“These plans deny women, do not comply with their obligations, and fabricate interpretations that do not provide them with access,” said Saundra Pelletier, CEO of Evofem.

The FDA said its chart is under review, pointing to the Department of Health Resources Services’ guidelines as the regulatory basis for detailing contraceptive coverage under the ACA.

The FDA charts are intended to be “guidelines,” Pelletier said, and are not intended for use by health care plans to determine which drugs are included in their formularies. “But the plan is using that as an excuse.”

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

“The chart does not serve as a complete list of individual contraceptive options,” she said.

Birth control issues began long before the High Court ruled in June eggThe ACA requires most private health insurance to cover birth control at no cost to consumers, but regulatory and industry interpretations of the mandate greatly favor generic products over more expensive brand names. I support you.

That approach has penalized innovative drugs approved by the FDA within the past decade, proponents say. Dose. Patients and their providers can petition for a full branded drug coverage plan if the physician deems the branded drug to be medically necessary. This is a time consuming process. Federal agencies say they continue to receive reports of non-compliance.

The Departments of Health and Human Services, Labor and Treasury have doubled down on efforts to ensure payers cover as many contraceptive options as possible. This includes pressure campaigns on plans and publishers to provide access to contraception at no cost to consumers. law.department too Publish updated guidance .

These efforts, along with January guidance addressing complaints about potential violations of contraceptive cover requirements, appear to be the first time regulators have threatened enforcement if insurers fail to comply.

“This is the strongest signal that the three agencies are sending to PBMs and insurers,” said Dana Singiser of the Contraceptive Access Initiative.

Insurance plans are permitted to limit zero-cost coverage to specific products as long as they cover at least one in each category of contraceptive methods outlined in federal guidelines. However, you should also follow your health care providers who recommend products to their patients, whether or not they are listed in the FDA’s current contraceptive guide.

A spokesperson for America’s Health Insurance Plans, which represents insurers, points to a July podcast featuring Kate Berry, the group’s senior vice president of clinical innovation and strategic partnerships, that plans claim more than 90% of birth control claims. “Cover at no cost”. Share at all. ”

A spokesman for the Pharmaceutical Care Management Association, the industry group representing PBM, said pharmacy intermediaries “almost always” support the use of generics when a substantially equivalent version of the branded drug exists. He said he respects the testimony from doctors that another contraceptive is another contraceptive. Medicines that are not on the formulary are “medically necessary” and must be covered free of charge by the consumer.

Ahead of the July guidance, a PCMA spokesperson said, “The government’s expectations for these new products were unclear as the category was established almost a decade ago.”

“PBM is only involved in negotiating savings on prescription drugs and is not involved in determining coverage for other forms of contraceptives,” the spokesperson said.

Branded drugs are sold at higher prices than generic drugs, making them less attractive to be covered by insurance companies and PBMs, especially free to consumers. The average retail price of Phexxi is around $357 for a box of 12 applicators, according to goodRx. Nextstellis, an oral contraceptive combination made with plant-based estrogen, approved by the FDA in April 2021, costs about $232 for a month’s supply.

But advocates and drug makers say the costs are out of proportion. The ACA requires payers to bear the full cost of a patient’s method of contraception, even if it is a branded drug, if the physician determines that use of the product is medically necessary. there is .

The importance of the FDA chart can be traced back to 2015. At that time, guidance was issued requiring PBMs and insurers to cover at least one form of contraception at no cost in each of the 18 method categories included in the agency’s guide.But as time went on, a plan was found, singer said “There are many other ways to avoid compliance and avoid coverage.”

“The significance of both the January guidance and the most recent triageal guidance is that they’re really moving away from the rigidities of the method chart,” she said.

But federal agencies and advocates say some plans continue to make unwarranted efforts for patients and their providers to obtain coverage for products deemed “medically necessary.” says. One approach deemed unacceptable by regulators is to require patients to “fail first” with other types of contraceptives before approving insurance coverage, essentially Force patients to document trying other methods that may not be recommended by a physician before ensuring coverage of other medications.

Federal guidelines call for plans to provide “easily accessible, transparent, and well-suited exception processes,” including standardized forms for patients and providers to obtain coverage, and for physicians. Recommendations should be followed. Still, drug makers, who tend to fall under that pre-approval process, say it’s an administrative burden that could cause providers to refuse to prescribe their products.

Brant Schofield, executive vice president of corporate development at Mayne Pharma, said: The company that makes Nextstellis is trying to buy out copays for patients who can’t make plans to cover their pills.

Certainly not all plans initially refuse to cover the patient’s preferred contraception. Evofem has struck deals with several payers to ensure no copayment for drugs or eliminate the pre-approval process.

Liz McCaman-Taylor, senior attorney for the National Health Act Program, conducted her own press experiment by having her doctor prescribe Fexy.

“Surprisingly, it was fully covered without cost sharing, so I don’t know what they think is the new way it should be covered without cost sharing, and what they think. , I think there are a lot of variations for insurance companies … new methods that can be incorporated underneath existing methods,” she said.

One way regulators can address the long-standing controversy over the scope of birth control is by creating a “living document” containing criteria for establishing new contraceptive categories, McCaman Taylor said. Pharmaceutical companies and advocates can recommend updates whenever new methods enter the market.

Contraceptive advocates say new contraceptive products, including those that fall into categories of existing methods, will fill an important niche in the market as different formulations help reduce potential side effects.Mayne Made with naturally occurring estrogen, Nextstellis boasts low breakthrough bleeding rates, according to Pharma.

Fexi as a non-hormonal alternative also appeals to women who want to avoid taking synthetic hormones and breast cancer patients who have been advised to avoid these drugs.

Manufacturers of new contraceptive products hope the Supreme Court’s abortion ruling will further persuade plans to make contraceptives readily available to patients. He said he uses this decision when negotiating.

“Do you want to be a plan to deny women?” she said.



Source link

By admin1