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National Coverage Determination (NCD)

Positron Emission Tomography (PET) Scans

220.6

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Tracking Information

Publication Number
100-3
Manual Section Number
220.6
Manual Section Title
Positron Emission Tomography (PET) Scans
Version Number
6
Effective Date of this Version
01/01/2022
Ending Effective Date of this Version
04/10/2023
Implementation Date
07/05/2022
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

Effective January 1, 2022, the Centers for Medicare & Medicaid Services removed the umbrella national coverage determination (NCD) for Positron Emission Tomography (PET) Scans. In the absence of an NCD, coverage determinations for all oncologic and non-oncologic uses of PET that are not included in another NCD under section 220.6 will be made by the Medicare Administrative Contractors under section 1862(a)(1)(A) of the Social Security Act. All PET indications currently covered or non-covered under NCDs under section 220.6 remain unchanged and MACs shall not alter coverage for indications covered under NCDs.
Indications and Limitations of Coverage
Cross Reference
See NCD for SPECT (§220.12).
Claims Processing Instructions

Transmittal Information

Transmittal Number
11272
Coverage Transmittal Link
https://www.cms.gov/files/document/r11272NCD.pdf
Revision History

05/2022 - Transmittal 11272, dated February 18, 2022, is being rescinded and replaced by Transmittal 11426, dated, May 20, 2022 to revise chapter 32 of the IOM for Pub. 100-04. This correction does not make any revisions to the companion Pub. 100-02 or Pub. 100-03; all revisions are associated with Pub. 100-04. All other information remains the same. (TN 11426) (CR12613)

02/2022 - The purpose of this Omnibus change request is to make Medicare contractors aware of the updates to remove two National Determination NCDs, updates to the Medical Nutritional Therapy (MNT) policy and updates to the Pulmonary Rehabilitation (PR), Cardiac Rehabilitation (CR), and Intensive Cardiac Rehabilitation (ICR) resulting from changes specified in the calendar year 2022 Physician Fee Schedule (PFS) final rule published on November 19, 2021. (TN 11272) (CR12613)

08/2013 - Effective for dates of service on or after March 7, 2013, local Medicare Administrative Contractors (MACs) may determine coverage within their respective jurisdictions for positron emission tomography (PET) using radiopharmaceuticals for their Food and Drug Administration (FDA) approved labeled indications for oncologic imaging.
This revision to the Medicare National Coverage Determinations Manual is a national coverage determination (NCD). NCDs are binding on all carriers, fiscal intermediaries,contractors with the Federal government that review and/or adjudicate claims, determinations, and/or decisions, quality improvement organizations, qualified independent contractors, the Medicare appeals council, and administrative law judges (ALJs) (see 42 CFR section 405.1060(a)(4) (2005)). An NCD that expands coverage is also binding on a Medicare advantage organization. In addition, an ALJ may not review an NCD. (See section 1869(f)(1)(A)(i) of the Social Security Act.) Effective date 03/07/2013. Implementation date 09/03/2013. (TN 156) (CR8381)

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. (TN 108) (CR6632)

Transmittal 108, dated October 16, 2009, is being rescinded and replaced with Transmittal 120. This transmittal restores language that was inadvertently removed from section 220.6. This transmittal also updates section 220.6.17, per Transmittal 110, Change Request 6753, dated December 18, 2009. All other information remains the same.(TN 120) (CR6632)

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) (CR6632)

04/2005 - Covered as an adjunct test for detection of pre-treatment metastases (i.e., staging) in newly diagnosed cervical cancer subsequent to conventional imaging that is negative for extra-pelvic metastasis. For all remaining indications that are subject of this NCD, as well as other indications for cervical cancer not specifically mentioned, covered only when providers are participating in, and patients are enrolled in, an approved FDG PET clinical study, or an FDG PET clinical trial meeting FDA category B IDE exemption status. Effective date 01/28/2005. Implementation date 4/18/2005. (TN 31) (CR 3741)

06/2003 - Expanded coverage for noninvasive imaging of perfusion of heart using FDA-approved Ammonia N-13 tracer, and restaging of recurrent or residual thyroid cancers of follicular cell origin that have been previously treated by thyroidectomy and radioiodine ablation and have a serum thyroglobulin >10ng/ml and negative I-131 whole body scan. Also maintained national noncoverage determinations for all uses of FDG-PET for soft tissue sarcoma and dementia and neurogenerative diseases. Effective and implementation dates 10/01/2003. (TN 171) (CR 2687)

05/2002 - Provided coverage for breast cancer and broader coverage for myocardial viability. Effective and implementation dates 10/01/2002. (TN 156) (CR 2138)

11/2001 - Clarified types of allowable PET scanners. Effective and implementation dates 01/01/2002. (TN 147) (CR 1886) Reduction in coverage announced in Federal Register, 66 FR 58741.

04/2001 - Expanded coverage to include diagnosis and staging/restaging of non-small cell lung cancer, esophageal cancer, colorectal cancer, lymphoma, melanoma, head and neck cancers, myocardial viability, and refractory seizures. Effective and implementation dates July 1, 2001. (TN 136) (CR 1603)

04/1999 - Added coverage for evaluation of recurrent colorectal cancer in patients with rising levels of carcinoembryonic antigen, staging of lymphoma (both Hodgkins and non-Hodgkins) when PET scan substitutes for gallium scan, and detection of recurrent melanoma. Effective July 1, 1999. (TN 113) (CR 861)

02/1999 - Added coverage for characterization of solitary pulmonary nodules and initial staging of lung cancer. Effective date 1/1/1998. (TN 106)

05/1995 - Provided limited coverage for use in noninvasive imaging of perfusion of heart for diagnosis and management of patients with known or suspected coronary artery disease. Effective date 03/14/1995. (TN 76)
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 (PET) Scans - RETIRED 7 04/10/2023 - N/A View
Positron Emission Tomography (PET) Scans 6 01/01/2022 - 04/10/2023 You are here
Positron Emission Tomography (PET) Scans 5 03/07/2013 - 01/01/2022 View
Positron Emission Tomography (PET) Scans 4 04/03/2009 - 03/07/2013 View
PET Scans 3 01/28/2005 - 04/03/2009 View
PET Scans 2 10/01/2003 - 01/28/2005 View
PET Scans 1 10/01/2002 - 10/01/2003 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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