Legislation Can Help Increase Uptake of PDTs, Improve Reimbursement

Legislation being considered would create a Medicare Part B benefit category and new product-specific codes to improve uptake of prescription digital therapeutics (PDTs), said Adam Colborn, JD, associate vice president of Congressional Affairs, AMCP.

Transcript

Uptake of prescription digital therapeutics has been slow because payer uptake has been slow. How can legislation change that and provide patients with better access to these treatments?

Legislation I think is really important here, especially in a post-Chevron world. We've seen CMS take a couple of actions that haven't gone quite as far as we need to create the infrastructure necessary for commercial payers to feel confident in coverage, as well. A big part of that is the coding. There's a legislation that AMCP supports, which is the Access to Prescription Digital Therapeutics Act, that is bicameral, bipartisan legislation that would create a Medicare Part B benefit category for prescription digital therapeutics—it's those PDTs that have gone through the FDA review for safety and efficacy and they've been authorized for market access.

Part of that bill would also direct CMS to develop product-specific HCPCS [Healthcare Common Procedure Coding System] codes. That is, in our view, one of the most important components of the legislation. Right now, there's only a couple of codes that are being used for PDTs. Many of them are on a shared A-code, and so that's an issue in terms of incomplete information on a claim. You have to go back to the provider, it takes time from them, it takes time from the payer. That's not good for anyone. It's not good for the patient. Their prescription is being delayed in that case.

We really want CMS to help clear up some of those issues through the coding piece and then sort of lay out their vision for how coverage looks. With a new modality like PDTs, this is different than traditional small molecule drugs or biologics, where we've known what those are for a very long time. This is new. I think this requires us to think a little bit differently about how we design coverage, but some of those missing puzzle pieces really need to be in place first before we can do that. And so that's what the Access to PDTs Act would do.

As I mentioned earlier, CMS, in a post-Chevron world, needs the clarity of statutory law. They were one of the agencies that relied very heavily on Chevron deference for carrying out their responsibilities. Without that in place, I think there is a question of what they can do with PDTs without statutory authorization. Although we have seen they proposed to cover about 5 products in the Physician Fee Schedule for 2025. We're waiting to see what the final fee schedule looks like. But if that's where we end up, I think we can feel pretty safe that is the extent of their authority without additional authorizing statutory language.