Oncology & Hematology Coding Alert

Question: Medicare covers NaF-18 PET to identify bone metastasis only for patients in a clinical study. How can I prove trial participation on the claim?

Florida Subscriber

Answer: Append modifier Q0 (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) to indicate that patient is in an approved study. Wait, there's more: To stand up to scrutiny and make it through the system, your claim for NaF-18 PET or NaF-18 PET/CT to inform initial or subsequent treatment strategy "for suspected or biopsy proven bone metastasis" must meet several requirements, according to MLN Matters article MM6861 (www.cms.hhs.gov/MLNMattersArticles/downloads/MM6861.pdf), effective Feb. 26, 2010.

The claim must include all of the following:

1. A PET or PET/CT code:

• 78608 -- Brain imaging, positron emission tomography (PET); metabolic evaluation
• 78811-78813 -- Positron emission tomography (PET) imaging ...
• 78814-78816 -- Positron emission tomography (PET) with concurrently acquired computed tomography (CT) ...

2. Modifier Q0

3. Either modifier PI (Positron emission tomography [PET] or PET/computed tomography [CT] to inform the initial treatment strategy of tumors ...) OR modifier PS (Positron emission tomography [PET] or PET/computed tomography [CT] to inform the subsequent treatment strategy of cancerous ...).

4. A9580 -- Sodium fluoride F-18, diagnostic, per study dose, up to 30 millicuries

5. A cancer ICD-9 code (such as 198.5, Secondary malignant neoplasm of other specified sites; bone and bone marrow, depending on documentation).

NCD: You can read the national coverage determination (NCD) in the NCD Manual, chapter 1, part 4, section 220.6 (go to www.cms.gov/Manuals/IOM).

Note: "Although this coverage decision is effective February 26, 2010, it will not be fully implemented until a clinical study is ready to enroll providers and patients," the MLN Matters article explains.

As a reminder, ensure the patient's medical record includes the trial name, sponsor, and sponsor-assigned protocol number. Although you don't need to submit this information with the claim, your practice must provide it if requested for medical review purposes. Tip: Review Medicare Claims Processing Manual, chapter 32, section 69 (also available from www.cms.gov/Manuals/IOM) for additional claims and documentation requirements for clinical trials.