Deborah Y. Kamin

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.

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.

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.

21 – Oncology and Health Care Policy

Abstract Policies promulgated by government at the federal, state, and local levels have profound effects on virtually every aspect of the day-to-day practice of oncology. In the face of growing financial pressures, policy makers will continue to make decisions that may have tremendous impacts on the cancer community. Federal policies play a critical role in cancer research. Although the national resources devoted to cancer research remain substantial (

Establishing a Core Set of Performance Measures to Improve Value in Cancer Care: ASCO Consensus Conference Recommendation Report

5.2 billion in 2016), they have not kept pace with inflation or increased scientific opportunities, and the nation is not making all of the progress it should. Legislation enacted in 2015 and 2016 increased the federal commitment to cancer research but does not overcome the impact of the combination of relatively flat funding for the National Cancer Institute since 2003 and biomedical inflation. The promise offered by new, highly effective cancer therapies has never been brighter, and as a result the benefits we are likely to realize from adequate and consistent research funding have never been greater. Policies adopted by the Medicare program regarding the prevention, diagnosis, and treatment of cancer have greatly influenced both the practice of oncology and the services available to both Medicare and non-Medicare patients throughout the United States. Both public and private insurers often rely on the coverage policies, reimbursement levels, and coding used by Medicare as a starting point for establishing their own policies. In the face of growing economic pressure, oncologists and other cancer care professionals must remain engaged in helping to inform policy makers and to shape these changes. This effort includes working to ensure that policies designed to reduce health care expenditures do not undermine access to care or the quality of care received by persons with cancer and that reimbursement for cancer care is fair and adequate. Oncologists and other cancer care specialists have unique insights involving the care of patients with cancer, and it will continue to be increasingly important to communicate these insights effectively. Policy can have a profound impact on practice, making engagement in the process not only important but also a professional responsibility.