In just two weeks, drug and device manufacturers will be required to start tracking and collecting data in connection with the Physician Payments Sunshine Act, which CMS refers to as the Open Payments program. Available data suggests that while manufacturers are generally prepared, physicians may not be aware of …
FDA Explains Decision Not to Seek Rehearing in Caronia
January 23, 2013 Leave a Comment
Yesterday FDA explained why it did not seek a rehearing of the Second Circuit’s December 3, 2012 decision in United States v. Caronia. In its decision (previously discussed here), the Second Circuit overturned the conviction of a sales representative for encouraging doctors to prescribe the suppressant Xyrem for …
Is Off-Label Enforcement Off Limits?
December 7, 2012 Leave a Comment
On Monday, the Second Circuit Court of Appeals issued a split decision in U.S. v. Caronia, vacating the criminal conviction of a pharmaceutical sales representative who was found guilty of misbranding, in violation of the Food, Drug & Cosmetic Act (FDCA), because he had promoted the sleep medication Xyrem for …
More Problems With ZPICs
September 25, 2012 1 Comment
A recent OEI report found troubling conflicts of interest and financial relationships among potential Zone Program Integrity Contractors (ZPICs) used by the Centers for Medicare & Medicaid Services (CMS) in their controversial new National Fraud Prevention Program. Medicare fraud costs the government an …
ERISA Preemption of Michigan Paid Claims Assessment Act
January 26, 2012 Leave a Comment
We previously posted regarding Michigan’s Paid Claims Assessment Act (the “Act”) which assesses carriers a 1% surcharge on paid health claims. The Act defines carriers to include group health plan sponsors, along with insurance companies and also assesses third party administrators. Thus, it is likely that …
Enforcement Grace Period Extended for New Internal Claims and Appeals Requirements
March 25, 2011 Leave a Comment
The Department of Labor has further delayed enforcement of the new requirements for internal claims and appeals that apply to non-grandfathered plans. Technical Release 2011-01 extends and slightly modifies the enforcement grace period that was set to expire on July 1, 2011 under Technical Release 2010-01. The …