Photo of Michael W. Peregrine

Michael W. Peregrine represents corporations (and their officers and directors) in connection with governance, corporate structure, fiduciary duties, officer-director liability issues, charitable trust law and corporate alliances. Michael is recognized as one of the leading national practitioners in corporate governance law. Read Michael W. Peregrine's full bio.

Released on March 27, 2017, the Compliance Program Resource Guide (Resource Guide), jointly prepared by the US Department of Health and Human Services Office of Inspector General (OIG) and the Health Care Compliance Association (HCCA) reflects the result of a “roundtable” meeting on January 17, 2017, of OIG staff and compliance professionals “to discuss ways to measure the effectiveness of compliance programs.” The resulting Resource Guide document catalogues the roundtable’s brainstorming discussions to “…provide a large number of ideas for measuring the various elements of a compliance program…to give health care organizations as many ideas as possible, to be broad enough to help any type of organization, and let the organization choose which ones best suit its needs.”

Here are a few main takeaways from the Resource Guide:

  • Ideas for Auditing: The Resource Guide contributes to the critical conversation about how to evaluate compliance program effectiveness by listing additional ideas on what to audit and how to audit those areas. The items listed in the Resource Guide generally center on ideas on auditing and monitoring compliance program elements, such as periodically reviewing training and policies and procedures to ensure that they are up-to-date, understandable to staff and accurately reflect the business process as performed in practice. Legal and compliance can use this document to identify those particular elements that may be most applicable to their individual organization.

Organizations would also benefit from considering the questions listed in the new compliance program guidance issued in February by the US Department of Justice (DOJ) Criminal Division’s Fraud Section, “Evaluation of Corporate Compliance Programs” (DOJ Guidance), as part of examining compliance program effectiveness. (We covered the DOJ Guidance previously.) Health care organizations may also use the various provider-specific compliance program guidance documents created by OIG over the years as another source for ideas on what to measure.

  • Not a Mandate: The Resource Guide is very clear that it is not intended to be a “best practice”, a template, or a “‘checklist’ to be applied wholesale to assess a compliance program.” This clarification is an important one since there is the potential for the Resource Guide to be (incorrectly) viewed by qui tam relators or others as creating de facto compliance program requirements or OIG recommendations.
  • How to Measure: The Resource Guide does not delve into how or who should undertake or contribute to the effectiveness review. Who conducts the review is a question that may have legal significance given the nature of a particular issue. General counsel and the chief compliance officer should consider this issue as part of the organization’s ongoing compliance program review. It may be valuable to include the organization’s regular outside white collar counsel to comment on such critical, relevant legal considerations as the proper conduct of an internal investigation; preserving the attorney-client privilege in appropriate situations; coordinating communications between legal, compliance and internal audit personnel; and applying “lessons learned” from the practices of qui tam relators and their counsel. Outside consultants may also have useful expertise and insight to contribute. In some situations, the organization may want to undertake a compliance program assessment conducted under attorney-client privilege as part of advising the executive team and the board audit and compliance committee.

Perhaps the greatest benefit of the Resource Guide is the extent to which it serves as a catalyst for closer, coordinated consideration of the metrics by which compliance program effectiveness may be measured by legal and compliance personnel and the audit and compliance committee. The Resource Guide is one of several resources that can be referenced by the general counsel and the chief compliance officer as they work together to support the organization’s audit and compliance committee in reviewing compliance program effectiveness.

Three recent, significant FCA settlements with hospitals involving Stark law allegations may also have unexpected governance implications. To varying degrees in these settlements, the Department of Justice (DOJ) appears to advance the highly controversial position that the Stark law is violated when a health system pays employed physicians more than the net professional income the physician generates. While DOJ has in the past expressed skepticism regarding health system tolerance for practice losses, the formal pursuit of such an enforcement theory could be fundamentally problematic to the continued operation of an integrated delivery system. Thus, this enforcement theory is precisely the type of information that would benefit from disclosure to system leadership through the board’s enterprise risk management process.

Read the full article from Bloomberg BNA Health Care Fraud Report™.

Two recent, unrelated federal court decisions may have significant implications for how a corporation, its board and its employees apply the timehonored ‘‘advice of counsel’’ defense in response to civil litigation challenges. In one decision, a court of appeals rejected a corporation’s attempt to rely on the defense, primarily because of problems the court identified in the process by which counsel were engaged and informed. In another decision, a district court rejected an employee’s ability to rely on the defense when his employer refused to waive the attorney-client privilege within which the advice was cloaked. The implications of these decisions should be brought by the general counsel to the attention of the audit and compliance committees, if not the full board.

Read the full article from Bloomberg BNA Corporate Law & Accountability Report™.

Several new, highly publicized fraud enforcement initiatives of the U.S. Department of Justice are likely to impact the roles of the general counsel and chief compliance officer. In most organizations, there are elements of overlap in how these officers relate to the compliance program structure and the conduct of internal investigations. In the context of these new initiatives, however, absolute clarity on executive-level leadership is necessary in order to ensure an effective and coordinated organizational response. The governing board, with its obligations for legal compliance oversight, will in most instances conclude that the general counsel is best qualified to lead that response.

Read the full article in Corporate Counsel.

Health care leaders should closely note the new guidelines on corporate conduct released on September 9, 2015 by the Department of Justice (DOJ) (Memorandum from Sally Quillian Yates, Deputy Attorney General, U.S. Department of Justice, September 9, 2015, Individual Accountability for Corporate Wrongdoing (Guidelines), available at www.justice.gov/dag/file/769036/download). These Guidelines reflect a substantially increased focus on individual accountability for corporate wrongdoing, both civil and criminal, and on the importance of corporate cooperation in the context of governmental investigations. It is not a “rifle shot” enforcement initiative focused solely on Wall Street or the broader financial sector. Rather, it is intended to apply across industry sectors (including, health care) (See http://www.reuters.com/article/2015/07/30/doj-compliance-hire-idUSL1N10A26420150730 (note reference to health care). The Guidelines can reasonably be expected to impact an organization’s approach to legal compliance, internal investigations, D&O insurance and indemnification protection, and interaction with management on matters of regulatory concern. They should, therefore, be taken seriously by senior leadership of health care companies.

Read the full article from AHLA Weekly.

Health care leaders should closely note the new guidelines on corporate conduct released on September 9, 2015 by the Department of Justice (DOJ). These Guidelines reflect a substantially increased focus on individual accountability for corporate wrongdoing, both civil and criminal, and on the importance of corporate cooperation in the context of governmental investigations. It is not a “rifle shot” enforcement initiative focused solely on Wall Street or the broader financial sector. Rather, it is intended to apply across industry sectors (including, health care).[2] The Guidelines can reasonably be expected to impact an organization’s approach to legal compliance, internal investigations, D&O insurance and indemnification protection, and interaction with management on matters of regulatory concern. They should, therefore, be taken seriously by senior leadership of health care companies.

Read the full article from AHLA Weekly.

Health care general counsel should advise their clients on the implications of the new guidelines on corporate conduct recently released by the Department of Justice (DOJ). These guidelines demonstrate a substantially increased government focus on individual accountability for corporate misconduct, and on corporate eligibility for cooperation credit in the context of government investigations.

Read the full article from Bloomberg BNA Health Law Reporter™.

The board of directors’ audit committee agenda just got quite a bit busier, thanks to a new U.S. Department of Justice staffing decision.

On July 30, Fraud Section Chief Andrew Weissman disclosed the DOJ’s decision to create the position of “compliance counsel,” the specific role of which will be to help determine whether corporations subject to DOJ investigation have maintained a good faith compliance program. The DOJ’s Principles of Federal Prosecution of Business Organizations (a/k/a the “Filip Guidelines”) make it clear that the existence and effectiveness of a corporation’s pre-existing compliance program is a factor DOJ will take into consideration when making a prosecution decision. This perspective has been underscored in a series of recent public speeches by DOJ Criminal Division officials.

Read the full article in Corporate Counsel.

An important new decision, In Re General Motors Company Derivative Litigation, decided by the Delaware Chancery Court on June 26, provides useful guidance on the board’s obligation to both assess corporate risks, and to act to prevent loss. On the one hand, the decision confirms the high burden of proof necessary to establish a derivative claim for breach of the board’s risk management duties. At the same time, it also highlights the type of conduct to which boards may strive in order to maintain effective risk oversight protocols. This may be particularly valuable for corporate boards operating in industries with complex risk and regulatory environments.

Read the full article from NYSE Governance Series: Hot Topics in Board Governance.