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Court Finds That Labs Must Ensure That the Tests They Perform are Medically Necessary

On June 9, 2017, the United States District Court for the District of Columbia denied the defendant’s motion to dismiss in the False Claims Act lawsuit titled U.S. et al. ex rel. Tina D. Groat v. Boston Heart Diagnostics Corp., No. CV 15-487 (RBW), 2017 WL 2533341, at *1 (D.D.C. […]

When Does a Drug Manufacturer’s Savings Card Program or Discount Coupon Violate the Anti-Kickback Statute?

A drug manufacturer’s savings card program or discount coupon under which individuals who have Medicare Part D prescription drug coverage receive discounts may violate the Anti-Kickback Statute (“AKS”), unless the drug being purchased is statutorily excluded from Part D coverage.  The key here is that the drug must be excluded […]

Pharmacy Discount Programs Can Lead to a Violation of the False Claims Act

Retail pharmacies that offer a discount drug pricing program to consumers must charge Medicare the same prices for drugs that they charge consumers who participate in those programs. To do otherwise violates the False Claims Act (“FCA”). The specific question is whether a pharmacy that offers a discount drug pricing […]

Common Challenges With the Qui Tam Seal Requirement: What Whistleblowers Can Expect

One of the various procedural requirements imposed on whistleblowers is that they file their cases “under seal.”  Not much is explained in the False Claims Act (“FCA”) as to what that means, other than the general understanding that no notification of the filing to the defendant takes place, what is […]

District Court Rejects the Industry-Wide Public Disclosure Bar, Part II

In Part I of this blog series, we discussed the False Claims Act (“FCA”)’s public disclosure bar and the so called industry-wide public disclosure bar. In this blog post, we will examine a 2017 qui tam case that discusses and rejects the industry-wide public disclosure bar. An industry-wide public disclosure bar […]