CHAMPVA Coverage of Audio-Only Telehealth, Mental Health Services, and Cost Sharing for Certain Contraceptive Services and Contraceptive Products Approved, Cleared, or Granted by FDA, 64190-64196 [2022-22905]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Proposed Rules]
[Pages 64190-64196]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22905]


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DEPARTMENT OF VETERANS AFFAIRS

38 CFR Part 17

RIN 2900-AR55


CHAMPVA Coverage of Audio-Only Telehealth, Mental Health 
Services, and Cost Sharing for Certain Contraceptive Services and 
Contraceptive Products Approved, Cleared, or Granted by FDA

AGENCY: Department of Veterans Affairs.

ACTION: Proposed rule.

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SUMMARY: The Department of Veterans Affairs (VA) proposes amending its 
medical regulations regarding Civilian Health and Medical Program of 
the Department of Veterans Affairs (CHAMPVA) coverage. This rulemaking 
would align with the Department of Defense for benefits administered 
through TRICARE and more closely align with requirements of other 
Federal programs. This rulemaking would remove the exclusion from 
CHAMPVA coverage for audio-only telehealth. In addition, we propose 
removing limitations on outpatient mental health visits as well as 
removing cost sharing requirements for certain contraceptive services 
and contraceptive products approved, cleared, or granted by the U.S. 
Food and Drug Administration (FDA).

DATES: Comments must be received by VA on or before November 23, 2022.

ADDRESSES: Comments must be submitted through www.regulations.gov. 
Except as provided below, comments received before the close of the 
comment period will be available at www.regulations.gov for public 
viewing, inspection, or copying, including any personally identifiable 
or confidential business information that is included in a comment. We 
post the comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: https://www.regulations.gov. VA will not post on 
Regulations.gov public comments that make threats to individuals or 
institutions or suggest that the commenter will take actions to harm 
the individual. VA encourages individuals not to submit duplicative 
comments. We will post acceptable comments from multiple unique 
commenters even if the content is identical or nearly identical to 
other comments. Any public comment received after the comment period's 
closing date is considered late and will not be considered in the final 
rulemaking.

[[Page 64191]]


FOR FURTHER INFORMATION CONTACT: Joseph Duran, Director, Policy, Office 
of Integrated Veteran Care (OIVC), Veterans Health Administration 
(VHA), Department of Veterans Affairs, Ptarmigan at Cherry Creek, 
Denver, CO 80209; 303-370-1637 (this is not a toll-free number).

SUPPLEMENTARY INFORMATION: The Department of Veterans Affairs (VA) 
proposes amending Civilian Health and Medical Program of the Department 
of Veterans Affairs (CHAMPVA) exclusions to allow coverage of 
telephonic (audio-only) medical visits and to remove limits on mental 
health coverage to be consistent with the Department of Defense (DoD) 
TRICARE program and current standards of practice in mental health and 
substance use care as well as the Mental Health Parity and Addiction 
Equity Act of 2008. In addition, we propose removing cost-sharing 
requirements for contraceptive services and contraceptive products 
approved, cleared, or granted by the U.S. Food & Drug Administration 
(FDA). VA believes these proposed changes are consistent with the goals 
and objectives of Executive Order (E.O.) 14070 (April 5, 2022) titled, 
``Continuing to Strengthen Americans' Access to Affordable, Quality 
Health Coverage.'' The E.O. directs federal agencies ``with 
responsibilities related to Americans' access to health coverage'' to 
``review agency actions to identify ways to continue to expand the 
availability of affordable health coverage.''
    Pursuant to 38 U.S.C. 1781, CHAMPVA is a health benefits program in 
which VA shares the cost of covered medical care services and supplies 
with certain spouses, children, survivors, and caregivers of veterans 
who meet specific eligibility criteria. Under section 1781(b), VA 
``shall provide for medical care in the same or similar manner and 
subject to the same or similar limitations as medical care is furnished 
to certain dependents and survivors of active duty and retired members 
of the Armed Forces under chapter 55 of title 10 [United States Code] 
(CHAMPUS).'' VA has implemented this requirement through the 
promulgation of its regulations at 38 CFR 17.270 et seq. We note that 
VA has consistently interpreted the ``same or similar'' language in 38 
U.S.C. 1781(b) to mean that CHAMPVA is not required to provide coverage 
identical to that provided by TRICARE. When warranted, CHAMPVA coverage 
and exclusions may differ from TRICARE due to factors such as 
dissimilarities in the respective patient populations, or policy 
considerations.
    We note that CHAMPUS was the original program administered by DoD 
to provide civilian health benefits for active duty military personnel, 
military retirees, and their dependents. 32 CFR 199.1. Although the 
CHAMPUS program is still referenced in DoD regulations, DoD effectively 
replaced the CHAMPUS program with what was commonly known as the 
``TRICARE Standard'' plan (``TRICARE''). See 32 CFR 199.1(r), 
199.17(a)(6)(ii)(D) (identifying ``TRICARE Standard'' as the basic 
CHAMPUS program available prior to January 1, 2018). In December 2017, 
Section 701 of the National Defense Authorization Act for Fiscal Year 
2017, Public Law 114-328, required inter alia the termination of 
TRICARE Standard as a distinct plan and the establishment of the 
TRICARE Select healthcare option. The CHAMPUS basic program benefits 
under 32 CFR 199.4 continue as the baseline of benefits for TRICARE 
Select. VA, therefore, administers CHAMPVA in the same or similar 
manner as TRICARE Select and, except where we discuss laws or 
regulations generally applicable to all TRICARE program options, 
references in this rulemaking to ``TRICARE'' are to TRICARE Select.

Audio-Only Telehealth

    Historically, TRICARE regulations excluded audio-only telehealth. 
32 CFR 199.4(g)(52) (2019). Similarly, the CHAMPVA regulations at 38 
CFR 17.272(a)(44) specifically exclude coverage for audio-only 
telehealth. However, on January 31, 2020, the Secretary of Health and 
Human Services (HHS) determined that a public health emergency existed 
since January 27, 2020. On March 13, 2020, the President declared a 
national emergency due to COVID-19. In light of the spread of COVID-19, 
the Centers for Disease Control and Prevention (CDC) urged Americans to 
work and engage in schooling from home whenever possible as well as to 
avoid congregating in groups. Various States and localities imposed 
more rigid restrictions on gatherings, requiring many businesses to 
restrict or close their operations, to prevent further spread of the 
disease. To prevent the spread of COVID-19 in accordance with local 
restrictions and guidelines, and to prioritize in-person treatments for 
seriously ill patients, health care professionals around the country 
limited in-person medical appointments. While in-person appointments 
were converted to video telehealth visits when possible, some patients 
were limited to audio-only telehealth appointments because either they 
or their providers didn't have access to the communications equipment, 
internet service, or internet bandwidth required for video telehealth.
    DoD published an interim final rule (IFR) on May 12, 2020, 
effective that same day, to temporarily remove the exclusion for audio-
only telehealth. 85 FR 27927. DoD temporarily removed the exclusion 
because doing so was necessary to ensure the health and safety of 
TRICARE beneficiaries. Allowing audio-only telehealth would permit 
beneficiaries to have their symptoms (which include COVID-19 symptoms, 
or symptoms of other covered illness or injury) evaluated by a provider 
over the telephone before, or in lieu of, obtaining an in-person 
appointment, which ultimately may not be necessary. In 2022, DoD 
provided that this temporary removal of the exclusion would cease to be 
in effect upon termination of the national emergency declared by the 
President in Proclamation 9994, in accordance with applicable law and 
regulation (e.g., 50 U.S.C. 1622(a)).
    Following publication of the IFR, DoD reviewed claims data from 
TRICARE private sector care as well as published industry information 
from the Centers for Medicare & Medicaid Services (CMS), health 
insurance plans, and statements from physicians' professional 
organizations regarding telephonic office visits to determine if this 
should be a permanent telehealth benefit. 87 FR 33002 (June 1, 2022). 
This data reflected utilization rates for telehealth services including 
telephonic (audio-only) medical visits, while statements from 
physicians' professional organizations reflected opinions of many 
health care provider regarding telehealth. The TRICARE claims data 
between mid-March and mid-September 2020 indicated beneficiary 
utilization of telephonic office visits was a small portion of all 
telehealth claims. Medicare and health insurance plans reported data 
indicating substantial utilization of telephonic office visits. 
Physicians' professional organizations issued statements indicating 
that physicians had a favorable experience with telephonic office 
visits.
    DoD published a final rule on June 1, 2022 (87 FR 33013) revising 
32 CFR 199.4(g)(52)(i) to provide that services or advice rendered by 
telephone are excluded with the exception of medically necessary and 
appropriate telephonic office visits which are covered as authorized in 
32 CFR 199.4(c)(1)(iii). That provision states in pertinent part that 
``Health care services covered by TRICARE and provided

[[Page 64192]]

through the use of telehealth modalities including telephone services 
for: telephonic office visits; telephonic consultations; electronic 
transmission of data or biotelemetry or remote physiologic monitoring 
services and supplies, are covered services to the same extent as if 
provided in person at the location of the patient if those services are 
medically necessary and appropriate for such modalities.'' The final 
rule made these provisions permanent and not limited to the duration of 
the public health emergency. We note that, effective January 1, 2022, 
CMS rules have also permanently changed to allow for Medicare coverage 
of audio-only telehealth for mental health services or substance use 
disorders (MH/SUD) in certain circumstances. See 42 CFR 405.2463(b)(3) 
and 410.67(b)(4) as well as discussion at 86 FR 65059, (November 19, 
2021). Additionally, states have broad flexibility to cover and pay for 
Medicaid services delivered via telehealth, including to determine 
which telehealth modalities may be used to deliver Medicaid-covered 
services. Nothing in federal Medicaid law or policy prevents states 
from covering and paying for Medicaid services that are delivered via 
audio-only technologies. This broad flexibility to cover and pay for 
Medicaid services delivered via telehealth, including via audio-only 
technologies, was in place prior to the COVID-19 public health 
emergency. CMS states that this flexibility will remain in place after 
the public health emergency ends. See https://www.medicaid.gov/medicaid/benefits/downloads/medicaid-chip-telehealth-toolkit.pdf.
    HHS Office of Civil Rights has issued guidance on how covered 
health care providers and health plans can use remote communication 
technologies to provide audio-only telehealth services when such 
communications are conducted in a manner that is consistent with the 
applicable requirements of the Health Insurance Portability and 
Accountability Act of 1996 (HIPAA) Privacy, Security, and Breach 
Notification Rule (collectively, the ``HIPAA Rules''). This guidance 
explains how the HIPAA Rules permit health care providers and plans to 
offer audio telehealth while protecting the privacy and security of 
individuals' health information. See https://www.hhs.gov/about/news/2022/06/13/hhs-issues-guidance-hipaa-audio-telehealth.html.
    VA proposes amending its regulations at 38 CFR 17.272(a)(44) to 
remove the exclusion of audio-only telehealth for CHAMPVA beneficiaries 
for services provided on or after May 12, 2020. This proposed amendment 
would align the administration of CHAMPVA to be the same or similar as 
TRICARE. VA believes this proposed change appropriate in order to 
ensure the safety of CHAMPVA beneficiaries as well as others in the 
community. The TRICARE rulemaking on audio-only telehealth was 
initially based on the need to respond to a new reality for clinical 
care delivery due to the declared COVID-19 public health emergency. DoD 
later determined that this exception should remain in place. As 
explained by DoD in its rulemaking, while existing telehealth platforms 
that incorporate both audio and video/visual two-way communication are 
preferred and already allowable for beneficiaries, there may be 
instances when this is not possible. For example, a provider, 
especially in a rural or medically underserved area, may not have 
access to broadband capability, or a beneficiary may not have in-home 
technology to support two-way audio/video communication. VA shares 
these concerns relative to CHAMPVA beneficiaries, many of whom live in 
rural areas or may have insufficient disposable income to purchase and 
maintain two-way audio/video communication in the home. As discussed 
below, demand by CHAMPVA beneficiaries for audio-only telehealth 
remains steady (per 2021 data).
    We note that this proposed amendment does not expand the services 
available to CHAMPVA beneficiaries; instead, it would make otherwise-
covered services, when rendered via telephone (audio-only), eligible 
for reimbursement and cost sharing when care is medically necessary and 
appropriate and meets all other requirements.
    This proposed amendment would apply retroactively to episodes of 
health care rendered during the President's declared national emergency 
in the US. Retroactivity would allow reimbursement of medically 
necessary audio-only telehealth services dating back to the date 
TRICARE published its rulemaking, if such claims are timely filed 
within 180 days of publication of the final rulemaking, in accordance 
with the provisions of 38 CFR 17.276(a)(3). VA intends to provide 
notice to affected beneficiaries and providers when the final rule 
publishes, stating that claims for payment or reimbursement must be 
filed within 180 days of the effective date of the final rule. 
Retroactivity provides the greatest benefit to CHAMPVA beneficiaries 
and is consistent with the requirement under 38 U.S.C. 1781(b) to 
provide medical care in a manner that is the same or similar to 
TRICARE, whose dates of coverage began on May 12, 2020. Additionally, 
audio-only telehealth claims submitted to the program were denied, 
requiring the beneficiary to pay for their audio-only telehealth visit, 
further exacerbating the financial burden of the beneficiary. Allowing 
retrospective reimbursement up to the CHAMPVA allowable amount will 
provide the beneficiary compensation for their payment for medically 
necessary care during the declared national emergency.
    CHAMPVA claims data indicate that audio-only telehealth visits 
appear to be utilized to a greater extent by CHAMPVA beneficiaries than 
usage reflected in TRICARE claims data as reported at 87 FR 33002. 
Claims data indicate that the greatest financial burden to CHAMPVA 
beneficiaries due to denials of audio-only telehealth claims occurred 
early in the pandemic before they and their health care providers were 
able to adapt to the pandemic-caused shift towards conducting business 
online. The highest demand for CHAMPVA coverage of audio-only 
telehealth occurred in April 2020 when approximately 18,400 audio-only 
visits were billed to CHAMPVA. Claims data indicates that demand for 
audio-only telehealth has continued throughout the pandemic period but 
tapered off in 2021 to a monthly average of approximately 3,000 audio-
only telehealth visits.
    Therefore, in this rulemaking, we would revise 38 CFR 17.272(a)(44) 
to state that services or advice rendered by telephone (audio only) are 
not excluded when otherwise covered CHAMPVA services are provided to a 
beneficiary through this modality if the services are medically 
necessary and appropriate. Specifically, section 17.272(a)(44) would be 
amended to read: ``Telephone Services, with the following exceptions:'' 
Section 17.272(a)(44)(i) would be redesignated as 38 CFR 
17.272(a)(44)(ii)(A) and 17.272(a)(44)(i) would read: ``Services or 
advice rendered by telephone (audio only) on or after May 12, 2020, are 
not excluded when the services are otherwise covered CHAMPVA services 
provided through this modality and are medically necessary and 
appropriate.'' Section 17.272(a)(44)(ii) would be redesignated as 38 
CFR 17.272(a)(44)(ii)(B) and 17.272(a)(44)(ii) would read: ``A 
diagnostic or monitoring procedure which incorporates electronic 
transmission of data or remote detection and measurement of a 
condition, activity, or function (biotelemetry) is

[[Page 64193]]

covered when:''. Current section 17.272(a)(44)(iii) would be 
redesignated as 38 CFR 17.272(a)(44)(ii)(C) without change to the text.

Parity for Mental Health Services

    The first federal law specifically related to the coverage of 
mental health services by private health insurers and group health 
plans was the Mental Health Parity Act (MHPA) of 1996 (Title VII, Sec.  
702 of Pub. L. 104-204, September 26, 1996) which required annual or 
lifetime dollar limits on mental health benefits to be no lower than 
any such dollar limits for medical and surgical benefits offered by a 
group health plan or health insurance issuer offering coverage in 
connection with a group health plan.
    The MHPA was largely superseded by the Paul Wellstone and Pete 
Domenici Mental Health Parity and Addiction Equity Act of 2008 (MHPAEA) 
(Title V, Subtitle B, Sec. Sec.  511 and 512 of Pub. L. 110-343, 
October 3, 2008). MHPAEA generally prevents group health plans and 
health insurance issuers that provide mental health and/or substance 
use disorder (MH/SUD) benefits from imposing less favorable (e.g., 
separate costs or more restrictive) benefit limitations on those 
benefits than those imposed on medical/surgical benefits. The Patient 
Protection and Affordable Care Act (Pub. L. 111-148, March 23, 2010), 
as amended by the Health Care and Education Reconciliation Act of 2010 
(Pub. L. 111-152, March 30, 2010), collectively referred to as the 
``Affordable Care Act'' or the ACA, extended this requirement by 
operation of law to individual health insurance coverage. See also E.O. 
13625 August 31, 2012; E.O. 14009 (January 28, 2021); E.O. 14070 (April 
5, 2022).
    In general, under these laws, financial requirements (such as 
coinsurance and copayments) and treatment limits (such as visit limits) 
imposed on MH/SUD benefits must be no more restrictive than the 
predominant financial requirements or treatment limitations that apply 
to substantially all medical/surgical benefits in a classification of 
benefits (this is referred to as the ``substantially all/predominant 
test''). MH/SUD benefits also may not be subject to any separate cost 
sharing requirements or treatment limitations that only apply to such 
benefits.
    The above-referenced legal provisions related to MH/SUD benefits 
parity with medical/surgical benefits are not applicable to CHAMPVA or 
TRICARE benefits. On August 26, 2014, VA and DoD issued a joint fact 
sheet in conjunction with issuance of a series of Executive Orders 
regarding mental health services for veterans, service members, and 
their families. DoD stated that it had initiated action to do what it 
can under its authority to eliminate unnecessary quantitative limits 
under TRICARE for MH/SUD coverage, thus achieving parity between MH/SUD 
and medical/surgical benefits. With publication of a final rule on 
September 2, 2016 (81 FR 61085), TRICARE established parity for MH/SUD 
coverage, similar to that required of plans covered by the ACA. 
CHAMPVA's current practice is to routinely waive day limitations/
exclusions on mental health services to ensure that beneficiaries 
receive needed mental health care. VA recognizes that the existing 
regulatory language regarding quantitative limits on mental health care 
should be amended to remove any ambiguity. In the past this was not a 
high priority for VA, as the practical end result of CHAMPVA waiving 
such limitations and exclusions is that a beneficiary experienced no 
discontinuity in care. In addition, we note that CHAMPVA has responded 
to several Congressional inquiries related to removal of the day 
limitations for mental health care, stating we plan to amend the 
existing regulation following publication of the final rulemaking that 
published July 13, 2022 (87 FR 41599). We are now addressing this 
oversight, in conjunction with making proposed changes to cost sharing 
for contraceptive care and services that would more closely align with 
ACA requirements for private health insurers.
    Current 38 CFR 17.272(a)(57)-(62) addresses exclusions from CHAMPVA 
coverage related to mental health services. These provisions cover 
exclusions for inpatient and outpatient mental health service, 
residential treatment care, institutional services for partial 
hospitalization, detoxification in a hospital setting or rehabilitation 
facility, outpatient substance abuse services, and family therapy for 
substance abuse. The exclusions vary by mental health service provided, 
some exclusions are per fiscal year while others are per benefit 
period, and all have exclusions for specific services in excess of 
certain time periods. Some exclusions apply unless a waiver for 
extended coverage is granted in advance. CHAMPVA does not apply similar 
quantitative limits on the receipt of outpatient, residential, or 
inpatient services for other classes of medical care provided to 
eligible beneficiaries.
    VA is required in 38 U.S.C. 1781(b) to provide medical care in a 
manner that is the same or similar to TRICARE medical benefits and 
subject to the same or similar limitations. VA supports parity in 
CHAMPVA coverage between MH/SUD benefits and other medical benefits. 
There are no CHAMPVA quantitative limits on non-MH/SUD medical 
benefits, and limitations on the number of mental health visits without 
the need for further approval is inconsistent with establishing parity. 
VA believes there are no dissimilarities in the respective TRICARE and 
CHAMPVA patient populations that would support continuation of 
quantitative limits on MH/SUD visits, and no similar limitation is 
imposed on mental health care for eligible veterans receiving health 
care from VA. Although the current regulatory allowance for waivers on 
the quantitative limits is imposed on outpatient, inpatient, and 
institutional MH coverage based on medical need, we acknowledge 
regulatory waivers based on medical need do not apply to SUD services 
described in current Sec.  17.272(a)(57)-(62). We therefore seek to 
remove unnecessary quantitative limits on MH/SUD coverage so that 
CHAMPVA is fully aligned with TRICARE MH/SUD coverage. More important, 
this change is in the best health care interests of our beneficiaries. 
VA proposes removing current paragraphs (a)(57) through (62) and 
redesignating subsequent paragraphs accordingly. In addition, we would 
remove current Sec.  17.273(c) which requires preauthorization for 
outpatient mental health visits in excess of 23 per calendar year and/
or more than two (2) sessions per week. Current Sec.  17.273(d) through 
(f) would be redesignated paragraphs (c) through (e).
    Cost sharing for contraceptive services, and contraceptive products 
approved, cleared, or granted by FDA.
    Under the ACA, contraceptive care is considered to be a preventive 
health service for women and as such most private health plans in the 
United States must cover the full range of contraceptive methods, 
services, and counseling without patient out-of-pocket costs like 
coinsurance, copayments, or deductibles. See 42 U.S.C. 300gg-13(a)(4), 
45 CFR 147.130(a)(1)(iv), 29 CFR 2590.715-2713(a)(1)(iv), 26 CFR 
54.9815-2713(a)(1)(iv), and Health Resources and Services 
Administration (HRSA) Women's Preventive Services Guidelines https://www.hrsa.gov/womens-guidelines. As noted in a letter dated June 27, 
2022, issued jointly by HHS, the Department of the Treasury, and the 
Department of Labor, ``The ACA requires that all FDA-approved, cleared, 
or granted contraceptive products that are determined by an 
individual's medical provider to be medically appropriate for the 
individual must be

[[Page 64194]]

covered under the individual's non-grandfathered group health plan or 
health insurance coverage without cost sharing.'' The ACA provisions 
cited above do not apply to TRICARE or CHAMPVA.
    The scope of TRICARE's family planning benefit is found at 32 CFR 
199.4(e)(3), and is consistent with that provided through CHAMPVA, 
including plan exclusions. TRICARE Policy Manual 6010.60-M (April 1, 
2015) Chapter 7, section 2.3 provides that certain family planning 
procedures and methods are subject to cost sharing. CHAMPVA is 
established as a cost sharing program. See 38 CFR 17.270(a). VA shares 
the cost of medically necessary services and supplies for eligible 
beneficiaries as set forth in 38 CFR 17.271 through 17.278. With the 
exception of services obtained through VA facilities, CHAMPVA pays the 
CHAMPVA-determined allowable amount less the deductible, if applicable, 
and less the beneficiary cost share. 38 CFR 17.274.
    As noted, VA is required to furnish medical care in CHAMPVA in the 
same or similar manner as TRICARE and subject to the same or similar 
limitations as TRICARE. However, as previously stated, VA has not 
interpreted the ``same or similar'' language in 38 U.S.C. 1781(b) to 
mean that CHAMPVA coverage must be identical per service item or 
limitation to that provided under TRICARE, particularly in light of the 
differing size and composition of our two beneficiary populations. The 
words ``or similar'' would be surplusage if CHAMPVA coverage had to be 
identical to that under TRICARE. Rather, VA interprets the statutory 
phrase ``or similar'' to allow it to deviate from TRICARE when VA 
determines that a deviation would best serve the needs of CHAMPVA 
beneficiaries. The CHAMPVA beneficiary population is a fraction of that 
covered by TRICARE, and the average age of those receiving CHAMPVA 
benefits is higher than that for TRICARE. A primary focus of CHAMPVA is 
providing such health care that would better promote the long-term 
health of CHAMPVA beneficiaries. As such, not every aspect of CHAMPVA 
will be identical to TRICARE. VA has regulated services covered by 
CHAMPVA to mean those medical services that are medically necessary and 
appropriate for the treatment of a condition and that are not 
specifically excluded. 38 CFR 17.270 et seq.
    An example of CHAMPVA exclusions differing from TRICARE is coverage 
for annual physical exams. TRICARE does not include an annual physical 
exam benefit for all TRICARE beneficiaries while CHAMPVA determined 
that this benefit should be available to all CHAMPVA beneficiaries. 38 
CFR 17.272(a)(30)(xiii). VA did not believe that limiting the provision 
of annual exams was appropriate from a clinical perspective because 
these types of comprehensive physical examinations may identify 
incipient medical problems. 83 FR 2401 (January 17, 2018).
    Additionally, VA has previously deviated from TRICARE in amending 
its CHAMPVA regulations to provide care that is broader than that 
offered by TRICARE when it determined that these deviations were 
necessary to best provide services to the CHAMPVA population while 
remaining ``similar'' to TRICARE. For instance, Public Law 110-417 
Sec.  711(b) prohibits waiver of copayments for preventive care 
provided to Medicare-eligible TRICARE beneficiaries. Conversely, 
CHAMPVA waives cost-sharing requirements for preventive services for 
Medicare-eligible beneficiaries. 38 CFR 17.274. VA determined that 
enforcing cost-sharing requirements for Medicare-eligible beneficiaries 
for preventive services would unfairly disadvantage them as compared to 
CHAMPVA beneficiaries with other health insurance. 83 FR 2396, 2404 
(January 17, 2018).
    In these examples, VA provided CHAMPVA benefits beyond those 
benefits offered by TRICARE when it determined that providing such 
health care would better promote the long-term health of CHAMPVA 
beneficiaries. In so doing, VA is providing for health care in a manner 
similar to TRICARE, but the care is being provided in a manner that 
best serves the CHAMPVA population. Similarly, here, VA is aligning 
CHAMPVA benefits with TRICARE benefits in certain ways, but VA is also 
providing benefits beyond those offered by TRICARE to better promote 
the long-term health of CHAMPVA beneficiaries.
    While TRICARE currently requires cost sharing for certain family 
planning care and services not provided by a military treatment 
facility, CHAMPVA beneficiaries are a smaller population comprised of 
dependents of service members who died in service, veterans who are 
permanently and totally disabled, or veterans who are severely injured 
and qualify for a VA-recognized caregiver and who are not otherwise 
eligible for TRICARE. In contrast to TRICARE dependents, these 
beneficiaries' family planning goals or objectives may be affected by 
these eligibility-based life circumstances. Some CHAMPVA beneficiaries 
may not have other health insurance through which they could receive 
this type of care or service at no cost to them. If so, current CHAMPVA 
cost sharing obligations may constitute a barrier to access. For these 
reasons, VA believes that contraceptive care should be exempt from 
CHAMPVA cost share requirements, and, in this regard, more closely 
aligned with the ACA.
    VA proposes amending Sec.  17.274 to exempt contraceptive services, 
and contraceptive products approved, cleared, or granted by FDA from 
cost sharing requirements. We would amend Sec.  17.274 by adding a new 
paragraph (f) to state that cost sharing and annual deductible 
requirements under 38 CFR 17.274(a) and (b) do not apply to: (1) 
surgical insertion, removal, and replacement of intrauterine systems 
and contraceptive implants; (2) measurement for, and purchase of, 
contraceptive diaphragms or similar FDA approved, cleared, or granted 
medical devices, including remeasurement and replacement; (3) 
prescription contraceptives, and prescription or nonprescription 
contraceptives used as emergency contraceptives; (4) surgical 
sterilization; and (5) outpatient care or evaluation associated with 
provision of services listed in proposed paragraph (f)(1)-(4).
    We would also amend Sec.  17.272(a)(28) to conform to proposed 
Sec.  17.274(f)(3). Currently, Sec.  17.272(a)(28) excludes non-
prescription contraceptives from CHAMPVA coverage. We would amend that 
paragraph to state that nonprescription contraceptives are excluded, 
except those non-prescription contraceptives used as emergency 
contraceptives.

30-Day Comment Period

    The Administrative Procedure Act requires federal agencies to 
publish a notice of proposed rulemaking in the Federal Register and 
give interested persons an opportunity to participate in the rule 
making through submission of written data, views, or arguments with or 
without opportunity for oral presentation. 5 U.S.C. 553(b) and (c). 
There is no minimum period specified in the statute for the comment 
period to remain open, and it often varies with the complexity of the 
rule. Most comment periods last between 30 and 60 days, and some are 
re-opened if the agency believes that there was insufficient time for 
the public to respond or that the agency did not receive as much 
feedback as it would like. The agency must then consider all comments 
that are submitted in determining the content of the final rulemaking. 
Executive Order 12866 Regulatory Planning and Review

[[Page 64195]]

(September 30, 1993) provides at section 6(a)(1) that ``each agency 
should afford the public a meaningful opportunity to comment on any 
proposed regulation, which in most cases should include a comment 
period of not less than 60 days.''
    VA has determined that a 30-day public comment period should be 
provided for this proposed rulemaking. VA believes the proposed changes 
to CHAMPVA program exclusions and cost sharing are not complex and 
would align the program with longstanding legislative initiatives. If, 
after the close of the public comment period, VA determines that 
additional public input is necessary, we will provide additional 
opportunity for public comment.

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.regulations.gov.

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, or tribal governments, in the aggregate, or by the 
private sector, of $100 million or more (adjusted annually for 
inflation) in any one year. This rule will have no such effect on 
State, local, or tribal governments, or on the private sector.

Paperwork Reduction Act

    This proposed rule includes provisions constituting a revised 
collection of information under the Paperwork Reduction Act of 1995 (44 
U.S.C. 3501-3521) that require approval by OMB. Accordingly, under 44 
U.S.C. 3507(d), VA has submitted a copy of this rulemaking action to 
OMB for review and approval.
    OMB assigns control numbers to collections of information it 
approves. In this case, OMB assigned OMB Control Number 2900-0219 for 
this approved information collection. VA may not conduct or sponsor, 
and a person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. If OMB does 
not approve the revised collection of information as requested, VA will 
immediately remove the provisions containing the collection of 
information or take such other action as is directed by OMB.
    Comments on the revised collection of information contained in this 
rulemaking should be submitted through www.regulations.gov. Comments 
should indicate that they are submitted in response to ``RIN 2900-AR55 
CHAMPVA coverage of audio-only telehealth, mental health services, and 
cost sharing for certain contraceptive services and contraceptive 
products approved, cleared, or granted by FDA'' should be sent within 
30 days of publication of this rulemaking. The collection of 
information associated with this rulemaking can be viewed at: 
www.reginfo.gov/public/do/PRAMain.
    OMB is required to make a decision concerning the revised 
collection of information contained in this rulemaking between 30 and 
60 days after publication of this rulemaking in the Federal Register 
(FR). Therefore, a comment to OMB is best assured of having its full 
effect if OMB receives it within 30 days of publication. This does not 
affect the deadline for the public to comment on the provisions of this 
rulemaking.
    The Department considers comments by the public on new collections 
of information in--
     Evaluating whether the new collections of information are 
necessary for the proper performance of the functions of the 
Department, including whether the information will have practical 
utility;
     Evaluating the accuracy of the Department's estimate of 
the burden of the new collection of information, including the validity 
of the methodology and assumptions used;
     Enhancing the quality, usefulness, and clarity of the 
information to be collected; and
     Minimizing the burden of the collection of information on 
those who are to respond, including through the use of appropriate 
automated, electronic, mechanical, or other technological collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    The collection of information associated with this rulemaking 
contained in 38 CFR 17.272 is described immediately following this 
paragraph, under its respective title. The paragraph below addresses 
only the revised number of respondents attributable to this rulemaking. 
OMB has previously approved information collection related to filing of 
CHAMPVA health benefits claims based on an estimate of 55,000 
respondents annually.
    Title: Civilian Health and Medical Program of the Department of 
Veterans Affairs (CHAMPVA) Benefits Forms.
    OMB Control No: 2900-0219.
    CFR Provision: 38 CFR 17.272(a)(44).
     Summary of collection of information: Proposed 38 CFR 
17.272(a)(44) would remove the exclusion of CHAMPVA benefits coverage 
for audio-only telehealth. Previously denied claims for audio-only 
telehealth would have to be resubmitted by the provider, or by the 
CHAMPVA beneficiary if the beneficiary has already paid for that 
medical service. To receive payment or reimbursement, submission of a 
VA Form 10-5979a CHAMPVA claim form is required with supporting 
evidence.
     Description of need for information and proposed use of 
information: VA cannot pay for medical benefits, or reimburse a CHAMPVA 
beneficiary for previously paid medical expenses, in the absence of a 
filed claim. In this case, that claim would be related to a previously 
denied claim for an audio-only telehealth visit.
     Description of likely respondents: Health care providers 
and CHAMPVA beneficiaries.
     Estimated number of respondents: 74,914 in FY2022. This 
represents health care providers and CHAMPVA beneficiaries with denied 
claims for audio-only telehealth.
     Estimated frequency of responses: One time.
     Estimated average burden per response: 10 minutes for 
respondents.
     Estimated total annual reporting and recordkeeping burden: 
Using the annual number of 74,914 respondents, VA estimates a total 
annual reporting and recordkeeping burden of 12,486 hours for 
respondents.
     Estimated cost to respondents per year: VA estimates the 
annual cost to respondents to be $349,732.86. This is based on Bureau 
of Labor Statistics mean hourly wage data for BLS wage code ``00-0000 
All Occupations'' of $28.01 per hour x 12,486 hours.

Regulatory Flexibility Act

    The Secretary hereby certifies that this proposed rule would not 
have a

[[Page 64196]]

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 allow for payment or reimbursement of 
audio-only telehealth services on behalf of CHAMPVA beneficiaries, 
provide for parity between mental health and substance use disorder 
care and other medical care, and eliminate cost sharing for certain 
contraceptive services and contraceptive products approved, cleared, or 
granted by FDA. Therefore, it would only affect individuals who are 
CHAMPVA beneficiaries. Without this rulemaking, health care providers 
who may be small entities would still receive payment for services, the 
payment would be from the CHAMPVA beneficiary and not from 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.

Assistance Listing

    The Assistance listing number and titles for the program affected 
by this document is 64.039--CHAMPVA.

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Alcohol abuse, Alcoholism, 
Claims, Day care, Dental health, Drug abuse, Foreign relations, 
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, Philippines, Reporting 
and recordkeeping requirements, Scholarships and fellowships, Travel 
and transportation expenses, Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on October 4, 2022, 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.

Jeffrey M. Martin,
Assistant Director, 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 (VA) proposes to amend 38 CFR part 17 as follows:

PART 17--MEDICAL

0
1. The general 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.  17.272 by:
0
a. Revising paragraphs (a)(28) and (a)(44);
0
b. Removing paragraphs (a)(57) through (62);
0
c. Redesignating paragraphs (a)(63) through (83) as paragraphs (a)(57) 
through (77).
    The revisions read as follows:


Sec.  17.272  Benefits limitations/exclusions.

    (a) * * *
    (28) Nonprescription contraceptives, except those nonprescription 
contraceptives used as emergency contraceptives.
* * * * *
    (44) Telephone Services, with the following exceptions:
    (i) Services or advice rendered by telephone (audio only) on or 
after May 12, 2020, are not excluded when the services are otherwise 
covered CHAMPVA services provided through this modality and are 
medically necessary and appropriate.
    (ii) A diagnostic or monitoring procedure which incorporates 
electronic transmission of data or remote detection and measurement of 
a condition, activity, or function (biotelemetry) is covered when:
    (A) The procedure, without electronic data transmission, is a 
covered benefit; and
    (B) The addition of electronic data transmission or biotelemetry 
improves the management of a clinical condition in defined 
circumstances; and
    (C) The electronic data or biotelemetry device has been classified 
by the U.S. Food and Drug Administration, either separately or as part 
of a system, for use consistent with the medical condition and clinical 
management of such condition.
* * * * *


Sec.  17.273  [Amended]

0
3. Amend Sec.  17.273 by removing paragraph (c), and redesignating 
paragraphs (d) through (f) as paragraphs (c) through (e).
0
4. Amend Sec.  17.274 by adding a new paragraph (f) to read as follows:


Sec.  17.274  Cost sharing.

* * * * *
    (f) Cost sharing and annual deductible requirements under 
paragraphs (a) and (b) of this section do not apply to:
    (1) Surgical insertion, removal, and replacement of intrauterine 
systems and contraceptive implants;
    (2) Measurement for, and purchase of, contraceptive diaphragms or 
similar FDA approved, cleared, or granted medical devices, including 
remeasurement and replacement;
    (3) Prescription contraceptives, and prescription or 
nonprescription contraceptives used as emergency contraceptives;
    (4) Surgical sterilization; and
    (5) Outpatient care or evaluation associated with provision of 
family planning services listed in paragraph (f)(1) through (4) of this 
section.

[FR Doc. 2022-22905 Filed 10-21-22; 8:45 am]
BILLING CODE 8320-01-P