Insurers and payers are inappropriately using a years-old FDA birth-control chart to limit access to novel contraceptives as the reproductive rights landscape shifts nationwide, consumer advocates and manufacturers said.
Plans are overly reliant upon an FDA birth control method chart - intended as an informational guide for consumers - to dictate which products they'll cover with no cost-sharing to patients, some manufacturers argue. That's made it difficult for companies such as Evofem, which makes the on-demand hormone-free vaginal gel Phexxi, to get insurers and PBMs to cover the product - though providers push back against the notion that they're doing anything to restrict coverage under Affordable Care Act provisions.
The Biden administration is responding, working to shore up reproductive health policies it can control in the wake of the Supreme Court's overturning of Roe v. Wade. That includes, for the first time, threatening investigations into and enforcement actions against health plans that make it difficult - if not impossible - for consumers to obtain the birth control they want at no cost.
"These plans are denying women, not complying with what is a mandate, and they are making up interpretations to not provide women access," said Evofem CEO Saundra Pelletier.
The FDA said its chart is under review, while pointing to Health Resources and Services Administration guidelines as the regulatory basis for detailing the scope of coverage for birth control under the ACA.
The FDA chart is intended to be "a guideline" and isn't supposed to be used by health care plans to decide which drugs are listed on their formularies, Pelletier said, "but the plans are using it as an excuse."
FDA spokesperson Shannon Hatch confirmed that the chart is a "high-level" educational tool that doesn't replace conversations between patients and providers.
"The chart does not serve as a complete list of every individual birth control option," she said.
Problems with birth control coverage began long before the high court's June ruling against Roe. The ACA requires most private health plans to cover contraception at no cost to consumers, however, regulators' and industry's interpretation of the mandate has largely favored generic products over pricier brand names.
That approach, advocates say, has put innovative drugs approved by the FDA within the past decade at a disadvantage - either because they're a first-in-class product with no precedent or they belong to a covered drug class but boast unique formulations or dosages. Patients and their providers can still petition plans to fully cover branded drugs if a doctor deems them medically necessary - a time-consuming process - and federal agencies say they continue to receive reports of noncompliance with the mandate.
The departments of Health and Human Services, Labor and Treasury have redoubled efforts to ensure payers are covering as many birth control options as possible, including a pressure campaign calling on plans and issuers to provide access to contraception at no cost to consumers as required under the law. The departments also issued updated guidance last month to plans and issuers reminding them that federal law requires all FDA-approved birth control methods to be covered with no copays, vowing increased enforcement of the mandate.
Those efforts, along with January guidance responding to complaints about potential violations of the birth control coverage requirement, appear to be the first time regulators have threatened enforcement if insurers don't comply.
"That is actually the most powerful signal that the tri-agencies are sending to PBMs and insurance companies," said Dana Singiser of the Contraceptive Access Initiative.
Insurance plans are allowed to limit zero-cost coverage to specific products, as long as they cover at least one in each birth control method category outlined in federal guidelines. But they're also required to defer to medical providers who recommend a product for a patient, regardless of whether it's listed in the FDA's current birth control guide.
A spokesperson for America's Health Insurance Plans, which represents insurance providers, pointed to a July podcast featuring Kate Berry, the group's senior vice president of clinical innovation and strategic partnership, saying plans cover more than 90 percent of birth control claims "with no cost-sharing at all."
A spokesperson for the Pharmaceutical Care Management Association, the trade group representing PBMs, said that, while the pharmacy middlemen "almost always" favor the use of generics when substantially equivalent versions to branded drugs exist, they'll respect attestations from doctors that another contraceptive drug not on the formulary is "medically necessary" and must be covered at no cost to the consumer.
Before the July guidance, the PCMA spokesperson said, "it was not clear what the government's expectations were for these new products because the categories were established nearly a decade ago."
"PBMs are only involved in negotiating savings for prescription medications and are not involved in coverage determinations for other forms of contraceptives," the spokesperson said.
Brand-name drugs retail at higher prices than generics, making them less attractive for insurers and PBMs to cover, especially at no cost to consumers. Phexxi's average retail price is about $357 for a box of 12 applicators, according to goodRx; Nextstellis, a combination birth control pill made with plant-sourced estrogen that the FDA approved in April 2021, runs about $232 for a month's supply.
But advocates and new drug manufacturers say the cost is besides the point - the ACA requires payers to fully cover the cost of a patient's birth control method, even if it's a branded drug, if their doctor determines it's medically necessary for them to use that product.
The FDA chart's significance can be traced to 2015, when agencies issued guidance requiring PBMs and insurers to cover at least one form of birth control without cost-sharing in each of the 18 method categories included in the agency's guide. But over time, Singiser said, plans found "lots of other ways to skirt compliance and skirt coverage."
"The significance of both the January guidance and the most recent tri-agency guidance is that they are actually getting away from the rigidity of the methods chart," she said.
But federal agencies and advocates say some plans continue to make patients and their providers jump through unreasonable hoops to win coverage of products considered "medically necessary" for them. One approach regulators have deemed unacceptable is requiring patients to "fail first" on other types of birth control before approving coverage, essentially compelling them to document trying other methods their doctor may not recommend for them before securing coverage of the other drug.
Federal guidelines require plans to provide an "easily accessible, transparent and sufficiently expedient exceptions process," such as a standardized form, for patients and providers to obtain coverage and must defer to the doctor's recommendation. Still, makers of drugs that tend to fall under that prior authorization process say it's an administrative burden that can turn providers off on prescribing their products.
"If the payers just implement what's written, I think we'll be in a better spot," said Brant Schofield, executive vice president for corporate development at Mayne Pharma. The company, which makes Nextstellis, has sought to buy down copays for patients who can't get their plans to cover the pill.
To be sure, not every plan initially refuses to cover a patient's preferred birth control. Evofem has reached deals with several payers to either ensure no copay for the drug or to eliminate the prior authorization process.
Liz McCaman Taylor, a senior attorney at the National Health Law Program, conducted her own coverage experiment by having her doctor prescribe her Phexxi.
"To my surprise, it was fully covered with no cost-sharing, so I also think there's a lot of insurer variation as to what they're considering to be new methods that have to be covered with no cost-sharing and what they consider new methods they can slot in under existing methods," she said.
One way regulators could address the longstanding tussle over birth control coverage would be to create a "living document" that would include criteria for establishing new contraception categories, McCaman Taylor said. Drug companies and advocates could then recommend updates whenever new methods enter the market.
Birth control advocates say newer contraceptive products, including those that fall into existing method categories, fill important niches in the market as different formulations can help mitigate potential side effects. Mayne Pharma says Nextstellis, made with a naturally occurring estrogen, boasts low rates of breakthrough bleeding.
And Phexxi, as a non-hormonal option, appeals to women who want to avoid ingesting synthetic hormones, as well as to breast cancer patients who are advised to avoid those drugs.
Makers of new birth control products say they hope that the Supreme Court's abortion ruling convinces plans to do more to make contraception readily available to patients. Pelletier said her company is using the decision when negotiating with payers.
"Do you want to be the plan that's denying women?" she said.