Certificate of Need

Issue: The continued trend toward managed health care has caused both legislators and state health departments to reassess regulation of the health care industry as a whole. Given the nationwide trend toward market-oriented approaches to ensure the quality and appropriateness of care, states are showing a growing interest in revising or eliminating one of the icons of state regulation, the certificate-of-need (CON) law.
Background: CON laws emerged in the 1970s and require providers to receive state approval for major capital expenditures, purchase of high-technology equipment, and expansion of services. These laws were enacted to prevent over utilization of services and keep health care costs in check. Proponents of CON believe that strict regulation is necessary to hold down health care costs and maintain quality. Opponents argue that the market produces more effective controls.
Why Is It Important to Cardiologists? CON remains the primary method of regulating cardiac surgical and some cardiovascular interventional programs. State health agencies are continually seeking to ensure quality of health care by reviewing, revising, and implementing alternative strategies designed to keep up with the rapid pace of technology in the health care arena. Primary targets for such regulation and oversight are coronary artery bypass surgery programs. An emergent trend is the regulation and oversight of cardiac catheterization and diagnostic imaging.
ACC Position:

While the ACC has not endorsed a position on CON, an ACC working group on CON and related issues has proposed six “working principles” upon which to base CON discussions:

1. Current and proposed open-heart surgery programs, cardiac catheterization and Diagnostic Imaging programs should be evaluated according to the incidence of heart disease of the population in the geographic region that the programs serve or will serve. Staffing and technology levels, as well as the total number of services rendered (coronary artery bypass graft surgery, valve replacement, and interventions, diagnostic imaging), need to be estimated. The incidence of acute interventions and the need for treatment of acute myocardial infarction must be considered.

2. The issue of transportation regionally must be considered. The infrastructure that will allow quick emergency transport of patients suffering acute myocardial infarction to reach a state-of-the-art facility needs to be considered. The time involved in emergency transfer during an acute event to a properly equipped facility needs to be taken into account, as should the time required for transfer between an acute care hospital and a tertiary-care facility.

3. The availability of adequately trained allied health personnel (nursing, laboratory, radiology, and anesthesia) in regions’ institutions should be carefully evaluated. Recommendations that define the meaning of adequately trained personnel should be developed with advice and input from the appropriate allied health professional societies. Guidelines for personnel continuing medical education and training need to be developed.

4. CON program modifications or repeal efforts need to consider the impact on the availability of physician training programs, fellows, and residents and the training of allied health personnel as well as access by inner city and/or underserved populations to hospitals and institutions that currently deliver care to the inner-city and underserved populations.

5. The quality of outcomes and mortality data must be considered. Often, CON programs place little emphasis on the measurement of quality parameters, such as morbidity and quality-of-life issues.

6. Appropriate national specialty organizations and their state affiliates should be consulted in the development and/or modification of specific CON requirements concerning personnel, technology and support facilities, and quality-of-care measurement tools.

State Action: State: Currently, 14 states have repealed CON laws. A number of states continue to examine the extent to which CON programs should play a role in regulating their health care systems. Such revisions are largely being considered in the areas of long-term health care, nursing facility beds, and the expansion of surgical programs, including open-heart surgery. Although there are reports that state budgets are improving, many states are looking for ways to decrease costs, several states have introduced amendments to either strengthen or relax their CON laws to satisfy health care needs.

In 2004, 14 states--Alaska, Connecticut, Florida, Hawaii, Illinois, Kentucky, Maine, Minnesota, Mississippi, Oklahoma, Rhode Island, Tennessee, Virginia and Washington--enacted legislation to address the applicability of their certificate of need (CON) programs. An emerging trend, particularly in Connecticut, Florida and Tennessee concerned the certificate of need process and specialty hospitals. In addition, a number of state legislatures enacted laws to create exemptions to the CON process.

The Federal Trade Commission and the Department of Justice released “Improving Health Care: A Dose of Competition,” in 2004. The report addresses CON’s ability to control health care costs at the state level. The two agencies found that “Where CON programs are intended to control health care costs, there is considerable evidence that they can actually drive up prices by fostering anticompetitive barriers to entry.” ACC is currently evaluating the report.

ACC Contacts: Adam Nelson, CAE, senior specialist, State Legislative Affairs, 301-897-2612

For more information about State Advocacy, please contact stateadvocacy@acc.org, or call 301-897-2612.

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