If the therapeutic equivalent drug is documented, the proposal would allow medical management techniques; however, if there is no therapeutic equivalent or drug-led combination product, plans or issuers would NOT be permitted to use medical management techniques.
The following example was provided, which we believe is helpful in understanding:
“If the Orange Book does not identify a therapeutic equivalent for either Pill A or Pill B, but identifies the latter four (Pill W, Pill X, Pill Y, and Pill Z) as therapeutic equivalents of each other, then under these proposed rules, the plan would be required to cover without cost sharing Pill A and Pill B, for which there are no therapeutic equivalents. The plan could utilize reasonable medical management techniques that result in it covering only one of Pill W, Pill X, Pill Y, or Pill Z without cost sharing because all four are therapeutically equivalent to each other.”
However, the Departments recognize in the Orange Book that the FDA does not evaluate therapeutic equivalence for OTC drugs or OTC drug-led combination products, so they are requesting comments on any alternative approaches to determining therapeutic equivalence and what medical management techniques should be considered appropriate.
Communicating OTC Contraceptive Coverage Requirements
The guidance also discusses how consumers should be notified of coverage of OTC contraceptives, considering OTC is often not covered. [10]
One proposal would require plans and issuers to explain coverage for OTC contraceptives whenever an enrollee requests information about any covered contraceptive drug or service. This would include information such as a phone number or internet link so an enrollee could learn more.
The Departments requested comments on several items:
- Should the OTC notification include both phone number and internet link, or just one?
- Whether plans or issuers should be required to include the general names or types of OTC contraceptive items that are covered (for example, “daily oral contraceptive,” “Plan B (levonorgestrel),” or “condoms”).
- Whether plans or issuers should be required to discuss therapeutic equivalents or the exceptions process on the disclosure and how that impacts cost-sharing.
- How challenging will it be to implement and maintain disclosure statements, their effectiveness, and other items to consider for other preventive services?
- Other methods of exposing the public to this information, specifically to vulnerable and underserved communities, including what steps should be taken to access OTC contraceptive items.
[10] II. Overview of the Proposed Rules – II. Overview of the Proposed Rules – B. Communicating OTC Contraceptive Coverage Requirements