Biden-Harris administration requires insurers to cover long-acting PrEP to prevent HIV

ACA Preventive Services Requirement Must be Enforced

Washington DC… Today, the Biden-Harris administration issued updated coverage guidance to insurers requiring them to cover long-acting PrEP without cost-sharing, in addition to daily oral PrEP, in order to prevent HIV.

In response to this positive development, Carl Schmid, executive director of HIV+Hepatitis Policy Institute issued the following statement:

“With low uptake of PrEP among the communities most impacted by HIV, this insurance coverage requirement with zero cost-sharing will help jumpstart the use of more effective forms of PrEP and lead to fewer HIV transmissions. We are grateful to the Biden-Harris administration for responding to our request to issue this guidance. Without it, we feel some insurers would continue to only cover daily oral PrEP, and not provide PrEP users with the choice they need.  With up to a third of privately insured PrEP users still being charged cost-sharing, we must ensure that both federal and state regulators vigorously enforce PrEP coverage requirements.”

Earlier this summer, the HIV+Hepatitis Policy Institute sent a detailed letter to CMS Administrator Chiquita Brooks-LaSure, which was followed up by a community letter signed by 63 HIV organizations calling on the administration to issue this guidance. In August 2023, the USPSTF issued an updated Grade “A” recommendation for PrEP that includes new long-acting PrEP. Almost three years after FDA approval of the first long-acting PrEP drug, some states required insurers to cover all FDA-approved forms of PrEP without cost-sharing, and there is an urgent need for the federal government to do the same. Under the ACA, newly issued plans must cover a preventive service beginning one year after a USPSTF recommendation. 

The FAQ issued by the Departments of Health and Human Services, Labor, and Treasury ensures that all non-grandfathered plans must abide by the new coverage requirements. Importantly, it requires insurers to cover all current forms of PrEP and does not allow them to use prior authorization to drive users to a specific drug.  In our letters to CMS, the HIV community stressed how insurer barriers, including prior authorization, are impacting PrEP uptake, and particularly harm racial and ethnic minority groups.

Today’s guidance was silent on whether insurers must cover all FDA-approved PrEP drugs in the future. The updated USPSTF recommendation is not drug-specific, but rather for PrEP in general to prevent HIV which includes “effective antiretroviral therapy.”  This will be important as new longer acting PrEP drugs become available. Last month, results of a drug trial for an investigative twice a year HIV preventive drug were released, paving the way for potential FDA approval in 2025. 

According to modeling conducted for the HIV+Hepatitis Policy Institute, about 55 percent of the estimated 1.2 million people eligible for PrEP have private insurance.

In a recent report authored by the CDC that examined claims data and appeared in JAMA, it found that there were over half a million people prescribed PrEP in 2023, with 62 percent of them (252,000) having private insurance. The CDC estimates that there are 1.2 million people in the US who are eligible for PrEP.

HIV+Hep is pleased that the tri-agencies have reiterated the need for insurers to comply with these ACA requirements and provided detailed information on coding to process PrEP claims. We continue to receive complaints from PrEP users who are being illegally charged cost-sharing for PrEP drugs and related services. While some states have taken aggressive enforcement action, the federal government has been slow to ensure compliance.

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The HIV+Hepatitis Policy Institute is a national, non-profit organization whose mission is to promote quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other serious and chronic health conditions.