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DOJ Updates Corporate Compliance Plan Guidance

Client Alert

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. 


Effective December 12, 2024: Key Updates to Ohio Medicaid Rules for CPC and CMC Programs

Ohio Medicaid has amended rules for the Comprehensive Primary Care (CPC) and Comprehensive Maternal Care (CMC) programs, effective December 12, 2024. Key updates include expanded provider eligibility, stricter cultural competency training timelines, new clinical quality metrics, and changes to maternal care requirements.

Ohio Medicaid Extends Timely Filing Deadline Until 2025

The Ohio Department of Medicaid (ODM) recently announced that it is extending its timely filing deadline to February 28, 2025. According to ODM, roughly 2% of providers have contract issues preventing them from meeting the previous timely filing deadline of December 1, 2024.

Another Drug Manufacturer Pursues Rebate Program as 340B Alternative

Some of the nation’s largest drug manufacturers are forging ahead to implement rebate programs for 340B drugs, even after the federal government has called these programs illegal. While it is unclear how these federal courts will rule, this could threaten the sustainability of safety net providers and their patients.

Hurry Up, STOP. . .Has CTA Been Struck Down By Courts?

Following a recent case in Texas, uncertainty has arisen regarding whether clients should file "beneficial owners" reports. This is a result of the Federal Government enjoined from enforcing the CTA. Contact your BMD Member Blake Gerney to find out how this affects you.

DEA and HHS Issue its Third Extension of Telemedicine Flexibilities through 2025

The DEA and U.S. Department of Health and Human Services (HHS) have extended telemedicine flexibilities for prescribing controlled medications through December 31, 2025. This extension builds on temporary exceptions made in 2020 due to COVID-19, allowing providers to prescribe Schedule II-V controlled substances based on a telemedicine evaluation alone. The extension ensures continued patient access to necessary prescriptions and provides time for providers to comply with future regulations.