Response to Comments: Allergen Immunotherapy (AIT) with Subcutaneous Immunotherapy (SCIT)

General Guidelines

We respectfully request that the Medicare Administrative Contractors (MACs) consider Atopic Dermatitis as a covered indication for subcutaneous immunotherapy (SCIT) under the general guidelines for coverage. Allergen immunotherapy is suggested for moderate and severe atopic dermatitis if patients are refractory, intolerant, or unable to use mid potency topical treatments, based on moderate certainty evidence (Chu et al., 2024). We specifically request that the list of covered indications include atopic dermatitis codes:

• Atopic dermatitis L20
• Unspecified Atopic Dermatitis L20.9
• Other Atopic Dermatitis L20.8

Additionally, as the policy language states medications are relatively easy for most patients to use, and when effective, they provide relief more rapidly than immunotherapy. Mayo Clinic requests that the MACs consider adding patients having intolerable side effects with medications to the policy as appropriate for SCIT.

Limitations for Immunotherapy

Under the Limitations for Immunotherapy section, atopic dermatitis should be removed as a limitation for immunotherapy. SCIT during pregnancy should be removed as this is a standard of care for pregnant women and SCIT during pregnancy is appropriate treatment when necessary.

The MACs must consider adding to the summary of evidence a section pertaining to atopic dermatitis which is echoed in the publication referenced below.

In summary, immunotherapy is beneficial in the treatment of atopic dermatitis. The overall evidence supporting the efficacy of allergen immunotherapy for atopic dermatitis is considered moderate and should be considered for coverage under this draft policy. Thank you in advance for your consideration of this request.

Reference:

1. Chu, D. K., Schneider, , Asiniwasis, R. N., Boguniewicz, M., De Benedetto, A., Ellison, K., Frazier, W. T., Greenhawt, M., & Huyn, J. (2024). Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE-and Institute of Medicine-based recommendations. Annals of Allergy, Asthma & Immunology, 132(3), 274-312.

Thank you for your comment. According to the article that was cited, the recommendations for allergen immunotherapy are conditional recommendations and suggestions from the AAAAI/ACAAI. From the article, the conclusion was that the AIT would be most beneficial in patients who had other allergic conditions requiring SCIT: “The panel inferred that most well-informed patients would value the moderate certainty for net benefit with AIT for moderate and severe atopic dermatitis especially if the patient had other allergic diseases that would respond to AIT”. Furthermore, the benefits of SCIT were correlated predominantly with patients who tested positive for house dust mites. The most benefit was achieved with patients who failed prior medical therapy, were continued on topical medications and who had moderate to severe AD due to dust mites. Therefore, coverage will be expanded to include patients who have failed medical therapy and have IgE-related immunity to house dust mites. Finally, in all of the studies cited in this article, the patients were also treated with topical therapy and other treatments which would infer a lesser impact from SCIT. The anticipated variability in values and preferences, particularly with age and allergic comorbidities, contributed to a conditional recommendation or suggestion. Based upon the moderate degree of evidence for SCIT for patients with AD due to house dust mites, coverage will be included as reasonable and necessary for these groups of patients who have moderate to severe AD due to dust mites.

Due to the risk of severe allergic reactions that may occur during pregnancy, it is not reasonable and necessary to initiate SCIT during the course of pregnancy. There are only a limited number of studies to support the initiation and continuation of SCIT during pregnancy and therefore this service is not considered reasonable and necessary. (Oykhman P, Kim HL, Ellis AK. Allergen immunotherapy in pregnancy. Allergy Asthma Clin Immunol. 2015;11:31.)

In consideration of your plans to review the CMS Local Coverage Determination (LCD) for Allergy Services, we urge that the reimbursement methodology for CPT codes 95115-95117, 95144-95165, and 95180, follow clinical best practices rather than impose arbitrary limits on the number of doses covered. Allergen immunotherapy is a cost-effective, disease-modifying treatment that not only reduces allergy symptoms but also significantly lowers long-term healthcare costs by decreasing medication dependence, emergency visits, and productivity losses associated with untreated allergic disease.

Allergen immunotherapy follows a structured build-up phase requiring frequent injections over several months, followed by a maintenance phase with ongoing treatment. Medicare policy already acknowledges that a "reasonable supply of antigens" can be prepared for up to 12 months (CMS Medicare Benefit Policy Manual, Pub. 100-02, Ch. 15, Section 50.4.4.1). Restricting the number of doses per vial beyond what is medically necessary disrupts standard treatment protocols, which typically involve preparing a full treatment set of 4-5 vials to ensure consistency, safety, and efficacy.

Beyond its clinical efficacy, allergen immunotherapy is a proven cost-effective strategy compared to the ongoing costs of symptomatic treatments such as antihistamines, nasal corticosteroids, and biologics, as well as the indirect costs of environmental allergies, including missed workdays, school absences, and lost productivity. Studies have shown that patients undergoing allergen immunotherapy experience fewer emergency department visits and hospitalizations related to asthma and allergic rhinitis, leading to overall healthcare savings. Additionally, the long-term benefits of immunotherapy persist even after treatment discontinuation, unlike pharmacologic therapies that require continuous use.

Instead of rigid per-vial dose limits, a more appropriate approach—adopted by insurers such as BlueCross BlueShield of North Carolina—is to apply an annual dosing limit, allowing up to 180 doses in the first year to accommodate the build-up phase and 120 doses during the maintenance phase. This method ensures appropriate utilization while supporting patient care needs.

We strongly urge CMS to reconsider the proposed limitations on ICD-10-CM codes and dosing restrictions, as they do not align with standard clinical practice and may hinder patient access to appropriate allergy care. A reimbursement model that reflects real-world allergy immunotherapy protocols will ultimately lead to better patient outcomes and long-term cost savings by reducing medication dependence and overall healthcare utilization.

Thank you for your comment. We recognize the benefits of allergen immunotherapy and the work required to administer immunotherapy and the preparation of antigens. MACs follow the guidelines provided in the IOM by CMS and are limited to those requirements.

It is critically important that the MAC’s policies align with guidelines developed by organizations representing clinical medical specialties. As a medical society representing the field of allergy, we regularly establish general industry standards guidelines, and we appreciate the MAC’s consideration of our recommendations. We respectfully offer the following comments concerning the documentation standards outlined in the proposed LCD. In addition, we ask that the MAC publish its policy clarifying that it will cover and pay for the preparation of build-up doses of antigens for allergen immunotherapy under Current Procedural Terminology (“CPT”) code 95165.

Documentation for Allergen Immunotherapy Services

In the proposed LCD, the MAC recommended the following documentation standards:

Clear and accurate recording of the initial prescription for an AIT extract is essential to ensure that it is mixed in an identical fashion each time it is filled. In addition, these forms allow transmission of information to any clinician who may undertake the allergy care of the patient. It is recommended that the following information be contained in the form:

• Patient information, including name, patient number, birth date, telephone number, and picture (if available), to reduce the risk of an extract being given to the wrong patient.
• Preparation information, including name of person preparing and date of preparation.
• AIT extract content, including (for each allergen) common name or genus and species, extract manufacturer, concentration of manufacturer's extract, volume of manufacturer's extract added, the type of diluent (if any), volume of diluent added, lot number, and expiration date of each individual component.

We support the documentation of the aforementioned information. However, we believe that the information/documentation requested during reviews of individual claims for payment should be limited unless there is evidence of fraud that warrants additional scrutiny. Excessive audits by payors and improper pre-payment denials of claims for allergen immunotherapy services described by CPT codes 95165, 95115, and 95117 are a persistent and significant issue for allergy practices. Inappropriate claims processing practices result in significant financial hardship for allergy practices, which are predominantly small practices with limited resources to appeal, pursue the provider dispute resolution process, or produce large volumes of documentation. The financial strain caused by these claims processing practices jeopardizes the viability of continuing to provide this important service to patients.

On November 5, 2024, ACAAI, American Academy of Allergy, Asthma, and Immunology (“AAAAI”), and American Academy of Otolaryngic Allergy (“AAOA”) jointly released guidance to advise payors of the documentation that they should—and should not—require in their review of claims for payment for services described by CPT codes 95165, 95115, and 95117.¹ The following summarizes our guidance on reasonable and unreasonable documentation requests for CPT codes 95165, 95115, and 95117. We believe that any payor should not request additional documentation beyond the following list of reasonable documentation. We have also included a list of unreasonable documentation requests for illustrative purposes only. It is not intended to be an exhaustive list of unnecessary documents for processing claims for allergen immunology services. Please refer to the enclosed guidance for a more detailed explanation of our recommendations.

CPT Code 95165

“Professional services for the supervision of preparation and provision of antigens for allergen immunotherapy; single or multiple antigens (specify number of doses)”

Based on the collective expertise and experience in the field of allergy medicine, ACAAI, AAAAI, and AAOA, strongly recommend that payors limit their documentation requests to the following documents to determine the medical necessity of CPT code 95165.

Reasonable Requests for Documentation

1. The identity of the physician who established the treatment plan.
2. The identity of the patient and a short description of the clinical indications for allergen immunotherapy.
3. A brief description of the treatment plan and the date on which it was formulated.
4. A description of the response to allergy immunotherapy and the need for continued allergen immunotherapy at routine visits.
5. A signed and dated order for allergen extract listing the allergy extract ingredients (i.e., antigens), concentrations (Allergy Unit, Bioequivalent Allergy Unit, and weight to volume), volumes of extract, and diluent (cubic centimeters or milliliters) should be available to document the contents of both the initial and refill allergy extracts vial.
6. The initials of the allergen extract compounding healthcare professional.

Unreasonable Requests for Documentation

A demand for the following documentation when a claim is submitted under CPT code 95165 is unnecessary and unduly burdensome on allergy practices.

1. A requirement that allergy extracts billed under CPT 95165 be based on a volume of 1 ml. or some other insurer-specific maximum. Depending on the condition of the patient and the composition of the appropriate allergen, the patient may receive injections of different volumes and require additional extract vials. In addition, there are limits to the number of allergens that can be compounded in a vial. Annual dose limits should allow these variations.
2. Adhering to medically unlikely edits (“MUEs”) limits or insurer-specific unit maxima. It is often the standard of care to provide allergen extracts that are not 1 mL.
3. Compounding logs for each dilution and lot numbers.
4. Results of allergy skin testing.

CPT Codes 95115 and 95117

CPT Code 95115 “Professional services for allergen immunotherapy not including provision of allergenic extracts; single injection”

CPT Code 95117 “Professional services for allergen immunotherapy not including provision of allergenic extracts; 2 or more injections”

The following documentation is appropriate to request to determine whether services described by CPT codes 95115 and 95117 are medically necessary.

Reasonable Requests for Documentation

1. The date of the injection, the patient’s name, and the patient’s birth date.
2. The dose administered, specifying volume, dilution, and number of injections.
3. The site(s) of the injection (e.g., right arm).
4. The initials or signature of the person administering the injection.

Unreasonable Requests

To require the following documentation for every claim submitted under these two codes imposes an entirely unnecessary and time-consuming burden on small practices.

1. Date of vial expiration/“best use by”.
2. Full planned dosing schedule.
3. Specification of subcutaneous administration. Anthem recognizes that all injections are subcutaneous.²
4. Signature of ordering healthcare professional. It is quite burdensome to obtain the signature of the ordering professional every time that a claim is submitted.
5. Credentials of the person administering the injection.
6. A history of previous injections.

Therefore, although we support the documentation standards set forth in the proposed LCD, we urge the MAC to provide additional direction to its reviewers to limit the requested documentation needed to pay each individual claim, in accordance with our guidance. We welcome the opportunity to meet with the MAC’s clinical team to discuss the proper evaluation of allergen immunotherapy services.

Build-Up Phase

Late last year, ACAAI had the pleasure of meeting with Palmetto and Noridian to discuss allergen immunotherapy services described by CPT code 95165. By email dated September 17, 2024, Palmetto stated: “there is no differentiation between initiation therapy and maintenance therapy.” By email dated December 13, 2024, Noridian stated: “Noridian treats diluted doses for the purposes of “build up” and maintenance dosing the same, as long as reasonable and necessary and within CMS NCCI MUE Edits.” Earlier this year, ACAAI had the pleasure of meeting with NGS to discuss allergen immunotherapy services described by CPT code 95165. By email dated February 12, 2025, NGS stated: “NGS will cover CPT code 95165, when medically reasonable and necessary for preparation and provision of maintenance and build up doses of antigens for allergen immunotherapy.” (emphasis added). This important announcement is not currently published on Palmetto’s, Noridian’s, or NGS’ website resulting in some confusion among our membership. Accordingly, we respectfully request that Noridian and NGS publish this policy on its website or in the final LCD and request that Palmetto publish its policy clarifying that it will cover and pay for the preparation of build-up doses of antigens for allergen immunotherapy under CPT code 95165.

By letter dated December 22, 2023, the Centers for Medicare and Medicaid Services Administrator clarified that “allergy immunotherapy build-up doses may be covered and paid to the extent that they are reasonable and necessary for the treatment of illness or injury under Section 1862(a)(1)(A) of the Act.” ACAAI has met with Noridian Healthcare Solutions, Palmetto GBA, and National Government Services regarding this letter, and those Medicare Administrative Contractors communicated to ACAAI that they will cover CPT code 95165, when medically reasonable and necessary for preparation and provision of build-up doses of antigens for allergen immunotherapy. We respectfully request that CGS adopt the same policy and publish it on CGS’s website or in the final LCD.

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¹ This guidance document supersedes any document or manual published previously by the above organizations.

² Anthem, Allergy Immunotherapy (Subcutaneous) (CG-MED-52) (Apr. 10, 2024).

Reference:

1. Meadows JA, Gross GN, Wasan AN, et al. Guidance for the evaluation by payors of claims submitted using current procedural terminology codes 95165, 95115, and 95117. Ann Allergy Asthma Immunol. 2024:1-3.

Thank you for your comment.

1. The documentation is only required upon claims review. This documentation is not required for normal claims that follow the billing and coding article. However, consistent with 42 CFR 424.5(a)(6), the following applies: Sufficient information. The provider, supplier, or beneficiary, as appropriate, must furnish sufficient information to the intermediary or carrier to determine whether payment is due and the amount of payment. Thus, the documentation requirements will be maintained per the Code of Federal Regulations.
2. See previous comments regarding dosing requirements from IOMs cited in the billing and coding article. According to the LCD, the following are the only recommended documentation requirements:

• Patient information, including name, patient number, birth date, telephone number, and picture (if available), to reduce the risk of an extract being given to the wrong patient.
• Preparation information, including name of person preparing and date of preparation.
• AIT extract content, including (for each allergen) common name or genus and species, extract manufacturer, concentration of manufacturer's extract, volume of manufacturer's extract added, the type of diluent (if any), volume of diluent added, lot number, and expiration date of each individual component.

However, individual MACs may request additional documentation beyond what is recommended in the LCD to determine the medical necessity of the procedure.

3. The build-up phase or the payment for the initiation of SCIT versus the maintenance of SCIT with code CPT 95165 is not differentiated from coverage and payment and is similarly provided as a reasonable and necessary service. The MACs will clarify this in the billing and coding article.