Facts about hospital-insurer contracting.

OBJECTIVES: To use publicly available price transparency data files to establish empirical regularities about hospital-insurer contracting. STUDY DESIGN: Retrospective analysis of 10 price transparency data files from HCA Healthcare. METHODS: Cross-sectional qualitative analysis of 524 hospital-insurer contracts across 10 hospitals. RESULTS: We ascertain 4 empirical regularities in these files. First, hospitals contract with many payers, ranging from 35 to 82 across the hospitals in the sample. Second, contract structure varies significantly within and across hospitals: Of the 524 contracts in our sample, the median contract contained 9 contract elements, whereas the mean contract contained 1285 contract elements. Third, most of the contracts in our sample contained multiple contracting methodologies (eg, both fixed fee and percentage of charges). Fourth, these contracts indicated substantial variation for the same service within and across hospitals, validating findings from analyses based on claims data and hospital price transparency files. CONCLUSIONS: Hospital-insurer contracts dictate the flow and structure of a significant portion of total health care expenditure in the US. Increased attention by both researchers and policy makers would lead to a greater understanding of this vital-yet understudied-element of the market for hospital services.

Exploring the Influence of Health Insurance Plans on Biosimilar Adoption Rates.

BACKGROUND: We conducted a study to investigate the role of health insurance plans on biosimilar adoption among commercially insured patients in the USA. Flexible and rigid health plans may exhibit differing biosimilar coverage due to variations in cost considerations, formulary design, and provider networks. OBJECTIVE: To identify the characteristics of switchers and biosimilar initiators for six biologic-biosimilar pairs. METHODS: Using claims data from 2015 to 2019, we implement sequential regression models to assess the role of health plans on biosimilars adoption. FINDINGS: We found that low-flexibility plans, such as Health Maintenance Organization (HMOs) and Exclusive Provider Organization (EPOs), are more likely to have patients who are switchers and/or biosimilar initiators. CONCLUSION: Our findings highlight the importance of health insurance plan design in promoting biosimilar uptake.

Outpatient apheresis billing: A photopheresis model shows that hospital price transparency data remain difficult to interpret.

OBJECTIVES: The US health care payment system is complex and difficult to interpret. Although federal regulations require that more data, in the form of charges and negotiated rates, be made available, compliance remains variable. We review chargemaster and negotiated rate values for extracorporeal photopheresis (ECP) to assess this variability. We sought to determine the availability of chargemaster and negotiated rates for health care consumers and to assess compliance and pricing among institutions using ECP as a model for apheresis billing. METHODS: We obtained ECP chargemaster data and negotiated rates from 20 institutions. We analyzed the availability of ECP chargemaster data and compared values with a previously published historic cohort. We evaluated the availability of negotiated rates and determined relative reimbursement using charge to reimbursement ratios. We determined calculated fines for hospitals based on bed size. RESULTS: Chargemaster availability increased from 2019 to 2022, though only 65% (13/20) of hospitals had both chargemaster and negotiated rate data. Chargemaster prices increased significantly from 2019 to 2022 (range, $3,586.83-$34,043.00). We reviewed 1,191 negotiated rates, with institutions averaging 93.6 different rates (SD, 189.5). Negotiated rates were variable, ranging from $3,586.83 to $34,043.00 per procedure. Reimbursement was higher among private insurers compared with reported Centers for Medicare & Medicaid Services negotiated rates. Of the 35% (7/20) that lacked chargemaster and negotiated rates, institutions faced an average annual fine of $1,430,800. CONCLUSIONS: Despite recent financial penalties, ECP pricing data are often unavailable or inadequate. Current available resources are unlikely to benefit the average health care consumer who requires ECP.

The price paradox of biosimilar-like long-acting insulin.

OBJECTIVES: To describe the uptake and out-of-pocket (OOP) costs of Basaglar, the first long-acting insulin biosimilar, in a commercially insured population in the United States. STUDY DESIGN: Retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets. METHODS: We assessed Basaglar uptake by examining trends in the composition of the long-acting insulin market in the United States from 2014 to 2018. As patient demographics and plan type may be important determinants of biosimilar uptake, we also assessed characteristics of all long-acting insulin users by drug. We examined Basaglar OOP costs by assessing mean OOP costs per claim for users of Basaglar and other long-acting insulins, overall and by plan type, and the number and source of co-payment offsets for Basaglar and other insulin glargine products from Basaglar market entry through 2018. We used multivariate linear models to examine the relationship between Basaglar OOP expenditures and insurer-negotiated amounts, overall and by plan type. RESULTS: Basaglar experienced a rapid uptake. However, there was no evidence that Basaglar users had lower OOP costs than reference product (Lantus) users. CONCLUSIONS: Given our results and the approval of the first interchangeable biosimilar, we recommend the empirical evaluation of biosimilar cost savings to patients and insurers prior to promoting their automatic substitution.

Hospital And Regional Characteristics Associated With Emergency Department Facility Fee Cash Pricing.

Self-pay patients are an understudied yet important and financially vulnerable population of emergency department (ED) users. As ED facility fees may be a key cost driver in patient ED bills, we leveraged newly available hospital pricing data to describe ED facility fees for self-pay patients (cash prices) and how they vary according to hospital and regional characteristics in a sample of 1,621 hospitals across the United States. The median cash price for ED facility fees ranged from $160.78 for a level 1 visit to $1,097.43 for a level 5 visit. Hospital for-profit status and a bed count of 251 or more beds were associated with higher cash prices for ED facility fees across all visit levels. Meanwhile, location in a county with a poverty rate of 16 percent or more was correlated with lower facility fee cash prices for ED visit levels 2 and up. We hope that these findings can inform targeted policy efforts to better ensure affordable ED care for vulnerable patients.

Dynamics of biosimilar uptake in emerging markets.

INTRODUCTION: Globally, biosimilars are expected to play a key role in lowering healthcare costs and providing increased patient access to biological therapies. Given this, and in line with the European Union and World Health Organization, many emerging nations have adapted and established biosimilar regulatory guidelines. Emerging nations present a lucrative market for biosimilar development and commercialization, yet they also pose unique challenges. A thorough understanding of the unique attributes of emerging markets in relation to biosimilars is needed to promote their successful uptake in low- and middle-income countries. AREAS COVERED: This article highlights the opportunities and challenges that emerging markets represent in terms of biosimilar uptake. A comprehensive analysis of biosimilar uptake in European countries, where biosimilars have gained significant market share, was carried out to identify policies that can enhance market penetration in emerging nations. EXPERT OPINION: Implementation of pricing and procurement policies, as well as provider and patient confidence in biosimilar efficacy, are key factors in their uptake. Due to the high cost of biosimilar development, incentivizing domestic companies with the biosimilar manufacturing capability to produce these drugs will be helpful in ensuring a sustainable biosimilar market and a steady supply chain.

Fewer Pharmacies In Black And Hispanic/Latino Neighborhoods Compared With White Or Diverse Neighborhoods, 2007-15.

The accessibility of pharmacies may be an overlooked contributor to persistent racial and ethnic disparities in the use of prescription medications and essential health care services within urban areas in the US. We examined the availability and geographic accessibility of pharmacies across neighborhoods based on their racial/ethnic composition in the thirty most populous US cities. In all cities examined, we found persistently fewer pharmacies located in Black and Hispanic/Latino neighborhoods than White or diverse neighborhoods throughout 2007-15. In 2015 there were disproportionately more pharmacy deserts in Black or Hispanic/Latino neighborhoods than in White or diverse neighborhoods, including those that are not federally designated Medically Underserved Areas. These disparities were most pronounced in Chicago, Illinois; Los Angeles, California; Baltimore, Maryland; Philadelphia, Pennsylvania; Milwaukee, Wisconsin; Dallas, Texas; Boston, Massachusetts; and Albuquerque, New Mexico. We also found that Black and Hispanic/Latino neighborhoods were more likely to experience pharmacy closures compared with other neighborhoods. Our findings suggest that efforts to increase access to medications and essential health care services, including in response to COVID-19, should consider policies that ensure equitable pharmacy accessibility across neighborhoods in US cities. Such efforts could include policies that encourage pharmacies to locate in pharmacy deserts, including increases to Medicaid and Medicare reimbursement rates for pharmacies most at risk for closure.

Assessment of Availability, Clinical Testing, and US Food and Drug Administration Review of Biosimilar Biologic Products.

Importance: Biosimilar biologic products were authorized in 2010, after the US Congress established an expedited pathway for approval of clinically similar versions of approved biologic products. Unlike for most small-molecule generic drugs, approval requirements for a biosimilar included animal studies and a comparative efficacy clinical trial. Objective: To analyze the evidence required to support a biosimilarity license application, examine the US Food and Drug Administration (FDA) evaluation process, and estimate the costs of the key clinical trial evidence. Design: This study evaluated all biosimilar biologic products approved from January 2010 through October 2019, using the publicly available FDA review documents, disclosures from ClinicalTrials.gov, and the published peer-reviewed literature. The costs of efficacy clinical trials were estimated using licensed proprietary software. Main Outcomes and Measures: The following elements of each approved biosimilar were evaluated: the extent of human clinical testing to establish that the biosimilar had no clinically meaningful differences with the reference product, results of comparative animal studies, and FDA-cited application deficiencies. The cited deficiencies included the following categories: (1) facility inspection, (2) manufacturing or product quality, (3) animal studies, (4) laboratory analytical studies, (5) phase 1 and/or immunogenicity studies, and (6) phase 3 comparative efficacy trials. Results: As of October 2019, the FDA had approved 23 biosimilar biologics for 9 reference products. The 29 clinical trials that established that the efficacy of the biosimilar products was comparable to that of the reference products enrolled a median (interquartile range [IQR]) of 504 (258-612) patients, had a median (IQR) estimated cost of $20.8 ($13.8-$35.3) million, and had a median (IQR) treatment duration of 52 (28-68) weeks. Substantial deficiencies temporarily halted the review of 9 applications, and the most frequent deficits were failed facilities inspections (n = 5) and manufacturing process quality problems (n = 6). The approved biosimilar submissions included 51 animal studies on species that included mice, rats, rabbits, dogs, and cynomolgus monkeys. Negative outcomes in 2 animal studies were attributed to differences between human and test species. The FDA generally met the standard 12-month review deadlines or stopped the review clock when serious deficiencies were identified. Conclusions and Relevance: This study found that most comparative efficacy trials supporting the FDA approval of biosimilars appeared to be as rigorous as and often larger, longer, and more costly than pivotal trials for new molecular entities. Further research is needed into whether less costly comparative efficacy trials could provide adequate evidence of biosimilarity and whether animal studies contribute useful scientific evidence.

Association Between Filgrastim Biosimilar Availability and Changes in Claim Payments and Patient Out-of-Pocket Costs for Biologic Filgrastim Products.

OBJECTIVES: To estimate the effect of filgrastim-sndz market entry on patient out-of-pocket costs and claim payments for filgrastim products. METHODS: This study used a single interrupted time series design with longitudinal, nationally representative, individual-level claims data from IBM MarketScan. Analyses included all outpatient and prescription claims for branded filgrastim (filgrastim and tbo-filgrastim) and biosimilar filgrastim (filgrastim-sndz) from January 1, 2014, to December 31, 2017. Outcomes of interest included changes in monthly claim payments and monthly patient out-of-pocket costs for filgrastim products. RESULTS: In the baseline period (January 2014 to February 2016), insurers paid an average of $472.21 (95% confidence interval [CI]: 465.38-479.03) for 480 mcg of branded filgrastim, whereas patients paid an average of $49.26 (CI: 34.25-64.27). Filgrastim-sndz market entry was associated with a statistically significant and immediate 1-month decrease in insurer payment of $30.77 (95% CI: -40.59 to -20.94) and a significant decrease in monthly insurer payment trend of $3.10 per month (95% CI: -3.90 to -2.31) relative to baseline. Long-term changes in patient out-of-pocket costs were modest and restricted to beneficiaries enrolled in high cost sharing plans. CONCLUSIONS: Biosimilar filgrastim availability led to significant immediate and long-term decreases in claims payments for filgrastim products, supporting efforts to facilitate biosimilar adoption in the United States. Nevertheless, there were only slight changes in patient out-of-pocket costs, restricted to beneficiaries enrolled in high cost sharing plans, suggesting the importance of further work assessing the relationship between biosimilar availability and patient out-of-pocket costs.

Recommendations to the Society for Epidemiologic Research for Further Promoting Diversity and Inclusion at the Annual Meeting and Beyond.

Increasing diverse engagement in the Society for Epidemiologic Research (SER) will positively impact the field of epidemiology. As the largest and longest-running epidemiologic society in North America, SER has long been a pioneer in promoting diversity and inclusion. A recent survey of SER members, however, showed there is still room for improving diversity, inclusion, representation, and participation in the Society. In this commentary, as members of both the SER and the Johns Hopkins Bloomberg School of Public Health Department of Epidemiology's Inclusion, Diversity, Equity, Anti-Racism, and Science (Epi IDEAS) Working Group, we recommend 4 goals for the SER Annual Meeting and beyond: 1) convene epidemiologic researchers with diverse backgrounds and ideas; 2) promote an inclusive environment at the SER Annual Meeting; 3) develop, compile, and disseminate best practices to honor diversity in epidemiologic research; and 4) increase prioritization of health disparities research and methods. We also suggest strategies for achieving these goals so that SER can better include, support, and elevate members from historically disadvantaged groups. While our recommendations are tailored specifically to SER, the greater epidemiologic and academic communities could benefit from adopting these goals and strategies within their professional societies and conferences.

Healthcare system distrust and the breast cancer continuum of care.

PURPOSE: To identify and synthesize the literature on healthcare system distrust across the breast cancer continuum of care. METHODS: We searched CINAHL, Cochrane, EMBASE, PubMed, PsycINFO, and Web of Science from January 1, 1990 to December 31, 2018 for all peer-reviewed publications addressing the role of healthcare system trust, distrust or mistrust in the breast cancer continuum of care. RESULTS: We identified a total of 20 studies, seven qualitative studies and thirteen quantitative studies. Two studies assessed genetic testing, eleven assessed screening and seven assessed treatment and follow-up. Twelve studies evaluated mistrust, five evaluated distrust, and three evaluated trust. Study populations included African American, American Indian, Latina, Hispanic, and Asian American participants. CONCLUSION: Healthcare system distrust is prevalent across many different racial and ethnic groups and operates across the entire breast cancer continuum of care. It is an important yet understudied barrier to cancer. We hope that the knowledge garnered by this study will enable researchers to form effective and targeted interventions to reduce healthcare system distrust mediated disparities in breast cancer outcomes.