Exposure to US Cancer Drugs With Lack of Confirmed Benefit After US Food and Drug Administration Accelerated Approval.

This cross-sectional study evaluates patient exposure to oncology drugs withdrawn from the US Food and Drug Administration (FDA) Accelerated Approval program.

The Association between Bundled Payment Participation and Changes in Medical Episode Outcomes among High-Risk Patients.

Background: Bundled payments for medical conditions are associated with stable quality and savings through shorter skilled nursing facility (SNF) length of stay. However, effects among clinically higher-risk patients remain unknown. Objective: To evaluate whether the association between participation in bundled payments for medical conditions and episode outcomes differed for clinically high-risk versus other patients. Design: Retrospective difference-in-differences analysis; Participants: 471,421 Medicare patients hospitalized at bundled payment and propensity-matched non-participating hospitals. Exposures were 5 measures of clinically high-risk groups: advanced age (>85 years old), high case-mix, disabled, frail, and prior institutional post-acute care provider utilization. Main Measures: Primary outcomes were SNF length of stay and 90-day unplanned readmissions. Secondary outcomes included quality, utilization, and spending measures. Key Results: SNF length of stay was differentially lower among frail patients (aDID −0.4 days versus non-frail patients, 95% CI −0.8 to −0.1 days), patients with advanced age (aDID −0.8 days versus younger patients, 95% CI −1.2 to −0.3 days), and those with prior institutional post-acute care provider utilization (aDID −1.1 days versus patients without prior utilization, 95% CI −1.6 to −0.6 days), compared to non-frail, younger, and patients without prior utilization, respectively. BPCI participation was also associated with differentially greater SNF LOS among disabled patients (aDID 0.8 days versus non-disabled patients, 95% CI 0.4 to 1.2 days, p < 0.001). Bundled payment participation was not associated with differential changes in readmissions in any high-risk group but was associated with changes in secondary outcomes for some groups. Conclusions: Changes under medical bundles affected, but did not indiscriminately apply to, high-risk patient groups.

Performance of Physician Groups and Hospitals Participating in Bundled Payments Among Medicare Beneficiaries.

Importance: Hospital participation in bundled payment initiatives has been associated with financial savings and stable quality of care. However, how physician group practices (PGPs) perform in bundled payments compared with hospitals remains unknown. Objectives: To evaluate the association of PGP participation in the Bundled Payments for Care Improvement (BPCI) initiative with episode outcomes and to compare these with outcomes for participating hospitals. Design, Settings, and Participants: This cohort study with a difference-in-differences analysis used 2011 to 2018 Medicare claims data to compare the association of BPCI participation with episode outcomes for PGPs vs hospitals providing medical and surgical care to Medicare beneficiaries. Data analyses were conducted from January 1, 2020, to May 31, 2022. Exposures: Hospitalization for any of the 10 highest-volume episodes (5 medical and 5 surgical) included in the BPCI initiative for Medicare patients of participating PGPs and hospitals. Main Outcomes and Measures: The primary outcome was 90-day total episode spending. Secondary outcomes were 90-day readmissions and mortality. Results: The total sample comprised data from 1 288 781 Medicare beneficiaries, of whom 696 710 (mean [SD] age, 76.2 [10.8] years; 432 429 [59.7%] women; 619 655 [85.5%] White individuals) received care through 379 BPCI-participating hospitals and 1441 propensity-matched non-BPCI-participating hospitals, and 592 071 (mean [SD] age, 75.4 [10.9] years; 527 574 [86.6%] women; 360 835 [59.3%] White individuals) received care from 6405 physicians in BPCI-participating PGPs and 24 758 propensity-matched physicians in non-BPCI-participating PGPs. For PGPs, BPCI participation was associated with greater reductions in episode spending for surgical (difference, -$1368; 95% CI, -$1648 to -$1088) but not for medical episodes (difference, -$101; 95% CI, -$410 to $206). Hospital participation in BPCI was associated with greater reductions in episode spending for both surgical (-$1010; 95% CI, -$1345 to -$675) and medical (-$763; 95% CI, -$1139 to -$386) episodes. Conclusions and Relevance: This cohort study and difference-in-differences analysis of PGPs and hospital participation in BPCI found that bundled payments were associated with cost savings for surgical episodes for PGPs, and savings for both surgical and medical episodes for hospitals. Policy makers should consider the comparative performance of participant types when designing and evaluating bundled payment models.

Characteristics, utilization, and concentration of outpatient care for dual-eligible Medicare beneficiaries.

OBJECTIVES: To characterize the (1) distribution of outpatient care for dual-eligible Medicare beneficiaries ("duals") and (2) intensity of outpatient care utilization of duals vs non-dual-eligible beneficiaries ("nonduals"). STUDY DESIGN: Using data preceding the introduction of several outpatient alternative payment models, as well as Medicaid expansion, we evaluated the distribution of outpatient care across physician practices using a Lorenz curve and compared utilization of different outpatient services between duals and nonduals. METHODS: We defined practices that did (high dual) and did not (low dual and no dual) account for the large majority of visits based on the Lorenz curve and then performed descriptive statistics between these groups of practices. Practice-level outcomes included patient demographics, practice characteristics, and county measures of structural disadvantage and population health. Patient-level outcomes included number of outpatient visits and unique outpatient physicians, primary vs subspecialty care visits, and expenditures. RESULTS: Nearly 80% of outpatient visits for duals were provided by 35% of practices. Compared with low-dual and no-dual practices, high-dual practices served more patients (1117.6 patients per high-dual practice vs 683.8 patients per low-dual practice and 447.5 patients per no-dual practice; P < .001) with more comorbidities (3.9 mean total Elixhauser comorbidities among patients served by high-dual practices vs 3.6 among low-dual practices and 3.3 among no-dual practices; P < .001). With regard to utilization, duals had 2 fewer outpatient visits per year compared with nonduals (13.3 vs 15.2; P < .001), with particularly fewer subspecialty care visits (6.5 vs 7.9; P < .001) despite having more comorbidities (3.5 vs 2.7; P < .001). CONCLUSIONS: Outpatient care for duals was concentrated among a small number of practices. Despite having more chronic conditions, duals had fewer outpatient visits. Duals and the practices that serve them may benefit from targeted policies to promote access and improve outcomes.

The Impact of Simultaneous Hospital Participation in Accountable Care Organizations and Bundled Payments on Episode Outcomes.

Among hospitals accepting bundled payments, simultaneous "co-participation" in accountable care organizations (ACOs) could impact episode outcomes compared to bundled payment participation alone. Difference-in-differences (DID) analysis of 1 857 653 ACO-attributed Medicare beneficiaries. The study exposure was hospitalization for 24 procedure-based and 24 condition-based episodes at hospitals participating in bundled payments and ACOs (co-participant) versus only bundled payments. Study outcomes included episode quality, postacute utilization, and spending. For procedure-based episodes, patients hospitalized at co-participant and bundled payment hospitals did not exhibit differential changes in risk-adjusted mortality (DID 0.04 percentage points [p.p.], 95% confidence interval [CI] -0.28 p.p. to 0.37 p.p., P = 0.79), readmissions (DID -0.32 p.p., 95% CI -1.5 p.p. to 0.82 p.p., P = 0.59), postdischarge institutional spending (DID $119, 95% CI -$216 to $455, P = 0.49), or postacute utilization. Similarly, outcomes for condition-based episodes did not vary between co-participant and bundled payment hospitals. Payment model co-participation may produce neither synergistic benefits nor negative effects for patients.

The Effect of Hospital Safety Net Status on the Association Between Bundled Payment Participation and Changes in Medical Episode Outcomes.

BACKGROUND: Under Medicare's Bundled Payments for Care Improvement (BPCI) program, hospitals have maintained quality and achieved savings for medical conditions. However, safety net hospitals may perform differently owing to financial constraints and organizational challenges. OBJECTIVE: To evaluate whether hospital safety net status affected the association between bundled payment participation and medical episode outcomes. DESIGN, SETTING, AND PARTICIPANTS: This observational difference-in-differences analysis was conducted in safety net and non-safety net hospitals participating in BPCI for medical episodes (BPCI hospitals) using data from 2011-2016 Medicare fee-for-service beneficiaries hospitalized for acute myocardial infarction, pneumonia, congestive heart failure, and chronic obstructive pulmonary disease. EXPOSURE(S): Hospital BPCI participation and safety net status. MAIN OUTCOME(S) AND MEASURE(S): The primary outcome was postdischarge spending. Secondary outcomes included quality and post-acute care utilization measures. RESULTS: Our sample consisted of 803 safety net and 2263 non-safety net hospitals. Safety net hospitals were larger and located in areas with more low-income individuals than non-safety net hospitals. Among BPCI hospitals, safety net status was not associated with differential postdischarge spending (adjusted difference-in-differences [aDID], $40; 95% CI, -$254 to $335; P = .79) or quality (mortality, readmissions). However, BPCI safety net hospitals had differentially greater discharge to institutional post-acute care (aDID, 1.06 percentage points; 95% CI, 0.37-1.76; P = .003) and lower discharge home with home health (aDID, -1.15 percentage points; 95% CI, -1.73 to -0.58; P < .001) than BPCI non-safety net hospitals. CONCLUSIONS: Under medical condition bundles, safety net hospitals perform differently from other hospitals in terms of post-acute care utilization, but not spending. Policymakers could support safety net hospitals and consider safety net status when evaluating bundled payment programs.

Association of Patient Outcomes With Bundled Payments Among Hospitalized Patients Attributed to Accountable Care Organizations.

Importance: It is unknown how outcomes are affected when patients receive care under bundled payment and accountable care organization (ACO) programs simultaneously. Objective: To evaluate whether outcomes in the Medicare Bundled Payments for Care Improvement (BPCI) program differed depending on whether patients were attributed to ACOs in the Medicare Shared Savings Program. Design Setting and Participants: This cohort study was conducted using Medicare claims data from January 1, 2011, to September 30, 2016, and difference-in-differences analysis to compare episode outcomes for patients admitted to BPCI vs non-BPCI hospitals. Outcomes were stratified for patients who were and were not attributed to an ACO. Participants included Medicare fee-for-service beneficiaries receiving care for medical and surgical episodes at US hospitals. Data were analyzed between October 1, 2018, and June 10, 2021. Exposures: Hospitalization for any of the 48 episodes (24 medical, 24 surgical) included in the BPCI at US hospitals participating in the BPCI for those episodes. Main Outcomes and Measures: The primary outcome was change in 90-day postdischarge institutional spending, and secondary outcomes included changes in quality and utilization. Results: A total of 7 108 146 beneficiaries (mean [SD] age, 76.9 [12.2] years; 4 101 081 women [58%]) received care for medical episodes, and 3 675 962 beneficiaries (mean [SD] age, 74.8 [10.1] years; 2 074 921 women [56%]) received care for surgical episodes. Compared with patients who were not attributed to ACOs, the association between bundled payments and changes in postdischarge institutional spending was larger among patients attributed to ACOs (-$323 difference; 95% CI, -$607 to -$39; P = .03) for medical episodes, but not surgical episodes. Attribution to an ACO also increased the strength of the association between bundled payments and changes in 90-day readmissions for both medical episodes (-0.98 percentage point difference; 95% CI, -1.55 to -0.41; P = .001) and surgical episodes (-0.84 percentage point difference; 95% CI, -1.32 to -0.35; P = .001). Conclusions and Relevance: In this cohort study, compared with inclusion in bundled payments alone, simultaneous inclusion in both ACOs and bundled payment programs was associated with lower institutional postacute care spending and readmissions for medical episodes and lower readmissions but not spending for surgical episodes. Receiving care under models such as ACOs may improve episode outcomes under bundled payments.

Spending and quality after three years of Medicare's bundled payments for medical conditions: quasi-experimental difference-in-differences study.

OBJECTIVE: To evaluate whether longer term participation in the bundled payments for care initiative (BPCI) for medical conditions in the United States, which held hospitals financially accountable for all spending during an episode of care from hospital admission to 90 days after discharge, was associated with changes in spending, mortality, or health service use. DESIGN: Quasi-experimental difference-in-differences analysis. SETTING: US hospitals participating in bundled payments for acute myocardial infarction, congestive heart failure, chronic obstructive pulmonary disease (COPD), or pneumonia, and propensity score matched to non-participating hospitals. PARTICIPANTS: 238 hospitals participating in the Bundled Payments for Care Improvement initiative (BPCI) and 1415 non-BPCI hospitals. 226 BPCI hospitals were matched to 700 non-BPCI hospitals. MAIN OUTCOME MEASURES: Primary outcomes were total spending on episodes and death 90 days after discharge. Secondary outcomes included spending and use by type of post-acute care. BPCI and non-BPCI hospitals were compared by patient, hospital, and hospital market characteristics. Market characteristics included population size, competitiveness, and post-acute bed supply. RESULTS: In the 226 BPCI hospitals, episodes of care totaled 261 163 in the baseline period and 93 562 in the treatment period compared with 211 208 and 78 643 in the 700 matched non-BPCI hospitals, respectively, with small differences in hospital and market characteristics after matching. Differing trends were seen for some patient characteristics (eg, mean age change -0.3 years at BPCI hospitals v non- BPCI hospitals, P<0.001). In the adjusted analysis, participation in BPCI was associated with a decrease in total episode spending (-1.2%, 95% confidence interval -2.3% to -0.2%). Spending on care at skilled nursing facilities decreased (-6.3%, -10.0% to -2.5%) owing to a reduced number of facility days (-6.2%, -9.8% to -2.6%), and home health spending increased (4.4%, 1.4% to 7.5%). Mortality at 90 days did not change (-0.1 percentage points, 95% confidence interval -0.5 to 0.2 percentage points). CONCLUSIONS: In this longer term evaluation of a large national programme on medical bundled payments in the US, participation in bundles for four common medical conditions was associated with savings at three years. The savings were generated by practice changes that decreased use of high intensity care after hospital discharge without affecting quality, which also suggests that bundles for medical conditions could require multiple years before changes in savings and practice emerge.

Designing a commercial medical bundle for cancer care: Hawaii Medical Service Association's Cancer Episode Model.

BACKGROUND: Oncology care is expensive and exhibits substantial variation in cost and quality across clinicians and patients. Unlike many conditions with established bundled payment programs, cancer care includes a mix of inpatient and outpatient care that precludes hospital-based designs. In 2018, we worked with Hawaii Medical Service Association (HMSA), the Blue Cross Blue Shield of Hawaii, to design a novel commercial bundle for cancer care, the Cancer Episode Model. METHODS: Descriptive analysis of HMSA's Cancer Episode Model, including its inclusion criteria, episode definitions, suite of enhanced services, shared savings model, and incentivized quality metrics. We also compare HMSA's Cancer Episode Model to Medicare's Oncology Care Model and three major commercial oncologic alternative payment models offered by Anthem, UnitedHealthcare, and Aetna. RESULTS: HMSA's Cancer Episode Model builds upon the successes and limitations of Medicare's Oncology Care Model and existing commercial alternative payment models. Compared to Medicare's Oncology Care Model, HMSA's Cancer Episode Model has stricter inclusion criteria, fewer incentivized quality metrics, a higher proportion of regional pricing, a different risk-adjustment model, and first-dollar shared savings. Compared to the majority of existing commercial models, HMSA's Cancer Episode Model includes total cost of care and a different risk-adjustment model. CONCLUSIONS: Reviewing features of the Cancer Episode Model in comparison to other programs is intended to provide guidance to health plans and health policymakers in the design of programs and policies aimed at improving cancer care value. LEVEL OF EVIDENCE: Level IV.

Spending And Quality After Three Years Of Medicare's Voluntary Bundled Payment For Joint Replacement Surgery.

Medicare has reinforced its commitment to voluntary bundled payment by building upon the Bundled Payments for Care Improvement (BPCI) initiative via an ongoing successor program, the BPCI Advanced Model. Although lower extremity joint replacement (LEJR) is the highest-volume episode in both BPCI and BPCI Advanced, there is a paucity of independent evidence about its long-term impact on outcomes and about whether improvements vary by timing of participation or arise from patient selection rather than changes in clinical practice. We found that over three years, compared to no participation, participation in BPCI was associated with a 1.6 percent differential decrease in average LEJR episode spending with no differential changes in quality, driven by early participants. Patient selection accounted for 27 percent of episode savings. Our findings have important policy implications in view of BPCI Advanced and its two participation waves.

Association of Bundled Payments for Joint Replacement Surgery and Patient Outcomes With Simultaneous Hospital Participation in Accountable Care Organizations.

Importance: An increasing number of hospitals have participated in Medicare's bundled payment and accountable care organization (ACO) programs. Although participation in bundled payments has been associated with savings for lower-extremity joint replacement (LEJR) surgery, simultaneous participation in ACOs may be associated with different outcomes given the prevalence of LEJR among patients receiving care at ACO participant organizations and potential overlap in care redesign strategies adopted under the 2 payment models. Objective: To examine whether simultaneous participation in a Medicare Shared Savings Program (MSSP) ACO affects the association between hospitals' participation in LEJR episodes under the Bundled Payments for Care Improvement (BPCI) initiative and patient outcomes compared with participation in the BPCI initiative alone. Design, Setting, and Participants: This cohort study, conducted from January 1 to May 31, 2019, used 2011 to 2016 Medicare claims data and incorporated an instrumental variable with a difference-in-differences method among 483 008 fee-for-service Medicare beneficiaries undergoing LEJR surgery at 212 bundled payment participant hospitals, 105 coparticipant hospitals, and 1413 nonparticipant hospitals in the United States. Exposures: Hospital participation in both the BPCI initiative and the MSSP (coparticipants), BPCI only (bundled payment participants), or neither (nonparticipants). Main Outcomes and Measures: Changes in clinical outcomes and mean LEJR episode spending. Results: A total of 483 008 patients (mean [SD] age, 73.0 [8.4] years; 308 173 [63.8%] female) were included in the study. No differential changes were found in patient and hospital characteristics across participation groups. In adjusted analysis, coparticipants had 1.5% (95% CI, 0.7%-2.2%; P < .001) more unplanned readmissions than did bundled payment participants. Compared with bundled payment participants, coparticipants also had differentially greater decreases in hospital length of stay (adjusted difference-in-differences value, -5.3%; 95% CI, -7.1% to -3.5%; P < .001) and home health care use (adjusted difference-in-differences value, -3.4%; 95% CI, -4.5% to -2.3%; P < .001) and greater increases in postdischarge outpatient follow-up (adjusted difference-in-differences value, 2.1%; 95% CI, 0.9%-3.3%; P < .001). Coparticipants and bundled payment participants did not have differential changes in episode spending (adjusted difference-in-differences value, 0.4%; 95% CI, -0.7% to 1.6%; P = .46), although both groups had more decreased spending compared with nonparticipants. Conclusions and Relevance: Among bundled payment participants, coparticipation in ACOs was not associated with LEJR episode savings but was associated with differential changes in postacute care use patterns and unplanned readmissions. These findings support the longer-term benefits of LEJR bundles and suggest that coparticipants may adopt care redesign strategies that differ from hospitals with bundled payments only.

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.