Temporary restraining orders—a first-of-its-kind against doctors allegedly prescribing opioids illegally under the Controlled Substances Act (CSA)—were served this week that forbid Michael P. Tricaso, D.O., of Akron, and Gregory J. Gerber, M.D., of Sandusky, Ohio from writing prescriptions.  The Justice Department filed two separate complaints to bar two Ohio doctors from prescribing medications and allege that an investigation revealed the doctors “recklessly and unnecessarily distributed painkillers and other drugs.”  Attorney General Jeff Sessions even made the trip to Cleveland, Ohio to make the announcement.  You can read the press release HERE for more information.

The motions for temporary restraining orders point to the Government’s authority under the Controlled Substance Act for the Attorney General to commence a civil action for appropriate declaratory or injunctive relief relating to any violation of 21 U.S.C. 843(f).

According to the filings, Dr. Tricaso was targeted by a confidential source working for the DEA at a gym.  The confidential source purchased various prescription drugs from Dr. Tricaso, including steroids and Percocet.  The transactions were recorded and Dr. Tricaso is alleged to have made some unfavorable comments including that he would only give the confidential source a prescription for 20 Percocet because that number is “under the radar.”

The allegations against Dr. Gerber are much more extensive, but defensible.  Dr. Gerber was a solo practitioner operating a pain clinic.  The Government claims that Dr. Gerber illegally issued hundreds of prescriptions that exceeded the amount for “legitimate medical purposes.”  As part of its investigation, the Government sent an undercover agent to Dr. Gerber’s offices six times.  The Government alleges that the agent was prescribed by Dr. Gerber a combination of controlled substances, including Oxycodone, with minimal medical examination and no complaints of pain.  The Government also notes that Dr. Gerber was connected to the Insys case and received $175,000 in speaker fees for promoting Subsys.

The motion for temporary restraining order directed at Dr. Gerber attaches an expert medical opinion, patient affidavit, and an affidavit from an agent.  The expert’s affidavit references a review of claims data and medical records.  The expert opines that the prescriptions exceed normal levels.

Also curious is that the Government also attaches as evidence of Dr. Gerber’s illegitimate practices correspondence from Walmart advising that, after an internal review, it will no longer fill prescriptions written by Dr. Gerber.

It will be interesting to watch these cases and see how it develops.

 

 

I am attending the American Bar Association’s 28th Annual National Institute on Health Care Fraud this week.  Yesterday, I had the opportunity to speak on a panel discussing data mining and other health care fraud enforcement trends with a great group of lawyers – AUSA Carolyn Bell, Kevin Napper, and Andrew Feldman.

The topic of data mining is timely because it has been widely reported that the Government is using real time data analytics to identify potential targets of criminal investigations.  The Government is collecting electronic billing information from health care providers across the country and centralizing the information in one location.  OIG has employed data analytics to constantly review and analyze the data to identify any “spikes” or “outliers.”  The Government refers to this information as “reliable” and “unfiltered.”

We discussed the use of data analytics in the Melgen case.  AUSA Bell was one of three prosecutors that worked on the case.  The Melgen case involved the prosecution of a South Florida ophthalmologist for health care fraud.  Dr. Melgen was reported to be on of the highest individual doctor billers for Medicare.  In the trial, the Government used charts that summarized Dr. Melgen’s billing data and compared it to his peers.   The charts showed huge differences in billings and claims submitted by Dr. Melgen as compared to his “peers.”  For instance, one chart showed that Dr. Melgen collected $57,371,547 for one procedure, while the National median collections for other providers for the same procedure was $3,030,041.

The Government introduced the charts as Rule 1006 evidence.  This was heavily disputed through motions in limine.  The defense argued that the charts should come in through a medical statistician under Rule 702. The Court ultimately ruled that “to the extent the government seeks to present comparison data without laying a proper foundation that the data provides a valid basis for comparison. This, however, does not preclude the government from presenting evidence of the percentages of Defendant’s patients that received various treatments and services based on a review of Defendant’s records, and from inquiring of its expert witnesses what types of percentages would they expect to see in their experience. See United States v. Chibber, 741 F.3d 852, 854-58 (7th Cir. 2017).”

Everyone on the panel was in agreement that defense attorneys will need to hire statisticians to assist in the defense of health care fraud prosecutions.  The statistician will need to review the data to identify flaws in the Government’s analysis and in order to explain why anomalies exist.

More importantly, the statistician will need to attack the Government’s “statistically significant sample” of patients.  Because it would be impossible to review all patient records in these data driven health care fraud prosecutions, the Government picks a “statistically significant sample” of patients to review and present to the jury.  The Government will extrapolate and claim that the sample is representative of all of the provider’s patients. The defense needs the statistician to establish that the Government sample is statistically deficient and not representative of all the patients.

Litigation over release of data in the opioid litigation gives a glimpse at the volumes of information available to the Department of Justice in health care fraud cases.

Judge Dan Aaron Polster of the Northern District of Ohio is presiding over a multidistrict litigation involving more than 400 federal lawsuits brought by cities, counties, and Native American tribes against makers of prescription painkillers, companies that distribute the painkillers, and pharmacy chains that sell the painkillers. Judge Polster was picked to preside over the litigation for several reasons, including that Ohio has been hard hit by the opioid crisis and that Judge Polster has extensive experience with multidistrict litigation.

In that litigation, the local governments suing the drug companies sought extensive documentation kept by the United States Drug Enforcement Administration (“DEA”) regarding data on painkiller sales. Status reports filed by the parties revealed that the DEA was worried the release of the information would reveal trade secrets.  The DEA also wanted to limit the amount of information provided and wanted a broad protective order to shield the information from release to the media.  The DEA finally relented and agreed to provide some information.

The New York Times has been covering the story, including outlining what data will be released.  A portion of the NYT article and a link to read more is below.

 

CLEVELAND — The U.S. Department of Justice has shared some federal data about prescription painkiller sales to help with settlement talks between local governments and drug companies targeted in hundreds of lawsuits over the opioid epidemic.

The department previously agreed to release certain data on the grounds it not be circulated publicly and be returned or destroyed when the litigation is finished. The information includes a year-by-year, state-by-state breakdown of companies that made and distributed most of the opioids in each state between 2006 and 2014. It also includes how many pills were sold annually in each state and each drug company’s market share.

DOJ Will Share Rx Painkiller Data For Opioid Lawsuit Talks – WOUB Digital

Interestingly, it seems that the DEA can track sales of opioids to the smallest detail, including state sold, year sold, and even manufacturer.  The DEA’s concerns regarding the trade secret nature of its data gives insight into the value of this information to the Government. In fact, data mining is steering prosecutions, but this data is not only valuable to the Government.  Defense attorneys may find value in this same data when defending health care fraud prosecutions.  Defense attorneys are well served demanding that the Government turn over all documents reflecting data mining resulting in the prosecution of the defendant, including cost reports.

Saloman Melgen sentenced to 17 years today.  A win for the defense, but tantamount to a life sentence for the 63 year old physician.

Melgen was charged in a 76 count indictment.  The case was brought after data mining by the OIG determined Melgen was the highest billing ophthalmologist to Medicare in the entire country. The Government alleged that Melgen was performing unnecessary eye injections and laser procedures and that Melgen was illegally dividing vials of the drug Lucentis into multiple doses.

The Government claimed this was one of the biggest health care fraud cases in the nation and claimed that Melgen robbed Medicare of $105 million.  The Government’s experts at trial testified that Melgen used antiquated tests, which were poorly done, to diagnose patients with wet macular degeneration.  The experts testified that most of Melgen’s patients didn’t even have the disease.  One expert referred to melgen’s practices as “abusive” and “horrifying.”

The defense presented the testimony of Melgen’s family and staff, who said he was a good doctor that cared about his patients.

The jury believed the Government and convicted Melgen of 64 counts.  Judge Marra tossed 9 of the 76 counts before the case went to the jury.

There was much litigation in advance of sentencing, including four days of hearings over two months focused on the loss at issue.  The Government argued that the loss to Medicare was $136 million.  The defense argued the loss was $64,000.  Judge Marra largely sided with the Government and set the loss figure at $73.4.

In two ultimately hollow victories for Melgen, the judge agreed that his treatment didn’t pose potentially fatal risks to his patients and that he didn’t target vulnerable people.

“(Melgen) was not able to perpetrate his fraud because his patients were vulnerable. He was able to do so because he was a trained physician in whom his patients place their trust,” Marra wrote. “The mere fact that the patients were elderly puts them in no different position than a patient of any age who trusts that his or her doctor is acting in their best interest.”

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Going into sentencing Melgen was facing 19 to 25 years in prison.  Melgen’s attorneys have vowed to appeal.