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Office of the Inspector General Risk Management

ArentFox Schiff

Navigating OIG’s Advisory Opinion on Medical Device Billing Arrangements and Anti-Kickback Statute Risks

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On July 1, the US Department of Health and Human Services’ Office of Inspector General (OIG) released Advisory Opinion No. 25-08, issuing an unfavorable determination regarding a proposed arrangement in which a medical device...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

Epstein Becker & Green

CMS Doubles Down on Medicare Advantage Recoupment: Announces Aggressive RADV Strategy to Reclaim Billions

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On May 21, 2025, the Centers for Medicare & Medicaid Services (CMS) announced an aggressive plan (Plan) to expand its efforts to address fraud, waste, and abuse in Medicare Advantage (MA)....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

Orrick, Herrington & Sutcliffe LLP

OIG makes seven recommendations for CFPB following major incident

On May 5, the OIG for the Fed authored a report with several recommendations for the CFPB following a major security incident regarding confidential supervisory information (CSI). The OIG issued four findings with seven...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Basic Compliance Academy - July 21st - 24th, Nashville, TN

Grounded in the OIG’s General Compliance Program Guidance and DOJ’s Evaluation of Corporate Compliance Programs, our immersive, three-and-a-half-day, classroom-style Healthcare Basic Compliance Academy equips compliance...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

Rivkin Radler LLP

Quality of Care Considerations in OIG’s Nursing Facility Compliance Guidance

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In November 2024, the U.S. Department of Health and Human Services’ Office of the Inspector General (“OIG”) published the long-awaited Industry Segment-Specific Compliance Program Guidance for Nursing Facilities (“Nursing...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

Orrick, Herrington & Sutcliffe LLP

Fed OIG report highlights need for enhanced training in community bank supervision

On March 3, the OIG for the Fed and CFPB published a report titled “The Bank Exams Tailored to Risk Process Promotes Risk-Focused Supervision of Community Banking Organizations, but Training Can Be Enhanced,” evaluating 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

Dentons

Ep. 51 – Building Effective Compliance Committee Agendas

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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

Orrick, Herrington & Sutcliffe LLP

FDIC OIG responds to senators’ letter on FDIC bank examiners

On February 19, the Office of Inspector General (OIG) for the FDIC responded to a letter from Sen. Elizabeth Warren (D-MA) and others concerning the FDIC’s decision to rescind over 200 jobs for bank examiners. As previously...more

Goodwin

OIG Issues Two Favorable Advisory Opinions for Dental Supply Loyalty Program and Pharmaceutical Manufacturer Sponsor of Genetic...

Goodwin on

In February 2025, the Office of Inspector General (OIG) for the US Department of Health and Human Services issued favorable advisory opinions Advisory Opinion 24-10 and Advisory Opinion 24-12, providing additional guidance on...more

Morgan Lewis - As Prescribed

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more

Arnall Golden Gregory LLP

OIG Deems Free Drug Patient Assistance Program Low-Risk in Advisory Opinion 25-01

On January 15, 2025, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 25-01, a favorable opinion analyzing a pharmaceutical manufacturer’s free product offering to...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

Epstein Becker & Green

Recent Developments in Health Care Cybersecurity and Oversight: 2024 Wrap Up and 2025 Outlook

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As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...more

Orrick, Herrington & Sutcliffe LLP

FDIC OIG reports on readiness to resolve large regional banks

Recently, the FDIC Office of Inspector General released a report entitled, “FDIC Readiness to Resolve Large Regional Banks,” which evaluated the FDIC’s preparedness to resolve large regional bank failures under the Federal...more

Polsinelli

The OIG’s Concerns with Potentially Fraudulent Medicare Advantage Marketing

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The HHS Office of Inspector General (“OIG”) released a Special Fraud Alert to inform health care professionals (“providers”) and Medicare Advantage Organizations (“MAOs”) about the OIG’s view of potentially abusive marketing...more

Arnall Golden Gregory LLP

OIG Updates Compliance Guidance for Nursing Facilities

In 1998, the Office of Inspector General (“OIG”) for the U.S. Department of Health and Human Services began issuing voluntary, compliance program guidance for various segments of the healthcare industry. Recently, the OIG has...more

Lathrop GPM

OIG Issues New Nursing Facility Compliance Guidance, Comes on the Heels of Enhanced Medicare Enrollment Requirements for SNFs

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The Office of Inspector General at the U.S. Department of Health and Human Services (OIG) recently followed up on a 2023 commitment to supplement its General Compliance Program Guidance (GCPG) by publishing its first...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

BakerHostetler

Looking in the Mirror: HHS OIG Audit Demonstrates HHS Agency’s Own Need for Focus on Cloud Security

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The OIG, the nation’s leader in fighting fraud, waste and abuse of Medicare, Medicaid and other HHS programs, periodically publishes reports on how federal healthcare programs could improve....more

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