A recent CMS (Centers for Medicare & Medicaid Services) advisory opinion provides an answer to the riddle, "When is a hospital bed not a hospital bed?" The answer provided by Advisory Opinion No. 2013-03, issued November 11, 2013, is that under certain circumstances a hospital bed in a physician-owned hospital …
A Case Statement for Privatization of Publicly-Owned Hospitals
December 11, 2013 Leave a Comment
Publicly-owned hospitals across the United States are facing hard times. Federal and state health reform is placing ever greater emphasis on quality, bundled or population-based payment methodologies while reimbursements overall continue to shrink. While private for-profit and nonprofit systems prepare to meet …
President Obama Signs the Drug Quality and Security Act
December 4, 2013 Leave a Comment
On November 27, 2013, President Obama signed the Drug Quality and Security Act (DQSA) into law. Title I of the Act establishes national standards for compounding pharmacies designed to fill regulatory gaps that contributed to the 2012 meningitis outbreak. Title II—arguably the more important of the two …
Physicians – Are You Ready for Sunshine Act Reporting?
July 22, 2013 1 Comment
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 …