News & Analysis as of

Laboratories Medicare

Alston & Bird

Health Care Week in Review: HHS Finalizes Provider Disincentives for Information Blocking and House Ways and Means Committee...

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

ArentFox Schiff

Investigations Newsletter: Government Brings FCA Action Against Laboratory Companies

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Government Brings FCA Action Against Laboratory Companies - On July 18, 2023, the US Department of Justice (DOJ) announced it has filed a complaint against multiple laboratory companies and their owner, Patrick...more

Benesch

Modern Vascular is the Latest Defendant in a Growing Trend of Qui Tam Relator Cases against Office-based Lab Companies

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Earlier this month a federal judge unsealed a federal qui tam relator complaint originally filed in January 2020 by Dr. Jay Radhakrishnan and Dr. William Julien against Arizona-based Modern Vascular and certain of its...more

Mintz - Health Care Viewpoints

OIG Expresses Concern about Laboratory Specimen Collection Payments to Hospitals in AO 22-09

Last week, the Office of Inspector General (OIG) for the Department of Health and Human Services (HHS) issued Advisory Opinion No. 22-09 (AO 22-09), which addresses a proposed arrangement pursuant to which the operator of a...more

Goodwin

DOJ Recoups a total of $1.8 Billion from Health Care Fraud in 2020, Laboratory Recoupments Alone Account for Hundreds of Millions

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The Department of Justice (“DOJ”) has reported that in 2020, the government prosecuted dozens of laboratory owners and operators for anti-kickback related offenses responsible for hundreds of millions in alleged federal...more

Rivkin Radler LLP

DOJ Announces COVID-19 Fraud Takedown

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On May 26, the U.S. Department of Justice (DOJ) announced criminal charges against 14 defendants in six states for participation in healthcare fraud schemes related to the COVID-19 pandemic. The coordinated takedown involved...more

Holland & Knight LLP

Healthcare Law Update: April 2021

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William F. Gould In United States v. Merino, No. 19-50291, 2021 WL 754589 (9th Cir. Feb. 26, 2021), the court of appeals reversed the conviction of Marina Merino of conspiracy to commit healthcare fraud in violation of 18...more

Rivkin Radler LLP

California Laboratory Settles FCA Claims Related To Genetic Testing

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Exceltox Laboratories, LLC, a California diagnostic laboratory, is paying a $357,584 settlement to resolve allegations of False Claims Act (FCA) violations. Exceltox allegedly submitted or caused to be submitted claims for...more

McAfee & Taft

New CMS regulations bolster enforcement of COVID-19 reporting by hospitals, long-term care facilities and labs

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On August 25, 2020 the Centers for Medicare & Medicaid Services (CMS) issued interim final regulations known as CMS-3401-IFC that become effective immediately upon publication in the Federal Register, scheduled for September...more

Chambliss, Bahner & Stophel, P.C.

Medicare Reimbursement of Pharmacy-Based COVID-19 Testing

On May 8, 2020, CMS issued guidance clarifying how pharmacies and other suppliers can obtain waivers to allow them to temporarily enroll as independent clinical diagnostic laboratories for the purpose of providing COVID-19...more

Health Care Compliance Association (HCCA)

Report on Medicare Compliance Volume 29, Number 15. News Briefs: April 2020 #2

Report on Medicare Compliance 29, no. 15 (April 20, 2020) - Maury Regional Medical Center in Tennessee has agreed to pay $1.7 million to settle false claims allegations over MS-DRG coding, the U.S. Attorney’s Office for...more

ArentFox Schiff

Investigations Newsletter: Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations

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Headlines that Matter for Companies and Executives in Regulated Industries - Kentucky Hospital Agrees to Pay $10 Million to Resolve False Claims Act Allegations - Jewish Hospital & St. Mary’s Healthcare Inc. d/b/a...more

Baker Donelson

False Claims Act Liability Without Submitting False Claims? Yes, That's a Thing

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Most health care providers recognize that submitting a knowingly false claim to a federally funded health care program violates the False Claims Act (FCA). However, it is less well known that indirectly "causing" someone else...more

ArentFox Schiff

Investigations Newsletter: Inpatient Rehabilitation Company Agrees to Pay $48 Million to Resolve FCA

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DOJ News - Inpatient Rehabilitation Company Agrees to Pay $48 Million to Resolve FCA Allegations - DOJ announced that Encompass Health Corporation (f/k/a HealthSouth Corporation), the nation’s largest operator of...more

Baker Donelson

Precision Medicine Advances: Medicare Coverage of Next Generation Sequencing Testing

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Medicare recently released a new national coverage determination (NCD) that addresses certain diagnostic laboratory tests using Next Generation Sequencing (NGS) for patients with advanced cancer. NGS technology has made it...more

Akin Gump Strauss Hauer & Feld LLP

New CMS National Coverage Determination and FDA Regulatory Approach: the Next Generation for NGS Testing Policy?

• The new national Medicare coverage determination covers only FDA-authorized NGS tests with companion diagnostic indications, leaving NGS cancer tests without that specific indication to seek coverage from local Medicare...more

Bass, Berry & Sims PLC

Healthcare Fraud & Abuse Review 2017

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A LOOK BACK... A LOOK AHEAD - While the uncertainty associated with legislative efforts to repeal the Patient Protection and Affordable Care Act (PPACA) dominated most of the headlines for the healthcare industry last year,...more

Holland & Knight LLP

Top Takeaways for Medicare Physician and Hospital Payments in 2018

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The Centers for Medicare & Medicaid Services (CMS) on Nov. 1, 2017, released the Medicare Hospital Outpatient Prospective Payment System (OPPS) and the Medicare Ambulatory Surgical Center (ASC) Payment System Final Rule for...more

Bracewell LLP

Nationwide Healthcare Prosecutions Targeting an Array of Practices . . . Is "Just The Beginning"

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On July 13, 2017, the Department of Justice ("DOJ"), in conjunction with the Department of Health and Human Services ("HHS"), continued its annual tradition of coordinating the filing of charges and sweeping arrests in...more

Mintz

What’s Lurking in Your Lab? Legal Risks for Hospital Laboratories

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Most health-care lawyers are accustomed to monitoring the high profile areas of regulatory enforcement in health care. However, many hospital lawyers, whether in-house or outside counsel, are unaware of the potential...more

King & Spalding

Also In The News - Health Headlines - July 2015 #4

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The Joint Commission Revises Nursing Care Center Requirements, Laboratory Requirements, and Outpatient Record Review Requirements for CAHs – On July 9, 2015, the Joint Commission announced revised requirements, effective...more

Baker Donelson

OIG Nixes Arrangements Involving Free Tests

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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

McDermott Will & Emery

CMS Announces Plans to Modernize and Update the Clinical Laboratory Fee Schedule

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On November 27, 2013, Centers for Medicare & Medicaid Services posted the final 2014 Medicare physician fee schedule and, in it, announced plans to change how and how much Medicare pays for clinical diagnostic laboratory...more

Bradley Arant Boult Cummings LLP

CMS Issues Proposed Rule to Reform "Unnecessary, Obsolete, or Excessively Burdensome" Medicare Participation Standards

On February 4, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule to reform Medicare regulations that CMS views as unnecessary, obsolete, and/or excessively burdensome on hospitals and health care...more

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