What Is CMS NTAP? AI Device Reimbursement Guide 2025
- Beng Ee Lim
- 17 minutes ago
- 7 min read
CMS New Technology Add-on Payment (NTAP) is the fastest path to Medicare reimbursement for AI medical devices, potentially unlocking $1,000+ per-use payments. With the FY 2027 application deadline of October 6, 2025 approaching, AI device companies need to secure this critical reimbursement pathway asap.
Quick Answer:Â CMS NTAP provides additional Medicare payments above standard DRG rates for qualifying new medical technologies. AI devices must meet three criteria: newness (within 2-3 years), cost adequacy, and substantial clinical improvement. NTAP can last up to 3 years (depending on newness) and can support adoption by reducing financial friction.
This guide covers everything you need to know about NTAP for AI devices, including application strategies, success examples, and the critical 2027 deadline.
What Is CMS NTAP and Why It Matters for AI Devices
The New Technology Add-on Payment (NTAP) is a Medicare program that provides additional payments to hospitals above standard Diagnosis-Related Group (DRG) amounts for qualifying new medical technologies. An NTAP designation enables additional payment to hospitals above the standard Medicare Severity Diagnosis-Related Group (MS-DRG) payment amount.
The reimbursement reality:Â Currently, the Centers for Medicare and Medicaid Services does not provide specific reimbursement for FDA-authorized AI technology. Companies have to use Medicare's New Technology Add-on Payments pathway, or another workaround to get covered.
Why NTAP Is Critical for AI Device Success
Immediate Market Access:Â NTAP approval removes the primary barrier to hospital AI adoption - uncertain reimbursement. Hospitals readily adopt technologies with Medicare payments.
Substantial Payment Amounts:Â AI devices with NTAP approval can receive significant per-use payments. For example, Viz.ai's stroke detection system receives approximately $1,000 per use, while IDx diabetic retinopathy screening gets around $40 per use.
Competitive Advantage:Â A product's NTAP designation lasts for no more than three years for a specific indication, creating a protected reimbursement window while competitors navigate uncertain payment landscapes.
The Three NTAP Criteria: What AI Devices Must Prove
42 CFR § 412.87(b) specifies three criteria that a new medical service or technology must meet to be eligible to receive the additional payment. Understanding these criteria is essential for building a winning NTAP application.
1. Newness Criterion
Requirement:Â The medical service or technology must be new.
For AI Devices:Â The newness period begins with the availability of the product on the US market (generally, on the date of FDA approval or clearance). To be eligible for the FY 2027 application cycle, a technology's newness period must begin no earlier than October 1, 2023.
Strategic Implications:Â AI devices approved by FDA after October 1, 2023, likely meet the newness criterion for FY 2027 applications. Companies should time their FDA submissions to align with NTAP eligibility windows.
2. Cost Criterion
Requirement:Â The medical service or technology must be costly such that the MS-DRG rate otherwise applicable to discharges involving the medical service or technology is determined to be inadequate.
For AI Devices:Â This criterion evaluates whether current DRG payments adequately cover the costs associated with using the AI technology. CMS analyzes whether hospitals lose money when using the technology under standard reimbursement rates.
Application Strategy:Â Companies must provide detailed cost analyses showing that current DRG payments are insufficient to cover the technology's implementation and use costs, including software licensing, training, and operational integration.
3. Substantial Clinical Improvement Criterion
Requirement:Â The medical service or technology must demonstrate a substantial clinical improvement over existing services or technologies.
For AI Devices:Â This is often the most challenging criterion, requiring robust clinical evidence that the AI system significantly improves patient outcomes compared to standard care.
Evidence Requirements:
Clinical data specific to or generalizable to Medicare patient population
Measurable improvements in diagnosis accuracy, treatment speed, or patient outcomes
Peer-reviewed studies or FDA-required clinical trials
Real-world evidence of clinical benefits
Critical NTAP Timeline for FY 2027
Understanding the NTAP application timeline is crucial for strategic planning. The process follows a strict annual cycle with non-negotiable deadlines.
Key Dates for FY 2027 Applications
August 11, 2025 (9:00 AM ET):Â Application system opens via Medicare Electronic Application Request Information System (MEARISâ„¢)
October 6, 2025 (5:00 PM ET):Â Final deadline for FY 2027 NTAP application submissions - no extensions
Spring 2026:Â CMS publishes proposed rule with preliminary NTAP decisions
Summer 2026:Â Final rule publication with confirmed NTAP approvals
May 1, 2026:Â Have FDA authorization for the indication in your NTAP app (most pathways)
October 1, 2026:Â FY 2027 NTAP payments begin for approved technologies
Strategic Timeline Recommendations
Immediate Actions (Now - August 2025):
Complete clinical evidence compilation
Finalize cost analysis and economic modeling
Prepare regulatory and clinical documentation
Engage healthcare economics consultants
Application Period (August - October 2025):
Submit application via MEARIS system
Respond to any CMS clarification requests
Monitor application status and provide additional information if requested
Alternative NTAP Pathways for AI Devices
CMS has created streamlined pathways for certain qualifying technologies that reduce application complexity and accelerate approval timelines.
Breakthrough Device Alternative Pathway
Qualification:Â Technologies that are part of FDA's Breakthrough Devices Program and receive marketing authorization as a Breakthrough Device for the indication covered by the Breakthrough Devices Program designation.
Advantages:
Only need to meet cost criterion (newness and substantial clinical improvement are assumed)
Potential faster time to market
Higher likelihood of approval
For AI Devices:Â Many AI medical devices qualify for FDA Breakthrough designation, making this pathway particularly relevant for the AI industry.
Standard vs. Alternative Pathway Comparison
Standard Pathway Requirements:
Prove all three criteria (newness, cost, substantial clinical improvement)
Extensive clinical evidence package
Detailed economic analysis
Timeline: Same IPPS cycle
Alternative Pathway Requirements:
FDA Breakthrough Device designation
Prove cost criterion only
Streamlined evidence requirements
Timeline: Same IPPS cycle
NTAP Success Stories: AI Devices That Won
Learning from successful NTAP applications provides valuable insights for developing winning strategies.
Viz.ai LVO (Large Vessel Occlusion) Stroke Detection
NTAP Value:Â Approximately $1,000 per use
Success Factors:
Clear clinical improvement in stroke detection speed
Robust cost analysis showing DRG inadequacy for complex stroke cases
Strong real-world evidence of patient outcome improvements
FDA clearance for specific clinical indication
Key Insight:Â Viz.ai focused on demonstrating time-to-treatment improvements, a measurable outcome directly tied to patient survival and recovery.
Caption Guidance Cardiac Ultrasound
NTAP Value:Â Additional payment for cardiac ultrasound procedures
Success Factors:
Evidence of improved diagnostic accuracy
Demonstrated reduction in repeat procedures
Cost-effectiveness analysis showing hospital savings
Integration with existing clinical workflows
Building a Winning NTAP Application Strategy
Clinical Evidence Development
Primary Endpoints:
Patient outcome improvements (mortality, morbidity, quality of life)
Diagnostic accuracy enhancements
Treatment time reductions
Clinical workflow efficiencies
Study Design Considerations:
Medicare population relevance
Comparison to current standard of care
Real-world evidence collection
Health economic outcomes measurement
Economic Analysis Requirements
Cost Components to Analyze:
Technology acquisition and licensing costs
Implementation and training expenses
Ongoing operational costs
Infrastructure requirements
DRG Inadequacy Demonstration:
Current reimbursement vs. actual costs
Financial impact on hospital margins
Patient population cost variations
Geographic cost differences
Regulatory Strategy Coordination
FDA Alignment:
Coordinate NTAP application with FDA clearance/approval
Ensure clinical evidence supports both regulatory pathways
Leverage FDA breakthrough designation for alternative pathway
Align clinical trial design with reimbursement requirements
Implementation Roadmap for NTAP Success
Phase 1: Preparation
Clinical Evidence Compilation:
Gather existing clinical data supporting substantial clinical improvement
Identify gaps in evidence package
Plan additional studies if needed
Engage key opinion leaders for clinical validation
Economic Analysis Development:
Conduct detailed cost-effectiveness studies
Analyze current DRG adequacy for target patient populations
Model financial impact on hospitals
Prepare budget impact assessments
Phase 2: Application Development
Documentation Preparation:
Complete NTAP application forms
Compile clinical evidence package
Finalize economic analysis reports
Prepare executive summaries and supporting materials
Stakeholder Engagement:
Brief clinical advisors on application strategy
Coordinate with FDA regulatory team
Engage healthcare economics consultants
Prepare for potential CMS questions
Phase 3: Submission and Follow-up
Application Submission:
Submit complete application by October 6, 2025 deadline
Monitor application status through MEARIS system
Respond promptly to CMS information requests
Track competitive applications and market dynamics
Decision Preparation:
Prepare for proposed rule publication
Plan market access strategy for approved technologies
Develop contingency plans for partial or denied applications
Coordinate with commercial and clinical teams for launch
Common NTAP Application Mistakes to Avoid
Clinical Evidence Pitfalls
Insufficient Medicare Population Data: Many applications fail because clinical evidence doesn't adequately represent Medicare beneficiaries. Ensure studies include appropriate age groups and comorbidities.
Weak Comparator Selection: Choosing inappropriate or outdated comparators undermines substantial clinical improvement claims. Use current standard of care as the comparison baseline.
Inadequate Real-World Evidence: Relying solely on controlled trial data without real-world evidence weakens applications. Include post-market surveillance data when available.
Economic Analysis Errors
Simplistic Cost Modeling: Basic cost calculations without considering implementation complexity, training, and workflow integration often underestimate true costs.
DRG Analysis Oversights: Failing to analyze cost adequacy across all relevant DRGs and patient subpopulations can lead to application rejection.
Hospital Perspective Gaps: Not considering varied hospital settings (academic, community, rural) and their different cost structures weakens economic arguments.
Strategic Timing Mistakes
Late Application Preparation: Starting NTAP application development too close to deadline compromises quality and completeness.
FDA Coordination Failures: Misaligning NTAP application timing with FDA regulatory milestones can create evidence gaps or delay market entry.
Competitive Intelligence Gaps: Not monitoring competitive NTAP applications or understanding market dynamics reduces strategic positioning effectiveness.
Future Outlook and Strategic Recommendations
Medicare AI Reimbursement Trends
Expanding Coverage: CMS is increasingly recognizing the value of AI technologies, with growing acceptance of AI-specific reimbursement models beyond traditional device classifications.
Value-Based Integration: Future reimbursement models will likely emphasize outcome improvements and cost savings rather than purely technology-based payments.
Alternative Payment Models: Bundle payments, shared savings programs, and risk-sharing arrangements are emerging as complementary reimbursement strategies for AI technologies.
Strategic Positioning for Success
Multi-Indication Planning: Companies should develop NTAP strategies that position for multiple indication expansions and future application cycles.
Partnership Development: Early engagement with health systems and clinical champions strengthens both NTAP applications and post-approval adoption strategies.
Global Strategy Integration: NTAP success in the US market provides valuable evidence and credibility for international reimbursement discussions.
About Complizen
Complizen simplifies regulatory compliance for medtech companies using AI, helping life-saving innovations reach patients faster. We guide companies through regulatory pathways, from early-stage startups to established medical device manufacturers. Our mission is to make regulatory expertise accessible so breakthrough medical technologies can improve lives worldwide.
Frequently Asked Questions
Can I apply for NTAP if my AI device doesn't have FDA approval yet?
No, NTAP applications require FDA clearance or approval. The newness period begins with FDA authorization, so plan your FDA and NTAP timelines accordingly.
What happens if my NTAP application is denied?
You can reapply in subsequent years if you address the deficiencies cited by CMS. Many successful applications are second or third attempts with improved evidence packages.
How does NTAP interact with other Medicare payment models?
NTAP provides additional payments above standard DRG rates. It complements rather than replaces other Medicare payment mechanisms.
Can I charge hospitals more than the NTAP amount?
Yes, NTAP is additional payment to hospitals, not a price ceiling for your technology. Your pricing strategy should consider total value proposition beyond reimbursement.
What if my AI device has multiple indications?
Each indication requires separate NTAP evaluation. Strategic companies often prioritize indications with strongest clinical evidence and largest patient populations for initial applications.