The PharmaCertify™ Team

Was last week cold enough for you? Arctic cold invaded the nation and brought crazy temperatures to the mid-west, northeast, and the deep south. As some friends in the mid-west pointed out, Chicago was colder than certain cities in Alaska last week. Well, at least January is almost over and we can look forward to spring! Speaking of something to look forward to, here’s this week’s News Week in Review.

The final rule for the Sunshine Act is still out in the cold, and it seems everyone is mad about it. AARP, the AFL-CIO and a number of other healthcare advocacy groups have written the White House, urging them to release the final rule toot sweet. The groups believe that the delay is having a negative impact on healthcare in terms of money spent on expensive brand-name drugs, and on patients who take these medications when older drugs are available. Not to be outdone, Senator Chuck Grassley sent a letter asking the President’s Chief of Staff to get this thing done. Grassley pointed out that Congress drafted the legislation so that the public would be aware of the payments physicians were receiving from the industry in September of this year, but that would now not happen due to the delay.

All is not hopeless on this front though. We learned that the OMB has de-iced the final rules for HIPAA/HITECH. Yes it is possible people. The rule will be effective in March of this year, with those affected having 180 days after that to come into compliance. The new rule will require insurers to enter into Business Associates Agreements when providing risk assessment services. It also clarifies the definition of a breach of PHI and changes the breach notification requirements.

Analysis by Mike Koehler suggests that a few settlements blanketed the reality of FCPA enforcement actions over the last six years. Koehler divided activity into single case actions and events and his investigation that may yield actions against multiple companies. The majority of FCPA enforcement occurred between 2007 and 2011, with three events in particular yielding a number of actions. While the statistics would suggest that the government has been very busy in enforcing the FCPA, in many cases the settlements are the result of one investigation with multiple settlement agreements occurring at the same time. Mr. Koehler believes compliance professionals should have an accurate picture of enforcement statistics, so they can best determine how to allocate their resources.

A new study reveals companies are not addressing vendors, CROs, and other external partners in their compliance training. The study finds that external training consumes 3% of a compliance teams’ budget and 1% of their time, whereas internal training uses 9% of the teams’ budget and 10% of their time. Often, the training responsibility falls on the department that enter into a contract with the service provider. Researchers suggest companies consider making the compliance department responsible for the training of external partners. Compliance teams have the most expertise in this area and are best equipped to assure external partners are adhering to regulations.

And speaking of training…you need it, we got it.  From federal and state disclosure laws to the FCPA and anti-bribery, PharmaCertify has the modules and mobile solutions for you. If you’re attending 2013 CBI Pharmaceutical Compliance Congress, stop by our booth, or visit www.pharmacertify.com to see a demo.

Enjoy the warm up everyone, before winter rears its ugly head again. Have a great week!