“These plans are turning women away, not following what is mandated, and making up interpretations to deny women access,” said Evofem Executive Director Saundra Pelletier.
The FDA said its chart is under review, while citing Health Resources and Services Administration guidance as the regulatory basis for detailing the scope of birth control coverage under the ACA.
The FDA chart is meant to be a “guideline” and should not be used by health plans to decide which drugs are listed on their formularies, Pelletier said. “but the plans are using it 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 Supreme Court’s June ruling Rowe. The ACA requires most private health plans to cover contraception at no cost to consumers, but the interpretation of the mandate by regulators and the industry has largely favored generic products over more expensive brands.
That approach, advocates say, has put innovative drugs approved by the FDA over the past decade at a disadvantage — either because they are a first-in-class product without precedent or belong to a covered drug class but boast unique formulations or dosages. Patients and their providers can still petition 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 noncompliance with the mandate.
The Departments of Health and Human Services, Labor and the Treasury have redoubled efforts to ensure that payers cover as many birth control options as possible, including a pressure campaign urging plans and issuers to provide access to contraception at no cost to consumers, as required by law. Departments too issued an updated guide last month to plans and issuers reminding them that federal law requires all FDA-approved birth control methods to be covered at no copay, promising increased enforcement of the mandate.
Those efforts, along with guidance from January in response 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 most powerful signal that the three 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 category of birth control method described in the federal guidelines. But they are also required to obey medical providers who recommend a product for a patient, regardless of whether it is listed in the FDA’s current birth control guidance.
A spokesman for American Health Insurance Plans, which represents insurance providers, pointed to a July podcast featuring Kate Berry, group senior vice president of clinical innovation and strategic partnerships, saying plans cover more than 90 percent of birth control claims “without cost-sharing at all.”
A spokesman for the Pharmaceutical Care Management Association, the trade group representing PBMs, said that while pharmacists “almost always” prefer to use generic drugs when substantially equivalent versions of brand-name drugs exist, they will honor certifications from doctors that another contraceptive drug , which is not on the formulary, is “medically necessary” and must be covered at no cost to the consumer.
Before the July guidelines, the PCMA spokesman said, “it was not clear what the government’s expectations were for these new products, as the categories were established 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 contraception,” the spokesperson said.
Branded 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 applicators, according to goodRx; Nextstellis, a combination birth control pill made with plant-based estrogen approved by the FDA in April 2021, costs about $232 for a monthly supply.
But advocates and new drug makers say price doesn’t matter — 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 it’s medically necessary. point of view to use this product.
The importance of the FDA chart can be traced back 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 guidance . But over time, Singiser said, found plans “many other ways to avoid the fit and coverage of skirts.”
“The significance of both the January guidance and the latest tri-agency guidance is that they actually break away from the rigidity of the method chart,” she said.
But federal agencies and advocates say some plans continue to make patients and their providers jump through unreasonable hoops to gain coverage for products considered “medically necessary” for them. One approach that regulators have found objectionable is requiring patients to “fail first” with other types of birth control before approving coverage, essentially forcing them to document trials of other methods that their doctor may did not recommend them before providing coverage for the other drug.
Federal guidelines require plans to provide an “readily accessible, transparent and reasonably appropriate waiver process,” such as a standardized form, for patients and providers to obtain coverage and must comply with a physician’s recommendation. Still, drugmakers who tend to fall into this prior authorization process say it’s an administrative burden that could dissuade providers from prescribing their products.
“If payers would just implement what’s written, I think we’d be in a better position,” said Brant Schofield, executive vice president of corporate development at Mayne Pharma. The company that makes Nextstellis has tried to buy out copays 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 reached agreements with several payers to ensure either no copayments for the drug or elimination of the prior authorization process.
Liz McCamman Taylor, a senior attorney at the National Health Law Program, conducted her own coverage experiment by getting her doctor to prescribe Phexxi.
“To my surprise, it was fully covered without cost sharing, so I also think there’s a lot of variation among insurers in terms of what they think are new methods that should be covered without cost sharing and what they think are new methods , which they can incorporate into existing methods,” she said.
One way regulators could address the long-running battle over birth control coverage is to create a “living document” that includes criteria for establishing new categories of contraception, McCamman Taylor said. Drug companies and advocates could then recommend updates as new methods come to market.
Birth control advocates say newer contraceptive products, including those that fall into the categories of existing methods, fill important niches in the market because different formulations can help mitigate potential side effects. Mayne Pharma says Nextstellis, made with natural estrogen, boasts low rates of breakthrough bleeding.
And Phexxi, as a non-hormonal option, appeals to women who want to avoid taking synthetic hormones, as well as breast cancer patients who are advised to avoid these drugs.
Manufacturers 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 plan that turns women down?” she said.