[03/31/20]
Posted on March 31, 2020 in COVID-19 Daily Updates
Published by: Hall Render
Tuesday, March 31 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. HHS, FEMA Create Supply Chain Task Force HHS and the Federal Emergency... READ MORE
Tags: cms, Columbia University, COVID-19, Dr. Brett Girior, Dr. Scott Gottlieb, FDA, FEMA, hhs, Mark McClellan, optimizing ventilator use, Personal Protective Equipment, Ready Reserve, Reopen America, Secretaries of Defense and Homeland Security, Section 1135 Waivers, Supply Chain Stabilization Task Force, Surgeon General Dr. Jerome Adams
[03/30/20]
Posted on March 30, 2020 in COVID-19 Daily Updates
Published by: Hall Render
Monday, March 30 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. CMS Updates Waivers & Flexibilities Late this afternoon, CMS updated the waivers... READ MORE
Tags: accelerated and advance payment program, April 30, Civil Rights Laws, cms, commercial labs, cost-report delays, COVID-19, DOL, Emergency Family and Medical Leave Expansion Act, Emergency Paid Sick Leave Act, emergency use authorizations, FCC, FDA, FEMA, HIPAA Flexibilities, Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency, Medicare provider enrollment relief, Mike Pence, OCR, relaxing certain conditions of participation, Stark law, Telehealth, waivers and flexibilities
[03/27/20]
Posted on March 27, 2020 in COVID-19 Daily Updates, Health Law News
Published by: Hall Render
Friday, March 27 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 Despite a last minute procedural objection from Rep. Tom Massie... READ MORE
Tags: CARES Act, CLIA Laboratory Requirements, COVID-19, DOL, DPA, expanded family and medical leave, Families First Coronavirus Response Act, FDA, Federal Communications Commission, General Motors, Health and Medical Resources, Medicaid Fiscal Accountability Rule, MFAR, Paid Sick Leave, Rural Health Care Program, SECTION 1135, Telehealth Webinar
[03/26/20]
Posted on March 26, 2020 in COVID-19 Daily Updates
Published by: Hall Render
Thursday, March 26 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 Just before midnight last night, the Senate approved the CARES... READ MORE
Tags: $2 trillion stimulus package, 3D Printing of medical devices, CARES Act, Coronavirus, COVID-19, DOL, Expanded FMLA, Families First Coronavirus Response Act, FDA, Gloves, HHS Letter, HHS Secretary Azar, Masks, N95, Paid Sick Leave, Ventilators, Verma
[03/26/20]
Posted on March 26, 2020 in Health Law News
Published by: Hall Render
The lack of medical supplies and equipment necessary to treat patients and to protect individuals and health care workers from becoming infected with and spreading COVID-19 has been a constant refrain during this pandemic. The overall supply of these essential items, ranging from ventilators to personal protective equipment (“PPE”) to prevent the spread of... READ MORE
Tags: COVID-19, Defense Production Act of 1950, Emergency Use Authorization, FDA, GPO, Group Purchasing Organization, instructions to manufacturers, Medical Supply Chain Emergency Act, NIOSH N95, Personal Protective Equipment, respirators, Secretary of HHS, Strategic National Stockpile, Supply chain, Telehealth, telemedicine
[03/25/20]
Posted on March 25, 2020 in COVID-19 Daily Updates
Published by: Hall Render
Wednesday, March 25 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 Early this morning, the Senate finally reached a tentative agreement... READ MORE
Tags: $2 trillion, COVID-19, DOL, Families First Coronavirus Response Act, FDA, FFCRA, hhs, oig, Public Health and Social Services Emergency Fund, Secretary Azar, Section 1135 Waivers, Telehealth FAQ, The Joint Commission, Washington
[03/22/20]
Posted on March 22, 2020 in COVID-19 Daily Updates
Published by: Hall Render
Sunday, March 22 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 A procedural vote to end debate and move to a... READ MORE
Tags: chip, COVID-19, FDA, Medicare quality reporting programs, risk evaluation and mitigation strategies, Telehealth
[03/21/20]
Posted on March 21, 2020 in COVID-19 Daily Updates
Published by: Hall Render
Saturday, March 21 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 After 12 hours of negotiation on Friday, Republicans and Democrats... READ MORE
Tags: 340B, CARES Act, Cepheid Xpert Xpress SARS-CoV-2 test, COVID-19, FDA, HIPAA, OCR, Telehealth
[03/19/20]
Posted on March 19, 2020 in COVID-19 Daily Updates, Health Law News
Published by: Hall Render
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
Tags: COVID-19, Elective Surgery, Family and Social Services Administration, FDA, stimulus package, Telehealth
[03/19/20]
Posted on March 19, 2020 in Health Law News
Published by: Hall Render
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
Tags: Clinical Investigators, Clinical Trials, COVID-19, FDA, Institutional Review Boards, Sponsors