Federal Regulatory Landscape

Starting an Infusion Center: The Federal Regulatory Landscape

help starting an infusion center
Are you interested in starting an infusion center?

Thank you for reviewing NICA’s free resource, “Starting an Infusion Center: The Federal Regulatory Landscape.” One of the most commonly asked questions we receive is, “How do I go about starting an infusion center?” Because guidelines vary from state-to-state, the best place to start is evaluating some of the federal regulations that every prospective infusion center owner must understand:

  • How will the center be paid?
  • How much will the center be paid?
  • When will infusion drugs be covered?
  • How do I obtain the drugs?
  • How do I submit claims?
  • What are the compliance concerns?

Additionally, you will want to consider if there is sufficient demand in your market, what the competitive landscape looks like, and what potential barriers to entry exist. For the purpose of this guide, we will only address the aforementioned bullet points. Whether you are hoping to open a free-standing infusion center or want to incorporate an infusion center into an existing clinical practice, the following content will elaborate upon the federal regulations you should be aware of. There are, of course, state law implications, which we will address in future resources.

The content in the following resource is meant to be used as general guidance and should not be construed as legal advice. NICA is not responsible for damages resulting from the use of this material.

Starting an Infusion Center
Free Guide: Federal Guidance for Starting an Infusion Center

The market for infusion therapy continues to grow. Many physician practices consider adding an infusion practice to increase ancillary services revenue, offer additional health care services to their existing patient population, or to simplify care coordination. Others may be interested in establishing a free-standing infusion center that is independent of group practices or hospitals. In either case, there are important federal regulations that must be first considered.

NICA Chairs

The National Infusion Center Association (NICA) is a nonprofit advocacy organization dedicated to protecting access to infusion therapy through advocacy, education, and resource development.