Addressing financial toxicity in cancer treatment-An opportunity for the 340B drug pricing program.

Cancer treatment has become increasingly expensive, partially due to the use of specialty drugs. The costs of these drugs are often passed down to patients, who may face the consequences of paying for more than they can afford, leading to financial toxicity. The 340B drug pricing program is a health care policy that may provide an opportunity to mitigate the financial consequences of cancer care. The 340B program requires manufacturers to sell outpatient drugs at a discount to hospitals caring for a significant number of socioeconomically disadvantaged individuals. The program intended for hospitals to use savings from discounted purchases to expand their safety net to vulnerable patients. Some studies have shown that participating hospitals do this by offering more charity and discounted care, whereas others have demonstrated that hospitals fail to sufficiently expand their safety net. A potential flaw of the program is the lack of guidance from governing bodies on how hospitals should use savings from discounted purchases. There has been growing discussion among stakeholders to reform the 340B program given the mixed findings of its effectiveness. With the rising costs of specialty drugs and associated prevalence of financial toxicity in patients with cancer, there is an opportunity to address these issues through reform that improves the program. Directing hospitals to offer specific safety net opportunities, such as passing along discounted drug prices to vulnerable populations, could help the growing number of patients who are financially burdened by medications at the core of the 340B program.

The 340B Program and oral specialty drugs for advanced prostate cancer.

INTRODUCTION: Expensive oral specialty drugs for advanced prostate cancer can be associated with treatment disparities. The 340B program allows hospitals to purchase medications at discounts, generating savings that can improve care of the socioeconomically disadvantaged. This study assessed the effect of hospital 340B participation on advanced prostate cancer. METHODS: The authors performed a retrospective cohort study of Medicare beneficiaries with advanced prostate cancer from 2012 to 2019. The primary outcome was use of an oral specialty drug. Secondary outcomes included monthly out-of-pocket costs and treatment adherence. We evaluated the effects of 1) hospital 340B participation, 2) a regional measure vulnerability, the social vulnerability index (SVI), and 3) the interaction between hospital 340B participation and SVI on outcomes. RESULTS: There were 2237 and 1100 men who received care at 340B and non-340B hospitals. There was no difference in specialty drug use between 340B and non-340B hospitals, whereas specialty drug use decreased with increased SVI (odds ratio, 0.95, p = .038). However, the interaction between hospital 340B participation and SVI on specialty drug use was not significant. Neither 340B participation, SVI, or their interaction were associated with out-of-pocket costs. Although hospital 340B participation and SVI were not associated with treatment adherence, their interaction was significant (p = .020). This demonstrated that 340B was associated with better adherence among socially vulnerable men. CONCLUSIONS: The 340B program was not associated with specialty drug use in men with advanced prostate cancer. However, among those who were started on therapy, 340B was associated with increased treatment adherence in more socially vulnerable men.

Urologist practice divestment from radiation vault ownership and treatment patterns for prostate cancer.

BACKGROUND: Urologists practicing in single-specialty groups with ownership in radiation vaults are more likely to treat men with prostate cancer. The effect of divestment of vault ownership on treatment patterns is unclear. METHODS: A 20% sample of national Medicare claims was used to perform a retrospective cohort study of men with prostate cancer diagnosed between 2010 and 2019. Urology practices were categorized by radiation vault ownership as nonowners, continuous owners, and divested owners. The primary outcome was use of local treatment, and the secondary outcome was use of intensity-modulated radiation therapy (IMRT). A difference-in-differences framework was used to measure the effect of divestment on outcomes compared to continuous owners. Subgroup analyses assessed outcomes by noncancer mortality risk (high [>50%] vs. low [≤50%]). RESULTS: Among 72 urology practices that owned radiation vaults, six divested during the study. Divestment led to a decrease in treatment compared with those managed at continuously owning practices (difference-in-differences estimate, -13%; p = .03). The use of IMRT decreased, but this was not statistically significant (difference-in-differences estimate, -10%; p = .13). In men with a high noncancer mortality risk, treatment (difference-in-differences estimate, -28%; p < .001) and use of IMRT (difference-in-differences estimate, -27%; p < .001) decreased after divestment. CONCLUSIONS: Urology group divestment from radiation vault ownership led to a decrease in prostate cancer treatment. This decrease was most pronounced in men who had a high noncancer mortality risk. This has important implications for health care reform by suggesting that payment programs that encourage constraints on utilization, when appropriate, may be effective in reducing overtreatment.

Real-World Effectiveness of Preventive Pharmacological Therapy in Patients With Urolithiasis: A Retrospective Cohort Study.

RATIONALE & OBJECTIVE: Data supporting the efficacy of preventive pharmacological therapy (PPT) to reduce urolithiasis recurrence are based on clinical trials with composite outcomes that incorporate imaging findings and have uncertain clinical significance. This study evaluated whether the use of PPT leads to fewer symptomatic stone events. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: Medicare enrollees with urolithiasis who completed 24-hour urine collections that revealed hypercalciuria, hypocitraturia, low urine pH, or hyperuricosuria. EXPOSURE: PPT (thiazide diuretics for hypercalciuria, alkali for hypocitraturia or low urine pH, or uric acid lowering drugs for hyperuricosuria) categorized as (1) adherent to guideline-concordant PPT, (2) nonadherent to guideline-concordant PPT, or (3) untreated. OUTCOME: Symptomatic stone event occurrence (emergency department [ED] visit or hospitalization for urolithiasis or stone-directed surgery). ANALYTICAL APPROACH: Cox proportional hazards regression. RESULTS: Among 13,942 patients, 31.0% were prescribed PPT. Compared with no treatment, concordant/adherent PPT use was associated with a significantly lower hazard of symptomatic stone events for patients with hypercalciuria (HR, 0.736 [95% CI, 0.593-0.915]) and low urine pH (HR, 0.804 [95% CI, 0.650-0.996]) but not for patients with hypocitraturia or hyperuricosuria. These associations were largely driven by significantly lower rates of ED visits after initiating PPT among the concordant/adherent group versus untreated patients. Patients with hypercalciuria had adjusted 2-year predicted probabilities of a visit of 3.8% [95% CI, 2.5%-5.2%%] and 6.9% [95% CI, 6.0%-7.7%] for the concordant/adherent PPT and no-treatment groups, respectively. Among patients with low urine pH, these probabilities were 4.3% (95% CI, 2.9%-5.7%) and 7.3% (95% CI, 6.5%-8.0%) for the concordant/adherent PPT and no-treatment groups, respectively. LIMITATIONS: Potential bias from the possibility that patients prescribed PPT had more severe disease than untreated patients. CONCLUSIONS: Patients with urolithiasis and hypercalciuria who were adherent to treatment with thiazide diuretics as well as those with low urine pH adherent to prescribed alkali therapy had fewer symptomatic stone events than untreated patients. PLAIN-LANGUAGE SUMMARY: Despite multiple clinical trials demonstrating the efficacy of thiazide diuretics and alkali for secondary prevention of kidney stones, they are infrequently prescribed due in part to a lack of data about their effectiveness in real-world settings. We analyzed medical claims from older adults with kidney stones for whom urine chemistry data were available. We found that patients who took prescribed thiazide diuretics for elevated urine calcium levels or alkali for low urinary pH were less likely to experience symptomatic stone recurrences than untreated patients. This benefit was expressed as lower rates of emergency department visits after initiating therapy. Our findings should inform the prescription of and adherence to treatment with thiazide diuretics and alkali for the prevention of recurrent kidney stones.

Effects of Advanced Practice Providers on Single-specialty Surgical Practice.

OBJECTIVE: To assess the effects of adding advanced practice providers to surgical practices on surgical complications, readmissions, mortality, episode spending, length of stay, and access to care. SUMMARY BACKGROUND DATA: There has been substantial growth in the number of nurse practitioners and physician assistants (ie, advanced practice providers) in the United States. The extent to which advanced practice providers have been integrated into surgical practice, and their impact on surgical outcomes and access is unclear. METHODS: Using a 20% sample of national Medicare claims, we performed a retrospective cohort study of fee-for-service beneficiaries undergoing one of 4 major procedures (coronary artery bypass graft, colectomy, major joint replacement, and cystectomy) between 2010 and 2016. We limited our study population for each procedure to patients treated by single-specialty surgical groups to ensure that the advanced practice providers have direct interactions with its surgeons and patients. All outcomes were measured at the practice level for the year before and the year after the addition of the first advanced practice provider. Outcomes included: complications, readmission, mortality, episode payments, length of stay. Models were adjusted for age, race, sex, comorbidity, socioeconomic class and procedure type. Secondary outcome: practice-level office visits by surgical group type. RESULTS: The number of advanced practice providers increased by 13%, from 6713 to 7596 between 2010 and 2016. The largest relative increases occurred in general (46.9%) and urologic (27.6%) surgical practices. The year after an advanced practice provider was added to a surgical practice, the odds of complications were 17% and 16% lower at 30- and 90-days postprocedure, respectively. Additionally, 90-day readmissions were 18% less likely and length of stay was 0.33 days shorter (a 7.1% reduction). Average 30-day and90-day episode spending was $1294.73 and $1427.76 lower, respectively ( P < 0.001). General surgical, orthopedic, and urology practices realized increases of 49.0 (95% CI 13.5-84.5), 112.0 (95% CI 83.0-140.5), and 205.0 (95% CI 117.5-292.0) in-office visits per surgeon, respectively. CONCLUSIONS: The addition of advanced practice providers to single-specialty surgical groups is associated with improvements in surgical outcomes and access. Future work should clarify the mechanisms by which advanced practice providers within surgical practices contribute to health outcomes to identify best practices for deployment.

Impact of Advanced Practice Provider Integration into Multispecialty Group Practices on Outcomes Following Major Surgery.

Background. While advanced practice providers (APPs) are increasingly integrated into care delivery models, little is known about their impact in surgical settings. Given that many patients undergo surgery in multispecialty group practice settings, we examined the impact of APP integration into such practices on outcomes after major surgery. Methods. We used a 20% sample of national Medicare claims to identify 190 101 patients who underwent 1 of 4 major surgeries (coronary artery bypass graft [CABG], colectomy, major joint replacement, and cystectomy) at multispecialty group practices from 2010 through 2016. The level of APP integration was measured as the ratio of APPs to physicians within each practice. Rates of mortality, major complications, and readmission within 30 days of discharge after the index surgery were compared between patients treated in practices with low, medium, and high levels of APP integration using multivariable regression analysis. Results. Relative to patients treated in practices with low APP integration, those treated in practices with medium or high APP integration had significantly lower rates of mortality (2.4% [low integration] vs 1.9% [medium integration] vs 2.0% [high integration]; P < .01), major complications (34.1% [low] vs 31.2% [medium] vs 30.2% [high]; P < .01), and readmission (11.7% [low] vs 10.6% [medium] vs 10.1% [high]; P < .01). This relationship was consistent for virtually all outcomes when considering each surgery type individually. Conclusions. Integration of APPs into multispecialty group practices was associated with improved postoperative outcomes after major surgery. Future research should identify the mechanisms by which APPs improve outcomes to inform optimal utilization.

Factors influencing treatment of veterans with advanced prostate cancer.

BACKGROUND: Treatments for metastatic castration-resistant prostate cancer (CRPC) differ in toxicity, administration, and evidence. In this study, clinical and nonclinical factors associated with the first-line treatment for CRPC in a national delivery system were evaluated. METHODS: National electronic laboratory and clinical data from the Veterans Health Administration were used to identify patients with CRPC (ie, rising prostate-specific antigen [PSA] on androgen deprivation) who received abiraterone, enzalutamide, docetaxel, or ketoconazole from 2010 through 2017. It was determined whether clinical (eg, PSA) and nonclinical factors (eg, race, facility) were associated with the first-line treatment selection using multilevel, multinomial logistic regression. The average marginal effects (AMEs) were calculated of patient, disease, and facility characteristics on ketoconazole versus more appropriate CRPC therapy. RESULTS: There were 4998 patients identified with CRPC who received first-line ketoconazole, docetaxel, abiraterone, or enzalutamide. After adjustment, increasing age was associated with receipt of abiraterone (adjusted odds ratio [aOR], 1.07; 95% credible interval [CrI], 1.06-1.09) or enzalutamide (aOR, 1.10; 95% CrI, 1.08-1.11) versus docetaxel. Greater preexisting comorbidity was associated with enzalutamide versus abiraterone (aOR, 1.53; 95% CrI, 1.23-1.91). Patients with higher PSA values at the start of treatment were more likely to receive docetaxel than oral agents and less likely to receive ketoconazole than other oral agents. African American men were more likely to receive ketoconazole than abiraterone, enzalutamide, or docetaxel (AME, 2.8%; 95% CI, 0.7%-4.9%). This effect was attenuated when adjusting for facility characteristics (AME, 1.9%; 95% CI, -0.4% to 4.1%). CONCLUSIONS: Clinical factors had an expected effect on the first-line treatment selection. Race may be associated with the receipt of a guideline-discordant first-line treatment.

Trends in Procedures to Initiate Renal Replacement Therapy among People Living with Spina Bifida.

PURPOSE: Given the increasing prevalence of chronic kidney disease in people with spina bifida, we sought to determine if this is associated with an increase in end stage kidney disease. We examined population based data to measure the frequency of procedures to establish renal replacement therapy-a marker for end stage kidney disease-among patients with spina bifida. MATERIALS AND METHODS: We used the Healthcare Cost and Utilization Project State Inpatient Database and State Ambulatory Surgery and Services Database from Florida, Kentucky, Maryland and New York (2000 to 2014), which include encounter level data. With a diagnosis code based algorithm we identified all procedural encounters made by patients with spina bifida. We determined the percentage of these encounters that were for facilitating renal replacement therapy (ie arteriovenous anastomosis, renal transplantation). We assessed for changes over time in this percentage with the Cochran-Armitage trend test. Bivariate analysis was performed using chi-square test. RESULTS: Of all procedures performed on patients with spina bifida over this time the proportion of procedures performed to establish renal replacement therapy significantly decreased in both the inpatient and outpatient settings (p=0.042 and p <0.001, respectively). People with spina bifida undergoing procedures to establish renal replacement therapy were, on average, young adults (mean age 34.5 and 36.0 years) with a high prevalence hypertension (75.8% of inpatients, 68.6% of outpatients). CONCLUSIONS: The frequency of surgeries to initiate renal replacement therapy among people with spina bifida undergoing procedures is low and is not increasing. This highlights the importance of consistent care throughout adolescence and young adulthood, and hypertension screening.

Arteriovenous Vascular Access-Related Procedural Burden Among Incident Hemodialysis Patients in the United States.

RATIONALE & OBJECTIVE: As the proportion of arteriovenous fistulas (AVFs) compared with arteriovenous grafts (AVGs) in the United States has increased, there has been a concurrent increase in interventions. We explored AVF and AVG maturation and maintenance procedural burden in the first year of hemodialysis. STUDY DESIGN: Observational cohort study. SETTING & PARTICIPANTS: Patients initiating hemodialysis from July 1, 2012, to December 31, 2014, and having a first-time AVF or AVG placement between dialysis initiation and 1 year (N = 73,027), identified using the US Renal Data System (USRDS). PREDICTORS: Patient characteristics. OUTCOME: Successful AVF/AVG use and intervention procedure burden. ANALYTICAL APPROACH: For each group, we analyzed interventional procedure rates during maturation maintenance phases using Poisson regression. We used proportional rate modeling for covariate-adjusted analysis of interventional procedure rates during the maintenance phase. RESULTS: During the maturation phase, 13,989 of 57,275 patients (24.4%) in the AVF group required intervention, with therapeutic interventional requirements of 0.36 per person. In the AVG group 2,904 of 15,572 patients (18.4%) required intervention during maturation, with therapeutic interventional requirements of 0.28 per person. During the maintenance phase, in the AVF group 12,732 of 32,115 patients (39.6%) required intervention, with a therapeutic intervention rate of 0.93 per person-year. During maintenance phase, in the AVG group 5,928 of 10,271 patients (57.7%) required intervention, with a therapeutic intervention rate of 1.87 per person-year. For both phases, the intervention rates for AVF tended to be higher on the East Coast while those for AVG were more uniform geographically. LIMITATIONS: This study relies on administrative data, with monthly recording of access use. CONCLUSIONS: During maturation, interventions for both AVFs and AVGs were relatively common. Once successfully matured, AVFs had lower maintenance interventional requirements. During the maturation and maintenance phases, there were geographic variations in AVF intervention rates that warrant additional study.

Burden and Cost of Caring for US Veterans With CKD: Initial Findings From the VA Renal Information System (VA-REINS).

Kidney disease is a common, complex, costly, and life-limiting condition. Most kidney disease registries or information systems have been limited to single institutions or regions. A national US Department of Veterans Affairs (VA) Renal Information System (VA-REINS) was recently developed. We describe its creation and present key initial findings related to chronic kidney disease (CKD) without kidney replacement therapy (KRT). Data from the VA's Corporate Data Warehouse were processed and linked with national Medicare data for patients with CKD receiving KRT. Operational definitions for VA user, CKD, acute kidney injury, and kidney failure were developed. Among 7 million VA users in fiscal year 2014, CKD was identified using either a strict or liberal operational definition in 1.1 million (16.4%) and 2.5 million (36.3%) veterans, respectively. Most were identified using an estimated glomerular filtration rate laboratory phenotype, some through proteinuria assessment, and very few through International Classification of Diseases, Ninth Revision coding. The VA spent ∼$18 billion for the care of patients with CKD without KRT, most of which was for CKD stage 3, with higher per-patient costs by CKD stage. VA-REINS can be leveraged for disease surveillance, population health management, and improving the quality and value of care, thereby enhancing VA's capacity as a patient-centered learning health system for US veterans.

Adherence and out-of-pocket costs among Medicare beneficiaries who are prescribed oral targeted therapies for advanced prostate cancer.

BACKGROUND: Abiraterone and enzalutamide are high-cost oral therapies that increasingly are used to treat patients with advanced prostate cancer; these agents carry the potential for significant financial consequences to patients. In the current study, the authors investigated coping and material measures of the financial hardship of these therapies among patients with Medicare Part D coverage. METHODS: The authors performed a retrospective cohort study on a 20% sample of Medicare Part D enrollees who underwent treatment with abiraterone or enzalutamide between July 2013 and June 2015. The authors described the variability in adherence rates and out-of-pocket payments among hospital referral regions in the first 6 months of therapy and determined whether adherence and out-of-pocket payments were associated with patient factors and the socioeconomic characteristics of where a patient was treated. RESULTS: There were 4153 patients who filled abiraterone or enzalutamide prescriptions through Medicare Part D in 228 hospital referral regions. The mean adherence rate was 75%. The median monthly out-of-pocket payment for abiraterone and enzalutamide was $706 (range, $0-$3505). After multilevel, multivariable adjustment for patient and regional factors, adherence was found to be lower in patients who were older (69% for patients aged ≥85 years vs 76% for patients aged <70 years; P < .01) and in those with low-income subsidies (69% in those with a subsidy vs 76% in those without a subsidy; P < .01). Both Hispanic ethnicity and living in a hospital referral region with a higher percentage of Hispanic beneficiaries were found to be independently associated with higher out-of-pocket payments for abiraterone and enzalutamide. CONCLUSIONS: There were substantial variations in the adherence rate and out-of-pocket payments among Medicare Part D beneficiaries who were prescribed abiraterone and enzalutamide. Sociodemographic patient and regional factors were found to be associated with both adherence and out-of-pocket payments.

Surgeon Characteristics and Dialysis Vascular Access Outcomes in the United States: A Retrospective Cohort Study.

RATIONALE & OBJECTIVE: An arteriovenous fistula (AVF) is the preferred access for most patients receiving maintenance hemodialysis, but maturation failure remains a challenge. Surgeon characteristics have been proposed as contributors to AVF success. We examined variation in AVF placement and AVF outcomes by surgeon and surgeon characteristics. STUDY DESIGN: Retrospective cohort study. SETTING & PARTICIPANTS: National Medicare claims and web-based data submitted by dialysis facilities on maintenance hemodialysis patients from 2009 through 2015. EXPOSURES: Patient characteristics, including demographics and comorbid conditions; surgeon characteristics, including specialty, prior volume of AVF placements, and years since medical school graduation. OUTCOMES: Percent of access placements that were an AVF from 2009 to 2015 (designated AVF placement), and percent of AVFs with successful use within 6 months of placement (maturation) from 2013 to 2014. ANALYTICAL APPROACH: Multilevel logistic regression models examining the association of surgeon characteristics with the outcomes, adjusted for patient characteristics and dialysis facilities as random effects. RESULTS: Among 4,959 surgeons placing 467,827 accesses, median AVF placement was 71% (IQR, 59%-84%). More recent year of medical school graduation and general surgery specialty (vs vascular, cardiothoracic, or transplantation surgery) were associated with higher odds of AVF placement. Among 2,770 surgeons placing 49,826 AVFs, the median AVF maturation rate was 59% (IQR, 44%-71%). More recent year of medical school graduation, but not surgical specialty, was associated with higher odds of AVF maturation. Greater prior volume of AVF placement was associated with higher odds of AVF maturation: OR of 1.46 (95% CI, 1.37-1.57) for highest (>84 AVF placements in 2years) versus lowest (<14) volume quintile. LIMITATIONS: The study relied on administrative data, limiting capture of some factors affecting access outcomes. CONCLUSIONS: There is substantial surgeon-level variation in AVF placements and AVF maturation. Surgeons' prior volume of AVF placements is strongly associated with AVF maturation.

The temporal and long-term impact of donor body mass index on recipient outcomes after kidney transplantation - a retrospective study.

The impact of increasing body mass index (BMI) on development and progression of chronic kidney disease is established. Even implantation kidney biopsies from obese living donors demonstrate subtle histologic changes despite normal function. We hypothesized that kidneys from obese living (LD) and deceased donors (DD) would have inferior long-term allograft outcomes. In a study utilizing US transplant registry, we studied adult kidney transplant recipients from 2000 to 2014. Donors were categorized as BMI <20 (underweight), 20-25 (normal), 25-30 (overweight), 30-35 (mildly obese), and >35 kg/m2 (very obese). Our outcome of interest was death censored graft failure (DCGF). Cox proportional hazards model were fitted separately for recipients of DD and LD kidneys, and adjusted for donor, recipient, and transplant characteristics, including donor and recipient size mismatch ratio. Among 118 734 DD and 84 377 LD transplants recipients, we observed a significant and graded increase in DCGF risk among the overweight (LD:HR = 1.06, DD:HR = 1.04), mildly obese (LD:HR = 1.16, DD:HR = 1.10), and very obese (LD:HR = 1.22, DD:HR = 1.22) compared to normal BMI (P < 0.05). The graded effect of donor BMI on outcomes begins early and persists throughout the post-transplant period. Donor obesity status is an independent risk factor for inferior long-term renal allograft outcome despite adjusting for donor and recipient size mismatch and other donor, recipient, and transplant factors.

An analysis of hot spots of ESRD in the United States: Potential presence of CKD of unknown origin in the USA?

We hypothesized that high incidence rates of end-stage renal disease (ESRD) in certain counties of the U.S. are partly due to patients with a type of ESRD resembling chronic kidney disease of uncertain etiology (CKDu), which has been observed in Central America and other countries. Using data on 338,126 incident ESRD patients from the United States Renal Data System (USRDS) (2011 - 2013) and the Behavior Risk Factor Surveillance System (BRFSS) Supplement on county-level variables (2006), we describe both patient-level and county-level characteristics in counties with the highest quartile of ESRD incidence rate standardized for age, sex, and race (> 420 cases/million population/year) compared to the rest of the U.S. and two specific "hotspots" of ESRD: the San Joaquin Valley and the Rio Grande Valley. Logistic regression was used to examine characteristics associated with patients who had either missing cause of ESRD or "unknown" listed as the primary cause of ESRD. High incidence rates of ESRD were observed in southern Texas, the Southeast and parts of California (including the San Joaquin valley area), while low rates were seen in the Northwest and the Mountain Regions. The median crude incidence rate of ESRD was 335 (range 0 - 2,341) new cases per million population per year among counties. Significant predictors of missing/unknown primary cause of ESRD included: older age, white or unknown race, non-Hispanic ethnicity, lack of comorbidities at ESRD onset, lower estimated glomerular filtration rate (eGFR) at initiation, and lack of pre-dialysis care. Large areas of the U.S. have very high rates of ESRD incidence. We cannot confirm that CKDu is present in the U.S. based on this preliminary work. This topic therefore requires further investigation, as many of these patients may well be undocumented aliens working as farm laborers and therefore not registered in the USRDS.
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Association Between Hospital Participation in Medicare Shared Savings Program Accountable Care Organizations and Readmission Following Major Surgery.

OBJECTIVE: To evaluate the effect of Medicare Shared Savings Program accountable care organizations (ACOs) on hospital readmission after common surgical procedures. SUMMARY BACKGROUND DATA: Hospital readmissions following surgery lead to worse patient outcomes and wasteful spending. ACOs, and their associated hospitals, have strong incentives to reduce readmissions from 2 distinct Centers for Medicare and Medicaid Services policies. METHODS: We performed a retrospective cohort study using a 20% national Medicare sample to identify beneficiaries undergoing 1 of 7 common surgical procedures-abdominal aortic aneurysm repair, colectomy, cystectomy, prostatectomy, lung resection, total knee arthroplasty, and total hip arthroplasty-between 2010 and 2014. The primary outcome was 30-day risk-adjusted readmission rate. We performed difference-in-differences analyses using multilevel logistic regression models to quantify the effect of hospital ACO affiliation on readmissions following these procedures. RESULTS: Patients underwent a procedure at one of 2974 hospitals, of which 389 were ACO affiliated. The 30-day risk-adjusted readmission rate decreased from 8.4% (95% CI, 8.1-8.7%) to 7.0% (95% CI, 6.7-7.3%) for ACO affiliated hospitals (P < 0.001) and from 7.9% (95% CI, 7.8-8.0%) to 7.1% (95% CI, 6.9-7.2%) for non-ACO hospitals (P < 0.001). The difference-in-differences of the 2 trends demonstrated an additional 0.52% (95% CI, 0.97-0.078%) absolute reduction in readmissions at ACO hospitals (P = 0.021), which would translate to 4410 hospitalizations avoided. CONCLUSION: Readmissions following common procedures decreased significantly from 2010 to 2014. Hospital affiliation with Shared Savings ACOs was associated with significant additional reductions in readmissions. This emphasis on readmission reduction is 1 mechanism through which ACOs improve value in a surgical population.

The relation between dialysis-requiring acute kidney injury and recovery from end-stage renal disease: a national study.

BACKGROUND: Approximately 4-6% of incident end stage renal disease (ESRD) patients in the U.S. recover enough kidney function to discontinue dialysis but there is considerable geographic variation. We undertook this study to investigate whether state-level variations in renal recovery among incident ESRD patients correlated with state-level variations in incidence of acute kidney injury requiring dialysis (AKI-D). METHODS: We conducted a national cross-sectional ecological study at the state-level using data from State Inpatient Databases and U.S. Renal Data System. All hospital admissions and all ESRD patients in 18 US states (AZ, AR, CA, FL, IA, KY, MA, MD, MI, NJ, NM, NY, NV, OR, RI, SC, VT, and WA) were included. Correlation between AKI-D incidence and rate of renal recovery across states was determined using Pearson's r (overall and in subgroups). We also calculated partial correlations adjusted for sex and age. RESULTS: AKI-D incidence ranged from 99.0 per million population (pmp) in Vermont to 490.4 pmp in Nevada. Rate of renal recovery among incident ESRD patients ranged from 8.8 pmp in Massachusetts to 29.3 pmp in Florida. A positive correlation between AKI-D incidence and rate of renal recovery among incident ESRD patients at state level was found overall (unadjusted r = 0.67; p = 0.002) and in age, sex, and race subgroups. The overall correlation persisted after adjusting for age (adjusted r = 0.62; p < 0.001) and sex (adjusted r = 0.65; p < 0.001). CONCLUSION: Our findings suggest that AKI-D incidence is an important driver of renal recovery rates among incident ESRD patients.

Medicare Accountable Care Organizations and Use of Potentially Low-Value Procedures.

OBJECTIVE: To evaluate the effect of Accountable Care Organizations (ACOs) on the use of vertebroplasty and arthroscopic partial meniscectomy, 2 procedures for which randomized controlled trials suggest similar outcomes to sham surgery and therefore may provide low value. Medicare Shared Savings Program ACOs aim to improve quality and decrease health care spending. Reducing the use of potentially low-value procedures can accomplish both of these goals. METHODS: We performed a retrospective cohort study of patients who underwent potentially low-value orthopedic procedures (vertebroplasty and partial meniscectomy) and a control (hip fracture) from 2010 to 2015 using a 20% sample of national Medicare claims. We performed an interrupted time-series analysis using linear spline models to evaluate the count of each procedure per 1000 patients, stratified by ACO participation. RESULTS: We identified 76 256 patients who underwent arthroscopic partial meniscectomy, 44 539 patients who underwent vertebroplasty, and 50 760 patients who underwent hip fracture admission. Arthroscopic partial meniscectomy rates decreased, vertebroplasty rates remained stable, and hip fracture rates increased for both groups during the study period, with similar trends among ACO and non-ACO patients. After January 1, 2013, ACO and non-ACO populations had similar trends for vertebroplasty (ACO incidence rate ratio [IRR] = 1.15 [1.08-1.23] vs non-ACO IRR = 1.11 [1.05-1.16]), meniscectomy (ACO IRR = 1.06 [1.01-1.12] vs non-ACO IRR = 1.03 [0.99-1.07]), and hip fracture (ACO IRR = 1.08 [1.01-1.14] vs non-ACO IRR = 1.08 [1.03-1.13]). CONCLUSIONS: ACOs were not associated with a reduction in the frequency of vertebroplasty and arthroscopic partial meniscectomy.

Variation in prostate cancer treatment and spending among Medicare shared savings program accountable care organizations.

BACKGROUND: Accountable care organizations (ACOs) have been shown to reduce prostate cancer treatment among men unlikely to benefit because of competing risks (ie, potential overtreatment). This study assessed whether the level of engagement in ACOs by urologists affected rates of treatment, overtreatment, and spending. METHODS: A 20% sample of national Medicare data was used to identify men diagnosed with prostate cancer between 2012 and 2014. The extent of urologist engagement in an ACO, as measured by the proportion of patients in an ACO managed by an ACO-participating urologist, served as the exposure. The use of treatment, potential overtreatment (ie, treatment in men with a ≥75% risk of 10-year noncancer mortality), and average payments in the year after diagnosis for each ACO were modeled. RESULTS: Among 2822 men with newly diagnosed prostate cancer, the median rates of treatment and potential overtreatment by an ACO were 71.3% (range, 23.6%-79.5%) and 53.6% (range, 12.4%-76.9%), respectively. Average Medicare payments among ACOs in the year after diagnosis ranged from $16,523.52 to $34,766.33. Stronger urologist-ACO engagement was not associated with treatment (odds ratio, 0.87; 95% confidence interval, 0.6-1.2; P = .4) or spending (9.7% decrease in spending; P = .08). However, urologist engagement was associated with a lower likelihood of potential overtreatment (odds ratio, 0.29; 95% confidence interval, 0.1-0.86; P = .03). CONCLUSIONS: ACOs vary widely in treatment, potential overtreatment, and spending for prostate cancer. ACOs with stronger urologist engagement are less likely to treat men with a high risk of noncancer mortality, and this suggests that organizations that better engage specialists may be able to improve the value of specialty care. Cancer 2018. © 2018 American Cancer Society.

Early effect of Medicare Shared Savings Program accountable care organization participation on prostate cancer care.

BACKGROUND: Accountable care organizations (ACOs) can improve prostate cancer care by decreasing treatment variations (ie, avoidance of treatment in low-value settings). Herein, the authors performed a study to understand the effect of Medicare Shared Savings Program ACOs on prostate cancer care. METHODS: Using a 20% Medicare sample, the authors identified men with newly diagnosed prostate cancer from 2010 through 2013. Rates of treatment, potential overtreatment (ie, treatment in men with a ≥75% chance of 10-year mortality from competing risks), and Medicare payments were measured using regression models. The impact of ACO participation was assessed using difference-in-differences analyses. RESULTS: Before implementation of ACOs, the treatment rate was 71.8% (95% confidence interval [95% CI], 70.2%-73.3%) for ACO-aligned beneficiaries and 72.3% (95% CI, 71.7%-73.0% [P = .51]) for non-ACO-aligned beneficiaries. After implementation, this rate declined to 68.4% (95% CI, 66.1%-70.7% [P = .017]) for ACO-aligned beneficiaries and 69.3% (95% CI, 68.5%-70.1% [P<.001]) for non-ACO-aligned beneficiaries. There was no differential effect noted for ACO participation. The rate of potential overtreatment decreased from 48.2% (95% CI, 43.1%-53.3%) to 40.2% (95% CI, 32.4%-48.0% [P = .087]) for ACO-aligned beneficiaries and increased from 44.3% (95% CI, 42.1%-46.5%) to 47.0% (95% CI, 44.5%-49.5% [P = .11]) for non-ACO-aligned beneficiaries. These changes resulted in a significant relative decrease in overtreatment of 17% for ACO-aligned beneficiaries (difference-in-differences, 10.8%; P = .031). Payments were not found to be differentially affected by ACO alignment. CONCLUSIONS: The treatment of prostate cancer and annual payments decreased significantly between 2010 and 2013, but ACO participation did not appear to impact these trends. Among men least likely to benefit, Medicare Shared Savings Program ACO alignment was associated with a significant decline in prostate cancer treatment. Cancer 2018;124:563-70. © 2017 American Cancer Society.

Temporal trends, center-level variation, and the impact of prevalent state obesity rates on acceptance of obese living kidney donors.

The impact of pre-donation obesity on long-term outcomes of living kidney donors remains controversial. Published guidelines offer varying recommendations regarding BMI (kg/m2 ) thresholds for donor acceptance. We examined temporal and center-level variation in BMI of accepted donors across US transplant centers. Using national transplant registry data, we performed multivariate hierarchical logistic regression modeling using pairwise comparisons (overweight, BMI: 25-29.9; mildly obese, BMI: 30-34.9; very obese, BMI: ≥35; versus normal BMI: 18.5-24.9). Metrics of heterogeneity, including median odds ratio (MOR), were calculated. Among 90 013 living kidney donors, 2001-2016, proportions who were very obese decreased and proportions who were mildly obese or overweight increased. Significant center-level heterogeneity was noted in BMI of accepted donors; the MOR varied from 1.10 for overweight to 1.93 for very obese donors. At centers located in the 10 states with the highest general population obesity rates, adjusted odds of very obese donor status were 185% higher (reference: normal BMI) than in states with the lowest obesity rates. Although there is a declining trend in acceptance of very obese living kidney donors, variation across centers is significant. Furthermore, local population obesity rates may affect the decision to accept obese individuals as donors.