A Medical Device Daily

Miami physician Keith Russell, 65, and physician's assistant Jorge Luis Pacheco, 50, were each sentenced to 97 months in prison, and physician's assistant Eda Marietta Milanes, 43, was sentenced to 63 months in prison, for their roles in fraud schemes that involved billing Medicare for $10,903,509 worth of unnecessary HIV infusion treatments, according to Assistant Attorney General Lanny Breuer of the Criminal Division; Acting U.S. Attorney Jeffrey Sloman of the Southern District of Florida; and Daniel Levinson, Inspector General of the Department of Health & Human Services (HHS).

Russell, Pacheco and Milanes were also ordered to pay more than $3.1 million in restitution to the Medicare program during their sentencing hearings before U.S. District Judge Ursula Ungaro. The three were convicted by a jury of conspiracy to commit healthcare fraud and multiple counts of healthcare fraud on March 17, after a two-week trial in Miami.

"Medical professionals serve as the gatekeepers of the Medicare system, and their single most important duty is to determine the best care for their patients," Breuer said. "Physicians and their assistants who choose instead to abuse the public trust and enrich themselves by gaming Medicare will be vigorously prosecuted, and we will continue to expand our strike force operations to stamp out this kind of blatant fraud."

"The infusion clinic in this case was established for the sole purpose of defrauding Medicare these doctors saw no patients, administered no legitimate medical services, and paid a cash kickback to patients for each visit," Sloman said. "In this way, the defendants bilked Medicare out of millions of dollars in false claims. The U.S. Attorney's Office in South Florida is committed to prosecuting these frauds, in the hopes of helping to restore the integrity of our healthcare system."

Trial evidence established that Russell, Pacheco and Milanes served as the medical staff for M&P Group of South Florida and Tendercare Medical Center, which purported to specialize in the treatment of HIV.

Russell was the medical director for both M&P Group and Tendercare during their operations. Pacheco and Milanes worked as medical assistants for Russell at both clinics. One of the owners of the clinics, Tony Marrero, testified at trial that the clinics were established for the sole purpose of defrauding Medicare. Marrero testified that the scheme was to submit claims for medically unnecessary HIV infusion and injection treatments.

Evidence at trial showed that the conspirators billed Medicare for $10,903,509 and were paid in excess of $3.1 million during roughly two years of operations. Trial witnesses testified that the unnecessary medicines were not administered, and that the clinics were only operated to create the appearance of legitimacy. Marrero stated that he had an arrangement with a pharmaceutical wholesale company, Lifecare Medical, to buy invoices showing the purchase of large amounts of medications, when only minor amounts were actually bought.

Marrero also testified that he paid Milanes and the M&P Group extra money to manipulate patients' blood samples so the lab results would appear to support the fraudulent claims. Another physician's assistant, Luz Borrego, testified how those samples were manipulated, and Borrego also stated that she would not give the medications because she knew the medications could hurt HIV patients if actually provided.

Trial testimony established that every patient who went to the clinics was paid a cash kickback of up to $200 per visit. Four patients testified at trial that they took bribes and never received medication at the clinics. One patient testified that he used his payments from the clinics to support his cocaine addiction. Another patient testified that he did not even have HIV, notwithstanding clinic documents showing he was being infused with medication to treat HIV.

Trial evidence established that Russell, Pacheco and Milanes worked at Tendercare and M&P Group at the same time. Further, patients testified at trial that they received cash and bogus treatments from both clinics.

This case was brought as part of the Medicare Fraud Strike Force, supervised by the Criminal Division's Fraud Section and Sloman. Since the inception of Strike Force operations in March 2007 Miami (Phase One), Los Angeles (Phase Two), Detroit (Phase Three), and Houston (Phase Four) the Strike Force has obtained indictments of more than 293 individuals and organizations that collectively have billed the Medicare program for more than $680 million. In addition, the Centers for Medicare and Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.

In other legalities, Somanetics (Troy, Michigan), manufacturer of the Invos Cerebral/Somatic Oximeter, a medical device designed to monitor oxygen saturation in the brain and other regions of the body, said it has filed a patent infringement action against CAS Medical Systems (Branford, Connecticut), in the U.S. District Court for the Eastern District of Michigan.

The complaint asserts that CAS' Fore-Sight Cerebral Oximeter willfully infringes upon one or more of Somanetics' patents, including U.S. Patents 6,615,065, 5,902,235 and 5,482,034. The complaint also asserts that CAS has engaged in unfair competition and false advertising, by making false or misleading statements in connection with its advertising and promotion of Fore-Sight, and false or misleading statements related to Somanetics' products. The complaint seeks, among other things, compensation for damages and an injunction against CAS from infringing upon Somanetics' patents.