Saturday, October 5, 2024

States seek federal input as they prepare for over-the-counter birth control.

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The Biden administration must update requirements for insurer contraceptive coverage to help states better prepare for the first daily over-the-counter oral birth control pill expected to soon hit US retail shelves, reproductive health groups and policy analysts say.

Opill, which the Food and Drug Administration
in July approved to be offered without a prescription, will be available in stores and online nationwide in “early 2024,” according to
Perrigo Co., the drug’s manufacturer. Reproductive health analysts say the OTC status has the potential to be a game changer in widening access to contraception as states impose abortion bans and other restrictions on reproductive health.

CVS Health Corp. and Walgreens Boots Alliance Inc. have both committed to offering the progesterone-only pill over-the-counter when the drug becomes available.

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 Affordable Care Act, which currently only requires coverage for prescription contraception.

A coalition of Democratic governors is pushing for the Biden administration to expand this requirement to contraception without a prescription, and also adopt a similar policy in Medicare, Medicaid, and other federally funded health insurance plans. Without a clear federal standard, states will be left with a patchwork of health insurance policies that threatens to limit Opill’s reach, especially to low-income and historically marginalized communities, policy analysts and health advocates say.

“Bringing birth control pills over the counter isn’t enough,” said Victoria Nichols, project director of Free the Pill, a coalition and campaign of Ibis Reproductive Health focused on bringing birth control medication over the counter in the US.

“We have to also ensure that it’s equitably accessible and a lot of that comes down to affordable access,” Nichols said in an interview.

Awaiting Federal Action

To expand Opill’s reach across the US population, “what the Biden administration has the opportunity to do is create a uniform policy across all 50 states,” said Dana Singiser, co-founder of the nonprofit Contraceptive Access Initiative and a partner at Keefe Singiser Partners. She served in the Obama 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.

In response, California Gov. Gavin Newsom (D) and other governors part of the multistate coalition Reproductive Freedom Alliance sent 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.”

“As Governors, we see firsthand the need for affordable and accessible reproductive health coverage in our communities,” wrote the governors, who also included Pennsylvania Gov. Josh Shapiro (D) and Massachusetts Gov. Maura Healey (D).

Newsom, along with other alliance members, are “working in close coordination with the Biden-Harris Administration to prepare for Opill coming to market,” Newsom spokesperson Brandon Richards said in an email.

The HHS, which closed its comment period in December, said in an email that the agency is reviewing the feedback it received in hopes of expanding its “understanding of the potential health equity effects of requiring coverage for OTC preventive products, without cost sharing and without a prescription by a health care provider.”

Beyond ACA-regulated plans, the Biden administration can also require the federal Medicaid program, TRICARE, the Federal Employees Health Benefits Program, and the Department of Veterans Affairs “to make sure that they’re using all of their authorities under law to make Opill and other over the counter forms of contraception fully covered by insurance,” Singiser said.

Without clear federal guidance, there’s “really this lack of information” among pharmacists on “how to properly bill for something that isn’t accompanied by a prescription,” said Michelle Long, a senior policy analyst for the women’s health policy program at KFF.

Filling Gaps

Federal guidance on OTC contraceptive coverage can also help address beneficiaries that state regulations aren’t able to reach, analysts and advocates say.

Roughly 60% of US women ages 19 to 64 received employer-sponsored health insurance in 2022, with 19% accessing health coverage through Medicaid, according to
KFF estimates based on US Census Bureau data.

“By having a federal regulation, that would impact people enrolled in both fully insured and self-funded plans, and would fill in that gap that there currently is in these state laws,” Long said.

State coverage requirements are limited to state-regulated health plans and self-funded Medicaid programs. States like California, Maryland, and New York have laws or regulations requiring private health insurance plans regulated by the state to cover some OTC contraception without a prescription, though New York’s requirement only applies to emergency contraception like the morning-after pill.

These three states, along with Illinois, Washington, and others, also have coverage requirements for Medicaid state-only funds, though most apply just to emergency contraception.

California’s Contraceptive Equity Act of 2022, which went into effect this month, requires point-of-sale coverage for over-the-counter FDA-approved contraceptive drugs, devices, and products at in-network pharmacies without cost sharing or medical management restrictions. The California Department of Managed Care told Bloomberg Law it issued letters to health plans in 2022 to inform them of their obligations under this law.

Access for the Uninsured

For those without insurance, there’s a need to make sure Opill is set at an affordable price, analysts and advocates said.

It’s still unclear how much pharmacies and retailers will charge for Opill. Perrigo said in email it would be providing “a manufacturer suggested resale price ahead of Opill becoming available, consistent with its past practice and standard operating procedures.” The company declined to give additional details on these plans.

Representatives for CVS and Walgreens said they had no additional updates on Opill’s timeline for release or its anticipated price.

While 77% of reproductive age women included in
KFF’s 2022 Women’s Health Survey said they would support making birth control pills available without a prescription, only 16% said they would be willing to pay more than $20 per month for the contraception. Of the reproductive age women who were uninsured, 21% said they would pay more than $20 each month.

“It’s important that this is priced affordably and that there are other options for low- and no-cost access to over-the-counter birth control pills,” including manufacturer assistance and other safety net programs, Nichols said.

“It’s a multipronged strategy in terms of ensuring equitable access,” Nichols said.

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