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Getting prior authorization

Healthcare providers caring for those with primary immunodeficiency (PI) can play an integral role in ensuring their patients have access to the procedures and treatments they need. 

Most private health insurance plans require certain procedures and treatments to be approved by the plan before they take place or are administered. This practice is called prior authorization. Items that may need prior authorization for patients with PI include genetic testing, diagnostic procedures like MRI or CT scan, some branded medications, and infusions such as immunoglobulin (Ig) or interferon gamma. 

Ig replacement therapy prior authorization checklist

This checklist is also available as a downloadable PDF.

  • Copies of the front and back of all of the patient’s medical insurance and prescription benefits cards.
  • Health insurance plan’s prior authorization form.
    • Use only forms specific to the patient’s health insurance plan.
    • Do not leave any areas blank. Fill in “Not Available” as necessary to avoid rejection for being incomplete.
  • Specialty pharmacy referral for service form.
  • Patient’s medical records with initial history, diagnosis code (ICD-10), and diagnostic information, including labs.
    • Pre-treatment quantitative IgG, IgA, and IgM serum levels (drawn on two different occasions when available).
    • Quantitative pre- and post-vaccine antibody levels to vaccine antigens AND documentation of vaccine administration date. Accepted vaccine antigens include tetanus, pneumococcal polysaccharide (Pneumovax), or Haemophilus influenzae type B (HIB). HIB may not be applicable to adults (requirements are changing).
  • History & physical exam (H&P) and progress notes (within the past 6 months), including treatment plan.
  • Procedure codes (CPT or J code).
  • Letter of medical necessity from the prescribing physician.

Save copies of all forms and information submitted to the insurance plan in case you need to reference it in the future.

Prior authorization for other services

For other types of prior authorization, substitute diagnostic labs with other documentation if applicable. Make sure you have the documentation to support the use of the therapy or service for which you are seeking prior authorization. Examples include:

  • Genetic testing supporting a CTLA4 deficiency diagnosis for abatacept.
  • DHR testing showing low or absent oxidative burst for interferon gamma.
  • Genetic testing supporting an APDS diagnosis for leneolisib.
  • Pulmonary biopsy results reflecting GLILD for rituximab.

Prior authorization tips

  • Make sure the prior authorization is submitted under the correct benefit plan (medical vs. prescription).
  • Indicate the correct site of service on the prior authorization to avoid denial.
  • Some vendors/providers, such as specialty pharmacies and genetic testing companies, have sample letters and forms to help you do prior authorizations for their products or will do the prior authorization for you.
  • Use payer websites (forms, downloads, or online prior authorization) to make it easier and avoid rejection. Some insurance plans prefer only online submissions, and others allow you to fax a form with clinic notes.
  • Some drug companies have departments that help with access to their medications. They work with providers to determine insurance coverage, assist with prior authorization, and help choose a pharmacy for patients.
  • Ask for longer approval periods for chronic conditions and long-term medications, the insurance plan may authorize them.
  • Clinical notes should have a good explanation of the indication for the service/treatment to help with future authorizations. This can avoid having to write a letter of request later.
  • Authorization does not mean “paid in full.” A patient/caregiver needs to understand their co-pays, co-insurance, and/or deductibles.
  • If it is something done in your office, know what procedure is approved (codes) to avoid denial of payment.
  • Authorizations may need to be resubmitted if dose, frequency or brand is changed mid-cycle of a current authorization. Some insurances/payers allow substitutions, but you always have to check.
  • A change in insurance may require a patient to switch vendors since insurance plans have preferred providers.

Handling prior authorization denials

Before filing an appeal, request a peer-to-peer review with an insurance company physician to discuss why your patient needs the service, benefit, or treatment. Note that some insurers do not allow peer-to-peer reviews after a written appeal has been filed. However, a successful peer-to-peer review may save you from having to file an appeal.

If a peer-to-peer review is not successful, the patient/caregiver has the right to appeal a prior authorization denial in writing. Their explanation of benefits (EOB) for the denied claim must provide information on how to appeal the decision and the amount of time they have to do so.

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

  1. If the dispute is over medical necessity, the letter should include studies supporting the benefit of the treatment. A service is medically necessary if it meets any one of the three standards below:
    1. The service or benefit will, or is reasonably expected to, prevent the onset of an illness, condition, or disability.
    2. 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.
    3. 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.
  2. The letter should state and provide evidence that:
    1. The service, benefit, or treatment is medically necessary as defined above.
    2. All other alternatives on the plan’s formulary or covered by the plan have either not been as effective/caused harm or are likely to not be as effective/cause harm based on sound clinical evidence and knowledge of the patient.
  3. If not already submitted, the patient or caregiver should write a letter for the appeal regarding their situation, the need for therapy, and the consequences of not getting therapy (infections, hospitalizations, work loss, organ damage, etc.).

Tips for overturning denials

Below are some tips from a clinical immunologist who has been successful in overturning Ig denials:

  • Keep the appeal concise but carefully documented. Insurance companies are reviewing thousands of appeals and you have roughly two minutes of the Medical Director's attention. The shorter the appeal, the shorter the turn-around time for a response.
  • Provide well-accepted studies and medical practice guidelines to justify the appeal.
  • Provide proof and documentation of serious infections/complications that have not been responsive to appropriate medical/surgical intervention, including clear radiographic evidence of persistent disease, clinical documentation of infections, etc.
  • Focus on the rationale. A physician's letter that states "because it is medically necessary" is not specific enough. Precise statements are required. For example, “there were three episodes of pneumonia with fever of 102°F, and there was a chest x-ray that showed lobar pneumonia and five days of antibiotics were required.”
  • When concluding the letter, add the names of immunologists who have done scientific research on the diagnosis in question, in case the insurer requests a peer review. For example, "Should you have any questions, I would request a peer review by either Dr. John Smith or Dr. Cheryl Jones from the University School of Medicine."

Escalating denials

  • If, after an 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.
  • 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.
    • 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.