News & Analysis as of

Safe Harbors Healthcare

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 & Emery

New MHPAEA Guidance Regarding NQTLs: Network Access and Composition

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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

Fenwick & West LLP

Compensating Physician Advisors with Equity: Considerations for Life Sciences Companies

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Life sciences companies often engage physicians as consultants and advisors to serve on scientific or clinical advisory boards, or to otherwise obtain their expertise relating to product-specific research and development,...more

Proskauer Rose LLP

Health Care - The Evolving Site of Service

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Over the past decade, health care has evolved both in how it is accessed and administered. Whereas care was once accessible only in hospitals and physician offices, today health care sites of service have shifted to include a...more

Nelson Mullins Riley & Scarborough LLP

Using the New Value-Based Rules to Enhance Your ACO

In November 2020, the Centers for Medicare & Medicaid Services (CMS) finalized value-based exceptions under the Stark law, and the Office of Inspector General (OIG) finalized value-based safe harbors under the Anti-Kickback...more

Stinson - Benefits Notes Blog

Agencies Issue Additional Guidance Regarding Over-the-Counter COVID-19 Test Coverage

As indicated in our January 11, 2022 blog post and alert, the Department of Labor, the Department of Health and Human Services, and the Treasury (the “Agencies”) issued FAQs Part 51 on January 10, 2022, requiring group health...more

Proskauer - Employee Benefits & Executive...

There’s More! Tri-Agencies Provide Clarifying Guidance on Group Health Plan Coverage of Over-the-Counter At-Home COVID-19 Tests

A few short weeks ago we told you in a blog post that, with only four days’ notice, the Departments of Labor, Treasury, and HHS (the Departments) required that, starting January 15, 2022, group health plans cover FDA-approved...more

Lowenstein Sandler LLP

Updated: A Survey of Health Care Anti-Kickback Law at the State Level

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The federal health care Anti-Kickback Statute (Federal AKS) targets bribery and corruption in the health care industry. There are two core provisions of the Federal AKS: one targeting the bribe recipient and one targeting the...more

Proskauer - Health Care Law Brief

OIG Publishes Favorable Advisory Opinion Related to the Employment Safe Harbor

In an advisory opinion posted November 10, 2021 (AO 21-15), the Office of the Inspector General of the United States Department of Health and Human Services (OIG) appeared to soften a disturbing position that it had taken in...more

PilieroMazza PLLC

Weekly Update Newsletter - November 2020 #3

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LITIGATION & DISPUTE RESOLUTION - Errors to Avoid when Moving State Litigation to Federal Court, November - Depending on the claims, parties, and preferences, there are multiple forums where litigants can choose to file...more

Dentons

Final Stark and Anti-Kickback Regulations Released Friday

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On November 20, 2020, the Centers for Medicare and Medicaid Services (CMS) released long-awaited final rules revising regulations implementing the Physician Self-Referral Law (known as “Stark”). Simultaneously, the Office of...more

Faegre Drinker Biddle & Reath LLP

The FCC Clarifies that Certain Communications to COVID-19 Patients Fall with TCPA’s “Emergency Purposes” Safe Harbor

In a Public Notice issued July 28, 2020, the FCC confirmed that the TCPA’s safe harbor for calls or text messages made for “emergency purposes” applies to calls and text messages made by or on behalf of health care entities...more

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