UNASSIGNED: Annual Chinese National negotiations for including innovative drugs in the National Reimbursement Drug List (NRDL) reveal an increasing number of new drugs with overlapping action mechanisms of action and similar indications. Yet, it is unclear if competition affects reimbursement decisions. Thus, we explored the impact of competition on reimbursement decisions for cancer drugs in China.
UNASSIGNED: We identified the cancer drugs involved in NRDL negotiations from 2017 to 2022 and focused on the initial reimbursement decision for eligible newly negotiated drugs. Drugs were classified as within-class competitors based on their equivalent biological mechanisms of action and approved indications, including identified and potential competitors. Other variables included drug type, clinical benefit and safety, monthly drug cost, and disease incidence rate. We employed traditional univariate and multivariate Firth\'s penalized logistic regression to assess the association between reimbursement decisions and variables at the indication and drug levels.
UNASSIGNED: Between 2017 and 2022, 102 cancer drugs corresponding to 141 indications were studied, and 66 drugs (64.7%) covering 95 indications (67.4%) were added to the NRDL. The proportion of reimbursements for indications with identified competition was significantly higher than that for indications without identified competition (84.6% vs 52.6%, p < 0.0001). However, the difference in reimbursement proportions between groups with and without potential competition was not statistically significant (66.7% vs 68.3%, p = 0.84). Firth\'s penalized logistic regression showed that identified competition was positively correlated with successful NRDL inclusion, whereas potential competition had no significant effect on negotiation outcomes. Improved overall survival or progression-free survival were positively associated with NRDL inclusion, whereas disease incidence negatively impacted reimbursement decisions.
UNASSIGNED: Improved clinical benefit and identified competition were positively correlated with NRDL inclusion. In China\'s value-based negotiation model, clinical benefits served as a crucial foundation of price negotiation for cancer drugs, and market competition helped these drugs enter the NRDL at more reasonable prices. This has important implications for reimbursement decisions and accessibility and affordability improvement for innovative drugs worldwide.
UNASSIGNED: National Natural Science Foundation of China (No. 72104151).

BACKGROUND: Whole genome sequencing (WGS) has transformative potential for blood cancer management, but reimbursement is hindered by uncertain benefits relative to added costs. This study employed scenario planning and multi-criteria decision analysis (MCDA) to evaluate stakeholders\' preferences for alternative reimbursement pathways, informing future health technology assessment (HTA) submission of WGS in blood cancer.
METHODS: Key factors influencing WGS reimbursement in blood cancers were identified through a literature search. Hypothetical scenarios describing various evidential characteristics of WGS for HTA were developed using the morphological approach. An online survey, incorporating MCDA weights, was designed to gather stakeholder preferences (consumers/patients, clinicians/health professionals, industry representatives, health economists, and HTA committee members) for these scenarios. The survey assessed participants\' approval of WGS reimbursement for each scenario, and scenario preferences were determined using the geometric mean method, applying an algorithm to improve reliability and precision by addressing inconsistent responses.
RESULTS: Nineteen participants provided complete survey responses, primarily clinicians or health professionals (n = 6; 32 %), consumers/patients and industry representatives (both at n = 5; 26 %). \"Clinical impact of WGS results on patient care\" was the most critical criterion (criteria weight of 0.25), followed by \"diagnostic accuracy of WGS\" (0.21), \"cost-effectiveness of WGS\" (0.19), \"availability of reimbursed treatment after WGS\" (0.16), and \"eligibility criteria for reimbursed treatment based on actionable WGS results\" and \"cost comparison of WGS\" (both at 0.09). Participants preferred a scenario with substantial clinical evidence, high access to reimbursed targeted treatment, cost-effectiveness below $50,000 per quality-adjusted life year (QALY) gained, and affordability relative to standard molecular tests. Reimbursement was initially opposed until criteria such as equal cost to standard tests and better treatment accessibility were met.
CONCLUSIONS: Payers commonly emphasize acceptable cost-effectiveness, but strong clinical evidence for many variants and comparable costs to standard tests are likely to drive positive reimbursement decisions for WGS.

BACKGROUND: A key decision facing nonthrombectomy capable (spoke) hospitals is whether to transfer a suspected large vessel occlusion (LVO) patient to a comprehensive stroke center (CSC). In a retrospective cohort study, we investigated the rate of transfers resulting in endovascular thrombectomy (EVT) and associated costs before and after implementation of an artificial intelligence (AI)-based software.
METHODS: All patients with a final diagnosis of acute ischemic stroke presenting across a five-spoke community hospital network in affiliation with a CSC were included. The Viz LVO (Viz.ai, Inc.) software was implemented across the spokes with image sharing and messaging between providers across sites. In a cohort of patients before (pre-AI, December 2018-October 2020) and after (post-AI, October 2020-August 2022) implementation, we compared the EVT rate among ischemic stroke patients transferred out of our health system to the CSC. Secondary outcomes included the EVT rate based on spoke computed tomography angiography (CTA) and estimated transfer costs.
RESULTS: A total of 3113 consecutive eligible patients (mean age 71 years, 50% female) presented to the spoke hospitals with 162 transfers pre-AI and 127 post-AI. The rate of transfers treated with EVT significantly increased (32.1% pre-AI vs. 45.7% post-AI, p = 0.02). There was a sharp increase in CTA use post-AI at the spoke hospitals for all patients and transfers that likely contributed to the increased EVT transfer rate, but prior spoke CTA use alone was not sufficient to account for all improvement in EVT transfer rate (37.2% pre-AI vs. 49.2% post-AI, p = 0.12). In a binary logistic regression model, the odds of an EVT transfer in the intervention period were 1.85 greater as compared to preintervention (adjusted odds ratio 1.85, 95% confidence interval 1.12-3.06). The decrease in non-EVT transfers resulted in an estimated annual benefit of $206,121 in spoke revenue and $119,921 in payor savings (all US dollars).
CONCLUSIONS: The implementation of an automated image interpretation and communication platform was associated with increased CTA use, more transfers treated with EVT, and potential economic benefits.

UNASSIGNED: This article politicizes a reimbursement model proposed by some professional nursing associations that aim to better align the price of nursing labor (nurses\' pay) to the value of nursing and make nurses\' contributions more visible.
UNASSIGNED: Using the concept of \"missing care,\" the critique reveals how professionalization directs attention to individual-level interactions between care seekers and practitioners while obscuring from view the harm inflicted by social institutions and structures constitutive of a capitalist political economy and the related carceral state.
UNASSIGNED: Direct reimbursement models render practitioners complicit in the harms perpetrated and perpetuated by the health care industrial complex while professionalization processes are deployed to reduce cognitive dissonance (and moral injury) produced by combining harm with nursing\'s normative principles.
UNASSIGNED: We describe and trace the complementary capitalist imperatives of extraction-based profit maximization and efficiency through the health care industrial complex to demonstrate how formative those imperatives are of the health care system, care-seekers\' outcomes, nurses\' experiences, nonconsensual modes of data collection, and surveillance.
UNASSIGNED: The naturalization of racial capitalism and the precarity and violence it entails foreclose the creation of ethical alternatives that prioritize well-being instead of the pursuit of profit that could bring the provision of and payment for care closer to the normative principles held by practitioners.

Aim: Regulatory and health technology assessment (HTA) agencies have increasingly published frameworks, guidelines, and recommendations for the use of real-world evidence (RWE) in healthcare decision-making. Variations in the scope and content of these documents, with updates running in parallel, may create challenges for their implementation especially during the market authorization and reimbursement phases of a medicine\'s life cycle. This environmental scan aimed to comprehensively identify and summarize the guidance documents for RWE developed by most well-established regulatory and reimbursement agencies, as well as other organizations focused on healthcare decision-making, and present their similarities and differences. Methods: RWE guidance documents, including white papers from regulatory and HTA agencies, were reviewed in March 2024. Data on scope and recommendations from each body were extracted by two reviewers and similarities and differences were summarized across four topics: study planning, choosing fit-for-purpose data, study conduct, and reporting. Post-authorization or non-pharmacological guidance was excluded. Results: Forty-six documents were identified across multiple agencies; US FDA produced the most RWE-related guidance. All agencies addressed specific and often similar methodological issues related to study design, data fitness-for-purpose, reliability, and reproducibility, although inconsistency in terminologies on these topics was noted. Two HTA bodies (National Institute for Health and Care Excellence [NICE] and Canada\'s Drug Agency) each centralized all related RWE guidance under a unified framework. RWE quality tools and checklists were not consistently named and some differences in preferences were noted. European Medicines Agency, NICE, Haute Autorité de Santé, and the Institute for Quality and Efficiency in Health Care included specific recommendations on the use of analytical approaches to address RWE complexities and increase trust in its findings. Conclusion: Similarities in agencies\' expectations on RWE studies design, quality elements, and reporting will facilitate evidence generation strategy and activities for manufacturers facing multiple, including global, regulatory and reimbursement submissions and re-submissions. A strong preference by decision-making bodies for local real-world data generation may hinder opportunities for data sharing and outputs from international federated data networks. Closer collaboration between decision-making agencies towards a harmonized RWE roadmap, which can be centrally preserved in a living mode, will provide manufacturers and researchers clarity on minimum acceptance requirements and expectations, especially as novel methodologies for RWE generation are rapidly emerging.

Advanced endoscopy has been shown to be useful in the diagnosis and treatment of both benign and low-grade malignant colorectal lesions. In fact, advanced endoscopic procedures are being adopted as standard approaches to these lesions in many places around the world; however, their implementation in the United States has not been as widespread. We ascribe the difficulty in implementation to two reasons: (1) lack of advanced endoscopic training and (2) failure in reimbursement models as they relate to endoscopy. In this article, we hope to describe these barriers and inspire colorectal surgeons to try and overcome them. As surgical specialists with a mastery of endoscopic techniques, colorectal surgeons would be able to maximize benefit for their patients and minimize health care costs in the long run.

BACKGROUND: The use of positron-emission tomography (PET)/computed tomography (CT) in radiation therapy (RT) has increased. Radiation oncologists (RadOncs) have access to PET/CT with a variety of tracers for different tumor entities and use it for target volume definition. The German Society of Nuclear Medicine (DGN) and the German Society of Radiation Oncology (DEGRO) aimed to identify current patterns of care in order to improve interdisciplinary collaboration.
METHODS: We created an online survey on participating RadOncs\' use of PET tracers for different tumor entities and how they affect RT indication, dose prescription, and target volume definition. Further topics were reimbursement of PET/CT and organizational information (fixed timeslots and use of PET with an immobilization device [planning/RT-PET]). The survey contained 31 questions in German language (yes/no questions, multiple choice [MC] questions, multiple select [MS] questions, and free-text entry options). The survey was distributed twice via the DEGRO member mailing list.
RESULTS: During the survey period (May 22-August 7, 2023) a total of 156 RadOncs (13% of respondents) answered the survey. Among these, 59% reported access to diagnostic PET/CT within their organization/clinic and 24% have fixed timeslots for their patients. 37% of survey participants can perform RT-PET and 29% have the option of providing a dedicated RT technician for planning PET. Besides [18F]-fluorodeoxyglucose (FDG; mainly used in lung cancer: 95%), diagnostic prostate-specific membrane antigen (PSMA)-PET/CT for RT of prostate cancer is routinely used by 44% of participants (by 64% in salvage RT). Use of amino acid PET in brain tumors and somatostatin receptor PET in meningioma is low (19 and 25%, respectively). Scans are reimbursed through private (75%) or compulsory (55%) health insurance or as part of indications approved by the German Joint Federal Committee (Gemeinsamer Bundesausschuss; 59%). 98% of RadOncs agree that PET impacts target volume definition and 62% think that it impacts RT dose prescription.
CONCLUSIONS: This is the first nationwide survey on the role of PET/CT for RT planning among RadOncs in Germany. We find high acceptance of PET results for treatment decisions and target volume definition. Planning PET comes with logistic challenges for different healthcare settings (e.g., private practices vs. university hospitals). The decision to request PET/CT is often based on the possibility of reimbursement.
CONCLUSIONS: PET/CT has become an important tool for RadOncs, with several indications. However, access is still limited at several sites, especially for dedicated RT-PET. This study aims to improve interdisciplinary cooperation and adequate implementation of current guidelines for the treatment of various tumor entities.

UNASSIGNED: While multiple studies have assessed the trends of Medicare reimbursement for orthopedic total joint arthroplasty (TJA) surgeries, none have forecasted reimbursement in relatable per-hour figures. The purposes of this study are to examine trends of reimbursement for primary and revision TJA and translate forecasted primary TJA reimbursement to relatable per-hour compensation.
UNASSIGNED: The Center for Medicare and Medicaid Services reimbursement data from 1992 to 2024 were used to create a historical view of reimbursement for primary and revision TJA. All monetary values were converted to 2023 USD to account for inflation. Polynomial and linear forecast equations were used to predict the future of the TJA reimbursement to 2030. Relative Value Scale Update Committee standard times for procedures were used with the forecasts to establish per-hour rates.
UNASSIGNED: Total reimbursement for primary total hip arthroplasty/total knee arthroplasty is forecasted to decrease 85.36%/86.14% by 2030. Using prior trends in reimbursement, TJA procedures are predicted to reimburse at or less than $100.00 2023 USD per Medicare case by 2030. Moreover, TJA surgeons are forecasted to earn $13.93/h per primary total hip arthroplasty and $14.97/h per primary total knee arthroplasty by 2030.
UNASSIGNED: This study highlights the concerning trends for both primary and revision arthroplasties as TJA surgeons are on a path to earn below minimum wage for primary TJAs by 2030. Mathematical models forecast a bleak future for orthopedic TJA reimbursement. This downward trajectory poses a risk to access and quality of care.

UNASSIGNED: The primary purpose of this study was to evaluate how utilization, physician reimbursement, and patient populations have changed for primary total knee arthroplasty (TKA) from 2013 to 2021 at both a regional and national level within the Medicare population.
UNASSIGNED: The Medicare Physician and Other Practitioners database was queried for all episodes of primary TKA between years 2013 and 2021. TKA utilization per 10,000 beneficiaries, inflation-adjusted physician reimbursement per TKA, and patient demographics of each TKA surgeon were extracted each year. Data were stratified geographically, and Kruskal-Wallis tests were utilized.
UNASSIGNED: Between 2013 and 2021, TKA utilization per 10,000 beneficiaries increased at the greatest rate in the Northeast (+15.1%). In 2021, TKA utilization was highest in the Midwest (97.6/10,000; P < .001). The Midwest had the greatest decline in average physician reimbursement per TKA between 2013 and 2021 (-26.3%) and the lowest average reimbursement ($988.70, P < .001) in 2021. Alternatively, the Northeast had the smallest decline in average TKA reimbursement (-22.6%). Nationally, the average number of beneficiaries per TKA surgeon declined (-6.8%), while the average number of TKAs per surgeon (+5.7%) and average services per beneficiary (+24.3%) both increased. The average number of patient comorbidities and proportion of patients with dual Medicare-Medicaid eligibility decreased over time across all regions.
UNASSIGNED: This study demonstrates that TKA utilization is increasing and average physician reimbursement per TKA is declining at varying rates across the country, with the Northeast and Midwest most affected. These findings should be addressed in policy discussions to ensure equitable arthroplasty care.

Alopecia is an undesirable side effect of cancer chemotherapy. The mitigation of alopecia is a desirable adjunct treatment for patients with cancer. FDA-cleared scalp cooling (SC) devices have been successfully used to prevent or reduce chemotherapy-induced alopecia (CIA). This paper provides an understanding of the implementation and value of the new Insurance-Based Billing Model used in the USA for SC and its benefits compared with the original self-pay model. This improved compensation change will result in all patients in need, including underserved and disadvantaged populations, receiving equitable healthcare by allowing access to this valuable supportive care technology.