Compliance News in Review, August 3, 2015

There was a rare occurrence in the skies this weekend. Hopefully you weren’t  standing alone without a dream in your heart when it happened, but if so, there’s a wonderful song by The Marcels that can be your soundtrack. The end of July marks the appearance of the Blue Moon.  Despite having a color in its name, the moon will not actually appear blue.  There is some dispute within the scientific community as to what constitutes a blue moon, but the criteria applying to the upcoming event is the second full moon to occur during one month. If you happened to have miss it, you won’t have to wait too long for the next one; just two and a half years. While you reflect on this somewhat rare occurrence, let us supply you with some reading material – this week’s News in Review.

We’ll start out this week’s news with a story not about the moonlight, but the Sunshine. CMS is seeking public comments about whether to add Open Payments data to individual physician pages on the Physician Compare website. CMS says this data is “of great interest to consumers,” and that consumers have indicated having this data available on Physician Compare website would “increase their ability to find and evaluate the information.” Comments must be submitted by September 8.

There isn’t much moonlight this time of year in Iceland, which is appropriate considering the Sunshine the industry association in the country has decided to spread around. The Icelandic Association of the Pharmaceutical Industry, Frumtök, has decided to adopt the EFPIA Disclosure Code. Frumtök is not a part of EFPIA, but previously adopted the EFPIA HCP Code. The head of the association says adoption of the Disclosure Code is on track, and questions have been raised by healthcare professionals, but overall there is support from national hospitals and the Icelandic Medical Association.

A National Health Service (NHS) spokesperson is howling at the moon about payments to NHS staff. A recent investigative report in the British paper, The Telegraph, showed that NHS staff were receiving payments from drug companies in an effort to persuade health care professionals to use specific drugs. According to the report, staffers served as consultants who were paid up to $23,000 to set up advisory boards at lavish hotels, often in foreign countries. NHS staffers that attended an advisory board in Germany told The Telegraph they reported the trip and payments received for their attendance, and were not involved in the decision to move to the drugs discussed at the meeting. A spokesman for the NHS said the situation was quite serious and there would be investigations into each allegation in the news report. Citing the U.S. Sunshine Act, the spokesman suggested the U.K. may want to consider creating a disclosure law. A spokeswoman for the Association of the British Pharmaceutical Industry said the industry works well under self-regulation, and would prefer to provide greater transparency under the that paradigm rather than under a law.

Cephalon may be feeling a bit blue after a recent court decision in a False Claims Act case. In a recent False Claims Act case filed by three former employees, Cephalon had a motion to dismiss denied in District Court. Part of the plaintiffs’ case asserts that Cephalon is responsible for reverse false claims (where the claim results from payments not paid to the government rather than from a false payment being received from the government) because the alleged activity occurred while Cephalon was under a CIA. The plaintiffs say because Cephalon did not report off-label marketing of two of its products, it falsely certified reports submitted to the OIG while under a CIA.  These false reports were subject to penalty per the CIA, therefore Cephalon did not pay the government the money it was due. Cephalon said the reverse false claim should not apply because the stipulated penalties in the CIA are at the discretion of the OIG. The judge disagreed with Cephalon’s argument, and compared the CIA penalties to a breach of contract.

This week’s news was certainly full of more Sunshine than moonlight. And of course, by Sunshine, we mean physician spend disclosure. As evident in this week’s news, disclosure of physician spend is truly a global concern. We believe there are a couple of key training considerations for companies in the midst of adapting to not only the U.S.’s transparency requirements, but those in force in other countries. One such consideration is ensuring you’re capturing the entire audience. It can be easy to focus on the immediate audience.  Need to train on Loi Bertrand? Obviously colleagues based in France are the target; it is a French law after all.  However, what of colleagues with regional responsibilities, and those in a global role who may interact with physicians in France. Another consideration is knowledge sharing. In the U.S. we’ve been at this for a while. States have had disclosure requirements for more than two decades. Sharing with colleagues overseas the lessons learned from training timing, methodology, deployment, and so on can be helpful in successfully getting a transparency program off the ground elsewhere. And that sharing doesn’t have to be one-way. Colleagues overseas should share their successes with U.S.-based colleagues to see what can be improved upon in programs here.

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