March 16, 2021
VisCardia Inc., a privately held medical device developer, announced today that the American Medical Association (AMA) has issued (ten) 10 new Current Procedural Terminology (CPT®) Category III codes in support of the implant procedure and management of Synchronized Diaphragmatic Stimulation (SDS®) therapy as provided through VisCardia’s proprietary, implantable VisONE® heart failure management system.
The CPT Category III codes for SDS will be effective Jan. 1, 2022, and provide the ability to track the VisONE implant and related procedures moving forward, including during VisCardia’s anticipated US IDE study.
Heart failure is reaching epidemic proportions in the U.S. due to an aging population, as well as other factors that can weaken the heart such as prior heart attacks, infections, high blood pressure, chemotherapy, drugs/alcohol abuse or other diseases like diabetes, and certain viruses. Peter Bauer, Ph.D., CEO of VisCardia, said, “We are very excited to bring a heart failure technology to the market that promises to improve patients’ lives. The issuance of these codes is another major step to establishing appropriate reimbursement for the system in advance of commercial release.”
Less than a year ago, the U.S. Food and Drug Administration (FDA) granted VisCardia Breakthrough Device Designation for its implantable VisONE system designed for the treatment of moderate to severe heart failure with reduced ejection fraction and preserved ventricular synchrony. In addition to prioritized reviews and efficient interactions with the FDA, the Centers for Medicare & Medicaid Services (CMS) will automatically grant reimbursement coverage for FDA-designated breakthrough medical devices like VisONE for a period of four (4) years after market release under the new Medicare Coverage of Innovative Technology (MCIT) ruling.
“Combining Breakthrough Device Designation, MCIT and the new CPT Category III codes empowers VisCardia to not only expedite the delivery of its innovative technology to patients with a life-threatening and debilitating condition, but it will provide those most in need of help with healthcare coverage and earlier access to treatment,” according to Gregg Harris, Vice President of Clinical & Regulatory Affairs.
The VisONE implantable system delivers VisCardia’s proprietary Synchronized Diaphragmatic Stimulation (SDS) therapy for improving cardiac function in heart failure patients. By electrically stimulating the diaphragm in an imperceptible manner, transient intrathoracic pressures synchronized to cardiac activity are modulated, improving both cardiac filling and output. The therapy is non-invasively adjusted and programmed using an external programmer to improve hemodynamic benefit and optimize stimulation parameters.
Category III codes are temporary codes established to allow physicians and other qualified health care professionals, insurers, health services researchers, and health policy experts to identify emerging technologies, services, procedures, and service paradigms for clinical efficacy, utilization, and outcomes.
The Centers for Medicare & Medicaid Services (CMS) released a final rule creating immediate coverage for innovative products that the FDA deems as “breakthrough” status. Under the MCIT Rule, Medicare may provide national coverage simultaneously with FDA approval, up to a period of four years, after which permanent coverage will be assigned based on real-world clinical data.