On appeal from the adoption of N.J.A.C. 13:35-4A by the New Jersey State Board of Medical Examiners.
Before Judges Lefelt, Alley and Fuentes.
The opinion of the court was delivered by: Alley, J.A.D.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued September 28, 2004
In recent years, physicians have been performing an increasing number of surgical procedures in their offices, rather than in hospitals. Often, certified registered nurse anesthetists ("CRNAs") or anesthesiologists have administered anesthesia during such office procedures. On May 19, 1997, the State Board of Medical Examiners ("BME") proposed regulations, subsequently codified at N.J.A.C. 13:35-4A.1 to -4A.18, setting forth standards for the administration of anesthesia in physicians' offices during non-minor surgeries and procedures. 29 N.J.R. 2238(a) (May 19, 1997).
The BME, apparently spurred by a young girl's death after anesthesia was administered to her by an unsupervised CRNA, provided in the proposed regulation that doctors who performed procedures necessitating anesthesia in their offices, as opposed to hospitals or ambulatory care sites, would need to meet certain requirements if they chose to employ CRNAs to administer the anesthesia. One such requirement was that the CRNA be supervised by an anesthesiologist or a Board-privileged physician not performing the procedure. The proposal was met with strong opposition from appellant, the New Jersey Association of Nurse Anesthetists ("NJANA"), which argues that the BME is regulating the profession in an unauthorized manner. Once the regulation was adopted, NJANA brought this appeal challenging its adoption.
The BME held a public hearing on the proposed regulation on June 9, 1997. Representatives from NJANA testified in opposition to the regulation. NJANA is a private non-profit organization representing the interests of over 400 CRNAs in New Jersey.
The regulation deals with three categories of anesthesia administration: general anesthesia, regional anesthesia and conscious sedation. See N.J.A.C 13:35-4A.3 (setting forth the definitions necessary for interpreting the regulation). Under the regulation,"general anesthesia" is defined as"the administration of a drug... which cause[s] loss of consciousness as the result of which the patient is unable to make meaningful responses but may still display refleX withdrawal from a painful stimulus." Ibid."Regional anesthesia" is defined as"the administration of anesthetic agents to a patient to interrupt nerve impulses without loss of consciousness and includes epidural, caudal, spinal and brachia plexus anesthesia." Ibid. The definition of"conscious sedation" is the administration of a drug... in order to induce the state of consciousness in a patient which allows the patient to tolerate unpleasant medical procedures without losing defensive reflexes, adequate cardio respiratory function and the ability to respond purposefully to verbal command or to tactile stimulation if verbal response is not possible as, for example, in the case of a small child or deaf person.
Under the regulation, the only individuals who may administer the three types of anesthesia are (1) physicians who meet certain privileging requirements or (2) CRNAs under the supervision of physicians meeting these privileging requirements. N.J.A.C. 13:35-4A.8(a), -4A.9(a), -4A.10(a).
Irrespective of how the physician obtained these privileges, the physician administering or overseeing the administration of anesthesia must also meet certain educational or certification requirements, depending on the type of anesthesia being administered."[D]uring every consecutive three-year period beginning July 1, 2004," a physician administering or overseeing the administration of general anesthesia must"complete at least [sixty] Category I hours of continuing medical education in anesthesia[,]" N.J.A.C. 13:35-4A.9(a); a physician administering or overseeing the administration of regional anesthesia must"complete eight Category I hours of continuing medical education in anesthesia exclusively, or in anesthesia as it relates to the physician's field[,]" id. at -4A.9(a); and a physician administering or overseeing the administration of conscious sedation must"complete at least eight Category I or II hours of continuing medical education in any anesthesia services, including conscious sedation exclusively, or in anesthesia as it relates to the physician's field of practice," id. at -4A.10(a).
During a CRNA's administration of general and regional administration"the supervising physician" must"be physically present and available to immediately diagnose and treat the patient in an emergency, without concurrent responsibilities to administer anesthesia or perform surgery, other than minor surgery." Id. at -4A.8(c) & -4A.9(c). This differs from the requirement pertaining to the administration of conscious sedation, where"the supervising physician shall be physically present, but may be concurrently responsible for patient care." Id. at -4A.10.
On June 15, 1998, the BME adopted the regulation, but it reserved promulgation of the alternative privileging procedure, N.J.A.C. 13:35-4A.12, for a later date.
The BME held a public hearing on December 7, 2001 on the alternative privileging provision, and on November 13, 2002, adopted the provision, codified at N.J.A.C. 13:35-4A.12. The BME published the alternative privileging requirements in the New Jersey Register ...