Durable medical equipment licensing requirements

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.

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