Herceptin for its listed off-label use in compendia. If CMS makes a national coverage determination on an intervention, then payment policies can be enforced. For example, CMS will not pay for an implantable cardiac defibrillator for anyone with an ejection fraction over 35 percent.

Presenter: Dr. Craig Earle

The IOM asserted in its recent report that survivorship care plans have strong face validity and can reasonably be assumed to improve care unless and until evidence accumulates to the contrary. The report recommended moving forward with implementation and at the same time engaging in applied research to define optimal models of delivery and quantify effects on survivors’ health and well-being. In the IOM report there is a strong recommendation for action and also a charge going out to the research community to accumulate the evidence surrounding use of survivorship care planning. Creating survivorship care plans is time-consuming and requires work from busy clinicians. Understanding the benefit to patients as well as the costs to health systems and providers will be important factors in disseminating survivorship care planning.

Research is needed to determine how the entire Survivorship Care Plan, in addition to the following elements of it, affect outcomes:¹

• Treatment summary;

• Description of possible clinical course (e.g., expected recovery from acute toxicities);

• Surveillance plan for recurrence and late effects;

• Psychosocial issues and available resources; and

• Lifestyle recommendations.

There are research questions associated with each of these elements. Are all of these elements needed for all cancer survivors? Are psychosocial interventions as important for a stage II colon cancer as they are for a woman with advanced breast cancer? Is the transition to survivorship really a teachable moment, or is it the case that lifestyle issues would be better addressed by a primary care provider 6 months later? These are empirical questions that need to be answered.

Research outcomes that could be considered occur at both the patient level and the systems level (Table 5-1).