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
On March 3, 2025, the U.S. Department of Health and Human Services (“HHS”) announced a new policy to reverse course on certain public notice and comment procedures. This marks a significant change to a process in place for...more
Federal and state agencies continue to remain active this year, particularly with regard to laws that impact healthcare technology. As part of our ongoing efforts to track health technology-related legislation and...more
This week, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a temporary rule extending the telemedicine waivers of the Ryan...more
As we previously covered, in March 2023, the Drug Enforcement Agency (DEA) announced a proposed rule on prescribing controlled substances via telehealth, aimed at addressing the “telehealth cliff” that was expected to occur...more
On May 10, 2023, the Drug Enforcement Agency (DEA) released a new regulation – “Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” – temporarily extending the “full set” of...more
With the COVID-19 Public Health Emergency (PHE) ending on May 11th, providers and practitioners must carefully consider the dates when various telehealth waivers and flexibilities end. This requires understanding the...more
The Consolidated Appropriations Act of 2023 (CAA), the massive $1.7 billion spending bill signed into law on December 29, 2022, had a number of important healthcare “gems” included. A critical provision for substance use...more
The OIG has indicated concern that patients suffering from opioid use disorder may experience difficulty accessing medication-assisted treatment (MAT), resulting in under-utilization of this intervention that offers what the...more
As federal agencies scramble to provide regulatory relief from the fall-out of the coronavirus pandemic taking hold in the United States, several waivers and bulletins provide guidance specifically applicable to substance use...more