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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
Multimedia, Client Alert

Pregnant Employee Protections - New Requirements for Employers

April 11, 2023New protections are coming to the workplace for pregnant employees in 2023! In the most sweeping changes since the Pregnancy Discrimination Act of 1978, two new federal laws were recently passed: (1) the PUMP for Nursing Mothers Act (otherwise known as the Pump Act), and (2) the Pregnant Workers Fairness Act. The requirements of these statutes will require employers with more than 15 employees to implement new policies for their handbooks.Client Alert

Five Common Pitfalls for Employers to Watch Out for Under the Fair Labor Standards Act

March 29, 2023The Fair Labor Standards Act (FLSA) sets forth requirements for employers including, but not limited to, minimum wage, overtime pay, and recordkeeping for covered employees. These requirements are not as simple as they may appear on their face, which leads many employers to fall into compliance issues that they did not realize even existed.Client Alert

The NLRB Limits the Reach of Confidentiality and Non-Disparagement Provisions in Severance Agreements Overruling Trump-Era Policies

March 14, 2023Employers should exercise caution and closely examine the content of severance agreements to ensure compliance with a recent National Labor Relations Board (“NLRB”) decision.  On February 21, 2023, the NLRB restricted the breadth of permissible language of confidentiality and non-disparagement clauses when it issued its decision in McLaren Macomb and overruled its Trump-era decisions in Baylor University Medical Center and IGT d/b/a International Game Technology.Client Alert

Ohio Medical Board Releases New Telehealth Rules

February 23, 2023On Tuesday, February 21, 2023, the State Medical Board of Ohio released its final telehealth rules to implement Ohio’s telehealth statute (O.R.C. 4743.09) for physicians, physician assistants, dieticians, respiratory care professionals and genetic counselors. Ohio’s advanced practice registered nurses (“APRNs”) should also take note of these rules. While the Medical Board does not govern APRNs directly, those APRNs who are required to have a collaborating physician and standard care arrangement (namely nurse practitioners, certified nurse midwives, and clinical nurse specialists) are still affected by the rules. Generally, if an APRN’s collaborating physician is limited in their practice, then the APRN will also be limited.Client Alert

The End of the Public Health Emergency is (Finally) Here

February 23, 2023The COVID-19 Public Health Emergency (“PHE”) that has been in effect for over three years is finally slated to end on May 11, 2023.[1] With the end of the PHE will come many changes for healthcare providers to be aware of; however, some changes may not come until much later.
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