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National Coverage Determination (NCD)

Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer

220.6.19

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Tracking Information

Publication Number
100-3
Manual Section Number
220.6.19
Manual Section Title
Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer
Version Number
2
Effective Date of this Version
12/15/2021
Ending Effective Date of this Version
Implementation Date
01/17/2022
Implementation QR Modifier Date

Description Information

Benefit Category
Diagnostic Tests (other)


Please Note: This may not be an exhaustive list of all applicable Medicare benefit categories for this item or service.

Item/Service Description

A. General

Positron Emission Tomography (PET) is a minimally-invasive, diagnostic imaging procedure that assesses the level of metabolic activity and perfusion in various organ systems of the body. A positron camera (tomograph) is used to produce cross-sectional tomographic images, which are obtained from positron-emitting radioactive tracer substances (radiopharmaceuticals) such as F-18 sodium fluoride (NaF-18).
Indications and Limitations of Coverage

B. Nationally Covered Indications

The confirmatory analyses were not published during the 24-month time period. Therefore, effective December 15, 2017, CMS determines that there are no nationally covered indications for PET NaF-18.

C. Nationally Non-Covered Indications

Effective December 15, 2017, CMS determines that PET NaF-18 PET is nationally non-covered.

D. Other

Other PET radiopharmaceutical tracers for cancer can be covered at local Medicare Administrative Contractor discretion when used according to their FDA-approved indication(s).

(This NCD last reviewed December 2017.)
Cross Reference

CED page
Claims Processing Instructions

Transmittal Information

Transmittal Number
11158
Coverage Transmittal Link
https://www.cms.gov/files/document/r11158ncd.pdf
Revision History

06/2022 - Transmittal 10832, dated June 2, 2021, is being rescinded and replaced by Transmittal 11453, dated, June 10, 2022, to revise NCD 90.2, NGS, revises business requirement 12124.2 and 12124.2.1 and its associated spreadsheet of coding by retainining all ICD-10 NOC diagnosis codes proposed for deletion effective July 1, 2022. (TN 11453) (CR12124)

12/2021 - The purpose for this change request is to update the NCD manual language to reflect that effective December 15, 2017, following the 24-month extension and absent any published, peer-reviewed journals regarding PET NaF-18 to identify bone metastases of cancer, NCD 220.6.19 reverted to a non-coverage determination. (TN 11158) (CR12526)

06/2021 - 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 10832) (CR12124)

05/2021 - 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 10804) (CR12124)

03/2021 - 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 10624) (CR12124)

02/2020 - 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 2439) (CR11655)

03/2013 - CMS translated the information for this policy from ICD-9-CM/PCS to ICD-10-CM/PCS according to HIPAA standard medical data code set requirements and updated any necessary and related coding infrastructure. These updates do not expand, restrict, or alter existing coverage policy. Implementation date: 10/07/2013 Effective date: 10/1/2015. (TN 1199) (TN 1199) (CR 8197)

03/2010 - CMS proposes that the evidence is not sufficient to determine that the results of NaF-18 PET imaging to identify bone metastases improve health outcomes of beneficiaries with cancer. Therefore CMS proposes that this use is not reasonable and necessary under Section 1862(a)(1)(A) of the Social Security Act (the Act). Effective date: 02/26/2010. Implementation date: 07/06/2010. (TN 119) (CR6861)
Other

National Coverage Analyses (NCAs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with NCAs, from the National Coverage Analyses database.

Coding Analyses for Labs (CALs)

This NCD has been or is currently being reviewed under the National Coverage Determination process. The following are existing associations with CALs, from the Coding Analyses for Labs database.

Additional Information

Other Versions
Title Version Effective Between
Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer 2 12/15/2021 - N/A You are here
Positron Emission Tomography (NaF-18) to Identify Bone Metastasis of Cancer 1 02/26/2010 - 12/15/2021 View
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Reasons for Denial
Note: This section has not been negotiated by the Negotiated RuleMaking Committee. It includes CMS’s interpretation of it’s longstanding policies and is included for informational purposes. Tests for screening purposes that are performed in the absense of signs, symptoms, complaints, or personal history of disease or injury are not covered except as explicity authorized by statue. These include exams required by insurance companies, business establishments, government agencies, or other third parties. Tests that are not reasonable and necessary for the diagnosis or treatment of an illness or injury are not covered according to the statue. Failure to provide documentation of the medical necessity of tests may result in denial of claims. The documentation may include notes documenting relevant signs, symptoms, or abnormal findings that substantiate the medical necessity for ordering the tests. In addition, failure to provide independent verification that the test was ordered by the treating physician (or qualified nonphysician practitioner) through documentation in the physician’s office may result in denial. A claim for a test for which there is a national coverage or local medical review policy will be denied as not reasonable and necessary if it is submitted without an ICD-9-CM code or narrative diagnosis listed as covered in the policy unless other medical documentation justifying the necessity is submitted with the claim. If a national or local policy identifies a frequency expectation, a claim for a test that exceeds that expectation may be denied as not reasonable and necessary, unless it is submitted with documentation justifying increased frequency. Tests that are not ordered by a treating physician or other qualified treating nonphysician practitioner acting within the scope of their license and in compliance with Medicare requirements will be denied as not reasonable and necessary. Failure of the laboratory performing the test to have the appropriate Clinical Laboratory Improvement Act of 1988 (CLIA) certificate for the testing performed will result in denial of claims.
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