Medicare Plans Research Articles

97 Burning a Hole in Our Pockets: 12 Year Trends of Medicare Reimbursement for Burn Procedures

Abstract Introduction Burn injuries cost the USA ~$976.6 million annually. Physician reimbursement has lagged despite years of lobbying by physician groups. The Centers for Medicare and Medicaid Services plan to cut physician reimbursement by 4.2% in 2023. Evaluating reimbursement data for hospital-based procedures is timely, including burn procedures. We hypothesized Medicare reimbursement trends for common burn procedures decreased from 2010-2022. Methods We obtained pricing data from the publicly-available Medicare Physician Fee Schedule Look-Up Tool for 26 Current Procedural Terminology (CPT) codes: “Burns–preparation of wound bed” (15002-15005), “Burns–split thickness skin graft” (15100-15101 & 15120-15121), “Burns–skin substitute” (15271-15278), “Cultured epidermal autograft” (15150-15152 & 15155-15157), and “Cell Suspension Epidermal Autograft” (15110-15111 & 15115-15116). We calculated percent differences for reimbursement; compound annual growth rate (CAGR); and percent differences for work, facility, non-facility, and malpractice relative value units (RVUs). Analysis was conducted in R 4.1.2. Results The three largest reimbursement increases were for CPT codes 15272 (24.6%), 15155 (23.7%), and 15003 (10.9%); the three largest decreases were for 15121 (-16.8%), 15120 (-6.1%), and 15275 (-5.0%). The three largest CAGR increases were for CPT codes 15272 (2.2%), 15155 (1.8%), 15274 (0.9%), and 15003 (0.9%); the three smallest were for 15121 (-1.5%), 15120 (-0.5%), and 15275 (-0.5%). Table 1 shows trends of RVUs. Conclusions Our 12-year analysis of Medicare reimbursement trends for 26 burn procedures demonstrated an overall increase in hospital reimbursement and parallel net decrease in physician work RVUs. Reimbursements were increasingly allocated away from surgeons to facility fees and malpractice insurance. Cultured epidermal autograft to the head, neck, hands, and feet (15155) saw the largest increase in Medicare reimbursement with no change in direct physician reimbursement while split-thickness skin grafts to the head, neck, & genitals (15120 & 15121) showed decreased rates. Future work is needed to understand why these trends are occurring to advocate against physician reimbursement cuts. Applicability of Research to Practice Studies contributing to price transparency allow stakeholders to focus on why burn surgeons are receiving lower reimbursements.

Hepatocellular Carcinoma Surveillance among Individuals with Cirrhosis: Trends by Payer, Etiology, and Calendar Year, from a Statewide, Multi-Payer Dataset, 2010-2018.

Hepatocellular carcinoma (HCC) surveillance is underutilized, with <25% of individuals with cirrhosis receiving surveillance exams as recommended. The epidemiology of cirrhosis and HCC in the United States has also shifted in recent years, but little is known about recent trends in surveillance utilization. We characterized patterns of HCC surveillance by payer, cirrhosis etiology, and calendar year in insured individuals with cirrhosis. We conducted a retrospective cohort study of individuals with cirrhosis using claims data from Medicare, Medicaid, and private insurance plans in North Carolina. We included individuals ≥ 18 years with a first occurrence of an ICD-9/10 code for cirrhosis between January 1, 2010, and June 30, 2018. The outcome was HCC surveillance by abdominal ultrasound, CT, or MRI. We estimated 1- and 2-year cumulative incidences for HCC surveillance and assessed longitudinal adherence to surveillance by computing the proportion of time covered (PTC). Among 46,052 individuals, 71% were enrolled through Medicare, 15% through Medicaid, and 14% through private insurance. The overall 1-year cumulative incidence of HCC surveillance was 49% and the 2-year cumulative incidence was 55%. For those with an initial screen in the first 6 months of their cirrhosis diagnosis, the median 2-year PTC was 67% (Q1, 38%; Q3, 100%). HCC surveillance initiation after cirrhosis diagnosis remains low, though it has improved slightly over time, particularly among individuals with Medicaid. This study provides insight into recent trends in HCC surveillance and highlights areas to target for future interventions, particularly among patients with nonviral etiologies.

Development of a Medicare plan dashboard to promote health equity.

To describe a multistage process of designing and evaluating a dashboard that presents data on how equitably health plans provide care for their members. We designed a dashboard for presenting summative and finer-grained data to health plans for characterizing how well plans are serving individuals who belong to racial/ethnic minority groups and individuals with low income. The data presented in the dashboard were based on CMS' Health Equity Summary Score (HESS) for Medicare Advantage plans. Interviews and listening sessions were conducted with health plan representatives and other stakeholders to assess understanding, perceived usefulness, and interpretability of HESS data. Usability testing was conducted with individuals familiar with quality measurement and reporting to evaluate dashboard design efficiency. Listening session participants understood the purpose of the HESS and expressed a desire for this type of information. Usability testing revealed a need to improve dashboard navigability and to streamline content. The HESS dashboard is a potentially useful tool for presenting data on health equity to health plans. The multistage process of continual testing and improvement used to develop the dashboard could be a model for targeting and deciding upon quality improvement efforts in the domain of health equity.

Implementation of a Medicare Plan Selection telephone counselling program

Implementation of a Medicare Plan Selection telephone counselling program

Review of Patient Outcomes After Referral to OT Embedded Within a Primary Care Practice.

Context: Interprofessional teams can reduce workload of primary care providers (PCP). Currently, there is no standardization regarding which professionals should be on the team. We completed a 2 year pilot imbedding an occupational therapist (OT) within a family medicine team. Our initial findings showed significant satisfaction among PCPs. This current study further analyses the outcomes from this pilot. Objective: To examine the treatment plans and corresponding outcomes for all patients that were seen by an OT in order to assess the impact on patients of integrating OT into a primary care setting. Study Design: We performed a retrospective chart review of all adult patients that were referred to OT during an office visit over a period of 23 months. Setting: Department of Family Medicine, Mayo Clinic AZ. Population: Consecutive patients 18 yrs or older referred to OT by a PCP within the designated family medicine clinic between 01/02/2020 and 11/30/2021. Intervention: A novel pilot program imbedding OT within a family medicine team was initiated in January 2020. Patients are referred to an embedded OT during an office visit with their PCP. Whenever possible, a warm hand-off was performed to facilitate the referral. Results: Total of 776 patients were referred to OT. 64.1% were female. Mean age 62.9 years. Insurance: 46% Medicare, 46.4% commercial. 7.2% both. Mean encounter duration: 35.17 minutes. Patients were referred for a variety of diagnoses including balance and movement disorders, musculoskeletal pain, dizziness /vertigo and neuropathy. A majority of patients, 84.21%, reported either partial (30.24%) or complete (54%) improvement. Only 2.9% did not improve, while 12.9% were lost to follow up. 59.7% of patients required a one time treatment, 40.1% were referred for further treatment outside the department (OT or PT). Conclusions: Imbedding OT within a primary care team resulted in partial or complete improvement of symptoms in 84.21% of patients with a variety of diagnoses. A majority of patients required only 1 treatment. Both Medicare and commercial insurance plans were successfully billed for OT services. Learning Objectives: OT imbedded within a primary care team can result in efficient and successful treatment of a wide variety of patient complaints. OT services embedded within a primary care team are reimbursable by Medicare and commercial insurance plans. Research Category: Original research Study Design: Retrospective chart review.

Hospital Utilization for Coronary Artery Disease, 1997-2014.

Coronary artery disease (CAD) is the leading cause of cardiovascular morbidity, mortality, and healthcare costs in the United States. There are few reports on how public health and payment reforms might have influenced inpatient hospital use among patients with CAD. This study describes trends in hospital discharges, hospital charges, and discharge destinations in a national sample of patients with CAD between 1997 and 2014. This was a longitudinal study with descriptive analysis of the Healthcare Cost and Utilization Project of National Inpatient Sample data. During this study period, the total number of discharges was 1 333 996. Patients with CAD between 65 and 84 years old were among the highest users of inpatient hospital services, followed by those in the 45- to 64-year age group. The death rate increased from 5961 to 7217 per 10 000 patients during this time. The mean charge increased more than 5 times, from $9100 to $49 643. There was a large difference in mean hospital charges in urban ($51 666) and rural ($25 548) locations in 2014. Coronary artery disease patients with private insurance paid more than those with Medicaid and Medicare plans. The discharge to home and healthcare costs increased by 4.1% and 4.8%, respectively. Future researchers should use data sets, such as Medicare claims/Medical Expenditure Panel Study, that can provide comprehensive insights into patient-level factors influencing the use of inpatient care services among patients with CAD. Healthcare providers in posthospital settings should be well skilled in providing advanced cardiac rehabilitation and education to patients with CAD.

Financing Benefits and Barriers to Routine HIV Screening in Clinical Settings in the United States: A Scoping Review.

The Centers for Disease Control and Prevention recommends everyone between 13-64 years be tested for HIV at least once as a routine procedure. Routine HIV screening is reimbursable by Medicare, Medicaid, expanded Medicaid, and most commercial insurance plans. Yet, scaling-up HIV routine screening remains a challenge. We conducted a scoping review for studies on financial benefits and barriers associated with HIV screening in clinical settings in the U.S. to inform an evidence-based strategy to scale-up routine HIV screening. We searched Ovid MEDLINE®, Cochrane, and Scopus for studies published between 2006-2020 in English. The search identified 383 Citations; we screened 220 and excluded 163 (outside the time limit, irrelevant, or outside the U.S.). Of the 220 screened articles, we included 35 and disqualified 155 (did not meet the eligibility criteria). We organized eligible articles under two themes: financial benefits/barriers of routine HIV screening in healthcare settings (9 articles); and Cost-effectiveness of routine screening in healthcare settings (26 articles). The review concluded drawing recommendations in three areas: (1) Finance: Incentivize healthcare providers/systems for implementing HIV routine screening and/or separate its reimbursement from bundle payments; (2) Personnel: Encourage nurse-initiated HIV screening programs in primary care settings and educate providers on CDC recommendations; and (3) Approach: Use opt-out approach.

Unintended Consequences? Medicare Commercial Partnerships Complicate Arthroplasty Care and Registry-Based Research: Commentary on an article by Jennifer C. Wang, BS, et al.: "The Rise of Medicare Advantage. Effects on Total Joint Arthroplasty Patient Care and Research".

Commentary The health-care environment has undergone major changes over the past 20 years, including the expansion of partnerships between commercial insurance carriers and the U.S. Department of Health and Human Services (HHS) through its subagency, the Centers for Medicare & Medicaid Services (CMS). Most orthopaedic surgeons performing arthroplasty procedures have probably observed the growing proportion of their patients with Medicare Advantage (commercially managed Medicare) plans. Few among us were likely aware of the full implication of this transition on clinical practice, patient outcomes, and the effectiveness of registry-based arthroplasty research. Wang and colleagues provide a thoughtful analysis of patient demographic characteristics, medical comorbidities, and 90-day postoperative adverse outcomes that were identified for 697,317 patients who underwent elective total hip or total knee arthroplasty in hospitals participating in the Premier Healthcare Database. The authors identified a 335% relative increase in patient participation in Medicare Advantage plans from 2004 to 2020, with increased enrollment of non-White patients, a propensity for increased Medicare Advantage enrollment in urban environments, and increased arthroplasty care engagement in teaching hospitals. While differences in medical comorbidities were not substantially different between patients enrolled in the 2 plan types, Medicare Advantage patients experienced an increased risk for stroke and acute kidney injury following surgery. The authors extrapolate their findings beyond the core data obtained to present their perspectives on the impact of CMS insurance privatization on the future of high-quality joint arthroplasty care. Increased administrative burdens, including pre-authorization coordination for appropriate and clinically indicated surgical treatment, have been encountered by most practicing surgeons and their support teams. The transition of quality reporting through qualified registries—including the American Joint Replacement Registry—has been built around traditional Medicare enrollment reporting mechanisms. At least 1 potentially unintended consequence of the transition toward Medicare Advantage plans is the shielding of patient-based procedural outcomes from these mechanisms—which may serve to undermine innovation and validation. There are some notable limitations of the study, which the authors have outlined. It is very challenging to use administrative databases to fully identify and investigate all factors that may influence adverse postoperative outcomes. While the database used by the authors identifies postoperative surgical and medical complications, it does not address the long-term performance of the implants and techniques. Moreover, the composite medical complexity of patients may not be fully represented in the analyzed data. The factors and conditions underlying patient decisions to select traditional Medicare or Medicare Advantage plans cannot be assessed, and the potential impact of selection bias on the study findings cannot be determined. The study highlights the unanticipated consequences that may arise when fiscally driven policy intersects with specialized medical care. Future studies will be valuable to determine whether the observations in this study are sustained as the growth of Medicare Advantage plans continues—especially with the trends suggesting that under-represented minority patients will potentially be the most adversely affected. With potential implications for arthroplasty care delivery and the future ability to utilize qualified registries to assess arthroplasty outcomes, it is crucial for advocacy efforts to guide policymakers toward ensuring the successful provision of arthroplasty care—including transparency of outcomes among patients who have elected to participate in Medicare Advantage programs.

The Price-Quality Mismatch: Are Negotiated Prices for Total Joint Arthroplasty Associated With Hospital Quality in a Large California Health System?

Price variations in healthcare can be caused by quality or factors other than quality such as market share, negotiating power with insurers, or hospital ownership model. Efforts to improve care value (defined as the ratio between health outcomes and price) by making healthcare prices readily accessible to patients are driven by the assumption this can help patients more easily identify high-quality, low-price clinicians and health systems, thus reducing price variations. However, if price variations are driven by factors other than quality, then strategies that involve payments for higher-quality care are unlikely to reduce price variation and improve value. It is unknown whether prices for total joint arthroplasty (TJA) are correlated with the quality of care or whether factors other than quality are responsible for price variation. (1) How do prices insurers negotiate for TJA paid to a single, large health system vary across payer types? (2) Are the mean prices insurers negotiate for TJA associated with hospital quality? We analyzed publicly available data from 22 hospitals in a single, large regional health system, four of which were excluded owing to incomplete quality information. We chose to use data from this single health system to minimize the confounding effects of between-hospital reputation or branding and geographic differences in the cost of providing care. This health system consists of large and small hospitals serving urban and rural populations, providing care for more than 3 million individuals. For each hospital, negotiated prices for TJA were classified into five payer types: commercial in-network, commercial out-of-network, Medicare Advantage (plans to which private insurers contract to provide Medicare benefits), Medicaid, and discounted cash pay. Traditional Medicare plans were not included because the prices are set statutorily, not negotiated. We obtained hospital quality measures from the Centers for Medicare and Medicaid Services. Centers for Medicare and Medicaid Services quality measures included TJA-specific complication and readmission rates in addition to hospital-wide patient survey star rating (measure of patient care experience) and total performance scores (aggregate measure of clinical outcomes, safety, patient experience, process of care, and efficiency). We evaluated the association between the mean negotiated hospital prices and Centers for Medicare and Medicaid Services quality measures using Pearson correlation coefficients and Spearman rho across all payer types. Statistical significance was defined as p < 0.0025. The mean ± SD overall negotiated price for TJA was USD 54,500 ± 23,200. In the descriptive analysis, the lowest negotiated prices were associated with Medicare Advantage (USD 20,400 ± 1800) and Medicaid (USD 20,300 ± 8600) insurance plans, and the highest prices were associated with out-of-network care covered by commercial insurance plans (USD 78,800 ± 9200). There was no correlation between the mean negotiated price and TJA complication rate (discounted cash price: r = 0.27, p = 0.29; commercial out-of-network: r = 0.28, p = 0.26; commercial in-network: r = -0.07, p = 0.79; Medicare Advantage: r = 0.11, p = 0.65; Medicaid: r = 0.03, p = 0.92), readmission rate (discounted cash price: r = 0.19, p = 0.46; commercial out-of-network: r = 0.24, p = 0.33; commercial in-network: r = -0.13, p = 0.61; Medicare Advantage: r = -0.06, p = 0.81; Medicaid: r = 0.09, p = 0.74), patient survey star rating (discounted cash price: r = -0.55, p = 0.02; commercial out-of-network: r = -0.53, p = 0.02; commercial in-network: r = -0.37, p = 0.13; Medicare Advantage: r = -0.08, p = 0.75; Medicaid: r = -0.02, p = 0.95), or total hospital performance score (discounted cash price: r = -0.35, p = 0.15; commercial out-of-network: r = -0.55, p = 0.02; commercial in-network: r = -0.53, p = 0.02; Medicare Advantage: r = -0.28, p = 0.25; Medicaid: r = 0.11, p = 0.69) for any of the payer types evaluated. There is substantial price variation for TJA that is not accounted for by the quality of care, suggesting that a mismatch between price and quality exists. Efforts to improve care value in TJA are needed to directly link prices with the quality of care delivered, such as through matched quality and price reporting mechanisms. Future studies might investigate whether making price and quality data accessible to patients, such as through value dashboards that report easy-to-interpret quality data alongside price information, moves patients toward higher-value care decisions. Efforts to better match the quality of care with negotiated prices such as matched quality and price reporting mechanisms, which have been shown to increase the likelihood of choosing higher-value care in TJA, could improve the value of care.

Examination of Disparities in Access to Chimeric Antigen Receptor (CAR) T Cell Therapies in Medicare Patients (Pts) with Relapsed or Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Who Had Failed at Least 2 Prior Lines of Therapy (LOT)

Background: The Medicare population, representing older pts with multiple comorbidities, has been successfully treated with CAR T cell therapy. However, prior research suggests that access to this therapy offering possible durable, long-term responses could be limited and subject to health disparities based on socioeconomic status, age, or other pt characteristics (Ahmed et al. Transplant Cell Ther. 2022). Prior research focused on examining determinants of access to CAR T cell therapy relative to a heterogeneous group of pts with respect to treatment history (ie, 0-3 prior lines, etc) or subsequent management (ie, active or maintenance therapy or no additional treatment). The current study examines and contextualizes determinants of receipt of CAR T cell therapy and disparities in access among pts with R/R DLBCL enrolled in a Medicare plan who failed ≥ 2 prior LOTs and were actively treated with ≥ 3 LOTs. Methods: This retrospective cohort study used the Medicare Limited Data Set (LDS) administrative claims data (from 01/01/2017 to 03/31/2021) containing 100% final action claims submitted for fee-for-service (FFS) Medicare beneficiaries. Claims data were linked to publicly available US census county-level measures of the Area Deprivation Index (ADI) 2019 as well as predisposing, enabling, and need contextual characteristics from the Area Health Resource Files from 2019 to 2020 to measure socioeconomic disadvantage. Pts with newly diagnosed DLBCL (ICD-10-CM: C83.3X) continuously enrolled for ≥ 6 months before diagnosis (baseline period) and who received rituximab (RTX)-based therapy during follow-up were included. DLBCL treatments received by pts were identified using ICD-10 procedure and HCPCS codes; Medicare Part D prescription drug claims were not available. Pts had to have received ≥ 2 prior LOTs after DLBCL diagnosis and initiated a subsequent LOT consistent with NCCN guidelines. Those with prior diagnoses of other non-Hodgkin lymphomas or hematologic cancers were excluded, except for primary mediastinal large B-cell lymphoma, chronic lymphocytic leukemia, and follicular lymphoma. The association between receiving CAR T cell therapy and key patient and county of residence characteristics was assessed using multivariate logistic regression models. Results: A total of 15,472 Medicare pts with DLBCL received RTX at any point during follow-up. Of those, 266 pts had 2 prior LOTs, RTX in combination with another chemotherapy as first line, and a third or later LOT that was an active comparator of interest (104 pts received CAR T cell therapy vs 162 pts who did not). Among pts who did not receive CAR T cell therapy, the distribution of third LOTs included stem cell transplant (27.8%), polatuzumab-based therapy (26.5%), and various salvage combinations of RTX with chemotherapy (45.7%). More CAR T cell therapy recipients were evaluated for clinical trial participation over the study period versus nonrecipients (37.5% vs 11.1%, respectively). In unadjusted analysis, those ≥ 76 y old were numerically associated with lower odds of receiving CAR T cell therapy vs those 66-75 y, but the difference was not statistically significant (OR = 0.501, P = 0.06). In multivariate adjusted analysis restricted to 209 pts excluding those who were evaluated for clinical trial participation (65 pts received CAR T cell therapy vs 144 pts who did not), CAR T cell therapy recipients were less likely to be female (odds ratio [OR] = 0.463, P = 0.04), have Charlson Comorbidity Index (CCI) score ≥ 3 (OR = 0.451, P = 0.04), or be residents of the South (OR = 0.284, P = 0.02) (Table). There was no association of ADI and receipt of CAR T cell therapy. Conclusions: Pts with R/R DLBCL on Medicare FFS who received CAR T cell therapy were less fragile, with a CCI < 3, and more likely to experience advanced LOTs. Despite the small sample size of this study, the findings suggest that access to CAR T cell therapy should be particularly improved in female pts and pts living in the South, possibly due to geographical limitations of CAR T centers and a high population of socioeconomically disadvantaged racial minorities. Given the demonstrated durable benefit in pts with R/R DLBCL, increased adoption of CAR T cell therapy can have a significant impact on pts’ lives and improve their health outcomes. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Chimeric Antigen Receptor T-Cell Therapy Setting of Care: A Retrospective Cohort Analysis of MCL and FL Patients in the US

Introduction The United States (US) Food and Drug Administration has recently approved chimeric antigen receptor (CAR) T-cell therapy for patients with relapsed/refractory mantle cell lymphoma (MCL) and follicular lymphoma (FL). Although CAR T-cell therapy is commonly administered in inpatient settings, as clinicians gain experience, there is growing interest in providing infusions and follow-up care in the outpatient setting. This study describes patient characteristics, treatment setting, CAR T-cell therapy-associated adverse events (CAR T-AEs), and health resource utilization (HRU) for real-world CAR T-cell therapy use for MCL and FL. Methods A retrospective analysis of the Anlitiks All-Payor Claims (AAPC) data for services rendered from April 2017 to March 2022 was conducted. The database includes open-source fully adjudicated pharmacy and medical claims of patients who are insured through Medicare, Medicaid, or commercial plans, representing over 80% of the US population. MCL (ICD-9/10-CMs: 200.x, C83.1x) and FL patients (ICD-9/10-CMs: 202.xx, C82.xx) with a first claim (index date) for CAR T-cell therapy (MCL: brexucabtagene autoleucel [brexu-cel] or unspecified CAR T-cell agent; FL: lisocabtagene maraleucel [liso-cel], tisagenlecleucel [tisa-cel], axicabtagene ciloleucel [axi-cel] or unspecified agent) between October 2017 and December 2021, with ≥ 180 days of pre-index and ≥ 90 days of post-index follow-up were identified. Demographics, clinical characteristics, and treatment (infusion) setting (inpatient/outpatient Authorized Treatment Centers [ATCs]) were examined. Incidence of observed CAR T-AEs and HRU were analyzed overall and stratified by infusion setting. Descriptive statistics were reported as frequencies and percentages for categorical variables; mean, median, and range for continuous variables. Chi-square tests (categorical measures), t-tests, and Wilcoxon-rank sum tests (continuous measures) were used to assess group differences, where appropriate. Time from leukapheresis to CAR T-cell infusion was assessed with adjusted Cox proportional hazards models. Results The final sample consisted of a total of 151 MCL and 267 FL patients treated with CAR T-cell therapy. Among MCL patients, 75% were male, mean age was 63.8 (±8.6) years, and 58.3% (n=88) were commercially insured while 30.5% (n=46), 8.6% (n=13) and 2.6% (n=4) had Medicare, Medicaid and unknown/other insurance types, respectively. Among FL patients, 65% were male, mean age was 61.4 (±10.3) years, and 70.0% (n=187) were commercially insured while 19.9% (n=53), 7.1% (n=19) and 3.0% (n=8) had Medicare, Medicaid and unknown/other insurance types, respectively. Overall, 71.5% and 80.9% of MCL and FL patients were infused inpatient, respectively. Among FL patients with a specified CAR T-cell therapy, axi-cel accounted for the majority of patients. Median time from leukapheresis to infusion was similar for inpatient (MCL/FL: 27 days) and outpatient (MCL: 25 days; FL: 27 days) settings. Both MCL brexu-cel and FL axi-cel patients had similar median time from leukapheresis to infusion compared to their respective unspecified CAR T patient cohorts (MCL: both 26 days; FL 25 and 27 days). A total of 113 (74.8%) and 182 (68.2%) MCL and FL patients had an observed CAR T-associated AE within 90 days post-infusion, respectively. HRU analysis is underway. Conclusions In this analysis, nearly 3 in 4 MCL patients and more than 4 in 5 FL patients received CAR T-cell therapy infusions in inpatient settings. Median time from leukapheresis to CAR T-cell infusion was similar for MCL and FL in both infusion settings. Approximately three-fourths of MCL patients and two-thirds of FL patients experienced at least one observed CAR T-associated AE within 90 days post-infusion. Recent data on real-world treatment patterns enhance understanding of CAR T-cell therapy use in the evolving MCL and FL treatment landscape. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Persistence with macitentan versus other endothelin receptor antagonists in patients with pulmonary arterial hypertension: experience from a real-world data repository in the USA

Abstract Background Pulmonary arterial hypertension (PAH) is a progressive and fatal disease and as such, it is imperative that patients remain on therapy to delay progression and maintain functional status. Previous research has demonstrated differences in overall survival in the real-world by endothelin receptor antagonists (ERA) treatments with a lower risk of death with macitentan than ambrisentan and bosentan. However, real-world data on persistence to ERAs are limited. Purpose To compare persistence to macitentan versus ambrisentan and bosentan) in patients with PAH. Methods This retrospective, non-interventional, observational study identified patients between 10/21/2013–3/31/2021 (study period) from the Decision Resources Group (DRG) Real World Data Repository. The repository links medical and prescription claims from commercial, Medicaid, and Medicare plans with electronic health records (EHRs) to provide longitudinal patient-level data representative of over 300 million patients in the US. Patients selected must have been dispensed an ERA prescription from 4/14/14–3/31/20 AND 1) either an inpatient diagnosis of pulmonary hypertension (PH), or 2) a right heart catheterization with any PH diagnosis, or 3) were taking a phosphodiesterase 5 inhibitor (PDE5i). The primary outcome was persistence defined by time from index to drug discontinuation (90-day gap after the end of the last prescription's days of supply). Descriptive analysis comprised means, standard deviations, medians, and interquartile ranges for continuous variables and frequencies and percentages for categorical variables. Three-sample proportion tests were conducted at baseline to detect differences between the three cohorts and identify potentially confounding variables. Hazard ratios (HR) for pairwise comparisons (macitentan vs ambrisentan; macitentan vs bosentan) were calculated using an inverse probability of treatment weighting (IPTW)-adjusted Cox proportional regression model, to adjust for potential confounders (see Table 1) of the probability of receiving a specific ERA. Data were analyzed by Kaplan-Meier method. Results A total of 4,526 patients were included, of whom 1,205 received macitentan, 2,592 received ambrisentan and 729 received bosentan. Study population characteristics were representative of a general PAH population (Table 1). Unadjusted Kaplan-Meier analysis showed that median persistence was shortest for ambrisentan (12.6 months) followed by bosentan (13.6 months) and greatest for macitentan (15.8 months; overall log-rank p-value: 0.061). Compared to macitentan, patients on other ERAs had a greater risk of discontinuation: ambrisentan (10%) and bosentan (18%) (Table 2). Conclusions Persistence to therapy was significantly greater for macitentan-treated patients than in those receiving ambrisentan or bosentan. Further research examining variability in key sub-groups as well as the impact of improved persistence on long-term outcomes is warranted. Funding Acknowledgement Type of funding sources: Private company. Main funding source(s): Janssen Scientific Affairs, LLC

ABCL-509 Healthcare Utilization and Costs in Chimeric Antigen Receptor T-Cell Therapy for B-Cell Lymphoma

In depth analyses of healthcare utilization and costs associated with Anti-CD19 chimeric antigen receptor T-cell therapy (CAR19) for B-cell lymphoma are sparse. Here we describe the financial impact of CAR19 at The Ohio State University Wexner Medical Center. Sixty-three patients who received CAR19 at OSU from January 2018 through June 2019 were analyzed. Charges and costs were assessed on inpatient CAR T infusion encounters from date of infusion to date of discharge. For outpatient infusions, the CAR T administration encounter was analyzed; if admission occurred within 30 days of infusion for CAR T related events, that admission encounter was also analyzed. Cohort characteristics were comparable to previously reported real world studies. Forty-five patients who received axicabtagene ciloleucel (axi-cel) were significantly younger and had higher ferritin and LDH than 18 patients who received tisagenlecleucel (tisa-cel). For patients who received axi-cel, the median charges assessed were $176,535.20 (range: $30,977.4-$1,187,965.3) compared to $64,834.1 (range: $4,007.3-$429.380.0) for tisa-cel (p<.001). Axi-cel was associated with more toxicity and longer length of stay (LOS) than tisa-cel: 96% with cytokine release syndrome (CRS) vs. 44% (p<0.01); 73% with neurotoxicity vs. 22% (p<0.01), LOS 14 days vs. 9 days (p<0.001). Median follow-up was 31.4 months for axi-cel and 23.8 months for tisa-cel; progression free survival (PFS) and overall survival (OS) were not significantly different. Patients with Medicare based insurance were more likely to incur out of pocket costs compared to patients without Medicare (50% vs. 14.6%; p=.0061), with no significant differences in cost incurred ($1,364 vs. $807; p=0.44). Total operational loss incurred by OSU for the encounters analyzed was $1.734 million. For patients with Medicare plans, $2.565 million was lost, however for commercial plans the operational gain was $1.255 million. For Medicare, $2.489 million was lost on inpatient infusions and $76 thousand on outpatient infusions. We observed higher hospital charges, LOS, and toxicity with axi-cel compared to tisa-cel. Patients with Medicare more frequently incurred out of pocket costs and hospital losses were driven by inpatient infusions for patients with Medicare. More robust retrospective studies are needed to further investigate our findings.

Clinical and economic impact of long-acting injectable antipsychotics in patients previously treated with short-acting oral antipsychotics.

BACKGROUND: Available literature supports the use of long-acting injectable (LAI) antipsychotics over short-acting oral (SAO) formulations. The majority of evidence is centered on patients with schizophrenia insured under the Medicaid benefit. OBJECTIVE: To assess real-world clinical and economic outcomes of LAI compared with SAO antipsychotics in patients with psychiatric conditions insured under commercial, health care exchange, or Medicare plans. METHODS: In this exploratory treatmenteffectiveness study, a retrospective, before and after study design was used to evaluate differences in clinical and economic outcomes in patients switching from SAO to LAI antipsychotics. Patients who had at least 1 claim for an LAI antipsychotic and a psychiatric diagnosis were considered eligible for the study if they were continuously enrolled in a commercial, health care exchange, or Medicare plan for 12 months before (preperiod) and 12 months after (postperiod) their first LAI antipsychotic claim. During the preperiod, patients were required to have filled at least a 30-day supply of any SAO antipsychotic medication. Clinical outcomes included health care resource utilization (eg, hospitalizations per member per year [PMPY]), adherence measures, and medication switch trends. Economic outcomes included total per member per month (PMPM) spending across the medical benefit alone, the pharmacy benefit alone, and the combined spending across both benefits. Additionally, we examined patient costs and health plan spending within each of these categories. RESULTS: There was a significant decrease in overall hospitalizations PMPY (1.80 vs 0.88; P < 0.001) and psychiatric hospitalizations PMPY (0.65 vs 0.20; P <0.001) when comparing patients treated with SAO antipsychotics in the preperiod to the same patients treated with LAI antipsychotics in the postperiod, respectively. No differences were observed in the percentage of days covered with SAO and LAI agents (87.4% vs 85.8%; P=0.312). More patients switched between SAO antipsychotics during the preperiod, as compared with the number who switched between LAI antipsychotics during the postperiod (57.4% vs 10.3%; P < 0.001). On average, patients switched medications sooner in the preperiod vs the postperiod (114.50 vs 211.26 days; P < 0.001). No difference was observed between the preperiod and postperiod in total spending PMPM ($3,798.76 vs $3,702.63; P = 0.826) CONCLUSIONS: Patients switching from SAO to LAI antipsychotics experienced fewer hospitalizations, with no change in overall spending. Adherence was similar, though fewer medication switches occurred and there was a longer time before switching medications with LAI compared with SAO antipsychotics DISCLOSURES: Funding for this study was provided by Highmark Inc., but the sponsor had no role in the study outside the final review of the submitted manuscript.

Engaging Payors and Primary Care Physicians Together in Improving Diabetes Prevention.

BackgroundType 2 diabetes can be prevented through lifestyle programs like the Diabetes Prevention Programs (DPP), but few people with prediabetes participate in them, in part because their insurance does not reliably cover DPPs. Prior studies have not focused on payor-level barriers.ObjectiveTo understand barriers to DPP uptake that exist and intersect at different levels (patients, PCPs, and payors) to inform strategies to improve diabetes prevention in primary care settings through interviews with PCPs and payors.DesignFrom May 2020 to October 2021, we conducted remote, semi-structured interviews with PCPs and payors.ParticipantsPCPs were from primary care practices affiliated with one mid-Atlantic academic system. Payor leaders were from regional commercial, Medicare, and Medicaid plans.ApproachUsing a standardized interview guide focused on barriers, facilitators, and potential intervention components, interviews were audio-recorded using Zoom and professionally transcribed. Two reviewers double-coded transcripts using the framework analytic approach.Key ResultsWe interviewed 16 PCPs from 13 primary care clinics and 7 payor leaders representing 6 insurance plans. Two themes emerged from PCP reports of patient-level barriers: (1) lack of programs and insurance coverage of resources to address nutrition and exercise and (2) inadequate resources to address social determinants of health that impact diabetes prevention. Among barriers PCPs faced, we identified two themes: (1) low PCP knowledge about DPPs and misperceptions of insurance coverage of DPPs and (2) inadequate clinical staff to address diabetes prevention. Barriers common to PCPs and payors included (1) absence of prediabetes quality measures and (2) inadequate engagement of PCPs and patients with payors.ConclusionsDiscussions with PCPs and payors revealed systemic barriers that suggest important priorities to improve prediabetes clinical care, including universal coverage of DPPs, clarity about coverage benefits, data reporting and outreach by payors to PCPs, and adoption of appropriate prediabetes quality measures.Supplementary InformationThe online version contains supplementary material available at 10.1007/s11606-022-07788-8.

Impact of comparative effectiveness research on Medicare coverage of direct oral anticoagulants.

Aim: To evaluate the association of comparative effectiveness research with Medicare coverage of direct oral anticoagulants. Materials & methods: A literature review for direct oral anticoagulants was conducted from 2011 to 2017. Monthly prescription drugplan and formularyfiles (n =28) were used to conduct change-point analysis and assess each outcome variable. Results: Up to 2013, studies showed that dabigatran was more effective than rivaroxaban. In 2015, apixaban was shown to be the safest and most effective drug in comparison with all direct oral anticoagulants. In 2016-2017, dabigatran and apixaban were shown to have similar efficacy. Approximately 75% of plans covered dabigatran under tier 3until 2015. From 2011 to 2017, less than 30% of plans required prior authorizations, 50% imposed quantity limits and mean copayment was lowest for rivaroxaban. Conclusion: Consistent with comparative effectiveness research, Medicare plans covered apixaban more favorably and edoxaban less favorably. However, discrepancies in comparative effectiveness research translation were found for rivaroxaban and dabigatran.

Trends in utilization and costs of migraine medications, 2017–2020

ObjectiveThis study examines changes in utilization and costs trends associated with migraine medications.BackgroundMigraine attacks are a burden to many patients. There are many pharmacotherapy options available with newer migraine drug classes entering the market in the past decade. Little is known about the use, associated costs, and the impact of the newer agents.MethodsThis retrospective, cross-sectional study examined 2017–2020 administrative claims from a large national pharmacy benefits manager. Patients aged ≥ 18 years enrolled in commercial, Medicare, Medicaid, or health insurance exchange insurance plans who filled ≥ 2 prescription claims for triptans, ergotamines, isometheptenes, gepants, ditans, and CGRP mABs were included. A two-sample t-test was conducted to estimate whether differences in mean utilization and costs between 2017 and 2020 were statistically significant for migraine drug classes, except for CGRP mABs, which were estimated between 2018 and 2020.ResultsThe sample ranged from 161,369 (2017) to 240,330 (2020) patients. 84.5% (n = 203,110; 2020) of patients were women. The number of 30-day adjusted prescription fills for prophylaxis remained stable over the four-year period, except for CGRP mABs, which increased from 0.5% (n = 0.007; 2018) to 5.3% (n = 0.075; 2020). Antiepileptics, antidepressants and beta blockers were the most common prophylaxes, while triptans, non-steroidal anti-inflammatory drugs/non-narcotic analgesics and opioids were the most common treatments utilized. CGRP mABs were the most expensive, while utilization of triptans were the highest. CGRP mABs had the largest increase in utilization (177.5%) and costs (166.3%) PPPM in 2020 ($291.17) compared to 2018 ($109.35), the year they were first available (p < 0.001). Between 2018 and 2020, costs increased overall and for commercial and Medicare enrollees, but remained unchanged for Medicaid and HIX members.ConclusionOur study demonstrates a shift in migraine medication utilization from 2017–2020, where increased use of CGRP mABs had a significant contribution to increased costs. These increased pharmacy costs must be weighed against the improved tolerability of these agents likely resulting in other healthcare and indirect cost savings.

Budget Impact Analysis of Vibegron for the Treatment of Overactive Bladder in the USA.

BackgroundOveractive bladder (OAB) is associated with considerable clinical and economic burden. Treatment of patients with OAB using anticholinergics is limited by tolerability issues and increased anticholinergic burden, which is associated with increased risk of dementia and falls/fractures. This analysis assessed the budget impact of introducing the β3-adrenergic agonist vibegron for the treatment of patients with OAB from US commercial payor and Medicare perspectives.MethodsA budget impact model (BIM) with a 5-year time horizon was developed using a top-down, prevalence-based approach and projected market shares for 1-million-member US commercial and Medicare plans. The BIM included vibegron, mirabegron, and anticholinergics, incorporating changes in clinical outcomes (efficacy, drug–drug interactions, anticholinergic burden (ACB), OAB-related comorbidities, and adverse events (AEs)). Costs per member per month (PMPM) and per treated member per month (PTMPM) were determined. One-way sensitivity analyses quantified the impact of changes in key variables.ResultsThe introduction of vibegron was associated with a modest increase in PMPM cost over 5 years of $0.12 (range for years 1‒5, $0.01‒$0.26) for commercial payors and $0.24 ($0.01‒$0.52) for Medicare (PTMPM cost: $2.70 ($0.17‒$4.85) and $3.15 ($0.19‒$5.82), respectively). Costs were partially offset by savings related to decreased third-line treatment use, yearly decreases in AE and comorbidity incidence, reduced drug–drug interactions, and reduced ACB associated with vibegron introduction. PMPM costs were most sensitive to vibegron market share assumptions, OAB prevalence, and vibegron persistence at 1 month for private payors and Medicare and additionally vibegron persistence at 12 months for Medicare.ConclusionsVibegron may address unmet needs in treating OAB and is a useful addition to health plans while minimizing risks of anticholinergic AEs, ACB, and drug–drug interactions, which may partially offset increased pharmacy costs.Supplementary InformationThe online version contains supplementary material available at 10.1007/s40273-022-01163-5.

Diabetes Care Among Older Adults Enrolled in Medicare Advantage Versus Traditional Medicare Fee-For-Service Plans: The Diabetes Collaborative Registry.

Medicare Advantage (MA), Medicare's managed care program, is quickly expanding, yet little is known about diabetes care quality delivered under MA compared with traditional fee-for-service (FFS) Medicare. This was a retrospective cohort study of Medicare beneficiaries ≥65 years old enrolled in the Diabetes Collaborative Registry from 2014 to 2019 with type 2 diabetes treated with one or more antihyperglycemic therapies. Quality measures, cardiometabolic risk factor control, and antihyperglycemic prescription patterns were compared between Medicare plan groups, adjusted for sociodemographic and clinical factors. Among 345,911 Medicare beneficiaries, 229,598 (66%) were enrolled in FFS and 116,313 (34%) in MA plans (for ≥1 month). MA beneficiaries were more likely to receive ACE inhibitors/angiotensin receptor blockers for coronary artery disease, tobacco cessation counseling, and screening for retinopathy, foot care, and kidney disease (adjusted P ≤ 0.001 for all). MA beneficiaries had modestly but significantly higher systolic blood pressure (+0.2 mmHg), LDL cholesterol (+2.6 mg/dL), and HbA1c (+0.1%) (adjusted P < 0.01 for all). MA beneficiaries were independently less likely to receive glucagon-like peptide 1 receptor agonists (6.9% vs. 9.0%; adjusted odds ratio 0.80, 95% CI 0.77-0.84) and sodium-glucose cotransporter 2 inhibitors (5.4% vs. 6.7%; adjusted odds ratio 0.91, 95% CI 0.87-0.95). When integrating Centers for Medicare and Medicaid Services-linked data from 2014 to 2017 and more recent unlinked data from the Diabetes Collaborative Registry through 2019 (total N = 411,465), these therapeutic differences persisted, including among subgroups with established cardiovascular and kidney disease. While MA plans enable greater access to preventive care, this may not translate to improved intermediate health outcomes. MA beneficiaries are also less likely to receive newer antihyperglycemic therapies with proven outcome benefits in high-risk individuals. Long-term health outcomes under various Medicare plans requires surveillance.

Appropriate management of patients with claudication

Appropriate management of patients with claudication