Real-World Incidence and Management of Immune-Related Adverse Events from Immune Checkpoint Inhibitors: Retrospective Claims-Based Analysis.

PURPOSE: We assessed real-world spectrum and patterns of irAEs for patients treated with anti-PD(L)1 ICIs. METHODS: irAEs were defined using medical and pharmacy claims for patients enrolled in a Medicare Advantage Prescription Drug plan who initiated treatment with anti-PD(L)-1 and received ≥ 1 dose of therapy between 1 September 2014 and 28 February 2018. RESULTS: Treatment was discontinued for 46.6% of patients, and withheld and subsequently restarted for 10.3%. While toxicity profiles did not differ by age, RiskRx-V co-morbidity index was higher in patients with irAEs. CONCLUSION: These data underscore the needs for tailored irAE diagnostic and management pathways.

Association Between a Bundled Payment Program for Lower Extremity Joint Replacement and Patient Outcomes Among Medicare Advantage Beneficiaries.

Importance: Much of the evidence for bundled payments has been drawn from models in the traditional Medicare program. Although private insurers are increasingly offering bundled payment programs, it is not known whether they are associated with changes in episode spending and quality. Objective: To evaluate whether a voluntary bundled payment program offered by a national Medicare Advantage insurer was associated with changes in episode spending or quality of care for beneficiaries receiving lower extremity joint replacement (LEJR) surgery. Design, Setting, and Participants: Cross-sectional study of 23 034 LEJR surgical episodes that emulated a stepped-wedge design by using the time-varying, geographically staggered rollout of the bundled payment program from January 1, 2012, to September 30, 2019. Episode-level multivariable regression models were estimated within practice to compare changes before and after program participation, using episodes at physician practices that had not yet begun participating in the program during a given time period (but would go on to do so) as the control. Data analyses were performed from July 1, 2021, to June 30, 2022. Exposures: Physician practice participation in the bundled payment program. Main Outcomes and Measures: The primary outcome was episode spending (plan and beneficiary). Secondary outcomes included postacute care use (skilled nursing facility and home health care), surgical setting (inpatient vs outpatient), and quality (90-day complications [including deep vein thrombosis, wound infection, fracture, or dislocation] and readmissions). Results: The final analytic sample included 23 034 LEJR episodes (6355 bundled episodes and 16 679 control episodes) from 109 physician practices participating in the program. Of the beneficiaries, 7730 were male and 15 304 were female, 3057 were Black, 19 351 were White, 447 were of other race or ethnicity (assessed according to the Centers for Medicare & Medicaid Services beneficiary race and ethnicity code, which reflects data reported to the Social Security Administration), and 179 were of unknown race and ethnicity. The mean (SD) age was 70.9 (7.2) years. Participation in the bundled payment program was associated with a 2.7% (95% CI, 1.3%-4.1%) decrease in spending per episode (mean episodic spending, $21 964 [95% CI, $21 636-$22 296] vs $22 562 [95% CI, $22 346-$22 779]), as well as reductions in skilled nursing facility use after discharge (21.3% for bundled episodes vs 25.0% for control episodes; odds ratio [OR], 0.81 [95% CI, 0.67-0.98]) and increased use of the outpatient surgical setting (14.1% for bundled episodes vs 8.4% for control episodes; OR, 1.79 [95% CI, 1.53-2.09]). The program was not associated with changes in quality outcomes, including 90-day complications (8.8% for bundled episodes vs 8.6% for control episodes; OR, 1.02 [95% CI, 0.86-1.20]) and readmissions (4.3% for bundled episodes vs 4.6% for control episodes; OR, 0.92 [95% CI, 0.75-1.13]). Conclusions and Relevance: In this study of an LEJR bundled payment program offered by a national Medicare Advantage insurer, findings suggest that physician practice participation in the program was associated with a decrease in episode spending without changes in quality. Bundled payments offered by private insurers, including Medicare Advantage plans, are an alternate payment option to fee for service that may reduce spending for LEJR episodes while maintaining quality of care.

Change in self-reported health: A signal for early intervention in a medicare population.

BACKGROUND: Health plans and risk-bearing provider organizations seek information sources to inform proactive interventions for patients at risk of adverse health events. Interventions should take into account the strong relationship between social context and health. This retrospective cohort study of a Medicare Advantage population examined whether a change in self-reported health-related quality of life (HRQOL) signals a subsequent change in healthcare needs. METHODS: A retrospective longitudinal analysis of administrative claims data was conducted for participants in a Medicare Advantage plan with prescription drug coverage (MAPD) who responded to 2 administrations of the Centers for Disease Control and Prevention 4-item Healthy Days survey within 6-18 months during 2015-2018. Changes in HRQOL, as measured by the Healthy Days instrument, were compared with changes in utilization and costs, which were considered to be a reflection of change in healthcare needs. RESULTS: A total of 48,841 individuals met inclusion criteria. Declining HRQOL was followed by increases in utilization and costs. An adjusted analysis showed that every additional unhealthy day reported one year after baseline was accompanied by an $8 increase in monthly healthcare costs in the subsequent six months for the average patient. CONCLUSIONS: Declining HRQOL signaled subsequent increases in healthcare needs and utilization. IMPLICATIONS: Findings suggest that HRQOL assessments in general, and the Healthy Days instrument in particular, could serve as a leading indicator of the need for interventions designed to mitigate poor health outcomes and rising healthcare costs. LEVEL OF EVIDENCE: III.

Comparison of Low-Value Services Among Medicare Advantage and Traditional Medicare Beneficiaries.

Importance: Low-value care in the Medicare program is prevalent, costly, potentially harmful, and persistent. Although Medicare Advantage (MA) plans can use managed care strategies not available in traditional Medicare (TM), it is not clear whether this flexibility is associated with lower rates of low-value care. Objectives: To compare rates of low-value services between MA and TM beneficiaries and explore how elements of insurance design present in MA are associated with the delivery of low-value care. Design, Setting, and Participants: This cross-sectional study analyzed beneficiaries enrolled in MA and TM using claims data from a large, national MA insurer and a random 5% sample of TM beneficiaries. The study period was January 1, 2017, through December 31, 2019. All analyses were conducted from July 2021 to March 2022. Exposures: Enrollment in MA vs TM. Main Outcomes and Measures: Low-value care was assessed using 26 claims-based measures. Regression models were used to estimate the association between MA enrollment and rates of low-value services while controlling for beneficiary characteristics. Stratified analyses explored whether network design, product design, value-based payment, or utilization management moderated differences in low-value care between MA and TM beneficiaries and among MA beneficiaries. Results: Among a study population of 2 470 199 Medicare beneficiaries (mean [SD] age, 75.6 [7.0] years; 1 346 777 [54.5%] female; 229 107 [9.3%] Black and 2 126 353 [86.1%] White individuals), 1 527 763 (61.8%) were enrolled in MA and 942 436 (38.2%) were enrolled in TM. Beneficiaries enrolled in MA received 9.2% (95% CI, 8.5%-9.8%) fewer low-value services in 2019 than TM beneficiaries (23.1 vs 25.4 total low-value services per 100 beneficiaries). Although MA beneficiaries enrolled in health management organization and preferred provider organization products received fewer low-value services than TM beneficiaries, the difference was largest for those enrolled in health management organization products (2.6 fewer [95% CI, 2.4-2.8] vs 2.1 fewer [95% CI, 1.9-2.3] services per 100 beneficiaries, respectively). Across primary care payment arrangements, MA beneficiaries received fewer low-value services than TM beneficiaries, with the largest difference observed for MA beneficiaries whose primary care physicians were reimbursed within 2-sided risk arrangements. Conclusions and Relevance: In this cross-sectional study of Medicare beneficiaries, those enrolled in MA had lower rates of low-value care than those enrolled in TM; elements of insurance design present in the MA program and absent in TM were associated with reduction in low-value care.

Claims identification of patients with severe cancer-related symptoms.

OBJECTIVES: The goal of this study was to establish a claims-based mechanism for identifying patients with metastatic non-small cell lung cancer (mNSCLC) and high levels of patient-reported cancer-related symptoms who could benefit from engagement with health care programs. STUDY DESIGN: A cross-sectional survey of patients with mNSCLC was conducted from July 2017 to May 2018. Surveys were mailed to patients who were within 3 months of cancer treatment and enrolled in a Medicare Advantage health plan. METHODS: Pain, fatigue, and sleep disturbance were measured using the Patient-Reported Outcomes Measurement Information System. Depression was assessed using the Patient Health Questionnaire-2. Medical claims were linked to survey results to identify comorbidities and assess preindex health care resource utilization. Cluster analysis was used to differentiate patients based on patient-reported pain interference, pain intensity, depression, and sleep disturbance. Logistic regression was used to identify claims-based measures associated with more severe symptoms. RESULTS: For 698 respondents, 2 distinct symptom clusters were identified: a less severe (38.4%) cluster and a more severe (61.6%) cluster. Patients in the more severe cluster were younger, were more frequently dually eligible for Medicare and Medicaid, and more frequently had prescription fills for opioids. Claims-based factors associated with the more severe cluster included 2 or more 30-day fills for opioids in the prior 6 months, age younger than 75 years, depression diagnosis or antidepressants, bone metastases, and pain-related outpatient visits. CONCLUSIONS: The claims-based factors associated with the severe symptom cluster can enable identification of patients with mNSCLC who could benefit from clinical outreach programs to enhance the care and support provided to these patients.

Using the Healthy Days Measure to Assess Factors Associated with Poor Health-Related Quality of Life for Patients with Metastatic Breast, Lung, or Colorectal Cancer Enrolled in a Medicare Advantage Health Plan.

This study investigated factors associated with patient-reported health-related quality of life (HRQoL) using the Centers for Disease Control and Prevention's Healthy Days tool for patients with Medicare Advantage undergoing treatment for metastatic breast, lung, and colorectal cancer. In 2015, a total of 6390 patients were mailed surveys regarding factors that may influence their HRQoL, including cancer-related symptoms. HRQoL was measured as the number of physically and mentally unhealthy days experienced in the past 30 days and summed for the total number of unhealthy days. Frequent unhealthy days was defined as ≥14 total unhealthy days in the prior month. Of 1567 respondents, the mean number of total unhealthy days (standard deviation) was 14.0 (11.9) with 46.2% experiencing frequent unhealthy days. On average, patients reported 10.5 (10.5) physically and 6.7 (9.4) mentally unhealthy days. Cancer-related symptoms, particularly pain and fatigue, were significantly associated with increased unhealthy days. In adjusted models, patients with pain had 83% more unhealthy days than patients without pain; patients with fatigue had 104% more unhealthy days than patients without fatigue. Diarrhea/constipation and shortness of breath also were associated with more unhealthy days. Cancer-related symptoms, most notably pain and fatigue, were associated with worse HRQoL for patients with metastatic cancer. Interventions aimed at ameliorating symptoms may improve quality of life for patients undergoing cancer treatment.

Does site-of-care for oncology infusion therapy influence treatment patterns, cost, and quality in the United States?

BACKGROUND: The increase in hospital acquisition of community oncology clinics in the US has led to a shift in the site-of-care (SOC) for infusion therapy from the physician office (PO) to the hospital outpatient (HO) setting. OBJECTIVE: To investigate differences by SOC in treatment patterns, quality, and cost among patients with cancer undergoing first-line infusion therapy. RESEARCH DESIGN AND METHODS: This retrospective analysis identified adult patients from Humana medical claims who initiated infusion therapy from 2008-2012 for five common cancer types in which infusion therapy is likely, including early stage breast cancer; metastatic breast, lung, and colorectal cancers; and non-Hodgkin's lymphoma or chronic lymphocytic leukemia. Differences by SOC in first-line treatment patterns and quality of care at end-of-life, defined as infusions or hospitalizations 30 days prior to death, were evaluated using Wilcoxon-Rank Sum and Chi-square tests where appropriate. Differences in cost by SOC were evaluated using risk-adjusted generalized linear models. MAIN OUTCOME MEASURES: Treatment patterns, quality of care at end of life, healthcare costs. RESULTS: There were differences in duration of therapy and number of infusions for some therapy regimens by SOC, in which patients in the HO had shorter duration of therapy and fewer infusions. There were no differences in quality of care at end-of-life by SOC. Total healthcare costs were 15% higher among patients in HO ($55,965) compared with PO ($48,439), p < .0001. LIMITATIONS: Analyses was restricted to a claims-based population of cancer patients within a health plan. CONCLUSION: This study, in an older, predominantly Medicare Advantage oncology cohort, found differences by SOC in treatment patterns and cost, but not quality. Where differences were found, patients receiving care in the HO had shorter duration of therapy and fewer infusions for specific treatment regimens, but higher healthcare costs than those treated in a PO.

An Early View of Real-World Patient Response to Sacubitril/Valsartan: A Retrospective Study of Patients with Heart Failure with Reduced Ejection Fraction.

INTRODUCTION: Sacubitril/valsartan has been established as an effective treatment for heart failure (HF) with reduced ejection fraction based on clinical trial data; however, little is known about its use or impact in real-world practice. METHODS: This study included data from medical and pharmacy claims and medical records review for patients (n = 200) who initiated sacubitril/valsartan between August 2015 and March 2016 preceding issuance of American College of Cardiology (ACC)/American Heart Association (AHA)/Heart Failure Society of America (HFSA) focused update on new pharmacological therapy for HF (May 2016), which included recommendations for sacubitril/valsartan. A within-subject analysis compared symptoms and healthcare resource utilization before and after treatment initiation. RESULTS: Patients treated with sacubitril/valsartan had multiple comorbidities, and nearly all had previous treatment for HF. Most patients initiated sacubitril/valsartan at the lowest dose of 24/26 mg twice a day (BID), which remained unchanged during the observation period for half of the patients. During the first 6 weeks of treatment, few patients discontinued sacubitril/valsartan treatment (5.5%), and only 17% achieved the target dose of 97/103 mg BID after 4 months of treatment. The proportion of patients with ≥ 1 all-cause inpatient stay decreased significantly between the pre-initiation period (27.5%) and the post-initiation period (17.0%), P = 0.009. Fatigue was noted in 51.8% of patients pre-initiation and 39.5% post-initiation, P = 0.027. Shortness of breath was documented for 66.7% of patients pre-initiation and 51.8% post-initiation, P = 0.008. CONCLUSION: The findings of this real-world investigation suggest sacubitril/valsartan is associated with symptom improvements and a reduction in hospitalizations within 4 months of treatment for patients with HF and reduced ejection fraction. FUNDING: Novartis Pharmaceuticals Corporation.

The Relationship Between Guideline-Recommended Initiation of Therapy, Outcomes, and Cost for Patients with Metastatic Non-Small Cell Lung Cancer.

BACKGROUND: Guideline-recommended therapy for metastatic non-small cell lung cancer (mNSCLC) encourages evidence-based treatment; however, there is a knowledge gap regarding the influence of guideline-recommended initiation of therapy on outcomes and cost. OBJECTIVE: To investigate if lack of guideline-recommended initiation of first-line systemic therapy was associated with worse patient outcomes and increased costs for patients with mNSCLC. METHODS: In this retrospective analysis, 1,344 Medicare patients with mNSCLC were identified from Humana data. Performance status (PS) was imputed using procedure, diagnosis, and durable medical equipment codes pre-index. Guideline-recommended initiation of therapy was defined as ≥1 cycle of National Comprehensive Cancer Network-recommended first-line therapy based on age and PS or targeted therapies regardless of age and PS. Demographics and clinical characteristics were compared by guideline-recommended initiation of therapy. A Cox model assessed factors associated with 6-month mortality. End-of-life quality of care indicators included hospital admission and oncology infusions 30 days preceding death and were evaluated using logistic regression models. A generalized linear model assessed the relationship between guideline-recommended initiation of therapy and total health care costs in the 6 months post-index controlling for clinical, demographic, and treatment characteristics. Logistic models for inpatient stays and emergency department visits were also evaluated. RESULTS: Guideline-recommended therapy initiation was observed in 75.5% of patients. Patients not initiating guideline-recommended therapy were older, with a mean (SD) age of 72.5 (6.7) versus 71.2 (6.2) years (P = 0.001), and more frequently identified as having a low-income subsidy (30.0% vs. 16.4%; P < 0.001). Among the 24.6% of patients who died ≤ 6 months post-index, a greater percentage had not initiated guideline-recommended therapy (28.8% vs. 23.2%; P = 0.040). In adjusted models, PS (not initiation of guideline-recommended therapy) was predictive of mortality (patients with poor PS had an 84% higher probability of death [P = 0.014]). Among decedents, 64.2% were hospitalized, and 33.9% had an oncology-related infusion within 30 days of death, with no differences by guideline-recommended initiation of therapy. These end-of-life quality indicators were not associated with guideline-recommended initiation of therapy in adjusted models. Overall, 47.5% of patients who initiated guideline-recommended therapy were hospitalized compared with 55.0% of patients who did not (P = 0.026). Patients initiating guideline-recommended therapy had higher post-index total and oncology-related health care costs and fewer hospitalizations. In models, these differences in costs and hospitalizations were not associated with initiation of guideline-recommended therapy. CONCLUSIONS: Most patients initiated guideline-recommended therapy, with no differences in mortality and quality of care at the end of life by guideline-recommended initiation of therapy, though adherence beyond treatment initiation was not assessed. Unadjusted hospitalization rates were lower and costs were higher for patients who initiated guideline-recommended therapy. These differences were no longer observed after risk adjustment, suggesting that they may have been influenced by patient characteristics, disease progression, and subsequent treatment decisions. DISCLOSURES: This study was sponsored by Genentech. Khoury, Michael, Parikh, and Bunce are employed by Genentech. Casebeer, Drzayich Antol, DeClue, Hopson, Li, and Stemkowski are employed by Comprehensive Health Insights, Humana, which was contracted by Genentech to conduct this study. Sehman is employed by Humana. Based on this research, 2 posters were presented at the Academy of Managed Care Pharmacy Nexus 2017 on October 16-19, 2017, in Dallas, Texas. Another poster was also presented at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Annual European Congress on October 29-November 2, 2016, in Vienna, Austria.

Retracted: Using the Healthy Days Measure to Assess Factors Associated with Poor Health-Related Quality of Life for Patients with Metastatic Breast, Lung, or Colorectal Cancer Enrolled in a Medicare Advantage Health Plan.

The article entitled, "Using the Healthy Days Measure to Assess Factors Associated with Poor Health-Related Quality of Life for Patients with Metastatic Breast, Lung, or Colorectal Cancer Enrolled in a Medicare Advantage Health Plan," by Casebeer AW et al, which published online ahead of print in Population Health Management [doi: 10.1089/pop.2018.0024], is being retracted by the authors so that they can remove references to the 8-item Morisky Medication Adherence Scale (MMAS-8) and republish the article without such references. Dr. Casebeer's team obtained a license to use the MMAS-8 scale from Dr. Morisky prior to conducting the study. Nevertheless, after publication of a separate article in the Journal of Patient-Reported Outcomes that also cited the MMAS-8, as the lead author, Dr. Casebeer was contacted by Dr. Morisky who requested that a number of changes be made to the article. Dr. Casebeer and her team have no desire to engage in a dispute with Dr. Morisky and therefore proactively contacted the Editor of Population Health Management and requested that the scale be removed from her published paper. After assessing all of the provided information, the Editor agreed to the authors' request. It is important to note that the retraction of Dr. Casebeer's article is not the result of any misconduct on her part or that of her team. The retraction serves to remove the published version of the article that contains the MMAS-8 scale and a revised version that does not contain the tool or any references to it will be published. The elimination of the scale does not alter the results or conclusions of the study. Population Health Management is committed to upholding the highest standards of peer review and the community it serves.