Dorsey Health Law Blog

One In – Two Out and Healthcare Regulation

Grace Fleming

President Trump signed an executive order (the “Order”) on January 30th, 2017 aiming to reduce bureaucracy by requiring agencies to remove two regulations for every one new regulation they implement. The cost of any new regulation should be offset by the elimination of these other two previously issued regulations. The Order could have major consequences...

Virtual Care Realities: Launching a Telehealth Initiative – Key Questions a Provider Should Address to Ensure Impact

Shira Hauschen

Author’s note: Dorsey Health Strategies (DHS), a healthcare business consultancy founded by Dorsey & Whitney, offers a comprehensive array of business advisory and regulatory services to health industry clients; accordingly, DHS articles will address healthcare business challenges and regulatory considerations.  Since telehealth/virtual care/digital health is an area of expertise at Dorsey Health Strategies, this article...

The Affordable Care Act in the Trump Administration

Alissa Smith

One of President Trump’s first actions in office was to sign an Executive Order stating that his Administration will seek to repeal the Affordable Care Act (the “Act”). In the meantime, President Trump directed the executive branch to take “all actions consistent with law to minimize the unwarranted economic and regulatory burdens of the Act,...

OIG Interprets and Incorporates Statutory Exceptions to CMP Law

Alex Stoflet

As of January 6, 2017, final rules published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) implementing certain exceptions to the Civil Monetary Penalty law (“CMP”) took effect. The CMP rules were published alongside final rules regarding safe harbors to the federal Anti-Kickback Statute (“AKS”), about...

Medical Software and the 21st Century Cures Act

Ross C. D'Emanuele

The 21St Century Cures Act, Pub. L. No. 114-255, 130 Stat. 1033, was signed into law on December 13, 2016.  This expansive statute addresses topics ranging from investigational drug clinical trial design, mental health program funding and insurance coverage, to a new Medicare benefit for home infusion therapy, among many others.  This post focuses on...

OIG Creates New AKS Safe Harbors, Codifies Others

Neal N. Peterson

On January 6, 2017, two new safe harbors to the federal anti-kickback statute (the “AKS”) will become effective pursuant to a final rule published by the United States Department of Health and Human Services Office of the Inspector General (the “OIG”) on December 7, 2016. The final rule also codifies safe harbors for certain AKS...

OIG Releases 2017 Work Plan

Nicole Burgmeier

Executive Summary The United States Department of Health and Human Services Office of the Inspector General (“OIG”) published its Fiscal Year 2017 Work Plan (“2017 Plan”) on November 10, 2016. The work plan is published annually by the OIG and identifies new and ongoing investigative, enforcement and compliance priorities for the OIG in the upcoming...

CMS Finalizes Payment Changes for Off-Campus Provider-Based Departments

Benjamin Fee

The Centers for Medicare & Medicaid Services (CMS) released its 2017 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center Payment System Final Rule (Final Rule) on Tuesday. The Final Rule implements section 603 of the Bipartisan Budget Act of 2015 relating to payment for items and services furnished by certain off-campus provider-based departments...