Birth Control Coverage Gaps Analyzed as the Reproductive Health Landscape Changes

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“These plans are denying women, not complying with what is a mandate, and they are inventing interpretations to not give access to women,” said the executive director of Evofem, Saundra Pelletier.

The FDA said its chart is under review, though it noted that Health Resources and Services Administration Guidelines as a statutory basis for detailing the scope of birth control coverage under the ACA.

The FDA chart is intended as “a guide” and should not 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 spokeswoman Shannon Hatch confirmed that the chart is a “high-level” educational tool that is not a substitute for conversations between patients and providers.

“The table does not serve as a complete list of each individual birth control option,” he 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, yet regulators and industry’s interpretation of the mandate has largely favored generic products over more expensive brand-name products .

That approach, advocates say, has put innovative FDA-approved drugs at a disadvantage over the past decade, either because they are an unprecedented first-in-class product or belong to a class of covered drugs but feature unique formulations or dosages. Patients and their providers can still request plans to fully cover brand-name drugs if deemed medically necessary by a doctor (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 their efforts to ensure that taxpayers cover as many birth control options as possible. including a pressure campaign call on plans and issuers to provide access to contraceptives at no cost to consumers as required by law. departments as well issued updated guidance last month reminding plans and issuers that federal law requires all FDA-approved birth control methods to be covered without copays, promising further enforcement of the mandate.

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Those efforts, along with guidance from January responding to complaints about potential violations of the birth control coverage requirement, appear to be the first time regulators have threatened to enforce the law if insurers don’t comply.

“That’s actually the most powerful signal that triagencies are sending to PBMs and insurance companies,” said Dana Singiser of the Contraceptive Access Initiative.

Insurance plans may limit zero-cost coverage to specific products, as long as they cover at least one in each birth control category outlined in federal guidelines. But they are also bound to bow to medical providers who recommend a product for a patient, regardless of whether it is listed in current FDA birth control guidance.

A spokesperson 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 partnership, saying the plans cover more than 90 percent of health insurance claims. birth control “at no cost”. share at all.”

A spokesman for the Association for Pharmaceutical Care Management, the trade group that represents PBMs, said that while pharmaceutical intermediaries “almost always” favor the use of generics when substantially equivalent versions of brand-name drugs exist, they will respect the Physicians’ certifications that another non-formulary contraceptive drug is “medically necessary” and should be covered at no cost to the consumer.

Before the July guidance, the PCMA spokesman said “it was unclear 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 prescription drug savings and are not involved in coverage determinations for other forms of contraception,” 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 for Phexxi is about $357 for a box of 12 applicators, according to goodRx; Nextstellis, a combined 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.

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But advocates and new drugmakers say cost is beside the point: The ACA requires payers to fully cover the cost of a patient’s birth control method, even if it’s a brand-name drug, if her doctor determines it’s medically necessary. need to use that product. .

The significance of the FDA chart dates 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 chart. agency guide. But over time, Singiser said, plans were found “many other ways to circumvent compliance and coverage.”

“The significance of both the January guidance and the most recent three-agency guidance is that they are actually moving away from the rigidity of the method table,” he said.

But federal agencies and advocates say some plans continue to make patients and their providers jump through unreasonable hoops to get coverage for products deemed “medically necessary” for them. One approach that regulators have found unacceptable is requiring patients to “fail first” with other types of contraception before approving coverage, essentially forcing them to document trying other methods their doctor doesn’t recommend before securing coverage for the contraceptive. other medication.

Federal guidelines require plans to provide an “easy-to-access, transparent, and sufficiently convenient exception process,” such as a standardized form, for patients and providers to obtain coverage and must yield to the doctor’s recommendation. Still, drugmakers that tend to be bound by that prior authorization process say it’s an administrative burden that can deter providers from prescribing their products.

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

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To be sure, not all plans initially refuse to cover a patient’s preferred birth control. Evofem has entered into agreements with various payers to ensure that there is no copay for the medication or to eliminate the prior authorization process.

Liz McCaman Taylor, a senior attorney with the National Health Law Program, conducted her own coverage experiment by having her doctor prescribe her Phexxi.

“To my surprise, I was fully covered with no cost sharing, so I also think there’s a lot of variation among insurers in what they consider new methods that should be covered without cost sharing and what they consider new methods that can fit in with existing methods. existing,” he said.

One way regulators could address the long-standing fight over birth control coverage would be to create a “living document” that would include criteria for establishing new categories of contraception, McCaman Taylor said. Pharmaceutical companies and advocates could then recommend updates whenever new methods enter the market.

Birth control advocates say newer contraceptive products, including those that fall under existing method categories, fill important niches in the market, as different formulations can help mitigate potential side effects. Mayne Pharma says that Nextstellis, made with a 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 such drugs.

Makers of new birth control products say they hope the Supreme Court’s abortion ruling will convince plans to do more to make contraceptives readily available to patients. Pelletier said his company is using the decision when negotiating with payers.

“Do you want to be the plan that is denying women?” she said.