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The past decade has seen considerable innovation in the delivery of care and payment in oncology. Key initiatives have included the development of oncology medical home care delivery standards, the Medicare Oncology Care Model, and multiple commercial payer initiatives. Looking forward, our next challenge is to reflect on lessons learned from these limited-scale demonstration projects and work toward models that are scalable and sustainable and reflect true collaboration between payers and providers sharing common objectives and methods to advance cancer care delivery. To this end, ASCO continues its work on care delivery standards, quality measurement, and alternative payment models. Over the past year, ASCO has received input from physicians, administrators, payers, and employers to update its Patient-Centered Oncology Payment (PCOP) model. PCOP incorporates current work on provider-payer collaboration, the oncology medical home, and the value of clinical pathways and recognizes the need for common quality measurement, performance methodology, and payment structure across multiple sources of payment. The following represents a summary of the entire model. The model includes chapters on PCOP communities, clinical practice transformation, payment methodology, consolidated payments for oncology care, performance methodology, and implementation considerations. In future work, ASCO will continue its support of the PCOP model, including further development of care delivery standards, quality measures, and technology solutions (eg, CancerLinQ).

Targeted cancer therapies are drugs and biologics designed to affect cancer cell growth by blocking or interfering with specific molecular pathways in the cancer cell. Use of targeted agents usually requires verification through molecular testing that the patient’s tumor harbors the molecular biomarker that is the target of the drug or is predictive of treatment benefit. Genomic mutations may be clinically actionable if they are associated with response or resistance to a potential therapy. If a genomic test reveals an actionable alteration, there are several options for accessing the targeted therapy. This article is intended to help clinicians determine if a tumor mutation is potentially treatable with a marketed or investigational drug or biologic product and to offer guidance on how to access the product of interest.

This report presents the American Society of Clinical Oncology’s (ASCO’s) evaluation of the adaptations in care delivery, research operations, and regulatory oversight made in response to the coronavirus pandemic and presents recommendations for moving forward as the pandemic recedes. ASCO organized its recommendations for clinical research around five goals to ensure lessons learned from the COVID-19 experience are used to craft a more equitable, accessible, and efficient clinical research system that protects patient safety, ensures scientific integrity, and maintains data quality. The specific goals are: (1) ensure that clinical research is accessible, affordable, and equitable; (2) design more pragmatic and efficient clinical trials; (3) minimize administrative and regulatory burdens on research sites; (4) recruit, retain, and support a well-trained clinical research workforce; and (5) promote appropriate oversight and review of clinical trial conduct and results. Similarly, ASCO also organized its recommendations regarding cancer care delivery around five goals: (1) promote and protect equitable access to high-quality cancer care; (2) support safe delivery of high-quality cancer care; (3) advance policies to ensure oncology providers have sufficient resources to provide high-quality patient care; (4) recognize and address threats to clinician, provider, and patient well-being; and (5) improve patient access to high-quality cancer care via telemedicine. ASCO will work at all levels to advance the recommendations made in this report.

Importance The Medicare Access and CHIP (Children’s Health Insurance Program) Reauthorization Act of 2015 (MACRA) instituted significant changes in payment methods for many Medicare Part B billing providers (eg, clinicians and health care facilities). Fulfilling its measures satisfactorily and adhering to its reporting requirements will significantly affect reimbursement, yet previous surveys suggest that clinicians’ understanding of MACRA is poor. This review provides fundamental background on MACRA for medical and radiation oncologists. Observations The Congress.gov database, PubMed, and the Center for Medicare & Medicaid Services website were searched for legislature and publications relevant to the history, structure, and predicted future for MACRA. MACRA originated from concerns of poor-quality care and from the failure of the traditional fee-for-service model and the Medicare Sustainable Growth Rate method to control rising health care costs. The Quality Payment Program of MACRA started the Merit-based Incentive Payment System (MIPS) and the Alternative Payment Model (APM) system to move from the traditional fee-for-service model to value-based payment. The most recent legislation extended the transitional period for MIPS and removed drugs and biologics covered by Medicare Part B. Currently, the primary APM for medical oncology is the Oncology Care Model, and an APM for radiation oncology is awaiting approval. Despite recent calls from the Medicare Payment Advisory Commission to end MIPS, there is no indication that either MIPS or APMs will be repealed in the near future. Conclusions and Relevance MACRA affects the methods of payment for many Medicare Part B billing providers; the included summary equips medical and radiation oncologists with an understanding of its structure and requirements.

Introduction: During March 2020, as the emergence of COVID-19 began to influence medical and social behaviors in the United States, oncology practices reported a disruption in normal referral and patient management patterns. Participants and staff of ASCO's PracticeNET learning network sought to explore and quantify the impact of this disruption through an analysis of patient activity at multiple hematology/oncology practices. Methods: 20 practices submitted their billing data for analysis; practices were located in 14 states and ranged in size from 2 to 29 hematologists/oncologists. From this dataset we analyzed a total of 11,453 new patient and consult visits (Current Procedural Terminology codes 99201-99205, 99241-99245, 99251-99255, and 99341-99345) performed by hematologists/oncologists from February 9 to April 18, 2020. The number of visits performed from February 9 to March 14, 2020 was compared to visits performed from March 15 to April 18, 2020. A principal diagnosis was assigned to each visit following usual coding and billing practices. Results: From February 9 to March 14, practices performed an average of 70.1 (median 55.5) new patient and consult visits per week. From March 15 to April 19, practices performed an average of 44.5 new patient and consult visits per week. The average decrease in visits among practices was 35% (95% confidence interval (CI): -42%, -29%). The decline in visits per practice ranged from -61% to -13%. New patient and consult visits for solid neoplasms decreased by an average of 22% (95% CI: -31%, -13%), visits for blood neoplasms decreased by an average of 36% (95% CI: -25%, -47%), and visits for benign hematology and circulatory disorders decreased by an average of 44% (95% CI: -53%, -34%). Conclusions: Oncology practices experienced a decline in new patient and consult visits, first observed in the week of March 15. New patient and consult visits for blood neoplasms, benign hematology, and circulatory disorders experienced a greater decline than visits for solid neoplasms. The decrease in activity could be the result of prioritization of resources or changes in patient behavior in seeking care. Further study is necessary to quantify the impact of these findings on patient access and outcomes and to monitor recovery efforts. Citation Format: Brian Bourbeau, Mou Guharoy, Elizabeth Garrett-Mayer, Stephen Grubbs, Paul Unger, Barbara McAneny, Richard L. Schilsky. Impact of COVID-19 pandemic on new patient and consult visits at 20 hematology/oncology practices in the ASCO PracticeNET learning network [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-022.

Introduction: In response to the need for social distancing and infection prevention during the COVID-19 pandemic, there has been increased use of telehealth services to manage cancer and hematology patients. Throughout March and April of 2020, the Medicare and Medicaid programs expanded coverage of telehealth services, allowing cancer and hematology patients to receive certain telehealth services from their home during the public health emergency. We analyzed data from ASCO’s PracticeNET learning network to examine the reported level-of-service for telehealth services compared to standard in-office visits. Methods: 20 practices submitted their billing data for analysis; practices were located in 14 states and ranged in size from 2 to 29 hematologists/oncologists. We analyzed a total of 33,435 established patient evaluation and management visits performed by hematologists/oncologists from March 15 to April 18, 2020. 3,062 (9.1%) visits were performed via telehealth and 30,373 were performed in a physician office or outpatient hospital department. The level-of-service of each visit was identified through the reported Current Procedure Terminology (CPT) code, where levels 1-5 correspond to CPT codes 99211-99215, respectively, and level 5 represents the highest complexity visit. Telehealth visits were identified through use of the modifiers 95, GQ, and GT, as appended to the applicable CPT code. Results: The level-of-service distribution for telehealth-based visits was level 1 (1%), level 2 (4%), level 3 (35%), level 4 (50%), and level 5 (11%). This contrasted with in-office visits: level 1 (3%), level 2 (2%), level 3 (27%), level 4 (51%), and level 5 (18%). Differences were greatest in level 3 visits (35% vs. 27%) and level 5 visits (11% vs. 18%). Differences in level-of-service persisted when exploring various disease cohorts, including patients with solid neoplasms, blood neoplasms, benign hematology disorders, and circulatory disorders. Conclusions: Analysis of established patient visits showed that telehealth visits were reported at lower level-of-service as compared to in-office visits. This finding may be related to directing straightforward visits to be performed via telehealth or due to limitations in using telehealth by patients with complex medical problems. Citation Format: Brian Bourbeau, Mou Guharoy, Stephen Grubbs, Elizabeth Garrett-Mayer, Kevin Olson, Richard L. Schilsky. Differences in level-of-service for telehealth visits as compared to in-office visits for cancer and hematology patients seen in practices within the ASCO PracticeNET learning network [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr PO-015.

Background: In April 2020, ASCO initiated a registry to capture and analyze status and outcomes of patients with cancer and COVID-19, and to describe effects of the pandemic on U.S. cancer practices. Initial findings of changes to care delivery are included. Methods: Practices provide data on changes to care delivery due to COVID-19 and longitudinal data on patients with cancer and confirmed COVID-19. At present, 26 cancer practices have enrolled in the Registry—5 academic, 15 hospital/health-system (H/HS) owned, and 6 physician-owned (P-O) located in 19 states. Enrollment of practices and data collection is ongoing. Results: Twenty sites, from 17 practices (3 academic, 9 H/HS owned, and 5 P-O in 15 states) responded (April 20-June 4). All incorporated telemedicine visits; 90% reported use of telemedicine was new. 30% reported “declining some but not all” new patient requests. For patients with cancer not on active therapy, 15% of sites postponed some routine visits, 35% conducted virtually all routine visits by telemedicine, and 50% used telemedicine for some routine visits. Most sites (95%) reported following clinical guidelines for visit postponement; 90% reported following local health authorities on when to resume routine visits. 90% screened patients prior to in-office visits for COVID-19 symptoms by phone and at clinic entrance; 10% screened patients using only one method. 30% modified intravenous (IV) drug infusions, including halting some or all (10%), shortening some or all (20%), or switching from IV to oral drugs (15%). While no sites conducted home-based, anticancer drug infusions, 30% are considering this option if COVID19 conditions change. Most sites modified laboratory specimen collection, including allowing a collection site closer to home (60%) and collection in a patient’s home (1 site). Two sites only allowed patients on oral anticancer drugs to use alternate collection sites. Only 1 site reported specimen collection in patients’ homes. All reported making the following changes to clinic arrangements: requiring use of masks, eliminating accompaniment by a support person (with exceptions), and reducing the visit numbers or increasing time between visits. No sites reported shortages of anticancer or supportive care drugs. 45% experienced shortages of nasopharyngeal swabs, 45% of medical hand sanitizer, and 75% of personal protective equipment. 40% of sites have experienced staffing reductions or changes due to reduced patient visits (30%), transfer to other clinical areas (20%), availability (15%), and COVID-19 illness (15%). Conclusions: The COVID-19 pandemic has had a substantial impact on most aspects of cancer care delivery in U.S. oncology practices. All practices incorporated telemedicine, which is new to most. Adjustments were made to patient visits and scheduled IV drug infusions. Sites reported shortages of equipment related to COVID-19, not cancer or supportive care drug shortages. At the time of the AACR meeting we expect to have data from more practices. Citation Format: Suanna S. Bruinooge, Elizabeth Garrett-Mayer, Stephen Meersman, Patricia Hurley, Brian Bourbeau, Allyn Moushey, Sybil Green, Deborah Kamin, Stephen Grubbs, Richard L. Schilsky. Changes implemented by U.S. oncology practices in response to COVID-19 pandemic: Initial report from the ASCO Registry on COVID-19 and cancer [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2020 Jul 20-22. Philadelphia (PA): AACR; Clin Cancer Res 2020;26(18_Suppl):Abstract nr S06-01.

Zoledronic acid, a third-generation aminobisphosphonate, reduces the incidence of skeletal-related events and pain in patients with bone metastases. The optimal dosing interval for zoledronic acid is uncertain.To determine whether zoledronic acid administered every 12 weeks is noninferior to zoledronic acid administered every 4 weeks.Randomized, open-label clinical trial conducted at 269 academic and community sites in the United States. Patients (n = 1822) with metastatic breast cancer, metastatic prostate cancer, or multiple myeloma who had at least 1 site of bone involvement were enrolled between May 2009 and April 2012; follow-up concluded in April 2014.Patients were randomized to receive zoledronic acid administered intravenously every 4 weeks (n = 911) vs every 12 weeks (n = 911) for 2 years.The primary end point was the proportion of patients having at least 1 skeletal-related event (defined as clinical fracture, spinal cord compression, radiation to bone, or surgery involving bone) within 2 years after randomization and a between-group absolute difference of 7% as the noninferiority margin. Secondary end points included the proportion of patients with at least 1 skeletal-related event by disease type, pain as assessed by the Brief Pain Inventory (range, 0-10; higher scores indicate worse pain), Eastern Cooperative Oncology Group performance status (range, 0-4; higher scores indicate worse disability), incidence of osteonecrosis of the jaw, kidney dysfunction, skeletal morbidity rate (mean number of skeletal-related events per year), and, in a subset of 553 patients, suppression of bone turnover (assessed by C-terminal telopeptide levels).Among 1822 patients who were randomized (median age, 65 years; 980 [53.8%] women; 855 with breast cancer, 689 with prostate cancer, and 278 with multiple myeloma), 795 completed the study at 2 years. A total of 260 patients (29.5%) in the zoledronic acid every 4-week dosing group and 253 patients (28.6%) in the every 12-week dosing group experienced at least 1 skeletal-related event within 2 years of randomization (risk difference of -0.3% [1-sided 95% CI, -4% to ∞]; P .001 for noninferiority). The proportions of skeletal-related events did not differ significantly between the every 4-week dosing group vs the every 12-week dosing group for patients with breast cancer, prostate cancer, or multiple myeloma. Pain scores, performance status scores, incidence of jaw osteonecrosis, and kidney dysfunction did not differ significantly between the treatment groups. Skeletal morbidity rates were numerically identical in both groups, but bone turnover was greater (C-terminal telopeptide levels were higher) among patients who received zoledronic acid every 12 weeks.Among patients with bone metastases due to breast cancer, prostate cancer, or multiple myeloma, the use of zoledronic acid every 12 weeks compared with the standard dosing interval of every 4 weeks did not result in an increased risk of skeletal events over 2 years. This longer interval may be an acceptable treatment option.clinicaltrials.gov Identifier: NCT00869206.

The Delaware Cancer Advisory Council was convened in 2001 by Governor Ruth Ann Minner to develop a statewide cancer control program. Rather than reporting a comprehensive cancer control program, the Council in 2002 recommended a limited number of achievable deliverables to reduce Delaware's high rates of cancer incidence and mortality. The Delaware Legislature and the Governor Minner accepted the recommendations and fully funded the program. Three key elements of the program include a statewide coordinated colorectal screening program with coverage of the uninsured, a cancer treatment program providing for the uninsured, and an emphasis of African American cancer disparity reduction. The screening program featured statewide nurse navigation, colonoscopy promotion, statewide marketing, and coverage for both screening and up to two years of cancer treatment for the uninsured. Over the next ten years, the program eliminated the Caucasian and African American colorectal cancer disparities between by raising screening rates, lowering the stage at diagnosis, reducing the incidence, and finally eliminating the mortality disparity. All Delaware populations achieved improved colorectal cancer outcomes with the greatest gain in the African American community that closed the disparity gaps. Delaware can be viewed as a model for success, achieved when all parties including government, health care systems, providers, and the public are determined together to improve health and tackle health disparities. Citation Format: Stephen Grubbs. Eliminating racial disparities in colorectal cancer. [abstract]. In: Proceedings of the AACR Special Conference on Colorectal Cancer: From Initiation to Outcomes; 2016 Sep 17-20; Tampa, FL. Philadelphia (PA): AACR; Cancer Res 2017;77(3 Suppl):Abstract nr IA29.

6110 Background: The NCCCP has engaged in special programs to enhance clinical trial accrual among underserved populations. These include cultural awareness webinars, nurse/lay navigators with tran...

6586 Background: The National Cancer Institute Community Cancer Centers Program (NCCCP) has developed a web based tracking tool to monitor screening of patients for clinical trial participation. The system is designed to collect data from multiple research sites throughout the geographically diverse group. The log blindly collects patient demographics, successful trial entry, and reasons for trial enrollment failure. Methods: Seven NCCCP sites utilized the log during the 60 day open accrual period for the Wake Forrest WFU 07–02–03 cancer control trial (chronic lymphocytic leukemia COLD- fX) in Novermber 2008 and December 2008. Results: 327 chronic lymphocytic leukemia patients were screened mostly by chart review. 162 (50%) were eligible for study entry. 45 (14%) entered the trial. 103 (31%) eligible patients declined entry. Of the 103, 72 (70%) did not wish to participate in research, 15 (15%) had travel constraints, 5 (5%) perceived excess toxicity, 9 (9%) gave no reason. 14 (3%) eligible had their physician decline entry. Overall, 28% of eligible patients entered the trial. 165 (50%) were trial ineligible. 82 (50%) for prior therapy, 30 (18%) for co morbid conditions, 10 (6%) missed an entry time requirement, 39 (24%) have incomplete data. Conclusions: The NCCCP trial screening log successfully captures real time clinical trial participation data from a diverse network of clinical trial sites. This data base will allow future analysis of individual clinical trial and site accrual barriers and empower strategies to increase trial participation. No significant financial relationships to disclose.

12018 Background: The primary endpoint of this prospective phase I study of DOX-TOP in pts with advanced solid tumors was to identify the maximum tolerated dose and dose-limiting toxicities (DLT) of this combination. Other objectives included a description of additional toxicities and efficacy in this patient population with refractory cancers. Pharmacokinetic sampling of TOP plasma levels will be reported separately. Methods: Eligible pts had advanced solid tumors and had either failed standard chemotherapy (chemo) or were pts for whom no standard therapy existed. They had ECOG PS = 0–2, adequate organ function, and gave written, informed consent. Initial doses included DOX 40 mg/m2 day 1 and TOP 2 mg/m2 days 1, 8 and 15 q 28 days. TOP was to be escalated in cohorts of pts. DLT was defined as febrile neutropenia, grade 4 thrombocytopenia, any grade 3 non-hematologic toxicity, or the inability to receive subsequent treatment due to ongoing toxicity. Treatment was held for ANC < 1000 or platelets < 75,000. Results: Fourteen pts have been enrolled on this phase I study, all of whom were evaluable for toxicity. There were 12 males and 2 females, and the median age was 57 years (range 25–86). Four had ECOG PS = 0, 9 had PS = 1, and 1 had PS = 2. Cancer types included head and neck (3), renal (2), and breast, pancreas, liver, esophagus, germ cell tumor, sarcoma, and others (one each). In the 6 pts treated at dose level 1, toxicities included grade 3 anemia (1) and neutropenia (2), and grade 4 neutropenia (1). DLT consisted of grade 4 thrombocytopenia (1) and inability to deliver day 15 TOP in 3/6 pts at this dose. Thus, TOP was reduced to 1.5 mg/m2 weekly for dose level -1, and 8 pts have been treated. Toxicities included grade 3 anemia (1)and neutropenia (2), and grade 4 neutropenia (1) and thrombocytopenia (1). Enrollment continues at this dose level to confirm tolerability. No patient achieved an objective response to therapy, but 2 pts have stable disease for up to 4 cycles. Conclusions: DOX-TOP can be safely combined in pts with advanced solid tumors, with hematologic toxicity as the DLT. The preliminary recommended phase II dose is DOX 40 mg/m2 and TOP 1.5 mg/m2. We plan to explore an additional dose level of DOX 30 mg/m2 and TOP 2 mg/m2. Phase II evaluation is contemplated in selected tumor types. [Table: see text]