Using Expired Allergenic Extracts for Medicare Billing
Expired allergenic extracts should not be used for patient treatment or billed to Medicare as they may have reduced potency, compromised safety, and their use violates established medical guidelines.
Why Expired Extracts Should Not Be Used
Allergen extract potency decreases over time, with the rate of potency loss influenced by multiple factors including storage temperature, presence of stabilizers, concentration, proteolytic enzymes, and storage volume 1.
The expiration dates for allergen extracts are established based on stability studies conducted by manufacturers, and these dates should not be exceeded 1.
Using expired medications and billing Medicare for them could constitute fraud and violate Medicare billing requirements, as Medicare expects providers to use unexpired, properly stored medications 2.
Factors Affecting Extract Stability
Storage temperature is critical - allergen extracts should be stored at 4°C (refrigerated) to minimize potency loss, as higher temperatures accelerate deterioration 1.
More dilute concentrations of allergy immunotherapy extracts (diluted greater than 1:10 vol/vol) are more sensitive to temperature effects and lose potency more rapidly than concentrated extracts 1.
The expiration date of any allergen mixture should not exceed the expiration date of the earliest expiring constituent in the mixture 1.
Guidelines for Proper Extract Handling
The AAAAI/ACAAI/JCAAI guidelines explicitly state: "Extracts beyond the expiration date of the manufacturer are to be discarded" 1.
Manufacturers conduct stability studies with standardized extracts under various conditions, and the resulting expiration dates are based on these studies 1.
Professional guidelines require that "The manufacturer's expiration dates must be followed" as part of proper allergen extract preparation 1.
Research on Extract Stability
While one study suggests that outdated allergen extracts maintained diagnostic efficacy for skin testing 3, this does not support their use for treatment purposes where therapeutic dosing is critical.
The FDA review of nonstandardized allergen extracts emphasizes that these products should be used according to professional guidelines to ensure safety 2.
Studies on allergen stability have shown that even under optimal storage conditions, potency decreases over time, which is why expiration dates are established 4, 5.
Practical Considerations
Using expired extracts could lead to:
The quality and consistency of allergen extracts are already challenging even when unexpired, making the use of expired products even more problematic 6.