Home

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.

Source CardiovascularNews

Duc Tin Clinic

Chia sẽ qua facebook bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua google bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua twitter bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua MySpace bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua LinkedIn bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua stumbleupon bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua icio bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua digg bài: Shockwave’s coronary IVL device gains TPT payment approval

Chia sẽ qua yahoo bài: Shockwave’s coronary IVL device gains TPT payment approval

Tin tức liên quan

Enrolment reaches midway point in trial of Early Bird bleed monitoring system

Eight-fold increased risk of heart attack seen in patients with subclinical obstructive coronary atherosclerosis

ACC 2023: REVIVED-BCIS-2 results challenge “long-held beliefs” on myocardial viability testing prior to PCI

Blood pressure successfully cut in RADIANCE II ultrasound renal denervation trial

New data examine mortality rates and cardiac damage in early-stage aortic stenosis patients

SUPPORT CONSULTANT

Make an Appointment

I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

I sincerely thank you !. Tel: 0938303275

Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.