Medicare's RAPID Pathway: A Leap Forward for Adults, But Children Remain in the Queue

Introduction

In late April, the Centers for Medicare and Medicaid Services (CMS) and the Food and Drug Administration (FDA) unveiled the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. This initiative promises to drastically reduce the time between FDA market authorization and Medicare national coverage—from the typical year or more down to just two months. For the medical device community, it appears to be exactly what was needed: a streamlined, synchronized process that could bring life-changing technologies to patients faster. However, while RAPID marks a significant breakthrough for adults, it does little to address the persistent disparities faced by children and those with rare diseases who rely on pediatric and orphan devices.

Understanding the RAPID Pathway

The RAPID pathway is a collaborative effort between CMS and FDA to align regulatory and coverage decisions. Under this framework, devices that receive FDA market authorization—especially those with breakthrough device designation—can qualify for a coordinated review that leads to a Medicare national coverage determination (NCD) within 60 days. This represents a dramatic improvement over the current system, where manufacturers often face months or years of uncertainty after FDA approval, waiting for insurers to decide whether to cover the new technology.

The pathway is designed to benefit both patients and innovators. By reducing the time to market access, RAPID encourages investment in novel devices and ensures that groundbreaking treatments reach those who need them without unnecessary delay. It also provides predictability, allowing companies to plan their commercial launches more effectively. For adult patients dealing with conditions like heart disease, diabetes, or cancer, this could mean faster access to cutting-edge stents, implantable monitors, or diagnostic tools.

The Persistent Pediatric Gap

Despite its promise, the RAPID pathway does not address the unique challenges facing pediatric and orphan devices. In fact, it may inadvertently widen the gap. The pathway is built around the existing Medicare framework, which primarily serves Americans aged 65 and older. Children and younger adults with rare diseases are often covered by Medicaid, private insurance, or state programs—not Medicare. As a result, RAPID’s benefits are largely inaccessible to the very populations that need faster coverage the most.

Pediatric device developers have long struggled with a fragmented reimbursement landscape. Unlike the adult market, where Medicare provides a clear path, children’s devices must navigate a patchwork of state Medicaid agencies, private payers, and specialized programs like the Children’s Health Insurance Program (CHIP). This complexity creates significant delays and uncertainty, discouraging investment in treatments for conditions that affect relatively small numbers of patients.

Why Children Are Left Behind

Several factors contribute to the lag in pediatric device coverage:

• Smaller patient populations: Pediatric and orphan diseases often affect fewer than 200,000 people in the U.S., making it hard for manufacturers to recoup development costs without strong reimbursement support.
• Lack of coordinated pathways: Unlike the adult-focused RAPID, there is no equivalent mechanism to synchronize FDA approval with coverage decisions across multiple payers for children.
• Insufficient incentives: While the FDA offers breakthrough device designation and priority review for pediatric devices, these don’t extend to coverage decisions, leaving a critical gap.

As one expert noted, “Reimbursement delay strangles technologies that children desperately need.” The result is that innovative devices for conditions like congenital heart defects, rare genetic disorders, or pediatric cancers often remain stuck in a regulatory and reimbursement limbo, while adults with similar—or even more common—conditions gain access through pathways like RAPID.

Potential Solutions to Bridge the Gap

To ensure that children are not left behind, policymakers and industry leaders must explore complementary strategies. One promising approach is the creation of a pediatric-specific coverage pathway that mirrors RAPID but involves Medicaid and private insurers. This could be modeled after the FDA’s Pediatric Device Consortia, which provides grants and support for developing devices for children, but expanded to include reimbursement coordination.

Another option is to leverage value-based payment models that reward manufacturers for real-world outcomes, reducing the risk for payers and accelerating coverage. Additionally, Congress could consider incentives for insurers to adopt faster coverage decisions for FDA-designated breakthrough pediatric devices, similar to how Medicare now handles adult devices under RAPID.

A Call to Action

The medical device community has long advocated for a more predictable and timely coverage process. The RAPID pathway is a commendable first step for adults, but it must not be the last. We need equal urgency for children. Without deliberate action, the gap between adult and pediatric device coverage will only widen, leaving the youngest and most vulnerable patients waiting years for treatments that could change—or save—their lives.

As the Centers for Medicare and Medicaid Services and the FDA celebrate the success of RAPID, they should also commit to developing a parallel pathway for pediatric and orphan devices. It’s time to ensure that innovation serves everyone, regardless of age.

Conclusion

The RAPID pathway represents a meaningful breakthrough in aligning regulatory and coverage processes for adult medical devices. However, it also highlights the systemic inequities that persist in healthcare for children. To truly advance medical technology, we must extend the same level of coordination and predictability to pediatric and orphan devices. Only then can we claim that the system works for all patients—not just those over 65.