Apps as birth control: What providers and insurers need to know

FDA clearance may not mean that apps are more effective than manual ovulation tracking.
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Hannah Minn

5 min read

There’s an app for everything these days: food delivery, pet sitting, and…birth control?

The market for women’s health apps, which can include tracking periods, pregnancy, and fertility, was expected to hit $3.9 billion by 2026, according to a 2019 study from Grand View Research. The FDA has cleared two apps to function as contraception (with more likely on the way). Yet, the idea of apps as contraception or fertility tracking has prompted ongoing questions about ob-gyns and insurers potentially covering these devices.

Most of the contraceptive and fertility apps on the market fall under the fertility-based awareness method (FAM) of the birth control umbrella.

The FAM method is not new.

For at least a century, people have used calendars to track menstrual cycles for family planning. What is new, though, is the use of apps and special basal temperature-tracking devices—aka more expensive tech than a simple calendar and drugstore thermometer.

FDA clears apps based on similarities

Natural Cycles, the controversial app that uses an algorithm to identify when a user is likely to be fertile, became the first FDA-cleared app for contraception in 2018 and that received some online criticism from users right after. (Clarifications have since been added to the app and its instructions, and company spokesperson Lauren Hanafin told Healthcare Brew, “As shown in numerous clinical and real-life effectiveness studies—including those evaluated by the FDA—Natural Cycles is 93% effective with typical use and 98% effective with perfect use. The higher effectiveness rate than other FAMs is due to a variety of reasons, including the removal of human error.”)

Some apps that track fertility data are still attracting consumers despite the mounting calls for people who can give birth to delete their data from these apps after the Dobbs decision.

Flo, a period- and ovulation-tracking app, has over 250 million users worldwide. Stardust, a lunar-themed period tracking app, had more than 440,000 downloads in the US the week of the Dobbs decision last year, according to data firm Statista. Natural Cycles has 2 million registered users and has been “seeing quite significant growth year over year,” company spokesperson Lauren Hanafin told Healthcare Brew.

The apps aren’t always free: A Natural Cycles subscription costs $99.99 a year (including the basal thermometer), and can be used with the Oura smart ring, which is an additional $299. The FDA cleared the app to be paired with third-party wearable devices such as the Oura ring in 2021.

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Flo’s free version includes period- and ovulation-tracking features, though a $50 annual subscription includes pregnancy tracking and other premium features. The Stardust app is free to download.

Other basal temperature-tracking devices have hit the market since the FDA cleared the Natural Cycles app (even the newest Apple Watch 8 can track basal body temperature for ovulation).

Clue became the second FDA-cleared app for birth control in 2021. The FDA cleared the app, noting that it was “substantially equivalent” to previously cleared tech on the market, per the FDA application.

More apps are expected to receive FDA approval through this process, which could raise some concerns, The Verge reported.

How does temperature-tracking tech work?

Planned Parenthood estimates that FAMs are usually 77%–98% effective.

Multiple factors, such as illness and even sleep disturbances, can manipulate basal body temperature data and make the method less accurate, said Aparna Sridhar, an ob-gyn at UCLA Health.

Plotting the data by hand can be just as effective as an app, but the app could help patients who may not be able to interpret the data, she said.

“The technology is not nuanced to understand each individual variation in the menstrual cycle,” Sridhar said. “So you have to be a little bit careful about completely relying on something because the consequence can be an unintended pregnancy.”

And as more states restrict access to abortion and ob-gyn access becomes scarce in some regions, an unintended pregnancy can be potentially dangerous.

Contraception covered by insurance

As of 2021, only Maryland, Illinois, and Washington, DC, cover birth control apps across their Medicaid eligibility pathways, according to a Kaiser Family Foundation survey. Medicaid coverage can also depend on whether the app is considered over the counter (OTC) or prescription. Coverage of OTC contraception varies from state to state.

Most private insurance plans and Medicaid expansion state programs must cover any prescribed “FDA approved, cleared, or granted contraceptive product,” according to 2022 federal guidance.

Sridhar said she caters birth control preferences, both hormonal and non-hormonal, to each patient.

“I believe strongly that a birth control is something that a particular person wants to use by fully understanding the risks, the benefits, the effectiveness, and the downsides,” she said.

Correction 3/2/23: A previous version of this story noted apps as having FDA approval, when they had FDA clearance. An additional comment from Natural Cycles’ spokesperson Lauren Hanafin has also been added at the company’s request.

Navigate the healthcare industry

Healthcare Brew covers pharmaceutical developments, health startups, the latest tech, and how it impacts hospitals and providers to keep administrators and providers informed.