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PI diagnosis documentation key for prior authorizations

January 29, 2026

Healthcare providers understand they have to get prior authorization from health insurance companies for certain medicines and procedures, but even the most detail-oriented providers sometimes run into roadblocks. That’s why it’s important to follow specific steps for prior authorization, especially for common medical needs related to primary immunodeficiency (PI).

As a way to control costs, health insurance companies increasingly require prior authorization for certain services, procedures, and treatments. Prior authorization means that healthcare providers must get approval from the patient’s health insurance company before providing care in order for it to be covered. Doctors must prove that the care is medically necessary.

In the case of PI, medical needs that may require prior authorization include biologics, genetic testing, surgeries, diagnostic imaging like magnetic resonance imaging (MRIs), and immunoglobulin (Ig) replacement therapy.

Obtaining prior authorization is a team effort. Providers gather documentation and include it with the prior authorization, while patients confirm with providers that they’re on track to submit the correct information. Patients should:

  • Know if a procedure, treatment, or other care requires prior authorization by their insurance and make sure the healthcare provider and their office know as well.
  • Check in to make sure the healthcare provider has submitted prior authorization paperwork on time.
  • Address prior authorization denials by talking to their healthcare provider to figure out why and if they need to submit any additional records to the insurance company.

Immunologist Dr. Nicholas Hartog said most doctors who manage patients with PI know the steps to take for prior authorization, which is especially important for Ig replacement therapy. Ig replacement therapy is the primary treatment for those with antibody deficiencies, like common variable Immune deficiency (CVID). To justify Ig replacement therapy, doctors need to show the patient has recurrent, difficult-to-treat, and severe infections, as well as an inability to make working antibodies, said Hartog.

“There are a lot more details, but this is the basis of what is needed,” said Hartog. “This makes sense, because showing these issues in the patient also gives me an idea that the patient will improve on this therapy.”

If you are seeking prior authorization for other types of treatment beside Ig replacement therapy, include diagnostic labs with other documentation, if applicable. For example, include a pulmonary biopsy showing granulomatous-lymphocytic interstitial lung disease (GLILD) if seeking rituximab or include genetic testing supporting an activated P13K delta syndrome (APDS) diagnosis for treatment with leniolisib.

Even when doctors follow a protocol that they think will fulfill the prior authorization requirements, they still face unexpected hurdles. For example, each health insurance company has different requirements for prior authorizations, and those requirements often change.

“What may be true for one company is not true for the other companies,” said Hartog. “Then when a company denies coverage, it often will not be transparent on the reason other than saying, ‘Your doctor has been provided with our coverage criteria.’”

Most health insurance companies require reauthorization for Ig replacement therapy every six months to a year. A patient will also have to seek reauthorization if they change health insurance companies. Sometimes, health insurance companies arbitrarily deny coverage for a person who has been on Ig replacement therapy long-term. That’s why it’s critical for patients to have the lab work from when they were first diagnosed that shows definitively that they meet the criteria for their diagnosis.

“I have learned to include ‘immunodeficiency history’ outlining a patient’s history of infections, original labs, vaccine response, and other information at the bottom of my note. I carry this over to every note, that way their history is on every note the insurance company sees. I have found that when I do this, the rejection rate with reauthorization is much lower,” said Hartog.

“Another trick I have is I have a form letter that has all the information needed. With every new Ig replacement therapy start, I will include this letter with the reauthorization. I have found this also helps.”

Providers spend substantial time and resources fulfilling prior authorization requests, which negatively impacts patient care and outcomes. Some patients delay or abandon care when they encounter prior authorization challenges, according to a 2024 American Medical Association prior authorization physician survey. Hartog, who works in a pediatric allergy and immunology practice with six other physicians, personally spends 1-3 hours per week on prior authorizations. Three non-physician office staff spend significant time on the task too.

“Prior authorizations are time consuming and tedious for our office,” said Hartog. “The biggest thing is knowing what documentation is generally needed and documenting that in every note for these patients. Getting the information upfront will prevent a lot of denials and back and forth.”