Koya Medical’s Dayspring Gains CMS Reimbursement Codes for Lymphedema

August 10, 2021—Koya Medical, which is focused on developing treatments for lymphedema and venous diseases, announced that the company’s Dayspring, a wearable, active compression therapy system for lymphedema, was issued new billing codes by the Center of Medicare & Medicaid Services (CMS) in accordance with the Healthcare Common Procedure Coding System. Providers may begin using the new codes on October 1, 2021.

In May 2021, the company announced it received FDA 510(k) clearance for the Dayspring system for the treatment of lymphedema and venous diseases that impact lymphatic flow in lower extremities. In June 2020, Koya received FDA clearance for Dayspring for upper extremities in June 2020. The company is currently conducting a limited pilot launch of Dayspring for upper extremities.

The company noted that preexisting reimbursement codes have covered traditional pneumatic or air-based compression systems for more than 3 decades. Dayspring’s new code addresses this advancement in active compression technology that supports the mobility for the user. The device delivers compression through Koya’s Flexframe technology, which uses electromechanical means and a mobile power source to deliver therapeutic pressures while enabling mobility and movements for patients.

Koya also announced the publication of findings from a clinical study using accepted and validated endpoints to evaluate the safety, efficacy, and quality of life in 40 patients who used Dayspring for 4 weeks for upper extremity lymphedema. “Clinical Evaluation of a Novel Wearable Compression Technology in the Treatment of Lymphedema, An Open-Label Controlled Study” by Stanley G. Rockson, MD, et al is available online in Lymphatic Research and Biology.

According to the company, the results showed Dayspring to be safe and effective with limb volume maintenance or improvement; significant improvements in overall and functional quality of life (18%; P < .001) from baseline to study completion; and strong therapy adherence (98%).

“Dayspring is an important new advancement to help treat patients with lymphedema and venous disease,” commented Dr. Rockson in the company’s press release. “There is already a large and growing body of evidence supporting Dayspring’s clinical effectiveness, and the product’s innovative design and features enable a very high level of patient adherence to therapy—addressing an important clinical need.”

Dr. Rockson, who serves as Koya’s Chief Medical Officer, is Professor and Chief of Consultative Cardiology and the Director of the Stanford Center for Lymphatic and Venous Disorders at Stanford University in Stanford, California. Additionally, he is Cofounder of LE&RN, the Lymphatic Education and Research Network; Director at the American Board of Venous and Lymphatic Medicine; and Editor-in-Chief of Lymphatic Research and Biology.