'Outsider' Oncologist Whistleblowers Share in $100M Reward

Insiders Usually Report Fraud

Nick Mulcahy

November 20, 2018

A $625 million False Claims Act settlement, which is one the largest ever, includes a reward of roughly $100 million that is being split up among a trio of whistleblowers who exposed an illegal cancer drug scheme perpetrated by AmerisourceBergen Corporation, the major US drug wholesaler.

One whistleblower, Michael Mullen, a former chief operating officer at AmerisourceBergen Specialty Group, is an "insider."

Insider or corporate employee whistleblowers are the norm because they have relatively easy access to view irregularities, according to a report last month on the Law360 website, a legal news outlet.

However, the other two whistleblower lawsuits came from "outsiders" — a pair of pharmacists at a Michigan hospital and a Florida multispecialty physician group, Omni Healthcare, which detected wrongdoing through its oncology practice.

That is unusual because medical false claims (ie, fraud) are usually rooted in billing and thus are difficult to detect by clinicians (ie, outsiders), said experts.

Agreed, said J. Marc Vezina, a Louisiana-based lawyer who represented Omni Healthcare in its whistleblower lawsuit, which originated from the "oncology side of the house" of the multispecialty practice.

Nonetheless, there were some clinical indicators or "triggers" that something was amiss in this case, he told Medscape Medical News.

The scheme involved the illegal creation and marketing of prefilled syringes of drugs that are used in the supportive care of cancer patients undergoing chemotherapy and are legally sold in vials, as previously reported by Medscape Medical News. The therapies included Procrit (epoetin alfa), Aloxi (palonosetron), Kytril (granisetron) and the generic form of granisetron, Anzemet (dolasetron), and Neupogen (filgrastim).

However, the prefilled syringes, which were created from the vials and profitably exploited the 10% "overfill" routinely placed in the vials, had expiration dates that raised suspicions.

According to Vezina, Omni Healthcare clinicians asked: "Why does this [syringe] have a 14-day expiration [period] when the vial [of the same drug] might be 30, 60, or 90 days?"

The syringes were placed in a refrigerator after cold-pack delivery, but they could not languish in the cooler like vials, observed the Omni oncology clinicians. "That was one factor," summarized Vezina.

There were also red flags related to dosing, according to a lawyer for the pharmacy whistleblowers.

The two pharmacists from St Joseph Mercy Hospital in Ypsilanti, Michigan, reportedly regularly received "prefilled syringes for fictitious patients in amounts that greatly exceeded the proper dosage amount for a single patient's treatment."

However, Vezina acknowledged that the biggest tell-tale sign of illegality with the prefilled syringes were the financial incentives offered by AmerisourceBergen's subsidiary, Oncology Supply, to motivate physicians to use the prefilled syringe.

Those incentives "put them [Omni] on notice to look at it," he said. "They split the profit of the overfill [from the vials] with the doctors who used their prefilled syringes," Vezina added. This is essentially a kickback because the product is then paid for by a federal healthcare program such as Medicare, he explained.

Vezina also noted that the whistleblower lawsuit awards in this case were previously reported as totaling $93 million but "are close to $100 million."

He also offered some insight as to why some other clinical practices may have not have questioned the syringes.

"A lot of people probably said to themselves: 'I am getting this stuff for 5% cheaper [with the syringe] than I am getting it with the vial and I don't have any labor costs to prepare the injection — it's already in the syringe.'"

Affordable Care Act Paved Way for Outsiders

The Affordable Care Act lessened the legal burden for outsiders to bring False Claims Act lawsuits that involve publicly disclosed information, eliminating a requirement that whistleblowers possess "direct and independent knowledge" of wrongdoing, according to Law360.com.

But it is still difficult to mount a False Claims Act lawsuit as an outsider, said experts. "It's harder if you're not an insider because if you're not there in the room, if you're not there with the internal documents, there's an extra level of proof you have to overcome," said Gordon Schnell, a lawyer at Constantine Cannon LLP, an international firm.

Omni Healthcare maybe be an outsider but it is very savvy about whistleblowing, suggested Vezina. "This is not Omni's first rodeo with the False Claims Act," he said.

Previously, the medical practice, which is based in Melbourne, Florida, helped the Department of Justice secured a $256 million settlement with Millennium Health over medically unnecessary urine drug testing.

They also may pursue at least one other False Claims Act suit in the future, said Vezina.

Follow Medscape senior journalist Nick Mulcahy on Twitter: @MulcahyNick

For more from Medscape Oncology, follow us on Twitter: @MedscapeOnc

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