Allergy Shots: Understanding Documentation Guidelines

10 Oct
Documenting allergy shots in the patient’s medical record is nothing to skimp on….We have all seen it –   something like the quote below seen in a recent audit:  “Allergy shot, Vial B, 0.10ml”


Is that sufficient documentation in the medical record to support the billed service?  The answer is a decisive “No!” So here’s the skinny on documentation for allergy shots.

Allergen Immunotherapy, also known as allergy shots, are frequently billed services, which have come under the scrutiny of the Office of the Inspector General (OIG) and many commercial payers.  Allergen immunotherapy is intended to reduce the patient’s reactions to particular allergens.  Title XVIII of the Social Security Act (the Act) limits Medicare coverage to services that are medically necessary (section 1862 (a)(1)(A)) and supported by documentation (section 1833(e)). Title XI of the Act requires that services provided to Medicare beneficiaries be of a quality that meets professionally recognized standards of health care (section 1156(a)(2)).  Federal regulations (42 CFR § 1001.2) define “professionally recognized standards of health care” as “Statewide or national standards of care that professional peers of the individual or entity recognize as applying to those persons practicing or providing care within a State.”  The Joint Task Force on Practice Parameters, which represents 95% of the allergist/immunologists in the United States, publishes standards of care for the diagnosis and treatment of allergies.  These standards specify medical necessity criteria, contraindications, and the proper duration of allergen immunotherapy. They also outline procedures for administering allergy tests, preparing and delivering injections, and providing follow-up care.[i]

So what should be documented in the medical record to support the billing of allergen immunotherapy?

First, and always foremost, the medical record must clearly document medical necessity…in other words, the procedure or service must be reasonable and necessary based on the documentation in the record.  Allergen Immunotherapy is effective for treatment of allergic rhinitis, allergic asthma, and stinging insect hypersensitivity.  However, clinical studies to date do not support the use of allergen immunotherapy for food hypersensitivity, chronic urticaria, and/or angioedema.[ii]  So look for the objective results of allergen testing and/or  IgE antibodies identifying specific allergens that meet this criteria. 


Second, the provider must discuss the results with the patient and an informed decision to participate in allergen immunotherapy must be clearly reported in the medical record.  In addition, once the patient has decided to move forward with allergy shots, the physician should prescribe the therapy, which must clearly detail the following:
  • There should be a prescription, signed and dated by the physician, documenting the specific     allergen extract(s) that will be administered;
  • Protocols for dosing and dose adjustments must be detailed, including schedules for:
    • Escalation, or projected build-up schedule,
    • maintenance dosing,
    • seasonal exposure adjustments, and
    • protocol for missed dose
The AAAAI provides templates for documentation and build-up schedules that may be freely used for these purposes.[iii]

Third, all allergen immunotherapy services should be administered in a setting where procedures that can reduce the risk of anaphylaxis are in place and where the prompt recognition and treatment of anaphylaxis are assured.  This means the office or clinical setting where a physician is onsite.  Look for a physician dated signature on each encounter record.

Fourth, according to the American  Academy of Allergy Asthma & Immunology (AAAAI)[iv], each encounter of immunotherapy should document the following in the patient’s medical record: 
  • Identification of the allergen extract,
  • The vial (identified by color, letter, or numeric designation),
  • The dilution or concentration,
  • The expiration of the dilutions,
  • The amount of serum administered,
  • The site(s) of administration,
  • The identification and attestation of the provider administering the injection(s), and
  • Inspection and description of injection site after 20 minutes (e.g. negative, inflammation, swelling, wheal and flare size in mm of longest diameter, etc.).
Finally, be sure to verify with individual commercial payers and/or LCDs for further guidance for any additional required documentation and detailed practice parameters, such as length of immunotherapy.  So while allergy shots are commonplace, proper documentation must be in the medical record to support the billed service and ensure the patient is receiving safe, effective, and medically necessary care.
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