FDG Positron Emission Tomography for Solid Tumors and Myeloma: Data Collection Ends Under the National Oncologic PET Registry

July 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.

Effective for claims with dates of service 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.
  • V70.7:  Examination of participant in clinical research: 

These changes onlyapply to services using FDG (HCPCS A9552) as the radiopharmaceutical. This does not apply to services using NaF-18 (HCPCS A9580). The changes also do not affect use of the following modifiers, which are still required on claims.

  • PI (initial treatment strategy)
  • PS (subsequent treatment strategy)

Note:This decision does not change coverage for use of PET or PET/CT using radiopharmaceuticals NaF-18 (fluorine-18 labeled sodium fluoride), ammonia N-13, or rubidium-82 (Rb-82).

CED continues under NOPR for NaF-18 PET and PET/CT for bone metastasis per section 220.6.19 of the NCD Manual.

The Internet Only Manuals will be updated soon to reflect these changes. See the CMS final decision memorandum for more detailed information. 

Please find CMS's release here midway down page 10.