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DOJ Updates Corporate Compliance Plan Guidance

Client Alert
June 18, 2020

With the passage of the Affordable Care Act in 2010, all healthcare providers were required to adopt and implement a corporate compliance plan. Historically, having an effective corporate compliance plan in place has been key to defending healthcare providers in fraud and abuse actions by Medicare, Medicaid, and commercial payers. Over the past couple of years, the U.S. Department of Justice’s (DOJ) Criminal Division has increased the number of prosecutions against U.S. corporations, including healthcare providers. Earlier this month, the DOJ’s Criminal Division updated its “Evaluation of Corporate Compliance Programs” guidance to educate prosecutors on how a corporate compliance program will be evaluated going forward. https://www.justice.gov/criminal-fraud/page/file/937501/download

If a healthcare provider is able to actively demonstrate its commitment to a culture of compliance as reflected in a comprehensive program, an Assistant U.S. Attorney (hereinafter “AUSA”) may elect to not file charges and/or may seek reduced charges. Regardless if an AUSA does bring formal charges, the new guidance allows a federal judge to impose a reduced sentence. Now, more than ever, it’s critically important that healthcare providers have an effective compliance program in place as it materially affects the penalties imposed for healthcare fraud and abuse violations. Having an effective compliance program can mean the difference in whether criminal charges are brought (which could result in prison time or large fines).

The June 2020 update from the DOJ covers a variety of specific topics, but essentially focuses on three questions in relation to an organization’s compliance program: 

  1. Is the compliance program well designed?
  2. Is the program applied earnestly and in good faith?
  3. Does the program work in practice?

In other words, an effective compliance plan must be a “living, breathing document” and not just a generic set of policies and procedures that is left forgotten on a shelf or computer system. 

A successful compliance program should focus on the provider’s internal compliance training program. The DOJ described an appropriately tailored training as “the hallmark of a well-designed compliance program” and periodic training helps to ensure that a compliance program is integrated into the organization. Relevant employees, as well as, senior managers (and in some situations, agents and business partners) should have training provided by the company regularly so that they may properly communicate and implement compliance policies and procedures. Furthermore, the organization must pay special attention to providing employees with the tools in which to seek assistance and/or respond to any potential compliance issues.

Throughout the update, the DOJ identifies specific areas where AUSA’s should focus in their determination of whether a compliance program is well-designed, earnestly implemented and effective. Two of these areas assist providers in designing, implementing and improving their compliance-based programs.

  1. Risk-Bask Training

Providers are expected to conduct an in-depth analysis of which employees require training and on what subjects. The organization should provide tailored trainings which reflect the specific risks in the work environment. Any employee who works in a high-risk role, has been involved in prior misconduct, or is senior management should receive ongoing trainings. 

  1. Form/Content/Effectiveness of Training

AUSA’s will not be impressed by merely having a program designed. They will instead focus on the form in which the training is being provided, including who is presenting the trainings. Real-world compliance lapses and testing by companies should be frequent.

The attorneys of Brennan, Manna & Diamond’s healthcare team are available to assist healthcare providers in drafting, implementing and improving their corporate compliance programs, trainings, and implementation processes.  Please contact Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001, Richard Crosby at rlcrosby@bmdpl.com or 614-246-7500, or your BMD healthcare attorney for more information. 

DOJDepartment of JusticeHealthcare ProvidersComplianceCompliance Planrisk-bask trainingeffectiveness of trainingAUSACompliance Programcompliance plan guidanceevaluation of corporate compliance programhealthcare fraud and abusehealthcare abuse violationhealthcare fraud violationmedicaremedicaidcommercial payersBMD Attorney Richard CrosbyJeana Singleton
Client Alert

Supreme Court Rules that Employers Must Show Substantial Increased Costs to Legally Decline Employees’ Religious Accommodation Requests

June 29, 2023On June 29, 2023, the Supreme Court ruled in Groff v. DeJoy that under Title VII of the Civil Rights Act of 1964 (“Title VII”) employers must show, in order to decline religious accommodations, that the burden of granting religious accommodations to employees will result in substantial increased costs in relation to the conduct of an employer’s particular business, thus amending the prior, simple standard of a “de minimis” undue hardship.Client Alert

Recent HIPAA Breach Settlements - Lessons Learned

June 19, 2023According to the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR), the consequences for providers may include settlements of $30,000 to $240,000. OCR recently released two settlements for improper breaches of protected health information (PHI) that are good examples of the major monetary penalties that can result from common HIPAA mistakes.Client Alert

Supreme Court Issues Major False Claims Act Decision

June 5, 2023Client Alert

Telehealth Flexibility Updates: HIPAA, DEA, and CMS

May 12, 2023The Covid-19 Public Health Emergency (PHE) officially ended on May 11, 2023. But what does that mean for telehealth, a field that expanded exponentially during the PHE? Fortunately, many of the flexibilities will remain intact, at least temporarily. This client alert presents a brief overview of the timelines that providers need to follow, but for a more comprehensive review of telehealth flexibilities and when they will endClient Alert, Multimedia

WEBINAR SERIES RECAP | Ending the Public Health Emergency + Post-Pandemic Check-Up

May 10, 2023Some may take the position that the rest of the country already returned to a new “normal” following the COVID-19 pandemic.  But healthcare providers continue to implement COVID protocols and navigate the ever-changing healthcare regulations at both the federal and state levels.  It is important for healthcare providers to take time for a “Healthcare Check-Up” with the start of 2023 and the ending of the Public Health Emergency (“PHE”).
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