Impact of health benefit package policy interventions on service utilisation under government-funded health insurance in Punjab, India: analysis of Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (PM-JAY).

Background: The design of health benefits package (HBP), and its associated payment and pricing system, is central to the performance of government-funded health insurance programmes. We evaluated the impact of revision in HBP within India's Pradhan Mantri Jan Arogya Yojana (PM-JAY) on provider behaviour, manifesting in terms of utilisation of services. Methods: We analysed the data on 1.35 million hospitalisation claims submitted by all the 886 (222 government and 664 private) empanelled hospitals in state of Punjab, from August 2019 to December 2022, to assess the change in utilisation from HBP 1.0 to HBP 2.0. The packages were stratified based on the nature of revision introduced in HBP 2.0, i.e., change in nomenclature, construct, price, or a combination of these. Data from National Health System Cost Database on cost of each of the packages was used to determine the cost-price differential for each package during HBP 1.0 and 2.0 respectively. A dose-response relationship was also evaluated, based on the multiplicity of revision type undertaken, or based on extent of price correction done. Change in the number of monthly claims, and the number of monthly claims per package was computed for each package category using an appropriate seasonal autoregressive integrated moving average (SARIMA) time series model. Findings: Overall, we found that the HBP revision led to a positive impact on utilisation of services. While changes in HBP nomenclature and construct had a positive effect, incorporating price corrections further accentuated the impact. The pricing reforms highly impacted those packages which were originally significantly under-priced. However, we did not find statistically significant dose-response relationship based on extent of price correction. Thirdly, the overall impact of HBP revision was similar in public and private hospitals. Interpretation: Our paper demonstrates the significant positive impact of PM-JAY HBP revisions on utilisation. HBP revisions need to be undertaken with the anticipation of its long-term intended effects. Funding: Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ).

A Way Forward for Comprehensive Cancer Caregiver Support.

Family caregivers are integral to patient care. However, a combination of systemic forces places enormous pressure on family caregivers, while simultaneously devaluing them. Recently, more public attention has been paid to caregivers' importance, prevalence, and needs, generating supportive responses by government, employers, and the media. As of yet, there has not been a commensurate response by health care institutions. We identify four key challenges to building comprehensive cancer caregiver support and propose five necessary components for future programs that cancer centers and organizations can adopt. Comprehensive cancer caregiver support is attainable but national organizations need to lead the effort through standardization of guidelines and metrics for cancer centers.

Declining Medicare reimbursement in spinal imaging: a 15-year review.

OBJECTIVE: To analyze and quantify the change in United States of America Medicare reimbursement rates for the 30 most commonly performed spinal imaging procedures. MATERIALS AND METHODS: The Physician Fee Schedule Look-Up Tool from the Centers for Medicare & Medicaid Services was utilized to find and extract the 28 most billed spinal imaging procedures. All data was adjusted for inflation and listed in 2020 US dollars. Percent change in reimbursement and Relative Value Units between 2005 and 2020, both unadjusted and adjusted, were calculated and compared. Additionally, percent change per year and compound annual growth rate were calculated and compared. RESULTS: After adjusting for inflation, the average reimbursement for all analyzed spinal imaging procedures between the years 2005 and 2020 decreased by 45.9%. The adjusted reimbursement rate for all procedures decreased at an average 4.3% per year and experienced an average compound annual growth rate (CAGR) of - 4.4%. Magnetic resonance imaging (MRI) had the most substantial adjusted decline of all imaging modalities at - 72.6%, whereas x-ray imaging had the smallest decline at - 27.33%. The average total RVUs per procedure decreased by 50.1%, from 7.96 to 3.97. CONCLUSION: From the years 2005 to 2020, Medicare reimbursement significantly decreased for all advanced imaging modalities involving the most common spinal imaging procedures. Among all practices, imaging procedures may be experiencing some of the largest decreases from Medicare reimbursement cutbacks.

Mental Health Agency Officials' Perceived Priorities for Youth Mental Health and Factors That Influence Priorities.

OBJECTIVE: This study aimed to characterize the perceived priorities of state and county policy makers for youth mental health services and the factors that influence those priorities. METHODS: Mental health agency officials (N=338; N=221 state officials, N=117 county officials) representing 49 states completed a Web-based survey in 2019-2020. On 5-point scales, respondents rated the extent to which 15 issues were priorities for their agency in providing youth mental health services and the extent to which nine factors influenced those priorities. RESULTS: Suicide was identified as the highest priority (mean±SD rating=4.38±0.94), followed by adverse childhood experiences and childhood trauma and then increasing access to evidence-based treatments. Budget issues (mean=4.27±0.92) and state legislative priorities (mean=4.01±0.99) were perceived as having the greatest influence on setting priorities. CONCLUSIONS: These findings provide insights into youth mental health policy priorities and can be used to guide implementation and dissemination strategies for research and program development within state and county systems.

Public value judgments about the criteria for reimbursement of medicines in South Korea.

OBJECTIVES: This study quantified the public value (PV) of the criteria and sub-criteria in the current drug reimbursement systems in South Korea and examined sociodemographic factors that associated with PV. METHODS: The Analytic Hierarchy Process (AHP) was used to quantify the PVs of criteria and sub-criteria. We developed a questionnaire to generate pairwise comparison matrices among criteria and sub-criteria. From 27 March to 1 April 2023, we recruited 1,000 study participants using a quota sampling method stratified by age, sex, and region based on Korean census data. RESULTS: The PVs for the criteria were highest for clinical usefulness (28.5%), followed by cost-effectiveness (27.1%), budget impact (24.3%), and reimbursement in other countries (20.1%). The sociodemographic characteristics of the participants had a significant impact on the PVs of the criteria. Willingness to pay additional premiums for national health insurance was negatively associated with PV for clinical usefulness and cost-effectiveness and positively associated with PV for reimbursement in other countries. CONCLUSIONS: The public prioritized clinical usefulness and cost-effectiveness as the main criteria. However, the PVs of the criteria were divergent and associated with sociodemographic factors. Divergent public interests require an evidence-informed deliberative process for reimbursement decisions.

Regional Differences in Primary Total Knee Arthroplasty Utilization, Physician Reimbursement, and Patient Characteristics.

Background: 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. Methods: 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. Results: 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. Conclusions: 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.

The Trend of Medicare Reimbursement for Total Joint Arthroplasty: Using Mathematical Models to Predict Possible Per-Hour Rate Out to 2030.

Background: 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. Methods: 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. Results: 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. Conclusions: 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.

Impact of competition on reimbursement decisions for cancer drugs in China: an observational study.

Background: 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. Methods: 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. Findings: 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. Interpretation: 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. Funding: National Natural Science Foundation of China (No. 72104151).

Complementary and integrative medicine - Resolving situations of reduced remuneration for additional work under the SwissDRG system.

Aim of the study: Complementary and integrative medicine (CIM) has been increasingly recognized as offering promising treatment adjunctions in various clinical settings, even amongst patients with serious, chronic, or recurrent illness. Today, only few tertiary care facilities in Switzerland offer dedicated CIM services for inpatients. The aim of the present study was to evaluate whether CIM services for complex medical conditions are adequately valued by the national inpatient SwissDRG reimbursement system. Methods: A simulation was performed by adding a specific code of the Swiss classification of interventions (CHOP) to the list of codes of each patient who received CIM therapies at the Lausanne University Hospital (CHUV) in 2021. This code is to be used when CIM services are provided. Hitherto, it was not entered due to a lack of specific documents justifying the resources used. The analysis focused on the impact of adding this CIM CHOP code on the Swiss Diagnosis Related Group (DRG) reimbursement. Results: In total, 275 patients received a CIM therapy in 2021. The addition of the CIM CHOP code 99.BC.12 (10-25 CIM sessions per stay) resulted in a simulated loss of income of CHF 766 630 for the hospital, while the net real result is already negative by more than CHF 6 million. The DRGs positively impacted by the addition of CIM CHOP code 99.BC.12 had a mean (SD) cost weight (CW) of 1.014 (0.620), while the DRGs negatively impacted had a mean (SD) CW of 3.97 (2.764) points. Conclusion: It is necessary to quickly react and improve the incentives contained in the grouping algorithm of the prospective payment system, whose effects can threaten the provision of adequate medical care to the patients despite suitable indications and potential for cost-savings.

Should they stay or should they go? Stroke transfers across a hospital network pre- and post-implementation of an automated image interpretation and communication platform.

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.

Getting Ours? "Girlbossing" and the Ethics of Nurse Reimbursement Models.

Introduction: 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. Methods: 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. Results: 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. Discussion: 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. Conclusion: 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.

How to Implement Pressurized Intraperitoneal Aerosol Chemotherapy into a National Health System Scenario: A Single-Center Retrospective Analysis of Costs and Economic Sustainability at a High-Volume Italian Hospital.

PIPAC is a new surgical procedure and a viable treatment option for PSM patients, due to promising therapeutic outcomes, minimal invasiveness, limited surgical morbidity, and systemic toxicity side effects. However, its implementation throughout hospitals is hard to obtain due to its fragile economical sustainability. A retrospective health economic analysis was conducted in order to evaluate the cost of hospitalization for patients undergoing PIPAC treatment at Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, in Rome. The average cost of a PIPAC procedure was defined based on the cost of surgery (cost of surgical material, operating room, intraperitoneal chemotherapy), hospital stay, diagnostic examinations, and drugs used during the stay. A total of 493 PIPAC procedures were performed on 222 patients with peritoneal metastases or primary peritoneal cancer from 2017 to 2023. Since the mean remuneration for each PIPAC hospitalization is €5916 and the mean expenditure per hospitalization is €6538, this results in an operating profit per PIPAC hospitalization of -€622. The reimbursement of PIPAC treatment by the Italian National Health System currently only partially covers the hospital's costs. Development of specific codes and adequate reimbursement for PIPAC by recognizing this procedure as a proper treatment for peritoneal carcinomatosis is essential.

Examination of differences between actual and potential revenue generation in a pharmacist-run ambulatory clinic.

BACKGROUND: Pharmacists are not billable healthcare providers under Medicare Part B or most insurance plans. Because of this, pharmacist services are relegated to incident-to-provider billing, despite pharmacists routinely providing services high in complexity. This discrepancy may negatively skew perceptions of pharmacists' contributions to outpatient clinic care. OBJECTIVES: The objective of this study was to identify the potential revenue generation for pharmacist-delivered services at a single, rural South Dakota clinic if pharmacists were considered billable healthcare providers. METHODS: This retrospective, single center study utilized a chart review of first-quarter data from a single ambulatory clinic served by a 0.5 full time equivalent pharmacist serving Chronic Disease Management (CDM) and COVID-19 patients. For each appointment, the chart note was reviewed for elements that would satisfy requirements for Current Procedural Terminology (CPT®) billing codes. Medicare and Medicaid reimbursement was determined using official 2022 Physician Fee Schedules and private insurance reimbursement was set at a single rate of 60% of the fee schedule of the most common private payer. RESULTS: During the three-month study period, 118 patients (206 appointments) were seen by the pharmacist. The amount paid to the clinic was estimated at $2,174.91. The hypothetical amount paid to the clinic if pharmacists were considered billable healthcare providers is $10,415.31 for CDM clinic and $7,953.48 for COVID-19 clinic, totaling $18,368.79. Excluding uninsured patients, the hypothetical total is $17,102.03, with a total unrealized revenue of $16,193.88. CONCLUSION: If pharmacists were considered billable healthcare providers and their services were billed accordingly, the potential revenue generation is significantly higher than actually generated revenue. This estimated data can be used to better quantify and qualify appointment-related data for non-pharmacist clinic managers.

Cost-effectiveness analysis of proximal femoral nail versus bipolar hemiarthroplasty for femoral neck fracture.

BACKGROUND: Hip fractures are a serious public health problem with high rates of morbidity, mortality, disability and care costs. The aim of the research was to perform cost effectiveness analysis of hip fracture treatments using proximal femoral nail and bipolar hemiarthroplasty surgeries. METHODS: The analysis was completed based on the perspectives of the paying institution and patient. A decision tree model was used to determine whether proximal femoral nail or bipolar arthroplasty was most cost effective for the management of a femoral neck fracture in this patient population. RESULTS: The findings from the decision tree model suggested that ICERs for BHP were TRY 43,164.53 TL/QALY based on reimbursement and TRY 3,977.35 TL/QALY based on patient expenditures. Compared to the calculated threshold value of TRY 60.575 TL, we concluded BHP to be a cost-effective option. Moreover, all parameter changes yielded stable results on the one-way sensitivity analysis. When it comes to the probabilistic sensitivity analysis, BHP with specified threshold value was found to be cost-effective in all the comparisons. Currently available data the use of bipolar hemiarthroplasty as the more cost- effective treatment strategy in this specific population. CONCLUSION: Overall, our findings showed HA as a cost-effective surgical technique at the calculated threshold in a population over 60 years of age. The impacts of HA on patients' quality of life and costs are remarkable.

Scenario analysis and multi-criteria decision analysis to explore alternative reimbursement pathways for whole genome sequencing for blood cancer patients.

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. CONCLUSION: 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.

Overcoming Barriers to Healthcare Reform: A Call to Action.

The success of healthcare reform hinges on policymaker, regulator, and administrator actions that shape policies at various levels. These policies can either facilitate or hinder the practice of healthcare professionals and collaborative work environments. It is imperative for all healthcare professionals to fully utilize their education and certification, as fostering an equitable workplace culture is vital for retaining staff and improving access to care. Using nurse practitioners (NPs) as an exemplar, this article aims to specify systemic barriers to healthcare reform and call for policymakers, regulators, and clinical agency administrators to enact change. Barriers to NP practice include restrictive oversight by external stakeholders, financial incentives for indirect billing, and hierarchical constraints that limit NP contributions to the healthcare system. The growing healthcare provider shortage disproportionately impacts primary care and rural settings. NPs are increasingly more likely to fill these roles than medical doctors and have documented positive patient health outcomes. Removing systemic obstacles for NP practice increases access to care. Nursing-the largest healthcare workforce with diverse roles-operates under complex oversight from multiple organizations for licensure, accreditation, certification, and education. The recent trend of external stakeholders influencing and requiring additional oversight has created barriers to nursing practice. Despite national education, accreditation, and certification standards, nursing licensure and practice are increasingly negotiated with external stakeholders and supervised at the state and institutional levels. Supporting all healthcare professionals to practice according to their education and certification can advance healthcare reform, address workforce shortages, increase access to care, and improve health.

The maze of real-world evidence frameworks: from a desert to a jungle! An environmental scan and comparison across regulatory and health technology assessment agencies.

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.

Matters We Metric Vs. Metrics that Matter.

Introduction: Geriatric fracture is a pressing global health issue, marked by elevated mortality and morbidity rates and escalating health care costs. The evolving health care system from fee-for-service to quality-based reimbursement has led to externally driven reward and reimbursement systems that may not account for the complexity of caring for older adults with fracture. Significance: The aim of this review is to highlight the need for a shift towards meaningful metrics that impact geriatric fracture care and to issue a call to action for all medical societies to advocate for national reimbursement and ranking systems that focus on metrics that truly matter. Results: Traditional metrics, while easier to capture, may not necessarily represent high quality care and may even have unintentional adverse consequences. For example, the focus on reducing length of stay may lead to older patients being discharged too early, without adequately addressing pain, constipation, or delirium. In addition, a focus on mortality may miss the opportunity to deliver compassionate end-of-life care. Existing geriatric fracture care metrics have expanded beyond traditional metrics to include assessment by geriatricians, fracture prevention, and delirium assessments. However, there is a need to further consider and develop patient-focused metrics. The Age-Friendly Health Initiative (4 Ms), which includes Mobility, Medication, Mentation, and what Matters is an evidence-based framework for assessing and acting on critical issues in the care of older adults. Additional metrics that should be considered include an assessment of nutrition and secondary fracture prevention. Conclusion: In the realm of geriatric fracture care, the metrics currently employed often revolve around adherence to established guidelines and are heavily influenced by financial considerations. It is crucial to shift the paradigm towards metrics that truly matter for geriatric fracture patients, recognizing the multifaceted nature of their care and the profound impact these fractures have on their lives.

Medicare-mandated shared decision making for left atrial appendage closure in clinical practice.

INTRODUCTION: The Centers for Medicare & Medicaid Services (CMS) required a shared decision-making (SDM) interaction, with an "independent" physician, before left atrial appendage closure (LAAC). The purpose of this study is to better understand how this requirement is implemented in clinical practice. METHODS: We surveyed LAAC-performing centers. The characteristics of respondent and nonrespondent hospitals were compared using the CMS Provider of Services File for 2017. RESULTS: We received 86 responses out of 269 surveys mailed (32%). Respondent and nonrespondent hospital affiliations were similar: mean hospital size 525 beds, 15% for-profit, and 34% teaching hospitals. Thirty-four respondents (39.5%) stated that the implanting physician conducts some or all of the SDM interactions. The percentage of patients who decide not to undergo LAAC after the SDM interaction was estimated at 8.1%. Out of 72 responses to an open-ended question about the benefit of the SDM interaction, 44 (61%) described the requirement in negative terms, of which most felt the requirement was burdensome for patients and providers. Only 28 respondents (39%) described the requirement in positive or mixed terms. CONCLUSION: In violation of the letter of the CMS policy for LAAC, implanting physicians perform the SDM interaction at nearly 40% of responding hospitals. Most respondents felt the SDM requirement was burdensome for patients. More detailed guidance from CMS on how to comply with the policy may result in better alignment between the intent of the policy and how it is implemented.