Clinical Trial Billing Errors Generate Multi-Million Dollar Fines

Brent Ibata, PhD, JD, MPH, FACHE, RAC, CCRC, CPI, CHRC, research compliance officer at Sentara Healthcare

Clinical trial billing errors continue to emerge at established, well-respected sites—and the penalties and publicity can hit hard, warns Brent Ibata, PhD, JD, MPH, FACHE, RAC, CCRC, CPI, CHRC, the research compliance officer at Sentara Healthcare.

It is rarely a case of out-and-out fraud, Ibata notes. Instead, it can be a lack of understanding. Clinical trial research studies must meet federal billing compliance requirements, including:

• no double billing at the site level;
• medical documentation must support coding;
• research modifiers, diagnosis codes, condition codes, and NCT# (the National Clinical Trial Number, or ClinicalTrials.gov Identifier) must be in place when the study is qualifying; and
• transparent documentation from the sponsor must be clear and definitive.

“Isolated instances of fraud and abuse artificially inflate the cost of healthcare to the federal government,” Ibata says. Some estimates say improper payments costs Medicare and Medicaid more than $50 billion annually. In some cases, sponsors are not getting everything they paid for, either. Billing compliance is a partnership between sites and sponsors to get it done correctly.

Kelly Willenberg, MBA, BSN, CHRC, CCRP, CHC, Kelly Willenberg & Associates

“Sites need to understand the coverage analysis process and how it protects them in clinical trial billing,” states Kelly Willenberg, MBA, BSN, CHRC, CCRP, CHC, of Kelly Willenberg & Associates. “Once you understand the rules, you can put best practice in place and show due diligence.”

Federal regulators are working to get some of the losses back. Several settlements demonstrate the seriousness of the situation. Those include:

• Rust University Medical Center agreed to a $1 million settlement after self-disclosure of improperly billing Medicare for physician and hospital services and as routine costs in cancer care.
• Tenet USC Norris Cancer Hospital settled for $1.9 million after self-disclosure of overbilling with oncology trials.
• The University of Alabama at Birmingham accepted a $3.39 million settlement for falsely billing Medicare for researcher time spent on patient care when no patients had been seen.
• Emory University agreed to a $1.5 million settlement for falsely billing Medicare and Medicaid for clinical trial services that were not permitted by the Medicare and Medicaid rules in a whistleblower case.

Billing requirements can be a baffling maze, Ibata says. Join Ibata and Willenberg for their ACRP 2016 Meeting & Expo session, Research Billing Compliance for Dummies.

Don’t Let Fear Stifle Innovation

Kai Kight, motivational speaker

As an accomplished motivational speaker, it would be pretty easy for classical violinist Kai Kight to stick with the same presentation over and over. However, that’s not how he rolls. “I’m nervous before every talk because I try new things all the time,” he says. Something’s obviously working: He was just named one of the 12 best speakers of 2015 by editors at MeetingsNet.

A product of Stanford University’s design and engineering program, known as the d.school, Kight, passionate about inspiring new ideas and new leaders, brings his unique insights to the ACRP 2016 Meeting & Expo in Atlanta, Ga., April 16–19. His perspective continues to be fueled by his own growth as an innovative classical music composer.

“Why wait for others” to define your life path? Kight challenges. Identify your own internal aspirations and desires. Consider new ideas. Take intelligent risks. It’s an approach he brings to every presentation.

“If I fail, it’s okay,” he says, in some ways distilling his own message down to five words. Fear is the enemy of innovation, Kight admonishes. “We all have a natural instinct to run away from discomfort,” he says.  Don’t fall into that trap. “The best musicians don’t run away from that dissonance,” Kight notes. “Bach was one of the first classical musicians to use that tension” to make incredible music. Harmony is about bringing different sounds together to create a new, stronger sound. Harnessed properly, tension creates beauty.

“You might embarrass yourself trying something new,” he admits. However, it’s not a wasted effort if you learn from the experience. It’s not “pain for pain’s sake,” as much as it is a strategic use of personal energy to take chances and reach new heights. “When I try a piece of new music, I can tell from the applause whether it is working or not,” he says. “I learn from that. I keep improving.”

Click here to learn more about Kight and his ACRP 2016 Meeting & Expo keynote session.

Steer Clear of Trouble with Strong Monitoring Visit Report, Expert Advises

Kathryn Kimmel, CCRC, CCRA, senior clinical research associate, PRA Health Sciences

Well-written monitoring visit reports will keep you out of trouble, says Kathryn Kimmel, CCRC, CCRA, a senior clinical research associate with PRA Health Sciences.

“It’s the first thing site auditors look at before they visit for a sponsor inspection,” she says. It gives them a framework for what to expect when they walk in the door. A good monitoring visit report inspires confidence, Kimmel adds.

There are several keys to writing a high-quality monitoring visit report:

1. Keep the audience in mind. Of course the report will be read by the sponsor and the project team. However, others, including site auditors/regulatory auditors, will give it the once over, too.
2. Try to identify and address inconsistencies in how project teams, sponsors, and monitors report and review results.
3. Keep it simple. “It’s about quality, not quantity,” Kimmel says. State the facts in a simple way that is understandable to anyone reading the report.

Kimmel also stresses viewing your report thorough a “how, who, what, when” prism. “Tell the story,” she says. “How did it happen, who did it, what are you going to do to fix it, and when will the corrective action be done?”

Vagueness is an enemy to avoid at all costs, Kimmel says. Example: A report that says something like “some informed consent forms were not signed properly.” Specificity is critical. “Which ones weren’t signed? What do you mean when you say some weren’t signed properly?”

Another shortcoming to be avoided: An absence of annotated trip report models. These are “invaluable” as a means to guide monitors. A strong model offers up clear “if/then” decision trees with guidance on how to handle unexpected issues.

Kimmel will present tips on monitoring visit report review plans during a panel session at the upcoming ACRP 2016 Meeting & Expo titled Quality Essentials: Monitoring Visit Report Review Plans.