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On June 9, 2023, Eunice Stallman, MD, a psychiatrist in Boise, Idaho, got some of the worst news of her life.

The worrisome symptoms she and her husband had been noticing in their 8-month old daughter for some time -- twitches in the right side of her body, trouble sitting up -- were due to brain cancer. After Zoey's doctors ran some tests, they discovered a large tumor spanning the left frontal, parietal, and temporal lobes of her brain. It had grown around a middle cerebral artery and its branch, making surgery nearly impossible without dire consequences.

But Stallman couldn't have predicted that her family's bad dream would turn into a uniquely American nightmare. What a team of doctors agreed was the best course of treatment for Zoey would be denied not just once, but three times by Stallman's insurance, delaying Zoey's care by weeks and plunging her family into a labyrinth of prior authorization submissions, insurance appeals, and medical reviews.

After a biopsy showed a very rare cancer -- infantile hemispheric glioma, ALK-altered subtype -- Zoey's doctors at St. Luke's Cancer Center in Idaho jumped into action. They consulted with a team at Seattle Children's Hospital, known for its pediatric brain tumor program. The MRI had shown an unusually large tumor, 9 × 5 × 6 cm in the left side of her brain and around the middle cerebral artery. Surgery near this major artery would bring with it a "significant risk of stroke and neurologic deficits," Zoey's doctor would later write in a letter to Stallman's insurer.

Zoey's care team explained to the family that without urgent treatment, the tumor would grow, and the cancer could spread. Radiation therapy, Zoey's oncologist wrote in the same letter, "is similarly not recommended at this age," and would "risk devastation to neurocognitive development," affecting her ability to learn and be independent.

Chemotherapy, doctors told the Stallmans, would also come with serious risks, like secondary cancers or infertility later in life -- not to mention, a week of inpatient hospital care every month for the foreseeable future.

The doctors on the brain tumor board at Seattle Children's Hospital agreed that because of the tumor's specific mutation, a newer ALK-inhibiting drug, oral lorlatinib (Lorbrena), would be the least invasive and most effective line of treatment. Lorlatinib had shown success in treating non-small cell lung cancer with the same mutation as Zoey's tumor, ALK, especially intracranially, and in a of cases to hers.

Once the tumor shrank enough from the drug, the doctors thought they would be able to remove it. "We were celebrating. It was great news," Stallman said. "I didn't even think that there would be a chance that it would be denied."

'Considered Investigational'

The office submitted imaging and treatment determination to Blue Cross of Idaho for prior authorization to cover the drug, which, at the recommended dose for Zoey, would cost around $13,000 a month. They would send along more information when a few more details from genetic testing came in.

Stallman waited. "It was painful. I think I called every day for almost 2 weeks, and each time [was] getting just punted around and told, you know, 'We're not there yet.'"

Once Zoey's oncologist sent in more chart notes as requested, Stallman remembers being told by Blue Cross of Idaho on the phone that the time for reviewing the case would reset now that the new information had come in, and delay a decision another 2 weeks.

"I threw a fit," Stallman said. "I said, this was ridiculous, that it's just more supporting information. They're not trying to change the course of treatment. ... This was an urgent situation and the longer that we go without approval, the bigger this tumor is going to grow." Zoey's doctors had even increased her seizure medication.

Internal notes from Zoey's case file show that whoever received the new information had mistaken it for part of a step after a prior authorization is denied, called a "pre-service provider appeal."

Finally, Stallman got an answer. The letter she eventually received from Blue Cross of Idaho read, "Unfortunately, we cannot approve the request for coverage. ... Lorbrena is considered investigational (still being studied) as a treatment for your child's infant-type hemispheric glioma." It wasn't approved under the insurer's policy and the clinical guidelines it uses for treating Zoey's cancer, they wrote.

Infant gliomas are already very rare at 1.38 per 100,000 children, or a 0.001% chance of occurring. The ALK mutation in Zoey's glioma was even more rare, making clinical studies with similar patients nearly impossible. Even the strongest case studies seemingly wouldn't have amounted to enough evidence for Blue Cross.

The insurers said that Zoey's glioma, "does not meet labelled safe and effective indications for Lorbrena." And according to the clinical guidelines Blue Cross follows, from the National Comprehensive Cancer Network (NCCN), lorlatinib did not meet criteria for a "grade 1 or 2A" recommended therapy.

Stallman was astounded. Zoey's doctor quickly appealed the insurer's decision, marking it urgent, noting "as further tumor growth may result in the need for urgent intervention, I ask that you review my request to overturn your denial of coverage for this treatment urgently."

The request was for an expedited appeal -- with a determination made in 72 hours instead of 15 days. Meanwhile, Zoey's seizures were getting worse -- her thumb had frozen to her right hand, making it impossible to grasp, and she had begun to use her left instead.

Stallman kept calling to check on the status. A nurse that worked under Blue Cross of Idaho's medical directors, Stallman recalled, told her the expedited appeal wouldn't be possible. "'We don't think it should be urgent, because there's no metastasis, it's not life-threatening,'" Stallman said she was told. "They said it's not medically necessary, and it's not urgent, so we're going to turn it into just a regular appeal."

"I got very mad," she said. "I told them that they can't decide whether or not something's urgent, because that's up to her treatment team to decide that. It's my baby with a brain tumor. I mean, it's a brain cancer -- there's no way you can call it not urgent."

Stallman remembers being told that the medical directors at Blue Cross would review the case again and get back to her. She stayed on the phone, refusing to hang up until she got an answer.

Independent Review

Stallman works at a state psychiatric hospital. A physician herself, the title "medical director" suggested to her that physicians with specialized expertise in pediatric brain cancers would review the evidence and arrive at a similar conclusion as they had.

Two specialists MedPage Today spoke to, who were not involved in the case but work with pediatric brain cancers, said they had not encountered as much pushback in cases like Zoey's, where they had recommended a specific treatment for a rare cancer.

Allison Martin, MD, director of the neuro-oncology program at the Children's Hospital at Montefiore in New York City, told MedPage Today that in her pediatric oncology cases she deals mostly with Medicaid, which she said is "more receptive to our academic input" than a private insurer might be.

Referring to the denial of lorlatinib, she said, "They're probably within their legal rights to say that there's not specific evidence to support the use in this case. But ... it's always unfortunate when we make recommendations as physicians, and then there's financial or other logistical obstacles to providing the care that we think is most appropriate."

Martin said she and her colleagues rely on another set of clinical guidelines from the Children's Oncology Group, not NCCN.

"It sounds like they got a second opinion, two independent teams recommended this therapy, [so] it's really surprising that the insurance company really dug their heels in on what was recommended," Martin added.

While Stallman waited on the phone for hours, the medical directors denied the appeal a second time, citing the same reasoning: the drug was not FDA approved for this use. It was investigational and therefore not covered by her plan.

But there was yet another way to escalate the claim: Blue Cross of Idaho would send the case out to what's called an "independent review organization" or IRO, which hires clinicians to review difficult claims and ostensibly, offer an impartial third-party opinion. It was called MCMC, and, according to its website, "provides independent, objective, and credible information for healthcare decision-making."

Surely now, Stallman thought, a clinician with relevant experience would review the claim and offer an outside opinion. Still on the line, Stallman waited while they sent it to a doctor in MCMC's "reviewer network" and got back to her after around 15 minutes, saying that he had also recommended denial.

A hematologist-oncologist in Texas had determined that there was not enough evidence to support the use of lorlatinib, again based on the NCCN guidelines.

Curiously, Stallman noticed later, that specialist had cited two papers in his report about a different class of mutations than the one Zoey had. But once again, her insurer had another reason to deny coverage.

Peer-to-Peer Meeting

Now, she was told, the Blue Cross medical directors could decide whether or not to reject or accept the MCMC recommendation. Stallman finally got off the phone, and received a call later that day. The medical directors had decided to accept MCMC's recommendation.

"I kind of went off," Stallman said. "I feel pretty badly for it, but I was desperate. And I was so furious at that point."

She pleaded with the Blue Cross representative, reviewing the insurance policy used for the denial with the caller line by line, making her case for the medical necessity of lorlatinib. She cited her daughter's molecular analysis showing that the tumor had a mutation -- ALK -- with high clinical significance.

The only option left would be a "peer-to-peer" meeting -- a phone call between Zoey's oncologist and another Blue Cross medical director to discuss the case. Stallman was still angry -- what were their credentials anyway, she asked?

The woman on the other line told her they were doctors of pharmacy.

Stallman remembered thinking, "Are you serious? Like, are you kidding me? So they're pharmacists who are not seeing Zoey directly. They don't have prescribing and treatment experience. ... And they're going against the recommendations of multiple doctors who are looking at her case."

But she felt hopeful that surely, after Zoey's doctor could explain the details of the case, any misunderstandings would be cleared up, the urgency of her condition would be conveyed, and her daughter could begin her care.

The medical director and Zoey's oncologist discussed her case for 45 minutes. But again, the insurers told her the answer was no.

Martin said it was rare to encounter this level of pushback from insurers. "The problem is, there aren't many experts in these situations. So most of the time, if I'm on the phone with somebody like that, they're going to end up deferring to my expertise," Martin said.

Andrew Kobets, MD, a pediatric neurosurgeon and co-director of surgical neuro-oncology, also from the Children's Hospital at Montefiore, said, "I've experienced -- with other situations, but with similar peer-to-peer requests -- literally just 'Okay, this was the rationale, fine.' Like two minutes on the phone."

Last-Ditch Efforts

At this point, Stallman had contacted St. Jude's to apply for care, and to Pfizer, which makes lorlatinib.

Stallman explored whether Pfizer's compassionate use program or its copay assistance program would be an option, but the requirements for both made them unfeasible for Zoey.

By this time, Stallman and her husband had made a GoFundMe to raise the thousands of dollars they would need each month. Another physician, Wendy Hasson, MD, about Zoey. The post garnered over 2 million views. X users started tagging Blue Cross of Idaho in angry posts. Stallman even reached out to a reporter at a prominent investigative news outlet, who had contacted her insurance on her behalf.

Finally, Stallman received a phone call from Blue Cross. They had called a meeting. The case had been discussed by vice president and medical director Steve Lucht, MD, who appears to have overturned the denials and grant the coverage of lorlatinib.

Two weeks after her doctor had first discovered the tumor hiding in her brain, Zoey could start treatment.

The Stallmans would still be responsible for $5,000 out-of-pocket for 2 months, but the ordeal was over. Ultimately, she attributed the change to her decision to take the dispute public.

Continued coverage of lorlatinib past 90 days would require "proof of efficacy," according to the approval letter, but Stallman said there was a good chance that with Zoey's positive response, coverage would continue.

A Larger Trend

Zoey's parents and siblings were elated. But without the significant resources Stallman had at her disposal -- her training as a physician, time off work to call Blue Cross, a network of educated peers to campaign on social media and recommend alternate medical paths -- it's likely Zoey's treatment would not have begun. Stallman is well aware of this.

"In a lot of cases, it's harder to even get through because people have to work. People can't just stay on the line for hours and hours," she said. "And most of the time, people don't have a reporter who can call on their behalf and threaten bad press and get the ball rolling. And so that was the saddest part."

Most patients with denied claims (69%) don't know they can appeal a decision, . Only 15% ever file a formal appeal to overturn a denial. Stallman, marshalling all of her resources, was able to fight three.

"The most remarkable thing for me was just hearing from others how common this is, that our experience was not unique, which is very sad to hear," she said.

Karen Van Nuys, PhD, of the University of Southern California, studies the pharmaceutical distribution system and prescription drug costs. She told MedPage Today that Stallman's case may reflect a larger national trend among insurers.

"This whole sort of, denial of claims and increasing formulary exclusions, increasing prior authorization requirements ... is a secular trend that's been going on for the last 10 years," Van Nuys said.

"I think it's part and parcel with a hollowing out of people's insurance benefits in general," she added. "Even though premiums have been going up over time, you're paying more and it gives you access to less."

Stallman later noticed, while poring over the claim file that she had requested from Blue Cross, two denial letters referenced the adult version of the NCCN guidelines, not the set for pediatric central nervous system cancers.

In response to a complaint Stallman would later file, Blue Cross stated that it had used the pediatric guidelines, and that in either case, lorlatinib would not have been approved as it was not referenced in either. Stallman argued that the pediatric guidelines would have allowed for lorlatinib as a treatment -- and even spoke to one of the authors of the guidelines, who agreed with her interpretation.

In response to more complaints to the State of Idaho Department of Insurance and the Texas Medical Board regarding the MCMC specialist, all told her the decisions were, in essence, correct and that a special exception had been made for coverage in her case.

After Zoey started treatment, the tumor shrank dramatically. In just a month, an MRI showed that nearly all the solid portions had melted away. The only side effect of lorlatinib has been weight gain, and a year later, the tumor remains tiny, almost imperceptible.

"We've had the best possible response that we could have expected from this," Stallman said. Zoey started sitting up again. Her right thumb came unstuck from her hand, and she was able to use it again. She's since said her first word -- "yeah."

This is true to her personality, Stallman said, since Zoey says yes to everything. "She's so happy and strong, and all her follow-up appointments, everyone knows her, because she's just so friendly," her mother said.

Zoey isn't afraid of strangers, and never cries getting her blood drawn or having an IV put in. She loves giving kisses. She has even learned to crawl. "She's getting into stuff," Stallman said, "and she's crawling around, saying 'yeah.'"

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