American Society of Clinical Oncology Road to Recovery Report: Learning From the COVID-19 Experience to Improve Clinical Research and Cancer Care.

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.

Updates to the ASCO Patient-Centered Oncology Payment Model.

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).

Impact on Oncology Practices of Including Drug Costs in Bundled Payments.

INTRODUCTION: This analysis evaluates the impact of bundling drug costs into a hypothetic bundled payment. METHODS: An economic model was created for patient vignettes from: advanced-stage III colon cancer and metastatic non-small-cell lung cancer. First quarter 2016 Medicare reimbursement rates were used to calculate the average fee-for-service (FFS) reimbursement for these vignettes. The probabilistic risk faced by practices was captured by the type of patients seen in practices and randomly assigned in a Monte Carlo simulation on the basis of the given distribution of patient types within each cancer. Simulations were replicated 1,000 times. The impact of bundled payments that include drug costs for various practice sizes and cancer types was quantified as the probability of incurring a loss at four magnitudes: any loss, > 10%, > 20%, or > 30%. A loss was defined as receiving revenue from the bundle that was less than what the practice would have received under FFS; the probability of loss was calculated on the basis of the number of times a practice reported a loss among the 1,000 simulations. RESULTS: Practices that treat a substantial proportion of patients with complex disease compared with the average patient in the bundle would have revenue well below that expected from FFS. Practices that treat a disproportionate share of patients with less complex disease, as compared with the average patient in the bundle, would have revenue well above the revenue under FFS. Overall, bundled payments put practices at greater risk than FFS because their patient case mix could greatly skew financial performance. CONCLUSION: Including drug costs in a bundle is subject to the uncontrollable probabilistic risk of patient case mixes.

The patient protection and affordable care act: exploring the potential impact on oncology practice.

The implementation of the Patient Protection and affordable care act will change oncology practice in many ways. Innovative payment models, new practice arrangements, and an increased focus on paying for quality and value will change the landscape for oncologists and people with cancer.

The costs of conducting clinical research.

PURPOSE: Physicians frequently receive payment for enrolling subjects onto clinical trials. Some view these payments as conflicts of interest. Others contend that these payments are necessary reimbursements for conducting clinical research. We evaluated the clinical and nonclinical hours and costs associated with conducting a mock phase III clinical research trial. METHODS: We collected data from representatives of 21 clinical sites, on the numbers of hours associated with 13 activities necessary to the conduct of clinical research. The hours were based on enrolling 20 patients in a 12-month randomized placebo-controlled trial of a new chemotherapeutic agent. The outcome measures were disease progression and quality-of-life reports. These costs were evaluated for both government and pharmaceutical industry-sponsored trials. RESULTS: On average, 4,012 hours (range, 1,512 to 13,319 hours) were required for a government-sponsored trial, and 3,998 hours (range: 1735 to 15,699) were required for a pharmaceutical industry-sponsored trial involving 20 subjects with 17 office visits, or approximately 200 hours per subject. Thirty-two percent of the hours were devoted to nonclinical activities, such as institutional review board submission and completion of clinical reporting forms. On average, excluding overhead expenses, it cost slightly more than 6,094 dollars (range, 2,098 dollars to 19,285 dollars) per enrolled subject for an industry-sponsored trial, including 1,999 dollars devoted to nonclinical costs. CONCLUSION: Based on the results of our mock trial, the time required for nontreatment trial activities is considerable, and the associated costs are substantial.

The role of government agencies in the development of cancer policy.

OBJECTIVES: To provide a review of federal government agencies that most directly affect cancer care and research and how cancer policy can be indirectly shaped or affected by federal and state programs. DATA SOURCES: Government reports and internet sources. CONCLUSIONS: The US government's role in cancer policy has grown substantially and involves ongoing dialogue among Congress, government agencies, and stakeholders in the cancer community. The government can be a powerful catalyst for progress or a seeming insurmountable barrier to high-quality cancer care and research. Working together can make a significant difference in the outcome of cancer policy. IMPLICATIONS FOR NURSING PRACTICE: Oncology nurses are an important voice in the development of legislation, regulation, and other national policies for cancer care. It is important for cancer care professionals to be aware of these federal programs and participate in deliberations.

American Society of Clinical Oncology 2001 Presidential Initiative: impact of regulatory burdens on quality cancer care.

PURPOSE: This study was conducted as part of the American Society of Clinical Oncology (ASCO) 2001 Presidential Initiative to assess the administrative burden of payer documentation requirements and their impact on oncology practice. METHODS: The study consisted of a physician questionnaire and an activity log. Site visits were conducted to support survey data. Analysis included 2,493 questionnaires and 1,115 activity logs; data were also collected from site visits to 10 oncology practices. RESULTS: Increased documentation was the greatest concern among respondents, greater even than the stress of dealing with death and dying. More than 97% of survey respondents reported an increase in documentation (averaging 1.4 h/d) and 77% reported an increase in work hours because of documentation in the past 5 years. As a result, more than 40% of respondents reported decreases in key aspects of patient care and decreases in teaching (48%) and research (39%). Site visit data demonstrate similar trends. CONCLUSION: It is critical to find ways to decrease physician burden without decreasing the ability to prevent fraud and abuse. Reforms include provisions in a recently passed bill in the United States House of Representatives to streamline Medicare regulation and increase physician education. To address oncology-specific concerns, changes also should be made to supervision requirements for residents and fellows and evaluation and management documentation for oncology follow-up visits.