Pathways' Pick of the Week: CMS Tightens NTAP Criteria

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CMS has finalized its eligibility criteria for its new-tech add-on payment program. Excerpted from Pathways' Picks August 2: NTAP Reforms, Comment Deadlines, User Fee Hikes, and More.

The Medicare agency finalized plans August 1 to tighten FDA authorization criteria for a product to be eligible for a new technology add-on payment (NTAP). Starting next year, a device maker needs to show confirmation that FDA has accepted its premarket submission in order to apply for an NTAP and the device needs to gain authorization by May 1 of the application year to qualify for the bonus reimbursement. Up until now, a company could apply for an NTAP in advance of an FDA submission and could win the extra payment if authorized by July 1. The changes were made as part of CMS’ FY 2024 hospital Inpatient Prospective Payment System rule.

Industry players had pushed back on the changes, arguing that they would unnecessarily reduce access to the program, which is intended to give hospitals a clearer financial incentive to adopt new innovative technologies before Medicare can settle on a longer term reimbursement policy. But CMS disagreed, stating that the changes were needed to give the agency more of the details they needed sooner to make NTAP decisions. “While a number of commenters noted their belief that the intent of these policies is to reduce the number of applications or decrease CMS’s workload, the intent of our proposal is instead to address the ever-increasing complexity and number of applications lacking critical information that is needed to evaluate whether the technology meets the eligibility criteria,” CMS said in the inpatient rule. 

9 new NTAPs awarded. Meanwhile, CMS awarded nine devices new NTAP payments beginning October 1 in the inpatient rule. All of them took advantage of the streamlined NTAP pathway for FDA-designated Breakthrough Devices, which doesn’t require proof of substantial clinical improvement. Notably, five of the nine devices gained FDA authorization in May or June of this year, meaning they wouldn’t have qualified based on the May 1 deadline that will kick in next year. The nine new NTAP devices with bonus payment amounts are:

  • Aveir AR Leadless Pacemaker (Abbott Laboratories): $10,725
  • Aveir Leadless Pacemaker(Dual Chamber) (Abbott): $15600
  • Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) (Zimmer Biomet): $850.85 per knee
  • Ceribell Status Epilepticus Monitor (Ceribell): $913.90 
  • DETOUR peripheral stent graft system (Endologix): $16, 250 
  • EchoGo Heart Failure 1.0 echocardiography diagnostic aid (Ultromics): $1,023.75
  • Phagenyx System for neurogenic dysphagia (Phagenesis): $3,250
  • SAINT Neuromodulation System for depression (Magnus Medical): $12,675.
  • TOPS System spine implant (Premia Spine): $11,375
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