NCD 220.6.17: Positron Emission Tomography (FDG) for Oncologic Conditions

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

• 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.

• 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.

• CMS continues to nationally cover FDG PET imaging for the detection of pre-treatment metastasis (i.e., staging) in newly diagnosed cervical cancers following conventional imaging.

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

• CMS continues to nationally non-cover initial anti-tumor treatment strategy in Medicare beneficiaries who have adenocarcinoma of the prostate.

• CMS continues to nationally non-cover FDG PET imaging for diagnosis of breast cancer and initial staging of axillary nodes.

• CMS continues to nationally non-cover FDG PET imaging for initial anti-tumor treatment strategy for the evaluation of regional lymph nodes in melanoma.

• 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 local Medicare Administrative Contractors.

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

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08/2026 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 13903 ) (CR14570)

04/2026 - Transmittal 13623 issued February 05, 2026, is being rescinded and replaced by Transmittal 13760, dated April 30, 2026, to remove business requirement 14356.4 and the corresponding spreadsheet for NCD 250.4 Treatment of Actinic Keratosis as this NCD was moved to the October 2026 CR. All other information remains the same. ( TN 13760 ) (CR14356)

02/2026 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 13623 ) (CR14356)

09/2025 - Transmittal 13383 issued August 26, 2025, is being rescinded and replaced by Transmittal 13401,

dated September 9, 2025, to add a new attachment to ensure the functionality of the NCD zip URL is working properly and to update the Policy section. All other information remains the same.

The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). ( TN 13401 ) (CR14194)

10/2024 - The purpose of the Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations(NCDs). No policy is being changed as a result of these updates. ( TN 12904 ) (CR13828)

02/2024 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. ( TN 12493 ) (CR13507)

01/2024 - Transmittal 12350 issued November 03, 2023, is being rescinded and replaced by Transmittal 12440 dated January 3, 2024, to make changes to NCD 90.2, Next Generation Sequencing, spreadsheet to align with revisions being made to CR 13278. All other information remains the same. ( TN 12440 ) (CR13391)

11/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates.( TN 12350 ) (CR13391)

10/2023 - The purpose of this Change Request (CR) is to provide a quarterly maintenance update of ICD-10 coding conversions and other coding updates specific to National Coverage Determinations (NCDs). No policy is being changed as a result of these updates. ( TN 12319 ) (CR13391)

10/2022 - Transmittal 11546, dated August 4, 2022, is being rescinded and replaced by Transmittal 11636, dated, October 5, 2022, to remove ICD-10 dx codes added in error to NCD 150.3, business requirement 12842.4, and restore ICD-10 dx C91.92 removed in error to NCD 110.23, business requirement 12842.3. All other information remains the same. ( TN 11636 ) (CR12842)

08/2022 - The purpose of this Change Request (CR) is to provide a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. ( TN 11546 ) (CR12842)

10/2021 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. ( TN 11083 ) (CR12482)

01/2021 - Transmittal 10515, dated December 10, 2020, is being rescinded and replaced by Transmittal 10566, dated, January 14, 2021 to remove FISS Reason Codes (RCs) 59041, 59042, 59209, and 59210 from the spreadsheet for NCD 160.18. All other information remains the same. ( TN 10566 ) (CR12027)

12/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. ( TN 10515 ) (CR12027)

10/2020 - This Change Request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to NCDs. These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received.

Previous NCD coding changes appear in ICD-10 quarterly updates that can be found at: https://www.cms.gov/Medicare/Coverage/CoverageGenInfo/ICD10.html , along with other CRs implementing new policy NCDs. Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent quarterly releases and individual CRs as appropriate. No policy-related changes are included with the ICD-10 quarterly updates. Any policy-related changes to NCDs continue to be implemented via the current, longstanding NCD process. ( TN 10432 ) (CR12027)