Aligning FDA and CMS Review

A woman standing in a kitchen looking at medication.

Initiatives have the potential to address the bottleneck that can lead to substantial delays in patient access to drugs and medical devices.


What's the Issue?

Both the Food and Drug Administration (FDA) and the Centers for Medicare and Med­icaid Services (CMS) play a critical role in the development and uptake of new medical tech­nologies. These two agencies have distinct (al­though related) statutory mandates that they must apply in making their decisions: The FDA approves drugs and devices based on evi­dence that the product is “safe and effective,” whereas CMS makes coverage determinations based on whether the product is “reasonable and necessary.”

In practice, this has created two separate evidentiary hurdles for some product spon­sors, which can lead to substantial delays or limitations in patient access or can even block market entry. This situation has generated particular criticism in the device market, as commercial payers are perceived as relying heavily on CMS coverage determinations to make their own reimbursement decisions.

Two initiatives have the potential to help address this bottleneck: parallel review and coverage with evidence development (CED). However, implementation of these two pro­grams has been slow and somewhat piecemeal, and they have yet to reach their full potential.

What's Next?

Although both parallel review and CED have great potential to reduce bottlenecks in pa­tient access to new therapies, the future of both programs is uncertain. Parallel review is slated to expire later this year, although there are indications that the FDA and CMS may once again extend the program, albeit with as-yet-undisclosed changes. The picture is less clear for CED.

An initial draft of the 21st Century Cures Act currently making its way through Con­gress included provisions aimed at reforming the statutory language related to CED, but this was removed in a subsequent draft. In addi­tion, the House Appropriations Committee recently approved a draft budget that would eliminate AHRQ entirely, which if passed would raise serious questions about whether or how CMS will even be able to invoke CED in the future.

Regardless of whether these budget cuts be­come a reality, CMS will be limited in its abil­ity to implement or improve either program without additional resources, and the current political environment makes that unlikely