Kusserow on Compliance: Compliance officers should have active roles in CIA negotiations

Laura Ellis, HHS Office of Inspector General (OIG) Senior Counsel, has a reputation for managing the most difficult and complicated corporate integrity agreements (CIAs) on behalf of the OIG. At the recent Health Care Compliance Association (HCCA) Compliance Institute, she urged compliance officers not to sit on the sidelines while a CIA is being negotiated with the OIG.   They should be actively involved in all facets of negotiation and should not wait to be involved until the agreement is signed and put into effect. She reminded everyone that once the CIA is signed, the compliance officer will be the face of the company to the OIG, not the attorneys.   From years of experience, she has found attorneys negotiating terms and conditions of a CIA often don’t have the operational experience to fully understand all the implications of what is being committed to in terms and obligation. As a result, it is not uncommon for attorneys to come back to the OIG after a CIA has been executed to try to renegotiate points.   This is triggered as result of management and the compliance officer realizing what is involved in meeting the terms and condition.   Ellis stated that the OIG is not inclined to reopen CIA negotiations.  The mistake was not having the compliance officer on the front end of negotiations and present during the negotiation process.  As the CIA settlement process takes shape, the compliance officer needs to:

  • be part of the negotiations;
  • review and comment on all drafts;
  • create a basic plan from the draft to determine what it takes to meet obligations;
  • conduct a min-gap assessment of what it takes to do what the CIA would require;
  • begin work on implementation strategies; and
  • start the process to determine resource needs to meet obligations.

Ellis also made the point that attitude matters once a CIA is in place, and compliance officers should work with the monitor in an open and honest way. A positive working relationship between the monitor and the compliance officer is to everyone’s best interest.  The earlier in the process that they get to know each other, the better.

Thomas Herrmann, J.D., was previously responsible on behalf of the OIG for negotiating CIAs and providing monitors, and subsequently gained many years of consulting experience working with more than a dozen clients with CIAs and as an independent review organization (IRO).  He says that what many fail to understand is that, although the OIG is involved in the Department of Justice (DOJ) settlement process, a different OIG attorney will be assigned as negotiator for the CIA.  Once the agreement is executed, it is passed on to a different OIG attorney to be the monitor to assure compliance with the terms of the CIA.   A very common mistake is for attorneys to deal with issues handled by someone earlier in the process, or in effect, re-litigate.  This is a big mistake.  The OIG will not re-litigate or interpret decisions made by the DOJ.  At the same time, the OIG monitor is definitely disinclined to deal with issues that were or should have been addressed with the OIG negotiator.  Herrmann goes on to explains that the OIG views the organization’s legal counsel as filling an adversarial role, but once things are executed, the OIG does not want to continue dealing with the advocate.  The focus of the relationship with the OIG should be on meeting the terms of the CIA. Herrmann sees it as a huge mistake for the legal counsel to continue making arguments or try to modify terms with the monitor, as this frequently leads to aggravation of matters and creates additional problems for the organization.  The monitor wants to deal with how the organization will meet its obligations, and that means working with the compliance officer to determine how the terms and conditions of the CIA will be fulfilled.  It behooves compliance officers to get to know their monitor as quickly as possible, evidence their commitment, and exhibit an attitude to work out what it takes to get the job done.

Carrie Kusserow has over 15 years’ compliance officer and consultant experience; in fact, she was brought in to be the compliance officer to an organization under a CIA while Laura Ellis was the monitor. Her experience with Ellis was precisely what Ellis explained during her presentation.   Maintaining the focus on meeting the obligations of the agreement is very important for credibility and permits ironing out of issues. By listening carefully and responding to Ellis’ questions openly in a forthright manner, Kusserow developed a very good working relationship.  This made work easier for everyone.  Compliance officers need to listen carefully to what the monitor expresses, working as needed and then immediately following up to report actions taken. The focus must stay on getting the job done to the satisfaction of the OIG.  It is also critical that the compliance officer at all times be “straight up” and honest with the OIG.  If this is done, then a bond of trust can be developed that can iron out details that are sure to arise. This can permit seeking non-adversarial clarification of terms and conditions. On the other hand, failing to develop a proper working relationship with the monitor can result in lack of understanding and increased work for everyone. As such, as soon as the CIA is signed, the compliance officer should come into direct contact with the OIG monitor.

Suzanne Castaldo, J.D., has worked both as a litigator and compliance consultant dealing with numerous organizations with CIAs. She confirmed what Ellis noted about attorneys negotiating with the OIG without active involvement of either management or the compliance officer. In almost every case, it has created avoidable issues.  She strongly recommends that anyone engaging a law firm to assist with CIA negotiations insist on including knowledgeable members of management and the compliance officer in all meetings with the OIG.  All terms that are being negotiated should be reviewed and assessed by them to understand all implications and resulting work obligations. Many attorneys will not find this to their liking and may argue against it.   However, not being part of this process reminds one of “arriving at the dance after it is over.”

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.

 

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.

Kusserow on Compliance: DOJ issues guidelines on corporate compliance programs

In February 2017, the Department of Justice (DOJ) issued its“Evaluation of Corporate Compliance Programs,” which provides an explanation as to how compliance programs are evaluated by prosecutors. This 119-question resource offers great insights for compliance officers working to build and enhance their compliance programs. One thing to remember about these guidelines is that they relate to all industry sectors.   The Principles of Federal Prosecution of Business Organizations in the United States Attorney’s Manual describes specific factors that prosecutors should consider in conducting an investigation of a corporate entity, determining whether to bring charges, and negotiating plea or other agreements. These factors, commonly known as the Filip Factors, include “the existence and effectiveness of the corporation’s pre-existing compliance program” and the corporation’s remedial efforts “to implement an effective corporate compliance program or to improve an existing one.” The guidance was formulated to evaluate compliance programs after a violation has been discovered and examine the existing misconduct as the benchmark against which the compliance program will be evaluated. The Compliance Program Guidance is divided into 11 sections. Each category includes a list of questions the DOJ may consider when evaluating a company’s compliance program when it confronts corporate misconduct. The sections are:

  1. Analysis and Remediation of Underlying Conduct;
  2. Senior and Middle Management;
  3. Autonomy and Resources;
  4. Policies and Procedures;
  5. Risk Assessment;
  6. Training and Communications;
  7. Confidential Reporting and Investigation;
  8. Incentives and Disciplinary Measures;
  9. Continuous Improvement, Periodic Testing and Review;
  10. Third Party Management; and
  11. Mergers & Acquisitions.

The DOJ noted that in developing this document, it used the U.S. Sentencing Commission Guidelines. The document also relates back to a number of other DOJ reports, including the Yates Memorandum that focused on individual accountability in corporate investigations, and not just organizational wrongdoing. Although the compliance guidance documents issued by the HHS Office of Inspector General (OIG) are tailored to the health care sector, the reading of the DOJ evaluation document is relatable to them. All seven elements of an effective compliance program are included in the DOJ guidelines. It is worthwhile for compliance officers of health care entities to read this document and incorporate those areas identified by the DOJ for their own work place. There are plenty of ideas among the 119-questions outlined in their document for use by compliance officers to improve their organizations’ compliance programs.

Tip

The OIG calls for ongoing monitoring of the compliance program to ensure that it is up to date and operating the way it is designed to. In addition, there should be periodic, independent auditing of the program to verify that monitoring is taking place and validate that the results of operation are making the compliance program effective in achieving its goals. The U.S. Sentencing Commission in its standards for compliance and ethics programs also call for organizations to “evaluate periodically the effectiveness of the organization’s compliance and ethics program.” Now the DOJ is calling for the same thing.  As such, those organizations that have not had their compliance program subject to an independent compliance program effectiveness evaluation should consider having it now, incorporating the DOJ guidelines as part of their review.

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.

DOJ comes for executive in Tenet fraud case

A former senior executive of Tenet Healthcare Corporation is facing charges for his alleged role in a fraud scheme that resulted in Tenet and its subsidiaries billing Medicaid programs more than $400 million over a thirteen-year period. The Department of Justice (DOJ) charged the former senior vice president of operations for Tenet’s Southern States Region and former CEO of North Fulton Medical Center with mail, health care, and major fraud. The executive pleaded not guilty to his alleged role in the scheme, which involved the payment of bribes to prenatal clinics in exchange for referrals of undocumented, pregnant Medicaid patients to Tenet Health System Medical, Inc. (THSM) hospitals, including North Fulton Medical, Atlanta Medical Center, Inc., Spalding Regional Medical Center, Inc., and Hilton Head Hospital.

Tenet, Atlanta Medical, and North Fulton Medical entered into a $513 million settlement in October 2016 to resolve criminal and civil charges; the settlement included the hospitals’ agreement to forfeit more than $145 million in Medicaid payments for unlawful referrals. Atlanta Medical and North Fulton Medical allegedly participated in the scheme while subject to a 2006 corporate integrity agreement (CIA) with the HHS Office of Inspector General (OIG). THSM and its subsidiaries entered into a three-year non-prosecution agreement, as well (see Corporations, beware: Tenet Healthcare to pay $513M to settle kickback charges, October 4, 2016).

In addition to the general scheme involving the payment of bribes and kickbacks from 2000 through 2013, Tenet operated an affiliated billing center than allegedly assisted in processing Medicaid billings for payment from 2007 through 2013. The DOJ alleges that the executive “took affirmative steps to conceal the scheme,” by working around internal accounting controls; falsifying books, records, and reports; and falsely certifying to the OIG that Tenet was complying with the terms of the CIA and Medicare and Medicaid requirements while knowing that Tenet was paying for illegal referrals.