News & Analysis as of

Healthcare Controlled Substances Act

Woods Rogers

Pharmacies and Pharmacists in the Crosshairs: DOJ’s $408 million Settlement with Rite Aid

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Last week, the Department of Justice (DOJ) announced that Rite Aid, ten subsidiaries, and affiliate pharmacies agreed to settle allegations that Rite Aid violated the Controlled Substances Act (CSA) and the False Claims Act...more

Bass, Berry & Sims PLC

Rite Aid and OptumRx Settlements Highlight Enforcement Focus on Pharmacy Corresponding Responsibility for Dispensing Controlled...

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On July 10, the Department of Justice (DOJ) announced a nearly $410 million settlement with Rite Aid Corporation to resolve allegations that Rite Aid and its affiliates ignored red flags and knowingly dispensed unlawful...more

Bradley Arant Boult Cummings LLP

Healthcare Execs Face Federal Drug Charges in Landmark Telehealth Case

In a first-of-its-kind prosecution, federal prosecutors have charged two healthcare executives with unlawfully distributing controlled substances, such as Adderall, through a telehealth website. These charges demonstrate...more

Bass, Berry & Sims PLC

False Claims Act Settlements to Know from Q1 2024

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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

Bass, Berry & Sims PLC

DOJ Releases Annual Civil Fraud Recovery Statistics and Results…A Look Behind the Numbers

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On February 22, the Department of Justice (DOJ) released its annual report of civil fraud recoveries for FY2023, along with a press release highlighting DOJ’s civil enforcement efforts.  Our top ten observations from...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

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F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Troutman Pepper

From “High Potential for Abuse” to “Accepted Medical Use”: Tracking Developments and Possible Outcomes of Federal Cannabis...

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Whether you believe that cannabis legalization has occurred too quickly or too slowly, one thing is certain: recent developments herald a potentially seismic shift in federal cannabis policy in the U.S. Reflecting on our...more

Husch Blackwell LLP

The First Leap to Receive Approval for a Novel Approach to PTSD Treatment

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On December 12, 2023, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (“MAPS PBC”) announced it has submitted a new drug application (“NDA”) to the FDA for the use of...more

Warner Norcross + Judd

HHS Recommends DEA Reschedule Marijuana from Schedule I to Schedule III – Now What?

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A year ago today on October 6, 2022, President Joe Biden asked the U.S. Secretary of Health and Human Services (HHS) and the U.S. Attorney General to initiate an administrative process to review how marijuana is scheduled...more

Epstein Becker & Green

HHS Recommends Re-Classification of Marijuana as a Schedule III Controlled Substance – A Bellwether for the Future of...

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On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In a letter...more

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

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Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more

Epstein Becker & Green

DEA to Host Listening Sessions on Remote Prescribing

On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect...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

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Bass, Berry & Sims PLC

DEA Releases Updated Practitioner’s Manual for Registrants Handling Controlled Substances

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On June 14, the Drug Enforcement Administration (DEA) released an updated Practitioner’s Manual, the first new version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling...more

McGlinchey Stafford

Federal Legalization of Marijuana May Be Closer Than You Think

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According to reporting from Kyle Jaegar of Marijuana Moment, the federal government aims to finish its review of marijuana’s current legal status by the end of 2023, based on remarks from the head of the U.S. Department of...more

Sheppard Mullin Richter & Hampton LLP

DEA Proposes Rule for Post-PHE Telemedicine

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

Robinson+Cole Health Law Diagnosis

As COVID-19 Emergency Waivers End, DEA Proposes to Expand Tele-Prescribing of Controlled Substances

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

Manatt, Phelps & Phillips, LLP

DEA Releases Proposed Rules Regarding Telemedicine Prescribing of Controlled Substances

The Big Picture - On February 24, the Drug Enforcement Administration (DEA), in consultation with the Department of Health and Human Services (HHS), issued two proposed rules that address the prescribing of controlled...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

Steptoe & Johnson PLLC

Supreme Court Rules in Favor of Physicians in Overprescribing Cases

The U.S. Supreme Court unanimously agreed that in prosecuting cases against physicians under the Controlled Substances Act (CSA), if the alleged physician demonstrates that his or her conduct is authorized per the CSA, the...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

Butler Snow LLP

Criminal Liability of Pharmaceutical Executives Under the Controlled Substances Act

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Civil lawsuits are an unavoidable and expected consequence of operating in a heavily regulated industry. While CEOs and other pharmaceutical executives may lose sleep over the outcome of civil trials and the potential...more

ArentFox Schiff

Texas Hospital to Pay Over $3 Million to Resolve False Claims Act Allegations

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John Peter Smith Hospital (JPS) agreed to pay more than $3.3 million to settle allegations that it violated the False Claims Act by upcoding hundreds of claims submitted to federal healthcare programs. Texas Hospital to...more

Farrell Fritz, P.C.

Second Circuit Holds Case Challenging Marijuana Classification As Schedule I Drug In Abeyance Pending Agency Exhaustion

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Last week, in Washington v. Barr, the Second Circuit addressed a case seeking to strike down the federal government’s classification of marijuana as a Schedule I drug under the Controlled Substances Act (CSA)....more

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