CMS Proposes Additional Payment for Shockwave’s Coronary IVL in Hospital Inpatient Cases
New Technology Add-on Payment (NTAP) Included in Proposed Fiscal Year 2022 Rule
SANTA CLARA, CALIF., April 27, 2021 (GLOBE NEWSWIRE) -- Shockwave Medical, Inc. (NASDAQ: SWAV), a pioneer in the development of Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced today that the Centers for Medicare and Medicaid Services (CMS) published the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule, which recommended that coronary IVL cases be eligible for incremental payment via a New Technology Add-On Payment (NTAP) from CMS when performed in the hospital inpatient setting. The proposed annual rule is now open for public comment and is expected to be finalized and in effect by October 1, 2021.
NTAP is a program designed by CMS to provide payment for qualifying new technologies in order to facilitate patient access to the new technology while CMS collects cost data. The NTAP program is intended to cover the majority of excess costs related to the new technology, though payment varies on a case-by-case basis. In its proposed ruling, CMS noted that coronary IVL is an FDA-designated Breakthrough Device that has met all the requirements for an NTAP and proposed that the maximum amount of NTAP payment for a procedure involving coronary IVL is an additional $3,666 to the hospital’s Medicare Severity Diagnosis Related Group (MS-DRG) payment.
“We applaud CMS for proposing an NTAP for Shockwave’s coronary IVL and for their commitment to improving Medicare beneficiary access to breakthrough technologies,” said Robert Fletcher, Vice President of Marketing and Market Access at Shockwave Medical. “This is another step forward in our early introduction of coronary IVL and in our mission to expand access to new technology that addresses a significant unmet need in the treatment of complex coronary artery disease.”
The Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting in the United States. It received PMA approval earlier this year in February 2021.
About Shockwave Medical, Inc.
Shockwave is focused on developing and commercializing products intended to transform the way calcified cardiovascular disease is treated. Shockwave aims to establish a new standard of care for the interventional treatment of atherosclerotic cardiovascular disease through differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL). IVL is a minimally invasive, easy-to-use and safe way to significantly improve patient outcomes. To view an animation of the IVL procedure and for more information, visit www.shockwavemedical.com.
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Source: Shockwave Medical, Inc.