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Initial treatment strategy includes diagnosis and initial staging.

The Centers for Medicare and Medicaid Services (CMS) covers, with certain limitations for melanoma, breast and cervical cancers, one ¹⁸F FDG PET study, per patient per cancer type, for initial treatment strategy for all cancers (except prostate cancer, which is not covered) that are biopsy proven or strongly suspected based on other diagnostic testing when the beneficiary’s treating physician determines that the ¹⁸F FDG PET study is needed to determine the location and/or extent of the tumor for the following therapeutic purposes related to the initial treatment strategy:

• To determine whether or not the beneficiary is an appropriate candidate for an invasive diagnostic or therapeutic procedure; or,
• To determine the optimal anatomic location for an invasive procedure; or,
• To determine the anatomic extent of tumor when the recommended anti-tumor treatment reasonably depends on the extent of the tumor

Local Medicare Administrative Contractors (MACs) have the discretion to cover or not cover within their jurisdictions any additional ¹⁸F FDG PET scans for initial treatment strategy as described above.¹

Taken from the Medicare Claims Processing Manual revised July 2007²:

The following modifiers have been created for use to inform for the initial treatment strategy of biopsy-proven or strongly suspected tumors:

PI – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the initial treatment strategy of tumors that are biopsy proven or strongly suspected of being cancerous based on other diagnostic testing.

Short descriptor: PET tumor init tx strat

The transmittals can be found on the following Internet pages:

http://www.cms.hhs.gov/transmittals/downloads/R1833CP.pdf
http://www.cms.hhs.gov/transmittals/downloads/R108NCD.pdf

References:

1. Transmittal 120.

http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R120NCD.pdf

1. Medicare Claims Processing Manual revised July 2007, Chapter 13, Section 60.16 Billing and Coding for PET Scans Effective for Services on or After April 3, 2009. (Rev. 1888, Issued: 01-06-10, Effective: 11-10-09, Implementation: 01-04-10)

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf

Subsequent treatment strategy includes monitoring tumor response to treatment during a planned course of therapy when a change in treatment is being considered and restaging after the completion of treatment to detect residual disease, or to detect suspected recurrence or to assess the extent of a known recurrence. The Centers for Medicare and Medicaid Services (CMS) nationally covers three ¹⁸F FDG PET scans when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-tumor therapy. Coverage of more than three ¹⁸F FDG PET scans to guide subsequent management of anti-tumor treatment strategy after completion of initial anti-tumor therapy shall be determined by the local Medicare Administrative Contractors.²

Local Medicare Administrative Contractors (MACs) have the discretion to cover or not cover within their jurisdictions any additional 18F FDG PET scans for initial treatment strategy as described above.¹

Taken from the Medicare Claims Processing Manual revised July 2007²:

The following modifiers have been created for use to inform for the subsequent treatment strategy of cancerous tumors:

PS – Positron Emission Tomography (PET) or PET/Computed Tomography (CT) to inform the subsequent treatment strategy of cancerous tumors when the beneficiary’s treatment physician determines that the PET study is needed to inform subsequent anti-tumor strategy.

Short descriptor: PS - PET tumor subsq tx strategy

The transmittals can be found on the following Internet pages:

http://www.cms.hhs.gov/transmittals/downloads/R1833CP.pdf
http://www.cms.hhs.gov/transmittals/downloads/R108NCD.pdf

References:

1. Transmittal 120. http://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R120NCD.pdf
2. Medicare Claims Processing Manual revised July 2007, Chapter 13, Section 60.16 Billing and Coding for PET Scans Effective for Services on or After April 3, 2009. (Rev. 1888, Issued: 01-06-10, Effective: 11-10-09, Implementation: 01-04-10)

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf

PET’s ability to measure cerebral metabolism and blood flow makes it valuable in certain neurological applications, such as refractory epilepsy.

Refractory Seizures

Medicare covers ¹⁸F FDG PET for the presurgery evaluation for the purpose of localization of a focus of refractory seizure activity.1

Current Procedural Terminology (CPT) Codes

• 78608 – Brain imaging, PET, metabolic evaluation for presurgical evaluation of refractory seizure
• A9552 – Fluorodeoxyglucose F18, FDG, diagnostic, per study dose

Brain Tumor
Brain tumors are covered under the decision memorandum on PET for Solid Tumors (see FAQ 2).^1,2

Current Procedural Terminology (CPT) Codes

• 78608 – Brain imaging, PET, metabolic evaluation for brain tumor
• A9552 – Fluorodeoxyglucose F18, FDG, diagnostic, per study dose

View the CMS neurology coverage determination at
http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_part4.pdf

References:

• Medicare Claims Processing Manual revised July 2007, Chapter 13, Section 60.3.2 Tracer Codes Required for PET Scans. (Rev. 2096, Issued: 11-19-10, Effective: 02-26-10, Implementation: 02-22-11) can be found at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf
• Appendix C of the Final Decision Memorandum on Positron Emission Tomography (PET) for Solid Tumors (CAG-00191R4) http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=263

The information below is taken from Medicare National Coverage Determinations Manual¹:

The identification of patients with partial loss of heart muscle movement or hibernating myocardium is important in selecting candidates with compromised ventricular function to determine appropriateness for revascularization. Diagnostic tests such as ¹⁸F FDG PET distinguish between dysfunctional but viable myocardial tissue and scar tissue in order to affect management decisions in patients with ischemic cardiomyopathy and left ventricular dysfunction.

Medicare covers ¹⁸F FDG PET for the determination of myocardial viability as a primary or initial diagnostic study prior to revascularization, or following an inconclusive SPECT.

Limitations: In the event a patient receives a SPECT test with inconclusive results, a PET scan may be covered. However, if a patient receives a ¹⁸F FDG PET study with inconclusive results, a follow up SPECT test is not covered.

Documentation that these conditions are met should be maintained by the referring physician in the beneficiary’s
medical record, as is normal business practice.¹

Medicare covers ¹⁸F FDG PET to assess myocardial viability following an inconclusive SPECT or as a primary or initial diagnostic study prior to revascularization.²

Current Procedural Terminology (CPT) Codes

• 78459 – Myocardial imaging, PET, metabolic evaluation
• A9552 – ¹⁸F FDG, per dose

References:

Medicare National Coverage Determinations Manual Chapter 1, Part 4 (Section 220.6.8 FDG PET for Myocardial Viability (Various Effective Dates) (Rev. 31; Issued: 04-04-05; Effective Date: 01-28-05; Implementation Date: 04-18-05) http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_part4.pdf
Medicare Claims Processing Manual revised July 2007, Chapter 13, Section 60.3.2 Tracer Codes Required for PET Scans. (Rev. 2096, Issued: 11-19-10, Effective: 02-26-10, Implementation: 02-22-11) can be found at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf

The information below is taken from Medicare National Coverage Determinations Manual¹:

PET scans performed at rest or with pharmacological stress 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 ¹³N NH3 ammonia are covered, provided the requirements below are met:

The PET scan, whether at rest alone, or rest with stress, is performed in place of, but not in addition to, a SPECT; or
The PET scan, whether at rest alone or rest with stress, is used following a SPECT that was found to be inconclusive. In these cases, the PET scan must have been considered necessary in order to determine what medical or surgical intervention is required to treat the patient. (For purposes of this requirement, an inconclusive test is a test whose results are equivocal, technically uninterpretable, or discordant with a patient’s other clinical data and must be documented in the beneficiary’s file.)¹

Medicare covers PET exams to assess myocardial perfusion in place of, but not in addition to SPECT or following an inconclusive SPECT.²

Current Procedural Terminology (CPT) Codes
• 78491 – Myocardial imaging, PET, perfusion; single study at rest or stress
• 78492 – Myocardial imaging, PET, perfusion; multiple studies at rest or stress
• A9555 – 82Rubidium, diagnostic, per study dose, up to 60 millicuries
• A9526 – 13N Ammonia, diagnostic, per study dose, up to 40 millicuries

References:

• Medicare National Coverage Determinations Manual Chapter 1, Part 4 (Section 220.6.1 PET for Perfusion of the Heart (Various Effective Dates) (Rev. 120; Issued: 05-06-10; Effective Date: 04-03-09; Implementation Date: 10-30-09) http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_part4.pdf
• Medicare Claims Processing Manual revised July 2007, Chapter 13, Section 60.3.2 Tracer Codes Required for PET Scans. (Rev. 2096, Issued: 11-19-10, Effective: 02-26-10, Implementation: 02-22-11) can be found at: http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf

Coverage for sodium fluoride F 18 (¹⁸F NaF) PET imaging is included under the Coverage with Evidence Development (CED) to: “assist initial antitumor treatment planning or to guide subsequent treatment strategy by the identification, location and quantification of bone metastases in beneficiaries in whom bone metastases are strongly suspected based on clinical symptoms or the results of other diagnostic studies.”¹

The National Oncologic PET Registry (NOPR) enrolls patients for ¹⁸F NaF Bone PET studies and reimburses ¹⁸F NaF PET scans when the beneficiary is enrolled in, and the ¹⁸F NaF PET provider and treating physician are participating in, the NOPR clinical study.

For more information, visit the NOPR website:
www.cancerpetregistry.org

Taken from Medicare Claims Processing Manual revised July 2007²:

Medicare covered PET procedures for bone scans should be reported using CPT® codes as well as the applicable Healthcare Procedure Coding System (HCPCS) Level II code for the radiopharmaceutical. According to CMS, effective for claims with dates of service on or after February 26, 2010, contractors shall accept PET oncologic claims billed with modifier 26 and modifier KX to inform the initial treatment strategy or strategy or subsequent treatment strategy for bone metastasis that include the following:

PI or PS modifier AND
PET or PET/CT CPT code (78811, 78812, 78813, 78814, 78815, 78816) AND
ICD-9 cancer diagnosis code AND
Q0 modifier – Investigational clinical service provided in a clinical research study, are present on the claim.

NOTE:

If modifier KX is present on the professional component service, Contractors shall process the service as ¹⁸F NaF PET rather than ¹⁸F FDG PET.
Contractors shall also return as unprocessable ¹⁸F NaF PET oncologic professional component claims (e.g., claims billed with modifiers 26 and KX).

References:

Medicare National Coverage Determinations Manual Chapter 1, Part 4 Section 220.6.19 Positron Emission Tomography (NaF-18 PET) to Identify Bone Metastases of Cancer (Effective February 26, 2010) (Rev. 119, Issued 03-26-10, Effective 02-26-10, Implementation 07-06-10) http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/ncd103c1_part4.pdf
Medicare Claims Processing Manual revised July 2007, Chapter 13, Section 60.18 Billing and Coverage Changes for PET (NaF-18) Scans to Identify Bone Metastases of Cancer Effective for Claims with Dates of Services on or After February 26, 2010 (Rev. 2096, Issued: 11-19-10, Effective: 02-26-10, Implementation: 02-22-11) http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c13.pdf

*FLUDEOXYGLUCOSE F 18 INJECTION

For Intravenous Use

INDICATIONS AND USAGE
Fludeoxyglucose F 18 injection (¹⁸F FDG) is indicated for positron emission tomography (PET) imaging in the following settings:

Oncology: For assessment of abnormal glucose metabolism to assist in the evaluation of malignancy in patients with known or suspected abnormalities found by other testing modalities, or in patients with an existing diagnosis of cancer.

Cardiology: For the identification of left ventricular myocardium with residual glucose metabolism and reversible loss of systolic function in patients with coronary artery disease and left ventricular dysfunction, when used together with myocardial perfusion imaging.

Neurology: For the identification of regions of abnormal glucose metabolism associated with foci of epileptic seizures.

IMPORTANT SAFETY INFORMATION
Radiation Risks: Radiation-emitting products, including fludeoxyglucose F 18 injection, may increase the risk for cancer, especially in pediatric patients. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Blood Glucose Abnormalities: In the oncology and neurology setting, suboptimal imaging may occur in patients with inadequately regulated blood glucose levels. In these patients, consider medical therapy and laboratory testing to assure at least two days of normoglycemia prior to fludeoxyglucose F18 injection administration.

Adverse Reactions: Hypersensitivity reactions with pruritus, edema and rash have been reported; have emergency resuscitation equipment and personnel immediately available.

Siemens' PETNET Solutions is a manufacturer of Fludeoxyglucose F18 Injection (¹⁸F FDG). Indication and important safety information as approved by the US Food and Drug Administration can be found at the links below for ¹⁸F FDG, adult dose 5-10 mCi, administered by intravenous injection.

*AMMONIA N 13 INJECTION
For Intravenous Use

INDICATIONS AND USAGE
Ammonia N 13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease.

IMPORTANT SAFETY INFORMATION
Radiation Risks: Ammonia N 13 Injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Adverse Reactions: No adverse reactions have been reported for Ammonia N 13 Injection based on a review of the published literature, publicly available reference sources and adverse drug reaction reporting systems. However, the completeness of these sources is not known.

Siemens' PETNET Solutions is a manufacturer of Ammonia N 13 Injection. Indication and important safety information as approved by the US Food and Drug Administration can be found at the links below for ¹³N Ammonia, adult dose 8-12 mCi, administered by intravenous injection.

*SODIUM FLUORIDE F 18 INJECTION
For Intravenous Use

INDICATIONS AND USAGE
Sodium Fluoride F 18 Injection is a radioactive diagnostic agent for positron emission tomography (PET) indicated for imaging of bone to define areas of altered osteogenic activity.

IMPORTANT SAFETY INFORMATION

Allergic Reactions: As with any injectable drug, allergic reactions and anaphylaxis may occur. Emergency resuscitation equipment and personnel should be immediately available.

Cancer Risk: Sodium fluoride F18 injection may increase the risk of cancer. Use the smallest dose necessary for imaging and ensure safe handling to protect the patient and health care worker.

Adverse Reactions: No adverse reactions have been reported for Sodium Fluoride F 18 based on a review of the published literature, publicly available reference sources, and adverse drug reaction reporting systems.

Siemens' PETNET Solutions is a manufacturer of Sodium Fluoride F 18 Injection (¹⁸F NaF). Indication and important safety information as approved by the US Food and Drug Administration can be found at the links below for sodium fluoride ¹⁸F NaF, adult dose 8-12 mCi, administered by intravenous injection.

Full Prescribing Information Sodium Fluoride F 18 Injection (8-12 mCi) as an intravenous injection in adults