Kusserow on Compliance: Understanding and addressing whistleblowers

The vast majority of the cases resolved by the Civil Division of the Department of Justice (DOJ) were cases brought by “whistleblowers” under the qui tam provision of the False Claims Act (FCA). Whistleblowers are responsible for an even higher percentage of cases resulting in OIG Corporate Integrity Agreements (CIAs). Although most compliance officers are well aware of this program, many remain unclear as to how the process works. Tom Herrmann, J.D., who served over 20 years in the Office of Counsel to the OIG and as an Appellate Judge for the Medicare Appeals Board, explained that Congress permitted a whisltleblower called the “Relator” to file a case with the DOJ under the FCA.  Since this provision of law went into effect in 1986, there have been over 10,000 qui tam cases filed with a current average of one such case being filed every day of the year. The intent was to create incentives for private parties to detect and pursue fraud under the FCA. In return for reporting this information, Relators receive a portion (usually about 15 to 25 percent) of any recovered damages.  Once the lawsuit is filed, it is placed “under seal”, meaning that it is kept secret from everyone but the government, in order to give the DOJ enough time to investigate the allegations in deciding whether to join (“intervene”) in the case. Intervention by the DOJ occurs only in about one in five qui tam lawsuits, leaving whistleblowers the option to pursue cases on their own, however the chances of success are much lower than in cases when the government joins. Most successful qui tam cases are resolved through settlement negotiations rather than a court trial, although trials may occur.

Kash Chopra, J.D., noted that the overwhelming number of cases that result in a CIA, arise from whistleblowers and these, in turn, are based upon violations of the federal Anti-Kickback Statute (AKS). It is the government’s position that all claims arising from a corrupt arrangement violating the AKS or in some cases, the Stark Law, are considered fraudulent. This is even when the services rendered were needed and provided appropriately.  She advises here clients that the best ways to manage the whistleblower risk is to ensure that they are channeled through internal communication channels and their complaints are promptly evaluated, investigated, and resolved.  It is worth considering the following:

  1. Using outside experts to independently audit arrangements with physicians and evaluate compliance communication channel effectiveness.
  2. Ensuring a 24/7 hotline operated externally by experts in recognizing health care compliance issues.
  3. Reviewing/updating hotline-related polices/procedures (confidentiality, anonymity, non-retaliation, duty to report, etc.).
  4. Making sure that the duty to report suspected wrongdoing is explained in the Code, policies and training.
  5. Having trained and competent people on hand to conduct prompt and competent investigations of matters raised through the hotline.
  6. Moving quickly to use CMS and OIG self disclosure protocols when there is credible evidence of violations; and not wait until the DOJ gets involved.

For more information on this subject, Kashish Parikh-Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413.

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.

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Copyright © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Internal investigations by any other name

In most organizations, there are many people who may be called upon to respond to a complaint or concern raised by an employee; few of these complaints or concerns, however, might rise to the level of requiring a formal investigation. Emil Moschella, JD is a highly experienced health care compliance consultant who previously served as an FBI executive and also taught at the FBI National Academy. He warns to be careful about calling something an “investigation,” as it is an emotionally charge term that may lead people to infer a lot more about what is occurring than is factually correct. If a person believes that something may result in referral to an enforcement agency, the situation may make them more defensive and cautious when responding to questions.  As such, wherever possible, he advises using neutral terminology to avoid unnecessarily exciting concerns and speculation among employees. There are a lot of other terms that can be used as the definition of “investigation.” It is a detailed and systematic inquiry into something, often through gathering facts and information to solve a problem or resolve an issue. A number of other activities in organizations could meet that general definition, including conducting an audit, evaluation, internal inquiry, or internal review. He has found that characterizing the activity using these “less charged” terms can avoid the potential emotional response of using the term investigation.

Kashish Parikh-Chopra, JD, MBA, CHC, CHPC works with compliance officers to train staff on conducting internal investigations. She notes that many complaints, allegations, and concerns are often very routine in nature that can be resolved within a day or two through normal management procedures or with Human Resources. However, when confronted with a serious or complex matter, it is necessary to have properly trained individuals conduct the investigation in order to avoid aggravating matters and potentially creating additional problems. Professional investigators cannot be expected to be available for a compliance office to conduct an internal investigation, however, certain basic principles should be taught to anyone taking on the role of an investigator in an organization. Those who may become actively involved in internal investigations may include individuals from the compliance office, Human Resources, internal audit, privacy/security officers, legal counsel, etc. They should undergo training by experts to learn how to plan an investigation, conduct proper interviews, organize evidence, prepare written reports, and manage documentation. This can be done by participating in investigator training through webinars, conferences, or having experts provide training on-site.

 

For more information, Kashish Parikh-Chopra can be reached at kchopra@strategicm.com or via telephone at (703) 535-1413.

 

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 © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: The relationship between an Interim Compliance Officer and the CEO

Getting the right start is the best way to have a good return on investment

Catie Heindel, J.D., a highly experienced compliance consultant who has served as an Interim Compliance Officer, notes it is increasingly common for healthb care organizations to seek a temporary compliance officer to cover a gap. Though the rationale behind hiring an interim compliance officer is different for every organization, the ultimate goal is usually the same—to provide high quality and efficient compliance program leadership that will reduce exposure to unwanted risks and problems. Preparation and communication with staff to introduce the person selected to act in an interim capacity is very important to having a successful result from the engagement.

Ensuring a successful hiring decision really needs the personal involvement of the CEO. The OIG compliance guidance stresses that the compliance officer should report directly to the CEO. This sentiment also applies to Interim Compliance Officers; and the best return on investment for having someone move in and successfully temporarily fill a compliance officer gap is for the CEO to establish a direct reporting relationship. It is also helpful for everyone involved if the CEO personally provides a detailed background briefing on the organization that includes:

  • management structure;
  • mission/vision;
  • why the person was engaged;
  • expectations for the engagement; and
  • their role in the organization.

Upon arrival, the CEO should ensure there is a proper “on-boarding” process that includes personally introducing the interim compliance professional to the executive leadership, key program managers, legal counsel, HRM, and Board members. This interaction, from the outset, sets the right tone and will help to ensure that the interim is in lockstep with the CEO.  Furthermore, this empowerment exercise will permit the interim to move more quickly in gathering the reins of the compliance program and guard against having anything fall “beneath the cracks”.  It will also help the interim compliance professional to “hit the ground” running immediately and begin productive work.

For more information regarding engaging and preparing Interim Compliance Officers, Catie Heindel can be contacted at www.cheindel@strategicm.com, or via phone at (847) 707-9830.

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 © 2018 Strategic Management Services, LLC. Published with permission.

Kusserow on Compliance: Tips on finding the right hotline vendor

One of the critical elements of an effective compliance program outlined by OIG compliance guidance is the establishment and maintenance of communication channels with employees and management. Such communication permits employees to report sensitive matters outside the normal supervisory channels. Both the U.S. Sentencing Commission and DHHS Office of Inspector General (OIG) call for a hotline. Results from the Ninth Annual Healthcare Compliance Benchmark Survey conducted by SAI Global and Strategic Management Services found that 55 percent of organizations outsource their hotline. Daniel Peake of the Compliance Resource Center provides hotline services and explained there are many reasons why so many choose to outsource their hotline. Although there are benefits of maintaining the function in-house, it is far outweighed by the advantages of outsourcing it to a professional vendor service. He cited some of these reasons why so many decide to use a professional vendor service, including the following:

  • Cost of staffing with qualified people in-house is prohibitive
  • Systems must blocked and “backstopped” to prevent anonymous caller identification
  • Those answering the calls in house should not be highly visible to the work force
  • Calls should never be answered in an area where they can be overheard by others
  • Hotline vendors have the training and experience to handle complainants
  • Callers are nervous and speaking with an outside party generally is reassuring

TIPS FOR EVALUATING HOTLINE VENDORS

  1. Cost of operation. Vendor’s services should be a set fee under $2/employee/year.
  1. Contract. Avoid contracts not permitting cancellation by 30 day written notice. Client should be held by good service, not by contracts.
  1. Industry expertise. Seek vendors knowledgeable of health care issues.
  1. Hotline services. Must include both live operator and Web-based reporting. Either approach alone has its deficiencies and is not a best practice.
  1. Policies and procedures. Vendor should assist with developing operating protocols for following up an allegations and complaints received through the hotline.
  1. Timelines. Insist on a provision of a full written report within one business day of receipt of the call. For urgent matters, it should be immediate.
  2. Reports provided. Written reports must clear, concise, and of high quality.
  3. Report Delivery. The manner the report is delivered is important. There is security problems with reports provided either by facsimile or email. Insist on secure web-based reporting with notification of a report being provided via email.
  1. Insurance. Like any other vendor, the company should have at least one to three million dollars liability coverage.

 

For more information, Daniel Peake can be reached at (dpeake@compliancereource.com or (703)-236-9854)

 

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 © 2018 Strategic Management Services, LLC. Published with permission.