Ensure Health Care & Other Compliance Practices Updated For New DOJ Voluntary Disclosure Policy

Health care, life sciences and other organizations and their leaders generally recognize the need for effective compliance programs to mitigate their organizational and individual criminal liability risks for violations of the constantly widening plethora of federal health care, tax, marketing, labor and employment, antitrust, marketing, securities, cyber liability, safety, environmental and other laws.

To maintain and promote the effectiveness of these efforts, organizations and their leaders now need to consider the advisability of enhancements or other modifications of their organization’s Federal Sentencing Guideline and other compliance programs and practices in light of the new corporate criminal conduct Voluntary Self-Disclosure Policy (“VSD policy”) announced by the Department of Justice on February 23, 2023. Concurrently, organizations and their leaders also will want to monitor and respond promptly to Justice Department statements and congressional recommendations on proposed Guideline changes providing critical insights into the Justice Department’s planned interpretation and enforcement of federal criminal laws and the Guidelines against organizations and their leaders like those available here.

While the application of the VSP policy inherently requires subjective decision-making, the VSP policy and other emerging statements reinforce to organizations and their leaders the advisability of ensuring their organizations adopt and administer effective Federal Sentencing Guideline compliance programs for the ever-growing list of laws applicable to their organizations that carry potential felony and class A misdemeanor criminal liability and timely to investigate and self-disclose violations with the assistance of legal counsel in accordance with the Guideline requirements for liability mitigation to mitigate the potential liability exposure of the organization and its leader.

VSD Policy Standardizes USAO Sentencing Guideline Organization Liability Determinations

Chapter 8 of the Federal Sentencing Guidelines sets standards for the assessment of criminal liability and punishment against corporations, partnerships, labor unions, pension funds, trusts, non-profit entities, and governmental units (“organizations”) and their leaders for legal violations committed by the organization that carry felony or Class A misdemeanor liability or when the Federal Sentencing Guidelines impute criminal liability to the organization for criminal acts that an employee of the organization commits an act within the apparent scope of his employment.

The standards for organizational sentencing offer organizations the opportunity to mitigate their liability exposure if it can persuade the prosecuting U.S. attorneys office (“USAO”) it had in place and followed an effective compliance program, promptly reported the violation to the authorities, and that high-level leaders were not involved in the actual offense conduct. On the other hand, an organization’s lack of an effective compliance program, delay in investigation, cover-up or failure or delay of timely disclosure and failure to make prompt restitution for violations are aggravating factors that can increase its potential sanction.

According to the Justice Department, the Justice Department intends that the VSD policy ensure that organizations can rely on receiving the same treatment and benefits for voluntarily self-disclosing criminal conduct under the Federal Sentencing Guidelines organizational liability rules to any USAO no matter where the organization operates by setting “a nationwide standard” for how USAOs will determine whether an organization has made a voluntary self-disclosure and making transparent the specific, tangible benefits to an organization that the USAO will offer the organization for making a voluntary self-disclosure, fully cooperating, and remediating the criminal conduct.

In furtherance of this goal, the new VSD policy provides that a USAG will consider an organization to have made a VSD for purposes of the Federal Sentencing Guidelines if it becomes aware of misconduct by employees or agents before that misconduct is publicly reported or otherwise known to the DOJ, and discloses all relevant facts known to the company about the misconduct to USAO in a timely fashion before an imminent threat of disclosure or government investigation. 

In the absence of any aggravating factor, the VSD policy calls for the USAG “significant benefits” to a corporation that voluntarily self-discloses criminal conduct committed by its employee or agent in accordance with the VSD policy, fully meets the other requirements of the VSD policy, fully cooperates and timely and appropriately remediates the criminal conduct including agreeing to pay all disgorgement, forfeiture, and restitution resulting from the misconduct.  The promised significant benefits for organizations making a qualifying VSD include that the USAO:

  • Will not seek a guilty plea;
  • May choose not to impose any criminal penalty and in any event will not impose a criminal penalty that is greater than 50% below the low end of the United States Sentencing Guidelines (USSG) fine range; and
  • Will not seek the imposition of an independent compliance monitor if the company demonstrates that it has implemented and tested an effective compliance program.

The VSD policy identifies three aggravating factors that could warrant a USAO seeking a guilty plea even if the other requirements of the VSD policy are met:

  • If the misconduct poses a grave threat to national security, public health, or the environment;
  • If the misconduct is deeply pervasive throughout the company; or
  • If the misconduct involved the current executive management of the company. 

The Justice Department says the presence of an aggravating factor does not necessarily mean that a guilty plea will be required. Rather, the USAO will assess the relevant facts and circumstances to determine the appropriate resolution.  If a guilty plea is ultimately required, the Justice Department says the organization will still receive the other benefits under the VSD policy, including that the USAO will recommend a criminal penalty of at least a 50% and up to a 75% reduction off the low end of the USSG fine range, and that the USAO will not require the appointment of a monitor if the company has implemented and tested an effective compliance program.

In cases where a company is being jointly prosecuted by a USAO and another DOJ component, or where the misconduct reported by the company falls within the scope of conduct covered by VSD policies administered by other DOJ components, the USAO will coordinate with, or, if necessary, obtain approval from, the DOJ component responsible for the VSD policy specific to the reported misconduct when considering a potential resolution.  Consistent with relevant provisions of the Justice Manual and as allowable under alternate VSD policies, the USAO may choose to apply any provision of an alternate VSD policy in addition to, or in place of, any provision of its policy.

VSD Policy Reenforces Necessity of Effective Compliance Program & Guideline Compliance

The stated goal of the VSD policy to incentivize companies to maintain effective compliance programs capable of identifying misconduct, expeditiously and voluntarily disclose and remediate misconduct, and cooperate fully with the government in corporate criminal investigations sends a strong message to organizations and their leaders to maintain and administer effective compliance programs and follow the VSD policy promptly when issues arise.

While the Justice Department touts the benefits of compliance with the VSD policy, its adoption also carries an implicit warning to organizations against failing to comply with its provisions.

With the Biden Administration accelerating enforcement of a wide range of federal laws carrying criminal liability, organizations and their leaders should heed this warning by auditing and enhancing their and their organization’s potential criminal exposures and the adequacy of their compliance policies, practices and documentation.

Because of the highly sensitive nature Campus of this type of analysis for the organization and its leaders, before starting the review, and throughout its conduct organizations are urged to engage and seek guidance from qualified legal counsel to position their review for protection, within the scope of attorney, client privilege, and other evidentiary protections, as well as to maximize the benefit of the effort undertaken in the event of future investigations or enforcement.

Possessing an up-to-date understanding of material civil and criminal legal obligations and exposures is absolutely critical to the effectiveness of this review. With laws and regulations constantly changing, organizations and their leaders must establish a documented, provable culture of compliance. This starts with ensuring their organizations have adopted strong policies of compliance coupled with processes for monitoring and identifying laws carrying potential criminal liability, exposure or otherwise, requiring corporate compliance programs. Along with requirements to comply, leadership also must implement appropriate processes for auditing compliance as well as receiving and investigating complaints or other indicators that arguably put their organization or its leadership on notice of potential compliance concerns.

When implementing compliance procedures, for any specific law, organizations, and their leaders will also want to ensure that their processes and policies are designed to meet the seven criteria that Chapter 8 of the Federal Sentencing Guidelines outlines for establishing an “effective compliance program”

  • The maintenance and enforcement of compliance standards and procedures reasonably capable of reducing the prospect of criminal activity;
  • Oversight by high-level personnel;
  • Due care in delegating substantial discretionary authority;
  • Effective Communication to all levels of employees;
  • Reasonable steps to achieve compliance, which include systems for monitoring, auditing, and reporting suspected wrongdoing without fear of reprisal.
  • Consistent enforcement of compliance standards including disciplinary mechanisms; and
  • Reasonable steps to respond to and prevent further similar offenses upon detection of a violation.

Taking into account these criteria and the new VSP policy, organizations and their leaders also should ensure their organization has appropriate procedures and protocols for receiving, investigating and reports of potential violations and the organization’s timely and appropriate response in a manner that best positions the organization to demonstrate the culture of compliance, and other factors necessary to qualify for the maximum leniency under the guidelines. in a manner that best positions the organization to demonstrate the culture of compliance, and other factors necessary to qualify for the maximum leniency under the guidelines.

When designing and administering compliance investigations and responses, documentation and other evidence regarding actions taken, communications and deliberations, play a key role in deciding how the organization and its leaders will be treated under the VCD policy and the guidelines. For this reason, organizations should include appropriate procedures to determine when and how legal counsel will become involved to guide the process and allow for the use of attorney-client privilege to help protect, sensitive discussions along the way. Legal counsel also should assist in documenting the process and findings for presentation to the Justice Department and subsequent communications with it through resolution.

More Information

We hope this update is helpful. For more information about these or other health or other legal, management or public policy developments, please contact the author Cynthia Marcotte Stamer via e-mail or via telephone at (214) 452 -8297.  

Solutions Law Press, Inc. invites you to receive future updates by registering on our Solutions Law Press, Inc. Website and participating and contributing to the discussions in our Solutions Law Press, Inc. LinkedIn SLP Health Care Risk Management & Operations Group, HR & Benefits Update Compliance Group, and/or Coalition for Responsible Health Care Policy. 

About the Author

Recognized by her peers as a Martindale-Hubble “AV-Preeminent” (Top 1%) and “Top Rated Lawyer” with special recognition LexisNexis® Martindale-Hubbell® as “LEGAL LEADER™ Texas Top Rated Lawyer” in Health Care Law and Labor and Employment Law; as among the “Best Lawyers In Dallas” for her work in the fields of “Labor & Employment,” “Tax: ERISA & Employee Benefits,” “Health Care” and “Business and Commercial Law” by D Magazine, Cynthia Marcotte Stamer is a practicing attorney board certified in labor and employment law by the Texas Board of Legal Specialization and management consultant, author, public policy advocate and lecturer widely-known for 35 plus years of health industry and other management work, public policy leadership and advocacy, coaching, teachings, and publications.

A Fellow in the American College of Employee Benefit Counsel, Chair of the American Bar Association (“ABA”) International Section Life Sciences and Health Committee, Chair-Elect of the ABA TIPS Section Medicine & Law Committee, Past Chair of the ABA Managed Care & Insurance Interest Group, Scribe for the ABA JCEB Annual Agency Meeting with HHS-OCR, past chair of the ABA RPTE Employee Benefits & Other Compensation Group and current co-Chair of its Welfare Benefit Committee, Ms. Stamer is most widely recognized for her decades of pragmatic, leading-edge work, scholarship and thought leadership on health and managed care and employer benefits legal, public policy and operational concerns in the healthcare, employer benefits, and insurance and financial services industries. She speaks and publishes extensively on HIPAA and other related compliance issues.

Ms. Stamer’s work throughout her career has focused heavily on working with health care and managed care, health and other employee benefit plan, insurance and financial services and other public and private organizations and their technology, data, and other service providers and advisors domestically and internationally with legal and operational compliance and risk management, performance and workforce management, regulatory and public policy and other legal and operational concerns.

For more information about Ms. Stamer or her health industry and other experience and involvements, see www.cynthiastamer.com or contact Ms. Stamer via telephone at (214) 452-8297 or via e-mail here

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NOTICE: These statements and materials are for general informational and educational purposes only. They do not establish an attorney-client relationship, are not legal advice or an offer or commitment to provide legal advice, and do not serve as a substitute for legal advice. Readers are urged to engage competent legal counsel for consultation and representation in light of the specific facts and circumstances presented in their unique circumstances at any particular time. No comment or statement in this publication is to be construed as legal advice or an admission. The author and Solutions Law Press, Inc.™ reserve the right to qualify or retract any of these statements at any time. Likewise, the content is not tailored to any particular situation and does not necessarily address all relevant issues. Because the law is rapidly evolving and rapidly evolving rules make it highly likely that subsequent developments could impact the currency and completeness of this discussion. The author and Solutions Law Press, Inc.™ disclaim, and have no responsibility to provide any update or otherwise notify anyone of any such change, limitation, or other condition that might affect the suitability of reliance upon these materials or information otherwise conveyed in connection with this program. Readers may not rely upon, are solely responsible for, and assume the risk and all liabilities resulting from their use of this publication. Readers acknowledge and agree to the conditions of this Notice as a condition of their access to this publication. 

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©2023 Cynthia Marcotte Stamer. Limited non-exclusive right to republish granted to Solutions Law Press, Inc.™

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