Health care policy and arthroscopic rotator cuff repair prices in the United States.

BACKGROUND: Arthroscopic rotator cuff repair (ARCR) is one of the most common orthopedic procedures in the general population. Despite its prevalence, the price of ARCR varies significantly across regions, hospital models, and settings. The purpose of this study was to examine the effect of Geographic Region, Certificate of Need (CON) laws, and Medicaid expansion on ARCR pricing. METHODS: This cross-sectional observational study used hospital payer-specific ARCR prices from the Turquoise Health Database using Current Procedural Terminology code 29827. These prices are negotiated rates or charges that hospitals establish with various payers, including insurance companies, Medicare, Medicaid, and self-pay patients, for medical services and treatments provided. Outliers below the 10th percentile and above the 90th percentile were excluded. State policies, including CON status and Medicaid expansion, were obtained from public sources, whereas additional socioeconomic and demographic data were sourced from the US Census. The state's region classification was determined based on 1 of 4 Geographic Regions defined by the US Census Bureau. A detailed analysis was also conducted for North Carolina, examining county-level data on urbanization and the Area Deprivation Index. RESULTS: There were 57,270 ARCR prices from 2503 hospitals across the United States, with a median interquartile range listed price of $6428.17 (interquartile range: $2886.88). States with CON regulations had significantly lower ARCR prices than those without ($6500 vs. $8000, P < .0001). Multivariable analysis indicated that hospitals in the Northeast and West Regions listed significantly higher prices for ARCR than those in the Midwest Region (P < .0001). In contrast, hospitals in the South Region listed lower prices for ARCR than those in the Midwest Region (P < .0001). Medicaid expansion was associated with increased ARCR prices (P < .0001), whereas CON laws were linked to reduced prices (P < .0001). In North Carolina, Area Deprivation Index and urbanization status did not significantly affect ARCR prices. CONCLUSION: The prices listed for ARCR varied significantly depending on the Geographic Region where hospitals were located. In addition, CON laws were associated with reduced ARCR prices, whereas Medicaid expansion correlated with increased prices. These findings highlight the complex interplay between health care policy, regulatory frameworks, and socioeconomic factors in determining surgical prices.

Nursing Home Certificate of Need Moratoria During the COVID-19 Pandemic Had Little Impact on Access.

In over half of US states, health planning boards monitor and control the supply of health care through certificate of need (CON) laws. The COVID-19 pandemic led several states to impose moratoria on CON regulations, hoping to bolster hospital and skilled nursing facility (SNF) beds. Using a difference-in-difference research design, we leverage 2015 to 2021 cost report data from SNFs to study the association between COVID-related CON moratoria and health care supply. Counties that imposed moratoria experienced a slight decline in per-capita SNF bed count. However, once adjusted for potential differential shocks in pre-pandemic high utilization counties, we find little evidence that moratoria led to increased nursing home capacity, overall or by urbanicity. In the context of nursing homes, we conclude that CON deregulation was relatively ineffective at mitigating pandemic-era supply concerns.

Examining the Impact of Certificate of Need Laws on the Utilization and Reimbursement of Cataract Surgeries Among Medicare Beneficiaries.

Background: Cataract surgery is an effective and commonly utilized procedure and can significantly improve quality of life and restore economic productivity. Certificate of need (CON) laws aim to regulate healthcare facility expansion and equipment acquisition to curtail costs, enhance quality, and ensure equitable access to care. However, little is known about the impact of CON laws on cataract surgery utilization and reimbursement. Objectives: To compare utilization and reimbursement for non-complex cataract surgery in CON and non-CON states. Methods: This retrospective database review analyzed publicly available data from the Centers for Medicare and Medicaid Services from 2017 to 2021 to identify the Medicare beneficiaries who underwent non-complex cataract surgery using Current Procedural Terminology code 66984 in Medicare outpatient hospitals. Utilization and reimbursement patterns were analyzed in states with and without CON laws using the compound annual growth rate, with reimbursement adjusted by the US Bureau of Labor Statistics Consumer Price Index. Results: The Centers for Medicare and Medicaid Services reported 893 682 non-complex cataract surgeries in the study period; of these, 609 237 were in CON and 280 215 in non-CON states. Inflation-adjusted reimbursement increased in both CON (1.17%) and non-CON (1.83%) states, while the reimbursement in non-CON states was greater than the national average adjusted reimbursement (1.67%). Utilization of non-complex cataract surgery declined during the study period in both CON and non-CON states. A larger decline in utilization was observed in CON states (-7.32%) than in non-CON states (-6.49%). Utilization was slightly higher in non-CON than in CON states for each year except 2019. Discussion: Utilization of non-complex cataract surgery by Medicare beneficiaries declined over the study period in both CON and non-CON states, possibly impacted by the COVID-19 pandemic. Inflation-adjusted reimbursement adjusted for Consumer Price Index increased more in non-CON than CON states, possibly reflecting shifts in market dynamics in CON-regulated states. Conclusions: Surgeons and policymakers should consider the implications of CON laws on the utilization and reimbursement of cataract surgery. Further study is necessary to ascertain whether these trends persist beyond 2021.

The impact of political partisanship, certificate of need, Medicaid expansion, and area deprivation index on total shoulder arthroplasty prices in the United States.

BACKGROUND: Recent mandates from the Center for Medicare and Medicaid Services require United States hospitals to disclose health care service pricing. Yet, there's a gap in understanding how state-level factors affect hospital service pricing, like total shoulder arthroplasty (TSA). Comprehending these influences can help policymakers and health care providers manage costs and improve care access for vulnerable populations. The purpose of this study was to examine the effect of state characteristics such as partisan lean, certificate of need (CON) status, and Medicaid expansion on TSA price. METHODS: TSA price data was extracted from the Turquoise Health Database using Current Procedural Terminology code 23472. State partisan lean was determined by evaluating each state during the 2020 election year for its legislature (both senate and house), governor, presidential vote, and Insurance Commissioner Affiliation, categorizing states as either "Republican-leaning" or "Democratic-leaning." CON status, Medicaid expansion, Area Deprivation Index (ADI), and population density information was obtained from publicly available sources. Multivariable regression models were used to assess the relationship between these factors and TSA price. RESULTS: The study included 2068 hospitals nationwide. The median (interquartile range) price of TSA across these hospitals was $12,607 ($9,185). In the multivariable analysis, hospitals in Republican-leaning states were associated with a significantly greater price of +$210 (P = .0151), while Medicaid expansion was also associated with greater price +$1,878 (P < .0001). CON status was associated with a significant reduction in TSA prices of -$2,880 (P < .0001). In North Carolina an ADI >85 was associated with a reduction in price (P = .0045), while urbanization designation did not significantly impact TSA price (P = .8457). CONCLUSION: This cross-sectional observational study found that Republican-leaning states and Medicaid expansion were associated with increased TSA prices, while an ADI >85 and CON laws were associated with reduced TSA prices.

Certificate of Need Laws in Health Care: Past, Present, and Future.

Certificate of need (CON) laws limit the supply of health care services in about two-thirds of U.S. states. The regulations require those who wish to offer new services or expand existing services to first prove to a regulator that the care is needed. While advocates for the regulation have offered several rationales for its continuance, the balance of evidence suggests that the rules protect incumbent providers from competition at the expense of patients, payors, and would-be competitors. In this article, I review the history of CON laws in health care, summarize the large literature evaluating them, and briefly sketch options for reform.JEL Classification: I11, I18, H75.

Associations Between Certificate of Need Policies and Hospice Quality Outcomes.

BACKGROUND: 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. AIM: This cross-sectional study examined the association of CON status on hospice quality outcomes using the hospice item set metric (HIS). DESIGN: 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. RESULTS: 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 (ß = .05, P = .009), pain assessment (ß = .05, P = .009), dyspnea treatment (ß = .08, P < .001) and the composite measure (ß = .09, P < .001). Treatment preferences, pain screening, dyspnea screening, and opioid bowel treatment were not statistically significant (P > .05). CONCLUSION: 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.

Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the Washington State Cardiac Care Outcomes Assessment Program.

Background It is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI. Methods and Results We performed a retrospective cohort study of all non-Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup (legacy hospitals, n=17); (2) full services without surgical backup (new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup (myocardial infarction [MI] access hospitals, n=9). Annual median hospital-level volumes were highest at legacy hospitals (605, interquartile range, 466-780), followed by new CON, (243, interquartile range, 146-287) and MI access, (61, interquartile range, 23-145). Compared with MI access hospitals, risk-adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48-0.72]) and new-CON hospitals (OR, 0.55 [95% CI, 0.45-0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access hospitals resulted in only an additional 1.5% of the population having access within 60 minutes. Conclusions Many PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low-volume centers treating high-risk patients with poor outcomes, without significant increase in geographic access. CON policies should re-evaluate the number and distribution of PCI programs.

Certificate-of-need laws and substance use treatment.

BACKGROUND: Certificate-of-need (CON) laws in place in most US states require healthcare providers to prove to a state board that their proposed services are necessary in order to be allowed to open or expand. While CON laws most commonly target hospital and nursing home beds, many states require CONs for other types of healthcare providers and services. As of 2020, 23 states retain CON laws specifically for substance use treatment, requiring providers to prove their "economic necessity" before opening or expanding. In contrast to the extensive academic literature on how hospital and nursing home CON laws affect costs and access, substance use CON laws are essentially unstudied. METHODS: Using 2002-19 data on substance use treatment facilities from the Substance Abuse and Mental Health Services Administration's National Survey of Substance Abuse Treatment Services, we measure the effect of CON laws on access to substance use treatment. Using fixed-effects analysis of states enacting and repealing substance use CON laws, we measure how CON laws affect the number of substance use treament facilities and beds per capita in a state. RESULTS: We find that CON laws have no statistically significant effect on the number of facilities, beds, or clients and no significant effect on the acceptance of Medicare. However, they reduce the acceptance of private insurance by a statistically significant 6.0%. CONCLUSIONS: Policy makers may wish to reconsider whether substance use CON laws are promoting their goals.

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.

Early Acceleration of COVID-19 in Areas with Larger Nursing Homes and Certificate of Need Laws.

BACKGROUND: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreaks have become common in large nursing homes, placing not only residents but also staff and community members at risk for infection. However, the relationship between larger nursing homes and the community spread of SARS-CoV-2 has not yet been documented. OBJECTIVE: To examine the association between county average nursing home bed size and presence of certificate of need (CON) laws, which influence nursing home size, with county-level SARS-CoV-2 prevalence over time. DESIGN: Cross-sectional study using county-level data from March 11 through June 12, 2020. PARTICIPANTS: All US counties with at least one nursing home (n = 2,883). MAIN MEASURES: The main explanatory variables were county average nursing home bed size and presence of a CON law. The main outcome was the cumulative number of SARS-CoV-2 cases on each day of the study period adjusted for county population size and density, demographic and socioeconomic characteristics, total nursing home bed supply, other health care supply measures, epidemic stage, and census region. KEY RESULTS: By June 12, a between-county difference in average nursing home size equal to 1 bed was associated with 3.92 additional SARS-COV-2 cases (95% CI = 2.14 to 5.69; P < 0.001), on average, and counties subject to CON laws had 104.53 additional SARS-CoV-2 cases (95% CI = 7.68 to 201.38; P < 0.05), on average. Counties with larger nursing homes also demonstrated higher growth in the frequency of SARS-COV-2 throughout the study period. CONCLUSIONS: At the county level, average nursing home size and CON law presence was associated with a greater frequency of SARS-CoV-2 cases. Controlling the impact of the coronavirus 2019 pandemic may require additional resources for communities with larger nursing homes and more attention towards long-term care policies.

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

BACKGROUND: 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. QUESTIONS/PURPOSES: 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. METHODS: 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. RESULTS: 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 30 days and infection within 6 months in non-CON states than in CON states. CONCLUSIONS: 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.

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.

Certificate-of-Need State Laws and Elective Posterior Lumbar Fusions: Is It Time to Repeal the Mandate?

OBJECTIVES: Our study aimed to assess whether elective posterior lumbar fusions (PLFs) performed in states with Certificate-of-Need (CON) laws versus states without CON laws had lower utilization rates, lower costs, and better quality of care. METHODS: The 2005-2014 100% Medicare Standard Analytical File was queried to identify patients undergoing elective 1- to 3-level PLF. Differences in per-capita utilization, 90-day reimbursements, and proportion of high-volume between CON and No-CON states were reported. Multivariate analyses were used to analyze 90-day complications and readmissions. RESULTS: A total of 188,687 patients underwent an elective 1- to 3-level PLF in a CON state and 167,642 patients in a No-CON state during 2005-2014. The average per capita utilization of PLFs was lower in CON states as compared with No-CON states (14.5 vs. 15.4 per 10,000 population; P < 0.001). Average 90-day reimbursements between CON and No-CON states differed by a small amount ($22,115 vs. $21,802). CON states had a higher proportion of high-volume facilities (CON vs. No CON-40.9% vs. 29.9%; P < 0.05) and lower proportion of low-volume facilities (CON vs. No-CON-37.2% vs. 45.0%; P < 0.05). PLFs performed in CON states had slightly lower odds of 90-day complications (odds ratio 0.97 [95% confidence interval 0.96-0.99]; P < 0.001) and readmissions (odds ratio 0.95 [95% confidence interval 0.93-0.97]; P < 0.001). CONCLUSIONS: The presence of CON laws was associated with lower utilization of elective 1- to 3-level PLFs and a greater number of high-volume facilities. However, their effect on quality of care, via reduction of 90-day readmissions and 90-day complications, is minimally significant.

Certificate of need laws: a systematic review and cost-effectiveness analysis.

BACKGROUND: Certificate of Need (CON) laws, currently in place in 35 US states, require certain health care providers to obtain a certification of their economic necessity from a state board before opening or undertaking a major expansion. We conduct the first systematic review and cost-effectiveness analysis of these laws. METHODS: We review 90 articles to summarize the evidence on how certificate of need laws affect regulatory costs, health expenditures, health outcomes, and access to care. We use the findings from the systematic review to conduct a cost-effectiveness analysis of CON. RESULTS: The literature provides mixed results, on average finding that CON increases health expenditures and overall elderly mortality while reducing heart surgery mortality. Our cost-effectiveness analysis estimates that the costs of CON laws somewhat exceed their benefits, although our estimates are quite uncertain. CONCLUSIONS: The literature has not yet reached a definitive conclusion on how CON laws affect health expenditures, outcomes, or access to care. While more and higher quality research is needed to reach confident conclusions, our cost-effectiveness analysis based on the existing literature shows that the expected costs of CON exceed its benefits.

Certificate of need and the cost of competition in home healthcare markets.

We used 2010-16 Medicare Cost Reports for 10,737 freestanding home health agencies (HHAs) to examine the impact of home health (HH) and nursing home (NH) certificate-of-need (CON) laws on HHA caseload, total and per-patient variable costs. After adjusting for other HHA characteristics, total costs were higher in states with only HH CON laws ($2,975,698), only NH CON laws ($1,768,097), and both types of laws ($3,511,277), compared with no CON laws ($1,538,536). Higher costs were driven by caseloads, as CON reduced per-patient costs. Additional research is needed to distinguish whether this is due to skimping on quality vs. economies of scale.

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

Objectives: 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.

Entry regulation and the effect of public reporting: Evidence from Home Health Compare.

Economic theory suggests that competition and information are complementary tools for promoting health care quality. The existing empirical literature has documented this effect only in the context of competition among existing firms. Extending this literature, we examine competition driven by the entry of new firms into the home health care industry. In particular, we use the certificate of need (CON) law as a proxy for the entry of firms to avoid potential endogeneity of entry. We find that home health agencies in non-CON states improved quality under public reporting significantly more than agencies in CON states. Because home health care is a labor-intensive and capital-light industry, the state CON law is a major barrier for new firms to enter. Our findings suggest that policymakers may jointly consider information disclosure and entry regulation to achieve better quality in home health care.

Certificate-of-Need State Laws and Total Hip Arthroplasty.

BACKGROUND: Many 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). METHODS: States 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. RESULTS: The 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. CONCLUSION: CON 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.

Contemporary analysis of practicing otolaryngologists.

OBJECTIVES/HYPOTHESIS: To investigate contemporary issues facing practicing otolaryngologists including workforce dynamics, ancillary service modeling, otolaryngic allergy integration, ambulatory surgery center utilization, and relevant certificate of need legislation. STUDY DESIGN: A cross-sectional survey analysis of academic and private practicing otolaryngologists in North and South Carolina in 2016. METHODS: A cross-sectional survey was e-mailed to 510 practicing otolaryngologists in North and South Carolina. RESULTS: A 21.3% survey response rate was achieved. Otolaryngology workforce was defined by horizontal aggregation of otolaryngologists into larger group models, with fewer solo practitioners being replaced by younger otolaryngologists or employing otolaryngology extenders. Excluding academic practice, few otolaryngologists have chosen direct hospital employment as a career option, although otolaryngologists with fewer years of practice are pursuing that option with greater frequency. Ancillary services showed audiology and hearing aid services being the most common, followed by otolaryngic allergy, point-of-service computed tomography, and ultrasound. Although otolaryngologists tend to avoid vertical integration, ambulatory surgery center (ASC) ownership trends favor a joint venture model with a hospital system partner. Most otolaryngologists favor changes to certificate of need legislation to improve patient access to these lower-cost facilities, regardless of whether they currently utilize or have access to an ASC. CONCLUSIONS: Otolaryngology is uniquely positioned to adapt and respond to current paradigm shifts within ambulatory medicine. Further analysis is needed to prepare current and future otolaryngologists for the demands and opportunities these challenges pose as patient-centered care models and consumer dynamics shape future patient expectations and utilization of healthcare. LEVEL OF EVIDENCE: 5. Laryngoscope, 2490-2499, 2018.

Certificate-of-Need State Laws and Total Knee Arthroplasty.

BACKGROUND: Many 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. METHODS: Publicly 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. RESULTS: Although 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. CONCLUSION: CON 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.