The End of COVID Waivers and Exceptions: What Now?
I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Fee Waivers for Small Businesses: Who Qualifies for the Small Business User Fee Waiver for Drugs and Biologics and How to Apply
NGE On Demand: COVID-19 and IP Waiver for Patent Protection with Kevin O'Connor and Olivia Luk Bedi
Prohibitions on Use of Chinese Telecommunications Equipment and Services, Complying with the NDAA
COVID-19: Where are we now?
Compliance Perspectives: Changes to the Physician Self-Referral and Anti-Kickback Rules
Value-based health care: fraud & abuse laws
What patients misunderstand about their right of informed consent
Bill on Bankruptcy: ResCap Report, a Bargain at $83 Million
The 340B Drug Program requires pharmaceutical manufacturers participating in the Medicaid program to provide covered outpatient drugs at significantly reduced prices to certain health care organizations and programs, referred...more
Responding to the COVID-19 national public health emergency, on March 13, 2020, the Secretary of the U.S. Department of Health and Human Services (HHS) exercised the authority granted by Section 1135 of the Social Security...more
As it has previously done for specific geographic areas affected by hurricanes, on March 15, the U.S. Department of Health and Human Services (HHS) issued a HIPAA Bulletin providing for a limited waiver of HIPAA sanctions and...more
The U.S. Department of Health and Human Services (HHS) has used its authority to waive certain provisions of HIPAA in response to Hurricane Harvey. HHS previously declared a public health emergency in Texas and Louisiana...more
Hurricane Harvey has been pummeling the Gulf Coast since Monday, with nearly 52 inches of rainfall in parts of Texas. The storm has displaced thousands of people from their homes and has resulted in over 30 reported deaths....more