December 2017 Q & A

Question: Drug Eluting Balloon C2623 with CPT 36902

Our facility is performing the AV angiography of the dialysis circuit as described in CPT code 36902. The surgery department is using the device code C2623 for the drug eluting balloon that is documented as being used by the surgeon. We are receiving denials that the drug eluting balloon code does not have a matching CPT code. From what I can find, it appears that drug eluting balloon code C2623 can only be used with fem/pop procedures; is this correct?


Yes, that is the correct code for the DEB, but it is currently only approved for and being paid in femoral/popliteal lower extremity revascularization procedures. In 2018, there may not be payment from Medicare even for lower extremity revascularizations (as currently noted in the Federal Register).

The use of a DEB in the femoral/popliteal distribution has given great results in the literature. Additionally, the non-payment issue is being addressed by several physician societies, as limiting payment for these devices may result in patient care issues (not using the technology if not reimbursed even if it is better for the patient long-term outcomes). We do not know of any push for payment in the AV dialysis circuit yet.


DEB’s did receive FDA approval (PMA) for treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae up to 8cm in length. This occurred August 25, 2017. HOWEVER, this will not change issues with CMS pass-through payment for HCPCS code C2623. Use of a DEB in the AV fistula is now FDA approved, just not the payment. Restoration of payment for use of a DEB ( C2623) in AV fistulae and femoral/popliteal arteries is to be evaluated by CMS in 2018. Societies continue to work closely with CMS to obtain payment for this product.

See comments from the FDA approval letter below. Here is the full  FDA approval letter.

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the Lutonix® 035 Drug Coated Balloon PTA Catheter, Model 9010. The LUTONIX® 035 Drug Coated Balloon PTA Catheter is indicated for percutaneous transluminal angioplasty (PTA), after predilatation, for the treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length. We are pleased to inform you that the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions of approval described below.