According to the findings of a new study, whistleblower lawsuits and resulting investigations likely pushed hospitals and doctors away from unnecessary heart stent operations, by highlighting widespread problems with patients being pressured to undergo the procedures.
Percutaneous coronary interventions (PCI), also known as heart stents, are designed to prop open arteries that are significantly blocked. The procedures can cost $10,000 or more, and are a lucrative practice area for hospitals and top surgeons.
Typically, the heart stent procedure is only considered necessary if there is at least a 70% artery blockage. However, in recent years, a number of investigations have highlighted instances where doctors recommended patients undergo unnecessary heart stent procedures to increase their profits and, in some cases, to receive kickbacks from stent manufacturers.
Researchers from Emory University and Yale School of Medicine published a research letter this week in the medical journal JAMA Internal Medicine, which found that whistleblowers working with the Department of Justice were able to not only bring down certain doctors who were performing unnecessary, and unethical, heart stent procedures, but also may have had some chilling effect on the practice as a whole.
Whistleblowers are able to file lawsuits against government contractors through the U.S. False Claims Act, if they have private knowledge that their employer or another entity has defrauded the government. In the medical cases, the fraud occurs when a claim is made for Medicare reimbursement for an unnecessary or overpriced procedure. If the Justice Department joins the case and it results in a court ruling or settlement agreement, the whistleblower typically receives a portion of the resulting payout.
In this study, researchers looked at PCI-related whistleblower claims, identifying 16 hospitals that were investigated in Florida, Kentucky, Maryland and New Jersey between 2007 and 2015.
According to their findings, 15 of the cases were resolved with a settlement agreement, and three cases resulted in defendants going to prison.
The researchers note that many of the cases were based on doctors overstating the degree of stenosis suffered by the patient, which they suggest could mean rates of unnecessary heart stent operations are underestimated. However, the study also found that the number of PCI procedures declined at the investigated hospitals after every investigation.
“It is difficult to precisely identify the association of the investigations with PCI use. Declines in procedure volumes at each hospital that was investigated generally coincide with the initiation of the investigations,” the researchers concluded. “The investigations may have led physicians at non-investigated hospitals to adopt more conservative practice styles.”
One of the highest profile cases was one involving Dr, Mark Midei, a former St. Joseph Medical Center cardiologist who has since been stripped of his medical license. In 2013 a Maryland jury determined that both Midei and the hospital were liable for implanting unnecessary heart stents.
The discovery of the problems with unnecessary heart stents by Dr. Midei was first uncovered by a U.S. Justice Department (DOJ) investigation into Medicare fraud and claims of kickbacks between the hospital and the MidAtlantic Cardiovascular Associates (MACVA), of which Midei was a member at one time. He was kicked out of his position at the hospital shortly after the investigation got underway.
Settlement agreements were reached in nearly 250 lawsuits against St. Joseph and Midei. As a result of the unnecessary procedures, St. Joseph also reached a $22 million settlement with the DOJ in 2010.