The Departments of Treasury, Labor, and Health and Human Services (Tri-Agencies) have released proposed regulations that, if adopted in their current form, would address a number of issues regarding preventive services as well as expanding over-the-counter (OTC) contraceptive coverage.

• Current preventive coverage requirements include the requirement to cover OTC contraception when prescribed by a medical provider. Under the proposed regulations, plans would be required to cover OTC contraception that can be legally obtained without a prescription, where preventive care guidelines do not require a prescription.
• The regulations would impose a requirement for plans to cover, without cost-sharing, all FDA-approved contraceptives that are drugs or drug-led combination products, except those for which there is at least one therapeutic equivalent.
• The proposed regulations would expand transparency requirements to require plans to provide a statement, upon a plan member’s request for cost-sharing information for any covered contraceptive items or services, a statement explaining that OTC contraceptives are covered, without cost-sharing, without a prescription, and to provide a phone number and link participants can use to get additional information.
• The proposed rules would maintain the ability for plan sponsors to apply reasonable medical management to preventive care with respect to frequency, method, treatment, or setting of care, but add requirements in order for medical management to be considered “reasonable”. Plans would be required to have an exceptions process that
  • is easily accessible, transparent, sufficiently expedient, and not overly burdensome on participant or provider
  • allows a member to receive coverage without cost-sharing for a medically necessary (as determined by the member’s provider) preventive service
• While the proposed regulations, if enacted, would be effective for 2026 plan years, they propose that the requirements regarding exceptions processes should apply on the date the final regulations take effect.
• The Tri-Agencies are seeking comment on whether the provisions applied to OTC contraception in the proposed rules should be extended to some or all other preventive services. The deadline to submit comments is December 27.
• An additional notice of proposed rulemaking regarding preventive services is expected in the near future.