Last Updated: September 15, 2026
Optimizing 340B revenue for clinics rarely fails because of drug pricing. It fails because of documentation, roster drift, and statements nobody reads closely. At The Marketing Lab, we run 340B programs and contract pharmacy relationships daily, and the pattern repeats: the money is there, but the paper trail is not.
The 340B Drug Pricing Program is a federal program that lets covered entities buy outpatient drugs at reduced ceiling prices and use the savings to stretch scarce federal resources. The savings only survive an audit if the eligibility file, the prescriber roster, and the claims data agree with each other.
A HRSA 340B audit readiness checklist is the single document that decides whether recertification is routine or painful. Start DOH document requests months before the February recert window, not weeks.
One clarification saves hours: HRSA issues only the 340B ID. When a form asks for an "MOU agreement number," it wants a state contract number, a CDC cooperative agreement number for a Section 318 grantee, or a wholesaler/TPA account number. Ask which before answering.
HRSA 340B covered entity recertification guidance
A 340B prescriber roster audit compares the TPA's prescriber configuration against an EHR claims report by rendering NPI. Do it quarterly, because TPA configs drift silently.
In one audit we ran, roughly a third of active rendering providers were missing from the TPA configuration, including the owner. Mid-levels were rendering under a supervising NPI, and the EHR carried the wrong NPI entirely. Claims tied to those providers can be questioned.
Reconcile in four steps:
340B contract pharmacy reconciliation only makes sense when the TPA monthly statement is read on both a cash and an accrual basis. Cash-basis "cumulative over/under" ledgers can show the clinic owing the pharmacy while accrual shows the pharmacy holding clinic margin in trailing insurer A/R.
That gap is timing, not error. In programs we run, roughly 30% of A/R collects in-month and about 70% the following month. "Cash start-up" advances at a fixed percent of charges create a liability that only flips once A/R collects.
Review contract pharmacy net-per-claim by drug class. Non-HIV generics often run negative and should be carved out or moved to a different program modality.
| Statement View | What It Shows | Action |
|---|---|---|
| Cash basis | Cumulative over/under ledger | Compare against accrual before reacting |
| Accrual basis | Trailing insurer A/R position | Request true-up of withhold reserve |
| Net-per-claim by class | Negative-margin generics | Carve out or change modality |
When changing pharmacies, sequence matters: reduce volume first, let A/R collect, request true-up of the withhold reserve, then give notice. Most PSAs carry 60-day no-cause termination, quarterly reconciliation, and a withhold reserve releasable on request.
Most 340B content stops at "use your EHR better." That is not a plan. The gap in many programs is the specific configuration work that makes 340B eligibility, prescriber attribution, and contract pharmacy claims reconcile without a human rebuilding a spreadsheet every month. In programs we run, the wiring is the difference between a program manager who audits quarterly and one who audits weekly by hand.
None of these talk by default. The integration work is deciding which system owns each field and building a monthly reconciliation between them.
This is the step almost nobody documents. Build it once and the roster audit becomes a report instead of a project.
That last step is the one that saves the most time. If the EHR export and the TPA export share column headers, the quarterly diff takes minutes instead of a day.
Marketing reporting only matters if it lands on kept visits. The CRM should carry one pipeline per service line with stages that mirror the clinical cadence, not a generic sales funnel.
| Pipeline | Stages | Rebooking Trigger |
|---|---|---|
| Oral PrEP | Booked, Tested, Follow-Up Booked | Every 3 months |
| Injectable PrEP | Booked, Tested, Visit 2 at 1 month, Maintenance every 2 months | Per injectable cadence |
| STI screening | Booked, Tested, Result Delivered | Per risk-based interval |
| 340B-eligible encounter | Checked In, Documented, Claim Reconciled | Monthly statement close |
Keep PHI out of ad platforms and analytics entirely. The CRM holds the patient record; the ad platform holds the campaign. The join happens inside the CRM, not in a Google or Meta dashboard.
A 340B program is only as auditable as its weakest data source. If the EHR export, the TPA prescriber config, and the contract pharmacy statement do not reconcile on the same fields, the savings are provisional, no matter how good the spreadsheet looks.
HRSA 340B program integrity and audit resources
A 340B program is a chain of small handoffs, front desk, medical assistant, prescriber, biller, program manager, and every handoff is a place where an encounter stops being auditable.
| Cadence | Activity | Owner |
|---|---|---|
| Onboarding | Role module plus one shadowed cycle | Practice administrator |
| Monthly | Statement review on both bases | 340B program manager |
| Quarterly | Prescriber roster reconciliation | 340B program manager |
| Quarterly | Billing code spot-check on preventive claims | Billing lead |
| Annually | Full policy review and staff attestation | Medical director |
Run the roster reconciliation before the quarter closes. Fixing a roster mid-quarter means re-adjudicating claims, which is far more work than catching the drift early.
HRSA 340B covered entity recertification guidance
Start with the files you already have. Reconcile the TPA prescriber configuration against an EHR claims report by rendering NPI each quarter, and pull an HIV test overdue list monthly so lapsed patients get rebooked. In our experience, a third of active rendering providers can be missing from the TPA config, which means claims that should generate 340B margin never do. Fixing roster drift and recall worklists usually recovers more revenue than any new hire.
Three repeat offenders: prescriber rosters that do not match what the TPA has configured, in-kind support for Section 318 eligibility documented with a single date instead of a funding date range, and Medicaid claims that should carry the carve-in codes but do not. HRSA tightened its information-collection expectations in the August 2025 and January 2026 notices, so unsigned subrecipient agreements and single-date in-kind entries are now easy findings. Build the checklist months before the February recertification window opens.
Read every TPA monthly statement on both a cash and an accrual basis. Cash-basis cumulative over/under ledgers can show the clinic owing the pharmacy while accrual shows the pharmacy holding clinic margin in trailing insurer A/R. Review net-per-claim by drug class and carve out non-HIV generics that run negative. If you change pharmacies, reduce volume first, let A/R collect, request a true-up of the withhold reserve, then give notice under the 60-day no-cause termination clause.
If your Medicaid ID is not on the HRSA Medicaid Exclusion File, you cannot bill Medicaid fee-for-service at the 340B ceiling price without creating a duplicate discount. Once the carve-in is set up correctly, FFS pharmacy claims carry Basis of Cost 08 and Submission Clarification Code 20, and managed care encounters use SCC 20 and 9 per each plan's spec. Getting the codes wrong is both a revenue leak and an audit exposure, so verify the Exclusion File listing before every recertification.
Bring us your patient acquisition, 340B program, or compliance bottleneck. We will show you what a 30-day launch looks like for your clinic — in English or Spanish, month to month, no long contract.
