Exempting Whole Health Well-Being Services From Copayment, 279-282 [2024-31494]
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Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Proposed Rules
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DroneXL (December 24, 2023), https://
dronexl.co/2023/12/24/autel-roboticsdrone-no-fly-zones-conflict/). If abused
by a malicious actor, pushed updates
like this could open users up to the risk
of newly defined and restricted ‘‘zones’’
that could affect the use and control of
their UAS. A foreign adversary could
exploit firmware updates of this type by
exercising influence or control over a
UAS service provider and instructing
them to push a certain update.
BIS seeks to better understand how
UAS OEMs may impact UAS
functionality through their incorporated
ICTS components. In particular, the
ANPRM seeks further comment on the
following topics but encourages the
submission of any comments that are
germane to the issues discussed in this
ANPRM:
41. In what instances, and how,
would OEMs be able to terminate
functionality of a UAS (i.e., denial of
service)?
a. What are the standards and best
practices governing the ability of OEMs
to terminate functionality of a UAS?
b. Are there instances in which a third
party or a subcomponent maker (e.g., a
maker of sensors) could remotely deny
service to and fully or partially
terminate functionality of a UAS or its
respective sensor or component
independently of the OEM?
c. Once service is denied or
functionality is terminated, what are the
standards and best practices for
reinstating full operability?
d. Are there instances in which a UAS
and its subcomponents can use any
inherent connectivity they possess to
connect to other devices, the cloud, or
connected software applications online
but be insulated against denial-ofservice updates or patches by the OEM?
f. Mitigations and Authorizations
In addition to the topics discussed
above, this ANPRM seeks comment on
processes and mechanisms that BIS
could implement in a potential rule to
authorize otherwise prohibited ICTS
transactions if the parties to such
transactions adopt certain mitigation
measures or otherwise mitigate the
undue and unacceptable risks to U.S.
national security, including U.S. ICTS
supply chains and critical
infrastructure, or to the safety and
security of U.S. persons. In particular,
the ANPRM seeks further comment on
the following topics but encourages the
submission of any comments that are
germane to the issues discussed in this
ANPRM:
42. Are there instances in which
granting a temporary authorization to
engage in otherwise prohibited UAS
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ICTS transactions would be necessary to
avoid supply chain disruptions or other
unintended consequences and in the
interest of the United States?
43. Which, if any, categories or
classifications of end users should BIS
consider excluding from any
prohibitions on transactions involving
foreign adversary ICTS integral to UAS
because transactions involving such end
users would not pose an undue or
unacceptable risk?
44. For what categories of ICTS
transactions relating to UAS should BIS
require a specific authorization before
the transaction is permitted in the
United States?
45. Please comment on potential
requirements for authorizations and
certifications for industry participants
(e.g., assemblers, manufacturers,
dealers, sellers) filed electronically with
BIS.
46. What certification or validation
process should be implemented in order
to validate mitigation actions taken?
Should third-party testing and
evaluation occur, and at what stage in
the process should this testing and
evaluation occur in order to validate
mitigation actions?
g. Economic Impact
BIS is mindful that any regulation of
transactions involving foreign adversary
ICTS integral to UAS could have
significant economic impacts on sectors
that have incorporated this technology
into their processes and may rely on
UAS. For example, BIS recognizes
regulations on these transactions could
pose supply chain obstacles that could
affect UAS and UAS component prices.
BIS is concerned, however, about the
short-term and long-term consequences
of UAS and UAS supply chain abuse by
foreign adversaries. Accordingly, this
ANPRM seeks further comment on the
following topics but encourages the
submission of any comments that are
germane to the issues discussed in this
ANPRM:
47. What, if any, anticompetitive
effects may result from regulation of
transactions involving foreign adversary
ICTS integral to UAS as contemplated
by this ANPRM? And what, if anything,
can be done to mitigate the
anticompetitive effects?
48. What data privacy and protection
impacts to U.S. businesses or the public,
if any, might be associated with the
regulation of transactions involving
foreign adversary ICTS integral to UAS
contemplated in this ANPRM? What are
the benefits and costs, if any, of these
impacts?
49. What additional economic
impacts to U.S. businesses or the public,
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279
if any, might be associated with the
regulation of transactions involving
foreign adversary ICTS integral to UAS
contemplated by this ANPRM?
a. If responding from outside the
United States, what economic impacts
to local businesses and the public, if
any, might be associated with
regulations of transactions involving
foreign adversary ICTS integral to UAS
in the United States?
50. What actions can BIS take, or
provisions could it add to any proposed
regulations, to minimize potential costs
borne by U.S. businesses or the public?
a. If responding from outside the
United States, what actions can BIS
take, or what provisions could it add to
any proposed regulations, to minimize
potential costs borne by local businesses
or the public?
Elizabeth L.D. Cannon,
Executive Director, Office of Information and
Communications Technology and Services.
[FR Doc. 2024–30209 Filed 1–2–25; 8:45 am]
BILLING CODE 3510–33–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AS23
Exempting Whole Health Well-Being
Services From Copayment
Department of Veterans Affairs
Proposed rule
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) proposes to revise its
medical regulations to exempt Whole
Health well-being services from the
copayment requirements for inpatient
hospital care and outpatient medical
care. These Whole Health well-being
services, which consist of Whole Health
education and skill-building programs
and complementary and integrative
health well-being services, are provided
to Veterans within the VA Whole Health
System of Care to improve Veterans’
overall health and well-being.
DATES: Comments must be received on
or before March 4, 2025.
ADDRESSES: Comments may be
submitted through www.regulations.gov.
Except as provided herein, comments
received before the close of the
comment period will be available at
www.regulations.gov for public viewing,
inspection, or copying, including any
personally identifiable or confidential
business information that is included in
a comment. We post the comments
received before the close of the
comment period on
SUMMARY:
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Federal Register / Vol. 90, No. 2 / Friday, January 3, 2025 / Proposed Rules
www.regulations.gov as soon as possible
after they have been received. VA will
not post public comments on
Regulations.gov that make threats to
individuals or institutions or suggest
that the commenter will take actions to
harm an individual. VA encourages
individuals not to submit duplicative
comments; however, we will post
comments from multiple unique
commenters even if the content is
identical or nearly identical to other
comments. Any public comment
received after the comment period’s
closing date is considered late and will
not be considered in the final
rulemaking. In accordance with the
Providing Accountability Through
Transparency Act of 2023, a plain
language summary (not more than 100
words in length) of this proposed rule
is available at www.regulations.gov,
under RIN 2900–AS23.
FOR FURTHER INFORMATION CONTACT:
Kavitha Reddy, Associate Director,
Employee Whole Health, Veterans
Health Administration, Department of
Veterans Affairs, 810 Vermont Avenue
NW, Washington, DC 20420, 314–312–
8126. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION:
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Authority
Section 1710 of title 38 United States
Code (U.S.C.) requires VA to furnish
hospital care and medical services that
VA determines to be needed for eligible
Veterans. Section 1701(6) defines
medical services as examination,
treatment, and rehabilitative services, as
well as other specifically listed services.
VA implemented the statutory
requirements through 38 Code of
Federal Regulations (CFR) 17.38,
frequently referred to as the Medical
Benefits Package. Under section
1710(g)(1), VA may not furnish medical
services to certain Veterans unless the
Veteran agrees to pay ‘‘the applicable
amount or amounts established by the
Secretary [of VA] by regulation.’’ VA has
interpreted section 1710(g)(1) to mean
that VA may establish in regulation the
amount of a copayment, even if that
amount is zero, meaning that VA
effectively has the authority to exempt
certain care from copayment
requirements. VA has set forth
copayment requirements for inpatient
hospital care, outpatient medical care,
and urgent care in 38 CFR 17.108.
Generally, 38 CFR 17.108 sets forth
requirements regarding copayments for
inpatient hospital care and outpatient
medical care provided to Veterans by
VA. 38 CFR 17.108(b) and (c). Services
not subject to copayments are listed in
38 CFR 17.108(e). VA has long
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acknowledged that copayments can
deter Veterans from obtaining certain
services and be a barrier to participation
in a program promoted by VA.
Therefore, to encourage Veterans to
become more actively involved in their
medical care, thereby improving health
care outcomes and, in turn, lowering
overall health care costs, VA has
exempted certain services from the
copayment requirements. There are
currently multiple copayment
exemptions listed in § 17.108(e) such as
weight management counseling and
publicly announced VA public health
initiatives (for example, health fairs) or
outpatient visits solely consisting of
preventative screening and
immunizations to encourage such
behavior. In this rulemaking, VA
proposes to add an additional
copayment exemption for Whole Health
well-being services to encourage
Veterans to be more actively involved in
their health care and further use these
important services.
Whole Health Well-Being Services and
the Whole Health System of Care
Whole Health well-being services,
which are services that focus on the
overall well-being of the Veteran
independent of treatment for a specific
medical condition or diagnosis, are an
important aspect of the Whole Health
System of Care. The Whole Health
System of Care is care that supports the
Veteran’s health and well-being in line
with what matters most to the Veteran.
The Whole Health System of Care
engages and empowers Veterans to
prioritize a healthy lifestyle—including
mental, emotional, functional, spiritual,
social, and community aspects—
equipping them to take charge of their
health and well-being by addressing
lifestyle and environmental root causes
of chronic disease. This approach has
improved Veterans’ perceptions of
health care, increased their engagement
in health care and self-care, and
improved their life’s meaning and
purpose.
One component of the Whole Health
System of Care focuses on the overall
well-being of the Veteran that is
independent of treatment of a specific
medical condition or diagnosis to equip
each Veteran to better manage their own
health. The well-being component
includes various services that are
centered around what matters most to
the Veteran and their health and wellbeing goals. Whole Health well-being
services are provided to Veterans
alongside conventional health care to
promote, preserve, and restore health.
All Whole Health well-being services
provided by VA are in line with
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accepted standards of medical practice,
serve to increase Veterans’ access to
care, and currently are authorized and
provided to Veterans as part of the
medical benefits package under 38 CFR
17.38. Whole Health well-being services
include Whole Health education and
skill-building programs and
complementary and integrative health
well-being services, both of which are
discussed in further detail herein.
VA determined it is necessary to
exempt these Whole Health well-being
services from copayment to remove a
barrier that may discourage Veterans
from proactively engaging in the Whole
Health System of Care and to further
encourage Veterans to better manage
their health and improve their overall
well-being. Whole Health well-being
services do not generally require the
expertise of a licensed clinical provider
or specialty care provider as these
approaches are not used for treatment of
a specific condition or diagnosis but
rather to support health and overall
well-being. A Veteran’s participation in
Whole Health well-being services can
initiate a cascade of health benefits that
result from a Veteran’s conscious,
committed participation in promoting,
restoring, and preserving the Veteran’s
own health. Exempting Whole Health
well-being services would encourage
Veterans to proactively take advantage
of well-being services to improve their
overall well-being.
Copayment Exemption for Whole
Health Well-Being Services
In this rulemaking, we propose to
amend 38 CFR 17.108 by adding new
paragraph (e)(20) to exempt Whole
Health well-being services from
copayment requirements. New
paragraph (e)(20) of section 17.108
would provide that ‘‘the following
Whole Health well-being services’’
would be exempt from copayment
requirements. As mentioned previously,
Whole Health well-being services
consist of Whole Health education and
skill-building programs as well as
complementary and integrative health
well-being services. Proposed
paragraphs (e)(20)(i) and (ii) would then
describe these two categories of wellbeing services that would be exempt
from copayment.
In addition, we would make two
minor technical edits to maintain proper
punctuation throughout the list of
copayment exempt services in
§ 17.108(e). We would remove ‘‘and’’ at
the end of current paragraph (17); we
would remove the period at the end of
paragraph (18) and in its place insert a
semicolon; and we would remove the
period at the end of paragraph (19) and
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in its place insert a semicolon followed
by ‘‘and.’’ These changes would ensure
that new paragraph (20) would properly
complete the list of currently exempt
services in § 17.108(e).
Whole Health Education and SkillBuilding Programs
Proposed § 17.108(e)(20)(i) would
describe ‘‘Whole Health education and
skill-building programs.’’ Whole Health
education and skill-building programs
would be defined as the services that
educate, instruct, and empower
Veterans to understand and implement
the principles and practices of Whole
Health. VA would use this definition for
Whole Health education and skillbuilding programs because it would
succinctly describe this category of
Whole Health-focused programs and
would be consistent with how Whole
Health education and skill-building
programs are provided to Veterans
within VA. Whole Health education and
skill-building programs have a Whole
Health-focused curriculum, contribute
to the overall well-being of the Veteran,
and may be offered individually or in a
group setting. Whole Health education
and skill-building programs generally
address Whole Health principles,
promote well-being approaches, and
focus on helping a Veteran meet their
health and well-being goals. Such
programs are developed in partnership
with the Veterans Health
Administration Office of Patient
Centered Care and Cultural
Transformation.
The following sentence would then
provide a non-exhaustive list of the
categories of programs that would be
included as Whole Health education
and skill-building programs. The list
would include Whole Health coaching,
Whole Health partner sessions, and
Whole Health education and skillbuilding courses. The list of these
categories of programs would be
consistent with how Whole Health
education and skill-building programs
currently are provided to Veterans
within VA. VA believes that a nonexhaustive list would be most beneficial
because these categories would
adequately capture any approved Whole
Health education and skill-building
programs available within the Whole
Health System of Care. However, as the
VA Whole Health System of Care
becomes more firmly established as the
model for how VA provides health care,
VA is developing, improving, and
expanding Whole Health education and
skill-building programs continuously
with an openness to innovation and
iterative improvement based on Veteran
feedback and evidence. Therefore, a
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non-exhaustive list would provide VA
with the flexibility it needs to continue
to provide Whole Health education and
skill-building programs that meet the
needs of Veterans and improve
Veterans’ overall well-being.
Whole Health coaching is a Veterancentered process that facilitates and
empowers Veterans to develop and
achieve their self-determined health and
well-being goals. In Whole Health
coaching, the coach supports Veterans
in mobilizing their internal strengths
and external resources to develop
strategies for making sustainable,
healthy lifestyle behavior changes that
support improved health and wellbeing. Whole Health coaching includes
connecting health and well-being goals
to what matters most to the Veteran and
following up on actions needed to
achieve these values-based goals. Whole
Health coaches work in close
collaboration with interdisciplinary staff
and teams throughout VA medical
facilities to enhance well-being and
assist with management of chronic
disease. This type of interprofessional,
team-based care is important for high
quality, Veteran-centered Whole Health
care.
In Whole Health partnering, a Whole
Health partner facilitates individual and
group sessions where Veterans learn
about the Whole Health approach and
identify their meaning and purpose.
They work in collaboration with staff
and teams, further supporting
interprofessional, team-based delivery
of health care. Veterans then can reflect
on their personal well-being and create
health and well-being goals centered
around what matters most to them for
their quality of life. Whole Health
partners welcome Veterans into the
Whole Health System of Care, have
knowledge of internal and external
Whole Health System of Care resources,
help Veterans navigate the Whole
Health System of Care, and connect
Veterans to the best options to support
their overall health and well-being.
Whole Health partners‘ often conduct
introductory sessions to orient Veterans
to Whole Health and assist them in
filling out elements of their personal
health plan.
Whole Health education and skillbuilding courses are courses that
generally address Whole Health
principles, promote well-being
approaches, and focus on helping the
Veteran meet health and well-being
goals. Current offerings within VA
provide education on the concept of
Whole Health, Whole Health coaching,
Whole Health partnering, and how
Veterans can take charge of their life
and health.
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281
Complementary and Integrative Health
Well-Being Services
Proposed § 17.108(e)(20)(ii) would
describe the complementary and
integrative health well-being services
that would be exempt from copayment
requirements. Like proposed paragraph
(i), proposed paragraph (ii) would first
define complementary and integrative
health well-being services.
Complementary and integrative health
well-being services would be defined as
the services that promote health, wellbeing, and self-care independent of
treatment of a specific medical
condition or diagnosis. In general,
complementary and integrative health
services are a group of diverse services
and practices not broadly considered to
be part of conventional health care, but
often used in conjunction with
conventional health care.
Complementary and integrative health
services are used in the Whole Health
System of Care as they place importance
on the relationship between the
practitioner and patient and focus on
the whole person.
The following sentence then would
provide a non-exhaustive list of the
types of services that would be included
as complementary and integrative
health well-being services. The services
would be guided imagery, meditation,
Tai Chi/Qigong, and yoga for well-being,
which would be consistent with how
complementary and integrative health
well-being services currently are
provided within VA. We believe listing
these types of services in regulation
would adequately capture the current
complementary and integrative health
well-being services available within the
Whole Health System of Care. Like
Whole Health education and skillbuilding programs in proposed
paragraph (i), we would use a nonexhaustive list to provide flexibility to
VA to continue to evaluate the efficacy
of additional complementary and
integrative health well-being approaches
that would meet the needs of Veterans
and improve Veterans’ overall wellbeing.
Guided imagery is the practice of
using a series of multi-sensory images
designed to trigger specific changes in
an individual’s physiology, emotions, or
mental state for the purpose of
increasing an individual’s healing
response or causing unconscious
change. Guided imagery may be
performed by a complementary and
integrative health provider in an
individual or group clinical setting.
Meditation is the defined practice or
technique (often arising from a
contemplative tradition) that primarily
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focuses on training an individual’s
attention regulation processes with the
intent of cultivating general mental
well-being and/or specific capacities
such as concentration, compassion, or
insight. The focus of meditation is on
training attentional processes rather
than specifically targeting a change in
mental content.
Tai Chi is the mind-body exercise
rooted in the Asian traditions of martial
arts, Chinese medicine, and philosophy
that combines slow-flowing intentional
movements with breathing, awareness,
and visualization. Tai Chi enhances
relaxation, vitality, focus, posture,
balance, strength, flexibility, and mood.
Qigong is the ancient Chinese healing
art (like Tai Chi) with a focus on
cultivating the body’s vital energy or
‘‘qi.’’ Qigong involves the coordination
of breath, posture, awareness,
visualization, and focused movements
and may be practiced as a stationary or
moving meditation.
Yoga is the mind-body practice rooted
in ancient Indian philosophy that
typically combines physical postures,
breathing techniques, meditation or
relaxation, and discussion on
applications to daily life. There are
many different yoga styles ranging from
gentle to physically demanding
practices. Yoga for well-being is the
practice of yoga to advance an
individual’s general sense of well-being.
Yoga for well-being is often practiced in
a group setting and focuses on general
health, stress reduction, fitness, and/or
community.
Executive Orders 12866, 13563, and
14094
Executive Order 12866 (Regulatory
Planning and Review; September 30,
1993) directs 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;
January 18, 2011) emphasizes the
importance of quantifying both costs
and benefits, reducing costs,
harmonizing rules, and promoting
flexibility. Executive Order 14094
(Modernizing Regulatory Review; April
6, 2023) supplements and reaffirms the
principles, structures, and definitions
governing contemporary regulatory
review established in Executive Order
12866 and Executive Order 13563. The
Office of Information and Regulatory
Affairs has determined that this
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rulemaking is not a significant
regulatory action under Executive Order
12866, as amended by Executive Order
14094. The Regulatory Impact Analysis
associated with this rulemaking can be
found as a supporting document at
www.regulations.gov.
Regulatory Flexibility Act
The Secretary hereby certifies that
this proposed rule would not have a
significant economic impact on a
substantial number of small entities as
they are defined in the Regulatory
Flexibility Act (5 U.S.C. 601–612). This
proposed rule would exempt certain
health care services from copayment.
This proposed rule would not cause a
significant economic impact on small
entities because it is limited to
copayments that would be received by
VA directly from Veterans. Therefore,
pursuant to 5 U.S.C. 605(b), the initial
and final regulatory flexibility analysis
requirements of 5 U.S.C. 603 and 604 do
not apply.
Unfunded Mandates
Paperwork Reduction Act
This proposed rule contains no
provisions constituting a collection of
information under the provisions of the
Paperwork Reduction Act of 1995 (44
U.S.C. 3501–3521).
List of Subjects in 38 CFR Part 17
Administrative practice and
procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Drug abuse,
Government contracts, Health care,
Health facilities, Health professions,
Mental health programs, Nursing
homes, Reporting and recordkeeping
requirements, Veterans.
Signing Authority
Denis McDonough, Secretary of
Veterans Affairs, signed and approved
this document on December 18, 2024,
and authorized the undersigned to sign
and submit the document to the Office
of the Federal Register for publication
Frm 00017
Fmt 4702
Consuela Benjamin,
Regulations Development Coordinator, Office
of Regulation Policy & Management, Office
of General Counsel, Department of Veterans
Affairs.
For the reasons stated in the
preamble, the Department of Veterans
Affairs proposes to amend 38 CFR part
17 as set forth below:
PART 17—MEDICAL
1. The authority citation for part 17
continues to read as follows:
■
Authority: 38 U.S.C. 501, and as noted in
specific sections.
*
*
*
*
*
2. Amend § 17.108 by revising
paragraphs (e)(17) through (19) and
adding paragraph (e)(20) to read as
follows:
■
§ 17.108 Copayments for inpatient hospital
care and outpatient medical care.
*
The Unfunded Mandates Reform Act
of 1995 requires, at 2 U.S.C. 1532, that
agencies prepare an assessment of
anticipated costs and benefits before
issuing any rule that may result in the
expenditure by state, local, and tribal
governments, in the aggregate, or by the
private sector, of $100 million or more
(adjusted annually for inflation) in any
one year. This proposed rule would
have no such effect on state, local, and
tribal governments, or on the private
sector.
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electronically as an official document of
the Department of Veterans Affairs.
Sfmt 9990
*
*
*
*
(e) * * *
(17) Mental health peer support
services;
(18) An outpatient care visit solely for
education on the use of opioid
antagonists to reverse the effects of
overdoses of specific medications or
substances;
(19) Emergent suicide care as
authorized under 38 CFR 17.1200–
17.1230; and
(20) The following Whole Health
well-being services:
(i) Whole Health education and skillbuilding programs. The programs that
educate, instruct, and empower
Veterans to understand and implement
the principles and practices of Whole
Health. Whole Health education and
skill-building programs may include,
but are not limited to, Whole Health
coaching, Whole Health partner
sessions, and Whole Health education
and skill-building courses.
(ii) Complementary and integrative
health well-being services. The services
that promote health, well-being, and
self-care independent of treatment of a
specific medical condition or diagnosis.
Complementary and integrative health
well-being services may include, but are
not limited to, guided imagery,
meditation, Tai Chi/Qigong, and yoga
for well-being.
*
*
*
*
*
[FR Doc. 2024–31494 Filed 1–2–25; 8:45 am]
BILLING CODE 8320–01–P
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Agencies
[Federal Register Volume 90, Number 2 (Friday, January 3, 2025)]
[Proposed Rules]
[Pages 279-282]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31494]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AS23
Exempting Whole Health Well-Being Services From Copayment
AGENCY: Department of Veterans Affairs
ACTION: Proposed rule
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) proposes to revise its
medical regulations to exempt Whole Health well-being services from the
copayment requirements for inpatient hospital care and outpatient
medical care. These Whole Health well-being services, which consist of
Whole Health education and skill-building programs and complementary
and integrative health well-being services, are provided to Veterans
within the VA Whole Health System of Care to improve Veterans' overall
health and well-being.
DATES: Comments must be received on or before March 4, 2025.
ADDRESSES: Comments may be submitted through www.regulations.gov.
Except as provided herein, comments received before the close of the
comment period will be available at www.regulations.gov for public
viewing, inspection, or copying, including any personally identifiable
or confidential business information that is included in a comment. We
post the comments received before the close of the comment period on
[[Page 280]]
www.regulations.gov as soon as possible after they have been received.
VA will not post public comments on Regulations.gov that make threats
to individuals or institutions or suggest that the commenter will take
actions to harm an individual. VA encourages individuals not to submit
duplicative comments; however, we will post comments from multiple
unique commenters even if the content is identical or nearly identical
to other comments. Any public comment received after the comment
period's closing date is considered late and will not be considered in
the final rulemaking. In accordance with the Providing Accountability
Through Transparency Act of 2023, a plain language summary (not more
than 100 words in length) of this proposed rule is available at
www.regulations.gov, under RIN 2900-AS23.
FOR FURTHER INFORMATION CONTACT: Kavitha Reddy, Associate Director,
Employee Whole Health, Veterans Health Administration, Department of
Veterans Affairs, 810 Vermont Avenue NW, Washington, DC 20420, 314-312-
8126. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION:
Authority
Section 1710 of title 38 United States Code (U.S.C.) requires VA to
furnish hospital care and medical services that VA determines to be
needed for eligible Veterans. Section 1701(6) defines medical services
as examination, treatment, and rehabilitative services, as well as
other specifically listed services. VA implemented the statutory
requirements through 38 Code of Federal Regulations (CFR) 17.38,
frequently referred to as the Medical Benefits Package. Under section
1710(g)(1), VA may not furnish medical services to certain Veterans
unless the Veteran agrees to pay ``the applicable amount or amounts
established by the Secretary [of VA] by regulation.'' VA has
interpreted section 1710(g)(1) to mean that VA may establish in
regulation the amount of a copayment, even if that amount is zero,
meaning that VA effectively has the authority to exempt certain care
from copayment requirements. VA has set forth copayment requirements
for inpatient hospital care, outpatient medical care, and urgent care
in 38 CFR 17.108.
Generally, 38 CFR 17.108 sets forth requirements regarding
copayments for inpatient hospital care and outpatient medical care
provided to Veterans by VA. 38 CFR 17.108(b) and (c). Services not
subject to copayments are listed in 38 CFR 17.108(e). VA has long
acknowledged that copayments can deter Veterans from obtaining certain
services and be a barrier to participation in a program promoted by VA.
Therefore, to encourage Veterans to become more actively involved in
their medical care, thereby improving health care outcomes and, in
turn, lowering overall health care costs, VA has exempted certain
services from the copayment requirements. There are currently multiple
copayment exemptions listed in Sec. 17.108(e) such as weight
management counseling and publicly announced VA public health
initiatives (for example, health fairs) or outpatient visits solely
consisting of preventative screening and immunizations to encourage
such behavior. In this rulemaking, VA proposes to add an additional
copayment exemption for Whole Health well-being services to encourage
Veterans to be more actively involved in their health care and further
use these important services.
Whole Health Well-Being Services and the Whole Health System of Care
Whole Health well-being services, which are services that focus on
the overall well-being of the Veteran independent of treatment for a
specific medical condition or diagnosis, are an important aspect of the
Whole Health System of Care. The Whole Health System of Care is care
that supports the Veteran's health and well-being in line with what
matters most to the Veteran. The Whole Health System of Care engages
and empowers Veterans to prioritize a healthy lifestyle--including
mental, emotional, functional, spiritual, social, and community
aspects--equipping them to take charge of their health and well-being
by addressing lifestyle and environmental root causes of chronic
disease. This approach has improved Veterans' perceptions of health
care, increased their engagement in health care and self-care, and
improved their life's meaning and purpose.
One component of the Whole Health System of Care focuses on the
overall well-being of the Veteran that is independent of treatment of a
specific medical condition or diagnosis to equip each Veteran to better
manage their own health. The well-being component includes various
services that are centered around what matters most to the Veteran and
their health and well-being goals. Whole Health well-being services are
provided to Veterans alongside conventional health care to promote,
preserve, and restore health. All Whole Health well-being services
provided by VA are in line with accepted standards of medical practice,
serve to increase Veterans' access to care, and currently are
authorized and provided to Veterans as part of the medical benefits
package under 38 CFR 17.38. Whole Health well-being services include
Whole Health education and skill-building programs and complementary
and integrative health well-being services, both of which are discussed
in further detail herein.
VA determined it is necessary to exempt these Whole Health well-
being services from copayment to remove a barrier that may discourage
Veterans from proactively engaging in the Whole Health System of Care
and to further encourage Veterans to better manage their health and
improve their overall well-being. Whole Health well-being services do
not generally require the expertise of a licensed clinical provider or
specialty care provider as these approaches are not used for treatment
of a specific condition or diagnosis but rather to support health and
overall well-being. A Veteran's participation in Whole Health well-
being services can initiate a cascade of health benefits that result
from a Veteran's conscious, committed participation in promoting,
restoring, and preserving the Veteran's own health. Exempting Whole
Health well-being services would encourage Veterans to proactively take
advantage of well-being services to improve their overall well-being.
Copayment Exemption for Whole Health Well-Being Services
In this rulemaking, we propose to amend 38 CFR 17.108 by adding new
paragraph (e)(20) to exempt Whole Health well-being services from
copayment requirements. New paragraph (e)(20) of section 17.108 would
provide that ``the following Whole Health well-being services'' would
be exempt from copayment requirements. As mentioned previously, Whole
Health well-being services consist of Whole Health education and skill-
building programs as well as complementary and integrative health well-
being services. Proposed paragraphs (e)(20)(i) and (ii) would then
describe these two categories of well-being services that would be
exempt from copayment.
In addition, we would make two minor technical edits to maintain
proper punctuation throughout the list of copayment exempt services in
Sec. 17.108(e). We would remove ``and'' at the end of current
paragraph (17); we would remove the period at the end of paragraph (18)
and in its place insert a semicolon; and we would remove the period at
the end of paragraph (19) and
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in its place insert a semicolon followed by ``and.'' These changes
would ensure that new paragraph (20) would properly complete the list
of currently exempt services in Sec. 17.108(e).
Whole Health Education and Skill-Building Programs
Proposed Sec. 17.108(e)(20)(i) would describe ``Whole Health
education and skill-building programs.'' Whole Health education and
skill-building programs would be defined as the services that educate,
instruct, and empower Veterans to understand and implement the
principles and practices of Whole Health. VA would use this definition
for Whole Health education and skill-building programs because it would
succinctly describe this category of Whole Health-focused programs and
would be consistent with how Whole Health education and skill-building
programs are provided to Veterans within VA. Whole Health education and
skill-building programs have a Whole Health-focused curriculum,
contribute to the overall well-being of the Veteran, and may be offered
individually or in a group setting. Whole Health education and skill-
building programs generally address Whole Health principles, promote
well-being approaches, and focus on helping a Veteran meet their health
and well-being goals. Such programs are developed in partnership with
the Veterans Health Administration Office of Patient Centered Care and
Cultural Transformation.
The following sentence would then provide a non-exhaustive list of
the categories of programs that would be included as Whole Health
education and skill-building programs. The list would include Whole
Health coaching, Whole Health partner sessions, and Whole Health
education and skill-building courses. The list of these categories of
programs would be consistent with how Whole Health education and skill-
building programs currently are provided to Veterans within VA. VA
believes that a non-exhaustive list would be most beneficial because
these categories would adequately capture any approved Whole Health
education and skill-building programs available within the Whole Health
System of Care. However, as the VA Whole Health System of Care becomes
more firmly established as the model for how VA provides health care,
VA is developing, improving, and expanding Whole Health education and
skill-building programs continuously with an openness to innovation and
iterative improvement based on Veteran feedback and evidence.
Therefore, a non-exhaustive list would provide VA with the flexibility
it needs to continue to provide Whole Health education and skill-
building programs that meet the needs of Veterans and improve Veterans'
overall well-being.
Whole Health coaching is a Veteran-centered process that
facilitates and empowers Veterans to develop and achieve their self-
determined health and well-being goals. In Whole Health coaching, the
coach supports Veterans in mobilizing their internal strengths and
external resources to develop strategies for making sustainable,
healthy lifestyle behavior changes that support improved health and
well-being. Whole Health coaching includes connecting health and well-
being goals to what matters most to the Veteran and following up on
actions needed to achieve these values-based goals. Whole Health
coaches work in close collaboration with interdisciplinary staff and
teams throughout VA medical facilities to enhance well-being and assist
with management of chronic disease. This type of interprofessional,
team-based care is important for high quality, Veteran-centered Whole
Health care.
In Whole Health partnering, a Whole Health partner facilitates
individual and group sessions where Veterans learn about the Whole
Health approach and identify their meaning and purpose. They work in
collaboration with staff and teams, further supporting
interprofessional, team-based delivery of health care. Veterans then
can reflect on their personal well-being and create health and well-
being goals centered around what matters most to them for their quality
of life. Whole Health partners welcome Veterans into the Whole Health
System of Care, have knowledge of internal and external Whole Health
System of Care resources, help Veterans navigate the Whole Health
System of Care, and connect Veterans to the best options to support
their overall health and well-being. Whole Health partners` often
conduct introductory sessions to orient Veterans to Whole Health and
assist them in filling out elements of their personal health plan.
Whole Health education and skill-building courses are courses that
generally address Whole Health principles, promote well-being
approaches, and focus on helping the Veteran meet health and well-being
goals. Current offerings within VA provide education on the concept of
Whole Health, Whole Health coaching, Whole Health partnering, and how
Veterans can take charge of their life and health.
Complementary and Integrative Health Well-Being Services
Proposed Sec. 17.108(e)(20)(ii) would describe the complementary
and integrative health well-being services that would be exempt from
copayment requirements. Like proposed paragraph (i), proposed paragraph
(ii) would first define complementary and integrative health well-being
services. Complementary and integrative health well-being services
would be defined as the services that promote health, well-being, and
self-care independent of treatment of a specific medical condition or
diagnosis. In general, complementary and integrative health services
are a group of diverse services and practices not broadly considered to
be part of conventional health care, but often used in conjunction with
conventional health care. Complementary and integrative health services
are used in the Whole Health System of Care as they place importance on
the relationship between the practitioner and patient and focus on the
whole person.
The following sentence then would provide a non-exhaustive list of
the types of services that would be included as complementary and
integrative health well-being services. The services would be guided
imagery, meditation, Tai Chi/Qigong, and yoga for well-being, which
would be consistent with how complementary and integrative health well-
being services currently are provided within VA. We believe listing
these types of services in regulation would adequately capture the
current complementary and integrative health well-being services
available within the Whole Health System of Care. Like Whole Health
education and skill-building programs in proposed paragraph (i), we
would use a non-exhaustive list to provide flexibility to VA to
continue to evaluate the efficacy of additional complementary and
integrative health well-being approaches that would meet the needs of
Veterans and improve Veterans' overall well-being.
Guided imagery is the practice of using a series of multi-sensory
images designed to trigger specific changes in an individual's
physiology, emotions, or mental state for the purpose of increasing an
individual's healing response or causing unconscious change. Guided
imagery may be performed by a complementary and integrative health
provider in an individual or group clinical setting.
Meditation is the defined practice or technique (often arising from
a contemplative tradition) that primarily
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focuses on training an individual's attention regulation processes with
the intent of cultivating general mental well-being and/or specific
capacities such as concentration, compassion, or insight. The focus of
meditation is on training attentional processes rather than
specifically targeting a change in mental content.
Tai Chi is the mind-body exercise rooted in the Asian traditions of
martial arts, Chinese medicine, and philosophy that combines slow-
flowing intentional movements with breathing, awareness, and
visualization. Tai Chi enhances relaxation, vitality, focus, posture,
balance, strength, flexibility, and mood.
Qigong is the ancient Chinese healing art (like Tai Chi) with a
focus on cultivating the body's vital energy or ``qi.'' Qigong involves
the coordination of breath, posture, awareness, visualization, and
focused movements and may be practiced as a stationary or moving
meditation.
Yoga is the mind-body practice rooted in ancient Indian philosophy
that typically combines physical postures, breathing techniques,
meditation or relaxation, and discussion on applications to daily life.
There are many different yoga styles ranging from gentle to physically
demanding practices. Yoga for well-being is the practice of yoga to
advance an individual's general sense of well-being. Yoga for well-
being is often practiced in a group setting and focuses on general
health, stress reduction, fitness, and/or community.
Executive Orders 12866, 13563, and 14094
Executive Order 12866 (Regulatory Planning and Review; September
30, 1993) directs 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; January 18,
2011) emphasizes the importance of quantifying both costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility. Executive
Order 14094 (Modernizing Regulatory Review; April 6, 2023) supplements
and reaffirms the principles, structures, and definitions governing
contemporary regulatory review established in Executive Order 12866 and
Executive Order 13563. The Office of Information and Regulatory Affairs
has determined that this rulemaking is not a significant regulatory
action under Executive Order 12866, as amended by Executive Order
14094. The Regulatory Impact Analysis associated with this rulemaking
can be found as a supporting document at www.regulations.gov.
Regulatory Flexibility Act
The Secretary hereby certifies that this proposed rule would not
have a significant economic impact on a substantial number of small
entities as they are defined in the Regulatory Flexibility Act (5
U.S.C. 601-612). This proposed rule would exempt certain health care
services from copayment. This proposed rule would not cause a
significant economic impact on small entities because it is limited to
copayments that would be received by VA directly from Veterans.
Therefore, pursuant to 5 U.S.C. 605(b), the initial and final
regulatory flexibility analysis requirements of 5 U.S.C. 603 and 604 do
not apply.
Unfunded Mandates
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C.
1532, that agencies prepare an assessment of anticipated costs and
benefits before issuing any rule that may result in the expenditure by
state, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation) in any one year. This proposed rule would have no such
effect on state, local, and tribal governments, or on the private
sector.
Paperwork Reduction Act
This proposed rule contains no provisions constituting a collection
of information under the provisions of the Paperwork Reduction Act of
1995 (44 U.S.C. 3501-3521).
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Drug abuse, Government contracts, Health care, Health
facilities, Health professions, Mental health programs, Nursing homes,
Reporting and recordkeeping requirements, Veterans.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, signed and approved
this document on December 18, 2024, 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.
Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy &
Management, Office of General Counsel, Department of Veterans Affairs.
For the reasons stated in the preamble, the Department of Veterans
Affairs proposes to amend 38 CFR part 17 as set forth below:
PART 17--MEDICAL
0
1. The authority citation for part 17 continues to read as follows:
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
0
2. Amend Sec. 17.108 by revising paragraphs (e)(17) through (19) and
adding paragraph (e)(20) to read as follows:
Sec. 17.108 Copayments for inpatient hospital care and outpatient
medical care.
* * * * *
(e) * * *
(17) Mental health peer support services;
(18) An outpatient care visit solely for education on the use of
opioid antagonists to reverse the effects of overdoses of specific
medications or substances;
(19) Emergent suicide care as authorized under 38 CFR 17.1200-
17.1230; and
(20) The following Whole Health well-being services:
(i) Whole Health education and skill-building programs. The
programs that educate, instruct, and empower Veterans to understand and
implement the principles and practices of Whole Health. Whole Health
education and skill-building programs may include, but are not limited
to, Whole Health coaching, Whole Health partner sessions, and Whole
Health education and skill-building courses.
(ii) Complementary and integrative health well-being services. The
services that promote health, well-being, and self-care independent of
treatment of a specific medical condition or diagnosis. Complementary
and integrative health well-being services may include, but are not
limited to, guided imagery, meditation, Tai Chi/Qigong, and yoga for
well-being.
* * * * *
[FR Doc. 2024-31494 Filed 1-2-25; 8:45 am]
BILLING CODE 8320-01-P