Financial ''risk-sharing'' or refund programs in assisted reproduction: an Ethics Committee opinion.

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016.

Informal risk-sharing between smallholders may be threatened by formal insurance: Lessons from a stylized agent-based model.

Microinsurance is promoted as a valuable instrument for low-income households to buffer financial losses due to health or climate-related risks. However, apart from direct positive effects, such formal insurance schemes can have unintended side effects when insured households lower their contribution to traditional informal arrangements where risk is shared through private monetary support. Using a stylized agent-based model, we assess impacts of microinsurance on the resilience of those smallholders in a social network who cannot afford this financial instrument. We explicitly include the decision behavior regarding informal transfers. We find that the introduction of formal insurance can have negative side effects even if insured households are willing to contribute to informal risk arrangements. However, when many households are simultaneously affected by a shock, e.g. by droughts or floods, formal insurance is a valuable addition to informal risk-sharing. By explicitly taking into account long-term effects of short-term transfer decisions, our study allows to complement existing empirical research. The model results underline that new insurance programs have to be developed in close alignment with established risk-coping instruments. Only then can they be effective without weakening functioning aspects of informal risk management, which could lead to increased poverty.

Strategy and risk sharing in hospital-postacute care integration.

ISSUE/TREND: Postacute care has been identified as a primary area for cost containment. The continued shift of payment structures from volume to value has often put hospitals at the forefront of addressing postacute care cost containment. However, hospitals continue to struggle with models to manage patients in postacute care institutions, such as skilled nursing facilities or in home health agencies. Recent research has identified postacute care network development as one mechanism to improve outcomes for patients sent to postacute care providers. Many hospitals, though, have not utilized this strategy for fear of not adhering to Centers for Medicare & Medicaid Services requirements that patients are given choice when discharged to postacute care. MANAGERIAL APPROACH: A hospital's approach to postacute care integration will be dictated by environmental uncertainty and the level of embeddedness hospitals have with potential postacute care partners. Hospitals, though, must also consider how and when to extend shared savings to postacute care partners, which will be based on the complexity of the risk-sharing calculation, the ability to maintain network flexibility, and the potential benefits of preserving competition and innovation among the network members. For hospital leaders, postacute care network development should include a robust and transparent data management process, start with an embedded network that maintains network design flexibility, and include a care management approach that includes patient-level coordination. CONCLUSION: The design of care management models could benefit from elevating the role of postacute care providers in the current array of risk-based payment models, and these providers should consider developing deeper relationships with select postacute care providers to achieve cost containment.

Utilization of Predictive Modeling to Determine Episode of Care Costs and to Accurately Identify Catastrophic Cost Nonwarranty Outlier Patients in Adult Spinal Deformity Surgery: A Step Toward Bundled Payments and Risk Sharing.

STUDY DESIGN: Retrospective review of prospectively-collected, multicenter adult spinal deformity (ASD) database. OBJECTIVE: The aim of this study was to evaluate the rate of patients who accrue catastrophic cost (CC) with ASD surgery utilizing direct, actual costs, and determine the feasibility of predicting these outliers. SUMMARY OF BACKGROUND DATA: Cost outliers or surgeries resulting in CC are a major concern for ASD surgery as some question the sustainability of these surgical treatments. METHODS: Generalized linear regression models were used to explain the determinants of direct costs. Regression tree and random forest models were used to predict which patients would have CC (>$100,000). RESULTS: A total of 210 ASD patients were included (mean age of 59.3 years, 83% women). The mean index episode of care direct cost was $70,766 (SD = $24,422). By 90 days and 2 years following surgery, mean direct costs increased to $74,073 and $77,765, respectively. Within 90 days of the index surgery, 11 (5.2%) patients underwent 13 revisions procedures, and by 2 years, 26 (12.4%) patients had undergone 36 revision procedures. The CC threshold at the index surgery and 90-day and 2-year follow-up time points was exceeded by 11.9%, 14.8%, and 19.1% of patients, respectively. Top predictors of cost included number of levels fused, surgeon, surgical approach, interbody fusion (IBF), and length of hospital stay (LOS). At 90 days and 2 years, a total of 80.6% and 64.0% of variance in direct cost, respectively, was explained in the generalized linear regression models. Predictors of CC were number of fused levels, surgical approach, surgeon, IBF, and LOS. CONCLUSION: The present study demonstrates that direct cost in ASD surgery can be accurately predicted. Collectively, these findings may not only prove useful for bundled care initiatives, but also may provide insight into means to reduce and better predict cost of ASD surgery outside of bundled payment plans. LEVEL OF EVIDENCE: 3.

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.

How to solve financing gap to ensure patient access to patented pharmaceuticals in CEE countries? - the good, the bad, and the ugly ways.

Introduction: There is significant difference in utilization of patented medicines in the EU, as pharmaceuticals at Western European price levels are usually not cost-effective in Central and Eastern European (CEE) countries. The article reviews options to solve the 'financing gap' posed by the challenge of covering patented medicines from more restricted resources in countries with greater unmet medical need.Areas covered: Hidden volume restrictions to patented pharmaceuticals implemented by payers to facilitate financial sustainability may increase European inequity in patient access. Confidential price discounts and financial risk-sharing agreements improve cost-effectiveness of pharmaceuticals with limited impact on the European floor price. Narrowing the eligible group of patients on the positive drug list can help to target the medicines to patients with potentially greater health benefit whilst reducing the budget impact. Pay-for-performance schemes can improve cost-effectiveness of pharmaceuticals with significant uncertainty or heterogeneity in the magnitude of added therapeutic value. Increased utilization of off-patent pharmaceuticals can increase patient access through re-investing the savings from generic or biosimilar price erosion.Expert opinion: Transparent and sustainable pharmaceutical policies aiming to improve the allocative efficiency of scarce resources should be implemented in CEE to reduce financing gap and improve patient access to high-cost medicines.

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.

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.

Impacts of shifting responsibility for high-cost individuals on Health Insurance Exchange plan premiums and cost-sharing provisions.

Insurance companies can respond to increases in expected per-capita healthcare expenditures by adjusting premiums, cost-sharing requirements, and/or plan generosity. We use a Difference-in-Difference model with Plan-level Fixed Effects to estimate the impacts of increases in expected expenditures generated by closure of state-operated High Risk Pools (HRPs). For Silver plans, we find that issuers responded to HRP closures by increasing both premiums and deductibles, and by increasing the ratios of premiums to deductibles. This adjustment to the structure of plan prices is consistent with the hypothesis that issuers will be reluctant to adjust deductibles, because consumers tend to overweight changes in deductibles over changes in premiums. The increase in the ratio of premiums to deductibles indicates that the increase in expected expenditures triggered an increase in the share of total risk-pool healthcare expenditures paid by low healthcare utilizers, and a decrease in the share paid by high utilizers.

The 2018 risk-adjustment reform in the Czech Republic: Introducing Pharmacy-based Cost Groups and strengthening reinsurance.

BACKGROUND: Risk-adjustment in resource allocation is commonly used for regional redistribution or for eliminating risk selection motives of multiple statutory health insurers. In the Czech Republic, revenue redistribution between health insurers takes place since the 1990's. Since 2018, the risk-adjustment mechanism includes an adjustment for insured with chronic diseases using Pharmacy-based Cost Group (PCG) classification. In addition, retrospective compensation for very high cost patients has been strengthened. AIM: To provide an internationally relevant overview of the Czech risk-adjustment system. To assess the implication of the 2018 reform for health insurers and for the development of chronic care. METHOD: The framework of the Health Reform Monitor is used to analyse the policy process. Data from Czech health insurers and Czech Ministry of Health are used to assess likely impact of the reform. RESULTS: The reform increases coverage of predictable individual health risks and combines prospective risk-rating with strengthened retrospective risk-sharing among insurers. The reform results in moderate changes in risk-adjusted allocations of individual insurers. CONCLUSION: The Czech experience with risk-adjustment reforms is relevant for countries with multiple health insurers as well as for countries with risk-adjusted regional redistribution mechanisms. Combining prospective risk factors of age, sex, and PCGs with retrospective compensation of expensive cases limits potential losses to a manageable level, also for small risk-pools. It reduces incentives for cream skimming based on health status, enables higher use of risk-sharing contracts, and incentivizes the development of disease management programs in the Czech Republic.

Measuring financial risk protection in health benefits packages: scoping review protocol to inform allocative efficiency studies.

INTRODUCTION: To progress towards Universal Health Coverage (UHC), countries will need to define a health benefits package of services free at the point of use. Financial risk protection is a core component of UHC and should therefore be considered a key dimension of health benefits packages. Allocative efficiency modelling tools can support national analytical capacity to inform an evidence-based selection of services, but none are currently able to estimate financial risk protection. A review of existing methods used to measure financial risk protection can facilitate their inclusion in modelling tools so that the latter can become more relevant to national decision making in light of UHC. METHODS AND ANALYSIS: This protocol proposes to conduct a scoping review of existing methods used to measure financial risk protection and assess their potential to inform the selection of services in a health benefits package. The proposed review will follow the methodological framework developed by Arksey and O'Malley and the subsequent recommendations made by Levac et al. Several databases will be systematically searched including: (1) PubMed; (2) Scopus; (3) Web of Science and (4) Google Scholar. Grey literature will also be scanned, and the bibliography of all selected studies will be hand searched. Following the selection of studies according to defined inclusion and exclusion criteria, key characteristics will be collected from the studies using a data extraction tool. Key characteristics will include the type of method used, geographical region of focus and application to specific services or packages. The extracted data will then be charted, collated, reported and summarised using descriptive statistics, a thematic analysis and graphical presentations. ETHICS AND DISSEMINATION: The scoping review proposed in this protocol does not require ethical approval. The final results will be disseminated via publication in a peer-reviewed journal, conference presentations and shared with key stakeholders.

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.

Assessing the Promise and Risks of Income-Based Third-Party Payment Programs.

Issue: Consumers' concerns about affordability limit participation in ACA marketplaces. Funded by local hospital systems and run by independent nonprofits, third-party payment (TPP) programs improve affordability for low-income consumers by paying premium costs not covered by tax credits. Goal: To assess the potential of TPP to make marketplace coverage more affordable, without harming insurance risk pools. Methods: Interviews in May and June 2016 with program administrators, hospital systems, carriers, and consumer groups in five localities and the Washington State marketplace. Key Findings: The most effective local program reached 1,148 people, or 25 percent of all eligible marketplace enrollees. Other local programs served between 202 and 934 consumers; the Washington State program reached 1,133. Findings suggest that without TPP, numerous beneficiaries would have remained uninsured. Hospitals funding these programs reported net financial benefits, with declines in uncompensated care exceeding program costs. Carriers reported no adverse selection in these carefully designed programs. Conclusions: Widespread adoption of TPP could help additional low-income consumers obtain marketplace coverage. Hospitals' financial gains from TPP programs make replication more feasible. However, broader policies, such as increased premium tax credits and cost-sharing reductions, are likely needed for major nationwide improvements to affordability.

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.

The Hidden Roles That Management Partners Play In Accountable Care Organizations.

Accountable care organizations (ACOs) are often discussed and promoted as driven by physicians, hospitals, and other health care providers. However, because of the flexible nature of ACO contracts, management organizations may also become partners in ACOs. We used data from 2013-15 on 276 ACOs from the National Survey of Accountable Care Organizations to understand the prevalence of nonprovider management partners' involvement in ACOs, the services these partners provide, and the structure of ACOs that have such partners. We found that 37 percent of ACOs reported having a management partner, and two-thirds of these ACOs reported that the partner shared in the financial risks or rewards. Among ACOs with partners, 94 percent had data services provided by the partner, 87 percent received administrative services, 68 percent received educational services, and 66 percent received care coordination services. Half received all four of these services from their partner. ACOs with partners were more heavily primary care than other ACOs. ACOs with and without partners had similar performance on costs and quality in Medicare ACO programs. Our findings suggest that management partners play a central role in many ACOs, perhaps supplying smaller and physician-run ACOs with services or expertise perceived as necessary for ACO success.

Payer and Pharmaceutical Manufacturer Considerations for Outcomes-Based Agreements in the United States.

BACKGROUND: Considerable interest exists among health care payers and pharmaceutical manufacturers in designing outcomes-based agreements (OBAs) for medications for which evidence on real-world effectiveness is limited at product launch. OBJECTIVES: To build hypothetical OBA models in which both payer and manufacturer can benefit. METHODS: Models were developed for a hypothetical hypercholesterolemia OBA, in which the OBA was assumed to increase market access for a newly marketed medication. Fixed inputs were drug and outcome event costs from the literature over a 1-year OBA period. Model estimates were developed using a range of inputs for medication effectiveness, medical cost offsets, and the treated population size. Positive or negative feedback to the manufacturer was incorporated on the basis of expectations of drug performance through changes in the reimbursement level. Model simulations demonstrated that parameters had the greatest impact on payer cost and manufacturer reimbursement. RESULTS: Models suggested that changes in the size of the population treated and drug effectiveness had the largest influence on reimbursement and costs. Despite sharing risk for potential product underperformance, manufacturer reimbursement increased relative to having no OBA, if the OBA improved market access for the new product. Although reduction in medical costs did not fully offset the cost of the medication, the payer could still save on net costs per patient relative to having no OBA by tying reimbursement to drug effectiveness. CONCLUSIONS: Pharmaceutical manufacturers and health care payers have demonstrated interest in OBAs, and under a certain set of assumptions both may benefit.

Evaluation of a pharmaceutical risk-sharing agreement when patients are screened for the probability of success.

We analyze a game-theoretic model of a risk-sharing agreement between a payer and a pharmaceutical firm. The drug manufacturer chooses the price while the payer sets the rebate rate and decides which patients are eligible for treatment. The manufacturer provides the payer with a rebate for nonresponding patients. We generalize on the existing literature, by making both price and rebate rate decision variables, allowing the rebate rate to be different from 100%, and incorporating 2 types of administrative costs. We identify a threshold for the expected probability of response for classifying the drug as a mass-market or niche type and investigate the optimal solutions for both types. We also identify a threshold for the rebate rate at which the net benefits become equal for responding and nonresponding patients. Through numerical examples, we examine how various parameters impact the drug manufacturer's and the payer's optimal solution.

If Congress Won't Salvage Reinsurance, State Waivers May Offer a Workaround.

Shards of a bipartisan effort to stabilize the individual health insurance markets emerged. They focused mostly on resurrecting the ACA cost-reduction payments and giving states flexibility to come up with their own ideas, like reinsurance, for shoring up the troubled individual market.

Stabilizing individual health insurance markets with subsidized reinsurance.

Subsidized reinsurance represents a potentially important tool to help stabilize individual health insurance markets. This brief describes alternative forms of subsidized reinsurance and the mechanisms by which they spread risk and reduce premiums. It summarizes specific state initiatives and Congressional proposals that include subsidized reinsurance. It compares approaches to each other and to more direct subsidies of individual market enrollment. For a given amount of funding, a particular program's efficacy will depend on how it affects insurers' risk and the risk margins built into premiums, incentives for selecting or avoiding risks, incentives for coordinating and managing care, and the costs and complexity of administration. These effects warrant careful consideration by policymakers as they consider measures to achieve stability in the individual market in the long term.