News & Analysis as of

Opioid Regulatory Oversight

Guidepost Solutions LLC

Can a Failed Privacy Program Lead to Fentanyl Trafficking or OFAC Violations?

In July 2024, the Federal Bureau of Investigation and Department of Treasury’s Financial Crime Enforcement Network and Office of Foreign Assets Control (OFAC) released a joint notice discussing how Mexican-based Transnational...more

Arnall Golden Gregory LLP

HHS and GSA Release New Guidance to Increase Naloxone Access in Federal Facilities

On December 21, 2023, the U.S. Department of Health and Human Services (“HHS”) and the U.S. General Services Administration (“GSA”) announced the release of updated guidelines for safety stations in federal facilities....more

Health Care Compliance Association (HCCA)

[Virtual Event] Hawaii Regional Healthcare Compliance Conference - October 7th, 7:55 am - 4:00 pm HST

Our Virtual Regional Healthcare Compliance Conferences provide updates on the latest news in regulatory requirement, compliance enforcement, and strategies to develop effective compliance programs. Watch, listen, and ask...more

Oberheiden P.C.

The FDA is Investigating Companies that Produce and Sell Poppy Seeds Due to Suspected Contamination

Oberheiden P.C. on

The U.S. Food and Drug Administration (FDA) is investigating companies that produce and sell poppy seeds due to growing concerns over contamination with a controlled substance. In doing so, it is collaborating with the Drug...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 25th Annual Compliance Institute - April 19th - 22nd, 9:30 am - 4:35 pm CDT

The Compliance Institute is celebrating 25 years! Join us for the Compliance Institute's 25th anniversary, April 19-22, 2021. This year, HCCA is excited to celebrate over two decades of compliance excellence with our...more

Manatt, Phelps & Phillips, LLP

[Webinar] National Roadmap on State-Level Efforts to End the Drug Overdose Epidemic - February 9th, 2:00 pm - 3:00 pm ET

How Can Mental Health and Substance Use Disorder (SUD) Parity Laws Help Battle the Overdose Epidemic? Learn the Answers—and Catch Up on the Most Recent State and Federal Developments—at a New Webinar from the AMA and Manatt. ...more

Robins Kaplan LLP

Financial Daily Dose 10.22.2020 | Top Story: OxyContin-maker Purdue Pharma to Plead Guilty, Pay $8.3B for Role in Opioid Crisis

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The Justice Department on Wednesday announced an $8.3 billion settlement with Purdue Pharma as part of a deal in which the company will plead guilty to criminal charges “related to its marketing of the addictive painkiller”...more

Seyfarth Shaw LLP

The Week in Weed: November 2019 #5

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Welcome back to The Week in Weed, your Friday look at what’s happening in the world of legalized marijuana. Those in the marijuana industry in California will face a higher tax bill in January.  The 15% tax rate will...more

Robins Kaplan LLP

Financial Daily Dose 10.6.2019 | Top Story: Drug Distributors and Maker in Talks for Multi-billion-dollar Opioid Litigation...

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A group of three major drug distributors—McKesson, AmerisourceBergen, and Cardinal Health—are in the midst of talks with representatives of state and local governments who have brought more than 2000 opioid-related lawsuits...more

Nossaman LLP

Death Certificate Project: A Dragnet!

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The Medical Board of California (“MBC”) began this project in 2013 when it required coroners to inform it of deaths resulting from opioids.  The influx of coroners’ reports triggered an intense enforcement effort by the MBC...more

Robinson+Cole Health Law Diagnosis

Spurred by Opioid Crisis, Government Proposes Additional Changes to Substance Use Disorder Confidentiality Regulations to...

On August 26, 2019, the Department of Health and Human Services Substance Abuse and Mental Health Services Administration (SAMHSA) published a notice of proposed rulemaking (NPRM) to “better align” its substance use disorder...more

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

$1 billion+ may seem like a lot of money. It still can’t resolve many questions.

Although lawsuits can result in needed financial support and welcome recognition of harms suffered by patients seeking medical services, the civil justice system has its limits. They showed in cases in the news in which...more

Robins Kaplan LLP

Your Daily Dose of Financial News

Robins Kaplan LLP on

OxyContin-maker Purdue Pharma and its owners, the Sackler family, reached a deal this week with the state of Oklahoma in which they will pay “$270 million to avoid going to a state court trial over the company’s role in the...more

Sheppard Mullin Richter & Hampton LLP

Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning...more

Holland & Knight LLP

FDA Commissioner Speaks Out on Compliance and Enforcement

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On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more

Mintz - Health Care Viewpoints

Health Care Weekly Preview from ML Strategies – November 2018 #3

On Friday, the news came out that Sen. Chuck Grassley (R-IA) would move back to chair the Finance Committee, leaving the top post at the Senate Judiciary Committee. Grassley led the Senate Finance Committee (SFC) Republicans...more

Mintz - Health Care Viewpoints

All-Payor Kickback Statute Included in the Recently Passed Opioid Legislation Applies Broadly to Laboratories

The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious...more

Stinson LLP

New Federal Anti-Kickback Prohibition Applicable to Clinical Laboratories

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Notwithstanding its name, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act of 2018 or the SUPPORT Act appears to regulate behavior that has nothing to do with...more

Baker Donelson

OIG October 2018 Work Plan Update

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The OIG added five new items to its Work Plan in the October 2018 update: (1) childcare provider compliance with criminal background check requirements; (2) early results from Opioid State Targeted Response Grants; (3)...more

Ballard Spahr LLP

FinCEN Director Addresses Virtual Currency and Touts Regulatory Leadership and Value of SAR Filings

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Address Emphasizes Role of SARs in Fighting Illegal Activity, Including Drug Dealing Fueling the Opioid Crisis - Kenneth Blanco, the Director of the Financial Crimes Enforcement Network (“FinCEN”), discussed last week...more

Bradley Arant Boult Cummings LLP

'Opioids and Legal Enforcement — A Primer' - HarrisMartin's Drugs & Medical Devices

The opioid crisis in America is now well known, affecting a staggering number of people directly or indirectly and occupying a regular place in media reports and political discussions. In addition to potential public health...more

Bricker Graydon LLP

DOJ conference remarks provide insight into government priorities related to health care

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National conferences tend to bring out a number of government employees willing to give a peek behind the curtain and insight into how the government thinks and what is on the horizon in terms of government priorities....more

Ruder Ware

Complying with Michigan’s New Controlled Substance Laws – The Bona-Fide Prescriber-Patient Relationship Requirement

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The state of Michigan has enacted a number of separate pieces of legislation to address the opioid epidemic. Most of these laws are directed at controlling the prescribing relationship between a physician and a patient....more

Farrell Fritz, P.C.

A Renewed Focus: 2018-19 New York State Intellectual and Developmental Disabilities Budget Highlights

Farrell Fritz, P.C. on

Since the beginning of the administration of Governor Andrew Cuomo, there has been a strong emphasis on reform of the acute, primary, and long term care systems, and, particularly with the recent focus on the opioid crisis,...more

Bricker Graydon LLP

The three-day rule for treating acute withdrawal symptoms

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Generally, federal law requires practitioners to obtain a Drug Enforcement Agency (DEA) registration or a waiver from the DEA registration to use narcotics to treat opioid addiction. ...more

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