Alicia Silver: Last week, I had the privilege of speaking at the American Society for Gene and Cell Therapies Policy Summit in Washington, DC, with a number of other esteemed colleagues, and what we focused on was looking ahead to 2025 payment policy and cell and gene therapy. 

One of the most important and hotly talked about topics at the conference and on the panel was the cell and gene therapy access model, which is the CMMI demonstration to look at value-based payments in gene therapy for sickle cell disease. This is a voluntary model across all 50 states. States can opt in voluntarily, and all the manufacturers have an option to opt-in, so we’ll see in the next couple of months which states opt-in, which manufacturers opt-in, and sign agreements. Those agreements start on a rolling basis in January 2025, so patients would begin to have access in participating states in 2025 as soon as the agreements in the model are signed, which is really exciting. Some things remain to be seen, namely, the changes to the model that enable Fee-for-Service first over managed care beneficiaries in Medicaid, but then also the access to fertility preservation services. The model requires manufacturers to pay for fertility preservation services as part of their agreement for the patients who are enrolled in the model, which is excellent and really exciting for patients. For states that don’t opt into the model, don’t participate in the cell and gene therapy access model, manufacturers are not allowed to pay for fertility preservation services outside the model. So there will be some disparities, of course, for patients in terms of their access to fertility preservation services. We’ll get to see some of the exciting developments in the cell and gene therapy access model over the next couple of months.

Other exciting news in the cell and gene therapy space is that the Accelerating Kids Access to Care Act is moving along nicely on the hill. We hope to see that signed before the end of the year into law which would enable Medicaid beneficiaries to access care across state lines in an easier way, basically by enabling providers who are in one state to contract easily with another state to enroll and be credentialed providers. This is really important in cell and gene therapy, because sometimes at launch we have manufacturers who only have three to five sites, and so if you have a kid who is in Texas who needs care in New York, for example, we would reduce the administrative burden of getting the child access to care in New York from Texas, speeding up the process and making sure that kids get to cell or gene therapy in a more expedient manner, which is really exciting.

We continue to see manufacturers have trouble launching in all 50 states, so this helps address some of that, but it definitely was a theme that was talked about on the panel in terms of making sure that there is adequate coverage and access across every 50 state program in Medicaid.

Finally, we talked about hospital inpatient reimbursement and ensuring that there is more of a focus on adequate reimbursement for cell and gene therapy products. This is important because manufacturers continue to see a lack of uniform reimbursement across states across payers, and we want to make sure that hospitals continue to be made whole and incentivized to provide lifesaving technologies to their patients. Some key things that we are seeing, that we continue to work on with our clients. and some exciting work ahead to close out the year in 2024, and look to 2025.

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