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SCOTUS Rejects Defense-Friendly Scienter Standard In Schutte Opinion

On June 1, 2023, the Supreme Court of the United States (SCOTUS) issued its much-anticipated opinion in United States ex rel. Schutte v. SuperValu Inc. and United States ex rel. Proctor v. Safeway, Inc. (Schutte), holding...more

DOJ Continues to Target Lab Sales Arrangements and Ordering Practices

Signaling its continued scrutiny of the laboratory industry, the Department of Justice (DOJ) entered into a settlement agreement with Texas lab Genotox Laboratories Ltd. last month related to compensation Genotox paid to...more

False Claims Act: Appellate Court Deepens Circuit Split in Favor of Healthcare Defendants

On March 28, 2023, the United States Court of Appeals for the Sixth Circuit issued its opinion in United States ex rel. Martin v. Hathaway, holding that plaintiffs in False Claims Act (FCA) cases alleging a violation of the...more

False Claims Act Recoveries 2022

The Department of Justice (DOJ) recently announced its False Claims Act (FCA) Recoveries for 2022, with the second-highest number of settlements in history. While the number of settlements increased, the total amount of...more

DOJ Strengthens Efforts to Combat Corporate Crime with Increased Focus on Individual Culpability and Self-Disclosure

As a product of the Department of Justice’s newly minted Corporate Crime Advisory Group, the DOJ has issued follow-up guidance to its October 2021 memo on corporate criminal enforcement, which reinstated prior guidance...more

Health Care Reimbursement and Payor Dispute Update - September 2022

Co-Location and the Provider-Based Rules – No News is…Good News? On July 15, the Centers for Medicare & Medicaid Services ("CMS") released the 2023 Outpatient Prospective Payment System proposed rule (“OPPS Proposed...more

Top Issues in Behavioral Health for 2022

Behavioral Health M&A Will Remain Hot in 2022 - Behavioral health had its most active year in 2021, which came on the heels of very active years that preceded it. There are many factors that contributed to this and that...more

340B Price Restriction Development - HRSA Moves 340B ADR Complaints Forward

Recently, HRSA verbally confirmed that it has assigned Administrative Dispute Resolution (ADR) panelists, a key development to move a handful of pending ADR complaints forward. Those complaints contain allegations that drug...more

As DOJ Focuses on Medicare Advantage Reimbursement, So Should Health Care Providers

Over the past year, the federal government has taken concrete steps to fulfill its promise of a heightened commitment to investigating and enforcing health care fraud within the Medicare Advantage program (Medicare Part C). ...more

Regulatory Updates for Non-Hospital Quality Programs

The Washington Department of Health (DOH) has amended WAC 246-50, the rules applicable to coordinated quality improvement programs (CQIPs) for non-hospital organizations.  The amendments go into effect on May 21, 2021. ...more

False Claim Act Recoveries During 2020: A Strong Year for the Department of Justice

On January 14, 2021, the United States Department of Justice (DOJ) announced that it had recovered $2.2 billion from False Claim Act (FCA) Cases during 2020. Each year, the DOJ publishes statistics about its recoveries under...more

In a Busy Year of Health Care Antitrust Enforcement, DOJ’s First Criminal Wage-Fixing Prosecution Targets a Health Care Provider

Over the last several years, antitrust prosecutors at the Department of Justice have repeatedly cautioned that anticompetitive agreements affecting labor markets can be the subject of criminal prosecution under the antitrust...more

The Washington Department of Health Files Notice of Proposed Rule

The Washington Department of Health (DOH) has filed a notice of proposed rule-making that may be of interest to a broad cross-section of the Washington health care community. DOH has proposed to amend the rule that provides...more

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