Oncology & Hematology Coding Alert

Question: What diagnosis codes should I report for a Medicare patient in a qualifying diagnostic clinical trial for patients with carcinomas of the esophagus or gastro-esophageal junction?

New Hampshire Subscriber Answer: You need to report the malignancy treated, but whether you report the V code for clinical research depends on the patient's status and whether you-re sending the claim to a fiscal intermediary (FI) or a carrier.
 
Carriers/non-control group: When you submit a claim to a carrier for a patient who is not a healthy control group volunteer, you should report the disease (such as 151.0, Malignant neoplasm of stomach; cardia, for a gastro-esophageal junction neoplasm).
 
CMS does not require you to report V70.7 (Examination of participant in clinical trial) for patients not in the healthy control group. You would alert CMS that the patient is in a trial using modifier QV (Item or service provided as routine care in a Medicare qualifying clinical trial) with all procedure codes for routine services. Remember: You can't bill any non-routine services (such as the drug and screening scans to determine trial eligibility) to insurance. Charge these services to the trial sponsor or against the trial's dollar pool.
 
Carrier/control group: You-re unlikely to need to use this rule for oncology trials because they don't use healthy volunteers. But if you do submit a claim to a carrier for a healthy control group volunteer, you should report V70.7 as the primary diagnosis. You should again append QV to the procedure code.
 
If you report V70.7 as a secondary diagnosis, your carrier will process the claim as a clinical trial service, not as a service to a healthy control group volunteer.
 
FI non-control group and control group: For FI non-control group and control group claims, report V70.7 as a secondary diagnosis. You should also use condition code 30 for all services and modifier QV for the routine outpatient services only.
 
Source: See the full details online at www.cms.hhs.gov/transmittals/downloads/R487CP.pdf.
 
Eye on the future: CMS has proposed changes to the clinical trial policy, including renaming it the Clinical Research Policy (CRP) and adding new Medicare-specific coverage requirements.
 
See the draft decision memo online at www.cms.hhs.gov/mcd/viewdraftdecisionmemo.asp?id=186.