High-Acuity Alcohol-Related Complications During the COVID-19 Pandemic.

Importance: Research has demonstrated an association between the COVID-19 pandemic and increased alcohol-related liver disease hospitalizations and deaths. However, trends in alcohol-related complications more broadly are unclear, especially among subgroups disproportionately affected by alcohol use. Objective: To assess trends in people with high-acuity alcohol-related complications admitted to the emergency department, observation unit, or hospital during the COVID-19 pandemic, focusing on demographic differences. Design, Setting, and Participants: This longitudinal interrupted time series cohort study analyzed US national insurance claims data using Optum's deidentified Clinformatics Data Mart database from March 2017 to September 2021, before and after the March 2020 COVID-19 pandemic onset. A rolling cohort of people 15 years and older who had at least 6 months of continuous commercial or Medicare Advantage coverage were included. Subgroups of interest included males and females stratified by age group. Data were analyzed from April 2023 to January 2024. Exposure: COVID-19 pandemic environment from March 2020 to September 2021. Main Outcomes and Measures: Differences between monthly rates vs predicted rates of high-acuity alcohol-related complication episodes, determined using claims-based algorithms and alcohol-specific diagnosis codes. The secondary outcome was the subset of complication episodes due to alcohol-related liver disease. Results: Rates of high-acuity alcohol-related complications were statistically higher than expected in 4 of 18 pandemic months after March 2020 (range of absolute and relative increases: 0.4-0.8 episodes per 100 000 people and 8.3%-19.4%, respectively). Women aged 40 to 64 years experienced statistically significant increases in 10 of 18 pandemic months (range of absolute and relative increases: 1.3-2.1 episodes per 100 000 people and 33.3%-56.0%, respectively). In this same population, rates of complication episodes due to alcohol-related liver disease increased above expected in 16 of 18 pandemic months (range of absolute and relative increases: 0.8-2.1 episodes per 100 000 people and 34.1%-94.7%, respectively). Conclusions and Relevance: In this cohort study of a national, commercially insured population, high-acuity alcohol-related complication episodes increased beyond what was expected in 4 of 18 COVID-19 pandemic months. Women aged 40 to 64 years experienced 33.3% to 56.0% increases in complication episodes in 10 of 18 pandemic months, a pattern associated with large and sustained increases in high-acuity alcohol-related liver disease complications. Findings underscore the need for increased attention to alcohol use disorder risk factors, alcohol use patterns, alcohol-related health effects, and alcohol regulations and policies, especially among women aged 40 to 64 years.

Association of State Insulin Out-of-Pocket Caps With Insulin Cost-Sharing and Use Among Commercially Insured Patients With Diabetes : A Pre-Post Study With a Control Group.

BACKGROUND: Twenty-five states have implemented insulin out-of-pocket (OOP) cost caps, but their effectiveness is uncertain. OBJECTIVE: To examine the effect of state insulin OOP caps on insulin use and OOP costs among commercially insured persons with diabetes. DESIGN: Pre-post study with control group. SETTING: Eight states implementing insulin OOP caps of $25 to $30, $50, or $100 in January 2021, and 17 control states. PARTICIPANTS: Commercially insured persons with diabetes and insulin users younger than 65 years. Subgroups of particular interest included members from states with insulin OOP caps of $25 to $30, enrollees with health savings accounts (HSAs) that require high insulin OOP payments, and lower-income members. MEASUREMENTS: Mean monthly 30-day insulin fills and OOP costs. RESULTS: State insulin caps were not associated with changes in insulin use in the overall population (relative change in fills per month, 1.8% [95% CI, -3.2% to 6.9%]). Insulin users in intervention states saw a 17.4% (CI, -23.9% to -10.9%) relative reduction in insulin OOP costs, largely driven by reductions among HSA enrollees; there was no difference in OOP costs among nonaccount plan members. More generous ($25 to $30) state insulin OOP caps were associated with insulin OOP cost reductions of 40.0% (CI, -62.5% to -17.6%), again primarily driven by a larger reduction in the subgroup with HSA plans. LIMITATIONS: Single national insurer; 9-month follow-up. CONCLUSION: Insulin OOP caps were associated with reduced insulin OOP costs but no overall increases in insulin use. A proposed national insulin cap of $35 for commercially insured persons might lead to meaningful insulin OOP savings but have a limited effect on insulin use. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases.

Acute Diabetes Complications After Transition to a Value-Based Medication Benefit.

Importance: The association of value-based medication benefits with diabetes health outcomes is uncertain. Objective: To assess the association of a preventive drug list (PDL) value-based medication benefit with acute, preventable diabetes complications. Design, Setting, and Participants: This cohort study used a controlled interrupted time series design and analyzed data from a large, national, commercial health plan from January 1, 2004, through June 30, 2017, for patients with diabetes aged 12 to 64 years enrolled through employers that adopted PDLs (intervention group) and matched and weighted members with diabetes whose employers did not adopt PDLs (control group). All participants were continuously enrolled and analyzed for 1 year before and after the index date. Subgroup analysis assessed patients with diabetes living in lower-income and higher-income neighborhoods. Data analysis was performed between August 19, 2020, and December 1, 2023. Exposure: At the index date, intervention group members experienced employer-mandated enrollment in a PDL benefit that was added to their follow-up year health plan. This benefit reduced out-of-pocket costs for common cardiometabolic drugs, including noninsulin antidiabetic agents and insulin. Matched control group members continued to have cardiometabolic medications subject to deductibles or co-payments at follow-up. Main Outcomes and Measures: The primary outcome was acute, preventable diabetes complications (eg, bacterial infections, neurovascular events, acute coronary disease, and diabetic ketoacidosis) measured as complication days per 1000 members per year. Intermediate measures included the proportion of days covered by and higher use (mean of 1 or more 30-day fills per month) of antidiabetic agents. Results: The study 10 588 patients in the intervention group (55.2% male; mean [SD] age, 51.1 [10.1] years) and 690 075 patients in the control group (55.2% male; mean [SD] age, 51.1 [10.1] years) after matching and weighting. From baseline to follow-up, the proportion of days covered by noninsulin antidiabetic agents increased by 4.7% (95% CI, 3.2%-6.2%) in the PDL group and by 7.3% (95% CI, 5.1%-9.5%) among PDL members from lower-income areas compared with controls. Higher use of noninsulin antidiabetic agents increased by 11.3% (95% CI, 8.2%-14.5%) in the PDL group and by 15.2% (95% CI, 10.6%-19.8%) among members of the PDL group from lower-income areas compared with controls. The PDL group experienced an 8.4% relative reduction in complication days (95% CI, -13.9% to -2.8%; absolute reduction, -20.2 [95% CI, -34.3 to -6.2] per 1000 members per year) compared with controls from baseline to follow-up, while PDL members residing in lower-income areas had a 10.2% relative reduction (95% CI, -17.4% to -3.0%; absolute, -26.1 [95% CI, -45.8 to -6.5] per 1000 members per year). Conclusions and Relevance: In this cohort study, acute, preventable diabetes complication days decreased by 8.4% in the overall PDL group and by 10.2% among PDL members from lower-income areas compared with the control group. The results may support a strategy of incentivizing adoption of targeted cost-sharing reductions among commercially insured patients with diabetes and lower income to enhance health outcomes.

Comparison of health care costs following sleeve gastrectomy versus Roux-en-Y gastric bypass among patients with type 2 diabetes.

OBJECTIVE: The objective of this study was to compare the impact of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on overall and diabetes-specific health care costs among patients with type 2 diabetes. METHODS: This retrospective cohort study examined patients with type 2 diabetes after SG and RYGB using data from Optum's deidentified Clinformatics® Data Mart database. The matched study group included 9608 patients who underwent SG or RYGB and were enrolled between 2007 and 2019. The primary outcomes assessed were overall and diabetes-specific health care costs. RESULTS: Health care costs associated with type 2 diabetes declined substantially in the first few years following both SG and RYGB. RYGB was associated with a larger decrease in pharmacy costs, as well as type 2 diabetes-specific office and laboratory costs. SG was associated with lower total health care costs in the first three follow-up periods and lower acute care costs in the first 2 years after surgery. CONCLUSIONS: In this nationwide study, patients with type 2 diabetes at baseline undergoing RYGB appear to experience a reduced need for ambulatory type 2 diabetes monitoring and reduced requirements for antidiabetes medication but, despite this, did not experience an overall medical cost-benefit in the first few years after RYGB versus SG.

Trends in High-Acuity Cardiovascular Events During the COVID-19 Pandemic.

This cohort study describes changes in myocardial infarction and stroke hospitalizations as well as congestive heart failure, angina, and transient ischemic attack incidents months before and after March 2020 among insured people in New England.

Returning personalized, genetic health test results to individuals of African descent or ancestry in precision medicine research.

Today, many epidemiological studies and biobanks are offering to disclose individual genetic results to their participants, including the National Institutes of Health's All of Us Research Program. Returning hereditary disease risks and pharmacogenetic test results to study participants from racial/ethnic groups that are historically underrepresented in biomedical research poses specific challenges to those participants and the health system writ large. For example, individuals of African descent are underrepresented in research about drug-gene interactions and have a relatively higher proportion of variants of unknown significance, affecting their ability to take clinical action following return of results. In this brief report, we summarize studies published to date concerning the perspectives and/or attitudes of African Americans engaged in genetic research programs to anticipate factors in disclosure protocols that would minimize risks and maximize benefits. A thematic analysis of studies identified (n = 6) lends to themes centered on motivations to engage or disengage in the return of results and integrating research and care. Actionable strategies determined in reaction to these themes center on ensuring adequate system and health education support for participants and personalizing the process for participants engaging in return of results. Overall, we offer these themes and actionable strategies as early guidance to research programs, and provide recommendations to policy makers focused on fair and equitable return of genetic research results to underrepresented research participants.

Acute Care Utilization and Costs Up to 4 Years After Index Sleeve Gastrectomy or Roux-en-Y Gastric Bypass: A National Claims-based Study.

OBJECTIVE: To compare acute care utilization and costs following sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB). SUMMARY BACKGROUND DATA: Comparing postbariatric emergency department (ED) and inpatient care use patterns could assist with procedure choice and provide insights about complication risk. METHODS: We used a national insurance claims database to identify adults undergoing SG and RYGB between 2008 and 2016. Patients were matched on age, sex, calendar-time, diabetes, and baseline acute care use. We used adjusted Cox proportional hazards to compare acute care utilization and 2-part logistic regression models to compare annual associated costs (odds of any cost, and odds of high costs, defined as ≥80th percentile), between SG and RYGB, overall and within several clinical categories. RESULTS: The matched cohort included 4263 SG and 4520 RYGB patients. Up to 4 years after surgery, SG patients had slightly lower risk of ED visits [adjusted hazard ratio (aHR): 0.90; 95% confidence interval (CI): 0.85,0.96] and inpatient stays (aHR: 0.80; 95% CI: 0.73,0.88), especially for events associated with digestive-system diagnoses (ED aHR: 0.68; 95% CI: 0.62,0.75; inpatient aHR: 0.61; 95% CI: 0.53,0.72). SG patients also had lower odds of high ED and high total acute costs (eg, year-1 acute costs adjusted odds ratio (aOR) 0.77; 95% CI: 0.66,0.90) in early follow-up. However, observed cost differences decreased by years 3 and 4 (eg, year-4 acute care costs aOR 1.10; 95% CI: 0.92,1.31). CONCLUSIONS: SG may have fewer complications requiring emergency care and hospitalization, especially as related to digestive system disease. However, any acute care cost advantages of SG may wane over time.

Comparison of Ambulatory Health Care Costs and Use Associated With Roux-en-Y Gastric Bypass vs Sleeve Gastrectomy.

Importance: Studies comparing contemporary bariatric surgical types could facilitate procedure selection for patients interested in reducing their frequency of health care visits and reliance on prescription drugs. Objective: To compare the association of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) with ambulatory health care costs and use for as long as 4 years after surgery. Design, Setting, and Participants: This comparative effectiveness study, which included patients undergoing bariatric surgery who were aged 18 to 64 years with at least 24 months of enrollment data before surgery and 12 months of enrollment data after surgery, used a retrospective interrupted time series with a comparison group. Data represent insurance claims dated January 2006 to June 2017, with analyses completed in September 2021. Data were collected from US commercial and Medicare Advantage claims database. Cohorts were matched on characteristics including baseline body mass index category, diabetes status, baseline ambulatory care costs, region of the United States, and year of surgery. Exposures: SG or RYGB, based on procedure codes. Main Outcomes and Measures: Annual ambulatory health care costs, and subtypes of cost and use including prescriptions, office visits, laboratory encounters, and radiology. Results: Matched cohorts included 3049 patients who underwent SG and 3251 patients who underwent RYGB, with a mean (SD) age of 45.2 (10.0) years; 4820 (77%) were women. Full follow-up was 37% for SG (514 patients) and 38% for RYGB (643 patients) among those eligible for 4-year follow-up. There were no significant differences between SG and RYGB in total ambulatory costs, office visit costs, or radiology costs in all follow-up years. Patients who underwent SG had significantly higher prescription costs than those who underwent RYGB bypass in year 4 ($852.8 per patient per year; 95% CI: $395.6-$1310.0 per patient per year) with more cardiometabolic medication fills in each year (eg, year 4: 42.5%; 95% CI, 13.7%-71.2%). In contrast, early after surgery, patients who underwent SG had relatively fewer specialist visits (eg, year 1: -7.2%; 95% CI, -14.3% to -0.2%) and lower laboratory costs (eg, year 1: -$118.9 per patient per year; 95% CI, -$220.2 to -$17.5 per patient per year). Conclusions and Relevance: Despite clinical studies showing greater weight loss and comorbidity improvement with RYGB vs SG, this study found no difference in total ambulatory costs for as long as 4 years after SG and RYGB. These findings may reflect the trade-off between greater improvements in cardiometabolic health and additional surgery-related care among patients undergoing RYGB. Studies with longer follow-up time could determine whether greater sustained weight loss from RYGB eventually results in lower costs compared with SG.

Diabetes Microvascular Disease Diagnosis and Treatment After High-Deductible Health Plan Enrollment.

OBJECTIVE: The Affordable Care Act mandates that primary preventive services have no out-of-pocket costs but does not exempt secondary prevention from out-of-pocket costs. Most commercially insured patients with diabetes have high-deductible health plans (HDHPs) that subject key microvascular disease-related services to high out-of-pocket costs. Brief treatment delays can significantly worsen microvascular disease outcomes. RESEARCH DESIGN AND METHODS: This cohort study used a large national commercial (and Medicare Advantage) health insurance claims data set to examine matched groups before and after an insurance design change. The study group included 50,790 patients with diabetes who were continuously enrolled in low-deductible (≤$500) health plans during a baseline year, followed by up to 4 years in high-deductible (≥$1,000) plans after an employer-mandated switch. HDHPs had low out-of-pocket costs for nephropathy screening but not retinopathy screening. A matched control group included 335,178 patients with diabetes who were contemporaneously enrolled in low-deductible plans. Measures included time to first detected microvascular disease screening, severe microvascular disease diagnosis, vision loss diagnosis/treatment, and renal function loss diagnosis/treatment. RESULTS: HDHP enrollment was associated with relative delays in retinopathy screening (0.7 months [95% CI 0.4, 1.0]), severe retinopathy diagnosis (2.9 months [0.5, 5.3]), and vision loss diagnosis/treatment (3.8 months [1.2, 6.3]). Nephropathy-associated measures did not change to a statistically significant degree among HDHP members relative to control subjects at follow-up. CONCLUSIONS: People with diabetes in HDHPs experienced delayed retinopathy diagnosis and vision loss diagnosis/treatment of up to 3.8 months compared with low-deductible plan enrollees. Findings raise concerns about visual health among HDHP members and call attention to discrepancies in Affordable Care Act cost sharing exemptions.

Concurrent hiatal hernia repair and bariatric surgery: outcomes after sleeve gastrectomy and Roux-en-Y gastric bypass.

BACKGROUND: Hiatal hernias are often repaired concurrently with bariatric surgery to reduce risk of gastroesophageal reflux disease-related complications. OBJECTIVES: To examine the association between concurrent hiatal hernia repair (HHR) and bariatric outcomes. SETTING: A 2010-2017 U.S. commercial insurance claims data set. METHODS: We conducted a retrospective cohort study. We identified adults who underwent sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) alone or had bariatric surgery concurrently with HHR. We matched patients with and without HHR and followed patients up to 3 years for incident abdominal operative interventions, bariatric revisions/conversions, and endoscopy. Time to first event for each outcome was compared using multivariable Cox proportional hazards modeling. RESULTS: We matched 1546 SG patients with HHR to 3170 SG patients without HHR, and we matched 457 RYGB patients with HHR to 1156 RYGB patients without HHR. A total of 73% had a full year of postoperative enrollment. Patients who underwent concurrent SG and HHR were more likely to have additional abdominal operations (adjusted hazard ratio [aHR], 2.1; 95% CI, 1.5-3.1) and endoscopies (aHR, 1.5; 95% CI, 1.2-1.8) but not bariatric revisions/conversions (aHR, 1.7; 95% CI, .6-4.6) by 1 year after surgery, a pattern maintained at 3 years of follow-up. Among RYGB patients, concurrent HHR was associated only with an increased risk of endoscopy (aHR, 1.4; 95% CI, 1.1-1.8)) at 1 year of follow-up, persisting at 3 years. CONCLUSIONS: Concurrent SG/HHR was associated with increased risk of some subsequent operative and nonoperative interventions, a pattern that was not consistently observed for RYGB. Additional studies could examine whether changes to concurrent HHR technique could reduce risk.

Risk of Operative and Nonoperative Interventions Up to 4 Years After Roux-en-Y Gastric Bypass vs Vertical Sleeve Gastrectomy in a Nationwide US Commercial Insurance Claims Database.

Importance: There are few nationwide studies comparing the risk of reintervention after contemporary bariatric procedures. Objective: To compare the risk of intervention after Roux-en-Y gastric bypass (RYGB) vs vertical sleeve gastrectomy (VSG). Design, Setting, and Participants: This cohort study used a nationwide US commercial insurance claims database. Adults aged 18 to 64 years who underwent a first RYGB or VSG procedure between January 1, 2010, and June 30, 2017, were matched on US region, year of surgery, most recent presurgery body mass index (BMI) category (based on diagnosis codes), and baseline type 2 diabetes. The prematch pool included 4496 patients undergoing RYGB and 8627 patients undergoing VSG, and the final weighted matched sample included 4476 patients undergoing RYGB and 8551 patients undergoing VSG. Exposures: Bariatric surgery procedure type (RYGB vs VSG). Main Outcomes and Measures: The primary outcome was any abdominal operative intervention after the index procedure. Secondary outcomes included the following subtypes of operative intervention: biliary procedures, abdominal wall hernia repair, bariatric conversion or revision, and other abdominal operations. Nonoperative outcomes included endoscopy and enteral access. Time to first event was compared using multivariable Cox proportional hazards regression modeling. Results: Among 13 027 patients, the mean (SD) age was 44.4 (10.3) years, and 74.1% were female; 13.7% had a preoperative BMI between 30 and 39.9, 45.8% had a preoperative BMI between 40 and 49.9, and 24.2% had a preoperative BMI of at least 50. Patients were followed up for up to 4 years after surgery (median, 1.6 years; interquartile range, 0.7-3.2 years), with 41.9% having at least 2 years of follow-up and 16.3% having at least 4 years of follow-up. Patients undergoing VSG were less likely to have any subsequent operative intervention than matched patients undergoing RYGB (adjusted hazard ratio [aHR], 0.80; 95% CI, 0.72-0.89) and similarly were less likely to undergo biliary procedures (aHR, 0.77; 95% CI, 0.67-0.90), abdominal wall hernia repair (aHR, 0.60; 95% CI, 0.47-0.75), other abdominal operations (aHR, 0.71; 95% CI, 0.61-0.82), and endoscopy (aHR, 0.54; 95% CI, 0.49-0.59) or have enteral access placed (aHR, 0.58; 95% CI, 0.39-0.86). Patients undergoing VSG were more likely to undergo bariatric conversion or revision (aHR, 1.83; 95% CI, 1.19-2.80). Conclusions and Relevance: In this nationwide study, patients undergoing VSG appeared to be less likely than matched patients undergoing RYGB to experience subsequent abdominal operative interventions, except for bariatric conversion or revision procedures. Patients considering bariatric surgery should be aware of the increased risk of subsequent procedures associated with RYGB vs VSG as part of shared decision-making around procedure choice.