Fertility care for all: impact of New York State's Medicaid expansion on infertility care.

PURPOSE: To assess whether the New York State (NYS) mandate expanding Medicaid coverage of fertility diagnostic testing and treatment is successfully increasing patient access to and utilization of fertility care. METHODS: A retrospective chart review was performed of NYS Medicaid patients who presented for fertility services to a large academic reproductive endocrinology and infertility (REI) clinic. Information on patient demographics, medical history, diagnostic testing, treatments, and outcomes was collected. Patients presenting to the clinic in the 1 year prior to the mandate (October 1, 2018-September 30, 2019) were compared to patients presenting in the 1 year after the mandate (October 1, 2019-September 30, 2020). Primary outcomes of the study were differences in presentation to the clinic between the two cohorts and differences in utilization of infertility diagnostic testing and treatment. Secondary outcomes were differences in treatment outcomes. RESULTS: A significantly larger percentage of Medicaid patients presented to the clinic for fertility assessment post-mandate (22%) as compared to pre-mandate (9%, p < 0.05). There were no demographic differences between the pre- and post-mandate patient groups. A similar percentage of patients completed diagnostic testing pre- vs. post-mandate. Post-mandate patients underwent more treatment cycles with ovulation induction medications compared to natural treatment cycles. There was no significant difference in pregnancy rates pre- vs. post-mandate. CONCLUSION: The NYS Medicaid mandate allowed a significantly larger percentage of Medicaid patients to present for fertility evaluation. The patients in the post-mandate cohort underwent more treatment cycles with ovulation induction medications compared to natural cycles.

Comparison of hospitalization costs for the same adverse reaction associated with different medications.

PURPOSE: Costs of hospitalization due to severe adverse drug reactions (ADRs) were previously estimated within the Veterans Health Administration (VHA), but additional analyses are needed to infer potential interventions to mitigate these negative outcomes. The objective of this study was to compare specific adverse reaction-related hospitalization costs between medications with similar indications. METHODS: Mean hospitalization costs associated with the same ADR symptom were compared for different drugs with similar indications using adjusted generalized linear models with a Bonferroni correction for multiple comparisons as well as a gamma distribution. RESULTS: Overall, hospitalization costs between medications with similar indications were not significantly different for specific adverse reactions. However, gastrointestinal hemorrhage-associated costs were higher for warfarin versus nonsteroidal anti-inflammatory drugs (model estimate of mean cost, $18,114 [range of lower and upper model estimates, $12,522-$26,202] vs $14,255 [estimate range, $9,710-$20,929]). Similarly, the estimated mean hospitalization cost associated with angioedema was higher for losartan versus lisinopril or lisinopril/hydrochlorothiazide: $14,591 (range, $9467-$22,488) versus $8,935 (range, $6,301-$12,669) and $8,022 (range, $5,424-$11,865), respectively. CONCLUSION: Although we found few differences in the cost of hospitalization when comparing drugs with similar indications and the same adverse reaction, there were specific drug-ADR pairs that merit attention and consideration of interventions to improve safe and appropriate medication use. Evaluation of the effect of those interventions on the incidence of ADRs is an area for future study.

Increased delay from initial concern to diagnosis of autism spectrum disorder and associated health care resource utilization and cost among children aged younger than 6 years in the United States.

BACKGROUND: Prolonged delays between first caregiver concern and autism spectrum disorder (ASD) diagnosis have been reported, but associations between length of time to diagnosis (TTD) and health care resource utilization (HCRU) and costs have not been studied in a large sample of children with ASD. OBJECTIVE: To address these informational gaps in the ASD diagnostic pathway. METHODS: This retrospective, observational, single cohort analysis of Optum's administrative claims data from January 1, 2011, to December 31, 2020, included commercially insured children who had 2 or more claims for an ASD diagnosis (earliest diagnosis designated as the index date), were between the ages of older than 1.5 years and 6 years or younger at index date, and were continuously enrolled for up to 48 months before and for 12 months after the index date. Two cohorts (between the ages of older than 1.5 years and 3 years or younger and between the ages of older than 3 years and 6 years or younger at ASD diagnosis) were divided into shorter (less than median) and longer (greater than or equal to median) TTD around each cohort median TTD calculated from the first documented ASD-related concern to the earliest ASD diagnosis, because TTD may vary by age at diagnosis. This exploratory analysis compared all-cause and ASD-related HCRU and costs during a 12-month period preceding ASD diagnosis among children with shorter vs longer TTD. RESULTS: 8,954 children met selection criteria: 4,205 aged 3 years or younger and 4,749 aged older than 3 years at diagnosis, with median TTD of 9.5 and 22.1 months, respectively. In the year preceding ASD diagnosis, children with longer TTD in both age cohorts experienced a greater number of all-cause and ASD-related health care visits compared with those with shorter TTD (mean and median number of office or home visits were approximately 1.5- and 2-fold greater in longer vs shorter TTD groups; P < 0.0001). The mean all-cause medical cost per child in the year preceding ASD diagnosis was approximately 2-fold higher for those with longer vs shorter TTD ($5,268 vs $2,525 in the younger and $5,570 vs $2,265 in the older cohort; P < 0.0001 for both). Mean ASD-related costs were also higher across age cohorts for those with longer vs shorter TTD ($2,355 vs $859 in the younger and $2,351 vs $1,144 in the older cohort; P < 0.0001 for both). CONCLUSIONS: In the year prior to diagnosis, children with longer TTD experienced more frequent health care visits and greater cost burden in their diagnostic journey compared with children with shorter TTD. Novel diagnostic approaches that could accelerate TTD may reduce costs and HCRU for commercially insured children. DISCLOSURES: This study was funded by Cognoa, Inc. Optum received funding from Cognoa to conduct this study. Dr Salomon is an employee and holds stock options of Cognoa, Inc. Dr Campbell was an employee of Cognoa, Inc., at the time this study was conducted. Dr Duhig was an employee of Cognoa, Inc., at the time the study was conducted and holds stock options. Dr Vu, Ms Kruse, Mr Gaur, and Ms Gupta are employees and/or stockholders of Optum. Dr Tibrewal was an employee of Optum at the time the research for this study was conducted. Dr Taraman is an employee and holds stock options of Cognoa, Inc., receives consulting fees from Cognito Therapeutics, volunteers as a board member of the American Academy of Pediatrics California and Orange County Chapter, is a paid advisor for MI10 LLC, and owns stock options of NTX, Inc., and HandzIn.

See one, do one, teach one: Reimagining reproductive endocrinology and infertility training programs to expand access to care.

Objective: To provide a review of the current literature surrounding barriers to reproductive medicine and present examples of how resident and fellow education can be used to overcome these barriers. Design: A review of the relevant literature addressing barriers to reproductive medicine, resident and fellow education, and related materials was completed. Setting: Academic medical institutions. Patients: None. Interventions: None. Main Outcome Measures: Health disparities and barriers in access to care. Results: Of barriers in access to care, 3 were reviewed in detail: cost of health care, racial inequities, and marginalization of immigrant communities. The suggested strategies to mitigate these barriers include the following: reducing racial inequities through improved diversity within reproductive medicine and through antiracism training, developing opportunities for trainees to engage in advocacy, strengthening reproductive endocrinology and infertility clinical exposure and educational curricula in training programs, inclusion of residents and fellows in clinical care, and improving the accessibility of fertility care through implementing approaches to optimize the management of infertility in challenging, resource-constrained settings. Conclusions: Infertility is one of the most prevalent reproductive health diseases, yet profound disparities and inequities in access to care exist today in the United States. Lower-income, minority, and immigrant communities are among those most marginalized. Improved access to care begins with broadened obstetrics and gynecology and reproductive endocrinology and infertility trainee education, which acknowledges the barriers these communities face and provides strategies to help overcome these obstacles to care.

Exploratory Cost-Effectiveness Analysis for Treatment of Methicillin-Resistant Staphylococcus aureus Bloodstream Infections: Is Linezolid or Daptomycin Favored Over Vancomycin?

BACKGROUND AND OBJECTIVE: Methicillin-resistant Staphylococcus aureus bloodstream infections (MRSAB) cause significant mortality, and often require extended antibiotic therapy. Vancomycin, the most common initial MRSAB treatment, carries significant monitoring burden and nephrotoxicity risks. Our objective was to compare the cost-effectiveness of vancomycin and other antibiotic regimens against MRSAB. METHODS: We estimated the cost-effectiveness of intravenous antibiotics (vancomycin, daptomycin, linezolid, ceftaroline/daptomycin) for Veterans Health Administration patients with MRSAB using an exploratory decision-tree model. Primary effectiveness outcome was composite of microbiological failure at 7 days and adverse drug event (ADE)-related discontinuation after at least 7 days. RESULTS: In base-case analyses, intravenous linezolid was the least expensive regimen at 4 and 6 weeks. Daptomycin was more expensive and more effective than linezolid, with an incremental cost-effectiveness ratio (ICER) of ~$13,000 (4 weeks) per composite failure avoided. With 6 weeks of treatment, daptomycin was more expensive and more effective than vancomycin (ICER ~$21,000 per composite failure avoided). Vancomycin and ceftaroline/daptomycin were dominated strategies at both 4 and 6 weeks. In one-way sensitivity analyses, vancomycin was favored when its microbiological failure risk was less than 20.1% (base-case: 27.2%), assuming a willingness to pay (WTP) threshold of $40,000/composite treatment failure avoided. In two-way sensitivity analyses, intravenous linezolid was favored if linezolid microbiological failure and ADE-related discontinuation rates were < 22.5% and < 17.3%, respectively. Daptomycin, vancomycin, and linezolid were favored in 50%, 31%, and 17% of 4-week probabilistic iterations, respectively, at $40,000 WTP. CONCLUSION: Daptomycin is likely less expensive and more effective than vancomycin or other initial regimens for MRSAB. More data are needed on the safety of linezolid against MRSAB.

Assessment of Use and Safety of Edaravone for Amyotrophic Lateral Sclerosis in the Veterans Affairs Health Care System.

Importance: Using real-world data, the US Department of Veterans Affairs (VA) initiated a surveillance evaluation of edaravone after its approval for amyotrophic lateral sclerosis (ALS) in 2017. The use and safety of edaravone for patients with ALS in the VA health care system remain to be assessed. Objective: To describe a pharmacovigilance surveillance initiative with edaravone to monitor patient characteristics, utilization (edaravone cycles and riluzole use), and safety and to evaluate safety/effectiveness. Design, Setting, and Participants: This propensity score-matched cohort study used data on 369 patients with documented definite or probable ALS in the Veterans Health Administration (VHA) with at least 1 prescription for edaravone between August 1, 2017, and September 30, 2019. The analysis compared edaravone (alone or with riluzole) with riluzole only. For chronic users (≥6 months of drug), a time-to-event model evaluated ALS-related outcomes, with censoring at outcome, death, or end of evaluation. Patients with Parkinson disease, dementia, schizophrenia, or significant respiratory insufficiency per diagnosis codes within 2 years before prescription initiation were excluded. In overall matched cohorts, 223 patients treated with edaravone were 1:3 propensity score matched based on predefined confounders. For the chronic user subgroup analysis, 96 patients receiving edaravone and 424 patients receiving riluzole only were included. Exposures: Edaravone (alone or with riluzole) vs riluzole only. Main Outcomes and Measures: Patient characteristics, ALS drug use, and mortality. Acute outcomes (within 6 months of index) included proportion and mean time to event for death, discontinuation, or all-cause hospitalization, and outcomes for chronic users (receiving >6 months of treatment) included hazard ratios of outcomes related to disease-state progression. Results: Of 369 patients who received edaravone, most were older (mean [SD] age, 64.6 [11.3] years), male (346 [93.8%]), and White (261 [70.7%]). As of September 2019, 59.9% of edaravone patients had discontinued treatment; of those, 49.5% (108 of 218) received only 1 to 3 treatment cycles. Approximately 30% (110 patients) died. In a matched evaluation, significantly more acute all-cause hospitalization events occurred with edaravone (35.4% vs 22.0% for riluzole only); 72.6% of the edaravone cohort received edaravone with riluzole. Among chronic users, edaravone patients (70.8% edaravone with riluzole) had an increased hazard ratio of ALS-associated hospitalization (2.51; 95% CI, 1.18-8.16). The death rate was lower with edaravone but the difference was not statistically significant. Conclusions and Relevance: Early edaravone discontinuation was common in the VA. Although outcomes favored use of riluzole only in the matched analysis, results should be interpreted with caution, as unmeasured bias in observational data is likely.

Sustainable implementation of innovative, technology-based health care practices: A qualitative case study from stroke telemedicine.

INTRODUCTION: Technology-based innovation requires long-term changes to workforce routines, otherwise practices will not be sustained. The aim of this study was to identify influential factors in the ongoing use of an acute stroke telemedicine programme. METHODS: A new acute stroke telemedicine programme in a regional hospital receiving 375 patients with stroke or transient ischaemic attack per year was used as an exploratory case study. Semi-structured interviews with acute care and emergency department clinicians (n = 25) were conducted at two time-points: after a six-month pilot and then after a further 12-month implementation phase. Interviews (between 12-60 min) were recorded, transcribed and analysed inductively using descriptive thematic analysis. Reported barriers and facilitators were compared with those previously reported pre-implementation (deductive analysis) to identify changes over time. Using an implementation framework and a behaviour change taxonomy, strategies were developed to address influential factors on sustainability. RESULTS: New facilitators were identified including hospital system changes, benefits to clinicians and telemedicine becoming standard practice. New and ongoing barriers included infrequent use, competing demands and the continued resistance to a specific treatment. DISCUSSION: Understanding the factors supporting a health service in successfully implementing change can accelerate population benefits. The innovation itself may include barriers to be addressed, and barriers and facilitators can change over time. Individual attitudes remain critical to initial and ongoing success. Strategies proposed included promoting benefits across the organisation and allaying uncertainties with site-specific evidence. The effectiveness of these strategies, however, needs to be evaluated. Strategies sustaining change post-implementation should be considered.

Cost-effectiveness of increased influenza vaccination uptake against readmissions of major adverse cardiac events in the US.

BACKGROUND: Although influenza vaccination has been shown to reduce the incidence of major adverse cardiac events (MACE) among those with existing cardiovascular disease (CVD), in the 2015-16 season, coverage for persons with heart disease was only 48% in the US. METHODS: We built a Monte Carlo (probabilistic) spreadsheet-based decision tree in 2018 to estimate the cost-effectiveness of increased influenza vaccination to prevent MACE readmissions. We based our model on current US influenza vaccination coverage of the estimated 493,750 US acute coronary syndrome (ACS) patients from the healthcare payer perspective. We excluded outpatient costs and time lost from work and included only hospitalization and vaccination costs. We also estimated the incremental cost/MACE case averted and incremental cost/QALY gained (ICER) if 75% hospitalized ACS patients were vaccinated by discharge and estimated the impact of increasing vaccination coverage incrementally by 5% up to 95% in a sensitivity analysis, among hospitalized adults aged ≥ 65 years and 18-64 years, and varying vaccine effectiveness from 30-40%. RESULT: At 75% vaccination coverage by discharge, vaccination was cost-saving from the healthcare payer perspective in adults ≥ 65 years and the ICER was $12,680/QALY (95% CI: 6,273-20,264) in adults 18-64 years and $2,400 (95% CI: -1,992-7,398) in all adults 18 + years. These resulted in ~ 500 (95% CI: 439-625) additional averted MACEs/year for all adult patients aged ≥18 years and added ~700 (95% CI: 578-825) QALYs. In the sensitivity analysis, vaccination becomes cost-saving in adults 18+years after about 80% vaccination rate. To achieve 75% vaccination rate in all adults aged ≥ 18 years will require an additional cost of $3 million. The effectiveness of the vaccine, cost of vaccination, and vaccination coverage rate had the most impact on the results. CONCLUSION: Increasing vaccination rate among hospitalized ACS patients has a favorable cost-effectiveness profile and becomes cost-saving when at least 80% are vaccinated.

Healthcare expenditures for privately insured US patients with cystic fibrosis, 2010-2016.

OBJECTIVES: Published cost estimates for cystic fibrosis (CF) are based on older data and do not reflect increased use of specialty drugs in recent years. We assessed recent trends in healthcare expenditures for CF patients in the United States (US) with employer-sponsored health insurance. METHODS: The study is a retrospective analysis of claims data for privately insured individuals aged 0-64 years who were continuously enrolled in non-capitated plans for at least 1 calendar year during 2010-2016. Mean annual expenditures during a calendar year were calculated for individuals who met a claims-based CF case definition. Average annual growth rates were calculated through linear regression of the natural logarithm of annual expenditures. RESULTS: The annual CF prevalence was 1.1-1.4 per 10 000 adults and 2.9-3.0 per 10 000 children. Average spending adjusted for inflation nearly doubled from roughly $67 000 per patient in 2010 and 2011 to approximately $131 000 per patient in 2016. Inflation-adjusted spending on outpatient and inpatient care increased by 0.5% and 2.5% per year, respectively, whereas pharmaceutical spending increased by 20.2% per year. Virtually all of the growth in pharmaceutical spending was accounted for by spending on specialty drugs; inflation-adjusted spending on other medications increased by 1.3% per year. The annual growth rate in pharmaceutical spending rose by 33.1% during 2014-2016, the years during which lumacaftor/ivacaftor was introduced. CONCLUSIONS: Per-patient expenditures for privately-insured patients with CF almost doubled during 2010-2016; specialty drugs were largely responsible for this increase, with a major contribution from new, genotype-targeted CFTR modulator medications.

Transitioning from a single-site pilot project to a state-wide regional telehealth service: The experience from the Victorian Stroke Telemedicine programme.

Scaling of projects from inception to establishment within the healthcare system is rarely formally reported. The Victorian Stroke Telemedicine (VST) programme provided a very useful opportunity to describe how rural hospitals in Victoria were able to access a network of Melbourne-based neurologists via telemedicine. The VST programme was initially piloted at one site in 2010 and has gradually expanded as a state-wide regional service operating with 16 hospitals in 2017. The aim of this paper is to summarise the factors that facilitated the state-wide transition of the VST programme. A naturalistic case-study was used and data were obtained from programme documents, e.g. minutes of governance committees, including the steering committee, the management committee and six working groups; operational and evaluation documentation, interviews and research field-notes taken by project staff. Thematic analysis was undertaken, with results presented in narrative form to provide a summary of the lived experience of developing and scaling the VST programme. The main success factors were attaining funding from various sources, identifying a clinical need and evidence-based solution, engaging stakeholders and facilitating co-design, including embedding the programme within policy, iterative evaluation including performing financial sustainability modelling, and conducting dissemination activities of the interim results, including promotion of early successes.

Telemedicine in the acute health setting: A disruptive innovation for specialists (an example from stroke).

INTRODUCTION: Telemedicine is a disruptive innovation within health care settings as consultations take place via audio-visual technology rather than traditional face-to-face. Specialist perceptions and experiences of providing audio-visual consultations in emergency situations, however, are not well understood. The aim of this exploratory study was to describe the experience of medical specialists providing acute stroke decision-making support via telemedicine. METHODS: Data from the Victorian Stroke Telemedicine (VST) programme were used. The experiences of specialists providing an acute clinical telemedicine service to rural emergency departments were explored, drawing on disruptive innovation theory. Document analysis of programme consultation records, meeting minutes and in-depth individual interviews with three neurologists were analysed using triangulation. RESULTS: Since February 2014, 269 stroke telemedicine consultations with 12 neurologists have occurred. Retention on the roster has varied between 1 and >4 years. Overall, neurologists reported benefits of participation, as they were addressing health equity gaps for rural patients. Negative effects were the unpredictability of consultations impacting on their personal life, the mixed level of experience of colleagues initiating the consult and not knowing patient outcomes since follow-up communication was not routine. CONCLUSIONS: Insights into workforce experience and satisfaction were identified to inform strategies to support specialists to adapt to the disruptive innovation of telemedicine.

Falls in the acute hospital setting--impact on resource utilisation.

OBJECTIVE: To determine the resource utilisation of patients who fall within an acute metropolitan hospital. DESIGN: Retrospective observational study, part of a larger falls prevention project in a 323-bed acute care, tertiary teaching hospital in Melbourne, Australia. A review of falls incidents was undertaken for all patient admissions for 18 months from January 2002, excluding the Day Procedure Unit, Intensive Care Unit, Coronary Care Unit and the Emergency Department. PROCEDURE: The most common diagnosis related groups (DRGs) associated with fallers were identified, and within each DRG, fallers were matched to non-fallers by age and gender. Difference in hospital length of stay (LOS) and disparity in resource consumption by these two groups were calculated. RESULTS: The DRG with the highest proportion of fallers was "Dementia and other chronic disturbances of cerebral function" (24%). Three of the top six DRGs had significantly longer LOS for fallers compared with non-fallers ("Delirium", "Stroke" and "Respiratory conditions") (P<0.05). Hospital-related costs were significantly higher for fallers compared with non-fallers for the DRG "Stroke with severe/complicating diagnosis/procedure" only (P<0.05). CONCLUSIONS: Inpatient LOS and total associated costs for patients who fell and were classified among the DRGs with the highest proportion of fallers were substantially higher than those of matched non-fallers. Effective falls prevention activities targeting these high-risk groups should be a priority, in the context of broader falls prevention activities within a hospital setting.