Suggesting global insights to local challenges: expanding financing of rehabilitation services in low and middle-income countries.

Purpose: Following the rapid transition to non-communicable diseases, increases in injury, and subsequent disability, the world-especially low and middle-income countries (LMICs)-remains ill-equipped for increased demand for rehabilitative services and assistive technology. This scoping review explores rehabilitation financing models used throughout the world and identifies "state of the art" rehabilitation financing strategies to identify opportunities and challenges to expand financing of rehabilitation. Material and methods: We searched peer-reviewed and grey literature for articles containing information on rehabilitation financing in both LMICs and high-income countries. Results: Forty-two articles were included, highlighting various rehabilitation financing mechanism which involves user fees and other innovative payment as bundled or pooled schemes. Few studies explore policy options to increase investment in the supply of services. Conclusion: this paper highlights opportunities to expand rehabilitation services, namely through promotion of private investment, improvement in provider reimbursement mechanism as well as expanding educational grants to bolster labor supply incentive, and the investment in public and private insurance schemes. Mechanisms of reimbursement are frequently based on global budget and salary which are helpful to control cost escalation but represent important barriers to expand supply and quality of services.

Design of an innovative digital application to facilitate access to healthy foods in low-income urban settings.

Background: Under-resourced urban minority communities in the United States are characterized by food environments with low access to healthy foods, high food insecurity, and high rates of diet-related chronic disease. In Baltimore, Maryland, low access to healthy food largely results from a distribution gap between small food sources (retailers) and their suppliers. Digital interventions have the potential to address this gap, while keeping costs low. Methods: In this paper, we describe the technical (I) front-end design and (II) back-end development process of the Baltimore Urban food Distribution (BUD) application (app). We identify and detail four main phases of the process: (I) information architecture; (II) low and high-fidelity wireframes; (III) prototype; and (IV) back-end components, while considering formative research and a pre-pilot test of a preliminary version of the BUD app. Results: Our lessons learned provide valuable insight into developing a stable app with a user-friendly experience and interface, and accessible cloud computing services for advanced technical features. Conclusions: Next steps will involve a pilot trial of the app in Baltimore, and eventually, other urban and rural settings nationwide. Once iterative feedback is incorporated into the app, all code will be made publicly available via an open source repository to encourage adaptation for desired communities. Trial Registration: ClinicalTrials.gov NCT05010018.

Improving COVID-19 vaccine uptake: a message co-design process for a national mHealth intervention in Colombia.

BACKGROUND: COVID-19 vaccination is a global priority. Latin American countries have some of the highest COVID-19 death rates worldwide with vaccination hampered by a variety of reasons, including mis- and disinformation, vaccine hesitancy, and vaccine supply constraints. Addressing vaccine hesitancy through effective messages has been found to help increase vaccine uptake. Participatory processes could be used to co-design health messages for this purpose. OBJECTIVE: This article describes the methodology used to co-design evidence-based audio messages to be deployed in a cohort of individuals through an interactive voice response (IVR) mobile phone survey intervention, aimed towards increasing vaccination uptake in an adult population in Colombia. METHODS: Participants of the COVID-19 vaccination message co-design process included a sample of the general population of the country, representatives of the funder organisation, and research team members. The co-design process consisted of four phases: (1) formative quantitative and qualitative research, (2) message drafting based on the results of the formative research, (3) message content evaluation, and (4) evaluation of the voices to deliver the audio messages; and was informed by reflexive meetings. RESULTS: Three categories of evidence-based audio messages were co-designed, each corresponding to an arm of the mHealth intervention: (1) factual messages, (2) narrative messages, and (3) mixed messages. An additional fourth arm with no message was proposed for control. The iterative co-design process ended with a total of 14 audio messages recorded to be deployed via the intervention. CONCLUSIONS: Co-developing health messages in response to health emergencies is possible. Adopting more context-relevant, participatory, people-centred, and reflexive multidisciplinary approaches could help develop solutions that are more responsive to the needs of populations and public health priorities. Investing resources in message co-design is deemed to have a greater potential for influencing behaviours and improving health outcomes.

Examining Opportunities to Increase Savings From Medicare Price Negotiations.

Importance: Allowing the US Centers for Medicare & Medicaid Services to negotiate prescription drug prices for Medicare may improve drug affordability. Objective: To estimate savings from Medicare price negotiation under the Inflation Reduction Act (IRA) and examine opportunities to increase savings. Design, Setting, and Participants: This cross-sectional, population-based study used data from 2020 Medicare prescription drug claims. The study was conducted and data were analyzed in 2022. Exposures: Eligibility for Medicare price negotiation under the IRA and alternative criteria. Main Outcomes and Measures: Minimum savings under the IRA's eligibility criteria were estimated and compared with savings within alternative scenarios, including (1) selecting drugs for negotiation based on net spending after rebates rather than gross spending; (2) extending eligibility to drugs with biosimilar or generic competitors; (3) reducing the minimum years since US Food and Drug Administration approval for eligibility; and (4) changing 2 or 3 of these factors. Estimated savings were calculated at different levels of scale-up of price negotiation under the IRA, from 10 Part D drugs in 2026 to 60 Part B and D drugs in 2029. Gross spending was calculated using the US Centers for Medicare & Medicaid Services 2020 Medicare drug spending dashboard. Rebates were estimated using SSR Health data. Information on FDA approvals, generics, and biosimilars was obtained from FDA websites. Results: Under IRA rules, estimated minimum savings from price negotiation in 2026 for 10 Part D drugs would be $3.2 billion. For 2029 for 60 Part D and B drugs, estimated savings were $16.0 billion. Selecting drugs for negotiation based on net rather than gross spending would be associated with estimated savings of $4.6 billion (a 45% increase) in 2026 and $18.9 billion (an 18% increase) in 2029. Including drugs with generic competitors or biosimilars would be associated with an estimated savings of $6.6 billion (a 109% increase) in 2026 and $24.9 billion (a 56% increase) in 2029. Making both changes would be associated with savings of $9.5 billion (a 200% increase) in 2026 and $28.3 billion (a 77% increase) in 2029. A sensitivity analysis suggested that reducing the required number of years since marketing approval by 2 years would be associated with increased estimated savings of 4% when 10 Part D drugs are negotiated and 12% when 60 Part D and B drugs are negotiated. Changing all 3 criteria would be associated with the greatest increase in estimated savings in 2029 (119% increase when 10 Part D drugs are negotiated and 93% increase for 60 Part D and B drugs). Conclusions and Relevance: The results of this cross-sectional study suggest that adjusting the eligibility criteria for Medicare prescription drug price negotiation to permit inclusion of drugs with biosimilar or generic competitors and selecting drugs based on net rather than gross spending may be a promising approach to substantially increase estimated savings.

The price paradox of biosimilar-like long-acting insulin.

OBJECTIVES: To describe the uptake and out-of-pocket (OOP) costs of Basaglar, the first long-acting insulin biosimilar, in a commercially insured population in the United States. STUDY DESIGN: Retrospective analysis of commercial pharmacy claims and pharmacy co-payment offsets. METHODS: We assessed Basaglar uptake by examining trends in the composition of the long-acting insulin market in the United States from 2014 to 2018. As patient demographics and plan type may be important determinants of biosimilar uptake, we also assessed characteristics of all long-acting insulin users by drug. We examined Basaglar OOP costs by assessing mean OOP costs per claim for users of Basaglar and other long-acting insulins, overall and by plan type, and the number and source of co-payment offsets for Basaglar and other insulin glargine products from Basaglar market entry through 2018. We used multivariate linear models to examine the relationship between Basaglar OOP expenditures and insurer-negotiated amounts, overall and by plan type. RESULTS: Basaglar experienced a rapid uptake. However, there was no evidence that Basaglar users had lower OOP costs than reference product (Lantus) users. CONCLUSIONS: Given our results and the approval of the first interchangeable biosimilar, we recommend the empirical evaluation of biosimilar cost savings to patients and insurers prior to promoting their automatic substitution.

The Baltimore Urban Food Distribution (BUD) App: Study Protocol to Assess the Feasibility of a Food Systems Intervention.

Low-income urban communities in the United States commonly lack ready access to healthy foods. This is due in part to a food distribution system that favors the provision of high-fat, high-sugar, high-sodium processed foods to small retail food stores, and impedes their healthier alternatives, such as fresh produce. The Baltimore Urban food Distribution (BUD) study is a multilevel, multicomponent systems intervention that aims to improve healthy food access in low-income neighborhoods of Baltimore, Maryland. The primary intervention is the BUD application (app), which uses the power of collective purchasing and delivery to affordably move foods from local producers and wholesalers to the city's many corner stores. We will implement the BUD app in a sample of 38 corner stores, randomized to intervention and comparison. Extensive evaluation will be conducted at each level of the intervention to assess overall feasibility and effectiveness via mixed methods, including app usage data, and process and impact measures on suppliers, corner stores, and consumers. BUD represents one of the first attempts to implement an intervention that engages multiple levels of a local food system. We anticipate that the app will provide a financially viable alternative for Baltimore corner stores to increase their stocking and sales of healthier foods, subsequently increasing healthy food access and improving diet-related health outcomes for under-resourced consumers. The design of the intervention and the evaluation plan of the BUD project are documented here, including future steps for scale-up. Trial registration #: NCT05010018.

Trajectories of prices in generic drug markets: what can we infer from looking at trajectories rather than average prices?

BACKGROUND: Well-functioning competitive markets are key to controlling generic drug prices. This is important since over 90% of all drugs sold in the US are generics. Recently, there have been examples of large price increases in the generic market. METHODS: This paper examines price trajectories for generic drugs using a group-based trajectory modelling approach (GBTM). We fit the model using quarterly price information in the IBM MarketScan claims database for the past decade. RESULTS: We identify three dominant price trajectories for this period: rapid increase trajectories, slow decline and rapid decline. Most generic drugs show a slow or a rapid decline in price trajectories. However, around 17% of all generic drugs show rapid price increase trajectories. CONCLUSIONS: As Congress is exploring an excise tax on drugs whose list price increases faster than the rate of inflation, we discuss what drugs would be most likely to be affected by this law.

A Novel Score for mHealth Apps to Predict and Prevent Mortality: Further Validation and Adaptation to the US Population Using the US National Health and Nutrition Examination Survey Data Set.

BACKGROUND: The C-Score, which is an individual health score, is based on a predictive model validated in the UK and US populations. It was designed to serve as an individualized point-in-time health assessment tool that could be integrated into clinical counseling or consumer-facing digital health tools to encourage lifestyle modifications that reduce the risk of premature death. OBJECTIVE: Our study aimed to conduct an external validation of the C-Score in the US population and expand the original score to improve its predictive capabilities in the US population. The C-Score is intended for mobile health apps on wearable devices. METHODS: We conducted a literature review to identify relevant variables that were missing in the original C-Score. Subsequently, we used data from the 2005 to 2014 US National Health and Nutrition Examination Survey (NHANES; N=21,015) to test the capacity of the model to predict all-cause mortality. We used NHANES III data from 1988 to 1994 (N=1440) to conduct an external validation of the test. Only participants with complete data were included in this study. Discrimination and calibration tests were conducted to assess the operational characteristics of the adapted C-Score from receiver operating curves and a design-based goodness-of-fit test. RESULTS: Higher C-Scores were associated with reduced odds of all-cause mortality (odds ratio 0.96, P<.001). We found a good fit of the C-Score for all-cause mortality with an area under the curve (AUC) of 0.72. Among participants aged between 40 and 69 years, C-Score models had a good fit for all-cause mortality and an AUC >0.72. A sensitivity analysis using NHANES III data (1988-1994) was performed, yielding similar results. The inclusion of sociodemographic and clinical variables in the basic C-Score increased the AUCs from 0.72 (95% CI 0.71-0.73) to 0.87 (95% CI 0.85-0.88). CONCLUSIONS: Our study shows that this digital biomarker, the C-Score, has good capabilities to predict all-cause mortality in the general US population. An expanded health score can predict 87% of the mortality in the US population. This model can be used as an instrument to assess individual mortality risk and as a counseling tool to motivate behavior changes and lifestyle modifications.

Misinformation in nutrition through the case of coconut oil: An online before-and-after study.

BACKGROUND AND AIMS: Despite recent scientific evidence indicating absence of cardiometabolic benefit resulting from coconut oil intake, its consumption has increased in recent years, which can be attributed to a promotion of its use on social networks. We evaluated the patterns, reasons and beliefs related to coconut oil consumption and its perceived benefits in an online survey of a population in southern Brazil. METHODS AND RESULTS: We conducted a before-and-after study using an 11-item online questionnaire that evaluated coconut oil consumption. In the same survey, participants who consumed coconut oil received an intervention to increase literacy about the health effects of coconut oil intake. We obtained 3160 valid responses. Among participants who consumed coconut oil (59.1%), 82.5% considered it healthy and 65.4% used it at least once a month. 81.2% coconut oil consumers did not observe any health improvements. After being exposed to the conclusions of a meta-analysis showing that coconut oil does not show superior health benefits when compared to other oils and fats, 73.5% of those who considered coconut oil healthy did not change their opinion. Among individuals who did not consume coconut oil, 47.6% considered it expensive and 11.6% deemed it unhealthy. CONCLUSIONS: Coconut oil consumption is motivated by the responders' own beliefs in its supposed health benefits, despite what scientific research demonstrates. This highlights the difficulty in deconstructing inappropriate concepts of healthy diets that are disseminated in society.

Cost-Effectiveness of the COVID-19 Test, Trace and Isolate Program in Colombia.

BACKGROUND: During the COVID-19 pandemic, Test-Trace-Isolate (TTI) programs have been recommended as a risk mitigation strategy. However, many governments have hesitated to implement them due to their costs. This study aims to estimate the cost-effectiveness of implementing a national TTI program to reduce the number of severe and fatal cases of COVID-19 in Colombia. METHODS: We developed a Markov simulation model of COVID-19 infection combined with a Susceptible-Infected-Recovered structure. We estimated the incremental cost-effectiveness of a comprehensive TTI strategy compared to no intervention over a one-year horizon, from both the health system and the societal perspective. Hospitalization and mortality rates were retrieved from Colombian surveillance data. We included program costs of TTI intervention, health services utilization, PCR diagnosis test, productivity loss, and government social program costs. We used the number of deaths and quality-adjusted life years (QALYs) as health outcomes. Sensitivity analyses were performed. FINDINGS: Compared with no intervention, the TTI strategy reduces COVID-19 mortality by 67%. In addition, the program saves an average of $1,045 and $850 per case when observed from the social and the health system perspective, respectively. These savings are equivalent to two times the current health expenditures in Colombia per year. INTERPRETATION: The TTI program is a highly cost-effective public health intervention to reduce the burden of COVID-19 in Colombia. TTI programs depend on their successful and speedy implementation. FUNDING: This study was supported by the Colombian Ministry of Health through award number PUJ-04519-20 received by EPQ AVO and SDS declined to receive any funding support for this study. The contents are the responsibility of all the individual authors.

Design of financial incentive interventions to improve lifestyle behaviors and health outcomes: A systematic review.

Background: Financial incentives may improve the initiation and engagement of behaviour change that reduce the negative outcomes associated with non-communicable diseases. There is still a paucity in guidelines or recommendations that help define key aspects of incentive-oriented interventions, including the type of incentive (e.g. cash rewards, vouchers), the frequency and magnitude of the incentive, and its mode of delivery.  We aimed to systematically review the literature on financial incentives that promote healthy lifestyle behaviours or improve health profiles, and focused on the methodological approach to define the incentive intervention and its delivery. The protocol was registered at PROSPERO on 26 July 2018 ( CRD42018102556). Methods: We sought studies in which a financial incentive was delivered to improve a health-related lifestyle behaviour (e.g., physical activity) or a health profile (e.g., HbA1c in people with diabetes). The search (which took place on March 3 rd 2018) was conducted using OVID (MEDLINE and Embase), CINAHL and Scopus. Results: The search yielded 7,575 results and 37 were included for synthesis. Of the total, 83.8% (31/37) of the studies were conducted in the US, and 40.5% (15/37) were randomised controlled trials. Only one study reported the background and rationale followed to develop the incentive and conducted a focus group to understand what sort of incentives would be acceptable for their study population. There was a degree of consistency across the studies in terms of the direction, form, certainty, and recipient of the financial incentives used, but the magnitude and immediacy of the incentives were heterogeneous. Conclusions: The available literature on financial incentives to improve health-related lifestyles rarely reports on the rationale or background that defines the incentive approach, the magnitude of the incentive and other relevant details of the intervention, and the reporting of this information is essential to foster its use as potential effective interventions.

Buttermilk as Encapsulating Agent: Effect of Ultra-High-Pressure Homogenization on Chia Oil-in-Water Liquid Emulsion Formulations for Spray Drying.

Functional foods are highly demanded by consumers. Omega-3 rich oil and commercial buttermilk (BM), as functional components, used in combination to produce emulsions for further drying may facilitate the incorporation to foods. Ultra-high-pressure homogenization (UHPH) has a great potential for technological and nutritional aspects in emulsions production. The present study aimed to examine the potential improvement of UHPH technology in producing buttermilk-stabilized omega-3 rich emulsions (BME) for further drying, compared with conventional homogenization. Oil-in-water emulsions formulated with 10% chia: sunflower oil (50:50); 30% maltodextrin and 4 to 7% buttermilk were obtained by using conventional homogenization at 30 MPa and UHPH at 100 and 200 MPa. Particle size analysis, rheological evaluation, colloidal stability, zeta-potential measurement, and microstructure observations were performed in the BME. Subsequent spray drying of emulsions were made. As preliminary approximation for evaluating differences in the homogenization technology applied, encapsulation efficiency and morphological characteristics of on spray-dried emulsions (SDE) containing 21.3 to 22.7% oil content (dry basis) were selected. This study addresses the improvement in stability of BME treated by UHPH when compared to conventional homogenization and the beneficial consequences in encapsulation efficiency and morphology of SDE.

Race, ethnicity, poverty and the social determinants of the coronavirus divide: U.S. county-level disparities and risk factors.

BACKGROUND: Communities with more Black or Hispanic residents have higher coronavirus rates than communities with more White residents, but relevant community characteristics are underexplored. The purpose of this study was to investigate poverty-, race- and ethnic-based disparities and associated economic, housing, transit, population health and health care characteristics. METHODS: Six-month cumulative coronavirus incidence and mortality were examined using adjusted negative binomial models among all U.S. counties (n = 3142). County-level independent variables included percentages in poverty and within racial/ethnic groups (Black, Hispanic, Native American, Asian), and rates of unemployment, lacking a high school diploma, housing cost burden, single parent households, limited English proficiency, diabetes, obesity, smoking, uninsured, preventable hospitalizations, primary care physicians, hospitals, ICU beds and households that were crowded, in multi-unit buildings or without a vehicle. RESULTS: Counties with higher percentages of Black (IRR = 1.03, 95% CI: 1.02-1.03) or Hispanic (IRR = 1.02, 95% CI: 1.01-1.03) residents had more coronavirus cases. Counties with higher percentages of Black (IRR = 1.02, 95% CI: 1.02-1.03) or Native American (IRR = 1.02, 95% CI: 1.01-1.04) residents had more deaths. Higher rates of lacking a high school diploma was associated with higher counts of cases (IRR = 1.03, 95% CI: 1.01-1.05) and deaths (IRR = 1.04, 95% CI: 1.01-1.07). Higher percentages of multi-unit households were associated with higher (IRR = 1.02, 95% CI: 1.01-1.04) and unemployment with lower (IRR = 0.96, 95% CI: 0.94-0.98) incidence. Higher percentages of individuals with limited English proficiency (IRR = 1.09, 95% CI: 1.04-1.14) and households without a vehicle (IRR = 1.04, 95% CI: 1.01-1.07) were associated with more deaths. CONCLUSIONS: These results document differential pandemic impact in counties with more residents who are Black, Hispanic or Native American, highlighting the roles of residential racial segregation and other forms of discrimination. Factors including economic opportunities, occupational risk, public transit and housing conditions should be addressed in pandemic-related public health strategies to mitigate disparities across counties for the current pandemic and future population health events.

Does contracting-out of primary health care services to non-state providers reduce child mortality in South Sudan? A synthetic control analysis.

Contracting-out is increasingly utilized as a health system strengthening strategy in lower- and middle-income countries (LMICs), to expand access to health interventions known to reduce child mortality. Existing scholarship suggests its effect has been mixed, limiting a definitive conclusion on its magnitude and direction. There are few studies assessing the impact on under-five mortality rate (U5MR) and fewer evaluations to-date have focused on Sub-Saharan Africa. We test the hypothesis that the contracting-out approach implemented in South Sudan in 2012 led to an observable reduction in U5MR. We use a novel approach, the synthetic control method to construct a synthetic South Sudan from a panel of LMICs using data from the World Bank Developmental Indicators (WDI) database. The analysis shows on average, contracting-out had a limited effect on the rate of decline of U5MR; U5MR declined by 5.2% annually between 2000 and 2011, and by 2.58% between 2012 and 2014. Relative to its synthetic control, U5MR is 2% and 5% higher in 2012 and 2013, continuing to diverge during the observation period. These findings suggest limitations in the contracting approach, and we discuss the possible policy implications of these findings.

Can financial payments incentivize short-term smoking cessation in orthopaedic trauma patients? Evidence from a discrete choice experiment.

BACKGROUND: Smoking increases the risk of complications and related costs after an orthopaedic fracture. Research in other populations suggests that a one-time payment may incentivize smoking cessation. However, little is known on fracture patients' willingness to accept financial incentives to stop smoking; and the level of incentive required to motivate smoking cessation in this population. This study aimed to estimate the financial threshold required to motivate fracture patients to stop smoking after injury. METHODS: This cross-sectional study utilized a discrete choice experiment (DCE) to elicit patient preferences towards financial incentives and reduced complications associated with smoking cessation. We presented participants with 12 hypothetical options with several attributes with varying levels. The respondents' data was used to determine the utility of each attribute level and the relative importance associated with each attribute. RESULTS: Of the 130 enrolled patients, 79% reported an interest in quitting smoking. We estimated the financial incentive to be of greater relative importance (ri) (45%) than any of the included clinical benefits of smoking cessations (deep infection (ri: 24%), bone healing complications (ri: 19%), and superficial infections (ri: 12%)). A one-time payment of $800 provided the greatest utility to the respondents (0.64, 95% CI: 0.36 to 0.93), surpassing the utility associated with a single $1000 financial incentive (0.36, 95% CI: 0.18 to 0.55). CONCLUSIONS: Financial incentives may be an effective tool to promote smoking cessation in the orthopaedic trauma population. The findings of this study define optimal payment thresholds for smoking cessation programs.

Association Between Filgrastim Biosimilar Availability and Changes in Claim Payments and Patient Out-of-Pocket Costs for Biologic Filgrastim Products.

OBJECTIVES: To estimate the effect of filgrastim-sndz market entry on patient out-of-pocket costs and claim payments for filgrastim products. METHODS: This study used a single interrupted time series design with longitudinal, nationally representative, individual-level claims data from IBM MarketScan. Analyses included all outpatient and prescription claims for branded filgrastim (filgrastim and tbo-filgrastim) and biosimilar filgrastim (filgrastim-sndz) from January 1, 2014, to December 31, 2017. Outcomes of interest included changes in monthly claim payments and monthly patient out-of-pocket costs for filgrastim products. RESULTS: In the baseline period (January 2014 to February 2016), insurers paid an average of $472.21 (95% confidence interval [CI]: 465.38-479.03) for 480 mcg of branded filgrastim, whereas patients paid an average of $49.26 (CI: 34.25-64.27). Filgrastim-sndz market entry was associated with a statistically significant and immediate 1-month decrease in insurer payment of $30.77 (95% CI: -40.59 to -20.94) and a significant decrease in monthly insurer payment trend of $3.10 per month (95% CI: -3.90 to -2.31) relative to baseline. Long-term changes in patient out-of-pocket costs were modest and restricted to beneficiaries enrolled in high cost sharing plans. CONCLUSIONS: Biosimilar filgrastim availability led to significant immediate and long-term decreases in claims payments for filgrastim products, supporting efforts to facilitate biosimilar adoption in the United States. Nevertheless, there were only slight changes in patient out-of-pocket costs, restricted to beneficiaries enrolled in high cost sharing plans, suggesting the importance of further work assessing the relationship between biosimilar availability and patient out-of-pocket costs.

Fairness in drug prices: do economists think differently from the public?

Using dual-entitlement theory as the guide, we conducted a survey of economists from the National Bureau of Economic Research asking them a series of questions about the fairness of drug prices in the United States. Public opinion surveys have repeatedly shown that the public perceives drug prices to be unfair, but economists trained in laws of supply and demand may have different perceptions. Three hundred and ten senior economists responded to our survey. Forty-five percent agreed that drug prices were unfair when people, specifically low-income individuals, could not afford their prescription medications. Sixty-five percent oppose a dollar threshold, or upper limit, on drug prices. The economists recommend the most promising policy change would be to provide the government additional negotiating power and price controls would moderately impact investment in pharmaceutical research and development.

Patient Selection After Mandatory Bundled Payments for Hip and Knee Replacement: Limited Evidence of Lemon-Dropping or Cherry-Picking.

BACKGROUND: On April 1, 2016, the Centers for Medicare & Medicaid Services (CMS) introduced bundled-payment programs for hip replacement and knee replacement (HKR) in selected metropolitan statistical areas (MSAs) to decrease the costs and cost variability of HKR and to increase the quality of care. Early program analyses showed cost savings; however, studies also demonstrated a trend toward the selection of healthier patients for HKR performed under the bundled system. We compared the characteristics of patients who underwent HKR before implementation of the bundled-payment system (pre-policy) with those of patients who underwent HKR after implementation (post-policy). METHODS: Patients who underwent HKR from 2015 to 2016 were identified from Medicare inpatient claims files. After matching for MSA characteristics, we used a difference-in-difference design to evaluate changes in patient case mix from pre-policy to post-policy by comparing Medicare beneficiaries receiving HKR in bundled MSAs (bMSAs) with those receiving HKR in non-bundled MSAs (nbMSAs). The main characteristics of interest were race, dual eligibility (for Medicare and Medicaid), tobacco use, obesity, presence of diabetes with or without complications, and Charlson Comorbidity Index (CCI) value. We also evaluated pre-policy to post-policy changes in patient case mix by comparing Medicare beneficiaries in bMSAs who underwent HKR compared with those who underwent hip hemiarthroplasty. Hip hemiarthroplasty was used as a control to determine whether there were changes in access to HKR. RESULTS: We found significant differences in the unadjusted baseline characteristics between the bMSA and nbMSA cohorts, both for unmatched and matched samples. We found no significant post-policy changes in the characteristics of patients undergoing HKR. Patients undergoing hemiarthroplasty had significantly higher CCI values than did those undergoing HKR in bMSAs post-policy, although the difference was small (0.36-point higher CCI value; p < 0.01). Patients undergoing hemiarthroplasty were also 2.4% more likely to have diabetes mellitus without complications compared with those who underwent HRK post-policy (p < 0.01). CONCLUSIONS: In contrast to previous investigators, we found little to no significant change in the characteristics (including race, dual eligibility, tobacco use, obesity, presence of diabetes with or without complications, and CCI value) of Medicare beneficiaries who underwent HKR after the initiation of the CMS mandatory bundled-payment policy.