TITLE 26 FOOD, DRUGS, AND COSMETICS

Section 4. Pharmacists and Pharmacies, 26-4-1 through 26-4-214.

ARTICLE 3 PRACTICE OF PHARMACY

26-4-51. Durable medical equipment supplier license; requirements; exemptions; rules and regulations.

1. Any person who supplies durable medical equipment to a consumer and submits a claim for reimbursement by a third party, either directly or through a contractual arrangement, shall possess a durable medical equipment supplier license issued by the board pursuant to this Code section.
2. The board shall be authorized to issue a license to an applicant for licensure as a durable medical equipment supplier if the applicant:
   1. Submits an application in the form prescribed by the board;
   2. Maintains an office or place of business within this state;
   3. Pays the license fee established by the board pursuant to paragraph (37) of subsection (a) of Code Section 26-4-28; and
   4. Meets all safety standards and requirements established by the board, including but not limited to the establishment of written procedures for:
      1. Ensuring that all personnel engaged in delivery, maintenance, and repair of durable medical equipment receives annual continuing education;
      2. Instructing the patient or patient's caregiver on how to use the durable medical equipment provided;
      3. Receiving and responding to complaints from patients;
      4. Maintaining records of all patients receiving durable medical equipment; and
      5. Management, maintenance, and servicing of durable medical equipment.
3. The board may issue a license to a Medicare enrolled out-of-state manufacturer or wholesale distributor that provides durable medical equipment directly to consumers if such manufacturer or wholesale distributor possesses a valid license from another state. Such manufacturer or wholesale distributor shall be exempt from the requirements of paragraph (2) of subsection (b) of this Code section.
4. Licenses issued pursuant to this Code section shall be effective for 36 months from the date of issuance and shall not be transferable or assignable.
5. The board may refuse to issue or renew, or may suspend, revoke, or restrict the licenses of, or fine any person pursuant to the procedures set forth in Code Section 26-4-60 for any of the grounds set forth in subsection (a) of such Code section or upon a finding that the applicant or licensee:
   1. Has violated any state or federal law or regulation related to the provision of durable medical equipment; or
   2. Fails to meet the safety standards established by the board.
6. The board reserves the right to initially and periodically inspect the applicant's or licensee's office or place of business within this state. Such applicant or licensee shall be required to pay a reasonable and adequate fee established by the board pursuant to paragraph (37) of subsection (a) of Code Section 26-4-28 to cover the cost of such inspections.
7. The following persons and entities shall be exempt from the requirements of this Code section unless any such person or entity has 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:
   1. Pharmacies and pharmacists;
   2. Hospitals;
   3. Ambulatory surgical centers;
   4. Health care facilities owned or operated by the state or federal government;
   5. Skilled nursing facilities;
   6. Assisted living facilities;
   7. Health care practitioners who:
      1. Provide durable medical equipment within the scope of practice of the health care practitioner's profession; and
      2. Are licensed in this state to practice the health care practitioner's profession;
   8. Suppliers of insulin infusion pumps and related supplies or services;
   9. Manufacturers or wholesale distributors that do not sell or rent durable medical equipment directly to consumers;
   10. Renal dialysis providers licensed under Code Section 31-44-4 and persons or entities that distribute devices necessary to perform home renal dialysis to patients with chronic kidney disease; and
   11. Suppliers of osteogenesis stimulators, transcutaneous electrical nerve stimulators, pneumatic compression devices, and related supplies or services.
8. The board shall promulgate rules and regulations necessary to implement the provisions of this Code section. Such rules and regulations shall be established with the intent of ensuring patient safety and quality of durable medical equipment. The board may provide by rules and regulations that any person accredited by organizations recognized by the federal Centers for Medicare and Medicaid Services is deemed to meet all or some of the requirements of this Code section. Further, the board shall be authorized to require the completion of background checks, including, but not limited to, criminal history record checks, on any applicants or licensees, on any persons who will have direct contact with patients, and on any other licensee personnel deemed necessary for purposes of patient safety.
9. Nothing in this Code section shall be construed to restrict or prohibit the ability of a person or business to engage in a private transaction between two parties.

(Code 1981, §26-4-51, enacted by Ga. L. 2017, p. 614, § 3/SB 41.)