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DOJ Updates Corporate Compliance Plan Guidance

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. 

Explosive Growth in Pot of Gold Opportunity for Bank (and Other) Cannabis Lenders Driving Erosion of the Barriers

Our original article on bank lending to the cannabis industry anticipated that the convergence of interest between banks and the cannabis industry would draw more and larger banks to the industry. Banks were awash in liquidity with limited deployment options, while bankable cannabis businesses had rapidly growing needs for more and lower cost credit. Since then, the pot of gold opportunity for banks to lend into the cannabis industry has grown exponentially due to a combination of market constraints on equity causing a dramatic shift to debt and the ever-increasing capital needs of one of the country’s fastest growing industries. At the same time, hurdles to entry of new banks are being systematically cleared as the yellow brick road to the cannabis industry’s access to the financial markets is being paved, brick by brick, by the progressively increasing number and size of banks that are now entering the market.

2021 EEOC Charge Statistics: Retaliation & Impact of Remote Work

The U.S. Equal Employment Opportunity Commission (EEOC) released its detailed information on workplace discrimination charges it received in 2021. Unsurprisingly, for the second year in a row, the total number of charges decreased as COVID-19 either shut down workplaces or disconnected employees from each other. In 2021, the agency received a total of approximately 61,000 workplace discrimination charges - the fewest in 25 years by a wide margin. For reference, the agency received over 67,000 charges in 2020, and averaged almost 90,000 charges per year over the previous 10 years.

Ohio’s Managed Care Overhaul Delayed – New Implementation Timeline

At the direction of Governor Mike DeWine, the Ohio Department of Medicaid (ODM) launched the Medicaid Managed Care Procurement process in 2019. ODM’s stated vision for the procurement was to focus on people and not just the business of managed care. This is the first structural change to Ohio’s managed care system since the Centers for Medicare & Medicaid Services' (CMS) approval of Ohio’s Medicaid program in 2005. Initially, all of the new managed care programs were supposed to be implemented starting on July 1, 2022. However, ODM Director Maureen Corcoran recently confirmed that this date will be pushed back for several managed care-related programs.

Laboratory Specimen Collection Arrangements with Contract Hospitals - OIG Advisory Opinion 22-09

On April 28, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) published an Advisory Opinion[1] in which it evaluated a proposed arrangement where a network of clinical laboratories (the “Requestor”) would compensate hospitals (each a “Contract Hospital”) for specimen collection, processing, and handling services (“Collection Services”) for laboratory tests furnished by the Requestor (the “Proposed Arrangement”). The OIG concluded that the Proposed Arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present. This is due to both the possibility that the proposed per-patient-encounter fee would be used to induce or reward referrals to Requestor and the associated risk of improperly steering patients to Requestor.

Property Owner Protection from Tax Valuation Challenges

New legislation provides significant new protections for commercial property owners against challenges to valuation primarily by local school boards and prohibiting side agreements to avoid tax valuation changes. The Ohio Legislature has approved House Bill 126 which will go into effect July 2022 but will effectively apply to the 2023 tax valuation year.