The PharmaCertify™ Team
“Did you hear that?” “Sounds like it came from the dark, scary basement that has only one way in or out.” “I think I’ll go down there and check it out – unarmed of course. What could go wrong?”
Ah, the famous last words of more than one victim from horror movies. It is that time of year, when Halloween (insert sequel number here) and Friday the 13th run practically non-stop on a variety of channels, and we anxiously await the return of the Great Pumpkin. Rest assured, there are no ghosts, goblins or chainsaw wielding psychopaths here at the PC News; just some of this week’s top news items from the world of pharma, bio and med device compliance. So read on good people….if you dare! <click for maniacal laughter>
Let’s start this week’s review with something lurking in the darkness…of physician’s cell phones.
Text messages! Not your average, run of the mill text message, but ones that are sent to other physicians about patients. According to a provider of a secure text messaging platform, around 70% of physicians use text messaging to communicate with other physicians about patients. If PHI is communicated in a text, the physician could be in violation of HIPAA’s security and privacy rules if proper safeguards are not in place.
On to the frightening financial relationship between the industry and physicians. Oklahoma doctors are the latest on the media hot seat based on analysis of Pro Publica’s data. One physician interviewed by Tulsa World said the relationship between the industry and his profession has changed over his 30 years of practice. While he has no problem with information about the financial relationship between doctors and industry being made public, he is concerned the data will be misinterpreted. To that point, the Sunshine Act raises communication concerns for stakeholders affected by the Act.
The former president of a telecom company was handed a blood curdling 15 year prison sentence this week for bribing Haitian government officials. The sentence is the longest one ever handed down in an FCPA case.
A privately held med device company also received a “treat” from the government this week in the form of a nearly $2.4 million settlement over False Claims Act and Anti-kickback violations. The government alleged the company paid physicians for each patient who completed a survey called a User Preference Evaluation. Completion of survey necessitated that the physician use one of the company’s devices, and the majority of the patients involved were Medicare beneficiaries. The government also alleged physicians were provided improper remuneration in the form of travel, expensive meals and entertainment. And if that didn’t give you chills, this just might: healthcare fraud enforcement in 2011 is on track to outpace 2010 by 85%. <click for blood curdling scream >
Next we travel across the dark, murky, foggy waters of the Atlantic to the U.K. where the first individual charged under the U.K. Bribery Act was found guilty this week. The former court clerk could face up to 10 years in prison when he is sentenced in November.
We wrap this up with a word of warning from the FDA: the black licorice which may show up in the trick-or-treat bag can come back to haunt you in a most unpleasant way…especially if you are over 40 (which let’s face it being over 40 is scary enough!). According to the FDA, eating two ounces of black licorice a day for two weeks can lead to irregular heart rhythm. The sweetener used in the licorice, glycyrrhizin, (um…wasn’t that one of Superman’s nemeses?) leads to drops in potassium levels which then leads to arrhythmia, high blood pressure and edema. Medical journals have linked black licorice to health problems in people over 40.
Well that’s the end of this spooktacular edition of the PC News week in review. If you’ll be attending the Pharmaceutical Compliance Congress next week be sure to stop by the PharmaCertify booth (#216) to enter our contest to give this wonderful publication a more fitting name. There just might be something in it for you, plus you get to meet us! We don’t bite…we promise. Seriously, we look forward to meeting many of you next week, and to discussing how we can help you meet your compliance challenges.
This is Halloween time so stay out of the woods, the basement and most importantly, stay away from black licorice as you go about your weekend!