Physician Oversight of CRNAs

Case in Point

Physician Oversight of CRNAs Stephanie D. Fullmer, JD In June 2009, the governor of California opted out of a federal regulation requiring physician supervision of certified registered nurse anesthetists (CRNAs). In response, the California Society of Anesthesiologists (CSA) and the California Medical Association (CMA) filed suit against the governor, alleging that the opt-out was illegal and that it harmed physicians and anesthesiologists. The court found that the opt-out did not violate state law and that state law does not require physician supervision of CRNAs. On appeal by the CSA and CMA, the appellate court upheld the lower court’s ruling, allowing California CRNAs to continue practicing without physician supervision.

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n March 2012, The Court of Appeal of the State of California First Appellate District Division Four affirmed a Superior Court ruling allowing certified registered nurse anesthetists (CRNAs) to continue practicing without the supervision of a physician. The ruling arose from a lawsuit filed jointly by the California Society of Anesthesiologists (CSA) and the California Medical Association (CMA) against Governor Arnold Schwarzenegger in February 2010. Petitioners alleged that the governor erroneously opted out of federal regulation that requires physician supervision of CRNAs.

Background On November 13, 2001, the Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) published a final rule amending the anesthesia services conditions of participation for hospitals, the surgical services conditions of participation for critical access hospitals, and the surgical services conditions of coverage for ambulatory care centers. This rule maintained the requirement that a physician supervise the practice of nurse anesthetists; however, it allowed a governor to opt out of this requirement. The opt-out required that a letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access and to the quality of anesthesia services in the state and has concluded that it is in the best interests of the state’s citizens to opt out of the current physician supervision requirement, and that the opt out is consistent with state law. (Medicare and Medicaid Programs, 2001) In a letter dated June 10, 2009, Governor Schwarzenegger informed the CMS of his intention to opt out of the federal regulation. His letter stated: Pursuant to the final rule published in the November 13, 2001, Federal Register, Volume 66, Number 219, I am exercising the option to exempt the State of California from the requirement that certified registered nurse anestheVolume 3/Issue 2 July 2012

tists be supervised by a physician. Having consulted with the California Board of Medicine and California Board of Registered Nursing and having determined that this exemption is consistent with the state law, I have concluded that it is in the interest of the people of California to opt out of this requirement. (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, February)

2010 Writ The following February, CSA and CMA filed a Writ of Mandate, Prohibition, or other Appropriate Relief and Request for Declaratory Relief with the San Francisco County Superior Court. CSA and CMA argued that the governor’s opt-out harmed their members and affected their “member’s practice of medicine, their ability to protect their patients, and their physician/patient relationships.” They also claimed that under the exemption, “Anesthesiologists…are placed in particular peril, and suffer special damage and injury under present circumstances, because physicians have traditionally provided the supervisions required by law in most facilities” (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, February). CSA and CMA offered that historically, federal CMS rules required physician supervision of CRNAs and the exception included in the Medicare rules in 2001 applied only if three requirements were met: 1. The governor consulted with the Boards of Medicine and Nursing. 2. The governor found that opting out was in the best interest of the state. 3. The opt-out was consistent with state law. Petitioners argued that requirements one and three were not met: The governor did not consult the Board of Medicine “regarding access to and quality of anesthesia services,” and California law required physician supervision of CRNAs. The latter, they maintained, was evident for the following reasons:

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The Nurse Practice Act required physician supervision of CRNAs. ⦁⦁ The Nurse Anesthetist Act was silent as to supervision. ⦁⦁ Court precedent under Chalmers-Francis v. Nelson (1936) 6 Cal.2d 402 held that physician supervision was required under California law. ⦁⦁ Attorney General opinions supported physician supervision. ⦁⦁ Legislative Counsel Bureau opinions supported physician supervision. In their Prayer for Relief, the petitioners requested that the court command the governor to withdraw his opt-out letter, declare that the governor lacked authority to submit the letter, and declare that California law requires physician supervision of CRNAs (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, February). The General Counsel for CMA averred, “It’s a patient safety issue when you have absolutely no supervision from a physician; it’s very risky” (Clark, 2010). The governor defended his decision to opt out with the argument that doing so “maintains patient safety at lower cost to consumers” (Sorrel, 2010). The Administration acted on its own, in accordance with federal law, in making this decision. Nurse anesthetists can be an important part of the healthcare team, especially at small and rural hospitals where anesthesiologists are not always available. Without the services of CRNAs, patient care may be put at risk—especially when emergency surgery is needed. (Clark, 2010) ⦁⦁

Lower Court Ruling On July 21, 2010, the Superior Court granted the California Association of Nurse Anesthetists’ (CANA) Motion to Intervene (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, July), and in December, the court granted the respondents’ motion for a summary judgment. In the Order, the court found that the Governor’s attestation to CMS that the opt out is consistent with California law was not so palpably unreasonable and arbitrary as to constitute an abuse of discretion. Moreover, this Court finds on independent review that the Governor’s attestation was, in fact, accurate because it was consistent with the language and structure of the controlling statute, the legislative history, other extrinsic evidence, and prior cases and [Attorney General] opinions. (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, December) The court held that under the federal rule, the decision to opt out of the supervision requirement was within the governor’s discretion. The court also found that California law does not require physician supervision of CRNAs. The law does require that anesthesia services be “ordered” by a physician, but the court ruled that the term ordered is not synonymous with the term supervised. The court offered examples of instances in which the legislature specifically 32

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required supervision and used the examples to show that the legislative intent did not specifically require supervision of CRNAs and that legislative history evidences the legislature’s intent to broaden the scope of nursing practice to include the administration of anesthesia. In its decision, the court concurred with the opinion of the Board of Registered Nursing, stating that although the board’s view is not controlling, “it is entitled to some weight, especially since the legislature has given the [board] sole responsibility to interpret nursing scope of practice in California” (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, December). The court also held that petitioners’ reliance on ChalmersFrancis v. Nelson was inappropriate. The Chalmers case determined that the administration of anesthesia by nurses was not the unlawful practice of medicine. It did not address whether supervision was required for the lawful administration. Similarly, petitioners’ claim that a physician would be liable for a nurse’s actions was disputed in Cavero v. Franklin General Benevolent Society, 36 Cal.2d 301, 302303, 306-308 (1950), in which it was held that surgeons were not liable for nurse’s administration of anesthesia (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, December). Finally, the court determined that the Attorney General’s opinions did not apply to the case at hand. The 1983 opinion addressed whether nurse anesthetists could inject contrast materials. The Attorney General stated that if the law does not expressly articulate whether a procedure may be performed by a CRNA, “factors such as common acceptance and usage should be examined to determine if a particular procedure is within the CRNA’s scope of practice.” However, the court noted that the administration of anesthesia by nurses is expressly stated in statute, leaving the Attorney General’s opinion moot. In 1984, the Attorney General determined that CRNAs could not administer anesthesia under standardized procedures because there was no physician “order.” According to the court, this opinion did not address the issue of supervision and did not apply (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010, December).

Reactions to the Ruling CANA emphasized that the judge made a point of saying that [petitioners] presented no evidence whatsoever to demonstrate any safety problems, nor did they rebut CANA’s claims that there were no safety problems. There have been no safety related incidents in any opt out state since opt outs were first initiated years ago. And in our view, this is just a red herring argument. (Clark, 2011) In response, CMA and CSA, while lauding the value of CRNAs, stressed that a lack of physician supervision presented patient safety concerns. CMA wrote: Nurses are highly valued members of a team of healthcare professionals that works closely together to give patients the best possible care….However, people must understand that

nurses do not receive the same extensive training and education that doctors do and are not interchangeable substitutes for practicing physicians. CSA stated, “For the governor and Superior Court to decide for the people of California that it is perfectly safe to remove the medical and physician component from anesthesia care is absolutely irresponsible” (California Medical Association, 2010). In January 2011, the petitioners filed a Notice of Appeal (California Society of Anesthesiologists et al v. Arnold Schwarzenegger, 2010/2011).

The Appeal In its brief, CANA asserted several arguments. First, CANA noted that nurses have administered anesthesia for over a century, and in California, “CRNAs are the sole anesthesia providers in six California counties. They are also the sole anesthesia providers in 36% of all rural hospitals and 55% of Critical Access Hospitals…that offer surgical and obstetrical services in the state” (California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, No. A131049 [Cal.App. Dist.1 03/15/2012] [Intervenor’s Brief, July 28, 2011]). Second, California law allows the unsupervised practice of CRNAs: When Section 2725(b)(2) authorizes a CRNA to administer anesthesia “ordered” by a physician, it means at most that the physician must prescribe the anesthesia for a specific patient, and that at the least it means that the physician must tell the CRNA to administer anesthesia to a particular patient. CANA also pointed to the statute language that specifically acknowledges the overlap in medicine and nursing scopes of practice (California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, 2011; see Table 1). Third, CANA relied on the findings of Dulisse and Cromwell (2010), who reviewed patient adverse outcomes in states that opted out of the federal rule and discovered “no evidence that opting out of the oversight requirement resulted in increased inpatient deaths or complications.” The Amici Curiae of the American Society of Anesthesiologists and the American Medical Association warned that upholding the governor’s decision to opt out would have “serious negative implications for the safety of Californians.” This, they argued, was due to the inability of CRNAs to handle the care of patients whose conditions have destabilized. “CRNAs, being unable to prescribe medications, and having far more abbreviated education and training for such interventions, simply are not qualified to practice ‘unsupervised’ under these circumstances” (American Society of Anesthesiologists and American Medical Association, 2011).

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Table 1

Overlapping Functions Section 2725 of the California Nurse Practice Act reads as follows: In amending this section at the 1973-74 session, the Legislature recognizes that nursing is a dynamic field, the practice of which is continually evolving to include more sophisticated patient care activities. It is the intent of the Legislature in amending this section at the 1973-74 session to provide clear legal authority for functions and procedures that have common acceptance and usage. It is the legislative intent also to recognize the existence of overlapping functions between physicians and registered nurses and to permit additional sharing of functions [emphasis added] within organized health care systems that provide for collaboration between physicians and registered nurses. Section 2827 of the Nurse Anesthetists Act outlines the anesthesia services that may be performed by the certified registered nurse anesthetist: The utilization of a nurse anesthetist to provide anesthesia services in an acute care facility shall be approved by the acute care facility administration and the appropriate committee, and at the discretion of the physician, dentist or podiatrist. If a general anesthetic agent is administered in a dental office, the dentist shall hold a permit authorized by Section 1646.

Appellate Court Ruling On appeal, The Court of Appeal of the State of California First Appellate District Division Four affirmed the ruling of the lower court. In its opinion, filed March 15, 2012, the court found that the case dealt with a single question: whether the governor abused his discretion in opting out of the federal requirements for physician supervision of CRNAs: We believe the Governor’s conclusion that the opt out is consistent with California law is entitled to deference requiring reversal only upon a finding that the Governor acted “in a palpably unreasonable and arbitrary manner as to indicate an abuse of discretion as a matter of law. The court came to this conclusion by finding that: Undisputed evidence has been presented that in many California medical facilities, especially in rural and underserved areas, CRNAs have been routinely administering anesthesia for decades pursuant to a physician order but without physician supervision….The record does not reflect that any disciplinary action has ever been taken against a CRNA for administering anesthesia without physician supervision. Furthermore, the court held that California law does not require physician supervision of CRNAs (California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, 2012). www.journalofnursingregulation.com

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The court stated that the Nurse Practice Act determines CRNA scope of practice and authorizes CRNAs to administer anesthesia upon the order of a physician. To understand the meaning of the term order, the court looked to the pharmacy law definition, which states: An “order” entered on the chart or medical record of a patient registered in a hospital or a patient under emergency treatment in the hospital, by or on the order of a practitioner authorized by law to prescribe drugs, shall be authorization for the administration of a drug. Being consistent with statutory construction rules, the court found that “order” and “supervise” are not interchangeable. “If the Legislature had intended to restrict a nurse’s ability to administer medications or therapeutic agents by making it subject to a physician supervision requirement, it could have easily so provided, as it has in so many other statutes” (California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, 2012). Finally, the court recognized that: As nursing becomes more specialized, many nursing functions will inevitably overlap with physician functions….If appellants remain concerned that a physician’s practical, ethical and legal responsibilities for his or her patient’s care will be jeopardized by the use of unsupervised CRNAs to administer anesthesia, the solution lies with the Legislature, not this court.” (California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, 2012)

Moving Forward After the appellate court ruling, CSA issued a press release announcing its intention to seek the California Supreme Court’s review of the case in addition to legislative remedies. “The CSA believes that the appellate decision is flawed and should be overturned because issues of substance brought before the court were not addressed.” CSA’s question before the Supreme Court will be: How is the imperative “that nurses should practice to the full extent of their education and training” to be balanced against protecting the safety of the public from potential degradation in the quality of care rendered by practitioners who are less educated and trained than are physicians? (California Society of Anesthesiologists, 2012) Meanwhile, CRNAs in California continue to practice without physician supervision as they have done for years and as their colleagues are doing in 16 other states: Alaska, Colorado, Idaho, Iowa, Kansas, Kentucky, Minnesota, Montana, Nebraska, New Hampshire, New Mexico, North Dakota, Oregon, South Dakota, Washington, and Wisconsin (American Association of Nurse Anesthetists, 2012).

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References American Association of Nurse Anesthetists. (2012, April 26). Kentucky Gov. Beshear removes physician supervision for nurse anesthetists. Retrieved from www.aana.com/newsandjournal/News/ Pages/042612-Kentucky-Gov--Beshear-Removes-Physician-Supervision-for-Nurse-Anesthetists.aspx American Society of Anesthesiologists and American Medical Association. (2011, September 30). Brief of Amici Curiae in Support of Plaintiffs and Appellants. California Medical Association. (2010, October 13). CMA says court ruling on nurse anesthetists is off base. Retrieved from http://sdcms.org/article/cma-says-court-ruling-nurse-anesthetists-base California Society of Anesthesiologists. (2012, April 9). CSA announces next steps in opt-out dispute. Retrieved from www.prnewswire. com/news-releases/csa-announces-next-steps-in-opt-out-dispute-146640735.html California Society of Anesthesiologists et al v. Arnold Schwarzenegger, No. CPF-10-510191, San Francisco County Superior Court (Writ of Mandate, Prohibition, or other Appropriate Relief and Request for Declaratory Relief, February 2, 2010). California Society of Anesthesiologists et al v. Arnold Schwarzenegger, No. CPF-10-510191, San Francisco County Superior Court (Order Granting California Association of Nurse Anesthetists’ Motion for Leave to Intervene Pursuant to Code of Civil Procedure Section 387, July 21, 2010). California Society of Anesthesiologists et al v. Arnold Schwarzenegger, No. CPF-10-510191, San Francisco County Superior Court (Order, December 27, 2010). California Society of Anesthesiologists et al v. Arnold Schwarzenegger, No. CPF-10-510191, San Francisco County Superior Court (2010) (Notice of Appeal, January 31, 2011). California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, No. A131049 (Cal.App. Dist.1 03/15/2012) (Intervenor’s Brief, July 28, 2011). California Society of Anesthesiologists et al v. the Superior Court of the City and County of San Francisco, No. A131049 (Cal.App. Dist.1 03/15/2012). Clark, C. (2010, February 3). Doctors sue to stop unsupervised nurse anesthetists from administering anesthesia. HealthLeaders Media. Retrieved from www.healthleadersmedia.com/page-1/PHY245956/Doctors-Sue-To-Stop-Unsupervised-Nurse-Anesthetistsfrom-Administering-Anesthesia Clark, C. (2011, February 3). Nurse anesthetists’ scope of practice challenged again in CA. HealthLeaders Media. Retrieved from www. healthleadersmedia.com/page-1/TEC-262136/Nurse-AnesthetistsScope-of-Practice-Challenged-Again-in-CA Dulisse, B., & Cromwell, J. (2010). No harm found when nurse anesthetists work without supervision by physicians. Health Affairs, 29(8), 1469–1475. Medicare and Medicaid Programs; Hospital Conditions of Participation: Anesthesia Services. (2001, November 13). Federal Register, 66(219). Retrieved from www.federalregister.gov/articles/2001/11/13/01-28439/medicare-and-medicaid-programs-hospital-conditions-of-participation-anesthesia-services Sorrel, A. (2010, February 22). California doctors sue to ensure nurse anesthetists are supervised. American Medical News. Retrieved from www.ama-assn.org/amednews/2010/02/22/prsa0222.htm

Stephanie D. Fullmer, JD, is the Legislative Affairs Associate at the National Council of State Boards of Nursing.