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Healthcare › Audits › Regulatory Requirements

Husch Blackwell LLP

OIG Announces 2025 Work Plan Review: What Clinical Laboratories Need to Know About Medicare Payments for Diagnostic Lab Tests

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In June 2025, the U.S. Department of Health and Human Services Office of Inspector General (OIG) announced a new item in its Work Plan: “Medicare Payments for Clinical Diagnostic Laboratory Tests in 2024.” This annual review,...more

Dentons

Ep. 68 – Before You Audit—Why Pre-Audit Planning Matters

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If you’re preparing to launch an audit within your healthcare organization, pause for a moment and consider this: how well you plan before the audit begins can significantly affect the outcome—and your risk exposure. This...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

Proskauer - Health Care Law Brief

CMS to Immediately Begin Auditing Medicare Advantage Plans in Significant Expansion of Enforcement Efforts

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On May 21, 2025, the Centers for Medicare and Medicaid Services (“CMS”) announced a significant expansion of its auditing efforts with respect to Medicare Advantage (“MA”) plans....more

Alston & Bird

Addressing Data Integrity Challenges in Medical Device Submissions

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The Food and Drug Administration’s (FDA) recent rejection of all study data from Mid-Link Testing highlights the importance of using reliable, valid data for medical device premarket submissions. Our FDA/Food, Drug & Device...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

McDermott Will & Emery

This Week in 340B: March 4 – 10, 2025

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Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more

Foley & Lardner LLP

The Intersection of Agentic AI and Emerging Legal Frameworks

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The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more

Ropes & Gray LLP

A Flurry of Healthcare Sector Cybersecurity Regulatory Developments in 2024

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2024 was a record year for cyberattacks in the healthcare sector. According to the Breach Portal maintained by the U.S. Department of Health and Human Services (“HHS”) Office of Civil Rights (“OCR”), to date this year, there...more

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