On October 19, 2015, Greene LLP announced the resolution of False Claims Act claims against Millennium Health, LLC in a settlement reached with the United States. The settlement, likely to exceed $231 million once interest is calculated, brought to an end the whistleblower suit initiated by Greene LLP and client Mark McGuire in January 2012 under the qui tam provisions of the False Claims Act.
The settlement resolved allegations that Millennium encouraged physicians to order drug testing performed by the company without an individualized assessment of patient need. The Greene LLP suit and the United States’s complaint in intervention alleged that Millennium caused physicians to order such tests by promoting the use of standing orders termed “custom profiles,” which included a default panel of tests for Millennium to run on each specimen physicians sent to its San Diego, California facility for testing. Also resolved by the settlement were the complaints’ claims that Millennium billed the federal and state governments for testing it was referred in exchange for providing physicians with free point-of-care testing supplies, cups containing test strips that also served as specimen containers.
The complaints alleged that after a change in CMS regulations effective January 2011, Millennium sought to make up for lost revenue by requiring all of the testing referrers with which it did business to execute Custom Profiles, and to keep a minimum number of tests selected on those standing orders. The complaints alleged that as part of its marketing strategy to encourage physicians to refer testing, Millennium provided free point-of-care test cups. Testing performed as a result when physicians sent specimens to Millennium with Custom Profiles executed was not selected for patients on the basis of whether they were medically necessary, a condition of payment by Medicare and Medicaid programs.
False Claims Act allegations filed against Millennium alleged that it initiated its business plan to make up for a 2011 downturn in revenue at the company’s highest levels at the end of August, 2011. Mark McGuire was the director of a large laboratory that conducted 1.1 million tests a year for a network of hospitals in Massachusetts. Millennium attempted to solicit the lab’s business from McGuire in October 2011, meeting with him regularly and detailing how it could help increase the lab’s testing and revenue with custom profiles.
“This settlement is a great example of what the False Claims Act is designed to encourage,” said Thomas M. Greene, who filed McGuire’s January 2012 suit. “When a person has enough information about a significant fraud against the government for the government to take action, the law provides a strong incentive to come forward.” As part of the settlement, the United States agreed to pay a relator’s share of 15% of its recovery. The settlement also provided for payments to state governments, a portion of which will also be awarded as relator shares under several state False Claims Acts.
On behalf of the United States, the case was handled by Doug Rosenthal of the Department of Justice in Washington, DC and Assistant U.S. Attorneys George Henderson III and Abraham George of the U.S. Attorney’s Office in Massachusetts. Also especially instrumental in the investigation was Kathleen VonHoene of the Florida Attorney General’s Office. “We were pleased to participate in what became an enormous investigation with talented attorneys, all working for the government to recover money for testing that should never have been performed,” said Greene.
Greene LLP is a complex civil litigation firm in Boston of seven attorneys, specializing in representing qui tam whistleblowers in False Claims Act litigation and employing a low-volume, high-attention approach to litigation. Each of the firm’s partners have over twenty years of experience in False Claims Act litigation, pioneering innovative theories of recovery, including the theory that off-label promotion of drugs can cause damages actionable under the False Claims Act.