The CMS Medicare National Coverage Determinations (NCD) Manual, IOM Publication 100-03, Section 220.6, discusses Positron Emission Tomography (PET) Scans coverage. This Billing and Coding Article provides billing and coding guidance regarding the use of PET scans for several non-oncologic conditions.
Specifically, this article addresses the sections listed above in the CMS National Coverage Policy.
Coding Guidance
Notice: It is not appropriate to bill Medicare for services that are not covered as if they are covered. When billing for non-covered services, use the appropriate modifier.
This contractor has listed specific ICD-10-CM diagnosis codes as eligible for coverage of PET non-oncologic claims. However, please note 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 of the applicable NCD must be met, and the clinical documentation in the medical record must support that all of the requirements of the NCD have been met. Please see the applicable NCD section for specific information regarding the clinical documentation expected to be found in the medical record to support that all of the requirements of the NCD have been met.
This article describes the least restrictive coverage possible. Providers must read the entire applicable NCD and related documents in order to correctly understand and apply the following coding guidance. In some cases, depending on the clinical scenario, the same ICD-10-CM diagnosis code describes a condition that may be covered, covered with evidence development only, both, or non-covered.
Dementia is a good example here. While the ICD-10-CM diagnosis codes for various types of dementia appear in this article, an eligible diagnosis is only one of the elements required for coverage. NCD Section 220.6.13 for FDG PET for Dementia and Neurodegenerative Diseases has many other required elements for coverage, and they differ by indication. NCD Section 220.6.13.B.1 discusses all of the requirements for a FDG PET scan to be considered medically reasonable and necessary when used in patients who have recently been diagnosed with dementia (documented cognitive decline of at least 6 months), and who meet diagnostic criteria for both Alzheimer's disease (AD) and Fronto-temporal dementia (FTD). NCD Section 220.6.13.B.2 discusses all of the requirements for a FDG PET scan to be considered medically reasonable and necessary when used in patients with mild cognitive impairment (MCI) or early dementia in the context of a CMS-approved clinical trial. NCD Section 220.6.13.C basically states that all other uses of FDG PET for dementia remain non-covered.
Medicare has recently concluded that the use of PET Aβ imaging (when billed using CPT code 78811 or 78814 and corresponding tracer code, A9586, Q9982, or Q9983) could be promising in certain scenarios. Therefore, Medicare has decided to allow coverage for PET Aβ imaging (one PET Aβ scan per patient) through coverage with evidence development (CED) to: (1) develop better treatments or prevention strategies for AD, or, as a strategy to identify subpopulations at risk for developing AD, or (2) resolve clinically difficult differential diagnoses (e.g., FTD versus AD) where the use of PET Aβ imaging appears to improve health outcomes. Both of these clinical situations require that the patient is enrolled in an approved clinical study under CED and that the services are billed appropriately. This would include the use of modifier Q0 or Q1, ICD-10-CM code Z00.6, and an additional approved diagnosis code. Please refer to NCD 220.6.20 for Beta Amyloid PET in Dementia and Neurodegenerative Disease for complete coverage indications.
Reporting Guidelines
- Professional and Technical Components
- 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.
- Clinical Trial
- FDG PET scans performed in the context of a CMS-approved practical clinical trial utilizing a specific protocol to demonstrate the utility of FDG PET in the diagnosis and treatment of disease should be reported with the Q0 modifier (number "0", not letter "O".)
- PET and CT
- 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, 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.
- PET Radiopharmaceutical/Tracer codes A9597 or A9598 should only be used when there is no existing dedicated PET tracer code available (reference Medicare Claims Processing Manual, Chapter 13, Section 60.3.2). 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., Q0 as applicable).
Positron Emission Tomography Reference Table
CPT |
Tracer/Code |
Comment |
78608 |
FDG/A9552 |
Covered indications: Alzheimer’s disease/dementias, only when used to differentiate between Alzheimer's Disease and Fronto-temporal dementia, intractable seizures only when used as part of a pre-surgical evaluation. |
78609 |
Not Applicable |
Nationally non-covered |
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.
Other Comments
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.
Documentation Requirements
- All documentation must be maintained in the patient's medical record and made available to the contractor upon request.
- Every page of the record must be legible and include appropriate patient identification information (e.g., complete name, dates of service[s]). The documentation must include the legible signature of the physician or non-physician practitioner responsible for and providing the care to the patient.
- The submitted medical record must support the use of the selected ICD-10-CM code(s). The submitted CPT/HCPCS code must describe the service performed.