News & Analysis as of

Medicare Office of the Inspector General Clinical Laboratories

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

Husch Blackwell LLP

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

Husch Blackwell LLP on

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

DOJ Intervenes in Kickback Lawsuit Against Lab and Hospital Execs

Rivkin Radler LLP on

The U.S. Department of Justice (DOJ) recently intervened in an action filed in Texas against two laboratory CEOs, one hospital CEO, and numerous other executives, employees, and recruiters, seeking civil penalties and treble...more

Womble Bond Dickinson

What to Expect as OIG and CMS Audits Focus on COVID-19 Testing?

Womble Bond Dickinson on

The COVID-19 pandemic has caused an enormous need for testing and has spawned the creation of new labs and specimen collection agencies to (try to) meet that need. In 2020 alone, Medicare spent $1.5 billion on COVID-19 tests....more

Oberheiden P.C.

OIG Compliance Program for Hospitals: 8 Keys to Success

Oberheiden P.C. on

The U.S. Department of Health and Human Services Office of Inspector General (HHS-OIG) is tasked with combating fraud under Medicare, Medicaid, and other federally funded healthcare programs. ...more

Parker Poe Adams & Bernstein LLP

OIG Releases 2017 Work Plan

On November 10, 2016, the Office of Inspector General (“the OIG”) of the U.S. Department of Health and Human Services (“DHHS”) is charged with ensuring the integrity of more than 100 programs administered by DHHS, including...more

King & Spalding

OIG Raises Concerns Regarding Accuracy of New Clinical Laboratory Payment System

King & Spalding on

On October 3, 2016, OIG released a report monitoring CMS’s progress on preparing for the implementation of the new payment system for clinical laboratory tests. The new payment system was mandated by the Protecting Access to...more

McGuireWoods LLP

Highlights From The 2016 OIG Work Plan

McGuireWoods LLP on

The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has released its Work Plan for Fiscal Year 2016. The annual work plan can provide valuable insights into the OIG’s planned areas of...more

Foley & Lardner LLP

Clinical Laboratories: Proposed Rule Implements Requirements for Reporting and Payment Based on Private Payer Rates

Foley & Lardner LLP on

As required by a 2014 statute, CMS has issued proposed regulations (Proposed Rule) implementing new requirements for laboratory reporting of, and eventually basing Medicare payment on, rates for clinical laboratory services...more

Baker Donelson

OIG Nixes Arrangements Involving Free Tests

Baker Donelson on

Labs Attempt to Counter Exclusive Lab Arrangements - With increasing frequency, clinical laboratories have found themselves unable to receive any payments for tests performed for individuals whose third-party insurer...more

King & Spalding

OIG Report Recommends Increased Scrutiny of Over 1000 Laboratories With Questionable Billing for Medicare Part B Clinical...

King & Spalding on

According to a recently released report by the HHS Office of Inspector General (OIG), over 1,000 labs had unusually high billing for Medicare Part B Clinical Laboratory Services for dates of service in 2010. Increased...more

Tucker Arensberg, P.C.

OIG Report: Questionable Billing for Medicare Part B Clinical Laboratory Services

Tucker Arensberg, P.C. on

Perhaps not coincidentally, immediately following the release of the Questionable Laboratory Payments Special Fraud Alert by the OIG, posted yesterday on the Med Law Blog, the OIG has followed up with Audit Report OIG –...more

Foley Hoag LLP

Summary of Clinical Laboratory Fee Schedule Reform Provisions in the Protecting Access to Medicare Act of 2014

Foley Hoag LLP on

On April 1, the Protecting Access to Medicare Act of 2014 was enacted into law (Pub. L. 113-93). Section 216, entitled Improving Medicare Policies for Clinical Diagnostic Laboratory Tests, modernizes the Medicare payment...more

McAfee & Taft

OIG rejects management arrangement that carves out federal healthcare program patients

McAfee & Taft on

The Office of Inspector General of the Department of Health and Human Services recently posted an Advisory Opinion describing a proposed arrangement by a clinical laboratory. ...more

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