Certificate Of Need Regulations Research Articles

Associations Between Certificate of Need Policies and Hospice Quality Outcomes.

Certificate of need (CON) laws are state-based regulations requiring approval of new healthcare entities and capital expenditures. Varying by state, these regulations impact hospices in 14 states and DC, with several states re-examining provisions. This cross-sectional study examined the association of CON status on hospice quality outcomes using the hospice item set metric (HIS). Data from the February 2022 Medicare Hospice Provider and General Information reports of 4870 US hospices were used to compare group means of the 8 HIS measures across CON status. Multiple regression analysis was used to predict HIS outcomes by CON status while controlling for ownership and size. Approximately 86% of hospices are in states without a hospice CON provision. The unadjusted mean HIS scores for all measures were higher in CON states (M range 94.40-99.59) than Non-CON (M range 90.50-99.53) with significant differences in all except treatment preferences. In the adjusted model, linear regression analyses showed hospice CON states had significantly higher HIS ratings than those from Non-CON states for beliefs and values addressed (β = .05, P = .009), pain assessment (β = .05, P = .009), dyspnea treatment (β = .08, P < .001) and the composite measure (β = .09, P < .001). Treatment preferences, pain screening, dyspnea screening, and opioid bowel treatment were not statistically significant (P > .05). The study suggests that CON regulations may have a modest, but beneficial impact on hospice-reported quality outcomes, particularly for small and medium-sized hospices. Further research is needed to explore other factors that contribute to HIS outcomes.

The Effects of Certificate-of-Need Laws on the Quality of Hospital Medical Services

Certificate-of-need (CON) laws restrict entry into health services by requiring healthcare providers to seek approval from state healthcare regulators before making any major capital expenditures. An important question is whether CON laws influence the quality of medical services in CON law states. For instance, if CON laws actually lower the quality of medical services, they fail to achieve their intended effect. This paper tests the hypothesis that hospitals in states with CON laws provide lower-quality services than hospitals in states without CON laws. Our overall results suggest that CON regulations lead to lower-quality care for some quality measures and have little or no effect on other quality standards. The results remain consistent across several robustness tests.

The impact of certificate of need laws on heart attack mortality: Evidence from county borders

Certificate of need (CON) regulations requires that health care providers obtain state approval before offering a new service or expanding existing facilities. The purported goal of CON regulations is to reduce health care costs by generating regional economies of scale and reducing redundant investments resulting from excessive competition. Critics of CON regulations note that the regulatory environment increases the costs of expansion and may incentivize health care providers to forgo capital investment, which can have a negative effect on health outcomes. To estimate the net effect of CON regulations, I use a border discontinuity design to measure within-regional heart attack mortality spanning 1968 to 1982. I estimate that CON regulations led to an increase in heart attack deaths, by 6%-10%, three years after the policy was enacted.

Assessing the Efficacy of Certificate of Need Laws Through Total Joint Arthroplasty.

Lawmakers suggest Certificate of Need (CON) laws' main goals are increasing access to healthcare, increasing quality of healthcare, and decreasing healthcare costs. This retrospective database study aims to evaluate the effectiveness of CON through analysis of total knee, hip, and shoulder arthroplasty (TKA, THA, and TSA, respectively). A review was performed using the Humana Insurance PearlDiver national database from 2007 to 2015. Access to care was approximated by the rates of total joint arthroplasty (TJA) in patients diagnosed with arthritis to the corresponding joint. The quality of care was assessed using complication rates after TJA. The total cost of TJA was approximated from average reimbursement to the healthcare facility per procedure. Patients in states without CON programs received TKA, THA, and TSA more frequently (p < .0001, p = .250, p = .019). No significant difference was found in studied complication rates between CON and non-CON states. Similarly, there was no trend found when comparing the cost of each procedure in CON versus non-CON states. These findings are consistent with other recent studies detailing the impact of CON regulation on THA and TKA. The apparent nonsuperiority of CON states in achieving their purported goals may call into question the effectiveness of additional bureaucracy and regulation, suggesting a need for further examination.

Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries

Certificate of need laws provide state-level regulation of health system expenditure. These laws are intended to limit spending and control hospital expansion in order to prevent excess capacity and improve quality of care. Several states have recently introduced legislation to modify or repeal these regulations, as encouraged by executive order 13813, issued in October 2017 by the Trump administration. To evaluate the difference in markers of hospital activity and quality by state certificate of need status. These markers include hospital procedural volume, hospital market share, county-level procedures per 10 000 persons, and patient-level postoperative outcomes. A cross-sectional study involving Medicare beneficiaries aged 65 years or older who underwent 1 of the following 10 procedures from January 1, 2016, through November 30, 2018: total knee or hip arthroplasty, coronary artery bypass grafting, colectomy, ventral hernia repair, lower extremity vascular bypass, lung resection, pancreatic resection, cystectomy, or esophagectomy. State certificate of need regulation status as determined by data from the National Conference of State Legislatures. Outcomes of interest included hospital procedural volume; hospital market share (range, 0-1; reflecting 0%-100% of market share); county-level procedures per 10 000 persons; and patient-level postoperative 30-day mortality, surgical site infection, and readmission. A total of 1 545 952 patients (58.0% women; median age 72 years; interquartile range, 68-77 years) at 3631 hospitals underwent 1 of the 10 operations. Of these patients, 468 236 (30.3%) underwent procedures in the 15 states without certificate of need regulations and 1 077 716 (69.7%) in the 35 states with certificate of need regulations. The total number of procedures ranged between 729 855 total knee arthroplasties (47.21%) and 4558 esophagectomies (0.29%). When comparing states without vs with certificate of need regulations, there were no significant differences in overall hospital procedural volume (median hospital procedure volume, 241 vs 272 operations per hospital for 3 years; absolute difference, 31; 95% CI, -27.64 to 89.64; P = .30). There were no statistically significant differences between states without vs with certificate of need regulations for median hospital market share (median, 28% vs 52%; absolute difference, 24%; 95% CI, -5% to 55%; P = .11); procedure rates per 10 000 Medicare-eligible population (median, 239.23 vs 205.41 operations per Medicare-eligible population in 3 years; absolute difference, 33.82; 95% CI, -84.08 to 16.43; P = .19); or 30-day mortality (1.17% vs 1.33%, odds ratio [OR], 1.04; 95% CI, 0.93 to 1.16; P = .52), surgical site infection (1.24% vs 1.25%; OR, 0.93; 95% CI, 0.83 to 1.04; P = .21), or readmission rate (9.69% vs 8.40%; OR, 0.80; 95% CI, 0.57 to 1.12; P = .19). Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.

Certificate-Of-Need Regulation and Healthcare Service Quality: Evidence from the Nursing Home Industry.

This quantitative study investigates the effect of certificate-of-need (CON) regulation on the quality of care in the nursing home industry. It uses county-level demographic data from the 48 contiguous US states that are extracted from the American Community Survey (ACS) and cover the years 2012, 2013, and 2014. In doing so, it employs a new set of service quality variables captured from a variety of county-level data sources. Instrumental variables results indicate that health survey scores for nursing homes that are computed by healthcare professionals are about 18–24% lower, depending on the type of nursing home under consideration, in states with CON regulation. We also find that the presence of CON regulation leads to a substitution of lower-quality certified nursing assistant care for higher-quality licensed practical nurse care, regardless of the type of nursing home under consideration.

The Impact of Certificate of Need Laws on Heart Attack Mortality: Evidence from County Borders

Certificate of need (CON) regulations requires that health care providers obtain state approval before offering a new service or expanding existing facilities. The purported goal of CON regulations is to reduce health care costs by generating regional economies of scale and reducing redundant investments resulting from excessive competition. Critics of CON regulations note that the regulatory environment increases the costs of expansion and may incentivize health care providers to forgo capital investment, which can have a negative effect on health outcomes. To estimate the net effect of CON regulations, I use a border discontinuity design to measure within-regional heart attack mortality spanning 1968 to 1982. I estimate that CON regulations led to an increase in heart attack deaths, by 6%-10%, three years after the policy was enacted.

Distortions in a segment of the commercial office market: the case of medical office buildings

ABSTRACT This article examines the U.S. market for Medical Office Buildings (MOB), a segment of the office market that has received little attention in the academic literature. Our attention is directed towards the impact of Certificate-of-Need (CON), a set of state level distortionary public laws that regulate health services planning. With respect to real estate, we find CON regulations increase rents and sales prices medical office building (MOB) rental rates. What makes these findings particularly interesting is that none of the states that currently have CON legislation in place have any language restricting MOB development. The empirical findings suggest that there is a supply constraint due to CON that has a distortionary effect on the MOB market.

Taking the CON out of Pennsylvania: Did hip/knee replacement patients benefit? A retrospective analysis

We analyze the effects of Certificate of Need (CON) laws on outcomes for hip and knee replacement procedures. Federal CON programs began in 1974 to stem rising health care costs by limiting hospital expansion and acquisition of equipment. The federal requirement for CON programs ended in 1987; however, 36 states and DC still maintain various forms of CON programs.In 1996, Pennsylvania (PA) let its CON law expire. We use data from the National Inpatient Survey from HCUP for the years 1993–1999 and examine four outcomes: hospital acquired infections, mortality, length of stay, and total charges. We use a difference-in-differences estimation method leveraging the expiration of PA's law to compare outcomes between patients in PA with patients in states that continued to have a CON law. We control for a number of covariates and pre-treatment trends in our analysis.We focus on hip and knee replacement surgeries — two procedures that have expanded greatly, have contributed increasingly to growing health care costs, and have not been well studied in the literature —for a population that includes Medicare beneficiaries and patients with other payment methods.Our results provide new evidence of the effects of CON (de)regulation. We find that the expiration of CON laws in PA increased length of stay within the patient population and reduced the probability of dying. The CON laws did not have statistically significant effects on hospital acquired infections or total charges.

Certificate-of-Need Programs Are Associated with a Reduced Incidence, Expenditure, and Rate of Complications with Respect to Knee Arthroscopy in the Medicare Population.

To curb costs at the state level, improve care quality, and promote access to care, certificate-of-need (CON) laws were established in many states in 1974. It is not known how CON regulations have affected the provision of knee arthroscopy, one of the most common orthopedic procedures performed in the USA. We sought to characterize the effects of CON regulations on knee arthroscopy in the national Medicare population by examining trends in procedure volumes, comparing trends in procedure charges, evaluating distribution of procedure volumes between high-, mid-, and low-volume facilities, and comparing adverse event and complication rates after knee arthroscopy between states with and without CON regulations. States with CON regulations covering both inpatient and outpatient operating rooms formed the study group (n = 25 states) and were compared with states without CON laws or laws that did not cover operating rooms during the study period (n = 20 states). The 100% Medicare Standard Analytical Files from 2005 through 2014 were used to compare knee arthroscopy procedure volumes, charges, reimbursements, distribution of procedures based on facility volumes and adverse events between the two groups. The rate of decrease in the incidence of knee arthroscopy was significantly greater in CON states than that in non-CON states. CON states also had significantly lower charges at all time points, and overall, compared with non-CON states. There were significantly more high- and mid-volume facilities in CON states than in non-CON states, and there were significantly more low-volume facilities in non-CON states than in CON states. Finally, there were significantly higher rates of emergency room visits within 30days and infection within 6months in non-CON states than in CON states. CON regulations appear to have achieved several of their intended goals for knee arthroscopy. Further research is needed to determine if CON regulations affect the quality and sustainability of care provided to patients undergoing knee arthroscopy.

Do certificate of need regulations impact total shoulder arthroplasty volumes and associated complication rates?

ABSTRACTObjectives: Certificates of Need (CON) laws were introduced to improve resource utilization and reduce unnecessary health-care expansion. While many states have repealed their use, the debate continues as to their efficacy in achieving these goals. As such, we asked: 1) Are there differences in TSA incidence in CON/non-CON states? 2) Are there differences in procedural charges or reimbursement between CON/non-CON states? 3) Are there differences in the proportion of cases treated in high-, mid- or low-volume facilities between groups? 4) Are there differences in complications and length-of-stay (LOS) between high-volume and low-volume facilities?Methods: The 100% Medicare Standard Analytic files were queried for all TSA between 2005 and 2013, with minimum 1-year follow-up. Publically available data was used to identify states that upheld or repealed CON regulations, and comparisons were subsequently made between groups for normalized incidence of TSA per year and procedural charges and reimbursement rates. Comparisons were then made regarding the distribution of high-, mid- and low volume facilities, post-operative complication rates, and length-of-stay (LOS) between the different volume centers.Results: 167,288 patients undergoing TSA were identified. Normalized rates of TSA increased in both groups. Non-CON states had higher per-patient reimbursement, but paradoxically lower reimbursement rates compared with CON states. CON regulations lead to a greater proportion of procedures being performed in high-volume facilities compared with non-CON (p = 0.002). Finally, 30-day and 1-year complications, and length-of-stay, were significantly lower in high-volume facilities versus low-volume facilities (p ≤ 0.016).Conclusions: Where upheld, CON regulations contributed to a notable increase in the percentage of procedures performed in high-volume facilities, which in turn lead to a significant reduction in post-operative complications and LOS. Further study is necessary to definitely establish this relationship and the utility of CON regulations for the delivery of TSA care, particularly as it relates to clinical outcomes.

Association of Statewide Certificate of Need Regulations With Percutaneous Coronary Intervention Appropriateness and Outcomes.

BackgroundCertificate of need (CON) regulations are intended to coordinate new healthcare services, limit expansion of unnecessary new infrastructure, and limit healthcare costs. However, there is limited information about the association of CON regulations with the appropriateness and outcomes of percutaneous coronary interventions (PCI). The study sought to characterize the association between state CON regulations and PCI appropriateness.Methods and ResultsWe used data from the American College of Cardiology's CathPCI Registry to analyze 1 268 554 PCIs performed at 1297 hospitals between January 2010 and December 2011. We used the Appropriate Use Criteria to classify PCI procedures as appropriate, maybe appropriate, or rarely appropriate and used Chi‐square analyses to assess whether the proportions of PCIs in each Appropriate Use Criteria category varied depending on whether the procedure had been performed in a state with or without CON regulations. Analyses were repeated stratified by whether or not the procedure had been performed in the setting of an acute coronary syndrome (ACS). Among 1 268 554 PCI procedures, 674 384 (53.2%) were performed within 26 CON states. The proportion of PCIs classified as rarely appropriate in CON states was slightly lower compared with non‐CON states (3.7% versus 4.0%, P<0.01). Absolute differences were larger among non‐ACS PCI (23.1% versus 25.0% [P<0.01]) and were not statistically significantly different in ACS (0.62% versus 0.63% [P>0.05]).ConclusionsStates with CON had lower proportions of rarely appropriate PCIs, but the absolute differences were small. These findings suggest that CON regulations alone may not limit rarely appropriate PCI among patients with and without ACS.

Certificate-of-Need State Laws and Total Hip Arthroplasty

BackgroundMany states have certificate-of-need (CON) programs requiring governmental approval to open or expand healthcare services, with the goal of limiting cost and coordinating utilization of healthcare resources. The purpose of the present study was to evaluate the associations between these state-level CON regulations and total hip arthroplasty (THA). MethodsStates were designated as CON or non-CON based on existing laws. The 100% Medicare Standard Analytic Files from 2005 to 2014 were used to compare THA procedure volumes, charges, reimbursements, and distribution of procedures based on facility volumes between the CON and non-CON states. Adverse postoperative outcomes were also analyzed. ResultsThe per capita incidence of THA was higher in non-CON states than CON states at each time period and overall (P < .0001). However, the rate of change in THA incidence over the time period was higher in CON states (1.0 per 10,000 per year) compared to non-CON states (0.68 per 10,000 per year) although not statistically significant. Length of stay was higher and a higher percentage of patients received care in high-volume hospitals in CON states (both P < .0001). No meaningful differences in postoperative complications were found. ConclusionCON laws did not appear to have limited the growth in incidence of THA nor improved quality of care or outcomes during the study time period. It does appear that CON laws are associated with increased concentration of THA procedures at higher volume facilities. Given the inherent potential confounding population and geographic factors, additional research is needed to confirm these findings.

Certificate of Need Regulation and Hospital Behavior: Evidence from MRIs in North Carolina

Certificate of Need (CON) regulations — restrictions on capital investment — are a key feature of the regulatory environment facing the US hospital industry, yet there is remarkably little evidence on how these regulations affect hospital investment and patient care in practice. In this paper, I use newly collected data on the magnetic resonance imaging (MRI) market in North Carolina and patient-level Medicare claims data to estimate the dynamic effects of marginal relaxations of CON restrictions on provider investment and patient care. Using a regression discontinuity approach that takes advantage of regulatory approval thresholds, I document two sets of key findings. First, CON regulations are a binding constraint on hospital investment. In response to this constraint, there is an active market for unregulated mobile MRI scanners that enable health care providers to mitigate the impact of CON restrictions. Second, CON rules affect not only hospital investment but also restricts utilization of MRI scans. In a specific case, CON regulations reduce the number of scans patients with low back pain receive, reducing medical spending by roughly $400. There is no evidence that this decrease in the intensity of care comes at the cost of increased future low back pain.

Certificate-of-Need Laws and Hospital Quality

We investigate the effect of certificate-of-need (CON) laws on the quality of hospitals. As of 2015, 36 states and the District of Columbia required healthcare providers to seek approval from a state’s healthcare regulator before making any major capital expenditures. These requirements restrict entry into the healthcare market. Therefore, incumbent medical providers in states with CON laws may face fewer competitive pressures. Hospital service quality is one important margin on which hospitals compete. In this paper, we test the hypothesis that hospitals in states with CON laws provide lower-quality services than hospitals in states without CON laws. Our results do not allow us to reject the hypothesis that CON hospitals deliver lower-quality care than non-CON hospitals. Nor do our results show that hospital quality is higher in CON states. Our overall results suggest that CON regulations lead to lower-quality care for some measures of quality and have little or no effect on other measures of quality. The results are largely robust to a variety of alternative samples and quality measures.

Are Certificate-of-Need Laws Barriers to Entry? How They Affect Access to Mri, Ct, and Pet Scans

Certificate of need (CON) laws in 21 states restrict acquisition of imaging equipment, including resonance imaging (MRI), computed tomography (CT), and positron emission tomography (PET) scans. We compare the effect of CON regulations for imaging services provided by hospitals and other providers to determine whether CON laws affect use of imaging services across provider types. We find that services by nonhospital providers, but not by hospital providers, are negatively associated with CON laws. We also find that CON laws reduce the overall number of medical providers, suggesting less availability of imaging services in CON states. We provide evidence consistent with this result showing that residents of CON states are more likely to travel out of state to obtain imaging services than are residents of non-CON states. These results imply that the effect of CON is heterogeneous on hospitals and nonhospitals, affecting the market structure for imaging services.

Certificate-of-Need State Laws and Total Knee Arthroplasty

BackgroundMany states in the United States have certificate-of-need (CON) programs designed to restrain health care costs and prevent overutilization of health care resources. The goal of this study was to characterize the associations between CON regulations and total knee arthroplasty (TKA) by comparing states with and without CON programs. MethodsPublicly available data were used to classify states in to CON or non-CON categories. The 100% Medicare Standard Analytical Files from 2005 through 2014 were then used to compare primary TKA procedure volumes, charges, reimbursements, and distribution of procedures based on facility volumes between the groups. Adverse events such as infection and emergency room visits after TKA were also evaluated. ResultsAlthough CON status was associated with lower per capita utilization of TKA, the annual incidence of TKA appears to have increased over time more rapidly in states with CON laws compared with non-CON states (overall increase of 5.6% vs 2.3%, P < .01). When normalized to the Medicare population, the incidence of TKA increased 2.0% in CON states, whereas it actually decreased 7.2% in states without CON regulations (P = .011). Average reimbursement (and thus Medicare spend) was 5% to 10% lower in non-CON states at all time points (P < .0001). In non-CON states, relatively more TKAs appear to be performed in lower volume hospitals. Examination of adverse events rates did not reveal any strong associations between any adverse outcome and CON status. ConclusionCON programs appear to have influenced the delivery of care for TKA. Although our data suggest that these laws are associated with lower per capita utilization of TKA and the use of higher-volume facilities, we were unable to detect any strong evidence that CON regulations have been associated with improved quality of care or have limited growth in the utilization of this procedure over time. Confounding population and geographic factors may influence these findings and further study is needed to determine whether or not these programs have served their purpose and should be retained.

Effect of Certificate of Need Law on the intensity of competition: The market for emergency care

PurposeThis article aims to contribute to the academic literature in better understanding the impact of Certificate of Need (CON) Law on Emergency Department (ED) care. Impact of CON Law on ED competition remains an unanswered empirical question. MethodsWe examine the impact of CON Law and its stringency on the intensity of competition (rivalry among competitors) between EDs measured by the Herfindahl-Hirschman Index (HHI). We then estimate the effects of CON Law on HHI by treating CON as an exogenous (endogenous) variable. FindingsOn average the CON legislation enhances ED competition. A possible reason is that the law hinders predatory behavior, and therefore acts as an effective anti-trust tool. Other findings indicate that competition is found to be positively related to a state's population size and median income and negatively related with the prevalence of employer provided insurance and magnitude of illegal immigration in a state. Practical implicationsThis article sheds some light on how political regulations could affect healthcare market and hence may provide public policy makers some insights on reducing healthcare cost. OriginalityOur analysis of the impact of CON regulation on ED competition significantly contributes to the healthcare and strategy literature. The law potentially serves as an anti-trust tool in the hands of the government. We extend the empirical literature by treating CON Law and its stringency as exogenous (endogenous). Our comprehensive analysis considers a host of control variables such as population demographics, their health status and access to health care, healthcare facilities, political environment, in addition to the CON features.

Do Certificate-of-Need Laws Limit Spending?

In 35 states, certificate-of-need (CON) laws in health care restrict the supply of medical services. These regulations require providers hoping to open a new healthcare facility, expand an existing facility, or purchase certain medical equipment such as an MRI machine or a hospital bed to first prove to a regulatory body that their community needs the service in question. The approval process can be time consuming and expensive, and it offers incumbent providers an opportunity to oppose the entrance of new competitors. However, it was originally hoped that these laws would, among other things, reduce healthcare price inflation. In this brief, I review the basic economic theory of a supply restriction like CON, then summarize four decades of empirical research on the effect of CON on healthcare spending. There is no evidence that CON regulations limit healthcare price inflation and little evidence that they reduce healthcare spending. In fact, the balance of evidence suggests that CON laws are associated with higher per-unit costs and higher total healthcare spending.

Abstract 18805: Association of State Certificate of Need Regulations With the Appropriateness of PCI Procedures

Introduction: Certificate of Need (CON) regulations are intended to limit healthcare infrastructure to control healthcare costs, prevent overuse, and improve quality of care. However, there is limited information about the impact of CON regulations on the use of invasive cardiac procedures. To address this gap, we examined the association of state CON regulations with the appropriateness of percutaneous coronary interventions (PCI). Methods: We used data from the ACC’s CathPCI Registry to analyze 1,143,402 PCIs performed at 1,297 hospitals between January 2010 and December 2011. We applied the 2012 Appropriate Use Criteria (AUC) to determine whether the procedure was considered appropriate, uncertain, or inappropriate, and we used chi-square analyses to assess whether the proportions of PCIs AUC categories differed depending on whether the procedure had been performed in a state with or without CON regulations. Analyses were repeated stratified by whether or not the procedure was performed in the setting of an acute coronary syndrome (ACS). Results: The characteristics and outcomes of patients undergoing PCI were similar in states with and without CON. The proportion of PCIs considered appropriate in non-CON states was slightly lower compared with CON states (85.5% versus 86.2%), and a higher proportion of procedures were considered inappropriate (4.6% versus 4.2%) [Table]. Absolute differences were larger among non-ACS PCI patients and were not statistically significant among ACS PCI patients. Conclusions: States with CON had a lower proportion of inappropriate PCIs as compared with states without CON. However, the absolute differences were small, suggesting that CON regulations alone may have a limited impact on preventing potential overuse of PCI procedures.