In November 2025 we published From Biologics to Bandages, Skin Substitutes Are No Longer the Biologics You Think They Are, flagging an unmistakable shift at the Centers for Medicare & Medicaid Services (CMS) toward constraining a massive increase in government spending on skin substitutes (the biological-based wound coverings used for burns, trauma, and chronic conditions … Continue Reading
A recent False Claims Act (FCA) ruling out of Tennessee offers a pointed reminder for hospitals and health systems: physician contracts that appear compliant on paper can still create serious enforcement risk if the economics tell a different story. In denying motions to dismiss FCA claims involving Erlanger Health System (Erlanger), the federal court allowed … Continue Reading
The U.S. Department of Justice’s (DOJ) first False Claims Act (FCA) settlement under its new Civil Rights Fraud Initiative offers key insight for federal contractors, federal funding recipients and healthcare providers. Under the settlement reached in April 2026, International Business Machines Corporation (IBM) agreed to pay over $17 million to resolve allegations that it violated the … Continue Reading
Fair market value arrangements and those that satisfy an exception to the physician self-referral law (Stark Law) can nonetheless violate the federal Anti-Kickback Statute (AKS). That is the message of two recent updates the U.S. Department of Health and Human Services Office of Inspector General (OIG) made to its Frequently Asked Questions (FAQs) about fraud … Continue Reading
Management service organizations (MSOs) with affiliated clinical labs and urgent care clinics should take note of newly identified guardrails that will facilitate their compliance with the federal Anti-Kickback Statute (AKS). Earlier this year, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued Advisory Opinion No. 26-02, a favorable opinion concluding … Continue Reading
The U.S. Department of Justice (DOJ) recently released its first-ever Department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy (CEP) for criminal matters. The new CEP creates a uniform national policy for how the DOJ rewards companies that voluntarily self-report criminal conduct. Building on the 2025 CEP of the DOJ’s Criminal Division, the new CEP supersedes all … Continue Reading
On March 9, 2026, the U.S. Department of Health and Human Services Office of Inspector General (OIG) issued a favorable advisory opinion regarding a retiring physician’s transfer of ownership interests in a Medicare-certified ambulatory surgical center (ASC) as part of his retirement plan.… Continue Reading
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 16, 2026. The DOJ announced a record level of recoveries from FCA resolutions in Fiscal Year (FY) 2025 (ending Sept. 30, 2025), which exceeded $6.8 billion. These statistics reflect the highest single-year dollar amount recovery on-record since the DOJ … Continue Reading
The much-anticipated appellate showdown regarding the constitutionality of the whistleblower (or qui tam) provision of the federal False Claims Act (FCA) took place before a three-judge panel of the Eleventh Circuit Court of Appeals (Judge Elizabeth L. Branch, Judge Robert J. Luck, and Senior District Court Judge Federico A. Moreno, sitting by designation). The panel … Continue Reading
CMS currently treats skin substitutes as biologicals for the purposes of Medicare payment. ….. In the CY 2026 PFS final rule, CMS will pay for skin substitutes under the PFS as incident-to supplies, a change expected to reduce Medicare spending on these products by nearly 90% without compromising patient access or quality of care. We … Continue Reading
The Department of Justice (DOJ) released its annual False Claims Act (FCA) enforcement statistics on January 15, 2025, announcing that it had recovered in excess of $2.9 billion from FCA resolutions during Fiscal Year (FY) 2024 (ending September 30, 2024).… Continue Reading
As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to hold that the qui tam provision of the federal False Claims Act violates the Appointments Clause of … Continue Reading
The latest Special Fraud Alert from the U.S. Department of Health and Human Services Office of Inspector General (OIG) warns about marketing schemes involving questionable payments and referrals among Medicare Advantage plans, health care professionals, and third-party marketers, such as agents and brokers. Issued on December 11, 2024, this new Special Fraud Alert focuses on … Continue Reading
For the first time ever, a judge has ruled that the qui tam provision of the False Claims Act (FCA), which whistleblowers have used to recover $52 billion on behalf of the government since 1986, is unconstitutional. … Continue Reading
How could alleged kickbacks threaten to render insolvent a publicly traded company with assets (taken from its latest SEC filing) in excess of $43 billion? The answer stems from a recent decision by the United States District Court for the District of Massachusetts. In its ruling denying the motion for summary judgment filed by defendants … Continue Reading
On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to information blocking (CMP Final Rule or Rule). The CMP Final Rule was published in the Federal Register on July 3, 2023. … Continue Reading
For the second time this month, the United States Supreme Court addressed a circuit split involving the False Claims Act (FCA, 31 U.S.C. §§ 3729 – 3733). Earlier, in the SuperValu decision (discussed in a recent Health Law Rx Blog), the Court clarified that subjective intent is relevant in determining whether an objectively reasonable (but … Continue Reading
Yesterday, the United States Supreme Court held that a False Claims Act (FCA) defendant cannot rely on an objectively reasonable interpretation of a law, regulation, or rule to negate the scienter element of the FCA. In United States ex rel. Schutte v. SuperValu Inc., the Court emphasized the importance of a defendant’s subjective belief in … Continue Reading
There are multiple components to the risk defendants must consider when faced with going to trial for a matter involving the False Claims Act (FCA). Setting aside the incalculable impact that litigation can have on business operations, the statute itself anticipates repayment of the proven overpayment, treble damages, and exposure to a civil statutory penalty … Continue Reading
What does it mean to “knowingly” or “recklessly” violate the law when that law consists of highly complex and ever-changing regulations, which may be open to interpretation? The U.S. Supreme Court recently agreed to review that question in two consolidated cases from the Seventh Circuit: U.S. ex rel. Tracy Schutte, et al. v. SuperValu Inc., … Continue Reading
Two recent multi-million dollar False Claims Act (“FCA”) settlements demonstrate the vigor with which the Department of Justice (“DOJ”) is investigating and prosecuting allegedly fraudulent health care billing practices. These large settlements demonstrate how imperative it is that providers routinely review billing practices with the guidance of counsel.… Continue Reading
To facilitate the provision of care during the pandemic, the federal government and many state governments enacted changes that encouraged physicians and other nonphysician practitioners (collectively, Practitioners) to use telehealth services. While this new flexibility increased access to care, it also increased opportunities for fraud. On July 20, 2022, the U.S. Department of Health and … Continue Reading
Currently, providers have different risks of potential False Claims Act (“FCA”) liability depending on where they are geographically located due to the difference in the standards required by the U.S. Courts of Appeals regarding the level of specificity when relators (whistleblowers) plead FCA violations. The FCA imposes civil liability on any person requesting government funds … Continue Reading
For the first time since 2013, on November 8, 2021, the Department of Health and Human Services Office of Inspector General (“OIG”) updated its Health Care Fraud Self-Disclosure Protocol (“SDP”). The updated SDP makes several important revisions and clarifications that directly impact providers and suppliers who seek to self-disclose potential violations of healthcare fraud statutes … Continue Reading
