October 9, 2013
Effective June 11, 2013, CMS ended the coverage with evidence development (CED) requirement for F-18 fluorodeoxyglucose positron emission tomography (FDG PET) and FDG PET/CT for all oncologic indications contained in section 220.6.17 of the Medicare National Coverage Determinations (NCD) Manual. This removes the current requirement for prospective data collection by the National Oncologic PET Registry (NOPR) for oncologic indications of FDG only.
On July 4, 2013, CMS released instructions important for billing FDG PET studies (these were noted on page 10 of a CMS press release on that day): “Effective for claims with dates of service (DOS) on or after June 11, 2013, FDG PET and FDG PET/CT claims, (codes 78608, 78811, 78812, 78813, 78814, 78815, 78816 and HCPCS A9552), for all oncologic conditions, no longer require the following modifier and diagnosis code: Q0 (zero): Investigational clinical service provided in a clinical research study that is an approved clinical research study.” Therefore the answer to the question regarding whether to append the Q0 modifier for these claims is no.
SNMMI members have been unsure whether to submit claims for FDG PET with DOS after June 11, 2013 if the study would have required submission under NOPR before that date. CMS has yet to send out a transmittal and the Medicare Administrative Contractors (and Medicare Advantage plans) have not given providers any further official local instructions. Therefore, the SNMMI is urging those who have not already submitted these claims to begin this process. We recommend you start small, submitting only a limited number of held claims, and be prepared to monitor closely and appeal any denied claims through the full spectrum of the appeal process, including to the Administrative Law Judge (ALJ) level, if necessary. However, providers should to be prepared for the possibility of denials and the need for appeals. Note that for patients in Medicare Advantage plans, NOPR claims were submitted to the local Medicare Administrative Contractors, and not to the Medicare Advantage plan. Since the NCD, these claims should now be sent to the Medicare Advantage plan.
SNMMI had provided a Q&A on this issue at our Coding Corner.