FDA's Early Payor Feedback Program (EPFP)May 04, 2022
The prospect of obtaining a new reimbursement code and corresponding coverage for a new medical device is daunting. So much so that many investors simply refuse to pursue medical device opportunities that lack an existing reimbursement code with sufficient coverage.
Why is this such a problem for medical device companies and investors?
Historically, companies have faced a valley of death after a medical device has been approved for the market but before reimbursement coding and coverage has been established. This process of reimbursement setup can take years -- meanwhile, companies have payroll to meet and other operational expenses to sustain. Many companies have been unable to fund themselves through this valley of death and have met their demise simply due to do delays in reimbursement setup.
Moreover, medical device companies have been unable to obtain reliable up-front perspectives from payors concerning the "reasonableness" and "effectiveness" criteria upon which future payments would be based. This information is vital to understanding the scope, timeline, and budgets required of clinical studies that would satisfy payor rationale. The lack of clarity creates a great deal uncertainty, and this uncertainty only lessens investor appetite for medical devices without coding and coverage already in-place.
Wouldn't it be nice if early feedback from Payors could be captured in the same way that early feedback is captured from FDA during the Q-Sub process?
Well, a new program at FDA called the Early Payor Feedback Program (EPFP) aims to do just that.
I reached out to the Payor Communications Task Force, and they kindly and promptly responded to my questions concerning the program. Below are their responses:
1. Approximately, how many organizations have engaged in the EPFP program to date?
As of March 2022, over 70 medical device companies have engaged in the Early Payor Feedback Program (EPFP).
2. Are there multiple Payors or a single Payor that attend the EPFP meeting?
The FDA recognizes that many sponsors that are small companies may not be aware of the many payors that are part of the EPFP. After the FDA introduces the sponsors to the payors, the sponsors often schedule individual meetings with the payors outside of the setting of the Q-submission meeting held with FDA. In most cases, sponsors engage with multiple payors and are welcome to invite whomever they would like to attend Q-submission meetings.
3. How are Payors selected for inclusion in the EPFP Program?
We have an open call for new payors to join the EPFP. To learn more, please visit our website at https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force.
The sponsor selects the payors listed on our website with whom they would like to engage. The sponsor provides the EPFP with publicly available information about their device, which is shared with the selected payors. If there is mutual interest, EPFP staff introduce the sponsor to the payors.
4. What is the scheduling time requirement for the EPFP Program?
We encourage sponsors to contact the EPFP before submitting the Q-Submission to CDRH. If a sponsor already has a Q-Submission under review, or their Q-Submission is closed, they still can reach out to the EPFP to be connected to a payor.
5. Does the EPFP Program delay the typical scheduling and response time for Q-Sub?
The EPFP is a voluntary program and does not change the response time for Q-submissions. Of note, the majority of sponsor-payor interactions occur outside of the Q-Submission meeting and are coordinated by the sponsor.
6-8. Are the participating payers able to comment on a device’s eligibility for existing coding and coverage? Are the participating payers able to comment on sponsor’s healthcare economic analyses and proposed coverage amounts for products/procedures that are not currently covered by existing codes? Are the participating payers able to comment on the proposed endpoints and clinical study design that would correspond to the healthcare economic analyses?
In the EPFP, the sponsor determines the amount of information they choose to share with payors. They could share their entire submission with the payor and invite them to the meetings with the FDA, or they could choose to meet privately with the payor and share limited information relevant for that discussion. Hence, the extent of the dialogue is determined by the sponsor and the payor and is not restricted by the FDA.
For CPT coding questions, the sponsor may reach out independently to, or work with the FDA to connect with, the American Medical Association. Please visit our website for more information.
9. Is there any published guidance on topics, questions, or agenda for the EPF Program?
The EPFP Program website lists all relevant information for the program including associated Federal Register notices.
The EPFP Program is voluntary and not a requirement of the Q-submission program.
Certainly, the EPF Program does not entirely solve the reimbursement challenge facing companies developing new medical devices without existing coding or coverage. Nonetheless, FDA appears to recognize the challenge and is making advancements through the following steps:
- Formalizing a process - The Q-sub process has helped countless medical device companies gain clarity on their pathways to market. Formalizing and publishing details around the EPFP is a crucial step in helping medical device companies navigate the payor uncertainties.
- Making connections - Putting medical device companies in direct contact with public and private payors can only help in developing a common understanding around the needs and challenges facing healthcare innovation and medtech's role.
I am optimistic that FDA will continue to advance this critical program. Doing so will encourage further investment and development in pioneering medical devices that have the potential to help patients and improve healthcare at large.
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