News & Analysis as of

Telehealth Enforcement Actions

Hogan Lovells

Investigation highlights risks of collaboration between pharmaceutical manufacturers and telehealth providers

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Four U.S. senators reported their findings of a nine-month investigation into direct-to-consumer telehealth platforms used by pharmaceutical manufacturers, highlighting risks and reinforcing the need for industry to carefully...more

Morrison & Foerster LLP

DOJ and HHS Announce Formation of False Claims Act Working Group and Results of National Health Care Fraud Takedown

As we reported in our recent client alert, the Trump administration has made clear that it is committed to using the False Claims Act (FCA) to prosecute healthcare fraud. Two recent Trump administration moves give important...more

Venable LLP

FTC Settles with NextMed Over Deceptive Pricing, Hidden Material Terms, and Fake Reviews and Testimonials in Telehealth Membership...

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This week, the Federal Trade Commission (FTC) announced a settlement with NextMed parent company Southern Health Solutions, Inc., in response to allegations that the telemedicine platform offered deceptive claims and fake...more

Epstein Becker & Green

Shielding Reproductive Freedom: Uncovering New York’s Law Protecting Providers from Civil and Criminal Liability

Epstein Becker & Green on

In the wake of the Dobbs decision, which eliminated the constitutional right to abortion, individual states were left to regulate or ban the procedure....more

Epstein Becker & Green

The First National Health Care Fraud Takedown of the Second Trump Administration: What Stayed the Same and What is New?

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On June 30, 2025, the U.S. Department of Justice (“DOJ”), together with the U.S. Department of Health and Human Services Office of Inspector General (“HHS OIG”) and other law enforcement partners, announced the results of the...more

Polsinelli

DOJ Unveils Record-Breaking National Health Care Fraud Takedown

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Key Takeaways - DOJ’s 2025 National Health Care Fraud Takedown was a record-breaking operation that resulted in criminal charges against 324 defendants and targeted schemes involving over $14.6 billion in intended losses....more

Hendershot Cowart P.C.

GLP-1 Shortage Ended: Can You Still Legally Prescribe or Compound Semaglutide and Tirzepatide?

Hendershot Cowart P.C. on

For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more

Dinsmore & Shohl LLP

Mixing Medicine and Risk: Ohio’s Joint Regulatory Statement Targets Retail IV Therapy Clinics

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On May 15, 2025, the State Medical Board of Ohio, the Ohio Board of Pharmacy and the Ohio Board of Nursing (collectively, the “Boards”) jointly issued a significant regulatory statement (the “Statement”) clarifying the legal...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | April 2025 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2025, including Centers for Medicare & Medicaid Services (CMS) updates to Medicare Advantage (MA) and other Medicare programs....more

Morgan Lewis

Seventh Circuit Overturns AKS Conviction in DME Marketing Case

Morgan Lewis on

The US Court of Appeals for the Seventh Circuit recently issued a decision that has important implications for stakeholders in the durable medical equipment (DME), medical device, and telehealth space as well as future civil...more

Wilson Sonsini Goodrich & Rosati

Telehealth Companies Sued for Selling Compounded GLP-1 Drugs and Violations of Corporate Practice of Medicine Laws

Branded drug manufacturers, including Eli Lilly and Company (Eli Lilly), have been pursuing various legal actions against compounding pharmacies and telehealth companies that provide compounded diabetes and weight-loss drugs,...more

Epstein Becker & Green

As State Legislatures Debate Strengthening the Corporate Practice of Medicine Limitations, a Drug Manufacturer’s Lawsuits Shine a...

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Drug manufacturer Eli Lilly has filed suit against four companies involved in making, prescribing, and/or selling compounded versions of its weight loss and diabetes drugs ZEPBOUND® and MOUNJARO®....more

Hendershot Cowart P.C.

FDA Update: Current Guidelines for Semaglutide and Tirzepatide Compounding

Hendershot Cowart P.C. on

Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more

Alston & Bird

FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers

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Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | January 2025 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for January 2025. This month features long-awaited proposed and final rules regarding the Health Insurance Portability and Accountability...more

ArentFox Schiff

FDA Announces End to Semaglutide Shortage, Impacting Compounders and Telehealth Providers Offering Injectable GLP-1 Drugs

ArentFox Schiff on

Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more

Fox Rothschild LLP

End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

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On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more

Greenbaum, Rowe, Smith & Davis LLP

Criminalizing Reproductive Care and Abortion Services through Telehealth

The January 30, 2025 issue of the New England Journal of Medicine contains an article entitled “Providing Interstate Telehealth Abortion Services to Patients in Restrictive States.” In the second sentence, the authors write:...more

Polsinelli

Monday Morning (Advertising) Quarterback – Unprecedented Hims & Hers Super Bowl Ad Has Legislators Concerned

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The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Goodwin

DEA Announces a Third Extension of COVID-19 Telehealth Flexibilities for Prescription of Controlled Medications

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On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more

BakerHostetler

DSIR Deeper Dive: Tracking the Crackdown on Tracking/Pixel Technologies: Web Litigation and Regulatory Landscape - Part 1

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Regulatory action and class action lawsuits related to pixels and other website technologies continued to surge in 2023 and 2024, particularly in the healthcare industry....more

Health Care Compliance Association (HCCA)

[Event] Healthcare Enforcement Compliance Conference - November 18th - 20th, Arlington, VA

Is your compliance strategy aligned with current enforcement priorities? Hear first-hand from government enforcement leaders about regulatory changes, expectations, and key areas of concern. Gain insight into current...more

McDermott Will & Emery

Healthcare Regulatory Check-Up Newsletter | May 2024 Recap

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This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for May 2024. We discuss several notable cases and enforcement resolutions, including the US Court of Appeals for the District of...more

Mintz

EnforceMintz — Tele-Fraud Enforcement in 2023 Remained Focused on Same Schemes as Years Past

Mintz on

Government enforcement activities focused on tele-fraudsters remained active in 2023, but did not break substantial new ground. Several significant criminal resolutions last year involved allegations that were similar to each...more

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