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DEA Substance Abuse

Guidepost Solutions LLC

Navigating the DEA Registration Application Process

Did you know that the United States currently has over 2 million Drug Enforcement Administration (DEA) registrants engaging in activities with controlled substances? Whether you’re a student in residency, a healthcare...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

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

McGlinchey Stafford

DEA is Going to Have a Hard Time Fighting Marijuana Rescheduling

McGlinchey Stafford on

Last week, the Department of Health and Human Services (HHS) released the full text of its letter (HHS Letter) to the Drug Enforcement Administration (DEA), recommending marijuana rescheduling from Schedule I to Schedule III....more

Womble Bond Dickinson

Chew on this...Xylazine Legislation Is Here

Womble Bond Dickinson on

Xylazine is a non-scheduled, non-opioid sedative/analgesic medication that is widely used in veterinary medicine. Xylazine was first produced by Bayer Pharmaceuticals in 1962, but investigations for use in humans were not...more

Alston & Bird

Health Care Week In Review: HHS Awards $218 Million in Grant Funding

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Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Jones Day

Vital Signs Digital Health Law Update | Spring 2023

Jones Day on

Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

McDermott Will & Emery

Teleprescribing of Controlled Substances Temporarily Extended Beyond PHE – What’s Next?

McDermott Will & Emery on

The US Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) are extending telehealth flexibilities that allow providers to prescribe controlled substances. While the...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

Manatt, Phelps & Phillips, LLP

DEA Releases Proposed Rules Regarding Telemedicine Prescribing of Controlled Substances

The Big Picture - On February 24, the Drug Enforcement Administration (DEA), in consultation with the Department of Health and Human Services (HHS), issued two proposed rules that address the prescribing of controlled...more

Quarles & Brady LLP

DEA’s “X” Waiver Eliminated by Congress

Quarles & Brady LLP on

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

Sheppard Mullin Richter & Hampton LLP

Don’t Let Drugs Bring You Down: The Importance of an Effective Drug Diversion Program

Overall, healthcare professionals are 10-15% more likely to develop substance abuse issues than the general population.[1] As addiction to prescription medication has reached nation-wide epidemic proportions, it has become a...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

Hendershot Cowart P.C.

Stricter than HIPAA: Is Your Substance Abuse or Mental Health Program in Compliance With 42 CFR Part 2?

Hendershot Cowart P.C. on

To protect patients seeking addiction treatment, the federal government passed strict regulations limiting the disclosure of substance abuse patient records. Substance abuse treatment programs must not only comply with the...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

Mintz - Health Care Viewpoints

White House Issues Telehealth Guidance on Substance Use Disorder Services

On June 22, 2022, the White House Office of National Drug Control Policy (ONDCP) issued guidance advocating for Congress and federal agencies to make permanent certain telehealth access measures for people struggling with...more

Foley & Lardner LLP

Behavioral Health Trends for 2022

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Over the last two years, behavioral health (BH) has been one of the biggest growth areas in the health care ecosystem, fueled by the Public Health Emergency (PHE) but in many ways an ignored, overlooked, understaffed, and...more

The Volkov Law Group

DOJ Files Civil Complaint Against Walmart for Illegal Opioid Distribution

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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

Mintz - Health Care Viewpoints

DEA Releases Long-Awaited Suspicious Orders Proposed Rule

It has been a long time coming. On November 2, 2020, the Drug Enforcement Administration (DEA) released its long-awaited proposed rule to revise the regulations related to suspicious orders of controlled substances. The...more

Oberheiden P.C.

DEA Compliance for 2021 - How the DEA’s 2021 Proposed Aggregate Production Quotas Affect Pharmaceutical Companies and Society

Oberheiden P.C. on

The DEA struggles to balance the pressing need to provide pain relief for those suffering from the novel coronavirus with the ongoing effort to reduce the opioid epidemic in the United States. I. Overview on the DEA and the...more

ArentFox Schiff

Investigations Newsletter: Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and...

ArentFox Schiff on

Department of Justice Announces $8.3 Billion Settlement with Opioid Manufacturer Purdue Pharma and Members of the Sackler Family - On October 21, the Department of Justice (DOJ) announced that it reached a global resolution...more

McDermott Will & Emery

TREATS Act Aims to Expand Use of Telehealth to Treat Substance Use Disorder

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A bipartisan pair of US senators have proposed legislation that would allow certain controlled substances to be prescribed via an initial telehealth encounter and—under certain conditions—expand Medicare reimbursement of...more

Foley & Lardner LLP

Telehealth and Substance Use Disorder Treatment: State Law Issues

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...Our prior article discussed federal law barriers to entry for the use of telehealth in substance use disorder (SUD), and specifically, opioid use disorder (OUD) treatment, and highlighted notable opportunities to use...more

Foley & Lardner LLP

Telehealth and Substance Use Disorder Treatment: Regulatory Barriers to Entry Can Mean Opportunity for Innovative Companies

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...As COVID-19 cases spread across the U.S., another public health issue continues to escalate: the rise of opioid-related overdose deaths. For patients with a substance use disorder (SUD), the pandemic has increased feelings...more

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