The 340B Program and High-Risk Prescribing of Oral Targeted Therapies for Advanced Prostate Cancer.

INTRODUCTION: The use of expensive oral targeted agents for advanced prostate cancer can be influenced by those who stand to gain from their use. The 340B drug pricing program allows eligible hospitals to purchase medications at steep discounts, generating millions of dollars in savings. The extent to which hospitals engage in higher-risk prescribing due to program incentives is unclear. METHODS: Medicare claims were used to perform a retrospective study of men with advanced prostate cancer. The primary outcome was targeted therapy use in men with high noncancer mortality risk. Secondary outcomes included androgen biosynthesis inhibitor use in men with cardiovascular history, androgen receptor inhibitor use in men with neurocognitive history, and therapy within 14 days of death. Proportional hazards models were used to assess time-to-event outcomes, while logistic regression was used for binary outcomes. RESULTS: In men with high noncancer mortality risk, targeted therapy use did not differ at 340B participating compared to nonparticipating hospitals (hazard ratio [HR] 1.1, 95% CI 0.67-1.5). There was no difference in androgen biosynthesis inhibitor use in men with a prior cardiac event (HR 0.96, 95% CI 0.70-1.3) or androgen receptor inhibitor use in men with a prior neurocognitive event (HR 1.5, 95% CI 0.65-3.4) in those treated at 340B participating compared to nonparticipating hospitals. Therapy use in the last 14 days of life did not vary by 340B participation (odds ratio 1.3, 95% CI 0.86-1.9). CONCLUSIONS: In men with advanced prostate cancer, high-risk prescribing and futility measures did not vary by participation in the 340B drug pricing program.

Adverse events in men with advanced prostate cancer treated with androgen biosynthesis inhibitors and androgen receptor inhibitors.

BACKGROUND: The use of androgen biosynthesis and second-generation androgen receptor inhibitors for advanced prostate cancer is increasing. Because these therapies alter the androgen pathway, they have been associated with cardiometabolic and neurocognitive toxicities. Although their safety profiles have been assessed in clinical trials, real-world data are limited. METHODS: A 20% sample of national Medicare claims was used to perform a retrospective cohort study of Medicare beneficiaries with advanced prostate cancer treated with androgen biosynthesis (ie, abiraterone) and second-generation androgen receptor inhibitors between 2012 and 2019. Outcomes were assessed after the first fill of either class of drug for the 12-month period after starting therapy. The primary outcome was a hospital admission or emergency department visit for a cardiometabolic event. Secondary outcomes included neurocognitive events and fractures. Multivariable regression was used to assess the association between the class of drug and occurrence of an adverse event. RESULTS: There were 3488 (60%) men started on an androgen biosynthesis inhibitor and 2361 (40%) started on an androgen receptor inhibitor for the first time. Cardiometabolic adverse events were more common in men managed with androgen biosynthesis inhibitor (9.2% vs 7.5%, P = .027). No difference between androgen biosynthesis and androgen receptor inhibitors was observed for neurocognitive events (3.3% vs 3.4%, respectively; P = .71) or fractures (4.2% vs 3.6%, respectively; P = .26). CONCLUSIONS: Men with advanced prostate cancer initiating an androgen biosynthesis inhibitor for the first time more commonly had cardiometabolic events than those started on androgen receptor inhibitors. Neurocognitive events and fractures did not differ by drug class.

Teaching Hospitals and Textbook Outcomes After Major Urologic Cancer Surgery.

OBJECTIVE: To assess textbook outcomes by hospital teaching status following major surgery for urologic cancers. METHODS: We used 100% national Medicare Provider Analysis and Review files from 2017-2020 to assess rates of textbook outcomes in patients undergoing bladder (ie, radical cystectomy), kidney (ie, radical or partial nephrectomy), and prostate (ie, radical prostatectomy) surgery for genitourinary malignancies. The extent of integration of learners into each hospital's workforce-defined as major, minor, and non teaching hospitals-was the primary exposure. A textbook outcome, measured at the patient level, was defined as the absence of in-hospital mortality and mortality within 30days of surgery, no readmission 30days following discharge, no postoperative complication, and no prolonged length of stay. RESULTS: Textbook outcomes were achieved in 51% (8564/16,786) of patients after bladder cancer surgery, 70% (39,938/57,300) of patients after kidney cancer surgery, and 82% (50,408/61,385) of patients after prostate cancer surgery. After adjusting for patient- and hospital-level characteristics, teaching hospitals had higher rates of textbook outcomes in those undergoing bladder (50.7% vs 44.0%; P = .001), kidney (72.0% vs 69.7%; P = .02), and prostate (85.3% vs 81.0%; P <.001) surgery. This effect was attenuated, but not eliminated, by surgical volume in additional sensitivity analyses for bladder (OR: 1.20, 95% CI: 1.00-1.42; P = .04) and prostate (OR: 1.15, 95% CI: 1.00-1.32; P = .04) surgery. There were no significant differences in kidney cancer surgery outcomes after adjusting for hospital volume (OR: 1.03, 95% CI: 0.93-1.14; P = .6). CONCLUSION: Undergoing major cancer surgery at a teaching hospital was associated with an increased likelihood of achieving a textbook outcome. This effect was attenuated by volume but persisted for bladder and prostate surgery.

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.

Bacillus Calmette-Guerin (BCG) therapy is safe and effective in non-muscle invasive bladder cancer (NMIBC) patients with immunomodulating conditions.

INTRODUCTION: Bacillus Calmette-Guerin (BCG) is the most effective therapy available to treat high-risk nonmuscle invasive bladder cancer (NMIBC) patients. However, for patients with immunomodulating conditions BCG is a relative contraindication due to efficacy and safety concerns. To our knowledge, no population-level study evaluating the efficacy and safety profile of BCG for immunomodulated patients exists. METHODS: NMIBC patients aged 66 years or older were identified in the Surveillance, Epidemiology, and End Results (SEER) - Medicare database from 1975-2013. All patients completed adequate BCG (at least 5 plus 2 treatments completed within 12 months of diagnosis). Two groups were defined: an immunomodulated population identified by immunomodulating conditions such as solid-organ transplantation, HIV, and autoimmune conditions, and an immunocompetent group. The primary endpoint was 5-year progression-free survival defined as progression to systemic chemotherapy, checkpoint inhibitors, radical or partial cystectomy, metastasis, or cancer-specific death. A safety analysis was performed as a secondary outcome. RESULTS: In a total of 4,277 patients with NMIBC who completed adequate BCG, 606 (14.2%) were immunomodulated. The immunomodulated group was older at diagnosis (P < 0.001), more likely to be female (P < 0.001), more likely to live in a metropolitan area (P < 0.001), and had higher Charlson comorbidity scores (P < 0.001). There were no differences in progression to chemotherapy (P = 0.17), checkpoint inhibitors (P > 0.99), radical cystectomy (P = 0.40), partial cystectomy (P = 0.93), metastasis (P = 0.19), cancer-specific death (P = 0.18) or 5-year total bladder cancer progression (P = 0.30) between the groups. For the safety analysis, rates of disseminated BCG were similar between immunomodulated and immunocompetent patients (0.7% vs. <1.8%, P = 0.51). On multivariable analysis 5-year total bladder cancer progression (HR 1.07 [CI 0.88-1.30]) was similar between the groups. CONCLUSION: Rates of bladder cancer progression and disseminated BCG complications 5-years after BCG therapy were similar regardless of immunomodulation status. These findings suggest that BCG intravesical therapy can be offered to immunomodulated patients with high-risk NMIBC although theoretical infectious complication risks remain.

Value-based payment models and management of newly diagnosed prostate cancer.

OBJECTIVE: To examine the effect of urologist participation in value-based payment models on the initial management of men with newly diagnosed prostate cancer. METHODS: Medicare beneficiaries with prostate cancer diagnosed between 2017 and 2019, with 1 year of follow-up, were assigned to their primary urologist, each of whom was then aligned to a value-based payment model (the merit-based incentive payment system [MIPS], accountable care organization [ACO] without financial risk, and ACO with risk). Multivariable mixed-effects logistic regression was used to measure the association between payment model participation and treatment of prostate cancer. Additional models estimated the effects of payment model participation on use of treatment in men with very high risk (i.e., >75%) of non-cancer mortality within 10 years of diagnosis (i.e., a group of men for whom treatment is generally not recommended) and price-standardized prostate cancer spending in the 12 months after diagnosis. RESULTS: Treatment did not vary by payment model, both overall (MIPS-67% [95% CI 66%-68%], ACOs without risk-66% [95% CI 66%-68%], ACOs with risk-66% [95% CI 64%-68%]). Similarly, treatment did not vary among men with very high risk of non-cancer mortality by payment model (MIPS-52% [95% CI 50%-55%], ACOs without risk-52% [95% CI 50%-55%], ACOs with risk-51% [95% CI 45%-56%]). Adjusted spending was similar across payment models (MIPS-$16,501 [95% CI $16,222-$16,780], ACOs without risk-$16,140 [95% CI $15,852-$16,429], ACOs with risk-$16,117 [95% CI $15,585-$16,649]). CONCLUSIONS: How urologists participate in value-based payment models is not associated with treatment, potential overtreatment, and prostate cancer spending in men with newly diagnosed disease.

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.

The immediate effects of private equity acquisition of urology practices on the management of newly diagnosed prostate cancer.

INTRODUCTION: Some worry that physician practices acquired by private equity may increase the use of services to maximize revenue. We assessed the effects of private equity acquisition on spending, use of treatment, and diagnostic testing in men with prostate cancer. METHODS: We used a 20% sample of national Medicare claims to perform a retrospective cohort study of men with prostate cancer diagnosed from 2014 through 2019. The primary outcome was prostate cancer spending in the first 12 months after diagnosis. Secondary outcomes included the use of treatment and a composite measure of diagnostic testing (e.g., imaging, genomics) in the first 12 months after diagnosis. Multilevel modeling was used to adjust for differences in patient and market characteristics. The effect of practice acquisition on each outcome was assessed using a difference-in-differences design. RESULTS: There were 409 and 4021 men with prostate cancer managed by urologists in acquired and nonacquired practices, respectively. After acquisition, prostate cancer spending was comparable between acquired and nonacquired practices (difference-in-differences estimate $1182, p = 0.36). Acquisition did not affect the use of treatment (difference-in-differences estimate 3.7%, p = 0.30) or the use of diagnostic testing in men who were treated (difference-in-differences -5.5%, p = 0.12) and those managed conservatively (difference-in-differences -2.0%, p = 0.82). CONCLUSIONS: In the year following acquisition of urology practices, private equity did not increase prostate cancer spending, the use of treatment or diagnostic testing in men with prostate cancer. Future work should evaluate the effects of private equity acquisition on practice patterns and quality over a longer time horizon.

Acquisition of Urology Practices by Private Equity Firms and Performance in the Merit-based Incentive Payment System.

INTRODUCTION: Private equity is increasingly engaged in the acquisition of urology practices. The implications of strategies to enhance practice value deployed by these firms for patients are unclear. METHODS: We conducted a retrospective study of urologist performance in the MIPS (Merit-based Incentive Payment System) program for 2017 to 2020 using national Medicare data from the Quality Payment Program file. The primary outcome was the overall MIPS score. Secondary outcomes included MIPS component scores (ie, quality, interoperability, improvement activities, cost) and the percentage of urologists receiving a bonus payment. Generalized estimating equations were used to estimate the relationship between private equity acquisition and outcomes using a difference-in-differences framework. RESULTS: Between 2017 and 2020, 181 urologists were in a urology practice acquired by private equity with MIPS data available the year before and after acquisition. Compared to urologists in practices not acquired by private equity, those in acquired practices had worse overall MIPS performance after acquisition (difference-in-differences estimate, -14 points, P = .04). The decrease in the overall score was driven by worse performance in the quality score (difference-in-differences estimate, -28 points, P < .001). Finally, acquisition resulted in a decrease in the percentage of urologists receiving bonus payments (difference-in-differences estimate, -43%, P < .001). CONCLUSIONS: Private equity acquisition of urology practices was associated with significantly lower MIPS performance. As private equity acquisition of urology practices becomes more prevalent, key stakeholders should ensure that the quality of patient care is maintained and that the involvement of for-profit entities in health care is being made transparent to patients.

Association between urology practice use of multiparametric MRI and genomic testing and treatment of men with newly diagnosed prostate cancer.

INTRODUCTION: Biomarkers for prostate cancer, such as multiparametric MRI (mpMRI) and tissue-based genomics, are increasingly used for treatment decision-making. Using biomarkers indiscriminately and thus ignoring competing risks of mortality may lead to treatment in some men who derive little clinical benefit. We assessed the relationship between urology practice use of biomarkers and subsequent treatment in men with newly diagnosed prostate cancer. METHODS: We used a 20% random sample of national Medicare data to perform a retrospective cohort study of men with newly diagnosed prostate cancer diagnosed from 2015 through 2019. Urology practice-level use of biomarkers was characterized based on urology practice propensity to use either biomarker after diagnosis (never, below median, above the median). Noncancer mortality risk within 10 years of diagnosis was calculated for all men. Multilevel models were used to assess the relationship between practice-level biomarker use and treatment by noncancer mortality risk. RESULTS: Between 2015 and 2019, 1,764 (65%) urology practices used mpMRI and 897 (33%) used genomic testing for prostate cancer. Compared with urology practices never using each biomarker, those using mpMRI above the median (56% vs. 47%, P = 0.003) and tissue-based genomics below the median (56% vs. 50%, P = 0.03) were more likely to treat men with >75% risk of noncancer mortality. Additionally, compared with urology practices never using either biomarker, use of mpMRI (72% vs. 69%, P = 0.07) or tissue-based genomics (71% vs. 70%, P = 0.65) did not impact treatment in the healthiest group (i.e., those with <25% risk of noncancer mortality). CONCLUSIONS: Compared to practices that do not use each biomarker in men with newly diagnosed prostate cancer, urology practices using mpMRI, and tissue-based genomics to a lesser extent, are more likely to treat men at very high risk of dying from competing risks of mortality within 10 years of prostate cancer diagnosis.

The effect of prior prostate cancer treatment on perioperative and pathological outcomes after cystectomy.

INTRODUCTION: A comprehensive analysis on outcomes in the perioperative and pathological setting in patients with a prior diagnosis of prostate cancer has not been performed. The objective of this study is to describe the effect of prior prostate cancer treatment on perioperative and pathological outcomes after cystectomy. MATERIALS AND METHODS: This was a retrospective review of all male patients who underwent cystectomy at our institution from 01/01/2007-01/01/2020. Patients who were previously diagnosed and treated for prostate cancer were identified and outcomes were assessed. RESULTS: In 525 male patients, 132 (25.1%) had a diagnosis of prostate cancer prior to cystectomy. In the patients with a history of prostate cancer, 59 (46.2%) patients underwent prior radical prostatectomy (RP), 52 (39.4%) underwent some form of radiation therapy and the remaining 21 were managed with other modalities, including 11.4% who were on active surveillance. When comparing perioperative outcomes, there were no significant differences in outcomes. Pathological outcomes revealed that pT4 disease was more common in the RT cohort (19.2%, p = 0.05). In patients with no history of prostate cancer, 151 (40.2%) were found to have incidental prostate cancer at the time of cystectomy. Most (67.5%) patients with incidental prostate cancer had Gleason < 7 disease and only 1.3% developed metastatic prostate cancer on follow up, compared to over 10% of the patients previously treated for prostate cancer (p < 0.05). CONCLUSIONS: Patients who underwent prostate cancer treatment prior to cystectomy may be at increased risk for worse perioperative and pathologic outcomes after cystectomy.

A comparison of naloxegol versus alvimopan at the time of cystectomy and urinary diversion.

INTRODUCTION: The use of alvimopan at the time of cystectomy has been associated with improved perioperative outcomes. Naloxegol is a less costly alternative that has been used in some centers. This study aims to compare the perioperative outcomes of patients undergoing cystectomy with urinary diversion who receive the mu-opioid antagonist alvimopan versus naloxegol. MATERIALS AND METHODS: This was a retrospective review that included all patients who underwent cystectomy with urinary diversion at our institution between 2007-2020. Comparisons were made between patients who received perioperative alvimopan, naloxegol and no mu-opioid antagonist (controls). RESULTS: In 715 patients who underwent cystectomy, 335 received a perioperative mu-opioid antagonist, of whom 57 received naloxegol. Control patients, compared to naloxegol and alvimopan patients, experienced a significantly (p < 0.05) delayed return of bowel function (4.3 vs. 2.5 vs. 3.0 days) and longer hospital length of stay (7.9 vs. 7.5 vs. 6.5 days), respectively. The incidence of nasogastric tube use (14.2% vs. 12.5% vs. 6.5%) and postoperative ileus (21.6% vs. 21.1% vs. 13.3%) was also most common in the control group compared to the naloxegol and alvimopan cohorts, respectively. A multivariable analysis revealed that when comparing naloxegol and alvimopan, there was no difference in return of bowel function (OR 0.88, p = 0.17), incidence of postoperative ileus (OR 1.60, p = 0.44), or hospital readmission (OR 1.22, p = 0.63). CONCLUSIONS: Naloxegol expedites the return of bowel function to the same degree as alvimopan in cystectomy patients. Given the lower cost of naloxegol, this agent may be a preferable alternative to alvimopan.

BCG Administration after Prior Radiation Treatment for Prostate Cancer.

INTRODUCTION: Prostate radiotherapy is associated with worse oncologic outcomes in patients with bladder cancer. The underlying mechanism is incompletely understood but is thought to be related to an altered microenvironment promoting tumorigenesis. However, there is a gap in the literature regarding how the effect of BCG varies according to prior radiotherapy in patients with non-muscle invasive bladder cancer (NMIBC). In this context, we sought to evaluate oncologic outcomes in NMIBC patients who have previously undergone prostate radiotherapy compared to patients with no prior history of pelvic radiotherapy. METHODS: This is a retrospective cohort study that includes all patients who received intravesical for NMIBC at our institution from 2001 to 2019. Patients were stratified into 3 cohorts: prior radiotherapy (RT), radical prostatectomy (RP), and no prostate cancer (No PCa). The outcomes of interest were recurrence at 1-year, progression to muscle-invasive bladder cancer (MIBC), and progression to metastatic disease. Comparisons were also made between cohorts with respect to elapsed time from radiation therapy. Wilcoxon rank-sum test was used for comparing continuous variables, while χ2 and Fischer's exact tests were used to examine categorical variables. RESULTS: In 199 total patients who underwent BCG for NMIBC, 23 had a prior history of prostate radiotherapy treatment, while 17 underwent prior radical prostatectomy. Overall, 41.2% of patients had recurrence at 1 year. There was no difference in the number of induction or maintenance BCG administrations received between the cohorts within the first year. There was no significant difference in recurrence at 1 year between the 3 cohorts (P = .56). There was also no difference in progression to MIBC or progression to metastatic disease with P = .50 and 0.89, respectively. CONCLUSION: The risk of recurrence after induction BCG treatment for high-grade NMIBC does not vary according to prior radiation treatment for prostate cancer.

Extended Anticoagulation after Radical Cystectomy Using Direct Acting Oral Anticoagulants: A Single-Institutional Experience.

INTRODUCTION: Extended prophylactic anticoagulation therapy with enoxaparin 40 mg daily is effective in reducing the incidence of venous thromboembolism (VTE) after radical cystectomy. In an effort to improve compliance, we modified our extended anticoagulation options to direct oral anticoagulants (DOAs; eg apixaban 2.5 mg twice daily or rivaroxaban 10 mg daily). This study assesses our experience with extended VTE prophylaxis using DOAs. METHODS: This is a retrospective review that included all patients who underwent radical cystectomy at our institution between January 2007 and June 2021. Multivariable logistic regression models were constructed to test the hypothesis that use of extended DOAs is similar to enoxaparin in terms of VTE events and risk of gastrointestinal bleeding. RESULTS: In 657 patients, the median age was 71 years. Of the 101 patients who received extended VTE prophylaxis, 46 (45.5%) patients received rivaroxaban/apixaban. At 90 days of followup, 40 patients (7.2%) who did not receive extended prophylaxis on discharge developed a VTE compared to 2 patients (3.6%) in the enoxaparin group and 0 patients in the DOA group (p=0.11). Seven patients (1.3%) who did not receive extended anticoagulation developed gastrointestinal bleeding compared to 0 patients in the enoxaparin group and 1 (2.2%) in the DOA group (p=0.60). On multivariable analysis, both enoxaparin and DOAs were associated with similar reductions in the risk of developing VTE compared to controls (enoxaparin: OR 0.33, p=0.09 and DOAs: OR 0.19, p=0.15). CONCLUSIONS: These preliminary data suggest that oral apixaban and rivaroxaban are acceptable alternatives to enoxaparin with similar safety and efficacy profiles.

Patient, Physician, Hospital Factors Associated With Readmission After Radical Cystectomy.

INTRODUCTION: Patient and clinical factors are the most commonly identified variables associated with hospital readmission after radical cystectomy, but other factors may be important drivers of outcomes, such as hospital and physician characteristics. This study investigates the contribution of patient, physician, and hospital factors in hospital readmission after radical cystectomy. METHODS: This was a retrospective review of the Surveillance, Epidemiology, and End Results-Medicare database focusing on bladder cancer patients who underwent radical cystectomy between 2007 and 2016. Medicare claims were identified using International Statistical Classification of Diseases-9/-10 or Healthcare Common Procedure Coding System codes from Medicare Provider Analysis and Review or National Claims History claims, from which the annual hospital/physician volumes were calculated and classified as low, medium, and high. A multivariable analysis was done for 90-day readmission as the outcome using a multilevel model to explore the association between readmission and characteristics of patient, hospital, and physician. Models with random intercepts were constructed to consider the variation from hospital and physician. RESULTS: Of 3,530 patients, 1,291 (36.6%) were readmitted within 90 days of the index surgery. On multilevel multivariable analysis, factors significantly associated with readmission included continent urinary diversion (OR 1.55, 95% CI 1.21, 2.00), greater National Cancer Institute comorbidity index (2<4 vs 0-<2, OR 1.35, 95% CI 1.05, 1.75; 4+ vs 0-<2, OR 1.76, 95% CI 1.20, 2.58), American Joint Committee on Cancer stage (P = .04), and hospital region (P = .05). Neither hospital volume, physician volume, teaching hospital status, nor National Cancer Institute center designation was associated with hospital readmission. The main source of variation was determined to be the patient factors (95.89%), followed by the physician (1.43%), and then hospital (2.68%) factors. CONCLUSIONS: Patient-specific factors are the most important in impacting the odds of readmission after radical cystectomy, while hospital and physician factors contribute minimally to this outcome.