News & Analysis as of

Office of the Inspector General False Claims Act (FCA) Safe Harbors

American Conference Institute (ACI)

[Event] FCPA & Anti-Corruption for the Life Sciences Industry - May 9th - 10th, New York, NY

Hosted by the American Conference Institute, the 19th Annual FCPA & Anti-Corruption Conference for the Life Sciences Industry returns for another exciting year with carefully researched programming based on critical findings...more

King & Spalding

OIG Issues Favorable Advisory Opinion Concluding Bonuses to Employed Physicians Are Not Kickbacks

King & Spalding on

Earlier this month, OIG issued Advisory Opinion 23-07, a favorable opinion regarding an employer’s proposal to pay bonuses to its employed physicians based on net profits derived from certain procedures performed by the...more

Morgan Lewis - Health Law Scan

July Fast Break Recap: Fourth Circuit AKS Case Enforcement Analysis

We hope you were able to join us for our July Fast Break on the US Court of Appeals for the Fourth Circuit's recently affirmed $114 million judgment in United States v. Mallory. If not, you missed a great session, featuring...more

Proskauer - Health Care Law Brief

Developments Regarding Commission-Based Compensation Arrangements with Independent Contractors

A recent Fourth Circuit decision, United States v. Mallory (988 F.3d 730), upheld damages and penalties for more than $100 million for violations of the Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)) (the “AKS”) and the...more

Morgan Lewis

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

Morgan Lewis on

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

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

Dorsey & Whitney LLP

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

Dorsey & Whitney LLP on

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

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

Akin Gump Strauss Hauer & Feld LLP

Life Sciences Due Diligence: A Reference Guide for Your Life Sciences Corporate Transactions

• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny. • Conducting effective legal and regulatory due diligence can mean uncovering risks...more

Troutman Pepper

HHS Proposes 'Sweeping' Changes to Pharmacy Drug Pricing

Troutman Pepper on

The pharmacy benefit manager (PBM) industry recently has come under significant scrutiny by the Trump administration....more

Holland & Knight LLP

Healthcare Law Update: December 2018

Holland & Knight LLP on

Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

Foley & Lardner LLP

Some Helpful Managed Care Guidance Provided in Advisory Opinion 18-11

Foley & Lardner LLP on

Practitioners in the Medicare or Medicaid managed care space place heavy reliance on the protection of the Anti-Kickback Statute (AKS) Safe Harbor found at 42 C.F.R. § 1001.952(t), generally known as the “EMCO [eligible...more

Holland & Knight LLP

Healthcare Law Update: September 2018

Holland & Knight LLP on

Regulation - CMS Contemplating Telemedicine Changes - The Centers for Medicare & Medicaid Services (CMS) recently published what it described as a "major proposed rule" that covers a number of topics that could have...more

Bradley Arant Boult Cummings LLP

DOJ Memoranda Signal Tempered Approach to FCA Cases But Are These New Constraints Changing the Tone? - AHLA PG Bulletin

Since early 2018, federal health care regulators and enforcers have seemingly sung a new tune. The Centers for Medicare & Medicaid Services’ (CMS’) walls bear posters inscribed with the phrase “Patients Over Paperwork.” The...more

Mintz - Health Care Viewpoints

Pharmaceutical Manufacturers and Healthcare Leaders cite Fraud and Abuse Laws as Obstacle to Value-Based Arrangements

As the healthcare industry moves towards value-based purchasing, pay-for-performance, and other payment reform models, industry leaders have identified federal fraud and abuse laws as a barrier to full implementation of such...more

McDermott Will & Emery

New OIG Exclusion Regulations About to Go into Effect

The Office of Inspector General (OIG) recently published a final rule regarding its exclusion authorities. The final rule goes into effect March 21, 2017, and expands OIG’s authority to exclude certain individuals and...more

Hogan Lovells

HHS OIG Finalizes New Exclusion Rules as Administration Exits

Hogan Lovells on

With just a week left before a new administration takes office, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) finalized changes to the regulations authorizing OIG to exclude...more

Mintz - Health Care Viewpoints

At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback...more

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