"It's a patient safety issue when you have absolutely no supervision from a physician; it's very risky," says Francisco Silva, general counsel for the California Medical Association. It has filed a suit against the regulation along with the California Society of Anesthesiologists.
It is not as if there is any severe shortage of anesthesiologists, they argue. "Our concern is, no one has shown that there was ever the need to require doing something this drastic," Silva says.
Also governor Arnold Schwarzenegger "completely ignored" federal law, which requires a number of procedural steps and consultations with state licensing agencies before taking the action, Silva says. The doctors last year asked Schwarzenegger to withdraw his June letter, but "the governor refused ... asserting that it was consistent with California law," according to the lawsuit, which was filed in San Francisco Superior Court.
The fight centers over 2001 Medicare rules that usually require a doctor to supervise when nurses administer anesthesia, but allow states to op out of the requirement if a governor sends a letter to the feds.
But Medicare rules also say the governor must consult with that state's Medical Board and Board of Nursing regarding issues such as the quality and accessibility of anesthesia services in the state, according to the physicians' lawsuit.
The governor didn't consult with those licensing agencies, the physicians claim. On the contrary, "the Medical Board, in a letter dated March 2, 2009 . . . did in fact state that it 'appears that a nurse anesthetist is required to have physician . . . supervision,'" the lawsuit claims. The governor ignored that requirement, Silva says.
Robert Hertzka, MD, a San Diego anesthesiologist and former CMA president, explains that allowing nurse anesthetists to deliver anesthesia to surgical patients is a bad idea because they're not trained for it.
"There's a huge gulf of training and experience" between an anesthesiologist and a nurse anesthetist, he says, comparing their respective roles to those of a cardiologist and a coronary care nurse, or an obstetrician and a labor and delivery nurse.
"We're worried about degradation of quality of care," Hertzka says. "And for what? There's no evidence that there's increased access."
He adds that nurse anesthetists are not trained to respond to complications from anesthesia, or problems in the recovery room. "You need a physician to oversee and assess."
The California Hospital Association said, "CHA has historically supported independent practice by highly skilled nurse anesthetists under the oversight of a physician," says spokeswoman Jan Emerson. "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 Certified Registered Nurse Anesthetists, patient care may be put at risk—especially when emergency surgery is needed."
The American Association of Nurse Anesthetists (AANA) supports California's decision to opt out of what it calls "unnecessary" federal physician supervision. "There is no evidence that patient safety has been compromised one iota in the 14 states that opted out previously," said AANA President James Walker, CRNA, DNP. "Opt-outs enable hospitals to organize their anesthesia services in the most safe and cost-effective arrangement for their patients. Anesthesia continues to be delivered safely in California, just as it is in the other 14 states that have exercised their right to opt out from this rule."
Peggy Broussard Wheeler, vice president for Rural Healthcare and Governance of the California Hospital Association, said small and rural hospitals appreciate being able to opt out of the CMS anesthesiologist oversight requirement.
Some hospitals, Ms. Broussard Wheeler said, had been forced to curtail anesthesia services because they could not afford to meet the CMS requirements. The opt-out rule "will allow facilities that used to offer some anesthesia services the ability to offer them again," she said.
Richard Figueroa, a health care adviser to Mr. Schwarzenegger, told Anesthesiology News
that the purpose of the opt-out decision was to reduce pressures on and increase access to services at small and rural hospitals. "The intent was not to give one profession higher status than others," Mr. Figueroa said. "All this does is give hospitals greater flexibility; it doesn't mandate they do anything one way or the other. It's up to the hospitals and their critical care staffs how they best deploy their anesthesiological resources."
But once a facility chooses to waive supervision, all patients must be treated the same way, said Kenneth Y. Pauker, MD, chair of the CSA Legislative and Practice Affairs Division.
"In opt-out states, wherein nurse anesthetists may care for Medicare patients without physician supervision, Medicare rules require that within one institution, all patients be treated in an equivalent way, such that if there is no supervision of Medicare patients, all other patients must also be cared for in an unsupervised way," Dr. Pauker said. Private insurers are likely to follow the Medicare determination, he added.
Mr. Schwarzenegger's action reinvigorates the controversy of state opt-outs. Fourteen states, mostly in the Midwest and West, exercised physician supervision opt-out from 2001 to 2005. This was followed by a four-year hiatus until California's action last year.