Since the 1980s, US health insurers have used prior authorization (PA) to determine whether a health care service or treatment is medically necessary before covering its cost. To initiate this process, a patient’s clinician submits an application that justifies the need for the service or treatment. The insurer then adjudicates necessity. PA was designed to mitigate overuse of expensive health services and treatments that patients may not need, thereby containing health care costs and promoting evidence-based care. PA originated largely from overuse of health services and treatments among elderly Medicare beneficiaries.1 Despite widespread use of PA among public and private insurers for adult patients, there is a paucity of information on PA in children, including the risks and benefits to children who experience it.
To advance knowledge on PA in children, Constant and colleagues2 assessed the initiation of expensive biologic medications (eg, antitumor-necrosis factor α) in 190 children with inflammatory bowel disease (IBD). IBD is a complex chronic gastrointestinal condition with a relapsing and remitting disease course that can become debilitating if insufficiently treated. Biologic medications are effective in moderate and severe IBD. The per-member-per-year (PMPY) cost of biologic mediations for pediatric patients with IBD is high (∼$41 100).3 Constant and colleagues found that nearly three-fourths of children experienced PA for use of a biologic medication. Thirteen percent experienced complicated PA, which included peer-to-peer review, letter of appeal, and/or step-therapy before approval was granted. Uncomplicated and complicated PA delayed biologic initiation for IBD by over 1 and 3 weeks, respectively. Children experiencing PA had significantly higher rates of IBD exacerbation that necessitated emergency department use, hospitalization, and exposure to systemic corticosteroids.
The findings from this study question the value of PA for biologic medications in children with IBD. On completion of the PA process, biologic medications were approved for all children with IBD in the study, suggesting that no unnecessary use occurred. Despite this, health might have been compromised because of the need to wait for PA approval. Although the retrospective case-control study design cannot be used to infer causal relationship between the need for PA and health outcomes, the imbalance of risk without benefit with PA for biologic medications in children with IBD in the study is evident.
Reading the study by Constant and colleagues invoked recollection of myriad PA and insurer-led denial-of-care experiences for children with complex medical needs cared for in our clinical practice. We have had patients with epilepsy experience recurrent seizures while waiting on PA approval for antiepileptic medications. Patients with severe neurologic impairment have vomited and aspirated while waiting on PA for gastroesophageal reflux and gastric promotility medications. One patient hospitalized with hypoxia because of a critical airway who was scheduled for tracheotomy and a laryngotracheal separation was denied hospital coverage because the insurer perceived that the patient’s health problems did not necessitate hospital level of care. Most if not all of these patients received coverage approval by the insurer after significant time and effort justifying need was performed by the patients’ clinicians.
With these experiences in mind, the findings from the study by Constant and colleagues complement the disdain expressed by many pediatric clinicians that PA is an administrative nuisance without any clear benefit to children. Multiple initiatives to reform and standardize the PA process have emerged to optimize efficiency and transparency as well as to address variation across insurers. Despite state-level legislation and national efforts from the American Medical Association,4 the burden of PA on clinicians remains heavy. US physicians reportedly spend up to 16 hours weekly on PA tasks. Forty percent of physicians hire office staff dedicated to PA.5 Labor costs for PA processing exceed $500 million annually.6
Constant and colleagues remind us that pediatric clinicians have no choice currently but to remain steadfast to complete the PA process for the patients who need it to get them the medications and treatments that require PA approval. This is especially true for general pediatric, complex care, and specialty clinicians caring for large numbers of children with complex and chronic medical needs. These children are at risk for a disproportionate share of PAs to attain needed medications and medical equipment. Strong partnerships among insurers, clinicians, patients, and families are essential when designing and implementing solutions to optimize the value of PA for pediatric patients. Future quality improvement and research endeavors should distinguish and disseminate successful PA collaborations. We should all work together to ensure safe and timely access to pediatric health services and treatments, regardless of their cost.
FUNDING: No external funding.
COMPANION PAPER: A companion to this article can be found online at www.pediatrics.org/cgi/doi/10.1542/peds.2021-052501.
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Competing Interests
CONFLICT OF INTEREST DISCLOSURES: The authors have indicated they have no conflicts of interest relevant to this article to disclose.
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