PET Scan - CAM 759HB

Policy   
ADULT AND PEDIATRIC MALIGNANCIES:
1 ONCOLOGICAL PET IS INDICATED FOR BIOPSY-PROVEN CANCER OR STRONGLY SUSPECTED CANCER BASED ON OTHER DIAGNOSTIC TESTING. The appropriateness of an ordered PET/CT study is dependent on which radiopharmaceutical will be used for the PET/CT.

INDICATIONS
Bone Tumors & Sarcomas
Angiosarcoma (1)

  • Initial Staging
    • Indicated
      • Chest CT, CT or MRI of the primary site, Brain MRI AND whole spine MRI are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT, CT or MRI of the primary site, Brain MRI AND whole spine MRI are indicated in addition to PET

Chondrosarcoma (2)

  • Initial Staging
    • NOT Indicated
  • Restaging
    • NOT Indicated

Chordoma (2)

  • Initial Staging
    • NOT Indicated
  • Restaging
    • NOT Indicated

Clear Cell Sarcoma (1)

  • Initial Staging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
         

Epithelioid Sarcoma (1)

  • Initial Staging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET

Ewing Sarcoma (2)

  • Initial Staging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Surveillance
    • For patients with a history of metastatic disease, indicated every 3 months for 2 years, then every 4 months up to year 3 post completion of treatment
      • CT or MRI of the primary site are indicated in addition to PET

Giant Cell Tumor of Bone (2)

  • Initial Staging
    • Not Indicated
  • Restaging
    • Not Indicated

Malignant Peripheral Nerve Sheath Tumor (MPNST) (1)

  • Initial Staging- biopsy confirmed diagnosis (regardless of NF1 Status)
    • Indicated if considering neoadjuvant therapy OR
    • With prior indeterminate imaging
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET for both indications
  • Initial Staging - suspected diagnosis in setting of known Neurofibromatosis Type 1 (NF1)
    • Indicated if there is concern for malignant transformation of neurofibroma to MPNST based on ANY of the following:
      • Change in conventional imaging (e.g. growth or change in characteristics of mass) OR
      • Change in texture on exam OR
      • Change in symptoms (new or worsening pain)
  • Restaging (for confirmed MPNST, regardless of NF1 status)
    • Indicated if being treated with chemotherapy OR
    • With prior indeterminate imaging
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET for either restaging indication

Myxoid/Round Cell Liposarcoma (1)

  • Initial Staging
    • Indicated
      • Chest CT, CT or MRI of the primary site, Brain MRI AND whole spine MRI are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT, CT or MRI of the primary site, Brain MRI AND whole spine MRI are indicated in addition to PET
         

Osteosarcoma (2)

  • Initial Staging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET

Rhabdomyosarcoma (1)

  • Initial Staging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
         

Soft Tissue Sarcoma - All Other Histologies (1)

  • Initial Staging
    • Indicated if considering neoadjuvant therapy OR
    • With prior indeterminate imaging
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET
  • Restaging
    • Indicated if being treated with chemotherapy OR
    • With prior indeterminate imaging
      • Chest CT AND CT or MRI of the primary site are indicated in addition to PET

Breast Cancer (3)
FDG PET

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging


Special Tracer PET (FES/Cerianna)

  • Initial Staging
    • Not Indicated
  • Restaging
    • FES (Fluoroestradiol F 18 or Cerianna®) is indicated for recurrent or metastatic breast cancer when all of the following are present:
      • Biopsy of recurrent or metastatic site is inconclusive or unable to be performed AND
      • ER status is needed to make a treatment decision


CNS Cancers (4)
All Histologies

When an oncologic PET using FDG (using CPT codes 78811 and 78814) is requested for a primary brain malignancy, it should be reordered as a Brain PET (CPT 78608).
 

When a tracer other than FDG is used (such as SSTR (dotatate) for meningioma), the CPT codes covered by this guideline (78811 and 78814) apply when medical necessity is met (see indications below) rather than the Brain PET code (CPT code 78608).

NOTE: See non-malignant disease section for amyloid/dementia

Meningioma

  • Special Tracer PET: SSTR (Dotatate) PET
    • Initial Staging:
      • Indicated after Brain MRI is insufficient or indeterminant for diagnosis
    • Restaging
      • Indicated after Brain MRI is insufficient or indeterminant for detection of residual or recurrent disease

NOTE: See above all histologies section regarding FDG

Primary CNS Lymphoma

  • Initial Staging:
    • Indicated
      • Brain MRI AND whole spine MRI are indicated in addition to PET
  • Restaging:
    • Indicated
      • Brain MRI AND whole spine MRI are indicated in addition to PET

Gastrointestinal Tract Cancers
Anal Carcinoma (5)

  • Initial Staging
    • With prior indeterminate imaging OR
    • For radiation planning (to define radiation field)
  • Restaging
    • With prior indeterminate imaging OR
    • For radiation planning (to define radiation field) OR
    • Following radiation if PET was used prior to radiation

NOTE: Normal pelvic lymph nodes are often not seen on imaging. When pelvic lymph nodes are visualized on imaging, even if normal in size, that finding raises concern for disease spread and can be considered indeterminate.


Colon Cancer (6)

  • Initial Staging
    • With prior indeterminate imaging OR
    • For potentially surgically curable metastatic disease OR
    • When image-guided liver-directed therapies are being considered

NOTE: When there are known or suspected liver metastases, Abdomen MRI is indicated in addition to PET

  • Restaging
    • With prior indeterminate imaging (including discordance between tumor markers (CEA) and imaging) OR
    • For potentially surgically curable metastatic disease OR
    • When image-guided liver-directed therapies are being considered


NOTE: When there are known or suspected liver metastases, Abdomen MRI is indicated in addition to PET

Esophageal & EJ Junction Cancers (7)

  • Initial Staging
    • Indicated after initial workup with CT/MRI if no evidence of metastatic disease on imaging
  • Restaging
    • Stages I-III: Indicated
      • NOTE: Following chemoradiation PET is indicated 5-8 weeks after completion of therapy
    • Stage IV: With prior indeterminate imaging

Gastric Cancer (8)

  • Initial Staging
    • Indicated after initial workup with CT/MRI if no evidence of metastatic disease on imaging
  • Restaging
    • Localized Disease:
      • Indicated when PET was used for initial staging OR
      • With prior indeterminate imaging
    • Metastatic Disease:
      • With prior indeterminate imaging

Gastrointestinal Stromal Tumors (9)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging OR
    • 2-4 weeks after initiation of TKI (tyrosine kinase inhibitor) therapy

Rectal Cancer (10)

  • Initial Staging
    • With prior indeterminate imaging OR
    • For potentially surgically curable metastatic disease OR
    • When image-guided liver-directed therapies are being considered

NOTE: When there are known or suspected liver metastases, Abdomen MRI is indicated in addition to PET

  • Restaging
    • With prior indeterminate imaging (including discordance between tumor markers (CEA) and imaging) OR
    • For potentially surgically curable metastatic disease OR
    • When image-guided liver-directed therapies are being considered


NOTE: When there are known or suspected liver metastases, Abdomen MRI is indicated in addition to PET

Small Bowel Adenocarcinoma (11)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging

Genitourinary Cancers
Bladder Cancer (12)

  • Initial Staging
    • Non-muscle invasive bladder cancer (NMIBC):
      • NOT indicated
    • Muscle-invasive bladder cancer (MIBC):
      • Indicated when prior imaging is suggestive of disease outside of the urinary tract (imaging does not need to be inconclusive)
  • Restaging
    • Non-muscle invasive bladder cancer (NMIBC):
      • NOT indicated
    • Muscle-invasive bladder cancer (MIBC):
      • With prior indeterminate imaging OR
      • Prior to surgical intervention (including cystectomy and potentially surgically curable metastatic disease)


Kidney Cancer (13)

  • Initial Staging
    • NOT indicated
  • Restaging
    • NOT Indicated

Prostate Cancer (14)

  • FDG PET
    • Initial Staging:
      • NOTindicated unless small cell variant is present on biopsy
    • Restaging:
      • NOTindicated unless small cell variant is present on biopsy
  • Special Tracer (PSMA) PET
    • Initial Staging (PSMA is the ONLY tracer appropriate for initial staging)
      • Indicated for ANY of the following:
        • Patients with very high risk, high risk, or unfavorable intermediate risk prostate cancer (see NOTE below) OR
        • With prior imaging that is indeterminate for either lymph node involvement or metastatic disease AND clarification of that finding will change treatment
          • Pelvis MRI (for surgical planning) is indicated in addition to PET for any above indication

NOTE: Any of the following criteria make PSMA PET indicated for initial staging:

    • Gleason score 8, 9 or 10
    • Primary pattern 4 (Gleason 4+3=7)
    • PSA > 20 AND Gleason score 3+3=6 or higher
    • PSA > 10 AND Gleason score 3+4=7
    • PSA > 10 AND Gleason score 3+3=6 AND clinical stage ≥ T2b
    • Clinical stage ≥ T3a AND Gleason score 3+3=6 or higher
    • Clinical stage ≥ T2b AND Gleason score 3+4=7 or higher
    • ≥ 50% of cores positive for cancer in a random, non-targeted prostate biopsy
    • Grade group 3, 4 or 5 disease

NOTE: When active surveillance was selected as the initial plan of care, PSMA PET is indicated when the disease progresses to very high risk, high risk or unfavorable intermediate risk using the most recent Gleason score/biopsy result, clinical stage and PSA level.

NOTE: A biopsy typically confirms the diagnosis of prostate cancer prior to PSMA PET. If the PSA is > 50, there is no clinical concern for infection AND there is an intent to treat the patient for prostate cancer without biopsy confirmation, PSMA PET can be approved.

    • Restaging (PSMA):
      • Post Radical Prostatectomy
        • Indicated for ANY of the following:
          • PSA persistence defined as detectable PSA (0.1ng/mL or greater) at 3 months post-operatively (only one level required) OR
          • Rising PSA on two or more occasions OR
          • PSA rise to > 0.1ng/mL if PSA was previously undetectable
            • NOTE: PSMA PET is indicated at biochemical recurrence but not to monitor rising PSA if that PET is negative
      • Post Radiation
        • Indicated with rising PSA above the nadir on two or more occasions (two separate levels above nadir required)
          • NOTE: PSMA PET is indicated at biochemical recurrence but not to monitor rising PSA if that PET is negative
      • Known Metastatic Disease
        • With prior indeterminate imaging OR
        • Discordance between imaging and PSA (i.e. rising PSA with stable imaging or stable PSA with progression on imaging)
      • Radioligand therapy (Lu-177/Pluvicto)
        • Indicated for ANY of the following:
          • When under consideration for radioligand therapy OR
          • Following completion of treatment with radioligand therapy OR
          • Discordance between imaging and PSA
  • Special Tracer (Axumin or Choline) PET
    • Initial Staging
      • Not indicated
    • Restaging
      • When the restaging criteria above are met (depending on the clinical scenario/prior treatment) AND
      • Prior indeterminate imaging is provided

NOTE: PET with Axumin or Choline can be considered on a case-by-case basis when a medical reason is given why that tracer would be used instead of PSMA

Penile Cancer (15)

  • Initial Staging
    • With prior indeterminate imaging OR
    • With suspected inguinal lymph node positive disease (based on imaging or exam)
  • Restaging
    • With prior indeterminate imaging OR
    • With suspected inguinal lymph node positive disease (based on imaging or exam)


Testicular Cancer (16)

  • Initial Staging
    • With prior indeterminate imaging when retroperitoneal dissection is under consideration and extent of disease needs clarification
  • Restaging
    • Non-seminoma:
      • NOT indicated
    • Pure seminoma:
      • With prior indeterminate imaging OR
      • With a residual mass > 3cm with a normal AFP and b-hcg AND it has been at least 6 weeks since completion of chemotherapy


NOTE: If this PET is equivocal or borderline for residual disease, an additional repeat PET >6 weeks later is appropriate to identify patients that can be safely observed without additional surgery. If a persistently FDG-avid mass is present on the second PET, resection or biopsy is recommended.

Gynecological Cancers
Cervical Cancer (including small cell neuroendocrine carcinoma of the cervix (NECC)) (17)

  • Initial Staging
    • Indicated
      • Pelvis MRI is indicated in addition to PET
  • Restaging
    • Indicated
  • Surveillance
    • Indicated for stage III or higher in the first 2 years following treatment

Uterine Sarcoma (18)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging

Endometrial Cancer (18)    

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging

Gestational Trophoblastic Neoplasia (19)

  • Initial Staging
    • With prior indeterminate imaging OR
    • Potentially surgically curable metastatic disease
  • Restaging
    • With prior indeterminate imaging OR
    • Potentially surgically curable metastatic disease OR
    • At completion of chemotherapy when hCG is not a reliable marker
  • Surveillance
    • Every 6-12 months for up to 3 years post completion of treatment when hCG is not a reliable marker

Ovarian, Fallopian Tube, and Primary Peritoneal Cancer (20)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging (including discordance between tumor markers and imaging)

Vulvar Cancer (21)

  • Initial Staging
    • Prior indeterminate imaging OR
    • If > T2 tumor (extension beyond vulva/perineum) OR
    • When sentinel lymph node biopsy is positive OR
    • When metastases are suspected
  • Restaging
    • Prior indeterminate imaging OR
    • Once 3-6 months after completion of primary therapyOR
    • When recurrence or metastatic disease is suspected

Head & Neck Cancer (22)

  • Initial Staging
    • Indicated
      • Neck CT (or MRI) AND CT (or MRI) of the primary site of disease are indicated in addition to PET
  • Restaging
    • Indicated
      • Neck CT (or MRI) AND CT (or MRI) of the primary site of disease are indicated in addition to PET
      • If the end of therapy PET demonstrates possible residual disease, one additional PET is appropriate > 6 weeks after end-of-therapy PET as it may help identify those patients who can be safely observed without additional cancer-directed treatment

Leukemias & Lymphomas
Acute Lymphoblastic Leukemia (ALL) (Pediatric and Adult) (23,24)

  • Initial Staging
    • For lymphomatous extramedullary disease (on exam or prior conventional imaging)
  • Restaging
    • For lymphomatous extramedullary disease (on exam or prior conventional imaging)

Acute Myeloid Leukemia (AML) (Pediatric and Adult) (25)

  • Initial Staging
    • If suspected extramedullary involvement (myeloid sarcoma) (on exam or prior conventional imaging)
  • Restaging
    • If suspected extramedullary involvement (myeloid sarcoma) (on exam or prior conventional imaging)

B-Lymphoblastic Lymphoma (Adult) (26)

  • Initial Staging
    • Indicated
      • Brain MRI is indicated in addition to PET
  • Restaging
    • Indicated

B-Lymphoblastic Lymphoma (Pediatric) (27)

  • Initial Staging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET
  • Restaging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET

NOTE: This portion of the guideline should be applied to patients treated at a pediatric institution on a pediatric protocol which can include young adults into their 20's.

Burkitt Lymphoma (Adult) (26)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

Burkitt Lymphoma (Pediatric) (27)

  • Initial Staging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET
  • Restaging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET

NOTE: This portion of the guideline should be applied to patients treated at a pediatric institution on a pediatric protocol which can include young adults into their 20's.
 

Castleman's Disease (26)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL) (28)

  • Initial Staging
    • For suspected high-grade transformation OR
    • To guide biopsy with prior indeterminate imaging
  • Restaging
    • With accelerated CLL OR
    • To guide biopsy with prior indeterminate imaging

Chronic Myeloid Leukemia (CML) (29)

  • Initial Staging
    • NOT Indicated
  • Restaging
    • NOT Indicated

Diffuse Large B Cell Lymphoma (Adult) (26)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated
  • Surveillance
    • When a site of disease was previously visualized on a PET Scan but not conventional imaging, PET is indicated every 6 months for 2 years
       

Diffuse Large B Cell Lymphoma (Pediatric) (27)

  • Initial Staging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET
  • Restaging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET

NOTE: This portion of the guideline should be applied to patients treated at a pediatric institution on a pediatric protocol which can include young adults into their 20's.

Follicular lymphoma (26)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated
  • Surveillance
    • When a site of disease was previously visualized on a PET Scan but not conventional imaging, PET is indicated every 6 months for 2 years

Mantle cell lymphoma (26)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

Hodgkin Lymphoma (Pediatric and Adult) (30,31)

  • Initial Staging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET
  • Restaging
    • Indicated
      • Dedicated CT scans of the original sites of disease are indicated in addition to PET
        • One repeat PET is appropriate if the end of treatment PET was positive (Deauville Score 4-5)

Kaposi Sarcoma (32)

  • Initial Staging
    • If concerns for coexisting Kaposi sarcoma-associated herpesvirus (KSHV) associated inflammatory cytokine syndrome (KICS), multicentric Castleman disease, or KSHV+ lymphoma
  • Restaging
    • Not Indicated

Post-Transplant Lymphoproliferative Disease (26)

  • Initial Staging
    • Indicated
      • Brain MRI is indicated in addition to PET
  • Restaging
    • Indicated

Primary Mediastinal Large B-Cell Lymphoma (Pediatric) (27)

  • Initial Staging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET
  • Restaging
    • Indicated
      • Neck CT, Chest CT AND Abdomen and Pelvis CT are indicated in addition to PET

NOTE: This portion of the guideline should be applied to patients treated at a pediatric institution on a pediatric protocol which can include young adults into their 20's.
 

T Cell Lymphomas (33)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

NOTE: This includes the following types of T-cell lymphoma: PTCL-NOS, Enteropathy- associated T-cell lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), ALCL ALK positive, ACLC ALK negative, Angioimmunoblastic T-cell lymphoma (AITL), follicular helper T-cell lymphoma, angioimmunoblastic type nodal TFH cell lymphoma, Follicular T-cell lymphoma, Breast Implant-Associated ALCL, T Cell Prolymphocytic Leukemia, T-Lymphoblastic lymphoma, Hepatosplenic T cell lymphoma, Extranodal NK/T-cell lymphoma


Waldenstrom Macroglobulinemia/Lymphoplasmacytic Lymphoma (34)

  • Initial Staging
    • NOT Indicated
  • Restaging
    • NOT Indicated

Liver & Hepatobiliary Cancers
Ampullary Adenocarcinoma (35)

  • Initial Staging
    • With prior indeterminate imaging OR
    • If high-risk features are present (markedly elevated CA 19-9 or CEA, large primary tumors, large regional lymph nodes, excessive weight loss and/or extreme pain)
  • Restaging
    • With prior indeterminate imaging OR
    • For pre-surgical evaluation

Biliary Tract Cancers (36)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging

Hepatocellular Carcinoma (37)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging

YTTRIUM-90 (Y90)
Y90 PET SCAN: Indicated when performed immediately after treatment of liver malignancy (primary or metastatic). The Y90 treatment is also the tracer for this and PET is performed within 24 hours of treatment (while Y90 is still detectible) to confirm the final distribution of the Y90. PET.

Lung Cancers
Non-Small Cell Lung Cancer (38)

  • Initial Staging
    • Indicated
      • Brain MRI is indicated in addition to PET
  • Restaging
    • Indicated for ANY of the following:
      • Pre-surgical evaluation OR
        • Chest CT is indicated in addition to PET
      • Suspected or confirmed recurrence/progression OR
        • Brain MRI is indicated in addition to PET
      • Indeterminate findings on conventional imaging OR
      • End of treatment evaluation

Small Cell Lung Cancer (39)

  • Initial staging (all patients)
    • Indicated if needed to clarify extent of disease
  • Restaging
    • With prior indeterminate imaging OR
    • For radiation planning

Lung Nodules
When a lung nodule is seen on low dose CT or standard Chest CT without known malignancy), PET is indicated for ANY of the following:

  • If the solid component of the dominant nodule (either solitary or clearly dominant) is 

8mm OR

  • If there is a part solid/mixed nodule with the solid component 6 mm or larger OR
  • If there is a mixed nodule (i.e., ground glass and solid nodule) with the solid

component of the nodule ≥ 4mm on LDCT when there has been EITHER

    • Interval growth of the solid component of at least 1.5mm OR
    • Interval development of a new mixed nodule with the solid nodule component 

4mm

Neuroendocrine & Adrenal Tumors (40)
Adrenocortical Carcinoma

  • FDG PET
    • Adrenal (other than pheochromocytoma/paraganglioma)
      • Initial Staging:
        • Indicated when conventional imaging and biochemical evaluation are highly suggestive of adrenocortical carcinoma
      • Restaging:
        • With prior indeterminate imaging

NOTE: Features of an adrenal mass on conventional imaging that are suspicious for adrenocortical carcinoma (ACC) include: size > 4 cm, homogenous mass with irregular margins and/or local invasion. If there is no history of another primary malignancy and these features are present on imaging, then PET is reasonable. If there is a history of another primary tumor and a metastasis is suspected, biopsy should be done first to determine tissue type. A biochemical evaluation is also done to evaluate for other tumor types (such as pheochromocytoma) for which a different tracer (such as dotatate) may be more appropriate.

Paraganglioma and Pheochromocytoma

  • Special Tracer SSTR (Dotatate) PET
    • Initial Staging
      • Indicated when there is a high clinical suspicion based on imaging and biochemical evaluation prior to biopsy OR
      • For biopsy proven disease
    • Restaging
      • Indicated when progression or recurrence is known or suspected (based on labs and/or conventional imaging) OR
      • SSRT directed therapy is being considered OR
      • With prior indeterminate imaging
  • FDG PET
    • Initial Staging
      • If negative initial staging SSTR PET
    • Restaging
      • Prior indeterminate imaging OR
      • With bone-dominant disease OR
      • If FDG PET positive at diagnosis AND progression or recurrence is known or suspected (based on labs and/or conventional imaging)

Well-Differentiated Neuroendocrine Tumors (NET)
Special Tracer SSTR (Dotatate) PET

  • Initial Staging:
    • Indicated
      • Abdomen MRI (liver) is indicated in addition to PET
  • Restaging:
    • With prior indeterminate imaging OR
    • With symptoms, laboratory or imaging findings of progression OR
    • When considering SSTR-directed therapy
      • Abdomen MRI (liver) is indicated in addition to PET for all restaging indications

FDG PET

  • Initial Staging:
    • Indicated for high-grade well-differentiated NET AND
    • With a high Ki67 (≥ 55%) AND
    • Negative initial staging SSTR PET
      • Abdomen MRI (liver) is indicated in addition to PET
  • Restaging:
    • Indicated when there is prior indeterminate imaging ORprogression (see above)

AND either of the following:

      • Recent negative SSTR PET OR
      • Prior positive FDG PET
        • Abdomen MRI (liver) is indicated in addition to PET for all restaging indications

Poorly Differentiated Neuroendocrine Tumors

  • FDG PET
    • Initial Staging
      • Indicated
        • Abdomen MRI (liver) is indicated in addition to PET
  • Restaging
    • With prior indeterminate imaging OR
    • With symptoms, laboratory or imaging findings of progression
      • Abdomen MRI (liver) is indicated in addition to PET for both restaging indications
  • Special Tracer SSTR (Dotatate) PET
    • Initial Staging
      • NOT Indicated
    • Restaging
      • NOT Indicated

NOTE: This includes large cell neuroendocrine carcinoma of the lung, mixed neuroendocrine tumors, extra-pulmonary small cell carcinoma (i.e. primary site of disease is not in the lung). See small cell lung cancer for primary site of disease in the lung. See cervical cancer for primary site of disease in the cervix.
 

Non-Malignant Disease
Dementia (41,42,43)

  • Special Tracer PET
    • Amyloid PET for evaluation for mild cognitive impairment or dementia in the following situations:
      • Detection of early Alzheimer's disease OR
      • Differentiation between Alzheimer's, dementia with Lewy body disease (DLB) and frontotemporal lobal degeneration (FTD) OR
      • Assessment for the presence of beta amyloid plaque in Alzheimer’s disease

when being considered for treatments that target beta-amyloid plaque

AND ALL the following criteria are met (criteria apply to ANY of the above 3 indications):

      • Brain MRI is insufficient or indeterminant AND
      • Objective measures demonstrate objective impairment (MMSE/MoCA < 26 or mild cognitive impairment on neuropsychological testing) AND
      • Full lab evaluation (thyroid function tests, CBC, CMP including LFTs and B12) has been completed and if abnormal, have been treated and cognitive difficulty persists AND
      • Medication side effects(44) and medical causes, such as vascular or traumatic or inflammatory etiologies have been excluded


NOTE: Brain CT is an alternative to brain MRI when MRI is contraindicated or cannot be performed for detection and differentiation but NOT for treatment planning as MRI is a prerequisite to beta-amyloid targeted treatment

Sarcoidosis

  • Known sarcoidosis:
    • ONLY if conventional testing (CXR, CT and inflammatory serology) are indeterminate for known sarcoid to determine:
      • If treatment might be helpful OR
      • Extent of disease, if it will potentially change management OR
      • Response to treatment
  • Suspected sarcoidosis:
    • To determine most suitable site to biopsy

Vasculitis

  • In limited circumstances for patients with known vasculitis, PET is indicated after conventional imaging (MRA/CTA/MR/CT) is insufficient to determine treatment

Other Malignancies
Castleman's Disease (26)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

Histiocytic Neoplasms (45)

  • Langerhan's cell histiocytosis, Erdheim Chester disease, Rosai-Dorfman disease
    • Initial Staging
      • Indicated
  • Restaging
    • Indicated
  • Surveillance
    • Every 3-6 months for 2 years then annually

Melanoma: Uveal (46)

  • Initial Staging
    • NOT indicated
  • Restaging
    • NOT indicated

Merkel Cell Carcinoma (47)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

Mesothelioma: Peritoneal (48)

  • Initial Staging
    • Indicated
  • Restaging
    • Indicated

Mesothelioma: Pleural (49)

  • Initial Staging
    • Indicated
      • Chest CT is indicated in addition to PET
  • Restaging
    • Indicated
      • Chest CT is indicated in addition to PET

NOTE: The evaluation of recurrent pleural effusion and/or pleural thickening includes CT chest, thoracentesis and pleural biopsy. The diagnostic sensitivity of this investigation is 70- 75%. If the first biopsy is non-diagnostic, there is a higher chance that subsequent biopsies will be non-diagnostic, thus a PET to guide subsequent biopsy is reasonable in this situation.

Neuroblastoma (50)

  • Initial Staging
    • Indicated when tumors are not avid on MIBG or there are discordant findings between MIBG and anatomic imaging
      • Due to the complexity of these tumors and the young age of patients, multiple overlapping imaging studies and modalities are often necessary in addition to PET.
      • Neuroblastoma tumors often encase vasculature, vascular imaging is appropriate if requested in addition to standard cross-sectional imaging and PET.
  • Restaging
    • Indicated when FDG PET was used for initial staging or if MIBG has become indeterminate or discordant
      • Due to the complexity of these tumors and the young age of patients, multiple overlapping imaging studies and modalities are often necessary in addition to PET.
      • Neuroblastoma tumors often encase vasculature, vascular imaging is appropriate if requested in addition to standard cross-sectional imaging and PET.
  • Surveillance
    • If PET is used for functional imaging evaluation in place of MIBG during treatment, surveillance PET is appropriate every 3-6 months for 1 year, then every 6 months for 1 year, then annually
      • Due to the complexity of these tumors and the young age of patients, multiple overlapping imaging studies and modalities are often necessary in addition to PET.


NOTE: Functional imaging with Iodine 123 (123I-MIBG) is routinely used as the standard functional imaging modality in this disease given the high specificity and sensitivity to identify metastatic disease.


Occult Primary (51)

  • Initial Staging
    • With prior indeterminate imaging
  • Restaging
    • With prior indeterminate imaging

NOTE: The typical evaluation for a suspected metastatic malignancy with an unknown primary includes CT of the Chest, Abdomen and Pelvis AND a biopsy of the site of disease.


Post Transplant Lymphoproliferative Disorder (PTLD) (26)

  • Initial Staging
    • Indicated when the diagnosis is made OR
    • If suspected based on abnormal physical exam, abnormal imaging or abnormal labs (i.e., significantly elevated or rising viral titers)
  • Restaging
    • Indicated

Thymomas & Thymic Carcinomas (52)

  • Initial Staging:
    • Indicated
  • Restaging:
    • Indicated

Thyroid Carcinoma (53)
Papillary, Follicular, Oncocytic and Poorly Differentiated:

  • Initial Staging:
    • NOT Indicated
  • Restaging Following Total/Completion Thyroidectomy and/or Radioiodine Ablation (RAI) for ANY of the following:
    • With known or suspected metastases (based on laboratory or imaging findings)

ANDI-123/131 is negativeOR

    • With rising or new Tg Antibody OR
    • Oncocytic thyroid cancer following thyroidectomy if ANY of the following are present:
      • Tumor > 2 cm
      • ≥ 1 focus of vascular invasion
      • Any positive lymph node (≥ cN1)
      • Gross extension outside thyroid
      • Positive margin
      • Postop Tg ≥ 1 ng/mL
  • Recurrence:
    • Indicated when recurrence is suspected based on laboratory or imaging findings AND
    • I-123/131 is negative (or was previously negative in the setting of known disease)

Anaplastic or De-Differentiated:

  • Initial Staging:
    • Indicated
  • Restaging:
    • Indicated

Medullary:

  • Special Tracer SSTR (dotatate) PET:
    • Initial Staging:
      • Indicated
    • Restaging:
      • Indicated when tumor markers (calcitonin and/or CEA) are rising AND

conventional imaging is negative

    • Recurrence:
      • Indicated when tumor markers (calcitonin and/or CEA) are rising AND

conventional imaging is negative

  • FDG PET
    • Initial Staging:
      • NOT indicated
    • Restaging:
      • NOT indicated

Wilms Tumor (54)

  • Initial Staging:
    • With prior indeterminate imaging
  • Restaging:
    • With prior indeterminate imaging


YTTRIUM-90 (Y90)
Y90 PET SCAN: Indicated when performed immediately after treatment of liver malignancy (primary or metastatic). The Y90 treatment is also the tracer for this and PET is performed within 24 hours of treatment (while Y90 is still detectible) to confirm the final distribution of the Y90 PET.


Pancreatic Cancer (55)

  • Initial Staging
    • With prior indeterminate imaging OR
    • Prior to neoadjuvant therapy and surgical resection is being considered OR
    • With any of the following high-risk features:
      • Borderline resectable disease
      • Markedly elevated CA19-9 (>180 U/ml)
      • Largely primary tumor/lymph nodes
      • Very symptomatic (jaundice, symptomatic gastric outlet obstruction, venous thromboembolism, extreme pain and excessive weight loss)
  • Restaging
    • With prior indeterminate imaging OR
    • For pre-surgical evaluation

Plasma Cell Dyscrasias
MGUS (56)

  • Initial Staging
    • NOT Indicated
  • Restaging
    • NOT Indicated


NOTE: Whole Body Low Dose CT is used rather than PET - see CG_063 (Unlisted Study) under Unlisted CT


Multiple Myeloma (56)

  • Initial Staging:
    • Indicated
  • Restaging on Active Treatment (including following Bone Marrow Transplant (BMT) or CAR-T treatment):
    • Indicated

NOTE: For individuals receiving Bone Marrow Transplant (BMT) or CAR-T treatment PET is indicated prior to treatment and at 1 month, 3 months AND 6 months post-treatment

  • Surveillance: Indicated annually (indefinitely)

Smoldering Myeloma (56)

  • Initial Staging:
    • Indicated
  • Restaging:
    • Indicated when there are symptoms and/or laboratory findings to suggest progression

Solitary Plasmacytoma (56)

  • Initial Staging:
    • Indicated
  • Restaging:
    • Indicated
  • Surveillance:
    • When initial staging or restaging on treatment was with PET, PET is indicated during surveillance at the following intervals:
      • 3 months after completion of treatment then
      • Annually up to 5 years

Systemic Light Chain Amyloidosis (57)

  • Initial Staging:
    • Indicated
  • Restaging:
    • Indicated

Skin Cancers
Basal Cell Skin Cancer (58)

  • Initial Staging
    • NOT Indicated
  • Restaging
    • NOT Indicated

Melanoma: Cutaneous (59)

  • Initial Staging
    • Indicated if considering systemic treatment with immunotherapy (typically stage IIB or higher)
  • Restaging
    • Indicated for patients receiving systemic treatment with immunotherapy OR
    • For workup of local satellite/in-transit and/or nodal recurrences
  • Surveillance
    • For select patients with primary disease in the extremities OR previous disease only able to be seen on PET, surveillance imaging is indicated in place of CT scans every 3-12 months for 2 years, then every 6-12 months for 3 years

Squamous Cell Skin Cancer (60)

  • Initial Staging
    • Indicated when lymph node or metastatic site has been biopsied and shows disease spread
  • Restaging
    • Indicated when lymph node or metastatic site has been biopsied and shows disease spread

Rationale
BACKGROUND

Definitions

  • INITIAL STAGING refers to imaging that is performed after the diagnosis of cancer is made, and generally before any treatment.
  • RESTAGING refers to imaging that is performed during treatment to determine response to treatment/monitor treatment, a single end of treatment study done within 6 months of completion of treatment, or when there is clinical concern for recurrence (i.e., new imaging, new signs, rising labs/tumor markers or symptoms relative to type of cancer and entire clinical picture). Recurrence is not required to be biopsy proven.
    • Imaging is typically performed 6-12 weeks after surgery
    • Imaging is typically performed 12 weeks after radiation (to avoid false positive findings that can be caused by treatment changes or healing).
      • PET/CT can be performed 1 - 3 weeks after neoadjuvant chemotherapy or neoadjuvant chemoradiation if done for presurgical planning to evaluate for distant metastatic disease or to evaluate known metastatic disease located in areas separate from the site(s) being radiated.
    • When an end of treatment PET scan performed at an appropriate post-treatment interval (see above) shows indeterminate findings, one additional repeat PET in 3 months is indicated.
    • Common exceptions are noted in the guideline. If not noted in the guideline, a valid clinical reason explaining why the interval needs to be shorter is needed.
  • TREATMENT includes chemotherapy, immunotherapy, radiation, as well as patients on “maintenance therapy” who have known, or existing, metastatic disease being controlled by this treatment. Allogenic bone marrow transplant and CART T-cell therapy should be considered ‘active’ treatment for at least 6 months after infusion/transplant and as such can be approved at 30 days, 100 days, and 6 months after the most recent infusion.
  • INDETERMINATE IMAGING:
    • When indeterminate imaging is required prior to PET, this typically means conventional imaging (CT, MRI, OR Nuclear Medicine Scan (i.e. bone scan)) shows a finding that is indeterminate AND clarification of that finding with PET will potentially change management.
    • The information provided should clearly explain why conventional imaging is insufficient to determine treatment or management.
    • Biopsy guidance:
      • To determine the best location to biopsy either within a tumor that has necrosis on imaging OR
      • To determine the best location to biopsy when there are findings on standard imaging that would require a significantly invasive procedure (such as laparoscopic or open surgical procedures) AND malignancy is highly suspected based on imaging.
    • When previous conventional imaging has been shown to be negative, yet a concurrent PET scan was positive (i.e. conventional imaging was falsely negative/ missed lesions seen on PET), we do not require repeat conventional imaging prior to every subsequent PET because conventional imaging was already shown to be insufficient. Appropriate interval criteria should still be met.

Further Information
PET with CONTRAINDICATIONS to contrasted CT AND MRI: The inability to image with contrasted conventional imaging includes contraindications to both CT (such as chronic renal failure with GFR < 30 OR significant iodinated contrast allergy) AND to MRI (such as gadolinium allergy, implanted device that is not MRI compatible, or GFR <40). When requested for surveillance due to the above reasons, PET can be considered during the time that the highest risk of recurrence for that cancer (typically the first two years after completion of treatment).

PET/MR: When PET/MR can be considered per the guideline, if the criteria are met for PET for that cancer and the plan is to do a PET/MR rather than a PET/CT, the PET scan can be approved. In the same way a separate approval for total body CT is not needed when a PET/CT is requested, a separate approval for the total body MR is not typically needed.
However, until a PET/MR CPT code is implemented, unlisted MR in addition to PET can be considered on a case-to-case basis.
 

References

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  1. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Bone Cancer Version 2.2024. National Comprehensive Cancer Network®. 2024.
  2. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 2.2024. National Comprehensive Cancer Network®. 2024.
  3. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Central Nervous System Cancers Version 1.2023. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Central Nervous System Cancers Version 1.2023. 2023.
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  5. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Colon Cancer Version 2.2024. National Comprehensive Cancer Network®. 2024.
  6. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Esophageal and Esophagogastric Junction Cancers Version 3.2024. National Comprehensive Cancer Network®. 2024.
  7. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Gastric Cancer Version 1.2024. National Comprehensive Cancer Network®. 2024.
  8. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Gastrointestinal Stromal Tumors Version 1.2024. National Comprehensive Cancer Network®. 2024.
  9. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Rectal Cancer Version 2.2024. National Comprehensive Cancer Network®. 2024.
  10. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Small Bowel Adenocarcinoma Version 3.2024. National Comprehensive Cancer Network®. 2024.
  11. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Bladder Cancer Version 4.2024. National Comprehensive Cancer Network®. 2024.
  12. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Kidney Cancer Version 3.2024. National Comprehensive Cancer Network®. 2024.
  13. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Prostate Cancer Version 4.2024. National Comprehensive Cancer Network®. 2024.
  14. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Penile Cancer Version 1.2024. National Comprehensive Cancer Network®. 2023.
  15. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Testicular Cancer Version 1.2024. National Comprehensive Cancer Network®. 2024.
  16. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Cervical Cancer Version 3.2024. National Comprehensive Cancer Network®. 2024.
  17. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Uterine Neoplasms Version 2.2024. National Comprehensive Cancer Network®. 2024.
  1. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Gestational Trophoblastic Neoplasia Version 1.2024. National Comprehensive Cancer Network®. 2023.
  2. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Ovarian Cancer Continue Including Fallopian Tube Cancer and Primary Peritoneal Cancer Version 2.2024. National Comprehensive Cancer Network®. 2024.
  3. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Continue NCCN.org Vulvar Cancer Version 4.2024. National Comprehensive Cancer Network®. 2024.
  4. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Head and Neck Cancers Version 4.2024. National Comprehensive Cancer Network®. 2024.
  5. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Lymphoblastic Leukemia Version 4.2023. National Comprehensive Cancer Network®. 2024.
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  8. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) B-Cell Lymphomas Version 2.2024. National Comprehensive Cancer Network®. 2024.
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  10. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Continue Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma Version 3.2024. National Comprehensive Cancer Network®. 2024.
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  14. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Kaposi Sarcoma Version 1.2024. National Comprehensive Cancer Network®. 2023.
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  17. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Ampullary Adenocarcinoma Version 1.2024. National Comprehensive Cancer Network®. 2023.
  18. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Biliary Tract Cancers Version 2.2024. National Comprehensive Cancer Network®. 2024.
  19. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Hepatocellular Carcinoma Version 1.2024. National Comprehensive Cancer Network®. 2024.
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  7. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Histiocytic Neoplasms Version 1.2024. National Comprehensive Cancer Network®. 2024.
  8. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Melanoma: Uveal Version 1.2024. National Comprehensive Cancer Network®. 2024.
  9. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Merkel Cell Carcinoma Version 1.2024. National Comprehensive Cancer Network®. 2023.
  10. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Mesothelioma: Peritoneal Version 1.2024. National Comprehensive Cancer Network®. 2023.
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  14. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Thymomas and Thymic Carcinomas Version 1.2024. National Comprehensive Cancer Network®. 2023.
  15. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Thyroid Carcinoma Version 2.2024. National Comprehensive Cancer Network®. 2024.
  16. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Wilms Tumor (Nephroblastoma) Version 1.2023. National Comprehensive Cancer Network®. 2023.
  17. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Pancreatic Adenocarcinoma Version 2.2024. National Comprehensive Cancer Network®. 2024.
  18. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Multiple Myeloma Version 4.2024. National Comprehensive Cancer Network®. 2024.
  19. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Systemic Light Chain Amyloidosis Version 2.2024. National Comprehensive Cancer Network®. 2023.
  20. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Basal Cell Skin Cancer Version 3.2024. National Comprehensive Cancer Network®. 2024.
  1. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Melanoma: Cutaneous Version 2.2024. National Comprehensive Cancer Network®. 2024.
  2. NCCN. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) —Squamous Cell Skin Cancer Version 1.2024. National Comprehensive Cancer Network®. 2023.
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  4. State of Arkansas. HB1357 - TO CONTINUE CARE FOR THE PROTECTION OF CANCER SURVIVORS. Arkansas State Legislature 93rd GeneralAssembly. 2021.

Coding Section

Codes

Number

Description

CPT 

78811

Positron emission tomography (pet) imaging; limited area (eg, chest, head/neck)

 

78812

Positron emission tomography (pet) imaging; skull base to mid-thigh

 

78813

Positron emission tomography (pet) imaging; whole body

 

78815

positron emission tomography (pet) with concurrently acquired computed tomography (ct) for attenuation correction and anatomical localization imaging; skull base to mid-thigh                                                              

 

78816

Positron emission tomography (pet) with concurrently acquired computed tomography (ct) for attenuation correction and anatomical localization imaging; whole body                                                                             

Type of Service

 

 

Place of Service

 

 

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.  

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross and Blue Shield Association technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association.  All Rights Reserved" 

History From 2024 Forward     

11/11/2024 Annual review, policy updated for clarity and consistency, grouping similar cancer types together, revised indeterminate imaging and contraindications to conventional imaging, adding the use of Amyloid PET for early Alzheimer’s updating surveillance PET, updating multiple different cancers to be consistent with national guidelines. Also updating rationale and references.
06/03/2024 Corrected formatting issue. No other changes
01/01/2024 New Policy
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