HRS Lends Advocacy Support to Secure Access to Dual-Chamber Leadless Pacemaker in the Outpatient Setting

Concerns about the reimbursement levels for the device in the outpatient setting, where CMS has yet to recognize the device for separate payment outside of its typical outpatient hospital bundled payment methodology, prompted the meeting. The discussion included a request that CMS consider the devices for "pass through payment" under the Hospital Outpatient Prospective Payment System (OPPS), where the device would be separately reimbursed until a permanent, appropriately priced bundled payment assignment can be made. If hospitals are reimbursed under OPPS at rates that do not cover the costs of the device, patient access could be compromised.

CMS already recognized the unique circumstance of the dual-chamber leadless pacemaker under its Inpatient Prospective Payment System (IPPS) and approved the devices for calendar year (CY) 2024 "new technology add-on payments," and so the request to CMS was to extend a similar policy under its outpatient payment system.

HRS will provide updates as they become available. The OPPS proposed rule for calendar year 2025, where CMS will likely publish its position on "pass through payment" for dual-chamber leadless pacemakers in the outpatient setting, will be published in July 2024.