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What do the FDA’s expanded ‘intended use’ regulations mean for safe-harbored communications about new uses?

Oct 06 2021

In advance of their webinar this Thursday, October 7, Coleen Klasmeier and Jaime Jones consider some of the effects of the final rule.

FDA’s final rule to amend its medical product ‘intended use’ regulations has now been in effect since September 1. The changes which the final rule makes to the definition of intended use, as interpreted by FDA in the accompanying preambles, expand the types of evidence that are deemed relevant to determining whether a lawfully marketed drug or device has a new intended use and whether a product is intended for use as a drug or device.

FDCA; Off-Label

District Court Rejects Anti-Kickback Statute Claim Due to “Conclusory” Assertions of Unlawful Intent

Sep 16 2021

Jaime L.M. Jones, Brenna Jenny and Megan Coggeshall

A court in the District of Maryland recently dismissed a declined qui tam action in which the relator, a bariatric surgeon, alleged that two medical device companies violated the AKS by providing surgeons with free advertising in exchange for physicians using the companies’ LAP-BAND medical devices in bariatric surgeries. See United States ex rel. Fitzer v. Allergan, Inc., et al., 1:17-cv-00668-SAG (D. Md. Sept. 10, 2021). The court’s decision granting defendants’ motions to dismiss is notable in its refusal to allow relator to proceed based on conclusory allegations that the defendants knew they were acting in violation of the AKS.

Anti-Kickback Statute; Knowledge/Scienter; Motion to Dismiss

Split Seventh Circuit Panel Spars Over Escobar Interpretation

Sep 02 2021

Jaime L.M. Jones, Brenna Jenny and Jennifer Haney

The United States Court of Appeals for the Seventh Circuit recently allowed a previously dismissed qui tam case to proceed against Molina Healthcare of Illinois (“Molina”). The suit, brought by a relator who founded Molina subcontractor GenMed, alleges that Molina fraudulently billed Illinois’ Medicaid program for skilled nursing facility (“SNF”) services that were not actually provided. The district court previously dismissed the case at the pleading stage in June 2020, finding that the relator’s complaint insufficiently alleged that Molina knew its alleged false claims were material. The Seventh Circuit, in a split decision, reversed and remanded the case for further proceedings.

7th Circuit; Enforcement; Materiality; Medicare/Medicaid; SNFs

Fraud Theories Fail Under Rigorous Standards for “Worthless Services” and Materiality

Sep 02 2021

Brenna Jenny and Matt Bergs

Earlier this week, a court in the Eastern District of Pennsylvania dismissed a declined qui tam action in which the relator, a licensed nurse, alleged that an operator of treatment facilities for disabled individuals fraudulently billed Medicare and Medicaid for substandard care and retaliated against her for investigating that fraud.

Implied Certification; Retaliation; Rule 9(b); Worthless Services

HHS Hires Four Outside Firms to Audit Provider Relief Fund Recipients

Aug 27 2021

Jaime L.M. Jones and Brenna Jenny

Federal records recently made available by ProPublica reveal that from late February through early April 2021, Health Resources and Services Administration (“HRSA”), the component of HHS that administers the CARES Act Provider Relief Fund, engaged multiple outside contractors for work relating to auditing and oversight of the Provider Relief Fund, with task descriptions such as “PRF audit support services,” “Audit and financial review services of HRSA Provider Relief Fund programs,” and “Program integrity support for HRSA Provider Relief Fund programs.” Amounts obligated so far for this work total more than $5.3 million.

COVID-19; Enforcement

Finding No Materiality, Court Grants Summary Judgment for Defense in Fraudulent Inducement Case

Aug 25 2021

Jaime L.M. Jones, Brenna Jenny and Joseph LoCascio

On August 12, 2021, the United States District Court for the District of Minnesota granted Boston Scientific Corporation’s (BSC) motion for summary judgment in relator Stephen Higgins’s declined qui tam, which alleged that BSC had fraudulently induced the Food and Drug Administration (FDA) to approve two types of defibrillators that the FDA later recalled.

FDA; Fraudulent Inducement; Materiality; Summary Judgment

D.C. Circuit Reinstates Parts C/D Overpayment Rule

Aug 19 2021

Jaime L.M. Jones and Brenna Jenny

The D.C. Circuit Court of Appeals recently overruled an earlier district court vacatur of the CMS Parts C/D Overpayment Rule, resulting in reinstatement of the rule. The decision adopted the government’s arguments in full and is likely a harbinger of renewed confidence by DOJ in pressing forward with FCA cases premised on Medicare Advantage “upcoding.”

Medicare Advantage; Overpayments

Welcome to Original Source: The Sidley Austin False Claims Act Blog

What do the FDA’s expanded ‘intended use’ regulations mean for safe-harbored communications about new uses?

District Court Rejects Anti-Kickback Statute Claim Due to “Conclusory” Assertions of Unlawful Intent

Split Seventh Circuit Panel Spars Over Escobar Interpretation

Fraud Theories Fail Under Rigorous Standards for “Worthless Services” and Materiality

HHS Hires Four Outside Firms to Audit Provider Relief Fund Recipients

Finding No Materiality, Court Grants Summary Judgment for Defense in Fraudulent Inducement Case

D.C. Circuit Reinstates Parts C/D Overpayment Rule

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