Positron Emission Tomography (PET) is a minimally invasive diagnostic imaging procedure used to evaluate metabolism in normal tissue as well as in diseased tissues in conditions such as cancer, ischemic heart disease, and some neurologic disorders. A radiopharmaceutical is injected into the patient that gives off sub-atomic particles, known as positrons, as it decays. PET uses a positron camera (tomograph) to measure the decay of the radiopharmaceutical. The rate of decay provides biochemical information on the metabolism of the tissue being studied.

This policy applies specifically to the oncologic condition uses of PET (including terms FDG PET, and FDG PET/CT). Refer to Medicare Advantage Medical Policy Bulletin N-215 for information on PET scans for non-oncologic conditions. 

PET for Oncologic Conditions (NCD 220.6.17)

Framework

The CMS adopted a coverage framework that replaces the 4-part diagnosis, staging, restaging, and monitoring response to treatment categories with a 2-part framework that differentiates FDG PET imaging used to inform the initial anti-tumor treatment strategy from other uses related to guiding subsequent treatment strategies after the completion of initial treatment. CMS made this change for all NCDs that address coverage of FDG PET for oncologic conditions as described below, including those indications that are covered under CMS’ coverage with evidence development (CED) paradigm.

Initial Anti-tumor Treatment Strategy

Solid Tumors
The CMS has determined that the evidence is adequate to determine that the results of FDG PET imaging are useful in determining the appropriate initial treatment strategy for patients with suspected solid tumors and myeloma and improve health outcomes and thus are reasonable and necessary.

Only one FDG PET study is covered for patients who have solid tumors that are biopsy proven or strongly suspected based on other diagnostic testing when the patient'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 related to the initial treatment strategy:

• To determine whether or not the patient 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.

PET scans performed for therapeutic purposes related to the initial treatment strategy are covered when medically necessary based on the patient’s individual clinical circumstances. 

Exceptions to the initial treatment strategy section above: 

Prostate  
FDG PET imaging is not covered for the determination of initial anti-tumor treatment strategy in Medicare Advantage patients who have adenocarcinoma of the prostate. CMS determined that the available scientific evidence does not demonstrate that FDG PET imaging improves physician decision-making or health outcomes for this indications, and is thus not medically necessary. Therefore, FDG PET is nationally non-covered for this indication of this tumor type.

Breast
FDG PET imaging is covered for the initial treatment strategy for male and female breast cancer only when used in staging distant metastasis.

FDG PET imaging for diagnosis and initial staging of axillary nodes (code G0252) is nationally non-covered and denied as not medically necessary.

Melanoma
FDG PET is nationally not covered for the evaluation of regional lymph nodes in melanoma (code G0219).

Other uses to determine initial treatment strategy for melanoma remain nationally covered.

Cervical Cancer
FDG PET imaging continues to be nationally covered as an adjunct test for the detection of pre-treatment metastasis (i.e., staging) in newly diagnosed cervical cancers following conventional imaging that is negative for extra-pelvic metastasis.

Medicare Advantage covers one (1) FDG PET for staging in patients who have biopsy proven cervical cancer when the patient’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 related to initial treatment strategy:

• To determine whether or not the patient 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.

However, there is no scientific evidence showing that FDG PET imaging is useful in making the initial diagnoses of cervical cancer, does not improve health outcomes, and is not reasonable and necessary. Therefore, FDG PET imaging for initial diagnosis of cervical cancer related to initial treatment strategy is not covered and will be denied as not medically necessary.

Subsequent Anti-tumor Treatment Strategy

CMS determined that the available evidence is adequate to determine that FDG PET imaging improves physician decision making in the determination of subsequent treatment strategy in patients  who have ovarian cancer, cervical cancer, and myeloma, improves health outcomes, and is thus reasonable and necessary.

Therefore, for tumor types other than breast, colorectal, esophagus, head and neck (non-CNS/thyroid), lymphoma, melanoma, non-small cell lung, ovarian, cervical, and myeloma, the available evidence is not adequate to determine that FDG PET imaging improves physician decision making in the determination of subsequent anti-tumor treatment strategy or improves health outcomes in patients and thus is not reasonable and necessary.

However, the available evidence is sufficient to determine that FDG PET imaging for subsequent anti-tumor treatment strategy for all other tumor types other than the indications noted above may be nationally covered as research through CED. Therefore, a subsequent FDG PET study is nationally covered for all other tumor types other than the indications noted above, when the patient’s treating physician determines that the FDG PET study is needed to inform the subsequent anti-tumor treatment strategy and the patient is enrolled in, and the FDG PET provider is participating in an FDG PET clinical study that is designed to collect additional information at the time of the scan to assist in patient management. 

Qualifying clinical studies must ensure that specific hypotheses are addressed; appropriate data elements are collected; hospitals and providers are qualified to provide the FDG PET scan and interpret the results; participating hospitals and providers accurately report data on all enrolled patients not included in other qualifying trials through adequate auditing mechanisms; and all patient confidentiality, privacy, and other Federal laws must be followed.

For patients whose treating physician determines that an FDG PET study is needed to formulate a subsequent anti-tumor treatment strategy, the prospective clinical study must provide information that the use of PET imaging will lead to: 

• A change in patient management to more appropriate palliative care; or,
• A change in patient management to more appropriate curative care; or,
• Improved quality of life; or,
• Improved survival.

The study must adhere to the standards of scientific integrity and relevance to the Medicare population.

For additional information on clinical trials, see Medicare Advantage Medical Policy Bulletin N-27.

NaF-18 PET Imaging to Identify Bone Metastases of Cancer (NCD 220.6.19)

Effective February 26, 2010, Medicare Advantage covers Sodium Fluoride-18 (NaF-18) PET imaging when the patient’s treating physician determines that the NaF-18 PET study is needed to determine the initial antitumor treatment strategy or guide subsequent antitumor treatment strategy after the completion of initial treatment. However, the patient must also be enrolled in, and the NaF-18 PET provider is participating in, the following type of prospective clinical study:

A NaF-18 PET clinical study that is designed to collect additional information at the time of the scan to assist in initial antitumor treatment planning or to guide subsequent treatment strategy by the identification, location and quantification of bone metastases in members in whom bone metastases are strongly suspected based on clinical symptoms or the results of other diagnostic studies. Qualifying clinical studies must ensure that:

• specific hypotheses are addressed;
• appropriate data elements are collected;
• hospitals and providers are qualified to provide the PET scan and interpret the results;
• participating hospitals and providers accurately report data on all enrolled patients not included in other qualifying trials through adequate auditing mechanisms; and
• all patient confidentiality, privacy, and other Federal laws must be followed.

The clinical studies for which Medicare Advantage will provide coverage must answer one or more of the following questions:  prospectively, in patients whose treating physician determines that the NaF-18 PET study results are needed to determine the initial antitumor treatment strategy or guide subsequent antitumor treatment strategy after the completion of initial treatment, does the addition of NaF-18 PET imaging lead to:

• A change in patient management to more appropriate palliative care; or
• A change in patient management to more appropriate curative care; or
• Improved quality of life; or
• Improved survival?

The study must adhere to the standards of scientific integrity and relevance to the Medicare population.

CMS also indicates that the evidence is not sufficient to determine whether the results of NaF-18 PET imaging to identify bone metastases improve health outcomes of patients with cancer and is not reasonable and necessary unless it meets the above criteria. All other uses and clinical indications of NaF-18 PET are considered not medically necessary and nationally non-covered. All other PET radiopharmaceutical diagnostic imaging agents are non-covered for this indication.

Modifiers Used to Report PET scans

Q0 - FDG PET scans performed under CED should be reported with the Q0 modifier (number "0," not letter "O").   

The following modifiers should be used to identify the initial treatment strategy of biopsy-proven or strongly suspected tumors, or subsequent treatment strategy of cancerous tumors:

PI - Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing.

PS - Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary's treatment physician determines that the PET study is needed to inform subsequent anti-tumor strategy.

All FDG PET oncologic-related claims MUST include modifier PI or PS, as appropriate, in order for the claim to be processed correctly.

KX – Effective February 26, 2011, the KX modifier (Requirements specified in the medical policy have been met)  should be used to report professional component claims (modifier 26) for sodium fluoride-18 (NaF-18) PET scans for bone metastases. The purpose of this modifier is to differentiate these claims from PET studies using FDG in the context of a clinical trial. 

PET/CT 

PET with concurrently acquired CT is reported with procedure codes 78814-78816 as appropriate. These codes should not be reported for PET scans performed on a non-hybrid scanner.

If a PET scan is obtained and, on the same date of service, diagnostic CT scan(s) are obtained at a separate session, then both the PET scan and the CT scan(s) may be coded individually. If a PET/CT study is performed concurrently on a hybrid PET/CT scanner and an additional diagnostic CT scan is also obtained non-concurrently, it is appropriate to code the PET/CT scan and the diagnostic CT scan(s) separately (whether the diagnostic CT scans are performed on a hybrid PET/CT scanner or on a dedicated CT scanner). To further clarify this, the CT component of a PET/CT scan is for concurrently obtained CT scans for attenuation correction and localization and does not include any additional diagnostic CT studies that may be requested.

When a diagnostic CT scan is performed concurrently with a PET scan, the appropriate PET scan and the appropriate diagnostic CT code may be reported. If a medically necessary diagnostic CT is performed non-concurrently with a PET/CT scan, either on the PET/CT scanner or on an independent CT scanner, the appropriate PET/CT procedure code and the diagnostic CT study(s) code may be reported.

Radiopharmaceutical Diagnostic Imaging Agents

The only radiopharmaceutical diagnostic imaging agents covered for oncologic PET imaging are 2-[F-18] Fluoro-D-Glucose (FDG) (procedure code A9552) and NaF-18 (sodium fluoride-18) used for bone metastases of cancer (procedure code A9580). All other uses and clinical indications of NaF-18 PET are not covered. All other PET radiopharmaceutical diagnostic imaging agents are not covered for oncologic imaging. 

Reasons for Noncoverage

The following procedure codes are not covered. They will be denied as not medically necessary.

78609 - Brain imaging, positron emission tomography (PET); perfusion evaluation
G0219 - PET imaging whole body; melanoma for non-covered indications
G0235 - PET imaging, any site, not otherwise specified
G0252 - PET imaging, full and partial-ring pet scanners only, for initial diagnosis of breast cancer and/or surgical planning for breast cancer (e.g., initial staging of axillary lymph nodes)

Services that do not meet the medical necessity criteria on this policy will be considered not medically necessary. A provider cannot bill the member for the denied service unless the provider has given advance written notice, informing the member that the service may be deemed not medically necessary and providing an estimate of the cost. The member must agree in writing to assume financial responsibility, in advance of receiving the service. The signed agreement, in the form of a Pre-Service Denial Notice, should be maintained in the provider's records.

Documentation Requirements

Please note that the diagnosis code is only one piece of information in support of the medical necessity of the service. All requirements must be met, and the clinical documentation in the medical record must support all of the requirements. Prostate cancer is again a good example here. While the diagnosis code for this cancer will appear in the eligible diagnosis list, it is nationally non-covered for initial treatment strategy use. For subsequent treatment strategy use, it is eligible for coverage only when provided under CED.

PET scans are covered only when performed at a PET imaging center with a PET scanner that has been approved or cleared by the FDA. When a claim is submitted, the provider is certifying this and must be able to produce a copy of this approval upon request. An official approval letter need not be submitted with the claim.

Either modifier -PI or -PS must be submitted with a PET scan code (78608, 78811, 78812, 78813, 78814, 78815, or 78816) AND the appropriate diagnosis code.

Modifier Q0 (number 0, not letter O) should be reported to indicate when an FDG PET or PET/CT scan is performed under coverage with evidence development (CED).

For initial treatment strategy, report the appropriate PET or PET/CT procedure code and the PI modifier and the appropriate diagnosis code.

For initial treatment strategy when performed under CED, report the appropriate PET or PET/CT procedure code and the PI modifier and the Q0 modifier and the appropriate diagnosis code. 

For subsequent treatment strategy, report the appropriate PET or PET/CT procedure code and the PS modifier and the appropriate diagnosis code.

For subsequent treatment strategy when performed under CED, report the appropriate PET or PET/CT procedure code and the PS modifier and the Q0 modifier and the appropriate diagnosis code.

Procedure code A4641 is not an applicable tracer for PET scans.

Providers performing only the technical or professional component of the test should use modifier TC or 26, respectively.

Claims for oncologic PET and PET/CT scans should be reported with the appropriate modifier(s): 

• PI modifier - initial treatment strategy
• PS modifier - subsequent treatment strategy
• Q0 modifier - provided under Coverage with Evidence Development (CED)
• KX modifier - requirements specified in the medical policy have been met. (This modifier should only be reported for PET and PET/CT scans using NaF-18 imaging for bone metastasis of cancer to differentiate these claims from PET for FDG in the context of a clinical trial.)

Provider News

04/2011, Oncologic PET and PET/CT coverage guidelines revised
04/2011. Modifiers used to report oncologic PET/CT scans
04/2011, New KX modifier and its uses described

CMS Online Manual 100-03 on National Coverage Determinations, Section 220.6.17

CMS Online Manual 100-04 on Medicare Claims Processing , Chapter 13, Sections 60.15, 60.16

CMS Transmittal 124, CR 7148

CMS Transmittal 2096, CR 7125

Highmark Medicare Services Billing and Coding Article A49325: NCD Coding Article for Positron Emission Tomography (PET) Scans Used for Oncologic Conditions

The chart below summarizes FDG PET coverage. 

*Formerly “diagnosis” and “staging”

**Formerly “restaging” and “monitoring response to treatment”

¹ Cervix: Nationally non-covered initial diagnosis of cervical cancer related to initial treatment strategy. All other indications for initial treatment strategy for cervical cancer are nationally covered.

² Breast: Nationally non-covered for initial diagnosis and/or staging of axillary lymph nodes; nationally covered for initial staging of metastatic disease. All other indications for initial treatment strategy for breast cancer are nationally covered.

³ Melanoma: Nationally non-covered for initial staging of regional lymph nodes. All other uses for initial treatment strategy for melanoma are nationally covered.

⁴ Thyroid: Nationally 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 for thyroid cancer are nationally covered under CED.

⁵ PET imaging using the radiopharmaceutical diagnostic imaging agent sodium fluoride-18 (NaF-18) is useful for imaging areas of altered osteogenic activity to identify patients who have symptomatic bone pain suspicious for metastases from a known primary tumor. However. the evidence is not sufficient to determine that the results of NaF-18 PET imaging to identify bone metastases improve health outcomes of members with cancer and is not reasonable and necessary unless it is to inform initial antitumor treatment strategy or to guide subsequent antitumor treatment strategy after completion of initial treatment, and then only under CED. As such, effective for claims with dates of service on or after February 26, 2010, PET imaging using NaF-18 is covered for suspected or biopsy-proven bone metastases when the patient’s treating physician determines that the NaF-18 PET study is needed to determine the initial anti-tumor treatment strategy or guide subsequent anti-tumor treatment strategy after the completion of initial treatment. For the NaF-18 PET scan for bone metastases to be covered, the patient must be enrolled in, and the NaF-18 PET provider must be participating in, a prospective clinical study. All other uses and clinical indications of NaF-18 PET are nationally non-covered and will be denied as not medically necessary.

It is the provider's responsibility to select codes carried out to the highest level of specificity and selected from the ICD-9-CM diagnosis code book appropriate to the year in which the service is rendered for the claim(s) submitted.

Covered Diagnosis Codes

The following diagnoses support the medical necessity of PET and PET/CT scans (codes 78608, 78811 through 78816) as per the specific indications and limitations of the NCD 220.6.17. The lists are separated by initial versus subsequent treatments strategies, and, by coverage, coverage with evidence development (CED), and non-coverage.

These diagnosis codes support the medical necessity for the Initial Treatment Strategy (PI modifier) not requiring coverage with evidence development (CED):

Note: Use diagnosis code 793.1 for suspicion of solitary pulmonary nodule.

Covered Diagnosis Codes

These diagnosis codes support the medical necessity for the Initial Treatment Strategy (PI modifier) requiring CED (Q0 modifier):

Note: For diagnosis codes 198.5 and 199.1, if sodium fluoride (NaF-18) is used, all the coverage requirements must be met and procedure code A9580 must appear on the same claim. If only billing the professional component, eliminate code A9580 and append the appropriate modifiers.

*Diagnosis code V70.7 can be used to denote a clinical study, and requires an additional diagnosis code to be used to identify the cancer diagnosis.

Covered Diagnosis Codes

These codes support the medical necessity for the Subsequent Treatment Strategy (PS modifier) not requiring CED:

Covered Diagnosis Codes

These codes support the medical necessity for the Subsequent Treatment Strategy (PS modifier) requiring CED (Q0 modifier):

Note: For diagnosis codes 198.5 and 199.1, if sodium fluoride (NaF-18) is used, all the above requirements must be met and procedure code A9580 must appear on the same claim. If only billing the professional component, eliminate code A9580 and append the appropriate modifiers.

*Diagnosis code V70.7 can be used to denote a clinical study, and requires an additional diagnosis code to be used to identify the cancer diagnosis.

Non-covered Diagnosis Codes

The following diagnosis codes are nationally non-covered for the Initial Treatment Strategy (PI modifier) and will be denied as not medically necessary.