Shockwave’s Coronary IVL Granted CMS Transitional Pass-Through Payment

June 11, 2021—Shockwave Medical, Inc., a developer of intravascular lithotripsy (IVL) to treat severely calcified cardiovascular disease, announced that the Centers for Medicare & Medicaid Services (CMS) granted approval for a Transitional Pass-Through (TPT) payment for the company’s Shockwave C2 Coronary IVL device, effective July 1, 2021.

The TPT status provides incremental payment for Shockwave C2 devices used in hospital outpatient settings, advised the company.

Shockwave Medical advised that in the July 2021 update of the Hospital Outpatient Prospective Payment System, CMS issued a new device TPT code (C1761) for use by hospitals to bill for Shockwave C2 coronary IVL catheters. In addition, as part of the payment calculation, CMS announced that a customary deduction known as a device offset will not be applied to coronary stenting procedures involving coronary IVL. The Shockwave C2 coronary IVL device will be eligible for TPT payments for 3 years.

On February 16, the company announced that the Shockwave IVL system with the Shockwave C2 coronary IVL catheter received FDA premarket approval. In the United States, the device is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic, de novo coronary arteries prior to stenting.

On April 27, the company announced that CMS recommended coronary IVL be eligible for incremental payment via a New Technology Add-on Payment (NTAP) as part of the CMS Fiscal Year 2022 Hospital Inpatient Prospective Payment System Proposed Rule. The intent of both the TPT and NTAP programs is to facilitate Medicare beneficiary access to the benefits of new and innovative devices while cost data is collected for eventual incorporation into the respective payment systems.

In September 2019, the company announced that the FDA granted a Breakthrough Device designation for the Shockwave C2 coronary IVL system based on the device’s potential to provide a more effective treatment for life-threatening or irreversibly debilitating conditions when compared to existing treatment options.