Webinar provides multiple perspectives on FCA cases

To avoid federal False Claims Act (FCA) (31 U.S.C. §3729 et seq.) liability, providers should implement an effective compliance program, stay ahead of the government’s investigation of possible FCA violations, and fix problems first. In a Health Care Compliance Association (HCCA) webinar entitled, “False Claims Act Cases—Perspectives from Both Sides of the Aisle,” Rachel V. Rose, principal at Rachel V. Rose—Attorney at Law, PLLC, and Sean McKenna, shareholder at Greenberg Traurig LLP, provided an overview of the process for filing federal FCA complaints and how to respond to investigations and lawsuits under the FCA.

Complaints

Qui tam relators file their complaints under seal, on behalf of the government. The Department of Justice (DOJ) has 60 days to investigate and decide whether to intervene, which happens only about 10 percent of the time. Even then, the government will prosecute only the strongest aspects of the case. The presenters warned that relators should use “an abundance of caution” when discussing an FCA case or the underlying allegations with anyone other than the whistleblower’s attorney or the government agents assigned to the case, as “breaking the seal” can result in dismissal or sanctions.

False claims

The type of false claim that most frequently leads to FCA liability is a claim for services not provided. Other categories of false claims include legally false claims (express), legally false claims by implied certification, and reverse false claims. In United Health Services, Inc. v. United States ex rel. Escobar, (2016), the U.S. Supreme Court upheld the implied certification theory and relied on whether the claim was material to payment, what McKenna called a “groundbreaking approach” (see Implied certification liability confirmed, limited to material compliance violations, Health Law Daily, June 16, 2016).

Since November 2, 2015, the range of penalties for violating the FCA increased from $5,500-$11,000 to $10,781-$21,562, plus treble damages and the relator’s attorney fees. FCA violations can also lead to exclusion, “the death penalty for health care providers.” Exclusion applies only to conduct from the past 10 years (42 C.F.R. Sec. 1001.901(c); see HHS OIG’s exclusion authority loosens, allows more discretion, Health Law Daily, January 12, 2017).

In parallel proceedings, simultaneous civil/criminal/administrative investigation of the same defendants occurs. It can be federal and state/local or multi-district. Not every case is appropriate for parallel proceedings, however. Examples of common parallel matters include procurement and government program fraud, health care fraud, internet pharmacies, and antitrust investigations.

Yates memo

The past several years in health care fraud and abuse prosecutions have seen an increased focus on individual actors such as executives, as reflected in a September 9, 2015 memo from former acting attorney general Sally Yates, known as the “Yates Memo.” The Memo emphasized the DOJ’s commitment to combat fraud “by individuals” and recommended that: (1) to qualify for a cooperation credit, a corporation must provide facts relating to the individuals responsible for the misconduct; (2) investigations should focus on individuals from the inception of the investigation; (3) culpable individuals should not be released from liability absent extraordinary circumstances; and (4) DOJ attorneys should not resolve matters with a corporation without a clear plan to resolve related individual case.

Best practices

If an FCA investigation occurs, providers should evaluate all liability (civil, criminal, administrative, state, licensure, and private), determine if anyone needs separate counsel or has talked to the government, preserve documents, and compile the right team, including consultants, billing and coding experts, and statisticians.

Is statistical sampling in audits, FCA cases, and recoupment valid?

The government has used random sampling for a very long time as a way to provide sufficient evidence of valid audits and intent or “reckless disregard” False Claims Act (FCA) cases. While the government considers a random sample a valid sample, “’random’” is not necessarily ‘valid’, according to Tracy M. Field, partner, Parker, Hudson, Reiner & Dobbs, LLP and Sandra Miller, partner, Womble Carlyle, Sendridge & Rice LLP. Health care providers must manage and defend against statistical evidence derived from a government audit or presented to a court. Field and Miller presented their viewpoints and practical tips in a session on March 26, 2017, at the Health Care Compliance Association Annual Compliance Institute.

Statistics in audits

Inferential statistics include a probe audit to ensure that there is a good understanding of the population and study design, according to the presenters. By definition, inferential statistics samples items to determine what a population might look like by selecting a random sample. Providing the example of 20 quarters pulled at random from a box of coins, the presenters asked “What do you know about the population based on the sample selected?” Do the quarters represent the actual coin content of the box? Are the sampled items, in this example, coins, providing a normal distribution or a skewed distribution that could be biased? Can the 90 percent confidence interval be “correct” for very imprecise data? Their answer was that we don’t always know how many quarters versus nickels are in the box and what how that concept relates to statistical samplings in claims audits.

Multiple strata. For audits to be more precise, claims are audited by identifying multiple strata. The presenters noted that a sampling unit for an Office of Inspector General (OIG) is a claim, but they stressed that “a beneficiary’s claim is really a cluster of claims which is less precise.” In another example of government audits, the multiple strata involved Current Procedural Terminology® (CPT®) codes but the audits did not take into account the payment variables or the number of claim lines sampled.

Error rates. According to the presenters, the government threshold for error rates is 5 percent in settlements. In addition, for Discovery Samples, OIG uses a 5 percent error rate to determine the full sample size, however, error rates can vary, specifically in Provider Reimbursement Review Board cases. Presenters recommended that providers speak to their legislators regarding audit issues and error rates.

Statistical sampling in False Claims Act cases

In FCA cases, statistics are used to prove the intent of the provider and establish damages. The presenters referred to court cases as they identified questions for providers to ask including whether the case involve medical necessity of the services, whether a realtor can use statistical sampling to prove both liability and damages, whether the sampling reflects patients that may need more rehabilitation, and whether patients are individually considered?

The presenters specifically pointed out the arguments in the brief of the U.S. ex rel Michael and Whitesides v. Agape case before the fourth circuit court, where the defendants argued that “statistical evidence is poorly adapted to providing the falsity and knowledge of elements of FCA liability generally, […] particularly in this case, which involves clinical judgments, such as whether a patient is terminal ill, which is “a highly individualized, context- specific, and uncertain.” In addition, the brief noted that “courts have consistently rejected attempts to use statistical sampling to prove liability in fraud cases.”

Recoupment

The brief in the Agape case explained the recoupment process as an administrative proceeding initiated by a claims processor to recover overpayments through the reduction of future Medicare payments, is a contractual set-off and is far different from an FCA case, according to the presenters. The recovery is limited to the actual amount of the overpayment plus interest while the FCA exposes defendants to treble damages and a fine of at least $5000 per claim. The burden of proof is on the payee to prove that it is entitled to the amount paid.  Further, sampling and extrapolation in recoupment action are authorized by statute if there is evidence of sustained or high level payment error (42 U.S.C. §1395ddd(f)(3)).

Kusserow on Compliance: Free Webinar! Conducting Internal Investigation Interviews—Some Best Practices and Tips

Wolters Kluwer is hosting a complimentary webinar on January 26, 2017, entitled, “Best Practices for Conducting Internal Investigations.” The presenters are Richard P. Kusserow, former FBI executive and HHS Inspector General, and Kashish Chopra, JD. Both have extensive experience with conducting internal investigations. Today’s blog provides some tips on the most critical part of most investigations; conducting witness interview. This subject will be provided in more depth during the webinar.

Always project a professional image

This begins with how one is attired. An interview is a formal business meeting and those conducting them should dress accordingly. Dressing down in jeans or other casual clothing does not project a professional image. Those interviewed are not friends; and therefore investigators should not dress and act as if they were. The demeanor of interviewer is important to outcome of interview. If interviewer appears quietly competent and professional, it will encourage confidence in the individual being interviewed. It also reduces nervousness in innocent parties, increases nervousness in guilty ones. The manner should always be polite but firm. Cooperation is essential; intimidation is counter-productive and possibly disastrous in outcome. Treat those interviewed with dignity, respect, and courtesy; and avoid use of any investigative jargon or slang

Begin with why the person is being interviewed

Identify self and any others participating in the interview and explain the purpose of the investigation, along with the authority to conduct inquiry. Make it clear they have a duty to provide complete and accurate facts and explain their comments will be kept confidential to the degree possible

Take time to establish rapport

This is critical to the result of the interview. Beginning an interview with five or ten minutes of easy conversation has the advantage of reducing tension and increases better communication and cooperation. It also permits the investigator to observe the person and their behavioral patterns during this initial more relaxed discourse that often proves very valuable when assessing responses when questioning begins addressing more serious issue areas. Any rapport established can be easily lost by careless use of terms or phrases that may evoke negative connotations, or cause the person to become more defensive and less cooperative.

Best way to have a productive interview is to do one’s homework in advance

This means (a) knowing the objectives of the investigation; (2) having an investigative plan to achieve those objectives; (3) identifying facts needed to properly understand and assess the issues; and (4) what the person being interviewed may offer in terms of facts. It is useful to prepare the key points to be covered for use as a guide, but just going down a list of questions is a bad practice, as it turns the interview into something more akin to an interrogation. Use open-ended questions and allow the person to speak. Often they will cover many of the points on your guide in their discourse. At the end of the interview, review the guide to see if all the points were covered”.

Keep control of the interview by asking, not answering, questions

The interviewer is not the dispenser of information and, as such, they should not reveal the status of the work; offer opinions; indicate what has been found so far; or what has been said by others. Offer no opinions relating to the investigation. Losing sight of that principle often leads to losing control of the interview and is one of the major causes of bad outcomes in the process.

Always remember the interview purpose is to establish facts

It is critical that the investigator remain at all times focused on facts. It is common to have those being interviewed to drift off of facts, especially if they are uncomfortable with the direction of the interview. Therefore, always follow through on questions asked and not be diverted by other comments. Ensure basic questions such as who, what, where, when, how, and why have been addressed. Keep the questions simple and direct, avoiding compound sentences. Ask open-ended questions and allow the person to fully answer.

Take notes, discreetly

It is important to maintain the interview as much like a conversation as possible. Losing eye contact can throw the interview off and detract from results. As such, although it is critical to take notes throughout the interview, it should be done as discreetly as possible. This means writing only key words and phrases that can be filled out after the interview is over. Taking copious notes and losing eye contact risk turning the interview into something that may appear to the individual as an interrogation and makes individuals tighten up and be less forthright in their comments.

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.

Subscribe to the Kusserow on Compliance Newsletter

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

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.

Subscribe to the Kusserow on Compliance Newsletter

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