The Coronavirus Aid, Relief, and Economic Security (CARES) Act provided trillions in economic relief in response to the COVID-19 pandemic, including hundreds of billions of dollars in aid for the healthcare industry.  Regulators in the healthcare industry have also adjusted regulations and procedures in response to the changing landscape caused by the pandemic.  While the CARES Act and regulatory changes provide much-needed help, accepting funds and navigating the regulatory changes can add many legal pitfalls to an already cluttered regulatory scheme.  As the government prepares to prosecute fraud and abuse by recipients of CARES Act funds, healthcare entities—the top payors of government enforcement and qui tam dollars—should take care to avoid claims of misconduct under the CARES Act.
Continue Reading Tips for the Unwary: Precautions Against Liability for Healthcare Businesses Receiving CARES Act Funds

The “Granston Memo” has proven to be a boon again in 2019 for False Claims Act (“FCA”) defendants.  In a January 15, 2019 Sheppard Mullin FCA Defense Blog article, we highlighted a growing movement by the Department of Justice (“DOJ”) to utilize its dismissal power on meritless and burdensome qui tam FCA cases following an internal policy memorandum issued in early 2018, now dubbed the “Granston Memo.”  The Granston Memo encouraged DOJ attorneys to seek dismissal of such cases where it served one or more important policy objectives.  The DOJ has met with almost uniform success in its continued focus on this effort: since the Memo issued, the DOJ has sought dismissal in 36 cases and been unsuccessful only twice. 
Continue Reading The Granston Memo in 2019: Recent Cases Highlight the Granston Memo’s Effectiveness as a Tool to Dismiss False Claims Act Cases

In a highly anticipated opinion in the AseraCare case, issued on September 9, 2019, the Eleventh Circuit Court of Appeals affirmed the district court’s holding that “a clinical judgment of terminal illness warranting hospice benefits under Medicare cannot be deemed false, for the purposes of the False Claims Act, when there is only a reasonable disagreement between medical experts as to the accuracy of their conclusion, with no other evidence to prove the falsity of the assessment.” U.S. v. AseraCare, Inc., No. 16-13004, at *3 (Sept. 9, 2019 11th Cir.) (“Op.”). Although the Court remanded the case to the district court to consider any such “other evidence” the Government might identify in the record, it also made clear that such evidence would need to “link” to specific claims submitted for payment, creating a substantial practical impediment to the Government’s ability to prove falsity in this and similar cases. See Op. at 56.
Continue Reading The Eleventh Circuit Remands AseraCare, But Affirms High Hurdle for Proving Falsity

On July 31, 2019, the U.S. Court of Appeals for the Eleventh Circuit affirmed a lower court’s decision to grant summary judgment to hospital operator HCA and dismiss relator Thomas Bingham’s allegations. Bingham v. HCA (S.D. Fla. July 31, 2019) (“Op.”). In a well-reasoned opinion, the Court affirmed several key holdings:

  • There is no “remuneration”, for Federal health care program anti-kickback statute (“AKS”) purposes, unless a benefit is conferred for less than fair market value. In other words, as long as compensation to or from a referral source is consistent with fair market value, the AKS is not implicated.
  • With respect to the Stark Law, showing that a space lease arrangement effectuates an “indirect compensation arrangement” between a hospital and a referring physician requires a showing that the space, rental rates, or benefits under the lease correlate with the volume of the physician’s referrals to the hospital.
  • It may be appropriate for a court to strike allegations from an amended False Claims Act complaint if they are based on information uncovered by a relator during discovery.

These holdings should be welcomed by defendants of alleged AKS, Stark Law, and False Claims Act violations.
Continue Reading Eleventh Circuit Affirms Key Kickback Statute, Stark Law, and False Claims Act Principles in Dismissing Allegations Against HCA

Federal prosecutors announced yesterday the Government’s settlement with electronic health records (“EHR”) vendor Greenway Health, LLC (“Greenway”) of False Claims Act (“FCA”) allegations for a payment of $57.25 million and Greenway’s acceptance of a Corporate Integrity Agreement (“CIA”). The Government’s FCA complaint was filed by the U.S. Attorney’s Office for the District of Vermont, the same office that handled the May 2017 civil settlement with EHR company eClinicalWorks for $155 million. The Greenway settlement is the second largest civil settlement in the District of Vermont’s history, topped only by the eClinicalWorks settlement.
Continue Reading Government Puts Electronic Health Records Companies “on Notice” of Vigorous False Claims Act Enforcement

Summer is almost here. For some, that means planning vacations to the beach, hitting the gym to shed that winter weight, or perhaps hitting the golf course—but for us at the Sheppard Mullin Healthcare Law Blog and the False Claims Act Defense Blog, summer signals the anniversary of the Supreme Court’s seminal decision in Universal Health Services, Inc. v. United States ex rel. Escobar
Continue Reading What Have We Learned About False Claims Act Litigation in the Two Years Since Universal Health Services, Inc. v. United States ex rel. Escobar? Quite a Lot, Actually

The False Claims Act contains numerous requirements that are designed to prevent meritless cases from proceeding to discovery and trial. Among these provisions is the rule that, to establish liability, the government or a relator must show that an actual claim was submitted to federal Medicare or state Medicaid for reimbursement. In some Circuits, such as the Eleventh, the government or a relator must identify claims at the pleading stage. Failure to do so will result in dismissal.
Continue Reading Healthcare Industry Beware: The Use of Statistical Sampling to Establish Damages and Liability Under the False Claims Act Remains a Viable Option for Plaintiffs

[1] On January 25, 2018, Associate Attorney General Rachel Brand issued a memorandum on behalf of the U.S. Department of Justice (DOJ) (the “Brand Memo”) which effectively limits the use and enforcement power of guidance documents for the purposes of affirmative civil enforcement cases, a development that could have a significant impact on how certain healthcare cases are handled at the federal level by federal departments, agencies, and administrations, including those that are fixtures of the healthcare marketplace – the Department of Health and Human Services (HHS) and its constituent agencies, including the Centers for Medicare and Medicaid Services (CMS), the Food and Drug Administration (FDA) and the HHS Office of Inspector General (OIG).
Continue Reading New DOJ Guidance Policy Limits Use of Guidance Documents in Federal Civil Actions

On January 19, 2018, the United States Court of Appeals for the Third Circuit affirmed a district court’s ruling granting summary judgment to a specialty pharmacy that was accused of violating the Anti-Kickback Statute and the federal False Claims Act (United States ex rel. Greenfield v. Medco Health Solutions, Inc. et al., No. 17-1152.). The court held that the relator, a former vice president of the specialty pharmacy, failed to link the pharmacy’s alleged kickback scheme to the actual submission of claims to Medicare. The decision is important because it stands for the proposition that to be liable under the False Claims Act a relator must allege more than the defendant was submitting claims for federal health care program beneficiaries while engaging in kickbacks. Rather, it must allege that at least one claim was submitted for services that were provided in violation of the Anti-Kickback Statute.
Continue Reading Temporal Proximity Is Not Enough: Third Circuit Nixes FCA/Anti-Kickback Suit For Failure To Link Alleged Scheme to Claims

The DOJ is empowered under the FCA to seek dismissal of unmeritorious qui tam suits brought in its name. The DOJ has historically used this power sparingly. We are happy to report, however, that more dismissals may be on the horizon.

On January 10, 2018, Michael Granston, Director of the Commercial Litigation Branch of the Fraud Section of the U.S. Department of Justice circulated an internal memorandum that was published last week in the legal press. The memorandum collects cases in which the Department sought dismissal of unmeritorious qui tams. It categorizes these cases into seven factors that DOJ attorneys should consider when evaluating whether the government should seek to dismiss a qui tam.

Nearly all FCA recoveries against healthcare entities in the last three years came from cases filed by qui tam relators. In other words, of $7.3 billion recovered from healthcare entities in 2015-17, $6.9 billion of that originated from qui tam suits. The Department of Justice’s guidance is welcome news for healthcare entities as it will likely further stymie unmeritorious qui tam litigation.

The following article, “DOJ Formalizes Guidance for Government Dismissal of Unmeritorious Qui Tam Suits,” by Michael Paddock, David T. Fischer and Matthew Turetzky was previously posted on January 25, 2018, on the Sheppard Mullin False Claims Act Defense Blog.
Continue Reading The Department of Justice Delivers Some Good News to the Healthcare Industry: New False Claims Act Guidance Predicts More Challenges to Qui Tam Plaintiffs

In a year when the Department of Justice recovers $2.5 billion from the healthcare industry in False Claim Act judgements and settlements, can there really be a silver lining?

Every December, the Department of Justice (DOJ) releases its annual False Claims Act (FCA) recovery statistics for the preceding fiscal year. The recovery statistics, as they have for the past several years, indicate the DOJ considers the healthcare industry to be the number one target for FCA enforcement activity. Of the $3.7 billion in judgments and settlements recovered by the DOJ in 2017, $2.5 billion of that came from the healthcare industry. That is a tremendous number and indicates that the DOJ’s enforcement priority continues to be healthcare—as it has been for the last several years. In 2016, the DOJ recovered $2.6 billion from the healthcare industry. And in 2015, the DOJ recovered $2.2 billion from the healthcare industry. Healthcare has been a focus of DOJ’s FCA enforcement strategy for several years—and it shows no signs of changing any time soon. 
Continue Reading The 2017 Department of Justice False Claims Act Recovery Statistics: