Bloomberg Law: Over-the-Counter Birth Control Fuels Push for Federal Coverage
Democratic governors and reproductive health groups are closely watching whether the Biden administration will soon require health plans to cover the first daily over-the-counter oral birth control pill hitting retail and pharmacy shelves later this month.
Pharmaceutical company Perrigo Co. announced Monday that it had shipped supplies of Opill to major retailers and pharmacies to begin selling the product without a prescription in the coming weeks. The progesterone-only pill has a manufacturer suggested retail price of $19.99 for a one-month supply and $49.99 for a three-month pack.
Opill, which the Food and Drug Administration in July approved to be available over the counter, has been found to be 98% effective at preventing pregnancy when taken as directed, according to Perrigo.
Lawmakers, reproductive health groups, and policy analysts praised the news, calling it a key step toward making birth control more accessible amid a patchwork of state abortion and reproductive health laws. But advocates who have long pushed for access to OTC oral contraceptives say Perrigo’s suggested price could still be a barrier to many low-income individuals.
A coalition of Democratic governors and reproductive health advocacy groups have pushed for the Biden administration to expand the Affordable Care Act’s prescription contraception requirement to also mandate coverage of contraception without a prescription. They also want to see a similar policy adopted in Medicare, Medicaid, and other federally funded health insurance plans.
“It’s vital that all women have equal access to contraception,” New Mexico Gov. Michelle Lujan Grisham (D) said in an emailed statement.
The Department of Health and Human Services told Bloomberg Law on Tuesday that it didn’t have any updates to share on progress toward a new coverage policy.
With states only having authority over state-regulated private health insurance plans or state-only Medicaid funds, a common federal standard for coverage is necessary to help expand Opill’s reach across the country, policy watchers say.
Opill’s availability is cause for “celebration,” but “we also are laser focused on making sure that insurance covers OTC contraception like Opill at no cost, and also that we find alternative pathways for people who don’t have insurance and who have low income,” said Dana Singiser, co-founder of the nonprofit Contraceptive Access Initiative and a partner at Keefe Singiser Partners.
Suggested Price
While Opill’s suggested price is within the range of what many said they would be willing to pay for the medication, reproductive health groups and analysts say the cost is likely still out of reach for many.
About one-third—34%—of reproductive age women included in KFF’s 2022 Women’s Health Survey said they would be willing and able to pay $11-$20 per month for Opill. Only 16% said they would be willing to pay more than $20 per month for the contraception.
Opill’s OTC availability is unlikely to have a major impact on insured patients whose contraception is fully covered by their health plan, but it “could make a difference to those without insurance, who would otherwise have to pay out of pocket to visit a doctor to get a prescription” and “also have to pay out of pocket for the pills themselves,” Karen Diep, a policy analyst for the women’s health policy team at KFF, said in an interview.
But Victoria Nichols, project director of Free the Pill, a coalition and campaign of Ibis Reproductive Health, said “there is still work to be done to ensure that contraception is accessible to every person who wants and needs it.”
“Opill’s suggested retail price will create barriers to access, especially for young people and those working to make ends meet,” Nichols said in an emailed statement.
Perrigo, which also plans to sell Opill online at a price of $49.99 for a three-month supply and $89.99 for a six-month supply, developed its pricing strategy based on input from groups like Free the Pill, as well as the company’s own research, Perrigo Executive Vice President Triona Schmelter said in an interview.
“We crafted a pricing strategy that had all of our consumers in mind,” Schmelter said. The company plans to launch a consumer assistance program by the end of March to help low-income, uninsured individuals pay for Opill at little to no cost, though Schmelter didn’t provide additional details on the program and how much of Opill’s cost it would cover.
Coverage Pathways
Reproductive health groups and analysts used Perrigo’s news as an opportunity to revive calls for the Biden administration to create a uniform federal coverage policy for Opill and other OTC preventative care services.
Eight states either require state-regulated private health insurance plans or state-only Medicaid funds, or both, to cover at least some methods of OTC contraception without a prescription. But these policies don’t apply to reproductive-age women covered by employer-sponsored insurance or other health plans subject to the ACA.
“State law only governs some insurance plans, not all of them, which is why we need that uniform federal standard requiring coverage,” said Singiser, who served in former President Barack Obama‘s White House as a member of the team that worked to get the ACA passed.
In October, the Department of Health and Human Services joined the Department of Labor and the Internal Revenue Service in issuing a request for public input on whether to require insurers to cover OTC birth control and other preventive care services and treatments that don’t require a prescription.
The comment period ended in December, but the HHS has not provided any updates since. Chiquita Brooks-LaSure, administrator of the Centers for Medicare & Medicaid Services, said at a Protect Our Care and NAACP event hosted at Howard University Feb. 29 that the agency will “continue to look at the issue” of whether the CMS could require coverage of OTC contraception without a prescription.
In response to the Biden administration’s RFI, Lujan Grisham joined Pennsylvania Gov. Josh Shapiro (D), California Gov. Gavin Newsom (D), and other governors who are part of the multistate coalition Reproductive Freedom Alliance in sending a letter to the HHS urging the agency to “clarify that the ACA’s preventive health mandate includes no-cost coverage of OTC contraceptives without a prescription.”
“An over-the-counter oral contraceptive without a prescription is a huge step toward improving access,” and “I’m hopeful” the HHS “will continue to expand access even further,” Lujan Grisham said Tuesday.
Proposed rulemaking is one option for the Biden administration to ensure coverage. Other pathways include having a universal billing process for pharmacists to use when Opill is purchased without a prescription at pharmacies, or having a tangible debit card for insurance policyholders to pay for Opill over the counter, Diep said.
Individual states have also taken action. Massachusetts Gov. Maura Healey (D), who signed onto the alliance letter, requested in her most recent state budget a standing order for OTC birth control. This comes in addition to a 2017 state law allowing eligible individuals to access a year’s supply of prescription contraception at no cost with one trip to the pharmacy.
Healey’s administration is focused on breaking down barriers to accessing reproductive health care, including over-the-counter contraceptives, a spokesperson for the governor said in an email Tuesday.
There’s also a push on Capitol Hill to enact an OTC contraceptive coverage requirement through federal legislation. Last year, Sens. Patty Murray (D-Wash.), Mazie Hirono (D-Hawaii), and Catherine Cortez Masto (D-Nev.) introduced the Affordability is Access Act, which would require insurers to fully cover FDA-approved, over-the-counter birth control without any fees or out-of-pocket costs.
“More needs to be done to make sure every American can access and afford the pill over the counter,” the senators said in a joint statement Monday, adding they would be “pushing hard to pass” their bill and “continue fighting to make sure everyone who needs access to birth control can get it, regardless of their income.”