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.

Effect of a national antibiotic stewardship intervention in China targeting carbapenem overuse: An interrupted time-series analysis.

OBJECTIVES: To assess trends and patterns of carbapenem use and to evaluate the effects of a nationwide antibiotic stewardship policy to reduce carbapenem overuse. METHODS: In this quasi-experimental study, using longitudinal data from the national drug procurement database and interrupted time-series analyses with carbapenems as the intervention group and possible carbapenem substitutes as the comparison group, we evaluated the effects of a national stewardship policy on carbapenem consumption and expenditures, by region and types of healthcare institutions. RESULTS: The carbapenem procurement volume declined by -28.8% (95% CI -35.0 to -22.6) (-334.4 thousand defined daily doses [DDDs] per month), and carbapenem expenditures showed a relative reduction of -38.1% (-43.9 to -32.2). The gap between the use of carbapenems and each drug in the comparison group narrowed after the policy intervention, with an increase in tigecycline use (14.9 thousand DDDs [10.8-18.9]) and a slower decrease in use of certain third-generation cephalosporin combinations (-85.7 [-143.0 to -28.4]), penicillin combinations (-200.9 [-421.4-19.6]), and fourth-generation cephalosporins (-116.9 [-219.8 to -14.0]). Consumption was highest during the pre-policy period, and declines were largest following the intervention in the eastern region (-32.1%, -39.8 to -24.4) and among tertiary hospitals (-266.2 [-339.5 to -192.9] thousand DDDs per month). CONCLUSION: This population-level drug utilization research represents the first comprehensive evaluation of the effectiveness of China's nationwide carbapenem stewardship. The national policy targeting carbapenem prescribing has led to a sustained reduction in carbapenem use with limited substitution. Effects varied geographically and were concentrated in tertiary and secondary hospitals.

The Effectiveness of Enhanced Primary Healthcare (EnPHC) interventions on Type 2 diabetes management in Malaysia: Difference-in-differences (DID) analysis.

AIMS: To evaluate the effectiveness of the Enhanced Primary Healthcare (EnPHC) interventions on process of care and intermediate clinical outcomes among type 2 diabetes patients. METHODS: This was a quasi-experimental controlled study conducted in 20 intervention and 20 control public primary care clinics in Malaysia from November 2016 to June 2019. Type 2 diabetes patients aged 30 years and above were selected via systematic random sampling. Outcomes include process of care and intermediate clinical outcomes. Difference-in-differences analyses was conducted. RESULTS: We reviewed 12,017 medical records of patients with type 2 diabetes. Seven process of care measures improved: HbA1c tests (odds ratio (OR) 3.31, 95% CI 2.13, 5.13); lipid test (OR 4.59, 95% CI 2.64, 7.97), LDL (OR 4.33, 95% CI 2.16, 8.70), and urine albumin (OR 1.99, 95% CI 1.12, 3.55) tests; BMI measured (OR 15.80, 95% CI 4.78, 52.24); cardiovascular risk assessment (OR 174.65, 95% CI 16.84, 1810.80); and exercise counselling (OR 1.18, 95% CI 1.04, 1.33). We found no statistically significant changes in intermediate clinical outcomes (i.e. HbA1c, LDL, HDL and BP control). CONCLUSIONS: EnPHC interventions was successful in enhancing the quality of care, in terms of process of care, by changing healthcare providers behaviour.

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.

Trends in Annual Surveillance Mammography Participation Among Breast Cancer Survivors From 2004 to 2016.

BACKGROUND: Annual mammography is recommended for breast cancer survivors; however, population-level temporal trends in surveillance mammography participation have not been described. Our objective was to characterize trends in annual surveillance mammography participation among women with a personal history of breast cancer over a 13-year period. METHODS: We examined annual surveillance mammography participation from 2004 to 2016 in a nationwide sample of commercially insured women with prior breast cancer. Rates were stratified by age group (40-49 vs 50-64 years), visit with a surgical/oncology specialist or primary care provider within the prior year, and sociodemographic characteristics. Joinpoint models were used to estimate annual percentage changes (APCs) in participation during the study period. RESULTS: Among 141,672 women, mammography rates declined from 74.1% in 2004 to 67.1% in 2016. Rates were stable from 2004 to 2009 (APC, 0.1%; 95% CI, -0.5% to 0.8%) but declined 1.5% annually from 2009 to 2016 (95% CI, -1.9% to -1.1%). For women aged 40 to 49 years, rates declined 2.8% annually (95% CI, -3.4% to -2.1%) after 2009 versus 1.4% annually in women aged 50 to 64 years (95% CI, -1.9% to -1.0%). Similar trends were observed in women who had seen a surgeon/oncologist (APC, -1.7%; 95% CI, -2.1% to -1.4%) or a primary care provider (APC, -1.6%; 95% CI, -2.1% to -1.2%) in the prior year. CONCLUSIONS: Surveillance mammography participation among breast cancer survivors declined from 2009 to 2016, most notably among women aged 40 to 49 years. These findings highlight a need for focused efforts to improve adherence to surveillance and prevent delays in detection of breast cancer recurrence and second cancers.

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.

Use of Palliative Care Among Commercially Insured Patients With Metastatic Cancer Between 2001 and 2016.

PURPOSE: Early palliative care, concomitant with disease-directed treatments, is recommended for all patients with advanced cancer. This study assesses population-level trends in palliative care use among a large cohort of commercially insured patients with metastatic cancer, applying an expanded definition of palliative care services based on claims data. METHODS: Using nationally representative commercial insurance claims data, we identified patients with metastatic breast, colorectal, lung, bronchus, trachea, ovarian, esophageal, pancreatic, and liver cancers and melanoma between 2001 and 2016. We assessed the annual proportions of these patients who received services specified as, or indicative of, palliative care. Using Cox proportional hazard models, we assessed whether the time from diagnosis of metastatic cancer to first encounter of palliative care differed by demographic characteristics, socioeconomic factors, or region. RESULTS: In 2016, 36% of patients with very poor prognosis cancers received a service specified as, or indicative of, palliative care versus 18% of those with poor prognosis cancers. Being diagnosed in more recent years (2009-2016 v 2001-2008: hazard ratio [HR], 1.8; P < .001); a diagnosis of metastatic esophagus, liver, lung, or pancreatic cancer, or melanoma (v breast cancer, eg, esophagus HR, 1.89; P < .001); a greater number of comorbidities (American Hospital Formulary Service classes > 10 v 0: HR, 1.71; P < .001); and living in the Northeast (HR, 1.43; P < .001) or Midwest (v South: HR, 1.39; P < .001) were the strongest predictors of shorter time from diagnosis to palliative care. CONCLUSION: Use of palliative care among commercially insured patients with advanced cancers has increased since 2001. However, even with an expanded definition of services specified as, or indicative of, palliative care, < 40% of patients with advanced cancers received palliative care in 2016.

The effectiveness of supervision strategies to improve health care provider practices in low- and middle-income countries: secondary analysis of a systematic review.

BACKGROUND: Although supervision is a ubiquitous approach to support health programs and improve health care provider (HCP) performance in low- and middle-income countries (LMICs), quantitative evidence of its effects is unclear. The objectives of this study are to describe the effect of supervision strategies on HCP practices in LMICs and to identify attributes associated with greater effectiveness of routine supervision. METHODS: We performed a secondary analysis of data on HCP practice outcomes (e.g., percentage of patients correctly treated) from a systematic review on improving HCP performance. The review included controlled trials and interrupted time series studies. We described distributions of effect sizes (defined as percentage-point [%-point] changes) for each supervision strategy. To identify attributes associated with supervision effectiveness, we performed random-effects linear regression modeling and examined studies that directly compared different approaches of routine supervision. RESULTS: We analyzed data from 81 studies from 36 countries. For professional HCPs, such as nurses and physicians, primarily working at health facilities, routine supervision (median improvement when compared to controls: 10.7%-points; IQR: 9.9, 27.9) had similar effects on HCP practices as audit with feedback (median improvement: 10.1%-points; IQR: 6.2, 23.7). Two attributes were associated with greater mean effectiveness of routine supervision (p < 0.10): supervisors received supervision (by 8.8-11.5%-points), and supervisors participated in problem-solving with HCPs (by 14.2-20.8%-points). Training for supervisors and use of a checklist during supervision visits were not associated with effectiveness. The effects of supervision frequency (i.e., number of visits per year) and dose (i.e., the number of supervision visits during a study) were unclear. For lay HCPs, the effect of routine supervision was difficult to characterize because few studies existed, and effectiveness in those studies varied considerably. Evidence quality for all findings was low primarily because many studies had a high risk of bias. CONCLUSIONS: Although evidence is limited, to promote more effective supervision, our study supports supervising supervisors and having supervisors engage in problem-solving with HCPs. Supervision's integral role in health systems in LMICs justifies a more deliberate research agenda to identify how to deliver supervision to optimize its effect on HCP practices.

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.

How does the effectiveness of strategies to improve healthcare provider practices in low-income and middle-income countries change after implementation? Secondary analysis of a systematic review.

BACKGROUND: A recent systematic review evaluated the effectiveness of strategies to improve healthcare provider (HCP) performance in low-income and middle-income countries. The review identified strategies with varying effects, including in-service training, supervision and group problem-solving. However, whether their effectiveness changed over time remained unclear. In particular, understanding whether effects decay over time is crucial to improve sustainability. METHODS: We conducted a secondary analysis of data from the aforementioned review to explore associations between time and effectiveness. We calculated effect sizes (defined as percentage-point (%-point) changes) for HCP practice outcomes (eg, percentage of patients correctly treated) at each follow-up time point after the strategy was implemented. We estimated the association between time and effectiveness using random-intercept linear regression models with time-specific effect sizes clustered within studies and adjusted for baseline performance. RESULTS: The primary analysis included 37 studies, and a sensitivity analysis included 77 additional studies. For training, every additional month of follow-up was associated with a 0.19 %-point decrease in effectiveness (95% CI: -0.36 to -0.03). For training combined with supervision, every additional month was associated with a 0.40 %-point decrease in effectiveness (95% CI: -0.68 to -0.12). Time trend results for supervision were inconclusive. For group problem-solving alone, time was positively associated with effectiveness, with a 0.50 %-point increase in effect per month (95% CI: 0.37 to 0.64). Group problem-solving combined with training was associated with large improvements, and its effect was not associated with time. CONCLUSIONS: Time trends in the effectiveness of different strategies to improve HCP practices vary among strategies. Programmes relying solely on in-service training might need periodical refresher training or, better still, consider combining training with group problem-solving. Although more high-quality research is needed, these results, which are important for decision-makers as they choose which strategies to use, underscore the utility of studies with multiple post-implementation measurements so sustainability of the impact on HCP practices can be assessed.

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.