Articles and Blogs

On March 18, 2020, the FDA issued FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic that provides guidance for Sponsors, Clinical Investigators and Institutional Review Boards (“IRBs”) on how to address disruptions in the conduct of clinical trials (“Trials”) as a result of COVID-19. COVID-19 Disruptions to Clinical Trials... READ MORE

As required by the Physician Payments Sunshine Act (“Sunshine Act”)[i], manufacturers of many drugs, medical devices, biologicals and other medical supplies — as well as applicable group purchasing organizations (“GPOs”) — will soon complete (March 30, 2020) their reporting to the Centers for Medicare and Medicaid Services (“CMS”) of payments made and other investment... READ MORE

Click here for information on the filing deadline extension. Separately from the enactment of the Families First Coronavirus Response Act by Congress on Wednesday, March 18, 2020, the Treasury Department and the Internal Revenue Service (“IRS”) issued Notice 2020-17 to provide special payment relief to individuals and businesses in response to COVID-19. Under the... READ MORE

Mergers and acquisitions in the health care industry present unique challenges that are not often present when undertaking similar transactions in other industries. Because of health care’s highly regulated nature, parties may falter if a health care transaction is not reviewed and negotiated carefully with respect to the distinct concerns that health care presents.... READ MORE

Wednesday, March 18 Update Note – ​We believe this is the most up-to-date information available at this time, but it is subject to change ​as circumstances warrant. Also, all finalized resources can be found ​on the COVID-19 ​Resource ​Center page ​of Hall Render’s website. Congressional Outlook Sen. Mitch McConnell (R-KY) reversed course and the Senate passed... READ MORE

In light of President Trump’s declaration of a national emergency with respect to the COVID-19 pandemic and so as not to distract vital health care providers from preparing for and caring for patients, three accreditation organizations with deeming authority from the Centers for Medicare & Medicaid Services (“CMS”) have decided to postpone surveys or... READ MORE

As part of the first COVID-19 legislative package, President Trump signed into law the “Telehealth Services During Certain Emergency Periods Act of 2020.” This particular legislation allows the HHS Secretary to lift certain constraints on Medicare payments for qualifying telehealth services in those geographic areas where a COVID-19 emergency has been declared. The intent... READ MORE

Until today, the United States Drug Enforcement Agency (the “DEA”) has prohibited telemedicine prescribing of controlled substances unless the provider had previously seen the patient in a traditional in‑person physical encounter, or under other various narrow circumstances. But today, the DEA invoked their emergency authority at 21 U.S.C. § 802(54)(D) to permit telemedicine prescribing... READ MORE

When landlords and tenants negotiated their leases, they probably did not have COVID-19 in mind. They could not have reasonably anticipated that a global pandemic could bring the global economy (as well as toilet paper inventory) to a grinding halt, reshaping how businesses operate for at least the near future. As a result, there... READ MORE

NATIONAL 5 hospitals quarantining workers amid coronavirus A ‘New Normal’ for Hospitals on the Front Lines Fighting Coronavirus Emergency physicians recommend policy changes to combat coronavirus outbreak AMA: 10 things to know about patient access to digital health records Amid growing coronavirus cases, hospitals have shared goal: Prevent the spread within their walls Amid... READ MORE