Clinical Indications

The chart below lists the clinical indications where PET and PET/CT have been found to be beneficial and if Medicare covers these clinical indications.

In January 2005 CMS announced its intention to expanded PET coverage for all presently non-covered cancers and the non-covered indications (e.g., treatment monitoring) for currently approved cancers if certain data about the PET studies are submitted to a national registry. More details will be posted about these changes as they become available.

Note: Diagnosis of breast cancer, staging of regional auxiliary nodes in breast cancer, and staging of regional lymph nodes in melanoma are nationally non-covered indications and will not be included in the expanded PET coverage.

Disease Category Clinical Indications Covered by Medicare
Breast Cancer
  • Staging (not reliable for axillary nodal involvement)
  • Evaluate suspected local and/or distant metastasis (inconclusive diagnostic imaging studies, lab studies)
  • Radiation therapy planning
  • Monitor response to treatment
Yes

Initial staging for distant metastases

Staging and re-staging locoregional recurrence or distant metastases
Evaluate response to treatment

Colorectal Cancer
  • Initial staging prior to surgery
  • Restaging post treatment
  • Restaging for rising CEA levels
  • Restage when other imaging studies are inconclusive
  • Differentiation of presacral post surgical change vs. recurrent tumor
  • Restage when abnormal physical exam or clinical symptoms of recurrence
  • Re-evaluation after radiofrequency ablation of hepatic colorectal metastases
  • Radiation therapy planning
Yes

Diagnosis*
Staging
Restaging
Monitoring covered under clinical trials protocols
(*CMS guidelines state that PET would rarely be used in the diagnosis of colorectal cancer)

Esophageal Cancer
  • Initial staging to evaluate local extent of disease and/or identify distant metastasis prior to scheduled surgery
  • Radiation therapy planning
  • Re-stage for suspected recurrence
Yes

Diagnosis*
Staging
Restaging
Monitoring covered under clinical trials protocols
(*CMS guidelines state that PET would rarely be used in the diagnosis of esophageal cancer)

Head & Neck Cancer
(Excluding CNS and thyroid)
  • Detection of unknown primary
  • Identify an appropriate site for biopsy
  • Staging of neck nodes
  • Staging outside of the head & neck
  • Radiation therapy planning
  • Differentiation of post surgical
    change from recurrent tumor
  • Exclusion of lesions that appear suspicious on other imaging modalities
Yes

Diagnosis
Staging
Restaging
Monitoring covered under clinical trials protocols

Lung Cancer
  • Distinguish malignant from benign pulmonary nodule(s)
  • Biopsy localization information
  • Mediastinal nodal staging
  • Staging for extrathoracic metastases
  • Radiation therapy planning
  • Re-stage to detect recurrent disease or residual tumor following definitive therapy
  • Differentiation of postsurgical change from recurrent tumor
Yes

Diagnosis*
Staging
Restaging
Monitoring covered under clinical trials protocols
(*PET is also covered to evaluate a solitary (single) pulmonary nodule, indeterminate on CT and > 4 cm – see indication Solitary Pulmonary Nodule)

Lymphoma
  • Initial staging to determine extent of disease prior to chemotherapy
  • Biopsy localization information
  • Radiation therapy planning for Hodgkin’s
  • Restage to evaluate response to treatment
  • Differentiation of residual soft tissue (scar) vs. tumor
Yes

Diagnosis*
Staging
Restaging
(*CMS guidelines state that PET would rarely be used in the diagnosis of lymphoma)

Melanoma
(Excludes the evaluation of regional nodes)
  • Initial staging to determine extent of disease prior to scheduled treatment (not covered for evaluation of regional nodes)
  • Restage to evaluate response to treatment
  • Restage to detect recurrence
Yes

Diagnosis*
Staging
Restaging
Monitoring covered under clinical trials protocols
(*CMS guidelines state that PET would rarely be used in the diagnosis of melanoma; CMS does not cover PET for evaluation of regional nodes when there is not suspicion for more extensive disease)

Thyroid Cancer
  • Re-staging patients with suspected recurrence in thyroid cancers of follicular cell origin, post surgery or I 131 ablation with > 10 ng/ml serum thyroglobulin level and negative I 131 whole body scan
Yes
Diagnosis, other staging, restaging, and monitoring covered under clinical trials protocols
(CMS covers PET for patients who have been treated for thyroid cancer of follicular cell origin (either surgically or with I 131) and have thymoglobulin level > 10 ng/ml and a negative I 131 WB scan)
Cardiac Viability
  • Initial staging to determine myocardial viability from infracted tissue when patients are being evaluated for revascularization or transplant
Yes

Staging
(PET is covered when the patient has had an inclusive SPECT study and effective 10.01.03 PET can be used as a first line study instead of a SPECT study)

Seizure Disorders
  • Staging to evaluate seizure focus prior to scheduled surgery
Yes

(Pre-surgical evaluation)

Solitary
Pulmonary Nodule

(A PET scan for SPN may be repeated after 90 days following a negative PET scan)
  • Evaluation of an indeterminate single/solitary lung nodule < 4 cm identified by CXR or CT
  • Evaluation of a lung nodule that shows an interval increase in size following a negative PET scan > 90 days prior
Yes

(CMS covers a PET scan for an indeterminate SPN by CT and when the single/solitary nodule is < 4cm)

Brain Cancer
  • Differentiation of radiation necrosis vs. residual/recurrent tumor
No

Covered under clinical trials protocols

Ovarian Cancer
  • Staging prior to surgery
  • Restaging when CA-125 levels
    are increasing
  • Radiation therapy planning
No

Covered under clinical trials protocols

Cervical Cancer
  • Staging prior to surgery (particularly good for evaluating paraaortic lymph nodes)
  • Evaluating response to therapy
Yes
Staging as adjunct to conventional imaging Diagnosis, other staging, restaging, and monitoring covered under clinical trials protocols
(CMS has proposed coverage for the detection of pre-treatment metastases in newly diagnosed cervical cancer, after negative conventional imaging)
Alzheimer’s Disease
  • Differentiation between AD, normal aging and neuropsychiatric conditions
  • Differentiation between AD and other dementia
  • Detect AD at its earliest stages
Yes
(PET is covered for the differential diagnosis of AD with atypical features vs. fronto-temporal dementia)