A much-awaited treatment for postpartum depression, zuranolone, hit the market in December, promising an accessible and fast-acting medication for a debilitating illness. But most private health insurers have yet to publish criteria for when they will cover it, according to a new analysis of insurance policies.

The lack of guidance could limit use of the drug, which is both novel — it targets hormone function to relieve symptoms instead of the brain’s serotonin system, as typical antidepressants do — and expensive, at $15,900 for the 14-day pill regimen.

Lawyers, advocates, and regulators are watching closely to see how insurance companies will shape policies for zuranolone because of how some handled its predecessor, an intravenous form of the same drug called brexanolone, which came on the market in 2019. Many insurers required patients to try other, cheaper medications first — known as the fail-first approach — before they could be approved for brexanolone, which was shown in early trials reviewed by the FDA to provide relief within days. Typical antidepressants take four to six weeks to take effect.

“We’ll have to see if insurers cover this drug and what fail-first requirements they put in” for zuranolone, said Meiram Bendat, a licensed psychotherapist and an attorney who represents patients.

Most health plans have yet to issue any guidelines for zuranolone, and maternal health advocates worry that the few that have are taking a restrictive approach. Some policies require that patients first try and fail a standard antidepressant before the insurer will pay for zuranolone.

In other cases, guidelines require psychiatrists to prescribe it, rather than obstetricians, potentially delaying treatment since OB-GYN practitioners are usually the first medical providers to see signs of postpartum depression.

Advocates are most worried about the lack of coverage guidance.

“If you don’t have a published policy, there is going to be more variation in decision-making that isn’t fair and is less efficient. Transparency is really important,” said Joy Burkhard, executive director of the nonprofit Policy Center for Maternal Mental Health, which commissioned the study.

With brexanolone, which was priced at $34,000 for the three-day infusion, California’s largest insurer, Kaiser Permanente, had such rigorous criteria for prescribing it that experts said the policy amounted to a blanket denial for all patients, according to an NPR investigation in 2021.

KP’s written guidelines required patients to try and fail four medications and electroconvulsive therapy before they would be eligible for brexanolone. Because the drug was approved only for up to six months postpartum, and trials of typical antidepressants take four to six weeks each, the clock would run out before a patient had time to try brexanolone.

An analysis by NPR of a dozen other health plans at the time showed Kaiser Permanente’s policy on brexanolone to be an outlier. Some did require that patients fail one or two other drugs first, but KP was the only one that recommended four.

Miriam McDonald, who developed severe postpartum depression and suicidal ideation after giving birth in late 2019, battled Kaiser Permanente for more than a year to find effective treatment. Her doctors put her on a merry-go-round of medications that didn’t work and often carried unbearable side effects, she said. Her doctors refused to prescribe brexanolone, the only FDA-approved medication specifically for postpartum depression at the time.

“No woman should suffer like I did after having a child,” McDonald said. “The policy was completely unfair. I was in purgatory.”

One month after NPR published its investigation, KP overhauled its criteria to recommend that women try just one medication before becoming eligible for brexanolone.

Then, in March 2023, after the federal Department of Labor launched an investigation into the insurer — citing NPR’s reporting — the insurer revised its brexanolone guidelines again, removing all fail-first recommendations, according to internal documents recently obtained by NPR. Patients need only decline a trial of another medication.

“Since brexanolone was first approved for use, more experience and research have added to information about its efficacy and safety,” the insurer said in a statement. “Kaiser Permanente is committed to ensuring brexanolone is available when physicians and patients determine it is an appropriate treatment.”

“Kaiser basically went from having the most restrictive policy to the most robust,” said Burkhard of the Policy Center for Maternal Mental Health. “It’s now a gold standard for the rest of the industry.”

McDonald is hopeful that her willingness to speak out and the subsequent regulatory actions and policy changes for brexanolone will lead Kaiser Permanente and other health plans to set patient-friendly policies for zuranolone.

“This will prevent other women from having to go through a year of depression to find something that works,” she said.

Clinicians were excited when the FDA approved zuranolone last August, believing the pill form, taken once a day at home over two weeks, will be more accessible to women compared with the three-day hospital stay for the IV infusion. Many perinatal psychiatrists told NPR it is imperative to treat postpartum depression as quickly as possible to avoid negative effects, including cognitive and social problems in the baby, anxiety or depression in the father or partner, or the death of the mother to suicide, which accounts for up to 20% of maternal deaths.

So far, only one of the country’s six largest private insurers, Centene, has set a policy for zuranolone. It is unclear what criteria KP will set for the new pill. California’s Medicaid program, known as Medi-Cal, has not yet established coverage criteria.

Insurers’ policies for zuranolone will be written at a time when the regulatory environment around mental health treatment is shifting. The U.S. Department of Labor is cracking down on violations of the Mental Health Parity and Addiction Equity Act of 2008, which requires insurers to cover psychiatric treatments the same as physical treatments.

Insurers must now comply with stricter reporting and auditing requirements intended to increase patient access to mental health care, which advocates hope will compel health plans to be more careful about the policies they write in the first place.

In California, insurers must also comply with an even broader state mental health parity law from 2021, which requires them to use clinically based, expert-recognized criteria and guidelines in making medical decisions. The law was designed to limit arbitrary or cost-driven denials for mental health treatments and has been hailed as a model for the rest of the country. Much-anticipated regulations for the law are expected to be released this spring and could offer further guidance for insurers in California setting policies for zuranolone.

In the meantime, Burkhard said, patients suffering from postpartum depression should not hold back from asking their doctors about zuranolone. Insurers can still grant access to the drug on a case-by-case basis before they formalize their coverage criteria.

“Providers shouldn’t be deterred from prescribing zuranolone,” Burkhard said. 

This article is from a partnership that includes KQED, NPR and KFF Health News.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

Jamie Holmes says a surgery center tried to make her pay for two operations after she underwent only one. She refused to buckle, even after a collection agency sued her last winter.

Holmes, who lives in northwestern Washington state, had surgery in 2019 to have her fallopian tubes tied, a permanent birth-control procedure that her insurance company agreed ahead of time to cover.

During the operation, while Holmes was under anesthesia, the surgeon noticed early signs of endometriosis, a common condition in which fibrous scar tissue grows around the uterus, Holmes said. She said the surgeon later told her he spent about 15 minutes cauterizing the troublesome tissue as a precaution. She recalls him saying he finished the whole operation within the 60 minutes that had been allotted for the tubal ligation procedure alone.

She said the doctor assured her the extra treatment for endometriosis would cost her little, if anything.

Then the bill came.

The Patient: Jamie Holmes, 38, of Lynden, Washington, who was insured by Premera Blue Cross at the time.

Medical Services: A tubal ligation operation, plus treatment of endometriosis found during the surgery.

Service Provider: Pacific Rim Outpatient Surgery Center of Bellingham, Washington, which has since been purchased, closed, and reopened under a new name.

Total Bill: $9,620. Insurance paid $1,262 to the in-network center. After adjusting for prices allowed under the insurer’s contract, the center billed Holmes $2,605. A collection agency later acquired the debt and sued her for $3,792.19, including interest and fees.

What Gives: The surgery center, which provided the facility and support staff for her operation, sent a bill suggesting that Holmes underwent two separate operations, one to have her tubes tied and one to treat endometriosis. It charged $4,810 for each.

Holmes said there were no such problems with the separate bills from the surgeon and anesthesiologist, which the insurer paid.

Holmes figured someone in the center’s billing department mistakenly thought she’d been on the operating table twice. She said she tried to explain it to the staff, to no avail.

She said it was as if she ordered a meal at a fast-food restaurant, was given extra fries, and then was charged for two whole meals. “I didn’t get the extra burger and drink and a toy,” she joked.

Her insurer, Premera Blue Cross, declined to pay for two operations, she said. The surgery center billed Holmes for much of the difference. She refused to pay.

Holmes said she understands the surgery center could have incurred additional costs for the approximately 15 minutes the surgeon spent cauterizing the spots of endometriosis. About $500 would have seemed like a fair charge to her. “I’m not opposed to paying for that,” she said. “I am opposed to paying for a whole bunch of things I didn’t receive.”

The physician-owned surgery center was later purchased and closed by PeaceHealth, a regional health system. But the debt was turned over to a collection agency, SB&C, which filed suit against Holmes in December 2023, seeking $3,792.19, including interest and fees.

The collection agency asked a judge to grant summary judgment, which could have allowed the company to garnish wages from Holmes’ job as a graphic artist and marketing specialist for real estate agents.

Holmes said she filed a written response, then showed up on Zoom and at the courthouse for two hearings, during which she explained her side, without bringing a lawyer. The judge ruled in February that the collection agency was not entitled to summary judgment, because the facts of the case were in dispute.

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Representatives of the collection agency and the defunct surgery center declined to comment for this article.

Sabrina Corlette, co-director of Georgetown University’s Center on Health Insurance Reforms, said it was absurd for the surgery center to bill for two operations and then refuse to back down when the situation was explained. “It’s like a Kafka novel,” she said.

Corlette said surgery center staffers should be accustomed to such scenarios. “It is quite common, I would think, for a surgeon to look inside somebody and say, ‘Oh, there’s this other thing going on. I’m going to deal with it while I’ve got the patient on the operating table.’”

It wouldn’t have made medical or financial sense for the surgeon to make Holmes undergo a separate operation for the secondary issue, she said.

Corlette said that if the surgery center was still in business, she would advise the patient to file a complaint with state regulators.

The Resolution: So far, the collection agency has not pressed ahead with its lawsuit by seeking a trial after the judge’s ruling. Holmes said that if the agency continues to sue her over the debt, she might hire a lawyer and sue them back, seeking damages and attorney fees.

She could have arranged to pay off the amount in installments. But she’s standing on principle, she said.

“I just got stonewalled so badly. They treated me like an idiot,” she said. “If they’re going to be petty to me, I’m willing to be petty right back.”

The Takeaway: Don’t be afraid to fight a bogus medical bill, even if the dispute goes to court.

Debt collectors often seek summary judgment, which allows them to garnish wages or take other measures to seize money without going to the trouble of proving in a trial that they are entitled to payments. If the consumers being sued don’t show up to tell their side in court hearings, judges often grant summary judgment to the debt collectors.

However, if the facts of a case are in dispute — for example, because the defendant shows up and argues she owes for just one surgery, not two — the judge may deny summary judgment and send the case to trial. That forces the debt collector to choose: spend more time and money pursuing the debt or drop it.

“You know what? It pays to be stubborn in situations like this,” said Berneta Haynes, a senior attorney for the National Consumer Law Center who reviewed Holmes’ bill for KFF Health News.

Many people don’t go to such hearings, sometimes because they didn’t get enough notice, don’t read English, or don’t have time, she said.

“I think a lot of folks just cave” after they’re sued, Haynes said.

Emily Siner reported the audio story.

After six years, we’ll have a final installment with NPR of our Bill of the Month project in the fall. But Bill of the Month will continue at KFF Health News and elsewhere. We still want to hear about your confusing or outrageous medical bills. Visit Bill of the Month to share your story.

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.