Chris Spaulding and his wife, Andrea.

Think about the last time you walked up a staircase. Did you hold the banister? Was it to help keep your balance? Was it simply out of habit? If you had let go, would you have fallen? These may seem like arbitrary questions, but for Chris Spaulding, they became central to a legal battle that would consume his life for months—all while dealing with a devastating diagnosis of ALS. 

Chris, who lives in Spring, TX, just outside of Houston, was diagnosed with ALS on June 4, 2024. He immediately began working with his doctor to make sure he was doing everything he could do to face the disease head-on—including getting access to all of the treatments available to him. 

A Diagnosis and Seeking Access to Treatments

Of course, anyone familiar with ALS is likely aware that, for the vast majority of people with the disease, there are no effective treatments to slow or stop progression. However, there are two FDA-approved drugs that have been shown to provide some benefits for people with ALS—edaravone, sold under the brand name Radicava, and riluzole. (A third drug, tofersen, has been approved for people with familial ALS related to mutations in the SOD1-gene.) While the effects of these treatments may be modest, for someone in Chris’ position, any potential benefits were of the utmost importance.

“At first, [my doctor] told me ‘We think there is a reasonable chance that you have a form of ALS that will progress slowly,’ because the onset was in my limbs,” says Chris. “They said, ‘You're still pretty strong. So, what we're going to do is we're going to get you on two drugs: Riluzole, which we’ll get you on right away, and Radicava, which we’ll get you on after 30 days.’”

Chris’ doctor, the prominent ALS clinician and researcher Dr. Stanley Appel, warned him that, while riluzole is often covered by insurance, obtaining coverage for Radicava can sometimes be more difficult. Many insurers will only provide coverage for people whose symptoms are less severe at the time they start treatment, citing evidence that the drug provides the most benefit when taken early on in the course of the disease. For example, the prominent insurance companies Aetna, Cigna, and United Healthcare all require that anyone seeking Radicava coverage score at least two points on all 12 areas of the ALSFRS-r scale, among other benchmarks.

However, Dr. Appel believed they should be able to eventually obtain coverage because Chris’ progression was still mild. Chris’ prescription drug coverage was through Medicare Part D, and he received benefits through the company Express Scripts, a pharmacy benefit management (PBM) company. A PBM is a third-party company that processes insurance claims and benefits for both private and public insurers.

Denials and Appeals

Dr. Appel submitted a prior authorization for Radicava to Express Scripts, which was denied, as he had warned Chris might happen. They appealed the decision but were denied again. Chris, who was still able to go about his daily activities with relative independence, says the reason given was shocking to him.

 “They said that there was no confirmation, by the information provided, that you have a score of two points or more on each item of the ALSFRS-r, which shows that you have not retained most or all activities of daily living,” he says.

At this point, the clinic was unable to help him pursue another appeal, but Chris could continue to fight for coverage himself. He was pointed toward another third party, C2C Innovative Solutions, a company contracted by Medicare to review appeals like his. His first appeal to them was again denied for the same reason—his ALSFRS-r score, according to C2C, said he did not currently retain all the functions necessary for everyday life.

Chris couldn’t believe it—his ALSFRS-r score at the time was 42 out of 48 possible points, a score indicating relatively low progression. He went back to his clinic, hoping to understand what category of daily function he could possibly have scored so low on. He was shocked to learn that the issue came from his ability to climb stairs. Even though he was still able to walk up or down a staircase by himself, he had been downgraded to a score of 1, meaning “needs assistance,” because he reported that he held onto the handrail.

Chris says the clinic had even tried to argue that his handrail use was for practical safety reasons—not because his ALS progression made it a necessity—but Express Scripts would not budge, and C2C further affirmed their decision. He was at a loss.

“I said, ‘This is wrong,’” says Chris. “I don't need to use the handrail, but I do so, and have always done so because it's a safe, smart thing to do. So, the first thing I did was write up a letter. I said, ‘I'm going to send this letter to a multitude of public officials at the local, state, and national levels detailing what's happening to me.’”

Taking the Fight Public

Chris’ letter outlined the challenge he was facing—despite having a prescription from an eminent neurologist, he was being denied medication that could help him in the face of a debilitating disease over what seemed to be an arbitrary technicality. He sent copies to officials including the President, Vice President, First Lady, Secretary of Health and Human Services, and Surgeon General of the United States, as well as members of the Texas State Senate. 

He also reached out to the ALS Association, where he connected with Melanie Lednall, ALSA’s Senior Vice President of Advocacy and Policy. They discussed his situation and the options he had to move forward. When Chris received his final denial from C2C, they informed him he had the option to request an additional hearing before an Administrative Law Judge. He was initially wary of getting into a full-on legal battle. But, he says, Melanie encouraged him to press on.

“She said, ‘Chris, the Administrative Law Judge hearing process sounds a lot worse than it is,’” he says. “We would love it if you would take it to the next step, and we'll help you because what you're going through is very common and not many people take this step.”

Making the Case for Coverage

As Chris began the process of requesting his hearing, he found that Melanie’s advice rang true—a hearing before an Administrative Law Judge was not nearly as burdensome as something like filing a lawsuit. To begin, he simply filled out a two-page form requesting a hearing. On the advice of a friend who is a lawyer, he elected not to hire his own legal representation.

“He told me, this is not going to turn into an esoteric legal matter or anything like that,” Chris says. “This is common sense, and you can state your case as well as anyone can. It's going to be more powerful if you say it.”

[NOTE: While legal representation is not required, the Center for Medicare Advocacy recommends people pursuing an Administrative Law Judge hearing should consider use an attorney.]

Chris sent in his paperwork, the letter he had written to the President, and all the documentation of his various coverage denials on August 29, 2024. He also requested an expedited hearing—arguing that, because of the progressive nature of ALS, he could not afford to wait the typical 90 days. Two days later, he received a reply. His requests for a hearing and for an expedited timeline were granted. 

The hearing took place the following week, on September 4. It was held over the phone, with Chris and the judge calling in. Also on the line were Melanie Lednall, who joined to help support Chris’ case, and a representative from Express Scripts. Chris testified about his doctor’s initial rationale for prescribing Radicava and laid out why Express Scripts had denied his claim—his use of a handrail while climbing the stairs.

He then proceeded to share all the reasons he chose to use a handrail. He shared statistics showing that over one million injuries a year are caused by falls on staircases. He pointed out that, throughout his long career in oil and gas exploration, he was required by safety regulations to use a handrail whenever he was climbing a staircase. Crucially, he also referenced a video he had put on YouTube before the hearing in which he climbed a staircase without touching the handrail.

Following his presentation, as well as supporting testimony from Melanie, the judge asked Express Scripts to present their counterargument. The representative said, simply, that in light of the video evidence that Chris could ascend a staircase without a handrail, the company’s position had changed. They would no longer deny his claim.

With that, the hearing was over. Three days later, he had his first dose of Radicava. It was a bittersweet moment—his ordeal was over, and he had been successful. But it had taken months of effort, all while he was dealing with an ALS diagnosis. 

“When I hung up the phone, I just broke down,” he says. “I’d been fighting this for two months, trying to get something that I felt like I was entitled to and unreasonably, incorrectly, and arbitrarily being denied. I had to fight back. I had a lot of people say to me, ‘Chris, you took on the insurance companies. And you won.’ Yeah, I did. But it took quite a bit. So that was hard, and it was really emotional.”

A National Issue

Melanie Lednall says that Chris’ situation was terrible—but it was far from unique. 

 “This is something that we have been seeing more since Qalsody was approved, since Radicava oral version was approved,” she says. “And we're not only seeing this for ALS drugs that have been FDA approved, but also for durable medical equipment like noninvasive ventilation. Obviously, that can have serious impacts on quality of life and quantity of life. And, unfortunately, this is something that seems to be increasing, anecdotally.”

However, while fighting an insurance denial can be intimidating, appealing these decisions often leads to success. According to the Kaiser Family Foundation, of the 46 million prior authorizations for drug coverage submitted to Medicare Advantage insurers in 2022, 3.4 million were initially denied. Just one in 10 of those denials were appealed. However, in cases where a physician or individual did move forward with an appeal, the denial was overturned more than 80% of the time.

“Most people don't go to the Administrative Law Judge,” says Melanie. “It sounds incredibly intimidating. It is time-consuming. However, when cases go before an ALJ, the patient almost always ends up with a favorable ruling. So, I encouraged Chris to take that route. I encouraged him to request an expedited hearing. A week later, we had an ALJ hearing, and within a few days, he was taking Radicava. It’s a great result, but, unfortunately, he should have never had to jump through these hoops.”

Sharing his Story for Others With ALS

Chris says that he fought so hard for Radicava for two reasons. The first, of course, was to have access to the drug himself. But he was also determined to fight back for others with ALS who are facing similar coverage denials. Now that his case has been successfully settled, he is turning his efforts to sharing his story. He has continued to write about his experience to various government officials at the state and local level, as well as ALS advocacy organizations. His aim is to both spread awareness of these practices on the part of insurers and to show others in his situation that they have options to fight back.

“For anyone in this position, as much as possible, don’t let it wear you down,” he says. “I was really discouraged. But then, going as far as I did, to the Administrative Law Judge hearing, in the end, it wasn’t that daunting. But, you have to have your plan all laid out. The people at the ALS Association were a great help to me. So, one piece of advice I would have for anyone who runs into this is to reach out to an organization like them, or I AM ALS. They’ll tell you what you’ve got to do.”

The ALS Therapy Development Institute (ALS TDI) is 100% focused on research to discover effective treatments for everyone with ALS. If you are looking for support, have questions about resources, or want to learn about current research, we encourage you to reach out and connect with a member of our development team. Get in touch by visiting https://www.als.net/let-us-help/.

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