Here are five questions in the wake of the FDA’s announcement.
Will Medicaid cover it?
Depends where you live.
A state Medicaid program shares the cost of covering prescription drugs with the federal government. There is some leeway for how Medicaid chooses to handle over-the-counter drug coverage.
The state can cover an over-the-counter drug, but the person must have a prescription to qualify for the federal matching funds.
Still, there are some ways states can get around this requirement to make it easier for people to get the drug.
For instance, a state can give pharmacists the power to prescribe the drug at the pharmacy counter. California enables pharmacists to prescribe prophylaxis, self-administered birth control and the overdose antidote naloxone among other products, according to a report from the legal advocacy group National Health Law Program.
Several prescribe similar contraceptives, which offers a clue as to which Medicaid programs might offer this new drug.
There are at least three state Medicaid programs that use a dummy provider identifier number, which is used to identify health care providers. A pharmacy in one of those states can submit the dummy number in place of a prescriber to get coverage for an emergency contraceptive such as the Plan B pill, according to the think tank KFF.
A 2022 survey conducted by KFF surveyed all states on their Medicaid coverage of family planning benefits. All 41 states that responded and the District of Columbia covered emergency contraception such as Plan B.
However, only seven states offered the Plan B pill without a prescription.
What will commercial and Obamacare plans do?
Emergency contraception such as Plan B may once again provide a window into what plans and the federal government will do.
The Biden administration issued guidance in 2022 that plans are required to cover any FDA-approved emergency contraception, even if it is available over the counter.
This applies to the Plan B pill and the similar pill Ella, which can be more effective.
Plans are also required to cover these drugs without cost-sharing. However, that requirement applies only if the consumer has a prescription.
The Affordable Care Act already requires insurers to cover birth control without any cost-sharing, but again only when there is a prescription.
HHS Secretary Xavier Becerra praised the FDA’s decision but did not elaborate on whether further guidance is coming for plans on coverage.
Will the pills be truly accessible for the people who need them?
Opill’s manufacturer has not yet revealed how much the drug will cost at point of sale without insurance coverage, though it said in a statement that it will be “accessible and affordable to women and people of all ages.”
For the uninsured and those who don’t feel comfortable using their insurance to purchase the pills — such as people in abusive relationships or minors whose parents don’t support them becoming sexually active — that retail price will greatly influence uptake.
A KFF study released in November found that women of reproductive age who say they would use the pills if approved cited a range of reasons, including cost, speed, confidentiality, and not having to schedule a doctor’s visit and a pelvic exam in order to get a prescription. Just 16 percent of those surveyed said they would be able to pay more than $20 per month for the drugs, compared with nearly 40 percent who said they would be able to pay between $1 and $10.
Accessibility will also depend heavily on which retailers choose to stock the drug. While CVS, one of the nation’s largest pharmacy chains, has pledged to carry the pills in its 10,000 locations around the country, other major pharmacy chains have not yet revealed whether they will do so.
Could employers sue due to moral or religious objections?
The Trump administration issued a rule in 2018 that let most employers with a religious or moral objection to birth control get an exemption from the coverage requirement.
The Supreme Court upheld the rule in 2020.
The Biden administration issued a proposed rule in January that removes the moral exemption but keeps the religious one. The proposed rule would also expand use of an accommodation that grants no-cost coverage to employees of a company that has a religious objection.
That rule has yet to be finalized, leaving the Trump regulation still in place.
Could there be other lawsuits?
It’s possible.
A federal district judge’s ruling earlier this year to undo longstanding FDA approval of the abortion drug mifepristone and ban its sale nationwide has raised hopes on the right and fears on the left of future challenges.
Alliance Defending Freedom, the conservative legal group representing medical organizations in that case who say they’ve been harmed by having to care for patients who took mifepristone and experience complications, did not immediately respond to whether they are looking at a similar challenge to the Opill approval.