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, 34133-34137 [2024-09072]

Agencies

• DEPARTMENT OF VETERANS AFFAIRS

[Federal Register Volume 89, Number 84 (Tuesday, April 30, 2024)]
[Rules and Regulations]
[Pages 34133-34137]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09072]


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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: Final rule.

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SUMMARY: The Department of Veterans Affairs (VA) adopts as final, with 
changes, a proposed rule to amend its medical regulations regarding 
Civilian Health and Medical Program of the Department of Veterans 
Affairs (CHAMPVA) coverage to remove the exclusion for audio-only 
telehealth, remove current quantitative limitations on mental health/
substance use disorder coverage, remove the current requirement for 
pre-authorization for outpatient mental health visits in excess of 23 
per calendar year and/or more than two (2) sessions per week, and 
exempt certain contraceptive services and prescription and 
nonprescription contraceptive products that are approved, cleared, or 
granted by the U.S. Food and Drug Administration (FDA) from cost 
sharing requirements.

DATES: This rule is effective May 30, 2024.

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: On October 24, 2022, VA published a proposed 
rule in the Federal Register (87 FR 64190) that would amend CHAMPVA 
exclusions to allow coverage of telephonic (audio-only) medical visits. 
VA also proposed removing specified quantitative limits on coverage for 
inpatient and outpatient mental health/substance use disorder (SUD) 
care appointments, i.e., inpatient and outpatient mental health 
services, residential treatment, institutional services for partial 
hospitalization, substance withdrawal management in a hospital setting 
or rehabilitation facility, outpatient SUD services, and family therapy 
for SUD. This would align the delivery of CHAMPVA mental health/SUD 
care with the Department of Defense (DoD) TRICARE program, current 
standards of practice in mental health and SUD care, and the goals of 
the Mental Health Parity and Addiction Equity Act of 2008. 87 FR at 
64193. VA also proposed removing the current preauthorization 
requirement for outpatient mental health visits in excess of 23 per 
calendar year and/or more than two (2) sessions per week. In addition, 
VA proposed removing cost sharing requirements for certain 
contraceptive services and prescription or nonprescription 
contraceptive products that are approved, cleared, or granted by the 
FDA.
    VA provided a 30-day comment period, which ended on November 23, 
2022. VA received 14 comments on the proposed rule, of which 7 comments 
were supportive and did not suggest changes or clarifications from the 
proposed rule. Commenters generally expressed support for all the 
proposed changes, but we received substantive comments with 
recommendations for change on audio telehealth coverage as well as the 
cost sharing exemption for contraceptives. We address these substantive 
comments below. Based on these comments, VA adopts the proposed rule as 
final, with changes.

Audio-Only Telehealth

    VA proposed amending its regulations to remove the exclusion of 
audio-only telehealth for CHAMPVA beneficiaries for services provided 
on or after May 12, 2020. As proposed, the amendment would apply 
retroactively and allow reimbursement of medically necessary audio-only 
telehealth services for CHAMPVA beneficiaries dating back to the date 
TRICARE published a similar interim final rulemaking (85 FR 27927 May 
12, 2020). CHAMPVA beneficiaries would be required to file a claim for 
reimbursement within 180 days of the effective date of a final 
rulemaking.
    One commenter suggested VA publish guidance to providers and 
patients related to the retroactive reimbursement period notice. The 
commenter suggested VA send text alerts notifying beneficiaries on how 
to file a claim for reimbursement. VA thanks the commenter for the 
suggestion and VA will take it into consideration, but utilization of 
specific communication methods for outreach is outside the scope of 
this rulemaking. However, we note that VA does have a communications 
plan in place to alert potential beneficiaries as well as providers of 
this retroactive change in audio-only telehealth coverage. We make no 
changes based on this comment.
    The remaining six comments suggested changes to the proposed rule. 
All of the comments recommended changes related to the coverage and 
cost sharing requirements for contraceptive services and products.
    Before addressing these comments, we first correct an erroneous 
statement we made at the proposed rule stage. When we proposed amending 
Sec.  17.272(a)(28) to provide for CHAMPVA coverage of nonprescription 
contraceptives used as emergency contraceptives we incorrectly 
indicated in the proposed rule that TRICARE does not provide coverage 
for nonprescription contraceptives used as emergency contraception. In 
accordance with 10 U.S.C. 1074g(a)(2)(F), as implemented by 32 CFR 
199.21(h)(5), the TRICARE Pharmacy Benefits Program covers over the 
counter Levonorgestrel 1.5 mg tablet (e.g., Plan B One-Step) as 
emergency contraception at no cost if obtained at a military medical 
treatment facility or retail pharmacy (not home delivery).

Comments That Suggested That CHAMPVA Should Expand Coverage for 
Nonprescription Contraceptives and Exempt Nonprescription 
Contraceptives From Cost Sharing Requirements

    VA proposed amending Sec.  17.274 to exempt contraceptive services, 
and contraceptive products approved, cleared, or granted by FDA from 
cost

[[Page 34134]]

sharing requirements. We proposed amending 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) through (4). 
We also proposed amending Sec.  17.272(a)(28) to state that 
nonprescription contraceptives are excluded from CHAMPVA coverage, 
except those non-prescription contraceptives used as emergency 
contraceptives.
    All six substantive comments suggested that CHAMPVA coverage of 
contraceptives should include all nonprescription contraceptives. Most 
of these comments generally suggested that VA should expand coverage to 
all nonprescription contraceptives. We note that the Department of 
Health and Human Services (HHS), the Department of the Treasury, and 
the Department of Labor have historically interpreted the ACA as not 
requiring coverage of contraceptives without cost-sharing unless the 
individual has a prescription for the preventive product.
    Other commenters provided additional reasons for providing coverage 
for the additional nonprescription contraceptives. For instance, one 
commenter explained that nonprescription contraceptives are an 
important option, especially for those who face barriers to care such 
as living in rural areas or are without reliable transportation. 
Another commenter explained that it was critical to provide 
nonprescription contraceptives because there are barriers to obtaining 
prescription-only contraception and the FDA is considering allowing 
certain prescription daily birth control pills to become over the 
counter instead of prescription-based. Another commenter stated that 
every individual is different and has different contraceptive needs and 
therefore all options should be covered without cost sharing.
    One commenter noted that any cost associated with contraception, 
even a small amount, could be a barrier for individuals to access 
needed contraception. This commenter suggested specific changes to the 
regulatory text to reflect their suggested changes. The commenter 
suggested that VA: remove that language in proposed Sec.  17.272(a)(28) 
that would have excluded coverage of nonprescription contraceptives; 
revise the language in Sec.  17.272(a)(75) to include coverage for 
nonprescription contraceptives; and revise Sec.  17.274(f)(3) to exempt 
all nonprescription contraceptives from cost sharing requirements. The 
commenter stated that these changes would effectively allow CHAMPVA 
coverage for both prescription and nonprescription contraceptives and 
exempt them all from cost sharing requirements.
    We make no changes based on comments suggesting that VA should 
expand coverage to all nonprescription contraceptives. TRICARE does not 
cover over the counter contraceptives such as condoms, nonprescription 
spermicidal foams, jellies or sprays. CHAMPVA similarly excludes these 
items from plan coverage. We note that the ACA does not currently 
require private health insurers or Medicaid plans to cover these items 
without cost sharing and without a prescription. We also note that VA 
is required under 38 U.S.C. 1781(b) to provide CHAMPVA care in the same 
or similar manner to TRICARE, not the ACA.
    We agree with commenters that any cost associated with 
contraception could be a barrier for individuals to access 
contraception. Similar concerns are seen with copayment obligations for 
health care and medication. The issue is not exclusive to CHAMPVA 
beneficiaries. As noted, TRICARE excludes coverage for prophylactics 
(condoms), spermicidal foams, jellies, and sprays not requiring a 
prescription.
    In addition, we note here that in July 2023 the FDA has approved an 
oral contraceptive Opill (norgestrel) for nonprescription use to 
prevent pregnancy--the first daily oral contraceptive approved for use 
in the U.S. without a prescription. Opill is now commercially available 
for purchase without a prescription at pharmacies, convenience stores 
and grocery stores, as well as online. While VA makes no changes in 
this rulemaking regarding cost sharing for non-emergency contraceptives 
not requiring a prescription, VA will consider further amendments to 
facilitate access to certain family planning options including daily 
oral contraceptives approved, granted, or cleared by the FDA not 
requiring a prescription, such as Opill.
    We stated in the proposed rule that TRICARE currently requires cost 
sharing for certain family planning care and services not provided by a 
military medical treatment facility (87 FR 64194), but did not specify 
how the proposed rule differed from TRICARE relative to cost sharing 
for contraceptives and family planning. Currently TRICARE covers 
reversible medical contraceptives with no cost-share as a preventive 
health benefit. TRICARE is also covering tubal sterilization procedures 
with no cost-shares for certain TRICARE-enrolled beneficiaries when the 
care is sought and delivered by a network provider as a clinical 
preventive service. By law, applicable cost sharing still applies to 
oral contraceptives and other prescription pharmaceutical agents 
dispensed through the TRICARE Pharmacy Benefit Program.
    As background, the law directs VA to provide CHAMPVA beneficiaries 
with medical care ``in the same or similar manner and subject to the 
same or similar limitations as medical care'' furnished to DoD TRICARE 
Select beneficiaries. 38 U.S.C. 1781(b) (emphases added). That text 
recognizes differences may exist between the two programs' respective 
beneficiary populations and their needs. Further, CHAMPVA beneficiaries 
(unlike TRICARE beneficiaries) include family caregivers of veterans, 
not just eligible dependents. 38 U.S.C. 1720G(a)(3)(A)(ii)(IV). 
Congress did not require that CHAMPVA coverage be identical to that 
provided under TRICARE. VA has previously regulated to provide CHAMPVA 
benefits beyond those benefits offered by TRICARE if providing such 
health care would better promote the long-term health of CHAMPVA 
beneficiaries. Thus, consistent with the statute's plain meaning, VA 
provides CHAMPVA beneficiaries certain care that is ``similar,'' but 
not necessarily identical, to care provided to beneficiaries of 
TRICARE.
    The distinctions made by TRICARE relative to copayment obligations 
are based on whether the service is prescribed or provided by a 
military medical treatment facility or a network provider, and in a few 
cases, the TRICARE plan in which the sponsor is enrolled. Several 
factors are weighed by VA when determining if a specific type of 
CHAMPVA benefit coverage should differ from that under TRICARE, 
including the makeup of the beneficiary population eligible for CHAMPVA 
(see 38 CFR 17.271(a), as well as agency priorities and policy 
considerations.
    Eligibility for TRICARE is broader than that for CHAMPVA. CHAMPVA 
eligibility categories include the spouse

[[Page 34135]]

or child of a veteran who has been adjudicated by VA as having a 
permanent and total service-connected disability; the surviving spouse 
or child of a veteran who died as a result of an adjudicated service-
connected condition(s); or who at the time of death was adjudicated 
permanently and totally disabled from a service-connected condition(s); 
the surviving spouse or child of a person who died on active military 
service and in the line of duty and not due to such person's own 
misconduct; certain individuals designated as a Primary Family 
Caregiver; and, an eligible child who is pursuing a course of 
instruction approved under 38 U.S.C. chapter 36, and who incurs a 
disabling illness or injury while pursuing such course of instruction. 
By contrast, TRICARE eligibility categories include active duty service 
members and their family members; retirees and their families; family 
members of activated Guard/Reserve members; non-activated Guard/Reserve 
members and their families who qualify for care under the Transitional 
Assistance Management Program; retired Guard/Reserve members at age 60 
and their families; certain survivors; Medal of Honor recipients and 
their families; and, qualified former spouses. As noted, cost sharing 
obligations for certain types of contraceptive care or services under 
TRICARE is dependent on whether the patient is active duty or whether 
the care or service is prescribed by a network provider.
    VA's motto is ``to fulfill President Lincoln's promise to care for 
those who have served in our nation's military and for their families, 
caregivers, and survivors.'' We do not believe TRICARE's statutorily 
required copayment obligations for these listed contraceptive and 
family planning services and products compels VA to follow suit. As 
explained above, those eligible for CHAMPVA are the spouse, surviving 
spouse, child, and caregiver of a qualifying veteran sponsor which in 
most cases is either a VA rated permanently and totally disabled 
veteran or a veteran that died of a VA rated service-connected 
condition, and not otherwise eligible for TRICARE. We note that 
removing the cost sharing obligation alleviates any further financial 
burden on such households. VA believes that exempting the services and 
products listed in Sec.  17.274(f) from cost sharing will benefit 
CHAMPVA beneficiaries and will retain that exemption in the final rule, 
with changes as explained below.

Comments That Requested Other Changes From the Proposed Rule

    In addition to the issues above related to coverage and cost 
sharing for nonprescription contraceptives, two of the six commenters 
raised other issues. One of the commenters also suggested that language 
in proposed Sec.  17.274(f) was not clear as to whether CHAMPVA 
coverage of contraceptives would include only those contraceptive 
methods and services expressly listed in paragraph (f), or also include 
``similar'' contraceptive methods and services and FDA-approved, 
cleared, or granted products. This commenter stated that, without 
clarification, Sec.  17.274(f) as proposed could be read to not cover 
those products that might be approved, cleared, or granted by the FDA 
in the future, and specifically stated that VA should ensure the 
inclusion of injectable contraceptives as an express type of 
contraceptive to be covered. The commenter suggested revising Sec.  
17.274(f)(1) as proposed to remove the word ``[S]urgical'' at the 
beginning of paragraph (f)(1) and adding at the end of the paragraph 
language that reads ``or similar FDA approved, granted, or cleared 
contraceptives that require insertion, removal, and replacement by a 
health care provider.'' This commenter also suggested adding a new 
paragraph (f)(3) to ensure explicit coverage of injectable 
contraceptives or similar FDA approved, granted, or cleared 
contraceptives that require administration by a health care provider. 
In adding a new paragraph (f)(3), the commenter lastly suggested that a 
renumbered paragraph (f)(4) (pertaining to exempting prescription 
contraceptives, and nonprescription contraceptives used as emergency 
contraceptives) should include at the end language that qualifies such 
contraceptives be those ``approved, granted, or cleared by the FDA.''
    VA agrees with the commenter's suggestions and makes the following 
changes accordingly. VA revises Sec.  17.274(f)(1) as proposed to 
remove the word ``[S]urgical'' from the beginning of the paragraph and, 
at the end of the paragraph, add language to ensure that similar FDA 
approved, granted, or cleared contraceptives requiring insertion, 
removal and replacement by a health care provider would be covered. VA 
will also add a new Sec.  17.274(f)(3) to ensure that injectable 
contraceptives or similar FDA approved, granted, or cleared 
contraceptives that require administration by a health care provider 
would be covered. By adding a new Sec.  17.274(f)(3), we will renumber 
paragraphs (f)(3) through (f)(5) as proposed to be paragraphs (f)(4) 
through (f)(6), respectively, and will revise renumbered paragraph 
(f)(4) to add language that clarifies all prescription, or 
nonprescription contraceptives used as emergency contraceptives, must 
otherwise be ``approved, granted, or cleared by the FDA.''
    Finally, another commenter suggested that VA policy be amended to 
allow a prescription for up to 13-month supply of combined hormonal 
methods of contraceptives to improve contraceptive continuation. We do 
not make changes from the proposed rule based on this comment as it 
relates to a clinical practice matter beyond the scope of the proposed 
rule. We note that a patient's condition may change over time, 
requiring an adjustment of medication. In addition, a 12-month duration 
of a prescription corresponds to the scheduling of annual comprehensive 
care visits. VA policy permits a 12-month supply of combined hormonal 
methods of contraceptives, and a VA medical facility may have standard 
operating procedures in place allowing extension of fills greater than 
12 months in certain circumstances.
    Current VHA Directive 1108.07(1), General Pharmacy Service 
Requirements, establishes that prescriptions must generally be filled 
for no more than a maximum three-month (90-day) supply of medication at 
a time, although exceptions can be made for non-controlled medications 
and supplies and for oral contraceptives. Therefore, VA pharmacies are 
already authorized to fill a longer term of this medication when 
requested by the CHAMPVA beneficiary and the health care provider under 
the CHAMPVA In-house Treatment Initiative (CITI) program. For CHAMPVA 
services furnished by non-VA providers, VA does cover such 
prescriptions for a maximum 90-day supply of medication per fill with 
three refills if prescribed by the non-VA health care provider and 
filled by the non-VA pharmacy. See CHAMPVA Operational Policy Manual 
chapter 2, section 22.1. VA intends to amend this section of the 
operational manual to allow for an exception for oral contraceptives.
    Based on the rationale set forth here and in the supplementary 
information to the proposed rule, VA adopts the proposed rule as final, 
with changes.

Executive Orders 12866, 13563, and 14094

    Executive Order 12866 (Regulatory Planning and Review) directs 
agencies to assess the costs and benefits of available regulatory 
alternatives and, when regulation is necessary, to select

[[Page 34136]]

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. Executive Order 14094 (Executive 
Order on Modernizing Regulatory Review) supplements and reaffirms the 
principles, structures, and definitions governing contemporary 
regulatory review established in Executive Order 12866 of September 30, 
1993 (Regulatory Planning and Review), and Executive Order 13563 of 
January 18, 2011 (Improving Regulation and Regulatory Review). The 
Office of Information and Regulatory Affairs has determined that this 
rulemaking is a significant regulatory action under Executive Order 
12866, as amended by Executive Order 14094. The Regulatory Impact 
Analysis associated with this rulemaking can be found as a supporting 
document at www.regulations.gov.

Regulatory Flexibility Act

    The Secretary hereby certifies that this final rule will not have a 
significant economic impact on a substantial number of small entities 
as they are defined in the Regulatory Flexibility Act (5 U.S.C. 601-
612). The factual basis for this certification is that this regulation 
updates CHAMPVA coverage to remove the exclusion for audio-only 
telehealth, removes limitations on outpatient mental health visits, and 
exempts certain contraceptive services and contraceptive products that 
are approved, cleared, or granted by the FDA from cost sharing 
requirements. It also removes the exclusion of CHAMPVA coverage for 
nonprescription contraception used in an emergency. The changes to the 
regulation only affect individuals who are CHAMPVA beneficiaries. 
Absent 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.

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 rule includes provisions constituting a revision to a 
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. 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. In this case, OMB previously 
assigned OMB Control Number 2900-0219 to an information collection that 
will be revised through this regulation. The information collection 
under 2900-0219 has a current Paperwork Reduction Act (PRA) clearance 
that expires on October 31, 2024. If OMB does not approve the revision 
to this 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.
    The collection of information associated with this rulemaking 
contained in 38 CFR 17.272 addresses only the revised number of 
respondents attributable to this rulemaking. OMB previously approved 
the part of the information collection under 2900-0219 related to 
filing of CHAMPVA health benefits claims using VA Form 10-7959a for a 
total of 9,167 burden hours, based on an estimate of 55,000 respondents 
annually. Section 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, using VA Form 10-7959a with supporting evidence. 
VA anticipates that the number of respondents submitting claims will 
increase as a result of this rulemaking. Applying the anticipated 
increase to 74,914 annual respondents, at 10 minutes per response, VA 
estimates an increase in the annual burden to 12,486 hours for 
respondents submitting claims using VA Form 10-7959a.
    Estimated cost to respondents per year: VA estimates the annual 
cost to respondents to be $371,583.36. This is based on Bureau of Labor 
Statistics mean hourly wage data for BLS wage code ``00-0000 All 
Occupations'' of $29.76 per hour x 12,486 hours.
    A notice of this revision to the information collection under 2900-
0219 was published in the proposed rule on October 24, 2022, at 87 FR 
pages 64190-64196. VA did not receive any public comments related to 
the increase in the burden hours for the revised information 
collection.

Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
the Office of Information and Regulatory Affairs designated this rule 
as not a major rule, as defined by 5 U.S.C. 804(2).

List of Subjects in 38 CFR Part 17

    Administrative practice and procedure, Claims, Health care, Health 
facilities, Health professions, Health records, Medical devices, Mental 
health programs, Veterans.

Signing Authority

    Denis McDonough, Secretary of Veterans Affairs, approved this 
document on April 17, 2024, and authorized the undersigned to sign and 
submit the document to the Office of the Federal Register for 
publication electronically as an official document of the Department of 
Veterans Affairs.

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

    For the reasons stated in the preamble, the Department of Veterans 
Affairs (VA) amends 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), respectively.
    The revisions read as follows:


Sec.  17.272  Benefits limitations/exclusions.

    (a) * * *

[[Page 34137]]

    (28) Nonprescription contraceptives, except those non-prescription 
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;
    (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), respectively.

0
4. Amend Sec.  17.274 by adding 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) Insertion, removal, and replacement of intrauterine systems, 
contraceptive implants, or similar FDA approved, granted, or cleared 
contraceptives that require insertion, removal, and replacement by a 
health care provider;
    (2) Measurement for, and purchase of, contraceptive diaphragms or 
similar FDA approved, cleared, or granted medical devices, including 
remeasurement and replacement;
    (3) Administration of injectable contraceptives or similar FDA 
approved, granted, or cleared contraceptives that require 
administration by a health care provider;
    (4) Prescription contraceptives, and prescription or 
nonprescription contraceptives used as emergency contraceptives, 
approved, granted, or cleared by the FDA;
    (5) Surgical sterilization; and
    (6) Outpatient care or evaluation associated with provision of 
family planning services listed in paragraphs (f)(1) through (5) of 
this section.

[FR Doc. 2024-09072 Filed 4-29-24; 8:45 am]
BILLING CODE 8320-01-P