Bridging the gap: Can International Consortium of Health Outcomes Measurement standard sets align outcomes accepted for regulatory and health technology assessment decision-making of oncology medicines.

Standard outcome sets developed by the International Consortium for Health Outcomes Measurement (ICHOM) facilitate value-based health care in healthcare practice and have gained traction from regulators and Health Technology Assessment (HTA) agencies that regularly assess the value of new medicines. We aimed to assess the extent to which the outcomes used by regulators and HTA agencies are patient-relevant, by comparing these to ICHOM standard sets. We conducted a cross-sectional comparative analysis of ICHOM standard sets, and publicly available regulatory and HTA assessment guidelines. We focused on oncology due to many new medicines being developed, which are accompanied by substantial uncertainty regarding the relevance of these treatments for patients. A comparison of regulatory and HTA assessment guidelines, and ICHOM standard sets showed that both ICHOM and regulators stress the importance of disease-specific outcomes. On the other hand, HTA agencies have a stronger focus on generic outcomes in order to allow comparisons across disease areas. Overall, similar outcomes are relevant for market access, reimbursement, and in ICHOM standard sets. However, some differences are apparent, such as the acceptability of intermediate outcomes. These are recommended in ICHOM standard sets, but regulators are more likely to accept intermediate outcomes than HTA agencies. A greater level of alignment in outcomes accepted may enhance the efficiency of regulatory and HTA processes, and increase timely access to new medicines. ICHOM standard sets may help align these outcomes. However, some differences in outcomes used may remain due to the different purposes of regulatory and HTA decision-making.

Evaluating the robustness of the CMS Hospital Value-Based Purchasing measurement system.

BACKGROUND: The Hospital Value-Based Purchasing Program (HVBP) is a pay for performance system that impacts traditional Medicare fee-for-service payments to hospitals through rewards and penalties. OBJECTIVES: To explore variation in overall and individual-hospital total performance score (TPS) and embedded domains for hospitals during 2014-2018. DATA SOURCE: Hospital data were retrieved from the publicly available HOSArchive dataset. STUDY DESIGN: Distribution of annual TPS and HVBP domain scores for 2014-2018 was evaluated using descriptive statistics. Transitional probabilities were analyzed to evaluate annual movement in the TPS ranking for outlier hospitals in the Top and Bottom 5%. PRINCIPAL FINDINGS: TPS scores are positively skewed while the distribution of domain scores vary with patient experience, (clinical) outcome, and efficiency domains having a large number of (positive) outliers. Mean TPS score decreased from 40.54 in 2014 to 38.04 by 2018. Improvement was shown in mean domain scores for clinical process of care and clinical outcome using 95% confidence intervals, with hospitals gaining 10 points over the study period in clinical outcome. Changes in the mean scores for other domains did not show consistent increases or decreases. Chi-square analyses of hospital ranking categories showed some evidence that, as a group, hospitals initially ranked in the Bottom 5% are making consistent annual movements to higher categories. In contrast, over half of the hospitals ranking in the initial Top 5% remained in the top category across all study years. CONCLUSIONS: It may be time for CMS to redesign the HVBP incentive program to assure the measures accurately demonstrate sustained improvement, the domain weights appropriately reflect the level of importance, and the TPS comparative ranking methodology does not discourage lower-performing hospitals from actively improving the care they deliver and achieving top ranks.

Magnet Hospitals and 30-Day Readmission and Mortality Rates for Medicare Beneficiaries.

BACKGROUND: US hospitals are penalized for excess 30-day readmissions and mortality for select conditions. Under the Centers for Medicare and Medicaid Services policy, readmission prevention is incentivized to a greater extent than mortality reduction. A strategy to potentially improve hospital performance on either measure is by improving nursing care, as nurses provide the largest amount of direct patient care. However, little is known as to whether achieving nursing excellence, such as Magnet status, is associated with improved hospital performance on readmissions and mortality. OBJECTIVE: The purpose of this study was to examine the relationship between hospitals' Magnet status and performance on readmission and mortality rates for Medicare beneficiaries. RESEARCH DESIGN: This is a cross-sectional analysis of Medicare readmissions and mortality reduction programs from 2013 to 2016. A propensity score-matching approach was used to take into account differences in baseline characteristics when comparing Magnet and non-Magnet hospitals. SUBJECTS: The sample was comprised of 3877 hospitals. MEASURES: The outcome measures were 30-day risk-standardized readmission and mortality rates. RESULTS: Following propensity score matching on hospital characteristics, we found that Magnet hospitals outperformed non-Magnet hospitals in reducing mortality; however, Magnet hospitals performed worse in reducing readmissions for acute myocardial infarction, coronary artery bypass grafting, and stroke. CONCLUSIONS: Magnet hospitals performed better on the Hospital Value-Based Purchasing Mortality Program than the Hospital Readmissions Reduction Program. The results of this study suggest the need for The Magnet Recognition Program to examine the role of nurses in postdischarge activities as a component of its evaluation criteria.

Early Performance of Hospital Value-based Purchasing Program in Medicare: A Systematic Review.

BACKGROUND: Under the Affordable Care Act, the Centers for Medicare and Medicaid Services has greatly expanded inpatient fee-for-value programs including the Hospital Value-based Purchasing (HVBP) program. Existing evidence from the HVBP program is mixed. There is a need for a systematic review of the HVBP program to inform discussions on how to improve the program's effectiveness. OBJECTIVE: To review and summarize studies that evaluated the HVBP program's impact on clinical processes, patient satisfaction, costs and outcomes, or assessed hospital characteristics associated with performance on the program. DESIGN: We searched the MEDLINE/PubMed, Scopus, ProQuest database for literature published between January 2013 and July 2019 using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. RESULTS: Of 988 studies reviewed, 33 studies that met the selection criteria were included. A small group of studies (n=7) evaluated the impact of the HVBP program, and no impact on processes or patient outcomes was reported. None of the included studies evaluated the effect of HVBP program on health care costs. Other studies (n=28) evaluated the hospital characteristics associated with HVBP performance, suggesting that safety-net hospitals reportedly performed worse on several quality and cost measures. Other hospital characteristics' associations with performance were unclear. CONCLUSIONS: Our findings suggest that the current HVBP does not lead to meaningful improvements in quality of care or patient outcomes and may negatively affect safety-net hospitals. More rigorous and comprehensive adjustment is needed for more valid hospital comparisons.

Do Magnet®-Designated Hospitals Perform Better on Medicare's Value-Based Purchasing Program?

OBJECTIVE: The aim of this study was to explore the relationship between a hospital's Magnet recognition status, tenure, and its performance in the Hospital Value-Based Purchasing (HVBP) program. BACKGROUND: Previous studies have sought to determine associations between quality of care provided in inpatient setting and the Magnet Recognition Program; however, no study has done so using the most recent (FY2017) iteration of the HVBP program, nor determined the influence a hospital's Magnet designation tenure has on HVBP scores. METHOD: This study used a cross-sectional study design of 2686 hospitals using propensity score matching to reduce bias and improve comparability. RESULTS: Magnet-designated hospitals were associated with higher total performance, process of care and patient experience of care scores, and lower efficiency score. No association was identified between the length of time hospitals have been Magnet designated. CONCLUSION: Findings suggest non-Magnet status hospitals need to consider implementing the principles of Magnet into their culture or participation in the Magnet Recognition Program to provide higher quality of care.

Value-based pricing: Toward achieving a balance between individual and population gains in health benefits.

OBJECTIVES: Value-based pricing of oncology drugs provides a best estimate for the price of a drug, as it relates to the benefits it provides for individual patients. To date, the impact of value-based pricing to reference cost-effectiveness thresholds (λ) on individual and population-level health benefits remains uncharacterized. The current study examined the potential benefits of value-based pricing by quantifying the incremental net health benefit (INHB) of publicly funded oncology drugs, if funding occurred at manufacturer-submitted price without value-based pricing. METHODS: Pan-Canadian Oncology Drug Review (pCODR) submissions were reviewed to identify eligible drug indications from which final economic guidance panel reports were reviewed for incremental costs (ΔC) and quality-adjusted life-years (ΔQALY) from manufacturer-submitted, pCODR lower-limit (pCODR-LL) and upper-limit (pCODR-UL) re-analyzed estimates. Annual number of cases in Ontario for each drug indication was obtained from population databases. Annual QALY gain per drug indication was determined by (ΔQALY × cases). Population QALY gain/loss in the absence of value-based pricing to reference λ was estimated by the INHB: (INHB = [ΔQALY - (ΔC/λ)] × cases). RESULTS: In total, 34 drug indications (4629 cases) were identified. Annual gain in QALYs for the funded drug indications using manufacturer, pCODR-LL, and pCODR-UL estimates was 1851, 1617, and 1301, respectively. At a λ $100 000/QALY, funding in the absence of value-based pricing resulted in loss of 2311, 2519, and 2604 QALYs. This would result in a provincial net annual loss of 460, 902, and 1303 QALYs. CONCLUSIONS: Despite an annual gain in QALY per funded drug indication, a net loss in QALY for the province, in the absence of value-based pricing, was demonstrated. Supportive evidence exists for value-based pricing toward the promotion of health benefits for the greater population.

Performance and Penalties in Year 1 of the Skilled Nursing Facility Value-Based Purchasing Program.

BACKGROUND/OBJECTIVES: Launched in October 2018, Medicare's Skilled Nursing Facility Value-Based Purchasing (SNF VBP) program mandates financial penalties for SNFs with high 30-day readmission rates. Our objective was to identify characteristics of SNFs associated with provider performance under the program. DESIGN: Retrospective cross-sectional analysis using Nursing Home Compare data for the 2019 SNF VBP. Facility-level regressions examined the relationship between structural characteristics (nursing home size, rurality, profit status, hospital affiliation, region, and Star Ratings) and patient characteristics (neighborhood income, race/ethnicity, dual eligibility, disability, and frailty) and facility performance. SETTING: US Medicare. PARTICIPANTS: A total of 14 558 SNFs. MEASUREMENTS: The 2019 SNF VBP performance scores and penalties. RESULTS: Nationally, 72% (10 436) of SNFs were penalized; 21% (2996) received the maximum penalty of 1.98%. In multivariate analyses, rural SNFs were less likely to be penalized (odds ratio [OR] = 0.85; 95% confidence interval [CI] = 0.78-0.92; P < .001; vs urban), while small SNFs were more likely to be penalized (≤70 beds: OR = 1.28; 95% CI = 1.15-1.42; P < .001; 71-120 beds: OR = 1.15; 95% CI = 1.05-1.26; P = .003; vs >120 beds). SNFs with lower nurse staffing had higher odds of penalties (low: OR = 1.15; 95% CI = 1.03-1.27; P = .010; vs high); nonprofit and government-owned SNFs had lower odds of penalties (OR = 0.79; 95% CI = 0.72-0.87; P < .001; government: OR = 0.72; 95% CI = 0.61-0.84; P < .001; vs for profit); and SNFs with higher Star Ratings had lower odds of penalties (5 stars: OR = 0.47; 95% CI = 0.40-0.54; P < .001; vs 1 star). In terms of patient population, SNFs located in low-income ZIP codes (OR = 1.17; 95% CI = 1.03-1.34; P = .019) or serving a high proportion of frail patients (OR = 1.39; 95% CI = 1.21-1.60; P < .001) were more likely to be penalized than other SNFs. SNFs with high proportions of dual, black, Hispanic, or disabled patients did not have higher odds of penalization. CONCLUSION: Structural and patient characteristics of SNFs may significantly impact provider performance under the SNF VBP. These findings have implications for policy makers and clinical leaders seeking to improve quality and avoid unintended consequences with VBP in SNFs. J Am Geriatr Soc 68:826-834, 2020.

Defining and Optimizing Value in Total Joint Arthroplasty From the Patient, Payer, and Provider Perspectives.

BACKGROUND: The purpose of this study is to define value in bundled total joint arthroplasty (TJA) from the differing perspectives of the patient, payer/employer, and hospital/provider. METHODS: Demographic, psychosocial, clinical, financial, and patient-reported outcomes (PROs) data from 2017 to 2018 elective TJA cases at a multihospital academic health system were queried. Value was defined as improvement in PROs (preoperatively to 1 year postoperatively) for patients, improvement in PROs per $1000 of bundle cost for payers, and the normalized sum of improvement in PROs and hospital bundle margin for providers. Bivariate analysis was used to compare high value vs low value (>50th percentile vs <50th percentile). Multivariate analysis was performed to identify predictors. RESULTS: A total of 280 patients had PRO data, of which 71 had Medicare claims data. Diabetes (odds ratio [OR], 0.45; P = .02) predicted low value for patients; female gender (OR, 0.25), hypertension (OR, 0.17), pulmonary disease (OR, 0.12), and skilled nursing facility discharge (OR, 0.17) for payers (P ≤ .03 for all); and pulmonary disease (OR, 0.16) and skilled nursing facility discharge (OR, 0.19) for providers (P ≤ .04 for all). CONCLUSION: This is the first article to define value in TJA under a bundle payment model from multiple perspectives, providing a foundation for future studies analyzing value-based TJA.

Misclassification of Myocardial Injury as Myocardial Infarction: Implications for Assessing Outcomes in Value-Based Programs.

Importance: Similar to other patients with acute myocardial infarction, patients with type 2 myocardial infarction (T2MI) are included in several value-based programs, including the Hospital Readmissions Reduction Program and the Hospital Value-Based Purchasing Program. To our knowledge, whether nonischemic myocardial injury is being misclassified as T2MI is unknown and may have implications for these programs. Objective: To determine whether patients with nonischemic myocardial injury are being miscoded as having T2MI and if this has implications for 30-day readmission and mortality rates. Design, Settings, and Participants: Using the new International Statistical Classification of Diseases and Related Health Problems, Tenth Revision code, we identified patients who were coded as having T2MI between October 2017 and May 2018 at Massachusetts General Hospital. Strict adjudication using the fourth universal definition of MI was then applied. Main outcome and Measures: Clinical adjudication of T2MI and 30-day readmission and mortality rates as a function of T2MI or nonischemic myocardial injury. Results: Of 633 patients, 369 (58.3%) were men and 514 (81.2%) were white. After strict adjudication, 359 (56.7%) had T2MI, 265 (41.9%) had myocardial injury, 6 (0.9%) had type 1 MI, and 3 (0.5%) had unstable angina. Patients with T2MI had a higher prevalence of cardiovascular comorbidities than those with myocardial injury. Patients with T2MI and myocardial injury had high in-hospital mortality rates (10.6% and 8.7%, respectively; P = .50). Of those discharged alive (563 [88.9%]), 30-day readmission rates (22.7% vs 21.1%; P = .68) and mortality rates (4.4% vs 7.4%; P = .14) were comparable among patients with T2MI and myocardial injury. Conclusions and Relevance: A substantial percentage of patients coded as having T2MI actually have myocardial injury. Both conditions have high 30-day readmission and mortality rates. Including patients with high-risk myocardial injury may have substantial implications for value-based programs.

Hospital quality indicators are not unidimensional: A reanalysis of Lieberthal and Comer.

OBJECTIVE: To evaluate the dimensionality of hospital quality indicators treated as unidimensional in a prior publication. DATA SOURCE/STUDY DESIGN: Pooled cross-sectional 2010-2011 Hospital Compare data (10/1/10 and 10/1/11 archives) and the 2012 American Hospital Association Annual Survey. DATA EXTRACTION: We used 71 indicators of structure, process, and outcomes of hospital care in a principal component analysis of Ridit scores to evaluate the dimensionality of the indicators. We conducted an exploratory factor analysis using only the indicators in the Centers for Medicare & Medicaid Services' Hospital Value-Based Purchasing. PRINCIPAL FINDINGS: There were four underlying dimensions of hospital quality: patient experience, mortality, and two clinical process dimensions. CONCLUSIONS: Hospital quality should be measured using a variety of indicators reflecting different dimensions of quality. Treating hospital quality as unidimensional leads to erroneous conclusions about the performance of different hospitals.

Hospital Value-Based Purchasing Performance: Do Organizational and Market Characteristics Matter?

EXECUTIVE SUMMARY: The hospital value-based purchasing (HVBP) program of the Centers for Medicare & Medicaid Services challenges hospitals to deliver high-quality care or face a reduction in Medicare payments. How do different organizational structures and market characteristics enable or inhibit successful transition to this new model of value-based care? To address that question, this study employs an institutional theory lens to test whether certain organizational structures and market characteristics mediate hospitals' ability to perform across HVBP domains.Data from the 2014 American Hospital Association Annual Survey Database, Area Health Resource File, the Medicare Hospital Compare Database, and the association between external environment and hospital performance are assessed through multiple regression analysis. Results indicate that hospitals that belong to a system are more likely than independent hospitals to score highly on the domains associated with the HVBP incentive arrangement. However, varying and sometimes counterintuitive market influences bring different dimensions to the HVBP program. A hospital's ability to score well in this new value arrangement may be heavily based on the organization's ability to learn from others, implement change, and apply the appropriate amount of control in various markets.

Elements of Program Design in Medicare's Value-based and Alternative Payment Models: a Narrative Review.

Increasing emphasis on value in health care has spurred the development of value-based and alternative payment models. Inherent in these models are choices around program scope (broad vs. narrow); selecting absolute or relative performance targets; rewarding improvement, achievement, or both; and offering penalties, rewards, or both. We examined and classified current Medicare payment models-the Hospital Readmissions Reduction Program (HRRP), Hospital Value-Based Purchasing Program (HVBP), Hospital-Acquired Conditions Reduction Program (HACRP), Medicare Advantage Quality Star Rating program, Physician Value-Based Payment Modifier (VM) and its successor, the Merit-Based Incentive Payment System (MIPS), and the Medicare Shared Savings Program (MSSP) on these elements of program design and reviewed the literature to place findings in context. We found that current Medicare payment models vary significantly across each parameter of program design examined. For example, in terms of scope, the HRRP focuses exclusively on risk-standardized excess readmissions and the HACRP on patient safety. In contrast, HVBP includes 21 measures in five domains, including both quality and cost measures. Choices regarding penalties versus bonuses are similarly variable: HRRP and HACRP are penalty-only; HVBP, VM, and MIPS are penalty-or-bonus; and the MSSP and MA quality star rating programs are largely bonus-only. Each choice has distinct pros and cons that impact program efficacy. Unfortunately, there are scant data to inform which program design choice is best. While no one approach is clearly superior to another, the variability contained within these programs provides an important opportunity for Medicare and others to learn from these undertakings and to use that knowledge to inform future policymaking.

Looking Under the Streetlight? A Framework for Differentiating Performance Measures by Level of Care in a Value-Based Payment Environment.

The majority of quality measures used to assess providers and hospitals are based on easily obtained data, focused on a few dimensions of quality, and developed mainly for primary/community care and population health. While this approach supports efforts focused on addressing the triple aim of health care, many current quality report cards and assessments do not reflect the breadth or complexity of many referral center practices.In this article, the authors highlight the differences between population health efforts and referral care and address issues related to value measurement and performance assessment. They discuss why measures may need to differ across the three levels of care (primary/community care, secondary care, complex care) and illustrate the need for further risk adjustment to eliminate referral bias.With continued movement toward value-based purchasing, performance measures and reimbursement schemes need to reflect the increased level of intensity required to provide complex care. The authors propose a framework to operationalize value measurement and payment for specialty care, and they make specific recommendations to improve performance measurement for complex patients. Implementing such a framework to differentiate performance measures by level of care involves coordinated efforts to change both policy and operational platforms. An essential component of this framework is a new model that defines the characteristics of patients who require complex care and standardizes metrics that incorporate those definitions.

Current State of Value-Based Purchasing Programs.

The US healthcare system is rapidly moving toward rewarding value. Recent legislation, such as the Affordable Care Act and the Medicare Access and CHIP Reauthorization Act, solidified the role of value-based payment in Medicare. Many private insurers are following Medicare's lead. Much of the policy attention has been on programs such as accountable care organizations and bundled payments; yet, value-based purchasing (VBP) or pay-for-performance, defined as providers being paid fee-for-service with payment adjustments up or down based on value metrics, remains a core element of value payment in Medicare Access and CHIP Reauthorization Act and will likely remain so for the foreseeable future. This review article summarizes the current state of VBP programs and provides analysis of the strengths, weaknesses, and opportunities for the future. Multiple inpatient and outpatient VBP programs have been implemented and evaluated; the impact of those programs has been marginal. Opportunities to enhance the performance of VBP programs include improving the quality measurement science, strengthening both the size and design of incentives, reducing health disparities, establishing broad outcome measurement, choosing appropriate comparison targets, and determining the optimal role of VBP relative to alternative payment models. VBP programs will play a significant role in healthcare delivery for years to come, and they serve as an opportunity for providers to build the infrastructure needed for value-oriented care.

Association between the Value-Based Purchasing pay for performance program and patient mortality in US hospitals: observational study.

OBJECTIVE: To determine the impact of the Hospital Value-Based Purchasing (HVBP) program-the US pay for performance program introduced by Medicare to incentivize higher quality care-on 30 day mortality for three incentivized conditions: acute myocardial infarction, heart failure, and pneumonia. DESIGN: Observational study. SETTING: 4267 acute care hospitals in the United States: 2919 participated in the HVBP program and 1348 were ineligible and used as controls (44 in general hospitals in Maryland and 1304 critical access hospitals across the United States). PARTICIPANTS: 2 430 618 patients admitted to US hospitals from 2008 through 2013. MAIN OUTCOME MEASURES: 30 day risk adjusted mortality for acute myocardial infarction, heart failure, and pneumonia using a patient level linear spline analysis to examine the association between the introduction of the HVBP program and 30 day mortality. Non-incentivized, medical conditions were the comparators. A secondary outcome measure was to determine whether the introduction of the HVBP program was particularly beneficial for a subgroup of hospital-poor performers at baseline-that may benefit the most. RESULTS: Mortality rates of incentivized conditions in hospitals participating in the HVBP program declined at -0.13% for each quarter during the preintervention period and -0.03% point difference for each quarter during the post-intervention period. For non-HVBP hospitals, mortality rates declined at -0.14% point difference for each quarter during the preintervention period and -0.01% point difference for each quarter during the post-intervention period. The difference in the mortality trends between the two groups was small and non-significant (difference in difference in trends -0.03% point difference for each quarter, 95% confidence interval -0.08% to 0.13% point difference, P=0.35). In no subgroups of hospitals was HVBP associated with better outcomes, including poor performers at baseline. CONCLUSIONS: Evidence that HVBP has led to lower mortality rates is lacking. Nations considering similar pay for performance programs may want to consider alternative models to achieve improved patient outcomes.