Oncologic Applications of PET Scanning - CAM 759

Policy
GENERAL NOTES:
ADULT AND PEDIATRIC MALIGNANCIES (NCCN, 2019, 2020): 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.

FDG-PET/CT (fluorodeoxyglucose-positron emission tomography)

LUNG NODULE seen on LDCT or CT+ contrast

  • Solid Component of Dominant Nodule ≥ 8mm or Part solid/mixed nodules with the solid component 8 mm or larger
  • Mixed nodule (i.e., ground glass and solid nodule) with solid component of the nodule ≥ 4mm on LDCT when there has been
    • Interval growth of the solid component of at least 1.5mm on subsequent LDCT scans OR
    • Interval development of a new mixed nodule on subsequent LDCT with the solid nodule component ≥ 4mm

USEFUL DEFINITIONS (to aid in using the following table(s))

  • INITIAL STAGING refers to imaging that is performed AFTER the diagnosis of cancer is made, and generally before any treatment.
  • RESTAGING includes scans that are either needed during active treatment* (subsequent treatment strategy**) to determine response to treatment, within 6 months after the end 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)
  • *ACTIVE TREATMENT includes traditional chemotherapy, immunotherapy, radiation, as well as patients on “maintenance therapy” who have known, or existing, metastatic disease being held in check 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.
  • **SUBSEQUENT TREATMENT STRATEGY
    • For restaging or monitoring response during active treatment (including immunotherapy), and/or a single evaluation after completion/cessation of therapy. The interval should ideally‡ be 6 – 12 weeks after surgery, and 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.

‡NOTE: A valid clinical reason explaining why the interval needs to be shorter than ideal must be present.

  • INCONCLUSIVE IMAGING see Background section at end of guidelines
  • SURVEILLANCE PET is generally not approvable. Surveillance means no active treatment, no current suspicion of recurrence and occurs 6 months or more after completion of treatment. Possible exceptions† where PET “may be considered” for surveillance:
    • Ewing’s
    • Osteosarcoma
    • Breast (Stage 4)
    • Cervical (Stage 2 – 4)
    • Diffuse Large B Cell Lymphoma when disease was only seen previously on PET
    • Melanoma (Stage 2b – 4)
    • Myeloma/plasmacytoma (ideally use same type imaging as was used in initial dx, up to 5 yrs after the diagnosis of plasmacytoma)
    • Seminoma (Stage 2b, 2c and 3)

†NOTE: These cases would need to include a clinical reason why PET is needed (i.e., being considered), rather than conventional imaging (CT, MRI, bone scan). Generally, this would be accepted only when ordered by the treating oncologist or clearly at their recommendation (not as routine follow-up ordered by PCP).

ONCOLOGICAL INDICATIONS FOR FDG PET (SEE SPECIAL TRACERS SECTIONS FOR INDICATIONS OTHER TRACERS)   

CANCER TYPE

INITIAL STAGING

RESTAGING

Adrenal (other than pheochromocytoma/ paraganglioma)

Not Indicated

Not Indicated

AIDS-related Kaposi Sarcoma

with prior inconclusive imaging

Not Indicated

Acute Lymphoblastic Leukemia (ALL)

 lymphomatous extramedullary disease

lymphomatous extramedullary disease

Acute Myelogenous Leukemia (AML)

If suspected extramedullary involvement

If suspected/known extramedullary involvement

Anal

with prior inconclusive imaging (can be done with PET (PET/CT or PET/MR‡‡ if available))

with prior inconclusive imaging

Basal Cell Carcinoma (BCCof the skin)

Not Indicated

Not Indicated

Bladder

Muscle invasive only, with prior inconclusive imaging

Metastatic only, with prior inconclusive imaging

Breast

Indicated for stage IIb and above (if only T and N are provided, this equates to T3 (tumor > 50mm); or T4 (tumor of any size with direct extension to chest wall and/or skin); or N2 (>3 axillary LN, ipsilateral internal mammary node); or the combination of T2 (tumor >20mm but <50mm) plus N1 (any positive lymph node involvement)

with prior inconclusive imaging OR if initial stagging was done with PET

Cervical

Indicated (can consider PET/MR‡‡ if available)

Indicated

Chordoma

with prior inconclusive imaging

Not Indicated

CHOLANGIOCARCINOMA

with prior inconclusive imaging

with prior inconclusive imaging

Chondrosarcoma (bone)

Not Indicated

Not Indicated

Colorectal

with prior inconclusive imaging (PET/CT indicated if potentially surgically curable M1 disease, when considered for image\u0002guided liver directed therapies)                                                        

with prior inconclusive imaging

Endometrial

with prior inconclusive imaging

with prior inconclusive imaging

ESOPHOGEAL and EGJ (esophagogastric junction epicenter < 2m into stomach)                          

Indicated

Indicated

Ewing Sarcromas- osseous

Indicated (all ages)

Patients <30 yrs old: Indicated Patients >30 yrs old: when initial staging showed metastatic disease Or other signs (PE/imaging) worrisome for progression beyond localized disease

FALLOPIAN TUBE CANCER

with prior inconclusive imaging

with prior inconclusive imaging

Gallbladder

with prior inconclusive imaging

with prior inconclusive imaging

GASTRIC (include EGJ tumors with epicenter >2cm into stomach)

with prior inconclusive imaging or if radiation is being considered (Not indicated for T1N0M0 or M1)

with prior inconclusive imaging.

PET/CT is indicated for post radiation imaging

Gestational Trophoblastic Cancer

with prior inconclusive imaging

with prior inconclusive imaging

Head and neck (including mucosal melanoma of the head and neck)

Indicated

  • May be done in conjunction with a dedicated face/neck CT/MRI when surgery or radiation is planned

Indicated 

  • Can concurrently approve a Neck MRI and PET 3-4 months after definitive treatment in patients with locoregionally advanced disease or with altered anatomy.
  • PET should not be done earlier than 12 weeks after definitive treatment unless signs or symptoms of recurrence
  • If final PET/CT is equivocal or borderline for residual disease, a repeat PET/CT at > 6 weeks may help identify those that can be safelyobserved without additional surgery observed without additional surgery

Hepatocellular

with prior inconclusive imaging

with prior inconclusive imaging

LEUKEMIA (refer to specific types listed in table when possible)

If there is lymph node involvement (lymphomatous features), soft tissue and/or extramedullary involvement (myeloid sarcoma) and/or if forms “chloromas” (leukemia tumor balls)

If there is lymph node involvement (lymphomatous features), soft tissue and/or extramedullary involvement (myeloid sarcoma) and/or if forms “chloromas” (leukemia tumor balls)                                                           

Lung

  • Non-Small Cell
  • Limited stage small cell Stage I-III
    • Except T3/T4
  • Extensive small cell
    • Stage IV and T3 or T4 disease

Indicated

Indicated

Not indicated

Indicated

Indicated

Not indicated

LYMPHOCYTIC LEUKEMIA

  • Chronic (CLL) and Small (SLL)

For suspected high-grade transformation or to guide biopsy with prior inconclusive imaging 

with accelerated CLL or to guide biopsy with prior inconclusi e imaging (includes negative CT with rising tumor markers or if conventional imaging documents mets, If clearly considering resection)

Lymphoma (Non -Hodgkins and Hodgkins)

Indicated (can consider PET/MR‡‡)

Indicated (can consider PET/MR‡‡)

Melanoma (See Uveal melanoma below for indications)

only stage III, IV

only stage III, IV

Merkel Cell

Indicated

Indicated

Mesothelioma (pleural)

Indicated only prior to surgery for stage I-IIIA                                                                                 

Indicated only prior to surgery for stage I-IIIA

Multiple Myeloma

  • Smoldering myeloma (asymptomatic)
  • Active myeloma
  • Plasmacytoma

 

  • Indicated
  • Indicated
  • Indicated

 

  • Not indicated (unless labs suggest progression to active myeloma)
  • Indicated
  • Indicated

NEUROBLASTOMA 

Indicated when MIBG is negative, inconclusive, or there are discordant findings between MIBG and pathology 

Indicated when the FDG PET was used for initial staging 

NEUROENDOCRINE TUMORS\u0002NET UNDIFFERENTIATED/DE\u0002DIFFERENTIATED (including pheochromocytoma, paraganglioma, extrapulmonary large/small cell) 

Indicated if used after prior negative or inconclusive Ga68 Dotatate scan 

Indicated when FDG was used for initial staging, or when used after prior negative/inconclusive Ga68 Dotatate scan (or MIBG scan) OR after inconclusive conventional imaging 

Ovarian

with prior inconclusive imaging

 with prior inconclusive imaging

Occult primary  

with prior inconclusive imaging (can consider PET/MR‡‡)

with prior inconclusive imaging

Osteosarcoma

  • Osseous 

For patients >30 years old: Indicated when the prior bone scan is inconclusive or negative (i.e. the primary bone tumor is not seen on bone scan). PET can be approved in conjunction with MR of primary site

For patients <30 years old: Indicated 

For patients >30 yrs old: Indicated when disease is positive on prior FDG-PET or when there is inconclusive conventional imaging. PET can be approved in conjunction with MR of primary site

Indicated

Pancreatic

With prior inconclusive imaging ORwith any of the following high- riskfeatures:

  • borderline resectabledisease
  • markedly elevated CA19-9 >180 U/ml
  • large primary tumor/ lymph nodes
  • very symptomatic (jaundice, symptomatic gastric outlet obstruction, venous thromboembolism, extreme pain and excessive weight loss 

Not Indicated

 

Penile 

with prior inconclusive imaging 

with prior inconclusive imaging 

PERITONEAL CANCER (PRIMARY)

with prior inconclusive imaging 

with prior inconclusive imaging 

POST TRANSPLANT LYMPHOPROLIFERATIVE DISORDER (PTLD)

Indicated when the diagnosis is made OR if suspected based on abnormal PE, abnormal imaging or abnormal labs (i.e. significantly elevated or rising viral titers)

Indicated 

PROSTATE (FDG PET only) *See other PET tracer section below for prostate cancer* 

Not Indicated 

Not Indicated 

Renal 

Not Indicated 

Not Indicated 

Skin squamous cell 

with prior inconclusive imaging

Not Indicated 

Small bowel adenocarcinoma 

Not Indicated 

with prior inconclusive imaging 

Soft Tissue Sarcoma (including soft tissue/extraosseous Ewing sarcoma and soft tissue/extraosseous osteosarcoma)/ GIST/ Rhabdomyosarcoma) 

For patients >30 years old: with prior inconclusive imaging

For patients <30 years old: Indicated (does not require inconclusive conventional imaging)

For patients >30yrs old with prior inconclusive imaging

For patients <30 years old: Indicated (does not require inconclusive conventional imaging) 

Testicular 

  • Seminoma
  • Non seminoma

Not Indicated

Not Indicated 

with prior inconclusive imaging or residual mass >3cm or 6 weeks post chemotherapy (If final PET/CT is equivocal or borderline for residual disease PET/CT, a repeat PET/CT a > 6 weeks may help identify those that can be safely observed without additional surgery)

Not Indicated 

Thymoma and thymic cancer 

Indicated 

Indicated 

Thyroid

  • Papillary, follicular, Hurthle 

 

 

 

 

 

 

 

  • Anaplastic

 

  • Medullary

 

  • Not Indicated 

 

 

 

 

 

 

 

  • With prior inconclusive imaging
  • Not Indicated (see Dotatate indications below)

Indicated with the following 3 criteria:

  • A thyroidectomy and radioiodine ablation were done initially; AND
  • Serum thyroglobulin is >2 ng/ml (unstimulated or stimulated) OR there is a high anti- thyroglobulin antibody (anti-Tg Ab) >1 year after treatment AND
  • A Negative current I\u0002131/123 scan OR a Negative prior stimulated whole body I-131/ I-123 scan done at TG level similar to the current TG level (a current scan is needed if on radioiodine sensitizing medications)

With prior inconclusive imaging

with prior inconclusive imaging when calcitonin levels ≥ 150 pg/ml or CEA levels >5 ng/ml post-surgery with prior insufficient Dotatate scan

Uterine 

with prior inconclusive imaging 

with prior inconclusive imaging 

Uveal Melanoma 

Not Indicated 

With prior inconclusive imaging 

Vaginal 

Indicated 

Indicated 

Vulvar 

≥T2 or after prior inconclusive imaging 

Indicated 

 MISCELLANEOUS (NON-ONCOLOGIC) INDICATIONS FOR FDG PET (excluding brain and cardiac PET which have separate Guidelines)

CANCER TYPE INITIAL STAGING RESTAGING
CASTLEMAN’S DISEASE Indicated  Indicated

LANGERHANS CELL HISTIOCYTOSIS

  • Predominantly osseous disease
  • Non-osseous disease

 

  • Indicated
  • Not Indicated

 

  • Indicated
  • Not Indicated

OTHER (NON-FDG) PET TRACERS covered GA68-DOTATATE, GA68-DOTATOC and CU64-DOTATATE

CANCER TYPE INITIAL STAGING RESTAGING
CARCINOID EXTRAPULMONARY LARGE AND SMALL CELL MEN-1/MEN-2 SYNDOMES NEUROENDOCRINE TUMORS (NET) PHEOCHROMOCYTOMA PARAGANGLIOMA
  • Biopsy proven AND to determine eligibility for somatostatin receptor (SSR) therapy (such Lutetium, Octreotide, Sandostatin)

OR

  • Biopsy proven AND prior CT/ MRI has been or is reasonably expected to be insufficient for any the following reasons:  
    • to determine extent of treatment plan
    • to determine if candidate for invasive diagnostic/ therapeutic procedure
    • to determine optimal anatomic location for invasive procedure
  • (can consider PET/MR‡‡)
  • for restaging or monitoring response to active treatment, and/or evaluation for suspicion of recurrence due to new or changing signs/symptoms when CT/MR is negative but biomarkers are rising
  • PET/MR‡‡ can be considered with negative CT/MR and rising biomarkers
  • asymptomatic surveillance is not approvable 
MEDULLARY THYROID

Prior CT/ MRI insufficient to

  • Determine extent of treatment plan
  • Determine if candidate for invasive diagnostic/ therapeutic procedure
  • Determine optimal anatomic location for invasive procedure 
When calcitonin levels ≥150 pg/ml or CEA levels >5 ng/ml post-surgery 

F18 FLUCICLOVINE (AXUMIN®), PSMA TRACERS (such as F18 piflufolastat (Pylarify®) and GA68) and C11 CHOLINE

CANCER INITIAL STAGING  RESTAGING 

PROSTATE
(PET/CT or PET/MRI‡‡)

  • After a negative Axumin® PET, a subsequent PSMA PET is not covered until a repeat PSA (done at least 3 months later) shows a progressive rise
  • 11-Choline should be approved only if PSMA and/or Axumin® are not available. Order of preference typically would be PSMA, then Axumin®, then 11-Choline

Only PSMA (not Axumin® or Choline) is indicated for high risk defined as 1 or more of the following:

  • T3a or higher,
  • PSA>20,
  • Gleason Score* 8-10,
  • Grade Group* 4-5
  • Gleason Primary Pattern** 5
Pelvic MRI can be approved concurrently if needed for surgical planning 

For post-surgery/radiation with persistent or rising PSA (two separate PSA levels required) as below:

  • PSA <2 PMSA indicated and DOES NOT require prior conventional imaging
  • PSA<2 Axumin® indicated if prior bone scan and CT/MRI are negative or inconclusive
  • PSA>2 PSMA, Axumin® or Choline indicated if prior bone scan and CT/MRI are negative or inconclusive 

*Equivalent Scorings:

Grade Group Gleason Score Gleason Pattern
4 8

4+4
3+5
5+3

5 9 or 10

4+5
5+4
5+5

**The Primary Pattern refers to the 1st number in the Gleason Pattern 

‡‡NOTE: If PET/MR study is requested, there is no specific CPT Code for this imaging study and a Health Plan review will be required. 

  • *ACTIVE TREATMENT includes traditional chemotherapy, immunotherapy, radiation, as well as patients on “maintenance therapy” who have known, or existing, metastatic disease being held in check 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.

BACKGROUND  
Inconclusive Imaging includes the following:

  • Equivocal or ambiguous other prior standard imaging if results will change management
  • Biopsy guidance (e.g., tumors with necrosis)
  • High suspicion of metastases due to clinical or histopathological or laboratory considerations but with no evidence of metastases on standard initial staging
  • Clinical or laboratory disease progression with negative standard imaging
  • Contraindications to IV contrast, including allergy and chronic renal failure precluding MRI in a patient with a known or highly suspected malignancy
    • PET/CT may be indicated if CT cannot be performed due to significant iodinated contrast allergy or chronic renal failure AND MRI cannot be performed due to significant gadolinium contrast allergy or if renal failure with GFR < 30 (RSNA, 2018).
  • Evaluation for other distant metastases prior to surgical resection of limited metastases/local disease and otherwise negative prior standard imaging
  • Response to neoadjuvant therapy when CT/MR insufficient
  • Residual masses after completion of therapy
  • Target definition for radiation planning
  • If previous conventional imaging has been inconclusive, and it seems reasonable to expect that to still be the case, new conventional imaging is NOT required 

In situations where there is questionable disease in an area that requires significantly invasive procedures to obtain tissue (such as open surgical procedures), and malignancy is high on the radiographic differential diagnosis, it is reasonable and medically appropriate to attempt to gain as much information about diagnosis from imaging prior to subjecting the patient to tissue diagnosis that has real risk of morbidity/mortality.

Definition of Disease Progression: 
For any signs of progression, as noted below, that could not be confirmed by other imaging, PET/CT is needed. Findings concerning for progression of disease include:

  • Worsening of symptoms such as pain or dyspnea
  • Evidence of worsening or new disease on physical examination
  • Declining performance status
  • Unexplained weight loss
  • Increasing alkaline phosphatase, alanine aminotransferase (ALT), aspartate transaminase (AST), or bilirubin
  • Hypercalcemia
  • New radiographic abnormality or increase in the size of pre-existing radiographic abnormality
  • New areas of abnormality on functional imaging (e.g,, bone scan, PET/CT)
  • Increasing tumor markers (e.g., carcinoembryonic antigen (CEA), CA 15-3, CA27.29)

PET/CT also helps to differentiate active tumor from necrotic or inactive scar tissue, malignant from benign tissue, and recurrent tumor from nondescript benign changes. 

Positron emission tomography-Computed Tomography (PET/CT) is a rapidly developing and changing technology that is able to detect biochemical reactions, e.g., metabolism, or abnormal distribution of cell receptors within body tissues. A radioactive tracer is used during the procedure. Unlike other nuclear medicine examinations, PET/CT can measure metabolic activity of the cells of body tissues, providing information about the functionality and structure of the particular organ or tissue examined. PET/CT may also detect biochemical changes that help to evaluate malignant tumors and other lesions.

TYPICALLY, separate CT/MR scans being requested concurrently with a PET are not needed. There should be very few instances where separate studies are needed, and when this does happen, it is usually SITE-SPECIFIC. Most PET scanners now in use can "simultaneously" perform PET and CT (whether CT Attenuation or a Diagnostic CT). Contrast can be given for the CT portion of the PET/CT. A separate request for diagnostic CTs in addition to PET is therefore not needed. The ordering MDO can specify to the imaging provider details about what type of CT scan is desired to be done with the PET portion. "Exceptions" generally occur when CT is needed in a plane other than standard axial imaging (for example: coronal CT for facial bone imaging that might be needed for surgical reconstruction). Separate MRIs are likewise rarely needed, but are perhaps somewhat more frequently needed than additional, separate CTs, since MRI does allow multiple imaging planes and may provide additional information. When evaluating for these "exceptions", the reason additional separate imaging is needed should be clearly delineated before approval.

The degree of radioactive tracer uptake may indicate increased metabolism in the cells of body tissues or an abnormal distribution of cell receptors. Cancer cells may show increased radioactive tracer relative to tissue not involved with tumor. Radioactive tracer uptake is often higher in fast-growing tumors; PET/CT is often not as beneficial for slow growing tumors. Radioactive tracer uptake may occur in various types of active inflammation and is not specific for cancer. FDG is the most widely known and frequently requested radiotracer; however, the use of "special tracers" is a rapidly progressing field. These "special tracers" are typically somewhat specific to a certain cancer type due to their physiological properties. As such, a particularly careful review should be made when there is concern that a "special tracer" is needed or requested, regardless of whether the ST icon is present. If the notes clearly indicate the desired tracer (and guidelines are met for the tracer and cancer type), the case should be adjudicated according to the notes rather than the presence or absence of the ST icon. However, if the notes do not clearly indicate what tracer is requested, this needs to be clarified when there is discrepancy between notes and the ST icon (or lack thereof).

Patients with certain malignancies may benefit more from PET/MRI since it detects brain and liver metastases better when compared with PET/CT. NCCN does suggest consideration of PET/MR in some malignancies (see table for specific cancers), but not specifically replacing PET/CT. PET/MRI should only be considered for certain malignancies and in specific situations (such as when extensive travel would be needed, for pediatric cases, particularly those requiring sedation or when reasonably expect a need for multiple PET scans where radiation exposure from CT would be a significant factor). Typically, PET/CT should suffice; however, under some circumstances, with clear explanation of why PET/MR is preferred rather than PET/CT, PET/MR may be an appropriate study‡‡ (NCCN, 2020).  

Langerhans Cell Histiocytosis (Jessop, 2020; Daldrup-Link, 2001; Obert, 2017; Phillips, 2009) is the most common type of histiocytosis, with variable presentations and sites involvement. The osseous structures are the most common site of involvement. PET/CT is highly sensitive and specific for whole body evaluation as FDG is a metabolite of the histocyte cell and allows for a reproducible evaluation for response to effectiveness of treatment on restaging exams. Some studies suggest PET/CT may be more effective in detecting bone lesions compared with MRI and bone scans in assessing disease response as healing/treatment changes of bone lesions on conventional imaging maybe delayed. PET/CT is, however, not the modality of choice in assessing disease response of lung or brain lesions; in these scenarios, Chest CT (HRCT) and Brain MRI would be the test of choice, respectively.

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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 2014 Forward     

11/01/2021 

Annual review, adding statements regarding CAR-T therapy and medical necessity criteria for PTLD. Also updating description and references. 

01/26/2021

Updating annual review date. 

11/17/2020 

Annual review with major format revision to a table format. Also multiple policy revisions related to NCCN recommendation changes. Updating description and references. 

02/13/2020 

Annual review, no change to policy intent. Updating rationale and references. 

02/07/2019 

Major revision of content for clarity without change to policy intent. 

04/10/2018 

Interim review to add medical necessity verbiage for Axumin (fluciclovine F 18) and a statement directing readers to CAM 512 as it relates to reimbursement for radiopharmaceuticals related to PET scanning. 

03/15/2018

Annual review, policy revised to indicate the following: "Additional details added to policy statements. Updated guidelines, rationale and references 

02/06/2017 

Annual review, no change to policy intent. 

02/17/2016 

Annual review, no change to policy intent. 

03/05/2015 

Annual review, added verbiage related to medical necessity related to gastric cancer, added related policies and coding. Updated guidelines, rationale and references. 

09/11/2014

Corrected typo error. No change in policy.

02/24/2014

Annual review.  Updated rationale and references. Changing policy verbiage to indicate initial treatment strategy for breast cancer & melanoma is investigational.

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Complementary Content
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