On July 19, HHS and the Departments of Labor and Treasury took an important step to remove insurance copayment requirements as a barrier to access to HIV preexposure prophylaxis (“PrEP”) medications. The three agencies issued joint guidance titled “FAQs About Affordable Care Act Implementation Part 47” that provides information about requirements for group or individual health insurers to cover PrEP and other preventative care without charging cost sharing amounts. As background, the Public Health Service Act requires that certain insurers cover items and services without cost sharing based on recommendations from agencies within HHS. The guidance applies to any commercial health insurance plan except for plans that pre-date passage of the Affordable Care Act of 2010 or that offer limited coverage like dental or vision only. As a result of recent recommendations, insurers will now be required to cover, without cost sharing, PrEP for individuals at high risk of contracting HIV as well as related services. Those related services include HIV testing, Hepatitis B and C testing, kidney function testing, pregnancy testing, sexually transmitted infection screening and counseling, and adherence counseling. Office visits to provide these services must also be covered without cost sharing if the payment for the service is bundled in the office visit payment. Insurers will also have to cover without cost sharing routine immunizations, including the COVID vaccine and COVID prevention services as well as preventative care and screening for women, infants, children, and adolescents.

The FAQs state that an insurer may use “reasonable medical management techniques” to set coverage limitations. For example, insurers may impose a copayment requirement for brand medications unless the brand drug is medically indicated by the patient’s health care provider. With respect to PrEP, the FAQs state that plans must have a reasonable process to allow prescribing and accessing PrEP medications on the same day that a patient receives a negative HIV test or decides to start taking PrEP. In addition, if PrEP is medically appropriate, insurers may not restrict the number of times that an individual may start PrEP. Enforcement of these new requirements will start on September 17, 2021.