Some of our clients have received denials on certain cardiovascular procedure cases (and others) whereby code Z00.6, Encounter for examination for normal comparison and control in clinical research program was not coded, and also WAS NOT in the SECOND code position on the UB-04 claim. This includes examination of participant or control in clinical research program.
Clinical trials are research studies performed in people that are aimed at evaluating a medical, surgical, or behavioral intervention. They are the primary way that researchers find out if a new treatment, like a new drug or diet or medical device (for example, a pacemaker) is safe and effective in people. Often a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the standard treatment.
Other clinical trials test ways to find a disease early, sometimes before there are symptoms. Still others test ways to prevent a health problem. A clinical trial may also look at how to make life better for people living with a life-threatening disease or a chronic health problem. Clinical trials sometimes study the role of caregivers or support groups.
Before the U.S. Food and Drug Administration (FDA) approves a clinical trial to begin, scientists perform laboratory tests and studies in animals to test a potential therapy’s safety and efficacy. If these studies show favorable results, the FDA gives approval for the intervention to be tested in humans.
See this site to search for clinical trials. https://www.clinicaltrials.gov/
Some clients have enrolled in clinical trials for certain procedures and devices or other medical treatments and are a part of the clinical trial registry. It is important for the coder to find out if their facility is participating in clinical trials and which ones they are. Not all facilities participate. Usually coders are given this information and specific instructions on the clinical trial and coding of the procedures. Coders should have this information handy when coding as it is easy to overlook the Z00.6 code and place it as the first secondary diagnosis on the claim (such as Palmetto, the Georgia MAC). Not all payors require it as the first secondary diagnosis, however some do. It is important to contact your MAC to see their requirements.
Please note that there may be other procedures not on this current list that affect your facility. Not all of the possible codes are displayed below. Coders can contact their facility on which procedures they are participating in clinical trials on.
NOTE THIS APPLIES TO BOTH INPATIENT AND OUTPATIENT PROCEDURES!
Keep in mind there may be more clinical trials going on at your facility. This is not an exhaustive list.
Check with your facility.
References
https://clinicaltrials.gov/ct2/show/NCT03209609
https://www.clinicaltrials.gov/ct2/show/NCT01702805?term=01702805&rank=1
https://www.clinicaltrials.gov/ct2/show/NCT02299414?term=02299414&rank=1
https://clinicaltrials.gov/ct2/show/NCT03089398?term=hybrid+coronary+revascularization&rank=2
https://clinicaltrials.gov/ct2/show/NCT01990612
https://clinicaltrials.gov/ct2/show/NCT01626079
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