A Medical Device Daily

Eighteen Los Angeles area residents have been charged in eight separate indictments for their roles in Medicare fraud schemes totaling more than $33 million, according to Acting Assistant Attorney General Matthew Friedrich of the Criminal Division and U.S. Attorney for the Central District of California Thomas O'Brien.

Federal and state Medicare Fraud Strike Force (MFSF) agents arrested the 18 people in the greater Los Angeles area. Agents targeted durable medical equipment (DME) company owners, medical professionals and medical clinic owners who are alleged to have engaged in various schemes to defraud Medicare of $33,264,133 in fraudulent billing.

The eight indictments in which the defendants are charged outline various types of fraud including schemes involving the fraudulent ordering of power wheelchairs, orthotics, hospital beds, enteral nutrition and feeding supplies. Enteral nutrition is sustenance ingested by patients through a feeding apparatus.

In addition, federal agents began executing search warrants at six locations throughout Los Angeles County.

These cases are a result of the operations by MFSF, a multi-agency team of federal, state and local prosecutors and agents designed specifically to combat Medicare fraud. Strike force operations began in the Los Angeles area on March 1.

In other legalities, following a complaint filed in July by Johnson & Johnson Vision Care (Jacksonville, Florida) a U.S. District Court in New York has ordered, on both parties' consent, Ocular Insight (Boca Raton, Florida) to permanently discontinue stating or communicating in its advertising or promotional materials or activities to eye care professionals for the company's Clear 58 contact lenses in the U.S., any of the following claims:

That Clear 58 is approved by FDA.

That Clear 58 is approved by FDA as a generic equivalent lens to J&J's Acuvue 2 brand contact lenses.

That Clear 58 is a generic equivalent to Acuvue 2.

That Clear 58 is an exact duplicate or is identical to Acuvue 2.

"In the interest of patient safety, we felt an urgent need to address these misleading claims as quickly as possible," says Naomi Kelman, president, Americas, for the Vistakon division of Johnson & Johnson Vision Care. "While Clear 58 has been 'cleared' for marketing by the FDA, it has not been 'approved' by the agency. Furthermore, the FDA does not perform the function of assessing whether a contact lens may be prescribed as a 'generic equivalent' lens."

According to Kelman, testing of the Clear 58 lens by Johnson & Johnson Vision Care shows that it is different from Acuvue 2 in material respects that would be expected to affect visual acuity, handling and/or comfort.

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