CMS NCD drops clinical trial requirement for FDG PET scans for solid tumors

by  Codapedia
December 11th, 2015

By: Scott Kraft (Tue, May/06/2014) 

Patients no longer need to be in a CMS-approved clinical trial for physician practices to get paid for doing as many as four FDG PET scans for solid tumors – one for an initial treatment strategy and three to guide subsequent treatments, according to CMS transmittal 8739 to its Medicare Claims Processing Manual.

In some instances, even more than four scans can be done when they are medically necessary, in line with the Medicare Administrative Contractors (MACs) payment policy for exceptions to the frequency limit and billed using the KX modifier (qualify for an exception under the automatic exception process).

The frequency limit is per cancer diagnosis, so a patient who has multiple cancers can get up to four scans when medically necessary for the treatment of each individual diagnosis. This policy change is a national coverage determination (NCD), meaning it applies to all MACs. 

The transmittal took effect April 18, but CMS has backdated the change to June 11, 2013. Any claims done on or after June 11 can be resubmitted to the MAC for reconsideration, but won’t automatically be reprocessed. 

The PET scan CPT® codes addressed under the NCD are 78608, 78811, 78812, 78813, 78814, 78815 and 78816.

Under the new policy, when billing the initial PET scan as part of establishing a treatment strategy for the cancer, you would append modifier PI. Each of the three additional PET scans allowed for subsequent treatment strategy would be billed with the modifier PS

Whether or not a PET scan is billed with modifier PI doesn’t have any bearing on the three PET scan limit for each cancer diagnosis billed with the PS modifier. The fourth PET scan billed with PS will automatically be denied, unless the KX modifier is attached as noted above.

Modifiers Q0 and Q1 for investigational research or clinical trials are no longer required on claims with dates of service on or after June 11, nor is diagnosis code V70.7 for examination of patient in a clinical trial. 

When these services are rejected because the PS modifier is not used you may see claim adjustment reason code 4 (the procedure code is inconsistent with the modifier used or a required modifier is missing), remittance advice remark code MA-130 (Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Submit a new claim with the correct/complete information). 

For a list of the diagnosis codes affected by the NCD change, see page 14 of the attached document. 

List of covered diagnoses for PET NCD (pdf)  


CMS NCD drops clinical trial requirement for FDG PET scans for solid tumors. (2015, December 11). Find-A-Code Articles. Retrieved from

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