Health Law Alert

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 […]

Via Medicare Learning Network (MLN) article, CMS announced its implementation of finger-print based background checks as part of the Heightened Medicare Enrollment Standards set out in Section 640 of the Affordable Care Act. (See MLN Matter Number SE1417.) The more intensive screening will be phased in during 2014. When fully […]