Articles and Blogs

On March 13, 2020, Secretary Azar of the Department of Health and Human Services (the “HHS”) issued a letter titled “Waiver or Modification of Requirements Under Section 1135 of the Social Security Act” (the “Azar Letter”) that grants the Centers for Medicare & Medicaid Services (the “CMS”) the authority to issue waivers specific to the…Read More

On March 13, 2020, President Donald Trump declared a National Emergency Declaration in response to the COVID-19 pandemic. Congress is passing new emergency legislation daily, and the states are declaring emergencies and issuing orders out of governors’ offices and Departments of Health. While the global extent of the crisis is unprecedented, the country has experienced…Read More

On the heels of the announcement earlier this week by the Treasury Department (the “Treasury”) and the Internal Revenue Service (the “IRS”) that delayed the Federal tax payment deadline from April 15, 2020, to July 15, 2020, Treasury Secretary Steve Mnuchin has signaled on Twitter that the corresponding filing deadlines will also be automatically extended…Read More

On March 19, 2020, the Family and Social Services Administration (the “FSSA”) announced Indiana Medicaid will temporarily cover telephone and telemedicine interactions between Medicaid beneficiaries and health care providers in an effort to contain the spread of COVID-19. These services will be reimbursed as if it was a face‑to‑face encounter. The FSSA says interactions must…Read More

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 copy…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 economic…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 of…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 interests…Read More

On Wednesday, March 18, 2020, President Trump signed the Emergency Families First Coronavirus Response Act (H.R. 6201) into law. Among other things, the new law creates the Emergency Family and Medical Leave Expansion Act and the Emergency Paid Sick Leave Act, each of which creates excused time off and paid leave for certain employees dealing with…Read More