Federal Register Extracts

Agency: "Department of Veterans Affairs."

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 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.

--This is a summary of a Federal Register article originally published on the page number listed below--

Final rule.

CFR Part: "38 CFR Part 17"

RIN Number: "RIN 2900-AR55"

Citation: "89 FR 34133"

Federal Register Page Number: "34133"

"Rules and Regulations"