Change to National Coverage Decision will have positive impact on clinical study budgets

Treating physicians use PET scans to evaluate whether or not a patient with a newly-discovered or suspected solid tumors are candidates for an invasive diagnostic or therapeutic procedure.  Most solid tumor clinical trials require an initial PET scan as part of the screening process to qualify study subjects for clinical studies and many sponsors mandate more than one PET scan in the course of treatment.  Oftentimes, the sponsor must compensate the clinical sites for subsequent PET scans as most study budgets are created to conform to the National Coverage Decision (NCD) guidelines.  It should be noted that PET scans provide essential data for evaluation of and treatment of solid tumors and, as a matter of course, the FDA will require numerous PET scans for a solid tumor clinical study.

CMS has now revised Section 220.6.17 of the NCD to expand the number of PET scans covered if the treating physician determines that additional PET scans are required to ensure proper medical care.  Now local Medicare administrators will have the flexibility to determine what the standard of care for number of PET scans will be in their respective regions. Of course, as local administrators vary in their standards, the removal of this restriction will not ensure that each and every Medicare administrator will expand PET scan coverage but it certainly will lessen the impact that numerous PET scans have on our clinical study budgets.