BlueCross and BlueShield of Montana Medical Policy/Codes
Positron Emission Tomography (PET)
Chapter: Radiology
Current Effective Date: December 27, 2013
Original Effective Date: December 27, 2013
Publish Date: December 27, 2013
Description

PET scans are based on the use of positron emitting radionuclide tracers coupled to organic molecules, such as glucose, ammonia, or water. The radionuclide tracers simultaneously emit two 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. Because of their short half-life, tracers must be made locally, the majority requiring an on-site cyclotron.

This policy only addresses the use of radiotracers detected with the use of dedicated PET scanners. There is a similar procedure to PET that uses the radiotracer 2-[F-18]- fluorodeoxyglucose (FDG) may be referred to as FDG-SPECT (fluorodeoxyglucose-single photon emission computed tomography), metabolic SPECT, or PET using a gamma camera. In this procedure radiotracers such as FDG may be detected using SPECT cameras.

Surveillance is closely monitoring a patient's condition, looking for sign(s) that a cancer has returned, but withholding treatment until symptoms appear or change; also called observation, watchful waiting, and expectant management.

The purpose of a cancer screening test is to identify the presence of a specific cancer in an individual who does not demonstrate any symptoms. Examples of cancer screening tests are the mammogram (breast), colonoscopy (colon), Pap smear (cervix), and PSA blood level and digital rectal exam (prostate).

PET/CT Fusion Imaging

PET/CT Fusion Imaging is a new diagnostic tool for the staging and restaging of cancer. Patients can be examined with both PET and CT in a single examination. This new technology correlates two simultaneous imaging modalities for a comprehensive examination that combines anatomic data with functional or metabolic information. The CT images are used for anatomic reference of the tracer uptake patterns images in PET, as well as for attenuation correction of the PET data.

Positron Emission Mammography (PEM)

Positron-emission mammography (PEM) is a new, specialized imaging modality utilizing radiopharmaceuticals and PET technology to detect breast cancer. PEM was developed to overcome the limitation of whole-body PET in detecting smaller breast lesions, and to improve visualization of fibrodense breast tissue and breasts with fibrocystic disease. With PEM, two high-resolution detector heads are placed on opposite sides of a compressed breast, and the data is integrated with conventional mammography.

The PEM Flex™ Solo II, the first commercially available U.S. Food and Drug Administration (FDA)-cleared, high-resolution PET scanner, is designed to image small body parts and can be used with other imaging modalities. Solo II utilizes PEM to allow physicians to visualize and characterize lesions as small as 1.5-2.0 mm, about the diameter of a mammary duct. In November 2008, the FDA granted 510(k) clearance for the Stereo Navigator™, which is the first commercially available breast PET-guided biopsy feature, to be used with PEM Flex Solo II. The FDA approval states “it is intended for the localization of lesions in female breasts, as identified on a PET image. By using the Stereo Navigator, the physician is able to guide compatible interventional devices towards the PET abnormality as medically indicated. The Stereo Navigator also provides a means to confirm localization of the lesion in advance of the interventional procedure.” 

Cardiac Pet Scan

In terms of myocardial perfusion studies, patient selection criteria for PET scans involve an individual assessment of the pretest probability of coronary artery disease (CAD), based on both patient symptoms and risk factors. Patients at low risk for CAD may be adequately evaluated with exercise electrocardiography. Patients at high risk for CAD may not benefit from a non-invasive assessment of myocardial perfusion, since, in this setting, a negative test may represent a false negative result. These patients may be immediately referred to coronary angiography.

Patient selection criteria for PET scans for myocardial viability are typically those patients with severe left ventricular dysfunction who are under consideration for a revascularization procedure. A PET scan may determine whether the left ventricular dysfunction is related to viable or nonviable myocardium. Patients with viable myocardium may benefit from revascularization, while those with non-viable myocardium will not. As an example, PET scans are commonly performed in potential heart transplant candidates to rule out the presence of viable myocardium.

For both perfusion and viability study indications, a variety of studies have suggested that the PET scans are only marginally more sensitive or specific than SPECT scans. Therefore, the choice between a PET scan (which may not be available locally) and a SPECT scan represents another clinical issue. PET scans may provide the greatest advantage over SPECT scans in obese patients where tissue attenuation of tracer is of greater concern.

Risk for Cardiovascular Heart Disease

In 1999, the American College of Cardiology (ACC) and American Heart Association (AHA) released a joint scientific statement describing the assessment of cardiovascular or coronary heart disease (CHD) risk to categorize patients for selection of appropriate interventions (available in the ACC website http://www.acc.org). The statement defines CHD, as derived from the Framingham Heart Study, to include angina pectoris, unstable angina or coronary insufficiency, and unrecognized myocardial infarction (MI) (defined by EKG). The ACC/AHA scientific statement further states, “The first step in determining the patient’s risk is to calculate the number of Framingham points for each risk factor”, by using the Framingham Global Risk Assessment Scoring:

 

Risk Factor

Risk Points

Men

Women

Age by year:

 

Less than 34

-1

9

35 – 39

0

-4

40 – 44

1

0

45 – 49

2

3

50 – 54

3

6

55 – 59

4

7

60 – 64

5

8

65 – 69

6

8

70 - 74

7

8

Total Cholesterol, mg/dL*:

 

Less than 160

-3

-2

169 – 199

0

0

200 – 239

1

1

240 – 279

2

2

Greater than or equal to 280

3

3

HDL cholesterol, mg/dL*:

 

Less than 35

2

5

35 – 44

1

2

45 – 49

0

1

50 – 59

0

0

Greater than or equal to 60

-2

-3

Systolic blood pressure, mm Hg**:

 

Less than 120

0

-3

120 – 129

0

0

130 – 139

1

1

140 – 159

2

2

Greater than 160

3

3

Diabetes:

 

No

0

0

Yes

2

4

Smoker:

 

No

0

0

Yes

2

2

*          mg dL = milligrams/deciliter

**        mm Hg = millimeter of mercury as it relates to a unit of pressure equal to 0.001316 atmosphere

Adding Up the Points

Age:

Cholesterol:

HDL – C:

Blood Pressure:

Diabetes:

Smoker:

Total Points:

Additionally the 1999 ACC/AHA scientific statement explained the following tables as demonstrating the relative and absolute risk estimates for CHD in men and women as determined for Framingham scoring, including this explanation for table information, “Relative risk estimates for each age range are compared with baseline risk conferred by age alone (in the absence of other major risk factors).”  Additionally described was, “Average risk refers to that observed in the Framingham population. Absolute risk estimates are given in the two right hand columns. Absolute risk is expressed as the percentage likelihood of developing CHD per decade. Total CHD risk equates to all forms of clinical CHD, whereas hard CHD includes clinical evidence of MI and coronary death. Hard CHD estimates are approximated from published Framingham data.”

In the following grids, the intermediate risk estimates (classified as moderately above average risk) will be identified as bolded and high risk as underlined. Following the last grid (for women), the keys for these symbols “*”, “#”, “++”, and “**” will be defined.

MEN

Age

30-34

35-39

40-44

45-49

50-54

55-59

60-64

65-69

70-74

 

 

Low Risk Level*

(2%)

(3%)

(3%)

(4%)

(5%)

(7%)

(8%)

(10%)

(13%)

Absolute Risk

Absolute Risk ++

Points#

 

 

 

 

 

 

 

 

 

Total CHD++

Hard CHD**

0

1.0

 

 

 

 

 

 

 

 

2%

2%

1

1.5

1.0

1.0

 

 

 

 

 

 

3%

2%

2

2.0

1.3

1.3

1.0

 

 

 

 

 

4%

3%

3

2.5

1.7

1.7

1.3

1.0

 

 

 

 

5%

4%

4

3.5

2.3

2.3

1.8

1.4

1.0

 

 

 

7%

5%

5

4.0

2.6

2.6

2.0

1.6

1.1

1.0

 

 

8%

6%

6

5.0

3.3

3.3

2.5

2.0

1.4

1.3

1.0

 

10%

7%

7

6.5

4.3

4.3

3.3

2.6

1.9

1.6

1.3

1.0

13%

9%

8

8.0

5.3

5.3

4.0

3.2

2.3

2.0

1.6

1.2

16%

13%

9

10.0

6.7

6.7

5.0

4.0

2.9

2.5

2.0

1.5

20%

16%

10

12.5

8.3

8.3

6.3

5.0

3.6

3.1

2.5

1.9

25%

20%

11

15.5

10.3

10.3

7.8

6.1

4.4

3.9

3.1

2.3

31%

25%

12

18.5

12.3

12.3

9.3

7.4

5.2

4.6

3.7

2.8

37%

30%

13

22.5

15.0

15.0

11.3

9.0

6.4

5.6

4.5

3.5

45%

35%

>14

26.5

>17.7

>17.7

>13.3

>10.6

>7.6

>6.6

>5.3

>4.1

>53%

>45%

 

WOMEN

Age

40-44

45-49

50-54

55-59

60-64

65-69

70-74

 

 

Low Risk Level*

(2%)

(3%)

(5%)

(7%)

(8%)

(8%)

(8%)

Absolute Risk

Absolute Risk ++

Points#

 

 

 

 

 

 

 

Total CHD++

Hard CHD**

0

1.0

 

 

 

 

 

 

2%

1%

1

1.0

 

 

 

 

 

 

2%

1%

2

1.5

1.0

 

 

 

 

 

3%

2%

3

1.5

1.0

 

 

 

 

 

3%

2%

4

2.0

1.3

 

 

 

 

 

4%

2%

5

2.0

1.3

 

 

 

 

 

4%

2%

6

2.5

1.7

1.0

 

 

 

 

5%

2%

7

3.0

2.0

1.2

 

 

 

 

6%

3%

8

3.5

2.3

1.4

1.0

 

 

 

7%

3%

9

4.0

2.7

1.6

1.1

1.0

1.0

1.0

8%

3%

10

5.0

3.3

2.0

1.4

1.3

1.3

1.3

10%

4%

11

5.5

3.7

2.2

1.6

1.4

1.4

1.4

11%

7%

12

6.5

4.3

2.6

1.9

1.6

1.6

1.6

13%

8%

13

7.5

5.0

3.0

2.1

1.9

1.9

1.9

15%

11%

14

9.0

6.0

3.6

2.6

2.3

2.3

2.3

18%

13%

15

10.0

6.7

4.0

2.9

2.5

2.5

2.5

20%

15%

16

12.0

8.0

4.8

3.4

3.0

3.0

3.0

24%

18%

>17

>13.5

>9.0

>5.4

>3.9

5.4

5.4

5.4

>27%

>20%

Symbols Key:

*          Low absolute risk level = 10-year risk for CHD end points for the person the same age, blood pressure less than 120 mm Hg systolic and less than 80 mm Hg diastolic, serum total cholesterol - 160 to 199 mg/dL, LDL-C - 100 to 129 mg/dL (LDL = low-density lipoprotein), HDL-C - greater or equal to 45 mg/dL in men and greater or equal to 55 mg/dL in women, nonsmoker, and no diabetes mellitus. Percentages show 10-year absolute risks for total CHD endpoints.

#          Points = number of points estimated from the Framingham Global Risk Assessment Scoring.

++        10-year absolute risk for total CHD end points estimated from the Framingham data corresponding to the Framingham (Global Risk Assessment Scoring) points.

**        10-year absolute risk for hard CHD end points approximated from the Framingham data   corresponding to the Framingham (Global Rish Assessment Scoring) points.

Sodium 18F-Fluoride (NaF-18) Radiotracer

NaF-18 is a diagnostic molecular imaging agent used for identification of new bone formation. Although NaF-18 was approved by the FDA in 1972, it was listed as a discontinued drug in 1984. NaF-18 is now being marketed again by PETNET Solutions. NaF-18 is injected intravenously, and is used to define areas of altered osteogenic activity.

Policy

Each benefit plan or contract defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their providers have the responsibility for consulting the member's benefit plan or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan or contract, the benefit plan or contract will govern.

Coverage

ONCOLOGIC APPLICATIONS

Positron emission tomography (PET) or positron emission tomography/computed tomography (PET/CT) may be considered medically necessary for Initial Treatment Strategy Planning and Subsequent Treatment Strategy Planning for known or suspected malignancy (but not for Screening or Surveillance) when the following criteria are met:

Initial Treatment Strategy Planning

One PET or PET/CT study may be considered medically necessary for Initial Treatment Strategy Planning for patients who have solid tumors that are biopsy proven, or suspected based on other diagnostic testing, when a PET or PET/CT 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.

NOTE:  BREAST CANCER, MELANOMA, AND PROSTATE CANCER HAVE SPECIFIC EXCLUSIONS FOR PET OR PET/CT, AS NOTED BELOW

Breast Cancer 

PET or PET/CT is considered experimental, investigational and unproven

  • for diagnosis of breast cancer; OR
  • to evaluate a suspicious breast mass; OR
  • for initial staging of axillary lymph nodes in patients with breast cancer.

Melanoma

PET or PET/CT is considered experimental, investigational and unproven for the evaluation of regional lymph nodes in melanoma.

Prostate Cancer

PET or PET/CT is considered experimental, investigational and unproven to determine initial anti-tumor treatment in patients with adenocarcinoma of the prostate.

Subsequent Treatment Strategy Planning

PET or PET/CT imaging for subsequent treatment strategy planning may be considered medically necessary when the initial diagnostic PET criteria were met and PET is needed:

  • for the purpose of detecting residual disease within six months after completion of any surgical, chemotherapy, or radiation therapy treatment has completed; OR
  • during the course of chemotherapy or radiation treatment when clinical signs and symptoms are significant and suggestive of disease progression or worsening despite treatment and the results are necessary to plan a new course of treatment; OR
  • to determine the extent of a known recurrence established by other diagnostic modalities; OR
  • to monitor tumor response to treatment during the planned course of therapy when a change in therapy is anticipated.

Surveillance of Asymptomatic Patients After Completion of Therapy for Malignancy

PET or PET/CT is considered not medically necessary for patients ≥12 months after completion of therapy for lymphoma, or ≥6 months after completion of therapy for all other malignancies, unless the patient demonstrates signs, symptoms, laboratory or other objective findings suggestive of recurrence or spread of the original malignancy.

Screening of Asymptomatic Patients 

PET or PET/CT is considered not medically necessary as a screening test (i.e., for evaluation of patients without specific signs and symptoms of disease).

CARDIAC APPLICATIONS

A. Myocardial Perfusion 

Cardiac PET scanning may be considered medically necessary as a technique to assess myocardial perfusion defects when the patient has at least intermediate risk* for coronary artery disease AND the following criteria are met:

  • Indeterminate noninvasive imaging tests (e.g., SPECT scan, myocardial perfusion imaging, stress echocardiogram); OR
  • Patients for whom SPECT could be reasonably expected to be suboptimal in quality due to body habitus (such as, but not limited to: moderate to severe obesity, i.e., BMI > 35 kg/m2; large breasts and/or implants; left mastectomy; chest wall deformity; etc.) or other technical problems (e.g., indeterminant prior SPECT, extensive prior MI, etc)

* Intermediate risk is discussed in the Description section.

B. Myocardial Viability

Cardiac PET scanning may be considered medically necessary to assess the myocardial viability in patients with severe left ventricular dysfunction as a technique to determine candidacy for a revascularization procedure

C. Cardiac Sarcoidosis

Cardiac PET scanning may be considered medically necessary for the diagnosis of cardiac sarcoidosis in patients who are unable to undergo magnetic resonance imaging (MRI) scanning. Examples of patients who are unable to undergo MRI include, but are not limited to, patients with pacemakers, automatic implanted cardioverter-defibrillators (AICDs), or other metal implants.

OTHER APPLICATIONS

Positron emission tomography (PET) or positron emission tomography/computed tomography (PET/CT) may be considered medically necessary for the following:

  • Diagnosis of chronic osteomyelitis;
  • Assessment of selected patients with epileptic seizures who are candidates for surgery. NOTE:  Appropriate candidates are those patients who have complex partial seizures that have failed to respond to medical therapy and who have been advised to have a resection of a suspected epileptogenic focus located in a region of the brain accessible to surgery. Conventional techniques for seizure localization must have been tried and provided data that suggested a seizure focus, but were not sufficiently conclusive to permit surgery.

EEG's AND PET EXAMINATION: The purpose of the PET examination should be to avoid subjecting the patient to extended pre-operative electroencephalographic recording with implanted electrodes.

Positron Emission Mammography (PEM)

Positron emission mammography (PEM) is considered experimental, investigational and unproven for breast cancer screening, diagnosis or management.

Positron emission tomography (PET) or positron emission tomography/computed tomography (PET/CT) is considered experimental, investigational and unproven for all other indications.

Sodium 18F-Fluoride (NaF-18) Radiotracer for Positron Emission Tomography (PET) Bone Scans

Sodium 18F-Fluoride (NaF-18) radiotracer for positron emission tomography (PET) bone scans is considered experimental, investigational and unproven for non-oncologic indications, including but not limited to osteomyelitis.

Rationale

ONCOLOGIC APPLICATIONS

This policy is based on multiple evaluations of PET, including Blue Cross Blue Shield Association (BCBSA) Technology Evaluation Center (TEC) Assessments. In the TEC Assessments, PET scanning was considered an adjunct to other imaging methods (i.e., CT, MRI, ultrasonography), often used when previous imaging studies are inconclusive or provide discordant results. In this setting, the clinical value of PET scans is the rate of discordance among imaging techniques and the percentage of time that PET scanning results in the correct diagnosis, as confirmed by tissue biopsy. Development of this medical policy also included consideration of other systematic reviews, meta-analyses, decision analyses, and cost-effectiveness analyses, including those conducted by Centers for Medicare and Medicaid Services (CMS) and the National Comprehensive Cancer Network (NCCN), as well as guidelines from the American College of Radiology, the Society for Nuclear Medicine, and others.

Breast Cancer

The NCCN Clinical Practice Guidelines Panel recommends against use of PET or PET/CT in the staging of breast cancer for patients with Stage I, IIA, IIB, or T3N1MO invasive breast cancer because of the high false negative rate in the detection of lesions that are small (<1cm) or low grade, the relatively low sensitivity for detection of axillary nodal metastases, the low prior probability of the patients having detectable metastatic disease, and the high rate of false positive scans. The NCCN Panel discourages the use of PET or PET/CT for the evaluation of Stage III and IV invasive breast cancer, except in situations where other staging studies are equivocal or suspicious; the Panel considers biopsy of suspicious sites to be more likely than PET to provide useful staging information.

Melanoma

In their review of management of malignant melanoma, Kumar et al. concluded that FDG-PET is of limited use in patients with early-stage disease and cannot replace sentinel node biopsy, which is more sensitive in detecting microscopic lymph node metastases. Wagner et al. compared FDG PET to conventional imaging studies and concluded that FDG PET is an insensitive indicator of occult melanoma lymph node metastases in patients with melanoma because of minute tumor volumes in this population, and does not have a primary role for staging regional lymph nodes in patients with clinically localized melanoma.

Prostate Cancer

FDG PET is not highly effective for primary diagnosis of prostate cancer, and has a limited role in staging and recurrence detection. The National Cancer Institute has an ongoing phase II/III clinical trial (NCT00002981) that is studying how well PET scans work in detecting cancerous changes in patients with metastatic prostate cancer. The American College of Radiology Appropriateness Criteria recommends the use of CT, MRI, Prostascint Scan, and Tc-99m Bone Scan for diagnosis and management of prostate cancer. Although research is promising, a search of peer-reviewed literature did not locate any studies that would support the use of PET for diagnosis or management of prostate cancer.

Surveillance and Screening

Prevalence of PET Used for Surveillance

It is unknown how frequently and for which cancers PET is used for surveillance. An unsystematic attempt to find studies in which PET was apparently used for surveillance reveals some literature. Unger et al. (2004) reports the findings of 26 asymptomatic patients after treatment for cervical cancer among a larger series of patients who underwent PET in order to detect recurrence. The scans were done at a mean of 7.8 months after treatment, but the range was 2-40 months. Chung et al. (2006) reports the findings of 30 women undergoing surveillance PET among a larger series of other patients with clinical indications of recurrence of cervical cancer.

The only study that was found through unsystematic searches, and that solely examined use of surveillance PET, was by Ryu et al. (2003). In this study from Korea, 249 patients with no evidence of recurrent cervical cancer at least six months after treatment received PET scans at a variable time after treatment. Thirty-two percent of patients had positive scans, and 11.2% were clinically or histologically confirmed as having recurrences. The calculated sensitivity and specificity were 90.3% and 76.1%, respectively. Subsequent treatment and survival are not reported in this study.

Registries of PET utilization and analyses of claims data do not report, and do not appear to be capable of counting, PET scans used for surveillance. The National Oncologic PET Registry, a data collection effort commissioned by the Centers for Medicare and Medicaid Services (CMS) to develop evidence to consider CMS coverage for various indications for PET, did not collect information on surveillance PET (Hillner et al. 2008). The data collection forms noted specifically that PET is not covered by Medicare for surveillance purposes, and surveillance was not offered as one of the possible indications for the PET scan.

A study by Zafar et al. (2010), using merged Medicare and the National Cancer Institute’s Surveillance, Epidemiology and End Results (SEER) Program data on patients undergoing resection for colorectal cancer, measured the use of PET in the 2-year period following surgery. Ten percent of patients underwent at least one PET scan following surgery. However, the study does not report which scans were done for surveillance, nor does it appear that such a calculation could be made using the data elements available from either Medicare or SEER.

Principles of Surveillance

Surveillance has also been called “tertiary prevention” or “monitoring.” Tertiary preventive services are those that are provided to persons who clearly have or have had a disease in order to prevent further complications. Although some might not consider surveillance for recurrent disease to be prevention, the principles of surveillance are actually similar, if not identical to, those of traditional screening tests used for initial early detection of disease.

The purpose of a regimen of surveillance is to detect recurrence or progression earlier than would have otherwise. The diagnostic characteristics of the surveillance test for patients without suspected recurrence should be consistent with a reasonable degree of accuracy for both accurate and efficient identification of recurrence. In addition, recognizing the recurrence or progression earlier than it would have without the surveillance regimen should result in clinical interventions that produce a better outcome than would have if the recurrence had been detected clinically. Thus, the cancer must be biologically more responsive to treatment at the time that it is detected with the surveillance test than it is when it is detected clinically. For example, if PET detects the recurrence at a point in time in which distant metastasis is less likely, then it is possible that a treatment of the local recurrence may be more likely to benefit the patient. This implies that the surveillance test must be able to detect the cancer at a meaningful, rather than trivially earlier, interval in time than clinical detection.

As in screening, evaluating surveillance is complicated by several potential biases when trying to determine its efficacy. Analyses of outcomes from observational data can be misleading. Lead-time bias can result in apparent longer survival in surveillance-detected cases simply due to the additional increment of time between asymptomatic detection and clinical detection of recurrence. Lead-time effects could be particularly harmful for cancer recurrence due to adverse effects of treatment.

Length-time bias and overdiagnosis bias result from the preferential detection of slow-growing recurrences by surveillance tests, again resulting in an apparent, but not real, improvement in survival when comparing the outcomes of surveillance-detected cases to historical controls or to clinically detected cases. If treatments for recurrence are started simply based on the results of surveillance tests without some kind of confirmation of recurrence, an extreme form of over-diagnosis bias can occur if the surveillance tests are falsely positive. Thus, it is difficult to determine the efficacy of surveillance regimens using most kinds of observational data, such as case series data. These biases have long been recognized for traditional screening tests, leading to the recognition that randomized, clinical trials are often necessary to demonstrate the efficacy of screening tests.

However, the evidence supporting any surveillance regimen after cancer treatment is scant. Most recommended surveillance strategies appear to be recommended based on consensus, rather than rigorous trials. However, for colorectal cancer at least, recommended surveillance guidelines have some support from randomized, clinical trials. The American Society of Clinical Oncology (ASCO) guidelines recommending abdominal CT after treatment for colon cancer cite randomized, clinical trials as providing some support for this particular surveillance test (Desch et al. 2005). However, the evidence is less than definitive, as the guidelines acknowledge that several other organizations do not recommend any routine imaging studies.

Several clinical trials were completed comparing clinical visits and mammography to more intensive surveillance regimens that included bone scans, chest x-rays, and laboratory tests for women after treatment for breast cancer. The separate results of the trials and a systematic review of all trials concluded that the more intensive regimens did not improve survival (Rojas et al. 2009). Thus, for at least a few diseases, surveillance regimens have been evaluated with randomized, clinical trials leading to guidelines which in one case (colon cancer) support a particular surveillance test (CT) while in another case (breast cancer) do not recommend a particular test (bone scan).

Use of PET for surveillance may be thought to be effective without rigorous proof because it may be believed that PET is a sensitive and specific diagnostic test for cancer. In the absence of clinical trials or a rigorous trail of evidence supporting the full chain of logic that supports the utility of surveillance, and the desire to do some sort of surveillance, physicians may opt to perform what they believe is the most sensitive test. Certain literature reviews may reinforce this emphasis on the diagnostic characteristics of the test rather than evidence of improved health outcome. For example, an Agency for Healthcare Research and Quality (AHRQ) technology assessment on PET appears to focus almost solely on the calculation of diagnostic characteristics of PET for various cancers (University of Alberta Evidence-based Practice Center 2008).

A recently published guideline statement on the use of PET for colorectal cancer cites numerous systematic reviews and meta-analyses that seem to suggest that PET has superior sensitivity and specificity to CT in detecting colorectal hepatic metastases (Fletcher et al. 2007). A cursory look at some of the studies included in these meta-analyses reveals that these conclusions may, in fact, be flawed. In one of these studies by Valk et al. (1999), patients were included in the study for suspicion of recurrence, of which one of the indications for suspicion was an abnormal CT scan. If having a positive test on one of the tests being analyzed is one of the referral criteria for being in the study, then its performance cannot be estimated in an unbiased fashion. In fact, the authors state themselves “…an unbiased determination of the accuracy of PET and CT cannot be obtained from studies of this type, in which many patients are selected for PET imaging because of positive CT findings.” However, the conclusion of the authors is that PET is more sensitive and specific than CT for detection of recurrent colorectal cancer. Another reason for viewing these results with caution is that the PET diagnostic characteristics were determined in the setting of suspected recurrence, not routine surveillance. In addition to the probability of recurrence being higher in this situation than in the surveillance setting, differences in the detectability of the recurrence, so-called “spectrum biases,” may mean that the results are not generalizable to the surveillance setting.

The justification of the use of PET for detection of suspected recurrence as stated in many guidelines tends not to be because of the additional identification of more curable or treatable recurrence (early detection), but in more accurate staging of suspected recurrence (restaging), which then often changes the treatment plan when the recurrence is discovered to be more extensive than originally thought. In this scenario, then, the improved outcome of the patients is generally not because of the overall superior outcomes of treating the recurrence (although the subset of patients that are more accurately identified as having only local recurrence will appear to have superior survival), but in the avoidance of the morbidity of radical attempts at cure. This is clearly a different scenario than that of disease surveillance; the probability of recurrent disease is high or close to one, negating for the most part the problem of false positive results. The avoidance of futile radical curative treatments is an unambiguous benefit for patients who have more extensive disease found by using PET.

In summary, several biases inherent in the evaluation of surveillance as a type of screening make it difficult to assess the efficacy of PET used in this situation. Rigorous trials evaluating PET as a method of cancer surveillance to improve patient outcomes have not been carried out. Lacking such evidence, belief that PET scan is a sensitive and specific test may drive its use. However, the sensitivity and specificity of PET scan in the surveillance setting is probably unknown, and the scientific literature may very well be flawed in comparisons of PET to other imaging techniques. Use of PET to make treatment decisions may result in the appearance of superior outcomes for certain subsets of patients, but aggregate outcomes for all patients subjected to PET scanning should be accounted for.

Potential Harms of PET Surveillance

While there is potential benefit of early detection of recurrence that ideally should be demonstrated in a rigorous trial, these would need to be greater than the potential harms of such surveillance. Such harms would include any adverse effects from further testing, treatments, or procedures resulting from false-positive tests.

The test itself has substantial radiation exposure and potential for inducing cancer. A study by Huang et al. (2009) estimated that radiation doses ranged from 13.5 mSv to 32.3 mSv for a whole-body PET/CT scan depending on the particular scanning protocol and the gender of the patient. A lifetime attributable risk for cancer of up to 0.514% for a scan in a 20-year old woman was estimated, very similar to an estimate from another study analyzing the potential risk from coronary CT angiography (Einstein et al 2007). Another study by Brix et al. (2005) estimated a radiation dose from a whole-body PET/CT scan to be about 25 mSv, consistent with the estimates from Huang et al. (2009). These estimates were based on the risk of a single scan. The potential harms mentioned above are multiplied over time when surveillance tests are repeated.

Guideline Statements and Systematic Reviews Regarding PET for Surveillance in Oncology

Guideline statements regarding the use of PET for cancer surveillance were reviewed. Statements or evidence reviews supporting the use of PET for surveillance were rarely found for any cancer. The following Guidelines and Reviews were included:

·        National Comprehensive Cancer Network Task Force Reports regarding use of PET;

·        NCCN guidelines on treatment of selected specific cancers;

·        AHRQ Technology Assessment on PET;

·        Technology Assessment by the National Health Service Research & Development Health Technology Assessment Programme;

·        CMS Technology Assessment in support of proposed coverage decision;

·        American Society of Clinical Oncology (ASCO)—Convened Panel Recommendation Statement;

·        Canadian Agency for Drugs and Technologies in Health (CADTH) Health Technology Assessment;

·        The American College of Chest Physicians.

Conclusions and Recommendations for Further Research

There is simply inadequate direct and indirect evidence supporting the efficacy of PET scanning for the purpose of surveillance. Reflecting this lack of evidence, current practice guidelines appear unanimously to recommend against the use of PET for surveillance. No strong support of the use of PET for surveillance was found in editorials, case reports, or other studies. Given such problems as lead-time bias, length-time bias, and the uncertain diagnostic characteristics of PET in the surveillance setting, it would be difficult to determine whether the efficacy of PET for surveillance could be determined with observational data. Clinical trials may be necessary to determine whether PET surveillance is effective in improving health outcomes.

Positron Emission Mammography (PEM)

PEM has shown promising results in detecting primary ductal carcinoma in situ and recurrent breast disease, as well as for directing biopsy of suspicious lesions.

Raylman et al. found initial testing of the PEM/PET scanner revealed that the imaging capabilities of the system are excellent; more advanced testing is ongoing.

Berg et al. prospectively assessed the diagnostic performance of PEM scanning at four centers on 94 consecutive women with known breast cancer or suspicious breast lesions. Readers were provided clinical histories and x-ray mammograms (when available). After excluding inevaluable cases and two cases of lymphoma, PEM lesions were correlated with histopathology for 92 lesions in 77 women. Overall, PEM sensitivity for detecting cancer was 90%, specificity 86%, positive predictive value (PPV) 88%, negative predictive value (NPV) 88%, accuracy 88%, and area under the receiver-operating characteristic curve (Az) 0.918. In three patients, cancer foci were identified only on PEM, significantly changing patient management. Excluding eight diabetic subjects and eight subjects whose lesions were characterized as clearly benign with conventional imaging, PEM sensitivity was 91%, specificity 93%, PPV 95%, NPV 88%, accuracy 92%, and Az 0.949 when interpreted with mammographic and clinical findings. The study concluded that FDG PEM has high diagnostic accuracy for breast lesions, including DCIS (ductal carcinoma in situ).

The National Institutes of Health (NIH) have several studies underway for PEM. An ongoing phase IV study (identified as NCT00484614) is a prospective multi-center clinical trial to evaluate the role of high resolution PEM, used in combination with the radiotracer FDG, for pre-surgical planning in women with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy) after full routine workup (including mammography, clinical breast exam, and additional ultrasound). Participants undergo both contrast enhanced MRI and PEM imaging. In order to control for potential bias in interpretation of the second examination (i.e., PEM or MRI), the order of interpretation of these examinations is randomly assigned at study entry. The primary objective of the study is to determine changes in surgical management resulting from PEM or MRI or both, separately and in conjunction with conventional imaging, and to determine whether these changes were appropriate (i.e., to excise malignancy) or inappropriate (e.g., wider excision or mastectomy for what proved to be benign disease).

A phase III trial (NCT00896649) is studying PEM to see how well it works compared with standard mammography in women with dense breast tissue or who are at high risk of breast cancer. This study is currently accepting participants.

Another study (NCT00981812) is not yet open for participant recruitment. The purpose of this research study is to evaluate the ability to perform breast biopsies using PEM and the Stereo Navigator software and to see whether PEM and Stereo Navigator help the doctors obtain results sooner (in fewer clinical visits) than if they use MRI, mammography and/or ultrasound.

In September 2009, the National Cancer Institute et al. of the NIH made a presentation titled “Diagnosis and Management of Ductal Carcinoma In Situ (DCIS)” at the NIH State-of-the-Science Conference. In their summary of future research directions they stated, “…Work must be continued with attention to newer imaging technologies, such as tomosynthesis, breast computed tomography, breast positron emission mammography, breast-specific gamma imaging, and others still in earlier phases of development.”

CARDIAC APPLICATIONS

In 2003, the American College of Cardiology (ACC) and the American Heart Association (AHA) published updated guidelines for cardiac radionuclide imaging. Cardiac applications of PET scanning were included in these guidelines. The ACC/AHA guidelines categorize specific indications for PET scanning:

·        Class I is defined as conditions for which there is evidence and/or general agreement that a given procedure or treatment is useful and effective.

·        Class IIa is defined as conditions for which there is conflicting evidence or a divergence of opinion but the weight of evidence/opinion is in favor of usefulness/efficacy.

·        Class IIb is similar to Class IIa except that the usefulness/efficacy is less well established by evidence/opinion.

The medically necessary indications for PET myocardial perfusion studies in this policy are consistent with Class I and Class IIa indications in the ACC guidelines.

Myocardial Viability

PET has perhaps been most thoroughly researched as a technique to assess myocardial viability to determine candidacy for a coronary revascularization procedure. For example, a patient with a severe stenosis identified by coronary angiography may not benefit from revascularization if the surrounding myocardium is non-viable. A fixed perfusion defect, as imaged on SPECT scanning or stress thallium echocardiography, may suggest non-viable myocardium. However a PET scan may reveal metabolically active myocardium, suggesting areas of hibernating myocardium that would indeed benefit from revascularization. The most common PET technique for this application consists of N-13 ammonia as a perfusion tracer and FDG as a metabolic marker of glucose utilization. A pattern FDG uptake in areas of hypoperfusion (referred to as FDG/blood flow mismatch) suggests viable, but hibernating myocardium. The ultimate clinical validation of this diagnostic test is the percentage of patients who experience improvement in left ventricular dysfunction after revascularization of hibernating myocardium, as identified by PET scanning.  

SPECT scanning may also be used to assess myocardial viability. For example, while initial myocardial uptake of thallium-201 reflects myocardial perfusion, redistribution after prolonged periods can be used as a marker of myocardial viability. Initial protocols required redistribution imaging after 24 to 72 hours. While this technique was associated with a strong positive predictive value, there was a low negative predictive value, i.e., 40% of patients without redistribution nevertheless showed clinical improvement after revascularization. The negative predictive value has improved with the practice of thallium reinjection. Twenty-four to 72 hours after initial imaging, patients receive a reinjection of thallium and undergo redistribution imaging.

The ACC/AHA guidelines conclude that PET imaging “appears to have slightly better overall accuracy for predicting recovery of regional function after revascularization in patients with left ventricular (LV) dysfunction than single photon techniques (i.e., SPECT scans).”  However, the ACC guidelines indicate that either PET or SPECT scans are Class I indications for predicting improvement in regional and global LV function and natural history after revascularization, and thus do not indicate a clear preference for either PET or SPECT scans in this situation.

Further supporting the equivalency of these two testing modalities, Siebelink and colleagues performed a prospective randomized study comparing management decisions and outcomes based on either PET imaging or SPECT imaging in 103 patients with chronic coronary artery disease and left ventricular dysfunction who were being evaluated for myocardial viability. Management decisions included drug therapy or revascularization with either angioplasty or coronary artery bypass grafting. This study is unique in that the diagnostic performance of the two studies was tied to the actual patient outcomes. No difference in patient management or cardiac event-free survival was demonstrated between management based on the two imaging techniques. The authors concluded that either technique could be used for management of patients considered for revascularization with suspicion of jeopardized myocardium.

Myocardial Perfusion

In patients with symptoms suggestive of CAD, a central clinical issue is to determine whether a coronary angiogram is necessary for further work-up. A variety of non-invasive imaging tests, including PET (using rubidium-82) and SPECT scans, have been investigated as a means of identifying reversible perfusion defects, which may reflect coronary artery disease, and thus identify patients who may benefit from further work-up with an angiogram. The following table summarizes the ACC guidelines for myocardial reperfusion for both SPECT and PET scans in patients with an intermediate risk of coronary artery disease 

Indication

SPECT Class

PET Class

Identify extent, severity, and location of ischemia (SPECT protocols vary according to whether patient can exercise).

I

IIA

Repeat test after 3–5 years after revascularization in selected high-risk asymptomatic patients (SPECT protocols vary according to whether patients can exercise).

IIa

 

As initial test in patients who are considered to be at high risk (i.e., patients with diabetes or those with a more than 20% 10-year risk of a coronary disease event) (SPECT protocols vary according to whether patients can exercise).

IIa

 

Myocardial perfusion PET when prior SPECT study has been found to be equivocal for diagnostic or risk stratification purposes.

NA

I

As noted in the table, the data and consensus opinion (as reflected by a Class I designation) favors limiting a PET scan to those situations in which a prior SPECT scan is inconclusive. In the text summary, the guidelines note, “Overall, because of the higher resolution of PET and the routine application of attenuation correction, it is probable that sensitivity and specificity are slightly higher for PET compared with SPECT, but there is not a robust database of head-to-head comparisons.”  The previous 1995 version of the guidelines stated, “PET is an expensive imaging modality, and whether the greater cost of PET is justified by a possible improvement in diagnostic accuracy requires further rigorous study. Thus, until data from large-scale, definitive studies are published, PET is considered an effective modality for the noninvasive diagnosis of coronary artery disease but should be considered for routine diagnostic purposes only if the costs of PET are equivalent to or less than the costs of SPECT imaging in the same community.”  This discussion of the relative costs of PET and SPECT has been eliminated in the 2003 version of the guidelines.

Studies continued to show the equivalence of SPECT and PET. As one example, Slart and colleagues concluded that there was overall good agreement between SPECT and PET for the assessment of myocardial viability in patients with severe LV dysfunction. Comparative studies reported on test accuracy and did not address impact on clinical outcomes.  

While comparative studies were identified for SPECT compared to PET in the evaluation of CAD, the comparative data are still limited. Using a thorax-cardiac phantom, Knesaurek concluded that PET was better at detecting smaller defects. In this study, a 1 cm (centimeter) insert was not detectable by SPECT, yet it was detectable using PET. Merhige reported on outcomes of non-contemporaneous patients with similar probabilities of CAD who were evaluated by SPECT or PET. In this study involving PET scans done at one center compared to those evaluated by SPECT, those receiving PET evaluations had lower rates of angiography (13% versus 31%) and revascularization (6% versus 11%) with similar rates of death and MI at one year of follow-up. These results were viewed as preliminary and additional comparative studies showing impact on outcomes are needed. Another publication also described the PAREPET study, which will determine whether the amount of viable dysfunctional myocardium and/or sympathetic dysinnervation is associated with the risk of sudden cardiac death.

The sensitivity and specificity of PET may be slightly better than SPECT. However, their diagnostic utilities are similar in terms of altering disease risk in a manner affecting subsequent decision making among patients with intermediate pretest probability of CAD. For example, a patient with a 50% pretest probability of CAD would have a 9% post-test probability of CAD following a negative PET scan compared to 13% after a negative SPECT. In either case, further testing would not likely be pursued.

Another consideration is that there are fewer indeterminate results with PET than SPECT. A retrospective study by Bateman et al. matched 112 SPECT and 112 PET studies by gender, body mass index, and presence and extent of CAD, and they were compared for diagnostic accuracy and degree of interpretative certainty (age 65 years; 52% male; mean BMI = 32 kg/m2; 76% with CAD diagnosed on angiography). Eighteen of 112 (16%) SPECT studies were classified as indeterminate compared to 4 of 112 (4%) PET studies. Liver and bowel uptake were believed to affect 6 of 112 (5%) PET studies, compared to 46 of 112 (41%) SPECT studies. In obese patients (BMI > 30), the accuracy of SPECT was 67% versus 85% for PET; accuracy in nonobese patients was reported to be 70% for SPECT and 87% for PET. Therefore, for patients with intermediate pretest probability of coronary artery disease, one should start with SPECT testing and only proceed to SPECT in indeterminate cases. Additionally, since obese patients are more prone to liver and bowel artifact, PET testing is advantageous over SPECT in severely obese patients.

In 2005, a joint statement from the Canadian Cardiovascular Society, Canadian Association of Radiologists, Canadian Association of Nuclear Medicine, Canadian Nuclear Cardiology Society, Canadian Society of Cardiac Magnetic Resonance recommended (Class I recommendation, level B evidence) “PET scanning for patients with intermediate pretest probability of CAD who have nondiagnostic noninvasive imaging tests or where such a test does not agree with clinical diagnosis, or may be prone to artifact that could lead to an equivocal other test, such as obese patients.”

While comparative studies were identified for SPECT compared to PET in the evaluation of coronary artery disease, the comparative data are still limited. Using a thorax-cardiac phantom, Knesaurek and Machac concluded that PET was better at detecting smaller defects. In this study, a 1-cm insert was not detectable by SPECT yet it was detectable using PET. Merhige and colleagues reported on outcomes of non-contemporaneous patients with similar probabilities of coronary artery disease that were evaluated by SPECT or PET. In this study involving PET scans done at one center compared to those evaluated by SPECT, those receiving PET evaluations had lower rates of angiography (13% versus 31%) and revascularization (6% and 11%) with similar rates of death and myocardial infarction at one year of follow-up. These results are viewed as preliminary and additional comparative studies showing impact on outcomes are needed. Another publication also described the PAREPET study that will determine whether the amount of viable dysfunctional myocardium and/or sympathetic dysinnervation is associated with the risk of sudden cardiac death.

A review by Di Carli and Hachamovitch describes the current and potential diagnostic uses of cardiac PET and is in agreement with the policy statements. The Study of Perfusion and Anatomy’s Role in CAD (SPARC) trial is recruiting patients to evaluate the role of cardiac PET/CT for the diagnosis of coronary artery disease. To date, there are no articles from the PAREPET or SPARC trials.

2011 Update

Published evidence on the utility of PET scanning for cardiac sarcoidosis is limited due to the relatively small numbers of patients with this condition. A recent review article concluded that imaging studies had incremental value when combined with clinical evaluation and/or myocardial biopsy in the diagnosis of cardiac sarcoidosis. This review reported that cardiac magnetic resonance imaging (MRI) was the more established imaging modality in diagnosing sarcoidosis, with an estimated sensitivity of 100% and specificity of 80%. There is limited evidence to define the sensitivity, specificity or predictive value of PET scanning for this purpose, but it appears to have reasonably good accuracy based on small series of patients.

In 2011, BCBSA requested clinical input from physician specialty societies and academic medical centers. Based on the input BCBSA received, coverage was expanded for an additional indication on the workup of cardiac sarcoidosis. Also, clinical input received in June 2011 was generally in agreement on the medical necessity of PET for myocardial viability or for patients with an indeterminate SPECT scan. However, input varied on using a strict BMI cutoff to define patients in whom a SPECT scan would be expected to be suboptimal. Therefore, the BMI requirements have been removed and replaced with suboptimal quality SPECT scan on the basis of body habitus.

Summary

Evidence from the medical literature supports the use of PET scanning to assess myocardial viability in patients with severe LV dysfunction who are being considered for revascularization. Results of primary studies and recommendations from specialty societies conclude that PET scanning is at least as good as, and likely superior, to SPECT scanning for this purpose. For assessing myocardial perfusion in patients with suspected coronary artery disease, PET scanning is less likely than SPECT scanning to provide indeterminate results. Therefore, PET scanning is also useful in patients with an indeterminate SPECT scan, as well as in patients whose body habitus is likely to result in indeterminate SPECT scans, for example patients with moderate to severe obesity. For patients who are undergoing a workup for cardiac sarcoidosis, MRI is the preferred initial test. However, for patients who are unable to undergo MRI, such as patients with a metal implant, PET scanning is the preferred test.

OTHER APPLICATIONS

Recent review articles discuss the potential applications for PET in various neurological and psychological conditions. Henry and Van Heertum recently suggested that “interictal FDG PET can be used in presurgical epilepsy evaluations to reliably: 1) determine the side of anterior temporal lobectomy, and in children the area of multilobar resection, without intracranial electroencephalographic recording of seizures; 2) select high-probability sites of intracranial electrode placement for recording ictal onsets; and 3) determine the prognosis for complete seizure control following anterior temporal lobe resection.”  The performance data for PET localization of seizure foci has already been established. It is suggested that FDG PET might also be used to localize and minimize the placement of intracranial electrodes that could reduce the morbidity associated with intracranial monitoring, even if invasive monitoring was not avoided altogether.

Parsey and Mann state that “brain imaging is not yet part of clinical practice in psychiatry,” and describe the various PET tracers and applications currently being investigated. PET radiotracers include the use of 18F-FDG to track metabolic activity, 15-O-water as a marker for cerebral blood flow, and a variety of 11-C tagged neuroreceptor markers to study serotonergic or dopaminergic activity as well as psychotropic drug effects.

The role of PET in dementia is an active area for research but is not yet clear. The Centers for Medicare and Medicaid Services (CMS) issued a decision memorandum on April 16, 2003, that would not support coverage of FDG PET in Alzheimer’s Disease (AD) because the evidence did not demonstrate its use for improved patient outcomes. This decision was based, in part, on a technology assessment conducted at Duke University through the AHRQ Evidence-based Practice Center. This assessment used decision-analysis modeling to examine whether the use of FDG PET would improve health outcomes when used for diagnosis of AD in three clinical populations: patients with dementia, patients with mild cognitive impairment, or subjects with no symptoms but a first-degree relative with AD. PET was considered to have an 88% sensitivity (79% to 94% = 95% confidence interval [CI]) and 87% specificity (77% to 93% = 95% CI) for diagnosing AD. The report concluded that outcomes for all three groups of patients were better if all patients were treated with agents such as cholinesterase inhibitors rather than using FDG PET to select patients for treatment based on PET results, since the complications of treatment were relatively mild and treatment was considered to have some degree of efficacy in delaying the progression of AD. Thus, the adverse effect of not treating subjects with AD who had false-negative PET results was influential in this analysis. However, this conclusion was sensitive to the toxicity associated with treatment.

In October 2003, CMS accepted a petition from the University of California at Los Angeles (UCLA) School of Medicine to reconsider its policy for “use of FDG PET to distinguish patients with AD from those with other causes of symptoms confounding the diagnosis of dementia or to assist with the diagnosis of early dementia in beneficiaries for whom the differential diagnosis included one or more kinds of neurodegenerative disease, in cases where specific criteria have been met.”  On September 15, 2004, Medicare made public its final decision memorandum announcing a positive national coverage decision for a subset of patients “with a recent diagnosis of dementia and documented cognitive decline of at least six months, who meet diagnostic criteria for both Alzheimer’s disease (AD) and frontotemporal dementia (FTD), who have been evaluated for specific alternative neurodegenerative diseases or causative factors, and for whom the cause of the clinical symptoms remains uncertain.”

For its reconsideration, CMS requested an update of the original AHRQ assessment. In addition, Medicare considered a consensus report by the Neuroimaging Work Group of the Alzheimer’s Association and proceedings of an expert panel discussion of neuroimaging in AD, convened by the National Institute of Aging and Medicare.

The updated technology assessment concluded that no new publications provided direct evidence to evaluate the use of PET to either differentiate among different types of dementia or to identify those patients with mild cognitive impairment who were at greatest risk to progress to AD.

The additional sources considered by Medicare, i.e., a consensus report, and an expert panel discussion, acknowledged the lack of direct evidence. However, these sources also suggested that, based on expert opinion, PET scanning potentially provided additional information in the small subset of patients presenting with diagnostic uncertainties between AD and FTD. It should be noted that the experts also expressed serious concerns about the potential misuse of PET scanning in patients with dementia, leading to unnecessary radiation exposure and costs.

In their decision memorandum, Medicare notes that they had previously indicated that they would consider “evidence from structured expert decision analysis of clinical scenarios…” in supporting coverage of such clinical indications. The salient points of the specific coverage criteria are summarized as follows:

“The evidence is adequate to conclude that an FDG-PET scan is reasonable and necessary in patients with a recent diagnosis of dementia and documented cognitive decline of at least six months, who meet diagnostic criteria for both Alzheimer’s disease (AD) and frontotemporal dementia (FTD), who have been evaluated for specific alternative neurodegenerative diseases or causative factors, and for whom the cause of the clinical symptoms remains uncertain. The following additional conditions must be met.

The onset, clinical presentation or course of cognitive impairment is aberrant for AD and FTD is suspected as an alternative neurodegenerative cause of the cognitive decline.

The patient has had a comprehensive clinical evaluation (as defined by the American Academy of Neurology [AAN] encompassing a medical history from the patient and well-acquainted informant (including assessment of activities of daily living, physical and mental status examination aided by cognitive scales or neuropsychological testing, laboratory tests, and structural imaging such as MRI or CT scan).”

Medicare also notes that it intends to cover PET scans in "practical clinical trials" that are Medicare approved for studying the use of PET in dementia. Medicare indicated it will work with the National Institute on Aging (NIA), AHRQ, Alzheimer's Association (AA), and experts in AD and imaging to develop the trials.

In contrast to the CMS national policy, this medical policy continues to consider PET for AD and dementia as investigational, due to the lack of direct evidence that this imaging technique will result in a change in management that will improve patient outcomes.

A recent scientific statement from the AHA provides guidelines and recommendations for perfusion imaging in cerebral ischemia. The authors state that “although the development of these techniques has been fascinating, their role in evaluating a variety of diseases of the CNS [central nervous system] is controversial.”  This report mentions that “oxygen extraction fraction (OEF) as measured with PET scanning” is being used in a new national trial to help “define the patient population with occlusive vascular disease at risk for stroke and the potential of an EC-IC [extracranial-intracranial] bypass to decrease that risk.”  This report further states that “other types of perfusion imaging with challenge tests may act as surrogate techniques for the more elaborate and expensive PET-OEF technique.”

Two additional studies were identified exploring the use of FDG PET to assist in the differential diagnosis of infection in musculoskeletal conditions. Schmitz et al. evaluated 16 consecutive subjects with suspected spondylodiscitis on the basis of clinical and imaging findings who underwent surgical histopathological evaluation. Interpretation of FDG PET was blinded to clinical information and final diagnosis. This study reported that FDG PET was able to identify the presence of spondylodiscitis in all 12 subjects who had surgically proven infection (100% sensitivity). Among the four cases without evidence of infection at surgery, PET was truly negative in three cases with either degenerative changes or fracture and falsely positive in one patient who had a spinal sarcoma but no associated infection (75% specificity). A study by Manthey et al. explored the use of FDG-PET for differentiating synovitis, loosening, and infection in 23 patients who had 14 hip and 14 knee prostheses, but PET interpretations were not clearly blinded. Results found that PET identified four of four cases with periprosthetic infection and four of five cases with periprosthetic loosening, and there were true-negative PET results in three cases without evidence of infection, loosening, or synovitis. Confirmation of these favorable preliminary results in well-designed, prospective studies including larger numbers of patients is needed.

In a systematic review and meta-analysis of diagnostic imaging to assess chronic osteomyelitis, the authors reviewed studies through July 2003 on six imaging approaches to chronic osteomyelitis, including fluorodeoxyglucose PET. The study concluded that PET is the most accurate mode (pooled sensitivity = 96% [95% CI: 88%-99%]; pooled specificity = 91% [95% CI: 81%-95%]) for diagnosing chronic osteomyelitis. Leukocyte scintigraphy is adequate in the peripheral skeleton (sensitivity = 84% [95% CI: 72%-91%]; specificity = 80% [95%CI: 61%-91%]), but is inferior in the axial skeleton (sensitivity = 21% [95% CI: 11%-38%]; specificity = 60% [95%CI: 39%-78%]). The assessment of PET is based on four prospective, European studies published between 1998 and 2003, with a total of 1,660 patients. However, the study populations vary and include the following: 1) 57 patients with suspected spinal infection referred for FDG PET and who had previous spinal surgery, but not “recently;” 2) 22 trauma patients scheduled for surgery who had suspected metallic implant-associated infection; 3) 51 patients with recurrent osteomyelitis or osteomyelitis symptoms for more than six weeks, 36 in the peripheral skeleton and 15 in the central skeleton; and 4) 30 consecutive non-diabetic patients referred for possible chronic osteomyelitis. The results appear to be robust across fairly diverse clinical populations, which strengthen the conclusions. A clinical trial funded by the U.S. National Institutes of Health at the University of Pennsylvania to look at the use of FDG PET in the complicated diabetic foot started in 2002 and began enrolling patients in March 2007, toward a target of 240 patients. This trial may provide additional information on the use of PET in this specific population.

Sodium 18F-Fluoride (NaF-18) Radiotracer

Although there are ongoing trials to compare NaF-18 to traditional technetium bone scan for oncologic use, literature is sparse on uses of NaF-18 for other indications, such as osteomyelitis. The Society of Nuclear Medicine (SNM) Guideline for Sodium18 F-Fluoride PET/CT Bone Scans state that no appropriateness criteria have been developed to date, but that PET/CT 18F bone scans may be used to identify skeletal metastases. However, insufficient information exists to recommend in other conditions, which they list, including back pain, osteomyelitis, arthritis, osteonecrosis of the mandible, complications of prosthetic joints, etc.

Coding

Disclaimer for coding information on Medical Policies

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.

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers. Only the written coverage position in a medical policy should be used for such determinations.

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes

92.01-92.19, 135, 140-209.79, 345.00 – 345.91, 425.8, 730.10 – 730.19

ICD-10 Codes

C00.0-C14.8, C15.3-C15.9, C18.0-C18.9, C19, C25.0-C25.9, C30.0-C31.9, C32.0-C32.9, C34.0-C34.92, C43.0-C43.9, C50.011-C50.929, C53.0-C53.9, C56.0-C56.9, C62.00-C62.92, C73, C76.0, C80.0-C80.1, C81.00-C81.99, C82.00-C88.9, D86.85, I51.9, I50.1, G40.001-G40-919, M86.30-M86.69, C23YYZZ, C23GKZZ, C23GMZZ, C23GQZZ, C23GRZZ, C23GYZZ, CB32KZZ, CB32YZZ, CB3YYZZ, C030BZZ, C030KZZ, C030MZZ, C030YZZ, CP211ZZ, CP21YZZ, CP221ZZ, CP22YZZ, CP231ZZ, CP23YZZ, CP241ZZ, CP24YZZ, CP261ZZ, CP26YZZ, CP271ZZ, CP27YZZ, CP281ZZ, CP28YZZ, CP291ZZ, CP29YZZ, CP2B1ZZ, CP2BYZZ, CP2C1ZZ, CP2CYZZ, CP2D1ZZ, CP2DYZZ, CP2F1ZZ, CP2FYZZ, CP2G1ZZ, CP2GYZZ, CP2H1ZZ, CP2HYZZ, CP2J1ZZ, CP2JYZZ, CP2YYZZ

Procedural Codes: 78459, 78491, 78492, 78608, 78609, 78811, 78812, 78813, 78814, 78815, 78816, A9580, G0219, G0235, G0252
References

Blue Cross Blue Shield Association Technology Evaluation Center (TEC) Assessments:

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  7. PET Myocardial Perfusion Imaging for the Detection of Coronary Artery Disease - Clinical Assessment, Volume 10, No. 21, October 1995, pages 1-25.
  8. PET, SPECT, or MRS in the Differential Diagnosis of Dementias, Volume 10, No. 29, April 1996, pages 1-15.
  9. PET or SPECT in the Management of Seizure Disorders, Volume 11, No. 33, March 1997, pages 1-17.
  10. PET or SPECT in the Diagnosis and Management of Brain Tumors, Volume 11, No. 34, March 1997, pages 1-25.
  11. PET or SPECT for the Assessment of Cerebrovascular Disease, Volume 11, No. 35, March 1997, pages 1-29.
  12. FDG Positron Emission Tomography for Non-CNS Cancers, Volume 12, No. 3, May 1997, pages 1-63.
  13. PET Myocardial Perfusion Imaging for the Detection of Coronary Artery Disease - Cost Effectiveness Analysis, Special Assessment, 1998, pages 1-18.
  14. FDG Positron Emission Tomography in Colorectal CA, Volume 14, No. 25, 4/2000.
  15. FDG Positron Emission Tomography in Lymphoma, Volume 14, No. 26, 4/2000.
  16. FDG Positron Emission Tomography in Melanoma, Volume 14, No. 27, 4/2000.
  17. FDG Positron Emission Tomography in Pancreatic Cancer, Volume 14, No. 28.
  18. FDG Positron Emission Tomography in Head and Neck Cancer, Volume 15, No. 4, 6/2000.
  19. FDG Positron Emission Tomography for Evaluating Breast Cancer, Volume 16, No. 5, 8/2001
  20. FDG Positron Emission Tomography for Evaluating Esophageal Cancer, Volume 16, No. 21, 4/2002.
  21. FDG Positron Emission Tomography (PET) For the Detection of Ovarian Cancer. 6/2002.
  22. FDG Positron Emission Tomography to Manage Patients with an Occult Primary Carcinoma and Metastasis Outside the Cervical Lymph Nodes, 6/2002.

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History
November 2013  Combined the policies in oncology to detect early response during treatment, cardiac appliacation, oncologic application, and other applications into one policy.  Removed HCPCs codes A4641, A9526, A9552, and A9555.
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Positron Emission Tomography (PET)