Week In Review, November 4, 2011

There is a crispness in the air, and leaves (and perhaps snow, depending where you are) are falling. It is a wonderful time of year for sure, and this Sunday marks one of the most joyful days of the year – the return to standard time.  We all get an extra hour of sleep! Oh happiness!  We have some business though before Sleepfest 2011 occurs. Keep the fluffy pillow and warm blanket on hold for now, as we present this week’s PC News Week in Review.

We’ll start this week’s review off with a story from the city that never sleeps. New York City agreed to settle charges that it overbilled Medicaid for $70 million.  The DOJ alleged that the city routinely renewed applications for 24 hour continuous care without a review by a local medical director as required by law. City Attorney, Michael Cordoza, said it was in the best fiscal interests of the city to settle the allegations due to the “highly punitive and draconian application of the False Claims Act.” Insert your own Captain Obvious comment here.

Is CMS sleeping on the job when it comes to producing draft guidance for implementing the Sunshine Act? In a letter to Senators Grassley and Kohl, CMS Administrator Don Berwick said the agency was working on the guidance for the implementation of the Sunshine Act, but gave no timetable when the draft guidance will be ready. Mr. Berwick said the delay was due to an executive order which requires federal agencies to reduce regulatory burden (please, try not to laugh), and the agency was still actively working with stakeholders to that end.  Senator Grassley was not pleased saying nothing new had been revealed and that the response was inadequate.

Speaking of executive orders, the President signed an executive order this week requiring the FDA to take certain steps to help deal with drug shortages. In the order, the FDA is to broaden its reporting of potential shortages; speed up approval of applications to change production of drugs headed for shortage; and inform the DOJ of suspected price gouging or collusion.

At the Pharma Congress Mary Riordan said the OIG would not be “falling back” on holding individuals accountable when it comes to healthcare fraud. The same holds true for FCPA investigations. More investigations of individuals for books and records violations of the FCPA are on the horizon.

Also at the Pharma Congress, Assistant Attorney General Tony West discussed healthcare fraud enforcement. In his remarks he cited a number of cases and settlements of healthcare fraud covering several facets of the healthcare industry with the final focus being on cases from the pharmaceutical industry.  As for the future, he indicated there would be a continued focus on individual accountability through use of the Park doctrine. He acknowledged that they know most companies and individuals want “to do the right thing”, and encouraged companies to come forward and self-disclose when problems are discovered.  You can read his full remarks here.

We’ll wrap up this week’s review with the big eye-opener of the week. GSK announced it will pay the U.S. $3 billion to settle criminal and civil investigations which included allegations of illegal marketing and Medicaid fraud. The investigations have been carried out over an eight year period and concern several products.

That does it for the review for this week, but before you run out to buy a Snuggy in preparation for the return to standard time, may we suggest that you stop by the PharmaCertify website first. With healthcare fraud and corruption overseas top priorities of enforcement agencies, we can help you get your teams the information they need with our library of compliance courseware and mobile apps focused specifically on the pharmaceutical and medical device industries.

For all of you in the Northeast, we hope life is back to normal after this past weekend’s snow storm. Now, go get that Snuggy and enjoy your weekend!

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