FILE - This illustration provided by Perrigo in May 2023, depicts proposed packaging for the company's birth control medication Opill. U.S. officials have approved the first over-the-counter birth control pill, a major change that will broaden access for women and teenagers. The Food and Drug Administration decision on Thursday, July 13, 2023 means drugmaker Perrigo can sell its once-a-day Opill without a prescription. (Perrigo via AP, File)
FDA approves first over-the-counter birth-control pill
07:31 - Source: CNN
CNN  — 

Dozens of Democratic lawmakers are urging the Biden administration to require private health insurance plans to fully cover the first over-the-counter birth control pill in the United States, which is expected to hit store shelves starting early next year.

The US Food and Drug Administration approved the medication Opill in July, making it the first daily oral contraceptive approved for use in the US without needing a prescription. This over-the-counter birth control pill, which contains only the hormone progestin, is expected to be available in drug stores, convenience stores and grocery stores, as well as online.

It’s still unclear what the retail price of Opill will be and, in a letter obtained by CNN, several dozen Senate Democrats are calling for federal agencies to ensure that private health insurance plans will fully cover the pill without a prescription. The letter, sent Monday morning, was addressed to Health and Human Services Secretary Xavier Becerra, Treasury Secretary Janet Yellen and Labor Secretary Julie Su.

“Over-the-counter birth control has the potential to be a real game-changer for so many women—but only if it’s actually affordable. The Biden Administration can and must do everything possible to get us there, and one major step they can take is requiring insurance companies to cover over-the-counter birth control without out-of-pocket costs or a prescription,” Washington Sen. Patty Murray, an author of the letter, said in an email.

“As someone who worked to pass the Affordable Care Act that mandated no-cost coverage of birth control, I see no reason the ACA’s coverage mandate wouldn’t apply to FDA-approved over-the-counter birth control as well,” she said. “And since over-the-counter birth control may very well become the most convenient contraceptive option for many women, it’s that much more important that we make sure it’s fully covered.”

In the letter, Murray — along with Vermont Sen. Bernie Sanders, Oregon Sen. Ron Wyden, Wisconsin Sen. Tammy Baldwin and 44 of their Senate colleagues — asked the heads of the US departments of Health and Human Services, Treasury and Labor to undertake “additional actions” ensuring coverage for over-the-counter contraceptive products without cost-sharing or the need for a prescription. Those three departments have the authority to require plans to cover over-the-counter contraception.

“The FDA’s approval of Opill is a milestone; however, for an OTC birth control pill to meet its potential and be truly accessible, federal departments must ensure that it is covered without cost-sharing and without the need for a prescription as a condition of coverage,” the lawmakers wrote in their letter.

The letter mentioned that additional training and billing guidance for pharmacists and other health care providers would help these efforts to expand access to over-the-counter contraceptives like Opill.

“To expand access to affordable contraception, we urge the tri-departments to issue new guidance that reflects current HRSA guidelines and clarifies that federally and state-regulated private health plans must cover OTC contraceptive products without cost-sharing, including when purchased without a prescription,” the lawmakers wrote, referring to guidelines from the Health Resources and Services Administration that currently doesn’t include a prescription requirement for coverage of contraception. “We request that you do this as soon as possible.”

‘Cost is a big part of access’

As for how much Opill might cost, a representative at Perrigo, the manufacturer of the drug, said in an email Thursday that “pricing of Opill at the shelf will be at the sole discretion of each retailer. Perrigo has not disclosed its suggested manufacturers retail price at this time. We are committed to ensuring that Opill will be accessible to people who need it, and more details will be shared in the coming months.”

Currently, federal law mandates most private health insurance plans and Medicaid expansion programs to cover the full range of FDA-approved contraceptive methods, but for that coverage, health plans typically say a prescription is needed — and such coverage varies state by state.

As of October, at least six states had passed laws requiring health plans to cover certain oral contraception without a prescription and without cost-sharing, according to a report released last month by the nonprofit KFF.

But in theory, if the three federal departments — HHS, Treasury and Labor — require private health insurers to fully cover over-the-counter contraceptives without a prescription, “this could certainly impact access across the United States and make that coverage more even,” said Michelle Long, an author of the KFF report and senior policy analyst of women’s health policy at KFF.

In June, President Biden issued an executive order directing administration officials to consider new ways to improve access to affordable over-the-counter contraception and to consider new guidance to ensure that private health insurance under the Affordable Care Act covers all FDA-cleared contraceptives without cost sharing.

Then earlier this month, the Departments of Treasury, Labor and HHS issued a “request for information” to gather input from the public regarding the potential benefits and costs of requiring coverage for over-the-counter preventive services, including contraception. The public can submit their comments until December 4.

These public comments will help inform any rules around extending coverage requirements to over-the-counter preventive products and services, including oral contraception.

“It’s one thing to put a law on the books. It’s another thing entirely to figure out the mechanics of it, and how to actually operationalize it,” Long said. “Obviously, cost is a big part of access and how far reaching and effective this OTC pill can be really depends on insurance coverage.”

On Friday, Biden administration officials convened a meeting with private sector leaders — including insurers and pharmacies — to discuss efforts to ensure access to affordable and high-quality contraception. Many of those same organizations are in the process of responding to the “request for information,” said Jennifer Klein, assistant to the President and director of the Gender Policy Council.

“The first daily oral contraceptive will be available for over-the-counter use and we need to make sure that the private sector as well as government actors are doing everything they can to make sure that that contraceptive product gets into the hands of people who need it,” Klein said. “We are looking at all of the options to ensure access.”

‘A full-blown health care crisis’

Without a federal requirement for private health insurers to fully cover over-the-counter contraceptives, consumers wanting to use Opill will have one of two options — pay out of pocket for whatever the retail price of Opill will be or get a comparable contraceptive pill prescribed by their provider with no out of pocket cost as it would be covered by their insurance, said Dana Singiser, a health care policy expert and co-founder of the advocacy nonprofit Contraceptive Access Initiative (CAI).

“On one hand, if you get a prescription, then your contraception is covered by insurance under the ACA. But if you buy it at the retail store over the counter, it’s not covered,” Singiser said. “So, it just makes no sense that a contraceptive product would be covered when you buy it on the shelf as opposed to when you obtain it with a prescription when it has the exact same health benefits.”

Singiser’s organization CAI is in support of the lawmakers’ letter, she said, adding that equitable access to contraception is even more important now, following last year’s Supreme Court Dobbs decision to reverse Roe v. Wade in the United States, which overturned the constitutional right to an abortion.

“We are working to eliminate the unnecessary prescription barrier for oral contraceptives, which Opill did by getting FDA approval to sell their product over the counter. We also need to address the affordability issue by making sure that Opill and other forms of OTC contraception are covered by insurance,” Singiser said.

“We can only really achieve fully equitable access if we address both the prescription barrier and affordability for Opill,” she said. “In the wake of the Dobbs decision, policymakers need to be doing everything possible to make contraception more affordable for pregnancy prevention, for personal autonomy, and for all of the health benefits that contraception offers.”

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In her email, Sen. Murray said the Dobbs decision led to a “health care crisis” and it is among the factors making the push for “accessible and affordable” birth control even more urgent now.

For decades, Murray has pushed for affordable and accessible birth control, and last year, before the approval of Opill, she introduced the Affordability is Access Actreintroducing it in May — which would ensure that insurers fully cover over-the-counter birth control without any fees or out-of-pocket costs.

“The Dobbs decision unleashed a full-blown health care crisis across the country—and in the wake of this disastrous decision that has made pregnancy more dangerous and has caused so many women to suffer, it’s more important than ever that we make sure birth control is as accessible and affordable as possible,” Murray said in her email.

“The truth is, we have always had to fight tooth and nail, and really be vocal about that fight, in order to get women contraception and basic reproductive health care they can actually afford,” she said in part. “This time is no different.”