Koya Medical recently announced that its wearable, active compression therapy system for lymphoedema—Dayspring—has been issued new billing codes by the Center of Medicare & Medicaid Services (CMS) in accordance with the Healthcare Common Procedure Coding System (HCPCS). According to a press release from the company, Dayspring is the first wearable and mobility-enabling active compression treatment cleared by the US Food & Drug Administration (FDA) to treat lymphoedema and other similar conditions. Providers may begin using the new codes on 1 October 1 2021.
Pre-existing reimbursement codes for lymphoedema have covered traditional pneumatic or air-based compression systems for more than three decades. Dayspring’s new code addresses what Koya Medical claims to be the 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.
Koya Medical states that 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 individualise treatment options and track utilisation.
“Securing codes from CMS is a significant step for advancing new treatment options for lymphoedema patients and their caregivers and providers,” said Andy Doraiswamy, Koya founder, president, and CEO. “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 lymphoedema.”
Published clinical data support Koya’s growth in bringing Dayspring to more patients
Koya also announced that the first of its multiple clinical studies has been published in the peer-reviewed journal Lymphatic Research and Biology. The paper “Clinical evaluation of a novel wearable compression technology in the treatment of lymphoedema, An open-label controlled 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 lymphoedema.
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<0.001) from baseline to study completion, and strong therapy adherence (98%).
“Dayspring is an important new advancement to help treat patients with lymphoedema and venous disease,” said Stanley Rockson, professor and chief of Consultative Cardiology and the director of the Stanford Center for Lymphatic and Venous Disorders at Stanford University (Stanford, USA), 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. “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.”