Update on "Cell Therapy" Clinics Offering Treatments of Ocular Conditions Using Direct-To-Consumer Marketing Websites in the U.S.

PURPOSE: To assess the scope of U.S.-based companies advertising and administering non-Federal Drug Administration (FDA) approved cell-based therapy (herein called NFACT) for ocular conditions based on information from companies' public websites after the FDA's legal actions against specific NFACT clinics in 2018 and 2019. Current findings are compared to previously published data from 2017. DESIGN: Trend study looking at U.S.-based companies that use direct-to-consumer marketing and have websites advertising therapy for ocular conditions. METHODS: A systematic and extensive keyword-based Internet search was utilized to identify, document, and analyze U.S. business websites offering NFACT for ocular conditions as of August 2022. Main outcomes measured include, clinic locations, marketed ocular conditions, types of NFACT offered, source of stem cells used, routes of administration, and treatment costs. RESULTS: From the prior analysis in 2017 to the 2019 analysis, there was a decrease in the number of NFACT clinics from 76 to 62 and companies from 40 to 39. Given the concerning persistence of NFACTs in August 2019 an additional analysis was performed in 2022 which showed a drastic decrease in NFACT clinics from 62 in 2019 to 18 in 2023 and from 39 companies to 13 in 2023. In both 2019 and 2022, the most commonly referenced ocular condition was age-related macular degeneration (2019 - 72%, 2022 - 92%). The state with the most clinics was in Texas (2019 - 12; 2022 - 5). Autologous adipose-derived stem cells were the most common cell type used in both analyses. CONCLUSIONS: In 2019 U.S.-based direct-to-consumer companies marketing NFACT persisted despite (1) a lack of high-quality clinical evidence supporting the efficacy of these procedures, (2) the association of some of these treatments with severe vision loss, and (3) increasing FDA oversight and recent legal action. In 2022 the number of clinics and companies decreased, but their persistence is a reminder that continued concern is necessary and ophthalmic associations need to continue advocacy efforts to protect patients from these potentially predatory organizations.

Effectiveness of Conventional Digital Fundus Photography-Based Teleretinal Screening for Diabetic Retinopathy and Diabetic Macular Edema: A Report by the American Academy of Ophthalmology.

PURPOSE: This American Academy of Ophthalmology Ophthalmic Technology Assessment aims to assess the effectiveness of conventional teleretinal screening (TS) in detecting diabetic retinopathy (DR) and diabetic macular edema (DME). METHODS: A literature search of the PubMed database was conducted most recently in July 2023 to identify data published between 2006 and 2023 on any of the following elements related to TS effectiveness: (1) the accuracy of TS in detecting DR or DME compared with traditional ophthalmic screening with dilated fundus examination or 7-standard field Early Treatment Diabetic Retinopathy Study photography, (2) the impact of TS on DR screening compliance rates or other patient behaviors, and (3) cost-effectiveness and patient satisfaction of TS compared with traditional DR screening. Identified studies then were rated based on the Oxford Centre for Evidence-Based Medicine grading system. RESULTS: Eight level I studies, 14 level II studies, and 2 level III studies were identified in total. Although cross-study comparison is challenging because of differences in reference standards and grading methods, TS demonstrated acceptable sensitivity and good specificity in detecting DR; moderate to good agreement between TS and reference-standard DR grading was observed. Performance of TS was not as robust in detecting DME, although the number of studies evaluating DME specifically was limited. Two level I studies, 5 level II studies, and 1 level III study supported that TS had a positive impact on overall DR screening compliance, even increasing it by more than 2-fold in one study. Studies assessing cost-effectiveness and patient satisfaction were not graded formally, but they generally showed that TS was cost-effective and preferred by patients over traditional surveillance. CONCLUSIONS: Conventional TS is an effective approach to DR screening not only for its accuracy in detecting referable-level disease, but also for improving screening compliance in a cost-effective manner that may be preferred by patients. Further research is needed to elucidate the ideal approach of TS that may involve integration of artificial intelligence or other imaging technologies in the future. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Treatment of Noninfectious Uveitic Macular Edema with Periocular and Intraocular Corticosteroid Therapies: A Report by the American Academy of Ophthalmology.

PURPOSE: To review the evidence on the effectiveness and complications of periocular and intraocular corticosteroid therapies for noninfectious uveitic macular edema. METHODS: A literature search of the PubMed database was conducted last in December 2021 and a post-assessment search was conducted in March 2023. The searches were limited to articles published in English and no date restrictions were imposed. The combined searches yielded 739 citations; 53 articles were selected for inclusion because the studies (1) evaluated periocular corticosteroid injection, intraocular corticosteroid injection or implant, suprachoroidal corticosteroid injection, or a combination thereof for uveitic macular edema; (2) had outcomes that included visual acuity (VA) or macular edema assessed clinically or imaged by OCT or fluorescein angiography; and (3) included more than 20 patients. RESULTS: This assessment reviewed 23 articles that provided level I or level II evidence from 18 studies on the use of periocular, suprachoroidal, and intravitreal triamcinolone acetonide injections and intravitreal dexamethasone and fluocinolone acetonide implants or inserts in noninfectious uveitic macular edema. These reports consistently demonstrated that all investigated periocular and intraocular corticosteroid therapies improved VA, macular structure, or both. One comparative study showed that intravitreal triamcinolone acetonide injection and the dexamethasone intravitreal implant had effectiveness superior to that of periocular triamcinolone acetonide injection for these outcomes. As a group, the studies highlighted the potential for these therapies to elevate intraocular pressure and to accelerate cataract formation. CONCLUSIONS: The published literature provides high-quality evidence that periocular and intraocular corticosteroid therapies are effective and safe for the treatment of noninfectious uveitic macular edema. However, information on the relative effectiveness and complication rates across the different therapies is limited. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Effects of Cost Sharing on Ophthalmic Care Utilization in the Affordable Care Act Marketplace.

PURPOSE: To determine the distribution and quantity of ophthalmic care consumed on Affordable Care Act (ACA) plans, the demographics of the population utilizing these services, and the relationship between ACA insurance coverage plan tier, cost sharing, and total cost of ophthalmic care consumed. METHODS: This cross-sectional study analyzed ACA individual and small group market claims data from the Wakely Affordable Care Act (WACA) 2018 dataset, which contains detailed claims, enrollment, and premium data from Edge Servers for 3.9 million individual and small group market lives. We identified all enrollees with ophthalmology-specific billing, procedure, and national drug codes. We then analyzed the claims by plan type and calculated the total cost and out-of-pocket (OOP) cost. RESULTS: Among 3.9 million enrollees in the WACA 2018 dataset, 538,169 (13.7%) had claims related to ophthalmology procedures, medications, and/or diagnoses. A total of $203 million was generated in ophthalmology-related claims, with $54 million in general services, $42 million in medications, $20 million in diagnostics and imaging, and $86 million in procedures. Average annual OOP costs were $116 per member, or 30.9% of the total cost, and were lowest for members with platinum plans (16% OOP) and income-driven cost sharing reduction (ICSR) subsidies (17% OOP). Despite stable ocular disease distribution across plan types, beneficiaries with silver ICSR subsidies consumed more total care than any other plan, higher than platinum plan enrollees and almost 1.5× the cost of bronze plan enrollees. CONCLUSIONS: Ophthalmic care for enrollees on ACA plans generated substantial costs in 2018. Plans with higher OOP cost sharing may result in lower utilization of ophthalmic care.

Ophthalmology Workforce Projections in the United States, 2020 to 2035.

PURPOSE: To analyze ophthalmology workforce supply and demand projections from 2020 to 2035. DESIGN: Observational cohort study using data from the National Center for Health Workforce Analysis (NCHWA). METHODS: Data accessed from the Department of Health and Human Services, Health Resources and Services Administration (HRSA) website were compiled to analyze the workforce supply and demand projections for ophthalmologists from 2020 to 2035. MAIN OUTCOME MEASURES: Projected workforce adequacy over time. RESULTS: From 2020 to 2035, the total ophthalmology supply is projected to decrease by 2650 full-time equivalent (FTE) ophthalmologists (12% decline) and total demand is projected to increase by 5150 FTE ophthalmologists (24% increase), representing a supply and demand mismatch of 30% workforce inadequacy. The level of projected adequacy was markedly different based on rurality by year 2035 with 77% workforce adequacy versus 29% workforce adequacy in metro and nonmetro geographies, respectively. By year 2035, ophthalmology is projected to have the second worst rate of workforce adequacy (70%) of 38 medical and surgical specialties studied. CONCLUSIONS: The HRSA's Health Workforce Simulation Model forecasts a sizeable shortage of ophthalmology supply relative to demand by the year 2035, with substantial geographic disparities. Ophthalmology is one of the medical specialties with the lowest rate of projected workforce adequacy by 2035. Further dedicated workforce supply and demand research for ophthalmology and allied professionals is needed to validate these projections, which may have significant future implications for patients and providers. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Applicant Perceptions of In-Person versus Virtual Interview Format for Surgical Retina Fellowship.

Purpose This article compares applicants' perceptions of and experiences with virtual and in-person interviews for surgical retina fellowship. Methods A survey was distributed via email to all applicants of three vitreoretinal surgery fellowship programs for the 2021 to 2022 and 2022 to 2023 application cycles. Main Outcome Measures Participants were surveyed regarding cost; burden of scheduling; number of applications and interviews completed; ability to gain a true feel of the program, location, and preceptor; and number of work and surgical days missed. Results Of 151 applicants contacted, 36 completed the survey (23.8% response rate). Of the respondents, 25.0% attended only virtual interviews, 19.4% attended mostly virtual interviews, 30.6% attended mostly in-person interviews, and 25.0% attended half virtual and half in-person interviews. Average expenditure was significantly lower for applicants with mostly and completely virtual interviews compared with applicants with mostly in-person and half virtual, half in-person ( p < 0.001). Applicants with mostly virtual interviews reported a lower ability to gain a true perception of the program and the program location ( p = 0.003 and p < 0.001, respectively). There was no difference in burden of scheduling, number of interviews completed, or number of work and surgical days missed. When applicants were asked what type of interview format they would prefer if they could repeat the cycle, those who interviewed mostly in-person largely chose in-person as their preference (72.7%), while participants who interviewed mostly or completely virtually were evenly split between in-person, virtual, and hybrid ( p = 0.136). Conclusion As fellowship programs and institutions decide whether they will return to in-person interviews or maintain a virtual interview format in the long term, they must weigh the lower cost of virtual interviews with the improved ability to gain a more accurate perception of the program and location allowed by in-person interviews, as well as potentially greater satisfaction with the in-person format.

Opportunity Cost of Vitreoretinal Surgeries.

Purpose: To compare physician reimbursements for vitreoretinal surgeries with office-based patient care. Methods: A theoretical model was performed comparing physician work reimbursements for the 10 most common vitreoretinal surgeries with office-based work relative value units (wRVUs) that could have been generated during the same global time period. The reference physician was modeled at 40 patients per 8-hour workday. A lower volume physician and higher volume physician were modeled at 30 patients/day and 50 patients/day, respectively. The reimbursement rates and allocated times for surgery were based on the 2021 values set by Medicare, and the average wRVU per office visit was based on 2021 real-world data from the Vestrum Retinal Healthcare Database. Results: In the reference case, performing any of the 10 most common vitreoretinal surgeries was associated with an opportunity cost with a weighted mean of 49% (range, 40%-68%) relative to lost office productivity. The Centers for Medicare & Medicaid Services (CMS) allocated a weighted mean intraservice time of 73 minutes; however, the reference physician would have to complete the surgery with a weighted average of 5 minutes (range, -31-12 minutes) for surgical wRVUs to equal office-based reimbursements. Performing these 10 surgeries was associated with a 25% opportunity cost even for the lower volume physician and 61% for the higher volume physician. Probability sensitivity analysis with a range of conditions identified opportunity costs from surgery in over 99% of simulated scenarios. Conclusions: Medicare reimbursements for the physician work component of vitreoretinal surgeries represented a significant opportunity cost for the physician relative to office-based patient care of equivalent time, especially for busier physicians. The model did not explore practice overhead and professional liability insurance, which are factored separately by CMS and may influence the opportunity cost depending on utilization. The average threshold surgery times for surgical reimbursements to equal office-based reimbursements may be difficult to achieve.

Trends in Imaging Utilization Among United States Medicare Beneficiaries and the Impact of the COVID-19 Pandemic.

This study characterizes trends in ophthalmic imaging volume and utilization in the United States among and assesses the potential impact of the COVID-19 pandemic using data from the Centers for Medicare and Medicaid Services. Utilization of macular optical coherence tomography (OCT), optic nerve OCT, and fundus photography steadily increased from 2013 to 2020 and was not impacted by the COVID-19 pandemic. At the same time, there was minimal adoption of anterior segment OCT and a decline in the utilization of dye-based angiography. Utilization patterns may be impacted by the advent of new technologies, role of the clinician, and alignment with treatment paradigms. [Ophthalmic Surg Lasers Imaging Retina 2023;54:661-665.].

Intravitreal triple therapy with vancomycin, ceftazidime, and moxifloxacin for bacterial endophthalmitis: A Twelve-year experience.

PURPOSE: Increasing rates of antibiotic resistance in endophthalmitis have been reported. This study examines outcomes of triple therapy with intravitreal vancomycin, ceftazidime, and moxifloxacin for endophthalmitis. METHODS: Retrospective, consecutive series of all patients treated with abovementioned intravitreal antibiotics from January 2009 to June 2021. Percentages of eyes attaining greater than or equal to 20/200 and 20/50 Snellen visual acuities and adverse events were evaluated. RESULTS: 112 eyes met inclusion criteria. 63 of 112 eyes (56%) achieved a visual acuity of 20/200 during follow-up, with 39 (35%) returning to at least 20/50. In subgroup analysis, 23 of 24 (96%) eyes with post-cataract endophthalmitis obtained ≥ 20/200 acuity and 21 of 24 (88%) obtained ≥ 20/50 acuity during follow-up. There were no cases of macular infarction. CONCLUSIONS: Intravitreal moxifloxacin (160 µg/0.1 mL) was well tolerated as an adjunct to vancomycin and ceftazidime for bacterial endophthalmitis. Use of this novel combination offers several theoretical advantages compared to standard therapy with two antibiotics, including expanded gram-negative coverage and potential synergy, and may be particularly valuable in geographies where the local antibiogram supports empiric use. Further study is merited to verify the safety and efficacy profile.

Time-driven Activity-based Costing Analysis of Fluorescein Angiography.

PURPOSE: To use electronic health record (EHR) time logs and time-driven activity-based costing (TDABC) to calculate the complete cost profile of office-based fluorescein angiography (FA). DESIGN: Economic analysis. SUBJECTS: Patients undergoing routine FA (Current Procedural Terminology [CPT] 92235) at Vanderbilt Eye Institute in fiscal year 2022. METHODS: Process flow mapping for routine FA was used to define the care episode after manual observation. Deidentified time logs were sourced from the EHR and all manually validated to calculate durations for each stage. The cost of materials was calculated from internal financial figures. Cost per minute for space, equipment, and personnel were based on internal figures. Published fluorescein costs were used for base-case analysis with scenario analysis based on a range of internal figures from pharmacy quotes. These inputs were used for a TDABC analysis. MAIN OUTCOME MEASURES: Time-driven activity-based costing of FA episode of care. Secondary scenario analyses focus on breakeven scenarios for key inputs, including medication costs RESULTS: Cost analysis of office-based FA resulted in an average total cost of $152.95 (nominal) per interpreted study per patient, which was $36.52 more than the maximum Medicare reimbursement for CPT 92235 in Mac Locality for Tennessee 10312 for fiscal year 2022 ($116.43; $76.11 [technical component] and $40.33 [physician component]). The negative contribution margin is strongly influenced by the cost of fluorescein, which comprises 39.8% of the episode costs, excluding overhead. CONCLUSIONS: The current analysis here shows that the recently increased cost of fluorescein has driven up the cost of office-based FA relative to the current maximum allowable Medicare reimbursement, leading to a negative contribution margin and financial loss. Given conservative cost estimates here, it is unlikely for profitability to be achieved without changes in the cost of fluorescein or increased reimbursement. These results may be informative for policy discussion regarding appropriate reimbursement for codes using injectable fluorescein. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Trends in Workplace-Related Eye Injuries in the United States From 2011 Through 2020.

Purpose: To provide insight into the current scope of workplace-related eye injuries (WREIs) by describing the demographic profiles and causes of WREIs from the years 2011 through 2020. Methods: The US Bureau of Labor Statistics (BLS) dataset on WREIs injuries was used. Descriptive data generated included the frequency of eye injuries, the setting, and demographic data. Results: The BLS reported an estimated 237 590 WREIs in the study timeframe. In that time, the incidence fell from 2.4 to 1.7 per 10 000 workers. These injuries commonly occurred in men (77.1%), White individuals (36.3%), those aged 25 to 34 years (26.9%), and those in the service (23.0%) and production (18.5%) industries. On average, WREIs resulted in a median of 2 missed workdays, with only 5.0% missing more than 1 month of work. Between 2019 and 2020, there was a 15.6% reduction in total WREIs in the US but a 39.3% increase in WREIs among healthcare workers. Conclusions: Men, White individuals, and younger workers might be at increased risk for WREIs. Public health interventions targeted toward improving access to and the quality of protective equipment in these groups and in fields involved in the primary or secondary sectors of industry and healthcare might be the most cost-effective measure to reduce the impact of WREIs on the US workforce.

Comparison of Incremental Costs and Medicare Reimbursement for Simple vs Complex Cataract Surgery Using Time-Driven Activity-Based Costing.

Importance: Cataract surgery is one of the most commonly performed surgeries across medicine and an integral part of ophthalmologic care. Complex cataract surgery requires more time and resources than simple cataract surgery, yet it remains unclear whether the incremental reimbursement for complex cataract surgery, compared with simple cataract surgery, offsets the increased costs. Objective: To measure the difference in day-of-surgery costs and net earnings between simple and complex cataract surgery. Design, Setting, and Participants: This study is an economic analysis at a single academic institution using time-driven activity-based costing methodology to determine the operative-day costs of simple and complex cataract surgery. Process flow mapping was used to define the operative episode limited to the day of surgery. Simple and complex cataract surgery cases (Current Procedural Terminology codes 66984 and 66982, respectively) at the University of Michigan Kellogg Eye Center from 2017 to 2021 were included in the analysis. Time estimates were obtained using an internal anesthesia record system. Financial estimates were obtained using a mix of internal sources and prior literature. Supply costs were obtained from the electronic health record. Main Outcomes and Measures: Difference in day-of-surgery costs and net earnings. Results: A total of 16 092 cataract surgeries were included, 13 904 simple and 2188 complex. Time-based day-of-surgery costs for simple and complex cataract surgery were $1486.24 and $2205.83, respectively, with a mean difference of $719.59 (95% CI, $684.09-$755.09; P < .001). Complex cataract surgery required $158.26 more for costs of supplies and materials (95% CI, $117.00-$199.60; P < .001). The total difference in day-of-surgery costs between complex and simple cataract surgery was $877.85. Incremental reimbursement for complex cataract surgery was $231.01; therefore, complex cataract surgery had a negative earnings difference of $646.84 compared with simple cataract surgery. Conclusions and Relevance: This economic analysis suggests that the incremental reimbursement for complex cataract surgery undervalues the resource costs required for the procedure, failing to cover increased costs and accounting for less than 2 minutes of increased operating time. These findings may affect ophthalmologist practice patterns and access to care for certain patients, which may ultimately justify increasing cataract surgery reimbursement.

Effectiveness of bevacizumab step therapy for neovascular age-related macular degeneration.

OBJECTIVE: To determine the effectiveness of bevacizumab step therapy for neovascular age-related macular degeneration (nAMD) in routine clinical practice. METHODS: In this retrospective case series, eyes initiating treatment for nAMD at an academic medical centre from 2011-2019 were included. Exclusion criteria included previous intravitreal anti-VEGF injections, prior non-cataract intraocular surgery, <1 year of treatment, and not starting on monthly bevacizumab therapy. Of 895 eligible eyes, 548 were excluded, yielding 347 eyes in the study population. These eyes were treated for nAMD under the bevacizumab step therapy protocol with an option to switch to another agent in the event of predefined treatment failure. Treatment failure was defined as losing 15 or more Early Treatment Diabetic Retinopathy Study letters or switching to an alternative anti-VEGF agent. Eyes that did not meet these criteria were deemed treatment successes. Annual change in mean VA from baseline (ΔVA) was the primary outcome. Secondary outcomes included treatment success rate, medication switch rate, and post-switch ΔVA. RESULTS: After 1 year, mean ΔVA was +8.4 letters (95% CI: +6.1 to +10.6 letters). 86% had treatment success, and 6% of eyes had switched to aflibercept. In years 2-7, ΔVA ranged from +7.0 to -0.7 letters, and treatment success rates ranged from 68 to 82%. 11% (n = 38) of eyes were switched to aflibercept. The post-switch ΔVA in these eyes was -7.1 letters (95% CI: -13.3 to -0.1) after a mean of 17.7 ± 12.6 injections over an average of 2.7 ± 2.0 years. CONCLUSION: A bevacizumab step therapy protocol in routine clinical practice is effective for long-term treatment of nAMD.

High-speed Beveled Tip Versus Standard Tip Vitrectomy Probe: A Prospective Randomized Clinical Trial.

Purpose: To compare the efficiency of the advanced ultravit beveled vitrector probe (10,000 cuts per minute) to the current standard ultravit highspeed (7500 cuts per minute) vitrector probe. Methods: A prospective, randomized controlled trial was conducted on patients undergoing routine vitrectomy surgery for epiretinal membrane, full-thickness macular hole, and vitreous opacities. Patients were randomly assigned to undergo PPV with the ultravit highspeed probe (Probe 1) or the advanced ultravit beveled probe (Probe 2). The main outcome measure was time to completion of core vitrectomy and vitreous base shave. Results: Forty patients were enrolled in this study, 20 in each cohort. The average time to completion of core vitrectomy was 10.4 +/- 1.8 min in the Probe 1 cohort compared to 9.7 +/- 2 min in the Probe 2 cohort (P = 0.21). The average time to completion of vitreous base shave was 9.6 +/- 2.7 min in the Probe 1 cohort compared to 9.4 +/- 1.8 min in the Probe 2 cohort (P = 0.39). Conclusion: In the current study, the advanced ultravit beveled probe was noninferior to the ultravit highspeed vitrectomy probe when looking at the time to completion of core vitrectomy and vitreous base shave. The increased cut rate did not affect the efficiency of vitreous removal.

Trainee Perspectives of Private Equity's Impact on Ophthalmology.

Objective The accelerated involvement of private equity (PE) in ophthalmology has many potential implications for the future of the field. The aim of this study was to evaluate trainee perspectives on PE's impact on ophthalmology. Methods An electronic survey was sent to trainees via an online ophthalmology research newsletter. The survey assessed for career goals and perspectives on the involvement of PE and its impact across a variety of attributes. Results A total of 41 United States-based respondents responded to the survey, 68% were medical students and 32% were residents or fellows. Seventy-eight percent of respondents reported they would not consider working for a PE-owned practice. There was a negative perceived impact of PE for physician autonomy, long-term physician income, career advancement, and quality of care. There was a positive perceived impact for the number of physician extenders, more referral sources, financial support, bargaining with insurance companies, starting physician salary, and administrative burden. All respondents agreed (76% strongly agree, 24% somewhat agree) that education about practice options and ownership structures is important to include in residency program education, with preferred modalities of small group discussions and on-site learning. Conclusions Trainees broadly perceive PE to negatively impact the practice of ophthalmology. While there were attributes perceived to be positively impacted by PE, these were not felt to be as important as those which may be negatively affected. New modalities for education about practice ownership options are necessary, and small group discussions and on-site learning may be of the highest yield for trainees.