[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]


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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 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