Massachusetts Physician Will Fight Kickback Charges

Alicia Ault

November 06, 2015

A physician who was indicted for allegedly writing prescriptions in exchange for drug company payments will fight the federal government.

The US Attorney's Office for the District of Massachusetts arrested Rita Luthra, MD, a Springfield-based gynecologist, on October 22, alleging that she violated antikickback laws and the Health Insurance Portability and Accountability Act (HIPAA), and lied to federal investigators.

Dr Luthra, 64, who was handcuffed and brought to a federal courthouse in Boston, pleaded not guilty. The physician "denies all the allegations, and she is confident that a jury will vindicate her," her attorney, Stephen Spelman, of Springfield, Massachusetts, told Medscape Medical News.

The physician was just one of a handful of people who were charged in connection with a wide-ranging investigation of Warner Chilcott by the US Justice Department. Days after Dr Luthra's indictment, the drug maker, now known as Actavis (a division of Allergan), agreed to plead guilty to giving inducements to physicians to get them to prescribe the drugs Actonel, Asacol, Atelvia, Doryx, Enablex, Estrace, and Loestrin.

The company also admitted guilt in manipulating prior authorizations to secure reimbursement for Atelvia, and for making unsubstantiated claims about Actonel. The former president, W. Carl Reichel, and two district managers also entered guilty pleas. Warner Chilcott paid a criminal fine of $23 million and a civil fine of $102 million.

Dr Luthra allegedly was paid $23,500 for speaker training and to conduct "med ed" sessions, agreeing to prescribe Actonel and Atelvia in exchange, according to the indictment. The US Attorney says that 31 times from October 2010 to November 2011, a sales representative brought food to Dr Luthra's office, and that she was paid $750 while she ate. She received $250 for speaker training, even though she never spoke to any other physicians, just to sales reps, said the prosecutors.

They also allege that her prescription volume fell once she stopped receiving payments from the company.

The indictment states that Dr Luthra enlisted a sales rep to help one of her office assistants complete prior authorization forms — a HIPAA violation, according to the prosecutors.

It also claims that she lied to investigators from the federal Department of Health and Human Services in 2014 when they asked about her relationship with Warner Chilcott and about the sales rep who had worked on the prior authorization forms.

"Sending a Message"

Spelman said his client denies all of the allegations. "Essentially what they've got to prove is that she took that money, and the reason she prescribed the drug is that she took the money," he said. Dr Luthra did not hide receipt of the payments, listing them on her tax returns, said Spelman.

Kevin Outterson, professor of health law, bioethics, and human rights at Boston University School of Law, said that it is unusual for federal prosecutors to single out individual physicians.

The overall amount of money she received "is not a huge red flag," he told Medscape Medical News. But Dr Luthra's conduct appears to be "egregious behavior," because she was not speaking to a group of physicians, and she was receiving above fair market value for her services, he said.

It looks like a good case for the US Attorney's Office, said Outterson. He also said that federal prosecutors have been trying to go beyond charging corporations, where the impact might be minimal on the business, its stock price, or its reputation, to going after individuals, where there might be a bigger effect.

With Dr Luthra's case, "the US Attorney is sending a message," Outterson said.

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