CMS Proposes to Eliminate the Breakthrough Device NTAP Alternative Pathway
The FY 2027 Proposed Rule introduces the most consequential reimbursement policy change in years for device and SaMD innovators. Here's what it means for your market access strategy.
Under current policy, FDA-designated Breakthrough Devices are exempt from demonstrating substantial clinical improvement under NTAP. CMS proposes to eliminate this exemption — meaning all applicants, including Breakthrough Devices, must satisfy all three traditional NTAP criteria: newness, high cost, and substantial clinical improvement.
Technologies currently under FY 2027 review under the alternative pathway remain eligible. Previously approved technologies continue to receive add-on payments with no disruption.
OPPS device pass-through applications received on or after this date must meet the standard substantial clinical improvement test, including the CY 2028 cycle through March 1, 2027.
All NTAP applicants — including Breakthrough Devices, QIDPs, and LPAD drugs — must demonstrate all three traditional criteria. The alternative pathway is eliminated for new applications.
Existing OPPS device category codes established for alternative pathway applications received by September 30, 2026 remain in effect for at least 2 but no more than 3 years.
Proposed inpatient payment update across acute care hospitals.
Long-term care hospital rate update mirroring the IPPS increase.
Pure SaMD amounts cluster $60–$240. Device-based AI commands higher add-ons.
| Technology | Description | Status | Max NTAP |
|---|---|---|---|
| Bayesian Health Sepsis Flagging Device | AI/ML SaMD for early sepsis detection and risk prediction within 4 days | Pending FDA Auth | $61.84 |
| Aidoc BriefCase-Triage: CARE | AI radiological triage for abdominopelvic CT; newness period begins Jan 7, 2026 | Proposed Approval | $137.53 |
| InVision Precision Cardiac Amyloid | ML algorithm identifying high suspicion of cardiac amyloidosis from routine echocardiograms | Proposed Approval | $162.50 |
| VUNO Med-DeepCARS | AI monitoring and risk assessment for impending cardiac arrest within 24 hours on general wards | Pending FDA Auth | $236.66 |
| Cara Medical CARA System | AI-based augmented fluoroscopy for cardiac conduction system visualization | Proposed Approval | $10,205.00 |
Strategic Implications for Your Portfolio
This rule materially changes the reimbursement value of FDA Breakthrough Device designation. Here is what to act on now.
The clinical improvement evidence package is now essential, not optional. Breakthrough Device designation alone no longer opens the NTAP door — robust clinical data must be built earlier in product development.
Technologies already approved under the alternative pathway continue to receive add-on payments. Confirm existing NTAP status and protect those designations through the transition.
The traditional three-criteria NTAP pathway remains intact. Reframe NTAP strategy around demonstrating newness, high cost, and clinical improvement through standard submission requirements.
Pure SaMD NTAP amounts cluster in the $60–$240 per-case range. Factor this ceiling into reimbursement modeling and value narrative development for software-only products.
Need a tailored analysis of how these changes affect your product's reimbursement pathway? Prevara's team is ready to help you navigate the transition.
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