Coverage Policy: Boosting or Busting Clinical Recruitment?

There are numerous obstacles that stand in the way of patient recruitment for clinical trials. This is neither a secret in the clinical research industry, nor is it difficult to understand. After all, at face value, being the subject of an experiment studying the unknown effects of a controlled substance may not, frankly, sound so appealing. Efforts to address this problem normally focus on communication: Doctors should promote clinical trial participation by reassuring their patients that the trials are backed up by safety data gathered in the preclinical phase, pointing out that clinical trials are a good way to gain access to otherwise unavailable treatments, and extolling the virtues of being on the cutting edge of medical research. The Internet and social media should be employed to bring recruitment efforts to a wider audience.

These strategies are important and should be pursued. But in addition to the so-called “guinea pig” fear, recruitment difficulties can be exacerbated by economic factors, not least of which are the policies of the many insurance companies who decline to cover the expenses associated with participating in a clinical trial. This is not supposed to happen. Historically, only certain states have required insurance companies to cover these expenses, but the Affordable Care Act (ACA) of 2010 mandates that most insurance companies nationwide cover the cost of participation in any clinical trial targeting cancer or other fatal conditions1. But while the mandate has been in place for several years, the rate of compliance during that time has been disappointing.

Reasons for, and extent of, coverage denial

A recent survey of oncologists found that nearly 63% of respondents had patients in 2014 whose insurance providers did not cover clinical trial participation. Some of these denials are the product of the vagueness that seeps into much of the language of the ACA, enabling insurers to find loopholes and avoid coverage requirements; other times, however, investigators found that the coverage denials were simply unjustified1. In any case, considering cancer-related clinical trials are already notoriously difficult to recruit for, declining to cover participation only adds insult to injury.

This problem extends to other corners of healthcare, with parallels in Medicare. Just as private insurance companies often skirt coverage requirements, Medicare has limitations on what costs associated with clinical trial participation are covered2; just as cancer trials are hard to recruit for even without this added hurdle, the elderly, who often rely on Medicare, are a difficult enough demographic to enroll as it is. These limitations in coverage are a step in the wrong direction. The good news, though, is that noise is being made: numerous organizations have banded together to brainstorm ways to remedy the problem1. The question, once again, is whether their proposals will be concrete and forceful enough to sufficiently guard against ambiguity and loopholes.

Clinical research has more than enough difficulty communicating the many benefits of participation. It’s important to find a way, whether it’s better enforcement of current regulations or the creation of new ones, to ensure that the public isn’t further discouraged by gaps in coverage.

1 Johnson, Kelly; Payers Still Denying Coverage Despite Clinical Trial Mandate; OncLive; 29 March 2016
2 Your Medicare Coverage;