November 16, 2024

The Departments also requested comments of various scenarios, including:

  1. If a preferred OTC contraceptive is out of stock, should non-preferred be covered without cost-sharing and an exception process? How should this be documented?
  2. What standards and guidance are helpful to ensure individuals can maintain access to OTC contraceptives without cost sharing out-of-network if in-network providers are not available?
  3. Is additional guidance required for individuals to obtain OTC contraceptives at zero cost sharing outside of the traditional system of network providers without burdensome reimbursement requirements?
  4. How can plans and issuers be incentivized to build a broad network allowing the full range of OTC contraceptives to be available in-network?
  5. How should exceptions process requirements apply to OTC contraceptives, where no provider is involved?

The Departments are also interested in establishing guidance on reasonable medical management techniques for contraception. Plans and issuers “may rely on the relevant clinical evidence base and established reasonable medical management techniques to determine the frequency, method, treatment, or setting for coverage of a recommended preventive health service.”[8] The following would not be considered reasonable or consistent:

  1. Coverage limitations that only allow for a 1-month supply of an OTC oral contraception per instance of dispensing.
  2. Imposing a prescription requirement for OTC contraception as a form of medical management, including requiring an individual to fail first using a prescription-only contraceptive item before providing coverage of an OTC contraceptive item without cost sharing or to require an individual to fail first with numerous prescription or OTC contraceptive items before the plan or issuer approves coverage for a medically necessary OTC contraceptive item.
  3. Age- and gender-based medical management of OTC contraceptive services is reasonable unless the technique relies on a clinical rationale for limiting access to individuals of a certain age or gender and is consistent with FDA approvals of any particular OTC contraceptive product.

Additionally, therapeutic equivalence was proposed as a guardrail against narrow drug formularies regarding contraceptive drugs and drug-led combination products. [9] The guidance proposes “a therapeutic equivalent drug or drug-led combination product would be designated with a code with the first letter “A” in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).”

[8] II. Overview of the Proposed Rules – A. Coverage of Recommended Preventive Services – 2. Coverage of Contraceptive Items – a. Coverage of OTC Contraceptive Items Without Cost Sharing – (2) Reasonable Medical Management Techniques for OTC Contraceptive Services

[9] II. Overview of the Proposed Rules – A. Coverage of Recommended Preventive Services – 2. Coverage of Contraceptive Items – b. Therapeutic Equivalence Approach to Reasonable Medical Management for Contraceptive Drugs and Drug-Led Combination Products

Pages: 1 2 3 4 5