Summary of Novitas Medicare for Allergen Immunotherapy LCD L35759

| August 13, 2015

Summary of Novitas Medicare for Allergen Immunotherapy LCD L35759

Summary of Novitas Medicare LCD for allergen immunotherapy (LCD L35759), effective August 13, 2015.​


The Advocacy Council of the ACAAI (formerly the JCAAI) recommends that you review the entire Medicare LCD for allergen immunotherapy. However, we have excerpted below what we believe are the most important provisions of which you should be aware.

In order for immunotherapy to be considered reasonable and necessary there must be:

  • Clinical relevance
  • Trials of avoidance or unavoidable exposure to allergy triggers identified in allergy testing
  • Adherence to medical regimens which is clearly documented in the medical record
  • Stable pharmacotherapy for certain conditions, such as asthma

Conditions for which immunotherapy is effective include:

  • Allergic rhinitis,
  • Allergic conjunctivitis,
  • Allergic asthma and
  • Stinging insect hypersensitivity.

The maintenance phase occurs when the effective therapeutic dose is reached. This dose is defined as the dose that provides therapeutic efficacy without significant adverse local or systemic reactions. This dose may not be the initial target concentration but documentation should clearly show why the target concentration is not being used. All references to the therapeutic effective dose should be referenced to the maintenance concentrate and should be noted as a volume-to-volume dilution (eg. 1:100 vol/vol dilution of maintenance concentrate).

Although all treatment regimens have to be individualized for a given patient, acceptable maintenance dose concentrations are generally as the following:
For standard allergen extracts:

  • 500 to 2,000 allergy units (AU; e.g. for dust mite): or
  • 1,000-4,000 bioequivalent allergy units (BAU; e.g. for grass or cat).

For non-standardized extracts:
A suggested maintenance dose is 3,000-5,000 protein nitrogen units (PNU) or 0.5ml of a 1:100 or 1:200 wt/vol

Dilution of manufacturer's extract;
Non-standard extracts are noted to be estimates and will need to be individualized.

For major known allergen concentration of the extract:

A range between 5 and 20 micrograms of major allergen is the recommended maintenance dose for inhalant allergens and 100 micrograms for Hymenoptra venon. Documentation of the extracts being used should include concentrations, even if an estimate is used for non-standard extracts.

Significant sub-therapeutic dosing in a maintenance manner will be considered not reasonable and necessary. Table IX and X in the Guidelines outline probable effective dose ranges. Sub-therapeutic dosing would be considered to be below these levels.

Providers of Immunotherapy: The physician prescribing immunotherapy should be trained and experienced in prescribing and administering immunotherapy. Should any Medicare entity (MAC, RA, ZPIC, OIG or DOJ) request documentation of training this information must be made available. Medicare expects practitioners' documented training to be commensurate with the degree to which his or her practice is related to allergy testing and immunotherapy.

Hence, if an auxiliary staff member, such as a registered nurse or technician, prepares the antigens, the physician must provide direct supervision of the services for the employee to bill 95165 incident-to the physician based on Medicare incident-to-rules. The preparation of allergen extract should have direct supervision of any employee. Definition of qualified non-physician practitioner (NPP) must meet incident-to guidelines. For services to qualify as incident-to:

  • The NPP must be licensed or certified to provide professional health care services in the state where the physician practice is located.
  • Generally, the NPP must be a full-time, part-time or leased employee of the physician or physician group practice. (In limited cases, the NPP may be an independent contractor of the physician or physician group practice.)
  • The NPP must provide services as an integral part of-and-incident-to the physician's services.
  • The NPP must provide such services under the direct supervision of the physician.

Direct supervision does not mean that the physician must be in the same room when the staff person prepares the antigens. The physician must be present in the office suite and immediately available to provide direction and assistance through the time the staff person is performing the service. The supervision physician should be documented. The physician must have examined the patient and determined a plan of treatment and a dosage regimen.

Place of Administration: Immunotherapy may have severe unpredictable systemic and local reactions within the first 30 minutes post injection. It is recommended that immunotherapy be administered in a setting that permits the prompt recognition and management of adverse reaction. The preferred location for such administration is the prescribing physician's office. However, the patients can receive immunotherapy at another health care facility if the physician and staff at that location are trained and equipped to recognize and manage immunotherapy reactions, particularly anaphylaxis. It is recommended that patients wait at the physician's office/medical clinic for at least 30 minutes after the immunotherapy injection.

Medicare payment for maintenance antigens administered by a trained individual in the patient’s home is permitted by regulation. In such cases the patient’s medical record must include information about the training and competence of the administering individual, especially training for emergency management of adverse reactions to immunotherapy injections (e.g. recognition of anaphylaxis and administration of rescue medications such as epinephrine). Such information must be made available to Medicare for review if requested.

Maintenance Dose Interval: The frequency of maintenance dosing can be variable depending on the extract used. During the first year, frequency may vary from subsequent years. The Task Force notes for some antigens, the maintenance dose could be every 4-8 weeks. However, the frequency should be at least every two weeks for this dosing.

Follow-up Care: During maintenance therapy, follow up visits to assess progress or lack of progress should be done at least every 6-12 months. This documentation must be available upon request.

Length of Maintenance Therapy: The duration of all forms of immunotherapy must be individualized. A presumption of failure can be made when, after 12-24 months of therapy, a person does not experience:

  • a noticeable decrease of symptoms,
  • an increase in tolerance to the offending allergen, and
  • a reduction in medication usage.

Treatment will not be reimbursed after a 2 year period when there is no apparent clinical benefit as noted above.

For many patients, the recommended duration of allergen immunotherapy is 3-5 years. However, the duration of immunotherapy should be individualized based on the clinical response, disease severity, immunotherapy reaction, patient preference and certain antigens in the therapy.