Articles and Blogs

In response to the spread of novel coronavirus (“COVID-19”), the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have issued guidance on how COVID-19 will impact merger review and filings under the Hart-Scott Rodino (the “HSR”) Act. On March 13, 2020, the FTC and DOJ suspended the submission of hard... READ MORE

Thursday, March 19 Recap 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 Senate Republicans released the attached proposal for the third COVID-19... READ MORE

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