Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists, 52072-52076 [2021-20196]
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Dated: September 14, 2021.
Aaron T. Siegel,
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[FR Doc. 2021–20221 Filed 9–17–21; 8:45 am]
BILLING CODE 5001–06–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 17
RIN 2900–AQ31
Elimination of Copayment for Opioid
Antagonists and Education on Use of
Opioid Antagonists
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is amending its medical
regulations that govern copayments to
conform with recent statutory
requirements. VA is eliminating the
copayment requirement for opioid
antagonists furnished to veterans who
are at high risk of overdose of a specific
medication or substance in order to
reverse the effect of such an overdose.
VA is also clarifying that no copayment
is required for the provision of
education on the use of opioid
antagonists. This final rule is an
SUMMARY:
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essential part of VA’s attempts to help
veterans at high risk of overdose.
DATES: This rule is effective October 20,
2021.
FOR FURTHER INFORMATION CONTACT:
Joseph Duran, Director of Policy and
Planning. 3773 Cherry Creek North
Drive, Denver, CO 80209. (303) 370–
1637. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On
November 6, 2020, VA published a
proposed rule in the Federal Register
(85 FR 71020) that would eliminate the
copayment requirement for opioid
antagonists furnished to veterans who
are at high risk of overdose of a specific
medication or substance in order to
reverse the effect of such an overdose
and for the provision of education on
the use of opioid antagonists. VA
provided a 60-day comment period,
which ended on January 5, 2021. VA
received 19 comments on the proposed
rule.
In an effort to reduce the incidence of
overdose among the veteran population,
Congress, in two separate statutes, has
required that VA must exempt from
copayment (1) opioid antagonists
furnished under chapter 17 to a veteran
who is at high risk for overdose of a
specific medication or substance in
order to reverse the effect of such an
overdose, and (2) education on the use
of opioid antagonists to reverse the
effects of overdoses of specific
medications or substances. See Public
Law 114–198, sec. 915 (July 22, 2016)
and Public Law 114–223, Division A,
sec. 243 (Sept. 29, 2016). These
provisions were effective upon
enactment and have already been
implemented. These provisions assist
veterans by eliminating copayments for
life-saving medication and education on
the use of such medication, with the
goal of reducing the incidence of
overdose deaths among the veteran
population. This final rule amends two
of VA’s copayment regulations, 38 Code
of Federal Regulations (CFR) 17.108 and
17.110, to accurately implement these
changes in law. This final rule also adds
an explanation of how VA would
identify a veteran at high risk for
overdose under the new provisions.
Positive Comments
Most commenters were in support of
the proposed rule. One commenter
stated that the rule would be a crucial
part of VA’s efforts to help veterans at
an extreme risk of overdose. Another
commenter stated that the rule is critical
in creating cross-governmental cohesion
in the fight against the opioid crisis in
our veteran population, and it solidifies
the message of a united front against the
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opioid crisis in our veteran community.
The commenter suggested that adding a
clear definition of who VA considers
high risk is also an essential step in
ensuring that any veteran needing these
measures will have the availability of
lifesaving opioid antagonists afforded to
them. A commenter stated that the
opioid crisis in the United State is
getting worse every day and it is VA’s
duty to eliminate copays for opioid
antagonists and education on use of
opioid antagonists. Another commenter
stated that high-risk veterans should
have adequate access to opioid
antagonists and that veterans should
also have access to counseling and
educational information on the subject
of opioid addiction.
A commenter stated that eliminating
the copayment for opioid antagonists
and the education on the use of opioid
antagonists will relieve a veteran of
those financial burdens while receiving
treatment. The commenter added that
veterans have sacrificed enough to
protect the people of this country and it
is our responsibility to provide proper
health care and encourage healthy
living. Eliminating the copayment will
allow veterans to fight this battle with
focus and determination and removing
a stressor such as a copayment can
increase the chances of a successful
recovery.
A commenter was in favor of the rule
and added that VA has several programs
in place to help veterans manage pain
that do not include the use of opioids.
This same commenter stated that the
use of naloxone rescue treatments is an
option for opioid risk mitigation and
that proper education on naloxone
should be given with frequent
observation of the veteran and
documentation in the veteran’s medical
records. This commenter also stated that
eliminating the copayment will allow a
veteran to fight this battle with focus
and determination. Treatment
timeframe varies per situation, but when
trying to heal the mind and body
simultaneously, removing a stressor can
increase the chances of a successful
recovery.
Another commenter was in support of
the proposed rule and stated that the
rule will be impactful to veterans
battling opioid use disorder. Several
commenters stated that by waiving the
requirement to pay a copayment to
receive opioid antagonists or education
on their use for qualifying veterans, VA
is recognizing that costs can pose a
barrier for veterans to health care
accessibility and it is taking the right
steps to alleviate those barriers. A
commenter added that this rule is a
statement by VA of support of their at-
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risk patients and that it places the
values of their patients’ lives over the
cost of this drug. Another commenter
similarly stated that removing
copayment requirements for veterans
will likely result in increased access to
these potentially life-saving
medications. The commenter praised
VA’s efforts and believes that this rule
will help reduce the incidence of
overdose deaths among the veteran
population.
A commenter stated that the proposed
rule was a fine example of an executive
agency ensuring compliance with
Congressional direction.
VA thanks the commenters for their
support of the rule. We are not making
any changes based on these comments.
Comment on use of term opioid
antagonist.
One commenter was in support of the
rule but stated that VA should change
the wording in the proposed rule from
antagonist to something that is more
relatable and not so demeaning to
people who will interpret it the wrong
way.
VA notes that the utilization of the
term antagonist in the proposed rule is
the correct medical term to describe the
specific class of medications being
authorized for provision to at risk
veterans. An antagonist is a chemical
that acts within the body to reduce the
physiological activity of another
chemical substance (such as an opioid).
Since the term specifically describes
this class of medication, VA is not
making changes based on this comment.
Comments on education on opioid
antagonists.
A commenter was in general support
of the rule but indicated that the
copayment for the outpatient visit
should be eliminated regardless of
whether the veteran’s medical visit is
solely for education on the use of opioid
antagonists or the education is provided
in conjunction with other types of care.
Under 38 United States Code (U.S.C.)
1710 and 38 CFR 17.108(c) VA is
required to charge copayments for
outpatient and inpatient health care
services when certain criteria are met.
VA clarifies, in 38 CFR 17.108(c)(2), a
veteran will only be charged one
copayment per day even if there are
multiple encounters. In accordance with
section 1710(g)(3)(B) of title 38, United
States Code, VA is exempting from the
copayment requirement those outpatient
health care visits whose sole purpose is
to provide education on the use of an
opioid antagonist. However, when the
outpatient visit provides health care
services in addition to the education on
an opioid antagonist, VA must assess
the veteran’s copayment for the
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additional services in accordance with
38 U.S.C. 1710. VA emphasizes that the
veteran will not be charged a separate
copayment for the education but will be
assessed one copayment for the entire
encounter. VA notes this results in the
same outcome as the veteran would
have experienced if the veteran had not
received education on the use of an
opioid antagonist. VA is not making any
changes based on this comment.
Comments on definition of at high
risk veterans.
Several commenters were generally in
support of the rule but were concerned
that the rule only focused on veterans
who VA classified as high risk. The
commenters stated that all veterans, not
just those with a diagnosed risk of
opioid overdose, should be eligible for
the waived copayment. A commenter
stated that if a veteran needs the opioid
antagonist, then costs should not be a
concern whether they are high risk or
not. The commenter added that the fact
the veteran is in need of the antagonist
is sufficient evidence the veteran is at
high risk. Also, the commenter stated
that while the proposed rule would be
an improvement and would lead to
more lives being saved, more aggressive
action to expand the target population
to all veterans would be warranted and
welcomed by the American people.
VA defined a high risk veteran in the
proposed rule as a veteran who is
prescribed or using opioids, or has an
opioid use history, and who is at
increased risk for opioid overdose as
determined by VA. VA also stated that,
in the alternative, a high risk veteran is
one whose provider deems, based on
their clinical judgment, that the veteran
may benefit from ready availability of an
opioid antagonist. VA believes this
definition is broad enough to allow
health care professionals the discretion
to provide opioid antagonists and
related education to any veteran who
needs it without charging a copayment.
In addition, VA has programs in place
to assist veterans who are suffering
financial hardship or who would face
difficulties in making copayments; these
efforts include measures to identify
barriers for veterans at high risk due to
substance use and to review the
veteran’s financial barriers and provide
assistance as needed. VA is not making
any changes based on this comment.
Another commenter stated that the
proposed rule assumes that all those
who are considered high risk would be
appropriately identified to meet the
requirements for the copayment waiver.
The commenter added that this
approach runs the risk of missing
vulnerable individuals who may not fall
within the parameters outlined by VA
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that are used to generate a high-risk
status and thus, a waived copayment.
The commenter recommended that VA
expand the rule to capture not only
those considered high-risk, but also
those residing in highly impacted
regions, such as rural communities.
Another commenter similarly
recommended including additional
items in the definition of high risk, such
as considering all veterans who
requested opioid antagonists in
geographical areas that see higher rates
of opioid use and areas considered rural
by the Federal Office of Rural Health
Policy to be high risk. The commenter
indicated that veterans in rural areas
have limited access to health care and
treatment centers, and delays in
emergency medical services become
critical when an accidental overdose
occurs. The commenter added that VA
should create the most inclusive
definition possible and consider other,
less obvious, circumstances veterans
may face that could render them at
‘‘high risk’’ of opioid addiction. The
commenter also stated that by utilizing
a model which casts a wider net for
assistance, more veterans and those in
their immediate circles are likely to
benefit from these proposals.
As previously stated in this
rulemaking, VA’s definition of high risk
veteran is broad enough to allow health
care professionals the discretion to
provide opioid antagonists and
education on those medications to any
veteran without charging a copayment.
In addition, VA has developed
numerous resources to support
identification of patients at risk for
overdose, including the VA Opioid
Overdose Education and Naloxone
Distribution (OEND) Risk Report (which
includes patients with various opioid
pharmacotherapy and Opioid Use
Disorder risk factors); VA Stratification
Tool for Opioid Risk Mitigation
(STORM), which uses predictive
analytics to identify patients prescribed
opioids who are at high risk for
overdose and/or suicide; and
incorporating the Risk Index for
Overdose or Serious Opioid-induced
Respiratory Depression (RIOSORD) into
multiple reports to assist with patient
identification. VA clinicians provide
patient-centered care that takes into
account the complexity of conditions
and circumstances with which patients
present—including their work, home,
support system, and community—when
conducting risk assessments and
developing treatment plans. Based on
the broad definition for this rule, which
allows clinicians to provide opioid
antagonists and related education to any
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veteran they deem may benefit from
ready availability of an opioid
antagonist, VA is not making any
changes to its definition of high risk in
response to this comment.
Another commenter stated that opioid
overdoses can occur even when
someone is taking an opioid exactly as
prescribed by their doctor, and even
veterans who are not considered ‘‘high
risk’’ can still die of an overdose or be
left with long term brain damage.
Therefore, the commenter concluded, it
is imperative that all veterans taking
opioids are educated on the dangers of
opioid induced respiratory depression
(OIRD) and are provided the monitoring
technology to help keep them safe. The
commenter encouraged VA to utilize
continuous physiologic monitoring with
notifications for all patients using
opioids, particularly during periods of
sleep and rest. The commenter added
that such monitoring has been shown to
reduce opioid overdose deaths through
earlier interventions and rapid response
team activations when necessary. The
commenter recommended that VA
include the following in the list of
factors that indicate that an individual
is at high risk of overdose: Individuals
taking other sedating medications,
including alcohol, marijuana,
benzodiazepines and/or gabapentin;
older adults; depression or mental
health conditions; sleep apnea.
VA notes the specific modalities for
treatment, such as monitoring for OIRD,
are determined by the VA national
program office responsible for
developing guidance to VA staff
overseeing the provision of care at the
facility level. The establishment of such
modalities are outside the scope of the
proposed rulemaking. VA believes that
the proposed definition of a high risk
veteran is broad enough to grant health
care professionals the discretion to
identify veterans who such
professionals consider to be high risk;
the addition of the factors identified by
the commenter would not enhance the
proposed definition. Moreover, VA’s
aforementioned STORM model takes
into consideration many of the factors
described by the commenter that are
available in VA data (e.g., substance use
disorders, benzodiazepine and
gabapentin prescriptions, age, mental
health diagnoses, and sleep apnea).
These factors are displayed in a VAprovider facing clinical dashboard for
patients prescribed opioids as well as
patients with opioid use disorders. VA
is not making any changes based on
these comments.
Comments on elimination of other
types of copayments.
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A commenter was generally in
support of the rule but recommended
the rule also eliminate any cost to
veterans relating to substance use
disorder counseling, rehabilitation,
psychological treatment, and inpatient
care. The commenter added that care
coordination between providers must
become an equal priority to prevent
over-prescription. In addition, the
commenter stated that opioid
antagonists should be treated as the last
resort in reducing overdose deaths and
not a course of treatment. The
commenter stated the proposed rule
should be only the first step in ensuring
that high risk veterans face no obstacles
in gaining access to the treatment that
they need ahead of any possible
overdose incident.
As previously stated in this
rulemaking, section 915 of Public Law
114–198 and section 243 of Division A
of Public Law 114–223 provide for the
elimination of a copayment for the
provision of opioid antagonists and for
outpatient visits whose sole purpose is
for the provision of education on the use
of opioid antagonists. The elimination
of copayments for substance use
disorder counseling, rehabilitation,
psychological treatment, and inpatient
care are beyond the scope of the
proposed rule. However, VA’s
implementation of opioid antagonist
education emphasizes the importance of
connecting patients, including those
with opioid use disorder, with treatment
(e.g., a standardized patient education
brochure recommends considering
seeking help for substance use disorder
[SUD] treatment and includes a link to
the VA SUD Program Locator). VA has
also streamlined Prescription Drug
Monitoring Program (PDMP) checks—
incorporating an integrated Information
Technology solution that allows
providers to check for controlled
substance prescriptions outside VA.
This mechanism makes it easy for
providers to check the PDMP for opioid
prescriptions external to VA within the
Computerized Patient Record System.
VA also has programs in place to assist
veterans experiencing financial
hardship, including measures to
identify barriers for veterans at higher
risk due to SUD. VA is not making any
changes based on this comment.
Comments on Outreach
One commenter suggested that the
rule should also ensure that VA provide
outreach services to identify high-risk
veterans, encourage educational
outpatient visits, and follow-up before
or after both outpatient and inpatient
visits for treatment and education. The
commenter indicated that providing
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outreach services will increase the
number of veterans who receive
antagonist prescriptions, aid in tracking
the most at risk of the high-risk
population, aid in the dissemination of
pain management alternatives, and
overall reduce the risk of opioid misuse
and overdose events. The commenter
also stated that outreach has proven
effective in several studies conducted
all over the US for people suffering with
Opioid Use Disorder and is a main
factor is reducing repeat overdose
events. The commenter stated that these
outreach practices are already occurring
in VA and should be folded into the
regulation to ensure their continuation
as outreach is an integral part of
increasing the effectiveness of this rule’s
stated goal.
VA notes that this rulemaking is
limited to the exemption of copayments
for opioid antagonist education and
dispensing of opioid antagonists to
veterans identified by VA health care
professionals as being at high risk of
overdose. VA already has treatment
programs and outreach programs in
place for identification and treatment of
veterans at risk of opioid use disorder.
The provision of VA outreach programs
for opioid use disorder is outside the
scope of the proposed rulemaking, and
VA generally seeks to avoid regulating
outreach practices to allow for
innovative approaches to be adopted to
support safe and effective patient care.
VA is not making any changes based on
this comment.
Comments on the impact analysis.
A commenter had concerns regarding
the impact analysis that accompanied
the rulemaking. The commenter stated
that the impact analysis projected a loss
of revenue of more than $150,000 with
increases for each year of this rule’s
existence due to the copayment
exemptions. The commenter noted that
the impact analysis did not state where
this revenue stream would be diverted
from internally and how this may
impact other veteran services of equal or
greater importance. The commenter
queried whether VA plans to apply for
a grant under the Food, Drug, and
Cosmetic Act (chapter 9 of title 21,
U.S.C.) for the emergency treatment of
opioid overdose, which can offset at
least $200,000 of antagonist costs that is
greater than the yearly projected loss of
revenue from this rule.
VA believes the benefits of educating
veterans on the risks of opioids and
utilization of opioid antagonists during
an overdose to potentially save a life
outweighs any loss of revenue from VA
copayments. VA anticipates no
reduction or diversion of funds from
other programs as a result of this
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rulemaking. VA has already been
implementing this authority, and VA’s
budget requests already reflect the loss
identified in the impact analysis. We are
not making any changes based on this
comment.
Based on the rationale set forth in the
Supplementary Information to the
proposed rule and in this final rule, VA
is adopting the proposed rule with no
changes.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563
direct agencies to assess the costs and
benefits of available regulatory
alternatives and, when regulation is
necessary, to select regulatory
approaches that maximize net benefits
(including potential economic,
environmental, public health and safety
effects, and other advantages;
distributive impacts; and equity).
Executive Order 13563 (Improving
Regulation and Regulatory Review)
emphasizes the importance of
quantifying both costs and benefits,
reducing costs, harmonizing rules, and
promoting flexibility. The Office of
Information and Regulatory Affairs has
determined that this rule is not a
significant regulatory action under
Executive Order 12866. 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 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). The adoption of the
rule does not directly affect any small
entities. There are no small entities
involved with VA’s process or
adjustment of veteran’s copayments for
medications or services. The provisions
of this rulemaking only apply to the
internal operations of VA and to
individual 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 final rule will have no
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52075
such effect on State, local, and tribal
governments, or on the private sector.
Paperwork Reduction Act
This final rule contains no provisions
constituting a collection of information
under the Paperwork Reduction Act of
1995 (44 U.S.C. 3501– 3521).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic
Assistance program number and title for
this final rule are as follows: 64.009,
Veterans Medical Care Benefits; 64.012,
Veterans Prescription Service; 64.019,
Veterans Rehabilitation Alcohol and
Drug Dependence; 64.041, VHA
Outpatient Specialty Care; 64.045, VHA
Outpatient Ancillary Services; 64.047,
VHA Primary Care; 64.048, VHA Mental
Health Clinics.
Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
designated this rule as not a major rule,
as defined by 5 U.S.C. 804(2).
List of Subjects in 38 CFR Part 17
Administrative practice and
procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug
abuse, Government contracts, Grant
programs—health, Grant programs—
veterans, Health care, Health facilities,
Health professions, Health records,
Homeless, Medical and Dental schools,
Medical devices, Medical research,
Mental health programs, Nursing
homes, Reporting and recordkeeping
requirements, Travel and transportation
expenses, Veterans.
Signing Authority
Denis McDonough, Secretary of
Veterans Affairs, approved this
document on September 10, 2021, 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 amends 38 CFR part 17 as set
forth below:
PART 17—MEDICAL
1. The general authority citation for
part 17 continues to read as follows:
■
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Authority: 38 U.S.C. 501, and as noted in
specific sections.
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■ 2. Amend § 17.108 by revising
paragraphs (e)(16) and (17) and adding
paragraph (e)(18) to read as follows:
§ 17.108 Copayments for inpatient hospital
care and outpatient medical care.
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(e) * * *
(16) In-home video telehealth care;
(17) Mental health peer support
services; and
(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.
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■ 3. Amend § 17.110 by adding
paragraph (c)(12) to read as follows:
§ 17.110
Copayments for medication.
*
*
*
*
*
(c) * * *
(12) Opioid antagonists furnished to a
veteran who is at high risk for overdose
of a specific medication or substance in
order to reverse the effect of such an
overdose.
(i) For purposes of this paragraph
(c)(12), a veteran who is at high risk for
overdose of a specific medication or
substance in order to reverse the effect
of such an overdose is a veteran:
(A) Who is prescribed or using
opioids, or has an opioid use history,
and who is at increased risk for opioid
overdose as determined by VA; or
(B) Whose provider deems, based on
their clinical judgment, that the veteran
may benefit from ready availability of an
opioid antagonist.
(ii) Examples of a veteran who is at
high risk for overdose of a specific
medication or substance in order to
reverse the effect of such an overdose
include, but are not limited to, the
following:
(A) A veteran with an opioid or
substance use disorder diagnosis;
(B) A veteran receiving treatment for
an opioid or substance use disorder
diagnosis, such as receiving opioid
agonist therapy or inpatient, residential,
or outpatient treatment for such
diagnosis, or attending a support group
for such diagnosis;
(C) A veteran with a history of
prescription opioid misuse or injection
opioid use;
(D) A veteran with a history of
previous opioid overdose;
(E) A veteran who is taking an
extended-release or long-acting
prescription opioid;
(F) A veteran with household or
community access to opioids who is at
VerDate Sep<11>2014
15:36 Sep 17, 2021
Jkt 253001
increased risk for overdose (e.g.,
psychiatric disorder or high risk for
suicide) as determined by VA; or
(G) A veteran predicted to be at high
risk for overdose based on standardized
assessments or predictive models (e.g.,
Risk Index for Overdose or Serious
Opioid-induced Respiratory Depression
[RIOSORD]; Stratification Tool for
Opioid Risk Mitigation [STORM]).
Note 1 to paragraph (c)(12). The examples
in paragraphs (c)(12)(ii)(A) through (G) of this
section apply even if the veteran has had a
period of abstinence from opioids (e.g., due
to treatment, detoxification, incarceration)
because loss of tolerance can increase the risk
for an overdose.
[FR Doc. 2021–20196 Filed 9–17–21; 8:45 am]
BILLING CODE 8320–01–P
DEPARTMENT OF VETERANS
AFFAIRS
38 CFR Part 38
RIN 2900–AR03
Referral for VA Administrative
Decision for Character of Discharge
Determinations
Department of Veterans Affairs.
Final rule.
AGENCY:
ACTION:
The Department of Veterans
Affairs (VA) is amending its regulations
to clarify that, when determining
eligibility for interment or
memorialization benefits, the National
Cemetery Administration (NCA) will
refer cases involving other than
honorable (OTH) discharges, certain
other discharges, or potential statutory
or regulatory bars to benefits, to the
Veterans Benefits Administration (VBA)
for character of discharge
determinations. VA is merely updating
its regulations to conform with statute
and current practice.
DATES: This rule is effective October 20,
2021.
FOR FURTHER INFORMATION CONTACT: Jerry
Sowders, Division Chief, Eligibility
Verification Division, National
Cemetery Administration, Department
of Veterans Affairs, 810 Vermont
Avenue NW, Washington, DC 20420.
Telephone: 314–416–6369. (This is not
a toll-free number.)
SUPPLEMENTARY INFORMATION: On
December 18, 2020, VA published in the
Federal Register (85 FR 82399) a
proposed rule revising its regulations to
clarify that, when determining
eligibility for interment or
memorialization benefits, NCA will
refer cases involving OTH discharges or
other character of discharge issues to
SUMMARY:
PO 00000
Frm 00006
Fmt 4700
Sfmt 4700
VBA for an administrative decision. The
public comment period ended on
February 16, 2021.
VA received one comment that
expressed disagreement with the
proposed rule, stating that the referral of
cases for a character of discharge
determination was ‘‘morally and
ethically reprehensible.’’ The
commenter also asserted that the
proposed rule sought to assume
Congress’s role ‘‘to write statute’’ by
redefining the term ‘‘veteran,’’ and
suggested that VA use an automated
formula to evaluate whether an
individual satisfies the statutory
definition of veteran. We thank the
commenter for this comment.
However, we disagree that this rule
redefines the term ‘‘veteran’’ in any
way. While the supplemental
information in the proposed rule
explained that eligibility for NCAadministered benefits is tied to an
individual establishing ‘‘veteran’’ status
or meeting other specified conditions,
this rule does not affect the statutory
definition of ‘‘veteran’’ as provided by
Congress in 38 U.S.C. 101(2). The rule
only amends 38 CFR 38.620 by adding
a note following paragraph (i) to inform
that a benefit request, pertaining to a
decedent whose character of discharge
may potentially bar eligibility to that
benefit, may be referred to VBA for
review in accordance with 38 CFR 3.12
(Character of discharge) or other
applicable sections. As such, we make
no changes based on the comment.
We appreciate the commenter’s
suggested alternative approach to
determining whether an individual
satisfies the statutory definition of
‘‘veteran’’, but Congress has delegated to
VA the authority to promulgate
reasonable regulations on VA benefits
eligibility, which it has done in 38 CFR
3.12. See Garvey v. Wilkie, 972 F.3d
1333 (Fed. Cir. 2020). It is not 38 CFR
38.620 or this rule (which merely
clarifies NCA current practice), but 38
CFR 3.12, that seems to pertain more to
the commenter’s concern.
Under 38 CFR 3.12(a), some
discharges, such as honorable and
general (under honorable conditions)
automatically convey ‘‘veteran’’ status.
However, other types of discharges
require in-depth examination under the
provisions of 38 CFR 3.12(d) to
determine whether the discharge should
be considered to have been issued under
dishonorable conditions. Moreover, the
provisions of 38 CFR 3.12(c), commonly
referred to as the statutory bars to
benefits (since they are derived from 38
U.S.C. 5303(a)) may also be implicated.
Because of VBA’s expertise and
familiarity with 38 CFR 3.12, NCA has
E:\FR\FM\20SER1.SGM
20SER1
]]>Agencies
[Federal Register Volume 86, Number 179 (Monday, September 20, 2021)]
[Rules and Regulations]
[Pages 52072-52076]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-20196]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ31
Elimination of Copayment for Opioid Antagonists and Education on
Use of Opioid Antagonists
AGENCY: Department of Veterans Affairs.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Department of Veterans Affairs (VA) is amending its
medical regulations that govern copayments to conform with recent
statutory requirements. VA is eliminating the copayment requirement for
opioid antagonists furnished to veterans who are at high risk of
overdose of a specific medication or substance in order to reverse the
effect of such an overdose. VA is also clarifying that no copayment is
required for the provision of education on the use of opioid
antagonists. This final rule is an essential part of VA's attempts to
help veterans at high risk of overdose.
DATES: This rule is effective October 20, 2021.
FOR FURTHER INFORMATION CONTACT: Joseph Duran, Director of Policy and
Planning. 3773 Cherry Creek North Drive, Denver, CO 80209. (303) 370-
1637. (This is not a toll-free number.)
SUPPLEMENTARY INFORMATION: On November 6, 2020, VA published a proposed
rule in the Federal Register (85 FR 71020) that would eliminate the
copayment requirement for opioid antagonists furnished to veterans who
are at high risk of overdose of a specific medication or substance in
order to reverse the effect of such an overdose and for the provision
of education on the use of opioid antagonists. VA provided a 60-day
comment period, which ended on January 5, 2021. VA received 19 comments
on the proposed rule.
In an effort to reduce the incidence of overdose among the veteran
population, Congress, in two separate statutes, has required that VA
must exempt from copayment (1) opioid antagonists furnished under
chapter 17 to a veteran who is at high risk for overdose of a specific
medication or substance in order to reverse the effect of such an
overdose, and (2) education on the use of opioid antagonists to reverse
the effects of overdoses of specific medications or substances. See
Public Law 114-198, sec. 915 (July 22, 2016) and Public Law 114-223,
Division A, sec. 243 (Sept. 29, 2016). These provisions were effective
upon enactment and have already been implemented. These provisions
assist veterans by eliminating copayments for life-saving medication
and education on the use of such medication, with the goal of reducing
the incidence of overdose deaths among the veteran population. This
final rule amends two of VA's copayment regulations, 38 Code of Federal
Regulations (CFR) 17.108 and 17.110, to accurately implement these
changes in law. This final rule also adds an explanation of how VA
would identify a veteran at high risk for overdose under the new
provisions.
Positive Comments
Most commenters were in support of the proposed rule. One commenter
stated that the rule would be a crucial part of VA's efforts to help
veterans at an extreme risk of overdose. Another commenter stated that
the rule is critical in creating cross-governmental cohesion in the
fight against the opioid crisis in our veteran population, and it
solidifies the message of a united front against the
[[Page 52073]]
opioid crisis in our veteran community. The commenter suggested that
adding a clear definition of who VA considers high risk is also an
essential step in ensuring that any veteran needing these measures will
have the availability of lifesaving opioid antagonists afforded to
them. A commenter stated that the opioid crisis in the United State is
getting worse every day and it is VA's duty to eliminate copays for
opioid antagonists and education on use of opioid antagonists. Another
commenter stated that high-risk veterans should have adequate access to
opioid antagonists and that veterans should also have access to
counseling and educational information on the subject of opioid
addiction.
A commenter stated that eliminating the copayment for opioid
antagonists and the education on the use of opioid antagonists will
relieve a veteran of those financial burdens while receiving treatment.
The commenter added that veterans have sacrificed enough to protect the
people of this country and it is our responsibility to provide proper
health care and encourage healthy living. Eliminating the copayment
will allow veterans to fight this battle with focus and determination
and removing a stressor such as a copayment can increase the chances of
a successful recovery.
A commenter was in favor of the rule and added that VA has several
programs in place to help veterans manage pain that do not include the
use of opioids. This same commenter stated that the use of naloxone
rescue treatments is an option for opioid risk mitigation and that
proper education on naloxone should be given with frequent observation
of the veteran and documentation in the veteran's medical records. This
commenter also stated that eliminating the copayment will allow a
veteran to fight this battle with focus and determination. Treatment
timeframe varies per situation, but when trying to heal the mind and
body simultaneously, removing a stressor can increase the chances of a
successful recovery.
Another commenter was in support of the proposed rule and stated
that the rule will be impactful to veterans battling opioid use
disorder. Several commenters stated that by waiving the requirement to
pay a copayment to receive opioid antagonists or education on their use
for qualifying veterans, VA is recognizing that costs can pose a
barrier for veterans to health care accessibility and it is taking the
right steps to alleviate those barriers. A commenter added that this
rule is a statement by VA of support of their at-risk patients and that
it places the values of their patients' lives over the cost of this
drug. Another commenter similarly stated that removing copayment
requirements for veterans will likely result in increased access to
these potentially life-saving medications. The commenter praised VA's
efforts and believes that this rule will help reduce the incidence of
overdose deaths among the veteran population.
A commenter stated that the proposed rule was a fine example of an
executive agency ensuring compliance with Congressional direction.
VA thanks the commenters for their support of the rule. We are not
making any changes based on these comments.
Comment on use of term opioid antagonist.
One commenter was in support of the rule but stated that VA should
change the wording in the proposed rule from antagonist to something
that is more relatable and not so demeaning to people who will
interpret it the wrong way.
VA notes that the utilization of the term antagonist in the
proposed rule is the correct medical term to describe the specific
class of medications being authorized for provision to at risk
veterans. An antagonist is a chemical that acts within the body to
reduce the physiological activity of another chemical substance (such
as an opioid). Since the term specifically describes this class of
medication, VA is not making changes based on this comment.
Comments on education on opioid antagonists.
A commenter was in general support of the rule but indicated that
the copayment for the outpatient visit should be eliminated regardless
of whether the veteran's medical visit is solely for education on the
use of opioid antagonists or the education is provided in conjunction
with other types of care.
Under 38 United States Code (U.S.C.) 1710 and 38 CFR 17.108(c) VA
is required to charge copayments for outpatient and inpatient health
care services when certain criteria are met. VA clarifies, in 38 CFR
17.108(c)(2), a veteran will only be charged one copayment per day even
if there are multiple encounters. In accordance with section
1710(g)(3)(B) of title 38, United States Code, VA is exempting from the
copayment requirement those outpatient health care visits whose sole
purpose is to provide education on the use of an opioid antagonist.
However, when the outpatient visit provides health care services in
addition to the education on an opioid antagonist, VA must assess the
veteran's copayment for the additional services in accordance with 38
U.S.C. 1710. VA emphasizes that the veteran will not be charged a
separate copayment for the education but will be assessed one copayment
for the entire encounter. VA notes this results in the same outcome as
the veteran would have experienced if the veteran had not received
education on the use of an opioid antagonist. VA is not making any
changes based on this comment.
Comments on definition of at high risk veterans.
Several commenters were generally in support of the rule but were
concerned that the rule only focused on veterans who VA classified as
high risk. The commenters stated that all veterans, not just those with
a diagnosed risk of opioid overdose, should be eligible for the waived
copayment. A commenter stated that if a veteran needs the opioid
antagonist, then costs should not be a concern whether they are high
risk or not. The commenter added that the fact the veteran is in need
of the antagonist is sufficient evidence the veteran is at high risk.
Also, the commenter stated that while the proposed rule would be an
improvement and would lead to more lives being saved, more aggressive
action to expand the target population to all veterans would be
warranted and welcomed by the American people.
VA defined a high risk veteran in the proposed rule as a veteran
who is prescribed or using opioids, or has an opioid use history, and
who is at increased risk for opioid overdose as determined by VA. VA
also stated that, in the alternative, a high risk veteran is one whose
provider deems, based on their clinical judgment, that the veteran may
benefit from ready availability of an opioid antagonist. VA believes
this definition is broad enough to allow health care professionals the
discretion to provide opioid antagonists and related education to any
veteran who needs it without charging a copayment. In addition, VA has
programs in place to assist veterans who are suffering financial
hardship or who would face difficulties in making copayments; these
efforts include measures to identify barriers for veterans at high risk
due to substance use and to review the veteran's financial barriers and
provide assistance as needed. VA is not making any changes based on
this comment.
Another commenter stated that the proposed rule assumes that all
those who are considered high risk would be appropriately identified to
meet the requirements for the copayment waiver. The commenter added
that this approach runs the risk of missing vulnerable individuals who
may not fall within the parameters outlined by VA
[[Page 52074]]
that are used to generate a high-risk status and thus, a waived
copayment. The commenter recommended that VA expand the rule to capture
not only those considered high-risk, but also those residing in highly
impacted regions, such as rural communities. Another commenter
similarly recommended including additional items in the definition of
high risk, such as considering all veterans who requested opioid
antagonists in geographical areas that see higher rates of opioid use
and areas considered rural by the Federal Office of Rural Health Policy
to be high risk. The commenter indicated that veterans in rural areas
have limited access to health care and treatment centers, and delays in
emergency medical services become critical when an accidental overdose
occurs. The commenter added that VA should create the most inclusive
definition possible and consider other, less obvious, circumstances
veterans may face that could render them at ``high risk'' of opioid
addiction. The commenter also stated that by utilizing a model which
casts a wider net for assistance, more veterans and those in their
immediate circles are likely to benefit from these proposals.
As previously stated in this rulemaking, VA's definition of high
risk veteran is broad enough to allow health care professionals the
discretion to provide opioid antagonists and education on those
medications to any veteran without charging a copayment. In addition,
VA has developed numerous resources to support identification of
patients at risk for overdose, including the VA Opioid Overdose
Education and Naloxone Distribution (OEND) Risk Report (which includes
patients with various opioid pharmacotherapy and Opioid Use Disorder
risk factors); VA Stratification Tool for Opioid Risk Mitigation
(STORM), which uses predictive analytics to identify patients
prescribed opioids who are at high risk for overdose and/or suicide;
and incorporating the Risk Index for Overdose or Serious Opioid-induced
Respiratory Depression (RIOSORD) into multiple reports to assist with
patient identification. VA clinicians provide patient-centered care
that takes into account the complexity of conditions and circumstances
with which patients present--including their work, home, support
system, and community--when conducting risk assessments and developing
treatment plans. Based on the broad definition for this rule, which
allows clinicians to provide opioid antagonists and related education
to any veteran they deem may benefit from ready availability of an
opioid antagonist, VA is not making any changes to its definition of
high risk in response to this comment.
Another commenter stated that opioid overdoses can occur even when
someone is taking an opioid exactly as prescribed by their doctor, and
even veterans who are not considered ``high risk'' can still die of an
overdose or be left with long term brain damage. Therefore, the
commenter concluded, it is imperative that all veterans taking opioids
are educated on the dangers of opioid induced respiratory depression
(OIRD) and are provided the monitoring technology to help keep them
safe. The commenter encouraged VA to utilize continuous physiologic
monitoring with notifications for all patients using opioids,
particularly during periods of sleep and rest. The commenter added that
such monitoring has been shown to reduce opioid overdose deaths through
earlier interventions and rapid response team activations when
necessary. The commenter recommended that VA include the following in
the list of factors that indicate that an individual is at high risk of
overdose: Individuals taking other sedating medications, including
alcohol, marijuana, benzodiazepines and/or gabapentin; older adults;
depression or mental health conditions; sleep apnea.
VA notes the specific modalities for treatment, such as monitoring
for OIRD, are determined by the VA national program office responsible
for developing guidance to VA staff overseeing the provision of care at
the facility level. The establishment of such modalities are outside
the scope of the proposed rulemaking. VA believes that the proposed
definition of a high risk veteran is broad enough to grant health care
professionals the discretion to identify veterans who such
professionals consider to be high risk; the addition of the factors
identified by the commenter would not enhance the proposed definition.
Moreover, VA's aforementioned STORM model takes into consideration many
of the factors described by the commenter that are available in VA data
(e.g., substance use disorders, benzodiazepine and gabapentin
prescriptions, age, mental health diagnoses, and sleep apnea). These
factors are displayed in a VA-provider facing clinical dashboard for
patients prescribed opioids as well as patients with opioid use
disorders. VA is not making any changes based on these comments.
Comments on elimination of other types of copayments.
A commenter was generally in support of the rule but recommended
the rule also eliminate any cost to veterans relating to substance use
disorder counseling, rehabilitation, psychological treatment, and
inpatient care. The commenter added that care coordination between
providers must become an equal priority to prevent over-prescription.
In addition, the commenter stated that opioid antagonists should be
treated as the last resort in reducing overdose deaths and not a course
of treatment. The commenter stated the proposed rule should be only the
first step in ensuring that high risk veterans face no obstacles in
gaining access to the treatment that they need ahead of any possible
overdose incident.
As previously stated in this rulemaking, section 915 of Public Law
114-198 and section 243 of Division A of Public Law 114-223 provide for
the elimination of a copayment for the provision of opioid antagonists
and for outpatient visits whose sole purpose is for the provision of
education on the use of opioid antagonists. The elimination of
copayments for substance use disorder counseling, rehabilitation,
psychological treatment, and inpatient care are beyond the scope of the
proposed rule. However, VA's implementation of opioid antagonist
education emphasizes the importance of connecting patients, including
those with opioid use disorder, with treatment (e.g., a standardized
patient education brochure recommends considering seeking help for
substance use disorder [SUD] treatment and includes a link to the VA
SUD Program Locator). VA has also streamlined Prescription Drug
Monitoring Program (PDMP) checks--incorporating an integrated
Information Technology solution that allows providers to check for
controlled substance prescriptions outside VA. This mechanism makes it
easy for providers to check the PDMP for opioid prescriptions external
to VA within the Computerized Patient Record System. VA also has
programs in place to assist veterans experiencing financial hardship,
including measures to identify barriers for veterans at higher risk due
to SUD. VA is not making any changes based on this comment.
Comments on Outreach
One commenter suggested that the rule should also ensure that VA
provide outreach services to identify high-risk veterans, encourage
educational outpatient visits, and follow-up before or after both
outpatient and inpatient visits for treatment and education. The
commenter indicated that providing
[[Page 52075]]
outreach services will increase the number of veterans who receive
antagonist prescriptions, aid in tracking the most at risk of the high-
risk population, aid in the dissemination of pain management
alternatives, and overall reduce the risk of opioid misuse and overdose
events. The commenter also stated that outreach has proven effective in
several studies conducted all over the US for people suffering with
Opioid Use Disorder and is a main factor is reducing repeat overdose
events. The commenter stated that these outreach practices are already
occurring in VA and should be folded into the regulation to ensure
their continuation as outreach is an integral part of increasing the
effectiveness of this rule's stated goal.
VA notes that this rulemaking is limited to the exemption of
copayments for opioid antagonist education and dispensing of opioid
antagonists to veterans identified by VA health care professionals as
being at high risk of overdose. VA already has treatment programs and
outreach programs in place for identification and treatment of veterans
at risk of opioid use disorder. The provision of VA outreach programs
for opioid use disorder is outside the scope of the proposed
rulemaking, and VA generally seeks to avoid regulating outreach
practices to allow for innovative approaches to be adopted to support
safe and effective patient care. VA is not making any changes based on
this comment.
Comments on the impact analysis.
A commenter had concerns regarding the impact analysis that
accompanied the rulemaking. The commenter stated that the impact
analysis projected a loss of revenue of more than $150,000 with
increases for each year of this rule's existence due to the copayment
exemptions. The commenter noted that the impact analysis did not state
where this revenue stream would be diverted from internally and how
this may impact other veteran services of equal or greater importance.
The commenter queried whether VA plans to apply for a grant under the
Food, Drug, and Cosmetic Act (chapter 9 of title 21, U.S.C.) for the
emergency treatment of opioid overdose, which can offset at least
$200,000 of antagonist costs that is greater than the yearly projected
loss of revenue from this rule.
VA believes the benefits of educating veterans on the risks of
opioids and utilization of opioid antagonists during an overdose to
potentially save a life outweighs any loss of revenue from VA
copayments. VA anticipates no reduction or diversion of funds from
other programs as a result of this rulemaking. VA has already been
implementing this authority, and VA's budget requests already reflect
the loss identified in the impact analysis. We are not making any
changes based on this comment.
Based on the rationale set forth in the Supplementary Information
to the proposed rule and in this final rule, VA is adopting the
proposed rule with no changes.
Executive Orders 12866 and 13563
Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety effects, and other advantages; distributive impacts;
and equity). Executive Order 13563 (Improving Regulation and Regulatory
Review) emphasizes the importance of quantifying both costs and
benefits, reducing costs, harmonizing rules, and promoting flexibility.
The Office of Information and Regulatory Affairs has determined that
this rule is not a significant regulatory action under Executive Order
12866. 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 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). The adoption of the rule does not directly affect any small
entities. There are no small entities involved with VA's process or
adjustment of veteran's copayments for medications or services. The
provisions of this rulemaking only apply to the internal operations of
VA and to individual 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 final rule will have no such effect on
State, local, and tribal governments, or on the private sector.
Paperwork Reduction Act
This final rule contains no provisions constituting a collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3521).
Catalog of Federal Domestic Assistance
The Catalog of Federal Domestic Assistance program number and title
for this final rule are as follows: 64.009, Veterans Medical Care
Benefits; 64.012, Veterans Prescription Service; 64.019, Veterans
Rehabilitation Alcohol and Drug Dependence; 64.041, VHA Outpatient
Specialty Care; 64.045, VHA Outpatient Ancillary Services; 64.047, VHA
Primary Care; 64.048, VHA Mental Health Clinics.
Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a major rule, as defined by 5 U.S.C. 804(2).
List of Subjects in 38 CFR Part 17
Administrative practice and procedure, Alcohol abuse, Alcoholism,
Claims, Day care, Dental health, Drug abuse, Government contracts,
Grant programs--health, Grant programs--veterans, Health care, Health
facilities, Health professions, Health records, Homeless, Medical and
Dental schools, Medical devices, Medical research, Mental health
programs, Nursing homes, Reporting and recordkeeping requirements,
Travel and transportation expenses, Veterans.
Signing Authority
Denis McDonough, Secretary of Veterans Affairs, approved this
document on September 10, 2021, 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 amends 38 CFR part 17 as set forth below:
PART 17--MEDICAL
0
1. The general authority citation for part 17 continues to read as
follows:
[[Page 52076]]
Authority: 38 U.S.C. 501, and as noted in specific sections.
* * * * *
0
2. Amend Sec. 17.108 by revising paragraphs (e)(16) and (17) and
adding paragraph (e)(18) to read as follows:
Sec. 17.108 Copayments for inpatient hospital care and outpatient
medical care.
* * * * *
(e) * * *
(16) In-home video telehealth care;
(17) Mental health peer support services; and
(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.
* * * * *
0
3. Amend Sec. 17.110 by adding paragraph (c)(12) to read as follows:
Sec. 17.110 Copayments for medication.
* * * * *
(c) * * *
(12) Opioid antagonists furnished to a veteran who is at high risk
for overdose of a specific medication or substance in order to reverse
the effect of such an overdose.
(i) For purposes of this paragraph (c)(12), a veteran who is at
high risk for overdose of a specific medication or substance in order
to reverse the effect of such an overdose is a veteran:
(A) Who is prescribed or using opioids, or has an opioid use
history, and who is at increased risk for opioid overdose as determined
by VA; or
(B) Whose provider deems, based on their clinical judgment, that
the veteran may benefit from ready availability of an opioid
antagonist.
(ii) Examples of a veteran who is at high risk for overdose of a
specific medication or substance in order to reverse the effect of such
an overdose include, but are not limited to, the following:
(A) A veteran with an opioid or substance use disorder diagnosis;
(B) A veteran receiving treatment for an opioid or substance use
disorder diagnosis, such as receiving opioid agonist therapy or
inpatient, residential, or outpatient treatment for such diagnosis, or
attending a support group for such diagnosis;
(C) A veteran with a history of prescription opioid misuse or
injection opioid use;
(D) A veteran with a history of previous opioid overdose;
(E) A veteran who is taking an extended-release or long-acting
prescription opioid;
(F) A veteran with household or community access to opioids who is
at increased risk for overdose (e.g., psychiatric disorder or high risk
for suicide) as determined by VA; or
(G) A veteran predicted to be at high risk for overdose based on
standardized assessments or predictive models (e.g., Risk Index for
Overdose or Serious Opioid-induced Respiratory Depression [RIOSORD];
Stratification Tool for Opioid Risk Mitigation [STORM]).
Note 1 to paragraph (c)(12). The examples in paragraphs
(c)(12)(ii)(A) through (G) of this section apply even if the veteran
has had a period of abstinence from opioids (e.g., due to treatment,
detoxification, incarceration) because loss of tolerance can
increase the risk for an overdose.
[FR Doc. 2021-20196 Filed 9-17-21; 8:45 am]
BILLING CODE 8320-01-P
