Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I recently became aware that CDRH's Early Payor Feedback Program include private payors, as well as CMS.  Haven't found much detail on how this works other than the website - https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2.  

My understanding is that a company can contact the task force to invite one (or more) public or private payors to a Q-sub meeting.  The Q-sub guidance mentions the task force once:
"You are invited and encouraged to include any additional outside individuals (e.g., Centers for Medicare & Medicaid Services (CMS), private payers, NIH grant reviewers) in your Q-Sub meetings, as appropriate. Including additional representatives may be helpful in maintaining transparency, efficiencies, and consistency among the various stakeholders for your device.  You are responsible for any additional attendees that you wish to invite and defining their roles and/or participation during the meeting. For submissions to CDRH, the Payor Communications Task Force may be able to assist with engaging payers. "

Does anyone have any experience with this type of meeting?  Would be very interested in understanding any positives/negatives associated with including payors in a Q-sub.  

Thanks in advance for help!

Remarkably little color on this program available.  Could not find any threads here on this topic, either.  

I only know of one instance for a Class III device.  Study design was intended to satisfy both FDA and CMS in one study.  But the result was a complex study design that ultimately was difficult to interpret.  Was okay for FDA purposes, but follow up studies had to be done to satisfy the payors.  In this case, there was not much benefit for the company.  Hard to judge from this one instance if these types of meetings have value.  Would be good to hear from others who have first-hand experience.

Cheers,
Melissa.

------------------------------
Melissa Walker RAC
President & CTO
Graematter, Inc.
St Louis MO
United States
------------------------------

Original Message:
Sent: 18-May-2021 14:28
From: Anonymous Member
Subject: Early Payor Feedback Program

This message was posted by a user wishing to remain anonymous

I recently became aware that CDRH's Early Payor Feedback Program include private payors, as well as CMS.  Haven't found much detail on how this works other than the website - https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2.

My understanding is that a company can contact the task force to invite one (or more) public or private payors to a Q-sub meeting.  The Q-sub guidance mentions the task force once:
"You are invited and encouraged to include any additional outside individuals (e.g., Centers for Medicare & Medicaid Services (CMS), private payers, NIH grant reviewers) in your Q-Sub meetings, as appropriate. Including additional representatives may be helpful in maintaining transparency, efficiencies, and consistency among the various stakeholders for your device.  You are responsible for any additional attendees that you wish to invite and defining their roles and/or participation during the meeting. For submissions to CDRH, the Payor Communications Task Force may be able to assist with engaging payers. "

Does anyone have any experience with this type of meeting?  Would be very interested in understanding any positives/negatives associated with including payors in a Q-sub.

Thanks in advance for help!

Is this the same program as the FDA & CMS parallel review program? I posted asking about that a few weeks ago but didn't get any responses.

------------------------------
Hiral Dutia
Regulatory Affairs Manager
Third Pole Therapeutics
Waltham, MA
USA
------------------------------

Original Message:
Sent: 18-May-2021 16:46
From: Melissa Walker
Subject: Early Payor Feedback Program

Remarkably little color on this program available.  Could not find any threads here on this topic, either.

I only know of one instance for a Class III device.  Study design was intended to satisfy both FDA and CMS in one study.  But the result was a complex study design that ultimately was difficult to interpret.  Was okay for FDA purposes, but follow up studies had to be done to satisfy the payors.  In this case, there was not much benefit for the company.  Hard to judge from this one instance if these types of meetings have value.  Would be good to hear from others who have first-hand experience.

Cheers,
Melissa.

------------------------------
Melissa Walker RAC
President & CTO
Graematter, Inc.
St Louis MO
United States

Original Message:
Sent: 18-May-2021 14:28
From: Anonymous Member
Subject: Early Payor Feedback Program

This message was posted by a user wishing to remain anonymous

I recently became aware that CDRH's Early Payor Feedback Program include private payors, as well as CMS.  Haven't found much detail on how this works other than the website - https://www.fda.gov/about-fda/cdrh-innovation/payor-communication-task-force#2.

My understanding is that a company can contact the task force to invite one (or more) public or private payors to a Q-sub meeting.  The Q-sub guidance mentions the task force once:
"You are invited and encouraged to include any additional outside individuals (e.g., Centers for Medicare & Medicaid Services (CMS), private payers, NIH grant reviewers) in your Q-Sub meetings, as appropriate. Including additional representatives may be helpful in maintaining transparency, efficiencies, and consistency among the various stakeholders for your device.  You are responsible for any additional attendees that you wish to invite and defining their roles and/or participation during the meeting. For submissions to CDRH, the Payor Communications Task Force may be able to assist with engaging payers. "

Does anyone have any experience with this type of meeting?  Would be very interested in understanding any positives/negatives associated with including payors in a Q-sub.

Thanks in advance for help!