Health Plan Members Research Articles

Appellate court overturns judgment for health plan members in Wit case

The news continues to be deeply disappointing for advocates who had believed the original decision in the Wit v. United Behavioral Health case represented a landmark moment for the rights of insured individuals. Following an appellate panel's 2022 reversal of the ruling for plan members in 2019, the full Ninth Circuit Court of Appeals last month reversed the U.S. District Court's original judgment that the managed behavioral health care company had wrongfully denied benefits to plan members.

Proactive Outreach for At-risk Health Plan Members During COVID-19 Pandemic in New Mexico.

-Explore the impact of proactive outreach to a health plan population during COVID-19 pandemic in New Mexico. -By March 2020, the 2019 novel coronavirus (COVID-19) was a global pandemic, circulating in more than 114 countries. As more information about virus transmission, symptoms, and comorbidities were reported over time, recommendations for reducing the spread of the virus within communities was provided by leading health organizations like the Centers for Disease Control and Prevention (CDC). -Criteria were developed to identify health plan members most at risk for virus complications. Once members were identified, a health plan representative contacted each member to inquire about member needs, questions, and provide them with resources. Members were then tracked for COVID-19 testing results and vaccination status. -Overall, 50,000+ members received an outreach call (during 8-month timeframe), and 26,000 calls were tracked for member outcomes. Over 50% of the outreach calls were answered by the health plan member. Of the members who were called, 1186 (4.4%) tested positive for COVID-19. Health plan members that could not be reached represented 55% of the positive cases. A chi-square test of the two populations (reached vs unable to reach) showed a significant difference in COVID-19 positive test results (N = 26,663, X2(1) = 16.33, P<0.01). -Community outreach was related to lower rates of COVID-19. Community connection is important, especially in tumultuous times, and proactive outreach to the community provides an opportunity for information sharing and community bonding.

How well is Brazil prepared for a disease‐modifying Alzheimer’s treatment?

AbstractBackgroundWhile the majority of patients with Alzheimer’s disease resides in low and middle‐income countries, little is known of their preparedness for emerging disease‐modifying treatments. We analyze the preparedness of Brazil, one of the most populous middle‐income countries, from a capacity and institutional preparedness perspective.MethodDesk research and 12 interviews for background and capacity data. Markov model to estimate wait times for access to treatment.ResultBrazil has no national dementia strategy or established pathway for evaluation of cognitive concerns, and dementia is typically diagnosed late if at all. While members of private health plans have ready access to elective specialty care, wait times in the public sector are long. Assuming potentially treatment‐eligible patients are referred from primary to specialty care based on a brief cognitive exam and a blood test for the Alzheimer’s pathology, available capacity will not be sufficient to match the projected demand (Figure 1). The biggest obstacle is availability of dementia specialist visits, and the effect of population growth and ageing means that the wait list for specialist appointment will continue to grow from around 400,000 in 2022 to over 2.2 million in 2040. We do not project substantial wait times for confirmatory biomarker testing and treatment delivery but note that this is a consequence of patients waiting for their specialist appointments. These queues will result in estimated persistent wait times for treatment of around two years on average with substantial differences between the public and private sectors, as capacity growth is insufficient to keep up with increasing demand.ConclusionOur findings suggest that Brazil is ill‐prepared to provide timely access to an Alzheimer’s treatment with predicted wait times of about two years, largely because of a limited number of dementia specialists. Access is likely to be unequal based on socioeconomic status and geographic location. Closing this gap will be challenging because of high public debt and chronic underinvestment, leaving a focus on prevention and on use of scalable technologies, such as digital cognitive and blood tests for Alzheimer’s disease as viable option. A national dementia plan with an implementation strategy would be an important first step.

Post-Colonoscopy Colorectal Cancer Etiologies in a Large Integrated US Health Care Setting

Post-Colonoscopy Colorectal Cancer Etiologies in a Large Integrated US Health Care Setting

Patients with IgM Monoclonal Gammopathy of Undetermined Significance (MGUS) or IgA with an M Band < 1.0 g/DL Have the Same Low Risk of Progression to Lymphoplasmacytic Neoplasm (LPN) As Those with IgG MGUS and an M-Band < 1.5 g/DL

Background Patients with MGUS can progress to LPN. Non-IgG subtype and the size of the M-band are known to correlate with the risk of progression. Consensus guidelines recommend that patients be monitored on an annual basis, but that IgG MGUS with an M-band < 1.5 g/dL, and a normal serum free light chain ratio is at low risk and can be managed with less intensive monitoring. There are limited data on the risk of progression to LPN in non-IgG MGUS with small M-bands. Methods Kaiser Permanente Northern California (KPNC) is a large integrated health care system serving more than 4 million members representative of Northern California residents. We identified a cohort of 3,303 KPNC health plan members who had at least one serum protein electrophoresis (SPEP) performed between January 1997 and December 2006 and extracted follow up data through December 2016. We excluded those with an M-Band > 3 g/dL, absence of a confirmatory immunofixation, or LPN before through 3 months after initial SPEP. The primary end point was progression to LPN, defined as multiple myeloma (MM), non-Hodgkin's lymphoma, or amyloidosis, and identified via an integrated tumor registry and, in the case of amyloidosis, by clinic diagnosis. Findings The median age of this cohort was 73 (IQR 63-80), 54.5% were male, and the ethnicity of this group was White 66.9%, Black 17.2%, Asian 6.7%, Hispanic 7.7%, and others 1.6%. Sixty six percent had an IgG gammopathy and 73% of gammopathies were < 1.0 g/dL. Overall, there were 2.1 (2.0-2.3) progressions per 100 patient years. The number of progressions per 100 patient years for an M-band < 1.0 g/dL, 1.0-1.5 g/dL, and 1.5-3.0 g/dL were 1.4 (1.2-1.6), 3.5(2.9-4.1), and 6.6 (5.5-7.7) respectively. As can be seen in the Figure, the cumulative risk of progression to LPN was clinically similar for patients with an IgG ≥ 1.5 g/dL and IgA ≥ 1.0 g/dL and considerably increased compared to those with an IgG gammopathy < 1.5 gm/dL, IgA gammopathy < 1.0 g/dL, or an IgM of any size. Discussion It has been estimated that there are several million individuals in the United States with MGUS. Following a patient with MGUS indefinitely is a financial burden and creates a substantial psychologic burden for the patient. Others have found that the effect of an MGUS diagnosis on quality of life is greater than a new diagnosis of symptomatic MM. Therefore, identifying additional categories of MGUS that could be assigned to a low-risk category could potentially diminish the burden and stress of ongoing monitoring. Limitations of our study are that, owing to the period from which our cohort was accrued, and the nature by which they were identified, free light chain levels were not obtained, bone marrow biopsies were done infrequently, and modern advanced imaging was not performed. In the modern era, many of our cohort would likely be identified with more advanced neoplasia such as smoldering or frank MM accounting for the higher rates of progression compared with other published reports. We found that during much of the period covered by our study, the clinical diagnosis of Waldenstrom's Macroglobulinemia was used in a non-discriminatory manner. We therefore limited our definition of progression only to those subjects developing frank malignancy that qualified for inclusion in our tumor registry rather than the less rigorously defined entity of "Waldenstrom's Macroglobulinemia.". This likely accounts for the lower risk of progression to LPN among our cohort with IgM gammopathy than has been described elsewhere. Conclusion Patients with either IgM MGUS of any size or IgA MGUS with an M-band < 1.0 g/dL have an equivalent clinical risk of progression as patients with an IgG MGUS < 1.0 g/dL and should potentially be assigned to a low-risk category to decrease the burden and stress of ongoing monitoring. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Persistence of Enrollment Among Commercial Enrollee Populations with Rare Hematologic Diseases: Implications for Long-Term Outcome Assessment and Value-Based Agreements

Background: Innovative therapies, including gene therapies for incurable hematologic conditions, have highlighted the need for long-term assessment of outcomes. Administrative claims are an important source for observing patients over time, but enrollment "churn" across health plans can limit the length of meaningful follow-up analysis. This analysis examined a large, United States (US) dataset with complete enrollment data for health plan members in order to assess continuous enrollment (CE) among commercial populations with and without rare hematologic diseases. Methods: From January 1, 2016 to December 31, 2021 (identification period), a matched-cohort analysis was used to compare enrollment data for commercial members using the Optum Research Database. Members were grouped into the following disease cohorts based on diagnosis codes on non-diagnostic medical claims and/or treatment during the identification period: sickle cell anemia (SCA), beta thalassemia (beta-thal), and hemophilia (HA or HB). SCA was defined using ≥2 claims, on different dates, with an SCA diagnosis code. Beta-thal was defined using ≥1 claim with a beta-thal diagnosis code and ≥2 claims, on different dates, for blood transfusion or luspatercept. Hemophilia was defined using ≥1 claim with a HA/HB diagnosis code and ≥2 claims, on different dates, for on-demand or prophylaxis treatment specific to HA/HB (factor VIII and IX concentrates and emicizumab-kxwh). Members without these rare diseases were eligible for the control cohort if they had at least 1 medical claim during the identification period. The date of the first identifying claim defined the index date. Persistence of CE (medical and pharmacy) was measured in months (30-days), from the index date to the earlier of the disenrollment date or end of data. Rare disease and control cohorts were matched 1:3 without replacement on age, gender, index year, geographic region, fully-insured/administrative services only coverage, and subscriber/dependent status. Member characteristics were descriptively summarized overall, and results were stratified by cohort, index year, and age group (at index). Results: Overall, among ~25.7 million members, 3,459 were identified with a rare hematologic disease of interest (Table 1). Per rare disease cohort, 2,168 with SCA, 422 with beta-thal, and 869 with HA/HB were identified; the average age (standard deviation, SD) was 29.0 (15.1), 36.8 (20.7), and 24.5 (16.0) years in each cohort, respectively. The average (standard deviation [SD]) CE length in months among those with rare disease compared with respective controls was shorter in SCA (19.2 [17.8] vs. 20.4 [18.4]), longer in beta-thal (22.5 [18.1] vs. 20.6 [18.1]), and longer in HA/HB (23.7 [19.4] vs. 21.0 [19.2]) (Table 2). This pattern was consistent across all index years stratifications and among pediatric patients and adults <45 years old. Conclusions/Implications: Continuous enrollment time was overall shorter among members with SCA compared with their controls but longer for those with beta-thal and hemophilia compared with their controls. Even among those with the earliest index year (thus maximum possible follow-up time of ~72 months), average persistence of enrollment ranged from 25-31 months across disease cohorts and their controls. Notably, these findings reflect average enrollment for commercial members, in the setting of no minimum enrollment requirements. By contrast, claims-based research often requires a minimum duration of CE for a particular study population, which often increases the average CE observed. CE varied not only from matched controls, but also across SCA, beta-thal, and HA/HB cohorts, supporting the need to specifically evaluate enrollment in eligible treatment populations. Value-based agreements traditionally have involved commercial populations and have contracted on short-term (6-12 month) outcomes. Providers, payers, and manufactures will need to assess current data assets, available follow-up, and innovative data-sharing solutions that allow for patient portability (e.g., multi-payer platforms) to measure long-term outcomes. These methodological considerations will provide the foundation for aligning risk-sharing interests so that patients may access and benefit from these innovative therapies. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

RF28 | PSUN216 Insulin Use Among Asian and Pacific Islander Adults with Diabetes Receiving Pharmacotherapy

Abstract Introduction Diabetes prevalence continues to increase in the US, although the burden of diabetes varies by race/ethnicity. Diabetes prevalence is higher in US Asian compared to non-Hispanic White adults and Asian adults may develop diabetes at an earlier age. Some studies suggest that Asians with diabetes have reduced insulin secretory capacity, but lower rates of insulin use have also been reported. This study seeks to characterize insulin use in a large clinical population of US Asian and Pacific Islanders (PI) with diabetes. Methods This cross-sectional observational study includes adult health plan members aged 45-79 years with diabetes prior to 2015 and receipt of diabetes pharmacotherapy in 2019. To estimate diabetes duration, those with diabetes identification during their first year of health plan membership (pre-existing diabetes) were excluded. Those without weight assessment in 2019 were also excluded. Race/ethnicity and Asian/PI subgroup were determined from self-reported data in health record databases. The primary outcome was insulin treatment in 2019, based on outpatient pharmacy records. Covariates included age, sex, BMI, diabetes duration, HbA1C, and calculated Charlson Comorbidity Index (CCI). A neighborhood deprivation index (NDI) was estimated using US Census data. Modified Poisson regression with robust variance was used to examine the association between ethnicity and insulin therapy, reporting relative risk (RR) with 95% confidence intervals (CI). Results Among 81,692 adults with diabetes (47% female), 21,187 (26%) were Asian/PI, 32,435 (40%) non-Hispanic White, 8901 (11%) Black, 16,855 (21%) Hispanic/Latinx, and 2314 (3%) Other/unknown. Compared to other racial/ethnic groups, Asians were less likely to use insulin (25% of Asian vs. 38%, 39%, and 37% of non-Hispanic White, Black, and Hispanic/Latinx, respectively, p&amp;lt;0.01). Within Asian/PI subgroups, the prevalence of insulin use varied: Japanese (32%), Native Hawaiian/Pacific Islander (33%), Filipino (28%), South Asian (23%), Chinese (21%) and Southeast Asian (20%). However, age, sex, duration of diabetes, level of diabetes control (HbA1c), BMI, and comorbid burden also varied among these populations. In multivariable analyses adjusting for these covariates, non-Hispanic White (RR 1.4, CI 1.3-1.4), Black (RR 1.1, CI 1.1-1.2), and Hispanic (RR 1.2, CI 1.2-1.2) adults had a higher relative risk of insulin use when compared to Asian/PI adults in aggregate. However, among the different Asian/PI subgroups, with Chinese as reference, only Japanese adults were more likely to use insulin (RR 1.2, CI 1.1-1.3) with no differences seen for Filipino, other Southeast Asian, and Native Hawaiian/PI. Conclusions This study provides insight into use of diabetes pharmacotherapy and specifically insulin use among Asian/PI subgroups compared to other populations. The lower rate of insulin use observed among Asian/PI subgroups is consistent with past studies and is likely multifactorial. Further research is needed to understand barriers against insulin treatment which will help optimize treatment and reduce diabetes burden in this population. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m., Monday, June 13, 2022 1:00 p.m. - 1:05 p.m.

Health insurance coverage patterns before and after a cancer diagnosis: Findings from adult patients with cancer in an integrated health system.

262 Background: Patients diagnosed with cancer experience intense medical care and high costs associated with the disease and its treatment. As a result, patients may consider changes to their health insurance coverage to adjust the medical benefits covered and/or the cost-sharing (e.g., annual maximum out-of-pocket [MOOP] limit) requirements. The purpose of this study was to assess the patterns of health insurance plan coverage patterns prior to and following a diagnosis of cancer among adult patients. Methods: Data from 13,237 patients aged ≥18, enrolled at Kaiser Permanente Northwest, diagnosed with cancer between Jan. 1, 2016–March 31, 2021 [index cancer], with ≥12 months of continuous health insurance coverage pre-cancer diagnosis were included. Patients enrolled in hospice prior to index cancer were excluded. Health insurance coverage outcomes included (1) coverage patterns (maintenance, interruption, termination, switch); (2) a composite of any coverage changes; and (3) cost-sharing patterns. Monthly health plan membership enrollment data was used to assess outcomes between two time periods: pre-diagnosis (12 months prior to index cancer) and post-diagnosis (12-18 months following index cancer). Patient sociodemographic, enrollment, health plan and clinical data were extracted from the electronic health record (EHR). Descriptive statistics were used to assess outcomes. Results: Approximately 40% of patients were ages 18-64, 54% were female and 9% were non-White. At index cancer diagnosis, 60% of patients had Medicare, 37% had a commercial plan and 3% had Medicaid. Among patients aged 18-64, 62% had any change in health insurance coverage between pre- to post-cancer diagnosis, including 41% who switched plans, 19% who terminated and 2% with an interruption. Among patients aged 65+, 50% of patients had any change in health insurance coverage, including 20% who switched plans, 30% who terminated and &lt; 1% with an interruption. For those who switched plans between the pre- to post-diagnosis periods, the most common patterns included switching out of commercial plans (-11% points) and switching into either Medicare (+9% points) or Medicaid (+5% points). Among all patients, 14% changed to a higher cost-sharing plan (difference in mean individual, in-network MOOP limit: $938) and 10% changed to a lower cost-sharing plan (difference in mean individual, in-network MOOP limit: -$1701). Conclusions: Our novel findings provide valuable information about health insurance plan coverage patterns among adults diagnosed with cancer and suggest a large proportion of patients may undergo changes to their health insurance coverage. Future studies that assess the implications of health insurance changes on care access and cancer outcomes are warranted.

Preparedness of the Brazilian health-care system to provide access to a disease-modifying Alzheimer's disease treatment.

While the majority of patients with Alzheimer's disease resides in low and middle-income countries, little is known of their preparedness for emerging disease-modifying treatments. We analyze the preparedness of Brazil, one of the most populous middle-income countries, from a capacity and institutional preparedness perspective. Desk research and 12 interviews for background and capacity data. Markov model to estimate wait times for access to treatment. Brazil has no national dementia strategy or established pathway for evaluation of cognitive concerns, and dementia is typically diagnosed late if at all. While members of private health plans have ready access to elective specialty care, wait times in the public sector are long. Assuming potentially treatment-eligible patients are referred from primary to specialty care based on a brief cognitive exam and a blood test for the Alzheimer's pathology, available capacity will not be sufficient to match the projected demand. The biggest obstacle is availability of dementia specialist visits, and the effect of population growth and ageing means that the wait list for specialist appointment will continue to grow from around 400,000 in 2022 to over 2.2 million in 2040. We do not project substantial wait times for confirmatory biomarker testing and treatment delivery but note that this is a consequence of patients waiting for their specialist appointments. These queues will result in estimated persistent wait times for treatment of around two years on average with substantial differences between the public and private sectors, as capacity growth is insufficient to keep up with increasing demand. Our findings suggest that Brazil is ill-prepared to provide timely access to an Alzheimer's treatment with predicted wait times of about two years, largely because of a limited number of dementia specialists.

Travelers and travel vaccines at six health care systems in the Vaccine Safety Datalink

BackgroundStudying the safety of travel vaccines poses challenges since recipients may be traveling during the risk window for adverse events and the identification of a suitable comparison group can also be difficult. The examination of traveler characteristics, travel vaccination patterns, and health care utilization using electronic health record (EHR) data can inform the feasibility of future travel vaccine safety studies. MethodsA retrospective cohort study of health plan members in the Vaccine Safety Datalink Project aged 9 months and older who had a travel-related encounter or received a travel vaccine from 2009 to 2018 was performed. Travel regions visited, travel duration, type of travel vaccine received (typhoid, yellow fever, Japanese encephalitis, rabies, and cholera), and timing of vaccination date before departure date were described. Sociodemographic information, clinical characteristics, and health care utilization were compared between travelers who received travel vaccines and travelers who did not. ResultsA total of 1,026,822 unique travelers departing from the United States were identified; 612,795 travelers received 898,196 doses of travel vaccines. The most commonly administered travel vaccine was typhoid vaccine and 77% of all travel vaccines were given more than one week prior to departure. Compared with travelers without travel vaccines, travelers with travel vaccines were overall similar but as a group were slightly younger, healthier, and had lower Hispanic representation. Health care utilization dramatically decreased during travel. Outpatient visits decreased from 294.8 visits per 10,000 person-days before travel to 24.2 visits per 10,000 person-days during reported travel dates. ConclusionsThrough the EHR information from almost a million travelers, a departure date and duration of travel were successfully captured for the majority of travelers with corresponding health care utilization data. Time after vaccination and prior to departure can potentially be used in the future to compare travelers who receive travel vaccines with travelers who do not receive travel vaccines when looking at adverse events of interest after vaccination.

Racial/Ethnic Disparities in Substance Use Treatment in Medicaid Managed Care in New York City: The Role of Plan and Geography.

The aim was to assess the magnitude of health care disparities in treatment for substance use disorder (SUD) and the role of health plan membership and place of residence in observed disparities in Medicaid Managed Care (MMC) plans in New York City (NYC). Medicaid claims and managed care plan enrollment files for 2015-2017 in NYC. We studied Medicaid enrollees with a SUD diagnosis during their first 6 months of enrollment in a managed care plan in 2015-2017. A series of linear regression models quantified service disparities across race/ethnicity for 5 outcome indicators: treatment engagement, receipt of psychosocial treatment, follow-up after withdrawal, rapid readmission, and treatment continuation. We assessed the degree to which plan membership and place of residence contributed to observed disparities. We found disparities in access to treatment but the magnitude of the disparities in most cases was small. Plan membership and geography of residence explained little of the observed disparities. One exception is geography of residence among Asian Americans, which appears to mediate disparities for 2 of our 5 outcome measures. Reallocating enrollees among MMC plans in NYC or evolving trends in group place of residence are unlikely to reduce disparities in treatment for SUD. System-wide reforms are needed to mitigate disparities.

New-Onset Cancer Cases in FDA's Sentinel System: A Large Distributed System of US Electronic Healthcare Data.

Evaluations of cancer etiology and safety and effectiveness of cancer treatments are predicated on large numbers of patients with sufficient baseline and follow-up data. To assess feasibility of FDA's Sentinel System's electronic healthcare data for surveillance of malignancy onset and examination of product safety, this study examined patterns of enrollment surrounding new-onset cancers. Using a retrospective cohort of patients based on administrative claims, we identified incident events of 19 cancers among 292.5 million health plan members from January 2000 to February 2020 using International Classification of Diseases (ICD) diagnosis codes. Annual incident cases were stratified by sex, age, medical and drug coverage, and insurer type. Descriptive statistics were calculated for observable time prior to and following diagnosis. We identified 10,697,573 incident cancer events among members with medical coverage. When drug coverage was additionally required, number of incident cancers was reduced by 41%. Medicare data contributed 61% of cases, with similar duration trends as other insurers. Mean duration of follow-up prior to diagnosis ranged from 4.0 to 4.6 years, whereas follow-up post diagnosis ranged from 1.1 to 3.3 years. Approximately a third (36.1%) had at least 2 years both prior to and following diagnosis. The FDA Sentinel System's electronic healthcare data may be useful for characterizing relatively short latency cancer risk, examining cancer drug utilization and safety after diagnosis, and conducting surveillance for acute adverse events among patients with cancers. A national distributed system with electronic health data, the Sentinel system provides opportunity for rapid pharmacoepidemiologic assessments relevant in oncology.

Skeletal muscle relaxant drug-drug-drug interactions and unintentional traumatic injury: Screening to detect three-way drug interaction signals.

The aim of this study was to identify skeletal muscle relaxant (SMR) drug-drug-drug interaction (3DI) signals associated with increased rates of unintentional traumatic injury. We conducted automated high-throughput pharmacoepidemiologic screening of 2000-2019 healthcare data for members of United States commercial and Medicare Advantage health plans. We performed a self-controlled case series study for each drug triad consisting of an SMR base-pair (i.e., concomitant use of an SMR with another medication), and a co-dispensed medication (i.e., candidate interacting precipitant) taken during ongoing use of the base-pair. We included patients aged ≥16 years with an injury occurring during base-pair-exposed observation time. We used conditional Poisson regression to calculate adjusted rate ratios (RRs) with 95% confidence intervals (CIs) for injury with each SMR base-pair + candidate interacting precipitant (i.e., triad) versus the SMR-containing base-pair alone. Among 58 478 triads, 29 were significantly positively associated with injury; confounder-adjusted RRs ranged from 1.39 (95% CI = 1.01-1.91) for tizanidine + omeprazole with gabapentin to 2.23 (95% CI = 1.02-4.87) for tizanidine + diclofenac with alprazolam. Most identified 3DI signals are new and have not been formally investigated. We identified 29 SMR 3DI signals associated with increased rates of injury. Future aetiologic studies should confirm or refute these SMR 3DI signals.

1-LB: Trends in Incidence and Age at Diagnosis of Youth-Onset Type 2 Diabetes, 2002–2018—The SEARCH for Diabetes in Youth Study

The SEARCH study ascertained individuals with type 2 diabetes (T2D) diagnosed at &amp;lt;20 years of age at 5 study centers in the US from 2002 to 2018 and calculated annual incidence as number of cases divided by the population &amp;lt;20 years in the catchment area (∼5 million annually based on US Census or health-plan member counts) . We estimated incidence trends using a generalized autoregressive (2-year) moving average model. From annual incidence, we calculated peak age at T2D diagnosis overall population and within period, sex, race and ethnicity strata. Incidence increased from 2002-2009 to 2010-2018 (p&amp;lt;0.0001) ; however, the peak age at diagnosis did not change (16 years; Figure) . Across all years, the peak age at diagnosis was similar between females (16 years [95% CI 15-18]) and males (16 years [16-18]) . The peak age at diagnosis was younger for non-Hispanic Black youth (NHB; 13 years) , while similar for American Indian (AI) , Asian and Pacific Islander (API) , Hispanic (HISP) , and non-Hispanic White (NHW) youth (16 years; Figure) . These data indicate continued increases in T2D incidence across ages associated with the pubertal transition, with a rapid decline following the incidence peak. They also highlight an earlier T2D onset among NHB youth. These results highlight the need for pre-pubertal or early pubertal intervention to mitigate risk of youth-onset T2D. Disclosure K. A. Sauder: None. A. Bellatorre: None. J. M. Lawrence: None. J. Divers: None. E. T. Jensen: Consultant; Regeneron Pharmaceuticals Inc. L. E. Wagenknecht: None. A. D. Liese: None. D. Dabelea: None. S. M. Marcovina: None. C. Pihoker: None. K. Reynolds: Research Support; Amgen Inc., Merck &amp; Co., Inc., Novartis Pharmaceuticals Corporation. A. S. Shah: None. L. M. Dolan: None. Funding Centers for Disease Control and Prevention and National Institutes of Health

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants

Only about half of patients with atrial fibrillation (AF) who are at increased risk for stroke are treated with an oral anticoagulant (OAC), despite guideline recommendations for their use. Educating patients with AF about prevention of stroke with OACs may enable them as agents of change to initiate OAC treatment. To determine whether an educational intervention directed to patients and their clinicians stimulates the use of OACs in patients with AF who are not receiving OACs. The Implementation of a Randomized Controlled Trial to Improve Treatment With Oral Anticoagulants in Patients With Atrial Fibrillation (IMPACT-AFib) trial was a prospective, multicenter, open-label, pragmatic randomized clinical trial conducted from September 25, 2017, to May 1, 2019, embedded in health plans that participate in the US Food and Drug Administration's Sentinel System. It used the distributed database comprising health plan members to identify eligible patients, their clinicians, and outcomes. IMPACT-AFib enrolled patients with AF, a CHA2DS2-VASc (cardiac failure or dysfunction, hypertension, age 65-74 [1 point] or ≥75 years [2 points], diabetes, and stroke, transient ischemic attack or thromboembolism [2 points]-vascular disease, and sex category [female]) score of 2 or more, no evidence of OAC prescription dispensing in the preceding 12 months, and no hospitalization-related bleeding event within the prior 6 months. Randomization to a single mailing of patient and/or clinician educational materials vs control. Analysis was performed on a modified intention-to-treat basis. The primary end point was the proportion of patients with at least 1 OAC prescription dispensed or at least 4 international normalized ratio test results within 1 year of the intervention. Among 47 333 patients, there were 24 909 men (52.6%), the mean (SD) age was 77.9 (9.7) years, mean (SD) CHA2DS2-VASc score was 4.5 (1.7), 22 404 patients (47.3%) had an ATRIA (Anticoagulation and Risk Factors in Atrial Fibrillation) bleeding risk score of 5 or more, and 8890 patients (18.8%) had a history of hospitalization for bleeding. There were 2328 of 23 546 patients (9.9%) in the intervention group with initiation of OAC at 1 year compared with 2330 of 23 787 patients (9.8%) in the control group (adjusted OR, 1.01 [95% CI, 0.95-1.07]; P = .79). Among a large population with AF with a guideline indication for OACs for stroke prevention who were randomized to a mailed educational intervention or to usual care, there was no clinically meaningful, numerical, or statistically significant difference in rates of OAC initiation. More-intensive interventions are needed to try and address the public health issue of underuse of anticoagulation for stroke prevention among patients with AF. ClinicalTrials.gov Identifier: NCT03259373.

Effects of an urban light rail line on health care utilization and cost: A pre-post assessment

In September 2015, a new light rail transit (LRT) line opened in metro Portland, Oregon, USA. We used this natural experiment to conduct an interrupted time series analysis of the effects of LRT introduction on health care costs. We hypothesized that such costs would decline over time based on demonstrated health benefits of increased transit-related physical activity. We wanted to evaluate whether introducing new LRT would lower the trajectory of monthly health care costs generated by a large sample of members of an integrated health care plan living near a new LRT station (cases) relative to similar members who did not (controls). We hypothesized that new LRT would stimulate higher transit use and consequently, higher transit-related physical activity among plan members living relatively closer to the LRT. However, the new LRT did not lower health care costs as hypothesized, at least relative to prior costs and within the first 4.5 years after the LRT opening. Results were consistent across outpatient visit costs and medication costs, as well as when only the 10 percent most expensive health plan members were considered. Although we did not find evidence of transit-related reductions in health care costs, research into the potential influence of public transit on physical activity and downstream health care costs remains warranted. Mechanisms through which such influence manifests are complex. Our negative results based on extensive and objectively measured health care cost data will contribute to the accuracy and validity of future models of the societal benefits of public transit.

Development and implementation of a prescription opioid registry across diverse health systems.

ObjectiveDevelop and implement a prescription opioid registry in 10 diverse health systems across the US and describe trends in prescribed opioids between 2012 and 2018.Materials and MethodsUsing electronic health record and claims data, we identified patients who had an outpatient fill for any prescription opioid, and/or an opioid use disorder diagnosis, between January 1, 2012 and December 31, 2018. The registry contains distributed files of prescription opioids, benzodiazepines and other select medications, opioid antagonists, clinical diagnoses, procedures, health services utilization, and health plan membership. Rates of outpatient opioid fills over the study period, standardized to health system demographic distributions, are described by age, gender, and race/ethnicity among members without cancer.ResultsThe registry includes 6 249 710 patients and over 40 million outpatient opioid fills. For the combined registry population, opioid fills declined from a high of 0.718 per member-year in 2013 to 0.478 in 2018, and morphine milligram equivalents (MMEs) per fill declined from 985 MMEs per fill in 2012 to 758 MMEs in 2018. MMEs per member declined from 692 MMEs per member in 2012 to 362 MMEs per member in 2018.ConclusionThis study established a population-based opioid registry across 10 diverse health systems that can be used to address questions related to opioid use. Initial analyses showed large reductions in overall opioid use per member among the combined health systems. The registry will be used in future studies to answer a broad range of other critical public health issues relating to prescription opioid use.

Retrospective Evaluation Of Suspected Vs. Confirmed Transthyretin Amyloid Cardiomyopathy (ATTR-CM) Cases

<h3>Intoduction</h3> Transthyretin amyloidosis (ATTR) is a progressive and potentially fatal disease which results from the accumulation of misfolded amyloid fibrils in various organs and tissues. The deposition of these fibrils in the heart can lead to transthyretin amyloid cardiomyopathy (ATTR-CM). Literature reports that this disease is often misdiagnosed as heart failure or a variety of other conditions due to otherwise non-specific symptoms. For these reasons, the true prevalence of ATTR-CM is not well known. It has been estimated there are approximately 100,000 people in the United States living with ATTR-CM, and only one to two percent of these patients have been diagnosed. The primary objective of this study was to determine both the suspected and confirmed numbers of hereditary ATTR (hATTR) and wild-type ATTR (wtATTR) cases within a large managed care organization in western Pennsylvania. The secondary objective was to determine (in the suspected ATTR-CM population) the percentage of patients who had a cardiologist visit during the study period. <h3>Hypothesis</h3> The hypothesis of this evaluation is that there may be many undiagnosed members with ATTR-CM due to the presence of certain medical conditions commonly associated with the disease. <h3>Methods</h3> : This retrospective review of pharmacy and medical claims included UPMC Health Plan members ages 65 and older who were continuously enrolled from March 1, 2019 through February 29, 2020 with both pharmacy and medical benefits through UPMC Health Plan. Members were included in the suspected ATTR-CM population who had a select diagnosis of heart failure and at least one of the 10 medical condition combinations that are commonly associated with ATTR-CM during the study period; this population excluded patients with a diagnosis of ATTR-CM. The confirmed ATTR-CM population included patients with at least one ICD-10 code for either wtATTR or hATTR during the study period. <h3>Results</h3> 183,580 continuously enrolled members who were 65 and older during the study period were reviewed. Of these members, 11,928 had a diagnosis of heart failure. 986 members were identified for the suspected ATTR-CM population with a mean age of 80 (SD 7.68). Each combination group had more female than male matches. In the suspected ATTR-CM population, 94% of patients had a cardiologist visit during the study period. Separately, as a comparison, there were 214 members who had a confirmed diagnosis of ATTR-CM. <h3>Conclusion</h3> Both cardiovascular and non-cardiovascular medical conditions typically associated with ATTR-CM were common among members ≥ 65 years of age with heart failure; therefore, ATTR-CM may be underdiagnosed in this patient population.

Health Care Resource Utilization and Costs Associated with Disease Progression in Ovarian Cancer.

IntroductionOvarian cancer (OC) is one of the leading causes of cancer mortality among women in the United States. With the approval of first-line maintenance therapies, patients with OC experienced prolonged first-line progression-free survival. While the literature addresses some costs associated with OC, further research is needed on the costs of progression that are potentially deferred or prevented by early maintenance. The objective of this study was to capture the health care resource utilization and costs of patients with advanced OC who never received poly(ADP ribose) polymerase (PARP) inhibitor maintenance.MethodsWe conducted a descriptive retrospective analysis of treatment patterns and the consequences of progression through several lines of therapy (LOTs) in patients with OC, using claims from commercial and Medicare Advantage health plan members in the United States from the Optum Research Database between January 1, 2010, and April 30, 2019. Patients were required to have an index OC diagnosis (≥ 2 non-diagnostic claims). We examined up to 4 LOTs and the time between treatments.ResultsA total of 5498 women met the eligibility criteria. As the number of LOTs increased, the median duration of each line decreased from 137 days in LOT1 to 94 days in LOT4, and the time between lines also decreased from 245 to 0 days. Ambulatory care visits were a major driver of health care resource utilization, with a median of about 6 monthly visits during active treatment. The mean total monthly health care costs for patients with at least 2 LOTs were US$8588 (SD: $8533) before LOT2 and increased to $15,358 (SD: $21,460) during or after LOT2.ConclusionsProlonging progression-free survival after first-line treatment in patients with OC may provide the opportunity to delay or prevent later treatment, the financial toxicity felt by patients, and the economic burden to the health care system associated with progression.

Reach of a Fully Digital Diabetes Prevention Program in Health Professional Shortage Areas.

The National Diabetes Prevention Program (NDPP) offers lifestyle change education to adults at risk for diabetes across the United States, but its reach is curbed due, in part, to limitations of traditional in-person programs. Diabetes Prevention Programs (DPPs) that are fully digital may increase reach by overcoming these barriers. The aim of this research was to examine the reach of Lark's DPP, a fully digital artificial-intelligence-powered DPP. This study assessed geographic features and demographic characteristics of a sample of Lark DPP commercial health plan members with complete data (N = 16,327) and compared several demographic features with a large composite sample of members from DPPs across the nation (NDPP; N = 143,489) and a National Health Interview Survey (NHIS) sample of prediabetic adults in the United States (NHIS; N = 2118). Examination of the Lark DPP sample revealed that 24.4% of members lived in rural areas, 30.8% lived in whole county health professional shortage areas, and only 7.6% of members lived in a zip code with an in-person DPP. When comparing the Lark sample with the NDPP and NHIS samples, Lark DPP enrollees tended to be younger and have a higher body mass index (BMI) (p's < 0.001). Lark provides convenient access to a DPP for individuals living in hard-to-reach areas who may face barriers to participating in in-person or telephonic DPPs or who prefer a digital program. Compared with the NDPP sample, Lark is also reaching younger and higher BMI users, who are traditionally difficult to enroll and have a high need for intervention.