Donate Help Contact The AHA Sign In Home
American Heart Association
Circulation
Search: search_blue_button Advanced Search
« Previous Article | Table of Contents | Next Article »
Circulation. 2007;115:1012-1019
Published online before print February 5, 2007, doi: 10.1161/CIRCULATIONAHA.106.658377
CLINICAL PERSPECTIVE
This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
115/8/1012    most recent
CIRCULATIONAHA.106.658377v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow Request Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Ross, J. S.
Right arrow Articles by Krumholz, H. M.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Ross, J. S.
Right arrow Articles by Krumholz, H. M.
Related Collections
Right arrow Health policy and outcome research

(Circulation. 2007;115:1012-1019.)
© 2007 American Heart Association, Inc.

Health Services and Outcomes Research

Certificate of Need Regulation and Cardiac Catheterization Appropriateness After Acute Myocardial Infarction

Joseph S. Ross, MD, MHS; Vivian Ho, PhD; Yongfei Wang, MS; Stephen S. Cha, MD, MHS; Andrew J. Epstein, PhD, MPP; Frederick A. Masoudi, MD, MSPH; Brahmajee K. Nallamothu, MD, MPH; Harlan M. Krumholz, MD, SM

From the Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, NY, and the Geriatrics Research, Education, and Clinical Center, James J. Peters VA Medical Center, Bronx, NY (J.S.R.); Baker Institute for Public Policy (V.H.), Rice University, Houston, Tex; Section of Cardiovascular Medicine, Department of Medicine (Y.W., H.M.K.), Department of Medicine (adjunct; S.S.C.), and Section of Health Policy and Administration, Department of Epidemiology and Public Health (A.J.E., H.M.K.), Yale University School of Medicine, New Haven, Conn; Section of Cardiovascular Medicine, Department of Medicine, Denver Health Medical Center, and the Colorado Health Outcomes Program, Department of Medicine, University of Colorado at Denver Health Sciences Center, Denver, Colo (F.A.M.); Division of Cardiovascular Medicine, Department of Medicine, University of Michigan, and the Health Services Research and Development Center of Excellence, Ann Arbor VA Medical Center, Ann Arbor, Mich (B.K.N.); and Robert Wood Johnson Clinical Scholars Program, Yale University School of Medicine and the Yale-New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Conn (H.M.K.)

Correspondence to Joseph S. Ross, MD, MHS, Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, One Gustave L. Levy Pl, Box 1070, New York, NY, 10029. E-mail joseph.ross{at}mssm.edu

Received August 14, 2006; accepted December 19, 2006.


*    Abstract
up arrowTop
 *Abstract
down arrowIntroduction
 down arrowMethods
 down arrowResults
 down arrowDiscussion
 down arrowReferences
 
Background— Certificate of need (CON) regulation was introduced to control healthcare costs and improve quality of care in part by limiting the number of facilities providing complex medical care. Our objective was to examine whether rates of appropriate cardiac catheterization after admission for acute myocardial infarction varied between states with and without CON regulation of cardiac catheterization.

Methods and Results— We performed a retrospective analysis of chart-abstracted data for 137 279 Medicare patients admitted for acute myocardial infarction between 1994 and 1996 at 4179 US acute-care hospitals. Using 3-level hierarchical generalized linear modeling adjusted for patient sociodemographic and clinical characteristics and physician and hospital characteristics, we compared catheterization rates within 60 days of admission for states (and the District of Columbia) with (n=32) and without (n=19) CON regulation in the full cohort and stratified by catheterization appropriateness. Appropriateness was categorized as strongly, equivocally, or weakly indicated. We found CON regulation was associated with a borderline-significant lower rate of catheterization overall (45.8% versus 46.5%; adjusted risk ratio [RR] 0.91, 95% confidence interval 0.82 to 1.00, P=0.06). After stratification by appropriateness, CON regulation was not associated with a significantly lower rate of catheterization among 63 823 patients with strong indications (49.9% versus 50.3%; adjusted RR 0.94, 95% confidence interval 0.86 to 1.02, P=0.17). However, CON regulation was associated with significantly lower rates of catheterization among 65 077 patients with equivocal indication (45.0% versus 46.0%; adjusted RR 0.88, 95% confidence interval 0.78 to 1.00, P=0.05) and among 8379 patients with weak indications (19.8% versus 21.8%; adjusted RR 0.84, 95% confidence interval 0.71 to 0.98, P=0.04). Associations were weakened substantially after adjustment for hospital coronary artery bypass graft surgery or cardiac catheterization capability.

Conclusions— CON regulation was associated with modestly lower rates of equivocally and weakly indicated cardiac catheterization after admission for acute myocardial infarction, but no significant differences existed in rates of strongly indicated catheterization.


Key Words: angioplasty • myocardial infarction • certificate of need • quality of health care • government regulation


*    Introduction
up arrowTop
 up arrowAbstract
 *Introduction
down arrowMethods
 down arrowResults
 down arrowDiscussion
 down arrowReferences
 
Certificate of need (CON) regulation, federally mandated as part of the 1974 National Health Planning and Resources Development Act, was introduced to restrain healthcare costs and improve healthcare quality, in part by limiting the number of facilities providing complex, high-cost medical care, such as cardiac, surgical, and imaging services. In 1984, the federal mandate ended, which allowed each state to determine whether to maintain CON regulation,1 and more than one third eliminated it soon thereafter. During the 1990s, CON regulation was eliminated in 7 other states. Missouri eliminated CON regulation in 2003 and Florida in 2004, and the merits of CON regulation are being actively debated in several states, including Virginia and Vermont, as well as the District of Columbia.2 Currently, 37 states have CON regulations.3 The Federal Trade Commission and the Department of Justice recently called for the complete elimination of CON regulation, citing its failure to contain healthcare costs and its anticompetitive risks.4 Because CON regulation is not associated with substantially restrained healthcare costs,5,6 the reluctance to maintain CON regulation may be partly because research examining its effect on healthcare quality has found inconsistent results.

Clinical Perspective p 1019

The earliest study demonstrated an association between CON regulation and increased mortality for several medical and surgical conditions.7 Subsequent research has focused primarily on cardiac procedures, and these studies show that states with CON regulation are more likely to have patients treated at higher-volume centers,8–11 which may indicate higher-quality care.12 However, CON regulation of either CABG surgery or cardiac catheterization has only been associated with lower mortality in 1 study11 and not in 4 others.8–10,13 Moreover, CON regulation has been associated with lower early revascularization rates after acute myocardial infarction (AMI),10 which may indicate lower-quality care given the beneficial effects of acute revascularization,14 and similar nonacute revascularization rates.

Given these described differences in revascularization rates between states with and without CON regulation,10 along with the wide variations in cardiac procedure use across different areas within the United States,15 examining procedure appropriateness is critical to understanding the impact of a policy that limits the number of facilities that provide a procedure, because it may affect the rates of both more and less appropriate care delivered. For instance, as has been suggested,10,16 without CON regulation to limit facilities, market forces may increase the use of revascularizations among less appropriate patients who derive little benefit. Conversely, limiting facilities and thereby concentrating patients at higher-volume centers may reduce the pressure to maintain facility volumes, which would reduce the likelihood that less appropriate patients would be referred for revascularization.

Our objective was to examine whether rates of appropriate catheterization after admission for AMI varied between states with and without CON regulation of cardiac catheterization. Our hypothesis was that CON regulation would be associated with lower rates of catheterization among patients with equivocal and weak indications but equal or higher rates among those with strong indications. We used the Cooperative Cardiovascular Project (CCP), medical record data abstracted for Medicare beneficiaries hospitalized with AMI between 1994 and 1996, which provided a unique opportunity to use a large, nationally representative database that permits comparison of state policies while also providing detailed clinical information that allows determination of procedure appropriateness.17–19 Moreover, CCP data were collected shortly before the discontinuation of CON regulation in several states, which enabled the examination of a more diverse group of state programs than would be possible today.


*    Methods
up arrowTop
 up arrowAbstract
 up arrowIntroduction
 *Methods
down arrowResults
 down arrowDiscussion
 down arrowReferences
 
CCP and the Study Cohort
CCP has been described elsewhere in detail.20 Briefly, the medical records of all Medicare patients hospitalized with a primary discharge diagnosis of AMI (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] code 410.X, with the exception of readmission code 410.X2)21 were abstracted, by state, for an 8-month period between January 1994 and February 1996. Among the 234 769 hospitalizations in CCP, we excluded patients younger than 65 years of age (n=17 593) or without a chart-confirmed AMI (n=31 186). Patients were sorted by admission date and readmissions were excluded (n=23 773). In addition, we excluded patients who were transferred during their hospitalization for whom index hospitalization information was not available (n=14 943); patients who were transferred and for whom index hospitalization information was available were assigned to the hospital in which they were initially hospitalized, a method suggested for hospital performance research.22 We also excluded patients for whom American Hospital Association (n=2363), American Medical Association (n=6796), 1990 US Census (n=10 810), or Medicare Part A (n=34 187) data were not available. Finally, we excluded 1765 patients hospitalized outside of the United States, 77 patients discharged after the study period, and 325 patients with unknown mortality status. A total of 97 490 patients met 1 or more of these criteria; the remaining 137 279 patients constitute the study cohort.

CON Regulation
Information about states’ CON regulation was obtained from a survey of state regulators contracted through the American Health Planning Association. Individual states and the District of Columbia were categorized according to whether state laws required CON regulation of cardiac catheterization from 1994 through 1996. Regulation was present for 32 states and absent in 19. Nevada, North Dakota, and Oregon all discontinued CON regulation in 1995, after CCP data collection in each state, and so were included among states with regulation present.

Cardiac Catheterization Use
The principal outcome was use of cardiac catheterization within 60 days of hospital admission, as determined by evaluating the hospital medical record and Medicare Part A billing records for ICD-9-CM procedure codes associated with cardiac catheterization (37.22, 37.33, and 88.53 to 88.57).

Cardiac Catheterization Appropriateness
Indications for having cardiac catheterization were evaluated after the acute phase of infarction (>12 hours after symptom onset). Using the 1996 American College of Cardiology/American Heart Association (ACC/AHA) guidelines17 and appropriateness criteria previously reported by Guadagnoli and colleagues,18 we classified patients into 3 groups (Table 1), as we have done previously.19 The strong indication group consisted of patients in whom cardiac catheterization was generally recognized as "beneficial, useful, and effective" (ACC/AHA class I).17 The equivocal group included patients for whom data on the effectiveness of the procedure were unclear (ACC/AHA class IIa [evidence may favor catheterization]; ACC/AHA class IIb [evidence may not favor catheterization]) or patients with uncomplicated AMIs (neither ACC/AHA class I, II, or III). The weak indication group consisted of patients who had conditions for which cardiac catheterization was considered unlikely to be effective (ACC/AHA class III). For patients who met >1 classification criterion (for example, a patient who had ischemia observed on an exercise stress test and concomitant metastatic cancer), classifications were prioritized by the following order: weak indications, strong indications, and equivocal indications; this was done to maximize specificity among patients classified with strong indications.


View this table:
[in this window]
[in a new window]

  		TABLE 1. Cardiac Catheterization Appropriateness Criteria*

Statistical Analysis
We compared states with and without CON regulation of cardiac catheterization for differences in patient sociodemographic characteristics, clinical presentation, past medical history, and comorbid conditions, and physician and hospital characteristics using {chi}2 and t test analyses. In addition, we compared patients in states with and without CON regulation by the appropriateness indications, and we compared states with and without CON regulation by the crude cardiac catheterization rates, both overall and stratified by procedure appropriateness.

We developed 3-level (patient, hospital, and state) hierarchical generalized linear models to compare rates of cardiac catheterization between states with and without CON regulation in the full study cohort and stratified by procedure appropriateness. The baseline model examined the unadjusted association between CON regulation and cardiac catheterization rate.

In the adjusted analyses, the first-level model specification included patient sociodemographic characteristics, clinical presentation, past medical history, and comorbid conditions and physician characteristics. Patient sociodemographic characteristics included age, gender, race, and residential ZIP code measures of income and education, as reported in the 1990 US Census.23 We accounted for the many clinical presentation characteristics ascertained at admission (Table 2). In addition, we based medical history measures on clinical experience and previously identified predictors of procedure use, and we also accounted for other comorbid conditions (Table 2). Physician characteristics (Table 2) were derived from the American Medical Association Masterfile.24


View this table:
[in this window]
[in a new window]

  		TABLE 2. Patient, Physician, and Hospital Baseline Characteristics (Patient-Level)*

The second-level model specification included hospital characteristics (Table 3), which we obtained from the 1994 American Hospital Association Survey of Hospitals.25 Of note, we created 2 different models, 1 including and 1 excluding the variable that defined hospital cardiac procedure availability: none, cardiac catheterization, or cardiac catheterization and CABG surgery. Because CON regulations limit the number of facilities that are authorized to provide cardiac catheterization and CABG surgery, and because a hospital’s availability of these cardiac services is associated with their use,26,27 adjustment for this variable may mediate the effect of CON regulation.


View this table:
[in this window]
[in a new window]

  		TABLE 3. Hospital Baseline Characteristics (Hospital-Level)*

The third-level model specification included the state-level presence of CON regulation. Hospital-level and state-level random effects, which account for the clustering (nonindependence) of patients within the same hospital and the clustering (nonindependence) of hospitals within the same state, were included in all analyses, unadjusted and adjusted. In addition, for adjusted analyses, missing data were imputed as the population median for continuous variables, assigned as nonpresence for dichotomous variables and considered as a category for categorical variables. Only 2 variables were missing data for >5% of patients. For left ventricular ejection fraction (35.5% missing), a missing category was created for analyses, whereas for serum albumin (26.6% missing), we categorized those missing data as having >3 g/dL and also used a dummy variable for the missing data for analyses. To facilitate interpretation of our results, ORs from adjusted analyses were converted to risk ratios (RR) by standard techniques.28 Statistical analyses were conducted with SAS software, version 9.1 (SAS Institute, Inc, Cary, NC). All statistical tests were 2-tailed.

The authors had full access to the data and take full responsibility for their integrity. All authors have read and agree to the manuscript as written.


*    Results
up arrowTop
 up arrowAbstract
 up arrowIntroduction
 up arrowMethods
 *Results
down arrowDiscussion
 down arrowReferences
 
Among the 137 279 patients hospitalized for AMI included in the present cohort, 68.5% were in states with CON regulation, the mean age was 77 years, 90.9% were white, and 50.8% were male. Compared with patients in states without CON regulation, patients in states with CON regulation were more likely to be white and female and more likely to have hypertension, diabetes mellitus, heart failure, or previous AMI; however, they were less likely to be admitted by a cardiologist, to be admitted to a public or nonteaching hospital, or to be admitted to a hospital where either catheterization or CABG surgery was available (Table 2). Indications for catheterization among patients in states with CON regulation were not significantly different than among patients in states without CON regulation; 46.5% had strong indications, 47.5% had equivocal indications, and 6.0% had weak indications, compared with 46.5%, 47.2%, and 6.3%, respectively (P=0.09).

There were 4179 hospitals in the present cohort, 60.2% of which were in states with CON regulation. Hospitals in states with CON regulation had significantly greater AMI volumes, were less likely to have public or for-profit ownership, and were more likely to be teaching hospitals and to have either CABG surgery or catheterization available than hospitals in states without regulation (Table 3). Crude rates of cardiac catheterization in states with CON regulation were 45.8% overall, 49.9% among patients with strong indications, 45.0% among patients with equivocal indications, and 19.8% among patients with weak indications, whereas in states without CON regulation, rates were 46.5%, 50.3%, 46.0%, and 21.8%, respectively (Table 4).


View this table:
[in this window]
[in a new window]

  		TABLE 4. Number of Patients Hospitalized for AMI and Posthospitalization Crude Rates of Cardiac Catheterization in States With and Without CON Regulation Among All Patients and Stratified by Procedure Appropriateness

In unadjusted analyses, CON regulation was not associated with a significantly lower overall rate of catheterization (RR=0.95, 95% CI 0.87 to 1.03, P=0.22; Table 5). CON regulation was not associated with significantly lower rates of catheterization among patients with strong indications (RR=0.97, 95% CI 0.90 to 1.04, P=0.39), among patients with equivocal indications (RR=0.92, 95% CI 0.82 to 1.01, P=0.10), or among patients with weak indications (RR=0.90, 95% CI 0.77 to 1.03, P=0.14). However, there was a nonsignificant trend toward CON regulation being associated with a lower rate of less appropriate cardiac catheterizations.


View this table:
[in this window]
[in a new window]

  		TABLE 5. Unadjusted and Adjusted Association Between CON Regulation of Cardiac Catheterization Services and Use of Cardiac Catheterization After Hospitalization for AMI, Stratified by Procedure Appropriateness

After adjustment for patient-level and hospital-level characteristics, excluding hospital cardiac procedure availability, there was a significant trend toward CON regulation being associated with a lower rate of less appropriate cardiac catheterizations. CON regulation was associated with a borderline-significant lower overall rate of catheterization (RR=0.91, 95% CI 0.82 to 1.00, P=0.06; Table 5). Among patients with strong indications, CON regulation was not associated with a significantly lower rate of catheterization (RR=0.94, 95% CI 0.86 to 1.02, P=0.17). However, CON regulation was associated with significantly lower rates of catheterization among patients with equivocal (RR=0.88, 95% CI 0.78 to 1.00, P=0.05) and weak (RR=0.84, 95% CI 0.71 to 0.98, P=0.04) indications.

When we included hospital cardiac procedure availability in the hierarchical models, the associations observed were substantially weakened. CON regulation was no longer associated with a significantly lower overall rate of catheterization (RR=0.96, 95% CI 0.88 to 1.03, P=0.27; Table 5), nor was CON associated with significantly lower rates of catheterization among patients with strong indications (RR=1.00, 95% CI 0.93 to 1.06, P=0.88), among patients with equivocal indications (RR=0.92, 95% CI 0.83 to 1.02, P=0.14), or among patients with weak indications (RR=0.91, 95% CI 0.79 to 1.05, P=0.21). Finally, we included an interaction term between CON status and cardiac catheterization appropriateness in our fully adjusted analyses, excluding cardiac procedure availability, and found that the relationship between CON regulation and catheterization appropriateness was not significantly different depending on catheterization indication (P=0.14).


*    Discussion
up arrowTop
 up arrowAbstract
 up arrowIntroduction
 up arrowMethods
 up arrowResults
 *Discussion
down arrowReferences
 
CON regulation is associated with significantly lower rates of cardiac catheterization 60 days after admission for AMI among Medicare patients with equivocal and weak indications for the procedure and no significant rate difference among patients with strong indications, although the estimate is modestly lower. The lower rate of cardiac catheterization for patients with equivocal or weak indications was eliminated after adjustment for the variable defining hospital availability of cardiac catheterization or CABG surgery, which suggests that CON regulation is associated with a lower rate of cardiac catheterization among patients with equivocal and weak indications because it limits the number of healthcare facilities authorized to provide catheterization services.

On the basis of prior work on the relationship between supply and utilization of cardiac procedures,26,27 in addition to a recent study that examined the effect of CON regulation on revascularization rates and mortality,10 we thought that not only was it likely that limiting facilities via CON regulation would affect where patients receive care, it would also affect which patients received care. The present study supports our hypothesis that CON regulation would be associated with lower rates of catheterization among patients with equivocal and weak indications, which suggests either that physicians do discriminate on the basis of procedure appropriateness when faced with reduced capacity to provide care or that facilities refer fewer less-appropriate patients for catheterization when greater facility volume is ensured.

The present study offers support for the rationale behind the introduction of CON regulation: We found regulation of cardiac catheterization was associated with the continued delivery of more appropriate care after admission for AMI and reduced delivery of less appropriate care. From a policy perspective, increasing more appropriate care and decreasing less appropriate care are considered quality improvements.29,30 However, we found substantial underuse of appropriate care, because only 50% of patients with strong indications in states with and without CON regulation received cardiac catheterization after admission for AMI, a rate described in prior work.31 Therefore, although the present study was consistent with part of our hypothesis, that CON regulation would be associated with lower rates of catheterization among patients with equivocal and weak indications, CON regulation was not associated with higher rates of catheterization among patients with strong indications and may have exacerbated the known underuse of appropriate care.32

Unexpectedly, we found that a greater proportion of hospitals in states without CON regulation had neither catheterization nor CABG surgery available compared with hospitals in states with regulation; however, a greater proportion of patients in states with CON regulation were admitted to hospitals that had neither catheterization nor CABG surgery available compared with patients in states without regulation, which is consistent with expectations and prior work.10 This hospital-level finding may be a consequence of state geography, because states without CON regulation are less densely populated than are states with CON regulation (62.4 versus 84.9 persons per square mile),23 although the proportion of urban hospitals in both groups of states was similar. In addition, a greater number of hospitals exist in states without CON regulation, where the mean number of general hospitals in 1994 was 2.11 per 100 000 residents compared with 1.88 per 100 000 residents in states with CON regulation.33 This may be because states that have a CON program regulating 1 healthcare service may be more likely to regulate another, such as acute-care hospital beds.

Study Limitations
Although the present study used data from 1994 through 1996 and was limited to a population insured solely by Medicare, our results remain important and relevant to the current health policy debate for multiple reasons. First, it is unlikely that patterns of care were different for Medicare beneficiaries relative to insured adults, because both Medicare and other commercial plans provide substantial reimbursement for cardiac catheterization. However, cardiac catheterization rates among the uninsured may be lower than among the insured, because lack of health insurance is recognized as a major barrier to receiving medical care, even for serious and morbid symptoms.34 Second, although US healthcare delivery has experienced substantial change since the mid-1990s, we would expect the patterns of care by appropriateness that we found to persist today, even with greater managed-care penetration18 and regionalization of care.31 Third, although there was a 31% increase in US cardiac catheterization capacity from 1993 to 1998,35 the indications for catheterization have only expanded.36,37 Moreover, the increased capacity was less than the increase in cardiac catheterization rates among this population, as 1 study demonstrated a 45% increase in rates of cardiac catheterization for Medicare enrollees during this same period, without a corresponding increase in underlying disease rates.38 Perhaps physicians have been forced to become more discriminating in patient referral for catheterization since the mid-1990s, because they may now be faced with greater absolute but lower relative capacity for care, which may strengthen the effect of CON regulation.

Other issues should be considered when interpreting the present study. Unlike the most recent study of CON regulation that examined overall revascularization after AMI (CABG surgery and catheterization),10 we only examined cardiac catheterization; however, clear guidelines that can be translated into appropriateness criteria with administrative data exist for cardiac catheterization17,18 but not for CABG surgery. In addition, catheterization is a gateway to CABG surgery, so understanding the effect of CON regulation on its use has wider implications. Second, CON regulation of cardiac catheterization is likely to be heterogeneous in character, which may lead to differences in the scope and stringency of the regulation. However, we found different patterns of care in states with and without CON regulation despite this heterogeneity. Third, the observational, cross-sectional design can only suggest but not prove a cause-and-effect relationship between CON regulation and use of cardiac catheterization. Finally, any association between CON regulation and use of cardiac catheterization may represent confounding due to other factors that differ systematically according to CON status. Hospital cardiac catheterization capacity,26,27 shorter distances between patients’ residences and catheterization facilities,39 and increased diagnostic testing40 are all determinants of cardiac catheterization after AMI. However, adjustment for these variables may overcontrol for the effect of CON regulation, because these are the processes by which its effects may be mediated. Further research is needed to determine whether these practice patterns vary at least in part because of CON regulation. The present analysis is unique in that it accounted for patient clinical presentation and medical history, along with physician and hospital characteristics, taking advantage of a clinically rich data source and allowing for analytic complexity prohibited by traditional administrative data.

Conclusions
As healthcare leaders promote systems-based solutions to improve healthcare quality,41 the present study informs policy makers with evidence from a current state regulation that is associated with reduced delivery of less appropriate care and continued delivery of more appropriate care, although not with increased delivery of more appropriate care. The present study suggests that CON regulation is associated with higher quality of care with respect to the use of cardiac catheterization for patients admitted for AMI, which supports part of the rationale behind the program. These benefits should be considered when decisions are made about the future of state CON regulations.


*    Acknowledgments
 
Sources of Funding

Dr Ross was a scholar in the Robert Wood Johnson Clinical Scholars Program at Yale University sponsored by the Robert Wood Johnson Foundation and Dr Cha was a scholar in the Robert Wood Johnson Clinical Scholars Program at Yale University sponsored by the Department of Veterans Affairs during part of their project involvement. The survey of state regulators about state CON status was contracted through the American Health Planning Association with support from a grant awarded to Dr Ho by the National Heart, Lung, and Blood Institute (R01 HL073825). The analyses on which this publication is based were performed under contract No. OK0412SC, funded by the Centers for Medicare & Medicaid Services, an agency of the US Department of Health and Human Services.

Disclosures

Dr Krumholz has research contracts with the Colorado Foundation for Medical Care and the American College of Cardiology, serves on an advisory board of Amgen and of UnitedHealthcare, is a subject matter expert for VHA, Inc, and is Editor-in-Chief of Journal Watch Cardiology of the Massachusetts Medical Society. No other authors have financial conflicts of interest to disclose.


*    References
up arrowTop
 up arrowAbstract
 up arrowIntroduction
 up arrowMethods
 up arrowResults
 up arrowDiscussion
 *References
 

  1. Altman SH, Ostby EK. Paying for hospital care: the impact of federal policy. In: Ginzburg E, ed. Health Services Research: Key to Health Policy. Cambridge, Mass: Harvard University Press; 1991: 46–68.
  2. Romano M. Pros and cons of certificates: American Health Planning Association directory suggests that certificate-of-need process is regulatory in theory, not in practice. Mod Healthc. 2003; 33: 1, 4–5.[Medline] [Order article via Infotrieve]
  3. American Health Planning Association. Certificate of Need information page. 2006. Available at: http://www.ahpanet.org/copn.html. Accessed November 22, 2006.
  4. Federal Trade Commission and the Department of Justice. Improving Health Care: A Dose of Competition. July 2004. Available at: http://www.ftc.gov/reports/healthcare/040723healthcarerpt.pdf. Accessed November 22, 2006.
  5. Conover CJ, Sloan FA. Does removing certificate-of-need regulations lead to a surge in health care spending? J Health Polit Policy Law. 1998; 23: 455–481.[Medline] [Order article via Infotrieve]
  6. Sloan FA, Steinwald B. Effects of regulation on hospital costs and input use. J Law Econ. 1980; 23: 81–109.[CrossRef][Medline] [Order article via Infotrieve]
  7. Shortell SM, Hughes EF. The effects of regulation, competition, and ownership on mortality rates among hospital inpatients. N Engl J Med. 1988; 318: 1100–1107.[Abstract]
  8. DiSesa VJ, O’Brien SM, Welke KF, Beland SM, Haan CK, Vaughan-Sarrazin MS, Peterson ED. Contemporary impact of state certificate-of-need regulations for cardiac surgery: an analysis using the Society of Thoracic Surgeons’ National Cardiac Surgery Database. Circulation. 2006; 114: 2122–2129.[Abstract/Free Full Text]
  9. Ho V. Certificate of need, volume, and percutaneous transluminal coronary angioplasty outcomes. Am Heart J. 2004; 147: 442–448.[CrossRef][Medline] [Order article via Infotrieve]
  10. Popescu I, Vaughan-Sarrazin MS, Rosenthal GE. Certificate of need regulations and use of coronary revascularization after acute myocardial infarction. JAMA. 2006; 295: 2141–2147.[Abstract/Free Full Text]
  11. Vaughan-Sarrazin MS, Hannan EL, Gormley CJ, Rosenthal GE. Mortality in Medicare beneficiaries following coronary artery bypass graft surgery in states with and without certificate of need regulation. JAMA. 2002; 288: 1859–1866.[Abstract/Free Full Text]
  12. Epstein AM. Volume and outcome: it is time to move ahead. N Engl J Med. 2002; 346: 1161–1164.[Free Full Text]
  13. Robinson JL, Nash DB, Moxey E, O’Connor JP. Certificate of need and the quality of cardiac surgery. Am J Med Qual. 2001; 16: 155–160.[Abstract]
  14. Ryan TJ, Antman EM, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel B, Russell RO, Smith EE III, Weaver WD, Gibbons RJ, Alpert JS, Eagle KA, Gardner TJ, Garson A Jr, Gregoratos G, Ryan TJ, Smith SC Jr. 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1999; 34: 890–911.[Free Full Text]
  15. Wennberg DE. The Dartmouth Atlas of Cardiovascular Health Care. Chicago, Ill: American Hospital Publishing; 2000.
  16. Hannan EL. Evaluating and improving the quality of care for acute myocardial infarction: can regionalization help? JAMA. 2006; 295: 2177–2179.[Free Full Text]
  17. Ryan TJ, Anderson JL, Antman EM, Braniff BA, Brooks NH, Califf RM, Hillis LD, Hiratzka LF, Rapaport E, Riegel BJ, Russell RO, Smith EE Jr, Weaver WD. ACC/AHA guidelines for the management of patients with acute myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Management of Acute Myocardial Infarction). J Am Coll Cardiol. 1996; 28: 1328–1428.[CrossRef][Medline] [Order article via Infotrieve]
  18. Guadagnoli E, Landrum MB, Peterson EA, Gahart MT, Ryan TJ, McNeil BJ. Appropriateness of coronary angiography after myocardial infarction among Medicare beneficiaries: managed care versus fee for service. N Engl J Med. 2000; 343: 1460–1466.[Abstract/Free Full Text]
  19. Rathore SS, Wang Y, Radford MJ, Ordin DL, Krumholz HM. Sex differences in cardiac catheterization after acute myocardial infarction: the role of procedure appropriateness. Ann Intern Med. 2002; 137: 487–493.[Abstract/Free Full Text]
  20. Marciniak TA, Ellerbeck EF, Radford MJ, Kresowik TF, Gold JA, Krumholz HM, Kiefe CI, Allman RM, Vogel RA, Jencks SF. Improving the quality of care for Medicare patients with acute myocardial infarction: results from the Cooperative Cardiovascular Project. JAMA. 1998; 279: 1351–1357.[Abstract/Free Full Text]
  21. Health Care Financing Administration. International Classification of Diseases, 9th Revision, Clinical Modification: ICD-9-CM. 6th ed. Washington, DC: US Government Printing Office; 1997.
  22. Kosseim M, Mayo NE, Scott S, Hanley JA, Brophy J, Gagnon B, Pilote L. Ranking hospitals according to acute myocardial infarction mortality: should transfers be included? Med Care. 2006; 44: 664–670.[CrossRef][Medline] [Order article via Infotrieve]
  23. Bureau of the Census. State and Metropolitan Area Date Book, 1991. Washington, DC: US Government Printing Office; 1991.
  24. Cherkin D, Lawrence D. An evaluation of the American Medical Association’s Physician Masterfile as a data source: one state’s experience. Med Care. 1977; 15: 767–769.[Medline] [Order article via Infotrieve]
  25. American Hospital Association. The Annual Survey of Hospitals Database: Documentation for 1994 Data. Chicago, Ill: American Hospital Publishing; 1994.
  26. Every NR, Larson EB, Litwin PE, Maynard C, Fihn SD, Eisenberg MS, Hallstrom AP, Martin JS, Weaver WD; Myocardial Infarction Triage and Intervention Project Investigators. The association between on-site cardiac catheterization facilities and the use of coronary angiography after acute myocardial infarction. N Engl J Med. 1993; 329: 546–551.[Abstract/Free Full Text]
  27. Dendukuri N, Normand SL, McNeil BJ. Impact of cardiac service availability on case-selection for angiography and survival associated with angiography. Health Serv Res. 2003; 38: 21–40.[CrossRef][Medline] [Order article via Infotrieve]
  28. Zhang J, Yu KF. What’s the relative risk? A method of correcting the odds ratio in cohort studies of common outcomes. JAMA. 1998; 280: 1690–1691.[Abstract/Free Full Text]
  29. Blumenthal D. Part 1: quality of care: what is it? N Engl J Med. 1996; 335: 891–894.[Free Full Text]
  30. Brook RH, McGlynn EA, Cleary PD. Quality of health care: part 2: measuring quality of care. N Engl J Med. 1996; 335: 966–970.[Free Full Text]
  31. Petersen LA, Normand SL, Leape LL, McNeil BJ. Regionalization and the underuse of angiography in the Veterans Affairs Health Care System as compared with a fee-for-service system. N Engl J Med. 2003; 348: 2209–2217.[Abstract/Free Full Text]
  32. McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. The quality of health care delivered to adults in the United States. N Engl J Med. 2003; 348: 2635–2645.[Abstract/Free Full Text]
  33. Area Resource File (ARF). Rockville, Md: US Department of Health and Human Services, Health Resources and Services Administration, Bureau of Health Professions; 1995.
  34. Baker DW, Shapiro MF, Schur CL. Health insurance and access to care for symptomatic conditions. Arch Intern Med. 2000; 160: 1269–1274.[Abstract/Free Full Text]
  35. Sheldon WC. Trends in cardiac catheterization laboratories in the United States. Catheter Cardiovasc Interv. 2001; 53: 40–45.[CrossRef][Medline] [Order article via Infotrieve]
  36. Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr, Alpert JS, Anderson JL, Faxon DP, Fuster V, Gibbons RJ, Gregoratos G, Halperin JL, Hiratzka LF, Hunt SA, Jacobs AK. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the 1999 Guidelines for the Management of Patients With Acute Myocardial Infarction). Circulation. 2004; 110: e82–e292.[Free Full Text]
  37. Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE III, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr. ACC/AHA guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction–2002: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on the Management of Patients With Unstable Angina). Circulation. 2002; 106: 1893–1900.[Free Full Text]
  38. Lucas FL, DeLorenzo MA, Siewers AE, Wennberg DE. Temporal trends in the utilization of diagnostic testing and treatments for cardiovascular disease in the United States, 1993–2001. Circulation. 2006; 113: 374–379.[Abstract/Free Full Text]
  39. McClellan M, McNeil BJ, Newhouse JP. Does more intensive treatment of acute myocardial infarction in the elderly reduce mortality? Analysis using instrumental variables. JAMA. 1994; 272: 859–866.[Abstract]
  40. Wennberg DE, Kellett MA, Dickens JD, Malenka DJ, Keilson LM, Keller RB. The association between local diagnostic testing intensity and invasive cardiac procedures. JAMA. 1996; 275: 1161–1164.[Abstract]
  41. Berwick DM, Calkins DR, McCannon CJ, Hackbarth AD. The 100,000 lives campaign: setting a goal and a deadline for improving health care quality. JAMA. 2006; 295: 324–327.[Free Full Text]
 

CLINICAL PERSPECTIVE

Certificate of need (CON) regulation was introduced originally by the federal government to control healthcare costs and improve quality of care, in part by limiting the number of facilities providing complex medical care. CON regulation is now under the auspices of state governments, and 37 states currently maintain CON regulation. Our objective was to examine whether rates of appropriate cardiac catheterization after admission for acute myocardial infarction varied between states with and without CON regulation of cardiac catheterization. We used the Cooperative Cardiovascular Project, medical record data abstracted for Medicare beneficiaries hospitalized with acute myocardial infarction between 1994 and 1996, which provided a unique opportunity to use a large, nationally representative database that permits comparison of state policies while also providing detailed clinical information that allows determination of procedure appropriateness. Although the absolute difference in procedure rates was small, we found that CON regulation was associated with a slightly lower overall rate of catheterization in our adjusted analyses. However, after stratification by appropriateness, CON regulation was associated with modestly lower rates of equivocally and weakly indicated cardiac catheterization after admission for acute myocardial infarction but no significant difference in rates of strongly indicated catheterization. Importantly, this association was no longer significant when we included hospital capacity to perform coronary artery bypass surgery or cardiac catheterization in our adjusted analyses, which suggests that CON regulation is associated with a lower rate of cardiac catheterization among patients with equivocal and weak indications because it limits the number of healthcare facilities authorized to provide catheterization services.


*    Footnotes
 
Neither the Robert Wood Johnson Foundation nor the Department of Veterans Affairs had any role in the design or conduct of the study; collection, management, analysis, or interpretation of the data; or preparation, review, or approval of the manuscript. The content of this publication does not necessarily reflect the views or policies of the US Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the US Government. The Centers for Medicare & Medicaid Services reviewed and approved the manuscript (tracking No. MASOUDICON-001-OK-0506).

This work was presented at the 2006 Society of General Internal Medicine Annual Meeting on April 27, 2006, in Los Angeles, Calif.




This article has been cited by other articles:


Home page
 J Am Coll CardiolHome page
S. R. Dixon, C. L. Grines, and W. W. O'Neill
The year in interventional cardiology.
J. Am. Coll. Cardiol., June 17, 2008; 51(24): 2355 - 2369.
[Full Text] [PDF]

Home page
 J Am Coll CardiolHome page
D. T. Ko, Y. Wang, D. A. Alter, J. P. Curtis, S. S. Rathore, T. A. Stukel, F. A. Masoudi, J. S. Ross, J. M. Foody, and H. M. Krumholz
Regional Variation in Cardiac Catheterization Appropriateness and Baseline Risk After Acute Myocardial Infarction.
J. Am. Coll. Cardiol., February 19, 2008; 51(7): 716 - 723.
[Abstract] [Full Text] [PDF]

This Article
Right arrow Abstract Freely available
Right arrow Full Text (PDF)
Right arrow All Versions of this Article:
115/8/1012    most recent
CIRCULATIONAHA.106.658377v1
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow Request Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Ross, J. S.
Right arrow Articles by Krumholz, H. M.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Ross, J. S.
Right arrow Articles by Krumholz, H. M.
Related Collections
Right arrow Health policy and outcome research

Circulation Home | Subscriptions | Archives | Feedback | Authors | Help | AHA Journals Home | Search
Copyright © 2007 American Heart Association, Inc. All rights reserved. Unauthorized use prohibited.