Dorsey Health Law Blog

Cybersecurity Task Force Issues Report on Improving Cybersecurity in the Health Care Industry

Ross C. D'Emanuele

The Cybersecurity Act of 2015 established the Health Care Industry Cybersecurity Task Force to respond to severe cyber-attacks within the rapidly-expanding information technology (“IT”) aspect of health care. Section 405(c) of the Act required the Task Force to research and develop a report summarizing the vulnerabilities in health care IT. On June 2nd, 2017, the...

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

Nicole Burgmeier

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based contracts for drug purchases, and to pursue trade policies that enhance the intellectual property rights of American pharmaceutical companies.” This is...

EHR Vendors Beware: eClinicalWorks Settles with DOJ for $155 Million

Alex Stoflet

The Department of Justice (“DOJ”) announced on May 31, 2017, a $155 million settlement of its lawsuit alleging False Claims Act (“FCA”) and Anti-Kickback Statute (“AKS”) violations committed by eClinicalWorks (“eCW”), one of the nation’s largest electronic health records (“EHR”) software vendors. Brendan Delaney, the original qui tam plaintiff in the case, will receive approximately...

FDA Requests Painkiller Removed From the Market

Grace Fleming

The FDA has called on the drugmaker Endo Pharmaceuticals to stop selling the opioid Opana ER. The press release on June 8th reflecting this announcement marks a novel approach from the FDA, as the agency for the first time has asked a company to remove a painkiller from the market based on the public health...

CMS Issues New SRDP Forms

Laura B. Morgan

The Centers for Medicare and Medicaid Services (“CMS”) issued new Self-Referral Disclosure Protocol (“SRDP”) forms, and, beginning June 1, 2017, these SRDP forms will be mandatory for those parties submitting voluntary self-disclosures of actual or potential violations of the federal physician self-referral law (the “Stark Law”) through the SRDP.  The Patient Protection and Affordable Care...

How Effective Is Your Compliance Program? New OIG and DOJ Guidance for Measuring the Effectiveness of Your Corporate Compliance Program

Alissa Smith

Compliance programs are an important tool for health care providers.  Compliance programs help to prevent fraud, waste and abuse, create a mechanism for catching problems early, and effective compliance programs can also provide the basis for a penalty reduction under the US Sentencing Guidelines if an entity is ever faced with sentencing for a criminal...

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...