Shockwave’s coronary IVL device gains TPT payment approval


Shockwave Medical has announced today that the Centers for Medicare & Medicaid Services (CMS) has granted approval for a Transitional Pass-Through (TPT) payment for Shockwave C2 Coronary intravascular lithotripsy (IVL) device, effective July 1 2021. The TPT status provides incremental payment for Shockwave C2 devices used in the hospital outpatient settings.

In the July 2021 Update of the Hospital Outpatient Prospective Payment System (OPPS), CMS issued a new device transitional pass-through 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 three years.

This announcement comes less than two months after CMS recommended Coronary IVL be eligible for incremental payment via a New Technology Add-on Payment (NTAP) as part of the Fiscal Year 2022 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. The intent of both the TPT and NTAP programs are 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.

The US Food and Drug Administration (FDA) granted the Shockwave C2 Coronary IVL system Breakthrough Device Designation (BDD) in 2019 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. Since 2020, CMS has provided an alternative pathway for innovative technologies that have received FDA marketing authorisation and BDD to quality for device pass-through payment.

“We thank CMS for its work to expand access to innovative medical technologies such as Coronary IVL and for their commitment to ensuring that breakthrough treatments are rapidly accessible to Medicare beneficiaries,” said Robert Fletcher, vice president of marketing and market access at Shockwave Medical. “Together with the proposed NTAP, the granting of the TPT payment means that incremental Medicare reimbursement for Coronary IVL would be available in all settings where coronary angioplasty procedures are performed, providing another important step in increasing access to our technology for patients suffering from complex, calcified coronary artery disease.”

The Shockwave IVL System with the Shockwave C2 Coronary IVL Catheter received PMA approval in February 2021 and is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting in the United States.


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