By Mary Lynn Kelley, President, eMAX Health Patient Services
Patient Assistance Programs are critical to ensuring access for those who need it most — but building one that’s both effective and compliant is increasingly complex.
Across my years in patient services, I’ve seen manufacturers face heightened regulatory pressure, funding volatility, and operational challenges that can expose even the strongest programs to risk.
During my Access USA discussion earlier this year, and in ongoing conversations with industry leaders, I shared four watch-outs that commonly weaken PAPs, and how to design around them.
1️⃣ Fragile Funding Foundations
Programs that rely too heavily on free-goods or unpredictable third-party foundations can collapse under shifting market or legal conditions.
When that happens, patients lose access, and brands lose trust.
Sustainable PAPs diversify their funding and use technology to identify alternative financial pathways, creating long-term stability.
2️⃣ Default-Mode Design
Too many programs follow the same template simply because “that’s how it’s always been done.”
But what worked five years ago won’t necessarily meet the compliance and efficiency expectations of today.
Every PAP should be purpose-built around the therapy’s access barriers, market dynamics, and patient experience — not legacy structure.
3️⃣ Brand Erosion Risks
Your PAP is a reflection of your brand.
When patients experience confusion, inconsistent communication, or delays, the consequences extend beyond access metrics — they affect perception and trust.
A well-run program should reinforce your brand promise, not undermine it.
4️⃣ Innovation Lag
Compliance guardrails often discourage innovation, but they shouldn’t.
Smart technology can reduce risk — not increase it — by creating better documentation, faster verification, and stronger audit readiness.
The goal isn’t just to automate; it’s to modernize in ways that improve both compliance and patient experience.
Building for Sustainability
A strong PAP balances compliance, compassion, and control.
That means:
- Real-time visibility into every case
- Processes that hold up under audit
- Data that proves outcomes, not just activity
Programs that withstand scrutiny aren’t built overnight. They’re built with foresight.
When designed well, they protect patients, brands, and the trust that connects them.