Insert Practice Name

[INSERT DATE]

[INSERT NAME] [INSERT PRACTICE NAME] [INSERT ADDRESS 1] [INSERT ADDRESS 2] [INSERT CITY/STATE/ZIP]

Dear [INSERT NAME OF REFERRING PHYSICIAN],

The [INSERT IMAGING CENTER NAME] PET/CT imaging team would like to clarify any questions you may have regarding oncologic PET/CT coverage.

On June 11, 2013, the Centers for Medicare and Medicaid Services (CMS) issued a final decision memorandum on Positron Emission Tomography (PET) for Solid Tumors.1 This decision memorandum was in response to the request of the National Oncologic PET Registry (NOPR) to lift the requirement for Coverage with Evidence Development (CED) for NOPR-covered FDG PET indications on subsequent PET scans for oncologic purposes.

There were three specific elements of this decision:

1. CMS ended the requirement for CED for FDG PET for oncologic indications. This removes the requirement for prospective data collection by the NOPR for those cancers or cancer types that had been covered under CED.

2. CMS determined that three FDG PET scans are nationally covered when used to guide subsequent management of anti-tumor treatment strategy after completion of initial anticancer therapy. Coverage of any additional FDG PET scans (that is, beyond three) for subsequent management will be determined by local Medicare Administrative Contractors.

3. CMS will nationally cover FDG PET when used to guide subsequent anti-tumor treatment strategy of prostate cancer.

To find out more information regarding PET/CT coverage and reimbursement, please see the attached chart.

In addition, we would like to clarify several points:

 Effective for claims with dates of service on or after June 11, 2013, The National Coverage Determination allows and considers “medically necessary and appropriate” four (4) FDG PET scans per patient per unique diagnosis. This includes (1) initial treatment strategy (ITS), formerly known as “diagnosis” and “staging” and three (3) subsequent treatment strategy (STS), formerly “restaging” and “monitoring response to treatment” for the same cancer diagnosis. Coverage for additional ITS and/or STS exams is determined and controlled by the regional Medical Administrative Contractors (MAC).

 The MACs are NOT limiting reimbursement to three (3) STS scans, but are requiring documentation of medical necessity for STS PET scans beyond (3). Cases of payment beyond (3) STS PET have been documented by customers.

 Modifiers “PI” for ITS and “PS” for STS remain and a “KX” modifier should be used on STS scans beyond 3. (Please note: these modifiers are current as of the date of this letter. However, modifiers may change. You should always verify with your local MAC.)  The only exception to the above frequency is with dx 185.0, prostate cancer, which is not covered for initial treatment strategy. Therefore, all PI modifiers for 185.0 would be denied and PS modifiers would follow the same frequency as other cancer dx codes.

 Scans performed prior to 6/11/13 do NOT count in the CMS limit.

 Ensure PET scan requests contain sufficient clinical history from the patient charts to document medical necessity.

A few additional points:

 18F NaF (Sodium Fluoride) PET Bone Scans continue to accrue under CED via NOPR and other clinical trials.

 None of these restrictions apply to non-Medicare or commercially insured patients.

To review clinical appropriateness for specific patients, or to schedule a PET/CT exam, please call us at [INSERT PHONE NUMBER]. Monday through Friday, X: 00 a.m. to X: 00 p.m.

As always, we look forward to serving you and your patients at [INSERT IMAGING CENTER NAME].

Sincerely,

[INSERT NAME AND TITLE] The following table is taken from Appendix C of the National Coverage Determination2 for FDG PET for oncologic conditions effective June 11, 2013

Subsequent Treatment Tumor Type Initial Treatment Strategy Strategy Colorectal Covered Covered Esophagus Covered Covered Head and Neck (not thyroid Covered Covered or CNS) Lymphoma Covered Covered Non-small cell lung Covered Covered Ovary Covered Covered Brain Covered Covered Cervix Covered with exceptions* Covered Small cell lung Covered Covered Soft tissue sarcoma Covered Covered Pancreas Covered Covered Testes Covered Covered Prostate Non-covered Covered Thyroid Covered Covered Breast (male and female) Covered with exceptions* Covered Melanoma Covered with exceptions* Covered All other solid tumors Covered Covered Myeloma Covered Covered All other cancers not listed Covered Covered

Initial Treatment Strategy (ITS) was formerly diagnosis and initial staging. One PET scan is nationally covered by Medicare with additional scans covered at the discretion of each local Medicare Administrative Contractor.

Subsequent Treatment Strategy (STS) was formerly treatment monitoring, restaging and detection of suspected recurrence. Three PET scans are covered by Medicare with additional scans covered at the discretion of each local Medicare Administrative Contractor.

*Cervix: Nationally 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: Nationally non-covered for initial staging of regional lymph nodes. All other indications for initial anti-tumor treatment strategy for melanoma are nationally covered.

Reference: 1. 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 2. Final Decision Memorandum on Positron Emission Tomography (PET) for Solid Tumors (CAG-00191R4). Appendix C. http://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=263