Medical Device Reimbursement Do’s and Don’ts
1. Do – Develop your reimbursement strategy early
Don't – Delay developing your reimbursement strategy until just before your product launch.
Real life examples:
- Example #1: Company A developed a 4-sensor product that competed with other available 6-sensor products. This product was clinically better and less expensive than its competitors. The company invited Mediclever to check whether they could utilize existing reimbursement mechanisms in France. A short assessment revealed available codes, a positive coverage policy, and payment rates that exceeded the company's expectations. However, the wording in the identified existing codes specifically indicated 6 sensors! Redesigning the product at that stage was too difficult, and the company was left out of the French market.
- Example #2: Company B developed and launched a product in the US market. Unfortunately, the pressure settings employed by their product deviated from the allowable range specified under existing reimbursement mechanisms. The CEO asked Mediclever to provide them with a “reimbursable” specification. The company is currently redesigning their product according to this spec.
Verify that existing clinical data supports the clinical and economic claims in the Value Story and economic model or add reimbursement related aspects to any planned clinical study protocol, along with the company's estimated results.
Your reimbursement strategy could affect your product design.
2. Do – Consider reimbursement when selecting an appropriate application
Don't – Choose your “killer app” only on the basis of R&D, regulatory criteria, or marketing.
Real life example:
Company C developed a platform that could be used for a few applications. The company invited Mediclever to develop and implement its reimbursement strategy, while its pivotal trial, focused on Application I, was underway.
Mediclever's assessment discovered that if the company proceeded with the current Application I, the likelihood for reimbursement was low and might only be granted in five to ten years at a considerable investment.
Consequently, the company abandoned Application I and is currently selling its product, under existing reimbursement mechanisms, for Application II.
Your reimbursement strategy could affect the first application of your product.
3. Do – Leverage your clinical trial(s) to gather reimbursement related data
Don't – Focus only on the regulatory aspects.
Real life example:
Company D developed outstanding clinical data for their product and invited Mediclever to help them develop specific reimbursement mechanisms for it.
Since economic aspects were not observed during the previous clinical trial, the company had to perform a new trial to gather the requested data.
4. Do – Develop your regulatory and reimbursement strategies in parallel
Don't – Think that since regulatory clearance comes before obtaining reimbursement that this is a serial process.
Real life example:
Company E asked Mediclever to start working on its reimbursement strategy after receiving regulatory clearance. Unfortunately, the wording used in the application substantially decreased the likelihood of reimbursement.
Short regulatory path ≠ optimal reimbursement.
Summary
We hope that these real-life examples will help avoid some of the above mentioned mistakes, reduce costs, and reach the market sooner.
If you have any reimbursement related questions, or would like to speak with one of our consultants, just let us know.
Key Takeaways
- Develop your medical device reimbursement strategy early.
- Align product design, regulatory strategy, and clinical studies with reimbursement requirements.
- Avoid assuming regulatory approval guarantees reimbursement.
Frequently Asked Questions
What does a medical device reimbursement consultant do?
They help companies navigate coverage, coding, and payment strategies to ensure your medical device can be reimbursed successfully in different markets.
When should I involve a reimbursement consultant?
Ideally, at the product design stage or before pivotal clinical trials. Early involvement avoids costly redesigns and delays in market access.
How do I get reimbursed for a medical device?
To get reimbursed, work with a reimbursement consultant early in product development to identify coverage policies, proper coding, and pricing strategies that support market access.
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