An efficient approach to expand equitable access to antiobesity medications: deprescribing after weight loss plateau.

The authors advocate for a consideration of 2 distinct phases of obesity management (ie, active weight loss and maintenance of weight loss) to allow substantially more people access to antiobesity medications.

Cheaper is not always better: Drug shortages in the United States and a value-based solution to alleviate them.

Drug shortages threaten patients' access to medications and are associated with adverse health outcomes and increased costs. Drug shortages disproportionately occur among generic drugs of limited profitability, most notably drugs administered by injection. In this perspective, we discuss how reimbursement and purchasing practices that were meant to create an efficient marketplace for generics have generated strong price pressure that threatens profitability in certain markets. We further explain how, faced with limited profitability, manufacturers lack incentives to invest in resilient supply chains, and in some cases, engage in cost-containment strategies or decide to exit the market, ultimately contributing to shortages. We propose the development and implementation of value-based reimbursement to provide needed incentives for drug purchasers and manufacturers to establish a more reliable supply chain as part of the policy solution to reduce the number and extent of drug shortages. This reimbursement model would necessitate the development of a rating system that measures supply chain resilience and maturity for each generic product. This rating would then be applied as a value-based modifier to reimbursement rates for generic products. The proposed model would result in higher reimbursement rates for generic products from more dependable supply chains, generating incentives for manufacturers to invest in supply chain resiliency. We propose the application of this reimbursement system originally in Medicare given Congressional interest on reforming Medicare payment to prevent drug shortages.

Predeductible Coverage and Receipt of Telemental Health Visits.

This cohort study examines the utilization changes associated with the reintroduction of cost sharing for patients receiving telemental health services.

Out-of-pocket costs for diagnostic testing following abnormal prostate cancer screening among privately insured men.

OBJECTIVE: Prostate cancer is the most common malignancy among men and following a positive prostate-specific antigen (PSA) screening test, patients may undergo more expensive diagnostic testing. However, testing-related out-of-pocket costs (OOPCs), which may preclude patients from completing the screening process, have not been previously quantified. OOPCs for follow-up diagnostic testing (i.e., prostate biopsy and/or magnetic resonance imaging [MRI]) in patients with private insurance undergoing prostate cancer screening were estimated. METHODS: Men ages 55 to 69 years old who underwent PSA-based prostate cancer screening from 2010 to 2020 from the IBM Marketscan database were identified. The number of patients undergoing follow-up diagnostic testing within 12 months of screening was tabulated, dividing patients into three groups: (1) biopsy only, (2) MRI only, and (3) MRI + biopsy. Over the study period, patients with nonzero cost-sharing and calculated inflation-adjusted OOPCs, adding copayment, coinsurance, and deductible payments, for each group were identified. RESULTS: Among screened patients (n = 3,075,841) from 2010 through 2020, 91,850 had a second PSA test and an elevated PSA level, of which 40,329 (43.9%) underwent subsequent diagnostic testing. More than 75% of these patients experienced cost-sharing, and median OOPCs rose substantially over the study period for patients undergoing biopsy only ($79 to $214), MRI only ($81 to $490), and MRI and biopsy ($353 to $620). CONCLUSIONS: OOPCs from diagnostic testing after prostate cancer screening are common and rising. This work aligns with the recent position statement from the American Cancer Society, that payers should eliminate cost-sharing, which may undermine the screening process, for diagnostic testing following cancer screening.

Utilization of low- and high-value health care by individuals with and without cognitive impairment.

OBJECTIVES: Cognitive impairment and dementia have rising prevalence and impact the health care utilization and lives of older adults. Receipt of low-value (LV) care and underutilization of high-value (HV) care by individuals with these cognitive disorders may have negative consequences for patient health, health system efficiency, and societal welfare. Evidence on health care value among cognitively impaired individuals is limited; we thus ascertained receipt of LV and HV health care in older adults with normal cognition, cognitive impairment without dementia (CIND), and dementia. STUDY DESIGN: Retrospective cohort study of Health and Retirement Study data linked to Medicare claims (1996-2018). METHODS: We examined the association between cognitive decline and the receipt of 5 LV and 7 HV services vs individuals with no change in cognition. RESULTS: Receipt of LV care ranged from 4% to 13% regardless of cognitive status. Cognitive decline (from unimpaired to either CIND or dementia) was associated with decreased probability of receipt of 1 LV service (colorectal cancer screening at 85 years and older [5-percentage-point reduction; P = .047]) and 3 HV services (glucose-lowering drugs [7-percentage-point reduction; P = .029], statins [32-percentage-point reduction; P = .045], and antiresorptive therapy [61-percentage-point reduction; P = .019]). CONCLUSIONS: LV service receipt is wasteful and may be harmful, but it was not consistently associated with cognitive status. Lack of HV care for those with cognitive impairment could be a missed opportunity to improve well-being or reduce preventable adverse events. Our results suggest opportunities for improving the quality of care received by all older adults, including those with cognitive impairment.

Reducing low-value care is a feasible approach to enhancing access and affordability of high-value care for older Americans.

The authors advocate for a strategy that reallocates the substantial workforce effort and financial resources currently devoted to low-value care to enhance access and affordability of high-value services.

Impact of racial disparities in follow-up and quality of colonoscopy on colorectal cancer outcomes.

BACKGROUND: The benefits of colorectal cancer (CRC) screening programs rely on completing follow-up colonoscopy when a noncolonoscopy test is abnormal and on quality of colonoscopy screening as measured by the endoscopists' adenoma detection rate. Existing data demonstrate substantially lower follow-up colonoscopy rates and adenoma detection rate for Black Americans than White Americans. However, the contributions of racial differences in follow-up colonoscopy and adenoma detection rate on CRC outcomes have not been rigorously evaluated. METHODS: We used established and validated CRC-Adenoma Incidence and Mortality (CRC-AIM) model as our analysis platform, with inputs from published literature that report lower follow-up colonoscopy rates and adenoma detection rate in Black adults compared with White adults (15% and 10% lower, respectively). We simulated screening with annual fecal immunochemical test, triennial multitarget stool DNA, and colonoscopy every 10 years between ages 45 and 75 years using real-world utilization of the screening modalities vs no screening. We reported lifetime outcomes per 1000 Black adults. RESULTS: Elimination of Black-White disparities in follow-up colonoscopy rates would reduce CRC incidence and mortality by 5.2% and 9.3%, respectively, and improve life-years gained with screening by 3.4%. Elimination of Black-White disparities in endoscopists' adenoma detection rate would reduce CRC incidence and mortality by 9.4% and improve life-years gained by 3.7%. Elimination of both disparities would reduce CRC incidence and mortality by 14.6% and 18.7%, respectively, and improve life-years gained by 7.1%. CONCLUSIONS: This modeling study predicts eliminating racial differences in follow-up colonoscopy rates, and quality of screening colonoscopy would substantially reduce Black-White disparities in CRC incidence and mortality.

Balancing innovation and affordability in anti-obesity medications: the role of an alternative weight-maintenance program.

Despite remarkable clinical advances in highly effective anti-obesity medications, their high price and potential budget impact pose a major challenge in balancing equitable access and affordability. While most attention has been focused on the amount of weight loss achieved, less consideration has been paid to interventions to sustain weight loss after an individual stops losing weight. Using a policy simulation model, we quantified the impact of a weight-maintenance program following the weight-loss plateau from the initial full-dose glucagon-like peptide 1 (GLP-1) receptor agonists or incretin mimetic use. We measured long-term health care savings and the loss of some health benefits (eg, maintenance of weight loss, improvements in cardiometabolic risk factors, and reductions in diabetes and cardiovascular events). Our model suggested that, compared with continuous long-term full-dose GLP-1 receptor agonists or incretin mimetic drugs, the alternative weight-maintenance program would generate slightly fewer clinical benefits while generating substantial savings in lifetime health care spending. Using less expensive and potentially less effective alternative weight-maintenance programs may provide additional headroom to expand access to anti-obesity medications during the active weight-loss phase without increasing total health care spending.

Smarter continuity in an era of expanding challenges in primary care.

If we are to achieve the clinical and economic benefits of primary care and care continuity, the implementation and evaluation of strategies that reward clinicians and patients are warranted.

Shingles Vaccination in Medicare Part D After Inflation Reduction Act Elimination of Cost Sharing.

This cross-sectional study uses data from retail pharmacies to examine shingles vaccine uptake among Medicare Part D beneficiaries following an IRA policy to eliminate cost sharing.

Projected environmental and public health benefits of extended-interval dosing: an analysis of pembrolizumab use in a US national health system.

BACKGROUND: Health care is a major source of greenhouse gas emissions, leading to climate change and public health harms. Changes are needed to improve the environmental sustainability of health-care practices, but such changes should not sacrifice patient outcomes or financial sustainability. Alternative dosing strategies that reduce the frequency with which specialty drugs are administered, without sacrificing patient outcomes, are an attractive possibility for improving environmental sustainability. We sought to inform environmentally sustainable cancer care by estimating and comparing the environmental and financial effects of alternative, clinically equivalent strategies for pembrolizumab administration. METHODS: We conducted a retrospective analysis using a cohort of patients from the Veterans Health Administration (VHA) in the USA who received one or more pembrolizumab doses between May 1, 2020, and Sept 30, 2022. Using baseline, real-world administration of pembrolizumab, we generated simulated pembrolizumab use data under three near-equivalent counterfactual pembrolizumab administration strategies defined by combinations of weight-based dosing, pharmacy-level vial sharing and dose rounding, and extended-interval dosing (ie, every 6 weeks). For each counterfactual dosing strategy, we estimated greenhouse gas emissions related to pembrolizumab use across the VHA cohort using a deterministic environmental impact model that estimated greenhouse gas emissions due to patient travel, drug manufacture, and medical waste as the primary outcome measure. FINDINGS: We identified 7813 veterans who received at least one dose of pembrolizumab-containing therapy in the VHA during the study period. 59 140 pembrolizumab administrations occurred in the study period, of which 46 255 (78·2%) were dosed at 200 mg every 3 weeks, 12 885 (21·8%) at 400 mg every 6 weeks, and 14 955 (25·3%) were coadministered with infusional chemotherapies. Adoption of weight-based, extended-interval pembrolizumab dosing (4 mg/kg every 6 weeks) and pharmacy-level stewardship strategies (ie, dose rounding and vial sharing) for all pembrolizumab infusions would have resulted in 24·7% fewer administration events than baseline dosing (44 533 events vs 59 140 events) and an estimated 200 metric tons less CO2 emitted per year as a result of pembrolizumab use within the VHA (650 tons vs 850 tons of CO2, a relative reduction of 24%), largely due to reductions in distance travelled by patients to receive treatment. Similar results were observed when weight-based and extended-interval dosing were applied only to pembrolizumab monotherapy and pembrolizumab in combination with oral therapies. INTERPRETATION: Alternative pembrolizumab administration strategies might have environmental advantages over the current dosing and compounding paradigms. Specialty medication dosing can be optimised for health-care spending and environmental sustainability without sacrificing clinical outcomes. FUNDING: None.

Estimated impact and value of blood-based colorectal cancer screening at varied adherence compared with stool-based screening.

OBJECTIVE: This analysis estimated the outcomes of triennial blood-based colorectal cancer (CRC) screening at various adherence, including perfect adherence, compared with triennial multi-target stool DNA (mt-sDNA) screening at the reported real-world adherence rate. METHODS: The validated CRC-AIM model simulated a US cohort of average-risk individuals receiving triennial screening with mt-sDNA or blood-based test from ages 45 to 75 years. Modeled specificity and sensitivity were based on reported data. Adherence was set at a real-world rate of 65.6% for mt-sDNA and at 65.6%, relative 10% incremental increases from 65.6%, or 100% for the blood-based test. Costs of mt-sDNA and the blood-based test were based on prices for clinically available tests ($508.87 and $895, respectively). Value-based pricing was estimated at a willingness-to-pay threshold of $100,000. RESULTS: Both tests resulted in life-years gained (LYG), reduced CRC cases, and reduced deaths versus no screening. With adherence for mt-sDNA set at 65.6% and for blood-based test set at 100%, mt-sDNA resulted in 30% more LYG, 52% more averted CRC cases, and 32% more averted CRC deaths. At reported sensitivity and specificity rates, mt-sDNA at 65.6% adherence dominates (is more effective and less costly) the blood-based test at any adherence. There was no price at which triennial screening with the blood-based test at any adherence was cost-effective compared with mt-sDNA at 65.6% adherence. CONCLUSIONS: Triennial screening with mt-sDNA resulted in better clinical outcomes at a lower cost compared with the modeled blood-based test even at perfect adherence, supporting application of blood-based tests only as a secondary screening option.

Blood-based colorectal cancer screening has lower diagnostic accuracy, lower clinical and health outcomes, and is more expensive than mt-sDNA, even with perfect blood-based screening participation. Although better than no screening at all, blood-based testing is unlikely to exceed performance of stool-based assessment unless a blood-based test is able to meaningfully detect precancerous growths.

Application of Time-Driven Activity-Based Costing for Head and Neck Microvascular Free Flap Reconstruction.

OBJECTIVE: Traditional hospital accounting fails to provide an accurate cost of complex surgical care. Here we describe the application of time-driven activity-based costing (TDABC) to characterize costs of head and neck oncologic procedures involving free tissue transfer. STUDY DESIGN: Retrospective cohort study. SETTING: Single tertiary academic medical center. METHODS: An analysis of head and neck oncologic procedures involving microvascular free flap reconstruction from 2018 to 2020 (n = 485) was performed using TDABC methodology to measure cost across operative case and postoperative admission, using quantity of time and cost per unit of each resource to characterize resource utilization. Univariate and generalized linear mixed models were used to examine associations between patient and hospital characteristics and cost of care delivery. RESULTS: The total cost of care delivery was $41,905.77 ± 21,870.27 with operating room (OR) supplies accounting for only 10% of the total cost. Multivariable analyses identified significant cost drivers including operative time, postoperative length of stay, number of return trips to the OR, postoperative complication, number of free flaps performed, and patient transfer from another hospital or via emergency department admission (P < .05). CONCLUSION: Operative time and postoperative length of stay, but not operative supplies, were primary drivers of cost of care for head and neck oncology cases involving free tissue transfer. TDABC offers granular cost characterization to inform cost optimization through unused capacity identification and postoperative admission efficiencies.

Estimated Average-Risk Colorectal Cancer Screening-Eligible Population in the US.

This cross-sectional study estimates the number of average-risk colorectal cancer screening­eligible individuals in the US since the US Preventive Services Task Force updated its recommendations in 2021.

Lives Saved Through Increasing Adherence to Follow-Up After Abnormal Cervical Cancer Screening Results.

OBJECTIVE: To model the potential number of cancers prevented and life-years saved over a range of adherence rates to cervical cancer screening, surveillance follow-up, and follow-up colposcopy that may result from removing financial barriers to these essential clinical services. METHODS: A previously validated decision-analytic Markov microsimulation model was used to evaluate the increase in adherence to screening, surveillance, and colposcopy after an abnormal cervical cancer screening result. For each incremental increase in adherence, we modeled the number of cervical cancer cases avoided, the stages at which the cancers were detected, the number of cervical cancer deaths avoided, and the number of life-years gained. RESULTS: Compared with current adherence rates, the model estimated that an optimized scenario of perfect screening, surveillance, and colposcopy adherence per 100,000 women currently eligible for screening in the United States was 128 (95% CI, 66-199) fewer cervical cancers detected (23%), 62 (95% CI, 7-120) fewer cervical cancer deaths (20%), and 2,135 (95% CI, 1,363-3,057) more life-years saved. Sensitivity analysis revealed that any increase in adherence led to clinically meaningful health benefits. CONCLUSION: The consequences of not attending routine screening or follow-up after an abnormal cervical cancer screening result are associated with preventable cervical cancer morbidity and premature mortality. Given the potential for the removal of consumer cost sharing to increase the use of necessary follow-up after abnormal screening results and to ultimately reduce cervical cancer morbidity and mortality, public and private payers should remove cost barriers to these essential services.

Episode-Based Cost Sharing to Prospectively Guarantee Patients' Out-of-Pocket Costs.

This Viewpoint proposes episode-based cost sharing as a way to prospectively guarantee out-of-pocket costs for patients while also preventing insurers from absorbing cost differentials created by unexpected complications of care.

Addressing patients' unmet social needs: checklists are a means, trust is foundational.

Identifying and addressing unmet social needs without attention to other contributors to health inequities-such as medical mistrust-is unlikely to yield desired outcomes.

Expanding the Catalog of Patient and Caregiver Out-of-Pocket Costs: A Systematic Literature Review.

Out-of-pocket (OOP) health care expenditures in the United States have increased significantly in the past 5 decades. Most research on OOP costs focuses on expenditures related to insurance and cost-sharing payments or on costs related to specific conditions or settings, and does not capture the full picture of the financial burden on patients and unpaid caregivers. The aim for this systematic literature review was to identify and categorize the multitude of OOP costs to patients and unpaid caregivers, aid in the development of a more comprehensive catalog of OOP costs, and highlight potential gaps in the literature. The authors found that OOP costs are multifarious and underestimated. Across 817 included articles, the authors identified 31 subcategories of OOP costs related to direct medical (eg, insurance premiums), direct nonmedical (eg, transportation), and indirect spending (eg, absenteeism). In addition, 42% of articles studied an expenditure that the authors did not label as "OOP." A holistic and comprehensive catalog of OOP costs can inform future research, interventions, and policies related to financial barriers to health care in the United States to ensure the full range of costs for patients and unpaid caregivers are acknowledged and addressed.

Developing an electronic health record measure of low-value esophagogastroduodenoscopy for GERD at a large academic health system.

OBJECTIVES: Low-value esophagogastroduodenoscopies (EGDs) for uncomplicated gastro-oesophageal reflux disease (GERD) can harm patients and raise patient and payer costs. We developed an electronic health record (EHR) 'eMeasure' to detect low-value EGDs. DESIGN: Retrospective cohort of 518 adult patients diagnosed with GERD who underwent initial EGD between 1 January 2019 and 31 December 2019. SETTING: Outpatient primary care and gastroenterology clinics at a large, urban, academic health centre. PARTICIPANTS: Adult primary care patients at the University of California Los Angeles who underwent initial EGD for GERD in 2019. MAIN OUTCOME MEASURES: EGD appropriateness criteria were based on the American College of Gastroenterology 2012 guidelines. An initial EGD was considered low-value if it lacked a documented guideline-based indication, including alarm symptoms (eg, iron-deficiency anaemia); failure of an 8-week proton pump inhibitor trial or elevated Barrett's oesophagus risk. We performed manual chart review on a random sample of 204 patients as a gold standard of the eMeasure's validity. We estimated EGD costs using Medicare physician and facility fee rates. RESULTS: Among 518 initial EGDs performed (mean age 53 years; 54% female), the eMeasure identified 81 (16%) as low-value. The eMeasure's sensitivity was 42% (95% CI 22 to 61) and specificity was 93% (95% CI 89 to 96). Stratifying across clinics, 62 (74.6%) low-value EGDs originated from 2 (12.5%) out of 16 clinics. Total cost for 81 low-value EGDs was approximately US$75 573, including US$14 985 in patients' out-of-pocket costs. CONCLUSIONS: We developed a highly specific eMeasure that showed that low-value EGDs occurred frequently in our healthcare system and were concentrated in a minority of clinics. These results can inform future QI efforts at our institution, such as best practice alerts for the ordering physician. Moreover, this open-source eMeasure has a much broader potential impact, as it can be integrated into any EHR and improve medical decision-making at the point of care.