Letter to Delaware legislature suggesting amendments to strengthen PrEP bills under consideration
Delaware House of Representatives
411 Legislative Avenue
Dover, DE 19901
The Honorable Marie Pinkney
Delaware State Senate
411 Legislative Avenue
Dover, DE 19901
Dear Representative Chukwuocha and Senator Pinkney:
The HIV+Hepatitis Policy Institute is a national organization dedicated to promoting quality and affordable healthcare for people living with or at risk of HIV, hepatitis, and other chronic conditions. We strongly support the goal of House Substitute 1 for House Bill 200 to protect and expand access to HIV prevention for Delawareans at risk of HIV, and we appreciate your leadership in sponsoring and advancing this legislation. We are encouraged by its passage in the House and its continued consideration in the Senate.
We have some concerns with the current language that we believe can be addressed as the bill moves forward. In particular, we are concerned that the “medical necessity” coverage standard creates unnecessary ambiguity that could limit access to the full range of PrEP options and may be weaker than current federal guidance. To strengthen the bill and ensure comprehensive, durable access, we recommend three targeted changes: clarifying the coverage standard to require all FDA-approved PrEP medications, strengthening the scope of covered services, and restoring the original 2027 effective date.
Recommendation 1: Explicitly Require Coverage of All FDA-Approved PrEP Medications
Reliance on a “medical necessity” standard introduces ambiguity that could reduce access to newer PrEP options, including long-acting injectable PrEP, which may better meet the needs of certain PrEP users, particularly those who face adherence challenges with daily oral medications. Allowing individuals and their providers to choose the PrEP option that works best for them reflects current best practices in HIV prevention and is consistent with existing federal protections.
Explicitly requiring coverage of “all FDA-approved PrEP medications” is especially important at a time when federal preventive service requirements face ongoing legal and policy uncertainty. By codifying a clear standard that guarantees access to the full range of PrEP options, Delaware can ensure continuity of coverage regardless of potential federal changes and provide certainty for patients, providers, and public health programs. Several states, including California, Illinois, Minnesota, and Oregon, have already adopted this approach by requiring coverage of all FDA-approved PrEP medications without cost or utilization management barriers. The District of Columbia recently enacted legislation with the same coverage standard.
Further, the “medically necessary” coverage standard, if narrowly interpreted by insurers, could mean they cover less PrEP options than current federal law under the Affordable Care Act (ACA).
- Under the ACA, insurers must cover without cost-sharing “A” and “B” rated preventive services by the U.S. Preventive Services Task Force (USPSTF) The USPSTF recommended PrEP with an “A” rating in 2019 (https://bit.ly/3GRsGtw) and updated this recommendation in 2023, which is not drug specific, to include evidence on new PrEP options including Descovy and Apretude, the first long-acting injectable (https://bit.ly/4lEL3Bd).
- In October 2024, the Departments of Labor, Health and Human Services and Treasury issued guidance confirming that all PrEP drugs and services must be covered without cost-sharing. In addition, it makes clear that prior authorization is not allowed for the purpose of steering PrEP users to a specific drug (https://bit.ly/3Uiv2EK)
- This means that at a minimum, at the time of the guidance, all plans must cover Truvada (or its therapeutic equivalent), Descovy and Apretude, and potentially all future PrEP drugs.
- The coverage by all major PBMs of Yeztugo, the new twice-yearly long-acting PrEP drug approved in June 2025 is a recognition that most payers are interpreting the ACA and the guidance to mean all PrEP drugs should be covered without cost-sharing and prior authorization.
Recommendation 2: Clarifying Coverage of the Necessary Services to Receive PrEP
We recommend clarifying the provision requiring coverage of “services related to administering the covered treatment.” As currently drafted, this language may be interpreted narrowly and could exclude services that are essential to effective PrEP and PEP use. Adopting clearer language such as “services integral to the provision of PrEP and PEP,” consistent with California’s approach, would help ensure coverage includes necessary clinical visits, laboratory services, and other components required to initiate and maintain treatment.
Recommendation 3: Restore the 2027 Effective Date
We also recommend restoring the bill’s original effective date of January 1, 2027, as included in Senate Bill 200, rather than delaying implementation to 2028 plan years. Given ongoing legal and policy uncertainty surrounding federal preventive service requirements, this delay risks creating a gap in coverage protections if the U.S. Preventive Services Task Force (USPSTF) recommendation for PrEP were to change or be modified. Maintaining the earlier effective date would help ensure timely, continuous access to PrEP and avoid unnecessary disruption for patients and providers.
For these reasons, we respectfully urge you to amend House Substitute 1 for House Bill 200 to explicitly require coverage of all FDA-approved PrEP medications without cost-sharing or utilization management, clarify the scope of covered services, and restore the original effective date. Doing so will ensure Delawareans have access to the full range of prevention tools needed to effectively reduce HIV transmission.
If you have any questions or need additional information, please contact our Government Affairs Manager, Zach Lynkiewicz, at zlynkiewicz@hivhep.org.
Thank you for your leadership and for your continued commitment to expanding access to HIV prevention in Delaware.
Sincerely,
Carl E. Schmid II
Executive Director