Dorsey Health Law Blog

FDA Issues Three New Rules Under the Food Safety Modernization Act

November 16, 2015 On November 13, 2015, the U.S. Food and Drug Administration (FDA) published three final rules issued under the Food Safety Modernization Act.  The new rules are: (1) the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety Rule), (2) the Foreign Supplier Verification Programs (FSVP) Rule...

OIG Releases 2016 Work Plan

November 11, 2015 Executive Summary The United States Health and Human Services Office of the Inspector General (“OIG”) published its Fiscal Year 2016 Work Plan (“2016 Plan”) on November 2, 2015.  The work plan is published annually by the OIG and identifies new and ongoing investigative, enforcement and compliance priorities for the OIG in the...

CMS Proposes Significant Revisions to Stark Law

July 23, 2015 In its CY 2016 physician fee schedule proposed rule, the Centers for Medicare and Medicaid Services (“CMS”) proposes significant amendments and clarifications to the federal physician self-referral regulations, commonly known as the “Stark” rules.1 In response to CMS’ experience reviewing several hundred self-disclosures made under the Voluntary Self-Referral Disclosure Protocol, many of...

EHR ROI: Meaningful Use and Leveraging Your Electronic Health Record

June 5, 2015 Shira Hauschen leads Dorsey Health Strategies LLC, a consulting firm serving the health industry affiliated with Dorsey & Whitney LLP. This article originally appeared in the Minnesota Hospital Association’s May 2015 issue of “Health Care Leader.” Meaningful Use (MU) is again at the forefront of many hospital leaders’ minds, as the Centers...

OIG Issues Practical Guidance for Health Care Governing Boards on Compliance Oversight

April 24, 2015 On April 20, 2015, the Office of the Inspector General of the United States Department of Health and Human Services (“OIG”), in collaboration with the Association of Healthcare Internal Auditors, the American Health Lawyers Association and the Health Care Compliance Association, issued a new guidance document to assist governing boards of health...