Health Care Continues to Drive False Claims Act Recoveries: Thought Leaders in Health Law Video Series
On July 11, 2025, in United States v. Schena,[1] the Ninth Circuit adopted an expansive interpretation of the Eliminating Kickbacks in Recovery Act (EKRA), applying the law to any payment that could have the effect of...more
The U.S. Court of Appeals for the Ninth Circuit has held that a laboratory owner’s payments to marketing intermediaries violated the Eliminating Kickbacks in Recovery Act (EKRA)—in its first interpretation of the statute...more
In one of the few prosecutions based on the Eliminating Kickbacks in Recovery Act (EKRA), and in an even rarer Court of Appeals opinion interpreting the statute, the Ninth Circuit in United States v. Schena, No. 23-2989, 2025...more
In an effort to address a variety of concerns that have arisen over the past several years related to “lab shopping” for the most favorable cannabis test results, the Massachusetts Cannabis Control Commission (the...more
The Food and Drug Administration (FDA) is being sued in two lawsuits after releasing its Final Rule on Laboratory Developed Tests (LDTs). The Final Rule requires laboratories to adhere to the same preapproval and...more
The Department of Health and Human Services, Office of Inspector General (“OIG”) recently released a favorable advisory opinion, OIG Advisory Opinion No. 24-10 (the “Opinion”) to a dental supplies distributor (the “Requestor”...more
One of the nation’s largest urine drug testing laboratories recently settled with the federal government by paying $27 million to resolve alleged violations of the federal False Claims Act (FCA) and state statutes. Precision...more
Patient biomarkers are now used in personalized medicine to predict disease progression, minimize side effects, and maximize therapeutic benefits in the treatment of disease. In oncology, the use of biomarkers has increased...more
On June 27, 2024, 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...more
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
Minnesota will amend its drug testing law to permit oral fluid testing for drugs, cannabis and alcohol, effective August 1, 2024. The Drug and Alcohol Testing in the Workplace Act (“DATWA”) currently requires employers who...more
The theoretical foundations of quantum computing emerged throughout the twentieth century, including Planck’s Quantum Hypothesis (1900), the Uncertainty Principle (1927), and Bell’s Inequality (1964). Practical applications...more
Introduction - Polsinelli proudly introduces the Health Care Fraud and Abuse 2023 Year in Review, a comprehensive examination of the evolving landscape surrounding the False Claims Act (“FCA”) and fraud & abuse enforcement...more
A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of...more
States are increasingly exercising regulatory oversight of health care transactions by enacting laws requiring prior notice or approval of certain health care transactions. Currently, 15 states have enacted health care...more
In Wortis v. Trustees of Tufts College, the Massachusetts Supreme Judicial Court (“Court”) held that a university’s agreement to provide academic freedom and economic security to tenured faculty in the tenure contract did not...more
As of Monday March 4, 2024—just three months after the end of its comment period on December 4, 2023—FDA’s rule on regulation of laboratory developed tests (“LDTs”) as medical devices is under review by the Office of...more
The US Food and Drug Administration (FDA) is resolute in its quest to phase out its enforcement-discretion approach for laboratory-developed tests (LDTs). On October 3, 2023, FDA published a proposed rule to confirm that LDTs...more
Please join us for the 9th Annual Nashville Healthcare Fraud Conference hosted by Bass, Berry & Sims and the Tennessee Hospital Association. Eligible for more than seven hours of CLE credit (including ethics), this...more
This course will cover: - Different types of engineering analyses - Steps in root cause failure analysis - The importance of the chain of custody - How a failure analysis lab can contribute to Subrogation matters...more
Last month, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services reaffirmed its longstanding position that an arrangement that “carves out” Federal health care program (FHCP) business is...more
Boston, the San Francisco Bay Area, and San Diego are once again the top markets for life sciences commercial real estate in the U.S., with plenty of opportunities for growth as biotech readies for a comeback, according to a...more
This opinion addresses a proposed agreement (“Proposed Arrangement”) between a national anatomic pathology laboratory (“Requestor”) and laboratories owned in whole or in part by physicians who may refer (“Referring...more
The average vacancy rate for laboratory and research and development space across the top 13 U.S. life sciences markets stood at 9% in the second quarter, up more than four percentage points from a year earlier and more than...more