HIV pre-exposure prophylaxis (PrEP) antiretroviral medication and essential support services are together considered preventive services that must be fully covered outside the deductible and with no cost-sharing, according to the federal agencies overseeing the Affordable Care Act (ACA).
On July 19, the IRS, Department of Labor (DOL), and Department of Health and Human Services (the tri-agencies) addressed issues regarding PrEP coverage in new frequently asked questions (FAQs). Plans must comply with this guidance by Sept. 17, 2021.
The ACA generally requires nongrandfathered group health plans to cover certain preventive services, such as many immunizations and disease screenings, without cost-sharing, consistent with the recommendations of the U.S. Preventive Services Task Force (USPSTF). If the relevant preventive services recommendation does not specify the frequency, method, treatment or setting for a recommended preventive service, then health plans are allowed to use reasonable medical management techniques to determine coverage limits.
On June 11, 2019, the USPSTF released a recommendation with an "A" rating that clinicians offer PrEP with "effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition." Consistent with the USPSTF recommendation, for plan years beginning on or after June 30, 2020, nongrandfathered plans must cover PrEP for participants, beneficiaries and enrollees without cost-sharing.
The three new FAQs clarify requirements regarding the PrEP preventive services, "because plans may not have understood that these requirements apply to all support services of the USPSTF's recommendation for PrEP," actuarial and consulting firm Cheiron noted. Because of this confusion, the agencies are delaying enforcement until Sept. 17, 2021.
The FAQs provide examples of preventive treatment services for PrEP such as:
- HIV testing.
- Hepatitis B and C testing.
- Pregnancy testing.
- Sexually transmitted infection screening and counseling.
- Drug-adherence counseling to ensure that PrEP is used as prescribed.
"The new federal guidance confirms that cost-sharing protections extend to the ancillary and support services that are needed for an effective PrEP regimen," wrote Katie Keith, a principal at Keith Policy Solutions. "This means that all nongrandfathered private health plans must cover those services, alongside PrEP medication, without cost-sharing. This clarification will reduce patient out-of-pocket costs and thus increase access to PrEP for high-risk individuals."
Next Steps for Employers
While the agencies indicated that they will not take enforcement action against a plan for failing to cover PrEP support services until Sept. 17, "employers should confirm that their group health plans are in compliance with the USPSTF PrEP recommendation and take the necessary steps to address any noncompliance before the end of the 60-day nonenforcement period," said Ben Lupin, senior director at consultancy Willis Towers Watson.
Greta Cowart, a partner in the Dallas office of law firm Jackson Walker, advised that "employer-sponsored group health plans that are not grandfathered under the ACA need to check with their group health plan's insurer or third-party administrator on how all elements of PrEP are being handled."
She further advised, "Employers should also verify that the contents of their group health plan's summary plan description, plan document and other employee communication materials accurately reflect the coverage of PrEP and are compliant with the requirements by Sept. 17, 2021.
Brand Name vs. Generic PrEP
Truvada, the brand-name PrEP medication, can cost $2,000 a month and "that out-of-pocket expense [was] preventing a lot of people from taking the PrEP treatment to prevent HIV infection," Healthline, a medical information website, reported last year.
However, as Cheiron noted, "since the branded version of PrEP is not specified in the USPSTF recommendation, plans may cover a generic version of PrEP without cost-sharing and impose cost-sharing on an equivalent branded version."
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