News & Analysis as of

Opioid Department of Health and Human Services (HHS) DEA

Epstein Becker & Green

DEA Telemedicine Rules Further Delayed Until (Nearly) 2026

Epstein Becker & Green on

Those waiting anxiously for the rules expanding the prescribing of buprenorphine via telemedicine and the controlled substance prescribing for patients at the Department of Veterans Affairs to officially go into effect will...more

Bass, Berry & Sims PLC

The Future of Telemedicine Prescribing Comes Into Focus: New Final and Proposed Rules

On January 17, the Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) jointly published two final rules addressing the prescription of controlled substances via telemedicine in...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

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

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

King & Spalding

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

King & Spalding on

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

Foley & Lardner LLP on

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

Foley & Lardner LLP on

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

Mintz - Health Care Viewpoints

HHS Issues Buprenorphine Practice Guidelines as Study Confirms Access Barriers

One of the spillover effects of the COVID-19 pandemic has been the increase in opioid-related deaths. These deaths overwhelmingly affect working-class Americans with limited access and resources to lifesaving drugs such as...more

K&L Gates LLP

HHS Exemptions for Buprenorphine (but not Methadone) Prescribers

K&L Gates LLP on

For the year ending August 2020, provisional data from the Centers for Disease Control and Prevention shows that opioid overdose deaths increased 26.8 percent compared to the previous 12 months, with opioid overdoses...more

Oberheiden P.C.

While COVID-19 Takes Center Stage, DOJ Continues to Target Providers for Opioid Epidemic

Oberheiden P.C. on

The COVID-19 pandemic has created many new enforcement priorities for the U.S. Department of Justice (DOJ). From selling ineffective personal protective equipment (PPE) to companies fraudulently seeking loan forgiveness under...more

Mintz - Health Care Viewpoints

Working Together, FDA, NTIA, and Domain Registries Take Down 30 Websites Illegally Selling Opioids

The Food and Drug Administration (FDA) and the National Telecommunications Information Administration (NTIA) in partnership with three domain name registries disabled nearly 30 websites illegally offering opioids for sale....more

ArentFox Schiff

Investigations Newsletter: HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute

ArentFox Schiff on

HHS Announces Final Rules Amending Stark Law Regulations and Anti-Kickback Statute - On November 20, 2020, the Centers for Medicare and Medicaid Services and the Department of Health and Human Services (HHS) published...more

Epstein Becker & Green

Deadline Looms for Responding to DEA’s Proposed Aggregate Production Quotas for 2021

Epstein Becker & Green on

On Tuesday, September 1, 2020, the Drug Enforcement Agency (“DEA”) proposed 2021 aggregate production quotas (APQs) for controlled substances in schedules I and II of the Controlled Substances Act (“CSA”) and an Assessment of...more

McDermott Will & Emery

Healthcare Enforcement Quarterly Roundup | Q2 2019

McDermott Will & Emery on

In this second installment of the Healthcare Enforcement Quarterly Roundup for 2019, we cover several topics that have persisted over the past few years and identify new issues that will shape the scope of enforcement efforts...more

Baker Donelson

Expanded Telehealth Coverage in New Opioids Legislation

Baker Donelson on

On October 3, 2018, the Senate voted 98-1 to pass a compromise opioids response package that includes key provisions to expand telehealth coverage and reimbursement. The House had previously passed the opioids agreement...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

Foley & Lardner LLP

Health Care Policy Newsletter - July 2018 pt 2

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly* Health Care Newsletter” in which we compile the latest Health Care policy news and legislation. *Please note that we...more

Foley & Lardner LLP

Health Care Policy Newsletter - May 2018 pt 3

Foley & Lardner LLP on

Foley & Lardner LLP’s (“Foley”) Bipartisan Public Policy Team is pleased to share our “Public Policy Weekly Health Care Newsletter” in which we compile the latest health care policy news and legislation....more

Alston & Bird

Alston & Bird Healthcare Week in Review

Alston & Bird on

Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health...more

K&L Gates LLP

K&L Gates Triage: The Opioid Epidemic: DEA’s Role in Regulating Individuals and Entities Handling Controlled Substances

K&L Gates LLP on

In the fifth episode of our series on the national opioid crisis, Hilary Bowman discusses the Drug Enforcement Administration’s (DEA) role in regulating individuals and entities handling controlled substances, including...more

McDermott Will & Emery

A Declaration without a Response: Senators Urge DEA to Enact Regulations on Opioid-Based Addiction Treatments Using Telemedicine

McDermott Will & Emery on

This past fall, after months of speculation, President Trump declared the opioid crisis sweeping the United States a national public health emergency. Upon the president’s declaration, Acting Health and Human Services...more

McDermott Will & Emery

Congress and Obama Administration Take Steps to Ease Buprenorphine Access

McDermott Will & Emery on

On Friday, July 22, President Obama signed the Comprehensive Addiction and Recovery Act of 2016 (CARA). Following on federal, state and local trends, CARA seeks to expand access for persons needing opioid treatment....more

Alston & Bird

A&B Healthcare Week in Review

Alston & Bird on

I. REGULATIONS, NOTICES, & GUIDANCE - On March 24, 2016, the Food and Drug Administration (FDA) issued a guidance entitled, “Draft Guidance for Industry: General Principles for Evaluating the Abuse Deterrence of Generic...more

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