1. Coverage Framework change
   CMS has adopted a new coverage framework that replaces the four-part diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework:
   • Initial Anti-tumor Treatment Strategy, formerly “diagnosis” and “staging”
   • Subsequent Anti-tumor Treatment Strategy, formerly “restaging” and “monitoring response to treatment”
2. Expand Coverage of the Initial Anti-tumor Treatment Strategy
   CMS has determined the evidence is adequate to determine that the results of FDG PET imaging are useful in determining the appropriate initial treatment strategy for beneficiaries with suspected solid tumors and myeloma. Therefore, CMS will cover only one FDG PET study for beneficiaries who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes:
   • To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or
   • To determine the optimal anatomic location for an invasive procedure; or
   • To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor.
   
   Restrictions: PET is not covered by CMS for initial treatment strategy evaluation for three specific cancer types/indications: 1) diagnosis and axillary nodal staging of breast cancer; 2) assessment of regional lymph nodes in melanoma; and 3) diagnosis of prostate cancer and initial staging of newly diagnosed prostate cancer.
   
   PET for initial treatment strategy evaluation is covered only with participation in the National Oncologic PET Registry (NOPR) for certain patients with suspected or proven cervical cancer and for patients with suspected or proven leukemia.
   
   The decision expands the national coverage of FDG PET for broad use in solid tumors and myeloma and for the covered indications eliminates the requirement to go through the NOPR.
3. Continue to Restrict Coverage for the Subsequent Anti-tumor Treatment Strategy
   The use of FDG PET for assessment of the success of the initial treatment strategy to determine the need for and content of a subsequent treatment strategy is covered by CMS for the following cancers: breast, cervix, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, thyroid, ovarian, and myeloma.
   
   For all other cancers, PET coverage for subsequent treatment strategy evaluation requires participation in an approved Coverage with Evidence Development Program i.e. the NOPR.

(1) Cervix: Covered for the detection of pre-treatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis. All other uses are CED.
(2) Breast: Noncovered for diagnosis and/or initial staging of axillary lymph nodes. Covered for initial staging of metastatic disease.
(3) Melanoma: Noncovered for initial staging of regional lymph nodes. All other uses for initial staging are covered.
(4) Thyroid: Covered for subsequent treatment strategy of recurrent or residual thyroid cancer of follicular cell origin previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin >10ng/ml and have a negative I-131 whole body scan. All other uses for subsequent treatment strategy are CED.