CMS announced the new codes on Nov. 1 as part of final rules for the 2018 Medicare Physician Fee Schedule (CMS-1676-F) and Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (CMS-1678-FC), according to Medtronic officials. The new rules take effect Jan. 1, 2018, with healthcare providers able to bill VenaSeal as a level 4 procedure under the new CPT codes 36482 and 35483.
“This definitely represents progress for us as we seek positive coverage for VenaSeal,” said Medtronic spokesperson Julia Baron.
The VenaSeal system uses a proprietary adhesive to close superficial veins in lower extremities in people suffering from symptomatic venous reflux, or varicose veins. Earlier this year, Medtronic released three-year outcomes and one-year data that demonstrated long-term clinical benefits and quality of life improvements for patients.
The procedure, however, remains under a self-pay model since its FDA clearance and U.S. launch in 2015.
“Medtronic has been working to pursue payer coverage, and we will continue to provide updates over the next several months as we work with regional Medicare Administrative Contractors (MACs) and private payers to obtain that coverage,” said Sandra Lesenfants, VP and general manager of Medtronic endoVenous.
About a fifth of all adults will suffer from varicose veins at some point in their lives, according to the U.S. National Library of Medicine. So the market is huge. While the condition rarely causes serious health problems, it negatively impacts quality of life. People with varicose veins can feel muscle cramping and heaviness in their legs. Plus, the veins look bad.
Medtronic touts VenaSeal as the only non-tumescent, non-thermal and non-sclerosant procedure, so it avoids the risk of nerve injury sometimes associated with certain thermal based treatments of the small saphenous vein presently in use, according to Medtronic. The VenaSeal closure system is also designed to allow rapid recovery with minimal downtime; people may not even need to use compression stockings after undergoing the procedure.
“While we cannot discuss market share, we do believe payer coverage will provide additional patient access and ultimately drive additional adoption and growth for VenaSeal,” Lesenfants said.