Is Regional Difference in Prior Authorization Disparity or Discriminatory?

Health insurers in the Southern US are more likely than in other regions to require prior authorization for coverage of pre-exposure prophylaxis (PrEP) medication for HIV, in what may be a discriminatory practice according to researchers.

Kathleen McManus, MD, MSCR, Division of Infectious Diseases and International Health, University of Virginia, Charlottesville, and lead author of the study explained to Contagion® that the requirement of prior authorization can delay and/or decrease use of indicated and appropriate medication, and that it has been cited by clinicians as one of the biggest barriers for PrEP uptake.

“If someone lives in the South, they are more likely to face this barrier than someone who lives in the Northeast,” McManus observed. “This is a problem because more than half of the United States' annual HIV diagnoses are in the South. The South is the region where we need increased PrEP uptake in order to curb new HIV infections.”

McManus and colleagues examined the records of over 16,000 health plans in the US which were certified as Qualified Health Plans (QHP) for meeting federal criteria of the Affordable Care Act (ACA), and had all data necessary for inclusion in the study. The QHPs were grouped by region, with 18.2% in the Northeast, 19.5% in the West, 25.0% in the Midwest, and 37.3% in the South.

The plans varied by such characteristics as issuance by a national or regional entity, different deductible and co-pay levels, categorizing PrEP as a specialty tier medication or at different costs in plans that differed by levels of “platinum” to “bronze.” In controlling for those differences, however, the investigators found that only the geographic region was associated with difference in likelihood of prior authorization requirement.

Prior authorization was found to be a requirement for coverage of the combined tenofovir disoproxil fumarate and emtricitabine PrEP formulation by 18.9% of all the QHPs. The requirement was imposed by 37.3% of QHPs in the South, compared to 2.3% in the Northeast, 6.2% in the West, and 13.3% in the Midwest.

Compared with QHPs in the Northeast, then, the health plans in the South were 15.89 (95% CI, 1.57-20.09) times more likely to require prior authorization. In comparison, plans in the Midwest and West were, respectively, 5.69 (95% CI, 4.45-7.27) and 2.65 (95% CI, 2.02-3.47) times more likely to require prior authorization than those in the Northeast.

The investigators suggest that the substantially higher likelihood of a prior authorization requirement is a discriminatory benefit design, which "prevents or delays people with complex or expensive conditions form obtaining appropriate treatment."

McManus and colleagues point out that prior authorization has typically been required when there is more than one therapeutically interchangeable agent available. Until recently, however, there has only been one product approved for PrEP. This suggests to the investigators that the prior authorization has been used “for other reasons, for instance, to determine HIV risk or clinical eligibility for PrEP.”

“This policy is an example of structural racism,” McManus declared. “More than half of African Americans live in the South where they are more likely to face this barrier, and the lifetime risk of acquiring HIV for African American men is 1 in 20 compared to 1 in 132 for white men.”

Although QHPs will be required to offer PrEP with no cost-sharing beginning in January 2021 by recommendation of the US Preventive Services Task Force, McManus and colleagues are concerned that insurers could limit access “by using arbitrary non-clinically based prior authorization.”

McManus called for change in policy and oversight, in discussing the study findings with Contagion®. “State insurance regulators or the Health and Human Services Office of Civil Rights should examine why national companies are putting additional barriers in place for PrEP in the South, and whether this constitutes discriminatory plan design,” she said. “Additionally, state or federal legislative bodies should consider passing laws that require one formulation of PrEP to be available without prior authorization.”