Highlights
The CMS sets the rate for the drugs using CMS’s standard ASP methodology, and the TDAPA payment per treatment is adjusted then based off – what we use, how many times it was used each month, and adjusted by the QIP.
At first if a drug qualifies for TDAPA, you would get paid for the TDAPA drug, and your PPS would not be adjusted downward. It should stay the same. The PPS only adjusts if the drug does not qualify for TDAPA, that’s the whole purpose for getting the cost under TDAPA, it’s to see whether the rate needs to be adjusted.
At the end of two years’ time, the TDAPA drug goes away, and the base rate adjusts, and it might not go up, you see that’s the other thing to recognize, that just because a TDAPA drug becomes available in two years’ time, there’s no automatic guarantee that the base rate payment is going to go up as a result of the TDAPA drug being bundled back into the PPS base rate.
CMS will take all of the data because they’re paying for the claims, so looking at all the incoming data, looking at the utilization of the drug, and then looking at the outcomes, and then they’re making a decision based on the TDAPA drug, and based on the outcomes, do they want to increase the PPS base rate or not, because if it turns out that the TDAPA drug doesn’t result in any improvement in outcomes, it doesn’t result in any reduction in complications, like the functional categories, if it doesn’t result in reductions in ER visits, hospitalizations, the CMS can say there’s no benefit, the CMS could say we’re going to either a) add this drug to an existing functional category, or b) create a new functional category, and either way if they do that, and they don’t adjust the base rate, then there’s no incentive to use the drug.
This interview with a US-based key opinion leader (KOL) provides insights into pricing and reimbursement dynamics and issues concerning anemia in chronic kidney disease, with a focus on the anticipated reimbursement of HIF stabilizers in the US.