Question: The new oncology demonstration project includes a code for clinical trials. Do I need to append a demonstration project modifier to this code?
Florida Subscriber
Answer: You-re unlikely to need to append modifier QV (Item or service provided as routine care in a Medicare qualifying clinical trial) to demonstration project code G9057 (Oncology; practice guidelines; management differs from guidelines as a result of patient enrollment in an institutional review board approved clinical trial). But you may need to append QV or QR (Item or service provided in a Medicare specified study) to the patient visit code, administration code, or other code to avoid an audit.
Example: Append QR to J8520 (Capecitabine, oral, 150 mg) when the patient receives the medication as part of a clinical trial for oral drugs fighting colorectal cancer. (See Medlearn Matters MM3742 at www.new.cms.hhs.gov/MedlearnMattersArticles/downloads/MM3742.pdf.)
Check out CMS- Clinical Trial page for all the details at www.cms.hhs.gov/ClinicalTrialPolicies/.