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U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.
Continue Reading Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

As described in an April 17, 2018 article originally posted on the Sheppard Mullin Richter and Hampton, LLP False Claims Act Defense Blog, Kmart Corporation and the U.S. Department of Justice entered into a False Claims Act settlement agreement dated March 8, 2018, to end an investigation that was conducted jointly by the United States Attorney’s Office for the Eastern District of California and California’s Bureau of Medicaid Fraud and Elder Abuse.

In a March 8, 2018 Press Release issued by the Department of Justice, the Department reported that the settlement was the result of a whistleblower lawsuit against Kmart in which the whistleblower, a Pharmacist-in-Charge at a California Kmart location in Lakeport, California, alleged that Kmart violated the federal False Claims Act by knowingly submitting claims for reimbursement to California’s Medi‑Cal program that were not supported by applicable diagnosis and documentation requirements.  As described in the March 8, 2018 Press Release, Kmart paid $525,000, as required by the Settlement Agreement; of this amount, $96,500 went to the whistleblower.
Continue Reading In Case Alleging Nationwide Pharmacy Fraud, Kmart Scores Narrow Settlement

A Florida federal court threw out a $350 million jury verdict against a nursing facility, citing the Supreme Court’s landmark decision in Universal Health Services, Inc. v. United States ex rel. Escobar. The court explained that the relators had failed to establish that the alleged violations were material to the federal Medicare and state Medicaid programs’ decision pay claims.

The ruling is another piece of welcome news to the healthcare community, which is historically the primary target of the government’s False Claims Act enforcement efforts. The ruling demonstrates that under Escobar, it is one thing to proclaim that a violation was material to the government’s decision to pay, but it is another thing to prove it.
Continue Reading Escobar’s Demanding Materiality Standard Nixes $350 Million Verdict Against Florida Nursing Facility

On June 16, 2016, the Supreme Court issued its opinion (“Op.”) in Universal Health Services v. U.S. ex rel. Escobar (“Escobar”), a case testing the viability and scope of the implied certification theory of False Claims Act (“FCA”) liability.  Under the implied certification theory, a defendant may be liable under the FCA based on the its failure to comply with certain statutory, regulatory, or contractual provisions, even if the defendant did not expressly certify compliance..  The circuits have split, both on whether an implied certification theory is viable at all and, if so, when non-compliance can trigger FCA liability.
Continue Reading Supreme Court Preserves But Significantly Changes “Implied Certification” Theory of False Claims Act Liability

The Health and Human Services (HHS) Office of Inspector General (OIG) provides health care providers an opportunity to disclose potential violations of certain Federal civil and criminal laws in relation to HHS contracts or subcontracts, pursuant to which OIG offers a means for facilitated resolution. A new publication issued by OIG offers guidance on completing the self-disclosure form, and has been posted alongside an FAQ on the protocol.[1]
Continue Reading New Guidance on Contractor Self-Disclosure

E-discovery is especially challenging in healthcare related litigation due to the healthcare industry’s reliance on electronically stored information (ESI), the volume of medical records often at issue in health care litigation, especially, qui tam litigation, the time periods often at issue given the lengthy statutes of limitations and the relevance of the information that the records contain.  A May 8, 2014, Report and Recommendation (Report) on a motion for sanctions alleging spoliation of medical records, in U.S. ex. rel. Elin Baklid-Kunz v. Halifax Hospital Medical Center et. al., offers a cautionary tale for both in-house and retained counsel about the importance of a coordinated and meticulously executed plan for producing electronically stored information (ESI).  After summarizing the underlying claims and discovery issues, this article offers guidance for laying the foundation of a sound, manageable ESI production plan.
Continue Reading Lessons From A Cautionary Tale of Electronic Discovery Pitfalls in Health Care Litigation