Health Law Alert

Two submissions under the Self-Referral Disclosure Protocol (SRDP) reporting possible violations of the Stark Law were settled by CMS on December 23, 2013. As reported by CMS on its website, the first submission involved an acute care hospital in Florida, which disclosed that its arrangement with 51 physicians failed to […]

Note: This is the first article in a 2-part series on HIPAA and data security and encryption. The June edition of the Health Law Advisory will include an article by James E. O’Connor of the Technology and Intellectual Property Practice Group. Four recent settlement agreements between health care organizations and […]

On May 23, 2014, a federal district court invalidated the 340B Program’s orphan drug exclusion after finding that the U.S. Department of Health and Human Services (HHS) acted beyond its statutory authority when it implemented the rule. The 340B Program requires manufacturers to give substantial discounts on outpatient prescription drugs […]

Monetization of a hospital’s intellectual property (IP) has long been thought to be the exclusive domain of academic or research hospitals. However, a growing number of other types of hospitals have recently begun to implement systems for procuring and exploiting their innovations in an effort to protect their property rights […]

On April 8, 2014, the Office of Inspector General (OIG) issued an Advisory Opinion disapproving a proposed fee structure in an electronic laboratory ordering arrangement. On the same day the OIG took the unusual step of withdrawing a prior 2011 favorable Advisory Opinion that had approved a fee structure with […]