About Durable Medical Equipment Licensing

Apr 28, 2023

If your business provides durable medical equipment (DME) or home medical equipment (HME), it is subject to several licensing requirements. These vary depending on the type of equipment and the jurisdiction in which you operate.

This is a highly regulated industry — both at the state and local level. To protect the public and institutions, governments require industry-level licenses in addition to local and tax registrations. DME covers a wide array of devices including crutches, catheters, wheelchairs, blood glucose monitors, and more. It is not always clear whether your business must be licensed in a particular state. It's important to verify the licensure requirements of your home state and any state in which you plan to operate before starting to do business.

Additional permitting may be required for certain types of equipment, such as pharmacy licenses for oxygen-related devices.

In this article, we explore what DME licenses your business may need, how to apply for these licenses, and how your business can maintain good standing.

As the name suggests, durable medical equipment is defined as medical equipment and supplies that are not disposable but are medically necessary and appropriate for home use.

Examples of DME include:

DME license requirements vary by state. They also differ depending on who your business sells to, whether it is wholesale to practitioners or facilities, or retail to consumers.

To understand what licenses are needed when selling to consumers vs. selling to facilities and practitioners by state, check out our DME smart chart.

Some states maintain exemptions for DME licensing for facilities that are already licensed as pharmacies or other more regulated facilities. This can be helpful when assessing the licensing needs if your business is an established pharmacy or other licensed entity and may be branching into the DME space, as opposed to starting a DME-specific business from the ground up.

To apply for a DME license, the following documents and steps are usually required:

You can expect the entire process of obtaining a DME license to take between four and eight weeks. Processing times can vary if foreign qualification and fingerprints are required.

Yes, DME licenses must be renewed, generally every one to two years.

If your business provides DME or HME without the proper licenses, it may be subject to civil and criminal penalties. Importantly, if your employees are involved in setting up or installing any DME equipment, you should also ensure that they are also properly licensed. Companies have incurred significant fines because of unlicensed employees.

Some states may require licensure for the distribution of medical devices, even if the devices aren't considered DME or HME specifically. Again, it is important to verify the licensure requirements of your home state and any state in which you plan to operate before starting to do business.

Managing compliance obligations, particularly license renewals, amidst ever-changing regulations should occupy an important part of your company's day-to-day operations. Keeping track of renewal dates, fees, and necessary documents can be complicated and time-consuming.

CT Corporation can help you navigate the DME industry's uniquely complex regulatory and licensing challenges.

Learn more

To learn more about how CT Corporation can help you manage your business license needs, contact a CT Corporation Service Representative or call (844) 878-1800.

Please complete the form below for immediate access to the eight-page smart chart about durable medical equipment business license requirements.

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