Appeal type: Lab
Decision: Favorable

 
We decided that the Plan has to pay for the Nodify CDT test provided on April 12, 2022. 
 
You asked the Plan to pay for the Nodify CDT test. You say that this test is covered by Medicare and is 
medically necessary. The Plan denied your request. The Plan says that this test is considered investigational 
and is not covered. 
 
The Plan must follow Medicare rules. Medicare rules say that if there are no specific coverage rules for an item 
or service, then that item or service will be covered when it is medically necessary.  
 
We asked our physician reviewer to carefully review the case file and apply the relevant Medicare rules to 
determine if the Plan was correct in denying the request to pay for the Nodify CDT test. Our reviewer says that 
the requested items/services are considered medically reasonable and necessary in this case. Our physician 
reviewer found the enrollee is a 72 year old woman with a solitary pulmonary nodule. Per information 
provided, nodule diameter is 6 x 10 mm, non-spiculated and the member has no history of cancer. Nodify Lung 
Nodule Risk assessment testing was performed. The Nodify CDT test is a blood-based lung nodule test that 
measures a panel of seven autoantibodies (AABs) to tumor-associated antigens (TAAs) that have been shown 
to be elevated for all types of lung cancer and from the earliest stage of the disease. 3 AABs can be detected 
swiftly and accurately in blood, reportedly a median of four years prior to clinical diagnosis, due to their 
amplification as a result of the immune response to lung cancer, thus allowing detection even in early stages. 4 
By measuring the immune response to TAAs, the Nodify CDT test is a non-invasive tool that provides an 
enhanced andindependent means of estimating the probability of a pulmonary nodule (PN) being malignant. 
The Nodify CDT test has been extensively validated analytically and clinically in multi-center peer-reviewed 
studies. With high specificity, the test has been optimized to complement the high sensitivity of computed 
tomography (CT) and other highly sensitive diagnostic testing, such as the Nodify XL2 test, to help identify 
those patients with a pulmonary nodule who are, in fact, at higher risk of a lung cancer being present. Use of 
the test provides a favorable improvement of benefits over harms, and it is highly cost effective for the intended 
use. The test can be used  as an aid in the early diagnosis of lung cancer in patients with incidentally detected 
solid pulmonary nodules 830 mm and an intermediate-risk of malignancy is likely to be cost-effective by 
current standards in comparison with the common current practice of CT surveillance alone for the initial 
evaluation of such nodules. Therefore, the use of this test in this case was medically reasonable and necessary. 
 
We looked at this physician's review, the file, and Medicare rules. Based on this information, we decided that 
Medicare rules for coverage of the Nodify CDT test have been met. Therefore, we decided that the Plan has to 
pay for the Nodify CDT test provided on April 12, 2022.  
 
If the Plan does not agree with our decision, they can ask us to open a case again. We only open a case again 
if we believe there was a mistake or if there is new information to review. The Plan has to show us the mistake 
and/or send us the new information. This does not happen often. If we decide to open the case again, we will 
send you a letter.