News & Analysis as of

Enforcement Actions Health Care Providers Pharmacies

Tucker Arensberg, P.C.

DOJ and HHS Launch New False Claims Act Working Group to Target Healthcare Fraud

Tucker Arensberg, P.C. on

The U.S. Department of Health and Human Services (HHS) and the Department of Justice (DOJ) have jointly announced the launch of a reinvigorated DOJ-HHS False Claims Act Working Group aimed at enhancing interagency...more

Cole Schotz

“First Do No Harm” Considerations for Healthcare Providers in Light of Historic Healthcare Fraud Enforcement Announcement by the...

Cole Schotz on

On Monday, the Department of Justice Criminal Division, led by Matthew R. Galeotti, announced its largest healthcare fraud enforcement charging individuals and entities across the globe in allegedly $14.6 billion criminal and...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

Dentons

Ep. 61 – Three Compliance Lessons from a False Claims Act Verdict

Dentons on

In a recent False Claims Act case, a long-term care pharmacy and consulting services provider was found liable for submitting false claims to the government, resulting in a jury verdict of over $135 million in damages. The...more

Paul Hastings LLP

Residency Match Programs for Healthcare Professionals Come Under Antitrust Scrutiny

Paul Hastings LLP on

In recent months, private class action lawsuits have challenged residency match programs for pharmacists and veterinarians under antitrust laws. In addition, a congressional subcommittee has begun an inquiry into the...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

McDermott Will & Schulte

Semaglutide Shortage Resolved

On February 21, 2025, the US Food and Drug Administration (FDA) revised its shortage categorization of semaglutide, a glucagon-like peptide 1 (GLP-1) medication, marking the shortage as “resolved” for all presentations of the...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

Fox Rothschild LLP on

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

McDermott Will & Schulte

This Week in 340B: January 28 – February 3, 2025

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: August 13 – 19, 2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

McDermott Will & Schulte

This Week in 340B: February 14 – 20, 2024

Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Napoli Shkolnik

The Opioid Crisis and Pharma Accountability: The Road So Far

Napoli Shkolnik on

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

McDermott Will & Schulte

Healthcare Regulatory Check-up Newsletter | October 2023 Recap

McDermott Will & Schulte on

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for October 2023. We discuss several enforcement actions that involve violations of the False Claims Act (FCA) and the...more

Oberheiden P.C.

The FDA’s Scrutiny of Novo Nordisk is Likely to Trigger Additional Semaglutide Investigations

Oberheiden P.C. on

Recently, the U.S. Food and Drug Administration (FDA) confirmed that it is investigating allegations that a 60 Minutes segment on the popular body weight loss drug Wegovy was actually an advertisement promoting the...more

WilmerHale

FTC Continues Enforcement Focus on the Use and Disclosure of Health Information for Advertising

WilmerHale on

On Thursday, March 2, the FTC announced an enforcement action against BetterHelp, Inc., an online mental health counseling service, relating to claims that the company’s collection and use of consumer health data were unfair...more

Womble Bond Dickinson

[Webinar] First Annual Health Care Fraud Symposium - March 14th, 12:00 pm - 1:30 pm ET

Womble Bond Dickinson on

Health Care fraud is a growing national issue. The National Heath Care Anti-Fraud Association estimates that health care fraud costs the nation about $68 billion annually — about 3 percent of the nation's $2.26 trillion in...more

Wyrick Robbins Yates & Ponton LLP

Not What the Doctor Ordered: GoodRx to Pay $1.5 Million in FTC’s First Enforcement of the Health Breach Notification Rule

The Federal Trade Commission earlier this month undertook an enforcement action against online pharmacy and telehealth provider GoodRx, in the latest example of the agency seriously pursuing its role as the nation’s de facto...more

WilmerHale

FTC Brings First of its Kind Enforcement Action against GoodRx for Violating the Health Breach Notification Rule

WilmerHale on

On February 1, 2023, the Federal Trade Commission (FTC) reached a settlement with digital health platform GoodRx for sharing users’ personal health information with third parties without properly disclosing their data...more

Mintz - Health Care Viewpoints

Health Care Enforcement Year In Review & 2022 Outlook

STATISTICAL TRENDS IN FALSE CLAIMS ACT LITIGATION - FCA case activity for 2021 reveals seemingly contrary trends. For the federal fiscal year (FY) that ended September 30, 2021, the DOJ annual report on FCA enforcement...more

Health Care Compliance Association (HCCA)

Hooper, Kearney and Macklin on Cutting Edge Topics in the False Claims Act

While the pandemic put many things on hold, it did not do the same for the False Claims Act (FCA). To find out what is happening in FCA activity we spoke with Patrick Hooper, Jordan Kearney and Alicia Macklin, partners at the...more

Baker Donelson

HHS Sends Enforcement Letters to Drug Manufacturers Regarding 340B Contract Pharmacies While Litigation Against HHS Continues

Baker Donelson on

On May 17, 2021, the Health Resources and Services Administration (HRSA) sent letters to six drug manufacturers notifying them that their actions placing restrictions on access to 340B-discounted drug prices by health care...more

Health Care Compliance Association (HCCA)

Report on Patient Privacy Volume 21, Number 1. Privacy Briefs: January 2021

Report on Patient Privacy 18, no. 1 (January 2021) - The HHS Office for Civil Rights (OCR) settled its 13th enforcement action in its Right of Access Initiative, first announced in 2019 to support individuals’ rights to...more

Foley Hoag LLP - Medicaid and the Law

The 340B Contract Pharmacy Saga Continues

Donald Trump extended two directives restricting the admission of certain immigrants and nonimmigrants to the U.S. Specifically, Presidential Proclamation (PP) 10014 restricting the admission of first-time immigrants and PP...more

Health Care Compliance Association (HCCA)

[Virtual Event] 2021 Managed Care Compliance Conference - February 1st - 3rd, 9:30 am - 3:45 pm CST

The first ever VIRTUAL Managed Care Compliance Conference will have the great speakers and content you have come to expect from the in-person event. Each year, we look forward to hosting compliance professionals at our...more

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