Elimination of Copayment for Opioid Antagonists and Education on Use of Opioid Antagonists, 71020-71022 [2020-24370]
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71020
Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Proposed Rules
(NEPA) is not required because the
proposed rule is covered by a
categorical exclusion. The NPS has
determined the proposed rule is
categorically excluded under NPS NEPA
Handbook 2015 Section 3.3(A)(8)
because this proposed rule revises
existing regulations for the Lakeshore in
a manner that would not (i) increase
public use to the extent of
compromising the nature and character
of the area or causing physical damage
to it; (ii) introduce noncompatible uses
that might compromise the nature and
characteristics of the area or cause
physical damage to it; (iii) conflict with
adjacent ownerships or land uses; or (iv)
cause a nuisance to adjacent owners or
occupants. The NPS has also
determined that the proposed rule does
not involve any of the extraordinary
circumstances listed in 43 CFR 46.215
that would require further analysis
under NEPA.
listed in the ADDRESSES section of this
document.
Effects on the Energy Supply (Executive
Order 13211)
This proposed rule is not a significant
energy action under the definition in
Executive Order 13211. A Statement of
Energy Effects is not required.
PART 7—SPECIAL REGULATIONS,
AREAS OF THE NATIONAL PARK
SYSTEM
Clarity of This Rule
We are required by Executive Orders
12866 (section 1(b)(12)) and 12988
(section 3(b)(1)(B)), and 13563 (section
1(a)), and by the Presidential
Memorandum of June 1, 1998, to write
all rules in plain language. This means
that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address
readers directly;
(c) Use common, everyday words and
clear language rather than jargon;
(d) Be divided into short sections and
sentences; and
(e) Use lists and tables wherever
possible.
If you feel that we have not met these
requirements, send us comments by one
of the methods listed in the ADDRESSES
section. To better help us revise the
rule, your comments should be as
specific as possible. For example, you
should tell us the numbers of the
sections or paragraphs that you find
unclear, which sections or sentences are
too long, the sections where you feel
lists or tables would be useful, etc.
Public Participation
It is the policy of the Department of
the Interior, whenever practicable, to
afford the public an opportunity to
participate in the rulemaking process.
Accordingly, interested persons may
submit written comments regarding this
proposed rule by one of the methods
VerDate Sep<11>2014
18:31 Nov 05, 2020
Jkt 253001
Public Availability of Comments
Before including your address, phone
number, email address, or other
personal identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
List of Subjects in 36 CFR Part 7
District of Columbia, National Parks,
Reporting and recordkeeping
requirements.
In consideration of the foregoing, the
National Park Service proposes to
amend 36 CFR part 7 as follows:
1. The authority for part 7 continues
to read as follows:
■
Authority: 54 U.S.C. 100101, 100751,
320102; Sec. 7.96 also issued under D.C.
Code 10–137 and D.C. Code 50–2201.07.
2. Amend § 7.32 by:
a. Revising the introductory text of
paragraph (a)(1).
■ b. Revising paragraphs (a)(1)(v),
(a)(1)(viii), and (a)(1)(ix).
■ c. Redesignating paragraph (a)(1)(x) as
paragraph (a)(1)(xvi).
■ d. Adding paragraphs (a)(1)(x) through
(a)(1)(xv).
■ e. Revising newly redesignated
paragraph (a)(1)(xvi).
■ f. Revising paragraph (a)(3).
■ g. Adding paragraph (a)(4).
The revisions and additions to read as
follows:
■
■
§ 7.32
Pictured Rocks National Lakeshore.
(a) * * *
(1) Snowmobiles are allowed on the
following routes and water surfaces
within Pictured Rocks National
Lakeshore:
*
*
*
*
*
(v) The road from County Road H–58
at the park boundary to the Little Beaver
Lake Campground.
*
*
*
*
*
(viii) The road from County Road H–
58 to the Log Slide parking area.
(ix) The section of Michigan
Dimension Road from the park
boundary to the Log Slide parking area.
(x) The South Grand Sable Lake Road,
starting at Towes Creek (T49N, R14W,
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
Sections 14 and 23), heading south in
and out of the fee zone area.
(xi) Portions of County Road H–58
that are within park boundaries between
Twelvemile Beach and Log Slide scenic
overlook (T49N, R15W, Sections 9, 10,
11, 13, 14, and 16 and T49, 14W,
Section 18).
(xii) Portions of County Road H–58
that are within park boundaries between
Log Slide Scenic Overlook and the
Grand Sable Visitor Center (T49N,
R14W, Sections 10, 11, 15, 16, and 17).
(xiii) County Road H–58 between
Grand Sable Visitor Center to the
eastern extent of the park boundary
(T49N, R14W, Sections 1, 11, and 12).
(xiv) Portions of Lowder Road that are
within park boundaries from M77 to
Grand Sable Lake Boat Ramp (T48N,
R16W, Sections 21 and 29).
(xv) Portions of Beaver Basin
Overlook Road from County Road H–58
to the Beaver Basin Overlook (T49N,
R14W, Sections 11, and 12).
(xvi) The frozen water surfaces of
Lake Superior and Grand Sable Lake.
*
*
*
*
*
(3) Snowmobile use outside
designated routes and frozen water
surfaces is prohibited. Snowmobiles are
restricted to the road shoulders of routes
that are plowed. The prohibitions in this
paragraph do not apply to emergency
administrative travel by employees of
the National Park Service or law
enforcement agencies.
(4) The Superintendent may open or
close these routes and water surfaces, or
portions thereof, to snowmobile travel
after taking into consideration the
location of wintering wildlife,
appropriate snow cover, public safety,
and other factors. The Superintendent
will provide notice of such opening or
closing by one or more of the methods
listed in § 1.7(a) of this chapter.
George Wallace,
Assistant Secretary for Fish and Wildlife and
Parks.
[FR Doc. 2020–24545 Filed 11–5–20; 8:45 am]
BILLING CODE 4312–52–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.
Proposed rule.
AGENCY:
ACTION:
SUMMARY: The Department of Veterans
Affairs (VA) is proposing to amend its
E:\FR\FM\06NOP1.SGM
06NOP1
Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Proposed Rules
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 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, 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
VerDate Sep<11>2014
18:31 Nov 05, 2020
Jkt 253001
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 longacting prescription opioid; a veteran
PO 00000
Frm 00020
Fmt 4702
Sfmt 4702
71021
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 lifesaving 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)
E:\FR\FM\06NOP1.SGM
06NOP1
71022
Federal Register / Vol. 85, No. 216 / Friday, November 6, 2020 / Proposed Rules
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 https://
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 https://
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.
Jkt 253001
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
1. The authority citation for part 17
continues to read as follows:
■
Authority: 38 U.S.C. 501, and as noted in
specific sections.
*
*
*
*
*
2. Amend § 17.108 by revising
paragraphs (e)(16) and (17) and adding
(e)(18) to read as follows:
■
§ 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.
*
*
*
*
*
■ 4. Amend § 17.110 by adding a new
paragraph (c)(12) to read as follows:
Copayments for medication.
*
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.
18:31 Nov 05, 2020
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.
§ 17.110
List of Subjects in 38 CFR Part 17
VerDate Sep<11>2014
Signing Authority
*
*
*
*
(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,
PO 00000
Frm 00021
Fmt 4702
Sfmt 4702
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 § 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.
*
*
*
*
*
[FR Doc. 2020–24370 Filed 11–5–20; 8:45 am]
BILLING CODE 8320–01–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R05–OAR–2016–0321; FRL–10016–
33–Region 5]
Air Plan Approval; Michigan; Partial
Approval and Partial Disapproval of
the Detroit SO2 Nonattainment Area
Plan
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; reopening of the
comment period.
AGENCY:
E:\FR\FM\06NOP1.SGM
06NOP1
]]>Agencies
[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.
-----------------------------------------------------------------------
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
https://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
https://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.
* * * * *
[FR Doc. 2020-24370 Filed 11-5-20; 8:45 am]
BILLING CODE 8320-01-P
