Oversight in Medicare Drug Fraud

As reported in this Wall Street Journal article, the Government Accountability Office released a report stating that some insurers do not have “in place all the fraud controls they’re supposed to.” This means that some of them have not “met the requirements for employee training and internal monitoring and auditing. The GAO also stated that this oversight “risks significant misuse of funds in this $39 billion program.” Acting administrator for Medicare, Kerry Weems, has stated that he disagrees, however, has admitted the funding cap for the Medicare Integrity Program has, “seriously degraded [Medicare’s] ability to meet its responsibilities in combating fraud abuse.”A copy of the full report can be found here.

Off-Label Drug promotions are not likely to be caught by the FDA

A new government study performed by the Government Accountability Office, detailed here at FDA News, states that if a company has off-label drug violations, they are unlikely to be caught by the FDA. The FDA issued 42 letters to companies between 2003 and 2007, but none of these cases reached the Justice Department. The eleven cases that were settled by the Justice Department were brought to the court by someone other than the FDA.

The article concludes by saying that the FDA doesn’t have an organized system that makes the FDA’s system unlikely to find off-label violations.