Assessing Medicare's Coverage With Evidence Development Program.

The Centers for Medicare and Medicaid Services (CMS) coverage with evidence development (CED) program provides coverage for items and services not meeting Medicare's "reasonable and necessary" standard while requiring participation in clinical studies. As additional evidence is available, CMS may reconsider CED decisions. Of twenty-six items and services in the CED program since its 2005 inception, CMS has reconsidered coverage for ten (38 percent).

Medicare Local Coverage Determinations: Evidence Quality Is Stronger For Covered Indications.

Under the 21st Century Cures Act of 2016, a summary of the evidence used to support local coverage determinations, which represent the vast majority of Medicare's coverage decisions for new technologies, must be made publicly accessible. Using reports from the Medicare Coverage Database on local coverage determinations and the medical literature, we examined the availability of these decisions and the quality of evidence cited for therapeutic drugs, biologics, and moderate- or high-risk devices during the period 2015-22 to understand whether evidence strength and generalizability differed for indications with favorable versus unfavorable coverage decisions. Evidence summaries were publicly available for 26 percent of coverage decisions originally effected during 2015-18 and 100 percent during 2019-22.

Function, cognition, and quality of life among older adults with lung cancer who live alone: A prospective cohort study.

Introduction: Among older adults without cancer, living alone is associated with poor health outcomes. However, among older adults with non-small cell lung cancer (NSCLC) who live alone, data on function, cognition, and quality of life (QOL) during systemic treatment remain limited.

Materials And Methods: We enrolled adults aged ≥65 with advanced NSCLC starting a new chemotherapy, immunotherapy, and/or targeted therapy regimen with non-curative intent.

Leveraging the Consolidated Framework for Implementation Research to Develop the American College of Rheumatology's Toolkit for Implementation of Rheumatoid Arthritis Outcome Measures in Clinical Practice: A Qualitative Study.

Objective: Despite the recognized benefits of collecting rheumatoid arthritis (RA) outcomes measures, their use in routine care is inconsistent. Using the Consolidated Framework for Implementation Research (CFIR), we conducted semistructured interviews with US rheumatologists and practice personnel to assess workflows, opportunities, and challenges in collecting RA outcome measures. Using insights from interviews, we developed the RA Measures Toolkit to enhance their use in clinical practice.

Patterns of Infliximab Biosimilar Uptake for Medicare, Medicaid, and Private Insurance from 2016 to 2022.

Objective: Biosimilars have the potential to reduce spending on biologic drugs, yet uptake has been slower than anticipated. We investigated how successive introductions of infliximab biosimilars influenced their adoption by major US insurance providers.

Methods: Data came from the Rheumatology Informatics System for Effectiveness, a national registry with electronic health records from more than 1,100 US rheumatologists.

Alzheimer disease-related biomarkers and cancer-related cognitive decline: the Thinking and Living with Cancer study.

Purpose: We evaluated whether plasma Alzheimer disease (AD)-related biomarkers were associated with cancer-related cognitive decline among older breast cancer survivors.

Methods: We included survivors aged 60-90 years with primary stage 0-III breast cancers (n = 236) and frequency-matched noncancer control paricipant (n = 154) who passed a cognitive screen and had banked plasma specimens. Participants were assessed at baseline (presystemic therapy) and annually for up to 60 months.

Reducing potentially inappropriate polypharmacy at a national and international level: the impact of deprescribing networks.

Introduction: Over the past decade, polypharmacy has increased dramatically. Measurable harms include falls, fractures, cognitive impairment, and death. The associated costs are massive and contribute substantially to low-value health care.

Latent Tuberculosis Screening Among New Users of a Biologic or Targeted Synthetic Disease-Modifying Antirheumatic Drug: Gaps in Screening Overall and Among Janus Kinase Inhibitors.

Objective: We combined claims and electronic health record (EHR) data to provide contemporary and accurate estimates of latent tuberculosis (TB) screening among new users of a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) and assess potential gaps in testing by drug type, patient characteristics, and practice.

Methods: Our denominator population was patients in the Rheumatology Informatics System for Effectiveness (RISE) registry and Medicare using a b/tsDMARD in 2018 without a claim or prescription in the year prior. TB screening was assessed in both Medicare and RISE 1 and 3 years before the medication start date.

Plant-based diet associated with better quality of life in prostate cancer survivors.

Background: Plant-based diets have many health benefits, including a lower risk of fatal prostate cancer, and greater environmental sustainability. However, less is known regarding the impact of plant-based diets on quality of life among individuals diagnosed with prostate cancer. The authors' objective was to examine the relationship between plant-based diet indices postdiagnosis with quality of life.

Differential expression of haptoglobin in individuals at clinical high risk of psychosis and its association with global functioning and clinical symptoms.

Background: Immune dysregulation has been observed in patients with schizophrenia or first-episode psychosis, but few have examined dysregulation in those at clinical high-risk (CHR) for psychosis. The aim of this study was to examine whether the peripheral blood-based proteome was dysregulated in those with CHR. Secondly, we examined whether baseline dysregulation was related to current and future functioning and clinical symptoms.

Physicians' Perspectives On FDA Regulation Of Drugs And Medical Devices: A National Survey.

Physicians' knowledge of Food and Drug Administration (FDA) approval processes is important in informing clinical decisions and patient discussions. Among a randomly selected national sample of 509 internists, cardiologists, and oncologists, 41 percent reported moderate or better understanding of the FDA's drug approval process, and 17 percent reported moderate or better understanding of the FDA's medical device approval process. Nearly all physicians thought that randomized, blinded trials that met primary endpoints should be very important factors required to secure regulatory approval.

Brain energy metabolism: A roadmap for future research.

Although we have learned much about how the brain fuels its functions over the last decades, there remains much still to discover in an organ that is so complex. This article lays out major gaps in our knowledge of interrelationships between brain metabolism and brain function, including biochemical, cellular, and subcellular aspects of functional metabolism and its imaging in adult brain, as well as during development, aging, and disease. The focus is on unknowns in metabolism of major brain substrates and associated transporters, the roles of insulin and of lipid droplets, the emerging role of metabolism in microglia, mysteries about the major brain cofactor and signaling molecule NAD, as well as unsolved problems underlying brain metabolism in pathologies such as traumatic brain injury, epilepsy, and metabolic downregulation during hibernation.

Studies Of Prescription Digital Therapeutics Often Lack Rigor And Inclusivity.

Little is known about the evidence to support prescription digital therapeutics, which are digital tools that rely primarily on software for diagnosis or treatment that have indications for use regulated by the Food and Drug Administration (FDA) and require a clinician's prescription. We conducted the first retrospective cross-sectional analysis of clinical studies of twenty prescription digital therapeutics authorized by the FDA and available on the market as of November 2022. Our analysis found that just two prescription digital therapeutics had been evaluated in at least one study that was randomized and blinded and that used other rigorous standards of evidence.

Screening for lung cancer: 2023 guideline update from the American Cancer Society.

Lung cancer is the leading cause of mortality and person-years of life lost from cancer among US men and women. Early detection has been shown to be associated with reduced lung cancer mortality. Our objective was to update the American Cancer Society (ACS) 2013 lung cancer screening (LCS) guideline for adults at high risk for lung cancer.

Association of Childhood Area-Level Ethnic Density and Psychosis Risk Among Ethnoracial Minoritized Individuals in the US.

Importance: The protective ethnic density effect hypothesis, which suggests that minoritized individuals who grow up in neighborhoods with a high proportion of ethnoracial minoritized groups are protected from the effects of perceived discrimination, has not been examined among individuals at clinical high risk of psychosis (CHR-P). This level of examination may help identify intervention targets for preventing psychosis among high-risk individuals.

Objective: To examine the association between area-level ethnic density during childhood, perceived discrimination, and psychosis risk outcomes among ethnoracial minoritized individuals with CHR-P.

Associations between childhood ethnoracial minority density, cortical thickness, and social engagement among minority youth at clinical high-risk for psychosis.

An ethnoracial minority density (EMD) effect in studies of psychotic spectrum disorders has been observed, whereby the risk of psychosis in ethnoracial minority group individuals is inversely related to the proportion of minorities in their area of residence. The authors investigated the relationships among area-level EMD during childhood, cortical thickness (CT), and social engagement (SE) in clinical high risk for psychosis (CHR-P) youth. Data were collected as part of the North American Prodrome Longitudinal Study.

Associations Between Childhood Area-Level Social Fragmentation, Maladaptation to School, and Social Functioning Among Healthy Youth and Those at Clinical High Risk for Psychosis.

Background And Hypothesis: Although studies have identified social fragmentation as an important risk factor for schizophrenia and other psychotic disorders, it is unknown whether it may impact social functioning. This study investigates whether social fragmentation during childhood predicts maladaptation to school as well as social functioning during childhood and adulthood.

Study Design: Data were collected from the North American Prodrome Longitudinal Study.

Clinically important change on the Unified Dyskinesia Rating Scale among patients with Parkinson's disease experiencing dyskinesia.

Background: The Unified Dyskinesia Rating Scale (UDysRS) evaluates dyskinesia in patients with Parkinson's disease (PD). A minimal clinically important change (MCIC)-the smallest change in a treatment outcome that a patient considers important-remains undefined for the UDysRS.

Objective: To utilize pivotal amantadine delayed-release/extended-release (DR/ER) trial data to derive MCICs for the UDysRS total score in patients with PD experiencing dyskinesia.