Birth control coverage gaps under scrutiny as reproductive health landscape changes

“These plans are denying women, they’re not fulfilling what’s mandated, and they’re making interpretations to not provide access to women,” said Saundra Pelletier, CEO of Evofem.

The FDA said its chart is under review, though it pointed to Health Services and Resources Administration guidelines as the regulatory basis for detailing the scope of birth control coverage under the ACA.

Pelletier said the FDA’s chart is intended to be “a guideline” and is not supposed to be used by health care plans to decide which drugs to list on their formularies. “But the plans use 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 comprehensive list of all individual birth control options,” 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, but regulators’ and industry’s interpretation of the mandate has largely favored generic products over more expensive brand names.

That approach, advocates say, has put breakthrough drugs approved by the FDA over the past decade at a disadvantage, either because they are an unprecedented first-in-class product or because they belong to 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 mandate violations.

The Departments of Health and Human Services, Labor and Treasury have redoubled efforts to ensure payers cover as many birth control options as possible, including a lobbying campaign calling on plans and issuers to provide access to no-cost contraceptives cost to consumers, as required by regulation. law The departments too has published an updated guide last month to plans and issuers reminding them that federal law requires all FDA-approved birth control methods to be covered without copayments, promising greater compliance with 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 most powerful signal that the three agencies are sending to PBMs and insurance companies,” said Dana Singiser of the Contraceptive Access Initiative.

Insurance plans can limit zero-cost coverage to specific products, as long as they cover at least one in each category of birth control methods described in federal guidelines. But they are also required to defer to 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 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 birth control claims “no cost-sharing at all”.

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

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

“PBMs are only involved in negotiating savings for prescription drugs 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 to insurers and PBMs, 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 combined birth control pill made with plant-based estrogen that was approved by the FDA in April 2021, is about $232 for a month’s supply.

But advocates and new drug makers say cost isn’t important: 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 your doctor determines that it is medically necessary for you 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 guide. But over time, Singiser said, plans were found “Many other ways to avoid compliance and skirt coverage.”

“The significance of both the January guidance and the more recent tri-agency guidance is that they are actually moving away from the rigidity of the method chart,” 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 deemed unacceptable is requiring patients to “fail first” on other types of birth control before being approved for coverage, essentially requiring them to document trying other methods that their doctor doesn’t recommend before to ensure coverage of the other medication.

Federal guidelines require plans to provide an “accessible, transparent and reasonably convenient waiver process,” such as a standardized form, for patients and providers to obtain coverage and must adhere to a physician’s recommendation . Still, drugmakers who typically undergo this prior authorization process say it’s an administrative burden that can prevent providers from prescribing their products.

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

By the way, not all plans initially refuse to cover a patient’s preferred birth control. Evofem has reached agreements with several payers to ensure there is no co-payment 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 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 from the insurer in terms of what new methods they consider to be covered without cost-sharing and what they consider. new methods that they can incorporate into existing methods,” he said.

One way regulators could address the long-running 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. Drug companies and advocates could recommend updates whenever new methods enter the market.

Birth control advocates say newer birth control products, including those in 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, has low bleeding rates.

And Phexxi, as a non-hormonal option, appeals to women who want to avoid ingesting synthetic hormones, as well as breast cancer patients who are advised to avoid these drugs.

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

“Do you want to be the plan that denies women?” she said

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