Dorsey Health Law Blog

The Impact of the Bipartisan Budget Act of 2015 on Off-Campus Hospital Outpatient Departments

Alissa Smith

November 23, 2015 On November 2, 2015, President Obama signed the Bipartisan Budget Act of 2015 (“Act”) into law significantly impacting how Medicare pays certain off-campus hospital departments.  Specifically, Section 603 of the Act provides that items and services furnished at off-campus departments of a hospital will not be reimbursed under the hospital outpatient prospective...

FDA Issues Three New Rules Under the Food Safety Modernization Act

Robert G. Hensley

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

Benjamin Fee

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

Ross C. D'Emanuele

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...