The Affordable Care Act’s embattled requirement to cover contraceptives ought to include the smartphone app that’s FDA-cleared to prevent pregnancy, according to experts. But it’s anyone’s guess how that might work.
The company that makes the app, also called Natural Cycles, clearly thinks insurers might be willing. Its product costs $79 per year or $9.99 per month. Soon, someone will fill an open position at the company and begin liaising with U.S. insurers — including, potentially, Medicaid.
That person will be stepping onto fraught legislative terrain. Under the Affordable Care Act, insurers should cover all FDA-approved contraceptive methods, and the person they are insuring should have no out-of-pocket costs. But that mandate has been repeatedly challenged in the courts and undermined by the executive branch.
It’s reasonably clear that Natural Cycles likely falls under that contraceptive mandate. “This is now an FDA-approved method,” said Mara Gandal-Powers, the director of birth control access and senior counsel at the National Women’s Law Center. “I think it should [be covered].”
The app works by running daily measurements of patient’s resting temperature, or basal body temperature, through an algorithm. Shifts in that temperature can indicate when users are ovulating — and therefore, when they’re at risk of becoming pregnant. According to the company, Natural Cycles is about 93 percent effective at preventing pregnancy. However, questions about the app’s accuracy arose when dozens of people in Sweden reported unplanned pregnancies while using the app. The Swedish Medical Products Agency closed its investigation on Thursday, finding that the app’s “failure rate” matched the one the company laid out in its marketing materials.
Prescription apps are nothing new. But if Natural Cycles must be covered, it will force insurers to address a sticky issue: How, exactly, can insurers cover an app?
Currently, the Health Resources and Services Administration’s Women’s Preventive Services Guidelines include “the full range of contraceptive methods for women,” including the birth control pill, IUDs, and sterilization procedures, as well as “additional methods as identified by the FDA.”
“These seem like ‘additional methods identified by the FDA.’ The question is, as identified where and how — what actually triggers the change?” said Adam Sonfield, a senior policy manager at the Guttmacher Institute. “What’s the official trigger that tells insurance companies they have to cover it now?”
And once that trigger gets pulled, it’s also not clear how long insurers will have to comply. In theory, Sonfield said, it could take as long as a year and a half — that’s how long it would take if the FDA clearance triggered a new requirement for coverage. Plans would get one year from the decision date, plus the time between that one-year time frame and the start of the next year of coverage — which generally happens in December or January.
But figuring out how to do that is going to be a technical challenge — one that Natural Cycles is presumably hoping its new director of market access and reimbursement will handle. According to LinkedIn data, more than 30 people have already applied for the job opening. (The company declined to comment for this article.)
“The way insurance is set up right now, no out-of-pocket costs means you go to the drugstore and you don’t have a copay,” Sonfield said. “There are systems for that that make sense. But we don’t have a system like that for Natural Cycles.
“It’s hard to imagine a system right now that wouldn’t involve after-the-fact reimbursement.”
Of course, figuring out the technicalities assumes a plan would cover birth control in the first place — which, despite the existence of a coverage mandate, is not guaranteed. In 2014, the Supreme Court ruled that for-profit corporations can exempt themselves from the contraceptive mandate if it goes against their owners’ religious beliefs.
The 2014 ruling allowed only “closely held” companies to exempt themselves and required them to still provide coverage using a workaround; the Trump administration attempted to make using that workaround optional on top of expanding which companies could decline to provide birth control to employees and on what grounds in October 2017. That rule is still stuck in a court battle.
Insurers may have more time to figure out whether and how they’ll cover Natural Cycles. “In some ways, it doesn’t matter because you’d need someone to enforce that anyway. And we don’t have someone enforcing that right now,” Sonfield said — at least, not at the federal level.
But ultimately, someone is going to have to dive headfirst into the regulatory weeds. “It’s like adding any new product that’s out there,” Gandal-Powers said. This may be the first truly new category of birth control in a long time, she said, but with other companies working on new things, “I don’t think it will be the last.”