By Jessie L. Bekker
The Alabama Board of Medical Examiners (“Board”) has proposed sweeping changes to the regulations guiding office-based surgeries in Alabama that, if passed, would create more stringent requirements with respect to procedures performed under anesthesia in physician offices across the state.
The proposed rules would repeal and replace existing regulations that were promulgated in 2003 as a joint effort of the Board and “an ad hoc committee representing various medical and surgical specialties,” according to the preamble to the current rule. Notably, the requirements for in-office use of anesthesia use permissive language, establishing a framework of rules that physicians “should” follow when administering anesthesia to patients in physician office settings. By contrast, the proposed rules set firm prerequisites for performing office-based surgeries by the use of stricter language (changing “should” to “shall”). Effectively, the shift from the current permissive language to the proposed more stringent language might bolster the Board’s authority to penalize noncompliance with the rules.
If adopted as proposed, compliance with the new rules will be required by January 1, 2026. Summarized below are five key changes that would impact Alabama physicians performing office-based surgeries:
Accreditation.
In a major shift from the current rules, the proposed rules would require physician offices to obtain accreditation or certification by an entity approved by the Board if the office is the site of any surgical procedures requiring registration. Under the proposed rules, registration requirements are expanded from current requirements to include physician offices in which: (a) a surgery is performed under moderate sedation, deep sedation or general anesthesia, (b) liposuction is performed using infiltration methods, (c) procedures are performed using propofol (an anesthetic), (d) a procedure is performed involving a major upper or lower extremity nerve block, or (e) MRI and other imaging studies are performed involving moderate sedation, deep sedation or general anesthesia. While physician offices would have until January 1, 2026 to comply with the rules, physician offices subject to the new accreditation requirements would not need to be immediately compliant. Instead, the proposal allows physician practices that have already submitted accreditation applications to continue to perform office-based surgeries, provided that they meet accreditation standards and obtain accreditation within one year of performing the first procedure under the new rules. The proposal does not list which accreditation agencies would satisfy the requirement, indicating that the Board may release those details in future guidance documents.
Training.
Under the proposed rules, every physician performing office-based surgeries and procedures is required to have completed training specific in the surgeries and procedures the physician performs. The rule specifies the criteria the Board would use to evaluate training that meets the requirement, offering that completion of an accredited residency or fellowship in the related surgery or procedure, or specialty board certification, would be sufficient. Further, physicians who propose to provide a new office-based surgical procedure would be required to conduct specific training for all personnel involved in the care of patients that is tailored to the new procedure prior to performing the procedure.
Quality Assurance.
The proposed rules would require physician offices to implement and maintain quality assurance programs that review the physician office’s procedures and quality of care. Moreover, as part of the quality assurance program, the Board would require physicians unaffiliated with the practice to conduct peer review activities, which could be established by an agency accrediting the practice or by a cooperative agreement with a hospital, another physician office or other peer review organization.
Call Coverage and Admitting Privileges.
The proposed rules would require physicians to maintain qualified call coverage at all times by a physician responsible for the emergency care of the physician’s patients during the physician’s absence. Physicians registered with the Board would be subject to a requirement that the physician maintain admitting privileges at a nearby hospital that can accept a transfer in the event of complications.
Emergency Planning.
The proposed rules require physicians to maintain onsite emergency plans and age-appropriate supplies and equipment to react in an emergency. The rules would also require physicians and support personnel to be trained and capable of recognizing and reacting to complications resulting from a procedure.
Patient Selection.
The proposed rules would require physicians to establish inclusionary and exclusionary written criteria for patient selection. Additionally, the Board would require physicians to submit procedure-specific patient selection criteria at the time of registration and anytime a physician begins performing a new procedure in-office.
Under both the current and proposed rules, the penalties for failure to comply include a finding of unprofessional conduct under the Alabama physician licensure laws, leading to disciplinary action that can escalate to revocation of a physician’s license.
Several questions remain with respect to the proposed rules. For example, the proposed rules do not clarify whether physicians currently registered with the Board would be required to submit new registration applications under an updated regulatory framework. Unlike the current rules, the registration form is not attached as an appendix to the proposed rules.
The Board will accept public comments to the proposed rules through February 4. Thereafter, the Board will have up to 90 days to review submitted comments before choosing whether to finalize its proposals.
Jessie Bekker is an Associate at Burr & Forman LLP practicing exclusively in the firm’s Health Care Practice Group. Jessie may be reached at (205) 458-5275 or jbekker@burr.com.
