Attorneys for a prominent Florida eye doctor charged with corruption along with New Jersey Sen. Bob Menendez attacked federal prosecutors' contention that their client defrauded Medicare by using single-use vials of a costly drug on multiple patients.
Attorneys for Dr. Salomon Melgen told U.S. District Judge Kenneth Marra on Tuesday that prosecutors are misapplying and misinterpreting Medicare law when they included in their indictment allegations that he drew three to four doses from single-use vials of Lucentis, a drug used to treat a common type of age-related eye degeneration.
Attorney Matthew Menchel said prosecutors "have been all over the map" on whether such dose splitting is illegal. He asked Marra to throw out that part of the 76-count indictment, which alleges that Melgen misdiagnosed and mistreated patients in a decade-long scheme to bilk the health care program out of up to $190 million.
Including the dose splitting is "just an attempt to show him (Melgen) to be greedy," Menchel said, and would prejudice the jury. Melgen's trial is scheduled for September. He has pleaded not guilty and is free on $18 million bond.
In the separate New Jersey case, prosecutors allege that Melgen lavished Menendez with flights, vacations and campaign contributions so the senator would intercede on his behalf to gain visas for Melgen's foreign girlfriends, press Dominican officials to honor a lucrative port contract for one of his businesses and influence Medicare officials on billing disputes.
In the Florida case, Tuesday's arguments focused primarily on whether prosecutors can charge Melgen criminally for using single-dose vials of Lucentis for multiple injections.
According to court documents, Lucentis is administered in extremely tiny doses, 0.5 milliliters per injection or about a sixty-fourth of a teaspoon. It comes in single-use vials that contain about four times that amount. The manufacturer's instructions say the doctor should pull the vial's entire contents into the syringe and then squeeze out and dispose of the excess, about a thirtieth of a teaspoon, before administering the injection, according to documents. According to the attorneys in court Tuesday, Medicare reimburses doctors their wholesale cost of approximately $1,900 per vial plus a 6 percent surcharge.
Prosecutors say that rather than throw away the excess, Melgen hired a lab that would fill three to four syringes from each vial. He would then charge Medicare an additional $1,900 per injection, which was almost pure profit, they said.
Menchel and attorney Kirk Ogrosky told Marra that dose splitting is common throughout medicine. They also argued that Melgen's practice of dose splitting cost Medicare nothing, it still would have paid $1,900 per injection even if he used a fresh vial every time. They also argued that the manufacturer, Genentech, was aware of the practice of splitting Lucentis doses because it would include four labels with each vial.
Genentech "actively encouraged multidosing of the drug" in order to increase its usage over a comparable but cheaper drug it also makes, Menchel said.
But Assistant U.S. Attorney Roger Stefin told Marra that Melgin had been warned repeatedly by Medicare officials since 2008 that he couldn't split vials but kept doing it, even after a 2011 directive made the ban even more explicit. He said Melgen's vial splitting increased his patients' risk of infection that could destroy their eye. He said trial testimony will show that Melgin's practice had a higher rate of infection than other practices.
Marra repeatedly questioned Melgen's attorneys, saying it seemed they wanted him to throw out the charges based on matters of fact, which is the jury's role, rather than matters of law, which is his. He did not say when he would issue his ruling.