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Leaders of the top three federal agencies that deal with the cancer problem spoke at ASCO's July Legislative Conference, and all organized their remarks around the theme of collecting, paying for, and acting on the wealth of data they currently have or will acquire. Centers for Medicare & Medicaid Services (CMS) Administrator Mark McClellan, MD, PhD, Director of the National Cancer Institute (NCI) and acting Commissioner of the U.S. Food and Drug Administration (FDA) Andrew von Eschenbach, MD, and former Commissioner of the FDA Lester Crawford, DVM, PhD, all delivered formal remarks on July 26, 2005.
Most oncologists are familiar with the CMS 2005 Oncology Demonstration Project, which was the initial topic brought to the table by McClellan. This 1-year, $300 million project was designed in part to mitigate the reimbursement reduction for Part B drugs under the Medicare Modernization Act of 2003 (MMA). The demonstration project payment was intended not only to make up for the reduction in the transition payment from 32% in 2004 to 3% in 2005, but also to compensate physicians for collecting and providing to CMS additional, symptom-related data. Oncologists participating in the project, officially called the Demonstration of Improved Quality of Care for Cancer Patients Undergoing Chemotherapy, are reimbursed for collecting data on pain, fatigue, and nausea and vomiting related to chemotherapy. New billing codes (part of the “G-code” series) were established. The use of G-codes to collect data retrofits the existing Medicare billing system as a data collection tool.
Preliminary data are now available from the demonstration project. McClellan believes that the data indicate that the policy changes that occurred as a result of MMA have not affected patients' access to care, because office-based chemotherapy was administered in 2005 at the same level as in the past. The early data also indicate that severe degrees of these symptoms affect a low percentage of patients: 2% of patients had substantial (“quite a bit” or “very much”) nausea and vomiting, 8% had a similar level of pain, and 26% had a similar level of fatigue. CMS plans to analyze the data as they become more complete, and to evaluate relationships between these symptoms and hospitalizations and emergency department visits for related conditions (such as intractable pain and dehydration).
CMS is seeing broad utilization of this “starter set,” and McClellan noted three positive findings: patient access was ensured despite the change in payment methodology, the project demonstrated that oncologists can report data, and CMS was interested in supporting the quality of life for patients with cancer. CMS is talking to oncology health care providers and others in the oncology community to obtain more information about their view of the effectiveness of the project and also to discuss ways to better capture data on the clinical care of patients with cancer. As of July 2005, CMS was uncertain as to the form, if any, that the project would take in 2006, though continuation of the project is supported by many legislators. For example, Arlen Specter (R-PA) and 39 other senators signed a letter to the White House and administration asking for the project to be continued through 2006. In the House of Representatives, Ralph M. Hall (R-TX) sent a letter to his colleagues noting that the project was “critically important” to protecting the quality of cancer care this year and urged them to support H.Res 261, which calls for the continuation of the demonstration project.
McClellan intends to continue harnessing the incentives created by payment updates to bring appropriate quality care through the practice community. He gave as one example the ASCO Quality Oncology Practice Initiative (QOPI), the oncologist-led, practice-based performance improvement program initiated in 2002. The preliminary findings from this pilot program are reported by Neuss et al in the September 1, 2005, issue of the Journal of Clinical Oncology (“A Process for Measuring the Quality of Cancer Care: The Quality Oncology Practice Initiative,” pp 6233-6239). Although QOPI is not recognized by CMS as a formal quality indicator, it is likely that this or similar quality measurement tools will be incorporated into future payment mechanisms. Other examples of data collection “harnessed” to the payment for services is the registry established for coverage of positron emission tomography scans, and the payment for biologic agents for treatment of colon cancer as part of a clinical trial.
Lastly, McClellan turned to CMS's previous focus on “paying for treatments when things went wrong” by way of illustrating what he hopes will be a new, preventive paradigm. His view is that preventive science is well developed enough to apply to the Medicare population, and the MMA—which mandates payments for preventive services—gives CMS the tools to apply prevention. High-quality care, which “gets it right the first time,” is one type of prevention. Smoking cessation counseling and drug therapies are also preventive services covered under provisions of the MMA. A “welcome to Medicare physical,” during which preventable risks can be revealed, is also newly covered under the MMA.
Shortly after von Eschenbach became director of the NCI nearly 4 years ago, he began implementing programs to streamline cancer research and to provide a cohesive research platform. In his presentation at the Legislative Conference, von Eschenbach updated attendees on progress with three of these programs: the Cancer Biomedical Informatics Grid (CaBIG), the Clinical Trials Working Group (CTWG), and the NCI/FDA Interagency Oncology Task Force (IOTF).
CaBIG, a $13 million program, is an information network or grid connecting individuals and institutions involved in clinical research to enable the sharing of data and tools. Nearly 500 researchers and other participants at 50 cancer centers have been working collaboratively on more than 70 projects during the first year of the pilot program. Participants are now reassessing priorities and identifying additional needs and emerging opportunities that will help to establish the programmatic agenda for the coming year.
von Eschenbach established the 37-member CTWG in 2004 to explore ways to optimize the NCI-supported clinical trials system. In June, the CTWG presented its report “Restructuring the National Cancer Clinical Trials Enterprise,” which includes 22 recommendations along with a 5-year plan to implement the changes. The NCI National Cancer Advisory Board (NCAB) accepted the proposal, and von Eschenbach called the report a “critical step” to reaching his goal for the NCI.
The initiatives proposed in the report fall into five categories: coordination, prioritization/scientific quality, standardization, operational efficiency, and enterprisewide. In addition, the recommendations call for initiatives that both create fundamental changes in the operation of the NCI clinical trials system and expand or enhance existing activities. The complete report is available online through the CTWG Web site (see Online Resources).
The IOTF represents von Eschenbach's continuing commitment to enhancing collaboration between the NCI and other government agencies. The first major program to be developed by the IOTF is the Research and Regulatory Review Fellowship Program, which is designed to provide a unique opportunity for clinicians and scientists to train with experienced FDA reviewers and researchers. By gaining a better understanding of the requirements of regulatory review of safety and efficacy, the researchers who complete these 1- to 3-year fellowships can help to bring safe and effective drugs, regimens, and devices from the bench to the bedside as quickly as possible.
von Eschenbach also noted that the NCI and FDA continue to work together on other projects and are collaborating to create a common collection of data standards that can be used to transmit clinical trials data from investigator to regulator. Also, the NCI is exploring partnerships among government agencies, industry, and academic centers that can help facilitate the dissemination and application of bioinformatics platforms that will enhance collaboration among these sectors.
Use of data collected by the FDA as part of the drug approval process was also a focus of Crawford's remarks. Turning this data into information that can be used to modernize the medical product development process—the Critical Path—to make product development more predictable and less costly is a current focus of the FDA. Because of its unique vantage point, the FDA can work with companies, patient groups, academic researchers, and other stakeholders to coordinate, develop, and/or disseminate solutions to scientific hurdles that impair the efficiency of product development industrywide. Drugs that have failed to gain approval for marketing, drugs that have succeeded in reaching approval, and those that have not reached approval within 6 months of submission are subjects of study and incorporation into the agency's Critical Path Opportunities list.
Crawford went on to comment on the currently controversial area of ensuring the safety of marketed drugs. He started out by saying that he believes that drugs are “safer today than they ever have been before.” Still, drug safety is a primary concern among both health care professionals as well as consumers. The Drug Safety Oversight Board (DSOB) was created to address this issue. The organizational structure, role, and responsibilities of this independent board are described in the Manual of Policies and Procedures of the Center for Drug Evaluation and Research (see Online Resources). [Editor's note: ASCO submitted comments to the FDA regarding the Board and the agency's proposed Drug Watch Web site. These comments are available on the ASCO Web site at http://www.asco.org/asco/downloads/Drug_Watch_Comments_8.8.pdf.]
The DSOB is scheduled to meet privately every 6 weeks, and its second meeting was held on July 27, 2005. Because of the proprietary nature of the information discussed, these meetings are not public, but summaries of the meetings are made available online. As a result of the discussion at the recent meeting, the FDA posted new or updated information for patients and health care professionals (at www.fda.gov/cder) on several drugs, including gefitinib.
Crawford reiterated that industry has a right to keep some information confidential because it constitutes trade secrets. While maintaining that confidentiality, the DSOB's review of information can provide insight into why drugs fail and how they can be developed better. Crawford also acknowledged that industry has the right to promote its products through direct-to-consumer advertising. He added, however, that the FDA is encouraging pharmaceutical companies to develop voluntary standards for such advertising. For example, he praised one pharmaceutical company for its establishment of a moratorium on direct-to-consumer advertising for 1 year after a drug is brought to market. Off-label use of marketed drugs is a right that the FDA will continue to uphold.
These three leaders of high-profile government agencies acknowledged the importance of enhancing the quality of cancer care by collecting, acting on, and paying for data in the conduct of complex programs. Practicing oncologists also have a role in the efforts. ASCO encourages its members to remain up to date with changes in the clinical trials system and on issues in drug safety (see Online Resources). Members who have not participated in the oncology demonstration project should enroll by billing according to the designated codes. Information about the codes is included on ASCO's Web site (http://www.asco.org/mma). The Society also urges members to contact their representatives in Washington, DC, about supporting continuation of the project. The Grassroots Action Center is available at ASCO.org to facilitate legislative contact. Members should feel free to contact the ASCO Cancer Policy and Clinical Affairs Department with their questions and suggestions.
Editor's Note: During the interval between the Legislative Conference and press time, Lester Crawford, DVM, PhD, resigned as U.S. Food and Drug Administration (FDA) commissioner, and Andrew von Eschenbach, MD, was appointed as acting commissioner, while continuing his current role as director of the National Cancer Institute. The FDA agenda may change with its new leadership, but the broad themes encompassed here are likely to remain.