Insurance Issues Research Articles

1795. Evaluation of Appropriate Daptomycin Usage in an Academic Medical Center

Abstract Background The usage of daptomycin at our institution has steadily increased, with a threefold increase from Jan 2020 to Jan 2022 according to Days of Therapy Data. The increased usage prompted this study to determine whether daptomycin use at our institution is appropriately indicated and supervised by the infection disease service. Methods We conducted a retrospective descriptive study on 74 patients who were selected randomly from a total of 234 pts who received daptomycin at our facility in Northwest Louisiana over the past two years. We studied the patient's age and gender, type of infection, indications, empiric versus targeted therapy, culture results, infectious disease consultation, and reason for early discontinuation. Results Seventy-four pts were included in the analysis. The median age was 53.50 (22-90 yrs), and 47 pts (63.5%) were male. The most common infections were bone and joint (37, 50.7%), followed by bacteremia (22, 30.1%), followed by infective endocarditis (4, 5.5%). The infectious disease service was consulted before administration of daptomycin in 87.3% (62 patients). In 70.3% (52 patients), daptomycin was used as targeted therapy. MRSA was the most common bacteria for which daptomycin was used (29, 42.6%), followed by Enterococcus faecalis (10, 14.7%) and Coagulase-negative staphylococcus (8, 11.8%). Fifty-five pts (74.3%) received vancomycin before switching to daptomycin. The most common indications was MRSA with vancomycin MIC ≥ 2 mcg/ml (25, 33.8%), followed by as an alternative to vancomycin in acute renal failure (14, 18.9%), followed by clinical or/and microbiological failure on the previous antibiotic regimen (10, 13.5%). Thirty-six pts (48.6%) completed their course, 20 (27%) pts had early discontinuation, 11 pts (14.9%) were lost to follow-up, 4 pts (5.4%) were still on daptomycin at the time of data collection, and 3 pts (4.1%) died during hospitalization. The most common cause of early discontinuation was the culture growing pathogen necessitating discontinuation of daptomycin (7 patients, 35%), followed by insurance issues that account for 15%. Conclusion Most daptomycin usage in our institution was wisely indicated under the supervision of the infectious disease service and was primarily used as targeted therapy. Disclosures All Authors: No reported disclosures.

A qualitative inquiry into the patient-related barriers to linkage and retention in HIV care within the community setting

BackgroundPeople with the Human Immunodeficiency Virus (PWH) experience barriers to care within the community that impedes their progress from when they discover that they are HIV positive to becoming virally suppressed. For individuals with HIV to achieve sustained viral suppression, they must be linked to care to start receiving anti-retroviral therapy and remain retained in care for continuous treatment. However, HIV surveillance data shows that many PWH are not linked to care and become lost to continuous follow-up care. Although pharmacists, PWH, and social workers interact with one another and are aware of their roles in HIV care, their perspectives on barriers to linkage and retention in care have not been investigated collectively. ObjectivesExplore the perspectives of PWH, pharmacists, and social workers on barriers to linkage and retention of HIV care within the community setting. MethodsConvenience sampling was used to recruit 15 stakeholders (five PWH, five community pharmacists, and five social workers) who participated in 1-h, semi-structured interviews based on three domains of the Patient-centered Medical Home Model including (1) experiences (individual and system-level barriers to care experienced by PWH), (2) activities (social workers and pharmacists initiatives that impact adherence to care)and (3) interventions (critical issues pharmacists can address in the community to engage PWH in their HIV care). We conducted a directed content analysis based on deductive coding. To establish rigor, we focused on Lincoln and Guba's criteria of rigorous qualitative methodology: credibility, dependability, confirmability, and transferability. Similarities and divergences of themes were discussed during data analysis and agreement was reached before interpretation. ResultsEmergent themes uncovered barriers to linkage and retention in HIV care as HIV-related stigma, having mental health illnesses including a history of substance abuse and social determinants of health such as homelessness, food insecurity, and insurance issues. ConclusionThe perspectives of pharmacists, social workers, and PWH can provide insight into barriers that should be identified and addressed in people living with HIV to enhance their linkage and retention in care.

Venous thromboembolism prophylaxis following colorectal surgery: a survey of American Society of Colon and Rectal Surgery (ASCRS) member surgeons.

Postoperative venous thromboembolism (VTE) is associated with significant morbidity. Evidence from other surgical specialties demonstrate inadequate use of extended VTE prophylaxis following cancer surgery. While guidelines recommend extended VTE prophylaxis for patients undergoing surgery for colorectal cancer (CRC), it is unknown to what extent colon and rectal surgeons adhere to these recommendations. An 18-question online survey was distributed to all surgeon members of the American Society of Colon and Rectal Surgeons (ASCRS). The survey was designed to capture knowledge, attitudes, and practices regarding ASCRS VTE prevention guidelines. Questions were also designed to elucidate barriers to adopting these guidelines. The survey was distributed to 2,316 ASCRS-member surgeons and there were 201 complete responses (8.7% response rate). Most respondents (136/201, 68%) reported that they were familiar with ASCRS VTE prevention guidelines and used them to guide their practice. Extended VTE prophylaxis was reported to be routinely prescribed by the majority of surgeons following CRC resection (109/201, 54%), with an additional 27% reporting selective prescribing (55/201). The most frequently reported reasons for not prescribing extended VTE chemoprophylaxis following CRC resection included patient compliance and insurance/copay issues. Most ASCRS-member surgeon respondents reported that they are familiar with ASCRS VTE prevention guidelines, though only 54% surgeons reported routinely prescribing extended VTE prophylaxis following CRC surgery. Patient compliance and insurance issues were identified as the most common barriers. Targeted interventions at the surgeon, patient, and payer level are required to increase the use of extended VTE prophylaxis following CRC resection.

Factors Influencing Patient Preferences for Phototherapy: A Survey Study

There is limited literature regarding patient preferences for phototherapy. Patients may consider different forms of phototherapy depending on a multitude of factors important to them, including safety, cost, efficacy, insurance issues, and convenience. This study aimed to determine which form of phototherapy-in-office UVB, at-home UVB, home tanning, salon tanning, and sunbathing-was preferred by survey participants and the reasons for their preferences. Additionally, participants were asked which forms of phototherapy they considered safest and most efficacious, cost-effective, and convenient.

Barriers and facilitators to diabetes screening and prevention after a pregnancy complicated by gestational diabetes.

Gestational diabetes mellitus (GDM) is increasing in the United States, with higher rates among minoritized racial and ethnic populations and lower income populations. GDM increases risk for type 2 diabetes (T2DM), and postpartum diabetes screening and prevention are imperative. This qualitative study examines barriers and facilitators to postpartum T2DM screening and prevention among non-privately insured individuals with a history of GDM in a state prior to Medicaid expansion. Thirty-six non-privately insured women with a history of GDM completed semi-structured interviews. Four focus groups and seven interviews were conducted with 30 nurse practitioners, physicians, physician assistants, nurses and registered dietitians from Federally Qualified Health Centers in St. Louis, MO. Interviews and focus groups were audio-recorded and transcribed. Data were analyzed using an integrative thematic analysis informed by the socio-ecological model. Barriers and facilitators to T2DM screening and prevention occur across multiple environments (society, healthcare system, interpersonal, and individual). Societal barriers include insurance issues, unemployment, and lack of transportation, childcare, safe housing, and healthy food access, while facilitators include government sponsored programs and community organizations. Healthcare system barriers include care fragmentation, scheduling policies and time constraints while facilitators include care coordination, pregnancy support groups, and education materials. Interpersonal barriers include negative care experiences, cultural differences, communication challenges, competing priorities, and lack of a social support network, while facilitators include family and friend support and positive care experiences. Individual barriers include health complications and unhealthy food and exercise patterns, while facilitators include child wellbeing, empowered attitudes and healthy food and exercise patterns. The socioecological model highlights the societal and systemic determinants that encompass individual and interpersonal factors affecting postpartum T2DM screening and prevention. This framework can inform multi-level interventions to increase postpartum T2DM screening and prevention in this high-risk population, including policy changes to alleviate higher-level barriers.

Transition from Initial Therapy to Hematopoietic Cell Transplantation for Non-Favorable Risk Acute Leukemia and MDS Patients in the Era of Haploidentical Donor Availability: Assessment of Efficacy, Barriers and Racial Disparities in 269 Consecutive Patients Treated in an Integrated Leukemia/HCT Program

Hematopoietic cell transplantation (HCT) remains the most effective consolidation therapy in patients with non-favorable risk acute leukemia (AL) and MDS. However, prior studies have demonstrated that only a relatively small proportion of patients who may benefit, actually proceed to HCT. Lack of timely access to conventional matched donors, and delays in referral to transplant physicians have historically been important obstacles. At our center, AL care and HCT services are provided by the same physicians eliminating referral delays, and donor search/ transplant evaluation for all patients is commenced at program entry. Furthermore, HLA-haploidentical (haplo) donors have routinely been utilized since 2006. We hypothesized that these factors would increase the proportion of AL patients proceeding to HCT and decrease time to transplantation. We also analyzed other barriers to transplantation at our center, which includes a relatively high proportion of treated black patients. Methods: All patients aged <75 receiving initial therapy at our center for non-favorable risk AML, ALL or MDS between 2016 and 2021 were included. Non-favorable was defined as intermediate and poor-risk AML by NCCN criteria, NCCN poor-risk ALL patients (age <40) and all ALL patients aged >40), MDS EB-1 and EB-2 and CMML). Data were extracted from our institutional leukemia and transplant database where they had been prospectively entered. Results: Of 269 consecutive patients who received initial therapy at our center for non-favorable risk AL and MDS between Jan 2016 and Dec 2021, 160 (59.5%) proceeded to HCT at a median of 119d (range 58-910d) from initial therapy. For patients who did not proceed to HCT, most common cited reasons were: comorbidities (36.7%), poor KPS, lack of adequate caregiver support, refractory malignancy (19% each) and patient refusal (17.4%) (Table 1a). Lack of a donor and insurance issues were rarely a cause (3% each). For patients aged <60, 71% proceeded to HCT versus only 47.3% of patients aged 60-75 (p<0.001). Comorbidities (15% vs 49.3%, p<0.001) and KPS (10% vs 24.6%, p=0.06) were less common as reasons for not proceeding to transplant in patients aged <60 vs 60-75, whereas lack of caregiver support was more common in patients aged <60 (30% vs 13%, p=0.031). Of 73 black patients treated, 52.1% received HCT vs 60.2% of 181 treated white patients (p=0.23)(Table 1b). However, lack of caregiver support (37.1% vs 11.1%, p=0.002) and induction death (17.1% vs 5.6% p=0.05), were more common reasons in black patients for no HCT. AML and ALL patients had a similar likelihood of proceeding to HCT (57.6% vs 61.6%) but refractory disease was more common in AML (25.6% vs 3.6%, p=0.012) as a reason for no HCT. For AML patients, a higher proportion of patients with intermediate risk disease vs poor-risk disease proceeded to HCT (71.7% vs 50.8%, p=0.007). On logistic regression analysis, age (OR 1.46 per 10 yr increment, p<0.001) and NCCN poor-risk (OR 1.83, p=0.032) were significant factors for failure to proceed to HCT. Characteristics of patients who proceeded to HCT were: median age 55 (18-75); 49% male; race- white 68%, black 24%, Asian 7%; donor -haplo 41%, MRD 29%, MUD 22%, auto 8%; cell source- PBSC 93%, BM 4%, CBU 3%; disease status - CR1 83%, other 17%. Median time from initial treatment to HCT were shorter for AML vs ALL (114 vs 136 d, p=0.002), MRD and haplo vs MUD - 113d each vs 148 d, p=0.011) but were similar for black vs white patients (112d vs 120d, p=0.91). In a landmark analysis, patients receiving HCT within 6 months since starting treatment had significantly better OS than those without HCT within 6 months (Fig 1). On multivariable Cox analysis assessing transplant as a time-dependent covariate, adjusting for patient age and year of treatment, HCT was of significant benefit compared to no-HCT for overall survival (HR 0.59, p=0.012) and disease-free survival (HR 0.64, p=0.025). Conclusions: Our data suggest that in a modern cohort treated within an integrated AL/HCT program incorporating routine use of haplo donors, up to 60% of all treated patients (71% for age <60) with non-favorable risk AL and MDS can proceed to HCT in a median of 118 d from initial treatment. This approach results in no significant difference in proportion transplanted or time to HCT between black and white patients but caregiver support maybe a greater barrier in black patients. HCT is associated with a significant survival benefit. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Phase II Study of PD-1 Blockade Following Fludarabine/Melphalan-Based Autologous Transplantation for Acute Myeloid Leukemia Patients Ineligible for Allogeneic Transplant

Allogeneic transplant (allo) remains the best post-remission therapy for non-favorable risk acute myeloid leukemia (AML) patients, secondary to the potent graft-versus-leukemia (GVL) effect of donor immune cells. Unfortunately, some patients may be ineligible for allogeneic transplant due to psychosocial barriers (e.g. lack of appropriate caregiver support) or unavailability of a suitable donor. Inhibition of the programmed cell death protein-1 (PD-1) pathway is an effective immunotherapeutic anti-cancer strategy for a number of malignancies. We hypothesized that PD-1 blockade following autologous transplant might simulate an allogeneic GVL effect and represent an alternative post-remission strategy in patients with non-favorable risk AML. To this end, we initiated a phase II study whereby AML patients deemed ineligible for allogeneic transplant received a high dose preparative regimen consisting of fludarabine on day -4, -3, -2 (30mg/m2/d) and melphalan on day -1 (180mg/m2 for age ≤60, 140mg/m2 for age >60), followed by autologous stem cell transplantation and post-transplant pembrolizumab starting day +1 (200mg/dose q3weeks x 8 doses) (auto-pembro). Eligible patients were AML patients beyond CR1 or non-favorable CR1 patients, including c-kit-mutated core-binding factor and FLT3-ITD+/NPM1+ AML. Of 32 patients consented/screened for the study, 20 received protocol-directed therapy from January 2017 to July 2021. Reasons for not receiving transplant were mobilization failure [6], failure to achieve CR [2], patient refusal [2], compliance issues [1] and insurance issues [1]. Baseline patient characteristics included a median (range) age of 64 (26-75) years, KPS <80 in 30%, HCT-CI ≥3 in 85% and non-Hispanic white in 45%. Disease characteristics included ELN 2017 favorable, intermediate and adverse risk in 20%, 40% and 40%, disease-risk index low, intermediate and high in 10%, 75% and 15%, secondary/treatment-related in 20%, CR1 status in 80%, and pre-BMT measurable residual disease (MRD) in 30%. Treatment was well tolerated in only 1 non-relapse death. Infections included 5 patients with bacterial infections, 2 with CMV viremia, 1 with localized VZV and 1 patient with HHV6 reactivation. Grade 3 non-hematologic toxicities included febrile neutropenia (30%), nausea/vomiting (25%), diarrhea (25%), hypertension (20%) and stomatitis/esophagitis (15%). There were no study-related grade 4 or 5 toxicities. Possible immune-related adverse events included 4 cases of hypothyroidism, 2 cases of colitis and 1 case each of pneumonitis, erythema multiforme and seronegative arthritis. After a median follow-up of 80 months (range, 15-134), 14 patients remain alive with 10 in continuous remission. Estimated 3-yr OS, DFS, NRM and CIR was 66%, 48%, 5% and 47% respectively. Transplant outcomes in auto-pembro recipients were compared to a contemporaneous cohort of consecutive AML patients receiving allo transplant in first or later CR (n=112) by Cox proportional hazards model, adjusting for significant demographic and risk variables. Compared with allo recipients, auto-pembro recipients were less likely to be non-Hispanic white (45% vs. 69%) and male (35% vs. 59%) but were otherwise similar in regard to baseline patient and disease characteristics. In multivariable analysis, OS and DFS were significantly impacted by age, ELN risk and year of transplant. In contrast, transplant type (auto-pembro vs. allo) had no effect on OS (HR 0.58, p=0.24) or DFS (HR 1.19, p=0.65). Adjusted 3-yr OS and DFS was 76% vs. 66% and 54% vs. 62% respectively (see figure). Although relapse was significant higher following auto-pembro (HR 2.38, p=0.031), it was offset by a corresponding decrease in NRM risk. In conclusion, auto-pembro is a safe and effective consolidation therapy for non-favorable AML patients who are ineligible for allo transplant, with comparable adjusted survival outcomes. Correlative studies are planned to analyze anti-leukemic effect of post-transplant PD-1 blockade following autologous transplant in AML patients. Given these promising results in non-favorable-risk AML patients lacking an allogeneic transplant consolidation option, confirmation in a larger multicenter prospective study is warranted. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Safety of Deferiprone in Patients with Myelodysplastic Syndromes: Results from the Deferiprone US Safety Registry and a Compassionate Use Program

Background: Myelodysplastic syndromes (MDS) are a heterogenous group of hematopoietic stem cell malignancies characterized by ineffective blood cell production. Treatment can include frequent blood transfusions, which may lead to iron overload and subsequent complications. Several treatment guidelines recommend iron chelation therapy (ICT) for lower-risk patients with MDS based on transfusion burden, ferritin level, or iron overload imaging studies. However, ICT options are limited for patients with MDS because deferoxamine is administered parenterally and requires a burdensome infusion regimen that may reduce treatment adherence. Deferasirox is administered orally and requires closely monitoring a patient's renal and hepatic function; deferasirox is contraindicated in patients with significant renal impairment (estimated glomerular filtration rate <40 mL/min/1.73m2), a frequent comorbidity in the primarily geriatric population of patients with MDS. Deferiprone (DFP) is an oral ICT approved for transfusional iron overload in thalassemia, sickle cell disease, and other anemias. Although DFP has no contraindication or dosing adjustment based on renal function, it requires close patient monitoring and laboratory testing, since its use is associated with severe neutropenia (absolute neutrophil count <0.5x109/L) in 1-2% of patients. While existing studies have evaluated the effects of DFP in patients with MDS, limited data on its safety are available for this patient population. Objective: To evaluate the DFP safety profile in patients with MDS from a US safety registry and a compassionate use program. Methods: The DFP US safety registry was established to meet FDA postmarketing requirements following DFP approval in the US in 2011. The registry assessed all reports of adverse events (AEs) in all patients, including those with MDS, from 2011 to 2021. The compassionate use program included patients in the US and Canada from 1996 to 2015. All AEs were assessed in all patients with MDS who received this chelator. In both the safety registry and the compassionate use program, DFP was administered at doses that ranged from 75 - 99 mg/kg/day. AEs were assessed irrespective of a causal relationship with DFP. Results: The US safety registry included 115 adults with MDS (mean ± SD age: 77.7 ± 9.0 y; 61.7% males). Mean ± SD DFP exposure was 1.1 ± 1.4 y (range: 0-7.9 y), with 59 (51.3%) patients receiving DFP for > 6 mo and 34 (29.6%) for > 12 mo. Reasons for discontinuation (> 1 patient) included death (n=30), physician direction (n=26), adverse reaction (n=16), hospice care (n=12), nonresponsive patient (n=6), insurance issues (n=4), and switching to another chelator/formulation (n=3). Observed AEs are summarized in Table 1. The most common AEs were diarrhea (n=34), nausea (n=32), vomiting (n=26), and fatigue (n=26). No deaths were attributed to DFP. In 3 patients, neutropenia was reported in temporal association with fatal outcome, but none were attributed to DFP. Four patients (3.5%) reported severe neutropenia/agranulocytosis: 2 events resolved; 1 case outcome was not reported; and 1 case was ongoing at last follow-up. The compassionate use program included 15 adults with MDS (mean ± SD age: 67.9 ± 10.4 y; 60% males). Mean ± SD DFP exposure was 1.2 ± 2.3 y, with a median (range) of 0.7 y (0-9.1 y). Reported AEs are summarized in Table 2. The most common AEs were nausea and decreased neutrophil count (n=3 each). There were 2 cases of severe neutropenia/agranulocytosis; both resolved. Conclusions: The findings of the safety registry and a compassionate use program suggest the DFP safety profile in MDS is potentially consistent with that of thalassemia, sickle cell disease, and other anemias. No unexpected AEs and no new safety concerns were found. The frequency of the most serious AE associated with DFP, severe neutropenia/agranulocytosis, was 3.5% within this population; of reported outcomes, all resolved. In the compassionate use program, 13.3% of patients reported agranulocytosis, which is higher than what has been shown in patient populations without MDS (2%); however, it is not clear if this percentage is higher than other ICT agents used in MDS, due to the patients' primary disease, or the relatively small sample size. While acknowledging these limitations and observational nature of the data, DFP may be a viable ICT for patients with lower-risk MDS. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Crizanlizumab Use in Recurrent Neurologic Symptoms Attributed to Sickle Cell Disease Induced Moyamoya Syndrome

Sickle cell disease (SCD) is a genetic disorder that affects about 100,000 Americans and carries the risk of significant complications including ischemic stroke. Moyamoya syndrome (MMS), a complication of SCD, is characterized by progressive stenosis of carotid arteries leading to ischemic stroke (Dobson, et al). To reduce these complications, the mainstay of treatment of SCD, until recently, has been transfusion and hydroxyurea. In 2019, the FDA approved the monoclonal antibody crizanlizumab. Crizanlizumab binds and blocks p-selectin to prevent downstream cell to cell interactions, including platelet aggregation, thereby improving blood flow and preventing vaso-occlusion (Ataga, et al). We report a case of a sickle cell patient with recurrent neurological symptoms and MRI findings of MMS that unexpectedly resolved with crizanlizumab treatment. A 26 year old woman with history of vitamin B12 deficiency, HbSS disease complicated by silent cerebral infarct in childhood treated with hydroxyurea and red blood cell (RBC) exchange presented to the hospital with left lower extremity weakness. She reported that her sickle cell crisis typically manifested with left sided weakness rather than pain. Her most recent RBC exchange six days prior had revealed a hemoglobin S level of 11.8%. Her initial workup including MRI brain demonstrated right parietal encephalomalacia and evidence of chronic ischemic change of the right frontal and parietal lobes consistent with previously known silent ischemia of the right middle cerebral artery (MCA). There was no evidence of acute stroke. The patient continued monthly RBC exchange, maintaining a hemoglobin S level less than 36% and continued to experience symptoms of intermittent weakness, typically of the left lower extremity, but also at times involving the bilateral lower extremities and left upper extremity. Repeat MRI brain did not demonstrate any additional acute infarctions. However brain MRA did reveal bilateral stenosis of the MCA arteries and high-grade stenosis of the M1 segment and considered stable from previous MRI, consistent with MMS. Her symptoms continued intermittently and additional evaluation including MRI cervical, thoracic, and lumbar spine was unrevealing. Of note, at one point laboratory evaluation demonstrated a vitamin B12 level of 248 pg/mL, however her symptoms continued in spite of adequate repletion. Approximately 21 months following her initial presentation, the SARS-CoV-2 pandemic began, resulting in limited access to hospital facilities including RBC exchange. Consequently the patient was started on crizanlizumab with intermittent simple transfusion for hemoglobin less than 8 g/dL in an effort to see if this therapeutic measure would alleviate her symptoms. Interestingly, after initiating crizanlizumab, even without continued RBC exchange and a hemoglobin S level of 83%, she had no further episodes of weakness until, due to insurance issues, her crizanlizmab was delayed. Subsequently her symptoms of weakness returned requiring hospital admission. Repeat workup including both MRI and MRA brain were negative for acute ischemia and again consistent with MMS. Resumption of crizanlizumab again alleviated symptoms until infusion was delayed again for insurance reasons. She was readmitted and repeat MRI and MRA of the brain again did not show acute ischemia. Given recurrent issues with insurance and easing of the SARS-CoV-2 pandemic restrictions she was resumed on both red-cell exchange followed by crizanlizumab and continues to do well to this day. SCD carries significant potential neurological morbidity and mortality. SCD patients experience a significantly higher risk of stroke due to repeated vaso-occlusive events leading to cerebral ischemia and the development of MMS. This is the first case we are aware of in which a patient with sickle cell disease and MMS and worsening neurologic symptoms but without acute stroke was successfully was treated with crizanlizumab after failure of RBC exchange. Crizanlizumab targets P-selectin which is implicated in increased platelet aggregation in sickle cell disease. It is possible that crizanlizumab improved the patient's symptoms by reducing the risk of transient cerebral ischemia associated with her underlying abnormal vasculature, which was suspected due to acute cerebral vaso-occlusion secondary to sickle cell disease induced moyamoya syndrome.

Continuous Glucose Monitoring in Primary Care: Understanding and Supporting Clinicians' Use to Enhance Diabetes Care.

Diabetes affects approximately 34 million Americans and many do not achieve glycemic targets. Continuous glucose monitoring (CGM) is associated with improved health outcomes for patients with diabetes. Most adults with diabetes receive care for their diabetes in primary care practices, where uptake of CGM is unclear. We used a cross-sectional web-based survey to assess CGM prescribing behaviors and resource needs among primary care clinicians across the United States. We used descriptive statistics and multivariable regression to identify characteristics associated with prescribing behaviors, openness to prescribing CGM, and to understand resources needed to support use of CGM in primary care. Clinicians located more than 40 miles from the nearest endocrinologist's office were more likely to have prescribed CGM and reported greater likelihood to prescribe CGM in the future than those located within 10 miles of an endocrinologist. Clinicians who served more Medicare patients reported favorable attitudes toward future prescribing and higher confidence using CGM to manage diabetes than clinicians with lower Medicare patient volume. The most-needed resources to support CGM use in primary care were consultation on insurance issues and CGM training. Primary care clinicians are interested in using CGM for patients with diabetes, but many lack the resources to implement use of this diabetes technology. Use of CGM can be supported with education in the form of workshops and consultation on insurance issues targeted toward residents, recent graduates, and practices without a nearby endocrinologist. Continued expansion of Medicare and Medicaid coverage for CGM can also support CGM use in primary care.

S943 A New Population With Inflammatory Bowel Disease: Clinical Characteristics of IBD in the Chaldean Population

Introduction: The Chaldean people originate from ancient Babylon, Mesopotamia, known as Iraq in modern times, with a population of approximately 2 million, with 500,000 in the US. It has been anecdotally observed that many Chaldeans suffer from inflammatory bowel disease (IBD), however there is little known about IBD in this population. Cho et al. described four Chaldean families and reported linkage and linkage disequilibrium at chromosome band 1p36 associated with IBD, but no clinical characteristics have been described. The aim of this study is to describe the clinical characteristics of IBD in the Chaldean population. Methods: This was an online survey study sent to the Chaldean community in Michigan via social media platforms. Data collected included demographic information, IBD specific characteristics, family history and barriers to seeking care. Patients who were < 18 years old (y), did not identify as Chaldean or have a diagnosis of IBD were excluded. Results: A total of 74 patients completed the survey (18 excluded due to age, diagnosis uncertainty). Of the 56 completed surveys, 25 (44.6%) with ulcerative colitis (UC), 22 (39.2%) with Crohn’s disease (CD), 9 (16%) with IBD-unspecified (IBD-U). Median age 31y (Range 19-55y), median duration of disease 9y (Range 1-28y) and median age of onset of disease 25y (Range 5-52y). 42 (75%) were females. 12 (21%) have a history of surgery for disease complications. 35% have first degree relative with IBD, 53% have second degree relative with IBD. 66% report delays in seeking medical attention after first symptoms, with minimization of symptoms and embarrassment being the most common reasons. Other reasons included fear, insurance issues and life stressors. (Table) Conclusion: This is the first study to describe clinical characteristics of Chaldean patients with IBD. We found similar rates of UC and CD in our survey population. There are more Chaldean females with IBD, compared to equal rates of males and females with IBD in the general population. In the Chaldean population, we found a significantly higher family history of IBD than the general IBD population which is reported at 8-14%. Despite a strong family history and presumed more exposure to those with IBD, most patients delay seeking medical attention for their symptoms. Further studies are indicated to describe IBD characteristics, clinical course, prognosis and genetic evaluation in the Chaldean population. Table 1. - Title: Demographic and Clinical Characteristics of 56 Chaldean Patients with IBD Variables N=56 Median age, y (Range) 31 (19-55) Median age of diagnosis, y (Range) 25 (5-52) Median duration of disease, y (Range) 9 (1-28) Females, n (%) 42 (75) Delays to seeking care, n (%)1 37 (66) Minimization of symptoms, n (%) 10 (42) Embarrassment, n (%) 6 (25) Fear, n (%) 3 (13) Life stressors, n (%) 3 (13) Insurance barriers, n (%) 2 (8) 1= 24 participants provided reasons for delays to seeking care; y = years

Characteristics Associated with Barriers to Eye Care: A Cross-Sectional Survey at a Free Vision Screening Event

Introduction: Social determinants of health can limit access to regular eye care, but their role in ophthalmology is underexamined. The purpose of this study is to assess the relationship between patient characteristics and self-reported barriers to eye care. Methods: This anonymous, cross-sectional survey was conducted at a 2-day free eye clinic event in Pittsburgh, Pennsylvania. Adult patients presenting for vision screening were eligible to participate. Patient characteristics (demographics, health status) and self-reported barriers to eye care were collected. Predictors of barriers to eye care were analyzed using binary logistic regression. Results: Of 269 eligible, consecutive patients approached for survey completion, 183 comprised the volunteer sample. The 183 participants (105 female patients [59%]) had a mean (standard deviation) age of 53 (15) years and generally self-identified as Black (74, 46%) or White (67, 41%). While a third reported having no health insurance (60, 34%), the remaining two-thirds of participants had public (84, 48%) or private coverage (34, 19%). Three-quarters of respondents reported at least one barrier to receiving regular eye care (136, 76%), most commonly medical costs (89, 50%) and insurance issues (73, 41%). Not having health insurance or vision insurance was strongly associated with reporting at least one barrier to care (OR: 5.00, p = 0.002, and OR: 7.46, p < 0.001, respectively). Those with self-reported eye disease were more likely to report transportation difficulties (OR: 4.45, p = 0.013), and employed participants reported difficulty getting time off work to attend eye exams (OR: 7.73, p = 0.002). Finally, compared to Black race, White race was associated with a higher likelihood of reporting any barrier to care (OR: 2.79, p = 0.013). Conclusion: Three-quarters of vision screening attendees reported at least one barrier to regular eye care, most commonly medical costs and insurance.

The Virtuous Hospital: A Catholic Organizational Healthcare Ethics

This paper addresses a perennial problem in Catholic organizational healthcare ethics. Catholic and secular ethicists have acknowledged that organizational healthcare ethics is underdeveloped. Scholars have traditionally focused on the “micro” issues arising in the clinical setting or the “macro” issues of national healthcare policy and health insurance. The “meso” or healthcare organizational level, involving both healthcare systems and hospitals has received far less attention. As a result, contemporary organizational healthcare ethics lacks a developed conceptual framework with which to analyze and guide the decision-making of HCOs. The paper responds to two specific deficiencies in the field. First, organizational ethics undertheorizes sociological realities. Second, the field employs exceedingly thin and incoherent ethical frameworks. Although scholars have introduced the term "organizational virtue," they have yet to develop a robust account of the concept leaving healthcare leaders incapable of assessing organizational character or guiding moral decision-making. In sum, because neither "organization" nor "ethics" is well articulated, the entire project of organizational healthcare ethics loses its capacity to explain, guide, and assess human action and social outcomes. The paper directly addresses these deficiencies. First, it offers greater precision in the use of sociological terminologies, such as "structure," "institution," "organization," and "culture." Using critical realist social theory, the paper distinguishes between a social structure in the general sense, which is a “web of relations among social positions,” and an organization, which is a highly complex social structure containing positions of authority. Next, it synthesizes organizational theory with virtue theory to develop an account of organizational virtue ethics capable of aiding in organizational moral decision-making and assessment. It then articulates cardinal organizational virtues, including organizational prudence, justice, beneficence, and solidarity. The paper then applies the cardinal organizational virtues to a composite case.

A Cross-Sectional Survey Reporting on the Value of Patient-Centered Ostomy Programs: A Smooth Transition After Ostomy Surgery.

PURPOSE:The purpose of the study was to evaluate a postsurgical ostomy patient support program in regard to postsurgical experience, education, skin care, pouching system and accessory use, insurance issues, supplier assistance, hospital readmission status, and the benefit of multiple interactions.DESIGN:Cross-sectional design.SUBJECTS AND SETTING:Potential respondents were randomly selected from a group of adults 18 years or older who underwent ostomy surgery within 6 months prior to survey completion. Nine hundred seventy-one individuals met inclusion criteria, and 297 were selected for analysis, based on having 1 or more program interactions. Data were collected between the second and third quarters of 2020. All participants were residents of the United States.METHODS:Participants were contacted by e-mail containing an invitation to participate in a survey; the e-mail also described the intent of the survey. Survey distribution was conducted by the sponsor and linked to a third-party survey management organization for compilation. The survey questionnaire, developed specifically for the purpose of this study, comprised 73 items that queried demographic and pertinent clinical data, participation in an industry-sponsored patient support program, and their post–hospital discharge experiences including unplanned health care provider visits, emergency department visits, and hospital readmissions.RESULTS:Eighty-three percent (n = 237) of respondents did not have postsurgical ostomy-related emergency department visits, 75% (n = 223) did not have related unplanned physician visits, and 90% (n = 268) did not have related hospitalizations. Participants with 2 or more interactions were more likely to contact a program representative for issues of stoma care, leakage and skin care, ostomy products/accessories, and supplier issues than their single-interaction counterparts.CONCLUSIONS:Study findings suggest that patients with new ostomies benefited from engagement in an industry-sponsored patient support program. The benefit appears to arise from personal interactions and respondents; 2 or more interactions were shown to have greater benefit than a single interaction.

Patient perspectives on barriers in obtaining timely abortion care in Los Angeles, California

ObjectivesAlthough California is a state with supportive abortion policies, recent evidence suggests people may still encounter barriers to obtaining timely abortion care. To provide an in-depth understanding of these barriers and augment existing literature focusing on restrictive and hostile states, we sought to understand the patient perspectives of barriers to timely abortion care in Los Angeles, California. Study designWe recruited participants from two, high-volume urban clinical sites and conducted semi-structured interviews with 17 individuals who visited three or more clinics and/or encountered more than 2 weeks between seeking and obtaining their abortion. Using thematic analysis, we analyzed deidentified transcripts by first developing and applying codes, then identifying overarching themes to describe barriers to timely abortion care. ResultsParticipants described three primary barriers leading to abortion care delay: (1) difficulties in ensuring insurance coverage or securing authorization for abortion care from private/employer-sponsored insurance, (2) inadequate screening resulting in multiple appointments where desired care could not be provided, and (3) difficulties with expeditious referrals to appropriate clinical sites. Participants also described accumulated fatigue from facing layers of resistance when pursuing avenues for care. ConclusionsEven in supportive abortion policy states, barriers to abortion care from insurance, screening, and referral-related issues may result in delayed or unaccessed care, negatively impacting patient experience. Understanding and mitigating reasons for delays are critical to improving patient experience with abortion care. ImplicationsStandardized telephone triage at local clinic facilities and streamlined MediCal authorization of abortion services may mitigate barriers to timely abortion care.

Brief Report: Previous Preexposure Prophylaxis Use Among Men Who Have Sex With Men Newly Diagnosed With HIV Infection in King County, WA.

Preexposure prophylaxis (PrEP) discontinuations are common and are associated with subsequent HIV acquisition. The population-level impact of PrEP discontinuations is unknown. Public health staff routinely asked men who have sex with men (MSM) with newly diagnosed HIV infection about their history of PrEP use as part of partner notification interviews in King County, WA, from 2013 to 2021. We assessed trends in the proportion of MSM who ever took PrEP and described reasons for PrEP discontinuation. A total of 1098 MSM were newly diagnosed with HIV during the study period; of whom, 797 (73%) were interviewed, and 722 responded to questions about their history of PrEP use. Ninety-four (13%) reported ever taking PrEP. The proportion of MSM who ever used PrEP before HIV diagnosis increased from 2.3% in 2014 to 26.6% in 2020-2021 ( P < 0.001 for trend). The median time from PrEP discontinuation to HIV diagnosis was 152 days, and median duration on PrEP was 214 days. Common reasons for stopping PrEP included self-assessment as being at low risk for HIV, side effects, and insurance issues. Nineteen men were on PrEP at the time of HIV diagnosis; mutations conferring emtricitabine/tenofovir resistance were identified in 8 (53%) of 15 men with available genotype data. More than 25% of MSM with newly diagnosed HIV from 2020 to 2021 had ever used PrEP. More than 50% who discontinued PrEP were diagnosed <6 months after stopping. Strategies to preempt PrEP discontinuations, enhance retention, and facilitate resumption of PrEP are critical to decrease new HIV diagnoses.

Work-related and non-work-related fatal road accidents: Assessment of psychoactive substance use in commuting.

Commuting road traffic collisions (RTCs) are one of the main causes of occupational death worldwide, including Italy. Among the prominent yet relatively understudied personal risk factors in the subpopulation of workers, there is the use of psychoactive substances. Since the phenomenon of driving under alcohol and drugs effects in the commuter sub-population has so far been poorly studied, we carried out a study by comparing results obtained from the analysis of commuters and non-commuters. The percentage of commuting RTCs victims was 10.4% out of all the RTCs. Commuter victims were mostly men, 51-60 years-old, motorcyclists (32.1%) or car drivers (28.6%), employees, deceased during Fridays and Saturdays, in the afternoon (35.7%) and in the evening (32.1%). It was possible to perform toxicological analyses in 60.7% of commuter cases: approximately 40% tested positive, always and only for ethanol (median Blood Alcohol Concentration, BAC, of about 1.03 g/L). Values above the legal limit were observed in 23.5% of the toxicological samples analyzed from commuter accidents. Our findings contribute to bridging the gap in knowledge in the area of RTCs and commuting and emphasize the importance of carrying out toxicological investigations, with possible repercussions on both insurance issues and public health strategies, which are relevant for analyzing the phenomenon structurally.

Medical Liability, Defensive Medicine, and Introduction to Professional Insurance in the Republic of Kazakhstan

This study aims at verifying relationships between the perception of medico-legal risks involved in the professional activity of Republic of Kazakhstan healthcare professionals (HCPs), defensive medical behavior and their understanding of healthcare professional liability (HCPL) insurance. The current paper also analyzes the experience of some foreign countries based on a study which suggests the ways of improving the medical liability, defensive medicine and introduction to HCPL insurance in the Republic of Kazakhstan. Additionally, the identified advantages to introduction insurance and mediation as an extra-judicial regulation of disputes, the authors point out the identified shortcomings of the matter in the legal acts of the Republic of Kazakhstan. Relevance of the topic is reasoned to the fact that complaints about medical malpractice have increased over time in Kazakhstan, as well as other countries around the world. The costs arising from medical liability lawsuits weigh not only on individual HCPs but also on the budgets of healthcare facilities, many of which in Kazakhstan are supported by public funds. A full understanding of the phenomenon of medical malpractice appears necessary in order to manage this spreading issue and mechanism of HCPL insurance in the Republic of Kazakhstan.&#x0D;

Factors affecting pathways to care for children and adolescents with complex vascular malformations: parental perspectives

BackgroundComplex vascular malformations (VMs) are rare disorders that can cause pain, coagulopathy, disfigurement, asymmetric growth, and disability. Patients with complex VMs experience misdiagnosis, delayed diagnosis, delayed or inappropriate treatments, and worsened health. Given the potential consequences of delaying expert care, we must identify the factors that impede or facilitate this access to care.ResultsWe performed semi-structured interviews with 24 parents (21 mothers; 3 fathers; median age = 42.5 years) of children with complex VMs and overgrowth disorders living in the US, recruited through two patient advocacy groups – CLOVES Syndrome Community, and Klippel-Trenaunay Support Group. We performed thematic analysis to assess parental perspectives on barriers and facilitators to accessing expert care. We identified 11 factors, representing 6 overarching themes, affecting families’ ability to access and maintain effective care for their child: individual characteristics (clinician behaviors and characteristics, parent behaviors and characteristics), health care system (availability of specialist multidisciplinary teams, care coordination and logistics, insurance and financial issues, treatments and services), clinical characteristics (accuracy and timing of diagnosis, features of clinical presentation), social support networks, scientific progress, and luck and privilege. Additionally, access to information about VMs and VM care was a crosscutting theme affecting each of these factors. These factors influenced both the initial access to care and the ongoing maintenance of care for children with VMs.ConclusionParents of children with VMs report multiple factors that facilitate or impede their ability to provide their child with optimal care. These factors represent possible targets for future interventions to improve care delivery for families affected by VMs.

Do bond market participants care about directors’ and officers’ liability insurance?——Empirical evidence based on the pricing of corporate bonds

ABSTRACT Based on the risk hedging perspective, this paper examines the impact of directors’ and officers’ liability insurance (hereafter referred to as D&O liability insurance) on the pricing of corporate bonds. We find that the purchase of D&O liability insurance can effectively reduce corporate bond insurance pricing. The path test shows that the purchase of D&O liability insurance can reduce the bond insurance pricing by improving the quality of company’s internal control. Furthermore, the paper finds that when management power is greater, investor protection is poor or financial risk is high,the impact of the D&O liability insurance is stronger. After purchasing D&O liability insurance, creditors will reduce the use of corporate governance contractual terms, but will set more investments and financing as well as option contractual terms. In addition, companies that purchase D&O liability insurance issue bonds with higher credit ratings and longer bond maturities.