Myeloma was one of the cancers assessed under NOPR 2006: the first phase of NOPR. Following this first phase, on April 3, 2009, CMS expanded coverage to include myeloma with respect to treatment monitoring, restaging, and evaluation of suspected recurrent disease.
From the perspective of myeloma patients, I strongly support the proposal to remove the remaining prospective data collection requirements for FDG PET imaging for those oncologic indications where such scans continue to be covered under CED. However, it is our understanding that CMS intends to impose a one-scan limitation to apply to subsequent patient management for ALL solid tumors including myeloma for which CED was removed and for which national coverage currently exists pursuant to CAG-00181R3.
Since national coverage already exists for myeloma, this should not be changed. It is strongly encouraged that CMS clarify the final decision memorandum to indicate that this policy only applies to tumors currently covered under CED in the NOPR 2009 and that myeloma, approved under NOPR 2006, will not be imposed with a one-scan limitation provision.
Any potential "one-scan limitation" is highly inappropriate for myeloma patients for whom the prevailing standard of care is similar to that for lymphoma patients and typically involves more than one subsequent treatment strategy scan for patient management. Any limitation would have the perverse effect of requiring alternate and more expensive imaging for disease assessment.
Better novel therapies and longer survival have increased the dependence on FDG PET imaging to restage non-secretory or hyposecretory myeloma disease (which resembles lymphoma). From an administrative standpoint, it is extremely harmful to consider a "one-scan limitation" for myeloma patients. By increasing the need for signature of ABN form, patients will end up receiving suboptimal and more expensive imaging which is truly counterproductive. From the opposite perspective, there is no evidence that FDG PET is used in an inappropriate surveillance fashion.
Thus, although one can appreciate potential concern about overutilization, there is no evidence (for example, from NOPR 2006) that this occurred to any extent.
Proposed Alternate National Coverage Framework: In summary, myeloma patients are best served if CMS rejects the proposed "one-scan limitation" and instead retains (or institutes or reinstitutes) national coverage which can be subject to local MAC discretion. This approach balances medical necessity and any concern about potential surveillance use of FDG PET.
Brian GM Durie, MD
Specializing in Myeloma and Related Diseases
Chairman of the Board of International Myeloma Foundation and International Myeloma Working Group
12650 Riverside Drive, Suite 206
North Hollywood, California 91607
International Myeloma Foundation (Chairman) & Cedars-Sinai