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.

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.

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.

Utilization and Spending With Preventive Drug Lists for Asthma Medications in High-Deductible Health Plans.

Importance: High-deductible health plans with health savings accounts (HDHP-HSAs) incentivize patients to use less health care, including necessary care. Preventive drug lists (PDLs) exempt high-value medications from the deductible, reducing out-of-pocket cost sharing; the associations of PDLs with health outcomes among patients with asthma is unknown. Objective: To evaluate the associations of a PDL for asthma medications on utilization, adverse outcomes, and patient spending for HDHP-HSA enrollees with asthma. Design, Setting, and Participants: This case-control study used matched groups of patients with asthma before and after an insurance design change using a national commercial health insurance claims data set from 2004-2017. Participants included patients aged 4 to 64 years enrolled for 1 year in an HDHP-HSA without a PDL in which asthma medications were subject to the deductible who then transitioned to an HDHP-HSA with a PDL that included asthma medications; these patients were compared with a matched weighted sample of patients with 2 years of continuous enrollment in an HDHP-HSA without a PDL. Models controlled for patient demographics and asthma severity and were stratified by neighborhood income. Analyses were conducted from October 2020 to June 2023. Exposures: Employer-mandated addition of a PDL that included asthma medications to an existing HDHP-HSA. Main Outcomes and Measures: Outcomes of interest were utilization of asthma medications on the PDL (controllers and albuterol), asthma exacerbations (oral steroid bursts and asthma-related emergency department use), and out-of-pocket spending (all and asthma-specific). Results: A total of 12 174 participants (mean [SD] age, 36.9 [16.9] years; 6848 [56.25%] female) were included in analyses. Compared with no PDL, PDLs were associated with increased rates of 30-day fills per enrollee for any controller medication (change, 0.10 [95% CI, 0.03 to 0.17] fills per enrollee; 12.9% increase) and for combination inhaled corticosteroid long-acting ß2-agonist (ICS-LABA) medications (change, 0.06 [95% CI, 0.01 to 0.10] fills per enrollee; 25.4% increase), and increased proportion of days covered with ICS-LABA (6.0% [0.7% to 11.3%] of days; 15.6% increase). Gaining a PDL was associated with decreased out-of-pocket spending on asthma care (change, -$34 [95% CI, -$47 to -$21] per enrollee; 28.4% difference), but there was no significant change in asthma exacerbations and no difference in results by income. Conclusions and Relevance: In this case-control study, reducing cost-sharing for asthma medications through a PDL was associated with increased adherence to controller medications, notably ICS-LABA medications used by patients with more severe asthma, but was not associated with improved clinical outcomes. These findings suggest that PDLs are a potential strategy to improve access and affordability of asthma care for patients in HDHP-HSAs.

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.

Evaluating Natural Experiments that Impact the Diabetes Epidemic: an Introduction to the NEXT-D3 Network.

PURPOSE OF REVIEW: Diabetes is an ongoing public health issue in the USA, and, despite progress, recent reports suggest acute and chronic diabetes complications are increasing. RECENT FINDINGS: The Natural Experiments for Translation in Diabetes 3.0 (NEXT-D3) Network is a 5-year research collaboration involving six academic centers (Harvard University, Northwestern University, Oregon Health & Science University, Tulane University, University of California Los Angeles, and University of California San Francisco) and two funding agencies (Centers for Disease Control and Prevention and National Institutes of Health) to address the gaps leading to persisting diabetes burdens. The network builds on previously funded networks, expanding to include type 2 diabetes (T2D) prevention and an emphasis on health equity. NEXT-D3 researchers use rigorous natural experiment study designs to evaluate impacts of naturally occurring programs and policies, with a focus on diabetes-related outcomes. NEXT-D3 projects address whether and to what extent federal or state legislative policies and health plan innovations affect T2D risk and diabetes treatment and outcomes in the USA; real-world effects of increased access to health insurance under the Affordable Care Act; and the effectiveness of interventions that reduce barriers to medication access (e.g., decreased or eliminated cost sharing for cardiometabolic medications and new medications such as SGLT-2 inhibitors for Medicaid patients). Overarching goals include (1) expanding generalizable knowledge about policies and programs to manage or prevent T2D and educate decision-makers and organizations and (2) generating evidence to guide the development of health equity goals to reduce disparities in T2D-related risk factors, treatment, and complications.

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.

High-Deductible Health Plans Paired With Health Savings Accounts Increased Medication Cost Burden Among Individuals With Bipolar Disorder.

Objective: High-deductible health plans paired with health savings accounts (HSA-HDHPs) require substantial out-of-pocket spending for most services, including medications. We examined effects of HSA-HDHPs on medication out-of-pocket spending and use among people with bipolar disorder.Methods: This quasi-experimental study used claims data for January 2003 through December 2014. We studied a national sample of 348 members with bipolar disorder (defined based on International Classification of Diseases, 9th Revision), aged 12 to 64 years, who were continuously enrolled for 1 year in a low-deductible plan (≤ $500) then 1 year in an HSA-HDHP (≥ $1,000) after an employer-mandated switch. HSA-HDHP members were matched to 4,087 contemporaneous controls who remained in low-deductible plans. Outcome measures included out-of-pocket spending and use of bipolar disorder medications, non-bipolar psychotropics, and all other medications.Results: Mean pre-to-post out-of-pocket spending per person for bipolar disorder medications increased by 149.7% among HSA-HDHP versus control members (95% confidence interval [CI], 109.9% to 189.5%). Specifically, out-of-pocket spending increased for antipsychotics (220.9% [95% CI, 150.0% to 291.8%]) and anticonvulsants (109.6% [95% CI, 67.3% to 152.0%]). Both higher-income and lower-income HSA-HDHP members experienced increases in out-of-pocket spending for bipolar disorder medications (135.2% [95% CI, 86.4% to 184.0%] and 164.5% [95% CI, 100.9% to 228.1%], respectively). We did not detect statistically significant changes in use of bipolar disorder medications, non-bipolar psychotropics, or all other medications in this study population of HSA-HDHP members.Conclusions: HSA-HDHP members with bipolar disorder experienced substantial increases in out-of-pocket burdens for medications essential for their functioning and well-being. Although HSA-HDHPs were not associated with detectable reductions in medication use, high out-of-pocket costs could cause financial strain for lower-income enrollees.

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.

Financing Strategies to Facilitate Access to High-Cost Anticancer Drugs: A Systematic Review of the Literature.

BACKGROUND: Each country manages access to anticancer drugs differently due to variations in the structure and financing of the health system, but a summary of the various strategies used is absent. This study aimed to review and summarize financing strategies implemented across countries to facilitate access to high-cost anticancer drugs. METHODS: We conducted a systematic review of articles referenced in PubMed, Embase, and Web of Science through May 12, 2021. Articles published in the English language from 2000 that describe strategies implemented in different countries to facilitate access to high-cost anticancer drugs were included. Letters, news articles, and proposed strategies were excluded. Quality assessment was not performed as we aimed to summarize the strategies. Data were analyzed by thematic analysis. A review protocol was registered at PROSPERO (CRD42018068616). RESULTS: The review included 204 studies from 176 countries. Three themes of financing strategies were identified: (1) Basic pharmaceutical reimbursement and pricing policies, (2) Alternative funding strategies specific to high-cost drugs, and (3) Financial assistance for individual patients. Access in most countries depends mainly on basic pharmaceutical reimbursement policies (165 of 176 countries). Apart from that, high-income countries (HICs) tended to use funding strategies targeting high-cost drugs (72% of HICs vs 0%-24% of the rest), such as managed entry agreements (MEAs) or dedicated funds for high-cost drugs. In contrast, lower-income countries tended to implement financial assistance programs for cancer patients as a tool to increase access (32% of HICs vs 62%-79% of the rest). CONCLUSION: Many countries have implemented a combination of strategies to increase access to high-cost anticancer drugs. Most low- and middle-income countries utilized placement of anticancer drugs on a national list of essential medicines and patient assistance programs (PAPs) to facilitate access, while many HICs implemented a broader range of strategies.

Real-world Use of and Spending on New Oral Targeted Cancer Drugs in the US, 2011-2018.

Importance: Launch prices of new cancer drugs in the US have substantially increased in recent years despite growing concerns about the quantity and quality of evidence supporting their approval by the US Food and Drug Administration (FDA). Objective: To assess the use of and spending on new oral targeted cancer drugs among US residents with employer-sponsored insurance between 2011 and 2018, stratified by the strength of available evidence of benefit. Design, Setting, and Participants: In this cross-sectional study, dispensing claims for oral targeted cancer drugs first approved by the FDA between January 1, 2011, and December 31, 2018, were analyzed. The number of patients with drugs dispensed and the total payment for all claims were aggregated by calendar year, and these outcomes were arrayed according to evidence underlying FDA approvals, including pivotal study design (availability of randomized clinical trials) and overall survival (OS) benefit, as documented in drug labels. This study was conducted from July 17, 2019, to July 23, 2021. Main Outcomes and Measures: Annual and cumulative numbers of patients who had dispensing events, and annual and cumulative sums of payment for eligible drugs. Results: Of 37 348 patients who had at least 1 of the 44 new oral targeted drugs dispensed between 2011 and 2018, 21 324 were men (57.1%); mean (SD) age was 64.1 (13.1) years. Most individuals (36 246 [97.0%]) received drugs for which evidence from randomized clinical trials existed; however, a growing share of patients received drugs without documented OS benefit during the study period: from 12.7% in 2011 to 58.8% in 2018. Cumulative spending on all sample drugs totaled $3.5 billion by the end of 2018, of which 96.8% was spent on drugs that were approved based on a pivotal randomized clinical trial. Cumulative spending on drugs without documented OS benefit ($1.8 billion [51.6%]) surpassed that on drugs with documented OS benefit ($1.7 billion [48.4%]) by the end of 2018. Conclusions and Relevance: The findings of this cross-sectional study suggest that drugs used for treatment of cancer without documented OS benefits are adopted in the health system and account for substantial spending.

High-cost high-need patients in Medicaid: segmenting the population eligible for a national complex case management program.

BACKGROUND: High-cost high-need patients are typically defined by risk or cost thresholds which aggregate clinically diverse subgroups into a single 'high-need high-cost' designation. Programs have had limited success in reducing utilization or improving quality of care for high-cost high-need Medicaid patients, which may be due to the underlying clinical heterogeneity of patients meeting high-cost high-need designations. METHODS: Our objective was to segment a population of high-cost high-need Medicaid patients (N = 676,161) eligible for a national complex case management program between January 2012 and May 2015 to disaggregate clinically diverse subgroups. Patients were eligible if they were in the top 5 % of annual spending among UnitedHealthcare Medicaid beneficiaries. We used k-means cluster analysis, identified clusters using an information-theoretic approach, and named clusters using the patients' pattern of acute and chronic conditions. We assessed one-year overall and preventable hospitalizations, overall and preventable emergency department (ED) visits, and cluster stability. RESULTS: Six clusters were identified which varied by utilization and stability. The characteristic condition patterns were: 1) pregnancy complications, 2) behavioral health, 3) relatively few conditions, 4) cardio-metabolic disease, and complex illness with relatively 5) low or 6) high resource use. The patients varied by cluster by average ED visits (2.3-11.3), hospitalizations (0.3-2.0), and cluster stability (32-91%). CONCLUSIONS: We concluded that disaggregating subgroups of high-cost high-need patients in a large multi-state Medicaid sample identified clinically distinct clusters of patients who may have unique clinical needs. Segmenting previously identified high-cost high-need populations thus may be a necessary strategy to improve the effectiveness of complex case management programs in Medicaid.

Trends in high deductible health plan enrolment and spending among commercially insured members with and without chronic conditions: a Natural Experiment for Translation in Diabetes (NEXT-D2) Study.

OBJECTIVES: To examine trends in high deductible health plan (HDHP) enrolment among members with diabetes and cardiovascular disease (CVD) compared with healthy members and compare out-of-pocket (OOP) and total spending for members with chronic conditions in HDHPs versus low deductible plans. DESIGN: Descriptive study with time trends. SETTING: A large national commercial insurance database. PARTICIPANTS: 1.2 million members with diabetes, 4.5 million members with CVD (without diabetes) and 18 million healthy members (defined by a low comorbidity score) under the age of 65 years and insured between 2005 and 2013. OUTCOME MEASURES: Percentage of members in an HDHP (ie, annual deductible ≥$1000) by year, annual mean OOP and total spending, adjusted for member sociodemographic and employer characteristics. RESULTS: Enrolment in HDHPs among members in all disease categories increased by 5 percentage points a year and was over 50% by 2013. On average, over the study period, HDHP enrolment among members with diabetes and CVD was 2.84 (95% CI: 2.78 to 2.90) and 2.02 (95% CI: 1.98 to 2.05) percentage points lower, respectively, than among healthy members. HDHP members with diabetes, CVD and low morbidity had higher annual OOP costs ($636 (95% CI: 630 to 642), $539 (95% CI: 537 to 542) and $113 (95% CI: 112 to 113)) and lower total costs (-$529 (95% CI: -597 to -461), -$364 (95% CI: -385 to -342) and -$79 (95% CI: -81 to -76)), respectively, than corresponding low deductible members when averaged over the study period. Members with chronic diseases had yearly OOP expenditures that were five to seven times higher than healthier members. CONCLUSION: High HDHP enrolment coupled with the high OOP costs associated with HDHPs may be particularly detrimental to the financial well-being of people with diabetes and CVD, who have more healthcare needs than healthier populations.

Controller Medication Use and Exacerbations for Children and Adults With Asthma in High-Deductible Health Plans.

Importance: High-deductible health plans (HDHPs) are increasingly common and associated with decreased medication use in some adult populations. How children are affected is less certain. Objective: To examine the association between HDHP enrollment and asthma controller medication use and exacerbations. Design, Setting, and Participants: For this longitudinal cohort study with a difference-in-differences design, data were obtained from a large, national, commercial (and Medicare Advantage) administrative claims database between January 1, 2002, and December 31, 2014. Children aged 4 to 17 years and adults aged 18 to 64 years with persistent asthma who switched from traditional plans to HDHPs or remained in traditional plans (control group) by employer choice during a 24-month period were identified. A coarsened exact matching technique was used to balance the groups on characteristics including employer and enrollee propensity to have HDHPs. In most HDHPs, asthma medications were exempt from the deductible and subject to copayments. Statistical analyses were conducted from August 13, 2019, to January 19, 2021. Exposure: Employer-mandated HDHP transition. Main Outcomes and Measures: Thirty-day fill rates and adherence (based on proportion of days covered [PDC]) were measured for asthma controller medications (inhaled corticosteroid [ICS], leukotriene inhibitors, and ICS long-acting ß-agonists [ICS-LABAs]). Asthma exacerbations were measured by rates of oral corticosteroid bursts and asthma-related emergency department visits among controller medication users. Results: The HDHP group included 7275 children (mean [SD] age, 10.8 [3.3] years; 4402 boys [60.5%]; and 5172 non-Hispanic White children [71.1%]) and 17 614 adults (mean [SD] age, 41.1 [13.4] years; 10 464 women [59.4%]; and 12 548 non-Hispanic White adults [71.2%]). The matched control group included 45 549 children and 114 141 adults. Compared with controls, children switching to HDHPs experienced significant absolute decreases in annual 30-day fills only for ICS-LABA medications (absolute change, -0.04; 95% CI, -0.07 to -0.01). Adults switching to HDHPs did not have significant reductions in 30-day fills for any controllers. There were no statistically significant differences in PDC, oral steroid bursts, or asthma-related emergency department visits for children or adults. For the 9.9% of HDHP enrollees with health savings account-eligible HDHPs that subjected medications to the deductible, there was a significant absolute decrease in PDC for ICS-LABA compared with controls (-4.8%; 95% CI, -7.7% to -1.9%). Conclusions and Relevance: This cohort study found that in a population where medications were exempt from the deductible for most enrollees, HDHP enrollment was associated with minimal or no reductions in controller medication use for children and adults and no change in asthma exacerbations. These findings suggest a potential benefit from exempting asthma medications from the deductible in HDHPs.

Impact of High-Deductible Health Plans on Medication Use Among Individuals With Bipolar Disorder.

OBJECTIVE: High-deductible health plans (HDHPs) require substantial out-of-pocket spending for most services, although medications may be subject to traditional copayment arrangements. This study examined effects of HDHPs on medication out-of-pocket spending and use and quality of care among individuals with bipolar disorder. METHODS: This quasi-experimental study used claims data (2003-2014) for a national sample of 3,532 members with bipolar disorder, ages 12-64, continuously enrolled for 1 year in a low-deductible plan (≤$500) and then for 1 year in an HDHP (≥$1,000) after an employer-mandated switch. HDHP members were matched to 18,923 contemporaneous individuals in low-deductible plans (control group). Outcome measures were out-of-pocket spending and use of bipolar disorder medications, psychotropics for other disorders, and all other medications and appropriate laboratory monitoring for psychotropics. RESULTS: Relative to the control group, annual out-of-pocket spending per person for bipolar disorder medications increased 20.8% among HDHP members (95% confidence interval [CI]=14.9%-26.7%), and the absolute increase was $36 (95% CI=$25.9-$45.2). Specifically, out-of-pocket spending increased for antipsychotics (27.1%; 95% CI=17.4%-36.7%) and anticonvulsants (19.2%; 95% CI=11.9%-26.6%) but remained stable for lithium (-3.7%; 95% CI=-12.2% to 4.8%). No statistically significant changes were detected in use of bipolar disorder medications, other psychotropics, or all other medications or in appropriate laboratory monitoring for bipolar disorder medications. CONCLUSIONS: HDHP members with bipolar disorder experienced a moderate increase in out-of-pocket spending for medications but preserved bipolar disorder medication use. Findings may reflect individuals' perceptions of the importance of these medications for their functioning and well-being.

Article 4: Impact assessment of supervision performance assessment and recognition strategy (SPARS) to improve supply chain management in health facilities in Uganda: a national pre and post study.

BACKGROUND: To strengthen medicines management capacity, including supply chain management, at public sector health facilities in Uganda, the Ministry of Health introduced a multipronged supervision, performance assessment, and recognition strategy (SPARS). The aim of this study was to assess the impact of SPARS on improving supply chain management. A series of four papers on SPARS described the SPARS concept, its impact on overall and domain practices and appropriate medicines use, and now in the fourth paper describing the effect on supply chain management. METHODS: District-based health workers trained as supervisors build facility-level capacity in medicines management using an indicator-based performance assessment followed by targeted supervisory visits. From 2010 to 2013, 1222 SPARS visits were implemented, and the SPARS performance indicator scores determined. This article assesses impact on 13 indicators in three of the five SPARS domains-stock management, storage management, and ordering and reporting quality-using a pre-post design. We also explored factors that may have influenced these outcomes. RESULTS: Between the first and last visit within one year of SPARS implementation, we found an average improvement of 16 percentage points (p < 0.001) in supply chain management measures across all levels of care. The improvement in scores for stock management, storage management, and ordering and reporting was 22 (ns), 16 (p < 0.001), and 11 (p = 0.032) percentage points, respectively. The study identified the key predictors of positive change as a low initial indicator score, frequent supervisory visits, and engagement of the district health officer. CONCLUSIONS: The multipronged SPARS approach was effective in building supply chain management capacity in lower-level health care facilities with statistically significant improvements in supply chain management overall and in almost all stock and storage- management and ordering and reporting measures after one year of implementation. We recommend broad dissemination of the SPARS approach as an effective strategy to strengthen supply chain management in low-income countries. TRIAL REGISTRATION: The study did not involve or use human participants or identifiable personal data, human tissue, or animals and thus did not require ethical approval or a waiver. It is a study implemented in collaboration with the Ministry of Health and does not require trial registration.

Affordability of Medical Care Among Medicare Enrollees.

Importance: Cost-sharing requirements can discourage patients from seeking care and impose financial hardship. The Medicare program serves many older and disabled individuals with multimorbidity and limited resources, but little has been known about the affordability of care in this population. Objective: To examine the affordability of medical care among Medicare enrollees, in terms of the prevalence of delaying medical care because of costs and having problems paying medical bills, and risk factors for these outcomes. Design Setting and Participants: Cross-sectional analyses conducted from November 1, 2019, to October 15, 2021, used logistic regression to compare the probability of outcomes by demographic and health characteristics. Data were obtained from the 2017 nationally representative Medicare Current Beneficiary Survey (response rate, 61.7%), with respondents representing 53 million community-dwelling Medicare enrollees. Main Outcomes and Measures: New questions about medical care affordability were included in the 2017 Medicare Current Beneficiary Survey: difficulty paying medical bills, ongoing medical debt, and contact by collection agencies. A companion survey question asked whether individuals had delayed seeking medical care because of worries about costs. Results: Respondents included 10 974 adults aged 65 years or older and 2197 aged 18 to 64 years; 54.2% of all respondents were women. The weighted proportions of Medicare enrollees with annual incomes below $25 000K were 30.7% in the older population and 67.4% in the younger group. Self-reported prevalence of delaying care because of cost was 8.3% (95% CI, 7.4%-9.1%) among enrollees aged 65 years or older, 25.2% (95% CI, 21.8%-28.6%) among enrollees younger than 65 years, and 10.9% (95% CI, 9.9%-11.9%) overall. Similarly, 7.4% (95% CI, 6.6%-8.2%) of older enrollees had problems paying medical bills, compared with 29.8% (95% CI, 25.6%-34.1%) among those younger than 65 years and 10.8% (95% CI, 9.8%-11.9%) overall. Regarding specific payment problems, 7.9% (95% CI, 7.0%-8.9%) of enrollees overall experienced ongoing medical debt, contact by a collection agency, or both. In adjusted analyses, older adults with incomes $15 000 to $25 000 per year had odds of delaying care more than twice as high as those with incomes greater than $50 000 (odds ratio, 2.47; 95% CI, 1.82-3.39), and their odds of problems paying medical bills were more than 3 times as high (odds ratio, 3.37; 95% CI, 2.81-5.21). Older adults with 4 to 10 chronic conditions were more than twice as likely to have problems paying medical bills as those with 0 or 1 condition. Conclusions and Relevance: The findings of this study suggest that unaffordability of medical care is common among Medicare enrollees, especially those with lower incomes, or worse health, or who qualify for Medicare based on disability. Policy reforms, such as caps on patient spending, are needed to reduce Medical cost burdens on the most vulnerable enrollees.

Comparative Effectiveness of Vertical Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Diabetes Treatment: A Claims-based Cohort Study.

OBJECTIVE: The aim of the study was to compare diabetes outcomes following vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB). BACKGROUND: There are few comparative studies on diabetes outcomes after VSG and RYGB. METHODS: We used a US-wide commercial insurance claims database to identify adults with diabetes undergoing VSG or RYGB in 2010 to 2016. We matched patients on baseline insulin use, total diabetes medication burden, age, presence of diabetes complications, and follow-up duration, and used adjusted Cox proportional hazards models to compare diabetes medication discontinuation between procedures. We used difference-in-differences analyses to compare changes in medication use intensity up to 2 years after surgery. RESULTS: The matched cohort included 1111 VSG and 922 RYGB patients: 16% were younger than 40 years, 11% were 60 years or older, 67% were women, 67% had a body mass index of 40 kg/m2 or higher, and 23% were on insulin at the time of surgery. Thirteen percent were lost to follow-up at 1 year, and 30% at 2 years after surgery. Patients with VSG were less likely than matched RYGB patients to discontinue all diabetes medications (hazard ratio 0.80, 95% confidence interval 0.72-0.88). Although both groups had substantial decreases in medication use after surgery, RYGB patients had an 86% (32%, 140%) lower total diabetes medication dose than VSG by the second half of postoperative year 2. CONCLUSIONS: In a large claims-based, nationwide cohort of bariatric patients with diabetes, those undergoing RYGB were more likely to come off all medications than those undergoing VSG. Patients with diabetes should consider this potential benefit of RYGB when making informed decisions about obesity treatments.