AI Corner: Chat GPT Compares Updates to FDA's Web Page about Payor Collaborations

 In conjunction with FDA's July 1, 2024, JAMA article on FDA, population health innovations, and payors, I noticed that FDA had updated its Payor Collaboration page on July 2, 2024.  However, FDA provides no change-list.

Payor Communication Task Force

https://www.fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force

Payor Early Feedback Program

https://www.archimedic.com/blog/early-payor-feedback-program

From the PCTF page, I used a December 2023 version ("Internet Archive") and the July 2 version.  I asked Chat GPT to explain differences.   (Note:  I also tried a free program Draftable.com, which has been great in the past, but it just spun wheels on this document pair, so no luck).

Chat GPT (Asked to compare December and July versions)

(Note, I had to ask twice to get enough detail and not just vague statements about changes).

Here are the specific additions and changes made in the July 2 version of the FDA webpage compared to the June 11 version, particularly focusing on the new FAQ sections and detailed answers provided:

New Sections and FAQ Additions in July 2 Version:

1. Frequently Asked Questions (FAQs) Section:

   • General Questions:

     • Question: "Why is CDRH encouraging manufacturers to communicate with payors?"
       • Answer: This provides insights into how patient access to medical devices may depend on insurance coverage. It explains the benefit of manufacturers communicating with payors to gather necessary data for positive coverage decisions early on, potentially expediting patient access to innovative medical devices.
     • Question: "How does CDRH define payor?"
       • Answer: CDRH defines payor broadly, including traditional health insurance companies, governmental agencies, health technology assessment groups, and others who influence insurance coverage, procurement, and reimbursement decisions.

   • Early Payor Feedback Program (EPFP):

     • Question: "Which manufacturers are eligible for the Early Payor Feedback Program (EPFP)?"
       • Answer: Details eligibility criteria for manufacturers, emphasizing the program’s goal to shorten the time between FDA marketing authorization and coverage decisions by incorporating payor feedback into their evidence generation strategies.
     • Question: "Are manufacturers of Digital Health devices eligible to apply?"
       • Answer: Confirms that digital health devices are eligible, provided they meet the criteria listed.
     • Question: "When is the best time to utilize the Early Payor Feedback Program (EPFP)?"
       • Answer: Recommends contacting the program during the planning phase of pivotal clinical trials or sooner, highlighting the importance of having a proposal ready for payor comments.
     • Question: "How is the Early Payor Feedback Program (EPFP) different from Parallel Review?"
       • Answer: Explains the EPFP as a potential first step in the Parallel Review process, facilitating early feedback from CMS regarding evidence needs.
     • Question: "What is the most frequent impact of manufacturer-payor interactions through the Early Payor Feedback Program (EPFP)?"
       • Answer: Describes how these interactions often confirm manufacturers’ approaches or lead to modifications in study designs, patient inclusion criteria, trial sites, and data collection methods.
     • Question: "How many requests have been matched with a payor through the Early Payor Feedback Program (EPFP)?"
       • Answer: Provides updated statistics, stating that 140 requests have been matched with payors as of June 2024.
     • Question: "As a direct result of this program, how many Q-Submission meetings have included payors?"
       • Answer: States that 13 Q-Submission meetings have included payors introduced through the EPFP, with 399 unique manufacturer-payor interactions.
     • Question: "Do you count one-off meetings as successes?"
       • Answer: Affirms that any interaction where a manufacturer learns what data is needed for a positive coverage decision is considered beneficial.
     • Question: "Have any manufacturers not been matched?"
       • Answer: Reports that six manufacturers did not find interested payors due to the voluntary nature of the program for payors.
     • Question: "My device has a Breakthrough designation. Can payors join the 'sprint' interactions?"
       • Answer: Confirms that payors can join sprint interactions for Breakthrough-designated devices.
     • Question: "Do I need to reach out to the Early Payor Feedback Program (EPFP) each time I want to talk with a payor?"
       • Answer: Clarifies that once a payor’s contact information is obtained, manufacturers can reach out directly, but new device feedback requests should go through EPFP again.
     • Question: "How does the Early Payor Feedback Program (EPFP) differ from the TAP Pilot?"
       • Answer: Describes the differences between EPFP and the Total Product Life Cycle Advisory Program (TAP) Pilot, emphasizing TAP's broader strategic decision-making and interactions with payors and reimbursement experts.

   • Parallel Review:

     • Question: "How many requests have been received for Parallel Review?"
       • Answer: States that 97 formal requests have been received as of June 2024.
     • Question: "How many devices have completed Parallel Review?"
       • Answer: Lists two devices that have completed Parallel Review: Exact Sciences’ Cologuard and Foundation Medicine’s FoundationOne CDx.
     • Question: "How much time did the companies save by using Parallel Review?"
       • Answer: Estimates the time savings achieved through Parallel Review, providing specific examples of reduced timelines for the NCD process.

Clarifications and Elaborations:

• The FAQs section includes detailed answers and elaborations that clarify the program processes, eligibility criteria, and the benefits of participation for both manufacturers and payors.
• The new sections aim to enhance understanding and transparency around the Early Payor Feedback Program and Parallel Review, helping stakeholders navigate these processes more effectively.

These detailed additions and expansions in the July 2 document provide comprehensive guidance and address potential queries that manufacturers and payors might have, thereby improving the clarity and usefulness of the information provided by the FDA.