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Controlled Substances Act Pharmaceutical Industry Pharmacies

Mintz - Health Care Viewpoints

EnforceMintz — Novel Criminal Charges and Emerging Civil Trends from Opioid Enforcement in 2024

In past years we have discussed how opioid-related enforcement efforts have remained a top federal and state priority (here, here, and here). In 2024, opioid-related enforcement efforts continued across the entire opioid...more

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

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

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

Quarles & Brady LLP on

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

ArentFox Schiff

Investigations Newsletter: DOJ Files FCA Complaint Against Major Pharmacy Retailer Based on Alleged Violations of Controlled...

ArentFox Schiff on

DOJ Files FCA Complaint Against Major Pharmacy Retailer Based on Alleged Violations of Controlled Substances Act - On March 13, 2023, the Department of Justice (DOJ) announced that it filed a complaint in intervention...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

Mintz - Health Care Viewpoints

Telehealth Update: DEA Issues Long-Awaited Proposed Rule on Prescribing Controlled Substances via Telehealth

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

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

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

McGuireWoods LLP

DEA Investigation Leads to Record-Setting Settlement for Drug Diversion at a Health Care System

McGuireWoods LLP on

The United States Department of Justice (DOJ) recently announced the nation’s largest settlement involving allegations of drug diversion at a health care system. The settlement, totaling $7,750,000, came after a years-long...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

The Volkov Law Group on

The Justice Department handed Walmart a huge slap in the face last year with the filing of a comprehensive civil case alleging that Walmart knowingly distributed large quantities of opioids in disregard of the law that fueled...more

Carlton Fields

Sixth Circuit Rejects a Novel Concept: Certification of “Negotiation Class” in Opioid Multidistrict Litigation

Carlton Fields on

The Sixth Circuit recently addressed whether a novel negotiation class could be certified to facilitate possible future settlement negotiations in multidistrict litigation (MDL)....more

Harris Beach Murtha PLLC

Partial Summary Judgment Win for Major Pharmacy Chains in New York Litigation Deemed "Essential"

The pharmacy defendants – major national corporations CVS Pharmacy, Inc., Rite Aid of Maryland, Inc., Walgreen Co., and Walmart Inc., sued by Long Island counties Nassau and Suffolk (County Plaintiffs) in their capacities as...more

Buchalter

Buchalter Client Alert COVID-19: Requirements on Telehealth Prescriptions Eased for COVID-19

Buchalter on

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

Foley & Lardner LLP

COVID-19: DEA Confirms Public Health Emergency Exception for Telemedicine Prescribing of Controlled Substances

Foley & Lardner LLP on

With the rapid spread of the novel coronavirus (COVID-19) pandemic and the looming possibility of large scale isolations and quarantines, lawmakers continue to demonstrate willingness to expand access to telehealth to combat...more

Harris Beach Murtha PLLC

Two Executives and Distributor Charged for Unlawfully Distributing Controlled Substances

Rochester Drug Co-Operative, Inc. (“RDC”), one of the 10 largest pharmaceutical distributors in the United States, was recently charged along with its former Chief Executive Officer and former Chief Compliance Officer, for...more

McDermott Will & Emery

DOJ Expands New Enforcement Tactic – Obtains TRO to Prevent Pharmacy From Dispensing Opioids

McDermott Will & Emery on

On February 8, 2019, the Department of Justice (DOJ) announced that it obtained a temporary restraining order (TRO) in the Middle District of Tennessee against two pharmacies, their owner and three pharmacists from dispensing...more

Mintz - Health Care Viewpoints

Congress Holds Hearings and Proposes Legislation to Combat Vexing Opioid Crisis

On Tuesday, May 8th, the House held three hearings related to combating the opioid epidemic. The first hearing came out of the Energy and Commerce (E&C) Subcommittee on Oversight and Investigations, which examined opioid...more

Mintz - Health Care Viewpoints

Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices. Earlier this month, the...more

Burr & Forman

Burr Alert: Part II: White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

Burr & Forman on

In part one of this series, I detailed how the U.S. Department of Justice has focused its attention on the aggressive investigation and prosecution of “pill mill” cases. See “Part One: DOJ Devotes Resources, Vows to Come...more

Burr & Forman

Burr Alert: Part I: White Collar Courier: Delivering News and Providing Guidance in White Collar Matters

Burr & Forman on

Before joining Burr & Forman, I was a federal prosecutor for a little over a decade focusing on health care fraud and general white collar matters. In that role, I was a member of a prosecution team that secured guilty...more

K&L Gates LLP

Pharmaceutical Diversion – Risks and Steps to Address a Major DEA Focus

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The opioid crisis, an ever-increasing focus of the Obama administration and 2016 Presidential Primary field, has highlighted the efforts of the Drug Enforcement Administration (DEA) and the Department of Justice (DOJ) to...more

Troutman Pepper

EPA'S Hazardous Waste Pharmaceuticals Rules May Impose Significant Burdens on Health Care Facilities - Comment Period Runs Until...

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The Environmental Protection Agency (EPA) has promulgated its proposed regulation of “hazardous waste pharmaceuticals,” i.e., pharmaceutical residues discarded from health care facilities which also meet EPA’s long-standing...more

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