Yes: The Safety of Your Patients Depends on It

    JP Abenstein, MSEE, MD
    Mayo Clinic
    Rochester, Minn.

For more than one hundred years, healthcare has followed a model of care that has worked extremely well in a variety of situations, from doctors' offices to operating rooms. The model has been that of doctors and nurses working together, and time and again, it's been proven that when these two professionals join forces, patients get the best possible care. This model is particularly important in the operating room. It stands to reason that when patients are given medications that render them completely helpless, at times stopping basic physiologic functions such as breathing, there is almost unlimited potential for something to go awry. In these situations, where a patient's life may hang in the balance, it is critical that the most qualified and educated individuals direct the anesthesia care.

Until just recently, federal regulations recognized the crucial role that physicians, and particularly anesthesiologists, play in managing anesthesia care. The Health Care Financing Administration (HCFA) required that health care facilities, including hospitals and ambulatory surgery centers, have a physician supervise anesthesia care for Medicare patients (the supervising physician does not have to be an anesthesiologist; it could be the operating surgeon). However, in December 1997 HCFA proposed removing the federal physician supervision requirement, deferring instead to state rules and individual hospital rules (under current law, hospitals and ASCs are required to provide physician supervision of nurse anesthetists in order to be in the Medicare program; the proposed rule eliminates that requirement). In most cases, these entities would probably still require physician management, because the vast majority of anesthesia care in the US involves an anesthesiologist. However, removing the federal mandate introduces the possibility that nurses could provide unsupervised anesthesia care. Despite intense educational efforts by the American Society of Anesthesiologists and many other concerned physician organizations, including the American Medical Society and the American College of Surgeons, HCFA passed the rule and sent it to the Office of Management and Budget in July, where it may soon acquire the force of law.

Facility managers need to know all the facts before they choose anesthesia providers for their facilities. It's crucial that they realize that the operating rooms of ambulatory surgery centers are at significant risk for mishaps. ASCs and other outpatient facilities are seeing more and more elderly patients, sometimes with advanced disease states and comorbidities, and they are hosting more complex and lengthy procedures. Their lack of easy access to advanced life support places their patients at higher risk than those of hospitals. Developing the anesthesia plans and overseeing anesthesia care for these patients is a complex and risky task, which is best done when an anesthesiologist is involved.

There are five key reasons why the best and safest anesthesia care occurs when a physician, and preferably an anesthesiologist, oversees that care.

1. Only anesthesiologists have the education and training to provide comprehensive anesthesia care. The educational continuum for an anesthesiologist is extraordinarily rigorous. After completing a four-year undergraduate degree, generally in a hard science major, anesthesiologists complete four years of medical school, followed by a rotating internship, where they participate in all facets of patient care, followed by at least three years of comprehensive anesthesia-specific residency training. Most anesthesiology residents administer a minimum of 1,400 anesthetics before they graduate. In contrast, about one-third of nurse anesthetists have never completed a bachelor's degree program. Their training regimen involves four years of undergraduate nursing school, after which they spend at least one year in the ICU as staff registered nurses, followed by 24 to 30 months of nurse anesthesia school. They are required to assist on at least 450 cases in order to graduate. It's important to understand that the difference in education is far more than just years of training. Medical education is much more rigorous, often measured by "contact hours." The hours per week of both classroom and clinical training is two to three times that of nursing education.

The differences in training are obvious-anesthesiologists, as medical doctors, are more knowledgeable and able to diagnose and treat underlying disease during the perioperative period, determine the best anesthetic plan, and rescue the patient if something should go wrong during the procedure. I do believe including nurse anesthetists in anesthesia care improves the overall quality of patient care during the perioperative period. They work with the anesthesiologist throughout the procedure, adding their knowledge and experience to that of the anesthesiologist. However, the benefit of having the anesthesiologist immediately available for the critical parts of the procedure is unquestionable.

2. Anesthesiologists are better equipped to handle emergencies. It is true that anesthesia safety has improved greatly in the last few decades-only one in 250,000 patients dies from anesthesia-related causes nowadays, compared to one in 10,000 a few decades ago. Indeed, this is one of the rationales that HCFA used to determine that it was acceptable to remove the physician supervision requirement. The advances in safety, however, have come about primarily because doctors trained in anesthesia have been overseeing most of the anesthesia care. While it may be true that complications such as cardiac arrest, difficult airways, malignant hyperthermia, and cardiac arrest are uncommon in ambulatory cases, they still do occur. When they do, it stands to reason that you would want to have the best-qualified individuals close at hand to rescue the patient.

Scientific studies have suggested that the safest anesthesia care occurs when anesthesiologists and nurse anesthetists work together (in an anesthesia care team). I published one such study1, which looked at anesthesia outcomes in over 1 million anesthetics, delivered via one of three practice models-anesthesiologists alone, nurse anesthetists supervised by the surgeon, and anesthesiologists medically directing nurse anesthetists, medical students, anesthesiology assistants, anesthesiology residents and nurse anesthesia students (i.e. the anesthesia care team practice model). In the 1 million anesthetics administered, there were 90 anesthesia-related deaths. When researchers compared the practice models, the results suggested that the anesthesia care team practice model was the safest, resulting in an anesthesia-related mortality in only one in 28,166 anesthetics. When anesthesiologists worked alone, the death rate increased to one in 24,500 anesthetics. And when nurse anesthetists were supervised by the surgeon, the anesthesia-related death rate grew to one in 20,723-a more than a 26 percent increase over the care-team model.

In another, more recent study published in July 2000 in Anesthesiology2, a group of University of Pennsylvania researchers examined Medicare billing data for 217,440 patients who had undergone general surgical or orthopedic procedures between 1991 and 1994. The study compared the outcomes of patients whose anesthesia was either delivered by a nurse anesthetist supervised by the surgeon or a nurse anesthetist medically directed by an anesthesiologist. It measured, among other outcomes, the death rate within 30 days of admission, the in-hospital complication rate defined as a change in the diagnosis during the episode of care, and the death rate following such complications. The study determined that when anesthesiologists were not involved in the anesthesia care, there were 2.5 excess (i.e. needless) deaths within 30 days per 1,000 patients. When there were complications, there were 6.9 needless deaths per 1,000 patients if an anesthesiologist was not involved.

These studies clearly show that the involvement of an anesthesiologist provides the safest, most comprehensive anesthesia care available. It also suggests that anesthesiologists provide more comprehensive post-op care, ensuring that patients recover completely from their anesthesia with as few side effects as possible.

3. Anesthesiologists can provide more cost-effective care. Studies have shown that when anesthesiologists medically direct nurse anesthetists, the anesthesiologists' productivity increases by about 20 percent, while adverse outcomes decrease. In addition, cost-effective analysis demonstrates that the improvement in patient outcomes is not only clinically significant but affordable when compared to other well-accepted medical therapies. To determine this, I conducted my own study based on the data from the University of Pennsylvania study discussed above. As I mentioned earlier, that study suggested that care with an anesthesiologist led to about 2.5 fewer deaths per 1,000 anesthetics. Using this data, I performed the following economic analysis:

• Average salary and benefits for an anesthesiologist = $281,375

• Average number of anesthetics delivered per year by anesthesiologists = 1,000

• Average salary and benefits for a nurse anesthetist = $110,751

• Average number of anesthetics delivered per year by nurse anesthetists = 800

• Cost effectiveness calculation = (($281,375/1000 - $110,751/800) * 1000)/2.5 = Dollars per life saved

Using this formula, I calculated that anesthesia care with an anesthesiologist costs about $57,200 per life saved. If the average life expectancy of a Medicare patient is 10 years, that works out to about $5,720 per life year saved. Now, consider that when you use similar calculations, Pap smear screening costs about $11,000 per life-year saved, renal dialysis costs about $40,000 per life year saved, and treating hypertension with the drug captopril costs $79,000 per life-year saved. All of these are common, accepted preventive measures-and, comparatively speaking, having an anesthesiologist involved in anesthesia care looks like a bargain.

What's important to realize is that I based these calculations on assumptions that purposefully do not favor anesthesiologists, since they are based on salary data rather than reimbursement for delivered services. Currently, the Medicare program pays only one fee for anesthesia care no matter how it is delivered. HMOs and insurance companies either follow Medicare's lead or at most pay a premium of only 10 to 20 percent for anesthesia care that includes an anesthesiologist. If you take this information into account, the incremental cost associated with the inclusion of an anesthesiologist is a small fraction of my calculations.

You don't have to perform an economic analysis, however, to see that using anesthesiologists is cost-effective. In fact, a recent study published in the New England Journal of Medicine3 suggested that anesthesiologists help to reduce overall case costs because they order fewer laboratory tests and provide medical consultations without requiring other specialists to review the case. In an ambulatory care facility, anesthesiologists can keep cases moving by performing comprehensive pre-op evaluations while nurse anesthetists prepare the ORs and stay with patients during the procedures. The anesthesiologists can "round" from OR to OR, monitoring the course of the anesthetics, conferring with the nurse anesthetists, adjusting the medical therapy and solving problems when they occur. This model allows each group of providers to use their unique skill sets to the greatest advantage of the patient.

When you take the cost of complications and mortality into consideration, the cost savings are even greater. The recent study published by the Institute of Medicine, To Err is Human, documented the significant improvement in patient outcomes when anesthesiologists were included in the anesthesia care. In addition, the IOM report discussed the economic impact of treating complications and eventual mortality secondary to medical errors. Another study4 showed that complications following cardiac surgery could more than double the cost of an episode of care. It follows that the improved outcomes associated with anesthesia care that includes an anesthesiologist is a minimal price to pay compared to the cost of complications and death.

A final note: Taking away the physician supervision requirement will not be any more cost effective than the current system. The amount payable under Medicare remains exactly the same. This fact makes HCFA's proposal to, in effect, lower anesthesia care standards, all the more confounding.

4. There are no data that suggest that nurse anesthetists can provide safe care while unsupervised. According to the American Association of Nurse Anesthetists, nurse anesthetists deliver 65 percent of the anesthetics provided in the US, and they are the sole anesthesia providers in more than 70 percent of the nation's rural hospitals. This statement is extremely misleading. In actuality, anesthesia care teams deliver about 55 percent of all anesthetics; 35 percent are delivered by anesthesiologists alone, and about 10 percent are delivered by nurse anesthetists supervised by the surgeon. In the vast majority of cases where nurse anesthetists are involved, they work under the direction or supervision of anesthesiologists-in fact, 90 percent of anesthetics delivered in the US benefit from the inclusion of an anesthesiologist. Furthermore, anesthetics provided in rural settings account for less than 5 percent of all surgeries. Although nurse anesthetists attack the purpose and methodology of the studies the anesthesiologist community is using to prove its points, the fact is that there are no scientific studies that prove or even suggest that nurse anesthetists working alone deliver safe care. In fact, there has been no data published showing any improvement in anesthesia-related mortality with nurse anesthetists who are supervised by the surgeon since the anesthesia-related mortality rate of 1 in 20,723, which I discussed earlier. In contrast, anesthesia care that includes an anesthesiologist has continued to improve and now stands at less than one death per quarter million anesthestics-an improvement of more than ten-fold!

Anesthesiologists believe that HCFA decided to remove the physician supervision requirement without adequate outcomes data either in the mistaken belief that the change will decrease the cost of care or for raw political purposes. A bill recently introduced in Congress, the Weldon-Green Bill (H.R. 5286), aims to correct this by requiring a comprehensive national outcomes study. Until the results of the study are known, HCFA would maintain the current supervision requirements. I'm very much in favor of the study, because I work for a very large organization where we use many non-physician providers. In order for us to run as efficiently as possible, we need to know what works and what does not. There's probably a "sweet point" in terms of the ratio of physicians and nurses where we have the best outcomes and lowest costs. It will only be with these kinds of studies that we can begin to understand where that point is.

5. Patients want physicians to oversee their care. Medicare patients are extremely concerned about HCFA's recent actions, and have made their feelings known. In two recent national polls, 80 percent of Medicare beneficiaries opposed eliminating the physician supervision requirement, and almost two-thirds of them were "strongly" opposed.

Nowhere else in medicine has there been a move to take away the physician component for medical care. Why should anesthesia be any different? At what point do we stop cutting corners? Even if HCFA's proposal does become law, I urge facility managers to maintain the highest standards and make sure anesthesiologists are involved in every anesthetic. This is the most cost-effective choice as well as the most efficient choice, and, most importantly, it assures the highest quality of care for every patient. In the final analysis it is the only ethical choice we have.

Dr. Abenstein joined the staff of Mayo Clinic in 1988 and works in the Division of Cardiovascular and Thoracic Anesthesiology. He currently serves on both the Health Technology Advisory Committee and the Medical Education and Costs Advisory Committee for the State of Minnesota.

References:
1. Abenstein JP, Warner MA. Anesthesia providers, patient outcomes, and costs. Anesthesia and Analgesia. 1996; 82(6):1273-83.
2. Silber JH, Kennedy SK, Even-Shoshan O, Chen W, Koziol LF, Showan AM, Longnecker DE. Anesthesiologist direction and patient outcomes. Anesthesiology. 2000;93(1):152-63.
3.Wiklund RA, Rosenbaum, SH. Anesthesiology. New England Journal of Medicine. 1997; 337(16):1132-1141.
4. Cheng DC, Karski J, Peniston C, Raveendran G, Asokumar B, Carroll J, David T, Sandler A. Early tracheal extubation after coronary artery bypass graft surgery reduces costs and improves resource use. A prospective, randomized, controlled trial. Anesthesiology. 1996;85(6):1300-10.

No: CRNAs Provide Safe Care at a Lower Cost

    Larry Hornsby, CRNA, BSN
    Springville, Ala.
 

As baby boomers get older and the surgical patient population grows, chances are we'll need every qualified anesthesia provider available to ensure that everyone has access to safe, effective anesthesia care. But as health care facilities' budgets continue to shrink, we'll also need to find more cost-effective ways of delivering that care. Fortunately, hospital and ambulatory surgery center facility managers can make a cost-effective choice when they select their anesthesia providers. When they select certified registered nurse anesthetists, they can rest assured that their patients will receive the highest quality care, and, in many cases, that care will cost much less than it would if they were using anesthesiologists. The bottom line is that although there is more than enough need for all qualified anesthesia providers, health care facilities don't need anesthesiologists to provide safe anesthesia care. In thousands of facilities nationwide, CRNAs are providing hands-on care that is just as safe and effective, and because a CRNA's salary is, on average, less than half that of an anesthesiologist's, they are helping these facilities realize substantial cost savings.

HCFA's proposal to remove the federal physician supervision requirement and defer to state law is a much-needed move-besides validating the important contributions that CRNAs make to anesthesia care, the proposal will allow health care facilities even greater flexibility and choice when selecting anesthesia providers. When HCFA first proposed removing the supervision requirement in 1997, the anesthesiologist community, led by the American Society of Anesthesiologists, became apoplectic, claiming that the action would result in more patients dying from anesthesia-related causes. But nurse anesthetists' stellar safety record, and the fact that anesthesia is safer today than ever, suggest otherwise. Anesthesiologists are vehemently opposed to the ruling for one simple reason: they fear loss of income, status, and control.

I believe there are five key arguments that support the safety records of CRNAs and validate the idea that they are fully capable of being any patient's sole anesthesia provider. After considering them, I believe any facility manager will be reassured and encouraged to welcome CRNAs into their facilities.

1. HCFA's proposal will actually have very little effect on how anesthesia is administered today. Let's get one thing straight. There is no mandate, either at the federal or state level, which requires a CRNA to be supervised by an anesthesiologist. Existing rules specify that any licensed physician, including the physician performing the surgical procedure, can supervise a CRNA. In my home state of Alabama, dentists and podiatrists also can provide this overall anesthesia supervision. However, because of their extensive, specialized education and experience, physicians heavily rely on CRNAs to assess and provide for their patients' anesthesia needs-in other words, the relationship between doctor and anesthetist truly is much more accurately described as being "collaborative" in nature, with the patients' best interests the unifying factor. Removing the federal physician supervision requirement in these cases would not make any difference at all in the quality of care-it would just recognize that the CRNA is responsible for the anesthesia, and reimburse him or her fairly, at 100 percent of the anesthesia fee.

2. CRNAs are fully capable of providing safe, high-quality anesthesia care in all situations. CRNAs attend four years of nursing school, obtain a minimum of one year of critical care experience, and then complete a 24- to 36-month graduate degree program in anesthesia, which includes more than 400 hours of clinical experience. By the time they graduate, they are well equipped to handle any anesthesia case, from an organ-transplant operation to an outpatient cataract procedure, with the same skill as any anesthesiologist. Anesthesiologists often refer to their four years of undergraduate schooling to boost their number of years of training, but in reality, those years have nothing to do with learning how to provide anesthesia care. When you compare the amount of time both professionals spend learning how to care for patients and provide anesthesia, the training time is remarkably similar-that is, seven to eight years.

The fact is, the knowledge base that is required to provide safe anesthesia care does not require a medical background. Anesthesiology is a body of knowledge unto itself, and CRNAs spend as many years as anesthesiologists do mastering that specific body of knowledge. CRNAs can and do care for patients with advanced disease states and know exactly what to do if something goes wrong during a case. If it were otherwise, the number of malpractice claims against CRNAs would be through the roof. Instead, malpractice premiums for CRNAs decreased 52 percent between 1988 and 1998.

3. The "studies" that anesthesiologists are using to push their agenda are questionable, at best. The main weapon in the ASA's arsenal for attacking CRNAs, commonly called the "Pennsylvania Study," which examined the billing records of 217,000 Medicare patients, is a dud, for several reasons:

• The study never meant to compare nurse anesthetists with anesthesiologists nor to explore the role that CRNAs play in anesthesia care. Rather, it sought to determine whether cases in which anesthesiologists were involved had fewer complications and death rates. Anesthesiologists have deliberately confused Congress and the public by implying that the study was meant to directly compare the two providers.

• The researchers said their data suggested that when an anesthesiologist was not involved in anesthesia care, more patients died. But it's very questionable whether the death rate could really be attributed to anesthesia care. Consider that most deaths directly attributable to anesthesia occur within 48 hours of surgery. The study, however, examined death rates within 30 days of admission, and it did not separate out the deaths that occurred within this 48-hour window. If you take into account that the patients were all elderly Medicare patients, some with advanced co-morbidities, it's only logical to conclude that most of these patients probably succumbed to something other than anesthesia-related complications. By examining 30-day survival rates, the researchers were really measuring the quality of post-op care, not anesthesia care.

• Finally, the researchers even admitted that their data collection methods were faulty. They stated, "the accuracy of our definitions for anesthesiologist direction...is only as reliable as the bills (or lack of bills) submitted by the caregivers...if anesthesiologists had a tendency not to submit bills for patients who died within 30 days of admission, our results could be skewed in favor of directed cases."

Not coincidentally, the Pennsylvania study was published in the ASA's own journal. It's not unreasonable to question the objectivity of the peer-review process here, particularly since no CRNAs were involved.

Anesthesiologists also point to a few other studies, some more than 20 years old, to try to suggest that CRNAs aren't capable of providing safe care on their own, and they suggest that safety advances are mainly due to anesthesiologist involvement. In reality, improved anesthesia drugs and monitoring technology are the true factors, along with increased educational requirements and tougher standards of care for all anesthesia providers. Even the ASA agrees that no study has ever shown significant differences between CRNA and anesthesiologist care, but in order to try to prove a point, and delay the HCFA proposal, they've proposed yet another, expensive nationwide outcomes study in the Weldon-Green bill. The only thing such a study would prove is what we already know-anesthesia care is safer than ever, and CRNAs are a big reason why.

4. CRNAs provide greater flexibility and substantial cost savings to healthcare facilities. At around $94,000, the average salary for a CRNA is less than half of that of an anesthesiologist. It also costs less and takes less time to educate a CRNA and get him or her up to speed and performing in the OR.

Removing the federal physician supervision requirement won't make a considerable difference in some areas, at least not initially, because some states and hospitals will still require a physician to supervise anesthesia care. But not having a federal mandate would give facilities the opportunity to make better use of their anesthesiologists: Instead of spending their time directing or supervising CRNAs, anesthesiologists could be required to put their medical backgrounds to good use providing more expansive patient care preoperatively and postoperatively, while CRNAs handle the anesthesia care they are equally qualified to provide. The anesthesiologists could remain available to CRNAs on a consultant basis. Further, elimination of the federal supervision requirement would provide greater flexibility for rural areas and inner-city hospitals, where CRNAs are often the only anesthesia providers. Surgeons in these facilities would no longer be burdened by the misconception that they have increased liability when supervising CRNAs-a misconception that has persisted despite the fact that case law has shown otherwise time and again.

5. Most patients are completely comfortable with CRNAs providing care. To block HCFA's proposed rule, the ASA has engaged in numerous tactics to confuse the government and scare patients, particularly seniors. The association claims that 80 percent of seniors oppose removing physician supervision. This only shows just how skewed polls can be. Another nationwide survey conducted by an independent research firm revealed that 88 percent of Medicare patients would be comfortable if a surgeon chose a nurse anesthetist to provide anesthesia, and nearly two-thirds said it would be acceptable if the CRNA were unsupervised.

The judicial system seems to be on the side of CRNAs as well. Just last month, a Florida judge struck down a rule proposed by that state's Board of Medicine that would have required that a physician anesthesiologist administer or supervise the administration of all general, regional, or heavy sedation anesthesia administered in office surgery suites. Currently, the operating surgeon oversees the anesthesia care in most office surgery settings. The judge found that the rule would unreasonably restrict competition for anesthesia services; furthermore, he stated that "there is no reliable data demonstrating that office surgery is safer with an anesthesiologist than with a nurse anesthetist."

My hope is that the entire healthcare community realizes that there is room and a vital need for all anesthesia providers. In healthcare facilities around the nation, physicians-including anesthesiologists and CRNAs-will continue to collaborate to provide the best possible anesthesia care. It benefits no one, least of all our patients, for anesthesiologists and CRNAs to disparage each other. We should work to move beyond political backbiting and foster an atmosphere of mutual respect and collaboration.

Mr. Hornsby is the president of the American Association of Nurse Anesthetists. He is the vice president of Anesthesia Resources Management Inc., which provides anesthesia services for hospital, ambulatory surgical centers, and office surgery facilities in Birmingham, Oxford, Huntsville, and Montgomery, Ala.