In a recent Statement of Interest, DOJ articulated a problematic, and incorrect, theory of materiality in an apparent effort to make it virtually impossible for defendants to defeat bare allegations of materiality at the motion to dismiss stage in cases that involve allegedly false claims for prescription drugs.
DOJ has repeatedly emphasized its commitment to pursuing fraud relating to the COVID-19 public health emergency (as discussed further here). But so far, little has been made public regarding enforcement scrutiny of payments from the Department of Health and Human Services Provider Relief Fund, which includes a designated fund for reimbursing providers for COVID-19 testing, treatment, and vaccination for the uninsured (“COVID-19 Uninsured Program”).
However, HHS officials recently announced that they had referred to the HHS Office of Inspector General a provider that is an outlier on reimbursement for treatment claims from the COVID-19 Uninsured Program. Providers that have received payments from the COVID-19 Uninsured Program should take steps to ensure that they are in full compliance with the terms and conditions for payment, including the balance billing restriction.
Sidley lawyer Brenna Jenny recently authored an article, available here, discussing this enforcement development.
Sidley lawyers Jaime L.M. Jones, Brenna E. Jenny, and Catherine D. Stewart recently published an article in Bloomberg Law entitled Tips for Responding to a DOJ Inquiry Into Pandemic Billing. The Department of Health and Human Services extended significant billing flexibility to providers during the COVID-19 public health emergency, and law enforcement can be expected to closely examine how providers have exercised those more relaxed rules. The article offers tips for the in-house legal and compliance functions of healthcare providers as to how they can best position their organizations for successfully engaging with DOJ and state attorneys general on False Claims Act investigations relating to the use of pandemic billing flexibilities.
A copy of the article is available here.
Sidley lawyer Brenna Jenny, along with Mihran Yenikomshian and Paul Greenberg of Analysis Group, authored an article entitled “Health Companies Can Reduce FCA Risk by Leveraging Data,” available here. One of the most notable recent trends in FCA enforcement is an evolution in how DOJ identifies cases for investigation. No longer reliant solely on whistleblowers, DOJ has begun implementing increasingly sophisticated data analytics to initiate many of its own FCA cases, as discussed further here and here. The article discusses how healthcare industry participants can defensively deploy their own data to identify potential problems through internal investigations before they become part of government investigations.
A federal district court recently issued a rare order denying the Department of Justice’s (DOJ) motion to intervene in a qui tam suit after the government’s initial declination months earlier. See United States ex rel. Odom v. Southeast Eye Specialists, PLLC, 3:17-cv-00689 (M.D. Tenn. Feb. 24, 2021). The False Claims Act allows the government to intervene in a case in which it previously declined to intervene upon “a showing of good cause.” Although DOJ does so not frequently seek to intervene after previously declining to do so, courts are generally deferential to the government’s shift in position. This decision provides important precedent for defendants in the position of arguing that a late intervention by DOJ is not appropriate.
During the Federal Bar Association’s 2021 Qui Tam Conference, two senior government lawyers—Neeli Ben-David, the Civil Division Deputy Chief and Health Care Fraud Coordinator for the U.S. Attorney’s Office for the Northern District of Georgia and Karen Glassman, Senior Counsel at the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”)—provided insights into how defendants can position themselves for successful engagement with the government and how DOJ and HHS-OIG coordinate behind the scenes to investigate and resolve FCA cases.
Yesterday during the Federal Bar Association’s 2021 Qui Tam Conference, Charlene Keller Fullmer, the Civil Assistant Chief for the Eastern District of Pennsylvania, discussed how enforcement actions involving violations of the Sunshine Act are poised to increase, aided by data analytics.
Yesterday, Senator Grassley, the architect of the 1986 False Claims Act amendments, and Brian Boynton, the Acting Assistant Attorney General of DOJ’s Civil Division, delivered the opening remarks at the Federal Bar Association’s 2021 Qui Tam Conference, previewing Senator Grassley’s priority legislative changes to the FCA and DOJ’s enforcement priorities under the Biden administration.
Two recent decisions by district courts in the Third Circuit illustrate the continued divide among courts regarding the extent to which the government’s declination decision bears on the materiality analysis set forth in Escobar and also underscore the challenges defendants can face in defeating materiality at the motion to dismiss stage.
A recently leaked internal DOJ memo reveals a dramatic shift in DOJ’s approach to dismissal of non-intervened qui tam suits. Citing the “significant resources” that the government expends even in non-intervened cases, the memo—drafted by Commercial Litigation Branch Director Michael Granston—sets forth a series of factors for lawyers with DOJ and U.S. Attorneys’ offices to consider when evaluating whether to seek dismissal of a qui tam case. (more…)