Our eyebrows were raised by Mylan’s October 7, 2016 announcement that it had reached a $465 million “settlement” with the United States Department of Justice (DOJ) and “other government agencies” over its Medicaid Drug Rebate obligations for EpiPen. The timing of the announcement was especially eyebrow-raising: close to 5 pm on a Friday afternoon at the start … Read more
On May 6th, we posted about the possibility that the Department of Justice (“DOJ”) might dramatically increase False Claims Act (“FCA”) penalties after the Railroad Retirement Board (“RRB”) nearly doubled the per-claim penalties it imposed under the FCA. After nearly two months of anticipation, DOJ published an Interim Final Rule yesterday announcing that it intended to increase the minimum … Read more
On Monday, the U.S. Supreme Court issued summary dispositions vacating the judgments in three cases brought under the False Claims Act (“FCA”). The Court remanded the cases back to their respective circuit courts for reconsideration in light of the Court’s decision in Universal Health Services, Inc. v. United States ex rel. Escobar, 579 U. S. ___ (2016). As we … Read more
A unanimous Supreme Court issued its long-awaited and closely watched decision today on the scope of the False Claims Act (“FCA”), and the Court affirmed the FCA’s long reach. Universal Health Services, Inc. v. United States ex rel. Escobar et al., No 15-7. The decision has momentous implications for health care providers and suppliers, and other entities, … Read more
On April 27, 2016, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule that would put in place key parts of the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA impacts a number of laws and government initiatives that have been implemented over the past two decades affecting physician reimbursement, and in … Read more
Much like the rest of the health care world, we have been following the AseraCare case since May of last year when the Alabama federal district court granted AseraCare’s motion to bifurcate its False Claims Act (FCA) trial into Phase I that would address “falsity” and Phase II that would address “knowledge” and other FCA elements. In … Read more
In a chain of events that should be a wake-up call to any entity using and storing critical health information, Hollywood Presbyterian Medical Center (“HPMC”) has announced that it paid hackers $17,000 to end a malware attack on the hospital’s computer systems. On February 5, HPMC fell victim to an attack that locked access to the medical … Read more
Rising drug prices and attempts to contain drug costs continue to take center stage at the federal level – particularly in the ramp-up to the 2016 presidential election. In January 2015, a bill was introduced that would repeal the government non-interference clause and allow the Centers for Medicare & Medicaid Services (CMS) to directly negotiate Medicare Part D … Read more
It seems that everything in our life is getting connected to the Internet. We now live in an age where household items like refrigerators have Internet-connected LCD screens and privacy experts talk about the so-called “Internet of Things.” Medical devices are increasingly becoming connected as well, and like any connected device, they are at risk of getting hacked. In 2014, the U.S. … Read more
A federal district court denied the Texas Medical Board’s (the Board) motion to dismiss an antitrust suit filed by a telemedicine company (Teladoc), finding that the Board is not entitled to state action immunity because its actions are not actively supervised by the state. Teladoc, Inc. v. Texas Medical Board, No. 1-15-cv-343 (W.D. Tex Dec. 14, … Read more