Compliance News in Review, June 5, 2015

Cephalon settles a generics case with the FTC over its sleep disorder drug and the OIG releases its mid-year update to its 2015 Work Plan, and we offer our take on how it impacts training.

Well, the summer blockbuster season is almost here. Superheroes, Sundance darlings, reboots and rom-coms will all be competing for our attention and discretionary dollars (is that a contradiction in terms?). While it may not carry the cache of the newest Clooney or Cruise release, we proudly offer our own little feature for your entertainment and edification…the latest edition of the Compliance News in Review. On with the show!

It’s finally a wrap on the Federal Trade Commission’s case against Cephalon. The FTC settled its pay for delay case with the company (now part of Teva) for $1.2 billion. The case involved Cephalon’s attempts to delay entry of generics for its sleep disorder drug. The settlement is the largest ever secured by the FTC.

The OIG has premiered its mid-year update to its Fiscal 2015 Work Plan. The update includes several new items, one of which is a review of the financial interests reported via Open Payments.

We will determine the number and nature of financial interests that were reported to CMS under the Open Payments Program. We will also determine the extent to which CMS oversees manufacturers’ and group purchasing organizations’ (GPOs’) compliance with data reporting requirements and whether the required data for physician and teaching hospital payments is accurately and completely displayed in the publicly available database.”

The OIG’s report on its findings is expected during fiscal year 2016. As Policy and Medicine points out, it will be interesting to see what sort of enforcement follows the OIG’s review, and if the information is used by the agency for its other activities involving fraud and abuse. This potential for enforcement involving this data should not be overlooked.

The first full calendar year of data has not even been released to the public yet, and the OIG is jumping right into a review. The agency’s actions underscore the importance of accurate data and the need for training to ensure that accuracy. From those engaging in transactions with covered entities, to those responsible for the reporting on the back end, understanding data collection and reporting requirements is critical. In addition to in-house staff, third-party vendors and partners that may be involved in reportable transactions on a company’s behalf need training on the basic requirements of the Sunshine Act and Open Payments.

Enjoy the weekend everyone, and we’ll see ya at the movies!

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