Multiple Local Coverage Determinations (LCDs) Open Public Meeting - October 11, 2023 - JE Part B

Kari DuPreez:
I am Kari DuPreez. I am one of the Medical Policy Specialists here at Noridian and I will be assisting with the meeting today. We want to welcome you to the Open Public Meeting for three proposed LCDs:

MolDx: Gene Expression Profile Test for Decision-Making in Castration Resistant and Metastatic Prostate Cancer DL39686 for JE and DL9688 for JF.

MolDx: Molecular Biomarkers for Risk Stratification for Indeterminate Pulmonary Nodules Following Bronchoscopy DL39678 for JE and DL39680 for JF. And,

MolDx: Molecular Testing for Risk Stratification of Thyroid Nodules DL39682 for JE and DL39684 for JF.

Before we begin the meeting, I would like to make the following announcements.

This meeting will be recorded. The recording and written transcript will be posted on our website following today's meeting. All lines are currently being muted and will remain muted throughout the meeting.

There were no commentors registered for today's meeting.

All comments should be submitted in writing, and all written comments received will be recorded in the Response to Comments Article.

I will now turn the meeting over to Dr. Barry Whites. Dr. Whites, you may begin.

Dr. Barry Whites:
Thank you very much, Kari.

Welcome to this meeting. This is an open meeting, opportunity for stakeholders to express their concerns, comments, corrections, and any additions that they may feel necessary to these three policies.

These are in collaboration with one of the partners with the MolDx group. And these were all of our partners. The first test, are these policy [inaudible] is Decision Making and Castration Resistant and Metastatic Prostate Cancer.

Each one of these policies follows the zip format. The format is for development coverage, indication, limitations, and medical necessity.

Then we get into the summary of the evidence and the analysis of that evidence.

Accompanying these, and we will not be discussing those today, will be the article, which are billing and coding articles, that define how the provider community is to bill for these testing, the diagnosis, and as well as the indications of how to file the, particularly the DEX codes that are necessary, in each one of these three policies.

This first test as mentioned, is for Decision Making and Castration Resistant Metastatic Prostate Cancer. There is not a single test, there is a group of tests, it is for gene expression profile test to assess risk for predictive getting responses in men who have established diagnoses of castration resistant or metastatic prostate cancer.

It is considered reasonable and necessary to help guide treatment in men with prostate cancer.

Life expectancy is set to candidates for prostate treatment. According to the most recent nationally recognized guideline, [some inaudible] testing are based on FDA labeling of the drugs and biologicals available as a potential treatment options.

So, the patient, not only has the diagnosis, but he must be able to withstand the treatment that may be proposed by the results of these tests may yield.

The scope of the policy and yet does include gene expression profile test, regardless of the methodology, but an exclusive of targeted and comprehension genomic profile testing. My next genomic sequencing or single biomarker expression.

The coverage criteria are separated into 10 different areas in this policy. Three of those have sub sections A and B. So there are specific indication for when these are to be done and in particular, when these are not to be done. The coverage criteria are based on evidence and the summary of the evidence is listed in the documents that that contained in this draft or proposed LCD.

Those documents do not need to be relisted. If you have a comment about those, we already have those in here. And, but you may comment on those, you do not need a full copy of them.

But if you're making reference to one of the articles that you feel has been misquoted or not represented correctly about this contractor, you do not have to include that part of it. But your comments must be in writing.

They must state any conflicts of interest that you have and who you represent when making this comment, and you will have where to submit those at the end of this call.

The main thing that I again want to make clear, is it not every indication, not every patient has of prostate cancer gets these tests. There are very specific reasons to have these tests. Very specific coverage criteria and those who order the tests whether those performing the test, has a very clear article, very detail, to guide one in utilizing these tests.

I will now entertain any comments from my audience about this test.

Hearing none, we will proceed to the second item and that is the Molecular Diagnostic Cancer for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy.

I do pulmonary critical care, and this certainly is a needed area.

As much as I like to think about bronchoscopy yielded diagnosis in all our patients, usually, it would be it would come that this was suggestive and cannot exclude diagnosis.

So, this LCD outlines limited coverage for this service with specific details under the coverage and limitations, indication and medical necessity section.

There are 11 different limitations and coverage indications in this particular draft LCD, there were 10 in the other one.

Some of these even go to; number one for example has a three components; number two has four.

So, there are a lot of conditions that need to be made to be sure that the right patient is getting the right test for the right reasons.

The evidence is also summarized here.

And the summary of that evidence, as well as the utilization of the evidence in this policy is also listed.

The test itself is, again, requires that a molecular diagnostic (MolDx) test assessment must be done.

How to and also, you must get a DEX code to do this. Both in the previous one and this one also, and there is specific instructions on how you get it.

A lot of these tests, just to be sure that we're giving the right test that they had all undergone a study that verifies the analytical utility and validity, as well as clinical utility and validity.

The difference in those two definitions there, in here, clinical utility, again as a practicing pulmonary physician, the clinical utility of the test means that test will be used to improve patient outcomes.

And, that, that's the most important, is not there just to decide that, really, yeah, you really got a bad cancers, too bad, but it has to be used to make decisions that could potentially benefit the patient and the patient must be someone who could withstand the treatment that would be determined by these tips.

Will now entertain any questions on the Risk Stratification for Pulmonary Nodules.

Kari DuPreez:
Any attendees that would like to make a comment, please use the raise hand function.

All right. And seeing no raised hands. Dr. White's, you can go ahead and continue.

Dr. Barry Whites:

On the third one, this is Risk Stratification for Thyroid Nodules.

To me it's again, I don't do the thyroid disease, but it has to do a lot with the reclassification redetermination.

Both using National CC and Federal guidelines as well as Bethesda 2 and 4 Nodule classifications.

It is a very technical test.

The data that was analyzed and summary of the evidence is very technical, and so if you this is your type of patient that you're taking care of, please pay close attention to what is covered, what is not covered, and what are the indications on this test it is very specific. These tests are very beneficial when used in the right format.

Again, the test should not have been, the patient should not have been tested in the same or similar assay for the same indication. Does have an indeterminate nodule defined by Bethesda category.

Nodule for which molecular testing may aid in the further stratification of the malignancy.

Results should be used as all of these tests should be in the surgical decision making or consideration of a type of therapy.

The test must be within the population that has an indication, which potentially develops.

The tests must demonstrate, as mentioned, both analytical validity, analytical validation, clinical validation, as well as, , clinical utility and validation.

It must show a clear and significant molecular biological basis for stratifying patients in such as selecting a clinical management decision and a clearly defined population.

So, each test undergoes a complete technical assessment by the MolDx group.

It also will undergo and has to get its own code specific to that particular test. So there is no separation, in particular, a different test that we can identify.

This is, to me, the most complicated policy of the three, but all have the same basic foundation.

They are there for the intended use of the patients to better stratify the risk thyroid nodule. To decide on if it is or is not a malignancy, what's the grade, is it potential for removal of the tumor or not? And what type of therapy may or may not be beneficial in the patients?

Will entertain a questions, again as she mentioned if you would just raise the hand on your chat form that would be great we would be happy to discuss.

Kari DuPreez:
Alright, and seeing none, we can go ahead and move on to the closing and next steps.

In closing, we would like to communicate the next steps in the policy development process. The comment period for all three proposed LCDs will remain open until October 14th, 2023. All comments to be considered by our medical directors for the proposed LCDs must be submitted in writing. Written comments can be e-mailed to policydraft@noridian.com or mailed to the address on your screen. Comments information for our proposed LCDs is located on our website at noridianmedicare.com.

Upon review of the comments, our medical director either finalize or retire the proposed LCDs. Responses to comments will be viewable in the response to comments articles.

Please monitor our Web site or register for listserv notifications to be informed of actions taken on our proposed LCDs.

Dr. Whites, do you have anything else you would like to say before we end today's meeting?

Dr. Barry Whites:
Would like to thank those who are in attendance, and again, we do appreciate it. This is absolutely necessary step, that we go through to be sure that all of those have the opportunity to express your opinion, if they so alike, and to submit information that we may not have considered. Again, thank you so much for your presence. That's all.

Kari DuPreez:
All right, this does then conclude our meeting. Thank you for attending the Noridian Open Public Meeting.