News & Analysis as of

Department of Health and Human Services (HHS) Clinical Laboratories

ArentFox Schiff

Investigations Newsletter: Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations

ArentFox Schiff on

Clinical Laboratory and CEO To Pay Over $13 Million to Settle False Claims Act Allegations - A New Jersey-based laboratory, RDx Bioscience Inc. (RDX), and its owner and CEO, Eric Leykin, agreed to pay $10,315,023 to the US...more

Akin Gump Strauss Hauer & Feld LLP

Unfinished Health Care Business: 10 Issues to Watch as Congress Rings in the New Year

Health care was one of the most active issue areas in 2023 and this trend is expected to continue when Congress returns in the New Year for the second session of the 118th Congress. The activity by the health committees of...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

Venable LLP

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

Venable LLP on

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

McDermott Will & Emery

10 Things Providers Should Know About California’s Data Exchange Framework

McDermott Will & Emery on

By January 31, 2023, general acute care hospitals, clinical labs and certain physician organizations and medical groups in California are required to enter into the Single Data Sharing Agreement (DSA) to participate in the...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

Epstein Becker & Green

Four Years After EKRA: Reminders for Clinical Laboratories

Epstein Becker & Green on

It has been four years since Congress enacted the Eliminating Kickbacks in Recovery Act (“EKRA”), codified at 18 U.S.C. § 220. EKRA initially targeted patient brokering and kickback schemes within the addiction treatment and...more

Mintz - Health Care Viewpoints

PAMA Laboratory Reporting In Flux: ACLA Wins HHS Lawsuit and Congress Introduces PAMA Amendment Legislation

Important developments related to required price reporting to Medicare for clinical laboratories under the Protecting Access to Medicare Act of 2014 (PAMA) have recently occurred. As a result, the clinical laboratory...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

Alston & Bird

Alston & Bird Health Care Week in Review - January 2022 #3

Alston & Bird on

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Oberheiden P.C.

5 Tips for Lab Compliance in 2023

Oberheiden P.C. on

In many ways, 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,...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

Akin Gump Strauss Hauer & Feld LLP

Diagnostics Reform Heats Back Up with Introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2021

In vitro diagnostics (IVD) reform re-entered the legislative fray this week. The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the...more

Saul Ewing LLP

Clinical Laboratory Agrees to Pay $25,000 to Settle Potential HIPAA Security Rule Violations

Saul Ewing LLP on

On May 25, 2021, the Office for Civil Rights (OCR) within the U.S. Department of Health and Human Services (HHS), announced that Peachstate Health Management, LLC d/b/a AEON Clinical Laboratories (Peachstate) agreed to pay...more

Fox Rothschild LLP

PA Department Of Health Proposes Permanent Medical Marijuana Regulations

Fox Rothschild LLP on

On March 5, 2021, the Pennsylvania Department of Health (the “Department”) proposed permanent regulations relating to medical marijuana, replacing the current temporary regulations at 28 Pa. Code Part IX...more

Oberheiden P.C.

Eight Keys to Developing an OIG Compliance Program for Hospitals

Oberheiden P.C. on

The Office of Inspector General is a division of the U.S. Department of Health and Human Services that is tasked with combating fraud committed against Medicare, Medicaid, and other federally funded government programs. The...more

Mintz - Health Care Viewpoints

FDA in 2020: What a Year!

What a year for the Food and Drug Administration! FDA, an agency with regulatory oversight of 20-25% of products on which consumers spend, including food and medicines, but which typically stays out of the limelight, was...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Oversight of Laboratory-Developed Tests Continues To Evolve

On August 19, 2020, the Trump administration made a major announcement that marks the latest development in the ever-evolving saga of the Food and Drug Administration’s (FDA) oversight of laboratory-developed tests (LDTs)....more

Bass, Berry & Sims PLC

Reimbursement and Liability Implications of Not Pursuing an Emergency Use Authorization for COVID-19 Laboratory-Developed Tests

In an unprecedented move touted as necessary to address the COVID-19 testing shortage, the U.S. Department of Health and Human Services (HHS) made a brief statement on August 19 that effectively rescinded the federal Food and...more

Verrill

News Flash: HHS Issues Statement Removing Premarket Review Requirements for Laboratory Developed Tests (“LDTs”), Including...

Verrill on

What happened? On August 19, 2020, the U.S. Department of Health and Human Services (“HHS”) issued a single paragraph statement rescinding U.S. Food and Drug Administration (“FDA”) guidance documents concerning premarket...more

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