OIG Compliance Program and Guidance re. Line Extensions

It’s a busy time in Government Pricing! Late last week, we had the decision from the United States Court of Appeals for the Fourth Circuit regarding the Patient definition for purposes of the 340B Program. (If you did not receive our Client Alert on this, let us know and we’ll be happy to share it with you.)

Yesterday, the Centers for Medicare and Medicaid Services issued Manufacturer Release #119, that is an FAQ about Line Extensions for purposes of calculating the Medicaid Unit Rebate Amount. There’s a lot to digest in the 12 pages of information and like many things in Government Pricing, there may still be nuances and there are always areas to discuss with legal counsel.

And on Monday, the US Department of Health and Human Services Office of Inspector General (OIG) released its new “General Compliance Program Guidance” (GCPC), the first comprehensive update in over 20 years to the OIG’s expectations for compliance within the health care community. And by “comprehensive,” we mean over 90 pages. The GCPG provides information about relevant Federal laws such as the Anti-Kickback Statute, the Stark Law, False Claims Act, and HIPAA Privacy and Security Rules.  It also addresses the Seven Elements of an Effective Compliance Program which were included in the OIG’s recommendations in 2003.

It is the OIG’s longstanding belief that pharmaceutical manufacturers should commit to implementing all seven elements to achieve a successful compliance program.  Although the GCPG is not binding on any individual or entity, it encompasses many different compliance resources and should be viewed as a valuable a tool by compliance officers and a frequent reference to build a “best-in-class” compliance program for their respective companies.

Remember, as we say at The Pricing Group, “Compliance is never optional, but flexibility should be.” The GCPC can help manufacturers achieve their goal of compliance without sacrificing flexibility if leveraged correctly.

If you have any questions on any of these latest developments or need assistance in evaluating how these latest developments may impact your organization, please contact us for more information.