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Positron emission tomography (PET) scanning has many established roles in oncology. One potential use of PET scanning is early in the course of treatment to assess treatment response, with the intent of altering therapy based on PET scan results.
Positron emission tomography (PET) scans are based on the use of positron emitting radionuclide tracers coupled to other molecules, such as glucose, ammonia, or water. The radionuclide tracers simultaneously emit 2 high-energy photons in opposite directions that can be simultaneously detected (referred to as coincidence detection) by a PET scanner, consisting of multiple stationary detectors that encircle the area of interest.
A variety of tracers are used for PET scanning, including oxygen-15, nitrogen-13, carbon-11, and fluorine-18. The radiotracer most commonly used in oncology imaging has been fluorine-18, coupled with deoxyglucose to form fluorodeoxyglucose (FDG), which has a metabolism related to glucose metabolism. FDG has been considered potentially useful in cancer imaging, since tumor cells show increased metabolism of glucose.
This policy focuses on the use of PET to determine early treatment response for cancer, that is, assessment of therapy response during cancer treatment. The purpose of the PET scan at this particular interval is to determine whether the treatment being given should be maintained or changed. Such a treatment strategy has been called "risk-adapted" or "response-adapted" treatment. This policy addresses detecting early response during short-term therapy (eg, during cycle(s) of chemotherapeutic agents and/or a course of radiotherapy) and not response during use of long-term agents, such as tamoxifen.
The technique of using PET for early treatment response assessment involves comparing PET images before treatment and at some interval after the initial course of treatment. Many intervals have been used in various studies, and there appears to be no standard interval. Comparison of the pre-treatment and mid-treatment PET images can either be performed qualitatively or quantitatively. If a quantitative technique is used, a quantity called the standardized uptake value (SUV) is calculated for a specific region of the image. Various methods are used to compare the SUVs between 2 images, and a specific cut-off value is selected to determine whether the patient is responding to therapy. A change in SUV between 40% and 60% has often been used in studies of early treatment response.
Use of PET to guide therapy decisions is to be distinguished from all uses of PET in the initial diagnosis and staging of cancer and other uses after treatment, such as routine surveillance or detection of progression or recurrence. This use also differs from what has been called "response assessment" or "treatment response" in some reports and clearly refers to imaging done after completion of therapy for the purpose of prognosis and future treatment planning. Some reports differentiate between PET during and after treatment by referring to PET during cancer treatment as "interim treatment response" or "interim staging" and PET at the conclusion of treatment as "restaging."
A number of PET scan platforms have been cleared by the U.S. Food and Drug Administration (FDA) through the 510(k) process since the Penn-PET scanner was approved in 1989. The device classification is: System, Tomography, Computed, Emission. Recently approved PET scanners include the Discovery™ PET/CT701 (GE Medical Systems, 2014) and Biograph Horizon™ PET/CT (Siemens Medical Solutions, 2016).
Indications for Oncological Applications of PET Scanning are addressed in a separate policy.
POLICYThe use of PET scans to determine early response to treatment (PET scans done during a planned course of chemotherapy and/or radiotherapy) in patients with cancer is considered investigational.
POLICY EXCEPTIONSFederal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member’s specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
There is no specific coding for PET scans to determine early response to treatment. The CPT codes for PET or PET/CT imaging (78811-78816) would be used.
POLICY HISTORY5/20/2009: Policy added
7/16/2009: Approved by Medical Policy Advisory Committee (MPAC)
11/24/2009: Policy Description Section updated with links to related policies, Policy Exceptions Section revised to include FEP verbiage.
02/23/2011: Policy reviewed; no changes.
08/11/2011: Policy reviewed; no changes.
09/27/2012: Policy reviewed; no changes.
10/22/2013: Policy reviewed; no changes.
10/10/2014: Policy title changed from "PET Scanning in Oncology to Detect Early Treatment Response" to "Interim PET Scanning in Oncology to Detect Early Response During Treatment." Policy reviewed; description updated. Policy statement updated to add that PET scans done during a planned course of chemotherapy and/or radiation therapy is considered investigational.
07/30/2015: Code Reference section updated for ICD-10.
11/04/2015: Policy description updated regarding devices. Policy statement unchanged. Policy guidelines section updated to add investigative definition.
05/31/2016: Policy number added.
10/13/2016: Policy description updated regarding devices. Policy statement updated to change "radiation therapy" to "radiotherapy."
SOURCESBlue Cross & Blue Shield Association Policy # 6.01.51
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.