News & Analysis as of

Safe Harbors Healthcare Fraud

Mintz

DOJ’s Criminal Division Announces Pilot Program on Voluntary Self-Disclosure for Individuals

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Drawing on a carrot and stick approach, Department of Justice (“DOJ” or the “Department”) guidance in 2023 focused heavily on incentivizing companies to voluntarily self-disclose their misconduct. This guidance included the...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

Womble Bond Dickinson

Current Trends and Real-World Best Practices in Healthcare Fraud Compliance

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Recently, Womble Bond Dickinson held its First Annual Health Care Fraud Symposium, a webinar designed to discuss critical healthcare fraud topics. WBD Partner Joe Whitley moderated a discussion with WBD attorneys Luke Cass,...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

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

McGuireWoods LLP

Fraud and Abuse Rules Part IV: Final Changes to Existing and New Anti-Kickback Statute Safe Harbors

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As discussed in a prior McGuireWoods alert, the U.S. Department of Health and Human Services (HHS) published final rules that significantly amend the Physician Self-Referral Law (Stark Law), the federal Anti-Kickback Statute...more

Morgan Lewis

Recent Anti-Kickback Safe Harbor Revisions: What Hospices Should Know

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The US Department of Health and Human Services Office of Inspector General (OIG) recently issued important updates to its Anti-Kickback Statute (AKS) safe harbor rules that provide additional legal protections and...more

Robinson+Cole Health Law Diagnosis

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations

HHS Publishes Significant Updates to Anti-Kickback Statute Safe-Harbors and Beneficiary Inducement CMP Regulations - On November 30 and December 2, 2020, the Department of Health and Human Services Office of Inspector...more

Morgan Lewis - Health Law Scan

HHS Regulatory Sprint Crosses the Finish Line: New Stark and Anti-Kickback Rules Forecast Big Changes for Patients and Value-Based...

Powerfully illustrating the efforts of the US Department of Health and Human Services (HHS) to transform the US healthcare system to a value-based model, the Office of the Inspector General (OIG) and the Centers for Medicare...more

Hogan Lovells

Trump Administration revives rebate safe harbor rule in late effort to reform drug pricing

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On November 20, 2020, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized its previously abandoned 2019 proposal to exclude certain rebates paid by drug manufacturers from the...more

Polsinelli

HHS and CMS Finalize Historic Changes to Medicare Fraud and Abuse Laws

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On November 20, 2020, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), and the Centers for Medicare and Medicaid Services (CMS) finalized three rules making historic changes to three of...more

Kilpatrick

No Harbor is Limitless: Restrictions of the Federal Anti-Kickback Statute's Safe Harbor Provisions

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The DOJ recently reached a $122 million settlement with Universal Health Services (“UHS”) and Turning Point Care Center, LLC (“Turning Point”) to resolve allegations of False Claims Act violations related to their billing...more

Kilpatrick

No Harbor is Limitless A Recent False Claims Act Settlement Involving a Georgia Healthcare Company Is a Good Reminder of the...

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The DOJ recently reached a $122 million settlement with Universal Health Services (“UHS”) and Turning Point Care Center, LLC (“Turning Point”) to resolve allegations of False Claims Act violations related to their billing...more

Manatt, Phelps & Phillips, LLP

[Webinar] Re-Mapping the Fraud and Abuse Landscape: Understanding Proposed Reforms - February 13th, 1:00 pm ET

What larger healthcare goals are fueling the proposed revisions to AKS and Stark? What safe harbors and exceptions are introduced in the proposed rules? And what would the potentially transformational changes mean for...more

Dorsey & Whitney LLP

Naughty or Nice: Feds Hand Out More Than Lumps of Coal When it Comes to Healthcare Fraud

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The United States government has an arsenal of agencies and civil and criminal statutes at its disposal to choose from in investigating and combatting healthcare fraud.  A recent federal indictment discussed below exemplifies...more

Dorsey & Whitney LLP

HHS Regulatory Sprint May Impact FCA Enforcement Trends

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The False Claims Act (“FCA”) is an ever-present concern among health care providers and counsel, which is why it is no surprise that the Department of Health and Human Services’ (HHS) recent “Regulatory Sprint to Coordinated...more

Bricker Graydon LLP

OIG proposes changes to existing Anti-Kickback Statute safe harbors

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On October 9, 2019, the Office of Inspector General (OIG) released proposed changes interpreting the federal Anti-Kickback Statute (AKS) and its regulatory safe harbors, including changes to several existing safe harbors. ...more

Polsinelli

Assessing the Stark and Anti-Kickback Proposals for Value-Based Arrangements

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Through two separate notices of proposed rule-making (NPRMs), the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG), seek to remove...more

Bricker Graydon LLP

CMS and OIG propose changes to existing rules for donations of electronic health records and new rules for donations of...

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On October 9, 2019, the Office of Inspector General (OIG) released proposed changes to the regulations interpreting the federal Anti-Kickback Statute (AKS). On the same day, the Centers for Medicare and Medicaid Services...more

Foley & Lardner LLP

Telemedicine and Digital Health Companies Will Benefit from Newly-Proposed Fraud and Abuse Waivers

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The OIG recently released proposed revisions to the Anti-Kickback Statute (AKS) and Civil Monetary Penalties (CMP) Law. Several of these changes, if finalized, will directly benefit companies offering telemedicine and digital...more

Robinson+Cole Health Law Diagnosis

HHS Proposes Changes to Permit Donation of Cybersecurity Technology

On October 17, 2019, the Department of Health and Human Services (HHS) published proposed rules to update the regulatory Anti-Kickback Statute (AKS) safe-harbors and exceptions to the Physician Self-Referral (PSR) Law, known...more

Ballard Spahr LLP

CMS and OIG Release Long-Awaited Stark Law and Anti-Kickback Statute Proposed Rules

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The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) and the Centers for Medicare & Medicaid Services (CMS) recently released two proposed rules restructuring the Physician Self-Referral...more

Dorsey & Whitney LLP

A Massive Number of New Health Law Regulatory Proposals as Part of the “Regulatory Sprint to Coordinated Care”: Proposed Changes...

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Today, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services (HHS) Office of Inspector General (OIG) each released their long-anticipated proposed rules to revise the federal...more

ArentFox Schiff

Investigations Newsletter: Doctors and Alabama Cardiac Center to Pay $1.1 Million to Resolve Kickback Allegations

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Doctors and Alabama Cardiac Center to Pay $1.1 Million to Resolve Kickback Allegations - On August 27, the US Attorney’s Office for the Western District of Washington announced a $1.1 million settlement with three...more

Bass, Berry & Sims PLC

The Philosophy for Investing in Urology: 5 Key Regulatory Risks

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In the wave of physician practice management transactions, urology is poised to be one of the next hot sectors. In addition to the issues to consider in connection with any physician practice transaction, below we discuss...more

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