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Release: Oct. 16, 2002

(Photo: Gary Rosenthal, M.D., UI professor of internal medicine and a director of the Program for Interdisciplinary Research in Health Care Organization at the Iowa City VAMC and a study author)

Study finds association between heart bypass survival and optional regulation

A new study shows that the risk of death following coronary (heart) bypass surgery is lower in states with certificate of need (CON) regulatory programs. Certificate of need, which became optional for states in the mid 1980s, was originally enacted to control heath care costs by regulating health care facilities' purchases of high-technology, high-cost medical equipment and the expansion or creation of their medical programs.

The study was led by investigators at the University of Iowa Roy J. and Lucille A. Carver College of Medicine and the Veterans Affairs Medical Center (VAMC) in Iowa City. Specifically, the team found that from 1994 to 1999 the risk of death for Medicare patients in hospitals or within 30 days following heart bypass surgery was about 22 percent higher in states that did not have CON regulation than those that did have the rules in place. The investigation, which was based on the nationwide administrative records of 911,407 Medicare beneficiaries age 65 and older, also found that the average number of heart bypass procedures performed by hospitals was much lower in states without CON regulation. The findings appear in the Oct. 16 issue of the Journal of the American Medical Association.

While the findings point to a very important association between CON regulation and mortality for bypass surgery, the study was not able to directly prove a direct cause and effect relationship. As a result, it would be premature to say that lower mortality is due strictly to CON, said Mary Sarrazin, Ph.D., UI assistant research scientist in internal medicine and a health services research specialist with the Iowa City VAMC and a study author.

However, the findings have implications for whether CON programs may be an effective way to help promote higher quality hospital treatment programs, said Gary Rosenthal, M.D., UI professor of internal medicine and a director of the Program for Interdisciplinary Research in Health Care Organization at the Iowa City VAMC and a study author.

"While it's possible that other factors are responsible for the differences, we think it's also reasonable that the presence of certificate of need regulation could promote the development of higher volume cardiac surgery programs, which have been shown by other studies to have superior patient outcomes," said Rosenthal, who also is a staff physician with the Iowa City VMAC and director of the UI Division of General Internal Medicine.

Certificate of need regulation was mandated by the federal government in 1974. In 1984, when deregulation was the norm in many sectors of the economy, the mandate was repealed, leaving it up to each state and the District of Columbia whether to maintain its CON program. During the period of the UI study, 1994 to 1999, 27 states still had CON regulation, 18 states had none and six states repealed their CON regulation during that period.

"Initially, certificate of need regulation was designed to limit hospital expansion, so it was meant to be more of a cost-control strategy," Sarrazin said. "Studies done in the 1980s generally failed to show lower costs associated with CON."

However, those studies did not look at the possible health benefits of CON regulation, she added.

In the six states that rescinded CON regulation during the period studied, the number of bypass cases per hospital (hospital volume) decreased significantly and the number of low-volume programs increased. Rosenthal said that a low-volume program typically performs fewer than 250 procedures annually.

Overall, the mean annual hospital bypass volume was 84 percent lower in states without CON than in states with CON. Hospitals with bypass programs in states without CON regulation handled an average of 104 bypass cases annually compared to an average 191 cases handled by hospitals offering the procedure in states with CON regulation.

"At a time when there is increasing emphasis being put on maintaining patient safety and increased reliance on the use of hospital volume as a criterion for selecting hospitals, it seems reasonable for public policy to look aggressively at the potential benefits of CON regulation," Rosenthal said. "The public may be more supportive of state-level regulations that seek to place certain standards for maintenance of programs such as bypass surgery and other clinical services."

At the same time, the study authors acknowledge that the issue of CON and surgical outcomes needs further study.

Sarrazin said there are other factors to consider in determining what might cause higher bypass mortality rates in certain states or hospitals, such as managed care, physician availability and population density.

The study may also have been limited by its focus on bypass patients 65 and older. Rosenthal is planning a follow-up study of patients younger than 65 to see if there are any variations in mortality rates.

Rosenthal noted that 93 percent of the patients in the study population were white, which does not reflect the nationwide racial distribution of patients who might benefit from heart bypass. However, other studies have shown that, despite need, African-American patients are less likely to undergo heart bypass surgery than are white patients. For that reason, the study may have reflected the typical distribution of patients undergoing heart bypass.

In addition to Sarrazin and Rosenthal, the study team included Edward Hannan, Ph.D., professor and chair of health policy, management and behavior at the State University of New York at Albany School of Public Health; and Carol Gormley of the Florida Hospital Association in Tallahassee, Fla.

Florida, Iowa and New York are among the states that still have CON regulation.

The study was funded in part by a contract with the Florida Hospital Association and by a grant from the federal Department of Veterans Affairs.

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