Shockwave’s Coronary IVL Eligible for NTAP in Hospital Patient Cases, Recommend CMS

April 27, 2021—Shockwave Medical, Inc. announced that the Centers for Medicare and Medicaid Services (CMS) recommended that coronary intravascular lithotripsy (IVL) cases, when performed in the hospital inpatient setting, be eligible for incremental payment via a CMS New Technology Add-On Payment (NTAP).

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 before stenting in the United States. It received FDA premarket approval in February 2021.

The recommendation was published in the CMS Fiscal Year 2022 Hospital Inpatient Prospective Payment System Proposed Rule. The proposed annual rule is now open for public comment and is expected to be finalized and in effect by October 1, 2021.

The company advised that 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 and 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 payment.