New Technology Payment Strategy
Early payment pathways drive accelerated adoption
Key Outcomes
Early incremental reimbursement for qualifying inpatient technologies
Reduced financial barriers to hospital adoption
Stronger alignment between coding, payment, and evidence
Enhanced value positioning for early commercial launches
CMS offers two early payment mechanisms that can significantly accelerate hospital adoption for novel medical technologies. New Technology Add On Payments, referred to as NTAP, provide incremental inpatient reimbursement for qualifying technologies during the first two to three years after FDA clearance or approval. Transitional Coverage for Emerging Technologies, referred to as TCET, is a program designed for breakthrough devices and provides provisional Medicare coverage while additional evidence is generated.
Both pathways reduce financial risk for hospitals and support faster adoption in clinical areas where reimbursement uncertainty can delay use. Companies often miss these opportunities because planning does not begin early enough or because the evidence does not meet CMS standards.
Our team aligns regulatory, clinical, and reimbursement strategy to determine eligibility and support a complete and defensible application.
CHALLENGES
Common Gaps That Limit NTAP and TCET Success
Companies entering the U.S. market often encounter predictable barriers
Unclear eligibility under CMS criteria for new or substantial clinical improvement
Insufficient evidence to justify improved outcomes or cost savings
Weak coordination between FDA timelines and CMS application deadlines
Lack of integration between coding, coverage, and the NTAP or TCET strategy
Missing hospital cost modeling or inadequate resource use data
Misalignment between coding structure and MS DRG payment logic
These issues can result in unsuccessful applications or delayed market access
OUR PROCESS
How We Structure NTAP and TCET Strategy
UnifiMed integrates NTAP and TCET planning into early evidence development, regulatory strategy, and hospital payer readiness to accelerate adoption following FDA clearance or approval
Eligibility and Feasibility Assessment
We assess CMS eligibility based on newness and cost thresholds, evidence of substantial clinical improvement, and Breakthrough Device status to determine NTAP or TCET feasibility and evidence requirements
Coding and Payment Alignment
We align CPT or HCPCS coding with MS-DRG or APC payment logic, hospital cost centers, and outlier payment considerations to ensure CMS can accurately evaluate incremental payment eligibility
Evidence and Value Framework Development
We develop the clinical, comparator, and economic evidence required for CMS review, including cost-offset modeling and real-world data plans aligned with NTAP and TCET expectations
CMS Application and Hospital Readiness
We prepare the CMS application and operationalize hospital adoption through billing guidance, documentation requirements, and revenue cycle workflows to support implementation
Ready to Learn More?
Contact our team to discuss how we can support your new technology payment strategy