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
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....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
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
During the COVID-19 pandemic, telehealth utilization exploded. Globally, the telehealth market is valued at $83.5 billion and is expected to grow by 24% between 2023 and 2030. As services delivered via telehealth became more...more
As we covered in a prior Telehealth Update, many of the flexibilities upon which telehealth providers have come to rely in recent years are tied to the federal Public Health Emergency related to the COVID-19 pandemic (the...more
The U.S. Department of Transportation’s Federal Motor Carrier Safety Administration (“FMCSA”) announced on June 5, 2020 an extension of the waiver period that is available when a commercial motor vehicle driver has been out...more
The Drug Enforcement Agency (DEA) recently published guidance relating to the COVID-19 public health emergency, including the ability to prescribe controlled substances via telemedicine without a prior in-person exam;...more
In response to the federal and state declarations of public health emergencies surrounding the COVID-19 pandemic, the California State Board of Pharmacy has issued the following waivers to California Board of Pharmacy...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
Alex Azar, Secretary of the U.S. Department of Health and Human Services (“HHS”), declared a public health emergency related to the coronavirus pandemic (“Emergency Declaration”) on January 31, 2020. ...more
On February 26, 2020, the US Drug Enforcement Administration (DEA) issued a Notice of Proposed Rule Making (NPRM), which proposes waiving the requirement of a separate DEA registration at each principal place of business or...more
Last year, the Oklahoma legislature joined a growing number of states in taking direct aim at the opioid crisis by enacting legislation designed to combat the forgery of paper prescriptions. More than a year and a half after...more
Generally, federal law requires practitioners to obtain a Drug Enforcement Agency (DEA) registration or a waiver from the DEA registration to use narcotics to treat opioid addiction. ...more
After receiving many comments on its Draft Call Letter, CMS published its Contract Year 2014 Final Call Letter on April 1, 2013. The Final Call Letter addresses a wide variety of issues that will affect all parties involved...more