Rule2024-09072
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
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Published
April 30, 2024
Effective
May 30, 2024
Issuing agencies
Veterans Affairs Department
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 84 (Tuesday, April 30, 2024)</title>
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="http://www.regulations.gov">www.regulations.gov</a>.
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
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