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PURPOSE: To model Medicare Part B and patient savings associated with increased bevacizumab payment and use for intravitreal anti-vascular endothelial growth factor (VEGF) therapy. DESIGN: Cost analysis. PARTICIPANTS: Intelligent Research in Sight (IRIS®) Registry data. METHODS: Medicare claims and IRIS® Registry data were used to calculate Medicare Part B expenditures and patient copayments for anti-VEGF agents with increasing reimbursement and use of bevacizumab relative to ranibizumab and aflibercept. MAIN OUTCOME MEASURES: Medicare Part B costs and patient copayments for anti-VEGF agents in the Medicare fee-for-service population. RESULTS: Increasing bevacizumab reimbursement to $125.78, equalizing the dollar margin with aflibercept, would result in Medicare Part B savings of $468 million and patient savings of $119 million with a 10% increase in bevacizumab market share. CONCLUSIONS: Increased use of bevacizumab achievable with increased reimbursement to eliminate the financial disincentive to its use would result in substantial savings for the Medicare Part B program and for patients receiving anti-VEGF intravitreal injections.
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Inibidores da Angiogênese/economia , Redução de Custos/economia , Planos de Pagamento por Serviço Prestado/economia , Medicare Part B/economia , Bevacizumab/economia , Gastos em Saúde , Injeções Intravítreas , Ranibizumab/economia , Receptores de Fatores de Crescimento do Endotélio Vascular , Proteínas Recombinantes de Fusão/economia , Sistema de Registros , Estados Unidos , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidoresRESUMO
BACKGROUND: Urine production in the kidney is generally thought to be an energy-intensive process requiring large amounts of metabolic activity to power active transport mechanisms. This study uses a thermodynamic analysis to evaluate the minimum work requirements for urine production in the human kidney and provide a new perspective on the energy costs of urine production. In this study, black-box models are used to compare the Gibbs energy inflow and outflow of the overall kidney and physiologically-based subsections in the kidney, to calculate the work of separation for urine production. RESULTS: The results describe the work done during urine production broadly and for specific scenarios. Firstly, it shows glomerular filtration in both kidneys requires work to be done at a rate of 5 mW under typical conditions in the kidney. Thereafter, less than 54 mW is sufficient to concentrate the filtrate into urine, even in the extreme cases considered. We have also related separation work in the kidney with the excretion rates of individual substances, including sodium, potassium, urea and water. Lastly, the thermodynamic calculations indicate that plasma dilution significantly reduces the energy cost of separating urine from blood. CONCLUSIONS: A comparison of these thermodynamic results with physiological reference points, elucidates how various factors affect the energy cost of the process. Surprisingly little energy is required to produce human urine, seeing that double the amount of work can theoretically be done with all the energy provided through pressure drop of blood flow through the kidneys, while the metabolic energy consumption of the kidneys could possibly drive almost one hundred times more separation work. Nonetheless, the model's outputs, which are summarised graphically, show the separation work's nuances, which can be further analysed in the context of more empirical evidence.
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Rim/irrigação sanguínea , Rim/metabolismo , Modelos Biológicos , Circulação Renal/fisiologia , Termodinâmica , Humanos , Concentração Osmolar , Potássio/sangue , Potássio/urina , Sódio/sangue , Sódio/urinaAssuntos
Extração de Catarata/economia , Análise Custo-Benefício/economia , Medicare Access and CHIP Reauthorization Act of 2015/economia , Reembolso de Incentivo/legislação & jurisprudência , Humanos , Oftalmologia/economia , Assistência Centrada no Paciente/economia , Mecanismo de Reembolso/economia , Recompensa , Estados UnidosRESUMO
Objective: To characterize the development and performance of a cataract surgery episode-based cost measure for the Medicare Quality Payment Program. Design: Claims-based analysis. Participants: Medicare clinicians with cataract surgery claims between June 1, 2016, and May 31, 2017. Methods: We limited the analysis to claims with procedure code 66984 (routine cataract surgery), excluding cases with relevant ocular comorbidities. We divided episodes into subgroups by surgery location (Ambulatory Surgery Center [ASC] or Hospital Outpatient Department [HOPD]) and laterality (bilateral when surgeries were within 30 days apart). For the episode-based cost measure, we calculated costs occurring between 60 days before surgery and 90 days after surgery, limited to services identified by an expert committee as related to cataract surgery and under the influence of the cataract surgeon. We attributed costs to the clinician submitting the cataract surgery claim, categorized costs into clinical themes, and calculated episode cost distribution, reliability in detecting clinician-dependent cost variation, and costs with versus without complications. We compared episode-based cost scores with hypothetical "nonselective" cost scores (total Medicare beneficiary costs between 60 days before surgery and 90 days after surgery). Main Outcome Measures: Episode costs with and without complications, clinician-dependent variation (proportion of total cost variance), and proportion of costs from cataract surgery-related clinical themes. Results: We identified 583 356 cataract surgery episodes attributed to 10 790 clinicians and 8189 with ≥ 10 episodes during the measurement period. Most surgeries were performed in an ASC (71%) and unilateral (66%). The mean episode cost was $2876. The HOPD surgeries had higher costs; geography and episodes per clinician did not substantially affect costs. The proportion of cost variation from clinician-dependent factors was higher in episode-based compared with nonselective cost measures (94% vs. 39%), and cataract surgery-related clinical themes represented a higher proportion of total costs for episode-based measures. Episodes with complications had higher costs than episodes without complications ($3738 vs. $2276). Conclusions: The cataract surgery episode-based cost measure performs better than a comparable nonselective measure based on cost distribution, clinician-dependent variance, association with cataract surgery-related clinical themes, and quality alignment (higher costs in episodes with complications). Cost measure maintenance and refinement will be important to maintain clinical validity and reliability. Financial Disclosures: Proprietary or commercial disclosure may be found after the references.
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PURPOSE: The purpose of this study was to report trends in the prevalence of early graft failure after endothelial keratoplasty in the United States. METHODS: Descemet membrane endothelial keratoplasty (DMEK) and Descemet stripping automated endothelial keratoplasty (DSAEK) graft volumes were collected from records maintained by 6 major eye banks in the United States from January 1, 2013, to December 31, 2018. The prevalence and presumed cause of early graft failures (defined as a graft with persistent edema or regrafted within 8 weeks after keratoplasty) each year were sourced from surgeon-reported adverse events. Failed graft cases from the 3 eye banks were compared with nonfailures at the donor and recipient levels to perform subset analysis of factors associated with early graft failure. RESULTS: A total of 51,887 endothelial keratoplasty tissues were distributed during the study period; 72% were DSAEK grafts. The total number of early graft failures reported was 168 of 14,284 (1.18%) for DMEK and 322 of 37,603 (0.86%) for DSAEK. Early DMEK failures decreased from 2013 (7.69%) to 2018 (0.68%). In generalized linear mixed model analyses adjusting for donor tissue characteristics, recipient age, and diagnosis, an association of borderline significance was found between higher donor age and early failure [odds ratio (95% confidence interval): 1.03 (1.00-1.05); unit change of 1 yr] and DSAEK [odds ratio 1.02 (1.00-1.04); unit of change 1 yr] cases. CONCLUSIONS: The proportion of early graft failures in DMEK decreased over time and was comparable with failure rates in DSAEK at the end of the study period. The surgical learning curve might have played a role.
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Doenças da Córnea , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior , Doenças da Córnea/epidemiologia , Doenças da Córnea/etiologia , Doenças da Córnea/cirurgia , Ceratoplastia Endotelial com Remoção da Lâmina Limitante Posterior/efeitos adversos , Endotélio Corneano , Sobrevivência de Enxerto , Humanos , Curva de Aprendizado , Razão de Chances , Estudos Retrospectivos , Estados Unidos/epidemiologia , Acuidade VisualAssuntos
Bevacizumab/uso terapêutico , Custos de Medicamentos , Oftalmopatias/tratamento farmacológico , Planos de Pagamento por Serviço Prestado/economia , Medicare , Sistema de Registros , Inibidores da Angiogênese/economia , Inibidores da Angiogênese/uso terapêutico , Bevacizumab/economia , Oftalmopatias/economia , Humanos , Receptores de Fatores de Crescimento do Endotélio Vascular/antagonistas & inibidores , Estados UnidosRESUMO
BACKGROUND AND OBJECTIVE: Because patients with diabetes mellitus may visit their primary care physician regularly but not their ophthalmologist, a retinal risk assessment in the primary care setting could improve the screening rate for diabetic retinopathy. An imaging system for use in the primary care setting to identify diabetic retinopathy requiring referral to an ophthalmologist was evaluated. PATIENTS AND METHODS: In a masked prospective study, images were obtained from 11 patients with diabetes mellitus using both the digital retinal imaging system and seven-field stereo color fundus photography. The ability to obtain gradable images and to identify diabetic retinal lesions was compared. RESULTS: Of all images, 85% of digital retinal imaging system images and 88% of seven-field images were gradable. Agreement based on "no retinopathy" versus "any retinopathy" was excellent (Kappa = 0.96). Agreement based on "microaneurysms or less retinopathy" versus "retinal hemorrhages or worse retinopathy" was very good (Kappa = 0.83). CONCLUSIONS: The agreement between the digital retinal imaging system and seven-field photography indicates that the digital retinal imaging system may be useful to screen for diabetic retinopathy.
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Retinopatia Diabética/diagnóstico , Diagnóstico por Computador/métodos , Técnicas de Diagnóstico Oftalmológico/instrumentação , Fotografação/métodos , Atenção Primária à Saúde , Retina/patologia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Cor , Diagnóstico por Computador/instrumentação , Feminino , Fundo de Olho , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Sensibilidade e Especificidade , Acuidade VisualRESUMO
PURPOSE: To investigate the incidence of fungal infections after corneal transplantation to determine whether storage media supplementation with an antifungal should be considered. METHODS: Adverse reactions reported to the Eye Bank Association of America through the online adverse reaction reporting system between January 1, 2007, and December 31, 2010, were reviewed to identify cases of recipient fungal infection. Data were collected regarding the donor, the donor cornea, recovery and processing, and mate culture and clinical course of the recipients. RESULTS: Thirty-one cases of culture-proven fungal keratitis (n = 14) and endophthalmitis (n = 17) were reported out of 221,664 corneal transplants performed using corneal tissue distributed by domestic eye banks (1.4 cases per 10,000 transplants performed). Although the annual incidence of postkeratoplasty fungal infection has not increased significantly since 2005, a trend toward an increasing rate of fungal infection has been observed. Fungal infections were more commonly reported after endothelial keratoplasty procedures (0.022%) than penetrating keratoplasty procedures (0.012%), but the difference was not statistically significant (P = 0.076). Additionally, no association was found between fungal infection after endothelial keratoplasty and whether the lamellar tissue cut was performed by the surgeon or the eye bank technician. Seventy-three percent (16 of 22) of the fungal cultures performed on the mate corneas were positive, with infection developing in 67% (10 of 15) of recipient eyes (endophthalmitis in 6 eyes and keratitis in 4 eyes). CONCLUSIONS: Although a nonsignificant increasing trend in the rate of fungal infection has been observed over the past 6 years, it is not sufficiently compelling to pursue antifungal supplementation of donor storage media.
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Córnea/microbiologia , Transplante de Córnea , Úlcera da Córnea/epidemiologia , Endoftalmite/epidemiologia , Bancos de Olhos/estatística & dados numéricos , Infecções Oculares Fúngicas/epidemiologia , Complicações Pós-Operatórias , Adulto , Idoso , Úlcera da Córnea/microbiologia , Endoftalmite/microbiologia , Bancos de Olhos/organização & administração , Infecções Oculares Fúngicas/microbiologia , Fungos/isolamento & purificação , Humanos , Incidência , Pessoa de Meia-Idade , Preservação de Órgãos/métodos , Organizações sem Fins Lucrativos , Doadores de Tecidos , Obtenção de Tecidos e Órgãos/métodos , Estados Unidos/epidemiologia , Adulto JovemRESUMO
PURPOSE: Evidence of the transmission of disease via donor ocular tissue has been demonstrated for adenocarcinoma, rabies, hepatitis B virus, cytomegalovirus, herpes simplex virus, Creutzfeldt-Jakob disease, and a variety of bacterial and fungal infections. METHODS: Although there is no evidence to date of disease transmission for HIV infection, syphilis, hepatitis C, hepatitis A, tuberculosis, HTLV-1 and -2 infection, active leprosy, active typhoid, smallpox, and active malaria, these entities remain contraindications for transplantation for all eye banks nationally and internationally. The potential sources of contamination include infected donors, during the process of removing tissue from cadaveric donors, the processing environment, and contaminated supplies and reagents used during processing. The transmissions of Herpes simplex virus and HSV via corneal graft have been shown to be responsible for primary graft failure. HSV-1 may also be an important cause of PFG. RESULTS: The long latency period of some diseases, the emergence of new infectious disease, and the reemergence of others emphasize the need for long-term record maintenance and effective tracing capabilities. CONCLUSIONS: The standardization of definitions for adverse events and reactions will be necessary to support the prevention and transmission of disease. International classification of a unique identification system for donors will be increasingly important for vigilance and traceability in cross-national exportation of human cells, tissues, and cellular- and tissue-based products. Opportunities for continuous improvement exist as does the need for constant vigilance and surveillance.
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Controle de Doenças Transmissíveis/métodos , Transplante de Córnea/efeitos adversos , Transmissão de Doença Infecciosa/prevenção & controle , Coleta de Tecidos e Órgãos/normas , Bancos de Olhos , Infecções Oculares/prevenção & controle , Infecções Oculares/transmissão , Humanos , Estados UnidosRESUMO
PURPOSE: To report 6 cases of apparently inseparable corneal lamellae during intraoperative preparation of tissue for Descemet stripping automated endothelial keratoplasty (DSAEK). METHOD: Collection of clinical case reports from an e-mail survey of The Cornea Society and endothelial keratoplasty discussion group participants and Eye Bank Association of America member eye banks. RESULTS: Five cases involved eye bank precut tissue. Surgery was aborted in 4 of these cases. In the fifth case, a free anterior cap was identified and the posterior lamella was successfully transplanted. In 1 case, in which an incomplete lamellar cut was made in the operating room, the surgery was continued after manual completion of the lamellar dissection. CONCLUSIONS: The most likely causes of inability to separate the lamellae after punching a DSAEK donor cornea are a decentered or incomplete lamellar cut and unsuspected premature separation of the lamellae. Premature separation can occur with an anterior cap that detaches before the central trephination or a posterior lamella that is inadvertently removed from the field after the central trephination. Careful inspection of the donor cornea under the operating microscope can reduce the risk of a decentered cut and can identify the presence of both lamellae. DSAEK may be completed successfully with an intact posterior lamella.