[Federal Register Volume 85, Number 216 (Friday, November 6, 2020)]
[Proposed Rules]
[Pages 71020-71022]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24370]


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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: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) is proposing to amend 
its

[[Page 71021]]

medical regulations that govern copayments to conform with recent 
statutory requirements. VA would be 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 would also clarify that no 
copayment would be required for the provision of education on the use 
of opioid antagonists. This proposed rule would be an essential part of 
VA's attempts to help veterans at high risk of overdose.

DATES: Comments must be received on or before January 5, 2021.

ADDRESSES: Comments may be submitted through www.Regulations.gov. 
Comments received will be available at regulations.gov for public 
viewing, inspection or copies.

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: 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 co-payment (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, 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 proposed rule would amend two of VA's copayment 
regulations, 38 CFR 17.108 and 17.110, to accurately implement these 
changes in law. This proposed rule would also add an explanation of how 
VA would identify a veteran at high risk for overdose under the new 
provisions.

17.108 Copayments for Inpatient Hospital Care and Outpatient Medical 
Care

    Section 17.108 establishes the copayment amounts for inpatient 
hospital care and outpatient medical care. Paragraph (e) lists the 
types of services that are exempt from the inpatient hospital care and 
outpatient medical care copayment. We are proposing to add a new 
paragraph (e)(18) to implement the laws described above. Under 
paragraph (e)(18), we clarify that VA will not charge a copayment for 
an outpatient medical care visit that is solely for education on the 
use of opioid antagonists to reverse the effects of overdoses of 
specific medications or substances. We note that while VA is not 
currently charging copayments for education on the use of opioid 
antagonists (in accordance with Pub. L. 114-198), codifying this in 
regulation will help ensure this policy continues to be followed. We 
also propose two minor conforming technical amendments to paragraphs 
(e)(16) and (e)(17) in section 17.108.

17.110 Copayments for Medication

    Section 17.110 establishes the copayment amount for medications. 
Paragraph (c) lists the medications that are not subject to the 
copayment requirement. To implement section 915 of the Public Law 114-
198, we propose adding a new paragraph (c)(12) to state that VA will 
not charge a copayment for 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. In paragraph 
(c)(12), we would also incorporate a definition of a high risk veteran 
for overdose for the purposes of this proposed rule. The proposed 
definition specifies that VA considers a high risk veteran for overdose 
to be 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 or whose provider deems, based on their clinical judgment, that 
the veteran may benefit from ready availability of an opioid 
antagonist. We would also provide the following 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: A veteran with an 
opioid or substance use disorder diagnosis; 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; a veteran with a history of prescription opioid 
misuse or injection opioid use; a veteran with a history of previous 
opioid overdose; a veteran who is taking an extended-release or long-
acting prescription opioid; 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; 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]); and a veteran in any of the 
aforementioned groups with a period of abstinence from opioids (e.g., 
due to treatment, detoxification, incarceration) as loss of tolerance 
can increase risk for overdose. This definition is necessary for VA to 
implement Public Laws 114-198 and 114-223. Public Laws 114-198 and 114-
223 do not define 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; however, providing a definition will facilitate the 
identification of such veterans. Early identification of these veterans 
can facilitate provision of life-saving opioid antagonist medication.

Paperwork Reduction Act

    This proposed rule contains no provisions constituting a collection 
of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3521).

Regulatory Flexibility Act

    The Secretary hereby certifies this proposed rule would not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601-
612. The adoption of the rule would not directly affect any small 
entities. There are no small entities involved with VA's process and/or 
adjustment of Veterans copayments for medications/services. The 
provisions of this rulemaking only apply to the internal operations of 
VA. 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.

Executive Orders 12866, 13563, and 13771

    Executive Orders 12866 and 13563 direct agencies to assess the 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, and other advantages; distributive impacts; 
and equity). Executive Order 13563 (Improving Regulation and Regulatory 
Review)

[[Page 71022]]

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.
    VA's impact analysis can be found as a supporting document at 
http://www.regulations.gov, usually within 48 hours after the 
rulemaking document is published. Additionally, a copy of the 
rulemaking and its impact analysis are available on VA's website at 
http://www.va.gov/orpm/, by following the link for ``VA Regulations 
Published From FY 2004 Through Fiscal Year to Date.''
    This proposed rule is not expected to be an E.O. 13771 regulatory 
action because this proposed rule is not significant under E.O. 12866.

Unfunded Mandates

    The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 
1532, that agencies prepare an assessment of anticipated costs and 
benefits before issuing any rule that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This proposed rule would have no such 
effect on State, local, and tribal governments, or on the private 
sector.

Catalog of Federal Domestic Assistance

    The Catalog of Federal Domestic Assistance program number and title 
for this proposed 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.

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

    The Secretary of Veterans Affairs, or designee, approved this 
document and authorized the undersigned to sign and submit the document 
to the Office of the Federal Register for publication electronically as 
an official document of the Department of Veterans Affairs. Brooks D. 
Tucker, Assistant Secretary for Congressional and Legislative Affairs, 
Performing the Delegable Duties of the Chief of Staff, Department of 
Veterans Affairs, approved this document on October 29, 2020, for 
publication.

Consuela Benjamin,
Regulations Development Coordinator, Office of Regulation Policy & 
Management, Office of the Secretary, Department of Veterans Affairs.

    For the reasons set forth in the preamble, the Department of 
Veterans Affairs proposes to amend 38 CFR part 17 as set forth below:

PART 17--MEDICAL

0
1. The authority citation for part 17 continues to read as follows:

    Authority:  38 U.S.C. 501, and as noted in specific sections.
* * * * *

0
2. Amend Sec.  17.108 by revising paragraphs (e)(16) and (17) and 
adding (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
4. Amend Sec.  17.110 by adding a new 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 Sec.  
17.110(c)(12)(ii)(A) through (G) 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.

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[FR Doc. 2020-24370 Filed 11-5-20; 8:45 am]
BILLING CODE 8320-01-P