---
name: "regulated-access-and-clinical-selling"
description: "Use when selling into hospitals, health systems, clinics, or pharmacies where formulary, reimbursement, or clinical protocol gates the deal."
triggers: ["formulary access", "hospital selling", "reimbursement path", "kol plan", "clinical protocol", "sampling compliance", "p&t committee"]
version: "1"
---
# Regulated access and clinical selling
Use this when formulary, reimbursement, or clinical protocol gates the deal.
Start from the account and its sites, the product and its indication, current
formulary or pathway status, the key opinion leaders (KOLs) and committee
owners, and the compliance rules you sell under (sampling, vouchers, co-pay,
patient assistance programs, hub services).
## Map access per account and site
Formulary or pathway status (blocked, in review, listed, preferred), the
committee or board that decides, and the next decision date. Include tumor
boards, integrated delivery networks, and federally qualified health centers
where they apply. Blank stays blank until verified.
## Build the reimbursement path beside the clinical one
Hub enrollment, patient-assistance-program eligibility, co-pay support, and
the vendor or contract
docs each site needs. A clinical yes with no reimbursement path is stalled,
not won.
## Write the KOL plan
Who influences the pathway decision, what evidence each needs, and the next
education step with a date. Education and in-services only, never inducement.
## Deploy inside the compliance rules
Samples, vouchers, and education: what is allowed, what needs sign-off, and
what is logged. Log every transfer of value for Sunshine Act and Open Payments
reporting: applicable manufacturers must report annually to the Centers for
Medicare & Medicaid Services payments and transfers of value to physicians,
teaching hospitals, and the covered non-physician practitioners above the
de minimis threshold CMS sets for that year — it is inflation-adjusted, so
look it up rather than assume a figure — published in a public database. If
the rule is unclear, stop and ask rather than guess.
## Run clinical etiquette for operating-room and emergency-department consults
Confirm the case need, bring exactly what was asked, keep inventory clean, and
debrief the staff contact after. Log every eval unit in and out.
## Keep call discipline
Before each call write the objective and the two questions that matter; after,
log what was learned, what changed on access, and the dated next step.
## What you hand back
The per-site access map with decision owners and dates, the reimbursement
path, the KOL plan, the compliant deployment log, and pre- and post-call
notes.
## Fallbacks
No formulary contact means you draft the access-discovery questions and work
from public pharmacy-and-therapeutics committee or pathway info labeled
INFERENCE. No compliance rules on file
means you ask for them before any sampling or voucher step.
## Approval gate
Nothing goes to the account and no access commitment is promised without your
explicit yes.