Allergen Immunotherapy (AIT) with Subcutaneous Immunotherapy (SCIT) Open Public Meeting - March 6, 2025 - JE Part A

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 Allergen Immunotherapy (AIT) with Subcutaneous Immunotherapy (SCIT) LCD.

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.

We did not have any speakers sign up to provide comments today.

Therefore, Dr. Sun will go over her presentation and then we will share closing and next steps.

We have added a closed caption feature in real time for today's call.

You will need to click on the close captioning button in the bottom right-hand corner of your screen for it to populate on your end.

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

Dr. Ann Marie Sun:
Hello, and thank you. I am one of the Contractor Medical Directors here at Noridian, and I have the pleasure of going over the Allergy Immunotherapy with Subcutaneous Immunotherapy, LCD.

And in this open meeting, I just wanted to briefly highlight some specific points in this proposed LCD draft.

Next slide, please.

Here on this slide, I just wanted to include the CMS national coverage policies that do impact this local coverage determination.

This, of course, is always in the early beginning part of our LCD for level-setting purposes, and I just wanted to point that out here.

Next slide, please.

Now, to clarify, this LCD is limited to IgE-mediated aeroallergens hypersensitivity.

Other allergens, such as venoms, are not considered in this LCD.

Subcutaneous allergy immunotherapy using preparations of aeroallergens can be considered reasonable and necessary in the management of the following disorders.

Seasonal and/or perennial, allergic rhinitis, allergic conjunctivitis, and/or allergic asthma.

Next slide, please.

Now, a patient is a candidate for subcutaneous allergy immunotherapy only if it has been established that there is a clinically important allergic component to his or her disease that is suspected to be due to IgE-mediated hypersensitivity.

Therefore, these clinical indications on this slide must be met to be considered reasonable and necessary.

And these indications include, number one, symptoms of allergic rhinitis, conjunctivitis, asthma, or any combination of these disorders after natural exposure to aeroallergens and the demonstrable evidence of clinically relevant specific IgE, for example, found in allergy diagnostic testing, and at least one of the following, poor response to pharmacotherapy, allergy, allergen avoidance, or both for a minimum of 28 consecutive days, unacceptable adverse effects of medication, avoidance of long-term pharmacotherapy and its side effects, or possible prevention of asthma in patients with allergic rhinitis.

So, to clarify, at least one of the following.

Next slide, please.

Oh, sorry.

Keep on this slide if you can.

So, in this slide, I am just wanting to clarify that we did have some formatting issues on the proposed draft that's currently viewable in the Medicare Coverage Database.

And what I'm specifically speaking to is numbers four through seven in the top left, which is what it looks like currently.

In the bottom right is the actual correct way that this should be formatted and is in the banner of what I just spoke to a few minutes ago.

So, please note that in the bottom right, it will be reformatted to appear in this fashion, and this hopefully will clear up some confusion, and we're sorry about that formatting snafu.

Next slide, please.

Now, the following are not considered reasonable and necessary, such that sub-Q immunotherapy will not be covered in these situations.

It will not be covered if used as, or it's not considered reasonable and necessary, excuse me, if used as first-line treatment for allergic rhinitis and/or conjunctivitis in the absence of previous medical treatment and environmental avoidance.

It is not considered reasonable and necessary when there is absence of clinically relevant IgE, or if used as treatment for atopic dermatitis.

Also, sublingual immunotherapy will not be covered, and that has already been previously established in one of our National Coverage Determinations.

Not considered reasonable and necessary as treatment for food sensitivities and treatment beyond a two-year period when there is no apparent clinical benefit will also be considered not reasonable and necessary.

Please note that for these patients who have equivocal testing of IgE-specific antibodies, but there is a strong clinical suspicion of allergic rhinitis that is supported by a positive reaction on nasal allergen challenge, the subcutaneous immunotherapy may be considered on a case-by-case basis.

And occasionally, this may be the case with equivocal testing.

Next slide, please.

Now, payment may be made for a reasonable supply of antigens that have been prepared for a particular patient when the antigen is prepared by a physician who is a Doctor of Medicine or osteopathy and the physician preparing the antigens has examined the patient, determined plan of treatment, and determined the dosing regimen.

The administration of the antigen prep must be done under the supervision of an appropriately trained physician and in an equipped facility that is capable of handling anaphylaxis emergencies.

Next slide, please.

Now, to support reasonable and necessary, it is recommended that the following information be contained in the medical record: patient information, including name, patient ID number, birth date, telephone number, and picture, if available, in the effort to reduce the risk of an extract being given to the wrong patient.

Preparation information, including name of person preparing and date of preparation, and an allergy immunotherapy extract content, including for each allergen, the common name or genus and species, extract manufacturer, concentration of manufacturer's extract, volume of manufacturers extract added, the type of diluent, if any, volume of diluent added, lot number, and expiration date of each individual component.

Next slide, please.

CPT code 95165 represents preparation of vials of non-venom antigens.

These codes report the physician's preparation of an antigen for allergen immunotherapy and provision of the antigen extract itself.

Proper billing and coding instructions that will be in the separate billing and coding article align with the Medicare Claims Processing Manual, Chapter 12, Section 200.

So, there will be, there should be no significant discrepancy by what is written in the manual and what it will be in our billing and coding, or what is in our billing and coding article.

Now, these codes do not, however, include the administration of the antigen, which also can be billed, such as CPT code 96372, which is the therapeutic, prophylactic, or diagnostic injection, sub-Q, or intramuscular.

That's all I have today, thank you.

Kari DuPreez:
All right, 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 March 23rd, 2025.

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 our website or register for listserv notifications to be informed of actions taken on our proposed LCDs.

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

Dr. Ann Marie Sun:
No, I don't but thank you all for attending.

Kari DuPreez:
All right, perfect.

Then this does conclude our meeting.

Thank you for attending the Noridian Open Public Meeting today.