For the first time, the OIG has rescinded an advisory opinion issued to a charity.
According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with
Third and Fifth circuits accept materiality arguments in throwing out qui tam cases
On November 16, 2017, the Third Circuit Court of Appeals affirmed the grant of summary judgment in favor of CVS Caremark, Corp. (“CVS Caremark”), finding that although the lower court’s reasoning was flawed, the whistleblower Anthony Spay failed to establish
FDA embraces medical innovation in 2017
On November 16, 2017, the US Food & Drug Administration (“FDA”) unveiled a comprehensive policy framework – a suite of four guidance documents – to oversee regenerative medicine products. Regenerative medicine is the science of restoring structure and function to
Senate tax bill would effectively repeal ACA individual mandate; House legislation to reverse 340B Drug Discount Program cuts; CMS addresses prescription drug costs and the opioid crisis
On November 14, Senate Finance Committee Chairman Orrin Hatch (R-UT) released the Chairman’s Mark to the Senate version of the Tax Cuts and Jobs Act. Hatch’s version of the tax plan effectively repeals the Affordable Care Act (ACA) individual mandate
DOJ policy shift in qui tam litigation?
Last week, a senior US Department of Justice official appeared to announce a surprising, and potentially significant, shift in policy regarding qui tam litigation. Michael Granston, director of the commercial litigation branch of the fraud section in the DOJ’s civil
U.S. House of Representatives passes the Veterans E-Health and Telemedicine Support Act of 2017
On November 8, 2017, the U.S. House of Representatives unanimously passed H.R. 2123, the Veterans E-Health and Telemedicine Support (“VETS”) Act of 2017. Under current regulations, VA health care providers in good standing may practice in another state if
340B drug discount program payment reductions challenged; Alex Azar nominated as next HHS Secretary
On November 13, the American Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals, Eastern Maine Healthcare Systems, Henry Ford Health System, and Fletcher Hospital filed a lawsuit in United States District Court for the District of Columbia seeking
FDA commissioner looks to curb tactics that restrict drug competition
On November 8, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner Scott Gottlieb spoke as a keynote speaker at the Federal Trade Commission (“FTC”) workshop, Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics (“Workshop”) and called
CMS issues 2018 Medicare physician fee schedule final rule and MACRA physician QPP final rule
On November 2, 2017, the Centers for Medicare & Medicaid (CMS) Services issued its Calendar Year (CY) 2018 Medicare Physician Fee Schedule (MPFS) final rule. The overall update to payments under the MPFS in 2018 will be +0.41 percent. The
CMS issues 2018 hospital OPPS and home health PPS final rules
On November 1, 2017, the Centers for Medicare & Medicaid Services (CMS) issued its final hospital outpatient prospective payment system (OPPS) and ambulatory surgical center (ASC) payment system final rule for Calendar Year (CY) 2018. On the same day CMS