Bass, Berry & Sims attorney Shannon Wiley discussed the traits that help infusion centers ensure that they are compliant with healthcare regulations, especially as many organizations grow beyond their initial model. Infusion center operators often add additional services such as pharmacy and practice management services, and every change in the model changes the compliance needs of the business.

With infusion centers a relatively new model in healthcare, the regulatory landscape is still emerging, leaving a lot of gray areas for compliance, Shannon said. In addition, multi-state operators must comply with a wide range of state licensure and corporate practice of medicine laws and regulations that have to be reckoned with.

The best way to mitigate these risks is a compliance program implemented by an internal compliance department that can identify the unique risks of a specific infusion center, based on how the business has grown and evolved, she added. Some of the critical elements of an infusion center’s compliance program include scrutinizing relationships with referral sources, storage and use of controlled substances, a billing audit program, and keeping all compliance programs up to date.

Investing in compliance also is a strong sign to regulators that an infusion center is committed to compliance, and that can help in a government investigation, Shannon said.

Moreover, being intentional about compliance early in the life of an infusion center company is important to code compliance in the DNA of the organization. Companies that lack this intentional focus on compliance develop practices that are difficult to unwind later to make them compliant, Shannon said.

Shannon was interviewed for the WeInfuse podcast, “Episode 53: How to be Intentional about Regulatory Compliance with Shannon Wiley,” that was released on October 4. The content is available online or wherever you get your podcast content.