Medicaid Aiming to Improve Patient Access to High-Cost Therapies

The Medicaid VBPs for Patients Act would clarify value-based contract pricing in Medicaid that aligns with Medicaid’s best price rule, and the new Cell and Gene Therapy Access Model allows for CMS to negotiate a value-based contract for expensive cell and gene therapies on behalf of states, which should expand patient access to these therapies, said Adam Colborn, JD, associate vice president of congressional affairs, AMCP.

This transcript is lightly edited for clarity.

Transcript

What are some of the value-based care programs being tried in Medicaid and how do they differ from the Medicare programs?

I'll say a lot of our focus is really on the Medicaid side. On the Medicare front, we see a lot more fee-for-service utilization there, particularly in traditional Medicare. We're sort of hopeful that these things that we're focusing on in Medicaid can help speed things along on Medicare as well.

At AMCP, our focus has really been on the Medicaid side of things. We are big supporters of a bill, the Medicaid VBPs for Patients [MVP] Act—VBP stands for value-based purchasing arrangement—introduced in the House and Senate. What that bill would do is codify the Medicaid “multiple best price” rule, which allows manufacturers to report a fee-for-service price and a value-based outcomes, value-based contract price for the purpose of the Medicaid best price rule. Most people watching this probably know that Medicaid is entitled to the lowest price paid anywhere in the country, but the question that was raised when value-based contracts first started to come onto the scene was, in the event of a drug failing—and the payer ends up paying $0 or they get a 100% rebate on the cost of the drug—does that then set the price at $0 for every Medicaid program in the country? And so the Medicaid multiple best price rule was intended to address that. But I think we've seen that there are some points that need clarification.

The MVP act in addition to codifying the multiple best price rule, it would also define some important terms that are not defined in regulation right now or defined elsewhere in statutory law. It defines the average manufacturer price, and it defines the average sales price of a drug, which are both very important for calculating your best price under the Medicaid best price rule. Then it also would carve out the value-based arrangements from the antikickback statute. So, operating within this program would not run afoul of that. And that's something that we've been paying a lot of attention to.

Also on the Medicaid front, there is a model at [Center for Medicare and Medicaid Innovation] that was just recently announced—I don't believe anyone has started this yet—but it's the Cell and Gene Therapy [CGT] Access Model, the CGT Access Model. It's essentially a multistate contracting approach. What this model would do is, CMS would negotiate a value-based contract for those high-cost cell and gene therapies, and states then would have the option of signing that contract that's negotiated on their behalf by CMS for whatever the therapy is. Maybe it's the gene therapy for sickle cell. CMS would go out and negotiate all of the terms, and it would be a form contract that Medicaid would then be entitled to. That was just announced in September or the end of August, and that is something that we're keeping an eye on as well, especially given that…we want to make sure those patients have access to the high-cost drugs.

Given the population covered by Medicaid, what is the importance of implementing value-based agreements to expand access to care?

One of the key reasons that we support the MVP Act is that Medicaid patients are not well equipped to get access to these treatments outside of the Medicaid program. They're the most vulnerable patients often in our communities, and some of the other options available to folks with commercial insurance may not be on the table for them.

And Medicaid programs as well, as we know, operate often on budgets that are fairly narrow. They don't have a lot of wiggle room. Even if it's a large budget, it's really just covering the expenses that they have and they're not in a good position to absorb the cost of a treatment that doesn't work, especially when we're talking about these cell and gene therapies where the cost is hundreds of thousands or millions of dollars.

Really to us, it's an equity issue. We want to see these policies—the CGT Access Model and the MVP Act—succeed so that Medicaid programs have the tools that they need to facilitate access for their beneficiaries.