Alfapump treats these fluid overload conditions that arise due to liver cirrhosis and malignant ascites. The fully implantable, wirelessly charged device continuously collects ascites as it forms in the abdominal cavity. It then moves into the bladder, where it naturally passes from the body through urination.
CMS published its Fiscal Year 2026 Hospital Inpatient Prospective Payment System (IPPS) Proposed Rule. This recommends the eligibility of Alfapump for incremental payment via a New Technology Add-On Payment (NTAP) from CMS when performed in the hospital inpatient setting.
In its proposed ruling, CMS noted that Alfapump has FDA breakthrough device designation. It received FDA approval to treat recurrent or refractory ascites due to liver cirrhosis in December 2024. The device meets NTAP requirements, according to CMS. It proposed the maximum allowable amount for an NTAP payment.
Sequana expects the proposed rule — now open for public comment — to be finalized by August 2025 and go into effect by Oct. 1, 2025.
“We applaud CMS for proposing an NTAP for the alfapump system and for their commitment to improving Medicare beneficiary access to breakthrough technologies,” said Martijn Blom Sequana CCO. “This is another step forward in our U.S. comercial launch and making this breakthrough therapy available to the large and growing US universe of patients that for too long have had to put with large volume paracentesis, a treatment that is virtually unchanged for thousands of years and has such a devastating impact on the clinical outcomes and quality of life for these patients.”
