Pharmacy vs. Medical

There are two primary forms of biologics:

• Pharmacy benefit (PBM): Handles take-home biologics. Requests usually flow through electronic prior authorization (ePA) rails. While faster than paper faxes, criteria are still strict and denials are common.

• Medical benefit (health plan): Covers infused biologics. Submissions require more documentation (e.g. infusion orders, weight-based dosing, clinical notes, site-of-care details) and each payer has their designated portal for this information.

The same drug can land in either bucket, depending on the payer’s design and site of care. That means providers often don’t know which rules apply until they’ve already started the PA process.

Why This Split Creates Complexity

The dual-benefit system drives complexity in three main ways:

• Multiple portals: PBM ePA rails for take-home biologics, insurer portals for infusions, and sometimes specialty pharmacy systems — each requiring duplicate data entry.

• Inconsistent rules: Pharmacy PAs may require step-therapy proof, while medical PAs add CPT/J-codes, infusion orders, and site-of-care attestations.

• Denial traps: Submitting under the wrong benefit lane almost guarantees rejection, forcing clinics to resubmit and delaying patient therapy.

National surveys show providers already spend 13-20 hours per week on PA tasks overall. For biologics, the split between medical and pharmacy lanes adds even more time and rework.

Payer Policy Shifts Making PA for Biologics Harder

The pharmacy vs. medical benefit divide is being reinforced by payer policies that create even more friction for clinics:

• White-bagging mandates: Many payers now require infused biologics to be shipped through a specialty pharmacy they control, rather than letting providers buy-and-bill. This forces duplicate paperwork and coordination with pharmacies.

• Site-of-care restrictions: Insurers often deny hospital infusions and push patients to lower-cost ambulatory centers or home infusion. Each shift requires new documentation and approvals.

• Frequent formulary changes: PBMs regularly change which biologics or biosimilars are “preferred,” which can force providers to redo PAs and justify switching stable patients to new therapies.

These policy levers help payers control costs, but they leave clinics juggling across multiple portals and constantly changing rules.