The United States Department of Justice (DOJ) recently announced the settlement of two qui tam whistleblower lawsuits against Omnicare Inc., the largest nursing home pharmaceutical and pharmacy services vendor in the nation. The suits alleged that Omnicare gave significant discounts to skilled nursing facilities in exchange for lucrative referrals and pharmacy provider contracts. This $124.24 million settlement is the largest ever in a “swapping” case brought under the Anti-Kickback Statute.

In addition to its size, this settlement is noteworthy because DOJ had initially declined to intervene in the underlying suits and relators pursued the claims independently. That go-it-alone decision was so resoundingly vindicated in Omnicare, it is likely that this case will encourage other whistleblowers to follow a similar course of action. Relators have long had the right to continue False Claims Act litigation without governmental participation. DOJ’s decision whether to intervene or not was traditionally (although not explicitly stated) viewed as a reflection of the strength of the whistleblower’s allegations.  With the increase in whistleblower complaints, the limitations on the number of cases that DOJ can put resources on, statutory changes, the rise of a specialized qui tam bar, and big dollar victories like this may significantly increase the number of independent qui tam lawsuits. Continue reading…

The Pennsylvania Department of Health (“DOH”) Bureau of Laboratories (“Bureau”) recently announced that it will begin to phase-in enforcement of Act 122, which amended the Pennsylvania Clinical Laboratory Act (“Lab Act”), even though Act 122 became effective on December 18, 2013. The Bureau also issued additional guidance regarding Act 122 in its Frequently Asked Questions, Volume 1 and Volume 2 (“FAQs”).

According to its Senate Co-Sponsorship Memoranda, the purpose of Act 122 was to: (1) prohibit the “placing of phlebotomists or specimen collectors in physician and other health care provider offices in the Commonwealth;” and (2) afford Pennsylvania laboratories “the ability to compete on a level playing field with out-of-state labs” who had been able to place staff in providers’ offices “without fear of sanction.” However, the broad language of Act 122 will also affect laboratories’ ability to collect specimens from skilled nursing facilities (“SNFs”). Continue reading…