2020 Payment Rules from the Centers for Medicare and Medicaid Services Bring CCM Therapy to Heart Failure Patients in the Outpatient Setting
Mount Laurel, NJ, November 5, 2019 – Impulse Dynamics, developer of the implantable Optimizer Smart System for delivering Cardiac Contractility Modulation (also known as CCM™ therapy), announced that it has secured transitional pass-through (TPT) payment for the Optimizer Smart System for the treatment of heart failure. In recent rulemaking, CMS has affirmed the substantial clinical improvement CCM offers to patients with heart failure and adjusted the payment offered for the technology accordingly to facilitate access. The new payment, issued on Friday, Nov. 1, 2019 in CMS’s calendar year 2020 Outpatient Prospective Payment System (OPPS) final rule, eases access to CCM therapy in the hospital outpatient setting, with improved reimbursement taking effect on Jan. 1, 2020.
“Heart failure patients in the U.S. received much needed assistance today in their quest for access to breakthrough treatment. Clinical improvements demonstrated by CCM therapy are now within reach,” said Chris Baer, vice president of commercial operations, Impulse Dynamics. “We applaud CMS for recognizing the critical importance of improving patient access to Optimizer Smart technology. Because of this, hope is finally here for a very large population of heart failure patients who had until now gone without further treatment options.”
The Optimizer Smart System offers CCM therapy for heart failure patients with reduced ejection fraction who are still suffering from the debilitating effects of the disease despite guideline-directed medical therapy. CCM is a unique electrical therapy delivered during the heart’s absolute refractory period, which is just after the heart muscle contracts. In contrast to a pacemaker or defibrillator, CCM works by modulating the strength of the heart muscle contraction rather than the rhythm. It helps the heart contract more forcibly, increasing the efficiency of each beat.
“Finally, we have an answer for a huge population of Class III heart failure patients who experience poor quality of life despite optimal medical management,” said Dr. Gery Tomassoni an electrophysiologist and Director of Cardiology Research at Central Baptist Hospital in Lexington, KY. “I am encouraged that CMS understands the important place CCM therapy represents in the treatment continuum for heart failure. Inadequate payment presents a major barrier for providers seeking to treat patients with breakthrough technologies. This ruling helps remove that barrier and will allow us to make CCM accessible for patients that currently have few alternatives.”
The Optimizer Smart System is the only CCM device approved by the U.S. Food and Drug Administration to improve six-minute hall walk distance, quality of life and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline directed medical therapy, who are in normal sinus rhythm, are not indicated for CRT, and have a left ventricular ejection fraction (LVEF) ranging from 25 to 45 percent. CCM aims to help the 70 percent of patients with chronic heart failure that are not eligible for CRT to manage their disease.
Designed to address a significant unmet medical need in heart failure, the Optimizer Smart System received Breakthrough Device designation from the FDA in 2015. It is the only Breakthrough Device to go before an FDA Advisory Committee (the Circulatory System Devices Panel) on Dec. 4, 2018, receiving a unanimous recommendation for approval based on their assessment of benefit versus risk. Optimizer then went on to receive FDA approval on March 21, 2019.
About the Optimizer® Integra CCM-D™ System and CCM® Therapy
The Optimizer Integra CCM-D System is an investigational device that combines CCM therapy and ICD therapy into one device. This device is being used in an FDA-approved Investigational Device Exemption (IDE) study and is not available for sale in the United States.
Impulse Dynamics currently offers the Optimizer system that is FDA-approved and CE-marked. The Optimizer system delivers CCM therapy — the company’s proprietary technology — to the heart. CCM therapy has been designed by Impulse Dynamics to improve the heart’s contraction, allowing more oxygen-rich blood to be pushed out through the body. CCM therapy is indicated to improve the 6-minute hall walk, quality of life, and functional status of NYHA Class III heart failure patients who remain symptomatic despite guideline-directed medical therapy, are not indicated for CRT, and have a left ventricular ejection fraction ranging from 25 to 45 percent.
CCM therapy delivers non-excitatory electrical pulses from the implantable Optimizer device in a manner designed to improve heart contraction. CCM therapy sends unique electrical pulses to the heart cells during their absolute refractory period. Impulse Dynamics has completed numerous clinical studies, including several randomized controlled trials, and CCM therapy has been published in more than 120 peer-reviewed journal articles.
About Impulse Dynamics
Impulse Dynamics is dedicated to advancing the treatment of heart failure for patients and the healthcare providers who care for them. The company pioneered its proprietary CCM therapy, which uses the Optimizer technology platform to improve quality of life in heart failure patients. CCM therapy is delivered through the Optimizer system, which includes an IPG implanted in a minimally invasive procedure and approved for commercial use in the United States and 44 countries worldwide. More than 9,000 patients have received the therapy as part of clinical trials and real-world use, where it is proven to be safe and effective for heart failure patients with debilitating symptoms who otherwise have few effective options available to them. To learn more, visit www.ImpulseDynamics.com, or follow the company on LinkedIn, Twitter, and Facebook.
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as ‘‘may,’’ ‘‘will,’’ ‘‘should,’’ ‘‘expect,’’ ‘‘plan,’’ ‘‘anticipate,’’ ‘‘could,’’ ‘‘intend,’’ ‘‘target,’’ ‘‘project,’’ ‘‘contemplate,’’ ‘‘believe,’’ ‘‘estimate,’’ ‘‘predict,’’ ‘‘potential’’ or ‘‘continue’’ or the negative of these terms or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements include, but are not limited to, statements concerning potential benefits of CCM therapy, and CCM therapy combined with an ICD delivered via a single device (CCM-D), and the absence of risks associated therewith; the ability for CCM therapy and our products to fill a significant unmet medical need for patients with heart failure; and the short-term and long-term benefits of the Optimizer Integra CCM-D System and CCM therapy in patients with heart failure, as well as to the physicians treating those patients. These forward-looking statements are based on management’s current expectations and involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this press release include, without limitation: the company’s future research and development costs, capital requirements and the company’s needs for additional financing; commercial success and market acceptance of CCM therapy; the company’s ability to achieve and maintain adequate levels of coverage or reimbursement for Optimizer systems or any future products the company may seek to commercialize; competitive companies and technologies in the industry; the company’s ability to expand its indications and develop and commercialize additional products and enhancements to its current products; the company’s business model and strategic plans for its products, technologies and business, including its implementation thereof; the company’s ability to expand, manage and maintain its direct sales and marketing organization; the company’s ability to commercialize or obtain regulatory approvals for CCM therapy and its products, or the effect of delays in commercializing or obtaining regulatory approvals; FDA or other U.S. or foreign regulatory actions affecting us or the healthcare industry generally, including healthcare reform measures in the United States and international markets; the timing or likelihood of regulatory filings and approvals; and the company’s ability to establish and maintain intellectual property protection for CCM therapy and products or avoid claims of infringement. The company does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date of this press release.
Impulse Dynamics (USA), Inc.
50 Lake Center Executive Park, 401 Route 73 N, ‐ Building 50 Suite 100
Marlton, NJ 08053
Phone: (856) 642‐9933