Kari Dupreez:
Good afternoon, everyone, and welcome to Noridian's Open Public Meeting. My name is Kari Dupreez, and I am one of the Medical Policy Specialists here at Noridian Healthcare Solutions.

We will be presenting the Allergy Diagnostic Testing LCD today.

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. Only those who registered to present will be allowed to comment on the proposed LCD today. If closed captions are needed, please click the more button at the top of your screen, then go to language and speech and show live captions. There is also a picture on the slide for visual.

For the presenters, you are being allotted ten minutes to make comments. As we only have one speaker today, if you go over a few minutes, we will allow you to finish your comments. Your line will be open when it is your turn to speak. Make sure you are not on mute within your system or we will not be able to hear your comments.

You should be prepared to begin your presentation immediately when called upon and will hear the moderator's voice when one-minute remains. If you submitted a PowerPoint presentation, please tell the moderator when to advance to the next slide. Please speak clearly to ensure that the system will be able to translate into captions for display. By signing in today, you are giving consent to the use of your recorded voice and your comments. Please be mindful of sharing any personal health information during your presentation.

In addition to comments that are made today, all comments should also be submitted in writing. All written comments received will be recorded in the Response to Comments article.

I will now turn this meeting over to Dr. Ann Marie Sun. Dr. Sun, you may begin.

Dr. Ann Marie Sun:
Thank you so much. Thank you everyone for calling in. We really, really appreciate this.

I know it's really important for transparency purposes that you can see kind of what we're doing in our preparation for getting this Allergy Diagnostic Testing LCD off the ground. So what I'd like to do just for a quick few minutes is to highlight several key elements in this draft LCD.

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This is just a basic national information, you know, covering the CMS National Coverage policies and regulations. A lot of this are the guardrails that we have to consider that help inform and help shape our LCD. So it's just kind of a basic understanding and framework for us to work with. So we just make sure we list it in our coverage policy, all things that may apply and then they're here on the slide.

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So a bit of background within Jurisdiction E, which includes states such as California and Nevada for instance, as just two of them as an example, we currently have an active LCD for Allergy Testing. In Jurisdiction F for states like Arizona, Utah, and others, the Dakotas as examples, we do not. And so, it's been a long time coming, but we've been wanting to ensure that there is consistency across both jurisdictions. And so, as a result, we determined that a full rewrite of the Allergy Diagnostic Testing LCD was necessary. And of course in that vein, we wanted to make sure we did a fresh review of the current evidentiary literature. And once finalized, this new LCD will replace and retire the existing JE allergy testing LCD. So, JE will of course adopt just as JF will. The finalized new, I'm sorry, Allergy Diagnostic Testing LCD. Sorry, mouthful there.

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As far as the coverage policy, similar to the existing JE policy I just mentioned, this draft LCD focused primarily on immediate IgE-mediated hypersensitivity reactions as well as the delayed cell-mediated hypersensitivities. It addresses both in vivo testing, such as skin testing and organ challenge testing, and in vitro testing, including serum specific IgE.

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In vivo testing, this section in our LCD draft outlines the covered indications and includes, of course, the various forms of skin and organ challenge testing procedures that you most commonly come across.

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And of course in vitro testing. This section is includes a brief, brief discussion of total serum IgE testing, but we really have more detailed attention that is given to allergen specific serum IgE testing.

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As with any coverage policy, there are limitations. And one point we want to emphasize is that of course, routine repeat skin testing is not considered reasonable and necessary unless there is a clear clinical indication. Are there new symptoms and signs? Are there concerns about effectiveness of your current allergy immunotherapy? Could there be new exposures and maybe some new allergens that you're concerned about that have yet been identified?

But overall, our goal was to align with what is most widely accepted as standard of care regarding the number of tests and the circumstances under which we repeat or in which additional testing is medically necessary.

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And lastly, I just want to talk about 21st Century Cures Act. This is basically including the framework of what LCDs today must include once again for transparency purposes. And as part of our comprehensive update, we have included a summary of evidence, our evidentiary analysis, and the rationale supporting the coverage criteria, along with a full reference list. So, it's a mighty long LCD draft but just wanted to kind of give the bullet points and highlights of our intent with this draft LCD.

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So, I will next introduce Dr. Kwong. I'll let you introduce yourself a little bit more in your background. I know you have an extensive background in this specialty, so please feel free to take over.

Dr. Kenny Kwong:
Great. Thank you so much.

Good afternoon and thank you for allowing me to comment and present on this LCD. Again, my name is Kenny Kwong. I'm presently Service Chief of the Division of Allergy Immunology, which basically means I have to see patients, organize a division, and also clean up after everybody. I'm also the Clinical Adjunct Professor of Pediatrics at the University of Southern California.

My clinical practice is entirely at the Los Angeles General Medical Center, which is a safety net hospital. And finally, I am a consultant and speaker for ThermoFisher Scientific.

The contents of my presentation are my personal professional viewpoints. And while Los Angeles General Medical Center allows equal access or parity to both in vitro testing and in vivo testing, skin testing and serum IgE, my presentations don't represent their official positions.

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So if you read the major guidelines on allergy and immunology, IgE testing and specific IgE testing has been recommended as one of the main modalities in which for management, namely diagnosis and treatment of allergic diseases. And just these are smattering examples. The first bullet point is the guidelines on allergic rhinitis. The second one is on asthma, where you want to like measure and detect allergens by specific IgE testing. And the third bullet is for food allergies, and of course, without specific IgE testing, it would be very difficult to manage those patients.

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So we have two main professional bodies of academic kind of institutions, the American Academy of Allergy and the American College of Allergy, and they put out joint task force practice parameters. And in the first bullet point, they put out a allergy diagnostic practice parameter and mainly they say there are two main categories of testing available to help us treat patients with allergy diseases that we previously talked about. And they include again allergy skin testing, including intradermal testing and IgE, specific IgE blood testing, and both modalities are used in a complementary fashion to include or exclude allergens. And while there is no clinical scenario where blood serum IgE testing is indicated or contraindicated. Well, maybe if the patient has no blood. There are some situations where skin testing is less preferable or in vitro testing is basically, more preferable, namely if patients cannot be taken off medications that interfere with skin testing like antihistamines or psychological meds, et cetera, or if patients have extensive skin disease like atopic dermatitis or the care or demographics.

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So again, a serum IgE testing is usually done in a laboratory. And skin testing, percutaneous prick testing, or intradermal is usually done at the office of the allergist specialists. And skin testing is usually billed as a procedure, while specific IgE testing is usually billed as a lab test.

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In terms of total IgE testing, I know this is not a main topic of this LCD, but there are certain indications for total IgE testing. Namely the first thing is it's a good indicator of atopic disease. Usually most serum IgE specific testing panels, for instance, will include a total IgE. Usually using this total IgE, you can use it to determine adequacy and evaluation of treatments and you usually can use that to trend.

And the last thing is that the total IgE is very good in helping to interpret specific IgE tests. For instance, if you have a patient with atopic dermatitis whose IgE is very, very high, there may be nonspecific positive results. Whether you do serum IgE testing or even skin testing, you might have a lot of reactivity.

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And the final thing that has come into the United States that's been pretty prevalently used in international areas in Europe is the use of component testing, or CRD. And these are molecular testing for specific parts of the allergen that becomes much more precise in diagnosis. And in the United States, there are actually a few conditions in which this is used as a primary diagnostic test, namely in the Peanut Practice Parameters put out by the American Academy and College of Allergy Immunology. Ara h 2 molecular diagnosis is a recommended test. And in the diagnosis of something very, very interesting, alpha-Gal syndrome, where patients have allergies to meat products after being bitten by a tick, the alpha-Gal component test is very, very accurate.

The European guidelines, you know, use component testing a lot more extensively for things like peanut, hazelnut and cashew to support the diagnosis in circumstances where skin testing and a specific IgE testing may not give the most accurate results. And I think that these other ones like hazelnut and cashew will be widespreadly used in the United States in the near future.

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And then I wanted to like quickly go over a little bit of our research. In 2023, we published this study in which we were actually the first people to look at total payments, you know, from Medicare for skin testing and serum IgE testing. And we actually took the entire Medicare population in 2019 and looked at the payments for serum IgE testing on the left, skin prick testing only, intradermal testing, skin prick and intradermal and serum testing, IgE and any skin test. And you can see that on the left hand side in the blue, serum IgE testing is a lot less expensive compared to skin prick testing only. And when you do skin prick testing plus intradermals or serum IgE plus skin testing, they are a lot more expensive.

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And we looked at the MACs, the MACs which allowed equal access to skin testing and serum testing, and those MACs which had no parity and favored skin testing over serum IgE testing. So the green are the MACs with equal parity, the blue are the MACs without parity. And we found that essentially the MACs with parity or equal access to skin and serum testing had much lower cost than the ones which did not allow parity. And one of the things we found was that the MACs with equal access had fewer allergy specialist visits compared to the MACs that restricted serum testing in favor of skin testing.

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And I wanted to draw attention that consistent with the shortage of physicians and other advanced care practitioners in the United States, there are not enough allergists in the United States. And this study really shows that in parts of the United States, there are areas which there are no allergy immunology specialists, and patients have to travel for skin testing.

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And so in conclusion, you know, personally I feel that patients and providers, you know, should have equal access to both serum IgE and skin testing to diagnose and manage their allergic diseases with a note that both skin testing and serum IgE testing can be used on a complementary equal basis for the management of allergic diseases. And this proposed LCD, I personally feel should reflect the equivalency of these diagnostic modalities. And the final very exciting thing is that component resolved diagnostics or molecular diagnostics is now an established approach for clinical use.

And with that I conclude and thank you very much for your attention.

Dr. Ann Marie Sun:
Thank you so much, Doctor Kwong. We really appreciate your input and expertise on this.

Thank you. Kari.

Kari Dupreez:
All right. Thank you.

In closing, we would like to communicate the next steps in the policy development process. The comment period for the proposed LCD will remain open until February 28, 2026. All comments to be considered by our medical directors for the proposed LCD must be submitted in writing. Written comments can be emailed to policydraft@noridian.com or mailed to the address on your screen. Comment information for our proposed LCD is located on our website at noridianmedicare.com.

Upon review of the comments, our medical directors will either finalize or retire the proposed LCD. Responses to comments will be viewable in the Response to Comments article. Please monitor the website or register for listserv notifications to be informed of actions taken on our proposed LCDs.

And Dr. Sun, do you have anything else you'd like to say before we end the meeting today?

Dr. Ann Marie Sun:
No, I don't. But just once again, thank you Dr. Kwong for your presentation, and thank you everybody for your attention on the matter here.

Kari Dupreez:
Alright, perfect. Thank you so much. Thank you for attending the Noridian Open Public Meeting today. Have a great day.