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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. 

Vaccination Considerations for Employers

Today, three Covid-19 vaccines have tested as highly effective (90%+ efficacy) and are advancing in the process for emergency use. This is especially welcome news in Ohio, which has skyrocketing cases and our strategic response has been to turn the entire state into the small town of Bomont with strict curfews and bans on social gatherings.

Did You Receive More than $750,000 in Provider Relief Funds?

The Provider Relief Funds (“PRF”) - authorized under the CARES Act - has been a vital tool for health care providers during the COVID-19 public health emergency. These funds have allowed providers to stay open and continue to offer care during these pressing times. While helpful, these funds do come with several important obligations. First, fund recipients are required to comply with certain record-keeping requirements as well as comply with certain balance billing prohibitions. See our Client Alert. Second, fund recipients are required to report their intent, use of funds, and other data elements, which helps promote transparency to the federal government. Please see our Client Alert on provider relief fund reporting requirements. Third, and perhaps a new concept for many providers, fund recipients of more than $750,000 must undergo a “single audit” to ensure program compliance and appropriate use of funds.

Important Updates Every Provider Should Know: Information Blocking

In December 2016, Congress passed the 21st Century Cures Act (“Cures Act”) which: (1) authorized funding for the National Institutes of Health to promote medical research and drug development, (2) implemented provisions aimed at addressing the prevention and treatment of mental illness and substance abuse, and (3) reformed certain standards of the Medicare program and federal tax laws to foster healthcare access and quality improvement.

PPP Update: Loan Necessity Questionnaires

On October 26, 2020, the Small Business Administration (“SBA”) published a notice in the Federal Register which foreshadowed the release of two new forms seeking information from for-profit and nonprofit organizations that received Paycheck Protection Program (“PPP”) loans of $2 million or more. If approved, the SBA would use information from these forms to evaluate and determine whether economic uncertainty made a PPP loan request necessary.

Exposure to COVID-19 Flow Chart

Exposure to COVID-19 Flow Chart