Koya Medical announces that its wearable, active compression therapy system for lymphedema—Dayspring— was issued new billing codes by the Center of Medicare & Medicaid Services (CMS) in accordance with the Healthcare Common Procedure Coding System (HCPCS).
Dayspring is a wearable and mobility-enabling active compression treatment cleared by the U.S. Food & Drug Administration (FDA) to treat lymphedema and other similar conditions. Providers may begin using the new codes on October 1, 2021.
Pre-existing reimbursement codes have covered traditional pneumatic or air-based compression systems for more than 3 decades. Dayspring’s new code addresses this first significant advancement in active compression technology and supports the mobility for the user, by delivering compression through Koya’s proprietary Flexframe technology, which uses electromechanical means and a mobile power source to deliver therapeutic pressures while enabling mobility and movements for patients.
Dayspring is unique from other active compression treatments and includes a low-profile active garment made of soft, breathable mesh using Flexframe technology; a smart, rechargeable, hand-held controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to individualize treatment options and track utilization, Koya Medical explains in a news release.
“Securing codes from CMS is a significant step for advancing new treatment options for lymphedema patients and their caregivers and providers. We appreciate the recognition and validation of our innovation and look forward to leveraging this milestone to expand access and to enhance treatment options for people living with lymphedema.”
— Andy Doraiswamy, PhD, Koya founder, president and CEO
Published Clinical Data
Koya also announces that the first of its multiple clinical studies has been published in the peer-reviewed journal Lymphatic Research and Biology. The study evaluated safety, efficacy and quality of life using accepted and validated endpoints in 40 subjects who used Dayspring for four weeks for upper extremity lymphedema.
The results suggest Dayspring to be safe and effective—with limb volume maintenance or improvement, significant improvements in overall and functional quality of life (18%, p<0.001) from baseline to study completion, and strong therapy adherence (98%), the release continues.
“Dayspring is an important new advancement to help treat patients with lymphedema and venous disease. 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. Stanley Rockson, professor and chief of Consultative Cardiology and the director of the Stanford Center for Lymphatic and Venous Disorders at Stanford University, co-founder of Lymphatic Education and Research Network (LE&RN), Director at the American Board of Venous and Lymphatic Medicine, and Koya’s chief medical officer
Lymphedema is a progressive, incurable condition where a buildup of protein-rich fluid causes painful swelling in the arm, leg, and/or other regions of the body. For most, lymphedema requires lifelong maintenance and various levels of therapy to control swelling and pain. Lymphedema is commonly caused by cancer and its treatment due to damage of the lymph system from the tumor itself, radiation treatment or the surgical impairment of lymph nodes.
About the Dayspring System
The Dayspring system is a wearable and mobility-enabled active compression system. It includes a low-profile active garment made of soft, breathable mesh using Koya’s proprietary Flexframe technology; a smart, rechargeable, hand-held controller that can be worn on a lanyard; and a mobile app that allows users or their clinicians to track therapy and program custom treatment options.
Dayspring is FDA 510(k) cleared to treat lymphedema and other similar conditions that impact lymphatic flow in upper and lower extremities, per the release.
[Source(s): Koya Medical, Business Wire]