On January 10, 2018, citing costs associated with record increases in the number of qui tam actions filed under the False Claims Act, the Department of Justice issued a memorandum[1] to certain DOJ attorneys, strongly signaling the Department’s intent to liberalize its use of section 3730(c)(2)(A) to seek dismissal of qui tam actions.

In the recently leaked memo, Michael Granston, Director of the Fraud Section of DOJ’s Commercial Litigation Branch, outlines “a general framework for evaluating when to seek dismissal” by identifying seven factors that have supported DOJ’s previous successful dismissal requests and emphasizes that the Department views its dismissal authority as one subject only to “highly deferential” review by the courts. The memo suggests DOJ will seek dismissal of these actions more often, making use of its authority to seek dismissal as “an important tool to advance the government’s interests, preserve limited resources, and avoid adverse precedent.” As further indication that the Department intends to pursue aggressively any available means of dismissal of these cases, the Director also recommends asserting in the alternative other independently available grounds for dismissal or requesting partial dismissal where appropriate, and the memo reminds attorneys that dismissal may occur at any stage of the proceedings, depending on the circumstances. The Director also stresses the importance of communication between the DOJ, the affected agency, and relators as a means of encouraging voluntary dismissal. Continue Reading DOJ Signals More Liberal Exercise of Power to Dismiss Qui Tam Actions under the FCA

The Inspector General took an unprecedented step Tuesday, rescinding a favorable Advisory Opinion first issued in 2006 that had provided assurances to the patient assistance charity, Caring Voice Coalition, that its drug subsidy program would not expose the organization to liability under the Anti-Kickback Statute. Continue Reading OIG Rescinds Favorable Advisory Opinion for Patient Assistance Charity, Caring Voice Coalition

money-closeup122486570On June 12, 2017, the Department of Health and Human Services Office of Inspector General (OIG) published a report with the objective of determining whether the Centers for Medicare & Medicaid Services (CMS) made proper incentive payments to providers for “meaningful use” of a certified electronic health record (EHR).  The report, entitled “Medicare Paid Hundreds of Millions in Electronic Health Record Incentive Payments That Did not Comply with Federal Requirements,” estimates that CMS improperly paid $729 million in EHR incentive payments to providers who did not actually comply with the requirements of meaningful use. Continue Reading OIG Turns Focus to Providers for Improper Meaningful Use Payments

Warning signThe Department of Justice (DOJ) recently announced a $155 million settlement agreement with an electronic health records (EHR) vendor, eClinicalWorks (ECW), to settle False Claims Act allegations against the company initially brought by a whistleblower/qui tam relator.  The whistleblower was a software technician for the City of New York City who was implementing ECW software in a prison healthcare system.  The DOJ subsequently intervened and filed suit.  The May 31, 2017 announcement is the first of its kind, holding an EHR vendor accountable for claims made about their certifications.

Provider clients of ECW relied on the assertions made by ECW that their EHR software met the criteria of the Office of the National Coordinator of Health Information Technology (ONC) certification program.  Based on ECW’s software and the assertion of EHR certification, providers believed they had achieved “meaningful use” and received incentive payments under the Medicare and Medicaid EHR Incentive Programs.  Continue Reading Warning EHR Vendors: Evaluate Certifications and Sales/Marketing Activities to Avoid Millions in Liability

abaEmerging Issues in Healthcare Law is coming to the Big Easy. The American Bar Association’s 18th annual conference is slated for New Orleans March 8-11.

Husch Blackwell is a platinum sponsor of this event featuring the most emergent topics facing the healthcare bar. As the industry faces changes and continues to grow under healthcare reform and enforcement, this conference allows attendees a perfect opportunity to stay ahead of the developments. Continue Reading Don’t miss Emerging Issues in Healthcare Law

dollar-signiStock_000013001848_LargeRoughly $2.95 for each $1 overpaid (plus legal costs and the overpayment) based on an August 24, 2016, U.S. Attorney’s Office press release regarding settlement of State of New York, ex rel. Robert P. Kane v. Healthfirst, Inc. et al case in the U.S. District Court for the Southern District of New York. Defendants previously lost a motion to dismiss this case based, in part, on the fact that defendants actually identified and repaid the overpayments. Specifically, about $1 million in overpayments were presented to the defendants in the form of a spreadsheet in February 2011. Subsequently, defendants repaid the overpayments in more than 30 installments from April 2011 to March 2013. Notwithstanding, the government took the position that, under the False Claims Act, repayment should have been made within 60 days of the date of the claims were identified in the spreadsheet. Defendants argued, among other things, that there was ambiguity about the term “identify” as used in the False Claims Act and that the spreadsheet was merely the first component of an investigation into the overpayments that was ongoing through the repayment process. Almost a year after losing the motion to dismiss, defendants settled the case for $2.95 million. Continue Reading How much does it cost to identify and repay federal health plan overpayments late?

flag_160540827The Supreme Court’s unanimous decision in Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7 (U.S. June 16, 2016) upholds the viability of the implied certification theory of False Claims Act liability. But it also makes cases arising from minor instances of noncompliance much harder to prove. The Court held that a knowing failure to disclose a violation of a material statutory, regulatory, or contractual requirement can create False Claims Act liability. The requirement need not be an express condition of payment, but it must be material to the government’s decision to pay. Continue Reading New standard of proof for implied certification liability under FCA

gavel2-touched upIn some courts in the United States today, a government contractor or a healthcare provider seeking reimbursement from a federal program can violate the False Claims Act even when its work is satisfactory and its invoices are correct. Under the theory of “implied certification,” a minor instance of non-compliance with one of the thousands of applicable statutes, regulations, and contract provisions can be the basis for a federal investigation, years of litigation, as well as fines, penalties, suspension and debarment, even imprisonment of company personnel. Continue Reading How the Supreme Court will limit False Claims Act liability for implied certification

dollar-signiStock_000013001848_LargeOn Feb. 12, the Department of Health and Human Services’ (“HHS”) Centers for Medicare & Medicaid Services (“CMS”) published its final rule regarding reporting and returning Medicare overpayments. This final rule comes nearly four years after its proposed rule regarding the reporting and return of Medicare overpayments that left the provider community nervous and uncertain about when an overpayment would be considered “overdue” under CMS’s vague 60-day standard. Continue Reading Summary of the final HHS rule for reporting and returning of overpayments

corporative buildingIn the 2016 Physician Fee Schedule Final Rule published on Nov. 16, 2014, the Centers for Medicare & Medicaid Services (CMS) finalized the proposed exception for timeshare arrangements that we discussed in our earlier blog post [80 Fed. Reg. 70,886, 71,300 (Nov. 16, 2015)]. As we stated in our earlier post, a timeshare or part-time “space use” arrangement typically provides a physician with the use of office space during scheduled time periods. The space usually includes furnishings with basic medical office equipment, supplies and support personnel so that the physician is able to use the space, on a turn-key basis, to see patients during scheduled times. Prior to the implementation of the new timeshare exception, these types of arrangements needed to be structured to comply with the Rental of Office Space Exception, which includes “exclusive use” requirements that many hospitals and physicians found burdensome [42 C.F.R. § 411.357(a)]. Continue Reading CMS finalizes new timeshare exception to the Stark law