News & Analysis as of

Controlled Substances Act Health Care Providers

Oberheiden P.C.

4 Things to Know About Ketamine Investigations

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Federal law enforcement agencies, including the U.S. Drug Enforcement Administration (DEA), have amped up their investigations into the drug ketamine in recent years, likely in reaction to some high-profile overdose deaths....more

Epstein Becker & Green

The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care

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

International Cannabis Bar Association...

[Event] Cannabis Law Institute 2024 - July 25th - 26th, Chicago, IL

The International Cannabis Bar Association (INCBA) is thrilled to announce the highly anticipated Cannabis Law Institute 2024 (CLI 2024), the marquee conference dedicated to advancing legal excellence in the rapidly evolving...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

Bass, Berry & Sims PLC on

Despite the recent downward trend in DOJ healthcare industry settlements, the first quarter of 2024 saw many noteworthy False Claims Act (FCA) and civil healthcare fraud settlements related to alleged kickbacks, medically...more

Saul Ewing LLP

2024 Health Care Predictions

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Happy 2024!  The entire Saul Ewing Health Law Practice Group wishes you and yours a healthy and prosperous new year and successful (and compliant) activities in the health care delivery system this year and beyond....more

Bass, Berry & Sims PLC

Controlled Substances Act and False Claims Act Collide

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The United States recently intervened in a False Claims Act lawsuit accusing Rite Aid of defrauding federal healthcare programs by seeking reimbursement for opioids the pharmacy allegedly dispensed in violation of the...more

Goodwin

Psychedelics & Drug Development - Key Considerations for Healthcare Industry and Life Sciences Companies as Congress Seeks to Tap...

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On March 8, 2023, US Sens. Cory Booker (D-NJ) and Rand Paul (R-KY) introduced an updated version of the Breakthrough Therapies Act, and US Reps. Nancy Mace (R-SC) and Madeleine Dean (D-PA) introduced companion legislation in...more

Goodwin

DEA Publishes Temporary Rule on the Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Substances

Goodwin on

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

Oberheiden P.C.

SARMs Enforcement and FDA Escalation

Oberheiden P.C. on

Always on the lookout for unapproved drugs and supplements being sold, the U.S. Food and Drug Administration (FDA) has ramped up its enforcement actions against selective androgen receptor modulators (SARMs), which are banned...more

McDermott Will & Emery

Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE – What’s Next?

McDermott Will & Emery on

The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...more

Goodwin

DEA Proposes Rules to Allow Prescribing Controlled Substances via Telemedicine, Subject to Significant Limitations

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Less than one month after the Biden administration’s announcement on January 20, 2023, declaring the end of the public health emergency (PHE) on May 11, 2023, the US Drug Enforcement Administration (DEA) has announced...more

Bradley Arant Boult Cummings LLP

DEA Issues Proposed Rule for Prescribing of Controlled Substances via Telemedicine

On March 1, 2023, the Drug Enforcement Administration (DEA) released the proposed rule, “Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical...more

King & Spalding

DEA Proposes New Rules for Telemedicine Prescriptions

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Would Require In-Person Examination In Many Prescribing Scenarios - Almost fifteen years ago, Congress amended the Controlled Substances Act (CSA) to reduce illegitimate, Internet-based access to controlled drugs while, at...more

McDermott Will & Emery

DEA Proposes Limited Post-PHE Telemedicine Prescription of Controlled Substances

On February 24, 2023, the US Drug Enforcement Administration (DEA) issued two proposed rules (the Telemedicine Controlled Substance Proposed Rule and the Telemedicine Buprenorphine Proposed Rule) that would establish...more

American Conference Institute (ACI)

[Event] 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - March 14th - 15th, Washington, DC

Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more

McDermott Will & Emery

Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?

McDermott Will & Emery on

On December 2, 2022, President Joseph Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act (Cannabis Research Act), which provides a mechanism for industry and academia to access and research cannabis,...more

Goodwin

Five Key Regulatory Considerations for Virtual Ketamine Clinics

Goodwin on

The off-label use of ketamine to treat anxiety, depression, and other behavioral health disorders —coupled with the COVID-19 telehealth era—has spurred the opening of virtual ketamine clinics nationwide. Some clinics offer a...more

Mintz - Health Care Viewpoints

Telehealth Update: Assessing PHE Flexibilities, Pending Legislation Entering Fall 2022

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

Epstein Becker & Green

Will the Supreme Court’s Latest Decision on Mens Rea Leave Medical Professional Prosecutions Ruan-ing on Empty?

Epstein Becker & Green on

In a brush-back pitch to DOJ opioid initiatives, the U.S. Supreme Court this past June issued an important decision clarifying the mental state the government must establish to convict a licensed medical professional of...more

Oberheiden P.C.

U.S. Supreme Court Overturns Doctors’ Opioid Convictions in Ruan v. United States, Paving the Way for Additional Appeals

Oberheiden P.C. on

On June 27, 2022, the U.S. Supreme Court issued an important decision for doctors who have been convicted of violating the federal Controlled Substances Act in connection with the nation’s opioid crisis. In Ruan v. United...more

Quarles & Brady LLP

High Court Rules “State of Mind” Relevant in Prosecuting Prescribers under the Controlled Substance Act

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Last week the Supreme Court ("the Court") released a decision holding that the Federal Controlled Substance Act (the "Act") provision that criminalizes the dispensing of a controlled substance “except as authorized” includes...more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Ruan v. United States

On June 27, 2022, the U.S. Supreme Court decided Ruan v. United States, No. 20-1410, and Kahn v. United States, No. 21-5261, in a consolidated ruling. The Court held that when a criminal defendant is authorized to dispense...more

Fox Rothschild LLP

Enhanced Scrutiny of Opioid Prescriptions Poses Legal Risks for Medical Professionals

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The U.S. Department of Justice recently charged multiple physicians and health care professionals for opioid-related crimes in a crackdown with a clear message to individuals in the industry: If you are involved with...more

Mintz - Health Care Viewpoints

Telehealth Update: New Bill Could Provide Much Needed Certainty to Providers and Patients

On Monday, February 7, 2022, U.S. Senators Catherine Cortez Masto, D-Nevada, and Todd Young, R-Indiana, introduced the Telehealth Extension and Evaluation Act, which if passed, would extend several of the telehealth waivers...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 30, Number 32. News Briefs: September 2021

Report on Medicare Compliance 30, no. 32 (September 13, 2021) - Saint Francis Medical Center in Missouri agreed to pay $1.625 million in a civil settlement of allegations it violated the Controlled Substances Act, the...more

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