CMS Pub. 100-03, ch. 1, § 220.6.17

(Effective June 11, 2013)

(Rev. 173, Issued: 09-04-14, Effective: Upon Implementation: of ICD-10, Implementation: Upon Implementation of ICD-10)

A. General

FDG (2-[F18] fluoro-2-deoxy-D-glucose) Positron Emission Tomography (PET) is a minimally-invasive

diagnostic imaging procedure used to evaluate glucose metabolism in normal tissue as well as in diseased

tissues in conditions such as cancer, ischemic heart disease, and some neurologic disorders. FDG is an

injected radionuclide (or radiopharmaceutical) that emits sub-atomic particles, known as positrons, as it

decays. FDG PET uses a positron camera (tomograph) to measure the decay of FDG. The rate of FDG

decay provides biochemical information on glucose metabolism in the tissue being studied. As

malignancies can cause abnormalities of metabolism and blood flow, FDG PET evaluation may indicate

the probable presence or absence of a malignancy based upon observed differences in biologic activity

compared to adjacent tissues.

The Centers for Medicare and Medicaid Services (CMS) was asked by the National Oncologic PET

Registry (NOPR) to reconsider section 220.6 of the National Coverage Determinations (NCD) Manual to

end the prospective data collection requirements under Coverage with Evidence Development (CED)

across all oncologic indications of FDG PET imaging. The CMS received public input indicating that the

current coverage framework of prospective data collection under CED be ended for all oncologic uses of

FDG PET imaging.

1. Framework

Effective for claims with dates of service on and after June 11, 2013, CMS is adopting a coverage

framework that ends the prospective data collection requirements by NOPR under CED for all oncologic

uses of FDG PET imaging. CMS is making this change for all NCDs that address coverage of FDG PET for

oncologic uses addressed in this decision. This decision does not change coverage for any use of PET

imaging using radiopharmaceuticals NaF-18 (fluorine-18 labeled sodium fluoride), ammonia N-13, or

rubidium-82 (Rb-82).

2. Initial Anti-Tumor Treatment Strategy

CMS continues to believe that the evidence is adequate to determine that the results of FDG PET imaging

are useful in determining the appropriate initial anti-tumor treatment strategy for beneficiaries with

suspected cancer and improve health outcomes and thus are reasonable and necessary under

§1862(a)(1)(A) of the Social Security Act (the Act).

Therefore, CMS continues to nationally cover one FDG PET study for beneficiaries who have cancers that

are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’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 anti-tumor treatment strategy:

• To determine whether or not the beneficiary 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.

See the table at the end of this section for a synopsis of all nationally covered and non-covered oncologic

uses of FDG PET imaging.

B.1. Initial Anti-Tumor Treatment Strategy Nationally Covered Indications

a. CMS continues to nationally cover FDG PET imaging for the initial anti-tumor treatment strategy for

male and female breast cancer only when used in staging distant metastasis.

b. CMS continues to nationally cover FDG PET to determine initial anti-tumor treatment strategy for

melanoma other than for the evaluation of regional lymph nodes.

c. CMS continues to nationally cover FDG PET imaging for the detection of pre-treatment metastasis

(i.e., staging) in newly diagnosed cervical cancers.

C.1 Initial Anti-Tumor Treatment Strategy Nationally Non-Covered Indications

a. CMS continues to nationally non-cover initial anti-tumor treatment strategy in Medicare

beneficiaries who have adenocarcinoma of the prostate.

b. CMS continues to nationally non-cover FDG PET imaging for diagnosis of breast cancer and initial

staging of axillary nodes.

c. CMS continues to nationally non-cover FDG PET imaging for initial anti-tumor treatment strategy

for the evaluation of regional lymph nodes in melanoma.

d. CMS continues to nationally non-cover FDG PET imaging for the diagnosis of cervical cancer

related to initial anti-tumor treatment strategy.

3. Subsequent Anti-Tumor Treatment Strategy

B.2. Subsequent Anti-Tumor Treatment Strategy Nationally Covered Indications

Three FDG PET scans are nationally covered when used to guide subsequent management of anti-tumor

treatment strategy after completion of initial anti-cancer therapy. Coverage of more than three FDG PET

scans to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy shall be determined by the MACs.

4. Synopsis of Coverage of FDG PET for Oncologic Conditions

Effective for claims with dates of service on and after June 11, 2013, the chart below summarizes national

FDG PET coverage for oncologic conditions:

FDG PET for Cancers

Tumor Type

Initial Treatment Strategy

(formerly “diagnosis” &

“staging”

Subsequent Treatment

Strategy (formerly

“restaging” & “monitoring

response to treatment”

Colorectal Cover Cover

Esophagus Cover Cover

Head and Neck (not thyroid,

CNS)

Cover Cover

Lymphoma Cover Cover

Non-small cell lung Cover Cover

Ovary Cover Cover

Brain Cover Cover

Cervix Cover with exceptions * Cover

Small cell lung Cover Cover

Soft tissue sarcoma Cover Cover

Pancreas Cover Cover

Testes Cover Cover

Prostate Non-cover Cover

Thyroid Cover Cover

Breast (male and female) Cover with exceptions * Cover

Melanoma Cover with exceptions * Cover

All other solid tumors Cover Cover

Myeloma Cover Cover

All other cancers not listed Cover Cover

*Cervix: Nationally non-covered for the initial diagnosis of cervical cancer related to initial anti-tumor

treatment strategy. All oth er indications for initial anti-tumor treatment strategy for cervical cancer are

nationally covered.

*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 anti-tumor treatment

strategy for breast cancer are nationally covered.

*Melanoma: Nationally non-covered for initial staging of regional lymph nodes. All other indications for

initial anti-tumor treatment strategy for melanoma are nationally covered.

D. Other

N/A