Compliance Week in Review, June 18, 2014

Comments to CMS show physicians and the pharmaceutical industry are wary about the Sunshine dispute resolution process, the American Medical Association passes a resolution to modify the Act, and Minnesota makes changes to its aggregate spend law.

Well, that was a big weekend. First we had a Friday the 13th to escape and/or celebrate (your choice), and then the big day, Father’s Day. Hopefully, you avoided any unfortunate incidents or questionable neckties. So now here we are on just another plain ol’ day in June. We’ll keep the “party” rolling by taking a look back at some of the big news stories of the past week. Time to for this week’s Compliance News in Review.

Comments received by CMS regarding the Sunshine dispute resolution process show physicians and the industry alike are feeling a bit wary about the future. Physician groups commented that the 60 days to resolution period is too short. It was pointed out that even if a physician submitted a dispute to CMS when the window opens, there is no guarantee CMS will forward the dispute in a timely manner to the manufacturer. In addition, teaching hospitals will need more time to complete their review of the data than an individual physician. The CME Coalition suggested that data publication be delayed until March of 2015. The group said physicians should be allowed more time to deal with discrepancies. On the industry side, PhRMA noted that CMS was correct in allowing manufacturers the ability to determine what disputes will be investigated and resolved.

The “lucky” number for the AMA House of Delegates is 100. During a recent meeting, the House of Delegates passed a resolution to lobby Congress to enact two significant changes to the Sunshine Act. First, the Medical Society of New Jersey (MSNJ) suggested the minimum threshold for reportable transfers of value be raised to $100. The MSNJ said the current threshold is too difficult for the industry and physicians to track. The second change involved the inclusion of medical textbooks and journal articles in the educational items exclusion. The change was suggested by the American Medical Group Association. The passage of the resolution is considered to be a message to the Washington D.C. office of the AMA to work with Congress to institute the changes to the Act.

A new article disputes the argument that conflicts of interest between the industry and physicians result in decisions that are harmful to patients. The authors of the article say the “conflict of interest campaign” has directed resources away from worthwhile medical care and research issues. The authors claim the huge settlements in off-label cases give the impression that patients were in harm’s way, however there is very little evidence that was actually the case. Where publication biases are concerned, the article’s authors say the conflict of interest detractors are asking the wrong question. Detractors focus on whether there are differences in industry-funded studies and studies conducted by non-profits, rather than focusing on whether the studies are scientifically unsound. Removing the assumption that positive results from industry studies are the result of misconduct, no reason exists to assume the studies are scientifically flawed.

Changes have been made to the granddaddy of aggregate spend laws. The Minnesota legislature passed a bill that expands the definition of a practitioner to include APRNs, Medical Assistants and Dental Assistants who are authorized to prescribe, dispense or administer medication. The expansion means these professionals now fall under the state’s gift ban and reporting laws. The Board of Pharmacy suggested companies begin tracking spend related to these professionals since reporting would likely be required in 2015.

To no one’s surprise, the Sunshine Act is still dominating the news. During a recent webinar aimed at physicians and teaching hospitals, CMS said that the dispute resolution period would be in the August/September time frame, but the agency did not offer specific dates. CMS still appears committed to a public release of the data by September 30. However, one of the callers on the webinar pointed out that the September 30th date was not included in the Final Rule and the Rule only states that 2013 data reports will be published in 2014. If CMS pushes the public release back, this would address one of the issues raised in the comments about the dispute resolution process. CMS also said it would not be expanding covered recipients to include mid-level practitioners. That sort of change would have to come from Congress.

There sure was plenty of Sunshine in this week’s news and there are bound to be plenty of Sunshine-related questions from healthcare professionals. The PharmaCertify™ eLearning module, The Sunshine Act: The Federal Physician Spend Disclosure Law, provides your sales representatives to up-to-date training on the Act, and includes a comprehensive list of the disclosure requirements included in the law.

Have a great week everyone!

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