Comment on CMS-2026-1256-0002

June 9, 2026 Via Electronic Submission The Honorable Mehmet Oz, MD Administrator, Centers for Medicare & Medicaid Services U.S. Department of Health and Human Services Attention: CMS-1849-P P.O. Box 8013 Baltimore, MD 21244–8013 RE:Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals (IPPS) and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year (FY) 2027 Rates [CMS-1849-P] Dear Dr. Oz: On behalf of Sequana Medical LLC, manufacturer of the implantable alfapump system for recurrent ascites, I am pleased to submit these comments to the Centers for Medicare & Medicaid Services (CMS) in response to the Notice of Proposed Rulemaking for the Medicare Hospital Inpatient Prospective Payment System (IPPS) for FY 2027 (“the Proposed Rule.”) alfapump system received U.S. FDA Premarket Approval in December 2024 for the treatment of recurrent or refractory ascites due to liver cirrhosis. It is the first and currently only U.S.-approved active implantable medical device (Class III) that automatically and continuously removes ascites from the abdomen into the bladder. In August 2025, CMS approved the New Technology Add-on Payment for the alfapump when performed in the hospital inpatient setting, effective October 1, 2025. (1)Continuation of the NTAP for alfapump Sequana respectfully requests continuation of the New Technology Add-on Payment (NTAP) associated with alfapump implantation during the 2027 Fiscal Year. NTAP was approved for the alfapump for the first time in FY 2026 (Mearis ID# NTP240930MJNT7) and commercial cases began in January 2026. Consistent with CMS policy, we request continuation of NTAP payment in Fiscal 2027, which would be the second year of NTAP payment. (2)Preservation of the Alternative Pathways for Breakthrough Devices Sequana supports industry comments in opposing the CMS proposal to eliminate the alternative pathway for NTAP and outpatient Transitional Pass Through pathways for FDA Designated Breakthrough Devices. These pathways are vital to ensuring a predictable pathway for rapid reimbursement for life saving devices and diagnostics. The proposal by CMS for sudden dissolution of this pathway is wholly disruptive to the innovations in the pipeline and would have an immediate chilling effect on the development of therapies for Medicare patients. (3)Increased Transparency for DRG Classification Changes Sequana also supports industry comments urging CMS to clarify its process for Medicare Severity Diagnosis Related Group (MS-DRG) classification changes. Though we do not at this time propose any change in DRG assignment for alfapump cases, we do note it is essential for CMS to have a transparent, predictable process for the reclassification of services within the MS-DRG framework. This should include the opportunity for submitting companies to meet with CMS and seek reconsideration before final deferral decisions. (4)Mandatory Use of Unique Device Identifiers (UDIs) Sequana urges caution regarding proposals under consideration to mandate include UDIs on Medicare claims, as this would be overly burdensome. Though the proposed adoption of UDI reporting under electronic health records (EHRs) under the Public Health and Clinical Data Exchange objective of the Medicare Promoting Interoperability program may be a reasonable goal, we think it is premature and requires further consideration of the operational challenges that it presents. We appreciate the opportunity to comment on proposed IPPS rule and your consideration of these issues. Sincerely, Ian Crosbie Chief Executive Officer Sequana Medical NV