News & Analysis as of

Clinical Laboratories Office of the Inspector General Department of Health and Human Services (HHS)

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

McDermott Will & Emery

OIG Pathology Lab: Don't Pay for Services You Don't Need

McDermott Will & Emery on

In September, the US Department of Health and Human Services Office of Inspector General (OIG) issued an unfavorable advisory opinion to a pathology laboratory concerning a proposed services arrangement with referring...more

Bass, Berry & Sims PLC

Labs Take Note: In a New Opinion, OIG Reminds Us that Fair Market Value Payments Can Still Violate the Anti-Kickback Statute

Bass, Berry & Sims PLC on

On September 25, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion 23-06, in which it declined to approve an anatomic pathology laboratory’s proposal to purchase...more

Mintz - Health Care Viewpoints

OIG Issues Advisory Opinion Nixing Purchased Services Arrangement Between Certain Anatomic Pathology Laboratories

Last week the Office of Inspector General for the U.S. Department of Health and Human Services (OIG) issued Advisory Opinion 23-06 (AO), which advised that a proposed arrangement between certain laboratories for the purchase...more

Health Care Compliance Association (HCCA)

[Event] 2023 Healthcare Enforcement Compliance Conference - November 5th - 7th, Washington, DC

Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more

Epstein Becker & Green

The 2023 DOJ Health Care Fraud Enforcement (f/k/a “Takedown”): Big Dollars or Clever Packaging?

Epstein Becker & Green on

On June 28, 2023, the U.S. Department of Justice (“DOJ”) and the U.S. Department of Health and Human Services, Office of Inspector General (“HHS-OIG”), along with other federal and state law enforcement partners, announced a...more

Sheppard Mullin Richter & Hampton LLP

Laboratory and Pathology Information Blocking Concerns

Recently, we were invited to speak on a panel at the Executive War College on Diagnostics, Clinical Laboratory and Pathology Management. We spoke about the federal information blocking rules, and highlighted how some actors...more

K&L Gates LLP

COVID-19: A Roadmap to Fraud Investigations: Office of Inspector General Targets Labs for Billing COVID-19 Add-On Tests

K&L Gates LLP on

Introduction - On 6 December 2022, the Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a report (Report) that summarized findings of HHS-OIG’s review of laboratories with questionably high...more

Robinson+Cole Health Law Diagnosis

Suspect Characteristics Identified under a Telehealth Special Fraud Alert

HHS-OIG issued a new Special Fraud Alert on relationships with “purported telemedicine companies” on July 20, 2022. The Special Fraud Alert comes on the heels of a nationally coordinated takedown charging dozens of...more

Oberheiden P.C.

Tips and Insights for Clinical Lab Compliance in 2025

Oberheiden P.C. on

The COVID-19 pandemic increased the business opportunities available to clinical labs, including molecular and respiratory labs. As the nation—and the world—struggled to develop adequate testing infrastructure, the federal...more

Oberheiden P.C.

Compliance Concerns for Respiratory and Clinical Labs Performing COVID-19 Testing

Oberheiden P.C. on

The tragedy of the COVID-19 pandemic is something we all agree we wish we could have avoided. However, the fact of the matter is that many respiratory and clinical labs have seen a boon to their bottom line due to the...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

King & Spalding

HHS OIG Permits Labs to Offer Free COVID-19 Antibody Tests and Oncology Practices to Offer Free Lodging in Certain Circumstances

King & Spalding on

OIG has updated its FAQs regarding the application of its administrative enforcement authorities to arrangements directly connected with COVID-19 with the addition of two new FAQs. On August 4, 2020, the OIG issued an FAQ...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

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

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

Chambliss, Bahner & Stophel, P.C.

OIG Sticks It to Physician Specimen Collectors

On June 25, the U.S. Department of Health & Human Services, Office of the Inspector General ("OIG") issued a Special Fraud Alert updating the previous guidelines concerning compensation by clinical laboratories to referring...more

Ballard Spahr LLP

OIG Releases Special Fraud Alert on Laboratory Payments to Physicians

Ballard Spahr LLP on

The Office of the Inspector General (OIG) for the Department of Health and Human Services recently issued a Special Fraud Alert regarding laboratory payments to referring physicians. The Special Fraud Alert reaffirms OIG’s...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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