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340B Drug Pricing Program Compliance
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Knock, knock! If the Drug Enforcement Administration (DEA) is already at your door, it may be too late. Enforcement is on the rise, and the microscope is fixed on controlled substances. What can industry stakeholders do to...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
News Briefs - New Foreign Nurse Visas Frozen by State Department - The State Department has essentially frozen foreign nurse visas for the rest of the fiscal year amid high demand, and health groups are warning it threatens...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
Prescription drug fraud has long been a focus for government regulators, but it has taken on new significance in the wake of America’s opioid crisis. The U.S. Department of Justice (DOJ), Department of Health and Human...more
On October 10, 2023, the Drug Enforcement Administration (DEA) published another temporary rule extending the COVID-era telemedicine flexibilities that allow physicians and other prescribers to prescribe controlled substances...more
On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule, further extending the ability to prescribe controlled substances via telemedicine...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for August 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
In today’s pharmacy world, most pharmacies, whether large national chains or small regional businesses, are required to hold licenses and registrations in several states. Unfortunately, there is no universal pharmacy license...more
In response to the large number of public comments received to its recent proposed telemedicine rules, the Drug Enforcement Administration (DEA) is holding public listening sessions to consider a special registration for...more
Since the declaration of the public health emergency due to the COVID-19 epidemic, Drug Enforcement Administration (DEA) registered practitioners have been able to prescribe controlled substances, without a prior in-person...more
On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced a new proposed rule, which provides some much-anticipated guidance related to the implications of telemedicine prescribing under Ryan Haight Act of 2008...more
With just over two months before the COVID-19 Public Health Emergency (PHE) expected expiration on May 11, 2023, the Drug Enforcement Agency (DEA) has finally announced its proposed rule on prescribing controlled substances...more
On February 24, 2023, the federal Drug Enforcement Administration (DEA) issued a pair of proposed rules to make permanent certain “telemedicine flexibilities” related to the prescribing of controlled substances via telehealth...more
The U.S. Department of Justice recently announced that a federal grand jury has charged two pharmacy owners, a mother-daughter duo from South Florida, with healthcare fraud, wire fraud, and payment of kickbacks in exchange...more
DOJ Announces Charges Against 345 Defendants in Historic Nationwide Health Care Fraud and Opioid Takedown - The DOJ announced a nationwide enforcement action charging 345 defendants across 51 federal districts with...more
On June 29, 2020, Governor Bill Lee issued Executive Order 50 which extends the state of emergency related to the COVID-19 crisis until August 29, 2020. To help facilitate the treatment and containment of COVID-19, the order...more
The catchphrase of the day is “social distancing” and it is the primary means of flattening the COVID-19 pandemic (the pandemic) curve by keeping contagious and healthy people apart. However, there is another kind of...more
The Drug Enforcement Administration (“DEA”) has waived the in-person examination requirement for prescribing controlled substances via telemedicine in the wake of COVID-19, relaxing the prescribing requirements under the...more
A waiver granted by the Drug Enforcement Administration (DEA) may provide a solution for long term care providers with opioid-addicted residents who are unable to access medication-assisted treatment (MAT) due to...more
The US Drug Enforcement Administration (DEA) stated in an FAQ on its website that prescribers may issue prescriptions for controlled substances based on a telemedicine encounter in the absence of an in-person medical...more