The use of innovative payment mechanisms for gene therapies in Europe and the USA

Innovative reimbursement mechanisms have long been considered potential solutions to the data uncertainty associated with one-off, high-value gene therapies that have long-term therapeutic potential, combined with limited supporting evidence at launch. The launches of increasing numbers of such gene therapies in Europe and the USA in the past 5 years provide valuable exemplars of how innovative reimbursement mechanisms are used by healthcare system decision makers in practice. This review details the use of such reimbursement schemes for recently launched gene therapies in key European countries and the USA, and shows that they are more widespread in Europe than in the USA. Although innovative payment schemes are increasingly used across countries, differences in healthcare system structures (e.g., single- vs multi-payer systems) and willingness to pay mean that decision makers in different countries have different incentives to manage uncertainties around long-term, real-world product value.

Spread, Scale-up, and Sustainability of Video Consulting in Health Care: Systematic Review and Synthesis Guided by the NASSS Framework

Background COVID-19 has thrust video consulting into the limelight, as health care practitioners worldwide shift to delivering care remotely. Evidence suggests that video consulting is acceptable, safe, and effective in selected conditions and settings. However, research to date has mostly focused on initial adoption, with limited consideration of how video consulting can be mainstreamed and sustained. Objective This study sought to do the following: (1) review and synthesize reported opportunities, challenges, and lessons learned in the scale-up, spread, and sustainability of video consultations, and (2) identify transferable insights that can inform policy and practice. Methods We identified papers through systematic searches in PubMed, CINAHL, and Web of Science. Included articles reported on synchronous, video-based consultations that had spread to more than one setting beyond an initial pilot or feasibility stage, and were published since 2010. We used the Nonadoption, Abandonment, and challenges to the Scale-up, Spread, and Sustainability (NASSS) framework to synthesize findings relating to 7 domains: an understanding of the health condition(s) for which video consultations were being used, the material properties of the technological platform and relevant peripherals, the value proposition for patients and developers, the role of the adopter system, organizational factors, wider macro-level considerations, and emergence over time. Results We identified 13 papers describing 10 different video consultation services in 6 regions, covering the following: (1) video-to-home services, connecting providers directly to the patient; (2) hub-and-spoke models, connecting a provider at a central hub to a patient at a rural center; and (3) large-scale top-down evaluations scaled up or spread across a national health administration. Services covered rehabilitation, geriatrics, cancer surgery, diabetes, and mental health, as well as general specialist care and primary care. Potential enablers of spread and scale-up included embedded leadership and the presence of a telehealth champion, appropriate reimbursement mechanisms, user-friendly technology, pre-existing staff relationships, and adaptation (of technology and services) over time. Challenges tended to be related to service development, such as the absence of a long-term strategic plan, resistance to change, cost and reimbursement issues, and the technical experience of staff. There was limited articulation of the challenges to scale-up and spread of video consultations. This was combined with a lack of theorization, with papers tending to view spread and scale-up as the sum of multiple technical implementations, rather than theorizing the distinct processes required to achieve widespread adoption. Conclusions There remains a significant lack of evidence that can support the spread and scale-up of video consulting. Given the recent pace of change due to COVID-19, a more definitive evidence base is urgently needed to support global efforts and match enthusiasm for extending use.

Ensuring intervention success: Assessing fit as an overlooked step of the implementation process

Ensuring fit between a service and the implementing context is a critical but often overlooked precursor of implementation success. This commentary proposes five key considerations that should be evaluated when exploring fit: alignment with needs and metrics; alignment with organizational resources and capabilities; alignment with organizational priorities and culture; alignment with reimbursement mechanisms for long-term sustainability; and alignment with the regulatory environment. Successful uptake and implementation hinges on careful planning and, most importantly, appropriate fit between the service and the implementing environment.

Supporting People With Dementia in the Community: Occupational Therapy Service and Reimbursement Innovations

The wide range of services needed to support a safe and quality life among people living with dementia at home is growing and extends beyond the bounds of traditional reimbursement models. Within the context of a health care system that is not designed to reimburse for these types of services, federal grants from the Alzheimer’s Disease Programs Initiative (ADPI) funded by the Administration for Community Living (ACL) have supported the delivery of home- and community-based services (HCBS) for people with dementia and their care partners with a pragmatic emphasis on sustainability, such as establishing successful reimbursement pathways. Drawing lessons from ACL’s ADPI program and from the Health Resources & Services Administration Geriatric Workforce Enhancement Program and Geriatrics Academic Career Award program, this symposium examines opportunities and strategies for providing services to people living with dementia in the community and highlights occupational therapy as a valuable dementia care service that has potential for sustainable delivery and opportunities for professional expansion. Papers address needed workforce development for delivering HCBS to diverse populations living with dementia and examine occupational therapy roles in delivering HCBS to persons with dementia and their care partners. Additionally, papers examine the implementation and outcomes of evidence-based occupational therapy and interprofessional interventions for persons living with dementia in the community. Reimbursement mechanisms for occupational therapy services delivered to people with dementia in the community are described. Discussion addresses how these innovative interventions and reimbursement mechanisms align with the recent surge of National Institute on Aging funding for pragmatic trials.

Application of Managed Entry Agreements for Innovative Therapies in Different Settings and Combinations: A Feasibility Analysis

The reimbursement of expensive, innovative therapies poses a challenge to healthcare systems. This study investigated the feasibility of managed entry agreements (MEAs) for innovative therapies in different settings and combinations. First, a systematic literature review included studies describing used or conceptual agreements between payers and manufacturers (i.e., MEAs). Identical and similar MEAs were clustered and data were extracted on their benefits and limitations. A feasibility assessment was performed for each individual MEA based on how it could be applied (financial/outcome-based), on what level (individual patients/target population), in which payment setting (centralized pricing and reimbursement authority yes/no), for what type of therapies (one-time/chronic), within what payment structures, and whether combinations with other MEAs were feasible. The literature search ultimately included 82 papers describing 117 MEAs. After clustering, 15 unique MEAs remained, each describing one or multiple similar agreements. Four of those entailed payment structures, while eleven entailed agreements between payers and manufacturers regarding price, usage, and/or evidence generation. The feasibility assessment indicated that most agreements could be applied throughout the different settings that were assessed and could be applied in different payment structures and in combination with multiple other agreements. The potential to combine multiple agreements leads to a multitude of different reimbursement mechanisms that may manage the price, usage, payment structure, and additional conditions for an innovative therapy. This overview of the feasibility of combinations of MEAs can help decision-makers construct a reimbursement mechanism most suited to their preferences, the type of therapy under evaluation, and the applicable healthcare system.

Challenges and Adverse Outcomes of Implementing Reimbursement Mechanisms Based on the Diagnosis-Related Group Classification System: A systematic review

In health insurance, a reimbursement mechanism refers to a method of third-party repayment to offset the use of medical services and equipment. This systematic review aimed to identify challenges and adverse outcomes generated by the implementation of reimbursement mechanisms based on the diagnosis-related group (DRG) classification system. All articles published between 1983 and 2017 and indexed in various databases were reviewed. Of the 1,475 articles identified, 36 were relevant and were included in the analysis. Overall, the most frequent challenges were increased costs (especially for severe diseases and specialised services), a lack of adequate supervision and technical infrastructure and the complexity of the method. Adverse outcomes included reduced length of patient stay, early patient discharge, decreased admissions, increased re-admissions and reduced services. Moreover, DRG-based reimbursement mechanisms often resulted in the referral of patients to other institutions, thus transferring costs to other sectors.Keywords: Health Insurance; Third-Party Payments; Reimbursement Mechanisms; Diagnosis-Related Groups; Quality of Health Care; Patient Outcome Assessment; Systematic Review.

Spread, Scale-up, and Sustainability of Video Consulting in Health Care: Systematic Review and Synthesis Guided by the NASSS Framework (Preprint)

BACKGROUND COVID-19 has thrust video consulting into the limelight, as health care practitioners worldwide shift to delivering care remotely. Evidence suggests that video consulting is acceptable, safe, and effective in selected conditions and settings. However, research to date has mostly focused on initial adoption, with limited consideration of how video consulting can be mainstreamed and sustained. OBJECTIVE This study sought to do the following: (1) review and synthesize reported opportunities, challenges, and lessons learned in the scale-up, spread, and sustainability of video consultations, and (2) identify transferable insights that can inform policy and practice. METHODS We identified papers through systematic searches in PubMed, CINAHL, and Web of Science. Included articles reported on synchronous, video-based consultations that had spread to more than one setting beyond an initial pilot or feasibility stage, and were published since 2010. We used the Nonadoption, Abandonment, and challenges to the Scale-up, Spread, and Sustainability (NASSS) framework to synthesize findings relating to 7 domains: an understanding of the health condition(s) for which video consultations were being used, the material properties of the technological platform and relevant peripherals, the value proposition for patients and developers, the role of the adopter system, organizational factors, wider macro-level considerations, and emergence over time. RESULTS We identified 13 papers describing 10 different video consultation services in 6 regions, covering the following: (1) video-to-home services, connecting providers directly to the patient; (2) hub-and-spoke models, connecting a provider at a central hub to a patient at a rural center; and (3) large-scale top-down evaluations scaled up or spread across a national health administration. Services covered rehabilitation, geriatrics, cancer surgery, diabetes, and mental health, as well as general specialist care and primary care. Potential enablers of spread and scale-up included embedded leadership and the presence of a telehealth champion, appropriate reimbursement mechanisms, user-friendly technology, pre-existing staff relationships, and adaptation (of technology and services) over time. Challenges tended to be related to service development, such as the absence of a long-term strategic plan, resistance to change, cost and reimbursement issues, and the technical experience of staff. There was limited articulation of the challenges to scale-up and spread of video consultations. This was combined with a lack of theorization, with papers tending to view spread and scale-up as the sum of multiple technical implementations, rather than theorizing the distinct processes required to achieve widespread adoption. CONCLUSIONS There remains a significant lack of evidence that can support the spread and scale-up of video consulting. Given the recent pace of change due to COVID-19, a more definitive evidence base is urgently needed to support global efforts and match enthusiasm for extending use.

Challenges of Payment Methods in the Iranian Health System and Solutions: A Qualitative Study

Background: The implementation of different reimbursement methods has various positive and negative effects on the health system of different countries. Identifying the challenges of these methods is essential to improve these reimbursement methods and modify them if required. This article aimed to qualitatively assess the challenges of current hospitals' payment systems in the Iranian health system and determine the required solutions for modifying these payment systems. Methods: This qualitative study was conducted in 2019. Semi-structured interviews were conducted recruiting 20 experts including operational, middle and top managers working in three different levels of health systems. Data collection was continued until it reached a saturation point. MAXQDA 10 was used for data analysis. The data content analysis method was used to analyze the data and the themes and categories were determined. Results: The challenges of the payment systems were categorized into four main themes regarding policy, cost, regulatory and functional challenges, and 15 sub-themes. The findings related to the proposed strategies were presented in six main themes consisting of legal solutions, structural reform, cost, quality improvement, service provider and client, and monitoring and evaluation; and 12 sub-themes. Conclusion: This study showed that the health systems in Iran face various structural and procedural challenges in terms of reimbursement mechanisms. Therefore, it is recommended that policymakers pay attention to these challenges before making any changes. Using hybrid payment systems can be one of the proper solutions.

TAILORED ACTIVITY PROGRAM (TAP) COSTS: OPPORTUNITIES TO STREAMLINE DELIVERY AND PURSUE REIMBURSEMENT

TAP intervention costs captured alongside the randomized controlled study included labor of program staff, mileage, supplies and materials. Staff time costs were converted to $US 2017 by multiplying hours spent by the appropriate wage rate plus fringe benefits; mileage was costed using the federal reimbursement rate. Research costs were excluded to approximate real world implementation. Costs varied based on number of visits required but mean component costs per dyad were: occupational therapist training ($133.50), home visit time ($527.57), travel ($718.02), work outside of intervention delivery ($57.14), program screening for eligibility ($3.73), supervision for quality assurance ($250.23), activity supplies ($51.64), and program materials ($29.32). Findings will be compared to a 2008 TAP pilot study post hoc cost analysis to identify how broader scale implementation impacts intervention costs. Opportunities to streamline program delivery will be discussed as well as potential reimbursement mechanisms via Medicare part B, Medicare Advantage, and Medicaid waiver programs.