Free Health Law Webinar–Dealing with the Government, Complainants, and Whistleblowers

It’s your last chance to register for the third free webinar in Wolters Kluwer Legal & Regulatory, U.S.’s four-part webinar series in partnership with Alston & Bird focusing on best practices for handling internal and external healthcare fraud and False Claims Act investigations.

“Dealing with the Government, Complainants, and Whistleblowers,” will explore the external and internal adversaries organizations face and participants will hear from a former United States Attorney about best practices for contending with them. To register, visit the link below:
Dealing with the Government, Complainants, and Whistleblowers 
Thursday, January 10, 2019 at 2 PM EST
Moderator: Frank Sheeder, Partner at Alston & Bird
Featured speakers: Former US Attorney Thomas Walker and Meredith Kingsley, Partners at Alston & Bird

For information on the full webinar series, visit http://health.wolterskluwerlb.com/2018/10/wk-announces-free-webinar-series-on-healthcare-investigations/

Kusserow on Compliance: Free Webinar! Best Practices for Conducting Internal Investigations

Channeling employees who wish to report allegations or complaints internally is critical to any effective compliance program, as well as to avoid the liabilities and other consequences to having them report externally. The HHS Office of Inspector General (OIG) and Department of Justice (DOJ), as well as other enforcement agencies, continue encouraging “whistleblowers” by offering great bounties for successes from their information. In 2016, recoveries totaled $3 billion with whistleblowers receiving as their share—$519 million. In addition, nearly a quarter-million whistleblowers contacted the OIG directly or through the agency’s hotline during the same period. Wolters Kluwer is hosting a complimentary webinar on January 26, 2017 from 1:00-2:30 PM EST, entitled, “Best Practices for Conducting Internal Investigations.” The presenters are Richard P. Kusserow, former FBI executive and HHS Inspector General, along with Kashish Chopra, JD. Both have extensive experience with conducting internal investigations. Today’s blog focuses on the predication of internal investigations that is also addressed in the webinar in more detail. There are many ways be called upon to respond to a complaint or concern raised by an employee, including compliance officers, human resource management (HRM), legal counsel, privacy/security officers, and risk managers, among others; however, only a few complaints would rise to the level of requiring an investigation.

An investigation is a search to uncover facts and seek the truth of an issue (who, what, when, where, why, how) and involves a detailed inquiry or systematic examination to gather facts and information to solve a problem, or resolve an issue. Other activities can meet this definition, including conducting audits, evaluations, and inquiries. All these other activities involve a detailed examination of facts. The fact is that vast majority of hotline complaints can be resolved fairly quickly—within hours or a day or two—without a formal investigation. Many complaints, allegations, and concerns are routine in nature and may be resolved through normal management procedures or through HRM. In determining how to respond to complaints and allegations properly, it should be a standard practice to, in effect, “triage” all the facts known, similar to what medical staff does when a patient arrives at an emergency room at the hospital. This involves an analysis of the complaint and any allegations to determine who is best equipped to resolve the issues. It may be the multiple functions may need to be involved. From this initial analysis, an investigative plan can be developed.

However, when it is determined that a matter requires an investigation, the key is how to do this properly, preferably using properly trained individuals to conduct the investigation. Anyone called to conduct an investigation must understand how to plan an investigation, conduct proper interviews, organize evidence, prepare written reports, and document management. Is unrealistic to have professional investigators in compliance offices, but certain basic principles should be taught to anyone taking on the role of an investigator, whether they come from the compliance office, HRM, legal counsel, privacy office, etc. Anyone who is likely to conduct an internal investigation should have as a minimum a basic understanding of best practices and methods. The upcoming webinar is designed to provide some of the basic principles in conducting a proper investigation in a timely manner.

Click here to register.

Richard P. Kusserow served as DHHS Inspector General for 11 years. He currently is CEO of Strategic Management Services, LLC (SM), a firm that has assisted more than 3,000 organizations and entities with compliance related matters. The SM sister company, CRC, provides a wide range of compliance tools including sanction-screening.

Connect with Richard Kusserow on Google+ or LinkedIn.

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Copyright © 2017 Strategic Management Services, LLC. Published with permission.

PharMerica requests Supreme Court review of FCA’s first-to-file bar

PharMerica Corporation, a provider of long-term care pharmacy services, asked the Supreme Court to change its position on the “first-to-file” bar under the False Claims Act (FCA). In a petition for a writ of certiorari, the pharmacy company asked the high court to review its May 2015 ruling in Kellogg Brown & Root Services, Inc. v. U.S. ex rel. Carter (Carter), in which the court ruled that an earlier FCA suit based upon substantially the same subject matter ceases to bar related and subsequent FCA suits after the earlier suit is dismissed. PharMerica objects to the 2015 ruling because it led to the revival of a whistleblower case brought against the company by a former employee. PharMerica’s petition warns that the Supreme Court needs to review its earlier decision to prevent the “neutering of the first-to-file bar.”

Trial court

The dispute arose from the qui tam action of a pharmacist formerly employed by PharMerica. Because a similar case was pending in Wisconsin (Wisconsin case) when the whistleblower’s case was filed, a district court dismissed the case on the grounds that it was barred under 31 U.S.C. §3730(b)(5). The trial court concluded that dismissal under the first-to-file bar was appropriate because the two actions were based on substantially the same facts and conduct.

First Circuit

After the case was dismissed, the Supreme Court handed down its decision in the Carter case, changing the outlines of the FCA’s first-to-file bar. Subsequent to that decision, the Wisconsin case that barred the whistleblower action was settled and dismissed. As a result, the whistleblower filed a motion to remand, seeking to either have the appeals court supplement his complaint with additional facts or have the case remanded to allow for supplementation. The First Circuit granted the whistleblower’s request to supplement his complaint (see FCA action dismissed under first-to-file bar may get another chance on remand, Health Law Daily, December 17, 2015).

Certiorari

PharMerica objected to the First Circuit’s decision in its petition, asserting that the Carter decision and the appellate court’s holding will allow copycat lawsuits to “circumvent the plain terms of the first-to-file bar.” The pharmacy service provider argued that the whistleblower should not have been able to resurrect his case simply by keeping it on the docket until the prior case was inevitably dismissed. PharMerica asserted that review is necessary to prevent copycat relators from “bringing placeholder suits, certain in the knowledge that earlier-filed actions will one day conclude.”

AHA urges Fourth Circuit to strike down false claims extrapolation

The American Hospital Association (AHA), in conjunction with the Catholic Health Association of the United States (CHA), urged the U.S. Court of Appeals for the Fourth Circuit to affirm a lower court’s ruling that qui tam relators are not permitted to use statistical sampling and extrapolation to determine the number of false claims submitted for reimbursement. The associations, via an amici curiae brief, emphasized the False Claims Act’s (FCA) (31 U.S.C. §3729) requirement of proof that a physician’s treatment decision was unreasonable to the point of fraud.

No proof, no settlement

Last year, the South Carolina district court ruled that the federal government can veto a qui tam settlement, even when it chooses not to intervene. In U.S. ex rel. Michaels v. Agape Senior Community, Inc., this veto was based upon the settlement’s reliance on statistical extrapolation to determine how many claims were fraudulent (see Between a rock and a hard place: U.S. won’t help with trial but blocks settlement, Health Law Daily, June 29, 2015). The relators brought the case against 24 affiliated skilled nursing facilities on the grounds that hospice claims and claims for general inpatient care services were filed without regard to medical necessity. The suit involved tens of thousands of claims, and review of each claim would cost between $16.2 and $36.5 million. In lieu of review, the relators proposed extrapolating the number of false claims from a sample of patient files. The relators and companies agreed to settle the case for $2.25 million, which the government rejected due to a belief that the case was worth $25 million.

Amici curae

The AHA and CHA find the notion of FCA liability based on extrapolation “extremely alarming,” as their members provide many services reimbursed by the government. The associations believe that the risks of allowing FCA extrapolation on health care providers would be enormous due to treble damages, per-claim penalties, and fee shifting for attorneys fees. The brief argues that extensive penalties should not be levied without requiring a relator to prove that claims are actually false, in accordance with prior Fourth Circuit rulings as well as the FCA itself.