Request for Comment on DRAFT Proposed Amended Regulation 4-2-73 Concerning Human Immunodeficiency Virus Pre-Exposure Prophylaxis Prescription Drugs and Amended Bulletin No. B-4.112 Policy Directives for Coverage of HIV

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The Division is seeking comments on the following draft proposed amended regulation and bulletin:

The purpose of this regulation is to establish the requirements for individual and group health benefit plans to provide coverage for human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP) as well as baseline and monitoring services in accordance with Article 16 of Title 10 of the Colorado Revised Statutes, and the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, 124 Stat. 119 (2010) and the Health Care and Education Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat. 1029 (2010), together referred to as the “Affordable Care Act” (ACA).

This regulation is being amended to incorporate the updated 2023 USPSTF recommendation related to coverage of PrEP.

Colorado law, 10-16-104(18) C.R.S., requires insurers, excluding grandfathered health plans, to cover items or services that have a rating of “A” or “B” in the current recommendations of the United States Preventive Services Task Force (“USPSTF”) without cost-sharing. In June 2019, the USPSTF issued an “A”-rated recommendation that clinicians offer pre-exposure prophylaxis (PrEP) with effective antiretroviral therapy to persons who are at high risk of human immunodeficiency virus (HIV) acquisition. This recommendation was updated in August 2023 to include two additional FDA-approved formulations of PrEP, and to clarify that the recommendation applies to all sexually active adults and adolescents weighing at least 35 kg (77 pounds) who do not have HIV and are at increased risk of HIV transmission. The 2023 USPSTF recommendation continues to recommend previously approved FDA-approved PrEP formulations, as well as baseline and monitoring services.

This bulletin is being amended to incorporate updated federal guidance related to the coverage of PrEP.

Please submit your comments on this draft proposed amended regulation and bulletin no later than 5 PM, January 16, 2025 to DORA_INS_RulesandRecords@state.co.us.

This draft proposed amended regulation and bulletin, as well as other draft regulations and bulletins currently released for informal public comment, can be found on the Division's DRAFT Regulations and Bulletins for Informal Public Comment website.

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