Coverage of Contraceptive Items
The Departments are concerned that women are not able to use their contraceptive of choice and cited many surveys and studies that showed many issuers are failing to provide coverage for a full range of contraceptive services consistent with Department expectations.[4] Therefore, the guidance proposes expanding the coverage scope for contraception using an incremental approach.
The Departments propose requiring that plans and issuers cover contraceptives available over the counter (OTC) without cost-sharing or requiring a prescription. OTC contraceptive products include but are not limited to, contraceptive sponges, spermicides, emergency contraception (levonorgestrel), and daily oral contraceptives, which have FDA approval. [5] Comments were also requested regarding a plan’s experience regarding the challenges of covering OTC products without a prescription or how this affects the ability to negotiate the price of OTC products.
Also, for a plan or issuer’s medical management techniques to be considered reasonable, a therapeutic approach is required to be applied to contraceptive drugs and drug-led products. Definitions for therapeutic approach and drug-led products were also proposed as:
- Drug-led combination product “means a combination product, as defined under 21 CFR 3.2(e), that comprises a drug and a device, and for which the drug component provides the primary mode of action.”
- Therapeutic equivalent has the meaning given the term therapeutic equivalents in 21 CFR 314.3(b), which “are approved drug products that are pharmaceutical equivalents for which bioequivalence has been demonstrated, and that can be expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.”[6]
The Departments requested comments on whether these proposals should only be included regarding contraceptives or if they should be applied to all preventive services (or a larger subset of preventive services), consistent with the goal of “minimizing barriers to coverage and expanding the scope of coverage without cost sharing for all recommended preventive services.” Tobacco cessation was mentioned as a preventive service that could benefit.
The proposed rule does not require preventive services to be provided out-of-network or at no cost-sharing out-of-network unless there are no providers in the network who can provide a recommended preventive service. [7] A discussion regarding pharmacies was included, whereby the rule acknowledges that retail stores that include pharmacies may not be considered in-network. Therefore, if contraceptives were purchased at the retail store, they would be considered out-of-network, and coverage would not be required. However, if purchased at the pharmacy, they would be covered at no cost-sharing. Additionally, contraceptive coverage is expected to be provided consistent with other preventive services.
[4] II. Overview of the Proposed Rules – A. Coverage of Recommended Preventive Services – 2. Coverage of Contraceptive Items
[5] 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
[6] https://www.ecfr.gov/current/title-21/chapter-I/subchapter-D/part-314/subpart-A/section-314.3
[7] 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 – (1) In-Network and Out-of-Network Coverage of OTC Contraceptive Items