American Journal of Managed Care最新文献

Objective: To examine how drug manufacturers disclosed prices for new molecular entities approved by the FDA between 2022 and 2024.

Study design: Retrospective study.

Methods: We included drugs approved through new drug applications or biologics license applications, excluding imaging agents, vaccines, blood products, and drugs without an assigned National Drug Code. For each drug, we assessed whether pricing was disclosed proactively (ie, in news releases or earnings calls) or reactively (ie, in media reports citing the company without prior proactive disclosure). We sourced launch prices from public disclosures and California filings. We also recorded company market capitalization, orphan drug designation, accelerated approval status, and Institute for Clinical and Economic Review assessments.

Results: Of 150 drugs, 107 (71%) had publicly disclosed launch prices: 49 proactively and 58 reactively. Proactive disclosure was more common among public companies with smaller market capitalizations-69% for firms worth $1 billion to $10 billion, compared with 7% for those worth more than $100 billion.

Conclusions: We found that pharmaceutical companies proactively released launch prices for one-third of drugs approved from 2022 to 2024 and reactively released prices for an additional 39%. Our findings suggest that securities regulations may influence disclosure behavior, particularly for smaller public companies. Greater transparency at launch could support better-informed public discourse on drug pricing and value.

Objectives: Medicaid holds significant responsibility for improving maternal and infant health in the US. Utilizing value-based care (VBC) that offers additional support to providers is one strategy by which the Medicaid system can improve these outcomes. In this analysis, we examined a Medicaid managed care plan's incentive-only VBC program, which is supported by a provider enablement team to assist care providers in meeting program goals.

Study design: Cross-sectional analysis of deliveries occurring between July 2020 and June 2022 from Elevance Health-affiliated Medicaid managed care plans operating in 16 states.

Methods: This study primarily relied on medical claims data to compare maternal, infant, and cost outcomes in Medicaid members with a care provider participating in a supported VBC program vs those with a care provider not participating in supported VBC. A propensity-balanced multivariable regression model was used to estimate the impact of participation vs nonparticipation in supported VBC on delivery, cost, and quality outcomes.

Results: Members with a care provider supported in the VBC program had significantly lower neonatal intensive care unit (NICU) lengths of stay, preterm births, and low birth weights; significantly better timeliness and adequacy of prenatal care rates; and significantly lower birth costs, NICU costs, and maternal and infant costs in the first year after birth.

Conclusions: These results provide insight into how payers and care providers can partner to improve maternal and infant outcomes among Medicaid members and subsequently experience cost savings.

Recent trends toward payment reform in the care of chronic conditions seek to mitigate quality-related barriers to optimal diabetes management. In type 2 diabetes (T2D) management, these risk-sharing agreements are intended to improve clinical outcomes by facilitating care coordination, data reporting, and the implementation of interventions to address social determinants of health. Outside a need for systems reform, optimal diabetes management may be impeded by the underutilization of advances in care interventions, including continuous glucose monitoring (CGM). An influx of recent evidence and expert recommendations has expanded the utilization of CGM in the population with insulin-treated T2D. Considering recent evidence and guideline recommendations, a small expert panel of payer and provider stakeholders-with specific knowledge in diabetes disease management and risk-based agreements-was selected for this exploratory study to discuss opportunities for CGM-based care management in risk-sharing agreements between payers and providers. The panelists were surveyed before 2 virtual roundtable meetings in which pertinent clinical and trend data were shared. A moderated discussion allowed the expert panelists to outline key elements of potential risk-sharing agreements from the perspective of agreement design, realistic outcomes measures, and strategies to facilitate payer and provider participation.

Medically integrated pharmacies (MIPs) offer a multidisciplinary, patient-centered approach essential for complex oral anticancer therapy. Unlike traditional pharmacy dispensing, which creates a fragmented approach to patient care, MIPs integrate pharmacists directly into the care team, leveraging electronic health records for informed decision-making, thereby enhancing continuity and reducing costs. For patients, critical challenges associated with oral anticancer medications include abandonment, adherence, and access and affordability. Using an integrated and comprehensive approach, core activities of MIPs have demonstrated reductions in prescription abandonment rates and increases in adherence rates through proactive interventions and education. MIPs also enhance affordability by seamlessly coordinating financial assistance programs that can lead to cost savings for both patients and health care systems, presenting a compelling value proposition for managed care. High levels of patient and provider satisfaction further underscore the benefits of this integrated model. The evidence within this commentary demonstrates that MIPs help patients with cancer adhere to their oral anticancer medications while simultaneously minimizing financial burdens, thus providing a robust underpinning for patient-centered value-based care.

Objectives: To assess payer-level completeness of 2025 Transparency in Coverage (TIC) negotiated-rate files for physician, hospital outpatient, and hospital inpatient service lines.

Study design: Cross-sectional descriptive review of 2025 TIC releases from 3 national payers (Aetna, Cigna, and UnitedHealthcare).

Methods: We created cleaned analysis files by ingesting machine-readable files and parsing and deduplicating TIC data sets for the major national plan of each insurer. We compared the network size from the TIC files against marketing materials that reported how many physicians and hospitals were in-network. We calculated what percentage of the most common billing codes had negotiated rate data for large family medicine, cardiology, and orthopedic surgery physician groups, hospital outpatient departments, and inpatient hospitals.

Results: Aetna and Cigna generally listed as many-or more-physicians and hospitals as their marketing materials did, whereas UnitedHealthcare listed fewer. Negotiated-rate completeness was highest for physician specialties and lowest-often minimal-for inpatient files. UnitedHealthcare's physician groups were near complete, but inpatient data were sparse. Cigna showed high completeness for physician specialties and inpatient data, but limited hospital outpatient rates. Aetna demonstrated moderate to good physician completeness, midrange outpatient hospital data, and heterogeneous inpatient results. Overall, physician and hospital outpatient data were typically usable; inpatient data were insufficient.

Conclusions: For these payers, 2025 TIC files support analysis of physician and hospital outpatient prices but are inadequate for inpatient benchmarking. CMS should evaluate TIC completeness-internally or via an external auditor-and enforce penalties when required information is not published.

Objectives: Medicaid's Institution for Mental Diseases (IMD) exclusion bars federal funding for treatment in facilities with more than 16 psychiatric beds, but some states have obtained waivers under Section 1115 of the Social Security Act to increase options for treating serious mental illness (SMI). This retrospective claims study assessed health care resource utilization, costs, homelessness, and incarceration among Medicaid beneficiaries with SMI in states with and without waivers.

Study design: Patients were 18 years and older and had at least 1 diagnosis of SMI and 12 months of continuous enrollment pre- and post index date.

Methods: Fixed-effect models, adjusted for patient and state characteristics, estimated the waivers' impact on outcomes.

Results: The odds of having psychiatric-specific inpatient admissions and emergency department (ED) visits were lower by 14% and 26%, respectively, in the waiver cohort (n = 130,224) vs the nonwaiver cohort (n = 3,102,971). Odds of all-cause inpatient admissions and ED visits were also lower (9% for both) in the waiver cohort, but the odds of having all-cause outpatient visits were 19% greater in the waiver cohort. States with waivers had 11% fewer incarcerations, or about 250 fewer cases per year, based on an average of 23,592 incarcerations.

Conclusions: Our findings underscore the beneficial impact of IMD exclusion waivers on psychiatric-specific and all-cause health care resource utilization and costs as well as on incarceration rates for individuals with SMI. CMS may want to consider the results of this study in addition to other available data when granting waivers to states and potentially removing this exception from the Medicaid law.

One in 6 patients with diabetes in the US reports rationing or abandoning their medications to save costs. Our objective was to describe the breadth, approach, and impact of interventions that sought to address cost-related nonadherence among patients with diabetes in 2003-2023. Studies were eligible if they were published in English, pertained to diabetes, described interventions or policies that reduced or eliminated diabetes medication costs, and evaluated medication adherence as a primary or secondary outcome. We identified studies using MEDLINE, Embase, and Scopus. Two independent reviewers assessed each article's abstract and full text in 2 phases; 29 articles met inclusion criteria. Sixteen interventions reduced diabetes-related co-payments: Seven found improvements in adherence, 6 found no improvement, and 3 did not evaluate changes over time. Eight interventions eliminated all or some diabetes-related costs: Five found improvements in adherence, 2 found no improvement, and 1 did not evaluate changes over time. Interventions that combined cost-reduction or cost-elimination strategies with wellness and disease management programs tended to lead to improved short- and long-term adherence. Six articles evaluated statewide or federal policies (eg, insulin co-payment caps), with varying effects on adherence. Interventions that eliminate diabetes-related costs and provide additional diabetes management assistance may improve access and adherence to medications. Additional work is needed to evaluate the impact of these interventions on long-term health and utilization outcomes.

Objective: To assess the correlates of changes in emergency department (ED) prices for self-pay patients from 2021 to 2023.

Study design: Retrospective longitudinal analysis of self-pay prices for ED facility fees (Current Procedural Terminology [CPT] codes 99283-99285) from 2021 to 2023, using multivariate weighted linear regression to examine the relationship between hospital- and area-level characteristics and trends in self-pay prices and correcting for selective noncompliance with price transparency reporting regulations.

Methods: We created a unique longitudinal database of self-pay rates for CPT codes 99283-99285 using national hospital price transparency data from September 29, 2021, and September 29, 2023. Hospital- and area-level characteristics were derived from the 2021 quarter 2 CMS Provider of Services File, the Agency for Healthcare Research and Quality's 2021 Compendium of US Health Systems, and the 2021 American Community Survey.

Results: From 2021 to 2023, self-pay prices increased by a mean of $98.69, $392.85, and $642.74 for CPT codes 99283, 99284, and 99285, respectively. Price increases were notably higher at for-profit hospitals compared with nonprofits, and system affiliation and serving a community with higher levels of uninsured Hispanic/Latino individuals were associated with greater relative price increases for CPT codes 99284 and 99285.

Conclusions: Self-pay patients face growing affordability issues in ED access. For-profit and system-affiliated hospitals saw the largest increases. With Medicaid enrollment declines stemming from the end of continuous coverage requirements, which started in mid-2023, the self-pay population may rise, highlighting the need to understand their financial risk exposure.

Background: Among patients with focal segmental glomerulosclerosis (FSGS), proteinuria and kidney function decline may be associated with increased economic burden. This study aimed to provide current information on the epidemiology and economic burden of FSGS in the United States.

Methods: In this descriptive, noninterventional, retrospective cohort study, 9899 patients were identified between January 2016 and December 2020 in Optum de-identified Market Clarity Data based on International Classification of Diseases code or Optum proprietary natural language processing data. Descriptive statistics were reported for categorical and continuous variables. Prevalence estimates were standardized to the age, gender, and race/ethnicity distribution of the general US population using direct methods and data from the 2021 United States Census Bureau. Per-patient-per-month health care resource utilization and associated costs (2024 US $) were reported by proteinuria (≤ 1.5 g/g vs > 1.5 g/g or < 3.5 g/g vs ≥ 3.5 g/g) and chronic kidney disease stage (stage 1-5/kidney failure). The Fisher exact test was used for categorical health care resource utilization outcomes, and linear regression (mean) and the Jonckheere-Terpstra test (medians) were used for continuous health care resource utilization and cost outcomes.

Results: Estimated annual US prevalence (average for 2016-2020) of FSGS was 212.6 per 1 million. There was a consistent trend toward higher health care resource utilization and total costs with both chronic kidney disease progression (stage 1-5/kidney failure) and higher levels of proteinuria (≤ 1.5 g/g vs > 1.5 g/g or < 3 .5 g/g vs ≥ 3.5 g/g).

Conclusions: The observed prevalence of FSGS increased in the US and was highest among Black individuals. More advanced chronic kidney disease and higher levels of proteinuria were both associated with greater health care resource utilization and costs. Treatments that reduce proteinuria and slow kidney function decline have the potential to delay disease progression and to reduce the economic burden associated with FSGS.

Objectives: To demonstrate the prevalence of comorbidities documented by Chronic Conditions Data Warehouse (CCW) data for Medicare beneficiaries and to illustrate how failing to account for differences in reported comorbidities can result in information bias.

Study design: Retrospective cohort study of Medicare beneficiaries who underwent coronary artery bypass grafting (CABG) between 2008 and 2019.

Methods: A total of 1,158,701 Medicare beneficiaries underwent CABG. The prevalence of CCW-reported comorbidities was compared between beneficiaries enrolled in Medicare Advantage (MA) or traditional Medicare (TM) plans. Median survival differences (with 95% CIs) were compared in unadjusted and risk-adjusted analyses using overlap propensity score weighting, with and without inclusion of CCW-reported comorbidities during risk adjustment.

Results: The proportion of MA-enrolled CABG recipients increased annually from 17.5% in 2008 to 38.3% in 2019. MA-enrolled beneficiaries had fewer CCW-reported comorbidities than TM-enrolled beneficiaries (average standardized mean difference across 27 CCW comorbidities, 0.431). After risk adjustment for demographics, median survival differed minimally between MA- and TM-enrolled beneficiaries (10.00 vs 10.05 years; difference, -15 [95% CI, -41 to 13] days). However, when CCW-reported comorbidity data were included in risk adjustment, MA-enrolled beneficiaries demonstrated substantially lower median survival (9.52 vs 10.91 years; difference, -507 [95% CI, -538 to -466] days).

Conclusions: The prevalence of CCW-reported comorbidities differs significantly between TM-enrolled and MA-enrolled beneficiaries who underwent CABG. These differences can introduce substantial bias in risk-adjusted analyses that erroneously assume equivalent CCW-reported comorbidity documentation across insurance types. Medicare outcomes research that relies on CCW-reported comorbidity data without accounting for insurance-related differences may produce biased treatment-effect estimates, potentially misinforming clinical or policy decisions.