Avoidance of care: how health-care affordability influenced COVID-19 disease severity and outcomes.

In this study we examined the association between payor type, a proxy for health-care affordability, and presenting COVID-19 disease severity among 2108 polymerase chain reaction-positive nonelderly patients admitted to an acute-care hospital between March 1 and June 30, 2020. The adjacent-category logit model was used to fit pairwise odds of individuals' having (1) an asymptomatic-to-mild modified sequential organ failure assessment (mSOFA) score (0-3) versus a moderate-to-severe mSOFA score (4-7) and (2) a moderate-to-severe mSOFA score (4-7) versus a critical mSOFA score (>7). Despite representing the smallest population, Medicare recipients experienced the highest in-hospital death rate (19%), a rate twice that of the privately insured. The uninsured had the highest rate of critical mSOFA score on admission and had twice the odds of presenting with a critical illness when compared with the privately insured (odds ratio = 2.08, P =.03). Because payor type was statistically related to the most severe presentations of COVID-19, we question whether policy changes affecting health-care affordability might have prevented deaths and rationing of scarce resources, such as intensive care unit beds and ventilators.

Investigating the coverage of the Arkansas All-Payer Claims Database for examining health disparities related to persistent poverty areas in colorectal cancer patients.

PURPOSE: We aimed to (1) determine the extent of coverage of colorectal cancer patients in Arkansas All-Payer Claims Database (APCD), (2) assess coverage difference between persistent poverty and other areas, and (3) identify patient, tumor, and area factors associated with inclusion in APCD. METHODS: Data were from 2018 to 2020 Arkansas APCD linked with 2019 Arkansas Central Cancer Registry (ACCR). We constructed four cohorts to assess APCD's coverage of CRC patients: (Cohort 1) ≥ 1 day of medical coverage in APCD in 2019; (Cohort 2) APCD coverage in the diagnosis month; continuous APCD coverage in the 30; Year around diagnosis (six months before to five months after diagnosis month) (Cohort 3); or until death within six months (Cohort 4). We compared proportions in the cohorts by area persistent poverty designation. Logistic regressions identified factors associated with inclusion in APCD cohorts. PATIENT SELECTION: CRC patients diagnosed in 2019 from ACCR, excluding in situ disease. RESULTS: Of the 1,510 CRC patients diagnosed in 2019, 83% had ≥ 1 day of medical coverage in 2019 APCD (Cohort1), 81% had coverage in the diagnosis month (Cohort 2), and 63% had continuous coverage in the year around diagnosis (Cohort 3). Additionally, 11% died within six months but had continuous coverage until death (Cohort 4, 74%). No coverage difference was found between persist poverty and other areas. Age and primary payer type at diagnosis were the main predictors of inclusion in APCD. CONCLUSION: Arkansas APCD had high coverage of Arkansas CRC patients. No selection bias by area of persistent poverty designation was present.

Payer-Negotiated Price Variation and Relationship to Surgical Outcomes for the Most Common Cancers at NCI-Designated Cancer Centers.

BACKGROUND: Federal rules mandate that hospitals publish payer-specific negotiated prices for all services. Little is known about variation in payer-negotiated prices for surgical oncology services or their relationship to clinical outcomes. We assessed variation in payer-negotiated prices associated with surgical care for common cancers at National Cancer Institute (NCI)-designated cancer centers and determined the effect of increasing payer-negotiated prices on the odds of morbidity and mortality. MATERIALS AND METHODS: A cross-sectional analysis of 63 NCI-designated cancer center websites was employed to assess variation in payer-negotiated prices. A retrospective cohort study of 15,013 Medicare beneficiaries undergoing surgery for colon, pancreas, or lung cancers at an NCI-designated cancer center between 2014 and 2018 was conducted to determine the relationship between payer-negotiated prices and clinical outcomes. The primary outcome was the effect of median payer-negotiated price on odds of a composite outcome of 30 days mortality and serious postoperative complications for each cancer cohort. RESULTS: Within-center prices differed by up to 48.8-fold, and between-center prices differed by up to 675-fold after accounting for geographic variation in costs of providing care. Among the 15,013 patients discharged from 20 different NCI-designated cancer centers, the effect of normalized median payer-negotiated price on the composite outcome was clinically negligible, but statistically significantly positive for colon [aOR 1.0094 (95% CI 1.0051-1.0138)], lung [aOR 1.0145 (1.0083-1.0206)], and pancreas [aOR 1.0080 (1.0040-1.0120)] cancer cohorts. CONCLUSIONS: Payer-negotiated prices are statistically significantly but not clinically meaningfully related to morbidity and mortality for the surgical treatment of common cancers. Higher payer-negotiated prices are likely due to factors other than clinical quality.

Endometriosis and mental health: a population-based cohort study.

BACKGROUND: Endometriosis is a chronic gynecologic disorder that leads to considerable pain and a reduced quality of life. Although its physiological manifestations have been explored, its impact on mental health is less well defined. Existing studies of endometriosis and mental health were conducted within diverse healthcare landscapes with varying access to care and with a primary focus on surgically diagnosed endometriosis. A single-payer healthcare system offers a unique environment to investigate this association with fewer barriers to access care while considering the mode of endometriosis diagnosis. OBJECTIVE: Our objective was to assess the association between endometriosis and the risk for mental health conditions and to evaluate differences between patients diagnosed medically and those diagnosed surgically. STUDY DESIGN: A matched, population-based retrospective cohort study was conducted in Ontario and included patients aged 18 to 50 years with a first-time endometriosis diagnosis between January 1, 2010, and July 1, 2020. Endometriosis exposure was determined through either medical or surgical diagnostic criteria. A medical diagnosis was defined by the use of the corresponding International Classification of Disease diagnostic codes from outpatient and in-hospital visits, whereas a surgical diagnosis was identified through inpatient or same-day surgeries. Individuals with endometriosis were matched 1:2 on age, sex, and geography to unexposed individuals without a history of endometriosis. The primary outcome was the first occurrence of any mental health condition after an endometriosis diagnosis. Individuals with a mental health diagnosis in the 2 years before study entry were excluded. Cox regression models were used to generate hazard ratios with adjustment for hysterectomy, salpingo-oophorectomy, infertility, pregnancy history, qualifying surgery for study inclusion, immigration status, history of asthma, abnormal uterine bleeding, diabetes, fibroids, hypertension, irritable bowel disorder, migraines, and nulliparity. RESULTS: A total of 107,832 individuals were included, 35,944 with a diagnosis of endometriosis (29.5% medically diagnosed, 60.5% surgically diagnosed, and 10.0% medically diagnosed with surgical confirmation) and 71,888 unexposed individuals. Over the study period, the incidence rate was 105.3 mental health events per 1000 person-years in the endometriosis group and 66.5 mental health events per 1000 person-year among unexposed individuals. Relative to the unexposed individuals, the adjusted hazard ratio for a mental health diagnosis was 1.28 (95% confidence interval, 1.24-1.33) among patients with medically diagnosed endometriosis, 1.33 (95% confidence interval, 1.16-1.52) among surgically diagnosed patients, and 1.36 (95% confidence interval, 1.2-1.6) among those diagnosed medically with subsequent surgical confirmation. The risk for receiving a mental health diagnosis was highest in the first year after an endometriosis diagnosis and declined in subsequent years. The cumulative incidence of a severe mental health condition requiring hospital visits was 7.0% among patients with endometriosis and 4.6% among unexposed individuals (hazard ratio, 1.56; 95% confidence interval, 1.53-1.59). CONCLUSION: Endometriosis, regardless of mode of diagnosis, is associated with a marginally increased risk for mental health conditions. The elevated risk, particularly evident in the years immediately following the diagnosis, underscores the need for proactive mental health screening among those newly diagnosed with endometriosis. Future research should investigate the potential benefits of mental health interventions for people with endometriosis with the aim of enhancing their overall quality of life.

Real-world evidence in the reassessment of oncology therapies: payer perceptions from five countries.

Aim: This study explored the perceived value of real-world evidence (RWE) in the reassessment of oncology therapies by collecting the perspectives of health technology assessment/payer decision-makers.Materials & methods: A web-based survey was conducted using the Market Access Transformation Rapid Payer Response online portal. 30 participants from France, Germany, Spain, the UK and the USA were recruited based on their expertise.Results: Participants agreed that the most common uses of RWE are to confirm efficacy and safety results from randomized controlled trials and to reevaluate the projected utilization of an oncology therapy. We found variability in other reported uses of RWE.Conclusion: The organizations developing RWE should ensure that their plans recognize the heterogeneity in payer perceptions.

A survey from the Market Access Transformation RPR portal queried decision-makers from five countries about the value of real-world evidence in oncology therapy reassessment. Participants agreed that RWE can confirm efficacy/safety and reevaluate utilization, but other uses varied.

A costing and health-related quality of life study of high intensity focused ultrasound in primary treatment of localized low or intermediate risk prostate cancer in Ontario.

INTRODUCTION: Prostate cancer is the third leading cause of death from cancer among Canadian men. High intensity focused ultrasound (HIFU) is a novel approach for primary treatment of localized prostate cancer. Little is known, however, about its costs. We aimed to collect the direct costs and health-related quality of life (HRQoL) data of HIFU in primary treatment of localized low and intermediate risk prostate cancer in Ontario. MATERIALS AND METHODS: We collected direct costs and HRQoL data of 20 patients with localized low or intermediate risk prostate cancer who received whole-gland HIFU at a privately owned clinic in Ontario. We compared the direct costs of HIFU, open radical prostatectomy (ORP), robot assisted radical prostatectomy (RARP), and external beam radiation therapy (RT) in primary treatment of localized low and intermediate risk prostate cancer. RESULTS: The average direct costs of HIFU, ORP, RARP, and RT per case in 2023 are $14,886.78, $14,192.26, $21,794.55, and $17,377.51, respectively. The median and interquartile range (IQR) of the study participants' age and HRQoL data prior to the HIFU procedure were 64.5 (11.25) years, 94.5 (8.65), 38.5 (4), 6.0 (4.46), and 22.5 (8.32), respectively. CONCLUSION: Our healthcare payer's perspective costing study revealed median direct costs per case of HIFU and favorable HRQoL outcomes compared to other treatment options for primary treatment of localized low and intermediate risk prostate cancer in Ontario. A health economic model is warranted to analyze the cost-effectiveness of HIFU compared to other treatment options in primary treatment of localized low and intermediate risk prostate cancer.

Are Patients without Insurance Coverage Less Likely to Undergo Surgery for Humeral Shaft Fractures? A National Database Analysis.

BACKGROUND: Historically, humeral shaft fractures have been managed non-operatively in a functional brace. However, recent studies suggest an increase in rates of operative fixation. Disparities in surgical management based on insurance status have been demonstrated across many orthopedic conditions. This study aimed to identify if a correlation exists between insurance coverage and the probability of undergoing operative fixation for a humeral shaft fracture. METHODS: A retrospective examination of the National Readmissions Database (NRD) from 2016 to 2021 was conducted. Patients diagnosed with isolated closed humeral shaft fractures were identified via International Classification of Disease, Tenth Revision (ICD-10) codes, and surgical interventions were identified using ICD-10 procedural codes. Utilizing weighted data, a total of 56,468 patients with isolated closed humeral shaft fractures were identified, 25,075 (44.4%) of whom underwent operative fixation. A univariate analysis was conducted using Pearson's chi-square test to isolate variables for inclusion in a multi-variable analysis. A binary logistic regression analysis was then employed to explore demographic and other pertinent factors. Findings were reported as odds ratios (ORs). RESULTS: After controlling for social and demographic variables, patients with Medicaid (OR, 0.54; 95% CI, 0.50-0.58; p<0.001), Medicare (OR, 0.64; 95% CI, 0.60 - 0.68; p<0.001), and self-pay patients (OR, 0.75; 95% CI, 0.67 - 0.84; p<0.001) were less likely to undergo operative fixation of humeral shaft fracture than those with private insurance. CONCLUSIONS: Patients without private insurance or those with no insurance coverage are less likely to undergo operative fixation for humeral shaft fractures compared to those with private insurance, even after adjusting for social and demographic variables. The observed variability underscores the necessity for more refined treatment guidelines for humeral shaft fractures. Surgeons should be aware of these potential biases affecting management decisions.

How to facilitate the introduction of value-based payment models?

Value-based payment (VBP) models are designed and implemented to improve outcomes at the same or lower costs. Their adoption requires significant changes in the way healthcare organisations and insurance companies operate. Usually, before VBP models are widely implemented, pilot projects are conducted. Payers need to have a comprehensive set of requirements to enter into agreements with healthcare organisations on these pilots. In this short communication, we outline key elements reported in the literature, inside and outside healthcare organisations, as well as within the contract, that need to be considered in a pilot VBP model. Discussions regarding the introduction of VBP models may be strongly affected by external contextual factors, including regulations, which are outside the control of healthcare organisations. It requires collaboration between organisations, including primary care organisations and hospitals, while within organisations, it frequently requires creating multidisciplinary teams. The focus is on ensuring transparency, collaboration, and shared decision-making, realised by standardising communication processes and regular meetings. Additionally, effective leadership is needed, in which leaders set goals and priorities, as well as manage change. In the contractual agreements between payers and healthcare organisations, outcome measures need to be adequately defined and measured, including individual patient outcomes and composite scores, as well as absolute and relative performance measures. These measures should be tested periodically and catered to the organisations adopting the model. Also, incentives should have adequate size and frequency and be intrinsic and extrinsic. The consideration of these sets of key elements by the payers is essential when implementing VBP model pilot projects.

What the Evolution of 1332 Waivers Tells Us about Their Innovative Potential.

Section 1332 of the Affordable Care Act (ACA) provides states unprecedented flexibility to alter federal health policy. The authors analyze state waiver activity from 2019 to 2023, applying a comparative approach to understand waivers proposed by Georgia, Colorado, Washington, Oregon, and Nevada. Much of the waiver activity during this period focused on reinsurance programs. During the Trump administration, the most innovative waiver application was from Georgia, which sought to restructure and decentralize its individual market, moving away from the framework established by the ACA. While the Biden administration suspended Georgia's efforts, Democratic-led states have focused implementing waiver programs supporting and expanding on the ACA. This has included adopting public-option insurance plans offered by private insurers and expanding eligibility for qualified health plans for previously ineligible groups. The authors' analysis offers insights into contemporary health politics, policy durability, and the role of the administrative presidency.

The impact of a statewide payment reform on transcatheter aortic valve replacement (TAVR) utilization and readmissions.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is an increasingly used but relatively expensive procedure with substantial associated readmission rates. It is unknown how cost-constrictive payment reform measures, such as Maryland's All Payer Model, impact TAVR utilization given its relative expense. This study investigated the impact of Maryland's All Payer Model on TAVR utilization and readmissions among Maryland Medicare beneficiaries. METHODS: This was a quasi-experimental investigation of Maryland Medicare patients undergoing TAVR between 2012 and 2018. New Jersey data were used for comparison. Longitudinal interrupted time series analyses were used to study TAVR utilization and difference-in-differences analyses were used to investigate post-TAVR readmissions. RESULTS: During the first year of payment reform (2014), TAVR utilization among Maryland Medicare beneficiaries dropped by 8% (95% confidence interval [CI]: -9.2% to -7.1%; p < 0.001), with no concomitant change in TAVR utilization in New Jersey (0.2%, 95% CI: 0%-1%, p = 0.09). Longitudinally, however, the All Payer Model did not impact TAVR utilization in Maryland compared to New Jersey. Difference-in-differences analyses demonstrated that implementation of the All Payer Model was not associated with significantly greater declines in 30-day post-TAVR readmissions in Maryland versus New Jersey (-2.1%; 95% CI: -5.2% to 0.9%; p =0.1). CONCLUSIONS: Maryland's All Payer Model resulted in an immediate decline in TAVR utilization, likely a result of hospitals adjusting to global budgeting. However, beyond this transition period, this cost-constrictive reform measure did not limit Maryland TAVR utilization. In addition, the All Payer Model did not reduce post-TAVR 30-day readmissions. These findings may help inform expansion of globally budgeted healthcare payment structures.

Private Payer and Medicare Coverage Policies for Use of Circulating Tumor DNA Tests in Cancer Diagnostics and Treatment.

BACKGROUND: Circulating tumor DNA (ctDNA) is used to select initial targeted therapy, identify mechanisms of therapeutic resistance, and measure minimal residual disease (MRD) after treatment. Our objective was to review private and Medicare coverage policies for ctDNA testing. METHODS: Policy Reporter was used to identify coverage policies (as of February 2022) from private payers and Medicare Local Coverage Determinations (LCDs) for ctDNA tests. We abstracted data regarding policy existence, ctDNA test coverage, cancer types covered, and clinical indications. Descriptive analyses were performed by payer, clinical indication, and cancer type. RESULTS: A total of 71 of 1,066 total policies met study inclusion criteria, of which 57 were private policies and 14 were Medicare LCDs; 70% of private policies and 100% of Medicare LCDs covered at least one indication. Among 57 private policies, 89% specified a policy for at least 1 clinical indication, with coverage for ctDNA for initial treatment selection most common (69%). Of 40 policies addressing progression, coverage was provided 28% of the time, and of 20 policies addressing MRD, coverage was provided 65% of the time. Non-small cell lung cancer (NSCLC) was the cancer type most frequently covered for initial treatment (47%) and progression (60%). Among policies with ctDNA coverage, coverage was restricted to patients without available tissue or in whom biopsy was contraindicated in 91% of policies. MRD was commonly covered for hematologic malignancies (30%) and NSCLC (25%). Of the 14 Medicare LCD policies, 64% provided coverage for initial treatment selection and progression, and 36% for MRD. CONCLUSIONS: Some private payers and Medicare LCDs provide coverage for ctDNA testing. Private payers frequently cover testing for initial treatment, especially for NSCLC, when tissue is insufficient or biopsy is contraindicated. Coverage remains variable across payers, clinical indications, and cancer types despite inclusion in clinical guidelines, which could impact delivery of effective cancer care.

All-cause unplanned readmissions in the United States: insights from the Nationwide Readmission Database.

BACKGROUND: There are few studies looking into adult, all-cause and age-group-specific unplanned readmissions. The predictors of such unplanned readmissions for all inpatient encounters remain obscure. AIMS: To describe the incidence and factors associated with unplanned readmissions in all inpatient encounters in the United States. METHODS: The US Nationwide Readmission Database (NRD) is a representative sample of hospitalisations in the United States (from approximately 28 states) accounting for approximately 60% of the US population. All inpatient encounters during January-November 2017 in the NRD were evaluated for the rates, predictors and costs of unplanned 30 days readmissions for age groups 18-44 years, 45-64 years, 65-75 years and ≥75 years. Elective readmissions and those patients who died on their index hospitalisations were excluded. Weighted analysis was performed to obtain nationally representative data. RESULTS: We identified 28 942 224 inpatient encounters with a total of 3 051 189 (10.5%) unplanned readmissions within 30 days. The age groups 18-44 years, 45-64 years, 65-74 years and ≥75 years had 7.0%, 12.0%, 11.7% and 12.3% readmissions respectively. Female gender, private insurance and elective admissions were negative predictors for readmissions. For the group aged 18-44 years, schizophrenia and diabetes mellitus complications were the most frequent primary diagnosis for readmissions, while in all older age groups septicaemia and heart failure were the most frequent primary diagnosis for readmissions. CONCLUSIONS: Thirty-day unplanned readmissions are common in patients over age 45 years, leading to significant morbidity. Effective strategies for reducing unplanned readmission may help to improve quality of care, outcomes and higher value care.

Incremental cost of premature birth - a public health care payer perspective from Hungary.

BACKGROUND: Preterm birth remains a significant burden to families, health systems and societies. The aim was to quantify the incremental prematurity-related public health expenditure in Hungary and to estimate the potential impact of a decrease in the prevalence of prematurity on the public payer's spending. METHODS: Over a 6-year time horizon, public financing data of inpatient, outpatient and pharmaceutical care for children born at ≥ 25 weeks of gestation in 2009/2010 were retrieved from the Hungarian National Health Insurance Fund database. In descriptive analysis, the public payer's spending was given as cost/capita. The impact of a decrease in prematurity prevalence was specified as the total budget impact. An exchange rate of 294 Hungarian forint/Euro was applied. RESULTS: A total of 93,124 children (including 8.6% who were premature babies) were included in the analysis. A strong negative relationship was shown between gestational age and per capita cost. The 6-year cost of care for the cohort born at 26 weeks of gestation (28,470 Euro per capita) was 24 times higher than that for the cohort born at 40 weeks. First-year inpatient spending accounted for the largest proportion of total health care spending across all gestational ages. All investigated prematurity complications (retinopathy of prematurity, necrotizing enterocolitis, bronchopulmonary dysplasia, intraventricular cerebral bleeding and leukomalacia) resulted in additional significant incremental spending. If 70% of pregnancies ending with preterm birth could be prolonged by 1 week, the savings would be almost 7.0 million Euros in the first 6 years of life. CONCLUSION: This comprehensive analysis of prematurity-related health care spending confirmed that premature infants have much higher costs for care than those born at term in Hungary. These quantitative outcomes can provide essential inputs for the cost-effectiveness analysis of medical technologies and public health interventions that can decrease the prevalence of premature birth. TRIAL REGISTRATION: Not applicable.

Characterizing the Relationship Between Payer Mix and Diagnostic Intensity at the Hospital Level.

BACKGROUND: Overuse of diagnostic testing in the hospital setting contributes to high healthcare costs, yet the drivers of diagnostic overuse in this setting are not well-understood. If financial incentives play an important role in perpetuating hospital-level diagnostic overuse, then hospitals with favorable payer mixes might be more likely to exhibit high levels of diagnostic intensity. OBJECTIVES: To apply a previously developed hospital-level diagnostic intensity index to characterize the relationship between payer mix and diagnostic intensity. DESIGN: Cross-sectional analysis SUBJECTS: Acute care hospitals in seven states MAIN MEASURES: We utilized a diagnostic intensity index to characterize the level of diagnostic intensity at a given hospital (with higher index values and tertiles signifying higher levels of diagnostic intensity). We used two measures of payer mix: (1) a hospital's ratio of discharges with Medicare and Medicaid as the primary payer to those with a commercial insurer as the primary payer, (2) a hospital's disproportionate share hospital ratio. KEY RESULTS: A 5-fold increase in the Medicare or Medicaid to commercial insurance ratio was associated with an adjusted odds ratio of 0.24 (95% CI 0.16-0.36) of being in a higher tertile of the intensity index. A ten percentage point increase in the disproportionate share hospital ratio was associated with an adjusted odds ratio of 0.56 (95% CI 0.42-0.74) of being in a higher intensity index tertile. CONCLUSIONS: At the hospital level, a favorable payer mix is associated with higher diagnostic intensity. This suggests that financial incentives may be a driver of diagnostic overuse.

Health technology assessment for gene therapies in haemophilia.

INTRODUCTION: Gene therapies are poised to become a new therapeutic option for persons with haemophilia (PwH), having begun to show durable efficacy and safety in clinical trials to date. However, value assessment of gene therapies faces challenges from small populations that preclude randomized clinical trials (RCT), ethical considerations when treating a serious genetic disorder with lifelong consequences, and appropriate endpoint selection that captures the full scope of the disorder and its lifelong complications. SUMMARY: Health technology assessment (HTA) for new haemophilia therapies may require greater flexibility in evidence requirements and recognition of factors that vary across patient populations and health systems, including current standard-of-care, gains in survival and health-related quality-of-life (HRQoL), and reduced replacement factor utilization. It will be important for HTAs to consider limitations of RCTs for gene therapy and to consider intra-patient data as evidence of clinical effectiveness. Despite long-term clinical trials with up to 8 years of follow-up, ongoing uncertainties about durability of effect may be informed by extrapolating clinical data out ∼10 years, using different projections of durability. Beyond objective endpoints, such as Petersson scores or annualized bleed rates, health utilities that accompany gene therapy (e.g., mental health, freedom of choice, peace of mind) should be considered in HTA evaluations, particularly for comparisons with low dose or no prophylaxis. CONCLUSION: HTAs of gene therapies in haemophilia are encouraged to rise to the challenge of filling evidence gaps and conducting assessments. KEY POINTS OF CONSIDERATION: It is important for HTA bodies to consider the limitations to conduct randomized controlled trials for gene therapy and to consider intrapatient data as evidence of comparative effectiveness. Given the uncertainties around the long-term gene therapy use, clinical trial data should be extrapolated ∼10 years, using scenarios that consider different durations of effect. The major value drivers in a model, in addition to drug pricing itself, will be based on assumptions about duration of effect and savings/cost offsets from reduced use of replacement therapy. Assessment methodologies and modelling configurations need to evolve to fully capture the value of gene therapy, including patient meaningful outcomes, in a validated and quantitative fashion. Regardless of payment system archetype, the intersection between NGOs, the clinical community's voice, HTA willingness to collaborate, and alignment with regulatory acceptance of benefit is critical. [Correction added on 21 February 2022, after first online publication: the 'Key Points of Consideration' have been added in this version.].

The Payer License Agreement, or "Netflix model," for hepatitis C virus therapies enables universal treatment access, lowers costs and incentivizes innovation and competition.

BACKGROUND AND AIMS: High unit prices of treatments limit access. For epidemics like that of hepatitis C virus (HCV), reduced treatment access increases prevalence and incidence, making the infectious disease increasingly difficult to manage. The objective of the current study was to construct and test an alternative pricing model, the Payer License Agreement (PLA), and determine whether it could improve outcomes, cut costs and incentivize innovation versus the current unit-based pricing model. METHODS: We built and used computational models of hepatitis C disease progression, treatment, and pricing in historical and future scenarios and quantitatively analyzed their economic and epidemiological impact in three high-income countries. RESULTS: This study had three key results regarding HCV treatment. First, if the PLA model had been implemented when interferon-free direct-acting antiviral (DAA) combinations launched, the number of patients treated and cured would have more than doubled in the first three years, while the liver-related deaths (LRDs) would have decreased by around 40%. Second, if the PLA model had been implemented beginning in 2018, the year that several Netflix-like payment models were under implementation, the number of treated and cured patients would nearly double, and the LRDs would decline by more than 55%. Third, implementing the PLA model would result in a decline in total payer costs of more than 25%, with an increase to pharmaceutical manufacturer revenues of 10%. These results were true across the three healthcare landscapes studied, the USA, the UK and Italy, and were robust against variations to critical model parameters through sensitivity analysis. CONCLUSIONS AND RELEVANCE: These results suggest that implementation of the PLA model in high-income countries across a variety of health system contexts would improve patient outcomes at lower payer cost with more stable revenue for pharmaceutical manufacturers. Health policy-makers in high-income countries should consider the PLA model for application to more cost-effective management of HCV, and explore its application for other infectious diseases with curative therapies available now or soon.

Assessing Payers' Preferences for Real-World Evidence in the United States: A Discrete Choice Experiment.

OBJECTIVES: To rank the US payers' preferences for attributes of real-world evidence (RWE) studies in the context of chronic disease and to quantify trade-offs among them. METHODS: We conducted a discrete choice experiment in which 180 employees from payer organizations were tasked to choose between 2 RWE studies assuming they were assessing evidence to inform formulary decisions for chronic disease treatment. Each RWE study was characterized by 7 attributes with 3 levels each: very informative, moderately informative, and not measured. We used a D-optimal main-effects design. Survey data were fitted to a conditional logit model to obtain a relative measure of the ranking of importance for each attribute. RESULTS: Clinical outcomes were the most preferred attribute. It was 4.68 times as important as productivity outcomes-the least preferred attribute. It was followed by health-related quality of life (2.78), methodologic rigor (2.09), resource utilization (1.71), and external validity (1.56). CONCLUSIONS: This study provides a quantification of the value payers place on key RWE attributes. Across attributes, payers have higher preferences for clinical and health-related quality of life outcomes than the other attributes. Between attributes' levels, payers prefer high levels of information in clinical outcomes and methodologic rigor but are indifferent in other attributes. Our results bridge the gap between the information that payers seek and the attributes that RWE studies prioritize and effectively guide future research design.

Cross-Sectional Analysis of US Health Insurance Payer Policies for Humanitarian Device Exemption Indications for Deep Brain Stimulation.

BACKGROUND: The US Food and Drug Administration (FDA) has granted deep brain stimulation (DBS) approval under the humanitarian device exemption (HDE) pathway for both dystonia and obsessive-compulsive disorder (OCD). However, recent reports from the community of functional neurosurgeons suggest that insurance authorization remains a disproportionate barrier to OCD DBS implantation despite both conditions having similar support from the FDA. This cross-sectional study of health insurance policies quantifies the current payer landscape for these two interventions. OBJECTIVES: The aim of this study was to quantify the current payer policy coverage of DBS under HDE status for OCD as compared to DBS for dystonia for eligible patients in the US insurance market. METHODS: A commercial health insurance policy database was queried for documentation on DBS for dystonia and OCD. Results were individually analyzed for payer policy coverage statements on DBS for either dystonia or OCD and categorized as unique or nonunique policies. Unique policy positions were then coded for the geographic region, whether coverage was offered, and guidelines cited as evidence and justification. RESULTS: From the 80 policies in the database, there were 34 unique policies addressing DBS for either dystonia or OCD representing coverage of all 50 states. Of the 34 unique policies, 3 (9%) covered DBS for OCD, while 32 (94%) covered dystonia. Only 2 policies covered neither intervention. CONCLUSIONS: In spite of similar levels of support from the FDA, DBS for OCD has less support from insurance companies on a national level. This study begins to quantify the disparity noted by functional neurosurgeons in recent literature.

The impact of price transparency and competition on hospital costs: a research on all-payer claims databases.

BACKGROUND: Public reporting has been considered effective in reducing health care costs by mitigating information asymmetry in the market as payers have incorporated publicly available information mandates into pay-for-performance programs and value-based purchasing. Therefore, hospitals have faced increasing pressures to provide price transparency. Despite the widespread promotion of healthcare transparency, the effectiveness of public reporting has not yet been sufficiently understood. This study analyzed the impact of transparency policy and competition on hospital costs by taking the state operations of all-payer claims databases (APCDs) as a case of interest. METHODS: We employed a fixed-effects regression, which allows the generation of hospital-specific effects, in accordance with the suggestion by the Hausman test. The study samples comprise nonprofit and for-profit general acute care hospitals in the United States for 2011-2017. The finalized dataset ranges from 3547 observations in 2011 to 3405 observations in 2015 after removing missing values. RESULTS: We found that hospitals in the states with APCDs tend to bear higher average operating expenses than those without APCDs, which may indicate that states maintaining higher healthcare expenditures are more attentive to a price transparency initiative and tend to adopt APCDs. With regard to competition, the results showed that weak market competition is significantly associated with higher operating costs, supporting the traditional competition theory. However, the combined effect of APCDs and competition did not indicate a significant association with operating expenses. Further investigation showed a continued tendency for a weak intensity of competition to be linked to lower hospital operating costs in states without APCDs. For those located in non-APCD adopted states, market consolidation helped hospitals coordinate care more effectively, economize operating costs, and enjoy economies of scale due to their large size. Similar trends did not appear in APCD-adopted states except for in 2015. CONCLUSIONS: This study observed limited evidence of the impact of APCDs and market competition. Our findings suggest that states need to make multifaceted efforts to contain hospital costs, not solely depending on the rollout of cost information or market competition. Market concentration may lead to coordinated care or cost economization in some cases. Still, the existing literature also demonstrates some potentially harmful impacts of increased concentration in the healthcare market, such as inefficient use of resources, unilateral market power, and deterrence of innovation. The introduction of a price transparency tool may require additional policy actions that take market competition into consideration.

Statewide trends and factors associated with genetic testing for hereditary cancer risk in Arkansas 2013-2018.

BACKGROUND: Early identification of hereditary cancer risk would save lives, but genetic testing (GT) has been inadequate. We assessed i) trends for hereditary breast and ovarian cancer (HBOC), Lynch syndrome, and other GT and ii) factors associated with receipt of GT. METHODS: We used data from the Arkansas All-Payer Claims Database from January 2013 through June 2018 (commercial, Medicaid), December 2017 (state employee), or December 2016 (Medicare) and identified enrollees with ≥1 month of enrollment. Using Current Procedural Terminology (CPT-4) codes, rates for GT were calculated per 100,000 person-quarters and time series regressions estimated. Second, GT and covariate information for enrollees with 24 months of continuous enrollment were used to estimate separate logistic regression models for each GT category. RESULTS: Among 2,520,575 unique enrollees, HBOC testing rates were 2.2 (Medicaid), 22.0 (commercial), 40.4 (state employee), and 13.1(Medicare) per 100,000 person-quarters and increased linearly across all plans. Older age (OR=1.24; 95%CI 1.20 - 1.28), female sex (OR=18.91; 95%CI 13.01 - 28.86), higher comorbidity burden (OR=1.08; 95%CI 1.05 - 1.12), mental disorders (OR=1.53; 95%CI 1.15 - 2.00), and state employee coverage (OR=1.65; 95%CI 1.37 - 1.97) were positively associated with HBOC testing. Less than 1 of 10,000 enrollees received Lynch syndrome testing, while < 5 of 10,000 received HBOC testing. CONCLUSION: GT rates for hereditary cancer syndromes have increased in Arkansas but remain low. Receipt of GT was explained with high discrimination by sex and plan type. IMPACT: Expansion of GT for hereditary cancer risk in Arkansas is needed to identify high-risk individuals who could benefit from risk-reduction strategies.