Coverage with Evidence Development
The Centers for Medicare and Medicaid Services (CMS) released a Draft Guidance on Coverage with Evidence Development (CED) on April 7. 2005. In the draft guidance, CMS proposes using CED as a means to encourage the collection of more clinical data about patients' treatment options by linking coverage decisions with data collection requirements. A revised draft guidance on CED is expected from CMS in fall, 2005.
Clinical research is essential to improving patient care. Expanding participation in and support of clinical research would benefit all stakeholders in our health care system by developing evidence to guide patients and physicians' choices of currently available treatment options and to continue the advancement of cancer care. It identifies better and worse treatments for patients, physicians, and payors.
While the expansion of clinical research opportunities is overwhelmingly supported, efforts must be undertaken with a full understanding of America's clinical research system and cancer as a complex disease. Key concepts should be addressed and subsequently prioritized by all stakeholders in the clinical research system—including patient groups, physicians, researchers, industry, Centers for Medicare and Medicaid Services (CMS), and private payors.
ACCC Welcomes All Stakeholders' Perspectives in Discussion of CMS Coverage Guidance Document.
Phone 301.984.9496, ext. 221, Email mfarber@accc-cancer.org

