News & Analysis as of

Compliance Office of the Inspector General Healthcare Fraud

Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations. ... more +
Compliance programs typically refer to formalized institutional procedures within corporations and organizations to detect, prevent and respond to indvidual and widespread instances of regulatory violations.  In response to many corporate scandals evidencing rampant unethical business practices, many nations, including the United States, began passing strict regulatory frameworks aimed at curbing these abuses. Notable pieces of legislation in this area include the U.S. Foreign Corrupt Practices Act (FCPA), Sarbanes-Oxley (SOX), and the U.K. Bribery Act, to name a few. The foregoing statutes and the severe penalties often associated with them form the basis of many modern institutional compliance programs. less -
Epstein Becker & Green

Vendor Fees Flagged as Kickback Risk in HHS OIG Advisory Opinion

On July 7, 2025, the Office of Inspector General (“OIG”) for the Department of Health and Human Services published Advisory Opinion 25-08 (“AO 25-08”), an unfavorable and strongly worded opinion interpreting the “arranging...more

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

Dentons

Ep. 67 – Integrating Quality & Safety into Your Compliance Program (Replay of Ep. 18)

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If you’re trying to strengthen your organization’s compliance program, one of the most important recommendations from the Office of Inspector General’s (OIG) General Compliance Program Guidance is to integrate quality and...more

DLA Piper

OIG Issues Favorable Advisory Opinion on Telehealth Marketplace MSO-PC Arrangement

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The Department of Health and Human Services, Office of Inspector General (OIG) recently issued a favorable advisory opinion under the federal Anti-Kickback Statute (AKS), wading into the world of not only telehealth but also...more

King & Spalding

OIG Releases Audit of Medicare Payments for Evaluation Management Services Billed on the Same Day as Eye Injections

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On May 27, 2025, HHS Office of Inspector General (OIG) issued a report outlining its finding that Medicare payments for evaluation management (E&M) services provided on the same day as eye injections were at risk for...more

Dentons

Ep. 64 – Three Communication Strategies to Reduce Whistleblower Risk

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In today’s complex healthcare landscape, whistleblower claims are a major source of regulatory and legal risk for organizations. Last year saw a record number of “qui tam” claims filed under the False Claims Act. While...more

Gardner Law

Can Companies Fund Diagnostic Testing for Conditions Their Product Treats?

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Many FDA-regulated companies are exploring ways to support diagnostic testing, especially when early diagnosis can impact treatment options. However, funding diagnostic testing tied to a company’s own product raises important...more

Mintz - Health Care Viewpoints

OIG Issues Another Favorable Advisory Opinion on Patient Recruitment Efforts by Community Health Centers

The Office of Inspector General for the Department of Health and Human Services (OIG) recently issued a favorable Advisory Opinion on a proposed arrangement by a community health center (Health Center) designated under...more

Husch Blackwell LLP

Navigating Compliance Risks in Laboratory Operations—Key Lessons from a Recent FCA Case

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A recent False Claims Act (FCA) litigation—Jensen ex rel. United States of America v. Genesis Laboratory—highlights critical compliance risks for laboratories. This case reinforces the need for laboratories to ensure...more

Bass, Berry & Sims PLC

[Webinar] Healthcare Regulatory & Compliance Summit - May 1st - 2nd, 9:00 am - 12:45 pm CT

Please join us for the inaugural Healthcare Regulatory & Compliance Summit, hosted by Bass, Berry & Sims. The in-person event will take place in our Nashville office on Thursday, April 24 from 8:30 a.m. to 5:30 p.m. CT. The...more

Bass, Berry & Sims PLC

[Event] Healthcare Regulatory & Compliance Summit - April 24th, Nashville, TN

Please join us for the inaugural Healthcare Regulatory & Compliance Summit, hosted by Bass, Berry & Sims. The in-person event will take place in our Nashville office on Thursday, April 24 from 8:30 a.m. to 5:30 p.m. CT. The...more

McDermott Will & Schulte

OIG Nursing Facility Compliance Program Guidance: Renewed Focus on Fraud and Abuse

The US Department of Health and Human Services Office of Inspector General’s (OIG’s) release of Nursing Facility Industry Segment-Specific Compliance Program Guidance (ICPG) for the first time since 2008 reemphasizes the...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

Whiteford

Ambulatory Surgery Center Trends in Regulation, Compliance, and Enforcement

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Ambulatory Surgery Centers (ASCs) are experiencing significant shifts in regulation, reimbursement, and operational practices. These changes are driven by evolving healthcare policies, technological advancements, and the...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

Rivkin Radler LLP

NYS OMIG Publishes 2025 Work Plan

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On January 29, the New York State Office of the Medicaid Inspector General (OMIG) published its 2025 Work Plan, which provides a preview of the OMIG’s program integrity initiatives for the upcoming year. While this post...more

Bass, Berry & Sims PLC

HHS-OIG Year in Review 2024

In 2024, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) provided useful insights to the healthcare industry regarding how it approaches various fraud and abuse issues in an...more

King & Spalding

OIG Issues Favorable Opinion Regarding a Program to Provide Patients with Free Access to a Pharmaceutical Product

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On January 10, 2025, OIG posted a favorable advisory opinion approving a proposed program (Program) to provide patients who meet certain financial need criteria with free access to a pharmaceutical product that has limited...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

Arnall Golden Gregory LLP

OIG Approves Pharmaceutical Manufacturer’s Proposed Free Genetic Testing

The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-12 (the “Opinion”) to a pharmaceutical manufacturer (the...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

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

Baker Donelson

Enhancing Compliance in Nursing Facilities: OIG's New Guidance

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The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued new Nursing Facility Industry Segment-Specific Compliance Program Guidance (Nursing Facility ICPG) for nursing facilities...more

Venable LLP

Event in Review: Major Fraud and Abuse Laws: Anti-Kickback and Self-Referral Prohibitions and False Claims

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Investment in the healthcare industry requires careful consideration, as it involves numerous distinct areas of the law. Venable's Private Equity Investment in Healthcare webinar series explores the unique issues and timely...more

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