PrEP coverage

FAQs Part 68 states that, for plan years beginning on or after August 31, 2024, plans must cover, without cost sharing, the three formulations of FDA-approved PrEP medications (two oral and one injectable) that the United States Preventive Services Task Force (USPSTF) recommended in 2023 be covered under the ACA: Truvada^® (a tablet approved in July 2012), Descovy^® (a tablet approved in October 2019) and Apretude (an injectable drug approved in December 2021).

Additionally, FAQs Part 68 clarifies that plans must not be permitted to use medical management techniques to direct individuals prescribed PrEP to use one formulation over another because the 2023 USPSTF recommendation for PrEP specifies three formulations of medications approved by the FDA for PrEP use.

FAQs Part 68 also reaffirms FAQs Part 47, which were issued on July 19, 2021, requiring that plans must cover without cost-sharing specified baseline, follow-up testing and monitoring services that are essential to the efficacy of PrEP. Baseline, follow-up, and monitoring services include HIV testing, Hepatitis B and C testing, creatinine testing and calculated estimated creatine clearance or glomerular filtration rate, pregnancy testing, sexually transmitted infection screening and counseling, and adherence counseling.

Coding for recommended preventive items and services

The new FAQs (FAQs Part 68) note it is critical that appropriate medical service codes identify when items and services are furnished as preventive items or services, and that plans correctly process such claims as claims for recommended preventive items and service.

In-network claims for preventive services

Plans should cover preventive services claims from in-network providers with no cost-sharing when providers submit the claims using industry-standard coding, unless the plan has individualized information that the services were not preventive for the individual. Mere suggestions that a claim was not preventive cannot be used to deny payment as preventive and should be further investigated by the plan. Plans can use their claims and appeals procedures to obtain substantiating information.

High-risk patients

If a provider determines that an individual belongs to a high-risk population and a preventive service recommendation applies to that high-risk population, then the plan is required to cover that service without cost sharing.

Fraud, waste and abuse

When evaluating claims, plans may use programs designed to detect and address fraud, waste and abuse (FWA). However, if a plan’s FWA protocols identify an issue with a claim for a recommended preventive item or service, plans and issuers should not impose cost sharing (or deny the claim) without individualized information to establish FWA concerns.

Examples

The FAQs provide examples of how the guidance applies to colonoscopies, injectable contraceptives, screening mammography and kidney function tests for individuals taking PrEP.

Breast reconstruction coverage under the ACA and WHCRA

If a health plan or insurer subject to the WHCRA provides medical and surgical benefits with respect to a mastectomy, the plan must cover all stages of reconstruction of the breast on which the mastectomy was performed and surgery and reconstruction of the other breast to produce a symmetrical appearance, in a manner determined in consultation with the attending physician and the patient.

The FAQs provide further detailed clinical guidance. They clarify that WHCRA requires group health plans and insurers offering group health benefits covering mastectomies to provide coverage for chest wall reconstruction with aesthetic flat closure as a type of breast reconstruction.

Action items

Plan sponsors should contact their pharmacy benefit managers to ensure that they will comply with the new requirements to offer PrEP without steering patients to one version or another.

Plans should review their coding guidelines, claims processing systems, and other relevant internal protocols and make any necessary modifications to ensure that claims for recommended preventive items or services (including items and services that are integral to the furnishing of a recommended preventive item or service) are properly covered without cost sharing.

The Departments did not specify an effective date for the clinical guidance on breast reconstruction coverage, so plan sponsors should implement this requirement immediately.