Impact of optional regulations on heart attack treatment

People who have heart attacks are about 15 percent less likely to be treated with bypass surgery or angioplasty within the first few days of the incident in states with certificate of need (CON) regulatory programs.

However, these patients are no more likely to experience adverse events, such as death, than patients who had heart attacks but were treated within the first days in states without CON.

These findings appear in a University of Iowa and Department of Veterans Affairs (VA) study published in the May 10 issue of the Journal of the American Medical Association.

CON programs involve state-enacted regulations that seek to limit unnecessary expansion of medical services. The study also showed that increased CON stringency is associated with lower use of the two procedures but without a negative impact on survival.

"The study implies that certificate of need programs, which require hospitals to obtain prior approval for establishing high-cost services, limit the growth of these services. In spite of limiting the diffusion of these services, CON regulations did not adversely affect patients," said Gary Rosenthal, M.D., the study's senior investigator and professor of internal medicine in the UI Roy J. and Lucille A. Caver College of Medicine. Rosenthal also is director of the Center for Research in the Implementation of Innovative Strategies in Practice at the VA Iowa City Health Care System.

The study involved a review of the administrative records of 1,139,792 Medicare beneficiaries age 68 and older who had heart attacks and had been admitted to 4,587 hospitals in the United States between 2000 and 2003.

Certificate of need became optional for states in the mid-1980s. During the study, 27 states, including the District of Columbia, had CON regulations for open-heart surgery.

The authors also rated the stringency of the state CON programs, based on the scope of services covered by the CON regulations and the review process hospitals experience when requesting authorization to establish a new program. Using this rating, three states had high CON stringency, eight states had moderate CON stringency and 16 states, including Iowa, had low CON stringency.

"The findings indicate that the more stringent the CON program, the lower the use of bypass surgery and angioplasty for these patients, yet death rates remained the same as in states with less stringent CON or states without CON," explained the study's lead author Ioana Popescu, M.D., a Quality Scholar with the VA Iowa City Health Care System and UI fellow in internal medicine.

Rosenthal and Popescu noted that there still is pressure on states to remove CON regulations because of claims that it limits free competition.

"A problem for policy makers is there haven't been enough studies on the impact of certificate of need programs on quality of care and how well patients do," Rosenthal said. "There may still be an important role for regulatory policy at the state level to ensure services are not unnecessarily duplicated and to control quality of care."

"States with CON regulations tend to have fewer hospitals performing high-tech procedures, thus consolidating the delivery of such services and creating higher volume programs. Hospitals that do more of a certain procedure to treat a certain diagnosis, will, on average, do better than hospitals that do fewer of the procedure," Popescu said.

Rosenthal said that maintaining higher volume per institution may be particularly important for bypass surgery, which is being used less frequently overall in the United States because more patients are being treated with angioplasty.