Experts preach caution after CMS decision for PET cancer imaging

CMS effectively ushered in a fresh start for oncologic PET imaging upon the final coverage decision for PET imaging of solid tumors announced on June 11. Elaboration of new coverage was provided on June 13 and the NOPR (the National Oncologic Pet Registry) was concluded as of June 11. Representatives from the Society of Nuclear Medicine and Molecular Imaging and NOPR moderated a webinar June 19 to discuss the decision and to counsel clinicians on how PET imaging is expected to move forward.

“The final decision we got on June 13 is quite a substantial expansion of PET coverage,” stated Barry Siegel, MD, NOPR co-chair at Washington University in St. Louis. “First, and I must say that I am not at all displeased about this--the data collection requirements under coverage with evidence development were ended by this [national coverage determination] so NOPR will no longer be collecting data for oncological uses of FDG PET.”

The CMS decision, officially labeled CAG-00181R4, lifted coverage with evidence development (CED) in place since 2004 for oncologic PET exams of solid tumors. NOPR for PET cancer imaging is now closed, but a second registry was recently opened for sodium fluoride PET imaging and remains open and in effect. Clinicians are advised to let CMS know about participating.

Three PET scans are now allowed under the new decision on a national basis regarding initial treatment strategies in oncologic applications. Coverage for additional scans is at the discretion of local Medicare administrative contractors (MACs) and advantage plans for oncologic indications when used to guide subsequent management of anti-tumor strategy after initial anticancer therapy. Scan counts begin as of June 11 and all previous scans before that time will not be counted.

“You can expect policies to begin changing probably within a month or so. Also, I personally would strongly advise practices to have good conversations between referring MDs and radiologists in any kind of marginal cases to make sure that the rationale for the PET study is clearly defined so that if you run up against issues of having to appeal claims with local contractors, that you have well documented medical necessity laid out in the records and the best place to lay it out is in the PET report,” said Siegel.

The new decision does not address other applications of FDG PET or PET with sodium fluoride, ammonia or rubidium-82. Nor does it prevent CMS from determining that another coverage analysis is needed. Local Medicare administrative contractors (MACs) will most likely deny claims as they turn over to the new protocol. It may take as long as 60 to 90 days for all parties to be on board for reimbursing new claims that would have been previously excluded from coverage.

“I personally recommend that you may want to consider holding your claims,” said Denise Merlino, a nuclear medicine technologist and certified professional coder advising for the SNMMI and the NOPR. “Medicare contractors will not tell you to do that; CMS will not tell you to do that. It is a personal recommendation. During the transition period, there are just too many unanswered questions as to the correct mechanism. However, having said that, you are perfectly welcome to submit your claims as long as you submit them in the correct manner with the right modifiers attached. If you were to do that, you’ve definitely got to keep a spreadsheet so that you can monitor exactly which ones are in the system, because you are going to get a denial. You should go through the appeal process and look very closely for when those MACs are ready to accept claims.”

Imaging for advanced treatment strategy for prostate cancer is now deemed reasonable, but not for initial strategy and MACs will likely be monitoring claims closely for appropriate use. The term PET imaging includes PET standalone, PET/CT and PET/MRI. Non-coverage for FDG oncologic PET includes breast cancer diagnosis, detection of axililary nodal disease for newly diagnosed breast cancer patients and detection of regional nodal disease in newly diagnosed melanoma patients. FDG PET can be used for distant metastases, but not for sentinel node assessment. Further clarification of coding requirements is available and clinicians are encouraged to contact their local MACs or payers for specific guidance on coding and counting for initial and subsequent anti-cancer treatment strategies using PET.