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DEA Opioid

ArentFox Schiff

Investigation Newsletter: Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims

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Teva Pharmaceuticals Agrees to Pay $450 Million to Resolve FCA Claims - On October 10, the US Department of Justice (DOJ) announced that Teva Pharmaceuticals USA Inc. and Teva Neuroscience Inc. will pay $450 million to...more

ArentFox Schiff

Investigations Newsletter: DOJ Launches Corporate Whistleblower Awards Pilot Program

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DOJ Launches Corporate Whistleblower Awards Pilot Program - On August 1, the US Department of Justice (DOJ) announced the details of its new Corporate Whistleblower Awards Pilot Program. According to the DOJ, the...more

Hendershot Cowart P.C.

A Pharmacist's Guide To Prescription Drug Fraud Investigations

Hendershot Cowart P.C. on

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

Goodwin

SAMHSA Final Rule Codifies Opioid Treatment Program Telehealth and Take-Home Medication Flexibilities

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On February 2, 2024, the Department of Health and Human Services (HHS) issued a Final Rule that expands access to medications for the treatment of opioid use disorder (OUD) via telehealth modalities and “take-home” doses....more

Console and Associates, P.C.

Parents Bring Kratom Lawsuits Following Overdose Deaths and Other Serious Injuries

Kratom, a natural substance derived from the leaves of the Mitragyna speciosa tree, has recently gained notoriety for its potential dangers. While proponents cite its therapeutic benefits, concerns have surged about its...more

Bass, Berry & Sims PLC

DEA Reaches $19 Million Administrative Settlement for Controlled Substances Act Violations

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On February 7, the U.S. Drug Enforcement Administration (DEA) announced that it has entered into a settlement requiring opioid distributor Morris & Dickson Co. to forfeit $19 million to resolve a years-long administrative...more

Akin Gump Strauss Hauer & Feld LLP

10 Health Issues to Watch as Congress Returns from August Recess

Health care has been one of the most active issue areas in the 118th Congress. The activity by the health committees of jurisdiction in both the House and the Senate has been fueled in part by efforts to reauthorize various...more

Quarles & Brady LLP

It's (Apparently) Never Too Late: DEA’s Revocation of Morris & Dickson’s Registrations

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On May 26, 2023, the Drug Enforcement Administration (DEA) published a final decision and order (the “Final Order”) affirming an Administrative Law Judge's (ALJ) August 29, 2019 recommendation (the “ALJ Order”) to revoke DEA...more

King & Spalding

HHS Announces Continuing Telehealth Flexibilities Following the End of the COVID-19 PHE

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On May 10, 2023, HHS announced that many telehealth and teleprescribing flexibilities will remain in place after the end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. Congress extended many telehealth...more

Foley & Lardner LLP

2023 Telemedicine & Digital Health Trends

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Medicare telehealth post-Public Health Emergency (PHE): With the COVID-19 PHE concluding on May 11, 2023, many of the telehealth flexibilities the Centers for Medicare & Medicaid Services (CMS) implemented during the PHE will...more

Foley & Lardner LLP

DEA’s Proposed Rules on Telemedicine Controlled Substances Prescribing after the PHE Ends

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On February 24, 2023, the Drug Enforcement Agency announced proposed rules for prescribing controlled substances via telemedicine after the COVID-19 Public Health Emergency expires. The proposed rules are open for public...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

DEA Supports Elimination of X-Waiver Requirement for Prescribing of Buprenorphine

McDermott Will & Emery on

On January 12, 2023, the US Drug Enforcement Administration (DEA) released a letter to registrants announcing DEA’s support of Congress’s recent removal of the requirement that healthcare providers possess a DATA-Waiver,...more

Quarles & Brady LLP

DEA’s “X” Waiver Eliminated by Congress

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On December 29, 2022, the Consolidated Appropriations Act of 2023 (Public Law No. 117-328) (the “Legislation”) was signed into law, which, under Section 1262 of the Legislation, contains the Mainstreaming Addiction Treatment...more

Foley & Lardner LLP

DEA Chopping Block: DATA-Waiver Requirement

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On January 12, 2023, the Drug Enforcement Administration (DEA) confirmed in a letter to registrants that the Consolidated Appropriations Act of 2023 (P.L. 117-328) (the Act), which was signed into law on December 29, 2022,...more

Foley & Lardner LLP

Expanded Medicare Telehealth Coverage for Opioid Use Disorder Treatment Services Furnished by Opioid Treatment Programs

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Starting January 1, 2023, Medicare will cover telehealth-based treatment services delivered by federally-accredited opioid treatment programs (OTPs), commonly referred to as “methadone clinics.” This new reimbursement is...more

Verrill

Maine, New Hampshire, & Vermont Remain DOJ Health Care Enforcement Priorities: Targeted Federal Enforcement Presents Serious Risk

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The United States Department of Justice (DOJ) has recently emphasized that Maine, New Hampshire, and Vermont are priorities for health care investigations and anticipated significant enforcement. Even well-managed (and...more

Mintz - Health Care Viewpoints

FDA Announces Review of Opioid Prescribing Regulations and Framework for Preventing Overdose-Related Deaths

The head of the Food and Drug Administration (FDA), Dr. Robert Califf, announced on August 30, 2022 that, in addition to an extensive review of opioid regulations, the agency is launching a framework aimed at preventing...more

Fox Rothschild LLP

New Illegal Opioid Prescription Task Force Signals Medical Professionals Will Continue to be Targets of Criminal Investigations

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On the heels of the Supreme Court decision in Xiulu Ruan v. United States, wherein the Supreme Court held that the government must prove beyond a reasonable doubt that a medical provider knowingly or intentionally acted in an...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

American Conference Institute (ACI)

[Event] Controlled Substances – Regulation, Litigation, and Enforcement - July 12th - 13th, Washington, DC

The only conference that presents strategies and solutions for every link of the controlled substances supply chain. Attend and learn how to best conform business practices to meet industry and regulatory demands, bolster...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

Jackson Lewis P.C.

Drug Overdoses in 2021 at Highest Level on Record According to CDC, Driven By Opioids

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The Centers for Disease Control and Prevention (CDC) published data on May 11, 2022 concluding that drug overdoses in 2021 reached the highest levels on record. CDC stated that an estimated 107,622 drug overdose deaths...more

Oberheiden P.C.

DOJ Opioid Enforcement Defense

Oberheiden P.C. on

The Controlled Substances Act (“CSA”) - The CSA (21 U.S.C. 801 et seq.) imposes a framework that regulates different categories of certain drugs that pose dependency and abuse risks to the public. The CSA applies only to...more

Patrick Malone & Associates P.C. | DC Injury...

Fake pills, laced with lethal fentanyl, are circulating widely, U.S. warns consumers

Federal officials have sharply escalated their battle with opioid painkiller abuse and overdoses, issuing an urgent public warning that street drugs of many different varieties may be tainted with tiny but lethal doses of the...more

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