Five Medicare Administrative Contractors (MACs) recently finalized new Local Coverage Determinations (LCDs) addressing allergy diagnostic testing for both immediate IgE-mediated hypersensitivity reactions and delayed cell-mediated hypersensitivity:
Effective for services on or after Sept. 27, 2026:
- Palmetto GBA (Palmetto) LCD L40328
- Noridian Healthcare Solutions (Noridian) LCD L40324
- Wellpoint Federal (formerly National Government Services) (Wellpoint) LCD L40330
- Wisconsin Physicians Service (WPS) LCD L40341
Effective for services on or after Oct. 4, 2026:
- CGS Administrators (“CGS”) LCD L40326
The Advocacy Council submitted detailed comments on the proposed LCDs during the public comment period earlier this year, advocating for policies that better reflect contemporary allergy practice and preserve access to clinically appropriate testing. The final policies incorporate many of those recommendations and provide important guidance on coverage of allergy diagnostic services. This article summarizes key provisions of the final LCDs.
Scope of the LCDs
The Advocacy Council is pleased that our recommendation to clearly distinguish traditional allergy diagnostic testing from broader immunologic testing was incorporated into the final policies. We believe that this will provide greater clarity regarding the scope of coverage.
Across all testing modalities, the final LCDs emphasize that testing should be guided by the patient’s clinical history, symptoms, relevant exposures, and differential diagnosis, with documentation supporting medical necessity. Importantly, the LCDs clarify that testing performed to evaluate broader immune-system function falls outside the scope of the policy. The LCDs also specify that omitted uses of total IgE testing for other conditions should not be interpreted as a non-coverage determination.
The LCDs are substantially similar across MAC jurisdictions and establish a common coverage framework for allergy diagnostic testing. Palmetto, Noridian, Wellpoint, and WPS finalized nearly identical policies, while CGS adopted a similar policy with a few notable differences. While two of the seven MACs have not yet finalized similar LCDs, the Advocacy Council will continue to monitor developments in other Medicare jurisdictions and advocate for coverage policies that reflect contemporary allergy practice.
Skin and serum testing
Under the LCDs, skin testing is designated as the first line diagnostic approach for type I IgE mediated hypersensitivity. Allergen-specific serum IgE testing is covered when skin testing is contraindicated, unreliable, or otherwise inappropriate based on the patient’s circumstances. Routine testing of the same allergen using both skin and serum testing is generally not covered, except in limited situations involving latex, Hymenoptera venom, and nut or peanut allergy. Members should note that the CGS LCD does not include Hymenoptera venom among its listed exceptions. At the same time, the LCDs emphasize that allergy testing should be individualized and follow a structured diagnostic approach beginning with a detailed clinical history and physical examination. The policies also recognize the role of the ordering provider in selecting the appropriate diagnostic approach within the coverage framework.
The Advocacy Council appreciates that the final LCDs provide additional flexibility for the use of serum IgE testing in circumstances where skin testing may not be appropriate. We are further encouraged by the emphasis on individualized testing and the role of physician judgment in selecting the most appropriate diagnostic strategy. This is consistent with our position that skin and serum testing should be recognized as complementary diagnostic tools selected according to clinical judgment. We will continue to advocate for that principle to be reflected more fully in the coverage criteria and for pregnancy to be expressly recognized as an indication for serum-specific IgE testing.
Patch testing
The final LCD sections cover patch testing for allergic contact dermatitis and other delayed hypersensitivity reactions. Importantly, the policies recognize that comprehensive patch testing may require up to 80-90 allergens. In addition, the LCDs finalized by Palmetto, Noridian, Wellpoint, and WPS recognize that patch-test reactions may require monitoring for up to 10 days when medically necessary. CGS discusses monitoring for 4-7 days rather than 10 days. While the CGS LCD adopted the expanded patch-testing framework, it retained different discussion language regarding patch-test monitoring.
Organ and bronchial challenges
The final LCD sections recognize that organ challenge testing may be performed in an open, single-blind, or double-blind fashion, reflecting the range of approaches used in clinical practice. The discussion of bronchial challenge testing in the Palmetto, Noridian, Wellpoint, and WPS LCDs includes commonly used non-allergen stimuli such as methacholine and mannitol. CGS adopted similar bronchial challenge provisions but did not specifically identify those agents in its discussion. The LCDs also require objective measurement of airway response during bronchial challenge testing, typically through spirometry or other pulmonary function testing.
The recognition of open organ challenges is particularly important because they are commonly used in everyday clinical care and are often the most practical approach for evaluating patients. The Advocacy Council is pleased that the final LCDs better reflect approaches commonly used in contemporary allergy practice. The Advocacy Council also raised concerns regarding proposed language that created uncertainty about how pulmonary function testing performed during bronchial challenge procedures would be reported. We are pleased that the final LCDs removed that language. Although the final policies do not provide additional billing clarification, we will continue to work with the MACs to promote clear guidance in this area.
Oral food challenges
The final sections of the LCDs continue to recognize oral food challenges (OFCs) for the evaluation of suspected IgE-mediated food allergy. The final LCDs specifically recognize that an OFC may be performed when necessary to determine whether sensitization identified through skin or serum testing is clinically relevant and to avoid unnecessary dietary restriction. CGS adopted the same coverage language but retained more traditional supporting discussion emphasizing OFCs following non-confirmatory testing.
We are pleased that the final LCDs provide overall greater flexibility for clinically indicated OFCs. However, these additional applications were not specifically addressed and remain important areas for future advocacy.
Drug challenges and delabeling
The final LCD sections broadly recognize the role of drug challenge testing in the evaluation of suspected drug allergy and acknowledge the importance of drug allergy delabeling. The policies permit challenges to evaluate questionable allergy histories and determine whether previously avoided medications, including antibiotics and chemotherapeutic agents, can be used safely.
Importantly, the LCDs finalized by Palmetto, Noridian, Wellpoint, and WPS provide broader supporting discussion regarding drug challenge testing and drug allergy de-labeling. These changes closely align with recommendations submitted by the Advocacy Council and reflect the growing recognition that inaccurate drug allergy labels can limit access to optimal treatment. CGS adopted similar coverage provisions but retained more restrictive discussion language regarding alternative diagnostic methods and drug substitutions.
Although biologic agents are not specifically identified in the coverage language, the broader approach adopted by Palmetto, Noridian, Wellpoint, and WPS provides important flexibility for evaluating a wide range of drug hypersensitivity reactions.
Multi-allergen panels and component-resolved diagnostics
For in vitro testing, the final LCD covers single plex testing directed at suspected allergens when supported by the patient’s clinical history, symptoms, exposures, or differential diagnosis. Broad screening tests that are not supported by the patient’s clinical presentation remain non-covered tests.
The LCDs finalized by Palmetto, Noridian, Wellpoint, and WPS recognize the clinical utility of component-resolved diagnostics (CRD) in selected situations, including testing involving Ara h 2 (peanut), Cor a 14 (hazelnut), Ana o 3 (cashew), and alpha-gal, as well as in certain immunotherapy planning decisions. CGS adopted similar coverage limitations for clinically directed testing but did not incorporate the same expanded discussion of component-resolved diagnostics.
The Advocacy Council is pleased that the final LCDs replace the proposed restriction on “unrelated” multi-allergen panels with a framework based on clinical history and medical necessity. We are also encouraged by the recognition of appropriate uses of component-resolved diagnostics, which better reflects current evidence and clinical practice.
Total serum IgE
The final LCDs cover total serum IgE testing for specific indications, including follow up of allergic bronchopulmonary aspergillosis, select immunodeficiencies, eczematous dermatitis, recurrent pyogenic infections, and evaluation for omalizumab therapy. Notably, the coverage indication for omalizumab therapy is not limited to asthma. While CGS retained more asthma-focused discussion language in its supporting evidence section, the coverage indication itself is broader.
The Advocacy Council supported broader recognition of total serum IgE testing, including its role in asthma endotyping, chronic spontaneous urticaria, and evaluation for omalizumab therapy in food allergy. The final LCDs recognize evaluation for omalizumab therapy without limiting coverage to asthma. Asthma endotyping and chronic spontaneous urticaria were not specifically added and remain areas for continued advocacy.
Conclusion
We believe that the final coverage framework overall reflects contemporary allergy practice while preserving access to important diagnostic tools used by allergists every day. While important issues remain, the Advocacy Council will continue working with the MACs to ensure that Medicare coverage policies support high-quality, evidence-based allergy care.
The Advocacy Council – ADVOCATING FOR ALLERGISTS AND THEIR PATIENTS.
