Prime related to
travel standards (opting to use average
driving time versus mileage). Similarly,
the wait time standards were derived
from research of non-VA network
expectations throughout the industry,
and they fell within the range of
appointment wait-time standards found
in other government organizations, State
programs, and commercial entities (e.g.,
7–28 days for primary care and 15–30
days for specialty care). Further, the
proposed wait-time standards are
achievable in most VA facilities and are
consistent with capabilities identified in
the private sector. On average, VA
national wait times in March 2019 for
new appointments (e.g., the first
appointment in a new episode of care
versus a subsequent appointment in the
continuation of an existing episode of
care) was approximately 20.6 days for
primary care, 10.8 days for mental
health care, and 22.4 days for specialty
care. These wait times have decreased
since the December 2018 reporting
period included in the proposed rule.
The proposed wait-time standard of 20
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26296
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
days for primary care and mental health,
for example, is both in line with other
similar industry standards and is a
manageable goal for access to VA care.
We do not make changes based on these
comments, as we believe VA’s access
standards as proposed were based on
reasoned research and analysis and are
therefore not arbitrary.
Regarding the assertions in comments
that VA should have delayed proposal
of its access standards until more
research or analysis could have been
completed (to include waiting for VA’s
market area assessments and potential
pilot testing to conclude), VA was
unwilling to engage in such delay as we
believe it would have delayed
implementation of access standards well
beyond the statutory deadline of June 6,
2019. Pilot testing is an extensive
process, which would have required the
results of the summary market area
assessments, which themselves were not
completed at the time of publication of
the proposed rule.
We received a few comments that
opposed the access standards generally
because of VA’s designation of nearly all
hospital care, medical services, and
extended care services available under
its medical benefits package. According
to the comments, VA’s designation of so
many services to have an applicable
access standard was contrary to
Congressional intent. According to these
comments, Congress only intended for
VA to designate a few types of care or
services, and a designation of more care
and services creates a risk of decreased
funding of VA’s direct provision of care.
Particularly, one comment stated that
VA’s impact analysis for the proposed
rule indicated that VA will consider the
performance of its facilities on wait time
access standards when making resource
allocation decisions and inquired if
funding or resources would be withheld
from a facility if it did not meet the
designated access standards. We do not
make changes based on these comments.
We acknowledge that VA did consider
during the development process of the
legislation that would become the
MISSION Act that only a limited
number of care or services might
ultimately be designated as having
access standards, VA proposed instead
to designate a majority of the care and
services available under its medical
benefits package. VA’s broader
designation of most care or services
maximizes the choice of covered
veterans and prevents veterans from
having to navigate a bifurcated system
where more limited care and services
would be available under the access
standard eligibility than under any other
eligibility criterion for VCCP.
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
Designation of access standards for a
majority of VA care and services makes
administration of the VCCP simpler for
VA for this same reason and ensures
better coordination of care. VA’s
designation of access standards for a
majority of its care and services,
however, does not force veterans into
the community to receive care. We
reiterate from the discussion at the
beginning of this final rule that section
1703(d)(3), as regulated at § 17.4020(a),
requires that eligible covered veterans
must still elect to receive care and
services through the VCCP. We clarify
that VA’s statement from the impact
analysis for the proposed rule, as
referenced in one of the comments, is
not a statement of intent to withhold
resources or funding per se if a facility
is not meeting access standards. It is a
statement that VA must consider use of
its services when considering allocation
of its resources, which could include
investment into facilities that require
assistance to meet access standards.
Regarding the question of Congressional
intent more specifically, we do not read
any limitation in 38 U.S.C. 1703 or
1703B regarding the number of
designated access standards; these
statutes provide broad authority to the
Secretary to make these determinations
and do not constrain his authority in the
ways described in the comments.
We received comments that opposed
the access standards generally because it
was unclear whether they would be
applied to non-VA providers, with some
comments further requesting that VA
make non-VA provider participation in
VCCP contingent upon compliance with
the same standards VA adopts for its
direct delivery of care and services.
Essentially, these comments asserted
that unless care available under the
VCCP could meet (or exceed) VA’s
access standards, it should not be
accessible to covered veterans because it
would not be providing care that could
be received sooner or closer than VA
could provide. We do not make changes
to § 17.4040 as proposed based on these
comments. We first reiterate from the
section of this final rule that discusses
eligible entities and providers that VA
will endeavor to ensure that community
providers are able to comply with the
applicable access standards established
by VA. Such access standards for nonVA providers, however, will be used to
measure network adequacy to ensure
that covered veterans who elect to
receive care through the VCCP are
generally getting timely care that is near
to their residence. VA will not strictly
apply its access standards to eligible
entities or providers as a factor to
PO 00000
Frm 00020
Fmt 4701
Sfmt 4700
determine their eligibility to furnish
hospital care, medical services, or
extended care services furnished the
VCCP. Although we understand the
rationale offered in the comments that
assert VA should strictly apply its
access standards to non-VA providers,
the concept of access standards for
determining VCCP eligibility is
fundamentally different than the
concept of access to care and services in
the private sector. VA must ensure its
access standards establish a consistent
mechanism to provide the option of
choice in the community to the covered
veteran if VA cannot meet those
standards. In the private sector, access
standards are a mechanism to measure
performance and network capacity, not
eligibility. As we have said before, no
covered veteran eligible to receive
community care is required to seek care
in the community. The veteran could
elect to receive care from VA or could
inquire about seeking care in the
community and change his or her mind
if the community options are not
convenient (in terms of distance or
scheduling availability). As VA gains
more experience with VCCP, we
anticipate our systems will be able to
provide information to veterans and
providers regarding community
locations and wait-times so that
veterans can make informed decisions
that work for them. We also reiterate
from the section of this final rule that
discusses eligible entities and providers
that we agree with a comment that
stated that VA should not apply its
access standards to eligible entities and
providers for purposes of eligibility as
this could amount to preferred
treatment of veteran patients over nonveteran patients and could discourage
eligible entities and providers from
participating in the VCCP.
We received comments that opposed
the access standards generally because
the comments asserted that not having
different (presumably, longer drive time
or wait time) standards for specialized
VA care or for VA’s foundational
services could erode patient volume
necessary to sustain such care and
services at VA, and that VA should take
a more refined approach to
distinguishing access for such services
to ensure the quality of care and veteran
satisfaction is maintained. A related
comment more specifically urged VA to
ensure that care and services to treat
spinal cord injury be excluded from any
designated access standard, to ensure
that such care may only be provided by
VA. We do not make changes based on
these comments.
We reiterate from an earlier
discussion in the purpose and scope
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
section of this final rule that expanding
access to care and services in the
community does not equate with forcing
veterans into the community to receive
care; covered veterans must still elect to
receive care in the community if eligible
under VA’s access standards. We agree
with the comments that it is critical for
VA to maintain focus on all care and
services it directly provides to veterans,
and we reiterate from the proposed rule
that VA will continue to sharpen its
focus on directly providing those
services that are most important to the
coordination and management of a
veteran’s overall medical and health
needs, including continued examination
of whether its designated access
standards should be revised with future
rulemakings to account for specialized
areas of VA expertise.
We received a few comments that
requested clarification of why VA did
not designate a particular access
standard for VA foundational services,
and one comment further seemed to
assert that lack of such designation
meant that these services were not
covered under the VCCP. We do not
make changes based on these comments
but clarify that the designated access
standards cover all forms of hospital
care, medical services, and extended
care services, with the exception of
institutional extended care services (this
exception is discussed further below).
We received one comment that
requested VA either revise § 17.4040 to
add an access standard for institutional
extended care service (e.g. nursing home
care) or provide a more robust rationale
than provided in the proposed rule for
why institutional extended care was not
included within VA’s designated access
standards. We do not make changes
based on this comment but do provide
additional rationale as requested by the
comment. Institutional extended care
such as nursing home care is simply not
apt to be measured in terms of access in
the same manner as other care and
services that, generally speaking, are
more standardized and available in the
community. For example, the law in
each State controls admission factors for
Medicaid-participating nursing homes,
which introduces too many variables to
provide relative comparisons to VA
nursing home admissions. As another
example, Medicaid-participating
nursing home facilities in the
community generally admit patients on
a first-come, first-served basis, and
maintains waiting lists for admission.
When a bed is vacant, facilities consult
the wait list to determine who is next on
the list to be admitted, but it is not an
accurate reflection of when any patient
will be admitted, primarily because
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
many people on the wait list are not yet
in need of nursing home care or they
have been placed in another facility. In
addition, a State’s regulations could
control when a patient may be admitted
under circumstances beyond first-come,
first-served—the most common example
is admission to a nursing home facility
directly from a hospital due to medical
need. People being admitted directly
from a hospital level of care may be seen
as having a greater need before anyone
on a wait list. Some States also have
rules concerning placing only patients
of the same gender together in each
room, or rules permitting admission
preference in cases requiring
intervention by the Department of
Human Services or Adult Protective
Services (or similar agency). We cannot
provide a full survey of all State laws
that may control or influence Medicaidparticipating nursing home facilities in
the community, and it may be that these
nursing homes also create special
admission rules to receive Medicareeligible individuals who are in need of
acute rehabilitation (for instance, for a
stay not to exceed 20 days). We reiterate
that there are many variables for
comparison to admission to VA nursing
home facilities that make assignment of
a designated access standard
impracticable, as it would not reflect
VA’s relative ability or inability to
directly provide nursing home care.
We received one comment that
requested VA revise § 17.4040 to add an
access standard specifically for mental
health care and services that would be
deemed to be needed immediately, as
similar to any access standard that VA
might apply for emergency care or sameday appointments. We do not make
changes based on this comment. We
will discuss more fully in the section of
the rule below that addresses wait times
specifically, but should any care or
service under a wait time access
standard be deemed necessary for a
covered veteran prior to reaching the
ending date of the applicable wait time
standard under § 17.4040(a)(1)(ii) and
(a)(2)(ii), then the best medical interest
eligibility criterion under § 17.4010(a)(5)
would enable a covered veteran to be
seen for such care or services through
the VCCP, assuming criteria under
§ 17.4010(a)(5) were met. We further
note that emergent mental health care is
available from VA on a same-day basis,
and VA’s urgent care benefit under
§ 17.4600 (section 1725A) should also
make some services available on an
expedient basis.
We received one comment that
requested VA clarify the interaction
between the average drive time and wait
time standards, as both § 17.4040(a)(1)(i)
PO 00000
Frm 00021
Fmt 4701
Sfmt 4700
26297
and (a)(2)(i) indicate that the standards
are considered together to determine
whether they are met (these regulatory
clauses indicate that the drive time is
considered as well as the wait time).
The comment more specifically asserted
that the average drive time and wait
time should be independently assessed
(the regulatory clauses should not use
the term and as a connector, but rather
a term such as either), to prevent
scenarios where (in the case of the
primary care standard) a facility that can
provide the care or services may be
more than 30 minutes away, but a
covered veteran would not quality for
VCCP because that facility can offer the
care or services within 20 days. We do
not make changes based on this
comment but do clarify that the average
drive time is an independent qualifier
and the wait time is not. The structure
of the regulatory clauses in
§ 17.4040(a)(1)(i) and (a)(2)(i) qualifies
instances where a VA facility that can
offer the care or services may be within
the average 30 minute driving time (in
the case of the comment’s primary care
example), but still not able to provide
the care within 20 days—in such cases,
a covered veteran would be eligible to
elect to use the VCCP. However, if a VA
facility that can offer the care or services
needed is not within 30 minutes average
drive time (in this example), then the
covered veteran would qualify for VCCP
without any assessment of how long it
would take a facility further away to
provide the needed care or services. The
wait time cannot be an independent
qualifier because there must be a
context within which to apply the wait
time—otherwise, the wait time could be
applied to any VA facility that could
provide the care or services needed
regardless of the average drive time from
the covered veteran’s residence. We
believe that the regulation addresses the
commenters concern: VA must be able
to furnish care within the average drive
time and the wait time standard. If VA
cannot meet both conditions, or in other
words if it fails either condition, the
covered veteran would be eligible to
elect to receive community care.
The proposed rule stated that if VA is
able to furnish a covered veteran with
care or services through telehealth, and
the veteran accepts the use of this
modality for care, VA would determine
that it was able to furnish such care or
services in a manner that complies with
designated access standards. We
received one comment that urged VA to
ensure that the option for the veteran to
have face-to-face care would be
maintained if the veteran did not choose
the telehealth modality. We do not make
E:\FR\FM\05JNR2.SGM
05JNR2
26298
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES2
changes based on this comment. As
stated in the preamble of the proposed
rule, VA will not require a veteran
accept the use of telehealth for the
purpose of meeting VA’s designated
access standards.
Lastly, we received a few comments
that requested clarification of how VA
will apply the access standards for
homeless Veterans without a residence.
We do not make changes based on these
comments but clarify that homeless
veterans may currently provide an
address to VA that is recorded in the
Veterans Health Information Systems
and Technology Architecture; this
address is used for other VHA benefits
and may be applied to veterans seeking
to participate in VCCP as well. For
example, any homeless veteran who is
residing in a place supported by a
Department of Housing and Urban
Development-VA Supportive Housing
voucher can list that address, and any
veteran using one of our communitybased programs like the Homeless Grant
and Per Diem or Health Care for
Homeless Veterans programs can supply
the address of the service provider.
Covered veterans that do not have a
residence may be assessed under other
eligibility criteria in § 17.4010(a)(1)
through (3) and (5) and (6), to receive
care or services through the VCCP.
Average Drive Time Standards
We first address comments similar to
those discussed above regarding the
access standards generally, where
commenters suggested that VA should
apply its average drive time standards to
the locations of eligible entities and
providers from which covered veterans
might elect to receive care through the
VCCP, to ensure such non-VA care
would not be further away from a
veteran’s residence than VA care.
Another comment urged VA to track zip
codes of where non-VA care was
provided through the VCCP, to ensure
care was received at the nearest facility.
We do not make changes based on these
comments. We reiterate from the
discussion above that the access
standards VA will establish for eligible
entities and providers will be used to
monitor network adequacy and will not
be used as a limitation on a covered
veteran’s eligibility to receive care and
services through the VCCP. VA must
ensure its access standards establish a
consistent mechanism to provide the
option of choice in the community to
the covered veteran if the VA cannot
meet those standards. In the private
sector, however, access standards such
as average drive times are a mechanism
to measure performance and network
capacity, not eligibility. We also restate
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
from discussion earlier in this final rule
that VA will use § 17.4030(c)(1) and (3)
to assess whether a non-VA provider is
accessible. By considering the length of
time a veteran would have to wait to
receive hospital care or medical services
from a non-VA entity or provider under
§ 17.4030(c)(1), VA can ensure that
veterans receive care as quickly as
possible. If a veteran selects a non-VA
provider who cannot see the veteran for
several months, VA would probably
determine that provider was
inaccessible, and could then provide the
veteran with other options of non-VA
providers to potentially schedule an
appointment sooner. By considering the
distance between the covered veteran’s
residence and the non-VA provider
under § 17.4030(c)(3), VA can ensure
that veterans receive care closer to their
residence. If a veteran resides in New
York and selects a provider in California
(to receive care in California when they
otherwise would not be residing in
California at the time of the
appointment), VA would probably
determine that provider was
inaccessible, and could then provide the
veteran with other options of non-VA
providers that would be closer to their
residence at the expected time of the
appointment. In either scenario
(distance or time for an appointment),
VA’s decision regarding accessibility is
not pre-determined; these will be caseby-case decisions.
We received some comments that
asserted VA should not use an average
drive time standard but instead should
continue to use a mileage-based
distance standard, with certain of the
comments additionally calling for new
mileage standards (one comment
advocated a new standard of 20 miles
for vision-related care or services
specifically, while other comments
advocated new standards of 30 or 35
miles without specifying particular care
or services). We do not make changes
based on these comments. We reiterate
from the proposed rule that a mileagebased access standard can be a poor
indicator of actual conditions that affect
travel to receive care and services, as
such a standard does not recognize the
inherent variation of driving speeds in
rural versus urban areas (as traffic levels
and speed limits typically allow rural
residents to travel farther, faster than
urban residents). Also, covered veterans
may benefit from a drive-time standard
as opposed to a mileage-based standard,
such as the case with veterans in
mountainous areas where it can take
significantly longer than 30 minutes (or
even 60 minutes) to travel 40 miles. We
believe that use of an average drive-time
PO 00000
Frm 00022
Fmt 4701
Sfmt 4700
criterion versus a mileage standard will
provide a more consistent and equitable
standard of access for all covered
veterans.
We received other comments that
urged VA to adopt different average
drive time standards than the 30
minutes and 60 minutes in
§ 17.4040(a)(1)(i) and (a)(2)(i) as
proposed, respectively. Multiple
comments advocated for an average
drive time standard of 40 minutes for
specialty care, 30 minutes for all
services, 60 minutes for all services, or
that the standards in § 17.4040(a)(1)(i)
and (a)(2)(i) should be flipped, where 60
minutes would apply to primary care
and mental health and 30 minutes
would apply to specialty care.
Particularly, the comments that
advocated flipping the 30-minute and
60-minute average drive time standards
stated that specialty care is arguably
more urgently needed than primary
care, or that travel to receive specialty
care is more burdensome, and therefore
the lesser timeframe of 30 minutes
should be applicable to specialty care.
We do not make changes to
§ 17.4040(a)(1)(i) or (a)(2)(i) based on
these comments.
We reiterate from the proposed rule
and the expanded discussion earlier in
this final rule that the average drivetime standards are derived from specific
analyses that showed trends of 30minute drive times for primary care and
60-minute drive times for specialty care
in TRICARE, State Medicaid plans, State
insurance departments, and commercial
health plans. We further clarify that the
different drive-time standards for
primary care versus specialty care
particularly are not intended to reflect
the relative importance of one type of
care versus the other, but rather the
relative availability of one type of care
versus the other, as specialty care tends
to be generally less available than
primary care and therefore requires
longer travel times to reach on average.
Nearly all individuals in a geographic
area require primary care at some point,
typically several times per year. But
only a subset of these same individuals
may require specialty care, and not
likely with the same frequency. We
believe distribution of health care
resources follows the basic premise
outlined above, to result in specialty
care generally being less widely
geographically dispersed, particularly
considering that such specialty services
often require specialized facilities and
equipment that are difficult and costly
to replicate. For these reasons, we
believe it is widely understood that
patients often times will need to travel
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
a bit farther for specialty care than
primary care.
We received multiple comments
related to how VA will calculate average
drive times under § 17.4040(b) as
proposed. Many of these comments
asserted that there were too many
variables related to actual drive time
(e.g., road or weather conditions,
congestion or traffic) for VA’s
calculations to be accurate if it used a
strict average of drive times throughout
a day (or week, or other defined
timeframe) versus using a predictive
system that is related to the time of
appointment. While some of these
comments urged VA to adopt new
definitions or clarifications to assist
with calculating average drive times
(e.g., defining the term hazardous
weather in § 17.4010(a)(5)(vii)(A)), other
comments suggested that, without
disclosing proprietary information
related to the geographic system
software VA will use, VA’s calculations
should consider how factors change
throughout a day, particularly traffic
patterns. More specifically, a few
comments urged that any drive time
calculation VA uses must consider peak
drive times to account for routine spikes
in traffic. We do not make changes to
§ 17.4040(b) as proposed based on these
comments. We believe that it is more
veteran-centric to maintain the
operational flexibility to refine and
improve VA’s calculations in response
to experience, feedback, and changing
real-world conditions, rather than to
detail in regulation a specific
methodology or considerations that
could constrain VA’s ability to improve
the calculation of average drive time in
the future.
We first note that further definition of
terms in § 17.4010(a)(5)(vii)(A), as
requested in one comment, does not
have any bearing on eligibility
determinations under § 17.4040(b) as
proposed (we also believe that terms to
characterize an unusual or excessive
burden in § 17.4010(a)(5)(vii)(A) are
sufficient as proposed). We address the
comments that requested clarification
on how VA will calculate average drive
times with other comments regarding
VA’s administration of its community
care programs in the portion of this final
rule that discusses miscellaneous
comments.
We received some comments that
requested VA consider use of nonpersonal vehicles (e.g., public transit)
when calculating applicable average
drive times. We do not make changes
based on these comments. We reiterate
from the proposed rule that calculating
average drive time based on the use of
a personal vehicle applies to many of
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
the veterans we serve, and that it would
be too difficult and potentially costly to
consistently implement and
operationalize a system that considers
the variety of transportation options
potentially available to an individual
veteran. In major metropolitan areas, a
veteran could travel by personal car,
bus, or rail, and each of these would
have different travel times.
Wait Time Standards
We first address comments that
opposed the 20-day or 28-day wait time
standards based on the timeframes
themselves. Some comments stated that
these timeframes were too long for
covered veterans to wait to be seen
when they may have conditions or
concerns requiring more immediate
attention, with a few comments further
urging VA to adopt different standards
(for instance, 14 days or less for all
services, 20 days for all services, or 14
days for primary care and 20 days for
specialty care). Other related comments
asserted that the wait time standards in
§ 17.4040(a)(1)(ii) and (a)(2)(ii) should
be flipped, where 28 days would apply
to primary care and mental health and
20 days would apply to specialty care,
because specialty care is arguably more
urgently needed than primary care. We
do not make changes based on these
comments. To address the concern that
20 or 28 days as applicable is too long
to wait to address more immediate
health care needs, we clarify that these
are timeframes by which VA can assess
whether it can provide care and services
under normal and not urgent or
emergent circumstances. Should any
care or service with an applicable wait
time be deemed necessary for a covered
veteran prior to reaching the ending
date of such wait time standard, then
the best medical interest eligibility
criterion under § 17.4010(a)(5) might
enable a covered veteran to be seen for
such care or services through the VCCP
(assuming criteria under § 17.4010(a)(5)
were met). To address the comments
concerning the 20-day and 28-day wait
times being flipped, we reiterate from
the section above that access standards
for primary care versus specialty care
are not intended to reflect the relative
importance of one type of care versus
the other, but rather the relative
availability of one type of care versus
the other, as specialty tends to be
generally less available than primary
care and therefore can requires longer
wait times on average.
The preamble of the proposed rule
introduced the concept that VA
preliminarily had established a goal of
reducing the wait times for primary care
and mental health services from 20 days
PO 00000
Frm 00023
Fmt 4701
Sfmt 4700
26299
in § 17.4040(a)(1)(ii) as proposed to 14
days no sooner than June 2020.
Although this reduction from 20 days to
14 days was not put forth in proposed
regulation text, we invited and received
comments on this issue, the vast
majority of which recommended that
VA should not wait until 2020 to reduce
such wait times to 14 days. Conversely,
we received a few comments that VA
should not reduce the primary care or
mental health wait times to 14 days
prematurely, and that VA should focus
on meeting the 20-day standard first.
More specifically, one comment
asserted that VA should wait for the
results of VA’s market area assessments
to drive any potential future reductions
in wait times. We do not make changes
based on these comments, but reiterate
from the proposed rule that presently, a
14-day wait-time standard would be
difficult for VA to implement due to the
current availability of providers and
variability in appointment wait-times
across VA facilities. However, VA will
pursue additional rulemaking should
we proceed with the goal to reduce the
primary care and mental health wait
time standards from 20 days to 14 days.
We received comments that did not
necessarily oppose the wait-time access
standards, but that requested
clarification of how VA would
determine whether care was primary
care, specialty care, or mental health
care. Some related comments more
specifically asserted that certain care
should fall within the 20-day standard
for primary care, for instance, most
women’s health care services, physical
therapy, and traumatic brain injury.
Another comment advocated that
certain case management services
associated with assisting homeless
veterans should be considered specialty
care. We do not make changes based on
these comments. We believe in a
majority of cases that it will be clear
what standard should be applied to
what care. Because we believe these
comments are primarily concerned that
certain services will not be given the
benefit of relatively shorter wait times,
we reiterate that if care is determined to
be needed prior to reaching the ending
date of an applicable wait time, then the
best medical interest eligibility criterion
under § 17.4010(a)(5) would enable a
covered veteran to be seen for such care
or services through the VCCP (assuming
criteria under § 17.4010(a)(5) were met).
We further advise that VA is
experienced in determining whether
care is primary care or specialty care, as
VA uses this distinction to assess
copayments under § 17.108.
We received one comment that
requested VA revise § 17.4040(a)(1)(ii)
E:\FR\FM\05JNR2.SGM
05JNR2
26300
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
and (a)(2)(ii) to establish that the start
date to begin counting any applicable
wait time should be the date that the
services are clinically indicated to be
needed, and not the date of request for
an appointment. We do not make
changes based on this comment. By
shifting the start of the wait time
standard under the VCCP from the
clinically indicated date to the date of
request, VA can optimize consistency in
decisions of eligibility that employ the
wait time access standard. Consistency
in decisions regarding eligibility is
desirable because it assists VA to
accurately forecast the use of VCCP
under this standard, and because it
supports parity in eligibility
determinations to support a sense of
fairness in veteran experience in using
the VCCP. Additionally, the option for
the covered veteran to choose a later
date in consultation with a provider still
permits for the wait time standards to be
counted starting on a date that is later
than the date of request, which could
encompass a starting date when the
services would be considered clinically
indicated.
jbell on DSK3GLQ082PROD with RULES2
Miscellaneous Comments
We received many comments that did
not directly relate to any regulatory
sections from the proposed rule, but that
expressed concerns with VA’s
administration of its community care
programs and further suggested
improvements. Although we do not
make changes to the proposed rule
based on these comments because they
are beyond the scope of the proposed
rule or address issues that would best be
handled through policy or contracting
mechanisms, we summarize the
comments below by grouping them by
topic and indicate where we provide
clarifications.
Transition From the Veterans Choice
Program
We received comments related to
VA’s transition from the Veterans
Choice Program (Choice) to the Veterans
Community Care Program (VCCP),
which primarily requested clarification
of administrative issues related to VA’s
contracting efforts to ensure that there
was a smooth transition to the VCCP.
The largest administrative issue raised
in comments was how VA would
mitigate gaps in coverage in
transitioning to the VCCP, where
specific requests for clarifications
included: Whether VA anticipated
delays in implementation due to any
contract protests; whether the same
services offered under Choice contracts
would be offered under VCCP contracts
(and more specifically, Veterans Care
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
Agreements); whether providers under
Choice provider agreements would be
grandfathered into VCCP contracts or
agreements (essentially asking whether
Choice providers would be considered
VCCP providers automatically until
VCCP contracts can be finalized); and
whether VA would issue guidance on
transition from Choice to VCCP, to
include more information on ‘‘other
arrangements’’ under which care can be
provided. VA has modified one of its
community care contracts that provided
coverage under the Veterans Choice
Program to engage the same third-party
administrator (TPA) (TriWest
Healthcare Alliance) to provide for
expanded nationwide coverage for the
VCCP until VA’s Community Care
Network (CCN) contracts have
established a fully functional network of
providers. We believe this nationwide
engagement of the same TPA from the
Veterans Choice Program to administer
the VCCP, until the CCN contracts are
in place and the networks required by
those contracts are fully operational,
will allay many concerns regarding
transition to the VCCP, as the
administrative procedures should be
familiar to those providers that
participated under the Veterans Choice
Program.
A related comment asserted that VA
should standardize its contracts and
contracting processes nationally, to
avoid what the comment asserted was
regional variation in contracts and
contracting processes that are present in
other non-VCCP community care
programs. This comment also urged VA
to make such contracts formed under
section 1703(h) publicly available, and
that any rules contained in such
contracts that seek to control the actions
of eligible entities and providers should
be developed by notice-and-comment
rulemaking so that stakeholders (that are
not the entities or providers) can
provide input on the impact of such
rules on entities or providers. We do not
make any changes based on these
comments. Any VA decisions regarding
contracting processes and
standardization are implemented
through separate processes and actions,
potentially including policies and
acquisition regulations. Separately,
contracts within the meaning of section
1703(h), and solicitations leading to
such contracts, are and will be subject
to the existing, comprehensive legal
framework governing public disclosure
of information relating to such
procurements and contracts. Any VA
decisions regarding public disclosures
of information relating to such
procurements and contracts will be
PO 00000
Frm 00024
Fmt 4701
Sfmt 4700
made in accordance with those laws.
Finally, VA does not commit to
establishing all contractual
requirements through notice-andcomment rulemaking, and does not
commit to establishing only national
contracts. Such commitments are
incompatible with the legal and
operational framework of Federal
procurement, including the flexibility,
discretion, and independence that are
often integral to the process of defining
requirements.
Veterans Need More Information To
Inform Their Election To Receive Care
Through the VCCP
We received comments that indicated
VA was not providing enough
information to veterans to enable them
to make informed choices of whether to
elect to receive community care. These
comments primarily stated that
comparisons between VA care and
community care were not apparent at
the point veterans might elect to receive
community care, and that veterans
needed access to more timely
comparisons between: VA and non-VA
wait times; distances from a veteran’s
residences to VA and non-VA providers;
and relative competency of VA and nonVA providers (particularly, for care to
treat conditions such as posttraumatic
stress disorder and traumatic brain
injury). Some of these comments
suggested specific improvements (such
as ensuring non-VA provider directories
are updated and available to veterans),
where other comments requested VA
clarify how relevant comparative
information will be provided to veterans
to elect to receive community care as
required by section 1703B(b). VA
understands the desire for more
information so covered veterans can
make informed choices regarding
providers. VA has included community
provider information in the VA facility
locator on www.va.gov that shows both
VA and community providers. This will
allow covered veterans to see the
locations of specific community
providers in relation to VA providers.
As VA begins to implement the new
CCN contracts, appointment availability
timeframes will also be available for the
VA to share with covered veterans to
assist them in making a decision on
providers.
Implementation of VA’s Average Drive
Time Standard
VA received comments that requested
clarification on how VA will calculate
average drive times. We note that some
detailed information regarding average
drive time calculations and algorithms
is proprietary. At a general level, VA’s
E:\FR\FM\05JNR2.SGM
05JNR2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES2
calculation of average drive times
between the veteran’s residence and an
applicable VA facility will take into
consideration a variety of factors,
including: Distance, route options, and
speed limits. In its current
configuration, VA’s geographic
information system tool bases these
calculations on historical data, rather
than real-time traffic information. As
VA gains more experience with VCCP
and receives feedback from veterans
regarding their experiences with the
program, we anticipate refining this tool
and our systems to improve our
consideration of actual conditions that
affect travel to receive care and services
and to provide more information to
veterans regarding calculation of
average drive times.
We received a comment that urged
VA to publish a report every six months
regarding the outcome of VA using an
average drive time standard versus a
mileage standard, to include a total
number of individuals qualifying under
the average drive time standards. We do
not make changes to the regulation
based on this comment, and do not
commit to publishing such a report,
although we note that VA will monitor
use of the VCCP care and services by
covered veterans, to include use that
qualifies under the designated access
standards. VA will report regularly to
Congress on utilization of the VCCP, as
required by section 1703(m).
Claims Adjudication and Payments
We received comments related to
administrative procedures for VA’s
processing of claims for payments for
hospital care, medical services, or
extended care services furnished
through the VCCP. These comments
essentially stated that claims and
payment procedures need to be clear
and minimally burdensome and that VA
must ensure it applies the prompt
payment provisions that are required
under section 1703D to ensure providers
are paid on timely (particularly, as
noted by one comment, to include
provisions that cover interest on
overdue claims). Some of these
comments further urged VA to confirm
its plans to publish future regulations to
implement the prompt payment
provisions in section 1703D, with some
requests that VA provide a more specific
timeframe in which it expects to
promulgate such regulations. Another
comment urged that VA should consider
establishing a maximum timeframe to
pay electronic claims within 14 days,
and to pay paper claims within 30 days,
when VA does promulgate regulations
to implement section 1703D. Lastly,
multiple comments generally asserted
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
that appeals procedures for adjudication
of claims or payment-related disputes
should be comprehensive and timely.
We first confirm that VA will be
undertaking future rulemaking to
implement the prompt pay provisions of
section 1703D, which will include
provisions to implement the
requirements under section 1703D (such
as establishing timeframes in which to
pay clean electronic and clean paper
claims, addressing interest on overdue
claims, and appeals procedures). We
cannot provide an exact timeframe in
which VA can expect such regulations
to be promulgated, and we will not
discuss specifics here of any policy
development regarding such
regulations, although we generally note
that two-stage rulemaking can typically
require 18–24 months to complete. We
received some related comments
regarding claims and payments
processing that asserted the
compensation options for eligible
entities or providers are difficult to
understand and that providers are not
paid timely as a result, but these
comments urged VA to publish a
comprehensive policy for eligible
entities and providers to resolve
misunderstandings. We clarify that the
compensation options are part of the
contract between VA and the TPA. VA
will work with the TPAs to ensure they
have appropriate information regarding
claims submission and processing that
will assist in preventing untimely
payments. Section 122 of the MISSION
Act requires VA to develop and
implement a training program for
employees and contractors on how to
administer non-Department health care
programs. As required by section 122 of
the VA MISSION Act, VA is providing
training to the TPAs regarding
administrative processes.
One comment indicated that on July
31, 2018, the Centers for Medicare and
Medicaid Services (CMS) published the
Prospective Payment System (PPS) and
Consolidated Billing for Skilled Nursing
Facilities (SNF) Final Rule for Fiscal
Year (FY) 2019. The comment further
noted that in this rule, CMS finalized a
proposal to replace the current Skilled
Nursing Facility Prospective Payment
System Resource Utilization Group
(RUGs) payment model with a new perdiem payment system called the PatientDriven Payment Model (PDPM)
beginning on October 1, 2019. This
comment ultimately urged that CMS
and VA communicate how the PDPM
reimbursement structures and VA’s
reimbursement structures will work
together. Because reimbursement is
included in the contracts with the TPAs,
VA will ensure that the payment
PO 00000
Frm 00025
Fmt 4701
Sfmt 4700
26301
methodology used is clearly explained
to the contractors so that eligible entities
and providers understand how VA’s
benchmark of using applicable Medicare
rates may shift with the publication or
annual or major Medicare rate shifts.
Improve Procedures and Practices of
VA’s Third-Party Administrators
We received many comments that
identified both general and specific
administrative improvements that could
be made by the third-party
administrators (TPA) with whom VA
contracts to generally administer the
VCCP. Most of these comments
identified the desired administrative
improvements by providing examples of
TPA deficiencies as experienced under
Choice, but we address these comments
here in relation to the VCCP. The most
general concerns expressed in these
comments related to a lack of
timeliness, accuracy, and follow-up
regarding TPA practices in referring and
scheduling care in the community.
These comments generally urged that
improvements were needed to
streamline scheduling, where specific
suggestions to achieve improvements
ranged from simplifying
communications systems (e.g.,
consolidating various call center
numbers to create a one-call/one-stop
experience for covered veterans to
interact with TPAs) to creating more
comprehensive guidance on how TPAs
obtain timely eligibility determinations
and authorizations from VA. VA is
generally responsible for scheduling
appointments for veterans in most
markets and will work with its TPAs to
improve administrative processes to
assist in streamlining scheduling in
other cases, particularly where VA can
improve its processes to verify
eligibility and communicate
authorizations of care.
Other comments indicated a need for
clearer policies and processes to ensure
that non-VA providers and covered
veterans understand what care is and is
not authorized, and a few comments
deemed that VA’s review of
authorizations for care were not timely
or consistent. One comment further
urged VA to adopt a more robust and
transparent process to ensure each
authorization for care includes: A
binding determination regarding the
scope of issues that might be raised for
coverage and payment purposes; a plan
to transfer a covered veteran back to VA
after conclusion of the treatment
authorized; prompt decisions to grant or
deny authorizations; and a statement
that clarifies non-VA providers will
receive payment for services provided
due to error on VA’s part or on the
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26302
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
covered veteran’s part. Much of what is
specifically raised by this comment is
contemplated in the contracts VA forms
with TPAs or directly with eligible
entities and providers to furnish care
and services through the VCCP, and VA
will work to improve consistency in its
authorization processes. Related
comments urged VA to develop
guidance to address oversight of its
TPAs that would include metrics to
measure effective communications
between the TPAs and eligible entities
or providers, and a process for such
entities or providers to contact VA for
dispute resolution regarding TPA
performance. We similarly respond that
much of what these comments raise is
contemplated in the contracts VA forms
with eligible entities and providers, and
VA will work to ensure appropriate
monitoring of TPAs as identified in the
contract.
We received some comments related
to VA’s processes in credentialing nonVA entities or providers to find them
eligible to furnish care and services
through the VCCP. Specifically, these
comments urged VA to reduce potential
duplication of credentialing processes
between VA and the TPAs with whom
VA contracts to administer community
care. One comment further urged VA to
maintain its recognition of a current
administrative process adopted by some
non-VA hospitals (particularly,
academic medical centers) to have the
TPA delegate provider credentialing to
the non-VA hospital, where such
hospital agrees to meet the credentialing
requirements through their own inhouse process and be audited as
necessary. We clarify that the
credentialing process to determine
whether non-VA entities or providers
are eligible to participate in the VCCP
will be conducted by the TPAs with
whom VA contracts and not by VA, so
we do not believe there is cause to be
concerned about duplicative
credentialing processes. For this same
reason, VA cannot respond to clarify
how a TPA’s credentialing processes
may be conducted, but VA would
support any TPA processes to continue
or establish credentialing that reduces
delays, so long as VA’s credentialing
requirements are met.
Some comments urged improvements
to administrative processes for
particular groups of covered veterans.
For instance, with regard to pregnant
veterans and veterans in need of
maternity care, one comment urged VA
to: Establish a more streamlined process
for prior authorizations for pregnant
veterans (to include priority access to
treatment of substance use disorder);
require authorization by VA of required
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
episodes of care no more than seven
days after pregnancy is diagnosed; make
Maternity Care Coordinators (MCC) a
full-time position in VA facilities as
needed; and ensure that pregnant
veterans receiving non-VA care are put
in contact with MCCs to assist
navigating non-VA care. One
commenter urged VA to require eligible
entities and providers in the community
to use VA’s universal housing instability
screener to ensure that homeless
veterans who may elect to receive care
in the community are aware of VA’s
homeless assistance programs. We
appreciate these comments and agree it
is important to maintain awareness if
certain veteran populations may require
particular VA assistance to navigate
community care or assistance to access
VA resources that do not necessarily
pertain to healthcare matters. VA will
ensure it maintains its focus to assist in
care coordination for all veterans who
elect to receive care in the community.
Lastly, we received a few comments
that stated that VA should not use TPAs
generally, as this creates an unnecessary
layer of administrative bureaucracy. A
few comments indicated more
specifically that VA should not use a
specific TPA with which it has
previously contracted to provide care in
the community, and instead should use
veteran contractors. Currently, VA’s
utilization of TPAs to perform certain
functions is important to ensuring VA
optimizes its provision of care in the
community. For instance, use of a TPA
provides VA an accredited network of
providers as well as claims processing
that is standardized in the health care
industry, which are two areas that VA
does not have the required
infrastructure or expertise to administer
directly at this time. With regard to the
comments that VA should not use a
specific TPA and should use veteran
contractors instead, we note that VA is
subject to, and abides by, the
comprehensive set of laws governing
Federal procurement. Those laws do not
permit indiscriminate awarding of
contracts to groups of individuals, as we
believe is suggested by the commenter.
Information Technology and
Information Sharing
We received multiple comments that
expressed concerns regarding VA’s
information technology (IT)
infrastructure and capabilities to enable
the level of information sharing required
to ensure smooth administration of the
VCCP. The general thrust of these
comments asserted that VA’s IT
systems, particularly its electronic
medical record system, required
improvements to ensure the timely and
PO 00000
Frm 00026
Fmt 4701
Sfmt 4700
seamless exchange of clinical
information between VA and non-VA
sources. More specifically, some
commenters urged VA to acquire and
use a single electronic system that
would be accessible 24 hours a day/7
days a week by non-VA entities and
providers, and that could be integrated
with VA’s electronic medical record to
assist with confirming VCCP eligibility
and otherwise to communicate all
clinical and administrative information
necessary to participate in VCCP (e.g.
eligible entities and providers would
submit and receive referrals or
authorizations, medical records, claims
forms, etc.). Other comments further
urged VA, whether it would adopt new
IT systems or modify its existing
systems, to allow non-VA providers
(specifically the large academic medical
centers and faculty practice plans) to
designate multiple staff members who
would have access to those systems. We
clarify that VA has been steadily
working on improvements for sharing of
medical information. VA participates in
standardized health information
exchanges in the health care industry,
and this summer is deploying a
commercial referral management
system, Healthshare Referral Manager,
which will be used to share
authorizations with community
providers and exchange medical
information. VA has already deployed
community viewer, which allows
community providers secure, web-based
access to medical information and
VirtruPro, which allows secure,
encrypted email exchange between the
VA and community providers. VA also
encourages all providers to submit
claims electronically using industry
standard transactions to ensure prompt
payment of claims.
We received one comment that urged
VA to modernize its IT systems as an
attempt to move away from the
administration of paper claims and
eventually require the submission of
electronic claims. VA will consider
addressing the submission of paper
claims and electronic claims in any
future rulemaking to implement the
prompt payment provisions of section
1703D. VA is also undertaking efforts to
modernize its IT systems for claims
processing. As noted above, VA
encourages all providers to submit
claims electronically using industrystandard transactions. VA is
additionally deploying an industrystandard claims processing system this
year that includes auto-adjudication and
will improve timeliness of claims
processing.
We received one comment that
expressed concerns that VA’s decision
E:\FR\FM\05JNR2.SGM
05JNR2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES2
support tool to determine whether a
covered veteran was eligible to
participate in VCCP (particularly with
regard to eligibility based on VA’s
designated access standards), will not be
ready for timely implementation on
June 6, 2019. VA expects the tool will
be ready by June 6, 2019. This tool will
assist with eligibility determinations by
displaying, documenting, and storing
relevant information related to
eligibility determinations in a
standardized and reportable manner. In
the event that the tool was not at full
functionality for any reason, VA can
also look to other systems to gather and
assess information related to eligibility
(such as VA’s Computerized Patient
Record System) as a contingency.
Emergency Care
We received comments related to the
administrative practices of VA in
reviewing and approving emergency
care. These comments generally relayed
concerns that covered veterans were
unduly subject to cost liabilities for
emergency treatment because the
administrative requirements VA
imposes were unclear or inefficient and
lead to VA failing to approve or pay for
the emergency care in a timely manner.
These comments suggested multiple
improvements, primarily comprised of
requests for VA to: Increase education
for providers and covered veterans (to
ensure the nearest VA facility is well
known for purposes of the 72-hour
notification, who is the appropriate VA
official at that facility to receive the
notice, etc.); and establish a single,
nationwide system (such as an online
portal and national call center) where
all emergency care matters under the
VCCP would be administered. The
administrative rules in place regarding
notice to the nearest local VA facility
are required to ensure that emergency
care can be authorized and claims can
be considered under all available
authorities for emergency care. The
local facility is in the best position (and
in many ways, the only position) to
actually assess criteria related to the
appropriateness of authorizing
emergency care (for instance, whether a
patient could be transferred to a nearby
VA facility). VA will work to improve
education and messaging to non-VA
providers and veterans concerning how
and where to submit timely notice of
use of emergency care to assist with
timely approvals.
Prescriptions
We received comments regarding
VA’s administrative practices in
reviewing and approving prescriptions
issued by non-VA providers. These
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
comments primarily voiced concerns
that VA’s practices were unnecessary or
unduly burdensome and either created
delays in getting prescriptions filled, or
created unnecessary administrative
costs for VA. Some comments further
suggested alternatives to VA’s current
practice of VA providers reviewing and
approving prescriptions from non-VA
providers, such as allowing non-VA
providers to fill prescriptions directly
with VA pharmacies through the TPA
that VA utilizes to administer its
community care programs. VA’s current
practices of reviewing and approving
prescriptions issued by non-VA
providers are in place to ensure
appropriate prescription monitoring,
care coordination, and cost and quality
controls. VA does not believe that this
review creates unnecessary
administrative costs for VA, but VA can
work to improve its internal review and
approval processes to reduce or
eliminate delays in getting non-VA
prescriptions filled.
Eligible Entities and Providers
We received comments related to
VA’s practices in disseminating
information to non-VA providers who
could potentially participate in VCCP,
for the purpose of maintaining and
increasing provider participation. These
comments generally called for
improvements in VA’s communicating
such information to providers and
suggested improvements ranged from
offering a webinar specifically on the
implementation of contracts or
agreements (particularly for Veterans
Care Agreements authorized under
section 1703A and §§ 17.4100 through
17.4135), to developing or improving
policies related to approving providers
to participate in the VCCP. VA will
examine its current outreach and
education efforts in maintaining and
increasing (as needed) provider
participation in the VCCP and will be
open to all options of communicating
with non-VA providers to ensure that
provider requirements to participate in
the VCCP are well understood.
We received one comment that urged
VA to clarify whether non-VA providers
who would furnish care and services
under the VCCP are considered Federal
contractors or subcontractors to be
subject to Federal contractor
requirements, including, but not limited
to Executive Order 11246, as amended,
Section 503 of the Rehabilitation Act of
1973, as amended, the Vietnam Era
Veterans’ Readjustment Assistance Act
of 1974, as amended, and the
McNamara-O’Hara Service Contract Act
of 1965, as amended, and any other
Federal contractor obligations, such as
PO 00000
Frm 00027
Fmt 4701
Sfmt 4700
26303
those related to Federal minimum wage
and sick leave. This comment urged that
non-VA providers participating in the
VCCP should not be considered Federal
contractors or subcontractors to avoid
application of Federal contractor
obligations imposed under the
jurisdiction of the Department of Labor’s
Office of Federal Contract Compliance
Programs (OFCCP). We clarify that
section 107 of the MISSION Act states
that Directive 2014–01 of the Office of
Federal Contract Compliance Programs
(OFCCP) of the Department of Labor
(effective as of May 7, 2014) applies to
any entity entering into an agreement
under section 1703A or section 1745 of
title 38 in the same manner as such
Directive applies to subcontractors
under the TRICARE program for the
duration of the moratorium established
by that Directive. VA has consulted with
the Department of Labor regarding this
provision, and we understand that
OFFCP intended, through a Directive
2018–02, to extend the moratorium from
OFCCP’s jurisdiction concerning
Executive Order 11246, section 503 of
the Rehabilitation Act, and the Vietnam
Era Veterans’ Readjustment Assistance
Act to cover health care providers in all
VA programs under which VA has
statutory authority to provide care to
veterans by contracting with private,
non-VA providers. Specifically, we
understand OFCCP to consider the
following categories of providers to be
within the scope of the 2018 Directive’s
moratorium: Independent contractors
operating in VA facilities, contract
community-based outpatient clinics,
and providers who are part of a network
and furnishing services pursuant to a
contract between VA and the network
administrator, contracts and agreements
directly between VA and providers (i.e.,
Federal Acquisition Regulation (FAR)based contracts subject to all
procurement laws, Choice provider
agreements, Veterans Care Agreements,
and agreements with State Veterans
Homes). We further note that the
Department of Labor is working to
establish the Directive’s moratorium
through a regulation, and we appreciate
their efforts in that effort.
Congressional Review Act
The Secretary of Veterans Affairs
finds that there is good cause under the
provisions of 5 U.S.C. 808(2) to make
the rule effective on June 6, 2019.
Specifically, the Secretary finds that it
would be contrary to the public interest
to delay the date this rule could be
operative and effective because any
delay in implementing the rule would
have a severe detrimental impact on
veterans’ health care.
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26304
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
Section 143 of the MISSION Act of
2018 amended section 101(p) of the
Veterans Access, Choice, and
Accountability Act of 2014 (Pub. L.
113–146; 38 U.S.C. 1701 note, as
amended, hereafter referred to as the
Choice Act) to state that VA may not use
the Choice Act to furnish care and
service after June 6, 2019. As a result,
on that date, VA will no longer be able
to use the Veterans Choice Program to
furnish care or services in the
community. Section 101 of the
MISSION Act will amend 38 U.S.C.
1703 to permit VA to administer a new
Veterans Community Care Program,
which will replace the Veterans Choice
Program. However, section 1703 will
not be so amended until VA
promulgates regulations under section
101(c) of the VA MISSION Act of 2018
by its own terms, which is the function
of this final rule. Therefore, if this final
rule is not effective on June 6, 2019, VA
would not have the Choice Act
authority or the MISSION Act authority
under which to administer care in the
community; the only authority VA
would have to administer such care
would section 1703 as it exists
unamended by the MISSION Act.
The provisions of section 1703 as
unamended by the MISSION Act, as
well as its implementing regulations at
38 CFR 17.52, do not provide a
sufficient legal basis to meet the
requirements of section 101 of the
MISSION Act in areas such as
eligibility, appeals, and payment rates,
nor do they provide for the same levels
of community care that have been
received by veterans under the Veterans
Choice Program through June 6, 2019.
If this final rule to implement the new
Veterans Community Care Program, and
to replace Veterans Choice Program, is
not effective on June 6, 2019, the
approximately 2 million veterans who
have received care under the Veterans
Choice Program (for over 46 million
appointments since inception) will be
forced to find alternative pathways to
care. These veterans will either be: (1)
Absorbed by existing VA facilities, (2)
sent out into the community under VA’s
more limited section 1703 authority, or
(3) might forego care all together. As
indicated below, all of these pathways
would result in delays in care, lack of
continuity in care, and absence of care
that would be significantly detrimental
to veteran’s health.
Absorbing the Veterans Choice
Program’s share of care for 2 million
veterans into existing VA facilities
would significantly strain VA’s
resources and cause problems impacting
veterans’ health. It would interrupt
continuity of care, pose significant
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
delays for scheduling care, and would
lead to long wait times. The VA system
is simply not capable of accommodating
this amount of care without causing
delays in access to care.
Some care, therefore, would need to
remain in the community. But with
neither the Veterans Choice Program nor
the new Veterans Community Care
Program in place, VA would have no
universally applicable eligibility criteria
for community care. Without such
national, clear, and consistent criteria in
place, individual VA facilities or VA
Health Care Systems may adopt local
criteria that do not support standardized
decisions regarding when veterans may
be eligible to receive VA community
care, and VA could return to the same
non-standardized community care
environment that led to the wait-time
issues in 2014, such as when access
barriers adversely affected the quality of
primary and specialty care at the
Phoenix VA Health Care System. After
the wait-time issues of the Phoenix VA
Health Care System were made public,
VA’s Office of Inspector General
examined the electronic health records
and other information from more than
3,000 veteran patients and identified 28
instances of clinically significant delays
in care associated with access to care or
patient scheduling. The Office of the
Inspector General (OIG) found that the
majority of the veteran patients
reviewed were on official or unofficial
wait lists and experienced delays
accessing primary care—in some cases,
pressing clinical issues required
specialty care, which some patients
were already receiving through VA or
non-VA providers. OIG further found
that some veterans on unofficial wait
lists were at risk of never obtaining their
requested or necessary appointments.
As OIG stated, inappropriate scheduling
practices were a nationwide systemic
problem. OIG identified multiple types
of scheduling practices in use that did
not comply with VHA’s scheduling
policy. We believe these deviations from
scheduling policy were due in part to
limited and inconsistently applied
criteria by which veterans may receive
community care.
By way of example, section 1703 as
unamended by the MISSION Act
provides VA authority to contract for
hospital care and medical services when
VA facilities are not capable of
furnishing economical care due to
geographic inaccessibility or are not
capable of furnishing care. However, our
implementing regulations at 38 CFR
17.52 generally establish eligibility
criteria based on type of care needed
and whether or not the veteran is
service-connected, and do not provide
PO 00000
Frm 00028
Fmt 4701
Sfmt 4700
additional clarity on what geographic
inaccessibility means. Nothing in
§ 17.52 or section 1703 as unamended
by the MISSION Act approximates the
specific eligibility criteria available
under the Veterans Choice Program or
contemplated under the MISSION Act
related to distance-related access
criteria. As such, the criterion of
geographic inaccessibility under section
1703 as unamended by the MISSION
Act can be interpreted many ways,
leading to inequitable eligibility
decisions for community care and bad
scheduling practices based on such
decisions.
A delay in the effective date of this
rule would result in a lack of
consistently applicable community care
criteria, which would create significant
disruptions for even a limited period of
time such as sixty days. Continuity of
care could particularly be disrupted,
and patient safety and health would be
in jeopardy, for any veterans who would
not be authorized to seek care from a
health care provider that has been
treating them for years under the
Veterans Choice Program. This could be
particularly harmful for veterans who
have mental health conditions and are
only comfortable seeking treatment from
their current mental health care
professional.
Such veterans may opt to simply
forego care from a different provider for
a delay of sixty days until this rule is
effective. Similarly, a sixty-day delayed
effective date could increase confusion
for even for new veteran users, new and
existing providers in the community, as
well as employees at VA, if VA were to
go from administering community care
under Veterans Choice Program criteria,
to then under significantly more limited
criteria of section 1703 as unamended
by the MISSION Act for a very limited
period of time, and then to
implementation of what are now
publicly vetted and broader criteria
under the new Veterans Community
Care Program. To avoid this confusion,
some veterans may simply choose not to
receive care until the new Veterans
Community Care Program is in place, or
providers may simply not participate, or
even VA may be at risk for
administering community care
incorrectly. This places veterans’ health
and safety at risk, particularly for
continuous and periodic care or
treatment that may be occurring under
the Veterans Choice Program through
June 6, 2019, and that must typically
occur on an immediate and stringent
schedule upon diagnosis (such as
treatment for cancer, or maternity care).
Accordingly, the Secretary finds it
would be contrary to the public interest
E:\FR\FM\05JNR2.SGM
05JNR2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
to delay the effective date of AQ46 and
that there is good cause to dispense with
the opportunity for a 60-day period of
prior Congressional review and to
publish this final rule with an operative
and effective date of June 6, 2019.
Administrative Procedure Act
For the reasons set forth in the
preceding section, the Secretary finds
that there is good cause under 5 U.S.C.
553(d)(3) to publish this rule with an
effective date that is less than 30 days
from the date of publication.
Effect of Rulemaking
The Code of Federal Regulations, as
revised by this rulemaking, represents
the exclusive legal authority on this
subject. No contrary rules or procedures
will be authorized. All VA guidance
will be read to conform with this
rulemaking if possible or, if not
possible, such guidance will be
superseded by this rulemaking.
jbell on DSK3GLQ082PROD with RULES2
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 will amend
information collection requirements
currently approved under control
number 2900–0823 and will impose
new collections of information
requirements and burden. Notice of
OMB approval for this information
collection will be published in the
Federal Register.
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. Although some
eligible entities or providers that will
furnish care and services to veterans
under this rule might be considered
small entities, there will be no
significant adverse economic impact. To
the extent there is any impact on small
entities and given the lapse in statutory
authority for the Veterans Choice
Program, it will be a potential increase
in business due to proposed expanded
eligibility for non-VA care. While this
rulemaking defines payment rates and
eligible entities and providers, it does so
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
in a way that is consistent with VA’s
current authorities. We note that
separate regulations at 38 CFR 17.4100
through 17.4135, authorizes VA to enter
into agreements with eligible providers,
many of whom will likely be small
businesses. We also do not believe there
will be a significant economic impact on
any insurance companies that might be
considered small businesses, as claims
would only be submitted for care that
would otherwise have been received
whether such care was authorized under
VCCP; the need for the care itself is not
generated by the VCCP, merely
furnished under the VCCP versus
another program. Therefore, pursuant to
5 U.S.C. 605(b), the Secretary has
determined that an initial and a final
regulatory flexibility analysis are not
needed.
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. Executive Order
12866 (Regulatory Planning and
Review) defines a ‘‘significant
regulatory action,’’ which requires
review by 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 the Executive Order. VA has
examined the economic, interagency,
budgetary, legal, and policy
implications of this regulatory action
and determined that the action is an
economically significant regulatory
action under Executive Order 12866.
PO 00000
Frm 00029
Fmt 4701
Sfmt 4700
26305
The total estimated budget impact (both
transfers and costs) is projected to be
$346.3 million in FY 2019 and $17.9
billion over a 5-year period. Transfers
are estimated to be $15.6 billion over a
5-year period and costs are estimated to
be $2.2 billion over a 5-year period.
These transfer impacts are from the
federal government to eligible Veterans.
The cost impacts are administrative
fees, claim fees and other non-provider
payment costs.
Benefits of the rulemaking will
strengthen the access to VA health care
overall by increasing the choices
Veterans have for their health care and
complementing the increasingly timely,
high-quality care provided by VA
medical facilities. Veterans will
continue to have the option to choose
whether to receive care at a VA medical
facility or a community provider.
Furthermore, the access expansion will
allow Veterans to receive care in the
community through a network of
providers when VA does not provide
the required care or services, wait times
do not conform with VA access
standards, service line does not meet
VA quality standards, the referring
clinician determines it is in the best
medical interest of the Veteran to
receive care or services in the
community. Additionally, Veterans will
be able to access community care when
the Veteran was eligible to receive care
under certain grandfathering provisions
or VA does not operate a full-service
medical facility in the State in which
the veteran resides.
VA’s regulatory 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
from FY 2004 through FYTD. This final
rule is an E.O. 13771 regulatory action.
VA has determined that the net costs are
$2.2 million over a five-year period
(FY2019–FY2023) and $429 million per
year on an ongoing basis discounted at
7 percent relative to year 2016, over a
perpetual time horizon. Details on the
estimated costs of this final rule can be
found in the rule’s economic analysis.
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
E:\FR\FM\05JNR2.SGM
05JNR2
26306
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
Authority: 38 U.S.C. 501, and as noted in
specific sections.
Catalog of Federal Domestic Assistance
*
The Catalog of Federal Domestic
Assistance numbers and titles for the
programs affected by this document are
as follows: 64.007, Blind Rehabilitation
Centers; 64.008, Veterans Domiciliary
Care; 64.009, Veterans Medical Care
Benefits; 64.010, Veterans Nursing
Home Care; 64.011, Veterans Dental
Care; 64.012, Veterans Prescription
Service; 64.013, Veterans Prosthetic
Appliances; 64.014, Veterans State
Domiciliary Care; 64.015, Veterans State
Nursing Home Care; 64.016, Veterans
State Hospital Care; 64.018, Sharing
Specialized Medical Resources; 64.019,
Veterans Rehabilitation Alcohol and
Drug Dependence; 64.022, Veterans
Home Based Primary Care; and 64.024,
VA Homeless Providers Grant and Per
Diem Program.
Section 17.38 is also issued under 38
U.S.C. 1703.
Section 17.46 is also issued under 38
U.S.C. 1710.
Section 17.52 is also issued under 38
U.S.C. 1701, 1703, 1710, 1712, and 3104.
Section 17.55 is also issued under 38
U.S.C. 513, 1703, and 1728.
Section 17.56 is also issued under 38
U.S.C. 1703 and 1728.
Section 17.108 is also issued under 38
U.S.C. 501, 1703, 1710, 1725A, and 1730A.
Section 17.110 is also issued under 38
U.S.C. 501, 1703, 1710, 1720D, 1722A, and
1730A.
Section 17.111 is also issued under 38
U.S.C. 101(28), 501, 1701(7), 1703, 1710,
1710B, 1720B, 1720D, and 1722A.
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 programsveterans, Health care, Health facilities,
Health professions, Health records,
Homeless, Medical devices, Mental
health programs, Nursing homes,
Reporting and recordkeeping
requirements, Veterans.
§ 17.38
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.
Robert L. Wilkie, Secretary, Department
of Veterans Affairs, approved this
document on April 23, 2019, for
publication.
Dated: May 30, 2019.
Michael P. Shores,
Director, Office of Regulation Policy &
Management, Office of the Secretary,
Department of Veterans Affairs.
PART 17—MEDICAL
1. The authority citation for part 17 is
amended by revising the entry for
§ 17.38 and adding entries for §§ 17.46,
17.52, 17.55, 17.56, 17.108, 17.110, and
17.111 and §§ 17.4000 through 17.4040
■
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
*
*
*
*
*
*
*
*
*
Sections 17.4000 through 17.4040 also
issued under 38 U.S.C. 1703, 1703B, and
1703C.
*
*
*
*
[Amended]
2. Amend § 17.38(a)(1)(iv) by
removing ‘‘§§ 17.52(a)(3), 17.53, 17.54,
17.120–132’’ and adding in its place
‘‘§ 17.52(a)(3), § 17.53, § 17.54, §§ 17.120
through 17.132, or §§ 17.4000 through
17.4040.’’
■
§ 17.46
[Amended]
3. Amend § 17.46:
a. In paragraph (a) introductory text by
adding the phrase ‘‘on or before June 6,
2019,’’ after the phrase ‘‘In furnishing
hospital care’’; and
■ b. Removing the authority citations at
the ends of paragraphs (a) and (b).
■ 4. Amend § 17.52 by removing the
authority citations at the ends of
paragraphs (a)(1) through (10) and
paragraph (b) and adding paragraph (c)
to read as follows:
■
■
§ 17.52 Hospital care and medical services
in non-VA facilities.
*
*
*
*
*
(c) The provisions of this section shall
not apply to care furnished by VA after
June 6, 2019.
§ 17.54
For the reasons set forth in the
preamble, we amend 38 CFR part 17 as
follows:
jbell on DSK3GLQ082PROD with RULES2
in numerical order to read in part as
follows:
(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.
[Removed and Reserved]
5. Remove and reserve § 17.54.
■ 6. Amend § 17.55 by revising the
introductory text and removing the
authority citation at the end of the
section to read as follows:
■
§ 17.55 Payment for authorized public or
private hospital care.
Except as otherwise provided in this
section, payment for public or private
hospital care furnished on or before
PO 00000
Frm 00030
Fmt 4701
Sfmt 4700
June 6, 2019, under 38 U.S.C. 1703 and
§ 17.52, or at any time under 38 U.S.C.
1728 and §§ 17.120 and 17.128 or under
38 U.S.C. 1787 and § 17.410, shall be
based on a prospective payment system
similar to that used in the Medicare
program for paying for similar inpatient
hospital services in the community.
Payment shall be made using the
Centers for Medicare & Medicaid
Services (CMS) PRICER for each
diagnosis-related group (DRG)
applicable to the episode of care.
*
*
*
*
*
■ 7. Amend § 17.56 by adding paragraph
(e) and removing the authority citation
at the end of the section to read as
follows:
§ 17.56 VA payment for inpatient and
outpatient health care professional services
at non-departmental facilities and other
medical charges associated with non-VA
outpatient care.
*
*
*
*
*
(e) Except for payments for care
furnished under 38 U.S.C. 1725 and
§ 17.1005, under 38 U.S.C. 1728 and
§§ 17.120 and 17.128, or under 38
U.S.C. 1787 and § 17.410, the provisions
of this section shall not apply to care
furnished by VA after June 6, 2019, or
care furnished pursuant to an agreement
authorized by 38 U.S.C. 1703A.
■ 8. Amend § 17.108:
■ a. In paragraph (b)(4):
■ i. By removing ‘‘§ 17.1500 through
17.1540’’ and adding in its place
‘‘§§ 17.1500 through 17.1540, or the
Veterans Community Care Program
under §§ 17.4000 through 17.4040’’; and
■ ii. Removing ‘‘paragraphs (b)(2) or
(b)(3)’’ and adding in its place
‘‘paragraph (b)(2) or (3)’’;
■ b. In paragraph (c)(4), by removing
‘‘§ 17.1500 through 17.1540’’ and adding
in its place ‘‘§§ 17.1500 through
17.1540, or the Veterans Community
Care Program under §§ 17.4000 through
17.4040’’; and
■ c. Removing the authority citation at
the end of the section.
§ 17.110
[Amended]
9. Amend § 17.110:
■ a. In paragraph (b)(4):
■ i. By removing ‘‘§ 17.1500 through
17.1540’’ and adding in its place
‘‘§§ 17.1500 through 17.1540, or the
Veterans Community Care Program
under §§ 17.4000 through 17.4040’’; and
■ ii. Removing ‘‘paragraphs (b)(1)(i)
through (b)(1)(iii)’’ and adding in its
place ‘‘paragraphs (b)(1)(i) through
(iii)’’; and
■ b. Removing the authority citation at
the end of the section.
■
E:\FR\FM\05JNR2.SGM
05JNR2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
§ 17.111
[Amended]
10. Amend § 17.111:
a. In paragraph (b)(3):
i. By removing ‘‘§ 17.1500 through
17.1540’’ and adding in its place
‘‘§§ 17.1500 through 17.1540, as well as
extended care services furnished
through the Veterans Community Care
Program under §§ 17.4000 through
17.4040’’; and
■ ii. Removing ‘‘paragraphs (b)(1) or
(b)(2)’’ and adding in its place
‘‘paragraph (b)(1) or (2)’’; and
■ b. Removing the authority citation at
the end of the section.
■
■
■
§ 17.1004
[Amended]
11. Amend § 17.1004 in paragraph (b)
introductory text by removing the
phrase ‘‘HCFA 1500’’ and adding in its
place ‘‘CMS 1500’’ and removing the
authority citation at the end of the
section.
■ 12. Add an undesignated center
heading and §§ 17.4000 through 17.4040
to read as follows:
■
Veterans Community Care Program
Sec.
17.4000 Purpose and scope.
17.4005 Definitions.
17.4010 Veteran eligibility.
17.4015 Designated VA medical service
lines.
17.4020 Authorized non-VA care.
17.4025 Effect on other provisions.
17.4030 Eligible entities and providers.
17.4035 Payment rates.
17.4040 Designated access standards.
Veterans Community Care Program
§ 17.4000
Purpose and scope.
(a) Purpose. Sections 17.4000 through
17.4040 implement the Veterans
Community Care Program, authorized
by 38 U.S.C. 1703.
(b) Scope. The Veterans Community
Care Program establishes when a
covered veteran may elect to have VA
authorize an episode of care for hospital
care, medical services, or extended care
services from an eligible entity or
provider. Sections 17.4000 through
17.4040 do not affect eligibility for nonVA care under sections 1724, 1725,
1725A, or 1728 of title 38, United States
Code.
jbell on DSK3GLQ082PROD with RULES2
§ 17.4005
Definitions.
For purposes of the Veterans
Community Care Program under
§§ 17.4000 through 17.4040:
Appointment means an authorized
and scheduled encounter, including
telehealth and same-day encounters,
with a health care provider for the
delivery of hospital care, medical
services, or extended care services.
Covered veteran means a veteran
enrolled under the system of patient
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
enrollment in § 17.36, or a veteran who
otherwise meets the criteria to receive
care and services notwithstanding his or
her failure to enroll in § 17.37(a)
through (c).
Eligible entity or provider means a
health care entity or provider that meets
the requirements of § 17.4030.
Episode of care means a necessary
course of treatment, including follow-up
appointments and ancillary and
specialty services, which lasts no longer
than 1 calendar year.
Extended care services include the
same services as described in 38 U.S.C.
1710B(a).
Full-service VA medical facility
means a VA medical facility that
provides hospital care, emergency
medical services, and surgical care and
having a surgical complexity
designation of at least ‘‘standard.’’
Note 1 to the definition of ‘‘fullservice VA medical facility’’: VA
maintains a website with a list of the
facilities that have been designated with
at least a surgical complexity of
‘‘standard,’’ which can be accessed on
VA’s website.
Hospital care has the same meaning
as defined in 38 U.S.C. 1701(5).
Medical services have the same
meaning as defined in 38 U.S.C.
1701(6).
Other health-care plan contract
means an insurance policy or contract,
medical or hospital service agreement,
membership or subscription contract, or
similar arrangement not administered
by the Secretary of Veterans Affairs,
under which health services for
individuals are provided or the
expenses of such services are paid; and
does not include any such policy,
contract, agreement, or similar
arrangement pursuant to title XVIII or
XIX of the Social Security Act (42 U.S.C.
1395 et seq.) or chapter 55 of title 10,
United States Code.
Residence means a legal residence or
personal domicile, even if such
residence is seasonal. A covered veteran
may maintain more than one residence
but may only have one residence at a
time. If a covered veteran lives in more
than one location during a year, the
covered veteran’s residence is the
residence or domicile where they are
staying at the time they want to receive
hospital care, medical services, or
extended care services through the
Veterans Community Care Program. A
post office box or other non-residential
point of delivery does not constitute a
residence.
Schedule means identifying and
confirming a date, time, location, and
entity or health care provider for an
PO 00000
Frm 00031
Fmt 4701
Sfmt 4700
26307
appointment in advance of such
appointment.
Note 1 to the definition of ‘‘schedule’’:
A VA telehealth encounter and a sameday care encounter are considered to be
scheduled even if such an encounter is
conducted on an ad hoc basis.
VA facility means a VA facility that
offers hospital care, medical services, or
extended care services.
VA medical service line means a
specific medical service or set of
services delivered in a VA facility.
§ 17.4010
Veteran eligibility.
Section 1703(d) of title 38, U.S.C.,
establishes the conditions under which,
at the election of the veteran and subject
to the availability of appropriations, VA
must furnish care in the community
through eligible entities and providers.
VA has regulated these conditions
under paragraphs (a)(1) through (5) of
this section. If VA determines that a
covered veteran meets at least one or
more of the conditions in paragraph (a)
of this section and has provided
information required by paragraphs (b)
and (c) of this section, the covered
veteran may elect to receive authorized
non-VA care under § 17.4020.
(a) The covered veteran requires
hospital care, medical services, or
extended care services and:
(1) No VA facility offers the hospital
care, medical services, or extended care
services the veteran requires.
(2) VA does not operate a full-service
VA medical facility in the State in
which the veteran resides.
(3) The veteran was eligible to receive
care and services from an eligible entity
or provider under section 101(b)(2)(B) of
the Veterans Access, Choice, and
Accountability Act of 2014 (Pub. L.
113–146, sec. 101, as amended; 38
U.S.C. 1701 note) as of June 5, 2018, and
continues to reside in a location that
would qualify the veteran under that
provision, and:
(i) Resides in Alaska, Montana, North
Dakota, South Dakota, or Wyoming; or
(ii) Does not reside in one of the
States described in paragraph (a)(3)(i) of
this section, but received care or
services under title 38 U.S.C. between
June 6, 2017, and June 6, 2018, and is
seeking care before June 6, 2020.
(4) Has contacted an authorized VA
official to request the care or services
the veteran requires, but VA has
determined it is not able to furnish such
care or services in a manner that
complies with designated access
standards established in § 17.4040.
(5) The veteran and the veteran’s
referring clinician determine it is in the
best medical interest of the veteran, for
the purpose of achieving improved
E:\FR\FM\05JNR2.SGM
05JNR2
jbell on DSK3GLQ082PROD with RULES2
26308
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
clinical outcomes, to access the care or
services the veteran requires from an
eligible entity or provider, based on one
or more of the following factors, as
applicable:
(i) The distance between the veteran
and the facility or facilities that could
provide the required care or services;
(ii) The nature of the care or services
required by the veteran;
(iii) The frequency the veteran
requires the care or services;
(iv) The timeliness of available
appointments for the required care or
services;
(v) The potential for improved
continuity of care;
(vi) The quality of the care provided;
or
(vii) Whether the veteran faces an
unusual or excessive burden in
accessing a VA facility based on
consideration of the following:
(A) Excessive driving distance;
geographical challenges, such as the
presence of a body of water (including
moving water and still water) or a
geologic formation that cannot be
crossed by road; or environmental
factors, such as roads that are not
accessible to the general public, traffic,
or hazardous weather.
(B) Whether care and services are
available from a VA facility that is
reasonably accessible.
(C) Whether a medical condition of
the veteran affects the ability to travel.
(D) Whether there is a compelling
reason the veteran needs to receive care
and services from a non-VA facility.
(E) The need for an attendant, which
is defined as a person who provides
required aid and/or physical assistance
to the veteran, for a veteran to travel to
a VA medical facility for hospital care
or medical services.
(6) In accordance with § 17.4015, VA
has determined that a VA medical
service line that would furnish the care
or services the veteran requires is not
providing such care or services in a
manner that complies with VA’s
standards for quality.
(b) If the covered veteran changes his
or her residence, the covered veteran
must update VA about the change
within 60 days.
(c) A covered veteran must provide to
VA information on any other health-care
plan contract under which the veteran
is covered prior to obtaining
authorization for care and services the
veteran requires. If the veteran changes
such other health-care plan contract, the
veteran must update VA about the
change within 60 days.
(d) Review of veteran eligibility
determinations. The review of any
decisions under paragraph (a) of this
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
section are subject to VA’s clinical
appeals process, and such decisions
may not be appealed to the Board of
Veterans’ Appeals.
(The information collection is pending
Office of Management and Budget
approval.)
§ 17.4015
lines.
Designated VA medical service
(a) VA may identify VA medical
service lines that are underperforming
based on the timeliness of care when
compared with the same medical
service line at other VA facilities and
based on data related to two or more
distinct and appropriate quality
measures of VA’s standards for quality
when compared with non-VA medical
service lines.
(b) VA will make determinations
regarding VA medical service lines
under this section using data described
in paragraph (a) of this section, VA
standards for quality, and based on
factors identified in paragraph (e) of this
section.
(c) VA will announce annually any
VA medical service lines identified
under paragraph (a) of this section by
publishing a document in the Federal
Register. Such document will identify
and describe the standards for quality
VA used to inform the determination
under paragraph (a), as well as how the
data described in paragraph (a) and
factors identified in paragraph (e) of this
section were used to make the
determinations. Such document will
also identify limitations, if any,
concerning when and where covered
veterans can receive qualifying care and
services at their election in the
community based on this section. Such
limitations may include a defined
timeframe, a defined geographic area,
and a defined scope of services. VA will
also take reasonable steps to provide
direct notice to covered veterans
affected under this section.
(d) VA will identify no more than 3
VA medical services lines in a single VA
facility under this section, and no more
than 36 VA medical service lines
nationally under this section.
(e) In determining whether a VA
medical service line should be
identified under paragraph (a) of this
section, and to comply with paragraph
(c) of this section, VA will consider:
(1) Whether the differences between
performance of individual VA medical
service lines, and between performance
of VA medical service lines and non-VA
medical service lines, is clinically
significant.
(2) Likelihood and ease of
remediation of the VA medical service
line within a short timeframe.
PO 00000
Frm 00032
Fmt 4701
Sfmt 4700
(3) Recent trends concerning the VA
medical service line or non-VA medical
service line.
(4) The number of covered veterans
served by the medical service line or
that could be affected by the
designation.
(5) The potential impact on patient
outcomes.
(6) The effect that designating one VA
medical service line would have on
other VA medical service lines.
§ 17.4020
Authorized non-VA care.
(a) Electing non-VA care. Except as
provided for in paragraph (d) of this
section, a covered veteran eligible for
the Veterans Community Care Program
under § 17.4010 may choose to schedule
an appointment with a VA health care
provider, or have VA authorize the
veteran to receive an episode of care for
hospital care, medical services, or
extended care services from an eligible
entity or provider when VA determines
such care or services are clinically
necessary.
(b) Selecting an eligible entity or
provider. A covered veteran may specify
a particular eligible entity or provider.
If a covered veteran does not specify a
particular eligible entity or provider, VA
will refer the veteran to a specific
eligible entity or provider.
(c) Authorizing emergency treatment.
This paragraph (c) applies only to
emergency treatment furnished to a
covered veteran by an eligible entity or
provider when such treatment was not
the subject of an election by a veteran
under paragraph (a) of this section. This
paragraph (c) does not affect eligibility
for, or create any new rules or
conditions affecting, reimbursement for
emergency treatment under section 1725
or 1728 of title 38, United States Code.
(1) Under the conditions set forth in
this paragraph (c), VA may authorize
emergency treatment after it has been
furnished to a covered veteran. For
purposes of this paragraph (c),
‘‘emergency treatment’’ has the meaning
defined in section 1725(f)(1) of title 38,
United States Code.
(2) VA may only authorize emergency
treatment under this paragraph (c) if the
covered veteran, someone acting on the
covered veteran’s behalf, or the eligible
entity or provider notifies VA within 72hours of such care or services being
furnished and VA approves the
furnishing of such care or services
under paragraph (c)(3) of this section.
(3) VA may approve emergency
treatment of a covered veteran under
this paragraph (c) only if:
(i) The veteran is receiving emergency
treatment from an eligible entity or
provider.
E:\FR\FM\05JNR2.SGM
05JNR2
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
jbell on DSK3GLQ082PROD with RULES2
(ii) The notice to VA complies with
the provisions of paragraph (c)(4) of this
section and is submitted within 72
hours of the beginning of such
treatment.
(iii) The emergency treatment only
includes services covered by VA’s
medical benefits package in § 17.38.
(4) Notice to VA must:
(i) Be made to the appropriate VA
official at the nearest VA facility;
(ii) Identify the covered veteran; and
(iii) Identify the eligible entity or
provider.
(d) Organ and bone marrow
transplant care. (1) In the case of a
covered veteran described in paragraph
(d)(3) of this section, the Secretary will
determine whether to authorize an
organ or bone marrow transplant for the
covered veteran through an eligible
entity or provider.
(2) The Secretary will make
determinations under paragraph (d)(1)
of this section, and the primary care
provider of the veteran will make
determinations concerning whether
there is a medically compelling reason
to travel outside the region of the Organ
Procurement and Transplantation
Network in which the veteran resides to
receive a transplant, in consideration of,
but not limited to, the following factors:
(i) Specific patient factors.
(ii) Which facilities meet VA’s
standards for quality, including quality
metrics and outcomes, for the required
transplant.
(iii) The travel burden on covered
veterans based upon their medical
conditions and the geographic location
of eligible transplant centers.
(iv) The timeliness of transplant
center evaluations and management.
(3) This paragraph (d) applies to
covered veterans who meet one or more
conditions of eligibility under
§ 17.4010(a) and:
(i) Require an organ or bone marrow
transplant as determined by VA based
upon generally-accepted medical
criteria; and
(ii) Have, in the opinion of the
primary care provider of the veteran, a
medically compelling reason, as
determined in consideration of the
factors described in paragraph (d)(2) of
this section, to travel outside the region
of the Organ Procurement and
Transplantation Network in which the
veteran resides, to receive such
transplant.
§ 17.4025
Effect on other provisions.
(a) General. No provision in this
section may be construed to alter or
modify any other provision of law
establishing specific eligibility criteria
for certain hospital care, medical
services, or extended care services.
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
(b) Prescriptions. Notwithstanding
any other provision of this part, VA
will:
(1) Pay for prescriptions no longer
than 14 days written by eligible entities
or providers for covered veterans,
including over-the-counter drugs and
medical and surgical supplies, available
under the VA national formulary system
to cover a course of treatment for an
urgent or emergent condition.
(2) Fill prescriptions written by
eligible entities or providers for covered
veterans, including over-the-counter
drugs and medical and surgical
supplies, available under the VA
national formulary system.
(3) 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 (e.g.,
splints, crutches, manual wheelchairs).
(4) Fill prescriptions written by
eligible entities or providers for covered
veterans for durable medical equipment
and medical devices that are not
required for urgent or emergent
conditions.
(c) Copayments. Covered veterans are
liable for a VA copayment for care or
services furnished under the Veterans
Community Care Program, if required by
§ 17.108(b)(4) or (c)(4), § 17.110(b)(4), or
§ 17.111(b)(3).
§ 17.4030
Eligible entities and providers.
To be eligible to furnish care and
services under the Veterans Community
Care Program, entities or providers:
(a) Must enter into a contract,
agreement, or other arrangement to
furnish care and services under the
Veterans Community Care Program
under §§ 17.4000 through 17.4040.
(b) Must either:
(1) Not be a part of, or an employee
of, VA; or
(2) If the provider is an employee of
VA, not be acting within the scope of
such employment while providing
hospital care, medical services, or
extended care services through the
Veterans Community Care Program
under §§ 17.4000 through 17.4040.
(c) Must be accessible to the covered
veteran. VA will determine accessibility
by considering the following factors:
(1) The length of time the covered
veteran would have to wait to receive
hospital care, medical services, or
extended care services from the entity or
provider;
(2) The qualifications of the entity or
provider to furnish the hospital care,
medical services, or extended care
services from the entity or provider; and
PO 00000
Frm 00033
Fmt 4701
Sfmt 4700
26309
(3) The distance between the covered
veteran’s residence and the entity or
provider.
§ 17.4035
Payment rates.
The rates paid by VA for hospital
care, medical services, or extended care
services (hereafter referred to as
‘‘services’’) furnished pursuant to a
procurement contract or an agreement
authorized by §§ 17.4100 through
17.4135 will be the rates set forth in the
terms of such contract or agreement.
Such payment rates will comply with
the following parameters:
(a) Except as otherwise provided in
this section, payment rates will not
exceed the applicable Medicare fee
schedule (including but not limited to
allowable rates under 42 U.S.C. 1395m)
or prospective payment system amount
(hereafter ‘‘Medicare rate’’), if any, for
the period in which the service was
provided (without any changes based on
the subsequent development of
information under Medicare
authorities).
(b) With respect to services furnished
in a State with an All-Payer Model
Agreement under section 1814(b)(3) of
the Social Security Act (42 U.S.C.
1395f(b)(3)) that became effective on or
after January 1, 2014, the Medicare
payment rates under paragraph (a) of
this section will be calculated based on
the payment rates under such
agreement.
(c) Payment rates for services
furnished in a highly rural area may
exceed the limitations set forth in
paragraphs (a) and (b) of this section.
The term ‘‘highly rural area’’ means an
area located in a county that has fewer
than seven individuals residing in that
county per square mile.
(d) Payment rates may deviate from
the parameters set forth in paragraphs
(a) through (c) of this section when VA
determines, based on patient needs,
market analyses, health care provider
qualifications, or other factors, that it is
not practicable to limit payment for
services to the rates available under
paragraphs (a) through (c).
(e) Payment rates for services
furnished in Alaska are not subject to
paragraphs (a) through (d) of this section
and will be set forth in the terms of the
procurement contract or agreement
authorized by §§ 17.4100 through
17.4135, pursuant to which such
services are furnished. If no payment
rate is set forth in the terms of such a
contract or agreement pursuant to which
such services are furnished, payment
rates for services furnished in Alaska
will follow the Alaska Fee Schedule of
the Department of Veterans Affairs.
E:\FR\FM\05JNR2.SGM
05JNR2
26310
§ 17.4040
Federal Register / Vol. 84, No. 108 / Wednesday, June 5, 2019 / Rules and Regulations
Designated access standards.
jbell on DSK3GLQ082PROD with RULES2
(a) The following access standards
have been designated to apply for
purposes of eligibility determinations to
access care in the community through
the Veterans Community Care Program
under § 17.4010(a)(4).
(1) Primary care, mental health care,
and non-institutional extended care
services. VA cannot schedule an
appointment for the covered veteran
with a VA health care provider for the
required care or service:
VerDate Sep<11>2014
19:22 Jun 04, 2019
Jkt 247001
(i) Within 30 minutes average driving
time of the veteran’s residence; and
(ii) Within 20 days of the date of
request unless a later date has been
agreed to by the veteran in consultation
with the VA health care provider.
(2) Specialty care. VA cannot
schedule an appointment for the
covered veteran with a VA health care
provider for the required care or service:
(i) Within 60 minutes average driving
time of the veteran’s residence; and
PO 00000
Frm 00034
Fmt 4701
Sfmt 9990
(ii) Within 28 days of the date of
request unless a later date has been
agreed to by the veteran in consultation
with the VA health care provider.
(b) For purposes of calculating
average driving time from the veteran’s
residence in paragraph (a) of this
section, VA will use geographic
information system software.
[FR Doc. 2019–11575 Filed 6–4–19; 8:45 am]
BILLING CODE 8320–01–P
E:\FR\FM\05JNR2.SGM
05JNR2
Agencies
[Federal Register Volume 84, Number 108 (Wednesday, June 5, 2019)]
[Rules and Regulations]
[Pages 26278-26310]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-11575]
[[Page 26277]]
Vol. 84
Wednesday,
No. 108
June 5, 2019
Part IV
Department of Veterans Affairs
-----------------------------------------------------------------------
38 CFR Part 17
Veterans Community Care Program; Final Rule
Federal Register / Vol. 84 , No. 108 / Wednesday, June 5, 2019 /
Rules and Regulations
[[Page 26278]]
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ46
Veterans Community Care Program
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) adopts as final a
proposed rule amending its regulations that govern VA health care. This
final rule implements its authority from the VA MISSION ACT of 2018 for
covered veterans to receive necessary hospital care, medical services,
and extended care services from non-VA entities or providers in the
community.
DATES: Effective Date: This rule is effective on June 6, 2019.
FOR FURTHER INFORMATION CONTACT: Joseph Duran, Office of Community Care
(10D), Veterans Health Administration, Department of Veterans Affairs,
Ptarmigan at Cherry Creek, Denver, CO 80209; [email protected],
(303) 370-1637. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On June 6, 2018, the President signed into
law the John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA
Maintaining Internal Systems and Strengthening Integrated Outside
Networks (MISSION) Act of 2018 (hereafter referred to as the ``MISSION
Act,'' Pub. L. 115-182, 132 Stat. 1395, as amended). This final rule
implements section 101 of the MISSION Act, which requires VA to
implement a Veterans Community Care Program to furnish required care
and services to covered veterans through eligible entities and
providers. Section 101, which amends 38 U.S.C. 1703 upon the effective
date of these final regulations, further establishes the conditions
under which VA determines if covered veterans are eligible to elect to
receive such care and services through eligible entities or providers,
as well as other parameters of the Veterans Community Care Program.
This final rule implements in a regulatory framework the requirements
in amended section 1703, consistent with the mandate in section 101(c)
of the MISSION Act that VA promulgate regulations to carry out the
Veterans Community Care Program. For the sake of convenience and
understanding, we will refer to provisions of section 1703 as it will
be amended on June 6, 2019, the effective date of this final rule. We
additionally clarify that throughout this final rule, the abbreviation
U.S.C. or the term section will be used to indicate discussion of or
reference to a statutory provision in the United States Code (e.g.,
section 1703) or in another statute, while the abbreviation CFR or the
section symbol Sec. will be used to indicate discussion of or
reference to an existing or proposed regulatory provision in the Code
of Federal Regulations (e.g., Sec. 17.4005 as proposed). There may be
instances where the term section rather than the section symbol must be
used at the beginning of a sentence to discuss or reference a
regulatory provision, but it should be clear in the sentence that a
regulatory provision is at issue. In general, any reference to a
section that uses a period in it (e.g., Sec. 17.55) is a reference to
the CFR, while any reference without such a period (e.g., section 1703)
is a reference to the U.S.C.
VA published a proposed rule regarding the criteria for determining
when covered veterans may elect to receive care and services through
community health care entities or providers, as well as other
parameters of the program, on February 22, 1019. 84 FR 5629. In
response to this proposed rule, VA received 23,557 comments. Over
18,000 comments were duplicated form responses that expressed strong
support for the overall rulemaking, with some suggestions for
substantive revisions to provisions from the proposed rule. We received
1,297 comments that were unique in that they were not duplicated form
responses in support of or in opposition to at least one portion of the
proposed rule, although VA did consider substantive issues raised in
such duplicated comments. More than 700 comments expressed support for
the proposed rule, in whole or in part, without substantive comment on
provisions in the proposed rule. We appreciate the support of such
comments, and do not address them below. Other comments expressed
support or disapproval, in whole or in part, with substantive
provisions in the proposed rule, and we discuss those comments and
applicable revisions from the proposed rule below. We note that the
discussion below is organized by the sequential order of the provisions
as presented in the proposed rule, from Sec. Sec. 17.4000 through
17.4040. As many of the comments we received were related to the access
standards as proposed, we alert readers that the discussion on access
standards can be found under the last section header Sec. 17.4040 in
this final rule, near the end of the Supplementary Information section
of this published document.
We make two technical corrections to the proposed revisions to
Sec. Sec. 17.46 and 17.55 to clarify the sunset date of these
regulations as they apply to VA's community care program such that
these will not apply to care furnished after June 6, 2019.
Sec. 17.4000, Purpose and Scope
We received over 200 comments that did not relate to specific
provisions of the proposed rule, but that related to the overall effect
that implementation of the Veterans Community Care Program (VCCP) would
have on either: (1) The care and services that VA directly furnishes,
or (2) the U.S. healthcare industry at large. We discuss these comments
in the context of Sec. 17.4000(a) as proposed, because Sec.
17.4000(a) established that Sec. Sec. 17.4000 through 17.4040 would
generally implement the VCCP as authorized by 38 U.S.C. 1703.
With regard to the effects on the care and services that VA
directly furnishes, commenters expressed concern that implementation of
the VCCP would deplete VA's allotted budgetary resources and thereby
negatively impact VA's ability to directly furnish care and services to
veterans (some comments referred to this impact as the ``privatization
of VA''). Commenters offered multiple reasons why implementation of
VCCP would negatively affect VA's direct provision of care, all
stemming from the assumptions that more covered veterans would choose
VA community care if access to such care were expanded, which would
then create a decreased need to fund VA's direct provision of care
(i.e., provision of care in a VA facility). A few comments further
stated that decreased funding of VA's direct provision of care would be
unavoidable unless such care was funded separately from the VCCP
(presumably, separately funded by Congress specifically through the
Federal appropriation process). Many of these comments further argued
that, rather than potentially expand the provision of non-VA care in
the community through implementation of the VCCP, VA should focus on
improving its own infrastructure, hiring practices, and quality of care
and services it directly provides. Some of these comments additionally
provided more specific suggestions for how VA could use resources
required to implement the VCCP to instead improve VA's direct provision
of care and services (e.g., VA could hire additional specific types of
providers or increase pay scales for its providers generally; or VA
could open additional VA facilities, expand or improve its existing
facilities, or expand sharing agreements with non-VA facilities).
We do not disagree with portions of these comments requesting that
VA look
[[Page 26279]]
to improving its direct delivery of care and services; indeed, a
portion of the proposed rule that was organized under a header titled
improving VA (see 84 FR 5629, 5645-5646) discussed how the MISSION Act
will assist VA in doing so. We do not, however, make any changes to
Sec. 17.4000 or any other part of the rule as proposed based on these
comments. Section 1703 requires VA to implement the VCCP and to
establish the conditions under which VA would determine if covered
veterans are eligible to elect to receive such care and services
through eligible entities or providers (see sections 1703(a)(1) and
(d)). Section 1703(a)(1) establishes a program to furnish hospital
care, medical services, and extended care services to covered veterans
through eligible entities and providers; it is VA's responsibility to
implement the VCCP. Section 1703(d)(3) creates a key condition on the
operation of the VCCP: that the covered veteran must elect to receive
care in the community, versus through VA. This election was further
identified and explained in Sec. Sec. 17.4000(b), 17.4010, and
17.4020(a) as proposed. VA's obligation to implement the VCCP does not
diminish VA's obligation to directly provide care and services to
eligible individuals as otherwise required by title 38 U.S.C,
particularly for covered veterans who are eligible for but do not elect
to receive care through the VCCP or veterans who are not eligible to
receive care through the VCCP. As Congress appropriates funding for VA,
VA will use those resources to implement the requirements Congress has
set forth. The regulatory impact analysis for this final rule and VA's
budget requests identify our anticipated needs, and we will closely
monitor utilization of our available resources.
With regard to the effects that implementation of the VCCP would
have on the U.S. healthcare industry at large, we find such comments
generally beyond the scope of the rule where they do not relate to VA's
direct provision of care and services or VA's ability to maintain its
other core missions. For instance, some comments asserted that covered
veterans seeking non-VA care could displace non-veteran patients that
rely on other Federal health care coverage (i.e., Medicare or
Medicaid), particularly if VA did not consider potential reductions to
other Federal health care funding in developing the proposed rule.
Conversely, other comments expressed concern that implementation of the
VCCP could put covered veterans seeking non-VA care in the position to
compete with non-veteran patients who have private insurance, because
non-VA providers simply will not have the capacity to absorb covered
veterans as additional patients. We do not make changes to the rule
based on these comments that relate to the potential effects that VCCP
implementation may have on capacity of non-VA providers to see
patients, either to a covered veteran's advantage or disadvantage when
compared with other patient cohorts as asserted by the comments.
However, we believe that the contracts, agreements, or other
arrangements VA enters with eligible entities and providers will help
to ensure provider availability for covered veterans who elect to
receive care through the VCCP; we have no reason to believe that the
effect, if any, on non-veteran patients would be significant. We
similarly do not make changes based on comments that generally argued
that expansion of eligibility for VA community care could create
increased consolidation of health care markets in a manner to require
VA to pay higher rates for non-VA care. We do not believe our actions
in implementing the VCCP will have that significant of an effect on the
health care industry. According to the National Health Expenditure Data
set, the United States spent $3.5 trillion on health care in 2017. By
comparison, VA obligated $12.9 billion for community care in FY 2017 or
17.8 percent of total VA Medical Care spending. As for other comments
that specifically noted that implementation of the VCCP could have
detrimental effects on the U.S. health care industry at large because
VA would not be able to maintain its core missions of research and
health care provider and clinician training, VA's obligation to
implement the VCCP does not diminish VA's obligation to fulfill any of
its core missions as otherwise required by title 38 U.S.C.
Sec. 17.4005, Definitions
We received more than ten comments that either suggested revisions
to or clarification of some terms defined in the proposed rule, or that
requested VA define additional terms. We address these comments below
as they relate to the terms in the order they were presented in Sec.
17.4005 as proposed.
One comment requested revision of the definition of the term
appointment to expressly include telehealth and same-day encounters.
While we believe the definition of appointment as proposed did include
telehealth and same-day encounters (by using the separately defined
term schedule), we agree with the suggestion to revise the definition
to expressly add these terms. The definition of appointment is
therefore revised to include telehealth and same-day encounters.
A few comments requested revisions to the term covered veteran. The
term covered veteran as proposed is identical to the statutory
definition in section 1703(b), which is limited to veterans. We
reiterate from the proposed rule that the regulations at Sec. Sec.
17.4000-17.4040 do not affect other VA authorities to provide care or
services for non-veterans. Therefore, VA's limited authority to furnish
care or services for non-veterans is generally not affected by
regulations that implement the VCCP. Other comments requested that VA
add a regulatory citation to 38 CFR 17.37(c) to the definition of
covered veteran, as this regulatory citation corresponds to the
statutory citation 38 U.S.C. 1705(c)(2) in the definition that
authorizes eligibility for certain veterans who do not have to enroll
prior to receiving VA care. We agree with the commenter that providing
a relevant regulatory citation for these certain veterans would make
the definition more consistent, as the definition does include the
regulatory citation for Sec. 17.36 as it relates to those veterans who
do have an affirmative requirement to enroll prior to receiving care.
We therefore revise the definition of covered veteran to reference 38
CFR 17.37(a)-(c), which implement section 1705(c)(2) related to
veterans who may receive VA care without first enrolling in VA's system
of patient enrollment. We do not further revise the definition as
requested to require enrollment for these certain veterans as a
condition of receiving non-VA care under the VCCP, because that is not
a requirement of section 1703 and believe such a revision could
frustrate efforts to assist veterans transitioning from service in the
Armed Forces.
One comment requested revision of the term eligible entity and
provider to expressly include the standards by which VA will assess
these entities and providers for adequacy, such as assessment for
compliance with VA's access standards as proposed, or compliance with
other Federal laws such as the Americans with Disabilities Act. We do
not make changes to the definition based on this comment, as the
definition itself references the relevant section related to entities
and providers, Sec. 17.4030 as proposed. We will discuss comments
related to entities and providers in the section of the final rule
related to Sec. 17.4030.
In the definition of episode of care, VA's only substantive
proposed change from the definition used in Sec. 17.1505 regarding the
Veterans Choice Program
[[Page 26280]]
was to remove the qualifying language that stated the one-year duration
for the episode began from the date of the first appointment with a
non-VA health care provider. We received one comment that requested we
add this qualifying language back to the definition, to ensure it was
clear that an episode of care included follow-up appointments and
ancillary and specialty care as needed. We do not make any changes
based on this comment, as the definition as proposed expressly included
follow-up appointments and ancillary and specialty services.
A few comments requested revisions to the term extended care
services. Some comments stated that defining the term extended care
services by referencing its applicable authority at 38 U.S.C. 1710B was
insufficient to indicate what services were covered under the VCCP,
particularly to ensure coverage of certain extended care services that
comments asserted were not covered by Medicare (such as adult day
health care). Other comments more specifically stated that the
definition should expressly list the types of extended care services
that would be covered, with some comments further advocating for
inclusion of particular services such as assisted living, or hourly
nursing services provided by home health agencies. We do not make
changes based on these comments. We believe the reference in the
definition to section 1710B(a) is sufficient to indicate the types of
extended care services covered because it does provide a specific
listing of services that encompasses both institutional and non-
institutional extended care services (section 1710B(a)(4), for example,
references adult day health care directly). Moreover, we see two
benefits to referencing the statutory authority instead of defining it
further in this rule. First, such a change would allow for any
amendments to the law (section 1710B) to have automatic effect on this
rule, and second, VA's interpretation of that provision of law will
also automatically carry over to this rule.
A few comments requested clarification of or revisions to the
definition of full-service VA medical facility. One comment requested
clarification of what a full-service VA medical facility was. We
reiterate from the proposed rule that this term means a VA medical
facility that provides hospital care, emergency medical services, and
surgical care and having a surgical complexity designation of at least
standard. This definition includes a note that states that VA maintains
a website with a list of the facilities that have been designated with
at least a surgical complexity of standard, which can be accessed on
VA's website. One commenter indicated that this note was not adequately
specific and should provide the exact hyperlink where this information
can be found. We do not make changes based on this comment, as we do
not want to create a gap in our regulations should VA's website
locations change in the future. For the public's awareness, as of the
publication of this final rule, this information can currently be found
at www.va.gov/health/surgery. Another commenter stated that the
definition should be revised to expressly include inpatient and
outpatient mental health services to ensure that veterans (particularly
in rural and remote areas) have access to such services. The definition
of a full-service VA medical facility is only relevant for
determinations of veteran eligibility under Sec. 17.4010(a)(2) as
proposed, which, consistent with section 1703(d)(1)(B), means that
covered veterans are eligible for VCCP if they reside in a State where
VA does not operate a full-service VA medical facility. Therefore,
while we understand the comment's concern that not including a specific
type of care in the definition would seem to affect eligibility for the
VCCP, we note that veterans requiring inpatient or outpatient mental
health services may be eligible under one of the other five eligibility
criteria in Sec. 17.4010(a)(1) and (a)(3) through (6) as proposed,
should a facility meet the requirements of this definition for full-
service medical facility but not have inpatient or outpatient mental
health services. We also note that the exclusion of a listed service
from the definition of full-service medical facility is not intended to
indicate that such services are not available from these facilities--to
the contrary, the existence of services that are included in the
definition, such as surgical services, tends to indicate that such
facilities are more complex medical facilities that offer many services
such as mental health, primary care, and many forms of specialty care,
etc.
One comment requested that VA add a new definition regarding the
best medical interest of the covered veteran, to assist in clarifying
this concept for the purposes of determining eligibility for the VCCP
under Sec. 17.4010(a)(5) as proposed. We do not make changes to the
definitions section based on this comment, although we will address the
comment's concern regarding clarification of the best medical interest
eligibility criterion in our consideration of comments on Sec.
17.4010, which discusses eligibility for the VCCP.
One comment requested clarification of the terms hospital care and
medical services, specifically seeking clarification of the explanation
for the terms that was provided in the preamble of the proposed rule.
The preamble of the proposed rule explained these terms in part by
referring to the medical benefits package at Sec. 17.38(b), where
hospital care and medical services will be provided only if 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
clarify, as requested by this comment, that appropriate healthcare
professionals can mean both VA and non-VA providers but are not making
any revisions to the regulations.
The definition of the term other health care plan contract as
proposed included language that stated such contracts did not include a
policy, contract, agreement, or similar arrangement pursuant to 10
U.S.C. chapter 55, which is the authority for the Department of Defense
TRICARE healthcare and insurance program. One comment requested a
revision to this definition to remove the exclusion related to 10
U.S.C. chapter 55, to permit VA to bill TRICARE for non service-
connected care provided under the VCCP. This comment asserted that VA
was not legally barred from treating TRICARE as a health care plan
contract for purposes of collecting reasonable charges for care or
services furnished under 38 U.S.C. 1729. We do not make changes based
on this comment, because we do not agree that section 1729 permits this
practice. The plain language of the statute does not support the
conclusion that VA may seek recovery from another Federal entity under
section 1729. Specifically, TRICARE is another Federal program and, as
such, does not meet the definition of ``health plan contract'' under
section 1729(i)(1)(A). Additionally, while the definition of ``third
party'' in section 1729(i)(3) includes a ``State or political
subdivision of a State[,]'' it does not include ``a Federal entity.''
Moreover, case law does not support the conclusion that VA may seek
recovery from another Federal entity under section 1729. In United
States v. Capital Blue Cross, the United States Court of Appeals for
the Third Circuit found that by excluding other Federal programs, such
as Medicare, from the reach of section 1729, Congress avoided the
``inefficient procedure of having one
[[Page 26281]]
arm of the federal government reimburse the another.'' 992 F.2d 1270,
1275 (3d Cir. 1993). Finally, the legislative history of 38 U.S.C. 1729
does not support the conclusion that VA may seek recovery from another
Federal entity under section 1729. See, e.g., H. Rep. 99-300, (finding
that no reimbursement could be obtained from Medicare or Medicaid by
VA). We note that this discussion of what is permissible under section
1729 does not prevent VA from billing DoD under agreements that control
the exchange of services under 38 U.S.C. 8111.
One comment requested a revision to the term residence to add
language that would clarify a residence as the place the covered
veteran stays on the date of the appointment. We do not make changes
based on this comment, as we believe the definition as proposed, which
defines a residence as where the covered veteran is staying at the time
they want to receive care or services, provides for the same outcome
without requiring constant monitoring by VA or updates by covered
veterans. A few comments communicated that individuals who maintain
more than one residence (the most common example provided was
maintaining a different residence in a warmer climate during winter
months, to accommodate health issues) can experience difficulties with
receiving non-VA care. These comments did not suggest changes to any of
the criteria or provisions in the proposed rule, so we are not making
any changes as a result. We believe it is sufficient to state that the
term residence in Sec. 17.4005 as proposed does not preclude covered
veterans from maintaining more than one residence at a time, but a
covered veteran may have one residence at a time. Such residence is
assessed in accordance with where the individual is physically staying
at the time the care or services are needed.
A few comments requested that VA add a definition of unusual or
excessive burden, to clarify how this term is used in the assessment of
whether the best medical interest eligibility criterion is met under
Sec. 17.4010(a)(5)(vii) as proposed. We do not make changes based on
these comments. This term has qualifying language in Sec.
17.4010(a)(5)(vii)(A)-(E) that we believe is sufficient to inform these
determinations, and we will address this qualifying language as raised
by comments more specifically in the section of this rule that
discusses eligibility.
One comment requested that VA add a definition for the term VA care
coordination team to provide examples of VA staff or clinicians who
comprise such a team. This comment requested this definition be added
because it was used in the preamble of the proposed rule to provide an
example of assessing when a covered veteran might be eligible for VCCP
under Sec. 17.4010(a)(1) as proposed, or eligibility when no VA
facility offers the care or services needed. We do not make changes
based on this comment. This term was used in the preamble of the
proposed rule to help provide background on the types of individuals
who might assist a covered veteran with understanding whether VA
facilities at large might not offer certain services (such as full
obstetrics care), but this term is not material to determinations of
eligibility under Sec. 17.4010(a)(1) and is not used in the regulatory
text, so its addition would be superfluous.
One comment stated that the term VA facility as defined in the
proposed rule was too broad to be useful for veterans to distinguish
between VA facilities, and suggested that VA should instead use: The
term center for non-medical facilities; the term hospital for full-
service facilities; and the term clinic for all medical service
facilities that are not full-service. We reiterate from the proposed
rule that the term VA facility references the types of care a facility
provides (i.e., hospital care, medical services, or extended care
services), rather than designations of VA facilities (such as a VA
medical center, or community-based outpatient clinic), to ensure that
any future re-designations of VA facility types would not result in a
gap in our regulations. If the public is interested in how VA currently
defines the scope of services available at different facility types,
Veterans Health Administration (VHA) Handbook 1006.02, VHA Site
Classifications and Definitions, should be instructive and is available
online. Additionally, we clarify that this term is relevant for
determinations of eligibility under Sec. 17.4010, and that such
determinations can only be consistently made with a broad definition
that references the types of care a facility provides rather than the
designation of a facility.
Lastly, one comment requested that the term VA medical service line
be revised to mean a clinic within a Department medical center, to
ensure that entire clinics could be designated as underperforming as
needed. While the commenter's suggestion would match the definition in
section 1703(o)(2), it would not clarify the meaning of that phrase for
purposes of this regulation, as we believe the proposed definition
does. The term clinic, in the context of health care, can have several
different meanings. Merriam-Webster, for example, defines a clinic in
the context of health care as a facility (as of a hospital) for
diagnosis and treatment of outpatients, as well as a group practice in
which several physicians work cooperatively. Merriam-Webster online,
https://www.merriam-webster.com/dictionary/clinic. The Cambridge
English Dictionary, alternatively, defines a clinic as a building or
part of a hospital where people go for medical care or advice.
Cambridge Dictionary online, https://dictionary.cambridge.org/us/dictionary/english/clinic. We believe these definitions reflect the
common understandings of the term clinic, as well as the ambiguity in
that term. In some contexts, a clinic is a physical structure, and in
others it is an organizational component of a larger institution. We
believe in the context of section 1703(o)(2) that the latter
interpretation is more reasonable, as it would be illogical for
Congress to define the term VA medical service line to mean a physical
structure within a larger physical structure. The very term service
line also reinforces conceptually that this authority is limited to a
group practice in which several physicians or clinicians work
cooperatively. VA policy also repeatedly uses the term service line to
refer to specific practice areas, such as cardiology, radiology,
oncology, and others. Each service line has different applicable access
standards or standards for quality for the purposes of assessing
underperformance under Sec. 17.4015 as proposed, which could serve as
a basis for eligibility for a covered veteran to participate in VCCP
under Sec. 17.4010(a)(6) as proposed. In this context, the definition
of VA medical service line as proposed, to be limited to a service or
set of services within a Department medical center, is more consistent
with the general meaning of the term, provides clarity as to the
intended effect of this provision, and more appropriately captures
those types of services that are actually underperforming and not other
services that could in fact be excelling. We note that it is
theoretically possible, however, for all VA medical service lines
within a clinic to be designated (depending on the organization of that
clinic, and the assessment of such medical service lines against VA's
standards, etc.), although we believe it would be unlikely that this
would actually happen.
Sec. 17.4010, Veteran Eligibility
We received over 18,000 comments concerning the criteria under
which VA determines a covered veteran may elect
[[Page 26282]]
to receive care and services under the VCCP. We address these comments
below in the order in which they raise issues related to provisions in
paragraphs (a)(1) through (6) of Sec. 17.4010 as proposed. We note at
the outset that the comments we received related to eligibility based
on designated access standards in Sec. 17.4010(a)(4) as proposed we be
addressed in the section of this document that discusses Sec. 17.4040
where such comments raised particular substantive issues related to the
access standards. We will only discuss access standards in relation to
Sec. 17.4010 below where comments raised broad versus specific
concerns regarding VA's establishment of such standards. We also note
that a majority of these comments are the result of a duplicated form
letter, within which at least one of the eligibility criteria from
Sec. 17.4010 as proposed was discussed.
We did not receive any comments that suggested changes to Sec.
17.4010(a)(1) as proposed, regarding a covered veteran being eligible
to receive care and services under the VCCP if no VA facility offered
such care or services. However, some comments seemed to assert that
this criterion could be unduly limiting if it was interpreted in a
manner that barred eligibility if a single VA facility offered such
care or services. One comment further requested clarification as to
whether the access-related eligibility criterion in Sec. 17.4010(a)(4)
as proposed would apply if the criterion in Sec. 17.4010(a)(1) was not
met. We clarify, by reiterating from the proposed rule, that the
criterion in Sec. 17.4010(a)(1) will not be used to limit access to
community care in instances where a single VA facility offers the care
or services required; in such a case, covered veterans will be assessed
under one of the other five eligibility criteria in Sec. 17.4010(a)(2)
through (6), for instance, the access-related criterion in Sec.
17.4010(a)(4). The criterion in Sec. 17.4010(a)(1) will function as a
unique qualifier for covered veterans that need certain types of care
that VA simply does not provide in any of its facilities (such as full
obstetrics care), and any covered veteran requiring such care or
services would not have to be assessed any further under other proposed
eligibility criteria for community care. We do not make any changes
based on these comments.
We received some comments related to Sec. 17.4010(a)(2), regarding
a covered veteran being eligible to receive care and services under the
VCCP if there is not a full-service VA medical facility in the State in
which the veteran resides. One comment seemed to oppose this criterion,
asserting that this eligibility criterion was inappropriate because it
did not consider full-service facilities across state lines that may be
accessible to veterans. Another comment seemed to support this
criterion, but also asserted that it was not appropriate because it did
not consider that in-state transit times vary by State. We clarify that
the criterion in Sec. 17.4010(a)(2) is an assessment of VA facility
locations within States, and does not consider transit times to
facilities, in accordance with section 1703(d)(1)(B). This criterion is
consistent with the statute, as well as prior VA practice in the
Veterans Choice Program. We do not make changes based on these
comments.
A few comments asserted that VA should not eliminate the 40-mile
distance eligibility criterion from the former Veterans Choice Program.
We interpret these comments to be expressing concern with the limited
grandfathering provision in Sec. 17.4010(a)(3)(ii) as proposed, where
the 40-mile criterion will be carried forward indefinitely for some,
but not all, covered veterans. We reiterate from the proposed rule that
the 40-mile grandfathering provision is consistent with 38 U.S.C.
1703(d)(1)(C), where such eligibility is carried forward indefinitely
for only those covered veterans that reside in Alaska, Montana, North
Dakota, South Dakota, or Wyoming and meet additional criteria. Any
covered veterans who do not reside in one of these States can only be
considered to have grandfathered eligibility related to the 40-mile
criterion until June 6, 2020. We therefore do not make any changes
based on these comments, although we note that other VCCP eligibility
criteria may apply for covered veterans after June 6, 2020, even if
they do not reside in the States identified for the indefinite
grandfathering provision.
Some comments objected to VA establishing any eligibility based on
access standards under Sec. 17.4010(a)(4) as proposed, suggesting
instead that VA community care should not have any qualifying
limitations related to VA's assessment of access. We do not make any
changes to Sec. 17.4010(a)(4) based on these comments. Congress
authorized veterans to elect to receive community care if VA was unable
to furnish care or services in a manner that complies with VA's
designated access standards under section 1703(d)(1)(D). Congress
further authorized the Secretary to establish access standards under
section 1703B. As explained in the proposed rule, as well as our report
to Congress, the Secretary is exercising his authority to establish and
designate access standards for purposes of eligibility. We reiterate
that we will discuss comments related to the substantive criteria of
the access standards themselves from in the section related to Sec.
17.4040 later in this document.
We received many comments related to the best medical interest
criterion in Sec. 17.4010(a)(5) as proposed. While some comments
merely sought clarification of this criterion, others asserted that the
covered veteran and his or her non-VA provider did not have enough
control in determining when the criterion could be met, and that a
determination by a non-VA provider that the criterion was met should
not be subject to VA's review or approval (specifically, over 18,000
comments received were duplicate form requests that VA should not
administratively or clinically review such determinations from non-VA
providers). Conversely, other comments asserted that VA must retain
review and approval for best medical interest determinations, or even
prevent such determinations from being made by non-VA providers. Other
comments more specifically suggested that certain conditions should be
found to create eligibility under this criterion. For instance, some
comments argued generally that a covered veteran's dissatisfaction with
care they received directly from VA in the past should meet the
criterion of best medical interest. Other comments suggested that
certain conditions or factors should be considered to constitute an
unusual or excessive burden as assessed under the best medical interest
criterion in Sec. 17.4010(a)(5)(vii), such as a veteran requiring
oxygen to travel, or a veteran having experienced military sexual
trauma.
We first address the issue within the comments concerning the level
of review or approval that may be required to find that a determination
of best medical interest has been met for purposes of eligibility for
VCCP. These comments offered opposing interpretations of whether VA
review or approval would (or should) be required to find that a
determination of best medical interest had been met. We believe these
opposing interpretations in the comments are due to an inconsistency
between the preamble explanation for Sec. 17.4010(a)(5) as published
in the proposed rule and the regulation text at Sec. 17.4010(a)(5) as
proposed. The preamble of the proposed rule contained language that
qualified a determination of best medical interest in Sec.
17.4010(a)(5), by stating that such a determination must be for the
purpose of the veteran achieving improved clinical outcomes by
receiving the care or services in the community versus
[[Page 26283]]
from a VA health care provider. In turn, the preamble of the proposed
rule further explained that the factors in Sec. 17.4010(a)(5)(i)-(vii)
as proposed would be considered in the context of clinical decision
making (where the referring clinician could be either a VA or a non-VA
clinician) to assess whether improved clinical outcomes would likely be
achieved by receiving care in the community.
Although the preamble explained that the qualifying language
related to a veteran's improved clinical outcomes would be in Sec.
17.4010(a)(5) as proposed, it was inadvertently omitted by VA in the
regulation text for Sec. 17.4010(a)(5). We clarify that VA intended
for this qualifying language to be in Sec. 17.4010(a)(5) as proposed
to allow VA to retain the ability to conduct a review of a best medical
interest determination made by a non-VA or a VA provider if such
determination did not appear to meet the standard for achieving
improved clinical outcomes. To clarify this intent, we revise Sec.
17.4010(a)(5) to add the qualifying language as stated from the
preamble of the proposed rule that best medical interest determinations
are made for the purpose of the veteran achieving improved clinical
outcomes. We believe this revision effectuates VA's intent as evidenced
in the preamble of the proposed rule. While we realize that this
revision does not establish an absolute VA review of best medical
interest determinations, and does not remove VA's review of these
decisions as suggested in some comments, we reiterate from the preamble
of the proposed rule that an assessment of best medical interest under
Sec. 17.4010(a)(5) is a clinical decision, and as such is made on a
case by case basis depending on the individual circumstances of a
covered veteran, to be guided by the factors further established in
Sec. 17.4010(a)(5)(i)-(vii). We believe that it is neither veteran-
centric nor administratively feasible for VA to regulate an absolute
requirement to review all determinations of best medical interest from
non-VA or VA providers. We do not make changes to add certain specific
qualifying conditions to Sec. 17.4010(a)(5) in response to comments
that requested VA consider specific conditions as meeting the best
medical interest criterion (as raised earlier, conditions such as a
veteran requiring oxygen to travel, or a veteran having experienced
military sexual trauma). We believe that the language in Sec.
17.4010(a)(5)(i)-(vii) is comprehensive to permit appropriate clinical
decisions on a case by case basis without being overly specific or
restrictive.
We received a few comments that requested clarification of how VA
would distinguish between a best medical interest determination that
may simply be for the convenience of the veteran (which was not
permitted under Sec. 17.4010(a)(5) as proposed), and a determination
of best medical interest based on an unusual or excessive travel burden
(which was permitted under Sec. 17.4010(a)(5)(vii)). One comment
further requested clarification of whether the undue or excessive
burden determination was clinical in nature, and whether it could
relate to the drive time access standard. To address the request to
clarify when the undue or excessive burden factors in Sec.
17.4010(a)(5)(vii)(A)-(E) might be met, we will not make changes from
the proposed rule, but we clarify that VA will work to develop guidance
for VA staff (that can be made available to VA and non-VA providers)
regarding how VA will interpret the factors to ensure there is a
consistent understanding of how the undue or excessive burden
considerations are assessed and applied. As a general example, a
covered veteran who requires physical therapy multiple times a week in
relation to a neck injury might be considered eligible under the
criterion in Sec. 17.4010(a)(5)(vii)(C), if the veteran's injured neck
is a medical condition that affects his or her ability to travel even
short distances. In such a case, it would not be for the mere
convenience of this veteran to be seen in the community at a location
that would be closer to their residence.
We further clarify, without making changes to Sec.
17.4010(a)(5)(vii), that the unusual or excessive burden assessment
would ultimately be a clinical determination, as we previously
clarified that the overarching best medical interest criterion is met
when it is clinically determined that a covered veteran could be
expected to experience improved clinical outcomes. Lastly, we clarify
without changes that the unusual and excessive burden factors in Sec.
17.4010(a)(5)(vii)(A)-(E) are independent of the access standard
eligibility in Sec. 17.4010(a)(4) and the standards themselves in
Sec. 17.4040; the undue and excessive burden factors might qualify a
veteran for VCCP, even if the access standard related to average drive
time might not be met. For example, a covered veteran could require
daily dialysis care that could be furnished at a VA facility that is 29
minutes away from the veteran's residence by average drive time. If VA
could furnish the care within the wait-time standard in Sec. 17.4040,
this veteran would not qualify under Sec. 17.4010(a)(4). However,
given the need for daily travel and the effect of travel for nearly an
hour in transit every day, the veteran and the provider could determine
it is in the best medical interest of the veteran to receive this daily
dialysis care through the VCCP at a non-VA facility that is only a
five-minute average drive from the veteran's home.
We received one comment related to Sec. 17.4010(a)(6) as proposed,
regarding a covered veteran being eligible to receive care and services
under the VCCP if VA determined that a VA medical service line that
would furnish the care or services the veteran requires is not
providing such care or services in a manner that complies with VA's
standards for quality. This comment asserted that VA should revise this
eligibility criterion to be discretionary and not mandatory, to be
consistent with 38 U.S.C. 1703(e), which is the statutory provision
related to discretionary eligibility based on a finding that a VA
medical service line is not providing care that complies with the
standards for quality VA further establishes under section 1703C. We
agree section 1703(e) authorizes and does not mandate the furnishing of
care when VA medical service lines are underperforming, but we do not
read our regulations in Sec. Sec. 17.4010(a)(6) and 17.4015 as
proposed to collectively to eliminate that discretion. Section 17.4015
permits, but does not require, the Secretary to identify
underperforming VA medical service lines. It further permits the
Secretary to establish limitations or conditions on the ability of
veterans to elect to receive care and services in the community. If the
Secretary makes a determination under Sec. 17.4015 and identifies
underperforming VA medical service lines and the conditions under which
covered veterans seeking care or services from such a medical service
line can elect to receive care in the community, then Sec.
17.4010(a)(6) would apply and covered veterans could elect to receive
care or services in the community consistent with the Secretary's
determination. Sections 17.4010(a)(6) and 17.4015 therefore effectively
preserve the discretionary nature of section 1703(e). We will address
comments related to the establishment of or notice procedures for VA's
standards for quality in the portion of the final rule that discusses
Sec. 17.4015.
We received one comment that requested clarification of VA's
rationale to require a covered veteran to submit to VA information
related to a change in the veteran's address in Sec. 17.4010(b) as
[[Page 26284]]
proposed, and information on any other health-care plan contract under
which the veteran is covered prior to obtaining authorization for care
and services the veteran requires. We reiterate from the proposed rule
that this information is required so that VA may make accurate
eligibility determinations under Sec. 17.4010(a)(2)-(6) that rely on a
veteran's place of residence, and so that VA can continue to recover or
collect reasonable charges for care and services furnished in the
community for a non-service connected disability from a health plan
contract, consistent with section 1703(j). We further note that
veterans are required to submit information regarding other health
insurance under section 1705A. Related to this comment concerning the
provision of information by the covered veteran, one comment asserted
that VA should make VCCP use conditional on the covered veteran's
acceptance of an automatic release of their medical information to non-
VA providers. The commenter asserted that this was necessary because it
was inefficient to require veterans to authorize individual releases of
their medical information, or to rely on non-VA providers to attest
that records were received. We do not make changes based on this
comment. VA currently has the authority to release veteran medical
information for treatment purposes without the written consent or
authorization of the veteran under applicable statutes and their
implementing regulations (see 38 U.S.C. 7332(b)(2)(H)). Therefore,
there is no need to require veterans to authorize individual releases
of their medical information if a veteran is receiving treatment using
VCCP.
Section 17.4010(d) as proposed established that eligibility
determinations for covered veterans to receive hospital care, medical
services, or extended care services through the VCCP would be subject
to VA's clinical appeals process, and not be appealable to the Board of
Veterans Appeals. We received some comments that suggested these
eligibility decisions should be appealable to the Board. We make no
changes based on these comments, as section 1703(f) expressly provides
that these eligibility decisions be subject to VA's clinical appeals
process and not be appealable to the Board of Veterans' Appeals. Other
comments did not request revisions to Sec. 17.4010(d) per se, but did
suggest that VA's appeals process should be comprehensive, and more
specifically that VA should develop a unique process within its
clinical appeals process, to ensure that individuals adjudicating the
VCCP eligibility determinations are not the same VA facility or VISN
staff that made the initial eligibility determinations. We clarify that
VA's current clinical appeals process can be found in VHA Directive
1041, Appeal of VHA Clinical Decisions, which can be found on VA's
website and provides for a comprehensive process of appealing clinical
decisions that includes elevating disputes beyond initial staff-level
determinations.
Lastly, one comment raised several concerns about different
provisions discussed in the proposed rule that potentially related to
eligibility, based on several assertions: First, the comment asserted
that VA's proposed rule would limit eligibility for VA community care
to only certain service-connected veterans, or veterans with only
certain discharges from active service; second, the comment asserted
that the rule would limit eligibility for care for a recently
discharged veteran to 12 months; and third, the comment asserted that
veterans should be treated for service connected disabilities
regardless of their character of discharge. All of the provisions cited
in this comment refer to other provisions of law unaffected by VA's
rule, namely Sec. 17.46 (concerning the first issue identified above),
which we are making no longer effective; section 1705(c)(2), which
authorizes VA to furnish care notwithstanding a veteran's failure to
enroll (concerning the second issue identified above); and section
5303(a), which statutorily limits VA's ability to furnish benefits to
certain persons. Because these authorities are either being made
ineffective through this rule (in the case of Sec. 17.46) or are
statutes that were unaffected by this rule (in the case of section
1705(c)(2) and section 5303(a)), we do not make changes based on this
comment.
Sec. 17.4015, Designated VA Medical Service Lines
We received over 25 comments concerning the process by which VA
would designate those VA medical service lines that were not able to
furnish care or services in a manner that complied with VA's standards
for quality, so that covered veterans who would receive care or
services through such VA medical service lines would be eligible for
the VCCP. We address these comments below in the order in which they
raise issues related to the provisions in paragraphs (a)-(e) of Sec.
17.4015 as proposed.
As a general matter, one comment suggested that any proposal to
eliminate entire service lines at VA facilities should not be
implemented. We clarify that no provision in the proposed rule sought
to eliminate VA medical service lines at VA facilities. Section 17.4015
as proposed sought to establish criteria by which VA would assess VA
medical service lines within its facilities to determine if they were
underperforming. If such medical service lines were so identified, then
Sec. 17.4010(a)(6) as proposed would allow covered veterans to elect
to receive the care or services they would have received under those
underperforming VA medical service lines through the VCCP. We do not
make any changes to the proposed rule based on this comment. We note
that section 1706A, as added by section 109 of the MISSION Act,
expressly requires remediation of any VA medical service lines
identified under this criterion, and as we discussed near the
conclusion of the preamble to the proposed rule, VA's remediation
efforts will not be limited to just those medical service lines
designated under Sec. 17.4015. These remediation efforts are intended
to bolster and support VA's medical service lines.
We received multiple comments related to Sec. 17.4015(a) as
proposed, concerning VA's basic parameters for identifying its
underperforming medical service lines. First and most generally, one
comment requested that VA revise paragraph (a) to make this provision
mandatory by using the word ``shall'' instead of ``may''; in the
alternative, the commenter suggested that VA must otherwise clarify if
it interprets the quality monitoring mandates imposed by section
1703(e) and 1703C to be optional. We do not make changes based on this
comment and clarify that not all provisions in the MISSION Act require
VA to take action. VA used the term ``may'' in Sec. 17.4015(a) as
proposed because VA is not required, and may be practically unable, to
identify any VA medical service line as underperforming, and
consequently, it may be the case that no covered veterans qualify for
community care under this criterion. We also, as noted above, allow the
Secretary to place conditions or limitations on the ability of covered
veterans to elect to receive care under this criterion.
One comment requested that VA revise Sec. 17.4015(a) to provide
for a comparison of timeliness between VA and non-VA medical service
lines, as this comparison of timeliness is not expressly prevented by
section 1703 or 1703C. We do not make changes based on this comment, as
the comparison of timeliness between only VA medical services lines is
consistent with section 1703(e)(1)(B)(i). We further note,
[[Page 26285]]
however, that Sec. 17.4015(a) identifies timely care as the first
domain of care, and hence the timeliness of care with non-VA service
lines would be considered indirectly.
We received multiple comments related to VA's standards for quality
themselves, a majority of which we interpret as beyond the scope of the
proposed rule because such standards are to be established and
announced via a separate process in the Federal Register, as stated in
the proposed rule. However, we summarize those comments here as they
could be interpreted to apply to Sec. 17.4015(a) as proposed, and that
paragraph's express statements of using VA's standards for quality to
determine when VA medical service line are underperforming. Multiple
comments argued that VA should not use VA's standards for quality, but
rather should use existing industry standards related to quality
monitoring (such as the National Committee for Quality Assurance's
Healthcare Effectiveness Data and Information Set, or Centers for
Medicare and Medicaid Services Merit-Based Incentive Payment System),
versus developing VA-based quality measures as indicated in Sec.
17.4015(a) as proposed. One comment more specifically requested that VA
revise Sec. 17.4015(a) accordingly to reflect that VA will use
industry standards for quality. Conversely, other comments suggested
that there seemed to be a deficiency of reliable data available to VA
that is related to quality measures or metrics concerning non-VA
providers; one comment further stated that until non-VA providers are
able to produce comparative data to be used in assessing VA medical
service lines, VA should only use its data to identify and remediate
its medical service lines. Other comments more specifically recommended
that VA use its existing tools such as VA's Strategic Analytics for
Improvement and Learning tool to identify its underperforming service
lines. Some of these comments further stated that VA should consider
unique veteran populations when developing standards, with one comment
requesting that VA require vascular surgery quality outcomes to be
assessed to ensure non-VA outcomes match VA outcomes. Other comments
did not suggest a particular approach regarding the use of VA or non-VA
quality measures, but rather requested clarification of what quality
measures or metrics VA would use. We do not make changes to Sec.
17.4015(a) based on these comments, but we reiterate from the proposed
rule that VA's standards for quality will be announced through a
separate document published in the Federal Register as set forth in
Sec. 17.4015(c) as proposed. We do note that VA's proposed standards
for quality, as submitted to Congress in a report earlier this year,
focused on the framework for quality identified by the National Academy
of Medicine.
We did not receive any comments on Sec. 17.4015(b) as proposed and
are not making any changes from the language we proposed.
We received a few comments related to VA providing notice of its
standards for quality once established, as well as comments on other
provisions set forth in Sec. 17.4015(c) as proposed. At the outset, we
note that multiple comments urged VA to publicly release VA's report
detailing its standards for quality that was submitted to Congress on
March 4, 2019. We do not make changes to Sec. 17.4015(c) based on this
comment, as we believe Sec. 17.4015(c) makes adequate provision for
public notice of the standards of quality.
Section 17.4015(c) as proposed contained language to establish
potential limitations of when and where covered veterans could receive
qualifying non-VA care and services at their election based on VA's
identification of its underperforming medical service lines. These
possible limitations on receiving qualifying non-VA care included a
limitation by defined geographic area. We received one comment that
stated this language implied that VA will interpret its standards for
quality based on a regional geographic standard versus a national
standard and asked that VA clarify whether this is the case. We clarify
that while VA will have national standards for quality, VA's quality
comparisons will generally be based on care that is locally available
and not on national averages. It would be of little use to patients in
a particular area or region to have VA care that is locally available
to them compared to care that is not locally available. The language in
Sec. 17.4015(c) related to limitations (including the limitation based
on geographic area) therefore serves to alert covered veterans that the
qualifying non-VA care they may elect to receive may be limited in its
location, in the type of care that may be received, etc., as it would
be offered as an option to the specific care that would be designated
in the specific VA medical service line that VA would have identified
as underperforming. We do not make changes based on this comment.
A few comments requested clarification of whether direct notice to
covered veterans of underperforming VA medical service lines, as set
forth in Sec. 17.4015(c) as proposed, would include other than
electronic communication (to include notification by mail, phone, etc.,
as well as a Federal Register document). A related comment requested
that VA ensure non-VA providers are provided the direct notice VA would
conduct when making determinations under Sec. 17.4015(c) on VA medical
service lines. We do not make changes based on these comments. We
reiterate from the proposed rule that VA will take reasonable steps to
provide direct notice to covered veterans affected under this section
to include written correspondence, electronic messages, or direct
contact (in person or by phone). We do not believe it necessary to
regulate VA's notice to community providers.
A few comments requested that VA revise Sec. 17.4015(d) as
proposed to permit VA to identify more than three underperforming VA
medical service lines and more than 36 underperforming VA medical
service lines nationally. One comment stated that there should be no
limit on the number of designated VA medical service lines per facility
or the total number nationally that could be designated as
underperforming, and one comment urged VA to seek a legislative fix to
allow VA to designate more than 36 VA medical service lines nationally.
We do not make changes based on these comments, as VA is limited by
statute to designating no more than three service lines per facility
and 36 service lines nationally, in accordance with section
1703(e)(1)(C). As the comment indicates, any resolution to allow more
than the permitted number of VA medical service lines to be designated
would require Congressional action and therefore is beyond the scope of
the proposed rule.
Multiple comments raised issues related to the factors VA would
consider when determining whether its medical services lines would be
identified as underperforming, as set forth in Sec. 17.4015(e) as
proposed. One comment noted that VA should limit comparison of
underperforming VA medical service lines against only similarly
underperforming non-VA medical service lines (and further, only those
non-VA underperforming medical service lines that are accessible to
covered veterans), to ensure that a covered veteran would not have the
option to choose to receive lower quality care from a non-VA medical
service line than a VA medical service line. Another comment asserted
that VA must consider whether non-VA medical
[[Page 26286]]
service lines would be able to provide the same type of care or better
care before designating a VA medical service line as underperforming.
We interpret these comments to be related to Sec. 17.4015(e)(1) as
proposed, as the general paragraph that would establish whether
differences in performance between VA and non-VA medical service lines
were clinically significant. We do not make any changes to Sec.
17.4015(e)(1) based on these comments. The language in Sec.
17.4015(e)(1) provides that VA will compare performance of its medical
service lines against the performance of non-VA medical service lines
to identify VA deficiencies. By the time VA is determining whether the
differences in performance are clinically significant, it will have
already assessed the quality of VA's medical service and non-VA medical
service lines and identified that there is in fact a difference. We
also reiterate from the proposed rule that the language related to
clinical significance in Sec. 17.4015(e)(1) would allow VA to
appropriately discern differences in performance between VA and non-VA
medical service lines to determine if VA medical service lines were
underperforming. Determinations regarding performance will be made
locally and should generally result in veterans being able to access
better quality care in the community than they would receive from
service lines designated as underperforming.
We received a few comments related to the factor in Sec.
17.4015(e)(2) as proposed, that VA would consider the likelihood and
ease of remediation of the medical service line within a short
timeframe when determining whether it was underperforming. We reiterate
from the proposed rule that the intent of this factor is to allow VA to
designate as underperforming those medical service lines in need of the
kind of intensive remediation envisioned by section 1706A, and not
necessarily those medical services lines where a simple action (such as
the purchase of new equipment) is likely to occur and would be
sufficient to remediate underperformance. One comment requested that VA
revise this factor in Sec. 17.4015(e)(2) to permit a temporary
designation of a VA medical service lines that may only require simple
actions likely to occur in a short timeframe, to prevent scenarios in
which veterans would receive what the comment asserted would be
substandard care even if on a temporary basis. We do not make changes
based on this comment. We do not agree with the comment's equating of
potential temporary underperformance of a VA medical service line with
delivery of substandard care. Further, we reiterate from the proposed
rule that Sec. 17.4015(e)(2) is necessary to allow VA to be selective
in engaging in remediation that will require allocation of VA
resources. We further note that, in such temporary situations, covered
veterans might still be eligible to receive care in the community under
the best medical interest criterion in Sec. 17.4010(a)(5), which may
provide more nimble and timely access to care than the designation of a
VA medical service line under Sec. 17.4015. A related comment
requested clarification of the effect of the factor in Sec.
17.4015(e)(2), more specifically whether VA intended this factor to be
used to identify only those medical service lines that could be
remediated easily. We clarify that this is not the intent of Sec.
17.4015(e)(2); to the contrary, we reiterate from above that this
factor should allow VA to designate as underperforming those VA medical
service lines in need of the kind of intensive remediation envisioned
by section 1706A, and not necessarily those services lines where a
simple action is likely to occur and would be sufficient to remediate
underperformance. As other commenters noted, VA is limited to the
number of VA medical service lines it can designate nationally and at
any particular facility. It would be a poor use of this authority to
waste one of those limited opportunities to designate a VA medical
service line that could be improved easily and quickly.
We received one comment that requested VA provide more information
on why data that may be required to assess the performance of VA and
non-VA medical service lines could take as long as 18-24 months to
collect or analyze, particularly if such data may already be collected
by VA related to the performance of its medical service lines. The
comment further urged VA to take steps to shorten this timeframe, to
prevent scenarios where a covered veteran may receive what the
commenter deemed sub-standard care for an extended time while VA
determines whether its medical service lines are underperforming. We
believe this comment is referring to the portion of the proposed rule
that explained Sec. 17.4013(e)(3), which is the factor that would
permit VA to consider recent trends concerning a VA or non-VA medical
service line when determining if a VA medical service line is
underperforming. The preamble of the proposed rule provided that the
process to gather, analyze, and verify quality data could take as long
as 18-24 months, and for this reason VA needed a factor that would
permit it to consider more contemporaneous information to determine
whether one of its medical service lines was underperforming. These
data are inherently time-lagged, as much of the data we use is
collected and reported by other entities (such as Medicare). Moreover,
it may take months to collect enough data to support valid conclusions;
small sample sizes are inherently unreliable, and if a particular VA
medical service line simply does not furnish care to that many
patients, it could take some time to generate enough cases to produce
reliable results that would be actionable. We again reiterate, though,
that covered veterans could still access care in the community under
any of the five other eligibility criteria in Sec. 17.4010, including
the best medical interest criterion under Sec. 17.4010(a)(5). We
believe that Sec. 17.4015(e)(3) as proposed actually resolves the
concern in the comment, because it expressly allows VA to consider
contemporaneous information, and we make no changes based on this
comment.
We received one comment that urged VA to remove the designation
factor in Sec. 17.4015(e)(6) as proposed, related to considering the
effect that designating a VA medical service lines would have on other
VA medical service lines. The comment characterized this factor as a
loophole that would allow underperforming VA medical service lines to
avoid designation, due to the negative effects such designation would
have on other medical services lines. We disagree with the comment's
characterization of this factor. We do, however, maintain that this
factor is critical to allow VA to be selective in its designations,
particularly for medical service lines whose designation may be more
vastly disruptive, both to other VA medical service lines and other
programs, than we believe is the intent of identifying any
underperforming VA medical service lines under section 1703(e)
generally. We do not make changes based on this comment.
We received a few comments that did not seem clearly related to any
of the factors in Sec. 17.4015(e)(1)-(6) as proposed, but that
suggested clarifications or potential changes to Sec. 17.4015(e) based
on particular services or particular veteran populations. One comment
requested that VA clarify to what extent extended care services could
be an underperforming medical service line, and another comment urged
VA to consider the unique needs of women veterans in designating VA
medical service lines as
[[Page 26287]]
underperforming. We do not make changes to Sec. 17.4015(e) based on
these comments but do clarify that the rule does not place any
limitations on what type of VA medical service lines may be designated,
so such VA medical service lines could be those that provide extended
care services (e.g., geriatrics) if VA finds them to be
underperforming. Additionally, we believe that Sec. 17.4015(e) as
proposed gives VA the latitude to consider all veteran populations,
including women veterans, and we agree that VA should consider the
unique needs of veteran populations when determining whether its
medical service lines are underperforming.
Lastly, we received a few comments that urged VA to develop and
make public a dataset that compares providers, facilities, and
practices based on VA's standards for quality, to provide covered
veterans with additional information they may use when determining
whether to elect to receive care in the community. We do not make any
changes based on these comments but note that we address VA's
communication of comparative information to inform health care
decisions in the portion of this final rule that discusses
miscellaneous comments.
Sec. 17.4020, Authorized Non-VA Care
We received over 100 comments concerning the process and
requirements for authorizing non-VA care under the VCCP. We address
these comments below in the order in which they raise issues related to
the provisions in paragraphs (a)-(d) of Sec. 17.4020 as proposed
(including VA's supplemental notice of proposed rulemaking related to
transplant care). We note that some of these comments did not suggest
changes to the regulation text in Sec. 17.4020 as proposed, and
further raised issues that were related more to administrative process
rather than the regulatory requirements under which VA will authorize
care. We will address below only those issues raised in comments
regarding VA's requirements and authorities to authorize non-VA care as
proposed and will address other issues related to administrative
process in another section of this final rule related to miscellaneous
comments.
We did not receive comments to revise a covered veteran's election
to receive care under the VCCP should they be so eligible, under Sec.
17.4020(a) as proposed. We do reiterate, however, in response to many
comments that expressed concerns related to the effects of expanding
non-VA care on VA's direct provision of care, that Sec. 17.4010(a)
requires a veteran's election to receive non-VA care under the VCCP; VA
does not force covered veterans to receive non-VA care.
Several comments did request clarification or revision of VA's
authorization of care and services to be furnished through the VCCP if
the covered veteran elects to receive such care, under Sec. 17.4020(a)
as proposed. Some of these comments broadly opposed VA's specific
authorization of care and services, for instance, those comments that
asserted that a veteran's VA identification card should be all that is
required to present to obtain care without further review or
authorization requirements. Other comments were more specific, for
instance, that VA should reduce or eliminate the requirement for VA
authorization of care or services from approved non-VA providers who
have a record of effective and efficient care within the Veterans
Choice program. Still other comments further advocated that VA should
eliminate the requirements for additional authorizations that may be
required within an episode of care (referred to as secondary
authorizations) because they were concerned that these authorizations
could unduly delay the provision of care or services, such as
additional testing that may be found to be required. One comment more
specifically requested that any authorization of an episode of care
that includes a surgical procedure should automatically cover any other
care furnished during that procedure, and a related comment even more
specifically requested that VA should require that follow up care for
vascular surgical procedures (particularly imaging) be provided by the
same non-VA vascular surgeon who provided the initial care or services
to the covered veteran. We do not make changes based on these comments.
We reiterate from the proposed rule that, in accordance with
section 1703(a)(3), VA is required to authorize care or services that a
covered veteran might elect to receive through the VCCP. This
authorization of care and services covers an episode of care that may
last up to one year, but only for care and services that are within the
scope of the care or services initially authorized. VA has developed a
process to facilitate access to necessary and ancillary services within
an episode of care; we refer to these authorizations as standard
episodes of care (SEOC). VA uses SEOCs to bundle services that are
necessary and related so that referrals between different specialists
are more easily facilitated and so that all specialty and ancillary
services are included within the episode of care. For example, a
veteran in need of knee replacement surgery would be authorized through
a SEOC for pre- and post-operative examinations, the surgery itself,
and physical therapy. The same would follow for a veteran in need of
vascular surgery, as raised by the comment described above, for all
specialty care and ancillary services that would reasonably be expected
to be medically necessary after the surgery itself. However, the
regulation will not prescribe at so granular a level, for instance,
automatic approvals for particular follow-up care or for care to be
provided by the same providers that initially performed surgical
procedures. Requests for authorization of services outside the SEOC
further allow VA to assess the need for care or services recommended by
a non-VA provider, and whether these services fall within the approved
episode of care or whether they constitute a new episode of care.
Several comments asserted that a covered veteran's selection of a
provider in Sec. 17.4020(b) as proposed did not actually ensure that a
covered veteran could see his or her provider of choice. The primary
reasons offered for why providers of choice were not available were
that delays in VA's payment of claims, or other complications
associated with VA's administration of its community care programs,
created too many disincentives for non-VA providers to participate in
such programs. We will address these comments, as well as other
comments regarding VA's administration of its community care programs,
in another section of this final rulemaking related to miscellaneous
comments. However, we do note that even setting aside these operational
concerns, VA cannot compel a private provider to furnish care and
services to a covered veteran. If the covered veteran identifies a
particular entity or provider as his or her preferred source of care,
and if that provider or entity is within VA's network and accessible to
the covered veteran, we would refer the veteran to that entity or
provider. If the identified provider is not part of VA's network and
does not wish to become part of VA's network (and VA cannot otherwise
secure the care through a sharing agreement, other arrangement, or
Veterans Care Agreement), VA cannot compel that provider to treat the
covered veteran. We do not make any changes to Sec. 17.4020(b) as
proposed based on these comments.
A majority of the comments VA received related to Sec. 17.4020 as
proposed raised issues related to emergency care that may be authorized
by VA as set forth in Sec. 17.4020(c) as
[[Page 26288]]
proposed. We reiterate that we will address below only those issues
raised in comments regarding VA's requirements and authorities to
authorize emergency care as set forth in Sec. 17.4020(c), and we will
address issues related more to administrative process of VA approving
emergency care in another section of this final rule related to
miscellaneous comments.
We received a few comments that requested VA clarify any potential
intersection or sharing of assessment criteria or other standards
between emergency care furnished under the VCCP and emergency care
separately furnished under 38 U.S.C. 1725 and 1728. We interpret these
comments to be related to Sec. 17.4020(c) as proposed, as paragraph
(c) established that it did not affect eligibility for, or create any
new rules or conditions affecting, reimbursement for emergency
treatment under sections 1725 or 1728. These comments ranged in their
primary concerns for identifying the relationships between emergency
care offered under different VA authorities. For instance, one comment
wanted clarification of the reasonableness standard that would be
applied under the VCCP to determine whether care or services were
emergent in nature, and further advocated that the prudent layperson
standard should be applied (specifically, to include post-
stabilization). Another comment requested clarification of the
relationship between the varying emergency care authorities to ensure
that covered veterans would understand when VA will likely authorize
emergency care and reimburse for such care, versus the veteran possibly
being liable. We do not make changes based on these comments.
We believe that Sec. 17.4020(c) is sufficient to indicate that
emergency care furnished through the VCCP is distinct from and does not
affect emergency care provided under sections 1725 or 1728. We do
clarify, however, that because paragraph (c)(1) of Sec. 17.4020 does
reference section 1725(f)(1) to define emergency treatment, VA will use
the prudent layperson standard as interpreted through section 1725. We
understand this clarification that VA will use its section 1725 prudent
layperson for emergency treatment furnished through the VCCP is not
what was requested by the comment, which asserted that this very
standard permitted VA to review decisions of reasonableness instead of
VA using what would perhaps be considered a broader industry standard
(for instance, as referenced by the comment to a Centers for Medicare
and Medicaid Services standard of prudent layperson in 42 U.S.C. 300gg-
19a(b)(2)(A)). However, we believe VA's prudent layperson standard is
reasonable to administer the furnishing of emergency treatment through
the VCCP. This same comment also requested that VA revise Sec.
17.38(a)(1)(iv) to expressly provide that emergency care under VCCP is
part of the medical benefits package. We agree and are revising Sec.
17.38(a)(1)(iv) accordingly. We believe this change will assist
individuals in understanding that emergency care provided under the
VCCP is separate from that provided under sections 1725 and 1728 and is
a covered benefit under the VCCP.
We received a comment that requested VA clarify that the term
emergency treatment includes mental health care, which we interpret to
be related to Sec. 17.4020(c)(1) as proposed as this paragraph
referenced the definition of emergency treatment in 38 U.S.C.
1725(f)(1). We do not make changes based on this comment, as we believe
the reference to the definition of emergency treatment in section
1725(f)(1) is sufficient to indicate that mental health services are
considered within the scope of emergency treatment. Section 1725(f)(1)
refers to medical care or services furnished in an emergency. We have
interpreted this to apply to any care or services within VA's medical
benefits package, which includes mental health services, as identified
in Sec. 17.38(a)(1)-(2).
Comments generally stated that the 72-hour rule in Sec.
17.4020(c)(2) as proposed was not reasonable. Primarily, these comments
asserted that the 72-hour timeframe was too short or did not provide
exceptions where it may be exceeded. There were multiple reasons
provided in the comments to support that the 72-hour rule should have
exceptions, which we summarize and respond to below. We note that some
of these reasons raise issues related to requirements in Sec.
17.4020(c)(3) and (4) as proposed, related to requirements for approval
and notice to VA, respectively.
One comment stated that Sec. 17.4020(c) as proposed did not
reflect what the comment asserted was the current regulatory option for
an exception to the 72-hour rule, to provide VA notice within a
reasonable amount of time after the emergency care was furnished. We
note that no such exception exists in current regulation under Sec.
17.54, and we see no reason to add such an exception here, as this rule
would only apply to covered veterans and eligible entities or
providers.
Other comments offered reasons to establish exceptions to the 72-
hour rule that were related to veterans or non-VA providers not
understanding what VA facility should receive the notice or who to
contact at such VA facility. Some of these comments more specifically
noted that neither the appropriate VA official nor the nearest VA
facility in Sec. 17.4020(c)(4)(i) as proposed were clearly defined or
characterized, particularly in instances where a veteran might be
traveling and not be familiar with VA facility locations, or non-VA
providers may not be familiar with VA facilities in their area. Some of
these comments further requested clarification of who is considered an
appropriate VA official, or requested that VA revise the requirement to
allow notice to be delivered to any VA facility. As we explained in the
proposed rule, only eligible entities or providers who have a contract
or agreement to furnish care on VA's behalf may furnish care under
Sec. 17.4020(c). While veterans who are traveling may not know the
local VA facility, we are confident that each community entity or
provider in our network will know the right VA facility to contact.
Other comments offered reasons to establish exceptions to the 72-
hour rule that were related to the nature of receiving emergency care
or services. For instance, these comments asserted that in many cases a
covered veteran seeking emergency care will be in a compromised medical
state, and therefore should not be expected to understand whether they
are seeking care from authorized entities or providers, or to
understand whether all care offered might be covered by the medical
benefits package.
Still other comments argued that exceptions are needed due to other
circumstances, such as when the nearest VA facility might be closed
after business hours or on holidays (to create delays in meeting the
72-hour rule), or when 72 hours may simply not be enough time for a
non-VA provider to have obtained all information required under Sec.
17.4020(c)(4) (for instance, if a covered veteran presents for
emergency treatment without identification). One of these comments
further requested that VA revise the rule so that the 72-hour period
would not begin until the later of when the entity or provider began
furnishing the care or the time when a reasonably diligent non-VA
entity or provider would have the information necessary to submit a
notice to VA in compliance with Sec. 17.4020(c)(4).
We do not make any changes based on these comments to create
exceptions to the 72-hour rule in Sec. 17.4020(c)(2) as proposed. We
reiterate from the
[[Page 26289]]
proposed rule that the 72-hour requirement is consistent with the
window for approval under existing Sec. 17.54(a), and we believe the
72-hour requirement continues to be a reasonable timeframe to allow
notification upon stabilization of the patient or upon the next
business day in the overwhelming majority of cases. VA will work to
improve its communication materials for both veterans and eligible
entities and providers concerning who may receive the notice and at
what VA facility, without making changes to Sec. 17.4020(c)(2) through
(4). We believe this improved communication will assist with effective
and timely provisions of notice within the 72-hour requirement. We also
clarify that if the 72-hour window is not met, VA will consider any
claims for reimbursement of the costs of the emergency treatment under
other authorities, specifically sections 1725 and 1728, which authorize
reimbursement of certain non-VA emergency treatment; there is no 72-
hour requirement under either of these other authorities, but we do
request notification under these authorities as soon as possible in the
interest of coordination of care. We note that a veteran's personal
financial liability, if any, could vary depending upon whether the care
is authorized under section 1703 under the 72-hour rule or reimbursed
under sections 1725 or 1728.
One comment requested that VA clarify if it will define someone
acting on the covered veteran's behalf in Sec. 17.4020(c)(2), or if VA
will provide an exception to automatically approve care if a covered
veteran is incapacitated (or, conversely, if VA will apply what the
comment asserted was the current VA emergency room standard to non-VA
emergency rooms). We do not make any changes based on this comment, as
we believe the issues raised may be conflating the concept of a covered
veteran's consent to receive emergency treatment with VA's approval of
such treatment furnished through the VCCP.
One comment requested that VA revise Sec. 17.4020(c) to permit
that two emergency room visits be permitted through the VCCP at no
charge to covered veterans. We interpreted this comment to be raising
issues more related to VA's administration of its approval of emergency
treatment, because it relayed concerns that covered veterans were
unduly subject to cost liabilities for emergency treatment that the
comment asserted VA failed to approve or pay timely. We will therefore
address this comment in the section of this final rule that pertains to
miscellaneous comments, although we do clarify here that Sec.
17.4020(c) as proposed does not limit the number of visits to an
emergency room for a covered veteran to receive emergency treatment
through the VCCP.
Lastly, one commenter asserted that VA should add urgent care in
addition to emergency treatment as available care and services under
the VCCP. We do not make changes based on this comment but do clarify
that VA is promulgating separate regulations, published elsewhere in
this issue of the Federal Register, to furnish urgent care through non-
VA providers (see RIN 2900-AQ47, published as a proposed rule on
January 31, 2019 (84 FR 627)).
On April 5, 2019, VA published a Supplemental Notice of Proposed
Rulemaking (SNPRM) to amend VA's proposed rule by proposing a minor
revision to paragraph (a) and a new paragraph (d) to account for
section 1703(l) and its language concerning organ and bone marrow
transplants. 84 FR 13576. VA received 10 comments on this SNPRM. One
comment was a request for case management assistance, which VA has
addressed but which was beyond the scope of the rulemaking. We make no
changes based on this comment. Four comments supported the changes
proposed by the SNPRM. We make no changes based on these comments. One
comment raised concerns regarding billing and payments for community
providers. The commenter stated that clear definitions of how payments
will be processed and paid between VA and the community providers is
important to minimize any confusion in the billing process. The SNPRM
did not address claims or billing issues because these were separately
addressed in Sec. 17.4035 of the proposed rule. We received comment on
the proposed rule regarding billing and claims payment, which we
address more fully below. In brief, however, we do not regulate VA's
process for claims submissions or billing at this time. VA contracts
and agreements will establish these requirements between the parties,
and rules of general applicability, particularly regarding prompt
payment, will be regulated at a later time. We make no changes based on
this comment.
One commenter requested that VA provide examples of medically
compelling reason for a veteran to seek transplant services outside of
the Organ Procurement and Transplantation Network (OPTN) region in
which the veteran resides. We do not make changes based on this comment
but clarify that examples of medically compelling reasons were provided
in Sec. 17.4020(d)(2)(i) through (iv) as proposed and were discussed
in the SNPRM. This same commenter requested for VA to clarify how OPTN
regions and distance considerations in Sec. 17.4020(d)(2)(iii) as
proposed will interact in determining whether a transplant will be
authorized. We do not make changes based on this comment but clarify
that Sec. 17.4020(d)(2)(iii) provides that VA will consider travel
burden on covered veterans when deciding to authorize transplantation
care at a transplant center outside the Veteran's OPTN region of
residence. Geographical proximity of a qualified transplant center in
an OPTN region adjacent to the patient's residence will be considered
when burden of travel is meaningfully impacted. Availability of
services in consideration for authorization of care in another OPTN
region is cited in Sec. 17.4020(d)(2)(iv) as timeliness of transplant
center evaluations and management. Transplant program qualifications
are further addressed by Sec. 17.4020(d)(2)(i) and (ii). Transplant
programs must meet standards for quality, and specific patient factors
may include a disease process or transplantation procedure that
warrants referral to selected transplantation centers, including those
in a different OPTN region.
One commenter suggested that VA permit Veterans to be listed on
more than one OPTN regional list if indicated, to increase their chance
of being matched. We do not make changes based on this comment but
clarify that the listing of Veterans on more than one OPTN regional
list is not prohibited by the regulation. Related policy will specify
that such listing is an appropriate consideration for authorization of
care in an OPTN region other than that of the Veteran's residence.
One commenter asserted that the SNPRM failed to clarify the
differences between solid organ transplant and bone marrow transplant.
This commenter more specifically noted that bone marrow transplant
falls outside of the scope of OPTNs, and that the proposed rule only
indicated how VA Transplant Programs and VA Transplant Centers interact
with OPTNs; hence, the commenter indicated that VA should clarify
whether the rule captures bone marrow transplants. We do not make any
changes based on this comment, as the MISSION Act includes provisions
for both bone marrow transplantation and solid organ transplantation.
VA understands that OPTN does not oversee bone marrow transplantation,
but the rule does cover bone marrow transplants. This same commenter
further suggested that the four factors in
[[Page 26290]]
Sec. 17.4020(d)(2) to be considered when determining a medically
compelling reason to travel outside of the OPTN must be revised to
include relevant details for bone marrow transplant. For instance, the
commenter noted that the factor related to assessing facilities outside
of an OPTN to determine whether they meet VA's standards for quality in
Sec. 17.4020(d)(2)(ii) as proposed was only explained in the preamble
of the SNPRM in reference to Scientific Registry of Transplantation
Recipients data, which is only applicable to solid organ. We do not
make changes based on this further comment. VA understands that
relevant patient factors may vary based upon the specific transplant
both among solid organ types and bone marrow transplant, which is
precisely why the SNPRM noted the four factors in Sec.
17.4020(d)(2)(i)-(iv) were a non-exhaustive list. The Scientific
Registry of Transplantation Recipients database is provided only as an
example. Additional standards for solid organ transplantation programs
and separate standards for bone marrow transplantation programs will be
developed during policy and procurement processes.
We received one comment that requested that VA clarify that it is
the veteran's choice whether to obtain a VA or non-VA transplant within
the Veteran's OPTN (the commenter essentially asserted that the SNPRM
was unclear that the veteran first has a choice of a non-VA transplant
center within the OPTN prior to any consideration of travel outside of
an OPTN). We do not make changes based on this comment. A covered
veteran who is determined by VA to meet eligibility criteria for
community care in proposed Sec. 17.4010 has the ability to decide
whether to receive transplantation care in the community within the
OPTN region of residence. Veterans who meet eligibility criteria for
community care may elect to receive care at a VA Transplant Center.
This commenter also asserted that section 1703(l) requires only that a
veteran be a covered veteran to be considered eligible for this
expanded access to transplant care and does not require such a covered
veteran to be separately assessed under any other criteria (e.g., the
criteria to receive community care generally under section 1703(d) or
(e)). We believe this portion of the comment was prompted by VA's
clarification in the SNPRM that this expanded access to transplant care
only applies for a covered veteran (as defined in Sec. 17.4005) who
meets one or more of the eligibility criteria for community care
generally under Sec. 17.4010. We do not make changes based on this
comment. We read section 1703(l) as qualifying the conditions of
eligibility set forth in section 1703(d) and (e); there is nothing in
section 1703(l) that suggests it is intended to establish an
additional, independent basis of eligibility for community care.
Moreover, the expanded access to transplant care under section 1703(l)
is available only if there is a medically compelling reason to travel
to receive such care. VA cannot envision any instance in which a
covered veteran would be found to have a medically compelling reason to
justify travel outside of an OPTN, but not be found to qualify
separately for community care generally under Sec. 17.4010(a),
particularly considering that the factors to determine a medical
compelling reason under Sec. 17.4020(d)(2)(i)-(iv) are related to many
of the eligibility factors in Sec. 17.4010 (for instance, factors
exist under Sec. Sec. 17.4010(a) and 17.4020(d) that relate to the
specific medical needs of a veteran, the travel burden for a veteran,
and the timeliness of care to be received). This commenter further
asserted that VA should ensure a veteran's primary care physician
receives deference over the Secretary in the determination of whether a
veteran is eligible to travel outside of the OPTN. We do not make
changes based on this comment. Section 1703(l) requires that the
Secretary make the determination of whether to authorize community care
for covered veterans requiring an organ or bone marrow transplant and
who have a medically compelling reason to travel outside of the OPTN
region in which they reside to receive the transplant. The Secretary's
determination is only made when the primary care provider has opined
that there is a medically compelling reason to travel outside the OPTN
region in which the veteran resides to receive such transplant; this
opinion is a threshold question of when the Secretary makes a
determination, and not a final resolution of the matter. Lastly, this
commenter urged that VA should include in the final rule a specific
timeframe within which VA is required to make a decision on requests to
travel outside OPTN for non-VA transplant, as well as a means for
expedited decision or waiver of such a decision. We do not make changes
based on this comment. Timeframes may be influenced by factors such as
the type of transplant, patient disease process, and patient acuity. It
would not be practicable to define specific timeframes by regulation,
given the variability of these factors. However, VA will develop policy
that will address such timeframes.
Sec. 17.4025, Effect on Other Provisions
We received over 50 comments concerning the effects of Sec. Sec.
17.4000 through 17.4040 as proposed upon provisions of VA law that
establish other criteria for the receipt of care or services. We
address these comments below in the order in which they raised issues
related to the provisions in paragraphs (a)-(c) of Sec. 17.4025 as
proposed.
We did not receive any comments that requested revisions to or
clarifications for Sec. 17.4025(a) as proposed, although as a general
matter we did receive some comments that seemed to call for expanding
eligibility for certain care and services under the VCCP beyond that
which is established in other specifically applicable provisions of VA
law (for instance, multiple comments called for the expansion of
eligibility for VA dental care). Other comments did not seek expanded
eligibility for certain care or services under the VCCP but did assert
that the rule as proposed did not provide adequate explanation of
eligibility for certain benefits such as dental care. We do not make
any changes based on these comments and reiterate from the proposed
rule that consistent with section 1703(n)(2), no provision in the rule
may be construed to alter or modify any other provision of law
establishing specific eligibility criteria for hospital care, medical
services, or extended care services (such as for dental care). If
specific services such as dental care under Sec. Sec. 17.160-17.169
have unique eligibility standards, only covered veterans who are
eligible under proposed Sec. 17.4010 and meet such eligibility
standards can elect to receive them through the VCCP.
A majority of the comments we received on Sec. 17.4025 as proposed
related to Sec. 17.4025(b), regarding VA's criteria under the VCCP to
fill or pay for prescriptions issued by non-VA providers. Some of these
comments did not suggest changes to or clarification of the regulation
text in Sec. 17.4025(b) as proposed, but rather seemed to present
issues related to administrative process rather than regulatory
requirements (primarily, VA's administrative practices in reviewing
prescriptions issued by non-VA providers). We will address below only
those issues raised in comments regarding VA's requirements in Sec.
17.4025(b) as proposed, and will address other issues related to
administrative process in another section of this final rule related to
miscellaneous comments.
[[Page 26291]]
As proposed, Sec. 17.4025(b)(1) established the rule that VA would
pay for prescriptions written by eligible entities and providers for a
course of treatment not to exceed 14 days, and paragraph (b)(2)
established that VA would fill prescriptions written by eligible
entities and providers without any accompanying 14-day limitation. As
explained in the preamble of the proposed rule, the intent of Sec.
17.4025(b)(1) and (2) was to establish in VA regulations the long-
standing VA practice of limiting its payment for medications written by
non-VA providers and filled through non-VA pharmacies, rather than
limiting VA's direct filling of such prescriptions through VA's
Consolidated Mail Order Pharmacy (CMOP) system. We first address a
comment that revealed an inadvertent omission in the regulation text at
Sec. 17.4025(b)(1) as proposed, related to when VA will pay for non-VA
prescriptions. This comment specifically urged VA to change its
practice of requiring veterans to pay for urgent or emergent
prescriptions filled outside of VA's CMOP and then seek reimbursement
from VA. This comment correctly summarized VA's practice at the time
the proposed rule published, although Sec. 17.4025(b)(1) as proposed
did not contain any qualifying language related to VA paying for
prescriptions written by non-VA providers only when they were urgently
or emergently needed. We therefore revise Sec. 17.4025(b)(1) to
include qualifying language that VA will pay for prescriptions no
longer than 14 days written by eligible entities or providers for
covered veterans, including over-the-counter drugs and medical and
surgical supplies, available under the VA national formulary system to
cover a course of treatment for an urgent or emergent condition. In
response to the request in this same comment that VA correct its
practice of reimbursing veterans, to instead pay directly for
prescriptions urgently or emergently needed for a course of treatment
not to exceed 14 days, we clarify that VA's use of the term ``pay''
versus ``reimburse'' in Sec. 17.4025(b)(1) was intended to and does
create the option for VA to pay directly for these prescriptions. VA
expects that upon full implementation of the Community Care Network of
eligible entities and providers, the pharmacy benefits management
options under those contracts will provide for VA to pay non-VA
pharmacies directly for prescriptions written by eligible entities and
providers to cover a course of treatment for an urgent or emergent
condition and not to exceed 14 days.
We received multiple comments that indicated a general
dissatisfaction with VA's practice of limiting payment for
prescriptions written by non-VA providers, as well as comments that
more specifically asserted that the 14-day limitation in Sec.
17.4025(b)(1) as proposed was unreasonable because VA did not establish
any exceptions to this limitation, with one comment requesting a
revision to Sec. 17.4025(b)(1) to allow for payment of a course of
treatment greater than 14 days if VA is unable to fill that greater
course through its Consolidated Mail Order Pharmacy (CMOP) system.
Other comments requested an expansion of the 14-day limitation, such as
a broad expansion of the limitation to 30 days, with one comment noting
that a 30-day supply of medication should be approved for outpatient
surgery specifically (to reduce potential post-surgical injuries or
complications). We received other comments that did not suggest
revisions or exceptions to the 14-day limitation per se, but that
requested clarifications regarding its application. For instance, one
comment requested clarification of VA's practices in paying for
medications that are prepackaged for durations exceeding 14 days and
that cannot be divided. We do not make any changes based on these
comments that expressed general dissatisfaction with the 14-day
limitation, or comments that VA should establish exceptions to or
expand the 14-day limitation. As explained above, VA's only pays for
non-VA prescriptions that are filled through non-VA pharmacies if they
are needed to cover a course of treatment for urgent or emergent
conditions. The 14-day limitation is a function of the limitation
related to urgent and emergent conditions, as courses of medication for
longer periods of time are not typically prescribed to treat urgent or
emergent conditions. VA also has a responsibility to monitor the
prescription of medications to ensure appropriate prescribing practices
and general patient care. Using the outpatient surgery example as
provided in one of the comments, typical medications issued following
surgery such as antibiotics and pain killers are particularly important
for VA to review and fill via the CMOP because such medications create
medical concerns (such as antibiotic resistance, potential opiate
monitoring issues, or other adverse events) if they were to be issued
for and taken longer than 14 days. We also reiterate from the proposed
rule that the current practice to limit payment for non-VA
prescriptions allows VA to ensure that any amount of medication
exceeding 14 days would be filled through VA's CMOP system to ensure
cost and quality controls. VA believes that the economies of scale
related to bulk purchase of medications allow for the best use of
Federal resources.
We received one comment that asserted non-VA providers must verify
that prescribed medications are available through VA's formulary and
comply with VA's practice guidelines, to avoid scenarios where covered
veterans might receive prescriptions VA will not fill. We first note
that we do not have anecdotal knowledge that there are widespread or
recurring issues that non-VA providers are issuing prescriptions that
VA cannot or will not fill because such medications are not on VA's
formulary, or because the prescription contradicts VA's practices or
guidelines. However, VA will review its administrative practices in
reviewing and filling prescriptions issued by non-VA providers, to
ensure it develops any necessary education or communication to non-VA
providers to prevent those scenarios. We do not make any changes based
on this comment but do note that Sec. 17.4025(b)(1) and (2) as
proposed generally requires that medications issued by non-VA providers
must be available under the VA national formulary system. There are
exceptions where VA may fill non-formulary prescriptions issued by non-
VA providers, and such requests for exceptions are reviewed under
specific procedures in VHA Directive 1108.08, VHA Formulary Management
Process, which can be found on VA's website.
We received a few comments related to the prescribing of durable
medical equipment (DME) by non-VA providers under Sec. 17.4025(b)(3)-
(4) as proposed. Some comments asserted that the rule should not
require VA oversight or approval of prescriptions from non-VA providers
for durable medical equipment (DME). Other comments were more specific,
with one comment requesting clarification of who determines and what
standards are used to determine when DME is immediately needed under
Sec. 17.4025(b)(3) as proposed, and further asserting that it should
be determined by the prescribing clinician. Another comment requested
that VA revise Sec. 17.4025(b)(3) as proposed to specify that DME is
an immediate need if it is required to safely discharge a patient from
an urgent or emergent care setting, and that Sec. 17.4025(b)(3) and
(4) should be revised to expressly include home oxygen as covered under
DME.
With regard to comments concerning general VA oversight and
approval of DME that is prescribed by non-VA
[[Page 26292]]
providers, we reiterate from the proposed rule that because DME and
medical devices prescribed by non-VA health care providers are specific
to a particular clinical need and in most cases are further
specifically tailored to fit or serve an individual, they require
oversight and approval by VA (except when urgently or emergently
needed) to ensure clinical appropriateness and the best use of Federal
resources. We therefore do not make any changes based on those
comments. With regard to comments concerning who determines and under
what standards that DME is immediately needed, as well as the comments
concerning the specific revisions related to immediate need, we first
reiterate that DME to address an immediate need for urgent or emergent
conditions does not require VA oversight or approval, and therefore
would be issued by the treating or prescribing clinician without VA
review. We next reiterate from the proposed rule that an immediate need
for DME exists when a covered veteran has a medical condition of acute
onset or exacerbation that manifests itself by severity of symptoms
including pain, soft tissue symptomatology, bone injuries, etc. We
believe the language in Sec. 17.4025(b)(3) as proposed provides
sufficient but non-exhaustive examples of the types of DME that are
typically necessary to address such immediate needs (i.e., splints,
crutches, manual wheelchairs), and Sec. 17.4025(b)(3) otherwise makes
clear that urgent and emergent conditions meet the immediate need
standards. We therefore do not make changes based on this comment. With
regard to the comment concerning expressly adding home oxygen as
covered DME, we clarify that home oxygen is considered DME for purposes
of Sec. 17.4025(b)(3) and (4) without further revisions to the
proposed rule.
We received comments related to covered veterans' possible
copayments in using community care under the VCCP, which we interpret
to be related to Sec. 17.4025(c) as proposed. Some comments urged that
the rule should not change anything related to current copay structures
and procedures. One comment asserted American Indian/Alaskan Native
veterans should not be charged copayments for care received under the
VCCP, as this was inconsistent with Federal trust obligations. We do
not make any changes to the rule based on these comments and reiterate
from the proposed rule that veterans will continue to be liable as
applicable under Sec. Sec. 17.108(b)(4) and (c)(4), 17.110(b)(4), and
17.111(b)(3) for copayments for community care that is furnished
through the VCCP. The VCCP will not alter the current treatment of
veteran copayments under VA's traditional community care program or the
Veterans Choice Program. We also reiterate from the proposed rule that
veterans who receive care from the Indian Health Service (IHS) and
Tribal Health Programs (THP) under a sharing agreement with VA will not
be affected by regulations that implement the VCCP; the existing VA
reimbursement agreements between IHS, THPs and VA control all
parameters of how that care is provided, including whether copayments
are charged.
Sec. 17.4030, Eligible Entities and Providers
We received over 200 comments related to non-VA entities and
providers that may furnish hospital care, medical services, or extended
care services through the VCCP. We address these comments below in the
order in which they raised issues related to the provisions in
paragraphs (a)-(c) of Sec. 17.4030 as proposed.
A majority of these comments asserted that VA should ensure non-VA
providers are similarly qualified and competent as VA providers to
furnish the same levels of care as VA providers. These comments more
specifically urged that non-VA providers must: Be properly licensed/
credentialed; use evidence-based treatment; and have specific training
in clinical areas where VA has developed particular expertise (e.g.,
post-traumatic stress disorder, traumatic brain injury, etc.). Some of
these comments further stated that if non-VA providers cannot furnish
care or services as well as VA providers, then those providers should
not be an option that covered veterans may choose to furnish community
care under the VCCP. Lastly, a few of these comments also asserted that
if non-VA providers do not submit full medical documentation for care
or services furnished under the VCCP (and not mere submission of
invoices or bills), VA must not pay them. We interpret these comments
to be related to Sec. 17.4030(a) as proposed, as some of the comments
specifically alluded to VA establishing more specific requirements for
providers in the contracts, agreements, or other arrangements the
providers enter into under Sec. 17.4030(a).
Regarding the general need for VA to establish requirements for
non-VA providers, we agree with the comments that it is critical for
covered veterans to receive competent care from qualified non-VA
providers should such veterans elect to receive care under the VCCP.
However, we do not make any changes to Sec. 17.4030 based on these
comments. The rule at Sec. 17.4030(c)(2) as proposed requires VA to
assess the qualifications of the entity or provider to furnish the
needed care or services in determining whether the provider is
accessible to the covered veteran. These assessments can include
licensing and credentialing information that VA collects under OMB
control number 2900-0823. VA additionally requires submission of
medical records as part of their claims for all non-VA care and
services furnished under the rule (also under OMB control number 2900-
0823) and as required by 38 U.S.C. 1703(a)(2)(A). VA reviews all
licensing and credentialing information to ensure non-VA providers meet
applicable standards for care needed, as well as medical records to
ensure care was provided appropriately and within the scope of
authorization. Although not part of the proposed rule, VA is
establishing competency standards and requirements for the provision of
care by non-VA providers in clinical areas where VA has developed
special expertise, in accordance with section 133 of the MISSION Act.
We are not regulating these standards to permit flexibility, as such
standards are based on clinical practice and can be subject to change.
VA's contracts, agreements, or other arrangements will impose
requirements to meet these competency standards.
We received some comments that asserted VA should permit Medicare
providers to participate in VCCP. We do not make changes based on these
comments, as Medicare providers are a type of provider permitted under
section 1703(c) to participate in VCCP, and are otherwise permitted to
enter into contracts, agreements, or other arrangements with VA to
furnish care and services under Sec. 17.4030(a).
We received a few comments that requested clarification on whether
or to what extent providers employed by VA could also participate in
VCCP as eligible entities and providers to furnish care or services
under Sec. 17.4030(b) as proposed. We reiterate from the proposed
rule, without changes to Sec. 17.4030(b) as proposed, that providers
who are employees of VA may not be acting within the scope of their
employment while providing care or services through the VCCP.
Essentially, VA providers may participate in VCCP as long as it is not
during their VA-employed work hours.
We received a few comments that requested clarification of how VA
would assess whether a non-VA provider is accessible to a covered
[[Page 26293]]
veteran under Sec. 17.4030(c) as proposed. These comments generally
seemed to inquire whether Sec. 17.4030(c)(1) and (3) (related to VA
assessing the length of time the veteran would have to wait to be seen
by the non-VA provider, and the distance between the veteran's
residence and that provider, respectively) were essentially VA's
application of its access standards to non-VA providers, as such access
standards were set forth in Sec. 17.4040 as proposed. Those comments
that assumed Sec. 17.4030(c) did seek to apply VA's access standards
to non-VA providers were primarily supportive of such an assumption.
However, a few comments noted that applying such standards to non-VA
providers was not feasible or advisable. One comment that opposed
applying VA's access standards to non-VA providers more specifically
asserted that non-VA providers would be discouraged from participating
in the VCCP if they had to comply with VA's access standards, as this
would amount to preferred treatment of veteran patients over non-
veteran patients in terms of timeliness of appointments.
We clarify that VA did not intend for Sec. 17.4030(c)(1) and (3)
to establish a regulatory mechanism to apply VA's access standards as
set forth in Sec. 17.4040 to non-VA providers. This does not mean,
however, that VA will not endeavor to ensure that community health care
providers are able to comply with the applicable access standards
established by VA, as VA is required to do so under section 1703B(f).
To clarify VA's intentions, VA intends to establish access standards
for non-VA providers in the contracts, agreements, or other
arrangements that eligible entities or providers enter into under Sec.
17.4030(a) as proposed, as opposed to establishing access standards for
non-VA providers in regulation. We do not make changes to Sec.
17.4030(c) as proposed based on these comments.
Although we do not make changes to Sec. 17.4030(c) as proposed
based on these comments, we do offer the following clarifications as
requested by comments regarding how VA will use Sec. 17.4030(c)(1) and
(3) to assess whether a non-VA provider is accessible. By considering
the length of time a veteran would have to wait to receive hospital
care or medical services from a non-VA entity or provider under Sec.
17.4030(c)(1) as proposed, VA can ensure that veterans receive care as
quickly as possible. If a veteran selects a non-VA provider who cannot
see the veteran for several months, VA would probably determine that
provider was inaccessible, and could then provide the veteran with
other options of non-VA providers to potentially schedule an
appointment sooner. By considering the distance between the covered
veteran's residence and the non-VA provider, VA can ensure that
veterans receive care closer to their residence. If a veteran resides
in New York and selects a provider in California (to receive care in
California when they otherwise would not be residing in California at
the time of the appointment), VA would probably determine that provider
was inaccessible, and could then provide the veteran with other options
of non-VA providers that would be closer to their residence at the
expected time of the appointment. In either scenario (distance or time
for an appointment), VA's decision regarding accessibility is not pre-
determined; these will be case-by-case decisions. We believe these
factors will be most relevant in situations where a covered veteran has
not selected a particular non-VA provider, but is looking for VA to
identify a non-VA provider that can furnish the care for them. In such
cases, we would use these factors to determine which providers should
be offered as possible options. If a covered veteran has selected a
particular provider, we may determine in some cases that the provider
is inaccessible (as in the New York/California example above), while in
other cases, such cross-country travel might be approved (if, for
example, there were only one or two providers in VA's network that
furnished a specific type of service). In more typical cases, we
anticipate that the veteran's selection of a particular provider will
likely be approved, even if a particular provider might have a slightly
longer wait time or be slightly further away from the veteran, as this
would be the veteran's choice.
We also note that Sec. 17.4030(c)(2) as proposed will consider the
qualifications of the entity or provider to furnish the hospital care,
medical services, or extended care services the veteran requires. If an
entity or provider does not have the expertise or equipment necessary
to provide the required care or services, the needed care is not
accessible from that provider, and VA may not authorize a patient to
receive care or services from that entity or provider. We raise this
last factor in Sec. 17.4030(c)(2) as proposed to reiterate as stated
above that VA will consider these factors together to make
accessibility determinations on a case-by-case basis, considering each
veteran's specific needs. Sometimes, there may be several eligible
entities or providers that could deliver care close to the veteran's
residence, and in such a scenario, distance likely will not matter. In
other situations, there may only be one provider near the veteran's
residence, but this provider either has extended wait times or lacks
the expertise or equipment to provide the necessary care. VA will need
to balance these competing interests and the preference of the veteran
to determine whether an entity or provider is accessible.
We are making minor changes to paragraph (c) to use the term
covered veteran in lieu of the term eligible veteran in several places.
The term eligible veteran is used in Sec. 17.1530 because it is a
defined term in Sec. 17.1505. Under the VCCP regulations, we use the
term covered veteran, as defined in Sec. 17.4005. This change simply
removes any ambiguity as to the term and does not alter the effect or
meaning of the rule.
Lastly, we received a comment that requested VA specifically
include in these regulations outreach, training, and other assistance
to non-VA providers to expand the Patient-Centered Community Care (PC3)
network, as the commenter asserted that such expansion is particularly
critical to deliver community care in underserved areas. We do not make
changes based on this comment, as this comment presents an operational
request that is more appropriately addressed through contract or
policy. We do clarify, however, efforts on VA's part to improve
education of providers regarding the formation of contracts under
section 1703(h) through the Community Care Network in the portion of
this document that discusses miscellaneous comments.
Sec. 17.4035, Payment Rates
We received over 25 comments concerning the parameters under which
VA establishes payment rates for care and services furnished through
the VCCP, as set forth in Sec. 17.4035 as proposed. We address these
comments below in the order in which they raised issues related to
provisions in paragraphs (a)-(e) of Sec. 17.4035 as proposed. We note
that some comments we received related more to administrative processes
associated with payment for care and services (e.g., how VA pays non-VA
providers), rather than the regulatory requirements from the proposed
rule; we will address such administrative comments in the section of
this final rule related to miscellaneous comments.
We received some comments that asserted that VA should not pay
below applicable Medicare fee schedules or prospective payment system
amounts, to ensure non-VA providers are not
[[Page 26294]]
discouraged from participating in the VCCP. One comment was more
specific, noting that VA should pay at full applicable rates for
inpatient care that go beyond Medicare's professional fee schedule,
including at academic hospitals that have both indirect medical
education (IME) and direct medical education (DME) billing components.
We do not make changes to Sec. 17.4035(a) as proposed based on these
comments. The limitation of VA's payment rates to be no higher than
Medicare, versus being designated the same as Medicare rates, is
consistent with section 1703(i)(1) that, with exceptions, the rates VA
pays for care and services may not exceed the applicable Medicare rate.
We clarify, however, that VA has typically paid at applicable Medicare
rates under the Veterans Choice Program, to avoid the scenario raised
by comments where non-VA providers are discouraged from participating
in VA community care programs. With regard to the specific concerns in
paying IME or DME billing for academic hospitals, we also do not make
changes to Sec. 17.4035(a) as proposed but do clarify that VA does pay
adjustments to Medicare costing as applicable and appropriate.
One comment requested that VA provide more details on how it will
determine payment rates for inpatient services provided by critical
access hospitals, as the statutory authority for setting rates for such
hospitals (42 U.S.C. 1395m) was referenced in Sec. 17.4035(a) as
proposed. This comment further voiced support for VA using a cost-based
approach to determine rates for critical access hospitals. We do not
make changes based on this comment. We believe the language in Sec.
17.4035(a) and its reference to 42 U.S.C. 1395m is sufficient to allow
VA to calculate appropriate rates for critical access hospitals.
One comment requested that VA confirm that use of the term Medicare
rate in Sec. 17.4035 generally means a rate unaffected by Federal
budget sequestration. We do not make changes based on this comment and
can only confirm that to the extent Medicare's rates or adjustments are
unaffected by budget sequestration, so too will VA's rate setting be
unaffected under the parameters established in Sec. 17.4035.
Similarly, and inversely, if sequestration did modify the rates paid
under the Medicare program, VA's rates would also potentially change.
We do not believe sequestration would change the Medicare fee schedule,
but we acknowledge that it could affect the Centers for Medicare and
Medicaid Services' (CMS) ability to pay. VA's payment rates for any
particular service to any particular provider will be established
through the terms set forth in the contract or agreement and may
reference the Medicare fee schedule in general. If such terms are fixed
to a specific dollar amount, any change in the Medicare rate will not
otherwise serve to modify the terms of that contract or agreement.
However, if the terms in the contract or agreement are relative, such
as by referencing the Medicare fee schedule, then changes to the
Medicare fee schedule would carry over per the terms of the contract or
agreement.
The parenthetical language in Sec. 17.4035(a) as proposed would
establish that VA's payment rate adjustments occur only on an annual
basis in line with Medicare's annual payment updates. One comment
requested that VA revise this parenthetical language to require VA to
conform to Medicare's rate adjustment approaches in their entirety.
This change would result in changes to VA's rates on a much more
frequent basis than the annual payment updates issued by Medicare that
VA presently follows. We do not make changes based on this comment. VA
does not have access to the information or systems that Medicare uses
to adjust payments on a more frequent basis than annually, based on
such factors as quality or performance, utilization, etc., and as such,
cannot operationalize this aspect of the Medicare program's payment
schedule.
We did not receive comments concerning Sec. 17.4035(b) as
proposed, and therefore do not make any changes.
We received one comment recommending VA revise Sec. 17.4035(c) as
proposed, to expand the definition of highly rural area to include
rural area. This comment further stated that VA should utilize the
Rural-Urban Commuting Areas system, developed by the Department of
Agriculture and the Department of Health and Human Services, to define
rurality. We do not make changes based on this comment. We reiterate
from the proposed rule that use of the term highly rural area is
prescribed by and specifically defined in statute in section
1703(i)(2)(B).
A few comments requested clarification as to how VA will determine
that limiting its payment rates to applicable Medicare rates is not
practicable, as permitted under Sec. 17.4035(d) as proposed. Some
comments further requested clarification of how eligible entities or
providers would be notified of allowable payment rates in excess of
Medicare rates. One comment specifically requested that VA should
ensure women veterans' medical needs were considered as a factor when
establishing rates in excess of Medicare. We do not make any changes
based on these comments, although we do reiterate from the proposed
rule that payment rates are ultimately set forth in the terms of the
contract or agreement under which the care and services are furnished.
As set forth in Sec. 17.4035(d), the factors that could prove
persuasive in terms of determining impracticability as identified in
the proposed rule include patient needs, market analyses, and provider
qualifications, among others. General market conditions usually
establish that supply and demand can establish a price equilibrium, and
we believe these conditions will also inform when it would be
impracticable to pay the Medicare rate.
A few comments requested clarification as to how VA will determine
payment rates for non-Medicare services, particularly for extended care
services (e.g., home health, adult day health care, and respite care).
Some of these comments further requested that VA be transparent about
establishing and updating these rates, but not necessarily that VA
revise Sec. 17.4035 to do so. We do not make changes based on these
comments. As noted in Sec. 17.4035(a), the rates paid by VA for
hospital care, medical services, or extended care services furnished
pursuant to procurement contract or an agreement authorized by
Sec. Sec. 17.4100 through 17.4135, will be the rates set forth in the
terms of such contracts or agreements. Any services for which there is
no Medicare rate will be determined in accordance with the defined
terms in the contract or agreement.
We received one comment related to the portion of the preamble that
explained Sec. 17.4035(e) as proposed, which requested that VA explain
why fiscal year (FY) 2003 data is used to determine amounts under VA's
Alaska Fee Schedule. We do not make changes based on this comment but
clarify that the VA Alaska Fee Schedule was originally introduced
following an actuarial study completed by VA in 2001, in which VA
determined that special circumstances exist in Alaska that warranted a
specific fee schedule be calculated in order to avoid limitations on
Veteran access to care. Based on this study, and pursuant to notice-
and-comment rulemaking, VA promulgated a regulation at 38 CFR 17.56(d)
to establish the VA Alaska Fee Schedule (see 70 FR 5926, February 4,
2005). The provision in Sec. 17.56(d) as originally
[[Page 26295]]
promulgated used FY 2003 data and indicated that VA will increase the
amounts on the VA Alaska Fee Schedule annually beginning in 2005 in
accordance with the published national Medicare Economic Index (MEI).
VA has used the MEI to annually update data from the previous fiscal
year's Alaska Fee Schedule, since this schedule was first established.
Given that these updates have occurred regularly, and that VA's systems
are built on maintaining this schedule, we believe it would be
administratively burdensome and likely of little value to change the
baseline reference from FY 2003. We further note that we received no
comments recommending a change from this baseline; the commenter simply
asked for VA's rationale for using this data. We believe this
methodology has proven effective for providers in Alaska.
We received a few comments that requested VA clarify or confirm,
and further expressly revise Sec. 17.4035 to reflect, that VA is
always the primary payer for care and services that covered veterans
receive through the VCCP. A related comment also requested VA revise
Sec. 17.4035 to indicate that VA's payment is payment in full and
extinguishes a covered veteran's liability. We do not make any changes
based on this comment but reiterate from the proposed rule that under
section 1703(j), VA shall recover or collect reasonable charges for
such care or services from a health plan contract described in section
1729 in accordance with such section. These provisions of law establish
VA's role as the primary payer. We further note that VA will seek to
ensure that the contracts or agreements VA enters into with eligible
entities and providers will include terms that limit their ability to
seek payment from a veteran when VA has made any payment for care or
services furnished to that veteran on VA's behalf. There is no need for
regulatory language to ensure that covered veterans do not face
additional liability (other than applicable copayments) for using the
VCCP.
Lastly, we received one comment that urged VA to adopt value-based
reimbursement models, particularly for mental health care, as permitted
under section 1703(i). This comment further stated that the ability of
VA to use value-based models should encourage VA's development of
innovative payment models, including bundled payment for certain
episodes of care. We do not make any changes based on this comment.
Again, the contract or agreement will set forth the terms of payment,
which could include the use of value-based models. To the extent such
value-based models could result in payment that exceeds the limitation
set forth in Sec. 17.4035(a), VA has the option of utilizing the
exception in Sec. 17.4035(d) when applicable to permit the use of such
models.
We are making minor changes to this section to reflect the
promulgation of regulations implementing the Veterans Care Agreement
authority in section 1703A. Specifically, we are replacing the
reference to section 1703A of this title and referring instead to
Sec. Sec. 17.4100 through 17.4135, as these regulations were added to
the Code of Federal Regulations through a separate VA rulemaking
published on May 14, 2019 (RIN 2900-AQ45, see 84 FR 21668).
Sec. 17.4040, Access Standards
We received over 18,000 comments related to the substantive
provisions of the access standards in Sec. 17.4040 as proposed. For
the sake of clarity, we have divided the discussion below into three
main sections. The first section will address the general concerns in
comments that are related to both the average drive time and wait time
standards as set forth in Sec. 17.4040 as proposed. The next section
will address more specific substantive issues related to the average
drive time standards, and the last section will address more specific
substantive issues related to the wait-time standards. We also clarify
that a majority of these comments were duplicated form responses, and
we address the access standard issues as jointly raised below.
Access Standards Generally
We received comments that generally opposed both the drive-time and
wait time access standards as proposed, based primarily on assertions
that the access standards were arbitrary because they were not
realistic, feasible, or sustainable, and VA did not conduct enough
research of all existing access models to properly propose its own
access standards. Some of these comments further asserted that VA
should have delayed proposal of access standards until more research or
analysis could have been completed (to include VA waiting on the
anticipated results of the market area assessments required by section
7330C(a) as added by section 106 of the MISSION Act, and not before
conducting pilot testing as needed).
Regarding the assertions in comments that the access standards as
proposed by VA were arbitrary, we reiterate from the proposed rule that
the drive-time standards were derived from specific analyses that
showed trends of 30-minute drive times for primary care and 60-minute
drive times for specialty care in TRICARE, State Medicaid plans, State
insurance departments, and commercial health plans. For instance,
TRICARE Prime (the Department of Defense's most comprehensive managed
care plan, uses a 30-minute drive time for primary care and a 60-minute
drive time for specialty care for non-active duty beneficiaries. VA
also assessed both the Medicaid Plans and other primary insurance plans
of 14 States, and found a majority of those States have a 30-minute
travel time standard for primary care, and a 60-90-minute travel time
standard for specialty care under State Medicaid plans and 45-60 minute
travel time standards for other primary State insurance plans. VA
determined that it would be reasonable to fall in line with these other
network expectations throughout the industry. VA further used the
results of its access standards analysis to develop and model several
options using VA's Enrollee Health Care Projection Model (EHCPM). VA's
EHCPM allowed VA to consider best practices in the industry in its
development of access standards as well as the financial impact of
various access standard scenarios. After considering this information
from analyses of similar drive times in other health care plans as well
as from VA's EHCPM, VA determined that its access standards should
reflect an average drive time-based criterion that considers the care
or services needed in relation to the veteran's residence, which is a
similar approach as TRICARE Prime related to travel standards (opting
to use average driving time versus mileage). Similarly, the wait time
standards were derived from research of non-VA network expectations
throughout the industry, and they fell within the range of appointment
wait-time standards found in other government organizations, State
programs, and commercial entities (e.g., 7-28 days for primary care and
15-30 days for specialty care). Further, the proposed wait-time
standards are achievable in most VA facilities and are consistent with
capabilities identified in the private sector. On average, VA national
wait times in March 2019 for new appointments (e.g., the first
appointment in a new episode of care versus a subsequent appointment in
the continuation of an existing episode of care) was approximately 20.6
days for primary care, 10.8 days for mental health care, and 22.4 days
for specialty care. These wait times have decreased since the December
2018 reporting period included in the proposed rule. The proposed wait-
time standard of 20
[[Page 26296]]
days for primary care and mental health, for example, is both in line
with other similar industry standards and is a manageable goal for
access to VA care. We do not make changes based on these comments, as
we believe VA's access standards as proposed were based on reasoned
research and analysis and are therefore not arbitrary.
Regarding the assertions in comments that VA should have delayed
proposal of its access standards until more research or analysis could
have been completed (to include waiting for VA's market area
assessments and potential pilot testing to conclude), VA was unwilling
to engage in such delay as we believe it would have delayed
implementation of access standards well beyond the statutory deadline
of June 6, 2019. Pilot testing is an extensive process, which would
have required the results of the summary market area assessments, which
themselves were not completed at the time of publication of the
proposed rule.
We received a few comments that opposed the access standards
generally because of VA's designation of nearly all hospital care,
medical services, and extended care services available under its
medical benefits package. According to the comments, VA's designation
of so many services to have an applicable access standard was contrary
to Congressional intent. According to these comments, Congress only
intended for VA to designate a few types of care or services, and a
designation of more care and services creates a risk of decreased
funding of VA's direct provision of care. Particularly, one comment
stated that VA's impact analysis for the proposed rule indicated that
VA will consider the performance of its facilities on wait time access
standards when making resource allocation decisions and inquired if
funding or resources would be withheld from a facility if it did not
meet the designated access standards. We do not make changes based on
these comments. We acknowledge that VA did consider during the
development process of the legislation that would become the MISSION
Act that only a limited number of care or services might ultimately be
designated as having access standards, VA proposed instead to designate
a majority of the care and services available under its medical
benefits package. VA's broader designation of most care or services
maximizes the choice of covered veterans and prevents veterans from
having to navigate a bifurcated system where more limited care and
services would be available under the access standard eligibility than
under any other eligibility criterion for VCCP. Designation of access
standards for a majority of VA care and services makes administration
of the VCCP simpler for VA for this same reason and ensures better
coordination of care. VA's designation of access standards for a
majority of its care and services, however, does not force veterans
into the community to receive care. We reiterate from the discussion at
the beginning of this final rule that section 1703(d)(3), as regulated
at Sec. 17.4020(a), requires that eligible covered veterans must still
elect to receive care and services through the VCCP. We clarify that
VA's statement from the impact analysis for the proposed rule, as
referenced in one of the comments, is not a statement of intent to
withhold resources or funding per se if a facility is not meeting
access standards. It is a statement that VA must consider use of its
services when considering allocation of its resources, which could
include investment into facilities that require assistance to meet
access standards. Regarding the question of Congressional intent more
specifically, we do not read any limitation in 38 U.S.C. 1703 or 1703B
regarding the number of designated access standards; these statutes
provide broad authority to the Secretary to make these determinations
and do not constrain his authority in the ways described in the
comments.
We received comments that opposed the access standards generally
because it was unclear whether they would be applied to non-VA
providers, with some comments further requesting that VA make non-VA
provider participation in VCCP contingent upon compliance with the same
standards VA adopts for its direct delivery of care and services.
Essentially, these comments asserted that unless care available under
the VCCP could meet (or exceed) VA's access standards, it should not be
accessible to covered veterans because it would not be providing care
that could be received sooner or closer than VA could provide. We do
not make changes to Sec. 17.4040 as proposed based on these comments.
We first reiterate from the section of this final rule that discusses
eligible entities and providers that VA will endeavor to ensure that
community providers are able to comply with the applicable access
standards established by VA. Such access standards for non-VA
providers, however, will be used to measure network adequacy to ensure
that covered veterans who elect to receive care through the VCCP are
generally getting timely care that is near to their residence. VA will
not strictly apply its access standards to eligible entities or
providers as a factor to determine their eligibility to furnish
hospital care, medical services, or extended care services furnished
the VCCP. Although we understand the rationale offered in the comments
that assert VA should strictly apply its access standards to non-VA
providers, the concept of access standards for determining VCCP
eligibility is fundamentally different than the concept of access to
care and services in the private sector. VA must ensure its access
standards establish a consistent mechanism to provide the option of
choice in the community to the covered veteran if VA cannot meet those
standards. In the private sector, access standards are a mechanism to
measure performance and network capacity, not eligibility. As we have
said before, no covered veteran eligible to receive community care is
required to seek care in the community. The veteran could elect to
receive care from VA or could inquire about seeking care in the
community and change his or her mind if the community options are not
convenient (in terms of distance or scheduling availability). As VA
gains more experience with VCCP, we anticipate our systems will be able
to provide information to veterans and providers regarding community
locations and wait-times so that veterans can make informed decisions
that work for them. We also reiterate from the section of this final
rule that discusses eligible entities and providers that we agree with
a comment that stated that VA should not apply its access standards to
eligible entities and providers for purposes of eligibility as this
could amount to preferred treatment of veteran patients over non-
veteran patients and could discourage eligible entities and providers
from participating in the VCCP.
We received comments that opposed the access standards generally
because the comments asserted that not having different (presumably,
longer drive time or wait time) standards for specialized VA care or
for VA's foundational services could erode patient volume necessary to
sustain such care and services at VA, and that VA should take a more
refined approach to distinguishing access for such services to ensure
the quality of care and veteran satisfaction is maintained. A related
comment more specifically urged VA to ensure that care and services to
treat spinal cord injury be excluded from any designated access
standard, to ensure that such care may only be provided by VA. We do
not make changes based on these comments.
We reiterate from an earlier discussion in the purpose and scope
[[Page 26297]]
section of this final rule that expanding access to care and services
in the community does not equate with forcing veterans into the
community to receive care; covered veterans must still elect to receive
care in the community if eligible under VA's access standards. We agree
with the comments that it is critical for VA to maintain focus on all
care and services it directly provides to veterans, and we reiterate
from the proposed rule that VA will continue to sharpen its focus on
directly providing those services that are most important to the
coordination and management of a veteran's overall medical and health
needs, including continued examination of whether its designated access
standards should be revised with future rulemakings to account for
specialized areas of VA expertise.
We received a few comments that requested clarification of why VA
did not designate a particular access standard for VA foundational
services, and one comment further seemed to assert that lack of such
designation meant that these services were not covered under the VCCP.
We do not make changes based on these comments but clarify that the
designated access standards cover all forms of hospital care, medical
services, and extended care services, with the exception of
institutional extended care services (this exception is discussed
further below).
We received one comment that requested VA either revise Sec.
17.4040 to add an access standard for institutional extended care
service (e.g. nursing home care) or provide a more robust rationale
than provided in the proposed rule for why institutional extended care
was not included within VA's designated access standards. We do not
make changes based on this comment but do provide additional rationale
as requested by the comment. Institutional extended care such as
nursing home care is simply not apt to be measured in terms of access
in the same manner as other care and services that, generally speaking,
are more standardized and available in the community. For example, the
law in each State controls admission factors for Medicaid-participating
nursing homes, which introduces too many variables to provide relative
comparisons to VA nursing home admissions. As another example,
Medicaid-participating nursing home facilities in the community
generally admit patients on a first-come, first-served basis, and
maintains waiting lists for admission. When a bed is vacant, facilities
consult the wait list to determine who is next on the list to be
admitted, but it is not an accurate reflection of when any patient will
be admitted, primarily because many people on the wait list are not yet
in need of nursing home care or they have been placed in another
facility. In addition, a State's regulations could control when a
patient may be admitted under circumstances beyond first-come, first-
served--the most common example is admission to a nursing home facility
directly from a hospital due to medical need. People being admitted
directly from a hospital level of care may be seen as having a greater
need before anyone on a wait list. Some States also have rules
concerning placing only patients of the same gender together in each
room, or rules permitting admission preference in cases requiring
intervention by the Department of Human Services or Adult Protective
Services (or similar agency). We cannot provide a full survey of all
State laws that may control or influence Medicaid-participating nursing
home facilities in the community, and it may be that these nursing
homes also create special admission rules to receive Medicare-eligible
individuals who are in need of acute rehabilitation (for instance, for
a stay not to exceed 20 days). We reiterate that there are many
variables for comparison to admission to VA nursing home facilities
that make assignment of a designated access standard impracticable, as
it would not reflect VA's relative ability or inability to directly
provide nursing home care.
We received one comment that requested VA revise Sec. 17.4040 to
add an access standard specifically for mental health care and services
that would be deemed to be needed immediately, as similar to any access
standard that VA might apply for emergency care or same-day
appointments. We do not make changes based on this comment. We will
discuss more fully in the section of the rule below that addresses wait
times specifically, but should any care or service under a wait time
access standard be deemed necessary for a covered veteran prior to
reaching the ending date of the applicable wait time standard under
Sec. 17.4040(a)(1)(ii) and (a)(2)(ii), then the best medical interest
eligibility criterion under Sec. 17.4010(a)(5) would enable a covered
veteran to be seen for such care or services through the VCCP, assuming
criteria under Sec. 17.4010(a)(5) were met. We further note that
emergent mental health care is available from VA on a same-day basis,
and VA's urgent care benefit under Sec. 17.4600 (section 1725A) should
also make some services available on an expedient basis.
We received one comment that requested VA clarify the interaction
between the average drive time and wait time standards, as both Sec.
17.4040(a)(1)(i) and (a)(2)(i) indicate that the standards are
considered together to determine whether they are met (these regulatory
clauses indicate that the drive time is considered as well as the wait
time). The comment more specifically asserted that the average drive
time and wait time should be independently assessed (the regulatory
clauses should not use the term and as a connector, but rather a term
such as either), to prevent scenarios where (in the case of the primary
care standard) a facility that can provide the care or services may be
more than 30 minutes away, but a covered veteran would not quality for
VCCP because that facility can offer the care or services within 20
days. We do not make changes based on this comment but do clarify that
the average drive time is an independent qualifier and the wait time is
not. The structure of the regulatory clauses in Sec. 17.4040(a)(1)(i)
and (a)(2)(i) qualifies instances where a VA facility that can offer
the care or services may be within the average 30 minute driving time
(in the case of the comment's primary care example), but still not able
to provide the care within 20 days--in such cases, a covered veteran
would be eligible to elect to use the VCCP. However, if a VA facility
that can offer the care or services needed is not within 30 minutes
average drive time (in this example), then the covered veteran would
qualify for VCCP without any assessment of how long it would take a
facility further away to provide the needed care or services. The wait
time cannot be an independent qualifier because there must be a context
within which to apply the wait time--otherwise, the wait time could be
applied to any VA facility that could provide the care or services
needed regardless of the average drive time from the covered veteran's
residence. We believe that the regulation addresses the commenters
concern: VA must be able to furnish care within the average drive time
and the wait time standard. If VA cannot meet both conditions, or in
other words if it fails either condition, the covered veteran would be
eligible to elect to receive community care.
The proposed rule stated that if VA is able to furnish a covered
veteran with care or services through telehealth, and the veteran
accepts the use of this modality for care, VA would determine that it
was able to furnish such care or services in a manner that complies
with designated access standards. We received one comment that urged VA
to ensure that the option for the veteran to have face-to-face care
would be maintained if the veteran did not choose the telehealth
modality. We do not make
[[Page 26298]]
changes based on this comment. As stated in the preamble of the
proposed rule, VA will not require a veteran accept the use of
telehealth for the purpose of meeting VA's designated access standards.
Lastly, we received a few comments that requested clarification of
how VA will apply the access standards for homeless Veterans without a
residence. We do not make changes based on these comments but clarify
that homeless veterans may currently provide an address to VA that is
recorded in the Veterans Health Information Systems and Technology
Architecture; this address is used for other VHA benefits and may be
applied to veterans seeking to participate in VCCP as well. For
example, any homeless veteran who is residing in a place supported by a
Department of Housing and Urban Development-VA Supportive Housing
voucher can list that address, and any veteran using one of our
community-based programs like the Homeless Grant and Per Diem or Health
Care for Homeless Veterans programs can supply the address of the
service provider. Covered veterans that do not have a residence may be
assessed under other eligibility criteria in Sec. 17.4010(a)(1)
through (3) and (5) and (6), to receive care or services through the
VCCP.
Average Drive Time Standards
We first address comments similar to those discussed above
regarding the access standards generally, where commenters suggested
that VA should apply its average drive time standards to the locations
of eligible entities and providers from which covered veterans might
elect to receive care through the VCCP, to ensure such non-VA care
would not be further away from a veteran's residence than VA care.
Another comment urged VA to track zip codes of where non-VA care was
provided through the VCCP, to ensure care was received at the nearest
facility. We do not make changes based on these comments. We reiterate
from the discussion above that the access standards VA will establish
for eligible entities and providers will be used to monitor network
adequacy and will not be used as a limitation on a covered veteran's
eligibility to receive care and services through the VCCP. VA must
ensure its access standards establish a consistent mechanism to provide
the option of choice in the community to the covered veteran if the VA
cannot meet those standards. In the private sector, however, access
standards such as average drive times are a mechanism to measure
performance and network capacity, not eligibility. We also restate from
discussion earlier in this final rule that VA will use Sec.
17.4030(c)(1) and (3) to assess whether a non-VA provider is
accessible. By considering the length of time a veteran would have to
wait to receive hospital care or medical services from a non-VA entity
or provider under Sec. 17.4030(c)(1), VA can ensure that veterans
receive care as quickly as possible. If a veteran selects a non-VA
provider who cannot see the veteran for several months, VA would
probably determine that provider was inaccessible, and could then
provide the veteran with other options of non-VA providers to
potentially schedule an appointment sooner. By considering the distance
between the covered veteran's residence and the non-VA provider under
Sec. 17.4030(c)(3), VA can ensure that veterans receive care closer to
their residence. If a veteran resides in New York and selects a
provider in California (to receive care in California when they
otherwise would not be residing in California at the time of the
appointment), VA would probably determine that provider was
inaccessible, and could then provide the veteran with other options of
non-VA providers that would be closer to their residence at the
expected time of the appointment. In either scenario (distance or time
for an appointment), VA's decision regarding accessibility is not pre-
determined; these will be case-by-case decisions.
We received some comments that asserted VA should not use an
average drive time standard but instead should continue to use a
mileage-based distance standard, with certain of the comments
additionally calling for new mileage standards (one comment advocated a
new standard of 20 miles for vision-related care or services
specifically, while other comments advocated new standards of 30 or 35
miles without specifying particular care or services). We do not make
changes based on these comments. We reiterate from the proposed rule
that a mileage-based access standard can be a poor indicator of actual
conditions that affect travel to receive care and services, as such a
standard does not recognize the inherent variation of driving speeds in
rural versus urban areas (as traffic levels and speed limits typically
allow rural residents to travel farther, faster than urban residents).
Also, covered veterans may benefit from a drive-time standard as
opposed to a mileage-based standard, such as the case with veterans in
mountainous areas where it can take significantly longer than 30
minutes (or even 60 minutes) to travel 40 miles. We believe that use of
an average drive-time criterion versus a mileage standard will provide
a more consistent and equitable standard of access for all covered
veterans.
We received other comments that urged VA to adopt different average
drive time standards than the 30 minutes and 60 minutes in Sec.
17.4040(a)(1)(i) and (a)(2)(i) as proposed, respectively. Multiple
comments advocated for an average drive time standard of 40 minutes for
specialty care, 30 minutes for all services, 60 minutes for all
services, or that the standards in Sec. 17.4040(a)(1)(i) and (a)(2)(i)
should be flipped, where 60 minutes would apply to primary care and
mental health and 30 minutes would apply to specialty care.
Particularly, the comments that advocated flipping the 30-minute and
60-minute average drive time standards stated that specialty care is
arguably more urgently needed than primary care, or that travel to
receive specialty care is more burdensome, and therefore the lesser
timeframe of 30 minutes should be applicable to specialty care. We do
not make changes to Sec. 17.4040(a)(1)(i) or (a)(2)(i) based on these
comments.
We reiterate from the proposed rule and the expanded discussion
earlier in this final rule that the average drive-time standards are
derived from specific analyses that showed trends of 30-minute drive
times for primary care and 60-minute drive times for specialty care in
TRICARE, State Medicaid plans, State insurance departments, and
commercial health plans. We further clarify that the different drive-
time standards for primary care versus specialty care particularly are
not intended to reflect the relative importance of one type of care
versus the other, but rather the relative availability of one type of
care versus the other, as specialty care tends to be generally less
available than primary care and therefore requires longer travel times
to reach on average. Nearly all individuals in a geographic area
require primary care at some point, typically several times per year.
But only a subset of these same individuals may require specialty care,
and not likely with the same frequency. We believe distribution of
health care resources follows the basic premise outlined above, to
result in specialty care generally being less widely geographically
dispersed, particularly considering that such specialty services often
require specialized facilities and equipment that are difficult and
costly to replicate. For these reasons, we believe it is widely
understood that patients often times will need to travel
[[Page 26299]]
a bit farther for specialty care than primary care.
We received multiple comments related to how VA will calculate
average drive times under Sec. 17.4040(b) as proposed. Many of these
comments asserted that there were too many variables related to actual
drive time (e.g., road or weather conditions, congestion or traffic)
for VA's calculations to be accurate if it used a strict average of
drive times throughout a day (or week, or other defined timeframe)
versus using a predictive system that is related to the time of
appointment. While some of these comments urged VA to adopt new
definitions or clarifications to assist with calculating average drive
times (e.g., defining the term hazardous weather in Sec.
17.4010(a)(5)(vii)(A)), other comments suggested that, without
disclosing proprietary information related to the geographic system
software VA will use, VA's calculations should consider how factors
change throughout a day, particularly traffic patterns. More
specifically, a few comments urged that any drive time calculation VA
uses must consider peak drive times to account for routine spikes in
traffic. We do not make changes to Sec. 17.4040(b) as proposed based
on these comments. We believe that it is more veteran-centric to
maintain the operational flexibility to refine and improve VA's
calculations in response to experience, feedback, and changing real-
world conditions, rather than to detail in regulation a specific
methodology or considerations that could constrain VA's ability to
improve the calculation of average drive time in the future.
We first note that further definition of terms in Sec.
17.4010(a)(5)(vii)(A), as requested in one comment, does not have any
bearing on eligibility determinations under Sec. 17.4040(b) as
proposed (we also believe that terms to characterize an unusual or
excessive burden in Sec. 17.4010(a)(5)(vii)(A) are sufficient as
proposed). We address the comments that requested clarification on how
VA will calculate average drive times with other comments regarding
VA's administration of its community care programs in the portion of
this final rule that discusses miscellaneous comments.
We received some comments that requested VA consider use of non-
personal vehicles (e.g., public transit) when calculating applicable
average drive times. We do not make changes based on these comments. We
reiterate from the proposed rule that calculating average drive time
based on the use of a personal vehicle applies to many of the veterans
we serve, and that it would be too difficult and potentially costly to
consistently implement and operationalize a system that considers the
variety of transportation options potentially available to an
individual veteran. In major metropolitan areas, a veteran could travel
by personal car, bus, or rail, and each of these would have different
travel times.
Wait Time Standards
We first address comments that opposed the 20-day or 28-day wait
time standards based on the timeframes themselves. Some comments stated
that these timeframes were too long for covered veterans to wait to be
seen when they may have conditions or concerns requiring more immediate
attention, with a few comments further urging VA to adopt different
standards (for instance, 14 days or less for all services, 20 days for
all services, or 14 days for primary care and 20 days for specialty
care). Other related comments asserted that the wait time standards in
Sec. 17.4040(a)(1)(ii) and (a)(2)(ii) should be flipped, where 28 days
would apply to primary care and mental health and 20 days would apply
to specialty care, because specialty care is arguably more urgently
needed than primary care. We do not make changes based on these
comments. To address the concern that 20 or 28 days as applicable is
too long to wait to address more immediate health care needs, we
clarify that these are timeframes by which VA can assess whether it can
provide care and services under normal and not urgent or emergent
circumstances. Should any care or service with an applicable wait time
be deemed necessary for a covered veteran prior to reaching the ending
date of such wait time standard, then the best medical interest
eligibility criterion under Sec. 17.4010(a)(5) might enable a covered
veteran to be seen for such care or services through the VCCP (assuming
criteria under Sec. 17.4010(a)(5) were met). To address the comments
concerning the 20-day and 28-day wait times being flipped, we reiterate
from the section above that access standards for primary care versus
specialty care are not intended to reflect the relative importance of
one type of care versus the other, but rather the relative availability
of one type of care versus the other, as specialty tends to be
generally less available than primary care and therefore can requires
longer wait times on average.
The preamble of the proposed rule introduced the concept that VA
preliminarily had established a goal of reducing the wait times for
primary care and mental health services from 20 days in Sec.
17.4040(a)(1)(ii) as proposed to 14 days no sooner than June 2020.
Although this reduction from 20 days to 14 days was not put forth in
proposed regulation text, we invited and received comments on this
issue, the vast majority of which recommended that VA should not wait
until 2020 to reduce such wait times to 14 days. Conversely, we
received a few comments that VA should not reduce the primary care or
mental health wait times to 14 days prematurely, and that VA should
focus on meeting the 20-day standard first. More specifically, one
comment asserted that VA should wait for the results of VA's market
area assessments to drive any potential future reductions in wait
times. We do not make changes based on these comments, but reiterate
from the proposed rule that presently, a 14-day wait-time standard
would be difficult for VA to implement due to the current availability
of providers and variability in appointment wait-times across VA
facilities. However, VA will pursue additional rulemaking should we
proceed with the goal to reduce the primary care and mental health wait
time standards from 20 days to 14 days.
We received comments that did not necessarily oppose the wait-time
access standards, but that requested clarification of how VA would
determine whether care was primary care, specialty care, or mental
health care. Some related comments more specifically asserted that
certain care should fall within the 20-day standard for primary care,
for instance, most women's health care services, physical therapy, and
traumatic brain injury. Another comment advocated that certain case
management services associated with assisting homeless veterans should
be considered specialty care. We do not make changes based on these
comments. We believe in a majority of cases that it will be clear what
standard should be applied to what care. Because we believe these
comments are primarily concerned that certain services will not be
given the benefit of relatively shorter wait times, we reiterate that
if care is determined to be needed prior to reaching the ending date of
an applicable wait time, then the best medical interest eligibility
criterion under Sec. 17.4010(a)(5) would enable a covered veteran to
be seen for such care or services through the VCCP (assuming criteria
under Sec. 17.4010(a)(5) were met). We further advise that VA is
experienced in determining whether care is primary care or specialty
care, as VA uses this distinction to assess copayments under Sec.
17.108.
We received one comment that requested VA revise Sec.
17.4040(a)(1)(ii)
[[Page 26300]]
and (a)(2)(ii) to establish that the start date to begin counting any
applicable wait time should be the date that the services are
clinically indicated to be needed, and not the date of request for an
appointment. We do not make changes based on this comment. By shifting
the start of the wait time standard under the VCCP from the clinically
indicated date to the date of request, VA can optimize consistency in
decisions of eligibility that employ the wait time access standard.
Consistency in decisions regarding eligibility is desirable because it
assists VA to accurately forecast the use of VCCP under this standard,
and because it supports parity in eligibility determinations to support
a sense of fairness in veteran experience in using the VCCP.
Additionally, the option for the covered veteran to choose a later date
in consultation with a provider still permits for the wait time
standards to be counted starting on a date that is later than the date
of request, which could encompass a starting date when the services
would be considered clinically indicated.
Miscellaneous Comments
We received many comments that did not directly relate to any
regulatory sections from the proposed rule, but that expressed concerns
with VA's administration of its community care programs and further
suggested improvements. Although we do not make changes to the proposed
rule based on these comments because they are beyond the scope of the
proposed rule or address issues that would best be handled through
policy or contracting mechanisms, we summarize the comments below by
grouping them by topic and indicate where we provide clarifications.
Transition From the Veterans Choice Program
We received comments related to VA's transition from the Veterans
Choice Program (Choice) to the Veterans Community Care Program (VCCP),
which primarily requested clarification of administrative issues
related to VA's contracting efforts to ensure that there was a smooth
transition to the VCCP. The largest administrative issue raised in
comments was how VA would mitigate gaps in coverage in transitioning to
the VCCP, where specific requests for clarifications included: Whether
VA anticipated delays in implementation due to any contract protests;
whether the same services offered under Choice contracts would be
offered under VCCP contracts (and more specifically, Veterans Care
Agreements); whether providers under Choice provider agreements would
be grandfathered into VCCP contracts or agreements (essentially asking
whether Choice providers would be considered VCCP providers
automatically until VCCP contracts can be finalized); and whether VA
would issue guidance on transition from Choice to VCCP, to include more
information on ``other arrangements'' under which care can be provided.
VA has modified one of its community care contracts that provided
coverage under the Veterans Choice Program to engage the same third-
party administrator (TPA) (TriWest Healthcare Alliance) to provide for
expanded nationwide coverage for the VCCP until VA's Community Care
Network (CCN) contracts have established a fully functional network of
providers. We believe this nationwide engagement of the same TPA from
the Veterans Choice Program to administer the VCCP, until the CCN
contracts are in place and the networks required by those contracts are
fully operational, will allay many concerns regarding transition to the
VCCP, as the administrative procedures should be familiar to those
providers that participated under the Veterans Choice Program.
A related comment asserted that VA should standardize its contracts
and contracting processes nationally, to avoid what the comment
asserted was regional variation in contracts and contracting processes
that are present in other non-VCCP community care programs. This
comment also urged VA to make such contracts formed under section
1703(h) publicly available, and that any rules contained in such
contracts that seek to control the actions of eligible entities and
providers should be developed by notice-and-comment rulemaking so that
stakeholders (that are not the entities or providers) can provide input
on the impact of such rules on entities or providers. We do not make
any changes based on these comments. Any VA decisions regarding
contracting processes and standardization are implemented through
separate processes and actions, potentially including policies and
acquisition regulations. Separately, contracts within the meaning of
section 1703(h), and solicitations leading to such contracts, are and
will be subject to the existing, comprehensive legal framework
governing public disclosure of information relating to such
procurements and contracts. Any VA decisions regarding public
disclosures of information relating to such procurements and contracts
will be made in accordance with those laws. Finally, VA does not commit
to establishing all contractual requirements through notice-and-comment
rulemaking, and does not commit to establishing only national
contracts. Such commitments are incompatible with the legal and
operational framework of Federal procurement, including the
flexibility, discretion, and independence that are often integral to
the process of defining requirements.
Veterans Need More Information To Inform Their Election To Receive Care
Through the VCCP
We received comments that indicated VA was not providing enough
information to veterans to enable them to make informed choices of
whether to elect to receive community care. These comments primarily
stated that comparisons between VA care and community care were not
apparent at the point veterans might elect to receive community care,
and that veterans needed access to more timely comparisons between: VA
and non-VA wait times; distances from a veteran's residences to VA and
non-VA providers; and relative competency of VA and non-VA providers
(particularly, for care to treat conditions such as posttraumatic
stress disorder and traumatic brain injury). Some of these comments
suggested specific improvements (such as ensuring non-VA provider
directories are updated and available to veterans), where other
comments requested VA clarify how relevant comparative information will
be provided to veterans to elect to receive community care as required
by section 1703B(b). VA understands the desire for more information so
covered veterans can make informed choices regarding providers. VA has
included community provider information in the VA facility locator on
www.va.gov that shows both VA and community providers. This will allow
covered veterans to see the locations of specific community providers
in relation to VA providers. As VA begins to implement the new CCN
contracts, appointment availability timeframes will also be available
for the VA to share with covered veterans to assist them in making a
decision on providers.
Implementation of VA's Average Drive Time Standard
VA received comments that requested clarification on how VA will
calculate average drive times. We note that some detailed information
regarding average drive time calculations and algorithms is
proprietary. At a general level, VA's
[[Page 26301]]
calculation of average drive times between the veteran's residence and
an applicable VA facility will take into consideration a variety of
factors, including: Distance, route options, and speed limits. In its
current configuration, VA's geographic information system tool bases
these calculations on historical data, rather than real-time traffic
information. As VA gains more experience with VCCP and receives
feedback from veterans regarding their experiences with the program, we
anticipate refining this tool and our systems to improve our
consideration of actual conditions that affect travel to receive care
and services and to provide more information to veterans regarding
calculation of average drive times.
We received a comment that urged VA to publish a report every six
months regarding the outcome of VA using an average drive time standard
versus a mileage standard, to include a total number of individuals
qualifying under the average drive time standards. We do not make
changes to the regulation based on this comment, and do not commit to
publishing such a report, although we note that VA will monitor use of
the VCCP care and services by covered veterans, to include use that
qualifies under the designated access standards. VA will report
regularly to Congress on utilization of the VCCP, as required by
section 1703(m).
Claims Adjudication and Payments
We received comments related to administrative procedures for VA's
processing of claims for payments for hospital care, medical services,
or extended care services furnished through the VCCP. These comments
essentially stated that claims and payment procedures need to be clear
and minimally burdensome and that VA must ensure it applies the prompt
payment provisions that are required under section 1703D to ensure
providers are paid on timely (particularly, as noted by one comment, to
include provisions that cover interest on overdue claims). Some of
these comments further urged VA to confirm its plans to publish future
regulations to implement the prompt payment provisions in section
1703D, with some requests that VA provide a more specific timeframe in
which it expects to promulgate such regulations. Another comment urged
that VA should consider establishing a maximum timeframe to pay
electronic claims within 14 days, and to pay paper claims within 30
days, when VA does promulgate regulations to implement section 1703D.
Lastly, multiple comments generally asserted that appeals procedures
for adjudication of claims or payment-related disputes should be
comprehensive and timely.
We first confirm that VA will be undertaking future rulemaking to
implement the prompt pay provisions of section 1703D, which will
include provisions to implement the requirements under section 1703D
(such as establishing timeframes in which to pay clean electronic and
clean paper claims, addressing interest on overdue claims, and appeals
procedures). We cannot provide an exact timeframe in which VA can
expect such regulations to be promulgated, and we will not discuss
specifics here of any policy development regarding such regulations,
although we generally note that two-stage rulemaking can typically
require 18-24 months to complete. We received some related comments
regarding claims and payments processing that asserted the compensation
options for eligible entities or providers are difficult to understand
and that providers are not paid timely as a result, but these comments
urged VA to publish a comprehensive policy for eligible entities and
providers to resolve misunderstandings. We clarify that the
compensation options are part of the contract between VA and the TPA.
VA will work with the TPAs to ensure they have appropriate information
regarding claims submission and processing that will assist in
preventing untimely payments. Section 122 of the MISSION Act requires
VA to develop and implement a training program for employees and
contractors on how to administer non-Department health care programs.
As required by section 122 of the VA MISSION Act, VA is providing
training to the TPAs regarding administrative processes.
One comment indicated that on July 31, 2018, the Centers for
Medicare and Medicaid Services (CMS) published the Prospective Payment
System (PPS) and Consolidated Billing for Skilled Nursing Facilities
(SNF) Final Rule for Fiscal Year (FY) 2019. The comment further noted
that in this rule, CMS finalized a proposal to replace the current
Skilled Nursing Facility Prospective Payment System Resource
Utilization Group (RUGs) payment model with a new per-diem payment
system called the Patient-Driven Payment Model (PDPM) beginning on
October 1, 2019. This comment ultimately urged that CMS and VA
communicate how the PDPM reimbursement structures and VA's
reimbursement structures will work together. Because reimbursement is
included in the contracts with the TPAs, VA will ensure that the
payment methodology used is clearly explained to the contractors so
that eligible entities and providers understand how VA's benchmark of
using applicable Medicare rates may shift with the publication or
annual or major Medicare rate shifts.
Improve Procedures and Practices of VA's Third-Party Administrators
We received many comments that identified both general and specific
administrative improvements that could be made by the third-party
administrators (TPA) with whom VA contracts to generally administer the
VCCP. Most of these comments identified the desired administrative
improvements by providing examples of TPA deficiencies as experienced
under Choice, but we address these comments here in relation to the
VCCP. The most general concerns expressed in these comments related to
a lack of timeliness, accuracy, and follow-up regarding TPA practices
in referring and scheduling care in the community. These comments
generally urged that improvements were needed to streamline scheduling,
where specific suggestions to achieve improvements ranged from
simplifying communications systems (e.g., consolidating various call
center numbers to create a one-call/one-stop experience for covered
veterans to interact with TPAs) to creating more comprehensive guidance
on how TPAs obtain timely eligibility determinations and authorizations
from VA. VA is generally responsible for scheduling appointments for
veterans in most markets and will work with its TPAs to improve
administrative processes to assist in streamlining scheduling in other
cases, particularly where VA can improve its processes to verify
eligibility and communicate authorizations of care.
Other comments indicated a need for clearer policies and processes
to ensure that non-VA providers and covered veterans understand what
care is and is not authorized, and a few comments deemed that VA's
review of authorizations for care were not timely or consistent. One
comment further urged VA to adopt a more robust and transparent process
to ensure each authorization for care includes: A binding determination
regarding the scope of issues that might be raised for coverage and
payment purposes; a plan to transfer a covered veteran back to VA after
conclusion of the treatment authorized; prompt decisions to grant or
deny authorizations; and a statement that clarifies non-VA providers
will receive payment for services provided due to error on VA's part or
on the
[[Page 26302]]
covered veteran's part. Much of what is specifically raised by this
comment is contemplated in the contracts VA forms with TPAs or directly
with eligible entities and providers to furnish care and services
through the VCCP, and VA will work to improve consistency in its
authorization processes. Related comments urged VA to develop guidance
to address oversight of its TPAs that would include metrics to measure
effective communications between the TPAs and eligible entities or
providers, and a process for such entities or providers to contact VA
for dispute resolution regarding TPA performance. We similarly respond
that much of what these comments raise is contemplated in the contracts
VA forms with eligible entities and providers, and VA will work to
ensure appropriate monitoring of TPAs as identified in the contract.
We received some comments related to VA's processes in
credentialing non-VA entities or providers to find them eligible to
furnish care and services through the VCCP. Specifically, these
comments urged VA to reduce potential duplication of credentialing
processes between VA and the TPAs with whom VA contracts to administer
community care. One comment further urged VA to maintain its
recognition of a current administrative process adopted by some non-VA
hospitals (particularly, academic medical centers) to have the TPA
delegate provider credentialing to the non-VA hospital, where such
hospital agrees to meet the credentialing requirements through their
own in-house process and be audited as necessary. We clarify that the
credentialing process to determine whether non-VA entities or providers
are eligible to participate in the VCCP will be conducted by the TPAs
with whom VA contracts and not by VA, so we do not believe there is
cause to be concerned about duplicative credentialing processes. For
this same reason, VA cannot respond to clarify how a TPA's
credentialing processes may be conducted, but VA would support any TPA
processes to continue or establish credentialing that reduces delays,
so long as VA's credentialing requirements are met.
Some comments urged improvements to administrative processes for
particular groups of covered veterans. For instance, with regard to
pregnant veterans and veterans in need of maternity care, one comment
urged VA to: Establish a more streamlined process for prior
authorizations for pregnant veterans (to include priority access to
treatment of substance use disorder); require authorization by VA of
required episodes of care no more than seven days after pregnancy is
diagnosed; make Maternity Care Coordinators (MCC) a full-time position
in VA facilities as needed; and ensure that pregnant veterans receiving
non-VA care are put in contact with MCCs to assist navigating non-VA
care. One commenter urged VA to require eligible entities and providers
in the community to use VA's universal housing instability screener to
ensure that homeless veterans who may elect to receive care in the
community are aware of VA's homeless assistance programs. We appreciate
these comments and agree it is important to maintain awareness if
certain veteran populations may require particular VA assistance to
navigate community care or assistance to access VA resources that do
not necessarily pertain to healthcare matters. VA will ensure it
maintains its focus to assist in care coordination for all veterans who
elect to receive care in the community.
Lastly, we received a few comments that stated that VA should not
use TPAs generally, as this creates an unnecessary layer of
administrative bureaucracy. A few comments indicated more specifically
that VA should not use a specific TPA with which it has previously
contracted to provide care in the community, and instead should use
veteran contractors. Currently, VA's utilization of TPAs to perform
certain functions is important to ensuring VA optimizes its provision
of care in the community. For instance, use of a TPA provides VA an
accredited network of providers as well as claims processing that is
standardized in the health care industry, which are two areas that VA
does not have the required infrastructure or expertise to administer
directly at this time. With regard to the comments that VA should not
use a specific TPA and should use veteran contractors instead, we note
that VA is subject to, and abides by, the comprehensive set of laws
governing Federal procurement. Those laws do not permit indiscriminate
awarding of contracts to groups of individuals, as we believe is
suggested by the commenter.
Information Technology and Information Sharing
We received multiple comments that expressed concerns regarding
VA's information technology (IT) infrastructure and capabilities to
enable the level of information sharing required to ensure smooth
administration of the VCCP. The general thrust of these comments
asserted that VA's IT systems, particularly its electronic medical
record system, required improvements to ensure the timely and seamless
exchange of clinical information between VA and non-VA sources. More
specifically, some commenters urged VA to acquire and use a single
electronic system that would be accessible 24 hours a day/7 days a week
by non-VA entities and providers, and that could be integrated with
VA's electronic medical record to assist with confirming VCCP
eligibility and otherwise to communicate all clinical and
administrative information necessary to participate in VCCP (e.g.
eligible entities and providers would submit and receive referrals or
authorizations, medical records, claims forms, etc.). Other comments
further urged VA, whether it would adopt new IT systems or modify its
existing systems, to allow non-VA providers (specifically the large
academic medical centers and faculty practice plans) to designate
multiple staff members who would have access to those systems. We
clarify that VA has been steadily working on improvements for sharing
of medical information. VA participates in standardized health
information exchanges in the health care industry, and this summer is
deploying a commercial referral management system, Healthshare Referral
Manager, which will be used to share authorizations with community
providers and exchange medical information. VA has already deployed
community viewer, which allows community providers secure, web-based
access to medical information and VirtruPro, which allows secure,
encrypted email exchange between the VA and community providers. VA
also encourages all providers to submit claims electronically using
industry standard transactions to ensure prompt payment of claims.
We received one comment that urged VA to modernize its IT systems
as an attempt to move away from the administration of paper claims and
eventually require the submission of electronic claims. VA will
consider addressing the submission of paper claims and electronic
claims in any future rulemaking to implement the prompt payment
provisions of section 1703D. VA is also undertaking efforts to
modernize its IT systems for claims processing. As noted above, VA
encourages all providers to submit claims electronically using
industry-standard transactions. VA is additionally deploying an
industry-standard claims processing system this year that includes
auto-adjudication and will improve timeliness of claims processing.
We received one comment that expressed concerns that VA's decision
[[Page 26303]]
support tool to determine whether a covered veteran was eligible to
participate in VCCP (particularly with regard to eligibility based on
VA's designated access standards), will not be ready for timely
implementation on June 6, 2019. VA expects the tool will be ready by
June 6, 2019. This tool will assist with eligibility determinations by
displaying, documenting, and storing relevant information related to
eligibility determinations in a standardized and reportable manner. In
the event that the tool was not at full functionality for any reason,
VA can also look to other systems to gather and assess information
related to eligibility (such as VA's Computerized Patient Record
System) as a contingency.
Emergency Care
We received comments related to the administrative practices of VA
in reviewing and approving emergency care. These comments generally
relayed concerns that covered veterans were unduly subject to cost
liabilities for emergency treatment because the administrative
requirements VA imposes were unclear or inefficient and lead to VA
failing to approve or pay for the emergency care in a timely manner.
These comments suggested multiple improvements, primarily comprised of
requests for VA to: Increase education for providers and covered
veterans (to ensure the nearest VA facility is well known for purposes
of the 72-hour notification, who is the appropriate VA official at that
facility to receive the notice, etc.); and establish a single,
nationwide system (such as an online portal and national call center)
where all emergency care matters under the VCCP would be administered.
The administrative rules in place regarding notice to the nearest local
VA facility are required to ensure that emergency care can be
authorized and claims can be considered under all available authorities
for emergency care. The local facility is in the best position (and in
many ways, the only position) to actually assess criteria related to
the appropriateness of authorizing emergency care (for instance,
whether a patient could be transferred to a nearby VA facility). VA
will work to improve education and messaging to non-VA providers and
veterans concerning how and where to submit timely notice of use of
emergency care to assist with timely approvals.
Prescriptions
We received comments regarding VA's administrative practices in
reviewing and approving prescriptions issued by non-VA providers. These
comments primarily voiced concerns that VA's practices were unnecessary
or unduly burdensome and either created delays in getting prescriptions
filled, or created unnecessary administrative costs for VA. Some
comments further suggested alternatives to VA's current practice of VA
providers reviewing and approving prescriptions from non-VA providers,
such as allowing non-VA providers to fill prescriptions directly with
VA pharmacies through the TPA that VA utilizes to administer its
community care programs. VA's current practices of reviewing and
approving prescriptions issued by non-VA providers are in place to
ensure appropriate prescription monitoring, care coordination, and cost
and quality controls. VA does not believe that this review creates
unnecessary administrative costs for VA, but VA can work to improve its
internal review and approval processes to reduce or eliminate delays in
getting non-VA prescriptions filled.
Eligible Entities and Providers
We received comments related to VA's practices in disseminating
information to non-VA providers who could potentially participate in
VCCP, for the purpose of maintaining and increasing provider
participation. These comments generally called for improvements in VA's
communicating such information to providers and suggested improvements
ranged from offering a webinar specifically on the implementation of
contracts or agreements (particularly for Veterans Care Agreements
authorized under section 1703A and Sec. Sec. 17.4100 through 17.4135),
to developing or improving policies related to approving providers to
participate in the VCCP. VA will examine its current outreach and
education efforts in maintaining and increasing (as needed) provider
participation in the VCCP and will be open to all options of
communicating with non-VA providers to ensure that provider
requirements to participate in the VCCP are well understood.
We received one comment that urged VA to clarify whether non-VA
providers who would furnish care and services under the VCCP are
considered Federal contractors or subcontractors to be subject to
Federal contractor requirements, including, but not limited to
Executive Order 11246, as amended, Section 503 of the Rehabilitation
Act of 1973, as amended, the Vietnam Era Veterans' Readjustment
Assistance Act of 1974, as amended, and the McNamara-O'Hara Service
Contract Act of 1965, as amended, and any other Federal contractor
obligations, such as those related to Federal minimum wage and sick
leave. This comment urged that non-VA providers participating in the
VCCP should not be considered Federal contractors or subcontractors to
avoid application of Federal contractor obligations imposed under the
jurisdiction of the Department of Labor's Office of Federal Contract
Compliance Programs (OFCCP). We clarify that section 107 of the MISSION
Act states that Directive 2014-01 of the Office of Federal Contract
Compliance Programs (OFCCP) of the Department of Labor (effective as of
May 7, 2014) applies to any entity entering into an agreement under
section 1703A or section 1745 of title 38 in the same manner as such
Directive applies to subcontractors under the TRICARE program for the
duration of the moratorium established by that Directive. VA has
consulted with the Department of Labor regarding this provision, and we
understand that OFFCP intended, through a Directive 2018-02, to extend
the moratorium from OFCCP's jurisdiction concerning Executive Order
11246, section 503 of the Rehabilitation Act, and the Vietnam Era
Veterans' Readjustment Assistance Act to cover health care providers in
all VA programs under which VA has statutory authority to provide care
to veterans by contracting with private, non-VA providers.
Specifically, we understand OFCCP to consider the following categories
of providers to be within the scope of the 2018 Directive's moratorium:
Independent contractors operating in VA facilities, contract community-
based outpatient clinics, and providers who are part of a network and
furnishing services pursuant to a contract between VA and the network
administrator, contracts and agreements directly between VA and
providers (i.e., Federal Acquisition Regulation (FAR)-based contracts
subject to all procurement laws, Choice provider agreements, Veterans
Care Agreements, and agreements with State Veterans Homes). We further
note that the Department of Labor is working to establish the
Directive's moratorium through a regulation, and we appreciate their
efforts in that effort.
Congressional Review Act
The Secretary of Veterans Affairs finds that there is good cause
under the provisions of 5 U.S.C. 808(2) to make the rule effective on
June 6, 2019. Specifically, the Secretary finds that it would be
contrary to the public interest to delay the date this rule could be
operative and effective because any delay in implementing the rule
would have a severe detrimental impact on veterans' health care.
[[Page 26304]]
Section 143 of the MISSION Act of 2018 amended section 101(p) of
the Veterans Access, Choice, and Accountability Act of 2014 (Pub. L.
113-146; 38 U.S.C. 1701 note, as amended, hereafter referred to as the
Choice Act) to state that VA may not use the Choice Act to furnish care
and service after June 6, 2019. As a result, on that date, VA will no
longer be able to use the Veterans Choice Program to furnish care or
services in the community. Section 101 of the MISSION Act will amend 38
U.S.C. 1703 to permit VA to administer a new Veterans Community Care
Program, which will replace the Veterans Choice Program. However,
section 1703 will not be so amended until VA promulgates regulations
under section 101(c) of the VA MISSION Act of 2018 by its own terms,
which is the function of this final rule. Therefore, if this final rule
is not effective on June 6, 2019, VA would not have the Choice Act
authority or the MISSION Act authority under which to administer care
in the community; the only authority VA would have to administer such
care would section 1703 as it exists unamended by the MISSION Act.
The provisions of section 1703 as unamended by the MISSION Act, as
well as its implementing regulations at 38 CFR 17.52, do not provide a
sufficient legal basis to meet the requirements of section 101 of the
MISSION Act in areas such as eligibility, appeals, and payment rates,
nor do they provide for the same levels of community care that have
been received by veterans under the Veterans Choice Program through
June 6, 2019.
If this final rule to implement the new Veterans Community Care
Program, and to replace Veterans Choice Program, is not effective on
June 6, 2019, the approximately 2 million veterans who have received
care under the Veterans Choice Program (for over 46 million
appointments since inception) will be forced to find alternative
pathways to care. These veterans will either be: (1) Absorbed by
existing VA facilities, (2) sent out into the community under VA's more
limited section 1703 authority, or (3) might forego care all together.
As indicated below, all of these pathways would result in delays in
care, lack of continuity in care, and absence of care that would be
significantly detrimental to veteran's health.
Absorbing the Veterans Choice Program's share of care for 2 million
veterans into existing VA facilities would significantly strain VA's
resources and cause problems impacting veterans' health. It would
interrupt continuity of care, pose significant delays for scheduling
care, and would lead to long wait times. The VA system is simply not
capable of accommodating this amount of care without causing delays in
access to care.
Some care, therefore, would need to remain in the community. But
with neither the Veterans Choice Program nor the new Veterans Community
Care Program in place, VA would have no universally applicable
eligibility criteria for community care. Without such national, clear,
and consistent criteria in place, individual VA facilities or VA Health
Care Systems may adopt local criteria that do not support standardized
decisions regarding when veterans may be eligible to receive VA
community care, and VA could return to the same non-standardized
community care environment that led to the wait-time issues in 2014,
such as when access barriers adversely affected the quality of primary
and specialty care at the Phoenix VA Health Care System. After the
wait-time issues of the Phoenix VA Health Care System were made public,
VA's Office of Inspector General examined the electronic health records
and other information from more than 3,000 veteran patients and
identified 28 instances of clinically significant delays in care
associated with access to care or patient scheduling. The Office of the
Inspector General (OIG) found that the majority of the veteran patients
reviewed were on official or unofficial wait lists and experienced
delays accessing primary care--in some cases, pressing clinical issues
required specialty care, which some patients were already receiving
through VA or non-VA providers. OIG further found that some veterans on
unofficial wait lists were at risk of never obtaining their requested
or necessary appointments. As OIG stated, inappropriate scheduling
practices were a nationwide systemic problem. OIG identified multiple
types of scheduling practices in use that did not comply with VHA's
scheduling policy. We believe these deviations from scheduling policy
were due in part to limited and inconsistently applied criteria by
which veterans may receive community care.
By way of example, section 1703 as unamended by the MISSION Act
provides VA authority to contract for hospital care and medical
services when VA facilities are not capable of furnishing economical
care due to geographic inaccessibility or are not capable of furnishing
care. However, our implementing regulations at 38 CFR 17.52 generally
establish eligibility criteria based on type of care needed and whether
or not the veteran is service-connected, and do not provide additional
clarity on what geographic inaccessibility means. Nothing in Sec.
17.52 or section 1703 as unamended by the MISSION Act approximates the
specific eligibility criteria available under the Veterans Choice
Program or contemplated under the MISSION Act related to distance-
related access criteria. As such, the criterion of geographic
inaccessibility under section 1703 as unamended by the MISSION Act can
be interpreted many ways, leading to inequitable eligibility decisions
for community care and bad scheduling practices based on such
decisions.
A delay in the effective date of this rule would result in a lack
of consistently applicable community care criteria, which would create
significant disruptions for even a limited period of time such as sixty
days. Continuity of care could particularly be disrupted, and patient
safety and health would be in jeopardy, for any veterans who would not
be authorized to seek care from a health care provider that has been
treating them for years under the Veterans Choice Program. This could
be particularly harmful for veterans who have mental health conditions
and are only comfortable seeking treatment from their current mental
health care professional.
Such veterans may opt to simply forego care from a different
provider for a delay of sixty days until this rule is effective.
Similarly, a sixty-day delayed effective date could increase confusion
for even for new veteran users, new and existing providers in the
community, as well as employees at VA, if VA were to go from
administering community care under Veterans Choice Program criteria, to
then under significantly more limited criteria of section 1703 as
unamended by the MISSION Act for a very limited period of time, and
then to implementation of what are now publicly vetted and broader
criteria under the new Veterans Community Care Program. To avoid this
confusion, some veterans may simply choose not to receive care until
the new Veterans Community Care Program is in place, or providers may
simply not participate, or even VA may be at risk for administering
community care incorrectly. This places veterans' health and safety at
risk, particularly for continuous and periodic care or treatment that
may be occurring under the Veterans Choice Program through June 6,
2019, and that must typically occur on an immediate and stringent
schedule upon diagnosis (such as treatment for cancer, or maternity
care).
Accordingly, the Secretary finds it would be contrary to the public
interest
[[Page 26305]]
to delay the effective date of AQ46 and that there is good cause to
dispense with the opportunity for a 60-day period of prior
Congressional review and to publish this final rule with an operative
and effective date of June 6, 2019.
Administrative Procedure Act
For the reasons set forth in the preceding section, the Secretary
finds that there is good cause under 5 U.S.C. 553(d)(3) to publish this
rule with an effective date that is less than 30 days from the date of
publication.
Effect of Rulemaking
The Code of Federal Regulations, as revised by this rulemaking,
represents the exclusive legal authority on this subject. No contrary
rules or procedures will be authorized. All VA guidance will be read to
conform with this rulemaking if possible or, if not possible, such
guidance will be superseded by this rulemaking.
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 will amend information collection requirements
currently approved under control number 2900-0823 and will impose new
collections of information requirements and burden. Notice of OMB
approval for this information collection will be published in the
Federal Register.
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. Although some eligible entities or providers that will furnish
care and services to veterans under this rule might be considered small
entities, there will be no significant adverse economic impact. To the
extent there is any impact on small entities and given the lapse in
statutory authority for the Veterans Choice Program, it will be a
potential increase in business due to proposed expanded eligibility for
non-VA care. While this rulemaking defines payment rates and eligible
entities and providers, it does so in a way that is consistent with
VA's current authorities. We note that separate regulations at 38 CFR
17.4100 through 17.4135, authorizes VA to enter into agreements with
eligible providers, many of whom will likely be small businesses. We
also do not believe there will be a significant economic impact on any
insurance companies that might be considered small businesses, as
claims would only be submitted for care that would otherwise have been
received whether such care was authorized under VCCP; the need for the
care itself is not generated by the VCCP, merely furnished under the
VCCP versus another program. Therefore, pursuant to 5 U.S.C. 605(b),
the Secretary has determined that an initial and a final regulatory
flexibility analysis are not needed.
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.
Executive Order 12866 (Regulatory Planning and Review) defines a
``significant regulatory action,'' which requires review by 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 the Executive Order. VA has
examined the economic, interagency, budgetary, legal, and policy
implications of this regulatory action and determined that the action
is an economically significant regulatory action under Executive Order
12866. The total estimated budget impact (both transfers and costs) is
projected to be $346.3 million in FY 2019 and $17.9 billion over a 5-
year period. Transfers are estimated to be $15.6 billion over a 5-year
period and costs are estimated to be $2.2 billion over a 5-year period.
These transfer impacts are from the federal government to eligible
Veterans. The cost impacts are administrative fees, claim fees and
other non-provider payment costs.
Benefits of the rulemaking will strengthen the access to VA health
care overall by increasing the choices Veterans have for their health
care and complementing the increasingly timely, high-quality care
provided by VA medical facilities. Veterans will continue to have the
option to choose whether to receive care at a VA medical facility or a
community provider. Furthermore, the access expansion will allow
Veterans to receive care in the community through a network of
providers when VA does not provide the required care or services, wait
times do not conform with VA access standards, service line does not
meet VA quality standards, the referring clinician determines it is in
the best medical interest of the Veteran to receive care or services in
the community. Additionally, Veterans will be able to access community
care when the Veteran was eligible to receive care under certain
grandfathering provisions or VA does not operate a full-service medical
facility in the State in which the veteran resides.
VA's regulatory 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 from FY 2004 through FYTD. This final rule is an E.O. 13771
regulatory action. VA has determined that the net costs are $2.2
million over a five-year period (FY2019-FY2023) and $429 million per
year on an ongoing basis discounted at 7 percent relative to year 2016,
over a perpetual time horizon. Details on the estimated costs of this
final rule can be found in the rule's economic analysis.
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
[[Page 26306]]
(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 as follows: 64.007, Blind
Rehabilitation Centers; 64.008, Veterans Domiciliary Care; 64.009,
Veterans Medical Care Benefits; 64.010, Veterans Nursing Home Care;
64.011, Veterans Dental Care; 64.012, Veterans Prescription Service;
64.013, Veterans Prosthetic Appliances; 64.014, Veterans State
Domiciliary Care; 64.015, Veterans State Nursing Home Care; 64.016,
Veterans State Hospital Care; 64.018, Sharing Specialized Medical
Resources; 64.019, Veterans Rehabilitation Alcohol and Drug Dependence;
64.022, Veterans Home Based Primary Care; and 64.024, VA Homeless
Providers Grant and Per Diem Program.
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-veterans, Health care, Health
facilities, Health professions, Health records, Homeless, Medical
devices, Mental health programs, Nursing homes, Reporting and
recordkeeping requirements, 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. Robert L.
Wilkie, Secretary, Department of Veterans Affairs, approved this
document on April 23, 2019, for publication.
Dated: May 30, 2019.
Michael P. Shores,
Director, Office of Regulation Policy & Management, Office of the
Secretary, Department of Veterans Affairs.
For the reasons set forth in the preamble, we amend 38 CFR part 17
as follows:
PART 17--MEDICAL
0
1. The authority citation for part 17 is amended by revising the entry
for Sec. 17.38 and adding entries for Sec. Sec. 17.46, 17.52, 17.55,
17.56, 17.108, 17.110, and 17.111 and Sec. Sec. 17.4000 through
17.4040 in numerical order to read in part as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
Section 17.38 is also issued under 38 U.S.C. 1703.
Section 17.46 is also issued under 38 U.S.C. 1710.
Section 17.52 is also issued under 38 U.S.C. 1701, 1703, 1710,
1712, and 3104.
Section 17.55 is also issued under 38 U.S.C. 513, 1703, and
1728.
Section 17.56 is also issued under 38 U.S.C. 1703 and 1728.
Section 17.108 is also issued under 38 U.S.C. 501, 1703, 1710,
1725A, and 1730A.
Section 17.110 is also issued under 38 U.S.C. 501, 1703, 1710,
1720D, 1722A, and 1730A.
Section 17.111 is also issued under 38 U.S.C. 101(28), 501,
1701(7), 1703, 1710, 1710B, 1720B, 1720D, and 1722A.
* * * * *
Sections 17.4000 through 17.4040 also issued under 38 U.S.C.
1703, 1703B, and 1703C.
* * * * *
Sec. 17.38 [Amended]
0
2. Amend Sec. 17.38(a)(1)(iv) by removing ``Sec. Sec. 17.52(a)(3),
17.53, 17.54, 17.120-132'' and adding in its place ``Sec. 17.52(a)(3),
Sec. 17.53, Sec. 17.54, Sec. Sec. 17.120 through 17.132, or
Sec. Sec. 17.4000 through 17.4040.''
Sec. 17.46 [Amended]
0
3. Amend Sec. 17.46:
0
a. In paragraph (a) introductory text by adding the phrase ``on or
before June 6, 2019,'' after the phrase ``In furnishing hospital
care''; and
0
b. Removing the authority citations at the ends of paragraphs (a) and
(b).
0
4. Amend Sec. 17.52 by removing the authority citations at the ends of
paragraphs (a)(1) through (10) and paragraph (b) and adding paragraph
(c) to read as follows:
Sec. 17.52 Hospital care and medical services in non-VA facilities.
* * * * *
(c) The provisions of this section shall not apply to care
furnished by VA after June 6, 2019.
Sec. 17.54 [Removed and Reserved]
0
5. Remove and reserve Sec. 17.54.
0
6. Amend Sec. 17.55 by revising the introductory text and removing the
authority citation at the end of the section to read as follows:
Sec. 17.55 Payment for authorized public or private hospital care.
Except as otherwise provided in this section, payment for public or
private hospital care furnished on or before June 6, 2019, under 38
U.S.C. 1703 and Sec. 17.52, or at any time under 38 U.S.C. 1728 and
Sec. Sec. 17.120 and 17.128 or under 38 U.S.C. 1787 and Sec. 17.410,
shall be based on a prospective payment system similar to that used in
the Medicare program for paying for similar inpatient hospital services
in the community. Payment shall be made using the Centers for Medicare
& Medicaid Services (CMS) PRICER for each diagnosis-related group (DRG)
applicable to the episode of care.
* * * * *
0
7. Amend Sec. 17.56 by adding paragraph (e) and removing the authority
citation at the end of the section to read as follows:
Sec. 17.56 VA payment for inpatient and outpatient health care
professional services at non-departmental facilities and other medical
charges associated with non-VA outpatient care.
* * * * *
(e) Except for payments for care furnished under 38 U.S.C. 1725 and
Sec. 17.1005, under 38 U.S.C. 1728 and Sec. Sec. 17.120 and 17.128,
or under 38 U.S.C. 1787 and Sec. 17.410, the provisions of this
section shall not apply to care furnished by VA after June 6, 2019, or
care furnished pursuant to an agreement authorized by 38 U.S.C. 1703A.
0
8. Amend Sec. 17.108:
0
a. In paragraph (b)(4):
0
i. By removing ``Sec. 17.1500 through 17.1540'' and adding in its
place ``Sec. Sec. 17.1500 through 17.1540, or the Veterans Community
Care Program under Sec. Sec. 17.4000 through 17.4040''; and
0
ii. Removing ``paragraphs (b)(2) or (b)(3)'' and adding in its place
``paragraph (b)(2) or (3)'';
0
b. In paragraph (c)(4), by removing ``Sec. 17.1500 through 17.1540''
and adding in its place ``Sec. Sec. 17.1500 through 17.1540, or the
Veterans Community Care Program under Sec. Sec. 17.4000 through
17.4040''; and
0
c. Removing the authority citation at the end of the section.
Sec. 17.110 [Amended]
0
9. Amend Sec. 17.110:
0
a. In paragraph (b)(4):
0
i. By removing ``Sec. 17.1500 through 17.1540'' and adding in its
place ``Sec. Sec. 17.1500 through 17.1540, or the Veterans Community
Care Program under Sec. Sec. 17.4000 through 17.4040''; and
0
ii. Removing ``paragraphs (b)(1)(i) through (b)(1)(iii)'' and adding in
its place ``paragraphs (b)(1)(i) through (iii)''; and
0
b. Removing the authority citation at the end of the section.
[[Page 26307]]
Sec. 17.111 [Amended]
0
10. Amend Sec. 17.111:
0
a. In paragraph (b)(3):
0
i. By removing ``Sec. 17.1500 through 17.1540'' and adding in its
place ``Sec. Sec. 17.1500 through 17.1540, as well as extended care
services furnished through the Veterans Community Care Program under
Sec. Sec. 17.4000 through 17.4040''; and
0
ii. Removing ``paragraphs (b)(1) or (b)(2)'' and adding in its place
``paragraph (b)(1) or (2)''; and
0
b. Removing the authority citation at the end of the section.
Sec. 17.1004 [Amended]
0
11. Amend Sec. 17.1004 in paragraph (b) introductory text by removing
the phrase ``HCFA 1500'' and adding in its place ``CMS 1500'' and
removing the authority citation at the end of the section.
0
12. Add an undesignated center heading and Sec. Sec. 17.4000 through
17.4040 to read as follows:
Veterans Community Care Program
Sec.
17.4000 Purpose and scope.
17.4005 Definitions.
17.4010 Veteran eligibility.
17.4015 Designated VA medical service lines.
17.4020 Authorized non-VA care.
17.4025 Effect on other provisions.
17.4030 Eligible entities and providers.
17.4035 Payment rates.
17.4040 Designated access standards.
Veterans Community Care Program
Sec. 17.4000 Purpose and scope.
(a) Purpose. Sections 17.4000 through 17.4040 implement the
Veterans Community Care Program, authorized by 38 U.S.C. 1703.
(b) Scope. The Veterans Community Care Program establishes when a
covered veteran may elect to have VA authorize an episode of care for
hospital care, medical services, or extended care services from an
eligible entity or provider. Sections 17.4000 through 17.4040 do not
affect eligibility for non-VA care under sections 1724, 1725, 1725A, or
1728 of title 38, United States Code.
Sec. 17.4005 Definitions.
For purposes of the Veterans Community Care Program under
Sec. Sec. 17.4000 through 17.4040:
Appointment means an authorized and scheduled encounter, including
telehealth and same-day encounters, with a health care provider for the
delivery of hospital care, medical services, or extended care services.
Covered veteran means a veteran enrolled under the system of
patient enrollment in Sec. 17.36, or a veteran who otherwise meets the
criteria to receive care and services notwithstanding his or her
failure to enroll in Sec. 17.37(a) through (c).
Eligible entity or provider means a health care entity or provider
that meets the requirements of Sec. 17.4030.
Episode of care means a necessary course of treatment, including
follow-up appointments and ancillary and specialty services, which
lasts no longer than 1 calendar year.
Extended care services include the same services as described in 38
U.S.C. 1710B(a).
Full-service VA medical facility means a VA medical facility that
provides hospital care, emergency medical services, and surgical care
and having a surgical complexity designation of at least ``standard.''
Note 1 to the definition of ``full-service VA medical facility'':
VA maintains a website with a list of the facilities that have been
designated with at least a surgical complexity of ``standard,'' which
can be accessed on VA's website.
Hospital care has the same meaning as defined in 38 U.S.C. 1701(5).
Medical services have the same meaning as defined in 38 U.S.C.
1701(6).
Other health-care plan contract means an insurance policy or
contract, medical or hospital service agreement, membership or
subscription contract, or similar arrangement not administered by the
Secretary of Veterans Affairs, under which health services for
individuals are provided or the expenses of such services are paid; and
does not include any such policy, contract, agreement, or similar
arrangement pursuant to title XVIII or XIX of the Social Security Act
(42 U.S.C. 1395 et seq.) or chapter 55 of title 10, United States Code.
Residence means a legal residence or personal domicile, even if
such residence is seasonal. A covered veteran may maintain more than
one residence but may only have one residence at a time. If a covered
veteran lives in more than one location during a year, the covered
veteran's residence is the residence or domicile where they are staying
at the time they want to receive hospital care, medical services, or
extended care services through the Veterans Community Care Program. A
post office box or other non-residential point of delivery does not
constitute a residence.
Schedule means identifying and confirming a date, time, location,
and entity or health care provider for an appointment in advance of
such appointment.
Note 1 to the definition of ``schedule'': A VA telehealth encounter
and a same-day care encounter are considered to be scheduled even if
such an encounter is conducted on an ad hoc basis.
VA facility means a VA facility that offers hospital care, medical
services, or extended care services.
VA medical service line means a specific medical service or set of
services delivered in a VA facility.
Sec. 17.4010 Veteran eligibility.
Section 1703(d) of title 38, U.S.C., establishes the conditions
under which, at the election of the veteran and subject to the
availability of appropriations, VA must furnish care in the community
through eligible entities and providers. VA has regulated these
conditions under paragraphs (a)(1) through (5) of this section. If VA
determines that a covered veteran meets at least one or more of the
conditions in paragraph (a) of this section and has provided
information required by paragraphs (b) and (c) of this section, the
covered veteran may elect to receive authorized non-VA care under Sec.
17.4020.
(a) The covered veteran requires hospital care, medical services,
or extended care services and:
(1) No VA facility offers the hospital care, medical services, or
extended care services the veteran requires.
(2) VA does not operate a full-service VA medical facility in the
State in which the veteran resides.
(3) The veteran was eligible to receive care and services from an
eligible entity or provider under section 101(b)(2)(B) of the Veterans
Access, Choice, and Accountability Act of 2014 (Pub. L. 113-146, sec.
101, as amended; 38 U.S.C. 1701 note) as of June 5, 2018, and continues
to reside in a location that would qualify the veteran under that
provision, and:
(i) Resides in Alaska, Montana, North Dakota, South Dakota, or
Wyoming; or
(ii) Does not reside in one of the States described in paragraph
(a)(3)(i) of this section, but received care or services under title 38
U.S.C. between June 6, 2017, and June 6, 2018, and is seeking care
before June 6, 2020.
(4) Has contacted an authorized VA official to request the care or
services the veteran requires, but VA has determined it is not able to
furnish such care or services in a manner that complies with designated
access standards established in Sec. 17.4040.
(5) The veteran and the veteran's referring clinician determine it
is in the best medical interest of the veteran, for the purpose of
achieving improved
[[Page 26308]]
clinical outcomes, to access the care or services the veteran requires
from an eligible entity or provider, based on one or more of the
following factors, as applicable:
(i) The distance between the veteran and the facility or facilities
that could provide the required care or services;
(ii) The nature of the care or services required by the veteran;
(iii) The frequency the veteran requires the care or services;
(iv) The timeliness of available appointments for the required care
or services;
(v) The potential for improved continuity of care;
(vi) The quality of the care provided; or
(vii) Whether the veteran faces an unusual or excessive burden in
accessing a VA facility based on consideration of the following:
(A) Excessive driving distance; geographical challenges, such as
the presence of a body of water (including moving water and still
water) or a geologic formation that cannot be crossed by road; or
environmental factors, such as roads that are not accessible to the
general public, traffic, or hazardous weather.
(B) Whether care and services are available from a VA facility that
is reasonably accessible.
(C) Whether a medical condition of the veteran affects the ability
to travel.
(D) Whether there is a compelling reason the veteran needs to
receive care and services from a non-VA facility.
(E) The need for an attendant, which is defined as a person who
provides required aid and/or physical assistance to the veteran, for a
veteran to travel to a VA medical facility for hospital care or medical
services.
(6) In accordance with Sec. 17.4015, VA has determined that a VA
medical service line that would furnish the care or services the
veteran requires is not providing such care or services in a manner
that complies with VA's standards for quality.
(b) If the covered veteran changes his or her residence, the
covered veteran must update VA about the change within 60 days.
(c) A covered veteran must provide to VA information on any other
health-care plan contract under which the veteran is covered prior to
obtaining authorization for care and services the veteran requires. If
the veteran changes such other health-care plan contract, the veteran
must update VA about the change within 60 days.
(d) Review of veteran eligibility determinations. The review of any
decisions under paragraph (a) of this section are subject to VA's
clinical appeals process, and such decisions may not be appealed to the
Board of Veterans' Appeals.
(The information collection is pending Office of Management and Budget
approval.)
Sec. 17.4015 Designated VA medical service lines.
(a) VA may identify VA medical service lines that are
underperforming based on the timeliness of care when compared with the
same medical service line at other VA facilities and based on data
related to two or more distinct and appropriate quality measures of
VA's standards for quality when compared with non-VA medical service
lines.
(b) VA will make determinations regarding VA medical service lines
under this section using data described in paragraph (a) of this
section, VA standards for quality, and based on factors identified in
paragraph (e) of this section.
(c) VA will announce annually any VA medical service lines
identified under paragraph (a) of this section by publishing a document
in the Federal Register. Such document will identify and describe the
standards for quality VA used to inform the determination under
paragraph (a), as well as how the data described in paragraph (a) and
factors identified in paragraph (e) of this section were used to make
the determinations. Such document will also identify limitations, if
any, concerning when and where covered veterans can receive qualifying
care and services at their election in the community based on this
section. Such limitations may include a defined timeframe, a defined
geographic area, and a defined scope of services. VA will also take
reasonable steps to provide direct notice to covered veterans affected
under this section.
(d) VA will identify no more than 3 VA medical services lines in a
single VA facility under this section, and no more than 36 VA medical
service lines nationally under this section.
(e) In determining whether a VA medical service line should be
identified under paragraph (a) of this section, and to comply with
paragraph (c) of this section, VA will consider:
(1) Whether the differences between performance of individual VA
medical service lines, and between performance of VA medical service
lines and non-VA medical service lines, is clinically significant.
(2) Likelihood and ease of remediation of the VA medical service
line within a short timeframe.
(3) Recent trends concerning the VA medical service line or non-VA
medical service line.
(4) The number of covered veterans served by the medical service
line or that could be affected by the designation.
(5) The potential impact on patient outcomes.
(6) The effect that designating one VA medical service line would
have on other VA medical service lines.
Sec. 17.4020 Authorized non-VA care.
(a) Electing non-VA care. Except as provided for in paragraph (d)
of this section, a covered veteran eligible for the Veterans Community
Care Program under Sec. 17.4010 may choose to schedule an appointment
with a VA health care provider, or have VA authorize the veteran to
receive an episode of care for hospital care, medical services, or
extended care services from an eligible entity or provider when VA
determines such care or services are clinically necessary.
(b) Selecting an eligible entity or provider. A covered veteran may
specify a particular eligible entity or provider. If a covered veteran
does not specify a particular eligible entity or provider, VA will
refer the veteran to a specific eligible entity or provider.
(c) Authorizing emergency treatment. This paragraph (c) applies
only to emergency treatment furnished to a covered veteran by an
eligible entity or provider when such treatment was not the subject of
an election by a veteran under paragraph (a) of this section. This
paragraph (c) does not affect eligibility for, or create any new rules
or conditions affecting, reimbursement for emergency treatment under
section 1725 or 1728 of title 38, United States Code.
(1) Under the conditions set forth in this paragraph (c), VA may
authorize emergency treatment after it has been furnished to a covered
veteran. For purposes of this paragraph (c), ``emergency treatment''
has the meaning defined in section 1725(f)(1) of title 38, United
States Code.
(2) VA may only authorize emergency treatment under this paragraph
(c) if the covered veteran, someone acting on the covered veteran's
behalf, or the eligible entity or provider notifies VA within 72-hours
of such care or services being furnished and VA approves the furnishing
of such care or services under paragraph (c)(3) of this section.
(3) VA may approve emergency treatment of a covered veteran under
this paragraph (c) only if:
(i) The veteran is receiving emergency treatment from an eligible
entity or provider.
[[Page 26309]]
(ii) The notice to VA complies with the provisions of paragraph
(c)(4) of this section and is submitted within 72 hours of the
beginning of such treatment.
(iii) The emergency treatment only includes services covered by
VA's medical benefits package in Sec. 17.38.
(4) Notice to VA must:
(i) Be made to the appropriate VA official at the nearest VA
facility;
(ii) Identify the covered veteran; and
(iii) Identify the eligible entity or provider.
(d) Organ and bone marrow transplant care. (1) In the case of a
covered veteran described in paragraph (d)(3) of this section, the
Secretary will determine whether to authorize an organ or bone marrow
transplant for the covered veteran through an eligible entity or
provider.
(2) The Secretary will make determinations under paragraph (d)(1)
of this section, and the primary care provider of the veteran will make
determinations concerning whether there is a medically compelling
reason to travel outside the region of the Organ Procurement and
Transplantation Network in which the veteran resides to receive a
transplant, in consideration of, but not limited to, the following
factors:
(i) Specific patient factors.
(ii) Which facilities meet VA's standards for quality, including
quality metrics and outcomes, for the required transplant.
(iii) The travel burden on covered veterans based upon their
medical conditions and the geographic location of eligible transplant
centers.
(iv) The timeliness of transplant center evaluations and
management.
(3) This paragraph (d) applies to covered veterans who meet one or
more conditions of eligibility under Sec. 17.4010(a) and:
(i) Require an organ or bone marrow transplant as determined by VA
based upon generally-accepted medical criteria; and
(ii) Have, in the opinion of the primary care provider of the
veteran, a medically compelling reason, as determined in consideration
of the factors described in paragraph (d)(2) of this section, to travel
outside the region of the Organ Procurement and Transplantation Network
in which the veteran resides, to receive such transplant.
Sec. 17.4025 Effect on other provisions.
(a) General. No provision in this section may be construed to alter
or modify any other provision of law establishing specific eligibility
criteria for certain hospital care, medical services, or extended care
services.
(b) Prescriptions. Notwithstanding any other provision of this
part, VA will:
(1) Pay for prescriptions no longer than 14 days written by
eligible entities or providers for covered veterans, including over-
the-counter drugs and medical and surgical supplies, available under
the VA national formulary system to cover a course of treatment for an
urgent or emergent condition.
(2) Fill prescriptions written by eligible entities or providers
for covered veterans, including over-the-counter drugs and medical and
surgical supplies, available under the VA national formulary system.
(3) 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 (e.g., splints, crutches, manual wheelchairs).
(4) Fill prescriptions written by eligible entities or providers
for covered veterans for durable medical equipment and medical devices
that are not required for urgent or emergent conditions.
(c) Copayments. Covered veterans are liable for a VA copayment for
care or services furnished under the Veterans Community Care Program,
if required by Sec. 17.108(b)(4) or (c)(4), Sec. 17.110(b)(4), or
Sec. 17.111(b)(3).
Sec. 17.4030 Eligible entities and providers.
To be eligible to furnish care and services under the Veterans
Community Care Program, entities or providers:
(a) Must enter into a contract, agreement, or other arrangement to
furnish care and services under the Veterans Community Care Program
under Sec. Sec. 17.4000 through 17.4040.
(b) Must either:
(1) Not be a part of, or an employee of, VA; or
(2) If the provider is an employee of VA, not be acting within the
scope of such employment while providing hospital care, medical
services, or extended care services through the Veterans Community Care
Program under Sec. Sec. 17.4000 through 17.4040.
(c) Must be accessible to the covered veteran. VA will determine
accessibility by considering the following factors:
(1) The length of time the covered veteran would have to wait to
receive hospital care, medical services, or extended care services from
the entity or provider;
(2) The qualifications of the entity or provider to furnish the
hospital care, medical services, or extended care services from the
entity or provider; and
(3) The distance between the covered veteran's residence and the
entity or provider.
Sec. 17.4035 Payment rates.
The rates paid by VA for hospital care, medical services, or
extended care services (hereafter referred to as ``services'')
furnished pursuant to a procurement contract or an agreement authorized
by Sec. Sec. 17.4100 through 17.4135 will be the rates set forth in
the terms of such contract or agreement. Such payment rates will comply
with the following parameters:
(a) Except as otherwise provided in this section, payment rates
will not exceed the applicable Medicare fee schedule (including but not
limited to allowable rates under 42 U.S.C. 1395m) or prospective
payment system amount (hereafter ``Medicare rate''), if any, for the
period in which the service was provided (without any changes based on
the subsequent development of information under Medicare authorities).
(b) With respect to services furnished in a State with an All-Payer
Model Agreement under section 1814(b)(3) of the Social Security Act (42
U.S.C. 1395f(b)(3)) that became effective on or after January 1, 2014,
the Medicare payment rates under paragraph (a) of this section will be
calculated based on the payment rates under such agreement.
(c) Payment rates for services furnished in a highly rural area may
exceed the limitations set forth in paragraphs (a) and (b) of this
section. The term ``highly rural area'' means an area located in a
county that has fewer than seven individuals residing in that county
per square mile.
(d) Payment rates may deviate from the parameters set forth in
paragraphs (a) through (c) of this section when VA determines, based on
patient needs, market analyses, health care provider qualifications, or
other factors, that it is not practicable to limit payment for services
to the rates available under paragraphs (a) through (c).
(e) Payment rates for services furnished in Alaska are not subject
to paragraphs (a) through (d) of this section and will be set forth in
the terms of the procurement contract or agreement authorized by
Sec. Sec. 17.4100 through 17.4135, pursuant to which such services are
furnished. If no payment rate is set forth in the terms of such a
contract or agreement pursuant to which such services are furnished,
payment rates for services furnished in Alaska will follow the Alaska
Fee Schedule of the Department of Veterans Affairs.
[[Page 26310]]
Sec. 17.4040 Designated access standards.
(a) The following access standards have been designated to apply
for purposes of eligibility determinations to access care in the
community through the Veterans Community Care Program under Sec.
17.4010(a)(4).
(1) Primary care, mental health care, and non-institutional
extended care services. VA cannot schedule an appointment for the
covered veteran with a VA health care provider for the required care or
service:
(i) Within 30 minutes average driving time of the veteran's
residence; and
(ii) Within 20 days of the date of request unless a later date has
been agreed to by the veteran in consultation with the VA health care
provider.
(2) Specialty care. VA cannot schedule an appointment for the
covered veteran with a VA health care provider for the required care or
service:
(i) Within 60 minutes average driving time of the veteran's
residence; and
(ii) Within 28 days of the date of request unless a later date has
been agreed to by the veteran in consultation with the VA health care
provider.
(b) For purposes of calculating average driving time from the
veteran's residence in paragraph (a) of this section, VA will use
geographic information system software.
[FR Doc. 2019-11575 Filed 6-4-19; 8:45 am]
BILLING CODE 8320-01-P