News & Analysis as of

Controlled Substances Healthcare

Troutman Pepper

North Carolina Attorney General Reaches $500,000 Settlement in False Claims Act Lawsuit Against Health Care Providers

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North Carolina Attorney General Josh Stein and the U.S. Attorney’s Office for the Middle District of North Carolina have reached a $500,000 settlement with Sharon Raynes Halliday and RAPHA Healthcare Services LLC, resolving a...more

McDermott+

Exploring the Virtual Care Policy Landscape One Year Post-PHE

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May 11, 2024, marked one year since the end of the COVID-19 public health emergency (PHE), and not much has changed in Medicare telehealth policy. We are still operating under temporary waivers and flexibilities and, as a...more

Nelson Mullins Riley & Scarborough LLP

Gold Dome Report - Committee Work Day - February 2024

There may be a calm before most storms, but there certainly isn’t one before Crossover Day in the Georgia General Assembly. Contrary to the popular idiom, House members spent late Tuesday and Wednesday pleading, cajoling,...more

Manatt, Phelps & Phillips, LLP

Changes to the Substance Use Disorder Confidentiality Regulation: Implications for Stakeholders

Last week, the Department of Health and Human Services (HHS) released a final rule intended to implement a 2020 modification to the federal substance use disorder (SUD) privacy statute. The final rule more closely aligns the...more

Quarles & Brady LLP

It's (Apparently) Never Too Late Part II: DEA & Morris & Dickson Settle

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This week, DEA announced it has entered into a settlement agreement with Morris & Dickson Co., LLC (“Morris & Dickson”), resolving the protracted dispute born out of a May 2, 2018 Order to Show Cause (“OTSC”) and Immediate...more

Nelson Hardiman, LLP

Too Much Of A Good Thing?

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F. Scott Fitzgerald famously declared that “Too much of anything is bad, but too much champagne is just right.” That may be true, but it now appears that it may have been “Special K” that proved the undoing of beloved actor...more

Troutman Pepper

From “High Potential for Abuse” to “Accepted Medical Use”: Tracking Developments and Possible Outcomes of Federal Cannabis...

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Whether you believe that cannabis legalization has occurred too quickly or too slowly, one thing is certain: recent developments herald a potentially seismic shift in federal cannabis policy in the U.S. Reflecting on our...more

Quarles & Brady LLP

FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals

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On January 5, 2024 the Food and Drug Administration (FDA) issued its approval of the State of Florida’s proposal to import certain prescription drugs from Canada under the Section 804 Importation Program (SIP). This approval...more

Napoli Shkolnik

The Opioid Crisis and Pharma Accountability: The Road So Far

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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

Vicente LLP

A Potential Breakthrough for Psychedelic Treatments: Ninth Circuit Court Ruling on Psilocybin Rescheduling

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On October 27, 2023, the Ninth Circuit Court of Appeals, in Aggarwal v. DEA, held that the U.S. Drug Enforcement Agency (DEA) must reconsider its denial of a petition to transfer psilocybin, the active ingredient in “magic...more

Husch Blackwell LLP

Developing a Regulatory Compliance Checklist for Ketamine-Assisted Therapy

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Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more

Burr & Forman

Telehealth Prescribing Flexibilities for Controlled Substances Extended Through End of 2024

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The rule allowing for providers to prescribe controlled substances via telehealth, set to expire for new patient-provider relationships on November 11, has been extended through the end of 2024....more

Robinson+Cole Health Law Diagnosis

DEA Further Extends COVID-19 Telemedicine Prescribing Flexibilities through December 31, 2024

On October 10, 2023, the federal Drug Enforcement Administration (DEA) issued another extension (Second Temporary Rule) of its pandemic-era telehealth flexibilities “in light of the need to further evaluate the best course of...more

Pullman & Comley - Connecticut Health Law

DEA Extension of Telemedicine Flexibilities and Impact on CT Practitioners

On October 10, 2023, the federal Drug Enforcement Administration (DEA) and the U.S. Department of Health and Human Services (HHS) published a new temporary rule which extends, through December 31, 2024, the ability of ...more

Sheppard Mullin Richter & Hampton LLP

Tele-Prescribing Flexibilities Extended Again in Second Temporary Rule

This month, the Drug Enforcement Administration (“DEA”), in conjunction with the Substance Abuse and Mental Health Services Administration (“SAMHSA”), issued a Second Temporary Rule further extending the telemedicine waivers...more

Polsinelli

DEA Issues Second Temporary Rule Extending Controlled Substance Prescribing Flexibilities Through December 2024

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On October 6, 2023, the Drug Enforcement Agency (DEA) and the Department of Health and Human Services (HHS) issued a Second Temporary Rule, further extending the ability to prescribe controlled substances via telemedicine...more

Epstein Becker & Green

DEA Issues Second Temporary Extension of COVID-19 Telemedicine Prescribing Flexibilities, Through 2024

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On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of...more

McDermott Will & Emery

DEA Further Extends Flexibilities for Controlled-Substance Prescribing via Telemedicine

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The United States Drug Enforcement Administration (DEA) and the Substance Abuse and Mental Health Services Administration (SAMHSA) have further extended flexibilities that allow providers to prescribe controlled substances...more

Epstein Becker & Green

HHS Recommends Re-Classification of Marijuana as a Schedule III Controlled Substance – A Bellwether for the Future of...

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On August 30, an official at the United States Department of Health and Human Services (HHS) released one of the most significant announcements made at the federal level concerning marijuana reclassification. In a letter...more

Quarles & Brady LLP

Protect Your CSOS Credentials…Or Else.

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Over the last decade, the increased use of Controlled Substance Ordering System (“CSOS”) applications (i.e., platforms used to electronically transmit controlled substance orders) and Electronic Prescriptions for Controlled...more

Manatt, Phelps & Phillips, LLP

DEA Announces Public Listening Sessions on Telemedicine Prescribing

In response to the large number of public comments received to its recent proposed telemedicine rules, the Drug Enforcement Administration (DEA) is holding public listening sessions to consider a special registration for...more

Epstein Becker & Green

DEA to Host Listening Sessions on Remote Prescribing

On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect...more

Perkins Coie

Psilocybin: Updates in Oregon and Around the Country

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Oregon is the first state in the country to offer controlled use of psilocybin to the public. As we detailed in a prior Update, the state had finalized regulations. Now, the state has licensed its first psilocybin service...more

Bass, Berry & Sims PLC

DEA Releases Updated Practitioner’s Manual for Registrants Handling Controlled Substances

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On June 14, the Drug Enforcement Administration (DEA) released an updated Practitioner’s Manual, the first new version of the manual since 2006. The Practitioner’s Manual provides guidance for all DEA registrants handling...more

Quarles & Brady LLP

New DEA Form 106 Theft & Loss Reporting Deadlines and Submission Requirements

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On June 22, 2023, DEA published a final rule regarding the timing with which registrants are required to report the theft or loss of controlled substances (the “Final Rule”). 88 FR 40707. DEA’s regulations have always...more

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