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ACCC Welcomes All Stakeholders’ Perspectives in Discussion of CMS Coverage Guidance Document
On May 23, 2005, Association of Community Cancer Centers (ACCC) Executive Director Christian Downs, JD, MPH, and ACCC Senior Director of Public Policy and Government Affairs Deborah Walter, MPA, welcomed close to 50 oncology organizations to a meeting on “Medicare Coverage and the Future of Patient Care Delivery.”
They joined a distinguished panel of clinicians, patient advocates, clinical researchers, and policy experts in Washington, DC, to listen and share perspectives about the Centers for Medicare and Medicaid Services’ new guidance on Coverage with Evidence Development, or CED.
The organizations represented a wide constituency of stakeholder groups, including the Lung Cancer Alliance, the Alliance for Prostate Cancer Prevention, and the American Red Cross. Comments were due to CMS by June 6, 2005.
ACCC prepared a patient advocacy and comment template designed to help stakeholders prepare comments to CMS.
Many overlapping stakeholder concerns emerged regarding the proposal by CMS to link a coverage decision to a requirement for additional data collection, such as through a clinical trial or a national registry. Generally, stakeholder concerns fell into the following areas, patient access to care, data collection, unclear or ambiguous language in the draft guidance, and the complexity of cancer care.
Patient access to care. Participants agreed that Medicare beneficiaries should be encouraged to participate in clinical trials, but they recognized that trials may not be the best treatment option for all beneficiaries. Approximately 85 percent of Medicare beneficiaries are ineligible to participate in clinical trials due to co-morbidities and complications. Other beneficiaries might not choose to participate if it would require them to travel, change physicians, or experience other significant inconvenience. Beneficiaries in rural areas, for example, often have to travel long distances if they choose to receive care in a medical center that participates in clinical trials. Participants wanted to know how this new policy would affect patients in rural and underserved areas.
While the new CMS approach could potentially expand coverage and access to care, participants asked if an unintended consequence might actually be to limit coverage. And despite the draft guidance acknowledgment that local carrier discretion should be preserved, some asked if this new approach might erode local carrier discretion.
Data collection. Many stakeholders expressed concern at the current lack of any infrastructure to perform data collection and analysis as described in the draft guidance. They wanted to know how this data collection effort would be paid for and how cancer programs would deal with the additional administrative burden and expense of this requirement.
Stakeholders also asked how this new research effort would mesh with CMS’s mission—cancer research is currently the mission of the National Cancer Institute, not CMS. Several stakeholders stated that the current research infrastructure was sufficient, pointing to the fact that many research enterprises already exist in the public/private sector. There was also concern that existing resources and efforts not be duplicated.
Many meeting attendees shared CMS’ concern about the cost of clinical research, and urged the agency to examine fully providers’ costs of participating in trials and registries. Providers who participate in clinical research currently bear considerable uncompensated costs, including the costs of drug administration, patient counseling, data collection, and the extra staffing required to comply with trials’ requirements. Many providers donate their time and resources to support clinical research, but as reimbursement for care outside trials becomes leaner, providers have fewer funds available for these efforts. If CMS plans to impose new data collection requirements on providers, meeting attendees voiced concern that the agency must also offer adequate compensation for these costs.
Unclear or ambiguous language in the draft guidance. Stakeholders pointed out a need for a clearer definition of certain terms used in the draft guidance such as “net health outcomes.” In addition, stakeholders expressed concern over a seeming shift in interpretation of the phrase “reasonable and necessary” in the 40-year-old Medicare statute.
Complexity of cancer care. Stakeholders reflected on the complexity of cancer care and the reality that cancer treatments are becoming increasingly individualized through the use of tumor markers and targeted therapies toward specific patient subgroups.
All stakeholders expressed a need for more information. While many at the meeting expressed respect and support for Dr. McClellan’s vision—common threads were an overriding concern for continued patient access to care; a need to look to existing resources for data collection and research; and finally, the importance recognizing the changing nature of cancer research and treatment.
ACCC is urging CMS to bring all stakeholders together to discuss ways to effectively increase support for and use of our clinical research system.
Don Jewler, Communications Director
