The shared ethical framework to allocate scarce medical resources: a lesson from COVID-19.

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children.

Ethical Responsibilities for Companies That Process Personal Data.

It has become increasingly difficult for individuals to exercise meaningful control over the personal data they disclose to companies or to understand and track the ways in which that data is exchanged and used. These developments have led to an emerging consensus that existing privacy and data protection laws offer individuals insufficient protections against harms stemming from current data practices. However, an effective and ethically justified way forward remains elusive. To inform policy in this area, we propose the Ethical Data Practices framework. The framework outlines six principles relevant to the collection and use of personal data-minimizing harm, fairly distributing benefits and burdens, respecting autonomy, transparency, accountability, and inclusion-and translates these principles into action-guiding practical imperatives for companies that process personal data. In addition to informing policy, the practical imperatives can be voluntarily adopted by companies to promote ethical data practices.

Spillover Effects of Medicare's Voluntary Bundled Payments for Joint Replacement Surgery to Patients Insured by Commercial Health Plans.

BACKGROUND: Under the Bundled Payments for Care Improvement (BPCI) program, bundled paymtents for lower-extremity joint replacement (LEJR) are associated with 2% to 4% cost savings with stable quality among Medicare fee-for-service beneficiaries. However, BPCI may prompt practice changes that benefit all patients, not just fee-for-service beneficiaries. OBJECTIVE: To examine the association between hospital participation in BPCI and LEJR outcomes for patients with commercial insurance or Medicare Advantage (MA). DESIGN: Quasi-experimental study using Health Care Cost Institute claims from 2011 to 2016. SETTING: LEJR at 281 BPCI hospitals and 562 non-BPCI hospitals. PATIENTS: 184 922 patients with MA or commercial insurance. MEASUREMENTS: Differential changes in LEJR outcomes at BPCI hospitals versus at non-BPCI hospitals matched on propensity score were evaluated using a difference-in-differences (DID) method. Secondary analyses evaluated associations by patient MA status and hospital characteristics. Primary outcomes were changes in 90-day total spending on LEJR episodes and 90-day readmissions; secondary outcomes were postacute spending and discharge to postacute care providers. RESULTS: Average episode spending decreased more at BPCI versus non-BPCI hospitals (change, -2.2% [95% CI, -3.6% to -0.71%]; P = 0.004), but differences in changes in 90-day readmissions were not significant (adjusted DID, -0.47 percentage point [CI, -1.0 to 0.06 percentage point]; P = 0.084). Participation in BPCI was also associated with differences in decreases in postacute spending and discharge to institutional postacute care providers. Decreases in episode spending were larger for hospitals with high baseline spending but did not vary by MA status. LIMITATION: Nonrandomized studies are subject to residual confounding and selection. CONCLUSION: Participation in BPCI was associated with modest spillovers in episode savings. Bundled payments may prompt hospitals to implement broad care redesign that produces benefits regardless of insurance coverage. PRIMARY FUNDING SOURCE: Leonard Davis Institute of Health Economics at the University of Pennsylvania.

Publication Ethics During Public Health Emergencies Such as the COVID-19 Pandemic.

Public health emergencies require real-time, accurate information to guide effective responses. Rapid publication of information can, therefore, advance both the scientific validity and the social value of research conducted in these contexts. Consequently, medical journals place a high priority on rapidly publishing reports on these emergencies, which the media often report on to the public. Today, the focus is on the rapid publication of research related to the COVID-19 outbreak. Tomorrow, it might be an influenza pandemic or a crisis related to a vaping-related illness. (Am J Public Health. Published online ahead of print May 14, 2020: e1-e2. doi:10.2105/AJPH.2020.305686).

Real-time Feedback in Pay-for-Performance: Does More Information Lead to Improvement?

BACKGROUND: Pay-for-performance (P4P) has been used expansively to improve quality of care delivered by physicians. However, to what extent P4P works through the provision of information versus financial incentives is poorly understood. OBJECTIVE: To determine whether an increase in information feedback without changes to financial incentives resulted in improved physician performance within an existing P4P program. INTERVENTION/EXPOSURE: Implementation of a new registry enabling real-time feedback to physicians on quality measure performance. DESIGN: Observational, predictive piecewise model at the physician-measure level to examine whether registry introduction associated with performance changes. We used detailed physician quality measure data 3 years prior to registry implementation (2010-2012) and 2 years after implementation (2014-2015). We also linked physician-level data including age, gender, and board certification; group-level data including registry click rates; and patient panel data including chronic conditions. PARTICIPANTS: Four hundred thirty-four physicians continuously affiliated with Advocate from 2010 to 2015. MAIN MEASURES: Physician performance on ten quality metrics. KEY RESULTS: We found no consistent pattern of improvement associated with the availability of real-time information across ten measures. Relative to predicted performance without the registry, average performance increased for two measures (childhood immunization status-rotavirus (p < 0.001) and diabetes care-medical attention for nephropathy (p = 0.024)) and decreased for three measures (childhood immunization status-influenza (p < 0.001) and diabetes care-HbA1c testing (p < 0.001) and poor HbA1c control (p < 0.001)). Results were consistent for subgroup analysis on those most able to improve, i.e., physicians in the bottom tertile of performance prior to registry introduction. Physicians who improved most were in groups that accessed the registry more than those who improved least (8.0 vs 10.0 times per week, p = 0.010). CONCLUSIONS: More frequent provision of information, provided in real-time, was insufficient to improve physician performance in an existing P4P program with high baseline performance. Results suggest that electronic registries may not themselves drive performance improvement. Future work should consider testing information feedback enhancements with financial incentives.

Association Between the Implementation of a Population-Based Primary Care Payment System and Achievement on Quality Measures in Hawaii.

Importance: Hawaii Medical Service Association (HMSA), the Blue Cross Blue Shield of Hawaii, introduced Population-based Payments for Primary Care (3PC), a new capitation-based primary care payment system, in 2016. The effect of this system on quality measures has not been evaluated. Objective: To evaluate whether the 3PC system was associated with changes in quality, utilization, or spending in its first year. Design, Setting, and Participants: Observational study using HMSA claims and clinical registry data from January 1, 2012, to December 31, 2016, and a propensity-weighted difference-in-differences method to compare 77 225 HMSA members in Hawaii attributed to 107 primary care physicians (PCPs) and 4 physician organizations participating in the first wave of the 3PC and 222 233 members attributed to 312 PCPs and 14 physician organizations that continued in a fee-for-service model in 2016 but had 3PC start dates thereafter. Exposures: Participation in the 3PC system. Main Outcomes and Measures: The primary outcome was the change in a composite measure score reflecting the probability that a member achieved an eligible measure out of 13 pooled Healthcare Effectiveness Data and Information Set quality measures. Primary care visits and total cost of care were among 15 secondary outcomes. Results: In total, the study included 299 458 HMSA members (mean age, 42.1 years; 51.5% women) and 419 primary care physicians (mean age, 54.9 years; 34.8% women). The risk-standardized composite measure scores for 2012 to 2016 changed from 75.1% to 86.6% (+11.5 percentage points) in the 3PC group and 74.3% to 83.5% (+9.2 percentage points) in the non-3PC group (differential change, 2.3 percentage points [95% CI, 2.1 to 2.6 percentage points]; P < .001). Of 15 prespecified secondary end points for utilization and spending, 11 showed no significant difference. Compared with the non-3PC group, the 3PC system was associated with a significant reduction in the mean number of primary care visits (3.3 to 3.0 visits vs 3.3 to 3.1 visits; adjusted differential change, -3.9 percentage points [95% CI, -4.6 to -3.2 percentage points]; P < .001), but there was no significant difference in mean total cost of care ($3344 to $4087 vs $2977 to $3564; adjusted differential change, 1.0% [95% CI, -1.3% to 3.4%]; P = .39). Conclusions and Relevance: In its first year, the 3PC population-based primary care payment system in Hawaii was associated with small improvements in quality and a reduction in PCP visits but no significant difference in the total cost of care. Additional research is needed to assess longer-term outcomes as the program is more fully implemented and to determine whether results are generalizable to other health care markets.

Outcomes for individuals turned down for living kidney donation.

BACKGROUND: A better understanding of the consequences of being turned down for living kidney donation could help transplant professionals to counsel individuals considering donation. METHODS: In this exploratory study, we used survey instruments and qualitative interviews to characterize nonmedical outcomes among individuals turned down for living kidney donation between July 1, 2010 and December 31, 2013. We assembled a comparator group of kidney donors. RESULTS: Among 83 turned-down donors with contact information at a single center, 43 (52%) participated in the study (median age 53 years; 53% female; 19% black). Quality of life, depression, financial stress, and provider empathy scores were similar between individuals turned down for donation (n = 43) and donors (n = 128). Participants selected a discrete choice response to a statement about the overall quality of their lives; 32% of turned-down donors versus 7% of donors (P < 0.01) assessed that their lives were worse after the center's decision about whether they could donate a kidney. Among turned-down donors who reported that life had worsened, 77% had an intended recipient who was never transplanted, versus 36% among individuals who assessed life as the same or better (P = 0.02). In interviews, the majority of turned-down donors reported emotional impact, including empathy, stress, and other challenges, related to having someone in their lives with end-stage kidney disease. CONCLUSIONS: Generic instruments measuring quality of life, depression, financial stress, and provider empathy revealed no significant differences between kidney donors and turned-down donors. However, qualitative interviews revealed preliminary evidence that some turned-down donors experienced emotional consequences. These findings warrant confirmation in larger studies.

The Medicare Physician Fee Schedule and Unethical Behavior.

This Viewpoint discusses the Medicare Physician Fee Schedule and its flaws, including how they might be remedied by severing CMS dependence on Relative Value Update Committee estimates of time and intensity.

Association of Hospital Participation in a Medicare Bundled Payment Program With Volume and Case Mix of Lower Extremity Joint Replacement Episodes.

Importance: Medicare's Bundled Payments for Care Improvement (BPCI) initiative for lower extremity joint replacement (LEJR) surgery has been associated with a reduction in episode spending and stable-to-improved quality. However, BPCI may create unintended effects by prompting participating hospitals to increase the overall volume of episodes paid for by Medicare, which could potentially eliminate program-related savings or prompt them to shift case mix to lower-risk patients. Objective: To evaluate whether hospital BPCI participation for LEJR was associated with changes in overall volume and case mix. Design, Setting, and Participants: Observational study using Medicare claims data and a difference-in-differences method to compare 131 markets (hospital referral regions) with at least 1 BPCI participant hospital (n = 322) and 175 markets with no participating hospitals (n = 1340), accounting for 580 043 Medicare beneficiaries treated before (January 2011-September 2013) and 462 161 after (October 2013-December 2015) establishing the BPCI initiative. Hospital-level case-mix changes were assessed by comparing 265 participating hospitals with a 1:1 propensity-matched set of nonparticipating hospitals from non-BPCI markets. Exposures: Hospital BPCI participation. Main Outcomes and Measures: Changes in market-level LEJR volume in the before vs after BPCI periods and changes in hospital-level case mix based on demographic, socioeconomic, clinical, and utilization factors. Results: Among the 1 717 243 Medicare beneficiaries who underwent LEJR (mean age, 75 years; 64% women; and 95% nonblack race/ethnicity), BPCI participation was not significantly associated with a change in overall market-level volume. The mean quarterly market volume in non-BPCI markets increased 3.8% from 3.8 episodes per 1000 beneficiaries before BPCI to 3.9 episodes per 1000 beneficiaries after BPCI was launched. For BPCI markets, the mean quarterly market volume increased 4.4% from 3.6 episodes per 1000 beneficiaries before BPCI to 3.8 episodes per 1000 beneficiaries after BPCI was launched. The adjusted difference-in-differences estimate between the market types was 0.32% (95% CI, -0.06% to 0.69%; P = .10). Among 20 demographic, socioeconomic, clinical, and utilization factors, BPCI participation was associated with differential changes in hospital-level case mix for only 1 factor, prior skilled nursing facility use (adjusted difference-in-differences estimate, -0.53%; 95% CI, -0.96% to -0.10%; P = .01) in BPCI vs non-BPCI markets. Conclusions and Relevance: In this observational study of Medicare beneficiaries who underwent LEJR, hospital participation in Bundled Payments for Care Improvement was not associated with changes in market-level lower extremity joint replacement volume and largely was not associated with changes in hospital case mix. These findings may provide reassurance regarding 2 potential unintended effects associated with bundled payments for LEJR.

Motivations, enrollment decisions, and socio-demographic characteristics of healthy volunteers in phase 1 research.

BACKGROUND/AIM: Phase 1 trials with healthy volunteers are an integral step in drug development. Commentators worry about the possible exploitation of healthy volunteers because they are assumed to be disadvantaged, marginalized, and inappropriately influenced by the offer of money for research for which they do not appreciate the inherent risks. Yet there are limited data to support or refute these concerns. This study aims to describe the socio-demographic characteristics, motivations, and enrollment decision-making of a large cohort of healthy volunteers. METHODS: We used a cross-sectional anonymous survey of 1194 healthy volunteers considering enrollment in phase 1 studies at Pfizer Clinical Research Units in New Haven, CT; Brussels, Belgium; and Singapore. Descriptive statistics describe motivations and socio-demographic characteristics. Comparisons between groups were examined. RESULTS: The majority rated consideration of risks as more important to their enrollment decision than the amount of money, despite reporting that their primary motivation was financial. Risk, time, money, the competence and friendliness of research staff, and contributing to medical research were important factors influencing enrollment decisions for most participants. The majority of healthy volunteers in this cohort were male, single, reported higher than high school education, and 70% had previous research experience. Many reported low annual incomes (50% below USD$25,000) and high rates of unemployment (33% overall). Nonetheless, risk as an important consideration, money, and other reported considerations and motivations, except for time, did not vary by income, employment, education, or previous experience. There were regional differences in both socio-demographic characteristics and factors important to participation decisions. CONCLUSION: Healthy volunteers in phase 1 studies consider risks as more important to their enrollment decisions than the amount of money offered, although most are motivated to participate by the offer of money. Healthy volunteers are indeed low income, disproportionately unemployed, and have significant prior research experience. Yet these factors do not appear to affect either their motivations for participation or factors important to their research enrollment decisions.