Birth control coverage gaps are being scrutinized as the reproductive health landscape changes

“These plans deny women, do not comply with what is mandated, and create interpretations to deny 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 birth control coverage under the ACA.

The FDA’s chart is meant to be a “guideline” and is not supposed to be used by health care plans to decide which drugs to list on their prescriptions, Pelletier said. “But the plans are using that as an excuse.”

FDA spokeswoman Shannon Hatch confirmed that the chart is a “high-level” educational tool that does not replace conversations between patients and providers.

“The chart does not serve as a complete list of every single birth control option,” she said.

Problems with birth control coverage began long before the high court’s decision against June Roe. The ACA requires most private health plans to cover contraception at no cost to consumers, however, interpretation of the mandate by regulators and industry has largely favored generic products over more expensive brands.

That approach, proponents say, has disadvantaged the innovative drugs that have been approved by the FDA over the past decade — either because they are first-in-class products without precedent or because they are in a covered drug class but have unique formulations or dosages. Patients and their providers can still apply for plans to fully cover brand-name drugs if a doctor deems them medically necessary — a time-consuming process — and Federal agencies say they continue to receive reports of non-compliance with the order.

The Departments of Health and Human Services, Labor and the Treasury Department have redoubled efforts to ensure that payers cover as many birth control options as possible, including a lobbying campaign calling on plans and issuers to provide access to contraception at no cost to consumers as required by law. The departments too issued updated guidance last month to plans and issuers reminding them that federal law requires that all FDA-approved birth control methods be covered without copay, promising 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.

“This is actually the strongest message the three agencies are sending to PBMs and insurers,” 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 category of birth control method described in the federal guidelines. But they’re also required to defer to doctors who recommend a product for a patient, regardless of whether it’s listed in the FDA’s current birth control guide.

A spokesman for America’s Health Insurance Plans, which represents insurance providers, pointed to a July podcast with Kate Berry, the group’s senior vice president of clinical innovation and strategic partnerships, saying plans cover more than 90 percent of screening requirements. births “no cost- I share at all.”

A spokesman for the Pharmaceutical Care Management Association, the trade group that represents PBMs, said that while pharmacy intermediaries “almost always” prefer to use generics when there are substantially equivalent brand-name versions, they will respect doctors’ assurances that another contraceptive The non-prescription drug is “medically necessary” and must be covered at no cost to the consumer.

Before July’s guidance, the PCMA spokesman said, “it was not clear what the government’s expectations were for these new products because the categories were created almost a decade ago.”

“PBMs are only involved in negotiating savings for prescription drugs and are not involved in determining coverage 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. The average retail price of Phexxi is about $357 for a box of 12 applications, according to goodRx. Nextstellis, a combination birth control pill made with plant-based estrogen that was approved by the FDA in April 2021, costs about $232 for a month’s supply.

But advocates and new drug makers say cost is beside the point — the ACA requires payers to cover the full cost of a patient’s birth control method, even if it’s a brand-name drug, if their doctor determines that it is medically necessary to use this product.

The importance of the FDA chart can be traced to 2015, when the 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, the plans were found “Many other ways to conform and cover the skirt.”

“The significance of both the January guidance and the more recent three-agency guidance is that they actually break away from the rigidity of the methods chart,” he said.

But federal agencies and advocates say some plans continue to make patients and their providers jump through unnecessary hoops to gain coverage for products deemed “medically necessary” for them. One approach that regulators have found unacceptable is to require patients to “fail first” on other types of birth control before being approved for coverage, effectively forcing them to document trials of other methods their doctor may not recommend before securing coverage. coverage of the other drug.

Federal guidelines require plans to provide an “easily accessible, transparent and reasonably convenient waiver process,” such as a standard form, so patients and providers can get coverage and must follow a doctor’s recommendation. But drugmakers who tend to fall under that prior approval process say it’s an administrative burden that can deter providers from prescribing their products.

“If payers just implement what’s written, I think we’ll be in a better position,” said Brant Schofield, executive vice president of corporate development at Mayne Pharma. The company, which makes Nextstellis, has tried buyout fees for patients who can’t get their plans to cover the pill.

Of course, not every plan initially refuses to cover a patient’s preferred birth control. Evofem has entered into agreements with several payers either to ensure that no kickbacks are made for the drug or to eliminate the prior approval process.

Liz McCaman Taylor, a senior attorney at the National Health Legal Program, conducted her own coverage experiment by asking her doctor to prescribe Phexxi.

“To my surprise, it was fully covered without cost-sharing, so I think there are a lot of differences by insurers in what they consider new methods that should be covered without cost-sharing and what they consider new methods that they can use with existing methods,” he said. .

One way regulators could address the long-running dispute over birth control coverage would be to create a “living document” that would include criteria for defining new categories of contraception, McCaman Taylor said. Drug companies and advocates could then propose 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 because different formulations can help mitigate potential side effects. Mayne Pharma says Nextstellis, made with a natural estrogen, boasts low bleeding rates.

And Phexxi, as a nonhormonal option, is aimed at women who want to avoid ingesting synthetic hormones, as well as breast cancer patients who are advised to avoid these drugs.

Makers of new birth control products say they hope the Supreme Court’s abortion ruling will persuade plans to do more to make contraception readily available to patients. Pelletier said her company uses the decision when negotiating with payers.

“Do you want to be the design that denies women?” he said.

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