By: HUB’s EB Compliance Team

On July 19, the agencies that issue Affordable Care Act guidance released FAQs regarding the coverage of HIV Preexposure Prophylaxis, or “PrEP”, as a preventive care item under group health plans. Employers should consider confirming with their insurance carriers and third-party administrators/administrative services only provider (“TPAs”) to make sure they are complying with these requirements.

Background

Under the Affordable Care Act, group health plans are generally required to cover certain preventive services without cost sharing. These include:

  • Evidence-based items or services that have in effect a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (USPSTF), except for USPSTF recommendations regarding breast cancer screening, mammography, and prevention issued in or around November 2009 (because prior recommendations provided broader coverage);
  • Immunizations for routine use in children, adolescents, and adults recommended by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC);
  • For infants, children, and adolescents, evidence-informed preventive care and screenings provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA); and
  • For women, preventive care and screenings provided in comprehensive guidelines supported by HRSA.

Plans are generally required to cover these items or services on the first plan year beginning on or after the first anniversary of when the recommendation changes. In other words, plans get at least a year after a new recommendation to include the recommended preventive service in plan benefits without cost-sharing.

In June 2019, the USPSTF issued a recommendation regarding the use PrEP as a preventive service. This meant plans were requried to cover PrEP without cost sharing for plan years beginning on or after June 30, 2020.

Where this gets tricky is that the above recommendations are designed for health care providers, not health plans. As a result, sometimes they do not specify details that might be relevant to plan coverage, such as the frequency of the treatment, the method by which it is provided, or the setting in which it should be provided. In that case, plans are allowed to apply reasonable medical management techniques to make such determinations. This can include, for example, covering a generic drug without cost sharing, but applying cost sharing to the brand name drug. However, in some circumstances, it may be medically inappropriate for the individual to take the generic drug. In that case, the plan must have an easily accessible appeal process that will allow the brand drug to be covered without cost sharing.

The FAQs

The FAQs provide some clarification on the method, setting, and other services that plans are required to cover in connection with PrEP. First, coverage without cost-sharing for USPSTF-recommended items or services, like baseline testing and monitoring services, is required. The baseline testing is used to determine if PrEP is appropriate. For example, the USPSTF says PrEP is not appropriate for individuals that already have acute or chronic HIV or if they contract HIV while taking PrEP. The monitoring is part of the “essential support services” the USPSTF recommended in connection with a PrEP prescription. The FAQs list several types of testing and counseling that are included as part of this recommendation, such as Hepatitis B and C testing and adherence counseling. Consistent with other guidance on preventive services, plans must also cover the cost of an office visit for these services, if one or more of these services is the primary purpose of the office visit.

Second, the FAQs confirm that plans must cover the tests and counseling described with the frequency included in the USPSTF recommendation. For example, the recommendation requires HIV testing every three months. The FAQs state it would not be reasonable to restrict HIV testing beyond that limit.

Finally, since the USPSTF recommendation does not specify a PrEP brand name, the FAQs confirm that plans can cover the generic without cost sharing and require cost sharing for the brand version. However, as described above, plans must have an exceptions process that allows individuals to receive the brand name without cost sharing, if necessary. Notably, the FAQs state the exception process must allow the individual to get the PrEP medication the same day as they receive a negative HIV test.

Takeaways

The administration of this requirement will fall primarily to carriers and TPAs. However, employers are ultimately responsible for plan compliance and therefore should consider confirming with their carriers or TPAs that they are covering PrEP in accordance with these guidelines. The FAQs note that the agencies will not take enforcement action against plans that fail to comply with these requirements for 60 days after they were published (i.e., before September 17).

If you have any questions, please contact your HUB Advisor. View more compliance articles in Hub’s Compliance Directory. 

NOTICE OF DISCLAIMER

Neither Hub International Limited nor any of its affiliated companies is a law or accounting firm, and therefore they cannot provide legal or tax advice. The information herein is provided for general information only, and is not intended to constitute legal or tax advice as to an organization’s or individual's specific circumstances. It is based on Hub International's understanding of the law as it exists on the date of this publication. Subsequent developments may result in this information becoming outdated or incorrect and Hub International does not have an obligation to update this information. You should consult an attorney, accountant, or other legal or tax professional regarding the application of the general information provided here to your organization’s specific situation in light of your or your organization’s particular needs.