Proposed Rule2021-28049
Modifying Copayments for Veterans at High Risk for Suicide
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Published
January 5, 2022
Issuing agencies
Veterans Affairs Department
Abstract
The Department of Veterans Affairs (VA) proposes to amend its medical regulations that govern copayments for VA outpatient medical care and medications (to include outpatient medical care and medications provided by VA directly or community care obtained by VA through contracts, provider agreements or sharing agreements) by effectively eliminating the copayment for outpatient care and reducing the copayment for medications dispensed to veterans identified by VA as being at high risk for suicide. These copayment changes would be applied until VA determines that the veteran is no longer at high risk for suicide.
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<title>Federal Register, Volume 87 Issue 3 (Wednesday, January 5, 2022)</title>
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[Federal Register Volume 87, Number 3 (Wednesday, January 5, 2022)]
[Proposed Rules]
[Pages 418-421]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-28049]
[[Page 418]]
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DEPARTMENT OF VETERANS AFFAIRS
38 CFR Part 17
RIN 2900-AQ30
Modifying Copayments for Veterans at High Risk for Suicide
AGENCY: Department of Veterans Affairs.
ACTION: Proposed rule.
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SUMMARY: The Department of Veterans Affairs (VA) proposes to amend its
medical regulations that govern copayments for VA outpatient medical
care and medications (to include outpatient medical care and
medications provided by VA directly or community care obtained by VA
through contracts, provider agreements or sharing agreements) by
effectively eliminating the copayment for outpatient care and reducing
the copayment for medications dispensed to veterans identified by VA as
being at high risk for suicide. These copayment changes would be
applied until VA determines that the veteran is no longer at high risk
for suicide.
DATES: Comments must be received by VA on or before March 7, 2022.
ADDRESSES: Comments may be submitted through <a href="http://www.Regulations.gov">www.Regulations.gov</a>.
Comments received will be available at <a href="http://regulations.gov">regulations.gov</a> for public
viewing, inspection or copies.
FOR FURTHER INFORMATION CONTACT: David Carroll, Ph.D., Executive
Director, Office of Mental Health and Suicide Prevention (11MHSP),
Department of Veterans Affairs, Veterans Health Administration, 810
Vermont Ave. NW, Washington, DC 20420; (202) 461-4058. (This is not a
toll-free number.)
SUPPLEMENTARY INFORMATION:
I. Background
Under 38 U.S.C. 1710(g), VA is required to set the copayment amount
for outpatient medical care provided to veterans who are eligible for
such care by reason of 38 U.S.C. 1710(a)(3). In general, this applies
to veterans enrolled in priority groups 7 and 8, which includes
veterans with no compensable service-connected disability and veterans
who have an annual income exceeding the applicable threshold. 38 CFR
17.36. VA regulates the copayment amount for outpatient medical care in
38 CFR 17.108(c). Under existing regulations, VA charges certain
veterans $15.00 for each primary care outpatient visit and $50.00 for
each specialty care outpatient visit. 38 CFR 17.108(c)(2). Across the
broad continuum of mental health services, mental health care may be
classified for billing purposes as primary care, such as an outpatient
general mental health appointment, or as specialty care, such as a
neuropsychological assessment.
Section 1722A(a)(1) of title 38 of the U.S. Code states that the
Secretary shall require a veteran to pay the United States $2 for each
30-day supply of medication furnished to such veteran under this
chapter on an outpatient basis for the treatment of a non-service-
connected disability or condition. In general, this applies to veterans
enrolled in priority groups 2 through 8 (38 CFR 17.36) and excludes
veterans with a service-connected disability rated 50 percent or more,
veterans who are former prisoners of war, veterans whose annual income
does not exceed the applicable threshold, and veterans awarded the
medal of honor. VA regulates the copayment amount for medications in 38
CFR 17.110(c). Section 1722A(a)(1) also states that if the amount
supplied is less than a 30-day supply, VA may not reduce the copayment
amount. While VA is not permitted to require a veteran to pay an amount
in excess of the cost to VA, 38 U.S.C. 1722A(b) authorizes the
Secretary to increase the copayment amount in effect under subsection
(a) to cover the agency's costs for medications by regulation. However,
the Secretary is not authorized to reduce the medication copayment
below $2 for each 30-day supply.
VA regulations set forth the categories of veterans who are exempt
from copayment requirements as required by law for inpatient and
outpatient medical care (38 CFR 17.108(d)-(f)), as well as medication
(38 CFR 17.110(c)).
II. Need for the Proposed Rule
VA has identified suicide prevention as a top clinical priority.
Implementation of evidence-based clinical practice guidelines is one
strategy VA has embraced to improve mental health care and access to
suicide prevention resources available to veterans by reducing
variation in practice and systematizing best practices. Jointly issued
by VA and the Department of Defense (DoD), the VA/DoD Clinical Practice
Guideline for the Assessment and Management of Patients at Risk for
Suicide (2019) (CPG) recommends health care professionals increase the
frequency of outpatient mental health encounters to provide more
intense care and preventive services for veterans who are determined to
be at high risk for suicide, as these evidence-based enhancements have
shown to reduce the risk of suicide. See, e.g., CPG pp. 23-25. <a href="https://www.healthquality.va.gov/guidelines/MH/srb/VADoDSuicideRiskFullCPGFinal5088212019.pdf">https://www.healthquality.va.gov/guidelines/MH/srb/VADoDSuicideRiskFullCPGFinal5088212019.pdf</a>.
However, VA understands that the increase in outpatient visits may
be a financial burden and a detriment to certain veterans who must pay
a copayment, as an increase in outpatient visits results in increased
numbers of copayments. Healthcare research has provided extensive
evidence that copayments can be barriers to healthcare for vulnerable
patients. For example, as summarized in the CPG, scientific and
clinical literature supports the principle that copayment rates can be
barriers to medication adherence and access to clinical services. See,
e.g., (No author listed). Impact of Copays in Vulnerable Populations,
American Journal of Managed Care, Vol. 12 No. 13 Nov. 2006, S359-363;
and, Simon GE, VonKorff M, Durham ML. Predictors of outpatient mental
health utilization by primary care patients in a health maintenance
organization, American Journal of Psychiatry, Vol. 151 No. 6 Jun. 1994,
908-913. Currently, there is no exemption from outpatient care
copayments for veterans who are at risk for suicide, and such veterans
have to pay a $15.00 or $50.00 copayment for each outpatient visit
(depending on whether the visit qualifies as primary care or specialty
care).
In addition, VA internal reporting documents, such as issue briefs,
have revealed that there are substantial numbers of suicides and
suicide attempts among veterans that result from overdoses of
medications that are prescribed by VA providers on an outpatient basis.
The CPG includes a strong recommendation to prescribe medication in
less than 30-day supplies for veterans at high risk of suicide in order
to prevent fatal or medically serious overdoses. See CPG p. 24. The
clinical necessity to prescribe medication in less than 30-day supplies
for veterans who are at high risk for suicide would likely arise, for
medications that are potentially dangerous or lethal in the event of
overdose, either by themselves or in combination with other medications
being used by a veteran. VA understands that providing less than a 30-
day supply would necessarily require more prescriptions, which may
cause an economic burden to veterans who must pay a copayment for each
prescription. In order to address both the necessity of prescribing
medication in less than 30-day supplies for veterans at high risk of
suicide and the consequent financial burden of issuing
[[Page 419]]
multiple prescriptions, each with fewer doses, for the same 30-day
period, VA believes that current 38 CFR 17.110 should be amended to
allow for lesser copayment amounts for medications prescribed for a
veteran at high risk of suicide.
III. Provisions of the Proposed Rule
VA seeks to revise two sections of our medical regulations, Sec.
17.108 regarding copayments for inpatient hospital care and outpatient
medical care and Sec. 17.110 regarding copayments for medication to
modify copayments for veterans who are determined by VA to be at high
risk of suicide. As Sec. Sec. 17.108 and 17.110 apply to care and
medication obtained by VA through contracts, providers agreements, and
sharing agreements, not just care and medication provided directly by
VA, the proposed revisions below would apply to outpatient care and
medication provided directly by VA as well as outpatient care and
medication provided by community providers. The determination of
whether a veteran is at high risk of suicide is a clinical decision
made by VA clinicians that is based upon the following essential
features: (1) A recent suicide attempt or preparatory behaviors, (2)
suicidal ideation with intent to die resulting in inpatient
hospitalization, or (3) active threats to harm oneself, seeking access
to means, or talking or writing about death, dying, or suicide when the
actions are out of character for the person.
In general, electronic flags and triggers are used in the
electronic health record to alert a provider to a variety of clinical
needs and prevention opportunities. VA restricts the use of the alert
to address immediate clinical safety issues. VA has implemented such
tools in several areas, including alerting VA providers through patient
record flags to a veteran's suicide risk. For purposes of readability,
we will use the term ``alert'' in this document rather than referring
to an electronic flag or trigger. The CPG at Sidebar 2a. Essential
Features from Risk Stratification Table--Acute Risk (p. 23) lists
essential features for a high acute risk of suicide as: Suicidal
ideation with intent to die by suicide; and an inability to maintain
safety, independent of external support/help. The CPG lists common
warning signs such as: A plan for suicide; recent attempt and/or
ongoing preparatory Behaviors; acute major mental illness (e.g., major
depressive episode, acute mania, acute psychosis, recent/current drug
relapse); and, exacerbation of a personality disorder (e.g., increased
borderline symptomatology). In addition, various psychosocial factors
are associated with risk for suicide and suicide attempts. These
include recent life events such as losses (especially employment,
careers, finances, housing, marital relationships, physical health, and
a sense of a future), and chronic or long-term problems such as
relationship difficulties, unemployment, and ongoing or pending legal
issues.
In addition, there are warning signs that empirically have been
shown to be temporally related to the acute onset of suicidal behaviors
(e.g., within hours to a few days). These signs should warn the
clinician of acute risk for the expression of suicidal behaviors,
especially in those individuals with other risk factors. See, e.g.,
Rudd MD, Berman AL, Joiner TE, et al. Warning signs for suicide:
Theory, research and clinical applications. Suicide and Life
Threatening Behavior; Volume 36 Issue 3, 255-62 (2006). Three of these
warning signs carry the highest likelihood of short-term onset of
suicidal behaviors and require immediate attention, evaluation,
referral, or consideration of hospitalization. These warning signs are:
(1) Threatening to hurt or kill self; (2) looking for ways to kill
self; seeking access to pills, weapons or other means; and, (3) talking
or writing about death, dying or suicide. See VA Suicide Risk
Assessment Guide. <a href="https://www.mentalhealth.va.gov/docs/suicide_risk_assessment_reference_guide.pdf">https://www.mentalhealth.va.gov/docs/suicide_risk_assessment_reference_guide.pdf</a>.
Once a veteran is determined to be at high risk for suicide by a VA
clinician, VA suicide prevention staff, as a matter of VA policy,
places an alert in the veteran's electronic health record indicating
that the veteran is at high risk for suicide. VA suicide prevention
staff then conducts a periodic review in all cases where a high-risk of
suicide alert has been added to the electronic health record to
determine whether the alert will remain active or be discontinued.
We note that community care providers do not have direct access to
the veteran's electronic health record, which is maintained by VA, and
therefore cannot add an alert into that record. VA intends to engage
community care providers and urge them to communicate to VA any finding
that a veteran patient is believed to be at high risk of suicide so
that VA can determine if a veteran is at high risk of suicide, as
appropriate.
A. Sec. 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 (c) of that
section lists the copayments for outpatient care. We propose to add a
new paragraph (c)(5), which would reduce to zero the outpatient
copayment amount for veterans that VA determines to be at high risk for
suicide.
We propose that this copayment level would align with the use of
the high risk of suicide alert in the veteran's electronic health
record. Therefore, it would begin once the veteran is determined to be
at high risk for suicide by a VA clinician and an alert is placed in
the veteran's electronic health record. This copayment level would
remain in place until the veteran is no longer at high risk for
suicide. VA would no longer consider a veteran to be at high risk for
suicide when an alert in the veteran's electronic health record
indicating that the veteran is at high risk for suicide has been
inactivated or removed by VA suicide prevention staff.
VA has interpreted 38 U.S.C. 1710(g)(1) to mean that VA has the
discretion to establish the applicable outpatient visit copayment
amount by regulation, even if such amount is zero. 77 FR 13195, 13196.
Therefore, if finalized as proposed, VA would effectively eliminate the
outpatient visit copayment for veterans when veterans are at high risk
for suicide by establishing the outpatient visit copayment amount as
zero. This copayment level would begin once the veteran is determined
to be at high risk for suicide and would remain in place until the
veteran is no longer at high risk for suicide. By proposing elimination
of copayments for all outpatient care it is VA's intent to remove any
financial deterrents or barriers that a veteran may have against
agreeing to an increase in the frequency of outpatient care when they
are at high risk of suicide. VA believes this proposed change will
assist VA in preventing suicide among veterans who are at high risk for
suicide by providing a CPG-informed intervention without introducing
new barriers to care, such as financial burdens. See, e.g., National
Academy of Science, Institute of Medicine. Reducing Suicide: A National
Imperative (2002).
The proposed copayment reduction would be for all outpatient care,
and not just limited to mental health care, for these veterans who are
at high risk of suicide. VA believes that active and increased
engagement in all medical care, not just mental health care, is a
protective factor against suicide. See Department of Veterans Affairs,
Veterans Health Administration. National Veteran Suicide Prevention
Annual Report (2002); National
[[Page 420]]
Academy of Science, Institute of Medicine. Reducing Suicide: A National
Imperative (2002). Mental health care is integrated into health care
provided across the full range of VA medical services, and mental
health care cannot reasonably and accurately be parsed out by provider
type (e.g., some oncologists, who ordinarily screen for and treat
cancer, also screen for depression and suicide risk) or setting type
(e.g., some patients receive the bulk of their mental health care,
including risk assessments and medication adjustments, in primary care
settings). VA believes that eliminating copayments for all outpatient
care supports provision of ongoing mental health screenings in clinical
settings by various VA health care professionals.
In addition, we propose revising paragraph (c)(1) by adding a
reference to new proposed paragraph (c)(5). Current paragraph (c)(1)
states that ``[e]xcept as provided in paragraphs (d), (e), or (f) of
this section, a veteran, as a condition for receiving outpatient
medical care provided by VA (provided either directly by VA or obtained
by VA by contract, provider agreement, or sharing agreement), must
agree to pay VA (and is obligated to pay VA) a copayment as set forth
in paragraph (c)(2) or (c)(4) of this section.'' We would revise this
paragraph to instead refer to ``a copayment as set forth in paragraph
(c)(2), (c)(4) or (c)(5) of this section.''
B. Sec. 17.110 Copayments for Medication
Section 17.110 establishes the copayment amounts for medications.
Under this proposed rule, a veteran would pay the copayment amount of
only $2 for a 30-day or less supply of medication while such veteran is
determined to be at high risk for suicide. We propose to add a new
paragraph (b)(6) to Section 17.110 to state that veterans who VA
determines to be at high risk for suicide will pay a $2 medication
copayment for all medications for each 30-day or less supply of a
medication. We also propose that the initiation and duration of this
medication copayment level would be the same as that established for
outpatient copayments in proposed Sec. 17.108(c)(5). In other words,
this copayment level would begin when the veteran is determined to be
at high risk for suicide and would remain in place until the veteran is
no longer considered to be at high risk for suicide. Also, VA would no
longer consider a veteran to be at high risk for suicide when the alert
in the veteran's electronic health record indicating that the veteran
is at high risk for suicide is inactivated or removed.
VA has three classes of medications, identified as Tier 1, Tier 2,
and Tier 3. Copayment amounts are fixed and vary depending upon the
class of medication as follows: $5 for a 30-day or less supply of a
Tier 1 medication, $8 for a 30-day or less supply of a Tier 2
medication, and $11 for a 30-day or less supply of a Tier 3 medication.
Currently, there is no exemption from medication copayments for
veterans who are at high risk for suicide, and such veterans would have
to pay a much higher amount in copayments if they are being prescribed
medication more frequently but with less supply (e.g., in increments of
two weeks or less) and still paying a full copayment for each
prescription filled. However, VA has consistently interpreted 38 U.S.C.
1722A(a) to mean that VA has discretion to determine the appropriate
copayment amount for medication furnished on an outpatient basis, as
long as that amount is at least $2. See, e.g., 74 FR 69283 (December
31, 2009); 75 FR 32668 (June 9, 2010); 81 FR 88117 (December 7, 2016).
Under this proposed regulation, if VA were to prescribe a veteran
medication on, for example, a weekly basis, the veteran would pay a $2
copayment every week and would ultimately pay a total of $8 in
copayments for a month's supply of medication regardless of tier. By
contrast, under the current regulations and in the same scenario, for a
Tier 1 medication (pursuant to 38 CFR 17.110(b)(1)), the veteran would
pay $5 in copayment every week and would ultimately pay a total of $20
in copayments for a month's supply of medication, or $44 for a Tier 3
medication.
Under the proposed rule, VA would adjust the copayment for
medications once the veteran is determined to be at high risk for
suicide and would remain in place until the veteran is no longer at
high risk for suicide. The copayment reduction would be for all
medications, regardless of tier, for these veterans who are at high
risk of suicide. This is because many medications, psychiatric or non-
psychiatric, may be non-lethal when taken alone, but lethal when
combined with other medication in an overdose. Also, it would be
impractical for VA to identify every potentially dangerous medication
combination for purposes of this copayment reduction.
VA believes that establishing a flat $2 medication copayment,
regardless of tier, for veterans determined to be at high risk for
suicide serves several purposes. Applying a flat copayment amount to
all prescribed medications means that there is no financial
disincentive to the veteran continuing with medications that are
prescribed to treat medical conditions other than for mental health,
such as ongoing chronic medical conditions. In addition, veterans
sometimes request that a clinician prescribe a Tier 1 or 2 medication
to treat a diagnosed condition rather than a Tier 3 medication
recommended by the clinician in order to decrease medication
copayments. Adopting a flat medication copayment regime ensures that
therapeutic options are not limited by concerns for medication
copayment amounts for these veterans determined to be at high risk of
suicide. Finally, as noted, a flat medication copayment of $2 helps
ensure that veterans determined to be at high risk for suicide are not
financially penalized because medications are prescribed in less than
30-day increments.
Therefore, if finalized as proposed, VA would reduce the copayment
amount for medications for veterans at a high risk for suicide as a way
to remove any deterrents or barriers that a veteran may have to
agreeing to an increased number of prescriptions when providers find it
clinically necessary to reduce the amount of certain medications
prescribed at one time (i.e., from a 30-day supply to a less than 30-
day supply). This will better enable VA to reduce lethality of
medications at hand and reduce the risk of medication-related suicide
attempts among veterans who are at high risk for suicide.
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 that 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). This proposed rule would only affect individual
veterans who receive VA health care. The proposed rule focuses on the
copayment amount that must be paid by a veteran who has been determined
to be at high risk of suicide. It does not impact payments made to non-
VA entities or health care providers, and does not create any
administrative or transition burdens for third parties that might
qualify as a small entity under the Regulatory Flexibility Act. Billing
for copayment amounts is administered solely by VA. Therefore, pursuant
to 5 U.S.C. 605(b), the initial and final regulatory flexibility
[[Page 421]]
analysis requirements of 5 U.S.C. 603 and 604 do not apply.
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 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.<a href="http://regulations.gov">regulations.gov</a>.
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.
Assistance Listing
The Assistance Listing program numbers and titles 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
Denis McDonough, Secretary of Veterans Affairs, approved this
document on June 8, 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,
Regulation 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 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 paragraph (c)(1) and adding paragraph
(c)(5) to read as follows:
Sec. 17.108 Copayments for inpatient hospital care and outpatient
medical care.
* * * * *
(c)(1) Except as provided in paragraphs (d), (e), or (f) of this
section, a veteran, as a condition for receiving outpatient medical
care provided by VA (provided either directly by VA or obtained by VA
by contract, provider agreement, or sharing agreement), must agree to
pay VA (and is obligated to pay VA) a copayment as set forth in
paragraph (c)(2), (c)(4) or (c)(5) of this section.
* * * * *
(5) The copayment for outpatient medical care furnished to a
veteran who VA determines to be at high risk for suicide is zero
dollars ($0). This copayment level will begin once the veteran is
determined to be at high risk for suicide and will remain in place
until the veteran is no longer at high risk for suicide.
* * * * *
0
3. Amend Sec. 17.110 by adding paragraph (b)(6) to read as follows:
Sec. 17.110 Copayments for medication.
* * * * *
(b) * * *
(6) Veterans at high risk for suicide. Veterans who VA determines
to be at high risk for suicide will be charged a $2 medication
copayment amount for all medications for each 30-day or shorter supply
of a medication. The initiation and duration of this medication
copayment level are the same as those established for outpatient
copayments in Sec. 17.108(c)(5).
* * * * *
[FR Doc. 2021-28049 Filed 1-4-22; 8:45 am]
BILLING CODE 8320-01-P
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