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Objectives: To evaluate how payers utilize Institute for Clinical and Economic Review (ICER) assessments to inform coverage or formulary decisions. Method(s): Double-blinded, web-based survey was fielded through Xcenda's research panel, the Managed Care Network, from June to July 2022. Result(s): A total of 51 payers from health plans (n=27), integrated delivery networks (n=12), and pharmacy benefit managers (n=12) participated in the survey. When assessing the usefulness of ICER's value assessment framework (VAF) to inform formulary decisions within their organizations, 57% of payers indicated it was extremely/very useful, 33% indicated somewhat useful, and 10% indicated not at all/not very useful. Most respondents (73%) agreed that ICER assessments are aligned with their organization's internal assessment. Utilization of ICER's VAF was most prevalent in high-cost drug or disease states (78%), rare/orphan disease states (71%), and oncology/hematology disease states (67%). Payers reported less use in primary care disease states (29%), COVID-19 (8%), and digital therapeutics (4%). In the last 24 months, 20% of payers reported ICER's recommendations often influenced coverage decisions, 59% indicated occasional influence, and 22% indicated no influence. In the last 24 months, payers indicated the top 5 ICER assessments that influenced their coverage decisions included high cholesterol (38%), Alzheimer's disease (36%), atopic dermatitis (33%), multiple myeloma (31%), and chemotherapy-induced neutropenia (28%). ICER assessments that were less impactful included beta thalassemia (3%), digital health technologies (3%), and supervised injection facilities (3%). Payers reported using ICER assessments to inform both expanded and restricted coverage decisions. Conclusion(s): Payers find ICER's VAF useful to inform their organization's formulary decisions. ICER's assessments often align with payers' internal assessments and are most frequently utilized for high-cost drugs or disease states. Payers indicate ICER assessments have affected both expansion and restriction in their coverage policies.Copyright © 2023
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Objectives: To examine temporal trends of FDA-approved and off-label second-generation antipsychotic (SGA) prescribing for adolescents over time through the Covid-19 pandemic. Method(s): This is a new-user, retrospective longitudinal panel study using electronic health record data from a large, integrated health care system. Outpatient prescription orders for a new SGA (index date) for adolescents (age 10-17 years) during 2013-2021 were analyzed. Prescription orders were linked to diagnoses at time of encounter to examine prescribing behavior. A one-year lookback period was used for baseline inclusion and exclusion criteria, including one-year "washout" of SGAs and continuous insurance enrollment. FDA-approved use was determined by two outpatient diagnoses (one baseline diagnosis and the prescription order diagnosis) for autism, psychotic disorders, bipolar disorders, or Tourette's;the remaining proportion was considered potentially off-label. We report crude annual prescribing rates per 1,000 youths. Result(s): There were 8,145 unique patients with new SGA prescription orders, of which 5,828 (71.6%) had linked diagnoses available. Calendar year 2013 had the highest prescribing rate prior to Covid-19 onset (2.1 per 1,000) but then declined through 2016 (1.7 per 1,000). Prescribing rates in 2020 (2.0 per 1,000) and 2021 (2.2 per 1,000) were higher than those between 2017-2019. Across all study years, SGA prescriptions were mostly off-label and ordered for aripiprazole, quetiapine, or risperidone. The proportion of off-label indications was highest in 2013 (80.1%) and lowest (69.1%) in 2019. Off-label proportions increased again in 2020 (76.1%) and in 2021 (74.1%). At baseline, patients frequently had other psychotropic prescriptions (e.g., antidepressants 63.3%, stimulants 22.9%, and sedatives/hypnotics 20.7%). Conclusion(s): A general decline in SGA prescribing rates among adolescents was observed from 2013 to 2019, but then increased following Covid-19 onset. Despite known safety risks, off-label use of SGAs remains prominent. Future studies are needed to better understand prescribing outside of pediatric professional society guidelines.Copyright © 2023
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Comprehensive medication management (CMM) is increasingly provided by health care teams through telehealth or hybrid modalities. The purpose of this scoping literature review was to assess the published literature and examine the economic, clinical, and humanistic outcomes of CMM services provided by pharmacists via telehealth or hybrid modalities. This scoping review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis extension for Scoping Reviews. Randomized controlled trials (RCTs) and observational studies were included if they: reported on economic, clinical, or humanistic outcomes;were conducted via telehealth or hybrid modalities;included a pharmacist on their interprofessional team;and evaluated CMM services. The search was conducted between January 1, 2000, and September 28, 2021. The search strategy was adapted for use in Medline (PubMed);Embase;Cochrane;Cumulative Index to Nursing and Allied Health Literature;PsychINFO;International Pharmaceutical s;Scopus;and grey literature. Four reviewers extracted data using a screening tool developed for this study and reviewed for risk of bias. Authors screened 3500 articles, from which 11 studies met the inclusion criteria (9 observational studies, 2 RCTs). In seven studies, clinical outcomes improved with telehealth CMM interventions compared to either usual care, face-to-face CMM, or educational controls, as shown by the statistically significant changes in chronic disease clinical outcomes. Two studies evaluated and found increased patient and provider satisfaction. One study described a source of revenue for a telehealth CMM service. Overall, study results indicate that telehealth CMM services, in select cases, may be associated with improved clinical outcomes, but the methods of the included studies were not homogenous enough to conclude that telehealth or hybrid modalities were superior to in-person CMM. To understand the full impact on the Quadruple Aim, additional research is needed to investigate the financial outcomes of CMM conducted using telehealth or hybrid technologies.Copyright © 2022 Pharmacotherapy Publications, Inc.
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Background: In US, only 12% of ESRD patients utilize PD as his/her RRT modality. Part of the reason is lack of effective education tool. Kaiser Permanente Northern California is an integrated health care system providing health care to 4.6 million members in greater San Francisco Bay area. We piloted a proof-of-concept study to test if utilizing virtual reality can improve patient dialysis modality education. Method(s): Nephrologists, PD nurses and technology-centered team from KPNC met regularly in 2019 to find out the gaps in dialysis modality educations. After several meetings and reviewing the current educational material, we decided to produce a 360 immersive video with 3 separate segments using a GoPro Camera. Google cardboard is used as the VR tool. We then tested on 9 patients during their patient education section. Result(s): Three segments showing nursing home visit, patient performing PD at home and patient sleeping during PD were produced. They can be assessed on YouTube: https:// www.youtube.com/watch?v=BayBNoZbNbA. We tested this VR tool for 9 patients. This number was limited due to in person trainings being curtailed during the COVID-19 pandemic. Most patients felt that the first-person nature of the video (without VR) helped because the content was so helpful. However, there were some challenges: some patient became confused due to too much movement needed, not able to focus. Overall, patients appreciated the content but felt the 360 VR was not needed. They hoped if the video could be steadied, they would have a better experience. Table one listed the demographics and feedbacks. Conclusion(s): VR is a viable option for better patient education if it can be improved with better ease of use. Further studies with improved technology and larger numbers of patients are warranted to improve patient dialysis modality education. (Table Presented).
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BACKGROUND: Despite COVID-19 vaccines' demonstrated effectiveness in mitigating COVID-related hospitalizations and death, large numbers of Americans, including U.S. veterans, have not completed the primary vaccine series or the third/booster dose. The Veterans Health Administration (VHA) is the largest integrated health care system in the U.S. Identifying subgroups of veterans that have not completed COVID-19 vaccination and booster/third doses may inform targeted interventions to decrease disparities and promote vaccine completion. METHODS: We included veterans enrolled at VHA facilities from Jan 1, 2021 (first COVID-19 vaccinations available for highest risk veterans per CDC guidelines) through December 22, 2021. The VA COVID-19 Shared Data Resource was linked to the Corporate Data Warehouse to provide vaccination and other COVID-related clinical information, as well as demographic and social determinants data. The main study outcome was completion of the COVID-19 primary vaccine series (two doses of either mRNA vaccine or one dose of the viral vector vaccine). Secondary outcome was completion of the booster or third dose among eligible veterans. Univariate descriptive statistics determined the proportion of veterans completing vaccination by subgroup of interest;relative risks calculated statistical significance. RESULTS: Of 6,235,555 veterans, 9.5% were women;mean age was 62.9 years (+/-16.8 years);31.2% were of non-White racial/ethnic minority groups;6.7% were Hispanic. Of these, 61.7% completed primary vaccination series. Primary vaccination rates were significantly lower in younger veterans ≤ 49 years (47.2%) compared to those >50 years (67.7%). In addition, lower primary vaccination rates were found in women vs. men (57.1% vs. 62.5%);those residing in highly rural vs. urban locations (53.9% vs. 64.5%);Native Americans (56%) compared to Black/African American (64.8%), Hispanic (63.9%) or White (61.6%) veterans;those reporting food insecurity vs. not (54.9% vs. 64.3%);housing insecurity vs. not (51.6% vs. 65.1%);having had a positive vs. negative COVID-19 test prior to vaccination (45.5% vs. 71.6%);and not assigned a primary care team vs. assigned (45.2% vs. 64.5%), (all pvalues < 0.001). Of 3,672,322 eligible veterans, 33.5% received their booster/ third doses as of 12/22/21. Subgroups at risk for not having received booster/ third doses were the same as for the primary series, with the youngest veterans (18-49 years) having the lowest rates of booster/third doses compared to veterans > 50 years (16.1% vs. 36.9%). CONCLUSIONS: Based on VA data, substantial proportions of veterans remain unvaccinated-or under-vaccinated, especially younger veterans, women, Native Americans, those with food or housing insecurity, prior COVID-19, and those not assigned to primary care. Impactful interventions, including health care staff encouraging vaccine completion among more vulnerable subgroups, are needed to avoid further disparities related to adverse COVID19 outcomes.
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Introduction: In the post-pandemic period of COVID-19, the majority of cities in China try to balance the normalization of epidemic prevention and social-economic development. However, the appearance of asymptomatic infected patients poses threats to public health, which might be infectious without clinical symptoms and only be detected by testing approaches. Methods: Along with the appearance of one symptomatic case, a regional large-scale screening program was carried out in Shenzhen City charged by a regionally integrated healthcare system. After describing the screening program, a retrospective cross-sectional study for the screening outcome and efficacy was conducted. Discussion: According to the screening results, the asymptomatic case was infectious and their close contacts should be quarantined cautiously as the close contacts of symptomatic cases. Besides, after integrating medical resources in Luohu district of Shenzhen, the medical capability of Luohu district improved greatly which could be demonstrated in inspection and organization abilities in this screening program. Conclusion: The large-scale screening contributed to preventing epidemic transmission. In the post-pandemic period, regular surveillance of asymptomatic cases and rapid response capability for emergent screening program are both crucial for the prevention and control of COVID-19 epidemic. The integrated healthcare system coordinating regional medical institutions and optimizing regional medical recourse has advantages to address public health emergencies.
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INTRODUCTION: Data on COVID-19 in pregnancy are skewed toward infection at time of labor and delivery, and few studies have controlled for confounding variables. We aimed to explore the sociodemographic and health risk factors for COVID-19 at any point in pregnancy and its impact on maternal outcomes in a diverse cohort during the first year of the pandemic. METHODS: We conducted a retrospective cohort study using data ed from the electronic medical record within Kaiser Permanente Mid-Atlantic States, an integrated health care system, from March 15, 2020, to March 15, 2021. We included women at least 15 years old and pregnant during that timeframe, comparing those who tested positive for COVID-19 to those who did not.We usedmultivariable logistic regression to identify risk factors for COVID-19 infection during pregnancy.We then used propensity score matching to create a comparison group to explore associations between infection and key outcomes. RESULTS: Among 18,285 pregnant members, 1,036 (5.7%) tested positive for COVID-19 during pregnancy, with 26%, 31%, and 43%, respectively, diagnosed in each trimester of pregnancy. Patients with COVID-19 were more likely to be young, Latina, obese, and multiparous;being White or Asian was protective (P<.001). Patients with COVID-19 during pregnancy were more likely to be hospitalized apart from delivery (P=.029). There were no significant differences in fetal demise, cesarean delivery, preterm delivery, gestational diabetes, hypertensive disorders of pregnancy, venous thromboembolism, postpartum readmission, or maternal death between groups. CONCLUSION: Our study was consistent with previously identified disparities in COVID-19 infection. Outcome data were surprisingly reassuring.
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BACKGROUND: Telehealth services have rapidly expanded as a result of the COVID-19 pandemic. Emergency government action has helped encourage the use of telehealth services by temporarily removing barriers to accessing telehealth and expanding the scope of covered services. Many private payers have followed suit by expanding their coverage of telehealth services. However, it is unclear to what extent different organizations have expanded their coverage and if these changes will remain permanent. OBJECTIVE: To evaluate current and future patterns of coverage for telehealth services as a result of the COVID-19 pandemic. METHODS: An online survey was fielded during November 2020 to a panel of managed care professionals from Xcenda's Managed Care Network. Respondents included in the survey were required to be active formulary decision makers within an organization that currently covers telehealth services. RESULTS: A total of 39 respondents completed the survey. Respondents represented integrated delivery networks (23%), pharmacy benefit managers (13%), and health plans (64%);36% were regional and 64% were national organizations. Of the respondents, 95% indicated that their organization expanded the coverage of telehealth services in response to the COVID-19 pandemic. The most common services expanded were behavioral health visits (73%), primary care visits (70%), and specialty provider visits (54%). Additionally, 70% of respondents indicated that some or all telehealth services covered under the expansion would be permanent. 49% of respondents indicated that copays for telehealth services had been eliminated, and 55% indicated that reimbursement for telehealth services had increased. A majority of respondents reported an increase in home infusion (62%) and self-injectable medications (54%) as a result of COVID-19. Lastly, 19% anticipate the expansion of telehealth services to change their formulary management in the future. CONCLUSIONS: Payers have expanded coverage of telehealth services in response to the COVID-19 pandemic, removing barriers to access and expanding the scope of covered services. Telehealth services will remain a prominent mode of providing healthcare in the future.
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BACKGROUND: Care fragmentation in the elderly population prompted the need for integrated health care systems. However, evidence regarding the impact of the integrated care system in Taiwan is unclear. We aimed to conduct a systematic review to evaluate the impact of Taiwan's integrated health care programs on geriatric population. METHODS: We searched bibliographic databases MEDLINE, Embase, Web of Science, and Airiti Library for relevant publications throughout May 2022. Studies investigating the effectiveness of Taiwan's integrated care programs were included. We used the critical appraisal skills programme (CASP) checklist, to assess the risk of bias of included studies. RESULTS: Thirty-four studies, with a total of 838,026 study subjects, were assessed. The systematic review on 11 subthemes (diabetes mellitus, chronic kidney disease, hepatitis C virus, fractures, cancer, dementia, atrial fibrillation, chronic obstructive pulmonary disease, mechanical ventilation, terminal illness, outpatients and community-dwelling patients), demonstrated that the implementation of integrated health care could not only provide benefits on survival, self-care ability, health quality, physical, and functional rehabilitation outcomes, but also significantly reduce medical utilization and expenditures. CONCLUSION: The integrated health care system for multiple morbidities benefits the Taiwanese geriatric population in physical and functional outcomes. The thematic synthesis provides references for future rigorous clinical trials.
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Delivery of Health Care , Health Expenditures , Aged , Humans , Taiwan/epidemiologyABSTRACT
BACKGROUND: Digital therapeutics (DTx) have grown in recent years in terms of market size and influence. Despite increasing interest, managed care organizations face barriers around DTx management. Disparate DTx coverage has led to unequal uptake and discrepancies around utilization management (UM) strategies. Thus, an unmet need exists for elucidating DTx coverage criteria and the evidence that shapes policy development. OBJECTIVE: To understand current DTx payer coverage policy patterns and anticipated future trends. METHODS: DTx medical policy research was conducted August to September 2020 using Canary Insights (Lakewood, CO). Following this surveillance, an online survey was fielded to payers from Xcenda's Managed Care Network. Respondents familiar with DTx were asked about DTx coverage, UM, policy criteria, and COVID-19 implications for DTx management. RESULTS: Fifty respondents (54% represent health plans, 26% pharmacy benefit managers, 20% integrated delivery network) completed the survey, and 88% evaluated ≥ 1 DTx in the past 12 to 18 months. Respondents reported that mobile apps (48%) and medication adherence platforms (40%) were the most reviewed and were expected to have the greatest increase in coverage demand over the next 12 to 18 months. Respondents indicated diabetes as the highest priority (66%) with the greatest impact in addressing unmet needs (52%). For UM, DTx coverage fell under medical benefit (41%) or was product dependent (43%). In evaluating DTx, clinical effectiveness (94%), safety (82%), and FDA-approved or cleared use (78%) were indicated as absolutely needed while clinical benefit (98%), peer-reviewed publications (94%), and return on investment (88%) were most useful for coverage decisions. The most cited rationale for either covering or denying DTx was evaluation of existing efficacy and safety data vs a lack of outcomes and cost data. For reauthorization, most respondents indicated documentation of positive clinical response (80%) and total cost of care reduction (71%) as requirements for re-authorization, while citing lack of long-term clinical data (73%) as the largest barrier for establishing re-authorization criteria, and 52% of respondents were interested in subscription-based or alternative pricing models for re-authorization. Respondents indicated that the COVID-19 pandemic has not impacted DTx coverage (58%), with no changes expected in the next 12 to 18 months (46%). CONCLUSIONS: Inconsistencies in DTx payer evaluation, coverage, and UM highlight the unmet need for establishing a standardized format for DTx appraisal.
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Introduction: Acute myocarditis after coronavirus disease 2019 (COVID-19) mRNA vaccination is not well described. Recent public reports have signaled that this is an entity that requires ongoing surveillance. The goal of this study is to investigate myocarditis incidence following COVID-19 mRNA vaccination, and to report the clinical course and outcomes. Methods: This is a retrospective population-based cohort study performed at Kaiser Permanente Southern California (KPSC), an integrated health care system in California. Patients who received at least one dose of BNT162b2 (Pfizer) or mRNA-1273 (Moderna) mRNA vaccine were included. Clinically significant cases of acute myocarditis within 10 days of COVID-19 mRNA vaccination were identified between 12/14/2020 and 5/31/2021. Key demographic, clinical, laboratory, diagnostic data, and clinical course were obtained from medical record review. Results: Of 1,776,608 KPSC members who received at least one dose of COVID-19 mRNA vaccines, 12 developed acute myocarditis within 10 days following vaccination, for an estimated incidence of 6.6 cases per 1 million patients. All patients were relatively healthy White or Hispanic men between the ages of 18 and 40 years. Patients reported chest pain two to eight days after vaccine administration (Moderna N=5;Pfizer N=7). Eleven patients developed myocarditis after the second dose, and one after the first dose. Troponin I elevations ranged from 1.53-32.30 ng/mL. All cases were self-limited, with troponin peaking within 24-48 hours of admission and symptom resolution prior to discharge. None of the patients had evidence of decompensated heart failure. Length of stay was 1-4 days, with all patients discharged home and no recurrence, readmission, or major adverse cardiac events. Conclusions: Acute myocarditis after COVID-19 mRNA vaccination is a rare and self-limited event that warrants further description and investigation.
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BACKGROUND: There is a keen interest on behalf of both patients and providers in knowing whether people who are potentially immunosuppressed due to steroids, immunomodulators, or biologics are at greater risk of developing severe COVID-19 outcomes. We examined this gap for medications used for a range of immune conditions, including inflammatory bowel disease, within Kaiser Permanente Northern California, a large integrated health care delivery system that provides care for nearly 4.4 million members throughout Northern California METHODS: A total of 39,686 adults with a positive SARS-CoV-2 PCR nasal swab between 2/25 and 9/9/2020 were identified to determine the association between use of one of the above therapies in the 105 days prior to a diagnosis and subsequent hospitalization, ICU stay, and death in the 45 days after a positive test or until 9/10/2020, whichever occurred first. Medication use was ascertained from electronic pharmacy records psoriatic arthritis, ankylosing spondylitis, lupus, autoimmune hepatitis, and prevent rejection of solid organ transplants. All analyses were adjusted for known risk factors for COVID-prognosis (age, gender, race/ethnicity, body mass index, Charlson comorbidity score, hypertension) and underlying immune condition determined through ICD-10 codes. We also adjusted for the week of diagnosis to account for changing testing and treatment practices over time. RESULTS: The proportion of SARS-COV-2 positive patients using prednisone was 2.4% (n=958), immunomodulator was 0.9% (n=366), and biologic was 0.3% (n=130). A total of 10.0% (n=3,977) had at least one outcome of interest. After adjusting for use of prednisone prior to a SARS-CoV-2 diagnosis remained associated with hospitalization CI 1.47-2.63), and death (OR 2.01, CI 1.37-2.93) (Figure 1). Immunomodulator or biologic use, except for immunomodulator therapy and mortality (OR 2.39;95%CI 1.18-4.84) were not associated with severe COVID-19 outcomes. Having Crohn’s disease or ulcerative colitis did not increase the odds of hospitalization (OR 1.25, CI:0.84-1.87), ICU admission (OR 0.95, CI:0.47-1.93), or death (OR 0.97, CI: 0.43-2.17). CONCLUSION: In a large, diverse, community-based population with access to comprehensive electronic health record data, use of oral prednisone prior to SARS-CoV-2 infection was a consistent risk factor for subsequent hospitalization, ICU admission and death. Our results suggest the optimal patient management of immune-modifying therapies during the COVID-19 pandemic should focus on minimizing outpatient steroids where possible. IBD is not an independent risk factor for severe COVID-19 outcomes.(figure presented)
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Background and Objective: With the onset of the Coronavirus Disease 2019 (COVID-19) pandemic, various aspects of health care have been affected;however, there has been an unknown effect on hospital admissions for gastrointestinal (GI) diseases and the potential consequences on specific illnesses. Our study aims to characterize the rates of GI disease hospitalizations during the pandemic as compared to prior and any differences between specific gastrointestinal diseases throughout this period. This will be important in highlighting any gaps of care as related to gastroenterology during COVID-19.Methods: We conducted a retrospective, cross-sectional study between the months of January to May from the years 2016-2020 in a regional integrated health care system. January –May 2020 was delineated as the COVID-19 period. ICD-10 codes were used to identify principal diagnoses related to the most common GI hospitalizations in the United States (upper GI hemorrhage, pancreatitis, liver disease, diverticular disease, cholelithiasis). Rates of hospitalization were then calculated per 100,000 members for each calendar month and each respective year. Rates for the 5 most identified GI diseases were then calculated using a similar method from 2019 as compared to 2020. The rate of percent change for each month for these diseases were then analyzed during the pandemic year of 2020 versus the preceding year of 2019.Results: A total of 4589 (rate of 19.57 per 100,000) hospitalizations for GI related diseases occurred between January – May 2020 as opposed to 5328 (rate of 23.10 per 100,000) hospitalizations from January – May 2019 (p=0.03). The median age in 2020 was 59.1 (p= 0.27 compared to 2019) with a 51% female to male ratio. 38% of patients were White, 42% Hispanic, 10% Black, 8% Asian (p=0.58 compared to 2019 for all ethnicities). There was a decrease in the rate of hospitalization in each month from January – April 2020 compared to 2019 with a subsequent rise in May. There was a 2.86 increase in rate of hospitalization (p<0.01) from April to May 2020. There were only significant differences (p<0.05) in hospitalization rates between the months of March – May from 2020 versus 2019. Of the 5 most common GI diseases, upper gastrointestinal hemorrhage showed the highest average rate change of -20% from 2020 to 2019. Cholelithiasis had a change of -15%, pancreatitis with a change of -14%, diverticular disease with a change of -11%, and liver disease with a change of -9%.Conclusion: GI related hospitalizations decreased during the COVID-19 pandemic as com-pared to the previous year. Upper gastrointestinal hemorrhage showed the most average rate change of the GI diseases. Further studies highlighting the implications of these findings, such as mortality and severity of illness during the pandemic, need to be completed to assess the impact COVID-19 on GI disease.(Figure presented)(Table Presented)