LCD Reference Article Response To Comments Article

Response to Comments: Allergen Immunotherapy

A59574

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Article ID
A59574
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Article Title
Response to Comments: Allergen Immunotherapy
Article Type
Response to Comments
Original Effective Date
02/15/2024
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The following are the comment summaries and contractor responses for Novitas Solutions Proposed Local Coverage Determination (LCD) DL36240 (Allergen Immunotherapy) which was posted for comment on September 28, 2023, and presented at the October 12, 2023 Open Meeting. All comments were reviewed and incorporated into the final LCD where applicable.

Response To Comments

Number Comment Response
1

A comment from the American Academy of Allergy, Asthma & Immunology (AAAAI) requests the removal of the non-coverage language from the LCD for allergen immunotherapy for cockroach hypersensitivity. The commenter states: "Prominent allergists have demonstrated that cockroach antigen does produce allergic symptoms. Further, even more recent research has emphasized the importance of Cockroach Antigen in indoor exposure. Finally, several articles acknowledge cockroach immunotherapy and indicate that studies on the component antigens may be useful." Three references were cited with this comment.

The comment is appreciated. However, in accordance with the CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.3, in the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. A reasonable effort was made to obtain and review the articles cited by the commenter. Only one of the three articles cited was freely and readily available via internet search. This article (Rudman Spergel et al 2021) does not present any data regarding treatment effectiveness. It only suggests that the data presented may be useful in the future development of immunotherapy.

The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

2

A comment from the Florida Society of Otolaryngology Head and Neck Surgery states: "We appreciate the recognition that Multiallergen immunotherapy is standard of care in the United States and will continue to be a covered service and agree with many of the recommendations regarding medical necessity and coverage for allergen immunotherapy and we commend the MAC for its attention to these issues."

Thank you for your comment.

3

A comment from the Florida Society of Otolaryngology Head and Neck Surgery requests that 'cockroach hypersensitivity' be removed from the list of non-covered indications in the LCD. The commenter states: "We take exception that cockroach sensitivity is not an indication for immunotherapy since it has been proven to be effective. Cockroach sensitization is an important risk factor for the development of asthma. Allergic inflammation is widely accepted as the fundamental driving force in the development of allergen sensitization that can ultimately lead to asthma. Like many other indoor/outdoor allergens, cockroach excrete particles that can gain access to the lungs by lodging across the nasal/oral cavities, where it can provoke allergic type inflammation by allergen-induced epithelial damage or direct contact with cells of the epithelium. Do et al summarized cockroach allergen-triggered signaling events that may contribute to the development of allergen inflammation. Cockroach allergen identification and their expression as biologically active recombinant proteins has provided a basis for studying the mechanisms regarding cockroach allergen induced allergic sensitization and asthma. It has been noted that the mechanisms underlying cockroach allergen-induced allergic inflammation is multifactorial with genetic and epigenetic factors also being a major determinant for development of allergy. A current multi center double blind placebo-controlled study is currently being completed and results are soon available." Five references were cited with this comment.

The comment is appreciated. However, in accordance with the CMS Publication 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.3, in the absence of any new full-text evidence submitted with the request, the LCD will not be revised as requested. A reasonable effort was made to obtain and review the articles cited by the commenter. Apart from the Wood et al 2014 which was thoroughly addressed in the LCD under the subheading Evidence Submitted for Reconsideration, none of the articles discussed immunotherapy as a treatment modality. Unpublished manuscripts cannot be considered in the development of an LCD as per the Medicare Program Integrity Manual.

The LCD Reconsideration Process may be followed to request a revision to the LCD once the LCD becomes effective.

4

A comment from the Florida Society of Otolaryngology Head and Neck Surgery requests the removal of non-coverage language for the following allergen immunotherapy routes of administration from the LCD: ‘oral or sublingual for food immunotherapy and epicutaneous immunotherapy’. Two references were cited with this comment.

Thank you for the comment. As stated in the draft LCD: " Per NCD 110.9, antigens must be administered by injection to be considered for coverage by Medicare." Local Coverage Determinations lack the authority to override National Coverage Determinations. As per Section 13.3.2 of the Medicare Program Integrity Manual: "If modification of the LCD would conflict with an NCD, the request would not be valid." Therefore, the LCD will not be revised as requested.

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Associated Documents

Medicare BPM Ch 15.50.2 SAD Determinations
Medicare BPM Ch 15.50.2
Related Local Coverage Documents
LCDs
L36240 - Allergen Immunotherapy
Related National Coverage Documents
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