A nurse is helping a woman with her crutches.
ComplianceJune 06, 2024

Durable medical equipment licensing requirements

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.

What is durable medical equipment (DME)?

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:

  • Blood sugar meters
  • Canes
  • Commode chairs
  • Continuous passive motion devices
  • Continuous positive airway pressure (CPAP) devices
  • Crutches
  • Hospital beds
  • Home infusion services
  • Infusion pumps & supplies
  • Lancet devices & lancets
  • Nebulizers & nebulizer medications
  • Oxygen equipment & accessories
  • Patient lifts
  • Pressure-reducing support surfaces
  • Suction pumps
  • Traction equipment
  • Walkers
  • Wheelchairs and scooters

What DME licenses do I need (by state)?

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.

Map of the United States showing the business license requirements for each state.
Durable medical equipment business license requirements smart chart
Understand what licenses are needed when selling to consumers vs. selling to facilities and practitioners

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.

Common durable medical equipment (DME) license application requirements

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

  • Corporate documents: Certificates of Incorporation of business and not-for-profit corporations or Articles of Organization of limited liability companies
  • Proof of insurance: This may be needed for commercial liability, workers’ compensation, and/or medical product liability
  • Sales tax permit: Many states do require DME suppliers to register for sales tax even though, very often, durable medical equipment is exempt from sales tax.
  • Proof of accreditation: If you are a DME retailer, you may also need to obtain accreditation from one of the 10 national accreditation services approved by the Center for Medicare & Medicaid Services (CMS).
  • Fingerprints of owners and officers: These fingerprints can be used for a fingerprint search by a state's criminal bureau and by the Federal Bureau of Investigations (FBI).
  • Home state license: If applying for a DME license in a state in which your business is not domestic, you must provide proof of licensure with the state in which your company was formed and/or principally located.
  • State expansion: If you expand into another state, that non-resident state may require verification that your business currently holds a resident DME license (or proof that a license is not required) from your home state.

Average DME license processing time

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.

Are renewals required?

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

Ramifications of non-compliance

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.

Conclusion

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.

Access the smart chart

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

Hans Howk
Manager, Content Management
Hans provides internal support to key members of the Business Licensing Team, assisting with understanding industry nuances, searching and synthesizing statutes and regulations relating to business law.
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