The PharmaCertify™ Team
It was a big party weekend for those of us here at the News. Where else but in America can you celebrate such an awesome spectacle of determination, hope and excitement? Despite the outcome, we love the process or at least some part of it. Happily, this year the outcome was just as we’d all hoped…an early spring! Thank you Phil! We hope you all had an equally exciting Groundhog Day. And now, we begin with the other big news of the week.
Wouldn’t it be nice if we could find a groundhog that could predict when the final rule of the Sunshine Act might appear? Oh wait, we don’t need one. The fine folks at Pharmalot fired the warning shot that rule had been sent from the OMB to CMS, and the next day CMS sent out a press release saying the rule was available for viewing. The document is currently in a “preview” state and will be officially published on Friday, February 8th. Here’s what we know so far – CMS will require companies to report a few months of data in 2014 and companies must begin collecting data on August 1 of this year. The first report will be due March 31, 2014.
In response to the news, we’ve updated the PharmaCertify Sunshine Act App and we’re now offering a complimentary version on our website. The app provides pharmaceutical and medical device sales representatives with a high-level overview of the reporting requirements of the law and the information manufacturers will be required to submit to CMS. Just point your reps to http://www.pharmacertify.com/sunshine_act.asp and have them follow the download directions to get their copy.
Across the pond, the ABPI, Royal Physician’s Academy and several other organizations have formed a group looking to cast off the shadow surrounding industry payments to physicians. The group is discussing the idea of establishing a public record of payments made to physicians by the industry. The co-chair of the group, who is the president of ABPI, says that the group will develop principles on how a system of payment disclosure would work. They will not make recommendations on the type of payments to disclose.
A federal judge in the Eastern District of Pennsylvania has sent a qui tam case against AstraZeneca into hibernation. An executive with Medco accused AZ of entering into sham contracts with the company in order to induce the prescribing and dispensing of brand name drugs over generic drugs to patients on government plans. AstraZeneca argued the allegations brought by the qui tam relator were already publically known at the time he filed his case. The judge agreed and dismissed the case.
Cornell Law School has plans to bring light to False Claims Act whistleblower cases by launching a new class on the subject. The course will be taught by the law school dean and a top qui tam lawyer, and it will focus on how the law encourages and protects whistleblowers.
The Department of Defense is casting a shadow over spending on national CME. A policy put in place to reduce travel and conference costs has the Army and Navy evaluating how to make sure their physicians are getting the necessary CME. It could mean asking the physicians to attend smaller conferences and on-line programs. In a related note, the Association of Military Surgeons of the United States cancelled its November conference when they realized there would not be enough military and government physicians in attendance to make the conference worthwhile.
Well, that’s the news of the week that was. After a big weekend of Sunshine news, Super Bowl parties, and clever (and some not-so-clever) commercials, we’re happy to be back at work.
As we inch tauntingly closer to spring, have you considered freshening up your compliance training for 2013? PharmaCertify can help with updated modules and mobile apps that bring critical compliance content where your learners need it most – in the field and at their fingertips.
Have a great week everyone!