Coverage indications and limitations, including nationally non-covered conditions (e.g., the use of FDG PET imaging to determine initial treatment strategy in patients with adenocarcinoma of the prostate), are described within the IOM sections referenced above. The NCD 220.6.17 includes a chart, which summarizes coverage, and non-coverage for initial and subsequent treatment strategies for FDG PET (see below). Change Request (CR) 12482 Transmittal 11083 provides a link to the NCD 220.6.17 spreadsheet for oncologic conditions. Please follow the link under the General Information section of the CR for a list of appropriate diagnosis codes accessed at: https://www.cms.gov/files/document/r11083otn.pdf.
Please note, however, that the ICD-10-CM diagnosis code, as always, is only one piece of information in support of the medical necessity of the service. All requirements must be met, and the clinical documentation in the medical record must support all of the requirements.
Effective for dates of service on and after June 11, 2013 Medicare will cover three FDG PET scans following initial (-PI modifier) anti-cancer treatment to guide subsequent (PS modifier) management. The scans must be for the same cancer diagnosis. When reporting the subsequent FDG PET scans the -PS modifier should be appended. Any subsequent (-PS modifier) FDG PET scan beyond the third scan will also require the use of the -KX modifier. Please append a -KX modifier, in tandem with medical necessity documentation in the patient record, whenever there is a justifiable need to order additional PET scans beyond three allowable PET scans for the same cancer diagnosis.
FDG PET Coverage for Oncologic conditions (per NCD 220.6.17 for Positron Emission Tomography [FDG] for Oncologic Conditions):
| FDG PET for Cancers Tumor Type | Initial Treatment Strategy | Subsequent Treatment Strategy |
|---|---|---|
| Colorectal | Cover | Cover |
| Esophagus | Cover | Cover |
| Head & Neck (not Thyroid CNS) | Cover | Cover |
| Lymphoma | Cover | Cover |
| Non-Small Cell Lung | Cover | Cover |
| Ovary | Cover | Cover |
| Brain | Cover | Cover |
| Cervix | Cover w/exceptions* | Cover |
| Small Cell Lung | Cover | Cover |
| Soft Tissue Sarcoma | Cover | Cover |
| Pancreas | Cover | Cover |
| Testes | Cover | Cover |
| Breast (female and male) | Cover w/exceptions* | Cover |
| Melanoma | Cover w/exceptions* | Cover |
| Prostate | Non-Cover | Cover |
| Thyroid | Cover | Cover |
| All Other Solid Tumors | Cover | Cover |
| Myeloma | Cover | Cover |
| All other cancers not listed herein | Cover | Cover |
*Cervix: 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: Non-covered for initial staging of regional lymph nodes. All other indications for initial anti-tumor treatment strategy for melanoma are nationally covered.
NaF-18 PET Imaging
Effective for claims with dates of service on or after 12/15/2017, HCPCS code A9580 (NaF-18) is nationally non-covered and all associated NaF-18 PET related coding including PET scan CPT codes are also non-covered.
Reporting Guidelines
- Professional and Technical Components/Clinical Trial
- The procedure codes listed for PET scans represent the global service. Therefore, providers performing only the technical or professional component of the test should use modifier TC or -26, respectively.
- Only claims for the technical component (TC) or global service require the radioactive tracer, HCPCS A9552. Claims for the professional component (PC) do not require the tracer but must contain the appropriate -PI or -PS modifier, PET/with computed tomography (CT) HCPCS procedure code, diagnosis code, and the -26 modifier for FDG PET studies.
- PI modifier – initial treatment strategy
- PS modifier – subsequent treatment strategy
- 26 modifier – professional component
- Clinical Trial
- PET scans performed in the context of a CMS-approved practical clinical trial utilizing a specific protocol to demonstrate the utility of PET in the diagnosis and treatment of disease should be reported with the Q0 modifier (number “0” not letter “O”).
- When used in a clinical trial, the Q0 modifier should be added in addition to the TC or -26 modifier accordingly.
- For Part A claims for all PET scans, use an additional ICD-10-CM code when coding involves a Z code.
- PET and CT
- PET with concurrently acquired CT is reported with procedure codes 78814-78816 as appropriate. These codes should not be reported for PET scans performed on a non-hybrid scanner.
- If a PET scan is obtained and, on the same date of service, diagnostic CT scan(s) are obtained at a separate session, then both the PET scan and the CT scan(s) may be coded individually. If a PET/CT study is performed concurrently on a hybrid PET/CT scanner and an additional diagnostic CT scan is also obtained non-concurrently, it is appropriate to code the PET/CT scan and the diagnostic CT scan(s) separately (whether the diagnostic CT scans are performed on a hybrid PET/CT scanner or on a dedicated CT scanner). To further clarify this, the CT component of a PET/CT scan is for concurrently obtained CT scans for attenuation correction and localization and does not include any additional diagnostic CT studies that may be requested.
- When a diagnostic CT scan is performed concurrently with a PET scan, the appropriate PET scan and the appropriate diagnostic CT code may be reported. If a medically necessary diagnostic CT is performed non-concurrently with a PET/CT scan, either on the PET/CT scanner or on an independent CT scanner, the appropriate PET/CT procedure code and the diagnostic CT study(s) code may be reported.
- CPT code 78609 is a non-covered service.
- HCPCS code A4641 is not an applicable tracer for PET scans.
- The applicable PET HCPCS/CPT code and the applicable tracer HCPCS/CPT code should be reported on the same claim.
- Per TN 1854, CR 10086, effective 01/01/2017, radiopharmaceuticals A9515 and A9588 are only approved for suspected prostate cancer recurrence, therefore, they are restricted to ICD-10 diagnoses C61 Malignant neoplasm of prostate, Z85.46, personal history of malignant neoplasm of prostate, and modifier -PS. CMS continues to nationally non-cover initial anti-tumor treatment strategy in Medicare beneficiaries who have adenocarcinoma of the prostate, therefore, the PI modifier is not allowed for these diagnoses and HCPCS codes.
- Gallium ga-68 (A9587) is to be reported for somatostatin receptor positive neuroendocrine tumors.
- Copper CU-64 (A9592) may also be reported for somatostatin receptor positive neuroendocrine tumors.
- CPT code(s) 78811 or 78814 and corresponding tracer may also be reported for non-oncologic PET Aβ imaging through coverage with evidence development (CED). For additional information, please refer to NCD 220.6.20 for Beta Amyloid Positron Tomography in Dementia and Neurodegenerative Disease and Local Coverage Article A53134, NCD Coding Article for Positron Emission Tomography (PET) Scans Used for Non-Oncologic Conditions.
- PET Radiopharmaceutical/Tracer codes A9597 or A9598 should only be used when there is no existing dedicated PET tracer code available (reference TN 3911, CR 10319). Specifically, there are two circumstances that would warrant the use of A9597 or A9598 as follows: (1) After Food and Drug Administration (FDA) approval of a PET oncologic indication, or (2) after CMS approves coverage of a new PET indication, and ONLY if either of those situations requires the use of a dedicated PET radiopharmaceutical/tracer code that is currently non-existent. An appropriate PET CPT code must be on the claim when any PET radiopharmaceutical/tracer code is reported, along with any appropriate modifiers (e.g., PI, PS, or Q0 as applicable).
Positron Emission Tomography Reference Table
| CPT | Tracer/Code | Comment |
| 78608 | FDG/A9552 | Covered for dedicated PET brain tumor imaging. Note: This code is also covered for Alzheimer’s disease/dementias and intractable seizures. Please refer to A53134, NCD Coding Article for PET Scans Used for Non-Oncologic Conditions. |
| 78609 | Not Applicable | Nationally non-covered |
| 78811 | FDG/A9552 | |
| 78812 | FDG/A9552 | |
| 78813 | FDG/A9552 | |
| 78814 | FDG/A9552 | |
| 78815 | FDG/A9552 | |
| 78816 | FDG/A9552 |
Note: This table is not a comprehensive listing of covered indications. Providers should refer to the applicable NCD sections for detailed information regarding covered indications for PET scans.
Notice: It is not appropriate to bill Medicare for services that are not covered (as described by the entire NCD) as if they are covered. When billing for non-covered services, use the appropriate modifier.
Documentation Requirements:
Please refer to IOM Pub. 100-03, Medicare National Coverage Determinations Manual, Chapter 1, Part 4, Section 220.6.17 and IOM Pub. 100-04, Medicare Claims Processing Manual, Chapter 13, Section 60, for more information regarding the documentation expected to be maintained in the medical record to support medical necessity.
PET scans are covered only when performed at a PET imaging center with a PET scanner that has been approved or cleared by the FDA. When a claim is submitted, the provider is certifying this and must be able to produce a copy of this approval upon request. An official approval letter need not be submitted with the claim.
Note: Original JH Source, Local Coverage Article, A52203, NCD Coding Article for Positron Emission Tomography (PET) Scans Used for Oncologic Conditions.