Addressing transportation barriers in oncology: existing programs and new solutions.

Transportation is an underrecognized, but modifiable barrier to accessing cancer care, especially for clinical trials. Clinicians, insurers, and health systems can screen patients for transportation needs and link them to transportation. Direct transportation services (i.e., ride-sharing, insurance-provided transportation) have high rates of patient satisfaction and visit completion. Patient financial reimbursements provide necessary funds to counteract the effects of transportation barriers, which can lead to higher trial enrollment, especially for low socioeconomic status and racially and ethnically diverse patients. Expanding transportation interventions to more cancer patients, and addressing knowledge, service, and system gaps, can help more patients access needed cancer care.

Disparities in clinical trial participation in ovarian cancer: A real-world analysis.

BACKGROUND: Significant disparities exist in clinical trial participation in non-gynecologic cancers, but little is known about disparities in ovarian cancer trial participation. Our objective was to examine patient, sociodemographic (race/ethnicity, insurance), cancer, and health system factors associated with clinical trial participation in ovarian cancer. METHODS: We conducted a retrospective cohort study of patients with epithelial ovarian cancer diagnosed from 2011 to 2021, using a real-world electronic health record derived database, representing around 800 sites of care in US academic and community practices. We used multivariable Poisson regression modeling to analyze the association of ever participating in an ovarian cancer clinical drug trial with patient, sociodemographic, health system, and cancer factors. RESULTS: Of the 7540 patients with ovarian cancer, 5.0% (95% CI 4.5-5.5) ever participated in a clinical drug trial. Patients of Hispanic or Latino ethnicity were 71% less likely to participate in clinical trials (RR 0.29, 95% CI 0.13-0.61) than non-Hispanic patients, and patients whose race was unknown or other than Black or White were 40% less likely to participate in clinical trials (RR 0.68, 95% CI 0.52-0.89). Patients who had Medicaid insurance were 51% less likely (RR 0.49, 95% CI 0.28-0.87) and those with Medicare were 32% (RR 0.48-0.97) less likely to participate in clinical trials than privately-insured patients. CONCLUSION: In this national cohort study, only 5% of patients with ovarian cancer participated in clinical drug trials. Interventions are needed to decrease race, ethnicity, and insurance disparities in clinical trial participation.

Insurance and racial disparities in prior authorization in gynecologic oncology.

While prior authorization aims to reduce unnecessary care, it may limit or delay medically necessary care. Delays in cancer care can impact survival and are more common in historically-marginalized populations. Our objective was to examine to what extent disparities occurred in prior authorizations for gynecologic oncology. Using electronic medical records, we performed a retrospective review of prior authorization occurrence during gynecologic oncology care and analyzed the association with patient race and insurance in a multivariate regression model. In this cohort of 1,406 patients treated at an academic gynecologic oncology practice, patients with Medicare Advantage and patients of Asian descent were more likely to experience prior authorization. Addressing insurance-mediate disparities, such as in the occurrence of prior authorization, may help reduce disparities in gynecologic cancer care.

Prior authorization in gynecologic oncology: An analysis of clinical impact.

BACKGROUND: Prior authorization was designed to minimize unnecessary care and reduce spending but has been associated with delays in necessary care. Our objective was to estimate the occurrence of prior authorization, and impact on cancer care, in gynecologic oncology. METHODS: We performed a retrospective cross-sectional study of patients seen in University of Pennsylvania gynecologic oncology practices (January-March 2021). Using electronic medical records, we measured the incidence of prior authorization during the 3-month period and prior experience of prior authorization for cancer care overall and by type of order (chemotherapy, imaging, surgery, prescription drugs). We assessed the impact of prior authorization occurrence on clinical outcomes (time to service, changes in care). RESULTS: Of the 2112 clinic visits of 1406 unique patients, 5% experienced prior authorization during the 3-month study period. An additional 20% faced prior authorization requests earlier in cancer care. Of the 83 prior authorization requests, imaging accounted for the majority (54%) followed by supportive medications (29%) and chemotherapy (17%). After appeal, 79% of cases were approved. For patients whose prior authorizations were approved, there was a mean of 16 days from order placement to care delivery (95% CI 11-20, range 0-98 days). Of the 17 denials, 3 (18%) led to a substantial change in care (i.e., not receiving planned treatment). CONCLUSION: 25% of gynecologic oncology patients experienced prior authorization during their cancer care. While 80% of claims were ultimately approved, patients experienced over a 2-week delay in care when prior authorization occurred. Reform is needed to reduce the burden of prior authorization in oncology.

Association of gynecologic oncology versus medical oncology specialty with survival, utilization, and spending for treatment of gynecologic cancers.

BACKGROUND: We examined the association of gynecologic oncology (GYO) versus medical oncology (MEDONC) based care with survival, health care utilization and spending outcomes in women undergoing chemotherapy for advanced gynecologic cancers. METHODS: Women with newly diagnosed stage III-IV uterine, ovarian, and cervical cancers from 2000 to 2015 were identified in SEER-Medicare. We assessed the association of provider specialty with overall survival, emergency department utilization, admissions, and spending. Outcomes were assessed using unadjusted and Inverse Treatment Probability Weighted propensity-score applied, multi-variable cox modeling, Poisson regression, and generalized models of log-transformed data. RESULTS: We identified 7930 gynecologic cancer patients (4360 ovarian, 2934 uterine, 643 cervix). 37% were treated by GYO and 63% by MEDONC. For ovarian patients, GYO care was associated with improved OS (median OS 3.3 v. 2.9 years; HR 0.85, 95%CI 0.80, 0.91, p < .0001) and similar mean spending per month ($4015 v. $4316, mean ratio 0.97 (95% CI 0.93, 1.02), p = .19), compared to MEDONC in adjusted analyses. For uterine patients, GYO care was associated with similar OS, but decreased spending ($3573 v. $4081, mean ratio 0.87 (95% CI.81, 0.93), p < .0001), and decreased ED utilization (RR 0.76, 95% CI 0.69, 0.85, p < .0001). For cervical patients, GYO care was associated with similar OS, and similar spending. Admissions were more likely in ovarian (RR 1.23, 95%CI 1.11, 1.37, p = .0001) and cervical patients (RR 1.26, 95% CI 1.05, 1.51, p = .015) treated by GYO, in adjusted analyses. CONCLUSIONS: GYO based care was associated with improved OS and equal spending for patients with advanced stage ovarian cancer. Uterine and cervix patients had similar OS, and less or equal spending respectively, when treated by GYO compared to MEDONC.

Surveillance for gestational trophoblastic neoplasia following molar pregnancy: a cost-effectiveness analysis.

BACKGROUND: Historically, published guidelines for care after molar pregnancy recommended monitoring human chorionic gonadotropin levels for the development of gestational trophoblastic neoplasia until normal and then for 6 months after the first normal human chorionic gonadotropin. However, there are little data underlying such recommendations, and recent evidence has demonstrated that gestational trophoblastic neoplasia diagnosis after human chorionic gonadotropin normalization is rare. OBJECTIVE: We sought to estimate the cost-effectiveness of alternative strategies for surveillance for gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after complete and partial molar pregnancy. STUDY DESIGN: A Markov-based cost-effectiveness model, using monthly cycles and terminating after 36 months/cycles, was constructed to compare alternative strategies for asymptomatic human chorionic gonadotropin surveillance after the first normal (none; monthly testing for 1, 3, 6, and 12 months; or every 3-month testing for 3, 6, and 12 months) for both complete and partial molar pregnancy. The risk of reduced surveillance was modeled by increasing the probability of high-risk disease at diagnosis. Probabilities, costs, and utilities were estimated from peer-reviewed literature, with all cost data applicable to the United States and adjusted to 2020 US dollars. The primary outcome was cost per quality-adjusted life year ($/quality-adjusted life year) with a $100,000/quality-adjusted life year willingness-to-pay threshold. RESULTS: Under base-case assumptions, we found no further surveillance after the first normal human chorionic gonadotropin to be the dominant strategy from both the healthcare system and societal perspectives, for both complete and partial molar pregnancy. After complete mole, this strategy had the lowest average cost (healthcare system, $144 vs maximum $283; societal, $152 vs maximum $443) and highest effectiveness (2.711 vs minimum 2.682 quality-adjusted life years). This strategy led to a slightly higher rate of death from gestational trophoblastic neoplasia (0.013% vs minimum 0.009%), although with high costs per gestational trophoblastic neoplasia death avoided (range, $214,000 to >$4 million). Societal perspective costs of lost wages had a greater impact on frequent surveillance costs than rare gestational trophoblastic neoplasia treatment costs, and no further surveillance was more favorable from this perspective in otherwise identical analyses. No further surveillance remained dominant or preferred with incremental cost-effectiveness ratio of <$100,000 in all analyses for partial mole, and most sensitivity analyses for complete mole. Under the assumption of no disutility from surveillance, surveillance strategies were more effective (by quality-adjusted life year) than no further surveillance, and a single human chorionic gonadotropin test at 3 months was found to be cost-effective after complete mole with incremental cost-effectiveness ratio of $53,261 from the healthcare perspective, but not from the societal perspective (incremental cost-effectiveness ratio, $288,783). CONCLUSION: Largely owing to the rare incidence of gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after molar pregnancy, prolonged surveillance is not cost-effective under most assumptions. It would be reasonable to reduce, and potentially eliminate, current recommendations for surveillance after human chorionic gonadotropin normalization after molar pregnancy, particularly among partial moles. With any reduction in surveillance, patients should be counseled on symptoms of gestational trophoblastic neoplasia and established in routine gynecologic care.

An increase in multi-site practices: The shifting paradigm for gynecologic cancer care delivery.

OBJECTIVE: To assess whether the number of practice sites per gynecologic oncologist (GO) and geographic access to GOs has changed over time. METHODS: This is a retrospective repeated cross-sectional study using the 2015-2019 Physician Compare National File. All GOs in the 50 United States and Washington, DC, who had completed at least one year of practice were included in the study. All practice sites with complete addresses were included. Linear regression analyses estimated trends in GOs' number of practice sites and geographic dispersion of practice sites. Secondary analyses assessed temporal trends in the number of geographic areas served by at least one GO. RESULTS: Although there was no significant change in the number of GOs from 2015 to 2019 (n = 1328), there was a significant increase in the number of practice sites (881 to 1416, p = 0.03), zip codes (642 to 984, p = 0.03), HSAs (404 to 536, p = 0.04), and HRRs (218 to 230, p = 0.03) containing a GO practice. The mean number of practice sites (1.64 versus 2.13, p < 0.001) and dispersion of practice sites (0.03 versus 0.43 miles, p = 0.049) per GO increased significantly. CONCLUSIONS: Between 2015 and 2019, an increasing number of GOs have multi-site practices, and more geographic regions contain a GO practice. Improvements in geographic access to GOs may represent improved access to care for many women in the US, but its effect on patients, physicians, and geographic disparities is unknown.

Impact of Medicaid expansion on women with gynecologic cancer: a difference-in-difference analysis.

BACKGROUND: Women with gynecologic cancer face socioeconomic disparities in care that affect survival outcomes. The Affordable Care Act offered states the option to expand Medicaid enrollment eligibility criteria as a means of improving timely and affordable access to care for the most vulnerable. The variable uptake of expansion by states created a natural experiment, allowing for quasi-experimental methods that offer more unbiased estimates of treatment effects from retrospective data than the traditional regression adjustment. OBJECTIVE: To use a quasi-experimental, difference-in-difference framework to create unbiased estimates of impact of Medicaid expansion on women with gynecologic cancer. STUDY DESIGN: We performed a quasi-experimental retrospective cohort study from the National Cancer Database files for women with invasive cancers of the uterus, ovary and fallopian tube, cervix, vagina, and vulva diagnosed from 2008 to 2016. Using a marker for state Medicaid expansion status, we created difference-in-difference models to assess the impact of Medicaid expansion on the outcomes of access to and timeliness of care. We excluded women aged <40 years owing to the suppression of the state Medicaid expansions status in the data and women aged ≥65 years owing to the universal Medicare coverage availability. Our primary outcome was the rate of uninsurance at diagnosis. Secondary outcomes included Medicaid coverage, early-stage diagnosis, treatment at an academic facility, and any treatment or surgery within 30 days of diagnosis. Models were run within multiple subgroups and on a propensity-matched cohort to assess the robustness of the treatment estimates. The assumption of parallel trends was assessed with event study time plots. RESULTS: Our sample included 335,063 women. Among this cohort, 121,449 were from nonexpansion states and 213,614 were from expansion states, with 79,886 posttreatment cases diagnosed after the expansion took full effect in expansion states. The groups had minor differences in demographics, and we found occasional preperiod event study coefficients diverging from the mean, but the outcome trends were generally similar between the expansion and nonexpansion states in the preperiod, satisfying the necessary assumption for the difference-in-difference analysis. In a basic difference-in-difference model, the Medicaid expansion in January 2014 was associated with significant increases in insurance at diagnosis, treatment at an academic facility, and treatment within 30 days of diagnosis (P<.001 for all). In an adjusted model including all states and accounting for variable expansion implementation time, there was a significant treatment effect of Medicaid expansion on the reduction in uninsurance at diagnosis (-2.00%; 95% confidence interval, -2.3 to -1.7; P<.001), increases in early-stage diagnosis (0.80%; 95% confidence interval, 0.2-1.4; P=.02), treatment at an academic facility (0.83%; 95% confidence interval, 0.1-1.5; P=.02), treatment within 30 days (1.62%; 95% confidence interval, 1.0-2.3; P<.001), and surgery within 30 days (1.54%; 95% confidence interval, 0.8-2.3; P<.001). In particular, large gains were estimated for women living in low-income zip codes, Hispanic women, and women with cervical cancer. Estimates from the subgroup and propensity-matched cohorts were generally consistent for all outcomes besides early-stage diagnosis and treatment within 30 days. CONCLUSION: Medicaid expansion was significantly associated with gains in the access and timeliness of treatment for nonelderly women with gynecologic cancer. The implementation of Medicaid expansion could greatly benefit women in nonexpansion states. Gynecologists and gynecologic oncologists should advocate for Medicaid expansion as a means of improving outcomes and reducing socioeconomic and racial disparities.

Assessment of poor functional status and post-acute care needs following primary ovarian cancer debulking surgery.

INTRODUCTION: Poor baseline functional status is associated with adverse surgical outcomes. Additionally, decline in the postoperative setting may result in the delay of additional treatments, impacting overall survival. This study assesses the incidence and risk factors for functional decline following primary ovarian cancer debulking surgery in previously independent women using discharge location as a surrogate. METHODS: All patients with a postoperative diagnosis of ovarian cancer who underwent surgical debulking and had documentation of discharge location were identified using the 2011-2012 American College of Surgeons National Surgical Quality Improvement Program database. Patients were excluded if their baseline functional status was dependent or partially dependent, or if they died before discharge. Discharge destination was dichotomized as home versus non-home. Descriptive data included demographics, comorbidities, and perioperative outcomes. Multivariable logistic regression was used to evaluate the association of clinical and surgical factors on discharge destination. RESULTS: 1786 patients met the criteria for analysis; 120 (6.7%) patients were discharged to non-home. Differences between home and non-home discharges included age (53.2% vs 83.3% ≥60), body mass index (26.5 vs 27.8 median), comorbidities (45.2% vs 64.2% with ≥1), and complications (8.6% vs 30.0% with ≥1, all p<0.05). In multivariable logistic regression analyses, only increasing age and complications were independently associated with discharge to non-home. Those age ≥70 had 9.0 times the risk (95% CI 3.5 to 23.4; p<0.001) as age <50. The presence of one or more postoperative complications carried 4.5 times (95% CI 2.9 to 7.0; p<0.001) the risk of those without complications. 30 day mortality was also increased in patients discharged to non-home. DISCUSSION: 6.7% of previously independent ovarian cancer patients were discharged to non-home following surgery. Major risk factors for non-home include older age, comorbidities, and postoperative complications. Efforts to optimize baseline functional status and minimize surgical complications may improve discharge rates to non-home and postoperative functional status.

Nested g-computation: A causal approach to analysis of censored medical costs in the presence of time-varying treatment.

Rising medical costs are an emerging challenge in policy decisions and resource allocation planning. When cumulative medical cost is the outcome, right-censoring induces informative missingness due to heterogeneity in cost accumulation rates across subjects. Inverse-weighting approaches have been developed to address the challenge of informative cost trajectories in mean cost estimation, though these approaches generally ignore post-baseline treatment changes. In post-hysterectomy endometrial cancer patients, data from a linked database of Medicare records and the Surveillance, Epidemiology, and End Results program of the National Cancer Institute reveal substantial within-subject variation in treatment over time. In such a setting, the utility of existing intent-to-treat approaches is generally limited. Estimates of population mean cost under a hypothetical time-varying treatment regime can better assist with resource allocation when planning for a treatment policy change; such estimates must inherently take time-dependent treatment and confounding into account. In this paper, we develop a nested g-computation approach to cost analysis to address this challenge, while accounting for censoring. We develop a procedure to evaluate sensitivity to departures from baseline treatment ignorability. We further conduct a variety of simulations and apply our nested g-computation procedure to two-year costs from endometrial cancer patients.

Low rate of intraperitoneal port placement in ovarian cancer patients, a population-based assessment.

INTRODUCTION: The National Comprehensive Cancer Network (NCCN) guidelines recommend intraperitoneal chemotherapy in optimally debulked stage III ovarian cancer patients. The objective of this investigation was to determine the rate of intraperitoneal port placement in patients undergoing surgery for ovarian cancer in a national database maintained by the American College of Surgeons. METHOD: We identified ovarian cancer patients in the National Surgical Quality Improvement Program database from 2006 to 2012. Demographics, comorbidities, operative outcomes, and postoperative complications were abstracted. Descriptive analyses were conducted using Wilcoxon rank-sum and Chi square tests, and multivariate regression models were used to analyze pre-operative and post-operative variables associated with intraperitoneal port placement. RESULTS: We identified 2659 ovarian cancer patients who underwent primary surgical management. Of these patients, only 128 (4.8%) had an intraperitoneal port placed at the time of surgery. In multivariable analyses, intraperitoneal ports were associated with body mass index ≤25, disseminated cancer, later portion of the study period (2009-2012), and operative time >200 min. Intraperitoneal port placement was not associated with any difference in surgical site infection, wound disruption, major postoperative complication, readmission within 30 days, or death within 30 days. DISCUSSION: Recent investigation of practice at NCCN institutions between 2003 and 2012 found only 35% of eligible ovarian cancer patients received intraperitoneal chemotherapy. Using intraperitoneal port placement as a surrogate for intraperitoneal chemotherapy administration, our investigation suggests an even lower rate (4.8%) nationally.

Society of Gynecologic Oncology Future of Physician Payment Reform Task Force report: The Endometrial Cancer Alternative Payment Model (ECAP).

Health care in the United States is in the midst of a significant transformation from a "fee for service" to a "fee for value" based model. The Medicare Access and CHIP Reauthorization Act of 2015 has only accelerated this transition. Anticipating these reforms, the Society of Gynecologic Oncology developed the Future of Physician Payment Reform Task Force (PPRTF) in 2015 to develop strategies to ensure fair value based reimbursement policies for gynecologic cancer care. The PPRTF elected as a first task to develop an Alternative Payment Model for thesurgical management of low risk endometrial cancer. The history, rationale, and conceptual framework for the development of an Endometrial Cancer Alternative Payment Model are described in this white paper, as well as directions forfuture efforts.

Estimating potential for savings for low risk endometrial cancer using the Endometrial Cancer Alternative Payment Model (ECAP): A companion paper to the Society of Gynecologic Oncology Report on the Endometrial Cancer Alternative Payment Model.

OBJECTIVE: To design an endometrial cancer (EC) alternative payment (ECAP) model focused on surgical management of EC, as well as identify drivers of cost in order to develop opportunities for cost-savings while maintaining quality of care. METHODS: National practice patterns and reimbursements were compared between private payers (MarketScan data, years 2009-13) and public payers (Medicare, year 2014) of EC patients who underwent hysterectomy. An episode of care for EC included the hysterectomy, stratified by surgical approach (laparotomy versus robotic versus laparoscopy), and in- and outpatient reimbursements from 30days preoperatively to 60days postoperatively. Reimbursements were categorized into cost centers. A decision model informed modifiable components influencing overall reimbursements for EC surgical care. Variations in length of stay (LOS), emergency department (ED visits), and readmissions were analyzed to create an optimal care model. RESULTS: A total of MarketScan (n=29,558) and Medicare (n=377) patients were included. Mean total reimbursement for an episode of care was $19,183 (SD $10,844) for Medicare and $30,839 (SD $19,911) for MarketScan. Mean reimbursements were greatest for abdominal cases in Medicare ($25,553; SD $11,870) and MarketScan ($35,357; SD $21,670), followed by robotic and laparoscopic. Among MarketScan patients, 7.6% of women were readmitted within 60days after surgery and 11.7% had an evaluation in the ED. The median reimbursement per patient for readmission was $14,474 (IQR $8584 to $26,149), and for ED visit was $6327 (IQR $1369 to $29,153). In an optimized care model, increasing the rate of minimally invasive surgery by 5% while reducing LOS by 10% and ED visits/readmissions by 10%, lowered the average case reimbursement by $903 (2.9%) for MarketScan and $1243 (5.9%) for Medicare. CONCLUSION: An ECAP model demonstrates that reimbursements vary by public versus commercial payers in the U.S. for the surgical management of endometrial cancer patients, and that opportunities for cost savings exist. Nominal increases in the rate of minimally invasive surgery and reduction in the rate of ED visits/readmissions and length of stay can result in substantial savings for endometrial cancer care.

Non-surgical management of ovarian cancer: Prevalence and implications.

PURPOSE: To identify prevalence, correlates and survival implications of non-surgically managed epithelial ovarian cancer (EOC). METHODS: The National Cancer Database (NCDB) was queried for EOC cases between 2003 and 2011. Type of treatment, survival data, reasons for non-surgical treatment, clinicopathologic and process-based factors were collected. Logistic regression identified independent predictors of surgical treatment; Cox proportional hazards regression modeled association between time to death and receipt of surgery. RESULTS: 172,687 of 210,667 patients (82%) received surgical treatment for EOC. 95% of patients treated non-surgically had stage III, stage IV or unknown stage disease. The reason for non-surgical treatment was unclear in 80% of cases. Black race and uninsurance were significantly associated with non-surgical treatment. Median survival time was 57.4months (95% CI: 56.8-57.9) for surgery with or without systemic treatment compared to 11.9months (95% CI: 11.6-12.2) for systemic treatment alone and 1.4months (95% CI: 1.3-1.4) for no treatment. Relative to surgical treatment, the adjusted hazard ratio for death associated with systemic treatment alone was 1.9 (p<0.001); hazard ratio for untreated patients was 4.7 (p<0.001). Among 29,921 patients older than 75 with Stage III/IV disease, 21.5% received only systemic treatment; 22.8% were entirely untreated. CONCLUSION: 18% of EOC patients in the NCDB did not receive surgical treatment. These patients experienced significantly worsened survival. Prospective investigation is needed to determine how often apparent deviation from best-practices guidelines is clinically appropriate. Non-surgically treated patients may be at risk for poor access to gynecologic oncology care and deserve further study.