Appeal type: Experimental/Investigational
Decision: Upheld

Diagnosis: Lung Mass

Treatment: Current Procedural Terminology (CPT) code 0239U

The insurer denied coverage for Current Procedural Terminology (CPT) code 0239U

The denial is overturned


This is a patient with a lung mass and no biopsy has been done. The treating provider has requested FoundationOne testing, which is under review.

The scientific evidence in peer-reviewed literature does support a result of improvement in the patient's health outcome.  

Next generation sequencing (NGS) panel is supported for Non-small cell lung cancer (NSCLC).      

The current procedural terminology (CPT) code 0239U does have final approval from the appropriate regulatory bodies for this diagnosis. 

FoundationOne has regulatory approval for NSCLC.     

This patient is a good candidate for the CPT code 0239U. This is blood-based testing.     

The CPT code 0239U is the best available treatment for this patient at this time. This would be valid testing as the patient is not a candidate for tissue biopsy.     

There are minimal risks for blood-based testing.
     
The requested FoundationOne testing is likely to be beneficial for this individual with lung cancer who cannot undergo tissue-based testing.

Therefore, the request for CPT code 0239U is medically necessary and is approved.

"In a hypothetical model where highly effective therapy (tx) is available to all identified patients with adenocarcinomas (ADOs), broad NGS testing compared to single gene testing (SGT) for epidermal growth factor receptor (EGFR)/anaplastic lymphoma kinase (ALK) leads to large gains in life years at reduced cost per lymphomatoid granulomatosis (LYG) compared to SGT, supporting universal NGS testing of all advanced NSCLC pts. Conversely, lower levels of testing or only testing for common ADOs (as is the current state) result in large numbers of pts being unidentified and not experiencing these benefits" (Pennell, N., et al., 2020).

"Next generation sequencing (NGS) has been an invaluable tool to put genomic sequencing into clinical practice. The incorporation of clinically relevant target sequences into NGS-based gene panel tests has generated practical diagnostic tools that enable individualized cancer patient care. The clinical utility of gene panel testing includes investigation of the genetic basis for an individual's response to therapy, such as signaling pathways associated with a response to specific therapies, microsatellite instability and a hypermutated phenotype, and deficiency in the deoxyribonucleic acid (DNA) double strand break repair pathway. In this review, we describe the concept of precision cancer medicine using target sequences in gene panel tests as well as the importance of the control of sample quality in routine NGS-based genomic testing" (Nagahashi M., et al., 2019).                                                    

In summary, the denial of Current Procedural Terminology (CPT) code 0239U and coverage for the requested service should be reversed. This treatment is likely to be more beneficial than any standard treatments for this patient's condition and the adverse risks are not substantially increased over standard treatments.