On March 30, 2017, the Georgia State Senate voted to pass SB41, which amends the Georgia Pharmacy Practice Act, regulating the practice of pharmacy in the state of Georgia. After passing both the House and Senate, the bill is currently enrolled, meaning Governor Nathan Deal has 30 days to sign or veto the bill.
SB41 was sponsored by Senator Renee Unterman (R-Buford) and Representative Jesse Petrea (R-Savannah). The bill establishes a licensure requirement for durable medical equipment (“DME”) suppliers who supply DME to consumers and submit claims for reimbursement by a third party, either directly or through a contractual arrangement. The bill also establishes a definition for DME, specifying that DME includes equipment requiring a prescription, including repair and replacement parts. To be considered DME, the equipment must be able to withstand repeated use; have an expected life of at least 3 years; be primarily and customarily used to serve a medical purpose; be generally not useful in the absence of illness or injury; and the equipment should be appropriate for use in the home.
In order to obtain a DME supplier license under the provisions of SB41, an applicant must submit the appropriate application forms as prescribed by the Georgia State Board of Pharmacy (the “Board”), submit the requisite license fee, and maintain an office or place of business within Georgia. The applicant must also meet all safety standards and requirements established by the Board. These safety standards include, but are not limited to, establishing written procedures to: ensure that all personnel engaged in delivery, maintenance, and repair of DME receive annual continuing education; provide instruction to the patient or patient’s caregiver on how to use DME; receive and respond to complaints from patients; maintain patient records for all patients receiving DME; and properly manage, maintain, and service DME.
Medicare enrolled out-of-state manufacturers or wholesale distributors that provide DME directly to consumers may be issued a license by the Board without compliance with the Georgia licensure requirements if the manufacturer or wholesale distributor holds a valid license from another state. Licenses issued by the Board are valid for 36 months and are not transferable or assignable. Licenses may be suspended, revoked, or restricted, applications may be rejected, or a fine may be assessed if the applicant or licensee is found to have violated any state or federal law or regulation related to the provision of DME or fails to meet the safety standards.
The bill also authorizes the Board to promulgate rules and regulations to implement these new licensure requirements. The Board may require the completion of background checks, including, but not limited to, criminal history record checks, on any applicants or suppliers holding licenses, on any person who will have direct patient contact, and on any other personnel of the license holder deemed necessary for the purposes of patient safety. The Board may also initially and periodically inspect an applicant or license holder’s office or place of business and may charge the applicant or license holder for the reasonable costs of such inspections.
The bill specifically exempts the following categories of persons or entities from the licensure requirements:
- Pharmacies and pharmacists; hospitals;
- Ambulatory surgical centers;
- Health care facilities that are owned or operated by the state or federal government;
- Skilled nursing facilities;
- Assisted living facilities;
- Health care practitioners who provide DME within the scope of their profession and are licensed in Georgia to practice the profession;
- Suppliers of insulin infusion pumps and related supplies or services; manufacturers or wholesale distributors that do not sell or rent DME directly to consumers;
- Renal dialysis providers licensed under the laws of Georgia and persons or entities that distribute devices necessary to perform home renal dialysis to patients with chronic kidney disease; and
- Suppliers of osteogenesis stimulators, transcutaneous electrical nerve stimulators, pneumatic compression devices, and related supplies or services.
The exemption does not apply if any such person or entity has a separate company, corporation, or division that is in the business of supplying DME to consumers and submits claims for reimbursement by a third party.
DME suppliers should be aware of and monitor the status of this bill and these requirements to remain in compliance with the new licensure standards.