Value-based payment for high-cost treatments in Singapore: a qualitative study of stakeholders' perspectives.

OBJECTIVES: The rising costs of drugs have necessitated the exploration of innovative payment methods in healthcare systems. Risk-sharing agreements (RSAs) have been implemented in many countries as a value-based payment mechanism to manage the uncertainty associated with expensive technologies. This study aimed to investigate stakeholder perspectives on value-based payment in the Singaporean context, providing insights for future directions in health technology assessment and financing. METHODS: This descriptive qualitative inquiry involved participant interviews conducted between October 2021 and April 2022. Thematic analysis was conducted in two phases to analyze the interview transcripts. RESULTS: Seventeen respondents participated in the study, and five key themes emerged from the analysis. Stakeholders viewed RSAs as moderately positive, despite limited experience with them. They emphasized the importance of clearly defining objectives and establishing transparent criteria for implementing these schemes. The current data infrastructure was identified as both a barrier and facilitator, as RSAs impose administrative burdens. To successfully implement these payment mechanisms, capacity building, and effective stakeholder engagement that fosters mutual trust and cocreation are crucial. CONCLUSION: This study confirms previously identified barriers and facilitators to successful RSA implementation while contextualizing them within the Singaporean setting. The findings suggest that value-based payment has the potential to address uncertainty and improve access to healthcare technologies, but these barriers must be addressed for the schemes to be effective.

Risk sharing or risk shifting? On the development of patient access schemes in the process of updating the national list of health services in Israel.

Background: Agreements between payers and pharmaceutical/medical device companies are widely implemented to address financial and clinical uncertainties. We analyzed the main characteristics of these agreements in Israel from 2011-2018.Research design and methods: We reviewed all agreements implemented during the study period. Information regarding the type of agreement, therapeutic indications, its time frame and the total budget involved are presented.Results: A total of 56 agreements were signed since 2011, of which 53 (95%) were financial-based and 50 (89%) referred to pharmaceuticals. The annual number of agreements increased from one in 2011 to 21 in 2018. The main therapeutic areas covered were: oncology (41%), hepatitis C (16%), neurology (11%), respiratory (9%), and cardiovascular (7%). The proportion of the annual budget allocated subject to these agreements increased accordingly from 3% in 2011 to 73% in 2018. The majority (63%) of the agreements were signed for 5 years, 9% were shorter-term and 20% have no time-limit. In 14 (44%) of the financial-based agreements implemented through 2017, the actual utilization exceeded the pre-specified threshold and the companies reimbursed the health-plans accordingly.Conclusions: The number of agreements and the allocated budget subject to these agreements increased substantially in recent years. Most agreements are financial-based that, in many cases, shifted the short-term financial risk from health-plans to the industry.

Delivery system performance as financial risk varies.

OBJECTIVES: Banner Health, a large delivery system in Maricopa County, Arizona, entered into both Medicare and commercial insurance contracts that varied the amount of financial risk that Banner assumed. Rates of utilization and spending under these various contracts were investigated. STUDY DESIGN: Prior to 2012, Banner held Medicare Advantage (MA) contracts, and in 2012 it began as a Medicare Pioneer accountable care organization (ACO). Banner also introduced a commercial ACO contract in that year. We compared risk-adjusted healthcare utilization and spending in the MA plan, the ACO, and a local traditional Medicare (TM) comparison group. We also compared risk-adjusted utilization and spending in Banner's commercial ACO with that of a comparison group drawn from the same employment groups who were not attributed to Banner providers. METHODS: We used claims and encounter data to measure utilization and spending. We risk adjusted using CMS and HHS Hierarchical Condition Categories. RESULTS: Within Medicare, MA enrollees had lower risk-adjusted utilization and total spending than either the Pioneer ACO participants or a local TM comparison group. Participation in the Pioneer ACO program was associated with a greater reduction in hospitalization rates for ACO patients relative to local TM patients served by non-ACO providers, but the effect on total medical spending was ambiguous. Risk-adjusted differences between the commercial ACO group and the fee-for-service comparison group were generally small. CONCLUSIONS: The results are consistent with CMS' efforts to shift reimbursement away from pure fee-for-service reimbursement.

Regulatory, Policy, and Operational Considerations for Outcomes-Based Risk-Sharing Agreements in the U.S. Market: Opportunities for Reform.

BACKGROUND: Although interest in outcomes-based risk-sharing agreements (OBRSAs) and other value-based contracts (VBCs) continues to grow, the number of VBCs in the United States is still limited. A better understanding of the evolving and fluid context of policies, regulations, and operational factors affecting their uptake in the United States is needed in order to lower or obviate barriers and advance OBRSAs. OBJECTIVES: To (a) identify and recognize priorities among policies, regulations, and other factors that are most likely to influence the feasibility, design, and execution of OBRSAs and (b) suggest opportunities for reform and other modifications that may advance OBRSAs in the United States. METHODS: Across 18 months during 2017-2018, we reviewed health policy literature, examined stakeholder group communications, and conducted semistructured interviews with representatives of 12 diverse stakeholder organizations. Across these, and incorporating real-time contextual changes, we identified priorities for enabling and improving OBRSAs. RESULTS: Regulatory and policy priorities most often cited by manufacturers were Medicaid best price rule, Medicare Part B average sales pricing, FDA restrictions on communications, and the Anti-Kickback Statute. While recognizing these, health plans were more concerned about operational barriers, particularly associated with data collection and analysis, selection of outcomes that are feasible to assess, bandwidth for managing OBRSAs, and implementation costs relative to return on investment. Most recognized limitations on access to personal health information, target population turnover, and insufficient information sharing of OBRSA experiences. Noteworthy were asymmetries of administrative burden and cost management: individual manufacturers may pursue OBRSAs for 1 or a few products per year, while health plans are approached by multiple manufacturers about OBRSAs for their respective products; manufacturers focus on drugs, while health plans must manage broader costs of care. CONCLUSIONS: While all stakeholders express interest in OBRSAs, health plans tend to consider them as a narrower priority than manufacturers. Solving operational barriers, in addition to addressing policy and regulatory barriers, is essential for aligning efforts to advance OBRSAs. Doing so depends on collaboration to improve decisions about when and how to pursue OBRSAs, with attention to data management, modeling and piloting OBRSAs, and information sharing. These findings pertain to companies operating in the United States and some likely extend to certain value-based arrangements in other countries. DISCLOSURES: This analysis was funded by Merck Sharp & Dohme (MSD), a subsidiary of Merck, as a component of the Learning Laboratory for Advancing Value-Based Healthcare, which is a multiyear collaboration of MSD and Optum, a health services, technology, and data company. The manuscript underwent an internal review by the sponsor. The Lewin Group (Lewin) is a subsidiary of OptumServe. OptumServe is wholly owned by UnitedHealth Group (UHG). Neither OptumServe nor UHG or its subsidiaries review the work products of Lewin. Lewin operates with editorial independence and provides its clients with health care and human services policy research and consulting services. Goodman and Villarivera are employees of Lewin; Gregor is an employee of Optum; and van Bavel is an employee of MSD. Goodman and Villarivera report fees from UHG, unrelated to this study. A poster presentation based on this manuscript was accepted and presented at the ISPOR Europe 2018 Conference in Barcelona, Spain, on November 13, 2018.

Acuerdos de Riesgo Compartido: Lecciones Para su Diseño e Implementación a la Luz de la Experiencia Internacional.

BACKGROUND: Despite the growing interest in risk-sharing agreements as appropriate payment mechanisms for high-cost treatments, few practical resources facilitate their adoption. OBJECTIVE: To identify and propose lessons for designing and implementing these models based on a review of the international experience, and to offer a concise model based on these lessons. METHODS: The steps of the Joanna Briggs Institute were adopted, which included identifying the concept and its relevant variants in scientific and gray literature. RESULTS: Forty-one references were examined in depth. The design of these payment mechanisms should be a process carried out by competent actors (payer, producer, specialists, patients, and a neutral entity); the design must be supported by a sound regulatory and contractual framework that structures its components and clarifies the functions of each actor. Finally, there are critical activities for each actor in each phase of the agreement's progress. CONCLUSIONS: The participation of all actors and the clarification of critical elements and tasks are fundamental for the optimal development of the experiences.

The current performance-linked and risk sharing agreement scene in the Spanish region of Catalonia.

Background: Traditional drug payment schemes in Catalonia are generally based on the negotiation of fixed prices; however, disadvantages arise in the case of innovative therapies. Risk sharing agreements distribute potential health and economic uncertainties and high prices on access across the interested parts.Objectives: To identify, characterize and analyze current publicly available agreement reports signed by the Catalan Health Service and different pharmaceutical companies evaluating the current market access scene for new drugs in Catalonia.Methods: A database of agreements implemented between 2013 and 2018 was developed by using publicly available data. Data analysis was performed in a descriptive way, presenting summaries in datasheets.Results: A total of 7 managed entry agreements were analyzed. Two extensions regarding previous agreements were also taken into account. The main involved disease area is oncology (57%) and the most common length is 1 year, whereas the longest is 3 years.Conclusions: Managed entry agreements are gaining popularity and are viewed as positive schemes by stakeholders, payers and health services, leading to a general increase of accords during the last years. However, there are hardly any studies regarding the impact of RSA post-implementation, a field of great relevance regarding health policies.

Effect of informal financial support for health care on health Insurance uptake: Evidence from a mixed-methods study in Tamale metropolis of northern Ghana.

Attempts to study the determinants of health insurance enrollment in resource-poor settings have often given less consideration to the potential influence of informal risk-sharing systems on individuals and households' decisions about health insurance. This paper contributes to existing discussions in this area by examining the effect of informal financial support for health care, an example of informal risk-sharing arrangement, on enrollment in the Ghana National Health Insurance Scheme (NHIS). It is based on a mixed-methods research in Tamale metropolis of northern Ghana. The study found widespread availability and reliance on informal support among low-income households to finance out-of-pocket health-care expenditure. Informal financial support for enrollment into the NHIS was noted to be less available. The study further found less strong but suggestive evidence that the perceived availability of informal financial support for health care by individuals diminishes their enrollment in the NHIS. The paper emphasizes the need for theory and policy on health insurance uptake in resource-constrained settings to consider existing informal risk-sharing arrangements as much as other known determinants of enrollment.

Revenue-sharing clubs provide economic insurance and incentives for sustainability in common-pool resource systems.

Harvesting behaviors of natural resource users, such as farmers, fishermen and aquaculturists, are shaped by season-to-season and day-to-day variability, or in other words risk. Here, we explore how risk-mitigation strategies can lead to sustainable use and improved management of common-pool natural resources. Over-exploitation of unmanaged natural resources, which lowers their long-term productivity, is a central challenge facing societies. While effective top-down management is a possible solution, it is not available if the resource is outside the jurisdictional bounds of any management entity, or if existing institutions cannot effectively impose sustainable-use rules. Under these conditions, alternative approaches to natural resource governance are required. Here, we study revenue-sharing clubs as a mechanism by which resource users can mitigate their income volatility and importantly, as a co-benefit, are also incentivized to reduce their effort, leading to reduced over-exploitation and improved resource governance. We use game theoretic analyses and agent-based modeling to determine the conditions in which revenue-sharing can be beneficial for resource management as well as resource users. We find that revenue-sharing agreements can emerge and lead to improvements in resource management when there is large variability in production/revenue and when this variability is uncorrelated across members of the revenue-sharing club. Further, we show that if members of the revenue-sharing collective can sell their product at a price premium, then the range of ecological and economic conditions under which revenue-sharing can be a tool for management greatly expands. These results have implications for the design of bottom-up management, where resource users themselves are incentivized to operate in ecologically sustainable and economically advantageous ways.

Progress Toward Universal Health Coverage: A Comparative Analysis in 5 South Asian Countries.

Importance: Achieving universal health coverage is one of the key targets in the newly adopted Sustainable Development Goals of the United Nations. Objective: To investigate progress toward universal health coverage in 5 South Asian countries and assess inequalities in health services and financial risk protection indicators. Design and Settings: In a population-based study, nationally representative household (335 373 households) survey data from Afghanistan (2014 and 2015), Bangladesh (2010 and 2014), India (2012 and 2014), Nepal (2014 and 2015), and Pakistan (2014) were used to calculate relative indices of health coverage, financial risk protection, and inequality in coverage among wealth quintiles. The study was conducted from June 2012 to February 2016. Main Outcomes and Measures: Three dimensions of universal health coverage were assessed: access to basic services, financial risk protection, and equity. Composite and indicator-specific coverage rates, stratified by wealth quintiles, were then estimated. Slope and relative index of inequality were used to assess inequalities in service and financial indicators. Results: Access to basic care varied substantially across all South Asian countries, with mean rates of overall prevention coverage and treatment coverage of 53.0% (95% CI, 42.2%-63.6%) and 51.2% (95% CI, 45.2%-57.1%) in Afghanistan, 76.5% (95% CI, 61.0%-89.0%) and 44.8% (95% CI, 37.1%-52.5%) in Bangladesh, 74.2% (95% CI, 57.0%-88.1%) and 83.5% (95% CI, 54.4%-99.1%) in India, 76.8% (95% CI, 66.5%-85.7%) and 57.8% (95% CI, 50.1%-65.4%) in Nepal, and 69.8% (95% CI, 58.3%-80.2%) and 50.4% (95% CI, 37.1%-63.6%) in Pakistan. Financial risk protection was generally low, with 15.3% (95% CI, 14.7%-16.0%) of respondents in Afghanistan, 15.8% (95% CI, 14.9%-16.8%) in Bangladesh, 17.9% (95% CI, 17.7%-18.2%) in India, 11.8% (95% CI, 11.8%-11.9%) in Nepal, and 4.4% (95% CI, 4.0%-4.9%) in Pakistan reporting incurred catastrophic payments due to health care costs. Access to at least 4 antenatal care visits, institutional delivery, and presence of skilled attendant during delivery were at least 3 times higher among the wealthiest mothers in Afghanistan, Bangladesh, Nepal, and Pakistan compared with the rates among poor mothers. Access to institutional delivery was 60 to 65 percentage points higher among wealthy than poor mothers in Afghanistan, Bangladesh, Nepal, and Pakistan compared with 21 percentage points higher in India. Coverage was least equitable among the countries for adequate sanitation, institutional delivery, and the presence of skilled birth attendants. Conclusions and Relevance: Health coverage and financial risk protection was low, and inequality in access to health care remains a serious issue for these South Asian countries. Greater progress is needed to improve treatment and preventive services and financial security.

Performance-Based Risk-Sharing Arrangements: An Updated International Review.

Enthusiasm for performance-based risk-sharing arrangements (PBRSAs) continues but at variable pace across countries. Our objective was to identify and characterize publicly available cases and related trends for these arrangements. We performed a review of PBRSAs from 1993 to 2016 using the University of Washington PBRSA Database. Arrangements were categorized according to a previously published taxonomy. Macro-level trends were identified related to the timing of adoption, countries involved, types of arrangements, and disease areas. Our search yielded 437 arrangements. Among these, 183 (41.9%) were categorized as currently active, while 58.1% have expired. Five main types of arrangements have been identified, namely coverage with evidence development (149 cases, 34.1%), performance-linked reimbursement (104 cases, 23.8%), conditional treatment continuation (78 cases, 17.8%), financial or utilization (71 cases, 16.2%), and hybrid schemes with multiple components (35 cases, 8.0%). The pace of adoption varies across countries but has renewed an upward trend after a lull in 2012/2013. Conditions in the USA may be changing toward a more favorable environment of PBRSAs. Interest in PBRSAs remains high, suggesting they are a viable coverage and reimbursement mechanism for a wide range of medical products.

USING CLAIMS DATA FOR EVIDENCE GENERATION IN MANAGED ENTRY AGREEMENTS.

OBJECTIVES: This study assesses the use of routinely collected claims data for managed entry agreements (MEA) in the illustrative context of German statutory health insurance (SHI) funds. METHODS: Based on a nonsystematic literature review, the data needs of different MEA were identified. A value-based typology to classify MEA on the basis of these data needs was developed. The typology is oriented toward health outcomes and utilization and costs, key components of a new technology's value. For each MEA type, the suitability of claims data in establishing evidence of the novel technology's value in routine care was systematically assessed. Assessment criteria were data availability, completeness, timeliness, confidentiality, reliability, and validity. RESULTS: Claims data are better suited to MEA addressing uncertainty regarding the utilization and costs of a novel technology in routine care. In schemes where safety aspects or clinical effectiveness are assessed, the role of claims data is limited because clinical information is not included in sufficient detail. CONCLUSIONS: The suitability of claims data depends on the source of uncertainty and, in consequence, the outcome measures chosen in the agreements. In all schemes, the validity of claims data should be judged with caution as data are collected for billing purposes. This framework may support manufacturers and payers in selecting the most suitable contract type and agreeing on contract conditions. More research is necessary to validate these results and to address remaining medical, economic, legal, and ethical questions of using claims data for MEA.

Private sector risk-sharing agreements in the United States: trends, barriers, and prospects.

OBJECTIVES: Risk-sharing agreements (RSAs) between drug manufacturers and payers link coverage and reimbursement to real-world performance or utilization of medical products. These arrangements have garnered considerable attention in recent years. However, greater use outside the United States raises questions as to why their use has been limited in the US private sector, and whether their use might increase in the evolving US healthcare system. STUDY DESIGN: To understand current trends, success factors, and challenges in the use of RSAs, we conducted a review of RSAs, interviews, and a survey to understand key stakeholders' experiences and expectations for RSAs in the US private sector. METHODS: Trends in the numbers of RSAs were assessed using a database of RSAs. We also conducted in-depth interviews with stakeholders from pharmaceutical companies, payer organizations, and industry experts in the United States and European Union. In addition, we administered an online survey with a broader audience to identify perceptions of the future of RSAs in the United States. RESULTS: Most manufacturers and payers expressed interest in RSAs and see potential value in their use. Due to numerous barriers associated with outcomes-based agreements, stakeholders were more optimistic about financial-based RSAs. In the US private sector, however, there remains considerable interest--improved data systems and shifting incentives (via health reform and accountable care organizations) may generate more action. CONCLUSIONS: In the US commercial payer markets, there is continued interest among some manufacturers and payers in outcomes-based RSAs. Despite continued discussion and activity, the number of new agreements is still small.

Accountable Care Organizations: The National Landscape.

There are now more than seven hundred accountable care organizations (ACOs) in the United States. This article describes some of their most salient characteristics including the number and types of contracts involved, organizational structures, the scope of services offered, care management capabilities, and the development of a three-category taxonomy that can be used to target technical assistance efforts and to examine performance. The current evidence on the performance of ACOs is reviewed. Since California has the largest number of ACOs (N=67) and a history of providing care under risk-bearing contracts, some additional assessments of quality and patient experience are made between California ACOs and non-ACO provider organizations. Six key issues likely to affect future ACO growth and development are discussed, and some potential "diagnostic" indicators for assessing the likelihood of potential antitrust violations are presented.

The Economics of Provider Payment Reform: Are Accountable Care Organizations the Answer?

A remarkable consensus has developed that the fee-for-service (FFS) approach for paying medical providers must be replaced. This payment approach is said to increase the volume of services without improving care coordination. In response to these calls, Medicare and private payers are experimenting with payment systems that combine the basic element of FFS - a fee for each service - with arrangements that allow providers to share the savings if they hold total spending per patient below a targeted amount. Medicare's accountable care organizations (ACOs) embody the shared savings approach to payment reform. Private payers have introduced total cost of care contracting (TCOC) in several locations. This article questions the consensus that FFS must go. If the fees are too high, then someone needs to "bite the bullet" and reduce fees in key areas. Hoping to control overspending by investment in ACOs is wishful thinking. I describe the theory and practice of shared savings payment systems and summarize recent TCOC contracting initiatives in the private sector. Medicare's shared savings approach is likely to be less effective than private contracts. Cutting providers' fees would be more efficient. Finally, the new payment models in the Affordable Care Act will not ease the problem of high prices for private payers.

Growth of Accountable Care Organizations in California: Number, Characteristics, and State Regulation.

Accountable care organizations (ACOs) result in physician organizations' and hospitals' receiving risk-based payments tied to costs, health care quality, and patient outcomes. This article (1) describes California ACOs within Medicare, the commercial market, and Medi-Cal and the safety net; (2) discusses how ACOs are regulated by the California Department of Managed Health Care and the California Department of Insurance; and (3) analyzes the increase of ACOs in California using data from Cattaneo and Stroud. While ACOs in California are well established within Medicare and the commercial market, they are still emerging within Medi-Cal and the safety net. Notwithstanding, the state has not enacted a law or issued a regulation specific to ACOs; they are regulated under existing statutes and regulations. From August 2012 to February 2014, the number of lives covered by ACOs increased from 514,100 to 915,285, representing 2.4 percent of California's population, including 10.6 percent of California's Medicare fee-for-service beneficiaries and 2.3 percent of California's commercially insured lives. By emphasizing health care quality and patient outcomes, ACOs have the potential to build and improve on California's delegated model. If recent trends continue, ACOs will have a greater influence on health care delivery and financial risk sharing in California.

Accountable Care Organizations: Integrated Care Meets Market Power.

Will accountable care organizations (ACOs) deliver high-quality care at lower costs? Or will their potential market power lead to higher prices and lower quality? ACOs appear in various forms and structures with financial and clinical integration at their core; however, the tools to assess their quality and the incentive structures that will determine their success are still evolving. Both market forces and regulatory structures will determine how these outcomes emerge. This introduction reviews the evidence presented in this special issue to tackle this thorny trade-off. In general the evidence is promising, but the full potential of ACOs to improve the health care delivery system is still uncertain. This introductory review concludes that the current consensus is to let ACOs grow, anticipating that they will make a contribution to improve our poor-quality and high-cost delivery system.

Partnering with payers? Key lessons to keep in mind.

Key factors healthcare leaders might wish to consider when evaluating potential partnerships with payers include: Use of safeguards to prevent a payer from using benefit design to shift expected volume from high-revenue service lines or channels. Right to participate in narrow networks. Use of segment-specific language, which protects providers from payers that may try to extend a rate decrease from one patient segment to another. Exclusive co-branding. Automatic price increases if volume is not achieved.