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PURPOSE This guideline updates recommendations of the ASCO guideline on chemotherapy and targeted therapy for patients with human epidermal growth factor receptor 2–negative metastatic breast cancer (MBC) that is either endocrine-pretreated or hormone receptor (HR)–negative. METHODS An Expert Panel conducted a targeted systematic literature review guided by a signals approach to identify new, potentially practice-changing data that might translate into revised guideline recommendations. RESULTS The Expert Panel reviewed abstracts from the literature review and retained 14 articles. RECOMMENDATIONS Patients with triple-negative, programmed cell death ligand-1–positive MBC may be offered the addition of immune checkpoint inhibitor to chemotherapy as first-line therapy. Patients with triple-negative, programmed cell death ligand-1–negative MBC should be offered single-agent chemotherapy rather than combination chemotherapy as first-line treatment, although combination regimens may be offered for life-threatening disease. Patients with triple-negative MBC who have received at least two prior therapies for MBC should be offered treatment with sacituzumab govitecan. Patients with triple-negative MBC with germline BRCA mutations previously treated with chemotherapy may be offered a poly (ADP-ribose) polymerase inhibitor rather than chemotherapy. Patients with HR-positive human epidermal growth factor receptor 2–negative MBC for whom chemotherapy is being considered should be offered single–agent chemotherapy rather than combination chemotherapy, although combination regimens may be offered for highly symptomatic or life-threatening disease. Patients with HR-positive MBC with disease progression on an endocrine agent may be offered treatment with either endocrine therapy with or without targeted therapy or single-agent chemotherapy. Patients with HR-positive MBC with germline BRCA mutations no longer benefiting from endocrine therapy may be offered a poly (ADP-ribose) polymerase inhibitor rather than chemotherapy. No recommendation regarding when a patient's care should be transitioned to hospice or best supportive care alone is possible. Additional information is available at www.asco.org/breast-cancer-guidelines .

82 Background: Palliative care has been underutilized in the setting of advanced cancer despite its established benefit in improving the quality of life in cancer patients. Few studies have evaluated socioeconomic disparities in receiving palliative care in the outpatient oncology setting. We aimed to evaluate for disparities in utilization of palliative care among patients with metastatic solid tumor malignancies at Tennessee Oncology, a large outpatient community oncology practice with an established palliative care program. Methods: We completed a retrospective review of medical records of 1513 patients that were seen in Tennessee Oncology clinics from 12/2020 to 12/2021. We compared the baseline characteristics of patients with metastatic solid tumor malignancies who did and did not receive palliative care. Chi-square and two-sample t-tests were used for data analysis with the 5% significance level using R statistical software. Results: Male patients utilized palliative care less often than female patients (17% versus 24% for females, p =.0002; 95% CI,.05-1.0). Of payer types, Medicare had the least palliative care utilization (14%) compared to commercial (25%) and other payers (23%). Utilization also varied by cancer type, with melanoma (9%), lung cancer (15%) and renal cancer (21%) being least likely to receive palliative care (p

209 Background: Advanced care planning (ACP) is an important aspect of shared decision making in cancer treatment. Due to its importance, in 2016, Medicare expanded coverage and reimbursement for advance care planning (ACP) services (CPT codes 99497 and 99498). Despite this, ACP has been underutilized in practice. Methods: Tennessee Oncology aimed to increase knowledge and utilization of this service by medical oncologists and advance practice providers and corresponding CPT codes through an educational and quality improvement project. We formed a multidisciplinary team with individuals representing medical oncology providers, palliative care team, billing and accounting, information technology and informatics, nursing, navigation team, and operations. This team created an educational video, incorporating the “PAUSE” framework for addressing advance care planning and its role in community oncology, and details of documentation and billing. We also built in documentation templates into the medical oncology note and created a process to automate the charge capture to avoid additional steps for oncology providers. Results: Prior to this initiative, there was no baseline method to measure ACP and corresponding documentation. After two months of launching our educational video and new documentation templates, 120 documented ACP discussions were completed. ACP documentation was performed by 61 total providers practicing across 16 clinics. Providers completing documentation included both medical oncology (n = 53, 86%) and palliative care (n = 8). Of medical oncology providers, 39 (73%) were physicians and 14 (27%) were advanced practice providers. The three most common cancer diagnoses in ACP encounters were lung (20%), breast (13%), and prostate (8%). Conclusions: This combination of education and automation with multidisciplinary team input helped establish a baseline for ACP measurement that will help identify gaps and improve ACP discussions and documentation in our practice going forward.

416 Background: Patients with cancer can experience disease- and treatment-related symptoms that are underreported and underestimated by physicians. This observational, non-interventional study evaluated the use of ePROs and their impact on duration of treatment (DoT) in patients with solid tumors receiving IO therapy in community practice. Methods: Patients initiating index IO therapy immediately prior to (Jan-2017 to Dec-2018) and after (Sep-2019 to Dec-2020) implementation of Noona, the ePRO platform at Tennessee Oncology clinics, were included in a retrospective historical control (HC) and ePRO cohort, respectively, and followed for up to 6 months. The ePRO cohort was further divided into ePRO users (platform enrollment ≤45 days from index) and non-users. ePRO questionnaires, based on Common Terminology Criteria for Adverse Events (CTCAE), were sent within a week after each IO infusion and could be completed using an internet browser or smartphone app. Patient characteristics and DoT were described and compared between the HC and ePRO cohorts and between the HC cohort and ePRO users subgroup. Use of ePROs was evaluated within the ePRO cohort. Differences in baseline characteristics between cohorts were adjusted using Cox proportional hazards models. Results: Data were collected for 538 HC and 1014 ePRO patients (319 ePRO users and 695 non-users). Patient characteristics were generally similar between cohorts, but more HC patients were diagnosed with Stage IV disease (54% vs 47%; p < 0.01) and initiated IO as monotherapy (82% vs 52%), while more ePRO patients initiated IO as combination therapy (48% vs 18%). ePRO users were more likely than non-users to be female, white, married, living with a spouse, and have higher education (college or graduate degree) (all p < 0.05). Use of ePROs was durable over follow-up, with a consistent number of questionnaires sent over Months 1-3 and Months 4-6 (median: 6 questionnaires in each period) and a slight decrease in the number answered (median: 4 vs 3 questionnaires). ePRO patients had a longer DoT than HC patients (median time to end of first IO regimen: not estimable vs 5.1 months). Significantly more ePRO than HC patients remained on their first IO regimen at 6 months (54% vs 46%; p < 0.05). Multivariate Cox regression showed the risk of ending first IO therapy was lower for ePRO versus HC patients (p < 0.05). Conclusions: The increased DoT observed in the ePRO versus HC cohort in this study suggests that use of ePROs may facilitate improved care coordination and enable patients to remain on IO therapy longer. However, ePRO uptake was only 31% in the ePRO cohort, with several social determinants appearing to influence use. Overcoming barriers in ePRO uptake is an area for future study.

393 Background: Genetic testing is an integral part of cancer care. To optimally facilitate testing, genetic counselors (GC) provide interpretation and direction for treatments in certain applicable solid tumors. A telemedicine (TM) genetic counseling program was initiated in 2019 at Tennessee Oncology, a large community oncology practice spanning over 30 clinical sites throughout Tennessee and Georgia. Methods: Appropriate patients were identified and referred through the Electronic Medical Record (EMR) for genetic testing based on current National Comprehensive Cancer Network (NCCN) guidelines. All counseling sessions were scheduled over TM to the patient’s home to enhance convenience, broaden access, and decrease no-show rates. Physician education regarding result-dependent appropriate screening recommendations per NCCN for mutation positive patients were provided through email communication and dedicated GC notes in the EMR. Results: Between 2019 and 2021, GC referrals per year grew from 195 to 840. Of these referrals, 84.6% of patients completed GC consultations, all of which were facilitated through TM. Of completed consultations, 81.4% underwent testing. Average time from referral to GC consultation was 8-13 business days. The no-show rate was low (< 7%). This program started at 1 clinic in 2019 and is now offered for patient care in 16 clinics across the state. Conclusions: Our program illustrates how remote GC programs are an effective choice for scaling genetics care across a large community oncology practice. Deep integration of TM-based genetic counseling within the EMR helps identify high-risk patients, improves test adoption, patient keep-rate and turn-around-time therefore helping to better patient outcomes. This quality assurance program is an important part of comprehensive cancer care that we can provide to our patients and their families.

206 Background: Tennessee Oncology (TO) is a large community oncology practice with over 180 oncology providers spanning over 30 clinics throughout Tennessee and northern Georgia. In 2017, TO began embedding palliative care (PC) providers in clinics. However, the program growth was slow and by the end of 2019, TO offered PC services within only five clinics. In early 2020, TO implemented various initiatives to expand access and improve utilization of palliative care. Methods: In May 2020, TO hired a palliative care physician to grow and oversee the program. TO physician leadership established and communicated the importance of PC to providers and began providing feedback to each provider on utilization of PC for metastatic lung and pancreatic cancer patients. These diseases were selected due to poor prognosis, high morbidity, and known benefit of palliative care. Expansion of telemedicine reimbursement helped our PC team offer in person and telemedicine visits. Increasing demand allowed for expansion of the team and hiring of additional physicians, advanced practice providers (APPs), and a PC nurse coordinator to provide triage, follow-up and scheduling for PC providers. Results: Between the end of 2019 and the end of 2021, the average number of PC visits per quarter (averaged across three quarters) increased from 1,279 to 2,480, representing a growth of 194%. During this time, TO provided over 19,600 PC visits for 3,955 unique patients, of which 53% were female and 47% were male. Of visits provided, 40% were performed through telemedicine. The program has grown from five providers to 11 providers (three physicians, eight APPs). The number of clinics offering in person PC services has grown from five to 13. The three most common malignancies associated with patient visits were lung (16%), breast (10%), and colorectal (7%). Conclusions: Embedding palliative care within a large community oncology practice is feasible and can grow rapidly. A combination of in-person and telemedicine visits can expand reach to improve accessibility across a large patient population.

436 Background: Tennessee Oncology is a large community oncology practice with over 30 clinics providing 89,000 treatments per year across Tennessee and northern Georgia. Tennessee Oncology’s scheduling application was unable to optimally schedule treatment appointments. This scheduling gap was causing frequent patient delays and employee extended hours. Tennessee Oncology partnered with Smirta, Inc., to develop a data and artificial intelligence (AI) driven scheduling overlay platform that would optimize and simplify cancer treatment scheduling as well as predict scheduling patterns and resource needs. Methods: Named OncoSmart, the scheduling optimization platform ingests historic scheduling data, detailed clinic configuration data including provider and nursing schedules, and available resource data such as treatment room chairs. Utilizing AI, the platform generates optimal scheduling recommendations matching the specific set of services that need to be scheduled. The platform overlays the current scheduling app and provides dynamic, real-time recommendations based on current resource (treatment room, provider, etc.) schedule availabilities and bookings. Tennessee Oncology piloted the scheduling optimization platform at 1 clinic and has currently expanded the pilot to 12 additional clinics. Results: After various ranges of clinic pilot times (6 months to 2 years), Tennessee Oncology treatment volumes have increased by 7%. In parallel to this increase, the optimization platform has helped decrease extended hours by over 32%. The original pilot site has shown major improvement in all 4 primary key performance indicators (KPI): treatment volume +12%; Chair utilization +12%; treatment delay -9%; extended hours -82%. Additionally, using the platform’s predictive analytics capabilities, analyses have been completed to generate optimal treatment scheduling patterns as well as optimal treatment nursing staffing models. Conclusions: Within a short period after deployment, Smirta Inc’s OncoSmart has helped Tennessee Oncology identify better treatment scheduling options for these 13sites. The scheduling optimization platform has proven to be very effective in identifying optimal treatment scheduling strategies and in identifying critical resource bottlenecks. The platform’s clinic management, optimization, nurse assignment, business intelligence, and resource management modules has empowered Tennessee Oncology to better manage critical clinical resources and reduce staff overtime during a period of growth.

215 Background: Integrative Oncology (IO) has become a specialized area of cancer care because of patient desire for holistic approach to care and in response to unmet symptom burden. Until now most IO programs have been limited to large academic medical centers. At Tennessee Oncology (TO), a large community oncology program spanning over 30 clinical sites of care throughout Tennessee and Georgia, an IO program was developed and implemented to bring IO to patients in the community. Methods: In June 2021, the IO program was launched with a physician and a nurse practitioner, both trained in Integrative Oncology. The program started at 8 clinics with visits primarily performed through telemedicine to allow access to each clinic. Providers were educated via email communication and a short video describing the program. Patient education was provided through our website and flyers placed in clinics. A referral order was created within the electronic health record. Results: Within one year, the IO program grew from seeing less than 20 patients per month to seeing over 100 patients per month. To date we have provided approximately 1,050 IO visits for 432 unique patients. Of these patients, 362 (83%) were female and 70 were male. The average age was 59 years old. The top three associated malignancies for patients were breast (n = 182), colorectal (n = 30), and gynecologic oncology (n = 29). Our IO program has expanded from eight to 16 clinics during this time frame. 75% of visits were provided through telemedicine. The most common reasons for IO referral were nutrition and symptom management (fatigue, neuropathy, etc). Conclusions: Implementation of an IO program is possible and scalable in a large community oncology setting. Future directions include studying the impact of our program on patient experience and overall health and wellness.

25 Background: In 2016, Medicare added coverage for advance care planning (ACP) services (CPT codes 99497 and 99498). ASCO’s Coverage and Reimbursement Steering Group sought to explore and quantify whether these codes are regularly utilized by hematology and oncology physicians, and to provide guidance on administrative best practices for successful reimbursement. Methods: We analyzed utilization of care management services using Physician/Supplier Procedure Summary (2016-2019) and Medicare Provider Utilization and Payment Data: Physician and other Supplier PUF CY2018 (PUF) files, available on data.cms.gov. Data files are limited to lines representing services to at least 11 unique Medicare beneficiaries; otherwise, Medicare imputes a blank value. Total ACP services submitted to Medicare and the total services denied were calculated for each year using the combination of Hematology, Hematology/Oncology, and Medical Oncology (collectively Hematology/Oncology) specialties, as well as for all specialties. Within Hematology/Oncology, we also pulled physician-level data for 6,335 physicians who had billed Medicare for at least 500 office or hospital outpatient evaluation and management services in 2018. Totals for codes 99497 and 99498 were calculated per physician, providing a distribution of volume. Results: Specialty utilization of ACP services has increased each year, from 708,183 submitted services in 2016 to 2,043,767 in 2019. Hematology/Oncology utilization increased from 2016 to 2017, followed by declines in volume for 2018 and 2019. Among 6,355 hematology/oncology physicians submitting at least 500 office or hospital outpatient evaluation and management visits, 145 billed Medicare at least 11 ACP services in either a facility or non-facility setting. Advance Care Planning Services (99497 and 99498) billed to Medicare in 2016-2019. Conclusions: Though Advance Care Planning is an integral part of cancer care, the codes are not frequently reported to Medicare as a separate service. This may be due to lack of awareness or understanding of the codes, and uncertainty as to how to implement the services into the workflow of the practice. To increase utilization and ensure appropriate reporting of ACP, Oncologists and Oncology practices would benefit from coding and reporting education, and well as guidance on administrative processes to successfully manage ACP services. ASCO's Coverage and Reimbursement Steering Group has developed a practice administration and reimbursement guide for publication on asco.org.[Table: see text]

6513 Background: Clinical trials are critical for improving outcomes for patients with cancer. However, there is some concern from health insurers that clinical trial participation can increase total cost of care for cancer patients. We investigated the impact of clinical trial participation on total costs paid by Medicare during the OCM program in a large community-based practice. Methods: Tennessee Oncology (TO) is a community oncology practice comprising over 90 oncologists across 30 sites of care. We linked TO trial data and electronic medical record data with OCM data for episodes of care from 2016-2018. To assess the impact of trial participation on total cost relative to routine care, we created matched comparator groups for each OCM episode based on cancer type, metastatic status, number of comorbidities, performance status, and age. Patients with breast cancer receiving hormone therapy only were excluded. Absolute and percent cost differences between groups were calculated for episodes that had a comparator group size of five or greater. Differences in total cost for trial episodes were compared to non-trial episodes, and significance was assessed using the Mann–Whitney U test. We also studied the impact of trial participation on receipt of active treatment in the last 14 days of life (TxEOL), hospice use, and hospitalizations. Results: During the study period, 8,026 completed OCM episodes met study criteria. Patients were enrolled in a clinical trial for 459 of these episodes. On average, episodes during which patients were on trial cost $5,973 less than matched non-trial episodes (Table), independent of early versus late-phase trial. Most savings resulted from decreased drug costs. There were no differences in rates of TxEOL (15% vs. 14% p=1.0), rates of hospitalizations (31% vs. 30% p=0.54), or hospice use (52% vs. 62% p=0.08) between trial and non-trial episodes. Median difference from comparator group average cost was significantly lower for clinical trial episodes (-18% vs. -6%, p

e18719 Background: Clinical pathways have been introduced as tools to optimize cancer care delivery, but evidence of their value in the real world is limited. This retrospective study was performed to assess treatment patterns and clinical outcomes in patients with non-small cell lung cancer (NSCLC) before and after pathway implementation at Tennessee Oncology (TO). Methods: Chart data were abstracted for patients (≥18 years) diagnosed with Stage I-IV NSCLC who initiated first-line (1L) systemic treatment at a TO clinic and had follow-up for ³6 months or until death. Patients were divided into two cohorts: pre-pathways (treatment initiation 2014–2015) and post-pathways (treatment initiation 2016–2018). Patient characteristics, treatment patterns, and outcomes were described and compared across cohorts. An exploratory study endpoint was the evaluation of outcomes based on disease stage at diagnosis. Results: Among 501 patients (251 pre-pathways and 250 post-pathways), most had advanced or metastatic NSCLC at diagnosis (Stage III: 40%; Stage IV: 42%). Chemotherapy comprised almost all 1L systemic therapy used pre-pathways (Stage I/II: 100%; Stage III: 96%; Stage IV: 83%). Post-pathways, chemotherapy remained the most common 1L therapy in patients with Stage I/II (89%) and Stage III (72%) disease, but among patients with Stage IV disease, use of chemotherapy decreased (47%) and immuno-oncology (IO) therapy alone or in combination became common (45%). Median duration of 1L therapy was longer post-pathways in patients with Stage III (2.1 months vs 1.4 months pre-pathways; P < 0.01) and Stage IV disease (3.3 months vs 2.3 months pre-pathways; P < 0.01) but did not differ among Stage I/II patients. Median progression-free survival was significantly longer post-pathways in patients with Stage IV disease (7.0 months vs 4.2 months pre-pathways; P < 0.05), but not in other disease-stage subgroups. Median overall survival increased non-significantly post-pathways for all disease stage subgroups (Stage I/II: 26 months vs 20 months pre-pathways; Stage III: 26 months vs 20 months; Stage IV: 10 months vs 9 months). For each disease stage, rates of severe adverse events were similar between cohorts. Conclusions: While outcomes for patients diagnosed with Stage III/IV NSCLC were generally improved following the implementation of clinical pathways, this change coincided with a dramatic shift in available treatment options. Improvements post-pathways were mainly observed in patients diagnosed with advanced disease. Thus, differences in outcomes between pre-pathways and post-pathways cohorts in our study are more likely attributable to other evolving practices in cancer care, particularly the availability of newer, more effective treatments such as IO therapy as part of standard practice, than implementation of the clinical pathways.

248 Background: Guidelines support the use of prophylactic antivirals to prevent reactivation of herpes varicella in patients with multiple myeloma (MM) on proteasome inhibitors (PI). In our network of five oncology practices spanning over 100 clinic sites, one practice has a built-in prompt for acyclovir use in patients receiving a PI, while the other four practices do not. We used this natural experiment to determine the impact of this prompt on appropriate prophylactic antiviral usage in this patient population. Methods: We retrospectively identified all patients in our network with MM beginning a regimen containing a PI between 1/1/19 and 5/28/20. Of these patients, we identified those with documentation of a prescription for acyclovir or valacyclovir before or within 2 days of the first PI dose. We compared prophylactic usage across five practices. Practice 1 had built a prompt for the prescription of acyclovir in regimens containing bortezomib or carfilzomib within the electronic medical record (EMR) which both reminded physicians and nurses and simplified the prescribing process. No other practices had similar EMR prompts. Results: We identified 583 patients with MM who received a PI during the study period. Wide variation in rates of prophylactic antiviral usage existed across the five practices (range 21%-94%). The highest rate of prophylactic antiviral usage was practice 1 (94%). This was the only practice with a built-in EMR prompt for acyclovir usage in PI regimens. We found no association between use of prophylactic antivirals and individual provider-level volume of patients with MM. Conclusions: Use of prophylactic therapy is heterogeneous across practices. A comprehensive treatment plan containing a prompt in the EMR can markedly increase appropriate utilization. We plan to add an EMR prompt and analytics-driven reminders across our network to improve utilization of all guideline-recommend, orally administered prophylactic medications. [Table: see text]

253 Background: Prophylaxis for highly emetogenic chemotherapy (HEC) is well established in clinical guidelines, but real-world treatment patterns are unclear. Today, consistent use of prophylaxis is more easily accomplished due to the incorporation of ordering premeds into the workflow prior to administration of intravenous chemotherapy. However, prescription of oral agents for treatment of breakthrough chemotherapy induced nausea and vomiting (CINV) is less consistent and standardized and has a scant evidence base. In an effort to standardize utilization, we evaluated the use of prophylaxis and oral breakthrough medications in a large national community oncology network. Methods: Data from electronic medical records at five practices comprising over 100 clinic sites was analyzed to examine the frequency of guideline-recommended triplet 5-HT3 receptor antagonist, NK-1 receptor antagonist, and corticosteroid use for prophylaxis prior to the administration of HEC agents. Oral breakthrough medication use and preference was also analyzed. Data was collected and analyzed at the practice level. Results: We identified 2645 patients that received HEC between 1/1/2019 and 5/8/2020. We found consistently high utilization of guideline-concordant triplet prophylaxis regimens for patients receiving HEC, ranging from 90-100% at each of the five practices. In addition, most patients (mean 83%, range 67% - 94%) received a prescription for at least one oral breakthrough medication, but the agent(s) utilized varied widely across practices (Table). Ondansetron was the most commonly prescribed oral breakthrough medication (mean 68%, range 53% - 88%), while olanzapine use for either prophylaxis or breakthrough CINV across practices ranged from 1% - 4%. Conclusions: In this national community oncology network, standard recommended triplet agent prophylaxis for HEC was delivered successfully. However, opportunity exists to increase appropriate use of olanzapine and reduce variation of oral breakthrough antiemetic medications in order to optimize clinical care. [Table: see text]

103 Background: Uninterrupted care is essential for optimal outcomes in cancer care. The COVID-19 pandemic presented numerous challenges in providing continuity of care for many facilities. Our practice was able to deliver ongoing treatment for a large volume of our patients while maintaining a safe environment. Methods: A practice-wide effort to continue therapy in cancer patients undergoing active treatment began in March 2020 as the peak of the pandemic was beginning in Tennessee. Those patients who were receiving active treatment continued the planned treatment while reducing non-acute treatment visits. We assessed the volume of patients receiving treatments in our facilities for two periods: JanuaryDecember 2019 and January-May 2020. We compared the aggregate number of chemotherapy infusions, therapeutic infusions and injections as well as total treatments. Results: Overall, treatments remained relatively stable without a significant change in treatment volumes. There was a 3.69% decline in total treatment with therapeutic infusions (-9.68%) and injections (-7.85%) which accounted for the majority of deferred treatments. Chemotherapy infusions remained stable with an average increase (1.90%) in treatments. Conclusions: During the COVID-19 pandemic, our facility was able to maintain stable treatment numbers while providing safe care to our patients. We had no known diagnosed COVID-19 cases from potential exposures in our clinics. Decreases in treatment reflected less critical therapies. There did seem to be a delay for chemotherapy/immunotherapy that seemed to resolve as the peak passed for this region. Offloading of less critical treatments can result in continued treatment of cancer patients during a pandemic. [Table: see text]

226 Background: Uninterrupted utilization of oral oncolytics is critical to maximizing safety and efficacy of cancer treatment. The COVID-19 pandemic presented numerous challenges to delivering a continuous and safe supply of oral oncolytics to patients with cancer including potential loss of insurance coverage, patient lost income making copays more difficult, remote pharmacy staffing difficulties, and logistical challenges in safely distributing drug to cancer patients. Tennessee Oncology has an in-house Specialty Pharmacy that utilizes home delivery of oral oncolytics while coordinating care with providers during changing patient situations. Methods: We analyzed patients who received an oral oncolytic from our pharmacy in two periods: January-May 2019 and January-May 2020. We compared the aggregate patient copay amounts during these periods, the number of patients who utilized copay assistance or foundational financial support. For insights on continuation we also assessed the medication possession ratios (MPR, the sum of the day’s supply for all fills of a given drug in a particular period divided by the number of days in that period) during these time periods for five of our most commonly dispensed drugs. Results: The aggregate patient copay was similar between the two time periods. A 22% increase in the utilization of copay cards indicated patient’s insurance coverage was sustained. We also observed a 12% increase in the number of patients utilizing foundation support for prescriptions filled. MPRs for five commonly dispensed oral oncolytics were unchanged during COVID-19. Conclusions: Our in-house specialty pharmacy maintained delivery of oral oncolytics during the COVID-19 pandemic. Patient cost share was contained by our pharmacy staff proactively utilizing copay cards for all eligible patients and diligently securing foundational grant support. The pharmacy interventions allowed for affordability, uninterrupted pharmacy operations, and consistent medication supply. This led to continued medication adherence. MPR for the 5 top dispensed medications was consistent in a year-on-year comparison. [Table: see text]

146 Background: During the COVID-19 pandemic, our community oncology practice, with over 150 providers at 33 locations, incorporated infection control guidance from the CDC into our Pandemic Emergency Plan, including visitor restrictions at all locations. There was an increase in patient fall events in our clinics after visitor restrictions were implemented in March 2020, as there were fewer care-givers available in the clinics to assist patients. Methods: Using our adverse event reporting system, we abstracted and trended all safety events that involved patient falls from March 2019 through May 2020. We compared patient fall events during the period of visitor restriction (March-May 2020) to the same period in 2019, and to the 3 months preceding March 2020 and the implementation of COVID-19 restrictions. We report patient fall events per 1,000 patient visits. Results: Prior to COVID-19, patient fall events averaged .207 falls per 1,000 patient visits for March thru May 2019 and .137 falls per 1,000 patient visits for Dec 2019 thru Feb 2020. Following the implementation of visitor restrictions in March 2020, patient fall events increased to .271 per 1000 visits, with a vast upward trend resulting in .435 patient fall events per 1,000 visits in May of 2020 when the restrictions were tightened, more than double previous averages prior to COVID-19. Conclusions: Family members and care-givers play an important role in the patient’s care team. We are confident that the significant increase in patient falls in May 2020 is attributed to visitor restrictions. These findings support the vital role of family and care-givers in patient safety. They not only provide transportation, emotional support and information on patient health status, but assist with ADLs, ambulation and transfer needs during the patients’ visits to the clinics. Healthcare facilities are often under-resourced and under-staffed to fully address patients’ physical needs. Limiting care-givers during a pandemic may reduce the transmission of infection, but also may lead to other unexpected adverse events. Using these findings, we will be implementing standard fall prevention procedures. The practice’s emergency pandemic plan on visitor restrictions will also be amended to take this into account.

22 Background: End-of-life anti-neoplastic treatment does not improve quality of life nor prolong survival of advanced cancer patients. It is also not cost-effective. To-date, there has been little data examining real-world patterns of chemotherapy and immunotherapy treatment at end of life. We investigated use of chemotherapy and/or immunotherapy in the last 14 days of life across a community oncology network of 5 practices, 100 sites of care, and 160 oncology providers. Methods: Using a real-time, network-wide database, we identified patients with solid tumor malignancies who died during an episode of active treatment, defined as having received intravenous (IV) chemotherapy and/or immunotherapy within 90 days of death. We then identified patients in this cohort who received IV chemotherapy and/or IV immunotherapy within 14 days of death (TxEoL). We studied TxEoL patterns by cancer type, treatment type, line of therapy, patient age, patient race, and oncology provider years in practice. Statistical significance was assessed using Pearson’s Chi-squared test. Results: 2,858 qualifying solid tumor cancer patients with dates of death between 1/1/2019 and 5/31/2020 were identified. Observed rates of TxEoL were 16.7% for immunotherapy alone vs. 19.6% for chemotherapy +/- immunotherapy (p = 0.09). We found high variation in TxEoL across 132 oncologists that had 5 or more deceased patients (range: 0% to 50%, mean: 19.2%, median: 19.6%). We found no association of TxEOL with physician years in practice, patient age or race. Rates of TxEoL in the first-line setting were significantly higher than in second-line setting or later (23.3% versus 16.4%, p < 0.01). Patients with head and neck, pancreatic, and hepatobiliary malignancies were the most likely to receive TxEoL, while patients with prostate, brain, and ovarian malignancies were the least likely to receive TxEoL. Conclusions: Our data and method identified wide variation in TxEoL patterns across a large community oncology network, suggesting room for provider-level interventions to improve treatment decisions in patients at high risk of death. Studies within our group, such as examining the impact of palliative care referrals on IV anti-cancer treatment in patients potentially facing end of life, are ongoing.

102 Background: Dependable and timely dispensing and delivery of oral oncolytics to patients with a new indication for therapy is a central part of modern cancer care. The COVID-19 pandemic has presented numerous impediments and challenges to patients receiving oral therapy from many specialty pharmacies in a timely due to remote pharmacy staffing and drug shipment. Tennessee Oncology has an integrated URAC and ACHC accredited Specialty Pharmacy to ensure the seamless care for our patients prescribed oral oncolytics. We investigated the effect of COVID-19 on the number of patients initiating care with an oral oncolytic and the time to fill during the pandemic. Methods: We analyzed the number of overall new patients to the practice and new patients receiving oral oncolytics in two year-to-year comparisons: (1) January-March 2019 vs. January-March 2020 and (2) April-May 2019 vs. April-May 2020. We then compared the average pharmacy turnaround time (defined as the time of entry of a regimen in the electronic medical record that contained an oral oncolytic until the time that prescription was ready for shipment) and the average time from regimen entry until the patient received that medication. Prescriptions received and filled on the day of order entry were recorded as a one-day turnaround time. Results: A year to year increase of 7% in practice new-patient volume was associated with a 13% increase in new oral oncolytic patients from January-March 2020. Year to year April and May comparisons, noted a 33% decrease in new-patient volume to our practice with an associated 10% decrease in new oral oncolytic patients. Time to fill remained consistent in March and April 2020 at 1.84 days vs. 1.78 for 2019. The time from regimen entry to patient shipment receipt was also stable year to year (3.10 vs. 3.06 days). Conclusions: Our in-house Specialty Pharmacy was able to continue delivery of new prescriptions for oral oncolytics during the COVID-19 pandemic. There was a fall in the number of new patient dispensing in April-May 2020 that we attribute to a decrease in cancer diagnoses related to COVID-19 as reflected by a fall in total practice new patients. New patient on-boarding activities including prior authorizations, co-pay assistance, patient education were maintained and the measured time to fill from regimen entry to patient receipt were unchanged.

263 Background: A large community oncology practice in Tennessee participates in value-based payment arrangements, the success of which depends on close patient monitoring. Telemedicine as an innovative solution was initiated in 2017. The service was limited, due to regulation, licensure requirements, and lack of reimbursement, to survivorship visits, clinical trial consent visits, rural hospital consults and genetic counseling. During the COVID pandemic and loosening of restrictions, telemedicine services were expanded. Methods: We identified a cloud-based platform that allowed patients to use any device with a camera and microphone and required no software downloads. On-line training sessions were provided to clinical staff. All training and workflow implementation were completed in a 2-week time frame. Telemedicine was expanded to include surveillance, urgent care, psychology, palliative care and post-BMT visits as well as new patient consults for medical, radiation and gynecologic oncology patients. Patient satisfaction surveys were administered. Results: Our telemedicine visits increased weekly beginning March 1, peaking in the month of April with an average of 77 scheduled telemedicine visits per day across the practice. During the month of April, our practice saw a record clinical trial accrual in our Phase-1 Drug Development Unit with a 22% increase over the previous average. Patients who responded to a satisfaction survey were highly satisfied with the telemedicine visit with a 73% positive response rate. Nearly half of our eligible patients did not have the technology or broad-band access to be able to participate in telemedicine. Conclusions: Our prior experience with telemedicine, though limited, facilitated the development of an infrastructure that provided adequate number of devices and internet bandwidth capacity to support rapid expansion of telemedicine. We were able to maintain high quality care and access to clinical trials during the pandemic and see the value of this service long-term. We hope to add tele-pharmacy and care coordination services. Political leadership and patient advocacy groups should explore ways to ensure that all patients may benefit from this technology, especially those in under-served areas.

172 Background: Tennessee Oncology partnered with an ePRO platform solution to support patients during their cancer care journey. This cloud-based ePRO platform is designed to assist in improving the management of symptoms. Providing two core pieces of functionality allow both the patient and care teams to retrieve information quickly and communicate effectively. The patient portal is patient input driven and allows the patient to communicate with their care team, track symptoms, and access their health records via website or mobile app. The clinician portal provides multiple care teams the ability to manage and prioritize patient needs as well as communicate directly with patients. In March 2020, due to the pandemic, patients needed a convenient and remote way to communicate with the care team. Our communication plan had to be nimble and provide immediate updates to our large patient population. We leveraged our ePRO platform to meet this need. Methods: We focused efforts on increasing patient engagement by educating them on the benefits of this communication platform. We utilized secure messaging to send appointment details and for Telehealth visits a link to the visit was sent. We were able to provide weekly updates outlining our latest information regarding our safety protocols. Results: We noted an increase in the activation of patient accounts and patient-initiated messages in our ePRO platform. We saw an average of 1,000 new patient accounts activated each month during March, April and May. We saw that patient-initiated messages through the platform showed a 15% increase from February to March. The response rate for patients completing post-treatment questionnaires increased 8% from February to May. Conclusions: By providing patients with a single communication platform to contact their care teams outside of their office visits, patients become an active part of their care journey. As an organization, we continue to identify ways to connect our patients to their care team in a meaningful way through technology. Whether during normal business hours or after-hours, patients need a simple, reliable and consistent way to engage with their care team.

9 Background: The use of biosimilar drugs in the treatment of cancer offer an opportunity for oncology providers to decrease total cost of care while preserving quality. However, it remains unclear whether providers and patients may resist biosimilar use due to concerns over safety and efficacy. Our national network of 5 practices with over 100 clinics committed to a conversion to therapeutic biosimilars for trastuzumab and bevacizumab after their introduction in July 2019. Methods: Common steps to foster therapeutic biosimilar conversion included frequent communication from medical directors to providers and staff, incorporation of biosimilars into default treatment regimen orders, providing clinical teams lists identifying candidates for conversion, and tracking reasons why biosimilar switch did not occur. Most practices prioritized converting patients initiating new treatments, then later transitioning patients receiving maintenance therapy. This phased approach was taken to ensure that prior authorization and patient consent could be obtained prior to conversion. Rates of biosimilar use were calculated by comparing the number of administrations for which a biosimilar was given to the total number of administrations for which a biosimilar could have been given. Cost savings were calculated by comparing the difference in Medicare allowed rates for each originator and biosimilar drug pair at the time of administration. Results: Biosimilar use increased over time at all practices, from 0% to an average of 67% for trastuzumab and 78% for bevacizumab. The decrease in cost attributed to the use of biosimilars in the study period totaled over $4.4 million. Challenges to biosimilar use included physician preference for the originator drug, difference in preferred agents across payers, and challenges with biosimilar drug storage. Patients rarely had concerns over efficacy and safety. Conclusions: Therapeutic biosimilar adoption in a large oncology network is feasible and can lead to significant cost savings. [Table: see text]

12103 Background: Palliative care improves quality of life and may increase overall survival in patients with solid tumor malignancies. Despite having the ability to refer patients to in-home and external palliative care services, we observed low palliative care referral rates in our practice of 90 oncologists across 30 clinics. We tested whether embedding palliative care providers directly in clinic would improve palliative care referral rates for solid tumor patients. Methods: Between 2017 and 2020, we embedded an independent palliative care provider into five clinics across middle Tennessee. Access to external palliative care services was present both before and after the intervention. Using data from our EHR and billing systems, we performed a pre-post analysis measuring palliative care referrals in the six-month periods immediately before (pre-intervention period) and after (post-intervention period) a palliative care provider was embedded in each clinic. Statistical significance was assessed using Welch’s two sample t-test. Results: 8,636 unique solid tumor patients were seen in the five clinics during the study periods (Table). Despite having the ability to refer patients to external palliative care services in the pre-intervention period, the placement of a palliative care provider into clinic increased the number of solid tumor patients that received a palliative care referral per month at all clinics (min.: 200%; max.: 990%; median: 600%). Four of the five increases were statistically significant (p-values < 0.05). Conclusions: Even when external palliative care services are available, embedding palliative care providers into community oncology clinics significantly increases the rate of palliative care referrals for solid tumor patients. [Table: see text]

138 Background: A nine provider, community oncology clinic had limited local access to genetic counseling. Additionally, the practice had no process for identifying appropriate patients for genetic counseling or testing and no method to track referrals and test results. The practice partnered with a contracted genetic counselor and a study was completed to standardize screening and follow-up and to increase referrals and testing. Methods: Baseline data on genetic testing performed in 2018 was obtained from three major genetic testing labs. Based on the NCCN guidelines for genetic assessment, the practice created automated screening reports from the EMR, supplemented by manual chart review, to identify appropriate patients for genetic counseling. Front office, clinical and billing workflows were created. Patients were scheduled to see the counselor via in-person appointments or remotely via a HIPAA compliant telemedicine platform. The genetic counseling sessions included education and consent for testing followed by review and discussion of results. Consultations and genetic testing results were documented in the practice’s EMR. Results: Baseline data showed that the clinic tested 7 patients in 2018; 2 patients in the first quarter. During the pilot from Jan-Mar 2019, 34 patients were referred for genetic counseling; 30 consented to testing. This is a 329% increase over 2018; 1400% for the first quarter. Of the 30 patients tested during the pilot, 6 were positive for a pathogenic mutation. Conclusions: By contracting with a genetic counselor, and establishing procedures for screening, counseling, consenting, testing and follow-up, the practice was able to increase the number of appropriate genetic testing considerably. This process will be scaled to multiple sites of a community practice.

278 Background: A rural oncology/hematology clinic located a far distance from the local community hospital was not able to provide hospital consultation support. Collaboration between the practice and the hospital resulted in a telemedicine pilot study to provide oncology and hematology consults to in-patients using a telemedicine robot that connected patients to a hematologist/oncologist (heme/onc) over the internet. Methods: When an appropriate patient was identified at the hospital, a referring provider contacted the heme/onc for a consult. The heme/onc determined and relayed the appropriate time to schedule and perform the telemedicine consult. The referring provider arranged for hospital staff to deliver the telemedicine robot to the patient’s room at the scheduled time. The heme/onc reviewed clinical data in the hospital EMR and logged into the telemedicine robot to speak in consultation with the patient. Notes and orders were placed in the EMR. Out-patient follow-up at the oncology/hematology clinic was scheduled as needed. Supporting front-office and clinical workflows were developed, and policy and procedure established. Surveys were sent to patients and referring providers. Results: At baseline, hospital consults were not provided. In 2018, there were 27 oncology/hematology consults, of which 89% (24 of 27) were for malignancies. 52% (14 of 27) were seen in the clinic after discharge. To date 40 telemedicine consults have been completed. Patient and referring physician satisfaction are inconclusive due to low survey return. Conclusions: Telemedicine provides an effective means to provide specialty consultative support to rural hospitals by remote community providers. Despite the complexity and sensitive nature of oncology and hematology concerns, the technology has been embraced by referring providers and patients.

281 Background: Early advanced care planning and palliative care improves outcomes during the end-of-life phase of care (EOL) for metastatic cancer patients. Identifying patients who are likely to transition to EOL is a necessary step to prioritize limited palliative care resources and is integral to success in value-based payment models. We analyzed whether physician documentation of prognosis in a clinical pathways system (CPS) could reliably predict when patients are nearing EOL for a large community oncology practice of more than 70 medical oncologists. Methods: Tennessee Oncology (TO) requires physicians to use CPS for all Medicare patients. CPS prompts physicians to answer the “prognostic question” “would you be surprised if this patient died in the next year?” for all OCM patients with advanced solid tumors at the beginning of treatment or at the time of a change in treatment plan. Prognostic question responses were compared to actual dates of death documented in the practice management system. Results: A total of 5,266 distinct patients were expected to trigger an OCM episode during 2017. The CPS prompted a response to the prognostic question for 1,228 (23%) of these OCM patients. There were 665 (54%) positive prognoses (expect patient to live more than 1 year) and 563 (46%) negative prognoses (expect patient to die within 1 year). Physicians documented accurate prognoses in 712 (58%) of cases. For patients with positive prognosis 557 (84%) were accurate. For patients with negative prognosis 155 (21.8%) were accurate. Conclusions: We found that for patients with terminal cancer, it is difficult for physicians to accurately predict prognosis. These findings support the importance of ASCO guidelines pertaining to patient access to palliative care during the entirety of cancer treatment for all patients with metastatic cancer. [Table: see text]

275 Background: Tennessee Oncology (TO) is a community medical, radiation and gynecology oncology practice with 90 physicians and 40 advanced practice providers (APPs) in 33 locations in Tennessee. TO participates in the Oncology Care Model (OCM), a CMMI experimental payment model to improve access, quality of care, patient experience and lower costs. Methods: To promote provider-patient communication to improve outcomes and lower healthcare costs, TO launched a telemedicine pilot. The pilot was designed to understand Tennessee’s rules and regulations, reimbursement policies for Medicare, Medicaid and commercial payers and technology requirements. As survivorship was aligned with clinical workflow, supported by existing technology and required minimal staff training, the Survivorship Program for OCM was selected as proof of concept for telemedicine. Education surrounding Survivorship is required as part of the OCM model. A portion of the MEOS payment was considered as reimbursement for this initiative. The goal was to increase the delivery and review of survivorship documents to eligible breast cancer patients using the telemedicine platform from 0% to 80%. Results: 4000 potential patients were eligible for survivorship visits within TO. The selection was narrowed to include only OCM patients with breast cancer. TO identified 4 APPs who were given special training. TO’s front office staff coordinated scheduling of the technology, provider and space available. There were 99 patients eligible for a Telemedicine visit. 36 patients completed a Telemedicine visit with 23 patients declining. 19 patients did not respond to requests for these visits. 10 patients completed surveys and were 100% satisfied with their visits. The APPs felt Telemedicine visits were more productive than in person visits. Conclusions: Telemedicine is an effective tool for delivery of health care. There are challenges that make this technology difficult to implement such as reimbursement and limitations to the use of technology in elderly. In our pilot we found that the APPs and patients found this to be an effective way of communication and delivery of care. In the future telemedicine could answer some of the shortages in health care delivery and could also improve coordination of care.

6635 Background: The Oncology Care Model (OCM) is intended to incentivize physicians to improve the quality and reduce the cost of cancer care. In OCM, providers are accountable for all costs during six month episodes of care relative to target costs (TC) derived from a baseline spending period (BSP; 2013-2015). This accountability is intended to foster care coordination to reduce preventable emergency department visits and hospitalizations (EDH). Benefits of reducing EDH may be diluted when new treatment indications for costly immunotherapies (IO) are introduced into clinical practice after BSP. Methods: We identified all non-small cell lung cancer (NSCLC) and bladder cancer (BC) OCM episodes attributed to Tennessee Oncology (TO), a large community oncology network of over 90 oncologists, during performance period 2 (PP2; the most recent PP with available data). We selected NSCLC and BC because both diseases have IO indications that became standard of care after BSP. Using claims data analytics software, we identified all NSCLC and BC episodes with spending above TC, and found a subset of these above target episodes (ATEs) without any EDH that remained above TC due to IO use. Two medical oncologists reviewed these cases in duplicate to assess guideline concordance of IO. Results: During PP2 there were 2,623 OCM episodes attributed to TO, including 240 NSCLC and 31 BC episodes. Spending was above TC in 118 (49%) and 13 (42%) of NSCLC and BC episodes, respectively. For these NSCLC and BC ATEs, EDH was prevented in 62 (53%) and 5 (38%) of cases, respectively. In NSCLC and BC ATEs without EDH, 43 (69%) and 5 (100%) of episodes included IO, respectively. Clinician review in duplicate (S.M.S.; C.A.W.) found that the use of IO was NCCN guideline concordant in 33 (77%) and 4 (80%) of these NSCLC and BC cases, respectively (K = 0.87). Conclusions: Guideline-concordant use of expensive IO as its treatment indications expand poses substantial challenges to meeting cost targets in OCM, even when practices prevent EDH. [Table: see text]

170 Background: A five physician, three nurse practitioner,community oncology clinic experiences high call volumes (average 352 daily), many of which are related to side-effects of chemo/biotherapy and health related issues. A study was completed to decrease the time for a patient symptom management call to be addressed and concluded. Methods: Initial primary data were collected over a four month period (April-August 2015) using the phone system and the Electronic Health Record (EHR) reporting capabilities, by cross-referencing the caller-ID data with the EHR patient demographics data; only documented symptom management calls within the EHR were included. Twenty-nine percent (202 of 691) of symptom management calls were identified for the sample. Secondary data were collected prospectively using a handwritten call log completed by triage nursing, detailing the purpose of every call routed to triage nursing. Changes were made in the daily telephone call process to include a full-time operator, additional triage nursing staff, and implementation of a structured case management system. Follow-up primary and secondary data were collected for six weeks (August-September 2015) utilizing the case management system. Of the calls routed to triage nursing, 100% were captured in the case management system; call response time and call purpose were recorded. Results: During the initial primary data collection, a baseline of 48% of symptom management calls being addressed within 2 hours was established. Staffing changes resulted in an improvement to 68%, and an additional improvement to 73% after implementation of the case management system. Secondary data collection at baseline showed that 35% of calls were inappropriately routed to triage nursing; this improved to under 1% after implementation of the case management system. Conclusions: The reallocation of staff to concentrate on patient call processes, and the use of a case management system, significantly improved symptom management call response time. The implementation of a case management system nearly eliminated all inappropriate calls routed to triage nursing.

2607 Background: NKP-1339 is a novel transferrin targeted ruthenium based anti-cancer compound which is intravenously administered. Its intracellular targets include GRP78, a key regulator of misfo...

7086 Background: Gefitinib has single agent activity and excellent tolerability in patients (pts) with refractory non-small cell lung cancer (NSCLC) and may be of benefit to previously untreated poor performance status (PS) pts. Methods: The objectives were to evaluate the feasibility/toxicity, response rate, and symptom response (SR) of gefitinib in a total of 60 poor PS untreated pts. Eligible pts had no prior systemic therapy; ECOG PS 2, 3; stage IV or IIIB NSCLC; adequate organ function. Gefitinib 250 mg/day was given orally until disease progression, with initial evaluation at 8 weeks. Symptoms were evaluated at baseline and SR weekly using the Lung Cancer Subscale (LCS) of the FACT-L. Results: Twenty-five pts of the required 60 pts have enrolled to date (male/female 17/8); median age 64 (range 58–84); ECOG PS 2/3 20/5; stage IIIB/IV 7/18; bronchioalveolar/adenocarcinoma/squamous/large cell/or other 2/8/8/6/1. The median treatment duration was 3 months (range 1–7) and duration of follow-up 1.2 months...