Trends in US Ambulatory Care Patterns During the COVID-19 Pandemic, 2019-2021.

Importance: Following reductions in US ambulatory care early in the pandemic, it remains unclear whether care consistently returned to expected rates across insurance types and services. Objective: To assess whether patients with Medicaid or Medicare-Medicaid dual eligibility had significantly lower than expected return to use of ambulatory care rates than patients with commercial, Medicare Advantage, or Medicare fee-for-service insurance. Design, Setting, and Participants: In this retrospective cohort study examining ambulatory care service patterns from January 1, 2019, through February 28, 2021, claims data from multiple US payers were combined using the Milliman MedInsight research database. Using a difference-in-differences design, the extent to which utilization during the pandemic differed from expected rates had the pandemic not occurred was estimated. Changes in utilization rates between January and February 2020 and each subsequent 2-month time frame during the pandemic were compared with the changes in the corresponding months from the year prior. Age- and sex-adjusted Poisson regression models of monthly utilization counts were used, offsetting for total patient-months and stratifying by service and insurance type. Exposures: Patients with Medicaid or Medicare-Medicaid dual eligibility compared with patients with commercial, Medicare Advantage, or Medicare fee-for-service insurance, respectively. Main Outcomes and Measures: Utilization rates per 100 people for 6 services: emergency department, office and urgent care, behavioral health, screening colonoscopies, screening mammograms, and contraception counseling or HIV screening. Results: More than 14.5 million US adults were included (mean age, 52.7 years; 54.9% women). In the March-April 2020 time frame, the combined use of 6 ambulatory services declined to 67.0% (95% CI, 66.9%-67.1%) of expected rates, but returned to 96.7% (95% CI, 96.6%-96.8%) of expected rates by the November-December 2020 time frame. During the second COVID-19 wave in the January-February 2021 time frame, overall utilization again declined to 86.2% (95% CI, 86.1%-86.3%) of expected rates, with colonoscopy remaining at 65.0% (95% CI, 64.1%-65.9%) and mammography at 79.2% (95% CI, 78.5%-79.8%) of expected rates. By the January-February 2021 time frame, overall utilization returned to expected rates as follows: patients with Medicaid at 78.4% (95% CI, 78.2%-78.7%), Medicare-Medicaid dual eligibility at 73.3% (95% CI, 72.8%-73.8%), commercial at 90.7% (95% CI, 90.5%-90.9%), Medicare Advantage at 83.2% (95% CI, 81.7%-82.2%), and Medicare fee-for-service at 82.0% (95% CI, 81.7%-82.2%; P < .001; comparing return to expected utilization rates among patients with Medicaid and Medicare-Medicaid dual eligibility, respectively, with each of the other insurance types). Conclusions and Relevance: Between March 2020 and February 2021, aggregate use of 6 ambulatory care services increased after the preceding decrease in utilization that followed the onset of the COVID-19 pandemic. However, the rate of increase in use of these ambulatory care services was significantly lower for participants with Medicaid or Medicare-Medicaid dual eligibility than for those insured by commercial, Medicare Advantage, or Medicare fee-for-service.

Out-of-pocket medical expenses compared across five years for patients with one of five common cancers in Australia.

BACKGROUND: Patient medical out-of-pocket expenses are thought to be rising worldwide yet data describing trends over time is scant. We evaluated trends of out-of-pocket expenses for patients in Australia with one of five major cancers in the first-year after diagnosis. METHODS: Participants from the QSKIN Sun and Health prospective cohort Study with a histologically confirmed breast, colorectal, lung, melanoma, or prostate cancer diagnosed between 2011 and 2015 were included (n = 1965). Medicare claims data on out-of-pocket expenses were analysed using a two-part model adjusted for year of diagnosis, health insurance status, age and education level. Fisher price and quantity indexes were also calculated to assess prices and volumes separately. RESULTS: On average, patients with cancer diagnosed in 2015 spent 70% more out-of-pocket on direct medical expenses than those diagnosed in 2011. Out-of-pocket expenses increased significantly for patients with breast cancer (mean AU$2513 in 2011 to AU$6802 in 2015). Out-of-pocket expenses were higher overall for individuals with private health insurance. For prostate cancer, expenses increased for those without private health insurance over time (mean AU$1586 in 2011 to AU$4748 in 2014) and remained stable for those with private health insurance (AU$4397 in 2011 to AU$5623 in 2015). There were progressive increases in prices and quantities of medical services for patients with melanoma, breast and lung cancer. For all cancers, prices increased for medicines and doctor attendances but fluctuated for other medical services. CONCLUSION: Out-of-pocket expenses for patients with cancer have increased substantially over time. Such increases were more pronounced for women with breast cancer and those without private health insurance. Increased out-of-pocket expenses arose from both higher prices and higher volumes of health services but differ by cancer type. Further efforts to monitor patient out-of-pocket costs and prevent health inequities are required.

Cost-Effectiveness Analysis of Branded Drugs With Market Demand and Insurance.

OBJECTIVES: Cost-effectiveness analysis of branded pharmaceuticals presumes that both cost (or price) and marginal effectiveness levels are exogenous. This assumption underlies most judgments of the cost-effectiveness of specific drugs. In this study, we show the theoretical implications of letting both factors be endogenous by modeling pharmaceutical price setting with and without health insurance, along with patient response to the prices that depend on marginal effectiveness. We then explore the implications of these models for cost-effectiveness ratios. METHODS: We used simple textbook models of patient demand and pricing behavior of drug firms to predict market equilibria in the drug and insurance markets and to generate calculations of the cost-effectiveness ratios in those settings. RESULTS: We found that ratios in market settings can be much different from those calculated in cost-effectiveness studies based on exogenous prices and treatment of all patients at risk rather than those who would demand treatment in a market setting. We also found that there may be considerable similarity in these market cost-effectiveness ratios across different products because drug firms with market power set profit-maximizing prices. CONCLUSIONS: We found that market cost-effectiveness ratios will always indicate an excess of benefits over cost. Insurance will lead to less favorable ratios than without insurance, but when insurers bargain with drug firms, rather than taking their prices as given, cost-effectiveness ratios will be more favorable.

Impact of Health Insurance, Poverty, and Comorbidities on Colorectal Cancer Screening: Insights from the Medical Expenditure Panel Survey.

BACKGROUND: Despite national campaigns and other efforts to improve colorectal cancer (CRC) screening, participation rates remain below targets set by expert panels. We hypothesized that availability and practice patterns of healthcare providers may contribute to this gap. METHOD: Using data of the Medical Expenditure Panel Survey for the years between 2000 and 2016, we extracted demographic, socioeconomic, and health-related data as well as reported experiences about barriers to care, correlating results with answers about recent participation in colorectal cancer screening. As CRC screening guidelines recommend initiation of testing at age 50, we focused on adults 50 years or older. RESULTS: We included responses of 163,564 participants for the period studied. There was a significant increase in CRC screening rates over time. Comorbidity burden, poverty, race, and ethnicity independently predicted participation in screening. Lack of insurance coverage and cost of care played an important role as reported barrier. Convenient access to care, represented by availability of appointments beyond typical business hours, and frequency of provider interactions, correlated with higher rates of screening. CONCLUSION: Our data show a positive effect of educational efforts and healthcare reform with coverage of screening. Easy and more frequent access to individual providers predicted a higher likelihood of completed screening tests. This finding could translate into more widespread implementation of screening programs, as the increasingly common virtual care delivery offers a new and convenient option to patients.

The effect of expanded insurance coverage under the Affordable Care Act on emergency department utilization in New York.

BACKGROUND: One of the proposed benefits of expanding insurance coverage under the Affordable Care Act (ACA) was a reduction in emergency department (ED) utilization for non-urgent visits related to lack of health insurance coverage and access to primary care providers. The objective of this study was to estimate the effect of the 2014 ACA implementation on ED use in New York. METHODS: We used the Healthcare Cost and Utilization Project State Emergency Department and State Inpatient Databases for all outpatient and all inpatient visits for patients admitted through an ED from 2011 to 2016. We focused on in-state residents aged 18 to 64, who were covered under Medicaid, private insurance, or were uninsured prior to the 2014 expansion. We estimated the effect of the expanded insurance coverage on average monthly ED visits volumes and visits per 1000 residents (rates) using interrupted time-series regression analyses. RESULTS: After ACA implementation, overall average monthly ED visits increased by around 3.0%, both in volume (9362; 95% Confidence Intervals [CI]: 1681-17,522) and in rates (0.80, 95% CI:0.12-1.49). Medicaid covered ED visits volume increased by 23,972 visits (95% CI: 16,240 -31,704) while ED visits by the uninsured declined by 13,297 (95% CI:-15,856 - -10,737), and by 1453 (95% CI:-4027-1121) for the privately insured. Medicaid ED visits rates per 1000 residents increased by 0.77 (95% CI:-1.96-3.51) and by 2.18 (95% CI:-0.55-4.92) for those remaining uninsured, while private insurance visits rates decreased by 0.48 (95% CI:-0.79 - -0.18). We observed increases in primary-care treatable ED visits and in visits related to mental health and alcohol disorders, substance use, diabetes, and hypertension. All estimated changes in monthly ED visits after the expansion were statistically significant, except for ED visit rates among Medicaid beneficiaries. CONCLUSION: Net ED visits by adults 18 to 64 years of age increased in New York after the implementation of the ACA. Large increases in ED use by Medicaid beneficiaries were partially offset by reductions among the uninsured and those with private coverage. Our results suggest that efforts to expand health insurance coverage only will be unlikely to reverse the increase in ED use.

Changes in Korean National Healthcare Insurance Policy and Breast Cancer Surgery Trend in Korea.

BACKGROUND: Since April 2015, the Korean National Health Insurance (NHI) has reimbursed breast cancer patients, approximately 50% of the cost of the breast reconstruction (BR) procedure. We aimed to investigate NHI reimbursement policy influence on the rate of immediate BR (IBR) following total mastectomy (TM). METHODS: We retrospectively analyzed breast cancer data between April 2011 and June 2016. We divided patients who underwent IBR following TM for primary breast cancer into "uninsured" and "insured" groups using their NHI statuses at the time of surgery. Univariate analyses determined the insurance influence on the decision to undergo IBR. RESULTS: Of 2,897 breast cancer patients, fewer uninsured patients (n = 625) underwent IBR compared with those insured (n = 325) (30.0% vs. 39.8%, P < 0.001). Uninsured patients were younger than those insured (median age [range], 43 [38-48] vs. 45 [40-50] years; P < 0.001). Pathologic breast cancer stage did not differ between the groups (P = 0.383). More insured patients underwent neoadjuvant chemotherapy (P = 0.011), adjuvant radiotherapy (P < 0.001), and IBR with tissue expander insertion (P = 0.005) compared with those uninsured. CONCLUSION: IBR rate in patients undergoing TM increased after NHI reimbursement.

Pre-exposure prophylaxis for preventing acquisition of HIV: A cross-sectional study of patients, prescribers, uptake, and spending in the United States, 2015-2016.

BACKGROUND: In 2015, there were approximately 40,000 new HIV diagnoses in the United States. Pre-exposure prophylaxis (PrEP) is an effective strategy that reduces the risk of HIV acquisition; however, uptake among those who can benefit from it has lagged. In this study, we 1) compared the characteristics of patients who were prescribed PrEP with individuals newly diagnosed with HIV infection, 2) identified the specialties of practitioners prescribing PrEP, 3) identified metropolitan statistical areas (MSAs) within the US where there is relatively low uptake of PrEP, and 4) reported median amounts paid by patients and third-party payors for PrEP. METHODS AND FINDINGS: We analyzed prescription drug claims for individuals prescribed PrEP in the Integrated Dataverse (IDV) from Symphony Health for the period of September 2015 to August 2016 to describe PrEP patients, prescribers, relative uptake, and payment methods in the US. Data were available for 75,839 individuals prescribed PrEP, and findings were extrapolated to approximately 101,000 individuals, which is less than 10% of the 1.1 million adults for whom PrEP was indicated. Compared to individuals with newly diagnosed HIV infection, PrEP patients were more likely to be non-Hispanic white (45% versus 26.2%), older (25% versus 19% at ages 35-44), male (94% versus 81%), and not reside in the South (30% versus 52% reside in the South).Using a ratio of the number of PrEP patients within an MSA to the number of newly diagnosed individuals with HIV infection, we found MSAs with relatively low uptake of PrEP were concentrated in the South. Of the approximately 24,000 providers who prescribed PrEP, two-thirds reported primary care as their specialty. Compared to the types of payment methods that people living with diagnosed HIV (PLWH) used to pay for their antiretroviral treatment in 2015 to 2016 reported in the Centers for Disease Control and Prevention (CDC) HIV Surveillance Special Report, PrEP patients were more likely to have used commercial health insurance (80% versus 35%) and less likely to have used public healthcare coverage or a publicly sponsored assistance program to pay for PrEP (12% versus 45% for Medicaid). Third-party payors covered 95% of the costs of PrEP. Overall, we estimated the median annual per patient out-of-pocket spending on PrEP was approximately US$72. Limitations of this study include missing information on prescription claims of patients not included in the database, and for those included, some patients were missing information on patient diagnosis, race/ethnicity, educational attainment, and income (34%-36%). CONCLUSIONS: Our findings indicate that in 2015-2016, many individuals in the US who could benefit from being on PrEP were not receiving this HIV prevention medication, and those prescribed PrEP had a significantly different distribution of characteristics from the broader population that is at risk for acquiring HIV. PrEP patients were more likely to pay for PrEP using commercial or private insurance, whereas PLWH were more likely to pay for their antiretroviral treatment using publicly sponsored programs. Addressing the affordability of PrEP and otherwise promoting its use among those with indications for PrEP represents an important opportunity to help end the HIV epidemic.

Poverty, insurance, and region as predictors of epilepsy treatment among US adults.

Disparities in epilepsy treatment have previously been reported. In the current study, we examine the role of socioeconomic status, health insurance, place of residence, and sociodemographic characteristics in past-year visit to a neurology or epilepsy provider and current use of antiseizure medications. Multiple years of data were compiled from the National Health Interview Surveys, Sample Adult Epilepsy Modules. The sample (n = 1655) included individuals 18 years and older who have been told by a doctor to have epilepsy or seizures. Independent variables included number of seizures in the past year, health insurance, poverty status, education, region, race/ethnicity, foreign-born status, age, and sex/gender. Two sets of weighted hierarchical logistic regression models were estimated predicting past-year epilepsy visit and current medication use. Accounting for recent seizure activity and other factors, uninsured and people residing outside of the Northeast were less likely to see an epilepsy provider, and people living in poverty were less likely to use medications, relative to their comparison groups. However, no racial/ethnic and nativity-based differences in specialty service or medication use were observed. Further research, including longitudinal studies of care trajectories and outcomes, are warranted to better understand healthcare needs of people with epilepsy, in particular treatment-resistant seizures, and to develop appropriate interventions at the policy, public health, and health system levels.

Influence of health insurance status on childhood cancer treatment outcomes in Kenya.

BACKGROUND: Survival of childhood cancer in high-income countries is approximately 80%, whereas in low-income countries, it is less than 10%. Limited access to health insurance in low-income settings may contribute to poor survival rates. This study evaluates the influence of health insurance status on childhood cancer treatment in a Kenyan academic hospital. METHODS: This was a retrospective study. All children diagnosed with a malignancy from 2010 until 2012 were included. Data on treatment outcomes and health insurance status at diagnosis were abstracted from patient charts. RESULTS: Of 280 patients, 34% abandoned treatment, 19% died, and 18% had progressive or relapsed disease resulting in 29% event-free survival. The majority of patients (65%) did not have health insurance at diagnosis. Treatment results differed significantly between patients with different health insurance status at diagnosis; 37% of uninsured versus 28% of insured patients abandoned treatment, and 24% of uninsured versus 37% of insured patients had event-free survival. The event-free survival estimate was significantly higher for patients with health insurance at diagnosis compared with those without (P = 0.004). Of patients without health insurance at diagnosis, 77% enrolled during treatment. Among those patients who later enrolled in health insurance, frequency of progressive or relapsed disease and deaths was significantly lower (P = 0.013, P < 0.001, respectively), while the event-free survival estimate was significantly higher (P < 0.001) compared with those who never enrolled. CONCLUSION: Childhood cancer event-free survival was 29% at a Kenyan hospital. Children without health insurance had significant lower chance of event-free survival. Childhood cancer treatment outcomes could be ameliorated by strategies that prevent treatment abandonment and improve access to health insurance.

Trends Associated with Hemorrhoids in Japan: Data Mining of Medical Information Datasets and the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan.

Hemorrhoids are a common anorectal disease. Epidemiological studies on medication trends and risk factors using information from real-world databases are rare. Our objective was to analyze the relationship between hemorrhoid treatment prescription trends and several risk factors using the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB) Open Data Japan and related medical information datasets. We calculated the standardized prescription ratio (SPR) based on the 2nd NDB Open Data Japan from 2015. The correlation coefficients between the SPR of antihemorrhoidals and those of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations" were 0.7474, 0.7366, 0.7184, 0.6501, 0.6320, 0.4571, and 0.4542, respectively. The correlation coefficient between the SPR of antihemorrhoidals and those of "average annual temperature," "percentage of people who were smokers," and "percentage of people who drank regularly" were -0.7204, 0.6002, and 0.3537, respectively. The results of cluster analysis revealed that Hokkaido and Tohoku regions tended to have low average annual temperature values and high percentage of people who were smokers and had comparatively high SPRs of "antispasmodics," "antiarrhythmic agents," "antidiarrheals, intestinal regulators," "purgatives and clysters," "hypnotics and sedatives, antianxietics," "psychotropic agents," and "opium alkaloids preparations." Antihemorrhoidals are frequently used in Hokkaido and Tohoku, Japan; thus, it is important for these prefectural governments to focus on these factors when taking measures regarding health promotion.

Results from an Epidemiological Follow-Up Survey on Home Artificial Nutrition in Switzerland from 2010 to 2015.

BACKGROUND: Home artificial nutrition (HAN) is an established treatment for malnourished patients. Since July 2012, the costs for oral nutrition supplements (ONS) are covered by the compulsory health insurance providers in Switzerland if the patient has a medical indication based on the Swiss Society for Clinical Nutrition guidelines. Therefore, the purpose of our study was to analyse the development of HAN, including ONS, before and after July 2012. METHODS: We obtained the retrospective and anonymized data from the Swiss association for joint tasks of health insurers (SVK), who registered patients on HAN. Since not all health insurers are working with SVK, this retrospective study recorded nearly 65% of all new patients on HAN in Switzerland from January 1, 2010, to December 31, 2015. RESULTS: A total of 33,410 patients (49.1% men and 50.9% women) with a mean BMI of 21.3 ± 4.5 kg/m2 and mean age of 68.9 ± 17.8 years were recorded. The number of patient cases on ONS increased from 808 cases in 2010 to 18,538 cases in 2015, while patient cases on home enteral nutrition (HEN) and home parenteral nutrition (HPN) remained approximately the same. The relative distribution of type of HAN changed from 26.2% cases on ONS, 68.7% cases on HEN and 5.1% cases on HPN in 2010 to 86.1% cases on ONS, 12.8% cases on HEN, and 1.1% cases on HPN in 2015. Treatment duration decreased for ONS from 698 ± 637 days to 171 ± 274 days, for HEN from 416 ± 553 days to 262 ± 459 days, and for HPN from 96 ± 206 days to 72 ± 123 days. Mean costs per patient decreased for ONS from 1,330 CHF in 2010 to 606 CHF in 2015. Total costs for HAN increased from 16,895,373 CHF in 2010 to 32,868,361 CHF in 2015. CONCLUSION: Our epidemiological follow-up study showed an immense increase in number of patients on HAN in Switzerland after July 2012. Due to shorter therapy duration and reduced mean costs per patient, total costs were only doubled while the number of patients increased 7-fold.

Influence of population aging on balance of medical insurance funds in China.

PURPOSE: The increasing intensification of population aging can affect the balance of social medical insurance funds, an issue that has aroused much research attention. Against this background, this paper studies the impact of population aging on the balance of medical insurance funds in China. FINDINGS: With the introduction of six intermediate variables, ie, economic level, dependency ratio of the elderly population, physical condition, medical demand, medical expenses, and medical resources, a structural equation model is constructed. Then, the relations among these variables are analyzed to explore how population aging affects the medical insurance fund balance. The direct impact of aging is found not to be significant. Physical condition, medical resources, and medical demand are intermediate variables that can affect the relationship. CONCLUSION: The results show that population aging does not have a significant impact on the balance of the medical insurance fund. However, China's aging trend suggests that the population aging level is very likely to continue to intensify in the future. Moreover, the proportion of revenue in the medical insurance fund is progressively declining, and population aging may threaten the balance between revenue and expenditure. Finally, based on the above analysis, several corresponding recommendations and future studies are proposed.

US Health Care Spending by Payer and Health Condition, 1996-2016.

Importance: US health care spending has continued to increase and now accounts for 18% of the US economy, although little is known about how spending on each health condition varies by payer, and how these amounts have changed over time. Objective: To estimate US spending on health care according to 3 types of payers (public insurance [including Medicare, Medicaid, and other government programs], private insurance, or out-of-pocket payments) and by health condition, age group, sex, and type of care for 1996 through 2016. Design and Setting: Government budgets, insurance claims, facility records, household surveys, and official US records from 1996 through 2016 were collected to estimate spending for 154 health conditions. Spending growth rates (standardized by population size and age group) were calculated for each type of payer and health condition. Exposures: Ambulatory care, inpatient care, nursing care facility stay, emergency department care, dental care, and purchase of prescribed pharmaceuticals in a retail setting. Main Outcomes and Measures: National spending estimates stratified by health condition, age group, sex, type of care, and type of payer and modeled for each year from 1996 through 2016. Results: Total health care spending increased from an estimated $1.4 trillion in 1996 (13.3% of gross domestic product [GDP]; $5259 per person) to an estimated $3.1 trillion in 2016 (17.9% of GDP; $9655 per person); 85.2% of that spending was included in this study. In 2016, an estimated 48.0% (95% CI, 48.0%-48.0%) of health care spending was paid by private insurance, 42.6% (95% CI, 42.5%-42.6%) by public insurance, and 9.4% (95% CI, 9.4%-9.4%) by out-of-pocket payments. In 2016, among the 154 conditions, low back and neck pain had the highest amount of health care spending with an estimated $134.5 billion (95% CI, $122.4-$146.9 billion) in spending, of which 57.2% (95% CI, 52.2%-61.2%) was paid by private insurance, 33.7% (95% CI, 30.0%-38.4%) by public insurance, and 9.2% (95% CI, 8.3%-10.4%) by out-of-pocket payments. Other musculoskeletal disorders accounted for the second highest amount of health care spending (estimated at $129.8 billion [95% CI, $116.3-$149.7 billion]) and most had private insurance (56.4% [95% CI, 52.6%-59.3%]). Diabetes accounted for the third highest amount of the health care spending (estimated at $111.2 billion [95% CI, $105.7-$115.9 billion]) and most had public insurance (49.8% [95% CI, 44.4%-56.0%]). Other conditions estimated to have substantial health care spending in 2016 were ischemic heart disease ($89.3 billion [95% CI, $81.1-$95.5 billion]), falls ($87.4 billion [95% CI, $75.0-$100.1 billion]), urinary diseases ($86.0 billion [95% CI, $76.3-$95.9 billion]), skin and subcutaneous diseases ($85.0 billion [95% CI, $80.5-$90.2 billion]), osteoarthritis ($80.0 billion [95% CI, $72.2-$86.1 billion]), dementias ($79.2 billion [95% CI, $67.6-$90.8 billion]), and hypertension ($79.0 billion [95% CI, $72.6-$86.8 billion]). The conditions with the highest spending varied by type of payer, age, sex, type of care, and year. After adjusting for changes in inflation, population size, and age groups, public insurance spending was estimated to have increased at an annualized rate of 2.9% (95% CI, 2.9%-2.9%); private insurance, 2.6% (95% CI, 2.6%-2.6%); and out-of-pocket payments, 1.1% (95% CI, 1.0%-1.1%). Conclusions and Relevance: Estimates of US spending on health care showed substantial increases from 1996 through 2016, with the highest increases in population-adjusted spending by public insurance. Although spending on low back and neck pain, other musculoskeletal disorders, and diabetes accounted for the highest amounts of spending, the payers and the rates of change in annual spending growth rates varied considerably.

Comparative effectiveness of generic and brand-name medication use: A database study of US health insurance claims.

BACKGROUND: To the extent that outcomes are mediated through negative perceptions of generics (the nocebo effect), observational studies comparing brand-name and generic drugs are susceptible to bias favoring the brand-name drugs. We used authorized generic (AG) products, which are identical in composition and appearance to brand-name products but are marketed as generics, as a control group to address this bias in an evaluation aiming to compare the effectiveness of generic versus brand medications. METHODS AND FINDINGS: For commercial health insurance enrollees from the US, administrative claims data were derived from 2 databases: (1) Optum Clinformatics Data Mart (years: 2004-2013) and (2) Truven MarketScan (years: 2003-2015). For a total of 8 drug products, the following groups were compared using a cohort study design: (1) patients switching from brand-name products to AGs versus generics, and patients initiating treatment with AGs versus generics, where AG use proxied brand-name use, addressing negative perception bias, and (2) patients initiating generic versus brand-name products (bias-prone direct comparison) and patients initiating AG versus brand-name products (negative control). Using Cox proportional hazards regression after 1:1 propensity-score matching, we compared a composite cardiovascular endpoint (for amlodipine, amlodipine-benazepril, and quinapril), non-vertebral fracture (for alendronate and calcitonin), psychiatric hospitalization rate (for sertraline and escitalopram), and insulin initiation (for glipizide) between the groups. Inverse variance meta-analytic methods were used to pool adjusted hazard ratios (HRs) for each comparison between the 2 databases. Across 8 products, 2,264,774 matched pairs of patients were included in the comparisons of AGs versus generics. A majority (12 out of 16) of the clinical endpoint estimates showed similar outcomes between AGs and generics. Among the other 4 estimates that did have significantly different outcomes, 3 suggested improved outcomes with generics and 1 favored AGs (patients switching from amlodipine brand-name: HR [95% CI] 0.92 [0.88-0.97]). The comparison between generic and brand-name initiators involved 1,313,161 matched pairs, and no differences in outcomes were noted for alendronate, calcitonin, glipizide, or quinapril. We observed a lower risk of the composite cardiovascular endpoint with generics versus brand-name products for amlodipine and amlodipine-benazepril (HR [95% CI]: 0.91 [0.84-0.99] and 0.84 [0.76-0.94], respectively). For escitalopram and sertraline, we observed higher rates of psychiatric hospitalizations with generics (HR [95% CI]: 1.05 [1.01-1.10] and 1.07 [1.01-1.14], respectively). The negative control comparisons also indicated potentially higher rates of similar magnitude with AG compared to brand-name initiation for escitalopram and sertraline (HR [95% CI]: 1.06 [0.98-1.13] and 1.11 [1.05-1.18], respectively), suggesting that the differences observed between brand and generic users in these outcomes are likely explained by either residual confounding or generic perception bias. Limitations of this study include potential residual confounding due to the unavailability of certain clinical parameters in administrative claims data and the inability to evaluate surrogate outcomes, such as immediate changes in blood pressure, upon switching from brand products to generics. CONCLUSIONS: In this study, we observed that use of generics was associated with comparable clinical outcomes to use of brand-name products. These results could help in promoting educational interventions aimed at increasing patient and provider confidence in the ability of generic medicines to manage chronic diseases.

Trends in future health financing and coverage: future health spending and universal health coverage in 188 countries, 2016-40.

BACKGROUND: Achieving universal health coverage (UHC) requires health financing systems that provide prepaid pooled resources for key health services without placing undue financial stress on households. Understanding current and future trajectories of health financing is vital for progress towards UHC. We used historical health financing data for 188 countries from 1995 to 2015 to estimate future scenarios of health spending and pooled health spending through to 2040. METHODS: We extracted historical data on gross domestic product (GDP) and health spending for 188 countries from 1995 to 2015, and projected annual GDP, development assistance for health, and government, out-of-pocket, and prepaid private health spending from 2015 through to 2040 as a reference scenario. These estimates were generated using an ensemble of models that varied key demographic and socioeconomic determinants. We generated better and worse alternative future scenarios based on the global distribution of historic health spending growth rates. Last, we used stochastic frontier analysis to investigate the association between pooled health resources and UHC index, a measure of a country's UHC service coverage. Finally, we estimated future UHC performance and the number of people covered under the three future scenarios. FINDINGS: In the reference scenario, global health spending was projected to increase from US$10 trillion (95% uncertainty interval 10 trillion to 10 trillion) in 2015 to $20 trillion (18 trillion to 22 trillion) in 2040. Per capita health spending was projected to increase fastest in upper-middle-income countries, at 4·2% (3·4-5·1) per year, followed by lower-middle-income countries (4·0%, 3·6-4·5) and low-income countries (2·2%, 1·7-2·8). Despite global growth, per capita health spending was projected to range from only $40 (24-65) to $413 (263-668) in 2040 in low-income countries, and from $140 (90-200) to $1699 (711-3423) in lower-middle-income countries. Globally, the share of health spending covered by pooled resources would range widely, from 19·8% (10·3-38·6) in Nigeria to 97·9% (96·4-98·5) in Seychelles. Historical performance on the UHC index was significantly associated with pooled resources per capita. Across the alternative scenarios, we estimate UHC reaching between 5·1 billion (4·9 billion to 5·3 billion) and 5·6 billion (5·3 billion to 5·8 billion) lives in 2030. INTERPRETATION: We chart future scenarios for health spending and its relationship with UHC. Ensuring that all countries have sustainable pooled health resources is crucial to the achievement of UHC. FUNDING: The Bill & Melinda Gates Foundation.

Independent Relationship of Changes in Death Rates with Changes in US Presidential Voting.

BACKGROUND: The outcome of the 2016 presidential election is commonly attributed to socioeconomic and ethnic/racial issues, but health issues, including "deaths of despair," may also have contributed. OBJECTIVE: To assess whether changes in age-adjusted death rates were independently associated with changes in presidential election voting in 2016 vs. 2008. DESIGN: We used publicly available data in each of 3112 US counties to correlate changes in a county's presidential voting in 2016 compared with 2008 with recent changes in its age-adjusted death rate, after controlling for population and rural-urban status, median age, race/ethnicity, income, education, unemployment rate, and health insurance rate. DESIGN SETTING: Cross-sectional analysis of county-specific data. SETTING/PARTICIPANTS: All 3112 US counties. MAIN MEASURES: The independent correlation of a county's change in age-adjusted death rate between 2000 and 2015 with its net percentage Republican gain or loss in the presidential election of 2016 vs. 2008. KEY RESULTS: In 2016, President Trump increased the Republican presidential vote percentage in 83.8% of counties compared with Senator McCain in 2008. Counties with an increased Republican vote percentage in 2016 vs. 2008 had a 15% higher 2015 age-adjusted death rate than counties with an increased Democratic vote percentage. Since 2000, overall death rates declined by less than half as much, and death rates from drugs, alcohol, and suicide increased 2.5 times as much in counties with Republican gains compared with counties with Democratic gains. In multivariable analyses, Republican net presidential gain in 2016 vs. 2008 was independently correlated with slower reductions in a county's age-adjusted death rate. Although correlation cannot infer causality, modest reductions in death rates might theoretically have shifted Pennsylvania, Michigan, and Wisconsin to Secretary Clinton. CONCLUSIONS: Less of a reduction in age-adjusted death rates was an independent correlate of an increased Republican percentage vote in 2016 vs. 2008. Death rates may be markers of dissatisfactions and fears that influenced the 2016 Presidential election outcomes.

Reconciling the Seemingly Irreconcilable: How Much Are We Spending on Drugs?

BACKGROUND: Estimates of drug spending are often central to the public policy debate on how to manage healthcare spending in the United States. Nevertheless, common estimates of prescription drug spending vary substantially by source, which can inhibit productive policy dialogue. OBJECTIVES: To review publicly reported estimates of drug spending and uncover the underlying methodological inputs that drive the substantial variation in estimates of prescription drug spending. METHODS: We systematically evaluated 5 estimates of drug spending to identify differences in the underlying methodological inputs and approaches. To uniformly assess and compare estimates, we developed a model to identify the inputs of 3 primary components associated with each estimate: numerator (How is drug cost measured?), denominator (How is healthcare cost measured?), and population (What group of individuals is included in the measurement?). We then applied standardized methodological inputs to each estimate to assess whether variation among estimates could be reconciled. We then conducted a sensitivity analysis to address important limitations. RESULTS: We found that the 18.8 percentage point range in the publicly reported estimates is predominately attributed to methodological differences. Reconciling estimates using a standardized methodological approach reduces this range to 4.0 percentage points. CONCLUSIONS: Because variation in estimates of drug spending is primarily driven by methodological differences, stakeholders should seek to establish a mutually agreed upon methodological approach that is appropriate for the policy question at hand to provide a sound basis for health spending policy discussions.

Analysis of National Health and Insurance Registers for All-Cause Mortality in Patients with Heart Failure with and without Diabetes Mellitus in Poland in 2012.

BACKGROUND This retrospective study aimed to analyze all-cause mortality in patients with heart failure with and without diabetes mellitus in 2012 in Poland using data from the National Health Fund [Narodowy Fundusz Zdrowia] (NFZ), the Central Register of the Insured [Centralna Baza Ubezpieczonych] (CBU), and the Polish Universal Electronic System for Registration of the Population (PESEL). MATERIAL AND METHODS Between 1st January 2012 and 31st December 2012, data were analyzed from the NFZ, CBU, and PESEL to include all patients with a primary diagnosis of heart failure, with and without diabetes mellitus and all-cause mortality data. Structured Query Language (SQL) was used to retrieve and manage data from NFZ, CBU, and PESEL. RESULTS In Poland, 32.58% of 201,586 patients with a primary diagnosis of heart failure who died in 2012 also had a diagnosis of diabetes mellitus. The overall mortality rate in men with heart failure and diabetes was eight times higher than for men with heart failure without diabetes. The overall mortality rate in women with diabetes and heart failure was 5.5 times higher compared with women with heart failure without diabetes. More than 90% of deaths in female patients with heart failure, with or without diabetes, occurred in women >60 years. For male patients with heart failure with or without diabetes, 70% of deaths occurred in men >60 years. CONCLUSIONS These findings support the need for continued prevention programs, early diagnosis, and treatment of diabetes, and highlight the increase in mortality for patients with heart failure and diabetes.

Impact of Insurance Status on Stage, Treatment, and Survival in Patients with Colorectal Cancer: A Population-Based Analysis.

BACKGROUND This study aimed to analyze data from the Surveillance, Epidemiology, and End Results (SEER) program to identify patients with colorectal cancer (CRC) who had specific insurance details and the effects of stage at diagnosis, definitive treatment, and survival outcome with insurance status. MATERIAL AND METHODS Between 2007 and 2009, SEER database analysis identified 54,232 patients with CRC. Logistic models examined the associations between insurance status and disease stage and definitive treatment. Kaplan-Meier analysis, the Cox model, and the Fine and Gray model were used to compare the tumor cause-specific survival (TCSS) for patients with different insurance status. RESULTS Insured patients were more likely to have earlier tumor stage at diagnosis when compared with patients receiving Medicaid (adjusted OR, 1.318; 95% CI, 1.249-1.391; P<0.001) and when compared with uninsured patients (adjusted OR, 1.479; 95% CI, 1.352-1.618; P<0.001). Insured patients were significantly more likely to undergo definitive treatment when compared with patients receiving Medicaid (adjusted OR, 0.591; 95% CI, 0.470-0.742; P<0.001) and compared with patients who were uninsured (adjusted OR, 0.404; 95% CI, 0.282-0.579; P<0.001). Insured patients had a significantly increased TCSS when compared with patients receiving Medicaid (HR, 1.298; 95% CI, 1.236-1.363; P<0.001) and compared with patients who were uninsured (HR 1.195, 95% CI, 1.100-1.297; P<0.001). CONCLUSIONS Insurance status was a significant factor that determined early diagnosis, definitive treatment, and clinical outcome and was an independent factor for TCSS in patients with CRC.

Evolving Trends in Insurance Coverage of Vascular Surgery Patients in Academic Practice.

BACKGROUND: Insurance coverage of vascular surgery patients may differ from patients with less chronic surgical pathologies. The goal of this study is to identify trends in insurance status of vascular surgery patients over the last 10 years at a busy academic center. METHODS: All consecutive patient visits for a vascular procedure from 2006 to 2016 were retrospectively reviewed from a prospectively collected institutional database. Data points included insurance status, procedures performed, and date of admission. The insurance status was categorized as Medicare, Medicaid, and uninsured. Samples were divided between 2006-2009 and 2011-2016 for comparison. Unpaired t-test, chi-squared test, and regression analysis were used to determine significant trends over the study period. RESULTS: From 2006 to 2016, 6,007 vascular surgery procedures were performed. Procedure volume increased significantly from 1,309 to 4,698 between the 2 timeframes (P < 0.05), whereas the percentage of Medicaid and Medicare patients trended upward but did not achieve significance. There was a significant decrease in the percentage of uninsured patients between the cohorts (5.65% vs. 2.96%, P < 0.05). In 2012, 10.14% of patients were uninsured compared with 2.56% in 2016 (P < 0.05). CONCLUSIONS: Insurance status affects access to care and subsequent outcomes. In our busy academic center, insurance coverage for vascular surgery has significantly increased over the past decade. The number of Medicaid and Medicare patients has slowly increased, but a significant and continuing decline in uninsured patients was observed. Implementation of the Affordable Care Act during this time period may have played a role in providing coverage for patient needing vascular surgery.