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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

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2020 EEOC Statistics – More Money and Fewer Charges

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A New Formation Solution – is the SSLC Right for Your Business?

March 4, 2021In early January 2021, Ohio adopted Senate Bill 276 which established a Revised Limited Liability Company Act (“ORLLCA”) as Ohio Revised Code Chapter 1706, which effectively replaces the current Ohio Limited Liability Company Act (Ohio Revised Code Chapter 1706). The ORLLCA will become effective on January 1, 2022. One of the principal changes within the ORLLCA is the ability to establish “series LLCs”. Ohio becomes the 15th state to adopt a “series LLC” (“SLLC”). The below FAQs will help you better understand the mechanics and nuances of a series LLC.Client Alert

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February 25, 2021SURPRISE! Congress passed The No Surprises Act at the end of 2020. Providers, particularly those billing as out-of-network providers, should start thinking about strategies to comply with this new law, set to take effect on January 1, 2022. In its most basic sense, the new law prohibits providers from billing patients for more than the in-network cost-sharing amount in most situations where surprise bills happen. It specifically applies to non-government payers and the amounts will be set through a process described in the new law. In particular, the established in-network cost-sharing amount must be billed for the following services:Client Alert

Ohio Enacts Substantial Changes to Employment Discrimination Laws

February 25, 2021In January, Governor Mike DeWine signed into law the Employment Law Uniformity Act, amending the employment protections in the Ohio Civil Rights Act in several significant ways. Such changes to the state’s anti-discrimination and anti-harassment laws have been considered and debated for years and finally made their way into Ohio law. What has changed for employment claims under the amended Ohio Civil Rights Act?
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