CMS Releases Instructions Related to the NCD to End the Coverage with Evidence Development Requirement for FDG PET for Solid Tumors

July 1, 2014

The Centers for Medicare & Medicaid Services (CMS) has released instructions to Medicare Administrative Contractors regarding the processing of claims pursuant to the June 11, 2013 final decision to end the coverage with evidence development (CED) requirement for certain FDG PET studies for solid tumors. These transmittals instruct contractors to coverone FDG PET scan for initial anti-tumor treatment strategy, designated by appending the PI modifier with the claim, and three scans when used to guide subsequent anti-tumor treatment strategy, designated by appending the PS modifier, after completion of initial anti-cancer therapy for the same cancer diagnosis. The counting in contractor systems begins on July 1, 2014; contractors are not required to search their past files. However, if contractors become aware of past FDG PET studies for the same cancer diagnosis, such as via the appeal process, they are allowed to count earlier studies dating back to June 11, 2013. The count begins again for FDG PET scans related to a different cancer diagnosis.

If providers perform more than one initial treatment strategy or more than three subsequent treatment strategy FDG PET studies for the same cancer indication, providers should ensure that these studies are medically necessary, and are not being done for screening (surveillance). For these medically necessary, non-screening studies, providers need to append a KX modifier, in addition to all other appropriate modifiers; the KX modifier will bypass contractor edits and allow the claim to be paid. However, providers should consider having a patient sign an Advanced Beneficiary Notice of Noncoverage (ABN) when more than three subsequent treatment strategy FDG PET studies have been performed, because payment for such studies will be at contractor discretion. There currently is limited information regarding which clinical circumstances contractors will consider to be medically necessary (and, accordingly, which claims will be paid). Claims should include a GA modifier when an ABN has been signed and a GZ modifier if no ABN is on file.

Since CED for certain FDG PET studies of solid tumors ended for claims with dates of service (DOS) on or after June 11, 2013, CMS has officially removed the requirement for the provider to append a Q0 (zero) modifier to any FDG PET claims.

Providers will know when they have exceeded the limit, as the claim rejection will identify such claims lacking a KX modifier with remark codes CARC 96, RARC N435, MSN 23.17, Group Code PR or CO.  As a reminder, appending the KX modifier documents that a scan performed beyond the limit is considered by the provider to be medically necessary. Providers must maintain good documentation of medical necessity of such scans, as they may be asked to provide documentation in a post-payment review by the Medicare contractor.

The CMS transmittal also notes that the contractors shall deny subsequent treatment strategy (PS) claims for oncologic FDG PET scans when no initial treatment strategy (PI) claim is present in history, when appropriate. Prostate cancer is an exception, since FDG PET is not covered for initial treatment strategy of prostate cancer. The transmittal further states that, to avoid non-payment of appropriate subsequent treatment strategy claims where the initial treatment strategy scan may have been provided prior to June 11, 2013 or prior to the patient enrolling as a Medicare beneficiary, the contractors should not reject PS claims.  The SNMMI has concerns regarding this mixed language and regarding contractor implementation, and has communicated these concerns to CMS and several contractors. The wording “when appropriate” may allow contractors to pay a claim when no PI is present in history; however, we expect providers may have to supply documentation to support the rationale and append the KX modifier to bypass edits in place. SNMMI will provide updates as more information on this issue becomes available from CMS or the contractors. Providers would be alerted that this may be the issue of a claim rejection if they receive one of the following remark codes, CARC B5, RARC N640 or Group Code PR or CO.

Further information can be found in CMS Transmittals 2932 and 166. The CMS Medicare Learning Network also offers a summary.