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Repay overpayments in 60 days
The U.S. Department of Health and Human Services' Office of Inspector General (OIG) now expects research institutions to monitor their own regulatory compliance and identify errors and overpayments. While voluntary disclosure has been an option since the 1990s, the OIG has made it a bigger focus lately, a regulatory expert says.
Voluntary disclosure involves having research institutions conduct internal reviews, find errors, and report them, says Pat Marion, CFE, principal of Compliance Concepts Inc. of Philadelphia, PA. Marion worked for the OIG for more than 20 years. Compliance Concepts is a 14-year-old health care compliance firm.
"This is always a much better way to find and correct problems," he says.
When a research organization discovers a billing error, it can report this and adjust payment to the Medicare carrier, accordingly.
"If you find an issue that potentially contains fraud, then those cases you take to the Office of Inspector General," Marion says.
Marion offers these suggestions for how to handle various compliance issues:
1. Listen to research participants' complaints about billing issues.
Occasionally, a research participant will receive a bill from Medicare that the person thought would be paid by the clinical trial. Perhaps they were told the trial would cover all costs.
Investigators might answer this complaint with a casual, "Don't worry about it." But this is precisely the type of situation a research compliance office should review, Marion says.
"When you get these complaints and ignore them they can turn into a bigger problem," he explains. "And sooner or later you're going to have OIG knocking on your door."
The research organization's research administrator should review the claim and then return to the patient with an explanation about why Medicare was billed for this item, he adds.
If the item billed to Medicare was not for standard of care and was billed inappropriately, then this should be corrected with a refund made to Medicare.
"Find out why it happened: was there a breakdown in Medicare coverage analysis? Did somebody not do something they should have?" Marion says. "Don't let this escalate to something bigger."
2. Pay close attention to effort reporting.
"One issue that people don't tend to be as mindful of is effort reports in universities," Marion says. "I think there is a huge liability if effort reports are not correctly filled out."
Marion has seen cases where researchers only keep track of their federal research time, a practice that is noncompliant with regulations.
"In the government's mind there is no such thing as a 40-hour workweek in an academic research setting," Marion says. "You have to report 100% of total university effort, including federal and nonfederal research time."
Researchers lose sight of this requirement and fail to complete accurate effort reports. But this is a compliance issue the federal government takes seriously, he adds.
"They have to include research time, instruction time, clinical time, and administration time," he says.
In one investigation Marion saw the investigator listed his time on the effort report as 100% for the federally-sponsored research. In reality, the investigator had other job responsibilities, including chairing a department, heading five committees, so it was impossible for him to have spent 100% of his time on just the research.
"The government takes great exception to that," he says.
3. Report all awards to the National Institutes of Health (NIH).
Researchers often list only their NIH awards on the support application, but the federal government wants to know of all of their awards – both public and private ones, Marion says.
"The government wants a thorough and accurate answer," he says.
The federal award process judges want to know how much time you might have available for the federal grant for which an investigator is applying.
"They want that information listed so they can make a decision about the full breadth of what a researcher is doing and make a decision on that basis," Marion explains. "If you have three other awards, the decision might have a different outcome than if you have 30 other awards."
But if investigators do not list all of their awards and NIH discovers this omission it could result in NIH asking for its grant money to be returned, he adds.
4. Collect co-payments properly.
Research institutions cannot arbitrarily waive co-payments, Marion says.
"That's always an issue in any program," he says. "You can't bring somebody in and say, 'We'll waive any co-pays on that.'"
For instance, the research participant receives an x-ray that is covered under Medicare's standard of care. There's a Medicare co-payment associated with that treatment. The researcher can't say this co-payment will be waived, he explains.
"We will have to disclose to people which things will be standard of care and might require a co-pay," he says. "You need to tell people what they will be responsible for, and you can't promise them the world."
5. Disclose errors discovered during internal review.
The first thing a research institution should do if it discovers an error during an internal review is disclose the mistake and return the funds, Marion says.
Some investigators question why they should return the money and why it isn't adequate to simply change the practice moving forward so that mistake won't recur, he notes.
"The answer is, 'No. If you know you have Medicare or Medicaid payments that are overlapped with research services, then you have to pay that money back within 60 days,'" he states.
"We've seen some investigations where organizations knew they had issues and did not correct them or pay back the money they should have paid back," Marion says. "In the future, it will get worse for these organizations."
"Make sure you close the loop and get that money back to the awarding agency or Medicare or wherever that overpayment came from," he adds. "That 60-day deadline to pay it back starts when you identify the overpayment through an internal investigation."
6. Follow three steps in reporting mistakes.
"For example, we were involved in an embezzlement case where we knew from the third day that there was theft of money, embezzlement involving federal dollars," he recalls. "Because of the nature of the investigation and activity, it was clearly a criminal case and was reported directly to the U.S. Attorney's office."
The institution also brought in outside counsel to conduct an internal investigation and to make the disclosure about the findings.
In cases like that one, institutions often enter a corporate integrity agreement in which they agree to pay back the money overpaid and describe how they will operate for the next five years to prevent future problems.
"It includes designating what your corporate compliance program should look like, the requirements for training, and some of these have a clause for having an outside auditor come in and look at claims for the next three to five years," Marion says. "If the federal government does an investigation and there's a settlement, then there's a 99% chance you'll receive a corporate integrity agreement."