News & Analysis as of

Enforcement Actions Office of the Inspector General Compliance

Skadden, Arps, Slate, Meagher & Flom LLP

OIG Issues Unfavorable Advisory Opinion: Provision of Free Services to Referral Sources Creates Kickback Risk

Key Points - - The Office of Inspector General of the Department of Health and Human Services (OIG) has issued Advisory Opinion No. 25-04 (AO 25-04), its first advisory opinion of the year addressing a proposed arrangement...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Arnall Golden Gregory LLP

Challenges in Enforcing Mental Health Parity: EBSA’s Struggle to Ensure Compliance

A recent audit conducted by the U.S. Department of Labor’s Office of Inspector General (“OIG”) has uncovered significant challenges encountered by the Employee Benefits Security Administration (“EBSA”) in ensuring compliance...more

Paul Hastings LLP

OIG Issues Favorable Opinion on Pharmaceutical Manufacturer’s Free Product Program

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In its first advisory opinion of the year, the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) assessed a pharmaceutical manufacturer’s free product program and found that, although the...more

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

Dentons on

Many healthcare organizations understand the importance of having a Compliance Committee but some struggle to use their committee effectively. The key to ensuring the Compliance Committee is effective is building smart...more

Patterson Belknap Webb & Tyler LLP

The Fourth Circuit Broadly Interprets “Inducement” and “Remuneration” Under the Anti-Kickback Statute and Creates a Circuit Split

On January 23, 2025, in Pharmaceutical Coalition for Patient Access v. United States, the Fourth Circuit held that a proposed patient assistance program, which would help cancer patients afford certain oncology drugs, would...more

Health Care Compliance Association (HCCA)

Delayed Action on Misconduct Costs Firm $4M; FCA Whistleblower Flagged Earlier Application

Scientist and pharmaceutical researcher Andrew P. Mallon—who first reported to NIH and others in 2016 his suspicions that then-Athira Pharma CEO Leen Kawas falsified data in published papers—filed the whistleblower suit...more

Hendershot Cowart P.C.

Texas Healthcare Providers Paid $21.3 Million to Resolve Stark Law Violations in 2024

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Healthcare fraud enforcement continues to be a top priority for federal authorities, with Stark Law violations remaining under particular scrutiny. The complex nature of physician self-referral regulations, combined with...more

Mintz - Health Care Viewpoints

EnforceMintz — Additional Health Care Provider Joins the OIG’s “Heightened Scrutiny” List in 2024

The HHS Office of Inspector General (OIG), in connection with its enforcement responsibilities, must exclude a party from the federal health care programs if the party is found to have violated certain federal laws. This type...more

Mintz - Health Care Viewpoints

EnforceMintz — FCA Enforcement in Value-Based Care Arrangements Heated Up in 2024 and Likely to Remain a Priority in 2025

Value-based care (VBC) is a health care delivery model that has grown increasingly common in recent years. Perhaps unsurprisingly, this growth seems to have attracted the attention of government enforcement agencies...more

Mintz - Health Care Viewpoints

EnforceMintz — Medicare Advantage and Part D Programs to Remain in the Enforcement Spotlight in 2025

As government scrutiny and enforcement targeting the Medicare Advantage (Medicare Part C) program continued in 2024, the industry’s response to agency actions escalated. Last year also resulted in the first sizable Part D...more

Husch Blackwell LLP

Forget the False Claims Act—How a Virginia Hospital Got Criminally Charged

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On January 8, 2025, a federal grand jury in Virginia returned an indictment against a hospital. This rare criminal event in healthcare alleges that Chesapeake Regional Medical Center conspired to defraud the United States and...more

Proskauer - Health Care Law Brief

OIG Releases Special Fraud Alert About Suspect Payments in Marketing Arrangements Related to Medicare Advantage and Providers

On December 11, 2024, the Office of Inspector General for the U.S. Department of Health and Human Services (“OIG”) issued a special fraud alert warning about certain marketing schemes that involve questionable payments and...more

Health Care Compliance Association (HCCA)

In This Month’s E-News: November 2024

On the heels of a $7.6 million payment by Cleveland Clinic to settle allegations of False Claims Act (FCA) violations and unallowable sharing of passwords, Michael Lauer, NIH deputy director for extramural research, penned a...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - October 11th, Denver, CO

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Enforcement Compliance Conference - November 18th - 20th, Arlington, VA

Is your compliance strategy aligned with current enforcement priorities? Hear first-hand from government enforcement leaders about regulatory changes, expectations, and key areas of concern. Gain insight into current...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - May 9th - 10th, San Juan, Puerto Rico

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education on a wide variety of current and emerging topics...more

Health Care Compliance Association (HCCA)

In Biggest Stark-Based FCA Settlement Ever, Indiana Hospital Pays $345M, Has Unusual CIA

Community Health Network (CHN) in Indiana has agreed to pay $345 million to settle false claims allegations that it paid over-the-top salaries to hundreds of physicians and rewarded them for their referrals in violation of...more

Mintz

EnforceMintz — DOJ and OIG Guidance Emphasizes the Importance of a Robust and Dynamic Compliance Program

Mintz on

2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice (DOJ) issued significant compliance...more

Foley & Lardner LLP

“Let’s Talk Compliance”: OIG’s General Compliance Program Guidance: How to Refresh Compliance Programs

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Editor’s Note: PYA and Foley & Lardner hosted the 6th Annual “Let’s Talk Compliance” two-day Virtual Conference on January 18 and 19, 2024. Panelists included Foley & Lardner attorneys and PYA experts. The event was hosted by...more

Health Care Compliance Association (HCCA)

Hospital Settles CMP Case Over Free APPs; 'Bona Fide' Use Shouldn't Inspire Fear, Lawyer Says

In a case that may hit a raw compliance nerve, Ascension Macomb Oakland Hospital in Michigan has agreed to pay $100,000 in a settlement with the HHS Office of Inspector General (OIG) over free services provided to certain...more

Sheppard Mullin Richter & Hampton LLP

OIG General Compliance Program Guidance November 2023

In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its...more

Harris Beach Murtha PLLC

HHS Office of Inspector General October 2023 Enforcement Activity

The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - September 15th, Minneapolis, MN

Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education that covers a wide variety of current and emerging...more

Harris Beach Murtha PLLC

HHS Office of Inspector General July 2023 Enforcement Activity

Harris Beach invites you to register for its 7 Element compliance program series addressing New York’s 2020 and 2022 updates to Medicaid Compliance Program requirements. Starting on August 16th, each live program will be no...more

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