CMS currently reimburses for fluorine-18 (F-18) FDG, rubidium-82 (Rb-82), nitrogen-13 (N-13) ammonia, and F-18 sodium fluoride in certain PET imaging applications. Other uses of PET with these radioisotopes are covered only in clinical studies under Medicare's Coverage With Evidence Development (CED) policy.
The agency's action was prompted by a joint request from the Medical Imaging and Technology Alliance, American College of Radiology, Society of Nuclear Medicine and Molecular Imaging, Council on Radionuclides and Radiopharmaceuticals, and World Molecular Imaging Society.
In a March 30 letter to CMS, the organizations noted that CMS generally does not issue a coverage decision for each particular item or service used to treat Medicare beneficiaries. However, the agency has a national coverage determination (NCD) in place denying coverage for PET radiopharmaceuticals outside of its approved list of four agents.
A new generation of radiopharmaceuticals that can be used to visualize physiologic processes is in clinical trials and under review at the U.S. Food and Drug Administration (FDA). This includes agents for evaluating myocardial perfusion, as well as the pathophysiology of Alzheimer's disease and Parkinson's disease.
Recent advances in imaging and CMS' past experience with PET coverage no long support a clinical rationale for a pre-emptive national no-coverage policy for new PET agents that have undergone FDA review and approval, the letter states.
CMS will consider whether to cover the remaining uses of PET by taking public comment until August 10. More information is available by clicking here.