Patient considering various forms of contraception including the Mirena IUD.
Morgan Rachel Levy—Redux
April 25, 2022 7:00 AM EDT

When the Affordable Care Act passed a decade ago, many women rejoiced: the law required most insurers to fully cover birth control, with no out-of-pocket costs whatsoever. But a decade later, the promise of free contraception remains out of reach for many people.

The reason is buried in the fine print. The law requires insurers to cover, with no copay, at least one form of each of the 18 Food and Drug Administration-approved birth control methods, such as pills, intrauterine devices (IUDs), patches, and rings. If patients have a medical reason for needing a contraceptive that is not fully covered by their plan, insurers must provide an “expedient exceptions process” that allows the patient to get that contraceptive covered. In theory, almost anyone with private insurance should be able to easily access whatever type of birth control they and their provider decides is best for them. But in reality, insurers have refused to fully cover many newer contraceptives, arguing that they already cover an older version in the same category. Patients who want or need those uncovered contraceptives are shunted, advocates say, into lengthy, cumbersome prior authorization processes and often denied coverage or slapped with unexpected costs.

At the heart of the issue is a standoff between two extraordinarily powerful industry forces—Big Pharma vs. Big Insurance—which collectively spent tens of millions of dollars last year lobbying the federal government over this and a multitude of other issues. Drug manufacturers argue that insurers, by refusing to cover newer products, are discouraging innovation. Insurers, for their part, say that they offer enough varieties of contraception to fully comply with the ACA—and that without coverage limits or federal action to control drug prices, insurance plans would become unaffordable. Meanwhile, patient advocates say regular Americans are trapped in the middle, unable to access the free contraception that the law is supposed to guarantee.

Congressional Democrats have taken a side. They are pushing the Biden Administration to issue more specific guidance about the exceptions process and level penalties against insurers that don’t comply—especially as reproductive health care in the U.S. could soon change if the Supreme Court dismantles the national right to abortion this spring.

“The folks that are not able to get the birth control they need are potentially either going without it or going with a method that doesn’t meet their needs,” says Mara Gandal-Powers, director of birth control access and senior counsel for reproductive rights and health at the National Women’s Law Center. “And that is just not the point of this part of the law. The point is … to help people prevent pregnancy when they don’t want to be getting pregnant.”

Patients struggle to access contraception

Last fall, a group of Democratic House committee chairs and then Senators Patty Murray and Ron Wyden sent letters to the Department of Health and Human Services (HHS), Department of Labor and Department of Treasury. In January, the three agencies responded with a FAQ reminding insurers of the ACA’s rules, and warning them that the agencies were “actively investigating” complaints and may take further enforcement action. Then, in February, a group of 34 Democratic Senators sent another letter urging the agencies to develop guidelines for a clear contraceptive exceptions process. Last month, another group of more than 100 House Democrats sent yet another letter, urging more enforcement action and asking the agencies to help make the public aware of the ACA requirement.

Patient advocates say that while they applaud the prolific letter-writing and the agencies’ FAQ, it’s not enough: it’s clear that women across the country are still getting charged for birth control, or having their contraception outright denied. The National Women’s Law Center runs a hotline where people can get help appealing coverage denials, and it is still seeing reports roll in, Gandal-Powers says.

In many cases, patients prefer one type of birth control over another because they have fewer side effects, are safer or more effective, advocates say. About 45% of pregnancies in the U.S. are unintended, and providers note that contraceptives are more likely to be successful at preventing pregnancy if individuals can take them correctly and tolerate any side effects. “It is really important to find the contraception that meets your needs. Otherwise you’re not going to take it,” says Beth Battaglino, a maternal–fetal medicine nurse and CEO of patient advocacy group HealthyWomen.

It’s not clear how widespread the problem is, although millions of women may be affected. A report from the nonpartisan Kaiser Family Foundation last year found that 21% of women with private insurance were still paying some out-of-pocket costs for contraception, and researchers say that violations can have a significant impact on patients. Reports collected by the National Women’s Law Center show that in some cases, patients who could only use a specific kind of birth control for medical reasons found their plan did not cover it at no cost, and did not offer a clear exceptions process, leaving the patients to pay hundreds or thousands of dollars out of pocket. Other complaints said women were charged thousands of dollars for services necessary to administer their contraception.

Additional patient reports separately shared with TIME showed pharmacy benefit managers requiring patients to complete what’s called step therapy, a process in which a patient must try and fail on other drugs before an insurer will cover the requested drug. One letter from CVS Caremark reviewed by TIME told a patient they must try and fail with three other types of birth control before getting their preferred contraceptive covered. Another letter from Express Scripts reviewed by TIME said the patient would only get coverage after they tried and failed at least five other contraceptive agents.

Advocates note that this is not only time consuming and unpleasant for patients, but that the stakes of an unintended pregnancy are higher now for many women around the country. The Supreme Court is expected to reshape the right to abortion in a case this term, and already conservative states have curtailed abortion access ahead of the Court’s decision.

Performers participate in ACT FOR ABORTION in front of the Supreme Court of the United States on Jan. 22, 2022.
Leigh Vogel—Act For Abortion/Getty Images

Murray, the chair of the Senate’s Health, Education, Labor, and Pensions Committee, says she’s been “hyper vigilant” as states have sought to restrict access to reproductive health care. “This is frightening that in 2022, women in this country have to say, ‘Am I going to be able to get the birth control I need? Am I going to be able to decide when and where and how I’m going to have a family?’” Murray tells TIME. She added that insurers should have been complying with the ACA “from day one,” and she hopes that federal agencies will take further action soon. “I really believe since we are seeing such egregious behavior they need to take the next step, put out comprehensive guidance and then have robust enforcement. That’s the only way that insurers will comply with this law.”

HHS and DOL both told TIME they are still actively investigating complaints. Those under the Centers for Medicare and Medicaid Services (CMS) could take six to 12 months, according to an agency spokesperson. “CMS takes complaints regarding contraceptive coverage seriously and is committed to robust enforcement to ensure that insurers and plans comply with the law,” the spokesperson said.

Does limiting coverage hurt innovation?

While the federal investigations into insurers’ decisions continue, advocates and pharmaceutical companies say the future of new birth control products could hang in the balance. “I am concerned that if we don’t see these new products get coverage that’s going to impact how companies think about contraceptive technologies and development over the next decade or 15 years,” Gandal-Powers says.

Some research has shown that when insurance coverage for drugs or vaccines expands, that can lead to more investment in new products. A NBER working paper published in 2020 offered a similar conclusion: when pharmacy benefit managers, which control prescription drug coverage for insurers, began excluding newly approved drugs for coverage around 2012, there was a relative decline in investment in new drugs in the classes that were at greatest risk of being excluded.

That behavior makes economic sense, says Leila Agha, an assistant professor of economics at Dartmouth College and lead author of the paper. “The amount of investment in research and development for new pharmaceutical drugs seems to depend on how profitable those drugs are expected to be. And the profitability of the new drug is going to in turn depend on how many consumers they can expect to purchase it at what price,” she says. “So if you make a drug more expensive by moving it up to a less favorable or less generous tier of your prescription drug plan, or if you exclude it from your prescription drug coverage altogether, it’s reasonable to expect that that drug would then have lower sales, and an expectation of that might affect innovation.”

Insurers’ decision to exclude certain contraceptives puts those manufacturers in a tough spot. Agile Therapeutics, which makes Twirla, a new, low-dose contraceptive patch, acknowledged financial struggles on its fourth quarter and full year 2021 earnings call last month. Chairman and CEO Al Altomari told investors that the Biden administration’s FAQ in January was a good sign and that if insurers change how they are complying with the ACA rules that could help more Twirla prescriptions go through. Evofem Biosciences, which makes Phexxi, a new non-hormonal contraceptive gel, had a similar message on its call. “I don’t want to seem delusional and say, ‘Oh, we don’t think it’s a huge issue.’ But our leadership of our sales team was at our corporate office this week, and we had a very serious come to Jesus about how difficult this is,” CEO Saundra Pelletier said during her call in March. She added that while they hope the situation will improve next year, the company’s pharmaceutical reps have been offering to help providers fill out insurers’ prior authorization forms so that they can get through the lengthy exception process if they do want to prescribe Phexxi.

The drug makers have launched lobbying efforts, too. Evofem spent $240,000 lobbying on “federal health policies pertaining to coverage for contraceptive services” and “access to contraception” last year, while Agile spent $120,000 on the topic and TherapeuticsMD which makes Annovera, a newer vaginal ring, spent $80,000.

Insurers try to control health costs

For their part, health insurers say they follow the law and are not doing anything wrong in limiting which contraceptives are covered at no cost. “Plans cover at least one option without cost sharing—and often much more—in each of the 18 FDA designated categories,” said Kristine Grow, a spokeswoman for America’s Health Insurance Plans (AHIP). “Coverage with some cost sharing, is not the same as not covered – your coverage is still saving you money.” Grow added that it can take time for new contraceptives to be covered because formularies are typically developed several months before each benefit year.

James Chambers, a researcher at the Center for the Evaluation of Value and Risk in Health at Tufts Medical Center, says that insurers have no choice but to limit what drugs are covered. If they don’t, costs would be unmanageable—and those costs would be passed down to consumers. “Health plans have to behave in this way in some regard, because if it was simply a free market, the health system would just explode in terms of the cost of these therapies,” he says.

The U.S. spends more on health care than any other wealthy nation, and efforts to reform prescription drug prices have so far been stalled in Congress. Chambers, who has studied variation in how insurers cover specialty drugs, says ideally the insurance companies would always make their decisions about what to cover in ways that are evidenced based and prioritize patients. But of course, the reality is complicated.

It’s difficult to determine the actual impact of reducing pharmaceutical innovation, researchers say. And even arguments about cost can be complex. Rep. Jackie Speier, co-chair of the Democratic Women’s Caucus, tells TIME that “contraception saves the insurers money.” “When you have contraception, you don’t get pregnant unintentionally, and you don’t have the costs associated with prenatal care and maternity care,” Speier says. “So it’s to their advantage to make sure that women have access to contraception.”

But insurance companies are often focused on more immediate costs, says Steve Lieberman, a health care policy expert at the USC-Brookings Schaeffer Initiative for Health Policy. Insurers have no guarantee a patient is going to stay on the same plan for years, so there’s little incentive for them to consider long-term savings or innovation in drugs that might help lower costs down the line. “Health plans’ interest is lowering the costs as much as they can for medically necessary drugs. And it’s not their concern whether those reimbursements are sufficient to incentivize investors to develop the next generation of drugs,” he says.

Lieberman also notes that if a particular drug is truly innovative and different enough from other products on the market, manufacturers can command high prices and insurers will usually cover it. “The drug companies have better weapons than the health insurers,” he says.

Still, while these forces play out, advocates and lawmakers say patients are caught needing access to their birth control.

“You’re not going to control costs on the backs of women,” Speier says. “You’re going to comply with the law. You don’t have the choice to require a copay for women accessing contraception. So either fix it, or we’ll come back with a sledgehammer if we need to. Hopefully, it won’t be required.”

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Write to Abigail Abrams at abigail.abrams@time.com.

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