Rule2021-20196
Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists
Primary source
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Published
September 20, 2021
Effective
October 20, 2021
Issuing agencies
Veterans Affairs Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 179 (Monday, September 20, 2021)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-20196]
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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.
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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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
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
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