A team of medical professionals dressed in scrubs and white lab coats meet while seated at a table.

The Compliance Plan Toolkit: Your Guide to Regulatory Compliance in Healthcare

In June 2016, the Department of Justice (DOJ), in coordination with the Department of Health and Human Services, announced "an unprecedented nationwide sweep" which resulted in the arrest of over 300 individuals, including "doctors, nurses and other licensed medical professionals." Accused of health care fraud in excess of $900 million, the 301 individuals facing both criminal and civil charges learned an important lesson from what was called the most "coordinated takedown…in history, both in terms of the number of defendants charged and loss amount."

In September 2021, the DOJ announced an enforcement action that resulted in charges involving over $1.4 billion in alleged losses, resulting in criminal charges against 138 defendants, including 42 doctors, nurses, and other licensed medical professionals. 

Healthcare fraud is a serious crime and the federal government prosecutes those that exploit the system.

The Affordable Care Act Changed the Regulatory Environment

Early in 2010 then-President Barack Obama signed into law the Patient Protection and Affordable Care Act of 2010 (ACA). Primarily aimed at ensuring more access to affordable health care, and lowering the overall financial burden health care places on the federal government, the ACA was, and remains, at hotly contested piece of legislation. Regardless of your views of the legislation, what we do know is that the passage of the ACA introduced not only a slew of new health care regulations, but also changed what it means to be compliant.

According to an article in RevCycleIntelligence.com, a leading online resource for the latest news about health care, Medicare, and Medicaid, "[h]ealthcare prosecutors generally have to decide if the organization in question implemented a legitimate compliance program…[i]f prosecutors determine that a health care organization maintained a legitimate compliance program, the government may reconsider its approach to prosecution and prevention strategies."

Regulatory Compliance Alone Is Not Enough – Healthcare Professionals Should Maintain a Legitimate Compliance Program

At Hendershot Cowart P.C., we believe that every health care organization should have a detailed Compliance Plan to help ensure your organization consistently meet the regulatory requirements of the ACA. In our toolkit, we highlight eight elements aimed at tackling regulatory compliance:

  1. A Code of Conduct which not only establishes an organizations commitment to regulatory adherence, but clearly defines the mission and ethical expectations of the entire workforce, encompassing everyone from board members to hourly employees.
  2. Written Policies and Procedures aimed at documenting not only the code of conduct, but other valuable resources such as compliance training, corrective action plans, disaster recovery plans, and internal control plans. These written policies and procedures are invaluable and ensure that all employees have access and knowledge of the organizations compliance goals.
  3. A Designated Corporate Compliance Officer (and compliance committees) who takes a lead role in ensuring that compliance remains an integral part of the organization. A compliance officer helps organizations stay on top of new and relevant regulations, while also updating current compliance plans and procedures based on organizational changes.
  4. The creation of Training and Education Programs to help organizations ensure that employees are informed of the compliance measures undertaken by the organization. This includes not only designing the training, but determining who will receive the training, how often they receive the training, and, most important, whether the training is working.
  5. Creating an environment and culture where Open Lines of Communication are not only available but encouraged. This includes ensuring employees know who they should go to with compliance related questions and concerns without fear of retribution or punishment.
  6. Designing a clear Enforcement Plan that establishes the actions taken when it has been determined that an employee is not in adherence with the compliance program. This includes employees who are not following whatever training requirements may exist.
  7. Creating the procedures that will outline the self-Auditing and Monitoring that is necessary to ensure your compliance program is continuously effective. This includes a consistent and rigorous review of current plans and outcomes.
  8. The implementation of a Corrective Action Plan that, building on your enforcement plan, details a clear line of action from training to violation, from violation to enforcement, from enforcement to internal review. A corrective action plan not only helps identify the violation, but helps provide insights in why the violation occurred.

Healthcare is serious business. Even well-meaning organizations run the risk of criminal and civil investigations, or worse, if they aren't compliant with the current regulations. With over 100 years of cumulative experience, the professional team at Hendershot Cowart P.C. are industry-leading health and medical law attorneys. We not only work to ensure that you're compliant with current regulations, but we also help you build a foundation that helps ensure your organization is compliant into the foreseeable future.

If you're interested in learning more about how we can help your organization – or to learn more about compliance plans for your health care organization – don't hesitate and contact us today.


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