Medicare

Coverage

The Centers for Medicare and Medicaid Services (CMS) coverage policies for Positron Emission Tomography (PET) indications are decided at a national level and are documented in a National Coverage Determination (NCD), section 220.6, and are summarized below.

Clinical Condition FDG PET	Coverage - is subject to additional guidelines set forth after the table and in the conditions and requirements of the CMS NCD described below.
Breast Cancer	Staging, restaging, and monitoring response to therapy
Cervical Cancer	Staging as an adjunct to conventional imaging
Colorectal Cancer	Diagnosis, staging and restaging
Esophageal Cancer	Diagnosis, staging and restaging
Head & Neck Cancers (excluding CNS and thyroid)	Diagnosis, staging and restaging
Lung Cancer (Non-Small Cell)	Diagnosis, staging and restaging
Lymphoma	Diagnosis, staging and restaging
Melanoma (Excludes evaluation of regional nodes)	Diagnosis, staging and restaging
Solitary Pulmonary Nodule	Characterization of indeterminate single pulmonary nodule
Thyroid Cancer	Restaging
Dementia	Differential diagnosis of fronto-temporal dementia (FTD) and Alzheimer's disease (AD) - or - CMS approved practical clinical trial
Refractory Seizures	Covered for pre-surgical evaluation to determine localization of a focus of refractory seizure activity.
Myocardial Viability	Primary or initial diagnosis, or following an inconclusive SPECT prior to revascularization

Clinical Condition NON FDG-PET	Coverage - is subject to additional guidelines set forth below and in the conditions and requirements of the CMS National Coverage Determination described below
Myocardial perfusion using Rubidium 82 tracer	Covered for noninvasive imaging of the perfusion of the heart
Myocardial perfusion using ammonia N-13 tracer	Covered for noninvasive imaging of the perfusion of the heart

General Conditions:
Regardless of any other terms or conditions, all uses of FDG PET scans, in order to be covered by the Medicare program, must meet the following general conditions as of July 1, 2001:

The provider of the PET scan should maintain on file the doctor's referral and documentation that the procedure involved only FDA approved drugs and devices, as is normal business practice.
The ordering physician is responsible for documenting the medical necessity of the study and that it meets the conditions specified in the instructions. The physician should have documentation in the beneficiary's medical record to support the referral to the PET scan provider.

For all uses of PET relating to malignancies the following conditions apply:

Diagnosis:
PET is covered only in clinical situations in which: (1) the PET results may assist in avoiding an invasive diagnostic procedure, or in which, (2) the PET results may assist in determining the optimal anatomical location to perform an invasive diagnostic procedure. In general, for most solid tumors, a tissue diagnosis is made prior to the performance of PET scanning. PET scans following a tissue diagnosis are generally performed for staging rather than diagnosis.

Note: PET is not covered as a screening test (i.e. testing of patients without specific signs and symptoms of disease).

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Staging:
PET is covered for staging in clinical situations in which: (1)(a) the stage of the cancer remains in doubt after completion of a standard diagnostic workup, including conventional imaging (computed tomography(CT), magnetic resonance imaging(MRI), or ultrasound), or (1)(b) if PET could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient; and (2) clinical management of the patient would differ depending on the stage of the cancer identified.

Restaging:
PET is covered for restaging: (1) after completion of treatment for the purpose of detecting residual disease, or (2) for detecting suspected recurrence or metastasis, or (3) to determine the extent of a known recurrence, or (4) if it could potentially replace one or more conventional imaging studies when it is expected that conventional study information is insufficient for the clinical management of the patient. Restaging applies to testing after a course of treatment is completed, and is covered subject to the conditions above.

Monitoring response to therapy:
This refers to the use of PET to monitor tumor response to treatment for locally advanced and metastatic breast cancer during the planned course of therapy (i.e., when a change in therapy is anticipated)

Breast Cancer:
Medicare covers FDG PET as an adjunct to standard imaging modalities for staging patients with distant metastasis, restaging patients with locoregional recurrence or metastasis and monitoring tumor response to treatment for locally advanced and metastatic breast cancer when a change in therapy is contemplated.

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Note: Diagnosis of breast cancer and initial staging of axillary lymph nodes are not covered by Medicare.

Cervical Cancer:
Medicare covers FDG PET as an adjunct test for the detection of pre-treatment metastases (i.e. staging) in newly diagnosed and locally advanced cervical cancer subsequent to conventional imaging (CT, MRI) that is negative for extra-pelvic metastasis.

Solitary Pulmonary Nodule:
Medicare covers FDG PET following evidence of initial detection of a primary lung tumor by CT, and the CT results indicate an indeterminate or possibly malignant lesion not exceeding 4 cm in diameter.

Note: Serial evaluation of SPN's are not covered if repeated within 90 days following a negative PET scan.

Thyroid Cancer:
Medicare covers the use of FDG PET for thyroid cancer only for restaging of recurrent or residual thyroid cancers of follicular cell origin that have been previously treated by thyroidectomy or radioiodine ablation and have a serum thyroglobulin >10ng/ml and a negative I-131 whole body scan performed.

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Dementia:
Medicare covers FDG PET scans for the differential diagnosis of fronto-temporal dementia (FTD) and Alzheimer's disease (AD) under specific requirements. These requirements are detailed in the NCD for Dementia and Neurodegenerative Diseases (220.6.1).

Additionally, in the NCD for Dementia and Neurodegenerative Diseases (220.6.13) CMS indicated that an FDG PET scan is considered reasonable and necessary in patients with mild cognitive impairment or early dementia only in the context of an approved clinical trial that contains patient safeguards and protections to ensure proper administration, use and evaluation of the FDG PET scan.

Myocardial Viability:
Medicare covers FDG PET for the determination of myocardial viability as a primary or initial diagnostic study prior to revascularization, or following an inconclusive SPECT. SPECT may not be used following an inconclusive PET scan.

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Myocardial Perfusion:
PET scans performed at rest or stress (exercise or pharmacological) are used for noninvasive imaging of the perfusion of the heart for the diagnosis and management of patients with known or suspected coronary artery disease using the FDA-approved radiopharmaceutical Ammonia N-13 or Rubidium 82 (Rb 82).

Note: PET scans are to be used in place of, but not in addition to SPECT, or can be used following an inconclusive SPECT.

Title	Description
Reimbursement Quick Reference Guide	Medicare covered indications, coverage criteria, and billing codes
Medicare Part A and Part B carriers	This link will take you to the CMS website where links to information about Medicare Part A and Part B carriers and intermediaries can be located.
CMS National Coverage Determination	Medicare's National Coverage Determination for PET detailing coverage and criteria
Medicare's National Coverage Determination on line
NCD for SPECT
Transmittal 31 Cervical Coverage
CMS National Coverage Analyses	Medicare's list of current National Coverage Analyses (NCAs)
CMS Track NCA Coverage Decisions	For more information on the NCA process and to track existing coverage requests
Medicare's National Coverage Analysis (NCA) for broad coverage	Original consideration for Positron Emission Tomography (FDG) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and Testicular Cancers (CAG-00181N)
Medicare's National Coverage Analyses (NCA) for Infection and Inflammation	Original consideration for Positron Emission Tomography (FDG) for Infection and Inflammation (CAG-00382N)
CMS NCA Tracking Sheet	Track the progress of indications submitted for CMS reimbursement
CMS NCA Comments	Comment on CMS proposed coverage
Medicare Approved Facilities	CMS facilities performing approved clinical trials

Disclaimer
This information provided by PETNET Solutions is based on published guidelines and on our experience, and is provided for general information only, as a service and at no charge to our customers. It is based on information found in published CMS National Coverage documents, but is not all-inclusive. We believe that the information set forth herein is generally accurate; however, we cannot provide assurance that it is complete, accurate or current. Always check with your local insurance carriers, as coverage may vary by region. The referring physician is responsible for pre-authorization and providing proof of medical necessity for any PET scan. PETNET Solutions and its representatives hereby expressly disclaim any and all liability for claims, including bodily injury or death, arising from any reliance on the information set forth herein.