Dorsey Health Law Blog

CMS Gives Clinical Labs Reporting Deadline Extension

Neal N. Peterson

Clinical laboratories have until May 30, 2017 to make required reports to the Centers for Medicare & Medicaid Services (“CMS”) regarding payment rates paid by private payors for certain diagnostic tests and the volume of such tests furnished for such payors, according to a CMS announcement on March 30, 2017. Last year CMS issued a...

DOJ Issues New, Practical Guidance on Effective Corporate Compliance Programs

Laura B. Morgan

On February 8th, the Department of Justice (DOJ) Criminal Division, Fraud Section issued new guidance (available here) on how it evaluates the effectiveness of a corporate compliance program when conducting an investigation of a corporation. This guidance is significant as it is the first of its kind since the confirmation of the new U.S. Attorney...

OIG Announces Drug Pricing and Reimbursement Web Portfolio

Nicole Burgmeier

On February 17, 2017 the Office of the Inspector General (OIG) posted a Drug Pricing and Reimbursement Web portfolio on its website that, according to the OIG announcement, “pulls together the HHS OIG’s body of work since 2010 as well as other relevant items that relate to drug pricing and reimbursement in HHS programs.” The...

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...