Patient access isn’t just reimbursement mechanics — it’s the infrastructure that determines whether life-changing innovation actually reaches patients. Ironically, the burden of a prior authorization denial is the only bridge to a coverage decision that could change everything. The challenge isn’t defending administrative burden. It’s making sure the bridge doesn’t get demolished before patients have a chance to cross it.
The healthcare industry is in a substantial push to eliminate prior authorization. Federal regulators have shortened response windows, demanded transparency, and pressured insurers to slash the number of services requiring approval. The momentum is real, and for routine, evidence-based care, the reforms are overdue.
But there’s a complication. For patients seeking access to innovative, emerging, or investigational medical technologies, prior authorization isn’t the villain — it may be the only formal pathway to coverage that still exists.
The Counterintuitive Truth About Innovation Access
Here’s the procedural reality most people overlook: when a payer says prior authorization “isn’t required” or “isn’t applicable” for a novel technology, they haven’t made coverage easier. They’ve closed the door to any formal coverage review at all.
Under the Affordable Care Act, patients have the right to independent external review of denied coverage decisions involving medical necessity or experimental treatment determinations. But that process has a prerequisite: A DENIAL. The sequence runs like this:
Prior authorization submitted → Initial denial issued → Internal appeals exhausted → External review requested → Independent physician reviewer assigned → Evidence-based decision rendered → Binding precedent created.
Remove prior authorization from the equation, and the entire chain collapses. No authorization means no denial. No denial means no appeal. No appeal means no external review. No external review means no binding decision — and no pressure on the payer to develop a coverage policy. The technology sits in a coverage vacuum indefinitely. Patients are left without recourse.
The Reform We Actually Need
This isn’t an argument for keeping prior authorization as it is. The current system — 53 million Medicare Advantage prior authorization determinations in 2024 alone, with 13% of denials later found to meet standard Medicare criteria — is broken for routine care. Those patients deserve faster, simpler access.
But reform should be precise, not blunt. The goal should be eliminating unnecessary prior authorization for routine, evidence-based procedures — colonoscopies, cataract surgeries, established drug therapies — while preserving and even strengthening formal review pathways for technologies that don’t yet have coverage policies.
As AI and real-time electronic systems increasingly automate prior authorization for standard care, we need to be deliberate about what we’re building. Streamlining the routine is good. Accidentally eliminating the only formal pathway for breakthrough innovation is a different problem entirely.
What This Means in Practice
For medtech manufacturers, the implication is clear: invest in reimbursement support infrastructure — clinical evidence packages, appeals assistance, patient advocacy partnerships — designed to navigate the prior authorization pathway, not avoid it. External review outcomes create precedent. Precedent drives policy. Policy determines whether a technology scales or stalls.
For policymakers, the ask is equally specific: write reform legislation that distinguishes between prior authorization as administrative burden and prior authorization as necessary evaluation infrastructure. Require payers to maintain formal coverage determination pathways for novel technologies, even as routine authorizations are streamlined or eliminated.
