New Technology Add-on Payment (NTAP) & Transitional Pass-Through (TPT): Experience That Spans the Program's History
From the first NTAP applications to the post-reform pathway — we've worked both sides of the desk.
David Davis has been involved with the NTAP and TPT processes since CMS implemented them 25 years ago — long enough to have watched the programs evolve from their original intent, through the breakthrough-device era, and into the tightened criteria of 2026 and beyond. That history matters now more than ever: CMS's FY 2027 IPPS final rule eliminated the alternative pathway for FDA Breakthrough Devices (with a narrow grandfather exception), and the CY 2027 OPPS rule is closing the outpatient TPT pathway to new applicants. Manufacturers face a more demanding approval environment than at any point in the program's history.
What we bring to NTAP and TPT engagements
25 years inside the programs. David has followed and worked within NTAP and TPT since inception — he understands not only the current criteria, but why they exist, where CMS has historically flexed, and where it hasn't.
Hands-on application experience. We've prepared and certified NTAP applications through CMS's MEARIS platform — including an alternative-pathway (Breakthrough Device) application for a branched aortic arch stent graft system, carried from initial submission through multiple revisions and CMS review.
Full-scope application management. Our work spans every element of a winning application: the three-part eligibility showing (newness, inadequate payment, substantial clinical improvement), the cost analysis and case-weighted threshold documentation, FDA status coordination, ICD-10-PCS and UB-04 claim-reporting readiness, and the timeline modeling that keeps FDA, clinical, and CMS deadlines aligned.
Parallel pathway architecture. When a single route creates timeline or approval risk, we design concurrent strategies — for example, pairing a standard pathway (existing codes, immediate payment on authorization) with an alternative pathway (Breakthrough designation → NTAP/TPT for higher-value payment) so near-term revenue and long-term payment optimization don't compete. We've built these dual-pathway strategies for catheter-based systems preparing for FDA submission in 2027–2028.
Post-2026 navigation. With the alternative pathway closed to most new applicants, the three-part criteria — particularly substantial clinical improvement — now decide everything. Historically, only about 25% of traditional-pathway applications gained approval, largely because of the SCI requirement. Applications on or after October 1, 2026 must clear all three criteria. We build applications for that reality: evidence strategy, cost documentation, and the policy narrative CMS actually weighs.
How we work with clients
Eligibility assessment — an honest read on whether your technology meets the three-part criteria, and what evidence would be needed to carry each one
Application development and submission — full MEARIS application build, cost analysis, and FDA-status coordination, with certified submission on your behalf
Timeline modeling — mapping FDA authorization, clinical data readiness, and CMS application cycles into one integrated calendar with internal buffers, so a missing document never costs you a payment year
Parallel pathway strategy — designing standard and alternative pathway strategies that run concurrently, so your commercial launch never waits on a CMS decision
Post-approval support — ICD-10-PCS reporting codes, UB-04 claim mechanics, and hospital billing enablement so the payment you win actually reaches the P&L
The bottom line
NTAP and TPT are no longer pathways you qualify for by designation alone — they're campaigns you build evidence for, sometimes years before launch. We've managed those campaigns from the application's first draft to CMS review, and we know where applications win and where they quietly fail.
Every engagement begins with a complimentary consultation.
info@marketaccessexperts.com | 480-717-7865 | marketaccessexperts.com
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