Chat GPT Helps with Interview Questions (for biotech conference)

I am doing an on stage interview with Dr Gabriel Bien-Willner of MOLDX in two weeks.  I fed ChatGPT 4 some stream of thought rapidly typed questions [at bottom] and asked it to spiff them up (redline them) and re order them if appropriate.  FYI only.

###

Here is an organized and more formal list of questions based on your initial suggestions

Here is a suggested order.  This new order begins with an introduction to the MolDx program and Dr. Bien-Willner's role within it, then delves into specific topics related to code assignment and pricing. The latter half of the interview shifts focus to broader policy questions, future visions, and the potential for expansion of the MolDx program. The final question allows Dr. Bien-Willner to address a specific point of concern.

1. To start us off, could you provide an overview of what's new and exciting with the MolDx program that our audience should be aware of?
2. In your role as leader of MolDx, what experiences from your previous jobs have proven most beneficial?
3. You have a significant leadership role in the expanding MolDx program. Can you share some insights about what you've learned regarding delegation versus personal involvement in decision-making?
4. I understand that you've recently entered into a new alliance with United Healthcare to provide the MolDx code set. Could you tell us more about this partnership, especially with regard to Z codes? Are they assigned solely based on a test description, or is there an associated review process? How does coverage policy factor into this?
5. MolDx provides a Z code for every molecular test, which is quite comprehensive. However, these codes don't encompass certain factors such as context, purpose, patient history, and other patient qualifications. How does the lack of this information in a Z code present challenges for payers?
6. There are faster PLA codes for highly digital or AI-based services, including algorithms for whole slide imaging. How do these PLA codes fit into the MolDx paradigm, especially considering you have to price these codes for CMS regardless of whether they are covered?
7. In terms of pricing, you've mentioned using the Equitable Pricing Model (EPM) for valuation. However, we've noticed some discrepancies such as a 23-gene test being priced at $1400 and a squamous cancer MAAA test priced at $3100 despite being assigned zero clinical value. Could you explain this apparent contradiction?
8. MolDx has started generating open-ended LCDs, known as Foundational LCDs. Can you explain how labs creating new tests can stay updated with your current review standards, especially when the published guidelines may be several years old?
9. Recently, the OIG reported that the NOVITAS Medicare Contractor wasted over a billion dollars on questionable genetic test claims. Can you comment on this, especially in comparison to the controls effort put forth by NGS MAC and MolDx MAC?
10. You provided early coverage for MRD, which has since seen substantial growth, making MolDx seem prescient. Can you comment on this success and how you managed to hit that home run?
11. Currently, there are two codes in process for MRD that use ddPCR (digital droplet PCR) for minimal residual disease monitoring. Could you share some details about this process?
12. Looking towards the future, how do you envision the MolDx program evolving in the next two to three years?
13. Currently, there are two CMS MACs in about 20 states that do not use MolDx. Are there plans for MolDx to expand to these remaining states? Why or why not? Do you foresee any potential challenges or obstacles with such an expansion?
14. Lastly, there have been instances where the LCD times have been quite lengthy, such as with Pacific Edge and Castle Squamous. Could you provide some insight into why the review periods for these can stretch over several years?
15. 
    

This new order begins with an introduction to the MolDx program and Dr. Bien-Willner's role within it, then delves into specific topics related to code assignment and pricing. The latter half of the interview shifts focus to broader policy questions, future visions, and the potential for expansion of the MolDx program. The final question allows Dr. Bien-Willner to address a specific point of concern.

###


RAW INPUT AS TYPED

On August 15, I will be at a biotech conference and I will interview Dr.  Gabriel Bien-Willner, MD PhD, director of the MOLDX program for 30 states.  The MolDx program sets coverage and pricing policy for novel genomic tests (for the Medicare program).   Often, MolDx has been thought leaders and has set pricing and policy ahead of other payers.  I need to interview him for a half hour, mostly with prepared questions.  (Then we will allow some audience open mic).

Here is a working list of question ideas, but not formally worded or in the best order.   ### PLEASE HELP ORGANIZE AND IMPROVE MY QUESTIONS THAT FOLLOW.   ###

Tell us from your perspective what’s new with MOLDX that the audience should know about?

You are in a new alliance or contract that provides your MOLDX code set (of 15,000 molecular codes) for use by United Healthcare.  In fact, UHC will require labs to use the Z codes for UHC patients.   Tell use more about Z codes licensing from you to UHC.   Are the Z codes assigned based on a test description alone ?   Or do they come with an obligatory review and pass/fail assessment on a technology assessment?    It doesn’t seem like you can review a tech assessment without a coverage policy in view, because you have to assess whether the test meets its claims, and you need to know what those claims are.

MOLDX issues a Z code for every molecular test, so one can look up the test description and get a very detailed one (exactly what genes, exons, SNPs, etc).    But in giving coverage for patients and tests, it’s not enough to know every detail of the genetic test, you must know context, purpose, patient history, patient qualifications (such as previous treatment with Drug X), and none of those are present in a Z code.   what problems does the payer therefore confront?

There are more rapid codes (called PLA codes) for highly digital or AI based services, such as algorithms based on 8 slide whole slide imaging WSI.   How do those fit into the MOLDX paradigm?   You have to price these codes for CMS whether you cover them yet or not.  

You have stated you use the Equitable Pricing Model for value (EPM) and valuation.  However, I’ve had a client with a 23 gene test priced at $1400, less than they expected.  And you priced a squamous cancer MAAA test at $3100 even though you didn’t cover it (you assigned it zero clinical value, so to speak).  Can you explain this contradiction?

Recently, the OIG reported that the NOVITAS Medicare Contractor wasted over a billion dollars on rediculous genetic test claims (such as for gene test 81408) which should never have been paid.  Do you have any comment?    81408 was not paid at NGS MAC (which had minimal controls effort) and not paid at MOLDX MAC (which has massive elaborate controls effort).

You now generate general, open ended LCDs called Foundational LCDs.   For example, they allow coverage for “minimal residual disease monitoring” or MDR, for validated tests.  The LCD contains one or two early tests that are reviewed as valid (or perhaps not valid).   But later tests are added simply by adding their code numbers as covered tests, without any more discussion of standards and risk/benefit.   How can labs generating a new test keep track of your current standards for review, when the published guidelines (the foundational LCD) becomes 3,4,5 years old.

HOw do you see the MOLDX program being different in 2,3, years from now.

There are Two CMS MACs (or MAC systems) in about 20 states that don’t use MOLDX.  Willl MOLDX expand to those last remaining 20 states?  Why or why not?   Does the MDT LCD (which sets up non coverage for any test not yet covered) represent a problem since CMS won’t let such LCDs be promulgated any more?

As leader of the increasingly large MOLDX program, what have you learned about delegationg vs being involved as a decision maker?    

What aspects of your previous jobs helps you the most today in MOLDX as its leader?

You provided early coverage of MRD and now, two years later, that field is booming and you look like geniuses.  Any comment?   How did you hit that home run?

There are two codes in process for MRD that use ddPCR (digital droplet PCR for minimal residual disease monitoring)

LCD times can be quite slow, such as Pacific Edge 2020 > May 2023, and Castle Squamous (similar).  What’s teh deal with 2-3-4 year reveiw periods such as these?