Care cascades following low-value cervical cancer screening in dually enrolled Veterans.

BACKGROUND: Veterans dually enrolled in the Veterans Health Administration (VA) and Medicare commonly experience downstream services as part of a care cascade after an initial low-value service. Our objective was to characterize the frequency and cost of low-value cervical cancer screening and subsequent care cascades among Veterans dually enrolled in VA and Medicare. METHODS: This retrospective cohort study used VA and Medicare administrative data from fiscal years 2015 to 2019. The study cohort was comprised of female Veterans aged >65 years and at low risk of cervical cancer who were dually enrolled in VA and Medicare. Within this cohort, we compared differences in the rates and costs of cascade services related to low-value cervical cancer screening for Veterans who received and did not receive screening in FY2018, adjusting for baseline patient- and facility-level covariates using inverse probability of treatment weighting. RESULTS: Among 20,972 cohort-eligible Veterans, 494 (2.4%) underwent low-value cervical cancer screening with 301 (60.9%) initial screens occurring in VA and 193 (39%) occurring in Medicare. Veterans who were screened experienced an additional 26.7 (95% CI, 16.4-37.0) cascade services per 100 Veterans compared to those who were not screened, contributing to $2919.4 (95% CI, -265 to 6104.7) per 100 Veterans in excess costs. Care cascades consisted predominantly of subsequent cervical cancer screening procedures and related outpatient visits with low rates of invasive procedures and occurred in both VA and Medicare. CONCLUSIONS: Veterans dually enrolled in VA and Medicare commonly receive related downstream tests and visits as part of care cascades following low-value cervical cancer screening. Our findings demonstrate that to fully capture the extent to which individuals are subject to low-value care, it is important to examine downstream care stemming from initial low-value services across all systems from which individuals receive care.

A Retrospective Cohort Study of the 2018 Angiotensin Receptor Blocker Recalls and Subsequent Drug Shortages in Patients With Hypertension.

BACKGROUND: Valsartan was recalled by the US Food and Drug Administration in July 2018 for carcinogenic impurities, resulting in a drug shortage and management challenges for valsartan users. The influence of the valsartan recall on clinical outcomes is unknown. We compared the risk of adverse events between hypertensive patients using valsartan and a propensity score-matched group using nonrecalled angiotensin receptor blockers and angiotensin-converting enzyme inhibitors. METHODS AND RESULTS: We used Optum's deidentified Clinformatics Datamart (July 2017-January 2019). Hypertensive patients who received valsartan or nonrecalled angiotensin receptor blockers/angiotensin-converting enzyme inhibitors for 1 year before and on the recall date were compared. Primary outcomes were measured in the 6 months following the recall and included: (1) a composite measure of all-cause hospitalization, all-cause emergency department visit, and all-cause urgent care visit, and (2) a composite cardiac event measure of hospitalizations for acute myocardial infarction and hospitalizations/emergency department visits/urgent care visits for stroke/transient ischemic attack, heart failure, or hypertension. We compared the risk of outcomes between treatment groups using Cox proportional hazard models. Of the hypertensive patients, 76 934 received valsartan, and 509 472 received a nonrecalled angiotensin receptor blocker/angiotensin-converting enzyme inhibitor. Valsartan use at the time of recall was associated with a higher risk of all-cause hospitalization, emergency department use, or urgent care use (hazard ratio [HR], 1.02 [95% CI, 1.00-1.04]) and the composite of cardiac events (HR, 1.22 [95% CI, 1.15-1.29]) within 6 months after the recall. CONCLUSIONS: The valsartan recall and shortage affected hypertensive patients. Local- and national-level systems need to be enhanced to protect patients from drug shortages by providing safe and reliable medication alternatives.

Prevalence and Cost of Care Cascades Following Low-Value Preoperative Electrocardiogram and Chest Radiograph Within the Veterans Health Administration.

BACKGROUND: Low-value care cascades, defined as the receipt of downstream health services potentially related to a low-value service, can result in harm to patients and wasteful healthcare spending, yet have not been characterized within the Veterans Health Administration (VHA). OBJECTIVE: To examine if the receipt of low-value preoperative testing is associated with greater utilization and costs of potentially related downstream health services in Veterans undergoing low or intermediate-risk surgery. DESIGN: Retrospective cohort study using VHA administrative data from fiscal years 2017-2018 comparing Veterans who underwent low-value preoperative electrocardiogram (EKG) or chest radiograph (CXR) with those who did not. PARTICIPANTS: National cohort of Veterans at low risk of cardiopulmonary disease undergoing low- or intermediate-risk surgery. MAIN MEASURES: Difference in rate of receipt and attributed cost of potential cascade services in Veterans who underwent low-value preoperative testing compared to those who did not KEY RESULTS: Among 635,824 Veterans undergoing low-risk procedures, 7.8% underwent preoperative EKG. Veterans who underwent a preoperative EKG experienced an additional 52.4 (95% CI 47.7-57.2) cascade services per 100 Veterans, resulting in $138.28 (95% CI 126.19-150.37) per Veteran in excess costs. Among 739,005 Veterans undergoing low- or intermediate-risk surgery, 3.9% underwent preoperative CXR. These Veterans experienced an additional 61.9 (95% CI 57.8-66.1) cascade services per 100 Veterans, resulting in $152.08 (95% CI $146.66-157.51) per Veteran in excess costs. For both cohorts, care cascades consisted largely of repeat tests, follow-up imaging, and follow-up visits, with low rates invasive services. CONCLUSIONS: Among a national cohort of Veterans undergoing low- or intermediate-risk surgeries, low-value care cascades following two routine low-value preoperative tests are common, resulting in greater unnecessary care and costs beyond the initial low-value service. These findings may guide de-implementation policies within VHA and other integrated healthcare systems that target those services whose downstream effects are most prevalent and costly.

Assessment of Care Cascades Following Low-Value Prostate-Specific Antigen Testing Among Veterans Dually Enrolled in the US Veterans Health Administration and Medicare Systems.

Importance: Older US veterans commonly receive health care outside of the US Veterans Health Administration (VHA) through Medicare, which may increase receipt of low-value care and subsequent care cascades. Objective: To characterize the frequency, cost, and source of low-value prostate-specific antigen (PSA) testing and subsequent care cascades among veterans dually enrolled in the VHA and Medicare and to determine whether receiving a PSA test through the VHA vs Medicare is associated with more downstream services. Design, Setting, and Participants: This retrospective cohort study used VHA and Medicare administrative data from fiscal years (FYs) 2017 to 2018. The study cohort consisted of male US veterans dually enrolled in the VHA and Medicare who were aged 75 years or older without a history of prostate cancer, elevated PSA, prostatectomy, radiation therapy, androgen deprivation therapy, or a urology visit. Data were analyzed from December 15, 2020, to October 20, 2022. Exposures: Receipt of low-value PSA testing. Main Outcomes and Measures: Differences in the use and cost of cascade services occurring 6 months after receipt of a low-value PSA test were assessed for veterans who underwent low-value PSA testing in the VHA and Medicare compared with those who did not, adjusted for patient- and facility-level covariates. Results: This study included 300 393 male US veterans at risk of undergoing low-value PSA testing. They had a mean (SD) age of 82.6 (5.6) years, and the majority (264 411 [88.0%]) were non-Hispanic White. Of these veterans, 36 459 (12.1%) received a low-value PSA test through the VHA, which was associated with 31.2 (95% CI, 29.2 to 33.2) additional cascade services per 100 veterans and an additional $24.5 (95% CI, $20.8 to $28.1) per veteran compared with the control group. In the same cohort, 17 981 veterans (5.9%) received a PSA test through Medicare, which was associated with 39.3 (95% CI, 37.2 to 41.3) additional cascade services per 100 veterans and an additional $35.9 (95% CI, $31.7 to $40.1) per veteran compared with the control group. When compared directly, veterans who received a PSA test through Medicare experienced 9.9 (95% CI, 9.7 to 10.1) additional cascade services per 100 veterans compared with those who underwent testing within the VHA. Conclusions and Relevance: The findings of this cohort study suggest that US veterans dually enrolled in the VHA and Medicare commonly experienced low-value PSA testing and subsequent care cascades through both systems in FYs 2017 and 2018. Care cascades occurred more frequently through Medicare compared with the VHA. These findings suggest that low-value PSA testing has substantial downstream implications for patients and may be especially challenging to measure when care occurs in multiple health care systems.

Use and Cost of Low-Value Health Services Delivered or Paid for by the Veterans Health Administration.

Importance: Within the Veterans Health Administration (VA), the use and cost of low-value services delivered by VA facilities or increasingly by VA Community Care (VACC) programs have not been comprehensively quantified. Objective: To quantify veterans' overall use and cost of low-value services, including VA-delivered care and VA-purchased community care. Design, Setting, and Participants: This cross-sectional study assessed a national population of VA-enrolled veterans. Data on enrollment, sociodemographic characteristics, comorbidities, and health care services delivered by VA facilities or paid for by the VA through VACC programs were compiled for fiscal year 2018 from the VA Corporate Data Warehouse. Data analysis was conducted from April 2020 to January 2022. Main Outcomes and Measures: VA administrative data were applied using an established low-value service metric to quantify the use of 29 potentially low-value tests and procedures delivered in VA facilities and by VACC programs across 6 domains: cancer screening, diagnostic and preventive testing, preoperative testing, imaging, cardiovascular testing and procedures, and other procedures. Sensitive and specific criteria were used to determine the low-value service counts per 100 veterans overall, by domain, and by individual service; count and percentage of each low-value service delivered by each setting; and estimated cost of each service. Results: Among 5.2 million enrolled veterans, the mean (SD) age was 62.5 (16.0) years, 91.7% were male, 68.0% were non-Hispanic White, and 32.3% received any service through VACC. By specific criteria, 19.6 low-value services per 100 veterans were delivered in VA facilities or by VACC programs, involving 13.6% of veterans at a total cost of $205.8 million. Overall, the most frequently delivered low-value service was prostate-specific antigen testing for men aged 75 years or older (5.9 per 100 veterans); this was also the service with the greatest proportion delivered by VA facilities (98.9%). The costliest low-value services were spinal injections for low back pain ($43.9 million; 21.4% of low-value care spending) and percutaneous coronary intervention for stable coronary disease ($36.8 million; 17.9% of spending). Conclusions and Relevance: This cross-sectional study found that among veterans enrolled in the VA, more than 1 in 10 have received a low-value service from VA facilities or VACC programs, with approximately $200 million in associated costs. Such information on the use and costs of low-value services are essential to guide the VA's efforts to reduce delivery and spending on such care.

Development of a Metric to Detect and Decrease Low-Value Prescribing in Older Adults.

Importance: Metrics that detect low-value care in common forms of health care data, such as administrative claims or electronic health records, primarily focus on tests and procedures but not on medications, representing a major gap in the ability to systematically measure low-value prescribing. Objective: To develop a scalable and broadly applicable metric that contains a set of quality indicators (EVOLV-Rx) for use in health care data to detect and reduce low-value prescribing among older adults and that is informed by diverse stakeholders' perspectives. Design, Setting, and Participants: This qualitative study used an online modified-Delphi method to convene an expert panel of 15 physicians and pharmacists. This panel, comprising clinicians, health system leaders, and researchers, was tasked with rating and discussing candidate low-value prescribing practices that were derived from medication safety criteria; peer-reviewed literature; and qualitative studies of patient, caregiver, and physician perspectives. The RAND ExpertLens online platform was used to conduct the activities of the panel. The panelists were engaged for 3 rounds between January 1 and March 31, 2021. Main Outcomes and Measures: Panelists used a 9-point Likert scale to rate and then discuss the scientific validity and clinical usefulness of the criteria to detect low-value prescribing practices. Candidate low-value prescribing practices were rated as follows: 1 to 3, indicating low validity or usefulness; 3.5 to 6, uncertain validity or usefulness; and 6.5 to 9, high validity or usefulness. Agreement among panelists and the degree of scientific validity and clinical usefulness were assessed using the RAND/UCLA (University of California, Los Angeles) Appropriateness Method. Results: Of the 527 low-value prescribing recommendations identified, 27 discrete candidate low-value prescribing practices were considered for inclusion in EVOLV-Rx. After round 1, 18 candidate practices were rated by the panel as having high scientific validity and clinical usefulness (scores of ≥6.5). After round 2 panel deliberations, the criteria to detect 19 candidate practices were revised. After round 3, 18 candidate practices met the inclusion criteria, receiving final median scores of 6.5 or higher for both scientific validity and clinical usefulness. Of those practices that were not included in the final version of EVOLV-Rx, 3 received high scientific validity (scores ≥6.5) but uncertain clinical usefulness (scores <6.5) ratings, whereas 6 received uncertain scientific validity rating (scores <6.5). Conclusions and Relevance: This study culminated in the development of EVOLV-Rx and involved a panel of experts who identified the 18 most salient low-value prescribing practices in the care of older adults. Applying EVOLV-Rx may enhance the detection of low-value prescribing practices, reduce polypharmacy, and enable older adults to receive high-value care across the full spectrum of health services.

Dosing profiles of concurrent opioid and benzodiazepine use associated with overdose risk among US Medicare beneficiaries: group-based multi-trajectory models.

BACKGROUND AND AIMS: One-third of opioid (OPI) overdose deaths involve concurrent benzodiazepine (BZD) use. Little is known about concurrent opioid and benzodiazepine use (OPI-BZD) most associated with overdose risk. We aimed to examine associations between OPI-BZD dose and duration trajectories, and subsequent OPI or BZD overdose in US Medicare. DESIGN: Retrospective cohort study. SETTING: US Medicare. PARTICIPANTS: Using a 5% national Medicare data sample (2013-16) of fee-for-service beneficiaries without cancer initiating OPI prescriptions, we identified 37 879 beneficiaries (age ≥ 65 = 59.3%, female = 71.9%, white = 87.6%, having OPI overdose = 0.3%). MEASUREMENTS: During the 6 months following OPI initiation (i.e. trajectory period), we identified OPI-BZD dose and duration patterns using group-based multi-trajectory models, based on average daily morphine milligram equivalents (MME) for OPIs and diazepam milligram equivalents (DME) for BZDs. To label dose levels in each trajectory, we defined OPI use as very low (< 25 MME), low (25-50 MME), moderate (51-90 MME), high (91-150 MME) and very high (>150 MME) dose. Similarly, we defined BZD use as very low (< 10 DME), low (10-20 DME), moderate (21-40 DME), high (41-60 DME) and very high (> 60 DME) dose. Our primary analysis was to estimate the risk of time to first hospital or emergency department visit for OPI overdose within 6 months following the trajectory period using inverse probability of treatment-weighted Cox proportional hazards models. FINDINGS: We identified nine distinct OPI-BZD trajectories: group A: very low OPI (early discontinuation)-very low declining BZD (n = 10 598; 28.0% of the cohort); B: very low OPI (early discontinuation)-very low stable BZD (n = 4923; 13.0%); C: very low OPI (early discontinuation)-medium BZD (n = 4997; 13.2%); D: low OPI-low BZD (n = 5083; 13.4%); E: low OPI-high BZD (n = 3906; 10.3%); F: medium OPI-low BZD (n = 3948; 10.4%); G: very high OPI-high BZD (n = 1371; 3.6%); H: very high OPI-very high BZD (n = 957; 2.5%); and I: very high OPI-low BZD (n = 2096; 5.5%). Compared with group A, five trajectories (32.3% of the study cohort) were associated with increased 6-month OPI overdose risks: E: low OPI-high BZD [hazard ratio (HR) = 3.27, 95% confidence interval (CI) = 1.61-6.63]; F: medium OPI-low BZD (HR = 4.04, 95% CI = 2.06-7.95); G: very high OPI-high BZD (HR = 6.98, 95% CI = 3.11-15.64); H: very high OPI-very high BZD (HR = 4.41, 95% CI = 1.51-12.85); and I: very high OPI-low BZD (HR = 6.50, 95% CI = 3.15-13.42). CONCLUSIONS: Patterns of concurrent opioid and benzodiazepine use most associated with overdose risk among fee-for-service US Medicare beneficiaries initiating opioid prescriptions include very high-dose opioid use (MME > 150), high-dose benzodiazepine use (DME > 40) or medium-dose opioid with low-dose benzodiazepine use.

Primary care physicians' approaches to low-value prescribing in older adults: a qualitative study.

BACKGROUND: Low-value prescribing may result in adverse patient outcomes and increased medical expenditures. Clinicians' baseline strategies for navigating patient encounters involving low-value prescribing remain poorly understood, making it challenging to develop acceptable deprescribing interventions. Our objective was to characterize primary care physicians' (PCPs) approaches to reduce low-value prescribing in older adults through qualitative analysis of clinical scenarios. METHODS: As part of an overarching qualitative study on low-value prescribing, we presented two clinical scenarios involving potential low-value prescribing during semi-structured interviews of 16 academic and community PCPs from general internal medicine, family medicine and geriatrics who care for patients aged greater than or equal to 65. We conducted a qualitative analysis of their responses to identify salient themes related to their approaches to prescribing, deprescribing, and meeting patients' expectations surrounding low-value prescribing. RESULTS: We identified three key themes. First, when deprescribing, PCPs were motivated by their desire to mitigate patient harms and follow medication safety and deprescribing guidelines. Second, PCPs emphasized good communication with patients when navigating patient encounters related to low-value prescribing; and third, while physicians emphasized the importance of shared decision-making, they prioritized patients' well-being over satisfying their expectations. CONCLUSIONS: When presented with real-life clinical scenarios, PCPs in our cohort sought to reduce low-value prescribing in a guideline-concordant fashion while maintaining good communication with their patients. This was driven primarily by a desire to minimize the potential for harm. This suggests that barriers other than clinician knowledge may be driving ongoing use of low-value medications in clinical practice.

Prescriber perspectives on low-value prescribing: A qualitative study.

BACKGROUND: Health systems are increasingly implementing interventions to reduce older patients' use of low-value medications. However, prescribers' perspectives on medication value and the acceptability of interventions to reduce low-value prescribing are poorly understood. OBJECTIVE: To identify the characteristics that affect the value of a medication and those factors influencing low-value prescribing from the perspective of primary care physicians. DESIGN: Qualitative study using semi-structured interviews. SETTING: Academic and community primary care practices within University of Pittsburgh Medical Center health system. PARTICIPANTS: Sixteen primary care physicians. MEASUREMENTS: We elicited 16 prescribers' perspectives on definitions and examples of low-value prescribing in older adults, the factors that incentivize them to engage in such prescribing, and the characteristics of interventions that would make them less likely to engage in low-value prescribing. RESULTS: We identified three key themes. First, prescribers viewed low-value prescribing among older adults as common, characterized both by features of the medications themselves and of the particular patients to whom they were prescribed. Second, prescribers described the causes of low-value prescribing as multifactorial, with factors related to patients, prescribers, and the health system as a whole, making low-value prescribing a default practice pattern. Third, interventions addressing low-value prescribing must minimize the cognitive load and time pressures that make low-value prescribing common. Interventions increasing time pressure or cognitive load, such as increased documentation, were considered less acceptable. CONCLUSIONS: Our findings demonstrate that low-value prescribing is a well-recognized phenomenon, and that interventions to reduce low-value prescribing must consider physicians' perspectives and address the specific patient, prescriber and health system factors that make low-value prescribing a default practice.

Source of Post-Transplant Care and Mortality among Kidney Transplant Recipients Dually Enrolled in VA and Medicare.

BACKGROUND AND OBJECTIVES: Many kidney transplant recipients enrolled in the Veterans Health Administration are also enrolled in Medicare and eligible to receive both Veterans Health Administration and private sector care. Where these patients receive transplant care and its association with mortality are unknown. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We conducted a retrospective cohort study of veterans who underwent kidney transplantation between 2008 and 2016 and were dually enrolled in Veterans Health Administration and Medicare at the time of surgery. We categorized patients on the basis of the source of transplant-related care (i.e., outpatient transplant visits, immunosuppressive medication prescriptions, calcineurin inhibitor measurements) delivered during the first year after transplantation defined as Veterans Health Administration only, Medicare only (i.e., outside Veterans Health Administration using Medicare), or dual care (mixed use of Veterans Health Administration and Medicare). Using multivariable Cox regression, we examined the independent association of post-transplant care source with mortality at 5 years after kidney transplantation. RESULTS: Among 6206 dually enrolled veterans, 975 (16%) underwent transplantation at a Veterans Health Administration hospital and 5231 (84%) at a non-Veterans Health Administration hospital using Medicare. Post-transplant care was received by 752 patients (12%) through Veterans Health Administration only, 2092 (34%) through Medicare only, and 3362 (54%) through dual care. Compared with patients who were Veterans Health Administration only, 5-year mortality was significantly higher among patients who were Medicare only (adjusted hazard ratio, 2.2; 95% confidence interval, 1.5 to 3.1) and patients who were dual care (adjusted hazard ratio, 1.5; 95% confidence interval, 1.1 to 2.1). CONCLUSIONS: Most dually enrolled veterans underwent transplantation at a non-Veterans Health Administration transplant center using Medicare, yet many relied on Veterans Health Administration for some or all of their post-transplant care. Veterans who received Veterans Health Administration-only post-transplant care had the lowest 5-year mortality.

Trends in list prices, net prices, and discounts of self-administered injectable tumor necrosis factor inhibitors.

BACKGROUND: List prices of tumor necrosis factor (TNF) inhibitors drastically increased during the last decade, but previous research has shown that half of these increases were offset by rising manufacturer discounts. It remains unclear to what extent manufacturers' discounts have offset increases in list prices of each self-administered injectable TNF inhibitor. Evaluating trends in net prices and discounts at the product level will be paramount in understanding the role of competition in the biologic market. OBJECTIVES: To (a) describe product-level changes in net prices of each self-administered injectable TNF inhibitor available in 2007-2019 and (b) quantify to what extent manufacturer discounts have offset increases in list prices. METHODS: We obtained 2007-2019 pricing data for etanercept, adalimumab, certolizumab, and golimumab from the investment firm SSR Health, which uses company-reported sales to estimate net prices and discounts for brand products manufactured by publicly traded companies. For each drug and year, we calculated annual costs of treatment for patients with rheumatoid arthritis based on list and net prices and discounts in Medicaid and other payers. RESULTS: From 2007-2019, list prices of etanercept and adalimumab increased by 293% and 295%, respectively; however, discounts offset 47% and 45% of these increases, leading to net price increases of 171% and 203%. List prices of golimumab and certolizumab increased by 183% and 182%, respectively, but with discounts offsetting 58% and 59% of these increases, net prices increased by 103% and 109%. Net prices of golimumab started to decrease after 2016, while net prices of adalimumab and certolizumab experienced their first drop in 2019. Across the study period, discounts in Medicaid and in other payers increased, respectively, from 21% to 85% and 6% to 32% for etanercept; from 26% to 88% and 19% to 35% for adalimumab; from 28% to 63% and 22% to 46% for golimumab; and from 29% to 83% and 27% to 47% for certolizumab. CONCLUSIONS: Despite growing manufacturer discounts, net prices of self-administered injectable TNF inhibitors still increased at a mean annual rate of 9.6% in 2007-2019. This led to net prices tripling for adalimumab and more than doubling for etanercept, golimumab, and certolizumab. DISCLOSURES: This study was funded by the Myers Family Foundation. Hernandez is funded by the National Heart, Lung and Blood Institute (grant number K01HL142847). Funding sources had no role in design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; or decision to submit the manuscript for publication. Hernandez has served on Pfizer's scientific advisory board. The other authors have nothing to disclose.

Evaluation of Low-Value Diagnostic Testing for 4 Common Conditions in the Veterans Health Administration.

Importance: Low-value care is associated with harm among patients and with wasteful health care spending but has not been well characterized in the Veterans Health Administration. Objectives: To characterize the frequency of and variation in low-value diagnostic testing for 4 common conditions at Veterans Affairs medical centers (VAMCs) and to examine the correlation between receipt of low-value testing for each condition. Design, Setting, and Participants: This retrospective cohort study used Veterans Health Administration data from 127 VAMCs from fiscal years 2014 to 2015. Data were analyzed from April 2018 to March 2020. Exposures: Continuous enrollment in Veterans Health Administration during fiscal year 2015. Main Outcomes and Measures: Receipt of low-value testing for low back pain, headache, syncope, and sinusitis. For each condition, sensitive and specific criteria were used to evaluate the overall frequency and range of low-value testing, adjusting for sociodemographic and VAMC characteristics. VAMC-level variation was calculated using median adjusted odds ratios. The Pearson correlation coefficient was used to evaluate the degree of correlation between low-value testing for each condition at the VAMC level. Results: Among 1 022 987 veterans, the mean (SD) age was 60 (16) years, 1 008 336 (92.4%) were male, and 761 485 (69.8%) were non-Hispanic White. A total of 343 024 veterans (31.4%) were diagnosed with low back pain, 79 176 (7.3%) with headache, 23 776 (2.2%) with syncope, and 52 889 (4.8%) with sinusitis. With the sensitive criteria, overall and VAMC-level low-value testing frequency varied substantially across conditions: 4.6% (range, 2.7%-10.1%) for sinusitis, 12.8% (range, 8.6%-22.6%) for headache, 18.2% (range, 10.9%-24.6%) for low back pain, and 20.1% (range, 16.3%-27.7%) for syncope. With the specific criteria, the overall frequency of low-value testing across VAMCs was 2.4% (range, 1.3%-5.1%) for sinusitis, 8.6% (range, 6.2%-14.6%) for headache, 5.6% (range, 3.6%-7.7%) for low back pain, and 13.3% (range, 11.3%-16.8%) for syncope. The median adjusted odds ratio ranged from 1.21 for low back pain to 1.40 for sinusitis. At the VAMC level, low-value testing was most strongly correlated for syncope and headache (ρ = 0.56; P < .001) and low back pain and headache (ρ = 0.48; P < .001). Conclusions and Relevance: In this cohort study, low-value diagnostic testing was common, varied substantially across VAMCs, and was correlated between veterans' receipt of different low-value tests at the VAMC level. The findings suggest a need to address low-value diagnostic testing, even in integrated health systems, with robust utilization management practices.

Using machine learning to predict risk of incident opioid use disorder among fee-for-service Medicare beneficiaries: A prognostic study.

OBJECTIVE: To develop and validate a machine-learning algorithm to improve prediction of incident OUD diagnosis among Medicare beneficiaries with ≥1 opioid prescriptions. METHODS: This prognostic study included 361,527 fee-for-service Medicare beneficiaries, without cancer, filling ≥1 opioid prescriptions from 2011-2016. We randomly divided beneficiaries into training, testing, and validation samples. We measured 269 potential predictors including socio-demographics, health status, patterns of opioid use, and provider-level and regional-level factors in 3-month periods, starting from three months before initiating opioids until development of OUD, loss of follow-up or end of 2016. The primary outcome was a recorded OUD diagnosis or initiating methadone or buprenorphine for OUD as proxy of incident OUD. We applied elastic net, random forests, gradient boosting machine, and deep neural network to predict OUD in the subsequent three months. We assessed prediction performance using C-statistics and other metrics (e.g., number needed to evaluate to identify an individual with OUD [NNE]). Beneficiaries were stratified into subgroups by risk-score decile. RESULTS: The training (n = 120,474), testing (n = 120,556), and validation (n = 120,497) samples had similar characteristics (age ≥65 years = 81.1%; female = 61.3%; white = 83.5%; with disability eligibility = 25.5%; 1.5% had incident OUD). In the validation sample, the four approaches had similar prediction performances (C-statistic ranged from 0.874 to 0.882); elastic net required the fewest predictors (n = 48). Using the elastic net algorithm, individuals in the top decile of risk (15.8% [n = 19,047] of validation cohort) had a positive predictive value of 0.96%, negative predictive value of 99.7%, and NNE of 104. Nearly 70% of individuals with incident OUD were in the top two deciles (n = 37,078), having highest incident OUD (36 to 301 per 10,000 beneficiaries). Individuals in the bottom eight deciles (n = 83,419) had minimal incident OUD (3 to 28 per 10,000). CONCLUSIONS: Machine-learning algorithms improve risk prediction and risk stratification of incident OUD in Medicare beneficiaries.

Changes in List Prices, Net Prices, and Discounts for Branded Drugs in the US, 2007-2018.

Importance: Most studies that have examined drug prices have focused on list prices, without accounting for manufacturer rebates and other discounts, which have substantially increased in the last decade. Objective: To describe changes in list prices, net prices, and discounts for branded pharmaceutical products for which US sales are reported by publicly traded companies, and to determine the extent to which list price increases were offset by increases in discounts. Design, Setting, and Participants: Retrospective descriptive study using 2007-2018 pricing data from the investment firm SSR Health for branded products available before January 2007 with US sales reported by publicly traded companies (n = 602 drugs). Net prices were estimated by compiling company-reported sales for each product and number of units sold in the US. Exposures: Calendar year. Main Outcomes and Measures: Outcomes included list and net prices and discounts in Medicaid and other payers. List prices represent manufacturers' price to wholesalers or direct purchasers but do not account for discounts. Net prices represent revenue per unit of the product after all manufacturer concessions are accounted for (including rebates, coupon cards, and any other discount). Means of outcomes were calculated each year for the overall sample and 6 therapeutic classes, weighting each product by utilization and adjusting for inflation. Results: From 2007 to 2018, list prices increased by 159% (95% CI, 137%-181%), or 9.1% per year, while net prices increased by 60% (95% CI, 36%-84%), or 4.5% per year, with stable net prices between 2015 and 2018. Discounts increased from 40% to 76% in Medicaid and from 23% to 51% for other payers. Increases in discounts offset 62% of list price increases. There was large variability across classes. Multiple sclerosis treatments (n = 4) had the greatest increases in list (439%) and net (157%) prices. List prices of lipid-lowering agents (n = 11) increased by 278% and net prices by 95%. List prices of tumor necrosis factor inhibitors (n = 3) increased by 166% and net prices by 73%. List prices of insulins (n = 7) increased by 262%, and net prices by 51%. List prices of noninsulin antidiabetic agents (n = 10) increased by 165%, and net prices decreased by 1%. List price increases were lowest (59%) for antineoplastic agents (n = 44), but discounts only offset 41% of list price increases, leading to 35% increase in net prices. Conclusions and Relevance: In this analysis of branded drugs in the US from 2007 to 2018, mean increases in list and net prices were substantial, although discounts offset an estimated 62% of list price increases with substantial variation across classes.

Overprescribing of Opioids to Adults by Dentists in the U.S., 2011-2015.

INTRODUCTION: Dentists prescribe 1 in 10 opioid prescriptions in the U.S. When opioids are necessary, national guidelines recommend the prescription of low-dose opioids for a short duration. This study assesses the appropriate prescribing of opioids by dentists before guideline implementation. METHODS: The authors performed a cross-sectional analysis of a population-based sample of 542,958 U.S. commercial dental patient visits between 2011 and 2015 within the Truven Health MarketScan Research Databases (data analysis October 2018‒April 2019). Patients with recent hospitalization, active cancer treatment, or chronic pain conditions were excluded. Prescription opioids were ascertained using pharmacy claims data with standardized morphine equivalents and recorded days' supply. Appropriate prescribing was determined from the 2016 Centers for Disease Control and Prevention guidelines for pain management based on a recommended 3 days' supply of opioid medication and anticipated post-procedural pain. RESULTS: Twenty-nine percent of prescribed opioids exceeded the recommended morphine equivalents for appropriate management of acute pain. Approximately half (53%) exceeded the recommended days' supply. Patients aged 18-34 years, men, patients residing in the Southern U.S., and those receiving oxycodone were most likely to have opioids prescribed inappropriately. The proportion of opioids that exceed the recommended morphine equivalents increased over the study period, whereas opioids exceeding the recommended days' supply remained unchanged. CONCLUSIONS: Between 1 in 4 and 1 in 2 opioids prescribed to adult dental patients are overprescribed. Judicious opioid-prescribing interventions should be tailored to oral health conditions and dentists.

Older Patient and Caregiver Perspectives on Medication Value and Deprescribing: A Qualitative Study.

OBJECTIVES: Shared decision making is essential to deprescribing unnecessary or harmful medications in older adults, yet patients' and caregivers' perspectives on medication value and how this affects their willingness to discontinue a medication are poorly understood. We sought to identify the most significant factors that impact the perceived value of a medication from the perspective of patients and caregivers. DESIGN: Qualitative study using focus groups conducted in September and October 2018. SETTING: Participants from the Pepper Geriatric Research Registry (patients) and the Pitt+Me Registry (caregivers) maintained by the University of Pittsburgh. PARTICIPANTS: Six focus groups of community-dwelling adults aged 65 years or older, or their caregivers, prescribed five or more medications in the preceding 12 months. MEASUREMENTS: We sought to identify (1) general views on medication value and what makes medication worth taking; (2) how specific features such as cost or side effects impact perceived value; and (3) reactions to clinical scenarios related to deprescribing. RESULTS: We identified four themes. Perceived effectiveness was the primary factor that caused participants to consider a medication to be of high value. Participants considered a medication to be of low value if it adversely affected quality of life. Participants also cited cost when determining value, especially if it resulted in material sacrifices. Participants valued medications prescribed by providers with whom they had good relationships rather than valuing level of training. When presented with clinical scenarios, participants ably weighed these factors when determining the value of a medication and indicated whether they would adhere to a deprescribing recommendation. CONCLUSION: We identified that perceived effectiveness, adverse effects on quality of life, cost, and a strong relationship with the prescriber influenced patients' and caregivers' views on medication value. These findings will enable prescribers to engage older patients in shared decision making when deprescribing unnecessary medications and will allow health systems to incorporate patient-centered assessment of value into systems-based deprescribing interventions. J Am Geriatr Soc 68:746-753, 2020.

Incidence and Predictors of Aspirin Discontinuation in Older Adult Veteran Nursing Home Residents at End of Life.

OBJECTIVES: Continuation of aspirin for secondary prevention in persons with limited life expectancy (LLE) is controversial. We sought to determine the incidence and predictors of aspirin discontinuation in veterans with LLE and/or advanced dementia (LLE/AD) who were taking aspirin for secondary prevention at nursing home admission, stratified by whether their limited prognosis (LP) was explicitly documented at admission. DESIGN: Retrospective cohort study using linked Veterans Affairs (VA) and Medicare clinical/administrative data and Minimum Data Set resident assessments. SETTING: All VA nursing homes (referred to as community living centers [CLCs]) in the United States. PARTICIPANTS: Older (≥65 y) CLC residents with LLE/AD, admitted for 7 days or longer in fiscal years 2009 to 2015, who had a history of coronary artery disease and/or stroke/transient ischemic attack, and used aspirin within the first week of CLC admission (n = 13 844). MEASUREMENTS: The primary dependent variable was aspirin discontinuation within the first 90 days after CLC admission, defined as 14 consecutive days of no aspirin receipt. Independent variables included an indicator for explicit documentation of LP, sociodemographics, environment of care characteristics, cardiovascular risk factors, bleeding risk factors, individual markers of poor prognosis (eg, cancer, weight loss), and facility characteristics. Fine and Gray subdistribution hazard models with death as a competing risk were used to assess predictors of discontinuation. RESULTS: Cumulative incidence of aspirin discontinuation was 27% (95% confidence interval [CI] = 26%-28%) in the full sample, 34% (95% CI = 33%-36%) in residents with explicit documentation of LP, and 24% (95% CI = 23%-25%) in residents with no such documentation. The associations of independent variables with aspirin discontinuation differed in residents with vs without explicit LP documentation at admission. CONCLUSION: Just over one-quarter of patients discontinued aspirin, possibly reflecting the unclear role of aspirin in end of life among prescribers. Future research should compare outcomes of aspirin deprescribing in this population. J Am Geriatr Soc 68:725-735, 2020.

Opioid Prescribing Safety Measures in Medicaid Enrollees With and Without Cancer.

INTRODUCTION: Opioid prescribing safety among individuals with cancer is poorly understood. This study estimates the prevalence of Pharmacy Quality Alliance opioid measures among individuals with cancer undergoing or not undergoing active treatment versus those without cancer. METHODS: Pennsylvania Medicaid data (2016) were analyzed in 2018 to identify adults aged 18-64 years with and without cancer diagnoses who had 2 or more opioid prescriptions. Active cancer treatment, defined as having chemotherapy, radiotherapy, cancer surgery, or hospitalization with a primary diagnosis of cancer, was evaluated from October 2015 to December 2016 allowing a ≥3-month look-back period for cancer diagnoses observed in the first quarter of 2016. Opioid dosages (>120 morphine milligram equivalents for ≥90 consecutive days), multiple providers (4 or more prescribers and 4 or more pharmacies), and opioid and benzodiazepines overlapping ≥30 days were evaluated. RESULTS: The sample with opioid prescriptions included 111,491 enrollees without cancer diagnoses and 12,819 with cancer, 58.8% of whom were not in active cancer treatment. Among enrollees undergoing cancer treatment, with cancer but not in active treatment, and without cancer, the prevalence of high morphine milligram equivalents was 7.1%, 6.0%, and 4.7% (p<0.001), respectively. The corresponding prevalence of multiple providers was 6.7%, 4.1%, and 3.4% (p<0.001). Concurrent opioid and benzodiazepine prescriptions occurred in 28.6%, 30.5%, and 26.8% (p<0.001), respectively. CONCLUSIONS: Individuals with cancer, regardless of treatment status, had higher-risk opioid use based on Pharmacy Quality Alliance measures versus those without cancer. Their systematic exclusion from opioid quality surveillance could create missed opportunities to identify patients at high risk of adverse opioid-related outcomes.

Advancing the Science of Deprescribing: A Novel Comprehensive Conceptual Framework.

Polypharmacy is common in older adults and associated with inappropriate medication use, adverse drug events, medication nonadherence, higher costs, and increased mortality compared with those without polypharmacy. Deprescribing, the clinically supervised process of stopping or reducing the dose of medications when they cause harm or no longer provide benefit, may improve outcomes. Although potentially beneficial, clinicians struggle to overcome structural, organizational, technological, and cognitive barriers to deprescribing, limiting its use in clinical practice. Deprescribing science would benefit from a unifying conceptual framework to prioritize research. Current deprescribing conceptual frameworks have made important contributions to the field but often with a focus on specific medication classes or aspects of deprescribing. To further this relatively nascent field, we developed a broader deprescribing conceptual framework that builds on prior frameworks and includes patient, prescriber, and system influences; the process of deprescribing; outcomes; and dissemination. Patient factors include patients' biology, experience, values, and preferences. Prescriber factors include rational (eg, based on explicit knowledge) and nonrational (eg, behavioral tendencies, biases, and heuristics) decision making. System factors include resources, incentives, goals, and culture that contribute to deprescribing. The framework separates the deprescribing decision from the deprescribing process. The framework captures the results of deprescribing by examining changes in clinical structures, performance processes, patient experience, health outcomes, and cost. Through testing and refinement, this novel, more comprehensive conceptual framework has the potential to advance deprescribing research by organizing the existing evidence, identifying evidence gaps, and categorizing deprescribing interventions and the settings in which they are applied. J Am Geriatr Soc 67:2018-2022, 2019.