News & Analysis as of

Health Care Providers Marketing

Pietragallo Gordon Alfano Bosick & Raspanti,...

Rare Circuit Court Decision on Eliminating Kickbacks in Recovery Act Demands Notice In and Beyond Addiction Treatment Industry

The Ninth Circuit recently decided United States v. Schena, 142 F.4th 1217 (9th Cir. 2025), which considered the Eliminating Kickbacks in Recovery Act (“EKRA”). EKRA, enacted in 2018 to address “body brokering” and other...more

Pietragallo Gordon Alfano Bosick & Raspanti,...

New Jersey Enacts Key Legislation Addressing Kickbacks and Deceptive Marketing Practices in the Substance Use Disorder Treatment...

On August 11, 2025, New Jersey’s Acting Governor, Tahesha Way, signed into law two bills to combat patient brokering and deceptive marketing practices in the Substance Use Disorder (“SUD”) treatment industry. The legislation,...more

Baker Donelson

EKRA's Application to Marketing Arrangements: Laboratories and Other Providers

Baker Donelson on

The Ninth Circuit recently affirmed two decisions that provide additional guidance regarding how arrangements with marketing agents implicate and violate the Eliminating Kickbacks in Recovery Act, 18 U.S.C. § 220(a)(EKRA)....more

Sheppard Mullin Richter & Hampton LLP

Inside the Ninth Circuit’s Interpretation of EKRA: Clarity for Kickback Law

On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more

Gardner Law

FDA’s Latest Untitled Letter: An Enforcement Tell?

Gardner Law on

FDA’s Office of Prescription Drug Promotion (OPDP) is active throughout each year issuing letters challenging promotional labeling they deem noncompliant. Any communication from FDA regarding a promotional claim they disagree...more

Loeb & Loeb LLP

In Our "Wellness Retreat" Era. But First, the Paperwork.

Loeb & Loeb LLP on

These days, the explosive growth of the wellness industry—fueled by increased consumer interest in healthy lifestyle choices—presents a prime opportunity for brands to showcase their offerings through “wellness retreats” with...more

Arnall Golden Gregory LLP

Limitations to the Anti-Kickback Statute? Seventh Circuit Reverses Conviction Finding “Aggressive” Marketing Tactics Insufficient...

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit reversed the conviction of the owner of a durable medical equipment (“DME”) distributor, ruling that there was insufficient evidence to support a...more

Epstein Becker & Green

New Seventh Circuit Decision Signals Greater Flexibility for Healthcare Marketing Services

Epstein Becker & Green on

On April 14, 2025, the United States Court of Appeals for the Seventh Circuit issued a decision in a case involving the federal Anti-Kickback Statute (“AKS”) and marketing services that the court framed as an appeal...more

Troutman Pepper Locke

Arizona AG Takes Action Against Company for Alleged Deceptive Marketing Practices

Troutman Pepper Locke on

Last month, Arizona Attorney General (AG) Kris Mayes announced a lawsuit alleging that CBR Systems, Inc. (CBR), one of the nation’s largest cord blood banking companies, engaged in deceptive and unfair practices....more

Sheppard Mullin Richter & Hampton LLP

Reminder: FDA Does, In Fact, Review DOF

When was the last time you thought about “data on file” (“DOF”)? Probably not recently, but last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted an untitled letter (the...more

Sheppard Mullin Richter & Hampton LLP

Finally, FDA’s Final Word on Unapproved Use Communications

On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of...more

Hendershot Cowart P.C.

Major Changes to Texas Medical Board Rules: What Healthcare Providers Need to Know

Hendershot Cowart P.C. on

On January 9, 2025, the Texas Medical Board (TMB) implemented comprehensive changes to its rules, marking a significant shift in how medical spas, IV hydration clinics, and other healthcare facilities operate in Texas....more

Hogan Lovells

FDA Finalizes Guidance for Communications About Unapproved Uses to HCPs, Clarifying Multiple Standards

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) has published final guidance on “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products” (SIUU...more

Ropes & Gray LLP

FDA Finalizes Guidance on Communication of Scientific Information on Unapproved Uses and Releases Updated First Amendment Analysis

Ropes & Gray LLP on

On January 7, 2025, FDA published a final guidance entitled Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products - Questions and Answers...more

King & Spalding

FDA Finalizes Guidance on Scientific Information on Unapproved Uses (SIUU)

King & Spalding on

Final Guidance Further Expands Scope of Permissible Proactive Off-Label Communications - On January 6, 2025, FDA finalized its guidance entitled Communications From Firms to Health Care Providers Regarding Scientific...more

Hinshaw & Culbertson - Health Care

Healthcare Providers, Agents, and Brokers: Please Stop, Look, and Listen Before Entering Into Suspect Medicare Advantage Plan...

The Office of Inspector General (OIG) of the U.S. Department of Health & Human Services (HHS) issues Special Fraud Alerts regarding healthcare fraud and abuse patterns or practices it has recently identified and intends to...more

Akerman LLP - Health Law Rx

Don’t Be Suspicious, Don’t Be Suspicious: New OIG Special Fraud Alert Warns About Suspect Payments in Medicare Advantage Marketing...

The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage...more

Stevens & Lee

Special Fraud Alert: Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

Stevens & Lee on

On Dec. 11, 2024, the OIG issued a Special Fraud Alert (Alert) related to certain fraud and abuse risks associated with marketing arrangements between Medicare Advantage Organizations (MAOs) and health care professionals...more

Quarles & Brady LLP

Legal Marketing Tactics or an Illegal Kickback Scheme? The Seventh Circuit’s Impending Decision on the Expansiveness of the...

Quarles & Brady LLP on

On December 4, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in USA v. Mark Sorensen, case number 24-1557, and it is now taking under advisement a case that could have widespread effects as to what...more

Fox Rothschild LLP

OIG Publishes Special Fraud Alert on Medicare Advantage Marketing Arrangements

Fox Rothschild LLP on

On December 11, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) published a Special Fraud Alert warning against suspect payment arrangements involving the Medicare Advantage (“MA”) program...more

Proskauer - Health Care Law Brief

OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more

Holland & Knight LLP

Novel Settlement Reached in Generative AI Deceptive Trade Practices Healthcare Investigation

Holland & Knight LLP on

The state of Texas, by and through its Attorney General Ken Paxton, reached a first-of-its-kind settlement agreement with Pieces Technologies Inc. (Pieces) following an investigation into Pieces' alleged violations of the...more

BCLP

Federal Court Rejects Motion to Dismiss Wiretap Claims Using HIPAA to Support Crime-Tort Exception Allegations

BCLP on

It has now become commonplace for Plaintiffs’ attorneys to bring claims alleging that routine marketing techniques, including the deployment of behavioral advertising cookies and pixels, constitute wiretaps in violation of...more

Mintz - Health Care Viewpoints

The OIG Issues New FAQs on Financial Assistance Policies and Marketing to Patients

On July 8, 2024, the Office of Inspector General (OIG) updated its General Questions on Fraud and Abuse Authorities (FAQs) related to the Anti-Kickback Statute (AKS) and the Beneficiary Inducement Prohibition of Civil...more

Davis Wright Tremaine LLP

March 2024 UDAAP Bulletin

Editor's Note The following document provides a monthly roundup summarizing enforcement actions, guidance, rulemakings, and other public statements from the Consumer Financial Protection Bureau, the Federal Trade Commission,...more

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