News & Analysis as of

Department of Health and Human Services (HHS) Safe Harbors Healthcare Fraud

Bass, Berry & Sims PLC

OIG Approves Proposal that Expands Patient Access to Covered Telehealth Services

Bass, Berry & Sims PLC on

On June 11, the U.S. Department of Health and Human Services Office of Inspector General (OIG) published Advisory Opinion 25-03, approving a proposal by a management services organization (MSO) and its friendly PC...more

Baker Donelson

First Circuit Requires But-For Causation for FCA Liability Based on AKS Violations

Baker Donelson on

Key Takeaways - The First Circuit ruled in United States v. Regeneron Pharmaceuticals, Inc., that the government must prove but-for causation to establish False Claims Act (FCA) liability based on violations of 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

McGuireWoods LLP

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

McGuireWoods LLP on

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

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

Hogan Lovells on

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

Polsinelli on

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 A Recent False Claims Act Settlement Involving a Georgia Healthcare Company Is a Good Reminder of the...

Kilpatrick on

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

Dorsey & Whitney LLP

HHS Regulatory Sprint May Impact FCA Enforcement Trends

Dorsey & Whitney LLP on

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

Polsinelli

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

Polsinelli on

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

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

Ballard Spahr LLP on

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

ArentFox Schiff

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

ArentFox Schiff on

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

Nossaman LLP

What’s in Your Local Transportation Policy?

Nossaman LLP on

Those in the business of providing healthcare services to Medicare and Medicaid beneficiaries are all too familiar with the federal Anti-kickback Statute (AKS). Among other dreadful sanctions, it imposes criminal penalties on...more

Skadden, Arps, Slate, Meagher & Flom LLP

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Cooley LLP

Blog: HHS OIG Releases Annual Solicitation for New and Modified Anti-Kickback Safe Harbors and for New Special Fraud Alerts

Cooley LLP on

On December 29, 2014, the U.S. Department of Health and Human Services Office of Inspector General (OIG) released its annual solicitation (the “Solicitation”) for proposals and recommendations for developing new and modifying...more

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