June 30, 2016

Regulations promulgated by the Virginia Board of Medicine already govern practice requirements for certain anesthesia used in an office setting. Effective July 27, 2016, amendments to these regulations will become final as they were approved by the Governor Terry McAuliffe on June 3, 2016.

The amendments to the office-based anesthesia regulations, 18 VAC 85-20-326 et. seq.) were advanced as a result of a petition for rulemaking filed at the Virginia Board of Medicine jointly by the Medical Society of Virginia, the Virginia Association of Family Physicians and the Virginia Society of Plastic Surgeons. Physician members of these three organizations wanted to make sure that office-based anesthesia regulations in the Commonwealth were up to date in order to best ensure patient safety. Representatives of these three associations sought technical input and guidance from staff of the Board of Medicine and the Department of Health Professions. Over one year of drafting resulted in a unified effort in support of the amendments.

To what levels of anesthesia do the regulations apply?

18 VAC 85-20-320 clarifies that the office-based anesthesia requirements apply to the administration of “moderate sedation/conscious sedation, deep sedation, general anesthesia, or regional anesthesia consisting of a major conductive block.” The applicability of the regulations is expanded by the amendments to include “the administration of 300 milligrams or more of lidocaine or equivalent doses of local anesthetic.”

The rationale for the inclusion of lidocaine and other local anesthetics center on reported cases in the Commonwealth and in other states where physicians opted to use significant doses of local anesthesia in office-based procedures and surgeries or commonly administered such dosages without full appreciation of the associated risk.

There are no changes to the types of anesthesia that are excluded from the requirements of the office-based anesthesia regulations. The exclusions are “the administration of topical anesthesia, local anesthesia, minor conductive blocks, or minimal sedation/anxiolysis, not involving a drug-induced alteration of consciousness other than minimal preoperative tranquilization.” 18 VAC 85-20-320.A.1.

What are the changes in documentation requirements?

The amendments to 18 VAC 85-20-320.B include the requirement that all levels of anesthesia or sedation intended by the doctor of medicine, osteopathic medicine, or podiatry be documented by the practitioner in the preoperative anesthesia plan. In addition, the amendments require documentation of “any complications occurring during surgery or during recovery” in the patient’s medical record. The documentation of complications will better enable tracking of the frequency and severity of complications.

What is required as far as patient interaction during planning?

The amendments require that the anesthesia plan be discussed with the patient or the patient’s responsible party. In addition, amendments clarify the requirement to ensure patient assessment and monitoring continue at all times through the pre-procedure, peri-procedure and post-procedure phases.

What are the new requirements on the length of the procedure or procedures?

Under current law, 18 VAC 85-20-340 requires that the office-based procedure performed shall be of a duration and a degree of complexity that will enable the patient to be recovered and discharged from a facility in less than 24 hours. The amendment to 18 VAC 85-20-340 provides that after the effective date “the procedure or combination of procedures shall be of a duration and a degree of complexity that shall not exceed four hours and that will permit the patient to be recovered and discharged from a facility in less than 24 hours.” One exception to this general rule included in the amendments provides that “the procedure or combined procedures may be extended for up to eight hours if the anesthesia is provided by an anesthesiologist or a certified registered nurse anesthetist.”

What are the new requirements for informed consent?

In addition to the requirement that the anesthesia plan be discussed with the patient or patient’s responsible party, informed consent is required. The amendments to 18 VAC 85-20-350 require that the informed consent shall “include a discussion of discharge planning and what care or assistance the patient is expected to require after discharge.” This is intended to reduce post-operative complications and enhance the appropriate level of post-operative care.

Second, a new requirement was included to mandate that the surgical consent form contain a statement that the doctor performing the surgery is “eligible or board eligible by one of the American medical specialty boards, the Bureau of Osteopathic Specialists of the American Osteopathic Association, or the American Board of Foot and Ankle Surgery.” In the event the doctor performing the procedure is not board certified or board eligible, the surgical consent form must so state. The rationale for this addresses concerns that patients need to be informed of their doctor’s credentials in advance of the procedure. In addition, it ensures transparency on what type or specialty of doctor is performing certain types of procedures. There were some reported cases of physicians who were not board certified or eligible in a surgical field performing surgery that prompted this new requirement.

Finally, an amendment to this regulation requires the surgical consent form to indicate whether the surgery is “elective or medically necessary.” Even though consent forms are generally not obtained in emergency situations, in the event a surgical consent form is obtained in an emergency situation for a procedure covered by this regulation, it shall indicate the nature of the emergency. The rationale for this change is to enhance efforts to track the frequency and nature of emergencies.

What’s new for emergency and transfer protocols?

18 VAC 85-20-370 currently requires written protocols for handling emergency situations. In addition, appropriate training for health care providers regarding these protocols and equipment for handling emergencies is required. There is also a requirement for written protocols addressing the timely and safe transfer of patients to a pre-specified hospital or hospitals within a reasonable proximity. Reasonable proximity was not previously defined but the amendment to this regulation now contains the definition, specifically:

Finally, current regulations require the existence of a transfer agreement with hospitals. The amendment to this regulation requires that the transfer agreement be either written or electronic. Previously, such transfer agreement could include verbal agreements; however, proving or disproving the existence of those verbal agreements was challenging.

What are the updates regarding discharge policies and procedures?

18 VAC 85-20-380 currently requires doctors to have written policies and procedures outlining discharge criteria. This regulation also addresses which health care provider is responsible for patient discharge.

The amendments to this section clarify that discharge from anesthesia care is the responsibility of the health care practitioner “providing or the doctor supervising” the anesthesia care. The amendments define in greater detail when discharge is permitted. Specifically, discharge from anesthesia care shall only occur if ”the patient has met the physician defined discharge criteria” and shall only occur if “the health care provider providing or the doctor supervising the anesthetic care has given the order for discharge.”

All health care practitioners that engage in office-based anesthesia are encouraged to review these regulations and update their policies and procedures to make sure they are in compliance with the new regulatory changes. In addition, education and training of all health care providers and staff participating in office-based anesthesia is recommended. Given that it may take some time to execute a written or electronic transfer agreement with a general hospital as is required as of the July 27, 2016 effective date, it is recommended that work begin on this immediately.

If you have any questions or need assistance, please contact Scott Johnson, Jerry Canaan, or Mary Malone.

^{The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., PC, is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C., PC be liable for any direct, indirect, or consequential damages resulting from the use of this material.}