By Lindsey Tomlinson Druhan
Recently, the Alabama Board of Medical Examiners (“ALBME” or the “Board”) overhauled its Office-Based Surgery (“OBS”) regulations, replacing the long-standing Chapter 540-X-10 rules that had been largely unchanged since 2003. OBS is surgery performed outside of a hospital or outpatient facility licensed by the Alabama Department of Public Health. The ALBME recognized that although surgical procedures in medicine have evolved over time, the well-being of the patient, weighed with the best interest and circumstances possible for the patient, remain crucial in OBS. The ALBME began this process in 2022 and welcomed Alabama physicians’ comments and suggestions throughout the process. The ALBME developed new guidance on OBS as highlighted below. The new rules are effective and require full compliance by January 1, 2027.
OBS Regulation Changes to Consider
Three-Level Risk System Replaces Five-Level System
Level I OBS
Surgery or diagnostic procedure in which pre-operative medicines are not required or used other than minimal pre-operative tranquilization/ anxiolysis of the patient. Examples include but are not limited to excisions of skin lesions, moles, warts, cysts; drainage of abscesses; limited endoscopies; insertions of IUDs; closed reductions of simple fractures. No registration is required.
Level II OBS
Surgery or diagnostic procedure using moderate sedation or higher, the use of IV sedation medications, or local or peripheral major nerve block. Examples include liposuction and some radiologic procedures where moderate sedation is used. Requires registration.
Level III OBS
Surgery or diagnostic procedure using deep sedation or general anesthesia, a major upper or lower extremity nerve block, such as an epidural, spinal, or caudal nerve block. Requires registration and accreditation.
Mandatory Accreditation
Level II and III offices must be accredited by a Board-approved entity within one year of performing the first procedure. A list of the approved accrediting entities may be found on ALBME’s website.
If a physician’s office loses its accreditation or certification and is no longer accredited or certified by at least one Board-approved entity, the physician shall immediately cease performing procedures in that physician office. Any changes to a physician office’s accreditation status shall be reported to the Board within five (5) business days.
Quality Assurance Program
A quality assurance (“QA”) program shall be implemented at least annually. The QA program may be administered by the physician office’s accredited entity. A registered physician and his or her partners cannot provide peer review of each other.
The QA program findings shall be documented and incorporated into the education programming, protocols and planning, as appropriate.
Patient Safety & Eligibility Restrictions
Intra-peritoneal and intra-pleural procedures are not permitted to be performed in a physician’s office without prior, written approval from the Board.
Patients with a solid organ transplant (except kidney) are not appropriate candidates for OBS.
Patients 85+ are not appropriate candidates for Level III OBS except in emergency or urgent circumstances or without prior, written Board Approval.
Level III OBS procedures shall not be performed on any patient with an American Society of Anesthesiologists (“ASA”) Physical Status Classification greater than or equal to 4.
Emergency Preparedness
Offices must maintain ACLS-trained staff, resuscitation equipment, and transfer protocols.
Risk Management Considerations:
Audit Your Accreditation Timeline: Level II and Level III offices must achieve formal accreditation by a Board-approved entity within one year of performing their first procedure. Select the partner now, factor the evaluation backlogs into the timeline to ensure compliance by January 2027.
Age and Frailty Screening: Strict statutory bans on Level III surgeries for ASA Class 4 patients, mandatory frailty scoring for patients 75+, and a ban on patients 85+ without prior Board approval. Consider building these hard stops directly into their Electronic Health Record (“EHR”) intake workflows so a procedure cannot physically be scheduled if a patient hits these criteria without the required approvals on file.
The Hard 5-Day Reporting Rule: Implement a strict internal protocol for mandatory reporting to the ALBME. Under the rule, any surgical-related death within 30 days of the procedure, events requiring CPR, wrong-site/wrong-patient surgery, or unplanned reoperation must be reported within 5 business days. Establish a clinic-wide policy where any emergency transfer or inoperative CPR event automatically triggers an alert to draft the ALBME report.
Appoint a Single Responsible Physician: Registration is no longer just individual; the revised rules require the physician office to register and identify one specific registered physician who is legally responsible for the accuracy of all reporting and data collection (such as the mandatory annual procedure lists and outcome data due every January 31). Formally appoint this role in writing, build peer-review checks to support the individual, and consider whether the physician’s or practice’s insurance policy provides coverage for this responsibility.
Propofol Audit: Any use of Propofol (or its derivatives/analogues) automatically elevates the procedure to Level III (Deep Sedation/General Anesthesia). Audit your medication inventory and lock Level III access. Ensure your EHR and scheduling protocols strictly forbid the selection of Propofol unless the procedure is tethered to a registered, accredited Level III workflow.
Mandate the “LAST” Kit for Tumescent Procedures: For practices performing Level II procedures like tumescent liposuction or complex local blocks, all personnel administering local anesthetics must be formally trained to handle Local Anesthetic Systemic Toxicity (“LAST”). A LAST rescue kit must be physically maintained on-site. Conduct hands-on, documented quarterly drills specifically for LAST management, and visually audit your lipid emulsion stock monthly.
Conclusion
After careful consideration and conversations with Alabama physicians, the ALBME overhauled the OBS regulations to provide the “best circumstances possible for the management of disease and well-being of the patientPhysicians are behooved to set up policies and procedures to comply with these changes to ensure a smooth transition prior to January 1, 2027.
Lindsey Tomlinson Druhan is an Attorney at Burr & Forman LLP practicing in the Health Care Practice Group. Lindsey may be reached at (205) 458-5342 or ldruhan@burr.com.