The PharmaCertify™ Team

To borrow quite liberally from Carole King, did you feel the earth moving under your feet this past week? Will the sky be tumbling down on you this weekend?  Earthquakes (yes, plural, Colorado had one the same day as Virginia) and now a hurricane on the way. It’s a busy week for Mother Nature, and full week for us here at the PC News Week in review as well. Make sure everything is secure around you, and let’s get going!

The DOJ is trying to shake some change loose from the defendants in the shot-show FCPA trial. In a filing Wednesday, the DOJ said it was changing the way it will produce material for the defendants in the case. The DOJ has contracted with a third party vendor to store all the material related to the trial and the defense will now have to pay to access the material. The government, at its own expense, will produce trial-related material to the relevant defendants. Material not relevant to a defendants’ trial will have to be paid for. Guess the $500M recovered from Google for directing the ads of Canadian pharmacies to U.S. consumers was just not enough to meet the budget needs.

A new survey finds doctors like attending dinner programs, if you keep it bouncing along and leave time for Q&A. The survey conducted by Sermo shows that nearly three quarters of the respondents like to attend speaker programs at medical meetings, and just over sixty percent attend traditional speaker programs. Interesting was that 27% said they don’t attend speaker programs due to the transparency movement in the industry. Wonder if that changes when the Sunshine Act goes in effect?

And speaking of the Sunshine Act, one M.D. is praising the transparency it is bringing to the industry-physician relationship. In her article, Maggie Kozel rolls out the case on how everything from providing drug samples to support of CME, influences physicians’ decisions. She goes on to point out that slowly the profession is recognizing the influence of the industry. Professional organizations are taking steps to raise awareness among their members about the influence even small gifts have on decision making, and the number of offices banning sales reps and samples is rising.

Physicians could find themselves on shaky ground if they aren’t prepared for the increased scrutiny that will be brought by the healthcare reform law according to comments made by a lawyer to a group of ophthalmologists. The new law drastically increased the money spent on enforcement, and provides for stiffer penalties under the Anti-kickback statute and False Claims Act. Medicare and Medicaid overpayments can now be considered false claims if they are not repaid within 60 days, and to catch those overpayments the government will be starting a special audit program. The same lawyer also spoke to the group about the reporting required by pharmaceutical companies under the Sunshine Act.

AstraZeneca breaks new ground with their physician spend reporting database. The company announced this week it was expanding the payment and support information it reports on its U.S. website. The company will include all direct and indirect payments made to physicians for meals, travel and the like as well as payments (both direct and indirect) made to clinics, hospitals or physician groups engaged in pre-clinical and clinical studies.

Don’t mess with Texas (or the Feds) when it comes to Medicaid and Medicare claims. The state’s AG announced a $24 million settlement was reached with Par Pharmaceuticals over the inflated drug prices to Medicaid. And just to prove that saying applies to cracking down on its own cities, the state joined the federal government in collecting $1.69 million from eleven Texas cities for false claims against Medicare and Medicaid.

That brings us to the end of this week’s PC News Week in Review. If your compliance training could use some shaking up we can help out with everything from games to off-the-shelf customizable eLearning on topics ranging from the FCPA to state gift ban and disclosure laws.

For those of you facing Hurricane Irene this weekend, batten down the hatches, be safe and try to stay dry. For the rest of you go out and get some extra enjoyment out of the weekend for our friends along the east coast.