Impulse Dynamics Announces CMS Proposed Rule Would Improve Medicare Coverage of CCM Therapy Delivered by the Optimizer System

Rule would give Medicare patients immediate access to breakthrough heart failure therapy

MT. LAUREL, N.J.--(BUSINESS WIRE)--Impulse Dynamics, Inc., a company dedicated to improving the lives of people with heart failure, today announced that a proposed rule by the Centers for Medicare and Medicaid Services (CMS) could further streamline coverage of its innovative CCM^® therapy delivered by the Optimizer^® system.

The proposed Medicare Coverage of Innovative Technology (MCIT) rule builds on recent efforts to improve the quality of care for patients by easing policies applicable to coverage for breakthrough devices like Optimizer^® which delivers CCM therapy for heart failure. Medicare patients needing CCM therapy today can already expect Medicare coverage, but this newly proposed rule would make the process for accessing it faster and easier by replacing the need for numerous local coverage determinations with immediate nationwide coverage for therapies that were granted Breakthrough Device designation by the FDA and were FDA-approved in 2019 or later.

“We applaud the current administration and CMS for taking this tremendous step toward ensuring patients have immediate access to transformational and life-saving therapies,” said Simos Kedikoglou, M.D., Chief Executive Officer of Impulse Dynamics. "CCM therapy is one of these therapies and we are highly encouraged that this rule would make the coverage pathway simpler than ever for a Medicare patient who needs it.”

Once implemented, the current version of the proposed MCIT rule would provide automatic national Medicare coverage for a four-year period commencing when the Optimizer^® system received FDA-approval on March 21, 2019. The proposed rule complements provisions in other recent proposed Medicare rulemaking that have specified new technology add-on payments, and current rules that ensure transitional pass-through payments for FDA-designated breakthrough technologies. Together, these provisions have helped grant access to and adequate payments for CCM therapy to almost all Medicare patients that need the therapy today. CMS will accept public comment on the MCIT rule until November 2, 2020. The final rule is expected to take effect shortly after the public comment period ends.

“CCM is truly a breakthrough therapy because of the dramatic impact it can have on the health and overall quality of life for eligible heart failure patients who had few or no effective options available to them before,” said Gery Tomassoni, M.D., Clinical Cardiac Electrophysiologist and Chairman/Director of the Lexington Cardiology Research Foundation in Kentucky. “The beneficial effect of this rule is very important because HF patients are known to be an at-risk population for contracting Covid-19 and it will simplify their access to CCM therapy so they can stay as healthy as possible during this challenging period in human history.”

CCM therapy, delivered by the Optimizer system, is a breakthrough approach to treating heart failure that is proven to improve quality of life for suitable patients.¹ The innovative therapy is the first of its kind designed to improve contraction of the heart, allowing more oxygen-rich blood to reach the body.¹ CCM therapy delivers precisely timed electrical pulses to the heart during the absolute refractory period of the beating cycle, just after the heart contracts. The Optimizer system was granted Breakthrough Device designation by the FDA and is the first and only FDA-approved device in the U.S. or elsewhere for the delivery of CCM therapy.

CCM therapy may be an appropriate treatment option for the approximately 70 percent of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy.¹

About Impulse Dynamics

Impulse Dynamics, based in Mount Laurel, N.J., is dedicated to improving the lives of people with heart failure by transforming how the condition is treated. The company has pioneered CCM^TM therapy (cardiac contractility modulation), which is delivered by the company’s Optimizer^® system, a breakthrough, FDA-approved treatment that is proven to improve the quality of life for heart failure patients.¹ CCM therapy is a safe and effective minimally invasive treatment option for many heart failure patients who otherwise have few effective options available to them.¹ To learn more visit www.impulse-dynamics.com, or follow the company on LinkedIn and Twitter.

¹ Abraham WT, Kuck KH, Goldsmith RL, et al. A randomized controlled trial to evaluate the safety and efficacy of cardiac contractility modulation. JACC Heart Failure. 6(10), 874-883 (2018).