Georgia's DME Supplier License and Designated Representative

Georgia requires a DME supplier license from the Georgia State Board of Pharmacy for a business located in Georgia "that provides durable medical equipment to a consumer and submits a claim for reimbursement by a third party, either directly or through a contractual arrangement," and for "any Medicare enrolled out-of-state DME manufacture or wholesale distributor that provides durable medical equipment to consumers in this state and who holds a valid license from another state" (Ga. Comp. R. & Regs. 480-7B-.02(1)). Each location is licensed separately, each needs a Board-approved designated representative, and licenses run 36 months. As of the Board's fee schedule, the license is $750 and renewal is $600.

What does Georgia count as durable medical equipment?

Only equipment "for which a prescription is required," including repair and replacement parts, that can withstand repeated use, has an expected life of at least three years, is primarily used for a medical purpose, is generally not useful without illness or injury, and is appropriate for home use (480-7B-.01(3)). The license is also tied to billing: a DME supplier is one that provides that equipment to a consumer "and submits a claim for reimbursement by a third party" (480-7B-.01(4)). A cash-only retailer of nonprescription aids sits outside the definition; a Medicare or Medicaid supplier of prescription equipment sits inside it.

Who is exempt?

The rule exempts several kinds of businesses unless they run "a separate company, corporation, or division that is in the business of supplying durable medical equipment to consumers and submits a claim for reimbursement by a third party" (480-7B-.02(6)). Among them:

• pharmacies and pharmacists;
• ambulatory surgical centers, skilled nursing facilities, assisted living facilities and government-run facilities;
• Georgia-licensed health care practitioners providing equipment within their scope of practice;
• "Suppliers of insulin pumps and related supplies or services";
• manufacturers or wholesale distributors that do not sell or rent directly to consumers;
• renal dialysis providers and distributors of home dialysis devices;
• "Suppliers of osteogenesis stimulators, transcutaneous electrical nerve stimulators, pneumatic compression devices, and related supplies or services."

The product exemptions are unusual. A supplier whose Georgia business is only insulin pumps, or only TENS units and compression devices, may need no Georgia DME license at all. A supplier that adds CPAP, oxygen equipment or power mobility is back in scope.

Can an out-of-state supplier get a Georgia license?

Only some can. The rule's out-of-state language covers Medicare-enrolled out-of-state DME manufacturers or wholesale distributors. The Board's DME supplier application, revised November 14, 2024, makes the line explicit. It asks, "Are you licensed in any state as a manufacturer or wholesaler/wholesale distributor?" and says, "If no, you DO NOT QUALIFY under the law for an out-of-state GA DME permit." Out-of-state applicants must also give "proof of a valid, unexpired license to operate as a DME supplier" in their home state (480-7B-.02(2)(a)(6)), and the application includes a certification form for each state licensing board to complete.

An out-of-state retail supplier that is not a licensed manufacturer or wholesaler should ask the Board how its Georgia shipments are treated, in writing, before assuming either that it needs nothing or that it can apply. See licensing as an out-of-state DME supplier.

What is a designated representative?

"The Board shall only issue a license to a DME supplier if a qualified individual has been approved as a designated representative" (480-7B-.03). The designated representative supervises the place of business, ensures compliance with state and federal law, and protects public health "in the handling, storage, warehousing, distribution, and shipment of durable medical equipment." Where a supplier has more than one licensed location, "each licensed place of business shall have at least one designated representative present."

To qualify, the individual must be at least 18, submit the Board's personnel certification form with the application, attest to knowledge of DME distribution law, quality control systems and USP and FDA storage and handling standards, and consent to and pay for a background check covering criminal and driver history. A pharmacist serving in the role lists every state license. The Board sends its notices to the designated representative, so this person needs to open the mail. More in designated representatives and exemptees.

Which documents go into the application?

Rule 480-7B-.02(2) lists the core: the business name, address and phone; every trade name; the proposed designated representatives and their qualifications; the type of ownership; and the names of owners, partners, or corporate officers and directors, the parent company and the state of incorporation. The Board also requires "a report from GDNA" (the Georgia Drugs and Narcotics Agency) certifying that the applicant meets the Board's safety standards, and an in-state applicant must maintain an office or place of business in Georgia (480-7B-.02(1)).

The Board's instructions add practical rules: "Any documents submitted as an attachment to the application must also be signed by the owner, partner, or one of the executive officers of the corporation and notarized," the application carries a sworn affidavit before a notary, and applicants should "Allow a minimum of 60 business days for the processing of the application." An application is valid for only one year (480-7B-.02(2)(c)). The Board may find that a supplier "accredited by an organization recognized by the federal Centers for Medicare and Medicaid Services has met all or some of the requirements for licensure" (480-7B-.02(1)).

How long does the license last?

"Licenses are issued for thirty-six months, expire on June 30th of every third year," and renew for three years with the fee for each place of business. If renewal is not filed and paid "before September 1st of the third year, the license shall lapse," and reinstatement "is at the sole discretion of the Board" (480-7B-.02(4)). The Board's fee schedule lists $600 for renewal and $900 for late renewal. A license is tied to its location: moving means a new application, and the Board must be notified before any change to the information on the application (480-7B-.02(5)). See a renewal calendar for state DME licenses.

How do we help with Georgia?

Georgia is one of our complex states at $899 (pricing) because of the designated representative, the GDNA report and the notarized attachments. We check whether your products fall under the exemptions, prepare the application and personnel certification, coordinate the home-state certification forms, and track the June 30 renewal. Your owner, partner or officer signs before a notary, the designated representative signs the personnel form and pays for the background check, and you pay the Board directly. The Board decides, on its own schedule. See the Georgia state page.