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For many living with primary immunodeficiency diseases (PI), immunoglobulin (Ig) replacement therapy is a lifesaving, life-long therapy. The healthcare providers caring for those with PI can play an integral role in ensuring their patients have access to the treatment they need. The following includes recommendations when a provider is seeking prior authorization of Ig therapy. In all cases, however, the patient and/or caregiver must work closely with their prescribing provider and their insurance company to ensure treatment is covered.

It is recommended that people with PI contact their insurance company and request a case manager to help coordinate care and services, should the plan provide one. Major medical coverage typically includes doctor’s office visits, hospitalization, medical supplies and services, prescription drugs and other healthcare expenses. The policy may require preauthorization from the plan before moving forward with a treatment, may deny coverage, or may provide coverage that makes the care available but unaffordable.

Prior Authorization of Immunoglobulin (Ig) Replacement Therapy

For providers, the prior authorization process typically involves:

  • Working with the patient/caregiver to confirm the policy of the insurance company (or payer) regarding coverage for Ig replacement therapy for PI.
  • Providing medical documents including PI diagnosis code, lab work (quantitative immunoglobulins x 2, pre and post vaccine titers, H&P notes and treatment plan).
  • Using only the designated health plan forms or designated portals. Do not leave any areas blank on the form. Fill in blanks as “Not Available.” In many cases, insurers will deny a prior authorization request because all of the required information was not supplied, such as incomplete form or missing information.
  • Providing prior medical records with initial history and diagnostic information including labs.
    • Other documentation that may add value:
      • Letter of Medical Necessity with request for treatment and indication in clinic visit notes.
      • Provide ICD 10 code, J-code and CPT code.
  • Saving copies of all forms and information submitted for future reference.

As the prescribing provider, what should I do if prior authorization is denied?

1. The patient has the right to appeal this decision in writing to the appropriate department. They can find the address to submit appeals in the denial letter, their coverage documents or by contacting their insurer using the member services telephone number on their ID card. If the patient has a case manager, check with them to verify which mandatory appeal forms must be used. If they do not have a case manager, they can contact their insurance company to see if one can be provided. 

2. Confirm the process for appeals, including the contacts, forms that must be used and any applicable deadlines.

3. Keeping the patient/caregiver involved, write a clear and simple letter that focuses on the reasons for denial listed in the denial letter and includes the plan’s wording regarding evidence for coverage.

  • If the dispute is over the medical necessity of treatment, the letter should include studies supporting the benefit of the treatment in question is invaluable. A service is medically necessary if it meets any one of the three standards below:
    • The service or benefit will, or is reasonably expected to, prevent the onset of an illness condition, or disability.
    • The service or benefit will, or is reasonably expected to, reduce or ameliorate the physical, mental or developmental effects of an illness, condition or disability.
    • The service or benefit will assist the individual to achieve or maintain maximum functional capacity in performing daily activities taking into account both the functional capacity of the individual and those functional capacities that are appropriate for individuals of the same age.
  • The letter should assert that the prescribed treatment is medically necessary and:
    • Any product on the formulary would not be as effective and/or would be harmful to the patient.
    • All other product or dosage alternatives on the plan’s formulary have been ineffective or caused harm, or based on sound clinical evidence and knowledge of the patient, are likely to be ineffective or cause harm.

The key in an appeal is to show that the care that is being denied should be covered by the plan based on its rules, that it is appropriate, and is medically necessary. Clearly state the plan’s benefits, as well as guidelines from the plan as to what constitutes medical necessity.

4. Contact the insurer and/or case manager after submitting the letter to make sure they have received it. Telephone communication can be key in this process.

5. If denied further, escalate the process by requesting a review with the medical director or a “peer-to-peer” with an immunologist. Providing current peer reviewed literature is critical evidence to support the request for treatment. The field of PI changes rapidly, and the health plan may not be aware or have updated policy to reflect those changes and the standard of care in PI management.

6. If not already completed, request a letter from the patient regarding their situation, the need for therapy, the consequences not getting therapy (infections, hospitalizations, work loss, organ damage, etc.).

7. If after internal appeal the plan still denies the request for payment or services, an Independent External Review can be requested. This will be a reconsideration of the original claim by professionals with no connection to the insurance plan. The plan must include information on the denial notice about how to request this review, do not assume this happens automatically. If the independent reviewers think the plan should cover the claim, the health plan must cover it.

Address Dissatisfaction:

  • File a complaint with the state agencies that oversee managed care plans in your location. These include the state health department, insurance commissioner and state attorney general offices. The phone numbers for these agencies are on the state government websites.
  • File the complaint in writing, and document events as carefully as possible. Provide the plan and state agencies with medical studies or expert opinion(s) that support the case in a dispute. Instruct the patient to contact the drug manufacturer to explore drug assistance programs or their employer benefits coordinator as indicated in the denial letter regarding Ig therapy as the standard of care for their PI. If Ig replacement therapy continues to be denied, consider hospitalizing the patient.

Tips for Success

Below are some tips from a clinical immunologist that has been successful in overturning Ig denials, followed by some additional helpful information, including a sample appeal letter that can be tailored to the patient's clinical history:

  • The appeal should be short, succinct and carefully documented. Keep in mind that the insurance companies are reviewing thousands of appeals; therefore, the larger packets, will be put to the side. The shorter the appeal, the shorter the turn-around-time for a response.
  • Keep in mind that you have two (2) minutes of the Medical Director's attention.
  • Provide well-accepted diagnostic studies which are in the practice guidelines.
  • Provide standards of practical criteria to support the laboratory studies.
  • Provider proof and documentation of serious infections/complications that have not been responsive to appropriate medical/surgical intervention; including clear radiographic evidence of persistent disease, e.g., lungs, sinuses, et. al., clinical documentation of infections, etc.
  • Focus on the rationale for Ig therapy – a physician's letter that states "because it is medically necessary" is not specific enough to be added to an appeal letter. Precise statements are required; for example, there were three (3) episodes of pneumonia with fever of 102, and there was a chest x-ray (if available) that showed lobar pneumonia and five (5) days of antibiotics were required.
  • When concluding the letter add the names of the immunologists that have completed the scientific research on the diagnosis in question, should the insurer request a peer review. For example, "Should you have any questions, I would request a peer review by either Dr. John Smith or Dr. Ann Jones from the University School of Medicine."

How much ACA rules will change your current appeal rights depends on the state you live in and the type of plan you have. Some group plans may require more than one level of internal appeal before you are allowed to submit a request for an external review. However, all levels of the internal appeals process must be completed within the timeframes above.

The IDF Medical Advisory Committee issued a resolution in January 2016 regarding the danger posed by the arbitrary insurer requirement for a diagnostic vaccine challenge for all previously diagnosed individuals with Common Variable Immune Deficiency (CVID). Click here to read the resolution.

For additional information:

  • Click here to download a Sample Appeal Letter.
  • Additional references to attach to appeal letter can be found at PubMed is a service of the U.S. National Library of Medicine that includes more than 18 million citations from MEDLINE and other life science journals for biomedical articles back to 1948.
  • The IDF Consulting Immunologist Program offers free physician to physician consults; consults or second opinions on issues of diagnosis, treatment and disease management; and access to a faculty of recognized leaders in clinical immunology.
  • The AAAAI Primary Immunodeficiency Diseases (PID) Committee has created the AAAAI IVIG Toolkit to educate payers and regulators who are responsible for coverage determinations, and aid physicians in the safe, effective and appropriate use of IVIG for people with PI. The toolkit has been approved by the AAAAI Board of Directors, and endorsed by the Clinical Immunology Society (CIS) and the Immune Deficiency Foundation (IDF).
  • The Model Coverage Policy for Immunoglobulin Replacement Therapy for Primary and Secondary Immunodeficiency Diseases with Impaired Antibody Response, approved by the IDF Medical Advisory Committee stands as a best practice, model coverage policy and is an excellent resource for physicians to utilize in appealing insurance denials.

If you have further questions, contact IDF: 800-296-4433 or