High variability in self-pay pricing for vasectomy and vasectomy reversal in the United States.

CONTEXT: In the United States (US) men who undergo vasectomy and/or vasectomy reversal (vasovasotomy) are likely to pay out-of-pocket for these procedures. We characterized the publicly disclosed pricing of both procedures with a focus on variability in self-pay prices. METHODS: We queried all US hospitals for publicly disclosed prices of vasectomy and vasovasotomy. We assessed interhospital variability in self-pay pricing and compared hospitals charging high (≥75th percentile) and low (≤25th percentile) self-pay prices for either procedure. We also examined trends in pricing after the 2022 US Supreme Court decision that allowed individual states to ban abortion. RESULTS: Of 6692 hospitals, 1375 (20.5%) and 281 (4.2%) disclosed self-pay prices for vasectomy and vasovasotomy, respectively. There was a 17-fold difference between the 10th and 90th percentile self-pay prices for vasectomy ($421-$7147) and a 39-fold difference for vasovasotomy ($446-$17,249). Compared with hospitals charging low (≤25th percentile) self-pay prices for vasectomy or vasovasotomy, hospitals charging high (≥75th percentile) prices were larger (median 150 vs. 59 beds, p < 0.001) and more likely to be for-profit (31.2% vs. 7.8%, p < 0.001), academic-affiliated (52.7% vs. 23.1%, p < 0.001), and located in an urban zip code (70.1% vs. 41.3%, p < 0.001). From October 2022 to April 2023, the median self-pay price of vasectomy increased by 10% (from $1667 to $1832) while the median self-pay price of vasovasotomy decreased by 16% (from $3309 to $2786). CONCLUSION: We found large variability in self-pay pricing for vasectomy and vasectomy reversal, which may serve as a barrier to the accessibility of male reproductive care.

Trends in hospital price transparency after implementation of the CMS Final Rule.

OBJECTIVE: To assess trends in hospital price disclosures after the Centers for Medicare & Medicaid Services (CMS) Final Rule went into effect. DATA SOURCES AND STUDY SETTING: The Turquoise Health Price Transparency Dataset was used to identify all US hospitals that publicly displayed pricing from 2021 to 2023. STUDY DESIGN: Price-disclosing versus nondisclosing hospitals were compared using Pearson's Chi-squared and Wilcoxon rank sum tests. Bayesian structural time-series modeling was used to determine if enforcement of increased penalties for nondisclosure was associated with a change in the trend of hospital disclosures. DATA COLLECTION/EXTRACTION METHODS: Not applicable. PRINCIPAL FINDINGS: As of January 2023, 5162 of 6692 (77.1%) US hospitals disclosed pricing of their services, with the majority (2794 of 5162 [54.1%]) reporting their pricing within the first 6 months of the final rule going into effect in January 2021. An increase in hospital disclosures was observed after penalties for nondisclosure were enforced in January 2022 (relative effect size 20%, p = 0.002). Compared with nondisclosing hospitals, disclosing hospitals had higher annual revenue, bed number, and were more likely to be have nonprofit ownership, academic affiliation, provide emergency services, and be in highly concentrated markets (p < 0.001). CONCLUSIONS: Hospital pricing disclosures are continuously in flux and influenced by regulatory and market factors.

Antibiotic Use in Hospital Urinary Tract Infections After FDA Regulation.

BACKGROUND: The FDA issued a "black box" warning regarding risks of fluoroquinolones in 2008 with updates in 2011, 2013, and 2016. OBJECTIVE: To examine antimicrobial use in hospital-treated UTIs from 2000 to 2020. DESIGN: Cross-sectional study with interrupted time series analysis. PARTICIPANTS: Patient encounters with a diagnosis of UTI from January 2000 to March 2020, excluding diagnoses of renal abscess, chronic cystitis, and infection of the gastrointestinal tract, lungs, or prostate. MAIN MEASURES: Monthly use of fluoroquinolone and non-fluoroquinolone antibiotics were assessed. Fluoroquinolone resistance was assessed in available cultures. Interrupted time series analysis examined level and trend changes of antimicrobial use with each FDA label change. KEY RESULTS: A total of 9,950,790 patient encounters were included. From July 2008 to March 2020, fluoroquinolone use declined from 61.7% to 11.7%, with similar negative trends observed in inpatients and outpatients, age ≥ 60 and < 60 years, males and females, patients with and without pyelonephritis, and across physician specialties. Ceftriaxone use increased from 26.4% encounters in July 2008 to 63.6% of encounters in March 2020. Among encounters with available culture data, fluoroquinolone resistance declined by 28.9% from 2009 to 2020. On interrupted time series analysis, the July 2008 FDA warning was associated with a trend change (-0.32%, < 0.001) and level change (-5.02%, p < 0.001) in monthly fluoroquinolone use. CONCLUSIONS: During this era of "black box" warnings, there was a decline in fluoroquinolone use for hospital-treated UTI with a concomitant decline in fluoroquinolone resistance and rise in ceftriaxone use. Efforts to restrict use of a medication class may lead to compensatory increases in use of a single alternative agent with changes in antimicrobial resistance profiles.

Trends, Cost, and Predictors of Local Hemostatics Use in Major Urological Surgery.

INTRODUCTION: The national usage and cost trends associated with hemostatic agents in major urologic procedures remain unknown. This study aims to describe the trends, costs, and predictors of local hemostatic use in major urologic surgeries. METHODS: We utilized the Premier Healthcare Database to analyze 385,261 patient encounters between 2000 and 2020. Our primary objective was to describe the usage patterns of topical hemostatic agents in open and laparoscopic/robotic major urological surgeries. The data from the last 5 years (2015-2020) were used to characterize specific cost trends, and multivariable regression analysis was performed to identify predictors of hemostatic agent use in relation to surgical approach, patient, and hospital characteristics. RESULTS: By 2020, at least 1 topical hemostatic agent was used in 37.3% (95% CI: 35.5-39.1) of laparoscopic/robotic prostatectomies and 30.7% (95% CI: 24.2-37.1) of open prostatectomies; 60.8% (95% CI: 57.6-64.1) of laparoscopic/robotic partial nephrectomies and 55.9% (95% CI: 47.3-64.5) of open partial nephrectomies; 40.7% (95% CI: 36.9-44.3) of laparoscopic/robotic radical nephrectomies and 43.2% (95% CI: 38.8-47.6) of open radical nephrectomies; and 40.52% (95% CI: 35.02-46.02) of open radical cystectomies. For the 2015-2020 cohort, predictors for hemostatic agent use varied by surgery type and included gender, race, surgical approach, insurance coverage, geographical location, urbanicity, and attending volume. The cost of the hemostatic agent accounted for less than 1.6% of the total cost of hospitalization for each procedure. CONCLUSIONS: The use of hemostatic agents in major urologic surgeries has grown over the past 2 decades. For all procedures, the specific cost of using a hemostatic agent constitutes a small fraction of the total hospitalization cost and does not vary significantly between open and laparoscopic/robotic approaches. Some patient, surgeon, and hospital characteristics are highly correlated with their use.

Prostate cancer genetic alterations in Hispanic men.

BACKGROUND: Differences in DNA alterations in prostate cancer among White, Black, and Asian men have been widely described. This is the first description of the frequency of DNA alterations in primary and metastatic prostate cancer samples of self-reported Hispanic men. METHODS: We utilized targeted next-generation sequencing tumor genomic profiles from prostate cancer tissues that underwent clinical sequencing at academic centers (GENIE 11th). We decided to restrict our analysis to the samples from Memorial Sloan Kettering Cancer Center as it was by far the main contributor of Hispanic samples. The numbers of men by self-reported ethnicity and racial categories were analyzed via Fisher's exact test between Hispanic-White versus non-Hispanic White. RESULTS AND LIMITATIONS: Our cohort consisted of 1412 primary and 818 metastatic adenocarcinomas. In primary adenocarcinomas, TMPRSS2 and ERG gene alterations were less common in non-Hispanic White men than Hispanic White (31.86% vs. 51.28%, p = 0.0007, odds ratio [OR] = 0.44 [0.27-0.72] and 25.34% vs. 42.31%, p = 0.002, OR = 0.46 [0.28-0.76]). In metastatic tumors, KRAS and CCNE1 alterations were less prevalent in non-Hispanic White men (1.03% vs. 7.50%, p = 0.014, OR = 0.13 [0.03, 0.78] and 1.29% vs. 10.00%, p = 0.003, OR = 0.12 [0.03, 0.54]). No significant differences were found in actionable alterations and androgen receptor mutations between the groups. Due to the lack of clinical characteristics and genetic ancestry in this dataset, correlation with these could not be explored. CONCLUSION: DNA alteration frequencies in primary and metastatic prostate cancer tumors differ among Hispanic-White and non-Hispanic White men. Notably, we found no significant differences in the prevalence of actionable genetic alterations between the groups, suggesting that a significant number of Hispanic men could benefit from the development of targeted therapies.

Impact of Magnetic Resonance Imaging Targeting on Pathologic Upgrading and Downgrading at Prostatectomy: A Systematic Review and Meta-analysis.

CONTEXT: The evidence supporting multiparametric magnetic resonance imaging (MRI) targeting for biopsy is nearly exclusively based on biopsy pathologic outcomes. This is problematic, as targeting likely allows preferential identification of small high-grade areas of questionable oncologic significance, raising the likelihood of overdiagnosis and overtreatment. OBJECTIVE: To estimate the impact of MRI-targeted, systematic, and combined biopsies on radical prostatectomy (RP) grade group concordance. EVIDENCE ACQUISITION: PubMed MEDLINE and Cochrane Library were searched from July 2018 to January 2022. Studies that conducted systematic and MRI-targeted prostate biopsies and compared biopsy results with pathology after RP were included. We performed a meta-analysis to assess whether pathologic upgrading and downgrading were influenced by biopsy type and a net-benefit analysis using pooled risk difference estimates. EVIDENCE SYNTHESIS: Both targeted only and combined biopsies were less likely to result in upgrading (odds ratio [OR] vs systematic of 0.70, 95% confidence interval [CI] 0.63-0.77, p < 0.001, and 0.50, 95% CI 0.45-0.55, p < 0.001), respectively). Targeted only and combined biopsies increased the odds of downgrading (1.24 (95% CI 1.05-1.46), p = 0.012, and 1.96 (95% CI 1.68-2.27, p < 0.001) compared with systematic biopsies, respectively. The net benefit of targeted and combined biopsies is 8 and 7 per 100 if harms of up- and downgrading are considered equal, but 7 and -1 per 100 if the harm of downgrading is considered twice that of upgrading. CONCLUSIONS: The addition of MRI-targeting results in lower rates of upgrading as compared to systematic biopsy at RP (27% vs 42%). However, combined MRI-targeted and systematic biopsies are associated with more downgrading at RP (19% v 11% for combined vs systematic). Strong heterogeneity suggests further research into factors that influence the rates of up- and downgrading and that distinguishes clinically relevant from irrelevant grade changes is needed. Until then, the benefits and harms of combined MRI-targeted and systematic biopsies cannot be fully assessed. PATIENT SUMMARY: We reviewed the ability of magnetic resonance imaging (MRI)-targeted biopsies to predict cancer grade at prostatectomy. We found that combined MRI-targeted and systematic biopsies result in more cancers being downgraded than systematic biopsies.

Insurer coverage of prostate cancer biomarkers.

INTRODUCTION: Several recently-developed prostate cancer (CaP) biomarkers are recommended per national guidelines, yet feasibility of obtaining these tests is unknown. We used a national database to assess insurance coverage of CaP biomarkers. MATERIALS AND METHODS: Insurance policies regarding 4K Score, ExoDx, My Prostate Score, Prostate Cancer Antigen 3, Prostate Health Index, and SelectMDx as of January 1, 2022 were extracted from the policy reporter database. Coverage was defined as a biomarker being deemed medically necessary, conditionally covered, or covered with prior authorization. Overall rates of biomarker coverage were compared by insurance type and region using Chi-squared test. SelectMDx was not covered by any queried policies and was omitted from analysis. RESULTS: A total of 186 insurance plans were identified among 131 payers. Of the 186 plans, 109 (59%) covered at least one biomarker, with prior authorization required for 38 (35%) of these plans. Prostate Cancer Antigen 3 and 4K Score had higher rates of coverage compared to ExoDx, Prostate Health Index, and My Prostate Score (52% and 43% vs. 26%, 26%, and 5%, respectively, P < 0.01). Medicare plans had higher rates of coverage compared to non-Medicare plans (80% Medicare vs. 17% commercial, 15% federal employer, and 13% Medicaid, P < 0.01), and nationwide plans had higher coverage rates compared to regional plans (43% nationwide vs. 32% midwest, 27% northeast, 25% south, 24% west, P < 0.01). Covered biomarkers under Medicare plans were less likely to require prior authorization compared to those covered by non-Medicare plans (12% Medicare vs. 63% commercial, 100% federal employer, 70% Medicaid, P < 0.01). CONCLUSIONS: Coverage of novel CaP biomarkers are relatively robust for Medicare plans but sparse for non-Medicare plans, with the majority of non-Medicare plans requiring prior authorization. Non-Medicare eligible men may face significant barriers to obtaining these tests.

Real-world practice in Peyronie's disease management: Results from a national survey of urologists.

BACKGROUND: Despite many available treatments for Peyronie's disease (PD), practice patterns of available therapeutics are not well characterized. OBJECTIVE: We conducted a national survey of urologists to characterize real-world practice patterns of PD management and to characterize the use of therapies discouraged by the American Urological Association guidelines on PD management. MATERIALS AND METHODS: A 34-item survey was distributed via RedCap to urologists who treat patients with PD in all American Urological Association sections. Questions elicited demographic information as well as practices in the diagnosis and treatment of PD. Comparisons were made with Pearson's chi-squared test. The primary outcome was reported use of therapies discouraged by the American Urological Association guidelines on PD. RESULTS: A total of 145 respondents completed the survey, of whom 19% were fellowship trained in andrology/sexual medicine, 36% practiced in an academic setting, and 50% had at least 20 years in practice. Only 60% of respondents reporting performing in-office curvature assessment prior to commencing intralesional injection or surgical treatment, with higher prevalence in andrology/sexual medicine fellowship-trained versus non-fellowship-trained urologists (85% vs. 54%, p = 0.003). The most popular treatment modalities were collagenase clostridium histolyticum (61% of respondents), phosphodiesterase-5 inhibitors (54%), and penile traction (53%). Twenty-one percent of respondents reported currently using a treatment that is explicitly discouraged by the American Urological Association guidelines (extracorporeal shockwave therapy for curvature, L-carnitine, omega-3 fatty acids, or vitamin E). DISCUSSION: Patients seeking PD treatment may be offered different therapies, some of which are not evidence-based, depending on the treating urologist. This study is limited by self-selection and response bias. Its strength is that it represents a cross-sectional overview of real-world practice patterns in PD management, which has not been previously described. CONCLUSIONS: A significant proportion of urologists reported PD management practices that are not evidence-based and not guideline-supported.

Price transparency of prostate cancer care in the United States: An analysis of pricing and disclosure following the centers for medicare and medicaid mandate.

BACKGROUND: Starting January 1, 2021, Centers for Medicare and Medicaid Services required United States hospitals to publicly disclose prices of their services provided. We analyzed publicly-disclosed prices of prostate cancer-related services. METHODS: All United States hospitals were queried for publicly-disclosed prices of total and free prostate-specific antigen, prostate magnetic resonance imaging, prostate biopsy, radical prostatectomy, and intensity-modulated radiation therapy as of May 2022. Prices were adjusted by regional price parity. Hospitals disclosing prices were compared with non-disclosing hospitals. RESULTS: Of 6013 hospitals, 3840 (64%) disclosed pricing for at least one prostate cancer-related service. Compared to non-disclosing hospitals, disclosing hospitals had higher median gross annual revenue ($318,502,426 vs. $62,930,436, p < 0.001) and were more likely to be non-profit (56% vs. 30%, p < 0.001), academic-affiliated (46% vs. 13%, p < 0.001), and in neighborhoods with low hospital density (68% vs 62%, p < 0.001). Self-pay prices were higher than insurance-negotiated prices for all services (p < 0.001) other than prostate biopsy. The range of pricing was widest for self-pay prostatectomy, with a 32-fold difference from 90th to 10th percentile ($47,445 to $1476). Self-pay prices of total prostate-specific antigen, magnetic resonance imaging, biopsy, intensity-modulated radiation therapy, and prostatectomy were higher at academic vs. non-academic, for-profit vs. non-profit hospitals, and hospitals in the top quartile of gross annual revenue vs. the third and fourth quartiles (p < 0.01). Self-pay prices of prostate biopsy and prostatectomy were higher in urban vs. rural neighborhoods and neighborhoods with high vs. low hospital density (p < 0.001). CONCLUSIONS: Self-pay prices of prostate cancer services were generally higher than insurance-negotiated prices and were higher at for-profit hospitals, academic hospitals, and hospitals in the highest quartile of gross annual revenue. Higher neighborhood hospital density was not associated with higher likelihood of price disclosure nor lower pricing of services, suggesting that local competition does not lead to lower prices and may disincentivize disclosure of prices.

Trends in Antimicrobial Prophylaxis for Inflatable Penile Prosthesis Surgery From a Large National Cohort.

OBJECTIVE: To assess changes in antibiotic prophylaxis for inflatable penile prosthesis surgery following publication of the American Urological Association (AUA) Best Practice Statement in April 2008. MATERIALS AND METHODS: The Premier Healthcare Database was queried for inflatable penile prosthesis surgeries from January 2000 to March 2020. The primary outcome was administration of an AUA-adherent antimicrobial regimen and secondary outcome was 90-day explant. Piecewise linear regression was used to compare antimicrobial trends before vs after guideline publication. Multivariable logistic regression models were constructed for primary and secondary outcomes. RESULTS: A total of 26,574 patients who underwent inflatable penile prosthesis surgery were identified, of whom 17,754 (67%) received AUA-adherent antibiotics. After guideline publication, there was a 42% relative increase in AUA-adherent regimen usage, with an increase in the usage trend on piecewise linear regression (from 0.1% to 0.8% of encounters per quarter, R2 = 0.75, P < .001). Increased usage trends were also observed for gentamicin (from 0.0% to 1.0% of encounters per quarter, R2 = 0.84, P < .001) and vancomycin (0.1%-0.7%, R2 = 0.77, P < .001). On multivariable regression, odds of AUA-adherence increased after guideline publication (OR: 1.67, 95% CI: 1.54-1.80, P < .001) and with surgery by a high-volume surgeon (OR: 2.21, 95% CI: 2.07-2.35, P < .01). Nonadherence to an AUA-recommended regimen with use of nonstandard antibiotics (OR: 1.16, 95% CI: 0.78-1.71, P = .5) or excess antibiotics (OR: 0.91, 95% CI: 0.62-1.30, P = .6) was not independently associated with increased risk of 90-day explant. CONCLUSIONS: Publication of the AUA Best Practice Statement was associated with subsequent increases in the usage of guideline-adherent antibiotic regimens, particularly vancomycin and gentamicin, despite absence of level-1 evidence supporting this combination.

Variability of Prostate MRI Charges Among U.S. Hospital-Based Facilities.

The Premier Healthcare Database was used to assess charge variation for prostate MRI examinations in U.S. hospitals from January 2010 to March 2020. In 552 facilities performing 37,073 examinations, the median charge per examination was $4419 with 26-fold variation between the lowest ($593) and highest ($15,150) median facility charges. In multilevel linear regression analysis, interfacility variation explained 63.9% of charge variation. Patients may be charged vastly different prices for prostate MRI depending on the facility.

Intensity of observation with active surveillance or watchful waiting in men with prostate cancer in the United States.

BACKGROUND: Population-based studies assessing various active surveillance (AS) protocols for prostate cancer, to date, have inferred AS participation by the lack of definitive treatment and use of post-diagnostic testing. This is problematic as evidence suggests that most men do not adhere to AS protocols. We sought to develop a novel method of identifying men on AS or watchful waiting (WW) independent of post-diagnostic testing and aimed to identify possible predictors of follow-up intensity in men on AS/WW. METHODS: A predictive model was developed using SEER watchful waiting data to identify men ≥66 years on AS between 2010-2015, irrespective of post-diagnostic testing, and applied to SEER-Medicare database. AS intensity among different variables including age, prostate-specific antigen (PSA) level, number of total and positive biopsy cores, Charlson comorbidity index, race (Black vs. non-Black), US census region, and county poverty, income, and education levels were compared using multivariable regression analyses for PSA testing, surveillance biopsy, and magnetic resonance imaging (MRI). RESULTS: A total of 2238 men were identified as being on AS. Of which, 81%, 33%, and 10% had a PSA test, surveillance biopsy, and MRI scan within 1-2 years, respectively. On multivariable analyses, Black men were less likely to have a PSA test (adjusted rate ratio [ARR] 0.60, 95% CI: 0.53-0.69), MRI scan (ARR 0.40, 95% CI: 0.24-0.68), and surveillance biopsy (ARR 0.71, 95% CI: 0.55-0.92) than non-Black men. Men within the highest income quintile were more likely to undergo PSA test (ARR 1.16, 95% CI: 1.05-1.27) and MRI scan (ARR 1.60, 95% CI 1.15-2.27) compared to men with the lowest income. CONCLUSIONS: Black men and men with lower incomes on AS underwent less rigorous monitoring. Further study is needed to understand and ameliorate differences in AS rigor stemming from sociodemographic differences.

Outpatient robotic assisted retroperitoneal lymph node dissection.

Robotic assisted laparoscopic retroperitoneal lymph node dissection (RPLND) has shorter hospitalizations and less morbidity compared to open RPLND. We describe and demonstrate with video the first report of outpatient robotic RPLND.