On December 14, 2017, the Commissioner of the U.S. Food and Drug Administration (“FDA”), Dr. Scott Gottlieb, posted Looking ahead: Some of FDA’s major policy goals for 2018 on FDA’s blog, FDA Voice, and discussed FDA’s policy agenda published
FDA commissioner discusses upcoming guidance to modernize its framework for medical device review
On December 11, 2017, the U.S. Food and Drug Administration (“FDA”) Commissioner, Scott Gottlieb, posted Advancing Policies to Promote Safe, Effective MedTech Innovation on FDA’s blog, FDA Voice and discussed FDA’s plans to modernize its policy framework for the review
CHIP Program funding remains in limbo; Senators advocate reversal of 340B Drug Discount Program cuts; CMS reports on 2016 U.S. health expenditures
Payments under the Children’s Health Insurance Program (CHIP) remain uncertain in many states without an extension of federal funding to the program. CHIP provides insurance coverage for children whose parents earn too much for Medicaid but cannot afford other health
U.S. Senate passes tax bill eliminating penalties for failure to comply with ACA individual health insurance mandate
On December 2, the U.S. Senate passed a tax bill by a 51-49 vote. The legislation would not repeal the Affordable Care Act (ACA) individual health insurance mandate but instead would eliminate tax penalties for con-compliance with the mandate. Senator
OIG rescinds advisory opinion to charity
For the first time, the OIG has rescinded an advisory opinion issued to a charity.
According to the OIG, the advisory opinion – issued in 2006 and modified in 2015 – was revoked because the charity “failed to comply with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