After four years of fighting, Donnette Smith reached her breaking point. She was exhausted and exasperated, tired of hearing that the rules were the rules. This was simple, she thought. There was a medication that could save her life when nothing else had worked. Her insurance company had no business telling her she couldn’t have it.
So one more time, Smith picked up the phone and called the toll-free number on the back of her Blue Cross Blue Shield insurance card. One more time, she was told no. She asked to speak to a supervisor. Another no. “That’s our policy,” the supervisor said, and hung up.
I’m going to do something drastic here, the 72-year-old Smith recalls thinking to herself.
She called back and, as she describes it, “I threatened to go to the Blue Cross Blue Shield office, the main office, and chain myself to the door and call the news media and say, ‘Look what they’re doing to this poor old lady who’s just trying to get her drugs.’”
A lifelong Alabama resident with the drawl to match, Smith speaks quickly and assertively, a demeanor that makes sense considering she’s spent her adult life with a “ticking time bomb” for a heart.
Smith was born with bicuspid aortic valve disease, a condition in which the valve that controls blood flow from the left ventricle to the aorta has two flaps instead of three. Bicuspid valves tend to leak and narrow, which forces the heart to work harder. That can lead to heart failure.
Growing up in Huntsville, Smith was an active kid. She played softball. A saxophonist, she marched in her high school band. She had trouble breathing at times, but her family doctor chalked that up to asthma. No one suspected a cardiac problem until she took a summer job as a stenographer at NASA in 1966. Her physical detected a severe heart murmur. By 2009, she’d had her third major heart surgery.
She still wasn’t out of the woods. Her LDL (or “bad”) cholesterol level was through the roof—almost 400, she says—dangerous given her cardiovascular disease. Nothing brought it down. Not diet. Not exercise. Statins caused such terrible body aches that “I couldn’t get out of a chair without assistance.”
Smith’s cardiologist, Dr. Stephen Bakir, suggested she try something new.
In the summer of 2015, the U.S. Food and Drug Administration approved two PCKS9 inhibitors, a type of drug that helps the liver eliminate LDL cholesterol from the blood. Designed for patients who can’t tolerate statins or have familial hypercholesterolemia, these medications showed enormous promise in early studies. Smith qualified on both counts.
Bakir prescribed Repatha, which had just hit the market.
Immediately, Blue Cross Blue Shield (BCBS) of Alabama sent a notice that the medication wasn’t covered by her plan. Without it, Repatha would cost more than $14,000 per year.
They asked BCBS to reconsider. BCBS refused.
At this point, many people—perhaps most people—would have given up. These are multibillion-dollar corporations. It’s David versus an army of Goliaths.
But Donnette Smith is not most people.
Smith’s indefatigability gave her a rare window into a health care system that paradoxically produces life-saving medicines only to deny people access to them. More than that, though, she discovered that no matter how powerless she felt going up against a behemoth, she could fight back, and she could win.
If nothing else, her story is a case study in the virtue of perseverance. Keep pounding at the door, and eventually it may just open.
But don’t expect it to be easy.
In 2019, U.S. District Court Judge Robert N. Scola Jr. was assigned the case of Cole v. UnitedHealthcare. UHC had refused to cover personal injury lawyer Richard Cole’s proton beam radiation therapy, a life-saving prostate cancer treatment it deemed experimental. Cole paid for it himself—$85,000—then filed a class-action lawsuit in South Florida.
Two years earlier, Scola wrote, he himself had been diagnosed with prostate cancer. He opted for surgery, but the experts he’d consulted had told him proton therapy would have been his best radiation option. Two years before that, he continued, a close friend needed proton therapy, but UHC refused to cover it until his friend paid $150,000 out of pocket and then threatened to sue.
“It is undisputed among legitimate medical experts that proton radiation therapy is not experimental and causes much less collateral damage than traditional radiation,” Scola scolded. “To deny a patient this treatment, if it is available, is immoral and barbaric.”
Million-dollar lawsuits over new, expensive treatments or drugs often make the news: Proton beam therapy or, a few years ago, a pair of medications that could cure hepatitis C. Heart-wrenching stories go viral, as well: the Illinois managed care company that declined to cover treatment for a 4-year-old boy’s rare genetic disorder, or the Oregon insurer that wouldn’t pay for surgery to help a 5-year-old girl’s degenerative neurological condition.
But these denials are more pervasive than many realize, especially when it comes to the prescription drugs on which two-thirds of American adults rely. More and more, insurance companies are inserting themselves between doctors and patients, covering far fewer drugs than they did a decade ago and making it more difficult to access the drugs they do cover. Nearly one in three Americans with prescription drug coverage say their insurance company has refused to cover a medication in the last year, according to a recent survey for NPR, the Robert Wood Johnson Foundation, and the Harvard T.H. Chan School of Public Health.
On top of that, between 2010 and 2019, the average Medicare Part D plan reduced the percentage of available drugs it carries to 56 percent from 73 percent, the drug-discount company GoodRx reports. Commercial insurers typically mirror Medicare plans, but Medicare has mandates commercial insurers don’t, which means “it’s likely that commercial plans have seen an even steeper decrease.”
The limits don’t end there. From 2015 to 2019, pharmacy benefits managers (PBMs), which manage drug coverage for insurance companies, dropped 318 drugs from their formularies, or lists of approved medications, the GoodRx report notes. At the beginning of 2020, the two largest PBMs, Express Scripts and CVS Caremark, removed more than 300 additional drugs from their formularies.
Insurance companies can deny coverage on the grounds that a drug or treatment is “experimental” or “medically unnecessary.” Even if a drug is on the formulary, they can make a subscriber jump through hoops to get it. Through PBMs, insurers employ restrictions called utilization management tools to drive consumers toward cheaper alternatives than what their doctors prescribed.
Two of them—step therapy and prior authorization—are nearing ubiquity. The former requires patients to show that less expensive treatments have failed before the insurance company approves pricier ones. The latter requires physicians to get pre-clearance before prescribing certain drugs.
Neither tool is popular among physicians, who see them as ways for insurance companies to stick their noses where they don’t belong.
“It feels like there’s a creepy third person in the room,” says Dr. David Charles, the Nashville-based founder of the Alliance for Patient Access. “I’m in the room and I’m seeing my patient and it’s just the two of us, and we make some decisions about what the next treatment is. And then as soon as the patient is trying to get access to that treatment, it’s like this creepy third person steps into the equation and tries to undo everything that the patient and I reached agreement upon.”
At least 26 states have passed laws to carve out exceptions to step therapy protocols, requiring insurers to cover medications and therapies that have already worked. The American Medical Association has launched an aggressive campaign against what it calls the “burdensome” and “overused” prior authorization process, the bane of the medical community. In a 2019 survey, more than nine in 10 physicians reported that prior authorizations have led to delays in care, while three in four said they caused patients to abandon treatment altogether.
An insurance company’s denial isn’t the last word. But many consumers either don’t know that or assume that appealing is pointless, says Wendell Potter, a former communications executive for Humana and Cigna who now campaigns to reform the health care system (and has received funding from the same source as No Patient Left Behind).
“They know that a lot of people just give up,” Potter says. “They think that the decision by the insurance company is final. There’s no point in trying to appeal it. They’re often not aware of, or at least savvy enough, or educated enough to be an advocate for themselves. So that’s just kind of baked in."
Insurance companies know that a significant percentage of people will just throw in the towel. Indeed, according to a Kaiser Family Foundation analysis, consumers who’d purchased policies on the federal healthcare exchange appealed less than 1 percent of insurance companies’ denials in 2017.
This is particularly true on the lower rungs of the socio-economic ladder. In the NPR survey, 51 percent of low-income people with a prescription plan said their insurer had denied coverage for a medication in the previous 12 months and that they’d never filled it.
The Affordable Care Act, or Obamacare as it’s popularly known, required group health plans and plans sold on state exchanges to “implement an effective appeals process.” Sometimes, the problem could be as simple as a coding error. Other times, a doctor’s letter explaining the rationale for the drug could do the trick. If that didn’t work, escalating a complaint up the chain of command might prompt a reversal.
Or it might not. It depends on the insurance company. “There’s quite a bit of variation from the extreme of no runs, no hits, no errors, no appeals, to a more robust solution,” says Ed Weisbart, a former chief medical officer for Express Scripts, one of the country’s largest PBMs.
In the Kaiser Foundation study, just 14 percent of appeals were overturned. At the other end of the spectrum, a federal review found that more than 73 percent of Medicare Part D appeals in 2017 led to reversals.
The ACA also required states to set up an external review process in which independent experts evaluate the claims of consumers who’ve exhausted their internal appeals, taking the final decision out of the insurer’s hands. (Self-funded plans, common among large corporations, must establish their own external review process, although they’re exempt from state regulations.)
These reviews appear to succeed more often than you might think.
Maryland insurers, for instance, reversed or modified 54 percent of appeals filed by consumers in the 2019 fiscal year, according to an annual report from the state’s Health Education and Advocacy Unit (HEAU). Residents assisted by HEAU also won 55 percent and 52 percent of medical necessity and coverage decision appeals.
Meanwhile, the North Carolina Department of Insurance says it assisted with 1,110 internal appeals from 2017 to 2019. About 47 percent of insurers’ decisions in those cases were overturned.
In California, only about 10 percent of the 140,000 health care complaints closed between 2016 and 2018 were reversed, according to the Office of the Patient Advocate’s 2018 Annual Health Care Complaint Data Report. Still, that’s roughly 14,000 people who benefited from fighting back.
Until PCSK9 inhibitors came along, Dr. Seth Baum had never thought much about prior authorizations. Appeals or denials, either. They weren’t something he dealt with, says Baum, who became Donnette Smith’s ally in her battle with BCBS.
But when Repatha and Praluent hit the market, that changed. His South Florida cardiology practice was filled with prime candidates for the new drugs, but “it felt like every single one of them was getting denied,” he says.
When Baum and other cardiologists investigated, they found that approval rates for PCSK9 inhibitors were just 30.5 percent among commercial insurers and 58 percent for Medicare recipients. They also discovered that, after early projections pegged the first-year costs of PCSK9 inhibitors at $1.2 billion, insurance companies “armed themselves with complex prior authorization requirements, burdensome step therapy demands, and approval processes that have been shown to be capricious,” Baum wrote for the American College of Cardiology in 2017.
“The last two years represent an unfortunate time in modern medicine,” Baum wrote. “Doctors possess a long-awaited superb, novel therapeutic; yet, they are unable to appropriately provide it to their patients.”
From a dollars-and-sense perspective, however, these precautions weren’t unreasonable. A few months after the PCSK9 inhibitors became available, the Institute for Clinical and Economic Review (ICER) released a cost-benefit analysis arguing that, while the drugs appeared to be effective, they cost too much per “quality-of-life-year-gained.” In other words, not enough bang for the buck.
At the time, Baum—who has consulted for Repatha maker Amgen—was president-elect of the American Society for Preventative Cardiology. One of his priorities, he says, was to help patients access these drugs. He became an outspoken advocate for PCSK9 inhibitors. He tried to shame insurers in the press. He also set up a series of town halls for patients who could benefit from the drug.
That’s where he met Smith.
“People were standing up in the audience telling their stories about how they were being denied this drug,” she recalls. “So, of course, me, I held up my hand, too, and I told my story. They were just like, ‘You’re kidding.’"
Baum told her he wanted to help.
It took two years. Smith kept appealing. Baum raised hell with BCBS. They sent in documentation showing that she had tried statins and they hadn’t worked. They kept getting rejected. Every time, Smith says, the language was the same: She didn’t meet the requirements; she needed to read the policy.
Finally, it happened. In January 2018, Smith got word that BCBS had signed off on Repatha. Her co-pay was $583 a month, but an Amgen assistance card brought it down to $5.
In the first 30 days, Smith’s LDL cholesterol fell from 283 to 70.
It was a “miracle drug,” she says.
Then, as quickly as it had come, the miracle ended.
* * * *
“They didn’t give me a reason,” Smith told U.S. Sen. Doug Jones of Alabama, who sits on the Special Committee on Aging. It was a snowy March morning in Washington, D.C., about a year after BCBS had informed Smith that it would not cover Repatha after her first three-month approval expired.
All she knew was that she’d have to go through pre-authorization again, something that had taken two years the first time. That meant more appeals, more denials, more frustration, and more ill health. Her general practitioner had been giving her samples of Repatha, but there wasn’t enough for the two injections a month she was supposed to take. Her cardiologist advised her to give herself one a month, or one every two month, whatever she could to keep the medication in her system.
“I have been hanging in there,” she told the committee. “But I don’t know what this is doing to my health for the rest of my life.”
BCBS told her to go through step therapy again. She refused. “I said, ‘Have you lost your mind?’ I mean, I’ve already done that. We’ve proven beyond a shadow of a doubt that the PCSK9 works for me.”
BCBS wouldn’t budge: Those are the requirements, she was told.
“You need to go back and look at your requirements because they’re awful,” Smith responded. “They’re not practical. They’re just downright stupid.”
This dragged on for months. Then, one day last autumn, Smith threatened to embarrass BCBS by chaining herself to the front door.
Soon after that, she says, she was at her general practitioner’s office for a regular checkup. He suggested they try again. He’d been having better luck with PCSK9 inhibitors, he said.
This time, without explanation, BCBS said yes.
“I don’t know if it had anything to do with my threat,” Smith says.
It’s possible. Or maybe it was a different kind of threat.
Without Smith knowing, Baum says, he’d also been putting the screws to BCBS. “I told them to look at The New York Times and Wall Street Journal articles about me fighting the insurance companies. That was the next phone call I was going to make.”
BCBS of Alabama did not respond to requests for an interview.
* * * *
“I really encourage [patients] to be their own advocate,” Smith told the Senate committee. “To speak out, and don’t give up. You just really have to be your own voice. People aren’t willing to do that.”
Not everyone is willing. But not everyone is able. For patients with painful, debilitating, or chronic conditions, mustering the energy can be not just difficult but impossible.
As important, not everyone will have the advantages Donnette Smith did.
After her first heart surgery in 1993, Smith became involved with the nonprofit Mended Hearts, a national support group for heart disease patients. She founded a local chapter. She became the regional director, then the national treasurer, and eventually the group’s president. She volunteered in a Huntsville hospital. She had support from physicians and the pharmaceutical companies behind the two ICSK9 inhibitors. She had the head of the American Society for Preventative Cardiology championing her cause.
Even with all of that, it took four years from first prescription to final approval.
“I’m very visible,” Smith says. “People know who I am. If I can’t get the drug, then how in the world is the average Joe or Jane out there going to get it? Who’s gonna help them get it? They’re just gonna give up. They’re not gonna fight all these wars that I’ve been in. They’re just gonna give up and die of a heart attack.”
It shouldn’t have been that difficult, she says.
“I’m telling you, it wasn’t a battle, it was a war,” Smith says. “It felt like I was fighting everybody. And I kept telling them, it should be up to the patient and the doctor. These other people need to stay out of it because they don’t know me.”
Her war might not be over. BCBS’s approval was only for a year. As of mid-October, Smith was down to her last box of Repatha.
“We’ll see how this plays out,” she says.
Jeffrey Billman is an award-winning investigative journalist based in North Carolina.
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