Dorsey Health Law Blog

Medicare Proposes Continued Relief for Critical Access and Rural Hospitals Through 2-Year Moratorium on Direct Supervision Requirements

On July 13, 2017, CMS released a proposed rule as part of its 2018 Outpatient Prospective Payment System proposals [available here: https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-14883.pdf] that is aimed at helping to reduce some of the burdens rural hospitals experience in recruiting physicians. Specifically, CMS proposes a two-year moratorium, for CY 2018 and CY 2019, on the direct supervision requirements...

New Medicare Proposals that Reduce Payment to Hospitals for 340B Drugs in 2018

On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule [available here https://s3.amazonaws.com/public-inspection.federalregister.gov/2017-14883.pdf] which, among other proposals, could have a significant impact on 340B covered entities.  The proposed rule states that CMS will change how Medicare pays hospitals that participate in the 340B...

Genesis Healthcare Settlement with Federal Government

On June 16th, 2017, The Department of Justice (“DOJ”) announced a $53.6 million dollar settlement with Genesis Healthcare Inc. (“Genesis”) over six federal whistleblower lawsuits alleging that subsidiaries of the rehabilitation and transitional care provider violated the False Claims Act (“FCA”). The original qui tam plaintiffs, former employees of companies acquired by Genesis, will receive...

CMS continues to tinker with new physician Quality Payment Program created by MACRA

The Centers for Medicare & Medicaid Services (CMS) released an advanced copy of its latest proposed rule revising the Quality Payment Program created by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). The proposed rule, among other things, would further streamline reporting requirements and ease administrative burdens for small and rural providers. By...

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

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

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

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

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...