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The first over-the-counter birth control pill is slated to hit drug stores in early 2024, but questions about cost and insurance coverage loom.
The U.S. Food and Drug Administration approved Opill (norgestrel) for preventing pregnancy without a prescription in July, but pill maker Perrigo has yet to announce the price of the contraceptive. So far, only six states require coverage of some OTC birth control methods: California (effective in 2024), Maryland, New Jersey, New Mexico, New York and Washington, according to KFF.
"Affordability is a key piece to ensuring that people have access to birth control and Opill once it is on shelves,"Victoria Nichols, project director of Free the Pill, said during a recent KFF news conference on insurance coverage of OTC birth control. Free the Pill is a coalition that has been advocating for the OTC status of birth control pills for close to two decades.
"A lot of people are used to not paying anything for birth control when it's prescribed, and [all birth control] should be fully covered by insurance in private and public plans,"Nichols noted.
There is a federal policy that requires most private health insurance plans and Medicaid expansion programs to cover all FDA-approved prescription contraceptive methods without a co-pay, but there is not a federal requirement that does the same for nonprescription birth control methods yet, she explained.
To get ahead of any potential access issues before Opill is rolled out, KFF researchers conducted interviews with 80 stakeholders from private insurance plans, state Medicaid programs and chain pharmacies in the states that already require such coverage.
What did they find in their report? People will generally need to get Opill at the pharmacy counter, as opposed to off the shelves, for their plan to cover it. In some private health plans, people may be able to pay for Opill at the cashier and then seek reimbursement from their plan.
"The current system is designed for covering prescription, not OTC, drugs, and there is a lack of uniformity in billing practices which leads to confusion among many key players,"said Michelle Long, a senior policy analyst for Women's Health Policy at KFF.
There's also an awareness gap. "Few plans provide information about this covered benefit to enrollees in enrollee-facing materials,"Long said.
The key is to make the process as seamless as possible, added Nichols. "If you require any additional steps for consumers, it is another barrier, such as requiring them to submit receipts,"she said.
Calling the states that have already enacted benefits for OTC contraceptives "trailblazers,"she said more work is needed to spread awareness about this benefit, and that these efforts may require funding.
There's also a need for greater awareness among pharmacists, said Don Downing, a clinical professor at the University of Washington School of Pharmacy in Seattle.
Pharmacists need to know there is no age restriction and no parental consent needed for Opill (unless such restrictions are imposed in given states), Downing said.
There's no nationally accepted claims processing system for pharmacists to use for OTC contraceptives, he added. Streamlining this process should include creating a universal dummy National Provider Identifier (NPI). An NPI is a unique identification number for health care providers so they can transmit health information.
Another option is for states to issue standing orders, which assert that a pharmacist is not prescribing but just fulfilling a pre-authorized request to provide a product. With standing orders, pharmacists won't be filling out claims information and can't be held liable, as they could be if they were prescribing the product.
Dr. Christine Gilroy, chief medical officer at Express Scripts in Denver, added that pharmacists must be reimbursed appropriately and not overly burdened by any claims submission processes. Their time could be better spent counseling patients and administering vaccines instead of entering copious amounts of information in a database to get reimbursed for Opill, she explained.
More information
KFF has more on OTC birth control pills.
SOURCES: Victoria Nichols, MPH, project director, Free the Pill, Oakland, Calif.; Michelle Long, MPH, senior policy analyst, Women's Health Policy, KFF, San Francisco; Don Downing, clinical professor, University of Washington School of Pharmacy, Seattle; Christine Gilroy, chief medical officer, Express Scripts, Denver; KFF news conference, Sept. 15, 2023