News & Analysis as of

Regulatory Requirements Opioid

Goldberg Segalla

FDA Approved Journavx, a Non-Opioid Drug for Pain Management

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On January 30, the U.S. Food and Drug Administration approved Journavx (suzetrigine) 50 milligram oral tablets, a first-in-class non-opioid analgesic, to treat moderate to severe acute pain in adults. It is the first new type...more

Cozen O'Connor

Purdue Pharma to Pay $7.4 Billion to Settle Thousands of Opioid-Related Lawsuits

Cozen O'Connor on

New York AG Letitia James, along with a bipartisan coalition of 15 other state AGs and additional parties, has reached a settlement in principle with members of the Sackler family and Purdue Pharma, Inc., to resolve...more

Holland & Knight LLP

DEA Extends Access to Telehealth Treatment with New Rules

Holland & Knight LLP on

The U.S. Drug Enforcement Agency (DEA) announced on Jan. 16, 2025, three new rules intended to implement patient protections and permanently extend certain COVID-era telemedicine prescription flexibilities. These new rules...more

King & Spalding

DEA Announces Three New Telemedicine Rules

King & Spalding on

On January 16, 2025, the Drug Enforcement Administration (DEA) announced two final rules and a proposed rule for telemedicine flexibilities. In 2024, the DEA issued a one-year extension of the COVID-era telemedicine...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Pullman & Comley - Connecticut Health Law

New Connecticut Health Care Laws Becoming Effective January 1, 2025

Hospitals and health insurance companies will bear the brunt of several new legal requirements taking effect on January 1, 2025. These requirements stem from the 2024 legislative session of the Connecticut General Assembly...more

Pullman & Comley - Connecticut Health Law

New Connecticut Health Care Laws Effective October 1

The 2024 legislative session of the Connecticut General Assembly produced a number of new statutory provisions impacting the operations of hospitals, physician groups and other health care providers. To alert the health care...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

Health Care Compliance Association (HCCA)

[Virtual Event] Louisville Regional Healthcare Compliance Conference - October 29th, 8:25 am - 4:30 pm EDT

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

Health Care Compliance Association (HCCA)

[Event] Nashville Regional Healthcare Compliance Conference - November 5th, Nashville, TN

Our one-day Regional Compliance Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...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

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Virtual Ann Arbor Regional Conference - June 12th, 8:30 am - 4:30 pm EDT

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

Health Care Compliance Association (HCCA)

[Virtual Event] 2020 Philadelphia Regional Conference - May 29th, 8:30 am - 4:30 pm EDT

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

Bricker Graydon LLP

HHS releases final rules on interoperability and information blocking

Bricker Graydon LLP on

On March 9, 2020, two final rules on electronic health information were issued by the Office of National Coordinator for Health Information Technology (ONC) and the Centers for Medicare and Medicaid Services (CMS)....more

Polsinelli

Changes Coming For Prescribers To The Texas Prescription Drug Monitoring Program

Polsinelli on

In response to the opioid epidemic, many states, including Texas, created prescription drug monitoring programs to monitor high-risk patients and provider behaviors. The Texas Prescription Drug Monitoring Program (“PMP”) is...more

ArentFox Schiff

DOJ Goes After The Dark Side of Artificial Intelligence (AI)

ArentFox Schiff on

A software developer of an electronic health records system utilizing AI is the recent target in a DOJ fraud investigation. On January 27, 2020, the DOJ announced that Practice Fusion, Inc. entered into a deferred...more

American Conference Institute (ACI)

[Virtual Event] 3rd Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement - July 21st-22nd, 9:00...

Be part of one-of-a-kind, interactive virtual conference where stakeholders can gather with peers, discuss challenges, and walk away with tailored strategies for overcoming these challenges. As our nation continues with...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Enforcement Compliance Conference - November 3rd-6th, Washington , DC

Prepare your organization to respond to the ever-increasing emphasis on healthcare compliance issues by enforcement authorities. Hear first-hand from government officials about regulatory changes, expectations, and key...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

Baker Donelson

Most Restrictive Medicare Enrollment Rules Proposed for Opioid Treatment Programs

Baker Donelson on

Grounded in the bipartisan Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act designed to "alleviate the nationwide opioid crisis," CMS's proposed...more

Mintz - Health Care Viewpoints

DOJ Updates its Justice Manual to Include Section Limiting Use of Guidance Documents in Litigation

Nearly one year ago, on January 25, 2018, the Department of Justice’s (DOJ) Regulatory Reform Task Force issued a memorandum entitled “Limiting Use of Agency Guidance Documents In Affirmative Civil Enforcement Cases.” Many...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

Stinson LLP on

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

Nossaman LLP

Avoiding Medical Board Discipline when Prescribing Opiates

Nossaman LLP on

There is a host of new, ever changing, and conflicting guidelines from a multitude of regulators and academic societies. This evolving and uncertain landscape is making the life of a practicing pain physician in the midst of...more

Hogan Lovells

Massachusetts anti-opioid law bans manufacturer copay assistance

Hogan Lovells on

On Thursday, August 9, 2018, Massachusetts Gov. Charlie Baker (R) signed H.4742, "An Act for prevention and access to appropriate care and treatment of addiction," which takes effect immediately. ...more

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