Commercial Litigation Update

The U.S. Court of Appeals for the First Circuit recently provided important clarity—and welcome relief—for clinical laboratories facing False Claims Act (“FCA”) allegations based on a lack of medical necessity for processing tests ordered by a physician. In a case of first impression, United States ex rel. OMNI Healthcare, Inc. v. MD Spine Solutions LLC,[1] the First Circuit held that clinical laboratories may rely on an ordering physician’s determination that lab tests billed to Medicare are medically necessary. The First Circuit held that laboratories need not second-guess a physician’s certification absent red flags or suspected improper conduct. While the First Circuit’s decision does not relieve clinical laboratories of their existing obligation under the FCA to ensure they are not submitting a false claim to government payors, it provides much-needed clarity for clinical laboratories across the country on what constitutes the knowing submission of false claims to the government and highlights several practical takeaways for managing compliance risk.

On October 3, 2023, the United States Supreme Court heard oral argument in Community Financial Services Association of America Ltd., et al. v. Consumer Financial Protection Bureau, et al., in which the Court was asked to determine the constitutionality of the Consumer Financial Protection Bureau’s (“CFPB”) independent funding structure.

In Community Financial Services Association of America Ltd., et al. v. Consumer Financial Protection Bureau, et al., the U. S. Court of Appeals for the Fifth Circuit held in a unanimous decision that the CFPB’s “unique” funding ...

The U.S. Court of Appeals for the Second Circuit issued a decision in Slattery v. Hochul, reversing the dismissal of a First Amendment challenge to New York Labor Law §203-e (also referred to as the “Boss Bill”). The Boss Bill prohibits employers from taking adverse employment actions against employees based upon their reproductive health decisions, including “a decision to use or access a particular drug, device or medical service,” and also forbids employers from “accessing an employee’s personal information regarding the employee’s . . . reproductive health decision making.” The term “reproductive health decision making” necessarily would include an employee’s decision to have an abortion or use contraception. The Boss Bill, unlike Title VII of the Civil Rights Act, does not contain an exemption for religiously affiliated organizations.