Positron Emission Tomography (FDG) for Oncologic Conditions

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

1. 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.
2. 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.
3. 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

1. CMS continues to nationally non-cover initial anti-tumor treatment strategy in Medicare beneficiaries who have adenocarcinoma of the prostate.
2. CMS continues to nationally non-cover FDG PET imaging for diagnosis of breast cancer and initial staging of axillary nodes.
3. CMS continues to nationally non-cover FDG PET imaging for initial anti-tumor treatment strategy for the evaluation of regional lymph nodes in melanoma.
4. 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:

*Cervix: Nationally non-covered for the initial diagnosis of cervical cancer related to initial anti-tumor treatment strategy. All other 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.

N/A

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)

07/2020 - 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. (TN 10261) (CR11905)

11/2018 - 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, long-standing NCD process.(TN 2200) (CR10859)

09/2018 - 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, long-standing NCD process.(TN 2138) (CR10859)

08/2018 - 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 to 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, long-standing NCD process. (TN 2122) (CR10859)

05/2018 - 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. (TN 2076) (CR10622)

02/2018 - Transmittal 2033, dated February 16, 2018, is being rescinded and replaced by Transmittal 2039, dated, February 28, 2018 to correct instructions in business requirement 7, NCD210.3, Colorectal Cancer Screening, and its accompanying spreadsheet. All other information remains the same. (TN 2039) (CR10473)

02/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (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, long-standing NCD process. (TN 2033) (CR10473)

01/2018 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (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, long-standing NCD process. (TN 2005) (CR10318)

11/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (NCDs). These NCD coding changes are the result of newly available codes, coding revisions to NCDs released separately, or coding feedback received. (TN 1975) (CR10318)

07/2017 - This Change Request (CR) constitutes a maintenance update of International Code of Diseases, Tenth Revision (ICD-10) conversions and other coding updates specific to National Coverage Determinations (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, long-standing NCD process. (TN 1875) (CR10184)

05/2017 - This change request (CR) constitutes a maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (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, long-standing NCD process. (TN 1854) (CR10086)

02/2017 - This change request (CR) is the 10th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (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 as follows: CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, CR9631, and CR9751, as well as in 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, long-standing NCD process. (TN 1792) (CR9861)

11/2016 - This change request (CR) is the 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, and CR9631. Some are the result of revisions required to other NCD-related CRs released separately.
Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1753) (CR9751)

08/2016 - This change request (CR) is the 9th maintenance update of ICD-10 conversions and other coding updates specific to national coverage determinations (NCDs). The majority of the NCDs included are a result of feedback received from previous ICD-10 NCD CR7818, CR8109, CR8197, CR8691, CR9087, CR9252, CR9540, and CR9631. Some are the result of revisions required to other NCD-related CRs released separately.
Edits to ICD-10 and other coding updates specific to NCDs will be included in subsequent, quarterly releases as needed. No policy-related changes are included with these updates. Any policy-related changes to NCDs continue to be implemented via the current, long-standing NCD process. (TN 1708) (CR9751)

05/2014 - Transmittal 166, dated April 18, 2014, is being rescinded and replaced by Transmittal 168, dated May 28, 2014 to make a technical correction to delete information in the Pub. 100-03 NCD manual that should not have been included. All other information remains the same. (TN 168) (CR 8739)

04/2014 - Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) for Solid Tumors (This CR rescinds and fully replaces CR8468/TR2873 dated February 6, 2014) (TN 166) (CR 8739)

02/2014 - The purpose of this Change Request (CR) is effective for claims with dates of service on and after June 11, 2013, CMS shall cover three FDG PET scans when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy for the same cancer diagnosis. Coverage of any additional FDG PET scans (that is, beyond three) used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-cancer therapy for the same diagnosis will be determined by the local Medicare Administrative Contractors. Effective date 06/11/2013 Implementation date 03/07/2014 (TN 162) (CR 8468)

09/2010 - On August 4, 2010, CMS issued a final decision that determined the current absolute restriction of one PET scan for therapeutic purposes associated with the initial treatment strategy for suspected solid tumors and myeloma is not supported by available evidence. CMS will amend 220.6.17 of the National Coverage Determinations (NCD) Manual to remove the restriction of only one FDG PET scan to determine the location and/or extent of the tumor for therapeutic purposes related to initial treatment strategy and allow local Medicare contractors discretion to cover (or not cover) within their jurisdictions any additional FDG PET scans for therapeutic purposes related to initial treatment strategy. Effective date 08/04/2010 Implementation date 10/25/2010 (TN 124) (CR 7148)

12/2009 - Effective for claims with dates of service on and after November 10, 2009, CMS will end the coverage with evidence development requirements for FDG PET for cervical cancer and will cover only one FDG PET for cervical cancer for staging in beneficiaries with biopsy-proven tumors when the treating physician determines that the study is needed to determine the location and/or extent of the tumor for specific therapeutic purposes related to initial treatment strategy.

10/2009 - This change request rescinds and replaces Transmittal 106, dated September 18, 2009. The effective date has been changed to April 3, 2009 and the implementation date has been changed to October 30, 2009. Business Requirements (BR) 6632.6.1 and 6632.6.2 have been revised to clarify that they are subsets of BR 6632.6 and are specific to CED. All other information remains the same.

09/2009 - CMS is adopting a coverage framework that replaces the four-part diagnosis, staging, restaging and monitoring response to treatment categories with a two-part framework that differentiates FDG PET imaging used to inform the initial antitumor treatment strategy from other uses related to guiding subsequent antitumor treatment strategies after the completion of initial treatment. CMS is making this change for all NCDs that address coverage of FDG PET for all oncologic conditions. Effective date 04/06/2009 Implementation date 10/19/2009 (TN 106) (CR 6632)