Doctors hold blood sample wearing ppe suit and face mask in hospital.

New Stark Law Waiver Opens Opportunity for Creative Physician Compensation and Benefits

By Carmel Shachar

On March 30, 2020 the Department of Health and Human Services (HHS) announced a partial waiver of some key elements of the Stark Law, a health care fraud and abuse law. The purpose of this waiver is to relax some of the fraud and abuse requirements around physician compensation during the COVID-19 pandemic to allow hospitals and physician groups to think creatively about meeting the needs of an overworked and stressed workforce. It also provides us an opportunity to consider the post-pandemic future of the Stark Law, long thought to be an impediment to innovative payment and delivery models.

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Implied Certification and the Problem of Interpretation Under the False Claims Act

By Joan H. Krause

[Cross-posted from Hamilton and Griffin On Rights]

In a recent post, I explained the contours of the False Claims Act (FCA) implied certification theory of falsity, the subject of the recent Supreme Court argument in Universal Health Services v. United States(UHS). In this post, I will address an issue largely overlooked by most commentators: the potential for differing interpretations of what is required by the underlying Medicare and Medicaid provisions that form the basis for the certification.

Recent years have seen an expansion of FCA cases from “factually false” misrepresentations to those involving “legally false” claims, where items or services were provided but the claimant also violated an underlying legal requirement. For example, UHS involves an allegation that the defendant clinic violated the FCA because, by submitting a claim for payment under MassHealth, it implicitly certified that it was in compliance with all relevant Massachusetts regulations – including the staffing and supervision requirements it later was found to have violated.

Courts have taken two broad approaches to defining the universe of regulatory provisions with which certification will be implied. Some courts, notably the Second Circuit in Mikes v. Straus, 274 F.3d 687 (2d Cir. 2001), limit the theory to violations of statutes or regulations clearly identified as conditions of payment. Other courts, such as the First Circuit in UHS, instead ask whether the claimant “knowingly represented compliance with a material precondition of payment,” which need not be “expressly designated.” The tests may sound similar, but differ both theoretically and functionally. First, defining implied certification by reference to “materiality” is curious in light of the fact that, since 2009, materiality has been an express – and distinct – element of the FCA false records provision in 31 US.C. § 3729(a)(1)(B). Yet implied certification cases such as UHS usually arise under the false claims provision in § 3729(a)(1)(A), which Congress did not amend to require materiality.

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Implied Certification and the Quest for Fraud that “Counts” Under the False Claims Act

By Joan H. Krause

[Cross-posted from Hamilton and Griffin on Rights]

Sometimes, we lie when we speak; other times, we lie when we don’t. Striking the right balance is the essence of the Universal Health Services (UHS) case recently argued before the Supreme Court, which challenged the applicability of the False Claims Act (FCA) to situations in which a claimant falsely “implies” compliance with underlying regulatory requirements.

UHS was brought by the parents of a young woman who died after receiving Medicaid-covered (MassHealth) mental health treatment from a clinic that did not satisfy state licensing and supervision regulations. The parents alleged that the claims for payment were fraudulent because they implicitly represented that the clinic was in full compliance with relevant state requirements. The district court dismissed the suit, finding that the staffing and supervision regulations were not “conditions of payment” whose violation would render subsequent claims false under the FCA. The First Circuit reversed, focusing instead on whether UHS had “knowingly represented compliance with a material precondition of payment.” Noting that preconditions need not be “expressly designated,” the court identified a set of regulations that, read together, appeared to limit MassHealth payment to properly supervised care. While such a fact-intensive dispute might at first appear an unlikely candidate for certiorari, UHS was one of several such “implied certification” opinions issued by the federal appellate courts in 2015. Perhaps because of its emotionally compelling facts – the other cases involved, inter alia, the recruitment practices of a for-profit college and a military contractor that falsified marksmanship scores – UHS was chosen as the vehicle to resolve a growing circuit split. Read More