In a dramatic rebuttal of how the Department of Health and Human Services Office of Civil Rights’ (“OCR”) has historically enforced HIPAA with potential far-ranging consequences, the Fifth Circuit Court of Appeals recently handed down a landmark decision criticizing and restricting how OCR interprets HIPAA and OCR’s penalty authority.  OCR brought an enforcement action against the University of Texas M.D. Anderson Cancer Center (“M.D. Anderson”) stemming from three separate alleged data breaches and violations of…

On Wednesday, January 20, 2021, President Biden’s chief of staff, Ronald A. Klain, circulated a memorandum (memo) to the heads of federal executive departments and agencies outlining an Executive Action implementing a 60-day freeze on any new or pending regulations. This is a customary practice for new administrations. The freeze allows the administration to conduct an appropriate review of these rules to determine if there is any conflict with the President’s policy objectives. Both the…

The Department of Justice kicked off 2021 with its first publicly filed, two-count indictment against Surgical Care Affiliates, LLC (SCA) and successor entity Scai Holdings, LLC, both accused of criminal antitrust violations for agreeing with other healthcare companies not to solicit each other’s senior-level employees. The charges are the first to come out of an ongoing investigation by the Antitrust Division into alleged no-poach agreements between employers. The indictment alleges that SCA entered into two…

The EU-UK Trade and Cooperation Agreement (the Agreement), announced just before Christmas, has now been agreed by the UK Parliament and EU Commission. This is now in place with a requirement for further approval by the EU Parliament. The Agreement is wide-ranging but in terms of trade mainly focusses on the supply of goods. As one of the most highly regulated sectors, pharmaceuticals are highlighted in a number of areas with specific provisions that touch…

In follow up to our post last month, on Wednesday, December 2, The Centers for Medicare and Medicaid Services (CMS) published final rules implementing many of the Stark Law changes first proposed in October 2019 (the Final Rules). These changes have been adopted to address the shift to a value-based and coordinated healthcare environment. The Final Rules represent CMS’s recognition that the healthcare delivery and payment environment has changed from the “fee-for-service” model under…