News & Analysis as of

Healthcare Safe Harbors

Robins Kaplan LLP

Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC

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Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 2025 WL 1298920 (Fed. Cir. May 6, 2025) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from...more

McDermott Will & Schulte

A win for telehealth providers, health plans, and participants: HDHP telehealth safe harbor permanently reinstated

On July 4, 2025, the president signed the One Big Beautiful Bill Act (H.R. 1) into law. Among many other healthcare provisions, the bill permanently extends the telehealth safe harbor for high-deductible health plans (HDHPs)...more

Venable LLP

OIG Reminds Us that Flat Fee Business Arrangements Aren’t Immune from AKS Scrutiny

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On July 1, 2025, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services issued Advisory Opinion No. 25-08, concluding that a medical device manufacturer’s proposed payment to access a...more

Hinshaw & Culbertson - Health Care

OIG Advisory Opinion 25-03: Navigating Anti-Kickback Rules and Safe Harbors in Telehealth Contractual Arrangements

On June 6, 2025, the Office of Inspector General (OIG) issued Advisory Opinion 25-03 (the “Opinion”), offering guidance for structuring telehealth collaborations in a manner that complies with the federal Anti-Kickback...more

Robinson+Cole Health Law Diagnosis

OIG Green Lights MSO Model Arrangement for Telehealth Platforms in New Advisory Opinion

On June 11, 2025, the Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03 (the Advisory Opinion), in which OIG approved of a proposed arrangement under which a management...more

Perkins Coie

New Utah AI Laws Change Disclosure Requirements and Identity Protections, Target Mental Health Chatbots

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Key Takeaways - - Utah has introduced five new bills that further shape its existing Artificial Intelligence Policy Act and add new requirements. - Both the scope of disclosure requirements surrounding the use of AI...more

Vorys, Sater, Seymour and Pease LLP

Telehealth Services Safe Harbor for High Deductible Health Plans Expires December 31, 2024

On December 21, 2024, President Biden signed into law the American Relief Act, 2025 (2025 Relief Act), which funds the federal government through March 14, 2025, and provides certain disaster relief provisions and other...more

Gardner Law

Honesty is the Best Policy: Navigating the DOJ’s M&A Safe Harbor

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The recent announcement of the Department of Justice’s (DOJ) M&A Safe Harbor policy has significant implications for companies involved in mergers and acquisitions (M&A) within the healthcare industry. This new policy...more

Stevens & Lee

DOJ and FTC Withdraw Guidelines for Collaborations Among Competitors

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The Justice Department’s Antitrust Division and the Federal Trade Commission (Agencies) announced on Dec. 11, 2024, that they have withdrawn the Antitrust Guidelines for Collaborations Among Competitors (Guidelines) issued in...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - October 2024

Ninth Circuit Affirms Dismissal of Insider Trading Claims Against Satellite Operator Investors Based on Stock Sales After FCC Chairman Vote - In re Silver Lake Grp., LLC Sec. Litig. (9th Cir. July 24, 2024) What to...more

Akerman LLP - Health Law Rx

New Safe Harbor and General Compliance Program Guidance Provides Opportunity for Buyers to Mitigate Litigation and Fraud Risk

By maintaining a robust compliance program, healthcare companies are better able to identify potential red flags early and to prevent violations of fraud and abuse laws. A failure to maintain an effective compliance program...more

Bradley Arant Boult Cummings LLP

Florida Bill Proposes Safe Harbor Against Breach Suits to Businesses Maintaining Recognized Cybersecurity Programs

A recently introduced bill in the Florida Legislature would provide businesses operating in Florida, including health care providers, with a legal defense to data breach lawsuits if they maintain robust cybersecurity measures...more

Bass, Berry & Sims PLC

2024 Healthcare Private Equity Outlook & Trends

W ith various headwinds resulting in down volume in 2023, buyers and sellers alike find themselves asking whether 2024 will see a rebound in deal activity. As we begin 2024, we have highlighted the issues and trends that...more

Bass, Berry & Sims PLC

OIG Approves Paying Employed Physicians Profits from ASCs Operated by Employer

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On October 13, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-07, approving a physician practice’s proposal to pay its physician-employees a portion of the...more

Seyfarth Shaw LLP

Mental Health Request for Public Comment Spoiler Alert – The Departments Need Help

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Seyfarth Synopsis: The Mental Health Parity and Addiction Equity Act (MHPAEA) requires group health plans and insurers to cover treatments for mental health and substance use disorders in a manner that is equitable to the...more

McDermott Will & Schulte

New MHPAEA Guidance Regarding NQTLs: Network Access and Composition

Recently proposed regulations attempt to ensure that health plans allow access to mental health or substance use disorder (MH/SUD) benefits as easily as medical or surgical (M/S) benefits. The proposed regulations, issued by...more

Health Care Compliance Association (HCCA)

Defensibility of a fair market value analysis

Fair market value (FMV) is a pinnacle issue with respect to healthcare regulatory compliance and compensation agreements. This article will analyze the issues related to an FMV defensibility analysis of compensation...more

Hogan Lovells

FTC joins DOJ in rescinding health care antitrust policies

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On July 14, 2023 the Federal Trade Commission (FTC) announced that it is withdrawing two antitrust policy statements related to antitrust enforcement in health care markets (the policy statements). Specifically, the FTC is...more

Jones Day

HHS-OIG Issues FAQ Guidance Related to Pharmacy Benefit Manager Arrangements

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The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more

Faegre Drinker Biddle & Reath LLP

NAIC Privacy Protections Working Group Meets to Discuss New Model Privacy Law

On June 5-6, 2023, the NAIC Privacy Protections (H) Working Group (“PPWG”) held an in-person interim meeting (“session”) to continue its work on drafting a new model privacy law, the Insurance Consumer Privacy Protection...more

ArentFox Schiff

Physician Wellness Programs: A New Stark Law Exception and AKS Safe Harbor to Combat Burnout

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The recently passed Consolidated Appropriations Act (CAA) of 2023 includes a new Stark Law exception and Anti-Kickback Statute (AKS) safe harbor, allowing hospitals and other health care entities to offer their physicians...more

Foley & Lardner LLP

DOJ Withdraws Policy Statements That Defined Limited Safe Harbor for Information Sharing Among Competitors

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On February 3, 2023, the U.S. Department of Justice’s Antitrust Division (DOJ) announced that it is withdrawing three policy statements the DOJ and Federal Trade Commission (FTC) issued between 1993 and 2011, related to...more

Morrison & Foerster LLP

DOJ Signals Intent to Increase Antitrust Scrutiny of Information Sharing

On February 2, 2023, the Principal Deputy Assistant Attorney General for the U.S. Department of Justice’s (DOJ) Antitrust Division, Doha Mekki, announced that the DOJ was withdrawing three policy statements outlining safe...more

Nelson Mullins Riley & Scarborough LLP

The Impact of the Decision in U.S. v. Holland on the One Purpose Test

The Court’s decision in U.S. v. Holland highlights the apparent contradiction between the judicially created and often relied upon “one purpose test” involving criminal and civil enforcement actions under the Federal...more

Nelson Mullins Riley & Scarborough LLP

Decision in U.S. v. Holland

The Court’s decision in U.S. v. Holland highlighted the apparent contradiction between the often relied upon “one purpose test” involving criminal and civil enforcement actions under the Federal Anti-Kickback Statute by...more

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