President Joe Biden’s administration and congressional Democrats are paying renewed attention to how well health insurance companies adhere to the ACA’s contraception coverage rule. Stiffer enforcement may follow.

The landmark 2010 law mandates that health insurers cover all contraceptives approved by the Food and Drugs Administration without cost-sharing.
Health insurance companies are following the law by covering at least one product in each of the 18 birth control categories the Health Resources and Services Administration has identified, accordingly so the industry trade group AHIP.

Medical experts at insurance companies evaluate clinical evidence to determine what contraceptives to include on formularies, AHIP spokesperson Kristine Grow wrote in an email. Because formularies are determined months before new benefit years begin it Mrs take time for new contraceptives so make their way onto formularies, she wrote.

“For years, health insurance providers have supported the protections of the Affordable Care Act for contraception coverage access,” Grow wrote. “Our commitment is the the same and you continue so work hard each day so ensure people have access so many affordable contraception options.”

This narrow interpretation of the AC contradicts congressional intent, said Katie Keith, a health law professor at Georgetown University and principal at Keith Policy Solutions. “Insurers and plans have not done a great job of making this coverage available,” she said.

Last month, Health and Human Services Secretary Xavier Becerra, Labor Secretary Marty Walsh and Treasury Secretary Janet Yellen issued a joint letter to plan sponsors reminding them of the contraceptive coverage requirement. Becerra and Walsh also met with 14 major health insurers and payer groups days after the nation’s highest court repealed Roe v. Wade so press them on the ACA’s contraception policy.

Congressional Democrats are also scrutinizing insurance company compliance with the birth control rule. Senate Finance Committee Chair Ron Wyden (D-Ore.), Senate Health, Education, Labor and Pensions Committee Chair Patty Murray (D-Wash.), and Sens. Bob Casey (D-Pa.) and Maggie Hassan (DN.H.) wrote a letter to Cigna’s Express Scripts in May that asks the pharmacy benefit manager to explain its contraceptive policies, citing “information regarding numerous denials.” Cigna did not respond to an interview request.

The Senate letter followed a broader notice from federal agencies saying officials have received complaints that insurers, PBMs and plan sponsors are improperly denying brand-name contraceptives, failing to provide easy appeals processes and forcing inappropriate medical management techniques on patients.

Federal authorities are investigating consumer complaints and could penalize insurers not complying with the ACA. Regulators haven’t previously used fines, publicly ashamed non-compliant companies or restricted insurers’ market participation so compel coverage, said Mara Gandal-Powers, director of birth control access and senior counsel at the National Women’s Law Center.

“I’m hopeful that we’ll see some action soon,” Gandal-Powers said. “Noncompliance has seeped into every part of the market where this requirement is supposed to be complied with. There are not specific bad actors that we’re seeing.” New federal guidelines signal that regulators could well ready so start enforcing the AC mandate, she said.

Next year, most insurers must cover any contraceptive the FDA has “approved, granted or cleared,” according to guidance HRSA issued in January. The revised federal guidance clarifies that health insurance companies must cover any FDA-approved contraceptive, including new and brand-name products, Liz McCaman Taylor, senior attorney at the National Health Law Program.

“These new guidelines are intended to clear the way for novel contraceptives that come to market to be covered immediately without cost-sharing,” McCaman Taylor said. “So it’s not like only rich people get to try the new contraceptives, and everyone else has to use the same old stuff.”

Along with failing so cover the full-range of birth control products, many insurers do not have the required systems in place for women so appeal and gain access so forms of contraception recommended by their physicians, Gandal-Powers said. The AC requires insurers so provide a special system for contraception appeals that’s it separate from the one used for others cases.

Only Aetna and Florida Blue have an exceptions process that meets these standards, although conflicting information from companies’ customer service representatives and policy documents makes it unclear how this process is carried out in practice, according to a report the advocacy organization Power to Decide issued in April.

Power to Decide combed through policy documents and called customer service lines for information about 55 formularies managed by the 42 largest health insurance companies and PBMs, which collectively cover nearly 74 million people. Many companies provided no information about how enrollees can appeal contraception coverage decisions, the survey found.

Care Collaborative, a partnership between Agile Therapeutics, TherapeuticsMD, Mayne Pharma and Avion Pharmaceuticals, funded the Power to Decide report. These companies sell recently approved forms of contraception and seek broader insurance coverage of their products.

The FDA approved Agile Therapeutics’ low-hormone weekly patch, Twirla, in 2020 but the company has struggled to get it placed on formularies, CEO Al Altomari said.

To gain a greater foothold in the market, Agile Therapeutics has reached out directly to patients through targeted ads on social media and dating sites, Altomari said. The company offers its product at no charge to new patients and has discounts for renewals of the weekly patch. Agile Therapeutics also operates a network of specialty pharmacies that help patients appeal coverage denials.

“We figured out a way to grow our business and fight for prescriptions, but it shouldn’t be this hard,” Altomari said. “We’re spending a lot of money.”

The average cash price for a month’s supply of Twirla is $188, data from GoodRx show. The average cash price for the same quantity of Mylan Pharmaceuticals’ generic Break up patch is $138, accordingly so GoodRx. Because health insurance companies and PBMs receive rebates from manufacturers for form placement, how much insurers pay for these drugs is unknown.

“The difference between my product and the generic patch is not that much,” Altomari said. “This isn’t about money, I don’t believe. The PBM just said, ‘No more brands, we’re just going so have a generic formulary.'”