News & Analysis as of

Opioid Prescription Drugs

King & Spalding

CMS Issues CY 2025 Physician Fee Schedule Proposed Rule

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On July 10, 2024, CMS issued a proposed rule that identifies and seeks public comments on a broad array of proposed changes to the Medicare Physician Fee Schedule (PFS) and Medicare Part B payments (the Proposed Rule) for...more

ArentFox Schiff

Investigations Newsletter: DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to...

ArentFox Schiff on

DOJ Announces Agreement With Rite Aid to Settle Allegations of Violating the FCA and CSA in Relation to Opioid Dispensing - On July 10, the US Department of Justice (DOJ) announced that Rite Aid Corporation and 10 of its...more

Lathrop GPM

Nearly 200 Health Care Providers Charged in Aggressive Enforcement Action by DOJ Health Care Fraud Strike Force Alleging Schemes...

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The Department of Justice announced one if its most aggressive and wide-ranging enforcement actions to date, a coordinated two-week operation spanning 32 federal districts. The orchestrated effort involved the FBI, HHS-OIG,...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

California’s Occupational Safety and Health Standards Board Votes on Naloxone Requirement

On June 20, 2024, the California Occupational Safety and Health Standards Board partially adopted Petition 602—a proposal to require employers to provide opioid overdose reversal medications (e.g., naloxone) at all worksites...more

Holland & Knight LLP

Holland & Knight Health Dose: May 21, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....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

Troutman Pepper

Reassessing Oregon’s Drug Policy: A Shift Toward Recriminalization

Troutman Pepper on

In the grand experiment of American democracy, it is often said that states serve as laboratories, testing policies that challenge the status quo without risking the stability of the whole. Oregon, known in recent years for...more

Cozen O'Connor

CVS Settles with Alaska AG for $10 Million over Opioid Allegations

Cozen O'Connor on

Alaska AG Treg Taylor has reached a settlement with CVS Pharmacy, Inc. to resolve allegations that the company violated Alaska’s Unfair Trade Practices and Consumer Protection Act by allegedly dispensing opioid-containing...more

Epstein Becker & Green

SAMHSA Final Rule Regarding OTPs Expands Access, Increases Flexibility for Patients

On February 1, 2024, the Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule revising 42 CFR Part 8, which regulates opioid treatment programs (OTPs). The final rule is the first update to...more

Goodwin

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

Goodwin on

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

FordHarrison

A Continuing Discussion on the Opioid Epidemic in the Workplace – Part 3

FordHarrison on

Executive Summary: This is Part 3 of a series of Alerts exploring different facets of the ongoing opioid addiction crisis afflicting our country. Our initial Alert on June 12, 2023 outlined the big-picture issues associated...more

Manatt, Phelps & Phillips, LLP

Improving Access to Care for Pregnant and Postpartum People with Opioid Use Disorder: Recommendations for Policymakers

Introduction - Over the past several years, the American Medical Association (AMA) and Manatt Health have partnered on recommendations that inform policymakers of best practices to eliminate barriers to care for opioid...more

Console and Associates, P.C.

Suboxone Shown to Cause Tooth Decay in Patients

Suboxone is a medication used to treat opioid addiction, containing buprenorphine and naloxone. While Suboxone is highly effective in helping individuals overcome opioid dependence, there have been concerns about its...more

Manatt, Phelps & Phillips, LLP

[Webinar] Improving Access to Care for Pregnant and Postpartum People With Opioid Use Disorder - March 5th, 2:00 pm - 3:00 pm ET

In recent years, drug-related overdoses have become a leading cause of death during pregnancy and the postpartum period, exacerbating a mounting maternal mortality crisis and underscoring the need for improved access to care...more

Benesch

Health & Human Services Releases Final Rule for Opioid Treatment Programs

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The U.S. Department of Health and Human Services (“HHS”) and the Substance Abuse and Mental Health Service Administration (“SAMHSA”) published a final rule on Feb. 2, 2024, that cemented significant Pandemic-era flexibilities...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

New California Bills Would Require Naloxone in the Workplace to Respond to Drug Overdoses

As evidenced by recent tragic events in the news, drug overdoses are an important issue across the nation. On January 30, 2024, two bills were introduced in the California Legislature to require naloxone in the workplace....more

Napoli Shkolnik

The Opioid Crisis and Pharma Accountability: The Road So Far

Napoli Shkolnik on

In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more

Sheppard Mullin Richter & Hampton LLP

HHS & DOJ FY 2022 Enforcement Targeted Fraud in COVID-19, Telemedicine, Opioid and Prescription Drugs, and Substance Use Treatment...

The Department of Health and Human Services (HHS) and the Department of Justice (DOJ) recently released its “Health Care Fraud and Abuse Control Program Annual Report for Fiscal Year 2022” (the “Report”), highlighting...more

Manatt, Phelps & Phillips, LLP

[Webinar] 2023 Health Care Enforcement Trends: Spotlight on Consumer Protection, Antitrust and Fraud - December 13th, 1:00 pm -...

In a recent speech, a senior official at the U.S. Department of Justice Antitrust Division noted that “in U.S. antitrust enforcement and competition policy, there is no more important question than what can we do to safeguard...more

Cozen O'Connor

Notice of Appeal - A quarterly newsletter reviewing Third Circuit opinions impacting white collar defense lawyers - Fall 2023

Cozen O'Connor on

BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more

Dinsmore & Shohl LLP

Ohio’s Opioid Fight: Board of Pharmacy’s Regulation of Office-Based Opioid Treatment Clinics Axed

Dinsmore & Shohl LLP on

Ohio is eliminating the Ohio Board of Pharmacy’s (“BoP”) regulation of office-based opioid treatment (“OBOT”) clinics. Ohio law currently requires any clinic where a prescriber provides treatment for opioid dependence or...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

Knobbe Martens

FDA Releases Draft Guidance for Studies of Medical Devices for Opioid Use Disorder

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The U.S. Food and Drug Administration (FDA) recently released draft guidance regarding clinical considerations for studies of medical devices intended to treat opioid use disorder (OUD).  According to the FDA’s press release,...more

Manatt, Phelps & Phillips, LLP

Impact of the Pandemic and the End of the Public Health Emergency on Opioid Use Disorder Treatment

This report was written in partnership with and funded by the Foundation for Opioid Response Efforts. During the COVID-19 pandemic, the federal government and many states offered regulatory flexibilities intended to make...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

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