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The Age of Compliance for Healthcare and Life Sciences Organizations

Compliance is a term that is bandied about often nowadays. It is one of the buzzwords in many professions, particularly in healthcare and life sciences, and has been for quite some time. There is a general realization that a compliance program is a positive, but yet many practices and organizations remain without one. So, what is a compliance program and why should you have one?

Simply put, a compliance program is a system or process that enhances your chances of following “the rules” – the myriad of laws, regulations and guidelines that apply to your practice and profession. A compliance program is a proactive measure, a good faith attempt, to operate correctly. It is about promoting ethical behavior and protecting your organization. That said, why is it in your best interest to have a compliance program and is it worth the cost?

The healthcare and life sciences regulatory landscape is forever changing and expanding. From coverage to billing and coding requirements, to HIPAA security and privacy, to licensing and certification, to Anti-Kickback Statute and STARK concerns- these are just a few examples of issues that, if not adequately addressed, can hamper or even torpedo a healthcare or life science operation.

A properly structured and vibrant compliance program is not only a great teaching and oversight tool, enhancing your efforts to set standards within your organization, but it also prevents and detects violations, and incentivizes ethical and lawful behavior. It also acts as organizational protection- if you are on the other end of an audit, investigation, administrative or civil action, or criminal prosecution, an ongoing compliance program can help demonstrate lack of fraudulent intent or act as a mitigating circumstance in any governmental evaluation of your organizational conduct. For example, in federal criminal matters, under Chapter Eight (Sentencing of Organizations) of the United States Sentencing Guidelines (USSG), having an effective “Compliance and Ethics Program” lowers an organization’s “culpability score”. 

Compliance programs can and should be tailored to the organization’s practice, size, structure and finances. They can be in-house, external or a combination of both. Regardless of size, form and complexity, to some degree they will all involve similar aspects: risk assessments, standards and ethical conduct incorporated into workplace regulations and guidelines, training, education and internal communication and feedback; designation of a compliance officer of committee; incentives and accountability; methodology for measuring compliance; and ongoing assessment. Of course, these broad topic areas are broken down to specific tasks tailored to the individual organization.

In this the “age of compliance” in healthcare and life sciences, the handwriting is on the wall: not having an effective compliance program is to risk increased chances of adverse consequences across the regulatory spectrum – whether administrative, civil or criminal, or any combination thereof. And of course, the consequential harm to your organization’s reputation. The time for healthcare and life sciences organizations to make compliance a priority now, before it is too late. Frier Levitt has extensive compliance experience, including risk assessments, drafting compliance programs and guidelines, organizational monitoring, and training. Contact Frier Levitt today to speak to an attorney regarding your organization’s compliance needs.