Socioeconomic and Demographic Disparities in the Use of Telemedicine for Ophthalmic Care during the COVID-19 Pandemic.

PURPOSE: To identify disparities in the use of telemedicine during the coronavirus disease 2019 (COVID-19) pandemic. DESIGN: A cross-sectional study of completed clinical encounters in an academic ophthalmology center from March 2020 through August 2020. PARTICIPANTS: A total of 5023 patients comprising 8116 ophthalmic clinical encounters. METHODS: Medical charts were abstracted for demographic information. We identified zip code-level socioeconomic characteristics, which were drawn from the 2019 American Community Survey 5-year estimates. MAIN OUTCOME MEASURES: The completion of a synchronous video encounter, the completion of a telephone (audio-only) encounter in the absence of any video encounters, or the completion of in-person encounters only. RESULTS: During the study period, 8116 total clinical encounters were completed for 5023 unique patients. Of these patients, 446 (8.9%) participated in a video encounter, 642 (12.8%) completed a telephone encounter, and 3935 (78.3%) attended clinical appointments in person only. In adjusted analysis, patients who were Black (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.52-0.80; P < 0.001) or Hispanic/Latino (OR, 0.65; 95% CI, 0.49-0.85; P = 0.002) were significantly less likely to complete a video or telephone appointment. Older patients (OR, 0.99; 95% CI, 0.98-0.99; P < 0.001), patients whose primary language was not English (OR, 0.49; 95% CI, 0.28-0.82; P = 0.01), Black patients (OR, 0.45; 95% CI, 0.32-0.62; P < 0.001), and Hispanic/Latino patients (OR, 0.56; 95% CI, 0.37-0.83; P = 0.005) were significantly less likely to complete a video encounter. Finally, among patients completing any type of telemedicine encounter, older age, (OR, 1.02; 95% CI, 1.01-1.03; P < 0.001), Medicare insurance (OR, 1.55; 95% CI, 1.11-2.17; P = 0.01), and Black race (OR, 1.97; 95% CI, 1.33-2.94; P < 0.001) were associated with using only phone visits. CONCLUSIONS: Ethnic/racial minorities, older patients, and non-English-speaking individuals were significantly less likely to complete a video telehealth encounter. With the expansion of telemedicine and the need to reduce the disparate impact of COVID-19 on minorities, it will be increasingly important to identify barriers to telehealth use and opportunities to improve access.

Association between Immunosuppressive Drugs and Coronavirus Disease 2019 Outcomes in Patients with Noninfectious Uveitis in a Large US Claims Database.

PURPOSE: To determine the dose-dependent risk of systemic corticosteroids (SCs) and the risk of other immunosuppressive therapies on coronavirus disease 2019 (COVID-19) infection, hospitalization, and death in patients with noninfectious uveitis (NIU). DESIGN: A retrospective cohort study from January 20, 2020, to December 31, 2020 (an era before widespread COVID-19 vaccination), using the Optum Labs Data Warehouse, a US national de-identified claims database. PARTICIPANTS: Patients who had at least 1 NIU diagnosis from January 1, 2017. METHODS: Unadjusted and adjusted hazard ratios (HRs) were estimated for each variable and COVID-19 outcome using Cox proportional hazards models, with time-updated dichotomous indicators for outpatient immunosuppressive medication exposure. To assess the dose-dependent effect of SC exposure, the average daily dose of prednisone over the exposed interval was included in the adjusted models as a continuous variable, in addition to the dichotomous variable. MAIN OUTCOME MEASURES: Incidence rates of COVID-19 infection, COVID-19-related hospitalization, and COVID-19-related in-hospital death. RESULTS: This study included 52 286 NIU patients of whom 12 000 (23.0%) were exposed to immunosuppressive medications during the risk period. In adjusted models, exposure to SCs was associated with increased risk of COVID-19 infection (HR, 2.66; 95% confidence interval [CI], 2.19-3.24; P < 0.001), hospitalization (HR, 3.26; 95% CI, 2.46-4.33; P < 0.001), and in-hospital death (HR, 1.99; 95% CI, 0.93-4.27; P = 0.08). Furthermore, incremental increases in the dosage of SCs were associated with a greater risk for these outcomes. Although tumor necrosis factor-α (TNF-α) inhibitors were associated with an increased risk of infection (HR, 1.48; 95% CI, 1.08-2.04; P = 0.02), other immunosuppressive treatments did not increase the risk of COVID-19 infection, hospitalization, or death. CONCLUSIONS: This study from an era before widespread COVID-19 vaccination demonstrates that outpatient SC exposure is associated with greater risk of COVID-19 infection and severe outcomes in patients with NIU. Future studies should evaluate the impact of immunosuppression in vaccinated NIU patients. Limiting exposure to SCs and use of alternative therapies may be warranted.

The Association between Noninfectious Uveitis and Coronavirus Disease 2019 Outcomes: An Analysis of United States Claims-Based Data.

PURPOSE: To identify if noninfectious uveitis (NIU) is associated with a greater risk of Coronavirus Disease 2019 (COVID-19) infection, hospitalization, and death. DESIGN: A retrospective cohort study from January 20, 2020 to December 31, 2020, using a national claims-based database. PARTICIPANTS: Enrollees who had continuous enrollment with both medical and pharmacy coverage for 3 years before January 20, 2020. Patients with an NIU diagnosis within 3 years of the start of the study were included in the NIU cohort. Those with infectious uveitis codes or new NIU diagnoses during the risk period were excluded. METHODS: Cox proportional hazard models were used to identify unadjusted hazard ratios (HRs) and adjusted HRs for all covariates for each outcome measure. Adjusted models accounted for patient demographics, health status, and immunosuppressive medication use during the risk period. MAIN OUTCOME MEASURES: Rates of COVID-19 infection, COVID-19-related hospitalization, and COVID-19-related in-hospital death identified with International Classification of Disease 10th revision codes. RESULTS: This study included 5 806 227 patients, of whom 29 869 (0.5%) had a diagnosis of NIU. On unadjusted analysis, patients with NIU had a higher rate of COVID-19 infection (5.7% vs. 4.5%, P < 0.001), COVID-19-related hospitalization (1.2% vs. 0.6%, P < 0.001), and COVID-19-related death (0.3% vs. 0.1%, P < 0.001). However, in adjusted models, NIU was not associated with a greater risk of COVID-19 infection (HR, 1.05; 95% confidence interval [CI], 1.00-1.10; P = 0.04), hospitalization (HR, 0.98; 95% CI, 0.88-1.09; P = 0.67), or death (HR, 0.90, 95% CI, 0.72-1.13, P = 0.37). Use of systemic corticosteroids was significantly associated with a higher risk of COVID-19 infection, hospitalization, and death. CONCLUSIONS: Patients with NIU were significantly more likely to be infected with COVID-19 and experience severe disease outcomes. However, this association was due to the demographics, comorbidities, and medications of patients with NIU, rather than NIU alone. Patients using systemic corticosteroids were significantly more likely to be infected with COVID-19 and were at greater risk of hospitalization and in-hospital death. Additional investigation is necessary to identify the impact of corticosteroid exposure on COVID-19-related outcomes.

Geographic atrophy severity and mortality in age-related macular degeneration.

PURPOSE: To examine the association between geographic atrophy (GA) disease characteristics and mortality risk. METHODS: We manually delineated color fundus photographs of 209 Age-Related Eye Disease Study (AREDS) participants with GA secondary to age-related macular degeneration to identify total area of atrophy, GA effective radius growth rate, disease laterality, and the presence of foveal center involvement. Associations between GA characteristics and mortality were assessed with Cox proportional hazards models adjusted for health status indicators. RESULTS: During a median follow-up of 6.8 years, 48 (23.0%) participants with GA died. In adjusted models, accounting for age, sex, and health status, participants with total GA area in the highest quartile had a significantly increased risk of all-cause mortality compared to those with total GA area in the lowest quartile (hazard ratio [HR], 3.42; 95% confidence interval [CI], 1.32-8.86; P = 0.011). GA effective radius growth rate, bilateral disease, and the presence of foveal center involvement were not significantly associated with mortality. In a multivariable model, including health status indicators and all GA characteristics, total area of atrophy in the highest quartile remained significantly associated with mortality (HR, 4.65; 95% CI, 1.29-16.70; P = 0.019). CONCLUSIONS: More extensive GA, as indicated by a greater total area of atrophy, was associated with an increased risk of all-cause mortality in our cohort. The extent of GA may reflect the extent of underlying disease processes that contribute to greater mortality risk, further suggesting that GA may be part of a systemic rather than purely ocular disease process.

Private Equity in Ophthalmology and Optometry: Analysis of Acquisitions from 2012 through 2019 in the United States.

PURPOSE: To identify temporal and geographic trends in private equity (PE)-backed acquisitions of ophthalmology and optometry practices in the United States. DESIGN: A cross-sectional study using private equity acquisition and investment data from January 1, 2012, through October 20, 2019. PARTICIPANTS: A total of 228 PE acquisitions of ophthalmology and optometry practices in the United States between 2012 and 2019. METHODS: Acquisition and financial investment data were compiled from 6 financial databases, 4 industry news outlets, and publicly available press releases from PE firms or platform companies. MAIN OUTCOME MEASURES: Yearly trends in ophthalmology and optometry acquisitions, including number of total acquisitions, clinical locations, and providers of acquired practices as well as subsequent sales, median holding period, geographic footprint, and financing status of each platform company. RESULTS: A total of 228 practices associated with 1466 clinical locations and 2146 ophthalmologists or optometrists were acquired by 29 PE-backed platform companies. Of these acquisitions, 127, 9, and 92 were comprehensive or multispecialty, retina, and optometry practices, respectively. Acquisitions increased rapidly between 2012 and 2019: 42 practices were acquired between 2012 and 2016 compared to 186 from 2017 through 2019. Financing rounds of platform companies paralleled temporal acquisition trends. Three platform companies, comprising 60% of platforms formed before 2016, were subsequently sold or recapitalized to new PE investors by the end of this study period with a median holding period of 3.5 years. In terms of geographic distribution, acquisitions occurred in 40 states with most PE firms developing multistate platform companies. New York and California were the 2 states with the greatest number of PE acquisitions with 22 and 19, respectively. CONCLUSIONS: Private equity-backed acquisitions of ophthalmology and optometry practices have increased rapidly since 2012, with some platform companies having already been sold or recapitalized to new investors. Additionally, private equity-backed platform companies have developed both regionally focused and multistate models of add-on acquisitions. Future research should assess the impact of PE investment on patient, provider, and practice metrics, including health outcomes, expenditures, procedural volume, and staff employment.

Ophthalmic Medication Expenditures and Out-of-Pocket Spending: An Analysis of United States Prescriptions from 2007 through 2016.

PURPOSE: To estimate temporal trends in total and out-of-pocket (OOP) expenditures for ophthalmic prescription medications among adults in the United States. DESIGN: Retrospective, longitudinal cohort study. PARTICIPANTS: Participants in the 2007 through 2016 Medical Expenditure Panel Survey (MEPS) 18 years of age or older. The MEPS is a nationally representative survey of the noninstitutionalized, civilian United States population. METHODS: We estimated trends in national and per capita annual ophthalmic prescription expenditures by pooling data into 2-year cycles and using weighted linear regressions. We also identified characteristics associated with greater total or OOP expenditures with multivariate weighted linear regression. Costs were adjusted to 2016 United States dollars using the gross domestic product price index. MAIN OUTCOME MEASURES: Trends in total and OOP annual expenditures for ophthalmic medications from 2007 through 2016 as well as factors associated with greater expenditures. RESULTS: From 2007 through 2016, 9989 MEPS participants (4.2%) reported ophthalmic medication prescription use. Annual ophthalmic medication use increased from 10.0 to 12.2 million individuals from 2007 and 2008 through 2015 and 2016. In this same period, national expenditures for ophthalmic medications increased from $3.39 billion to $6.08 billion and OOP expenditures decreased from $1.34 to $1.18 billion. Per capita expenditure increased from $338.72 to $499.42 (P < 0.001), and per capita OOP expenditure decreased from $133.48 to $96.67 (P < 0.001) from 2007 and 2008 through 2015 and 2016, respectively. From 2015 through 2016, dry eye (29.5%) and glaucoma (42.7%) medications accounted for 72.2% of all ophthalmic medication expenditures. Patients who were older than 65 years (P < 0.001), uninsured (P < 0.001), and visually impaired (P < 0.001) were significantly more likely to have greater OOP spending on ophthalmic medications. CONCLUSIONS: Total ophthalmic medication expenditure in the United States increased significantly over the last decade, whereas OOP expenses decreased. Increases in coverage, copayment assistance, and use of expensive brand drugs may be contributing to these trends. Policy makers and physicians should be aware that rising overall drug expenditures ultimately may increase indirect costs to the patient and offset a decline in OOP prescription drug spending.

Association of the Affordable Care Act Medicaid Expansion with Dilated Eye Examinations among the United States Population with Diabetes.

PURPOSE: To evaluate the association between Medicaid expansion and diabetic dilated eye examinations. DESIGN: A retrospective difference in differences (DiD) analysis using individual-level survey response data from January 1, 2009, to December 31, 2017. PARTICIPANTS: A total of 52 392 survey responses from 50 states and the District of Columbia between 2009 and 2017. Responders were adults aged 18 to 64 years reporting a previous diagnosis of diabetes and a household income below 138% of the US federal poverty line (FPL). METHODS: The Centers for Disease Control and Prevention's Behavioral Risk Factor Surveillance System data were used to identify survey responders who were asked about the presence of dilated eye examinations from years before and after Medicaid expansion implementation. MAIN OUTCOME MEASURES: The DiD in proportion of dilated eye examinations among diabetic persons aged 18 to 64 years with household incomes below 138% of the FPL between states that did and did not implement Medicaid expansion. RESULTS: Implementation of Medicaid expansion policies was associated with a 1.3% (95% confidence interval [CI], -3.8 to 6.4; P = 0.61), 6.3% (95% CI, 1.3-11.3; P = 0.016), 4.1% (95% CI, -0.8 to 9.0; P = 0.11), and 2.3% (95% CI, -1.6 to 6.2; P = 0.23) increase in the proportion of diabetic persons aged 18 to 64 years with incomes below 138% of the FPL receiving a dilated eye examination within the past year due to Medicaid expansion 1, 2, 3, and 4 cumulative years after expansion, respectively. CONCLUSIONS: Medicaid expansion policies were significantly associated with an increase in dilated eye examination rates within the first 2 years after implementation. However, this increase did not persist beyond this period, with nonsignificant increases 3 and 4 cumulative years after implementation. Healthcare policymakers should be aware that additional measures beyond expanding insurance coverage may be necessary to increase and sustain the rate of dilated eye examinations among diabetic populations.

Domestic Violence-Related Ocular Injuries Among Adult Patients: Data from the Nationwide Emergency Department Sample, 2008-2017.

PURPOSE: To investigate domestic violence (DV)-related ocular injuries among adult emergency department (ED) patients in the US. METHODS: This was a retrospective, cross-sectional study of patients with a diagnosis of DV and diagnosis of ocular injury in the Nationwide Emergency Department Sample (NEDS) from 2008-2017. We identified patient- and hospital-level variables associated with DV-related ocular injuries. We calculated annual incidence rates using US Census data. Adjusting for inflation using the Consumer Price Index, we calculated mean and total charges. RESULTS: From 2008-2017, there were 26,215 ED visits for ocular injuries related to DV with an average incidence of 1.09 per 100,000 adult population (female patients, 84.5%; mean age [SE], 34.3 [0.2]). DV-related ocular injuries were most prevalent among patients in the lowest income quartile (39.1%) and on Medicaid (37.4%). Most ED visits presented to metropolitan teaching (55.4%), non-trauma (46.7%), and south regional (30.5%) hospitals. The most common ocular injury was contusion of eye/adnexa (61.1%). The hospital admission rate was 5.2% with a mean hospital stay of 2.9 [0.2]. The inflation-adjusted mean cost for medical services was $38,540 [2,310.8] per encounter with an average increase of $2,116 per encounter, annually. The likelihood of hospital admission increased for patients aged ≥60 years old, on Medicare, and with open globes or facial/orbital fractures (all p < .05). CONCLUSION: Contusion of the eye/adnexa was the most common ocular injury among patients with DV-related ED visits. To better facilitate referrals to social services, ophthalmologists should utilize DV screenings, especially towards women and patients of less privileged socioeconomic status.

Cost Analysis of Dropless Cataract Surgery Prophylaxis with Intracameral Antibiotics and Subconjunctival Steroids.

PURPOSE: To determine whether dropless, injection-based cataract surgery prophylaxis with intracameral antibiotic and subconjunctival steroid may reduce healthcare system costs and patient out-of-pocket costs compared to topical medication regimens. SETTING: United States national medical expenditures database. DESIGN: Retrospective cost analysis. METHODS: Costs were analyzed for topical ophthalmics from the 2020 Medical Expenditure Panel Survey (MEPS) and for dropless medications from pharmaceutical invoices/catalogs. Main outcomes included system costs, from insurance and patient payments, and out-of-pocket costs for cataract surgery topical and dropless, injection-based prophylactic medication regimens, per eye and nationally. System costs for individual topical medications and same-class dropless, injection-based medications were compared using two-sided, one-sample t-tests. RESULTS: There were 583 prophylactic topical ophthalmic purchases in MEPS. Mean system costs per eye were $76.20 ± SD 39.07 for the lowest cost topical steroid (prednisolone) compared to $4.01 for the lowest cost subconjunctival steroid (triamcinolone acetonide) (p < 0.001). Per eye, the lowest cost dropless, injection-based regimen, at $15.91, results in an $87.99 (84.7%) reduction in overall healthcare costs and a $43.64 (100%) reduction in patient out-of-pocket costs relative to the lowest cost topical regimen ($103.90 ± 43.14 mean system cost and $43.64 ± 37.32 mean out-of-pocket cost per eye). Use of intracameral moxifloxacin and subconjunctival triamcinolone acetonide can reduce annual national healthcare system and out-of-pocket costs up to $450,000,000 and $225,000,000, respectively. CONCLUSIONS: An evidence-based cataract surgery prophylactic medication regimen of intracameral moxifloxacin and subconjunctival triamcinolone acetonide can reduce healthcare system and patient out-of-pocket costs in comparison to various topical regimens.

Epidemiologic trends of domestic violence-related ocular injuries among pediatric patients: data from the Nationwide Emergency Department Sample 2008-2017.

PURPOSE: To study the epidemiology of all domestic violence (DV)-related ocular injuries among pediatric emergency department (ED) patients in the United States. METHODS: This is a retrospective, cross-sectional study of isolated children (<18 years of age) with a diagnosis of DV and primary or secondary diagnosis of ocular injuries in the Nationwide Emergency Department Sample, 2008-2017. We calculated annual incidence of DV-related ocular injuries and prevalence by demographic variables, including age, sex, and income quartile. Median charges, median length of inpatient hospital stay, and factors associated with hospitalization were also measured. RESULTS: From 2008 to 2017, there were 4,125 ED encounters, with an average incidence of 0.56 per 100,000 population (males, 50.0%; mean age [SE], 9.2 [0.3]). Patients in the lowest income quartile (42.6%) and with Medicaid insurance (63.2%) were the most prevalent. The most common known perpetrator was a family member (29.4%). Most ED encounters took place at southern regional (28.6%), metropolitan teaching (67.1%) and designated trauma hospitals (57.8%). Contusion of the eye/adnexa and being struck by or against an object were the most common ocular diagnosis and known mechanism of injury, respectively. An estimated 12.4% of patients were admitted with a median hospital stay of 4 (IQR, 2-6). Median charges during the study period were $27,415.10 (IQR, $13,142.70-$54,454.90). CONCLUSIONS: DV-related ocular injuries were most prevalent among patients with a low socioeconomic status. Given the historical underreporting of DV, future studies are warranted to identify more specific social determinants of health that contribute to such presentations.

Shifts in ophthalmic care utilization during the COVID-19 pandemic in the US.

BACKGROUND: Healthcare restrictions during the COVID-19 pandemic, particularly in ophthalmology, led to a differential underutilization of care. An analytic approach is needed to characterize pandemic health services usage across many conditions. METHODS: A common analytical framework identified pandemic care utilization patterns across 261 ophthalmic diagnoses. Using a United States eye care registry, predictions of utilization expected without the pandemic were established for each diagnosis via models trained on pre-pandemic data. Pandemic effects on utilization were estimated by calculating deviations between observed and expected patient volumes from January 2020 to December 2021, with two sub-periods of focus: the hiatus (March-May 2020) and post-hiatus (June 2020-December 2021). Deviation patterns were analyzed using cluster analyses, data visualizations, and hypothesis testing. RESULTS: Records from 44.62 million patients and 2455 practices show lasting reductions in ophthalmic care utilization, including visits for leading causes of visual impairment (age-related macular degeneration, diabetic retinopathy, cataract, glaucoma). Mean deviations among all diagnoses are 67% below expectation during the hiatus peak, and 13% post-hiatus. Less severe conditions experience greater utilization reductions, with heterogeneities across diagnosis categories and pandemic phases. Intense post-hiatus reductions occur among non-vision-threatening conditions or asymptomatic precursors of vision-threatening diseases. Many conditions with above-average post-hiatus utilization pose a risk for irreversible morbidity, such as emergent pediatric, retinal, or uveitic diseases. CONCLUSIONS: We derive high-resolution insights on pandemic care utilization in the US from high-dimensional data using an analytical framework that can be applied to study healthcare disruptions in other settings and inform efforts to pinpoint unmet clinical needs.

The COVID-19 pandemic disrupted healthcare services globally, including eye care in the United States. Using a US eye disease database, we measured how the pandemic impacted patient visits for 261 eye diagnoses by comparing actual visit volumes for each diagnosis with what would have been expected without the pandemic. We identified groups of conditions with similar changes in visit levels and examined whether these shifts were related to characteristics of the diagnoses studied. We found extended decreases in patient presentations for most eye conditions, with greater reductions for less severe diagnoses, and with anomalies and differences in this trend across diagnosis categories and pandemic sub-periods. This highlights areas of potentially unmet need in vision care arising from the pandemic.

The Impact of International Pricing Index Models on Anti-Vascular Endothelial Growth Factor (VEGF) Drug Costs in the United States.

OBJECTIVE: To evaluate the impact of three international pricing index models on Medicare Part B spending for intravitreal anti-vascular endothelial growth factor (VEGF) drugs Design: Cost analysis Methods: U.S. and international sales data from the Multinational Integrated Data Analysis (MIDAS) database was used with data from the U.S. Centers for Medicare and Medicaid Services (CMS) to calculate Medicare Part B spending on anti-VEGF drugs Main Outcome: Medicare Part B expenditures of anti-VEGF drugs under various international pricing index models Results: Total Medicare Part B savings was greatest (75%) under the "most favored nation" proposal to peg the U.S. price to the lowest international price. Under the "most favored nation" proposal, prices of aflibercept are reduced from $1825.80 to $507.17, bevacizumab from $74.39 to $27.55, and ranibizumab (3 units or 0.3mg) from $1057.08 to $99.72. CONCLUSION: International pricing index models are one of many pricing strategies that could lead to savings in Medicare Part B costs.

Characterization and corroboration of safety signals identified from the US Food and Drug Administration Adverse Event Reporting System, 2008-19: cross sectional study.

OBJECTIVE: To characterize potential drug safety signals identified from the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS), from 2008 to 2019, to determine how often these signals resulted in regulatory action by the FDA and whether these actions were corroborated by published research findings or public assessments by the Sentinel Initiative. DESIGN: Cross sectional study. SETTING: USA. POPULATION: Safety signals identified from the FAERS and publicly reported by the FDA between 2008 and 2019; and review of the relevant literature published before and after safety signals were reported in 2014-15. Literature searches were performed in November 2019, Sentinel Initiative assessments were searched in December 2021, and data analysis was finalized in December 2021. MAIN OUTCOME MEASURES: Safety signals and resulting regulatory actions; number and characteristics of published studies, including corroboration of regulatory action as evidenced by significant associations (or no associations) between the drug related to the signal and the adverse event. RESULTS: From 2008 to 2019, 603 potential safety signals identified from the FAERS were reported by the FDA (median 48 annually, interquartile range 41-61), of which 413 (68.5%) were resolved as of December 2021 (372 of 399 (93.2%) signals ≥3 years old were resolved). Among the resolved safety signals, 91 (22.0%) led to no regulatory action and 322 (78.0%) resulted in regulatory action, including 319 (77.2%) changes to drug labeling and 59 (14.3%) drug safety communications or other public communications from the FDA. For a subset of 82 potential safety signals reported in 2014-15, a literature search identified 1712 relevant publications; 1201 (70.2%) were case reports or case series. Among these 82 safety signals, 76 (92.7%) were resolved, of which relevant published research was identified for 57 (75.0%) signals and relevant Sentinel Initiative assessments for four (5.3%) signals. Regulatory actions by the FDA were corroborated by at least one relevant published research study for 17 of the 57 (29.8%) resolved safety signals; none of the relevant Sentinel Initiative assessments corroborated FDA regulatory action. CONCLUSIONS: Most potential safety signals identified from the FAERS led to regulatory action by the FDA. Only a third of regulatory actions were corroborated by published research, however, and none by public assessments from the Sentinel Initiative. These findings suggest that either the FDA is taking regulatory actions based on evidence not made publicly available or more comprehensive safety evaluations might be needed when potential safety signals are identified.

Economic Evaluation of the Merit-Based Incentive Payment System for Ophthalmologists: Analysis of 2019 Quality Payment Program Data.

Importance: The Merit-Based Incentive Payment System (MIPS) is intended to promote high-value health care through quality-related Medicare payment adjustments. Objective: To assess the economic evaluation of MIPS scoring and reporting on ophthalmologists. Design, Setting, and Participants: In this retrospective, cross-sectional, multicenter economic evaluation conducted from October 10 to November 30, 2021, MIPS performance and related payment adjustments were evaluated using the US Centers for Medicare & Medicaid Service (CMS) public data files for ophthalmologists. Participants were stratified by reporting affiliation. Analysis of variance and summary statistics were used to characterize and compare total and subcategory MIPS scores and adjustments received by participants. Reported CMS methodology and performance year (PY) 2019 payment percentages were used to estimate payment adjustments for the following categories: positive MIPS adjustment plus potential additional adjustment for exceptional performance, positive MIPS adjustment, neutral payment adjustment, negative MIPS payment adjustment, and maximum negative MIPS payment adjustment. Study participants included ophthalmologists registered for Medicare Part B with participation in the Quality Payment Program (QPP) in PY 2019. Main Outcomes and Measures: Proportion of ophthalmologists qualifying for payment adjustments and payment adjustments. Results: For PY 2019, 76.5% of ophthalmologists (13 621) who registered for Medicare participated in the MIPS pathway of the QPP. Ophthalmologists practiced in a predominantly large metropolitan area (12 302; 90.3%). Roughly 99% of participants (11 182) received nonnegative reimbursement adjustments, and 92.6% (10 367) received positive adjustments. Ophthalmologists filing as individuals were less likely to achieve exceptional performance scores compared with those who had a filing category of advanced alternative payment model (APM; odds ratio [OR], 0.0003; 95% CI, 0.00002-0.00481) or group (OR, 0.21013; 95% CI, 0.19020-0.23215). When analyzing participating ophthalmologists with available Medicare payment data (11 193), a total of 8777 (78.4%) achieved exceptional MIPS scores corresponding to mean (SD) adjustments per physician of $244.60 ($217.36) to $4864.78 ($4323.08), or 0.07% ($2 146 835.21 of $3 212 011 252.88) to 1.33% ($42 698 166.89 of $3 212 011 252.88), of the total nondrug Medicare payment. Conclusions and Relevance: Results of this economic evaluation showed that although 78.4% of ophthalmologists received exceptional positive payment adjustments, roughly 84% (798916 of 954615) of all health care professionals nationally achieved this benchmark. Exceptional MIPS was associated with filing as group or APM, resulting in, on average, a relatively small additional payment per participant; this suggests that ophthalmologists who file as individuals should consider an alternative filing approach. Changes in MIPS methodology may disproportionately affect certain ophthalmologists, which warrants further study.

Urology Practice Acquisitions by Private Equity Firms from 2011-2021.

INTRODUCTION: Private equity firms have recently acquired several large urology practices in the United States. As little is known about these acquisitions, we sought to characterize trends in urology practice consolidation. METHODS: We compiled urology practice acquisition data via financial databases, news outlets, practice websites, and Internet keyword search for the time period January 1, 2011 through March 15, 2021. For each acquisition, we determined the acquiring group, number of employed urologists, practice locations, and status of ancillary services (pathology, radiology, or surgery centers). We estimated workforce effects based on the 2019 American Urological Association workforce census. RESULTS: We identified 69 independent practice acquisitions in the study period, including 19 (28.4%) by hospital systems, 7 (10.4%) by multispecialty physician groups, 23 (34.3%) by urology practices, and 20 (29.9%) by private equity-backed platforms. Private equity firms initially targeted large urology practices (mean of 60.8±32.6 urologists) with ownership of ancillary services and consolidated local market share through acquisitions of smaller practices (mean of 15.9±14.5 urologists). As of March 2021, we estimate that 7.2% of private practice urologists in the U.S. were employed by one of 5 private equity-backed platforms; over 25% of all urologists practicing in New Jersey and Maryland are employed by a private equity-backed platform. CONCLUSIONS: Private equity acquisitions have accelerated to become a dominant form of urology practice consolidation in recent years and have achieved significant market influence in certain regions. Future research should assess the impact of private equity investment on practice patterns, health outcomes, and expenditures.

The Effect of Sample Medication Use on Subsequent Anti-VEGF Agent Selection for Neovascular Age-Related Macular Degeneration.

PURPOSE: Medication samples of anti-VEGF agents can represent a good option for retina specialists to provide timely treatment for newly converted neovascular age-related macular degeneration (nvAMD) while prior-authorizations (PA) are pending. Our study examines the effect of medication sample use (ranibizumab or aflibercept) on future anti-vascular endothelial growth factor (VEGF) agent selection in nvAMD. DESIGN: Retrospective cohort study. PARTICIPANTS: nvAMD patients who underwent an initial anti-VEGF injection with a sample medication were compared to nvAMD control patients who never received a medication sample. METHODS: Charts from 2017 through 2020 were reviewed for data regarding demographics, anti-VEGF agent selection, and visual acuity outcomes for both groups. The utilization of different anti-VEGF agents in each group was compared at various time points using chi-square tests for independence of proportions. MAIN OUTCOME MEASURES: Anti-VEGF agent selection for the first four injections and at one year were examined. RESULTS: Adherence to the initial agent was high between first and subsequent injections (2nd, 3rd, 4th injection, and 1 year) in sample (96.2%, 95.9%, 91.9%, 93.4%, respectively), and control groups (98.1%, 94.2%, 94.9%, 87.8%, respectively). Bevacizumab usage was significantly lower among eyes receiving samples relative to controls at the second (1.9% vs. 38.7%, p < .001), third (3.1% vs. 41.3%, p < .001), fourth injections (4.7% vs. 40.4%, p < .001), and at 1 year (0% vs. 33.8%, p < .001). Aflibercept usage was significantly higher in sample eyes relative to controls at the second (78.3% vs. 43.4%, p < .001), third (76.3% vs. 41.5%, p < .001), and fourth injections (76.7% vs. 43.4%, p < .001), and at 1 year (77.0% vs. 52.7%, p < .001). CONCLUSIONS: Sample medications in nvAMD may be initiated for many reasons, including awaiting PA approval. Our study found that eyes receiving a sample anti-VEGF agent (ranibizumab or aflibercept) for their initial injection were less likely to receive bevacizumab at future visits relative to eyes that did not receive an anti-VEGF sample, even after one year of treatment. Given the persistent use of more expensive medications at subsequent injections for patients who were initiated on samples, insurance payors may consider waiving PA requirements for bevacizumab to avoid a paradoxical increase in health-care costs.