Navigating TPT Payments: Our Starter Kit
Transitional Pass-Through Payment (TPT) Toolkit
This TPT Toolkit includes:
- What the TPT Payment Is
- How Payment Rates Are Set
- The Approval Process
- Our TPT Payment Analysis
- Our Process
- FAQs
- Why Gettysburg Healthcare Consulting
- Your Next Step
Medicare Transitional Pass-Through Payment Defined
Medicare Transitional Pass-Through (TPT) payment is a temporary Medicare add-on payment for new medical devices used in hospital outpatient settings.
It provides separate reimbursement before the device is bundled into standard payment rates. CMS will only approve TPT if your device is:
- New
- Costly
- Shows Substantial Clinical Improvement
Take the Next Step
Navigating Medicare TPT: Insights from Years of CMS Decisions
If you’re launching a new medical device that serves Medicare patients, securing Transitional Pass-Through (TPT) payment could mean the difference between adoption and inertia.
The Opportunity
TPT is a unique opportunity. It provides temporary, separate reimbursement under the Medicare hospital outpatient prospective payment system (OPPS) for new devices that meet certain criteria—before they’re bundled into packaged payment rates. For many companies, TPT can help bridge the gap between market clearance and long-term payment stability, making it a critical part of a launch strategy.
Who We Can Help
We work with:
- Early-stage medtech companies preparing to launch
- Market access teams seeking Medicare strategy
- Investors performing reimbursement diligence
Our TPT Analysis
At Gettysburg Healthcare Consulting, we’ve analyzed years of CMS TPT decisions to help device manufacturers like you understand:
- What works
- What doesn’t
- And why
With decades of Medicare policy experience and a track record of helping clients navigate reimbursement pathways, we translate CMS policy into actionable strategy.
Five Insights From Our Analysis Revealed
1
Approval isn’t guaranteed — CMS denies nearly 50% of applications.
TPT is not a rubber stamp. Our data shows that CMS denied half of all TPT applications. This means your application must be carefully constructed, with strong evidence and a clear policy narrative that addresses each criterion.
2
Most denials fail the “clinical improvement” test — not cost.
In most denied applications, the fatal flaw wasn’t cost or coding—it was a failure to demonstrate Substantial Clinical Improvement (SCI). CMS wants to see that your device meaningfully improves outcomes over existing technologies. Evidence gaps or weak comparisons can quickly tank your chances.
3
Breakthrough-designated devices have a much higher approval rate
Devices that qualify for the “alternative pathway” (e.g., FDA Breakthrough Devices or certain PMA/HDE products) are exempt from the SCI requirement. These products had a significantly higher success rate. If your device qualifies, this pathway is one of the strongest levers you can pull.
4
Reapplying can work — some companies succeed on their second try.
We observed several instances where companies were initially denied but later succeeded with a revised application. Often, they supplemented their original evidence or clarified how their device met CMS criteria. A denial isn’t always the end of the road—it can be a signal to regroup and strengthen your case.
5
TPT is time-limited — you get 2–3 years of bonus payment, max.
TPT payment is temporary. If approved, your device receives separate Medicare reimbursement for up to three years, after which it will be folded into bundled outpatient payments. Plan ahead for what happens when TPT expires.
Our Experience
At Gettysburg Healthcare Consulting, we have assembled a team of Medicare and Medicaid policy pros who are dedicated to delivering top-notch consulting services.
With years of experience and in-depth knowledge, our team is committed to helping you navigate the complex world of healthcare policy. Whether you need assistance with compliance, reimbursement, or strategic planning, our experts are here to guide you every step of the way. Trust Gettysburg Healthcare Consulting for all your healthcare consulting needs.
Our Expertise Shines
- Our comprehensive understanding of Medicare Outpatient payment helps avoid reimbursement disasters.
- Clients trust us to review their devices and help navigate through the Medicare TPT process
- Clients trust us to review their novel diagnostics and determine the best coding approach for their unique needs.
Get the Help You Need to Maximize Your Revenue!
Our experts know the ins and outs of obtaining the help you need, so your product can start generating income as soon as possible.
TPT FAQs
What is TPT Payment?
A temporary Medicare add-on payment for new outpatient devices that meet specific criteria: newness, cost, and clinical benefit.
How long do TPT payments last?
TPT payment lasts up to three years, after which the device becomes part of bundled outpatient payment.
Who reviews TPT applications?
CMS evaluates TPT requests during the annual OPPS rulemaking cycle, typically finalizing decisions by November each year.
What is “substantial clinical improvement”?
It means your device offers meaningful benefits over existing treatments, such as reduced complications, faster recovery, or improved quality of life.
Can I apply for TPT approval more than once?
Yes. CMS allows reapplications, and some previously denied products have been approved in later years with stronger evidence.
What’s the alternative pathway?
If your device has Breakthrough Device designation or similar FDA status, you may bypass the clinical improvement requirement.
What’s my next step?
Book a free 30-minute consultation, and we can discuss your options. Contact us
Why Choose Gettysburg Healthcare Consulting
At Gettysburg Healthcare Consulting, we are experts in Medicare and Medicaid policy. With years of industry experience, our team of professionals is dedicated to helping healthcare providers navigate the complex world of healthcare regulations. We understand the challenges you face and are committed to providing you with the knowledge and guidance you need to succeed. Trust the policy pros at Gettysburg Healthcare Consulting to help you achieve your goals.