After his mother died of pancreatic cancer, Rob Maliff felt compelled to take action to improve the outlook for himself and others at high risk of developing a disease that is among the deadliest of cancers because it is often detected only once it has spread.

So he enrolled in a clinical trial at Penn Medicine that would test whether annual endoscopic ultrasounds improve early detection. No screening tests are currently recommended for people of average risk for pancreatic cancer, but endoscopic scans may be suggested for people at high risk, according to the American Cancer Society.

He never saw a bill for his first two years in the five-year trial. But after switching insurers, Maliff got a bill for this year’s ultrasound: $1,500.

“I was, like, wait a minute,” said Maliff, 53, of Philadelphia. “I was a little shocked because I hadn’t received the bill for two prior procedures.”

For patients with critical diagnoses, clinical trials can be a lifeline to new treatments that could help them get better, or at least help advance medicine. But clinical trials aren’t free to participants. Investigators are required to outline orally and in written contracts how services will be billed, but patients who are hurting, overwhelmed by their prognosis, or simply unfamiliar with how trials work may overlook the financial details, only to wind up in a position like Maliff: stuck with a bill they weren’t expecting.

“I would like to [continue in the trial], but I certainly don’t have $1,500 to spend on medical care that I technically do not need,” Maliff said.

The burdens of clinical trials

Clinical trial enrollment and dropout rates are ongoing concerns for institutions — according to several studies, less than 5 percent of eligible patients enroll in a clinical trial, and many trials never meet their enrollment goals. Yet program administrators say they do not think out-of-pocket treatment costs are a significant barrier to entry or a reason people drop out. More often, patients point to travel, time off from work, meals away from home, hotels, and child care as burdens to completing a trial, said Emma Meagher, a doctor and Penn Medicine’s chief clinical research officer. Others are deterred by the idea of participating in a medical experiment or are reluctant to switch to new doctors.

But researchers from Fox Chase Cancer Center who surveyed 1,200 cancer clinical trial participants concluded that money is top of mind, especially for critically ill patients concerned that experimental therapies may compound already expensive treatment.

“People have difficulty making decisions about just normal, regular, already established cancer treatments. Even more so, the decision to enroll in a clinical trial is complex,” said Suzanne Miller, the director of patient empowerment and decision making at Fox Chase, and a co-author of the 2016 study. “Cost is a major factor that influences their decision-making about clinical trial enrollment.”

About 40 percent of the patients researchers surveyed said they were worried their insurance wouldn’t pay for a clinical trial, and 30 percent said they were worried they wouldn’t be able to afford a clinical trial.

What insurance will and won’t cover

Typically, any treatment that patients would receive as the standard of care for their medical condition is billed to their insurance plan. The trial pays for whatever new intervention or therapy is being tested, said Pat Jolley, director of clinical initiatives for the National Patient Advocate Foundation in Washington.

For example, if a patient would normally receive a CT scan as part of routine treatment once every three months, and the trial calls for a CT scan every month, the trial would pay for the two extra scans, but not all three, she said.

Private insurance plans typically pay for standard of care treatments even if you are enrolled in a clinical trial, so long as the doctors and hospitals involved are part of the plan’s network. Clinical investigators typically check that participants are covered by in-network health plans, but if you’re considering enrolling in a trial, it is worth calling your insurance company to ask, Jolley said.

Medicare is also required to cover standard of care treatment for people enrolled in clinical trials; however, Medicaid is not.

“There’s often a misperception that clinical trials are free; they’re not free,” she said. “Anybody who participates in a trial is going to experience some cost. The amount of your out-of-pocket liability would depend on your specific plan.”

Lead investigators and administrative support staff go to great lengths to make sure patients are aware up-front of what will be billed to insurance and what will be covered by the trial, said Penn’s Meagher.

Before being formally enrolled, patients go through an “informed consent agreement” that details how services will be paid for in language that must be approved for clarity by an institutional review board.

Theoretically, out-of-pocket treatment costs for trial participants should not be anything more than what you would pay for standard care outside of a trial. But sometimes patient costs are unpredictable.

“It’s sometimes unclear what the insurance company will cover and what it won’t. You can estimate what the costs will be, but if a patient’s insurance company balks at paying a cost they believe is a research-related cost, the patient is left in the middle,” Meagher said.

When Maliff got the $1,500 bill for his clinical trial-ordered endoscopic ultrasound, he called up the trial administrator, who reminded him that the consent form he’d signed years earlier stated that the procedure would be billed to insurance. He had forgotten that — after all, when he received no bill for the first two years, he assumed the trial was picking up the cost.

“So, yeah, shame on me — I didn’t read the informed consent. But who does?” he said.

With help from a billing advocate service through his employer, Maliff was able to get the issue resolved. The procedure had been billed incorrectly and the cost was mistakenly passed on to Maliff. After reprocessing the bill, his insurer covered the ultrasound without any additional cost to Maliff.

Though Maliff’s bill was a mistake, the confusion points to the need for clinical trial investigators to address cost more clearly, rather than assuming that participants will absorb long, complex written agreements, Fox Chase’s Miller said.

As part of their 2016 study, the research team she is part of developed two-minute videos, each addressing a different barrier to participation. The team found patients had a better understanding of key points after watching the videos, compared with their understanding from reviewing written agreements or listening to investigators describe the process to them.

“So often, we do this research, we publish it in great journals, we talk about it to each other, and then it doesn’t make it into clinical practice. Every cancer center should be employing this tool,” she said.