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This paper discusses the administrative aspects of molecular diagnostics in oncology, including US Food and Drug Administration (FDA) oversight, the regulatory approval process, clinical, and operational workflows, and payment models. Comprehensive molecular testing is important to deliver optimal oncology care and improve patient outcomes. Despite the potential benefits of testing, utilization remains low. The FDA regulatory approval process is reviewed for in vitro diagnostic products, which includes classification into three regulatory classes on the basis of risk. Companion diagnostic devices are used to guide treatment decisions. The clinical and operational challenges associated with molecular testing in oncology are also discussed, including the rapidly evolving landscape of precision oncology, the wide range of biomarker testing options, and complexities of test ordering, interpretation, and result delivery. There is a need for a multifaceted support approach involving education, technology enhancements, and workflow support to overcome these challenges. In terms of payment models, coverage policies between Medicare and commercial payers are compared with differences in coverage criteria, with Medicare focusing on FDA approval or clearance, whereas commercial payers consider additional factors such as National Comprehensive Cancer Network and ASCO guidelines. Commercial payers tend to cover smaller panels on the basis of guideline-recommended biomarkers, whereas coverage for broad tumor profiling is limited. Several strategies can increase the utilization of molecular testing, including integrating test results into electronic medical record platforms, standardizing billing practices, increasing clinical trials, and primary literature supporting the use of molecular testing, educating physicians, and using tumor boards for result interpretation and treatment discussions.

A recent interpretation of the Stark Law limits cancer practices from delivering drugs to their patients by mail or courier-a perverse interpretation of a law meant to curb physician self-referrals and one that has led to patient harm.

Purpose: Advanced pancreatic cancer is synonymous with a high mortality rate, debilitating symptom profile, and minimal prolongation in overall survival. Therefore, health-related quality of life (HRQOL) is important in patients with pancreatic cancer (PwPC). In chronic conditions, patient activation is positively associated and higher HRQOL. However, no known study has evaluated patient activation, HRQOL, and their association in PwPC., Methods: A 43-item cross-sectional survey assessed patient activation and HRQOL of patients with locally advanced and metastatic pancreatic cancer undergoing chemotherapy. Variables were analyzed descriptively, and relationships were assessed using bivariate statistics (sig p < 0.05)., Results: Fifty-six patients participating in the study had an average age of 69.5 ± 11.1 years, and the majority were females (51.8%), Caucasians (61.8%), married/partnered (64.3%), and had at least a college degree (59%). Almost half were at stage 4 (48.2%), and most were newly diagnosed (66.1%). Mean patient activation score was 63.5 ± 17.2 (scale range: 0-100), with most at higher activation levels of 3 or 4 (66.7%). Mean HRQOL score of 41.0 ± 12.7 (scale range: 0-72) was low. Patient activation levels, age, education level, and gender explained 21% of variation in overall HRQOL scores. Patients at activation level 4 had significantly higher overall HRQOL versus those at lower activation (level 1 or 2). Higher patient activation was significantly associated with having either private insurance only or multiple insurances and being partnered., Conclusion: Patient activation significantly predicted HRQOL in PwPC despite the low sample size. Initiatives to increase patient activation should focus on patients of low socioeconomic status and those without partner support., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objectives: CMS created the Oncology Care Model (OCM) to increase the delivery of cost-efficient cancer care, but in linking medical oncologist compensation to total costs of care, the model also prompted concerns about reductions in radiation therapy utilization. We compare practices that participated in the model with those that did not through its launch to estimate whether radiation therapy utilization was reduced under the OCM., Study Design: Retrospective analysis of a secondary claims-based data set., Methods: We used 5 years of reimbursement claims data from a large community oncology network in which approximately half of the practices participated in the OCM to measure the relative change in utilization following OCM participation compared with practices that did not participate in the OCM. We evaluated use of radiation therapy for all cancer diagnoses and, more specifically, bone metastases, lung cancer, and breast cancer to assess whether effects varied by setting using 3 quasi-experimental estimation techniques (difference-in-differences, event study, and triple differences regressions)., Results: We found no evidence of reductions in radiation therapy utilization associated with the OCM between participant and nonparticipant practices in any of the specifications or subpopulations analyzed., Conclusions: Despite the potential incentives for medical oncologists to reduce radiation therapy utilization, we found no evidence that such reduction occurred.

Health literacy is recognized as a critical factor affecting communication across the continuum of cancer care and plays a key role in patients' ability to meaningfully discuss their condition with healthcare providers. However, there is no consensus on the best approach to measure health literacy in clinical practice. The aims of this study were to compare general and disease-specific measurements of health literacy in patients with breast cancer as well as examine their relationships with patient-provider communication. During office visits, patients with HER-2 + breast cancer who received care at oncology clinics with value-based models of care completed a survey including the 6-item cancer health literacy tool (CHLT-6), 6-item newest vital sign (NVS), 2 items measuring difficulty of patient-provider communication, and 11 demographic/clinical items. The mean age of 146 participants was 57.1 ± 10.8 years. Most participants had adequate general health literacy as measured by the NVS (79%) and a high probability of adequate cancer health literacy (≥ 0.7) as measured by the CHLT-6 (92%). Most patients easily communicated with healthcare providers (90.2%) and understood information they provided (83.5%). However, there was no significant relationship between patient-provider communication and health literacy. Both the CHLT-6 and NVS may be useful tools to assess the health literacy of patients with cancer in clinical practice. Study findings of adequate health literacy and ease of communication might have been influenced by the value-based care models adopted by participating clinics. Further research in more diverse samples of patients with cancer and different types of oncology practice settings is warranted., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: The Oncology Care Model (OCM) incentivized care coordination and cost-efficiency and has been associated with short-term care reductions, but its multi-year associations are less well-studied., Methods: We used monthly provider-level claims data spanning nearly five years between July 1 st, 2014 and May 30th, 2019 from a large community oncology practice network where roughly half of the practices participated in the OCM. The key outcome measures were monthly mean office visits, costs, and buy-and-bill drug costs among prostate, colon, breast, and lung cancers. We conducted two quasi-experimental analyses: an event study, which measures the monthly association of providing care in an OCM relative to a non-participating practice, and a difference-in-differences model, which summarizes the event study results into post-launch average estimates. We controlled for mean differences between practices, providers, and patient., Results: The event study analysis shows similar pre-period estimates and trends for each cancer. The difference-in-differences estimates for office visits are statistically significant for each cancer: 33 percentage point reductions in prostate cancer (95 % CI: -0.66 to 0.00; p = 0.05), 22 percentage point reductions in colon cancer (95 % CI: -0.48 to 0.04; p = 0.09), 21 percentage point reductions in breast cancer (95 % CI: -0.45 to 0.02; p = 0.08), and 24 percentage point reductions in lung cancer (95 % CI: -0.49 to 0.00; p = 0.05). Monthly prostate cancer costs also reduced by $505 (95 % CI: -$1108 to $99; p = 0.10)., Conclusion: Our results suggest that the OCM was associated with relative reductions in office visits and, for prostate cancer, in overall costs too. These associations generally decreased within the first year of launch and sustained through roughly two years., Policy Summary: Novel payment models that incentivize care coordination and cost-efficiency like the OCM may modestly yet sustainably reduce office visits and overall costs., (Copyright © 2021 Elsevier Ltd. All rights reserved.)

Participation in the Centers for Medicare & Medicaid Services (CMS) value-based payment reform, the Oncology Care Model (OCM), requires that every beneficiary has a documented 13-point Institute of Medicine treatment plan (TP) when commencing antineoplastic therapy. The intent is to enhance shared decision-making between the patient and care team by providing transparent treatment recommendations and engaging patients and caregivers in meaningful discussion. There is limited discussion in the literature about how to adapt the CMS recommendations to diverse practice settings while maintaining fidelity to the intent of the TP. Here, the authors compare how 3 clinically and geographically unique OCM participating institutions implemented the TP in their respective institutions within the domains of the Consolidated Framework for Implementation Research. Similar themes in implementation are identified, including engaging stakeholders, leveraging information technology, and considering scalability. Adaptations that are unique to the culture and setting of each site are also described., (Copyright © 2021 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.)

Background: Assessing health literacy and patient activation at the beginning of care could facilitate the provision of appropriate information to patients with breast cancer and increase the effectiveness of interventions geared toward improving patient involvement in self-managing their health and, consequently, their quality of life., Objective: The aim of this study was to evaluate cancer health literacy and patient activation in patients with breast cancer as well as examine their relationships to health-related quality of life (HRQoL) and resource use., Methods: Patients with breast cancer positive for human epidermal growth factor receptor 2 (HER2+) receiving care at 12 oncology clinics in Texas were offered participation in the study via convenience sampling. The survey consisted of the 6-item Cancer Health Literacy Tool, the 13-item Patient Activation Measure, the 27-item Functional Assessment of Cancer Therapy - General (version 4), and single-item measures for number of emergency department visits and hospitalizations as well as clinical and demographic characteristics., Key Results: The mean age of the 146 study participants was 57.1 ± 10.8 years; 92% ( n = 134) had a high probability (≥0.7) of adequate cancer health literacy whereas 68% percent ( n = 99) had high patient activation (level 3 or 4). Cancer health literacy had significant positive relationships with education and household income. Patient activation, education, and number of treatment types received explained 23% of the variation in HRQoL, and all except cancer health literacy were positive and significant predictors. No bivariate/multivariate analysis was conducted for emergency department visits and hospitalizations because there were few reported incidents., Conclusions: Interventions that aim to improve HRQoL in patients with breast cancer could target modifiable factors like patient activation. The homogeneity of cancer health literacy among study participants might have influenced its nonsignificant relationship with HRQoL and patient activation. Further assessments of health literacy and patient activation in larger and more diverse populations of patients with breast cancer are warranted. [ HLRP: Health Literacy Research and Practice . 2021;5(3):e171-e178.] Plain Language Summary: In this study, the majority of patients with breast cancer were found to have high levels of cancer health literacy, patient activation, and health-related quality of life (HRQoL). The significant relationship between patient activation and HRQoL implies that patients with breast cancer who are able to actively participate in managing their health and health care are more likely to have higher HRQoL. Interventions that aim to improve HRQoL in patients with breast cancer could target modifiable factors like patient activation.

Purpose: Among patients receiving chemotherapy, symptom monitoring with electronic patient-reported outcomes (ePROs) is associated with improved clinical outcomes, satisfaction, and compliance with therapy. Standard approaches for ePRO implementation are not established, warranting evaluation in community cancer practices. We present implementation findings of ePRO symptom monitoring across a large multisite community oncology practice network., Methods: Patients initiating a new systemic therapy at one of the 210 practice sites at Texas Oncology were invited to use the Navigating Cancer ePRO platform, with stepped-wedge implementation from July to December 2020. Participating patients received a weekly prompt by text message or e-mail to self-report common symptoms and well-being. Severe self-reported symptoms triggered a real-time notification to nursing triage to address the symptom. Enrollment and compliance were systematically tracked weekly with evaluation of barriers and facilitators to adoption and sustainability., Results: Four thousand three hundred seventy-five patients planning systemic treatment were enrolled and participated. Seventy-three percent (1,841 of 2,522) of enrolled patients completed at least one ePRO assessment. Among these individuals, 64% (16,299 of 25,061) of available weekly ePRO assessments were completed. Over a 10-week period, compliance declined from 72% to 52%. Barriers currently being addressed include lack of a second reminder text or e-mail prompt, inconsistent discussion of reported ePROs by clinicians at visits, and COVID-related changes in workflow. Facilitators included ease of use and patient and staff engagement on the importance of PROs for symptom management., Conclusion: ePROs can be effectively implemented in community oncology practice. Utilization of ePROs is high but diminishes over time without attention to barriers. Ongoing work to address barriers and optimize compliance are underway., Competing Interests: Debra PattEmployment: Texas Oncology, McKesson, MednaxLeadership: McKesson, Mednax, Texas OncologyStock and Other Ownership Interests: MednaxConsulting or Advisory Role: Pfizer, Roche, AstraZenecaResearch Funding: Merck, Eisai, Seattle Genetics, LillyTravel, Accommodations, Expenses: McKesson Lalan WilfongEmployment: McKessonSpeakers' Bureau: Pfizer, NCCNTravel, Accommodations, Expenses: E.R. Squibb Sons LLC Kathryn Elizabeth HudsonEmployment: Texas OncologyLeadership: Texas OncologyConsulting or Advisory Role: Daiichi Sankyo Amila PatelEmployment: Navigating Cancer, Flatiron HealthStock and Other Ownership Interests: Roche/Genentech Ben PearsonEmployment: Navigating Cancer Kristin Olson-CelliEmployment: Navigating CancerStock and Other Ownership Interests: Navigating Cancer Ethan BaschConsulting or Advisory Role: SIVAN Innovation, Carevive Systems, Navigating Cancer, AstraZenecaOther Relationship: Centers for Medicare and Medicaid Services, National Cancer Institute, American Society of Clinical Oncology, JAMA—Journal of the American Medical Association, Patient-Centered Outcomes Research Institute (PCORI)Open Payments Link: https://openpaymentsdata.cms.gov/physician/427875/summaryNo other potential conflicts of interest were reported.

COVID-19 places unprecedented demands on the oncology ecosystem. The extensive pressure of managing health care during the pandemic establishes the need for rapid implementation of telemedicine. Across our large statewide practice of 640 practitioners at 221 sites of service, an aggressive multidisciplinary telemedicine strategy was implemented in March by coordinating and training many different parts of our healthcare delivery system. From March to September, telemedicine grew to serve 15%-20% of new patients and 20%-25% of established patients, permitting the practice to implement safety protocols and reduce volumes in clinic while continuing to manage the acute and chronic care needs of our patient population. We surveyed practice leaders, queried for qualitative feedback, and established 76% were satisfied with the platform. The common challenges for patients were the first-time use and technology function, and patients were, in general, grateful and happy to have the option to visit their clinicians on a telemedicine platform. In addition to conducting new and established visits remotely, telemedicine allows risk assessments, avoidance of hospitalization, family education, psychosocial care, and improved pharmacy support. The implementation has limitations including technical complexity; increased burden on patients and staff; and broadband access, particularly in rural communities. For telemedicine to improve as a solution to enhance the longitudinal care of patients with cancer, payment coverage policies need to continue after the pandemic, technologic adoption needs to be easy for patients, and broadband access in rural areas needs to be a policy priority. Further research to optimize the patient and clinician experience is required to continue to make progress.

Purpose: To describe onboarding and utilization of telemedicine across a large statewide community oncology practice and to evaluate trends, barriers, and opportunities in care delivery during the coronavirus disease 2019 pandemic., Methods: We describe telemedicine onboarding and utilization across a statewide oncology practice, covering 221 sites of service and more than 650 practitioners. We describe qualitatively the onboarding process of a diverse set of administrative, technical, and clinical partners. We describe quantitatively utilization throughout the practice. We describe a survey conducted to enlighten barriers and opportunities for optimal utilization., Results: Multistakeholder education was directed to clinical teams, administrative and technical support staff, and patients through webinars and team meetings. Utilization was high from April through October 2020, representing 15% to 20% of new-patient visits and 20% to 25% of established-patient visits. In a survey offered to all clinicians, 96% of respondents indicated they are using telemedicine, with 33% using it for more than 25% of patient encounters. Among respondents, 59% reported that the use of telemedicine helps expedite diagnosis and treatment more than seeing patients in person in the clinic, 55% of respondents managed urgent issues by telemedicine, 80% believed that patients benefited From urgent assessment by telemedicine, and 57% believed an emergency department visit or a hospitalization was avoided because of a telemedicine visit. Most clinicians reported that patients enjoy benefits of telemedicine because of decreased exposure risk, decreased transportation requirements, and ease of including caregivers in the visit with the treating clinician. The most common barriers to patients accessing telemedicine were technical challenges and broadband access. Despite this, less than 5% of respondents routinely use telephone-only communication, as most typically use bimodal audio/video communication. Many clinicians have expansion ideas on how telemedicine can further expand the longitudinal care delivery for our patient population., Conclusions: Telemedicine can be implemented successfully across a large statewide oncology practice and service a high volume of patients. Clinicians utilize telemedicine for new and established patients with minimal dysfunction. Clinicians believe patients benefit From telemedicine For new, established, and urgent care visits. Broadband access functionality should be explored to optimally serve our patient population.

Importance: Health insurers reimburse clinicians in many ways, including the ubiquitous fee-for-service model and the emergent shared-savings models. Evidence on the effects of these emergent models in oncological treatment remains limited., Objectives: To analyze the early use and cost associations of a recent Medicare payment program, the Oncology Care Model (OCM), which included a shared savings-like component., Design, Setting, and Participants: This nonrandomized controlled study used a difference-in-differences approach on 2 years of data, from July 1, 2015, to June 30, 2017-1 year before and 1 year after launch of the OCM-to compare the differences between participating and nonparticipating practices, controlling for patient, clinician, and practice factors. Participation in the OCM began on July 1, 2016. Associations of participation with care use and cost were estimated for care directly managed by clinicians from a large network within their Medicare populations for breast, lung, colon, and prostate cancers. Data were analyzed from September 2019 to March 2020., Exposures: Participating practices were paid a monthly management fee of $160 per beneficiary and a potential risk-adjusted performance-based payment for eligible patients who received chemotherapy treatment, in addition to standard fee-for-service payments., Main Outcomes and Measures: Office visits, drug administrations, patient hydrations, drug costs, and total costs., Results: Monthly means data at the physician-level were evaluated for 11 869 physician-months for breast cancers, 11 135 physician-months for lung cancers, 8592 physician-months for colon cancers, and 9045 physician-months for prostate cancers. Patients at OCM practices had a mean (SD) age of 63.4 (3.1) years, and a mean (SD) of 59% (7 percentage points) of their patients were women. Participation in the OCM was associated with less physician-administered prostate cancer drug use (difference, 0.29 [95% CI, -0.47 to -0.11] percentage points, or 24.0%) translating to a mean of $706 (95% CI, -$1383 to -$29) less in drug costs per month. Monthly drug costs were also lower, at $558 (95% CI, -$1173 to $58) less for treatment for lung cancer. Total costs were lower by 9.7% or $233 (95% CI, -$495 to $30) for breast cancer, 9.9% or $337 (95% CI, -$618 to -$55) for lung cancer, 14.2% or $385 (95% CI, -$780 to $10) for colon cancer, and 29.2% or $610 (95% CI, -$1095 to -$125) for prostate cancer; however, these differences were largely offset by program costs. Clinician visits were also lower by 11.2% or 0.11 (95% CI, -0.20 to -0.01) percentage points among patients with breast cancer and by 14.4% or 0.19 (95% CI, -0.37 to -0.02) among patients with colon cancer., Conclusions and Relevance: These findings suggest that payment models with shared-savings components can be associated with fewer visits and lower costs in certain cancer settings in the first year, but the savings can be modest given the costs of program administration.

Quality improvement (QI) initiatives and health services research (HSR) are commonly used to target health care quality. These disciplines are increasingly important because of the movement toward value-based health care as alternative payment and care delivery models drive institutions and investigators to focus on reducing unnecessary health care use and improving care coordination. QI efforts frequently target medical error and/or efficiency of care through the Plan-Do-Study-Act methodology. Within the QI framework, strategies for data display (e.g., Pareto charts, run charts, histograms, scatter plots) are leveraged to identify opportunities for intervention and improvement. HSR is a multidisciplinary field of study that seeks to identify the most effective way to organize, deliver, and finance health care to maximize the quality and value of care at both the individual and population levels. HSR uses a diverse set of quantitative and qualitative methodologies, such as case-control studies, cohort studies, randomized control trials, and semistructured interview/focus group evaluations. This manuscript provides examples of methodologic approaches for QI and HSR, discusses potential challenges associated with concurrent quality efforts, and identifies strategies to successfully leverage the strengths of each discipline in care delivery.