On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more
4/15/2025
/ Anti-Kickback Statute ,
Appeals ,
False Claims Act (FCA) ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Medicaid ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regeneron ,
SCOTUS ,
Settlement ,
Whistleblowers
The Washington State Supreme Court significantly expanded the scope of potential hospital tort liability for the allegedly negligent actions of nonemployee, independently contracted emergency room service physicians, and...more
This Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act (the Act). Part 1 provided a high-level outline of the entities regulated under the Act and the corresponding...more
6/8/2023
/ Biometric Information ,
Genetic Materials ,
Gramm-Leach-Blilely Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HIPAA Privacy Rule ,
Mental Health ,
PHI ,
Privacy Laws ,
Reproductive Healthcare Issues ,
Small Business
A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more
6/6/2023
/ Drug Pricing ,
False Claims Act (FCA) ,
Fraud ,
Healthcare ,
Oral Argument ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Reasonable Interpretations ,
Safeco ,
Safeco Insurance Co of America v Burr ,
Scienter ,
SCOTUS ,
US ex rel Thomas Proctor v Safeway Inc ,
US ex rel Tracy Schutte et al v SuperValu Inc et al
The U.S. Department of Justice (DOJ), Antitrust Division, recently withdrew three sets of guidelines that had been relied upon heavily by the healthcare industry: the 1993 Antitrust Enforcement Policy Statements Issued for...more
2/8/2023
/ Antitrust Division ,
Antitrust Litigation ,
Antitrust Provisions ,
Antitrust Violations ,
Competition ,
Department of Justice (DOJ) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Investigations ,
Legislative Agendas ,
Policy Statement ,
Unfair Competition
COVID-19 has financially stressed the U.S. healthcare system in several ways. In many cities, hospitals have needed to add healthcare capacity (especially ICU beds) to serve rapidly increasing numbers of COVID-19 patients. At...more
On May 30, 2014, the Departmental Appeals Board (DAB) issued a decision invalidating the long-standing National Coverage Determination (NCD) prohibiting Medicare payment for transsexual surgery (now known as gender...more
On April 22, the U.S. Department of Health and Human Services (HHS) announced settlements with both Concentra Health Services (Concentra) and QCA Health Plan, Inc. (QCA). Through these latest settlements, HHS is reiterating...more
On August 2, 2013, the Centers for Medicare and Medicaid Services (CMS) issued an advance copy of its final rulemaking that adopts a new approach to evaluating the medical necessity of inpatient hospital admissions. ...more