Auditors test practice against policy. Both have to be true.
A policy manual that describes an ideal program you do not actually run is worse than no manual at all — it hands an auditor the standard you will be measured against, written by you.
At a glance
- 01Built from
- Your actual workflow
- 02Reviewed again
- Day 60
- 03Training
- Role-specific
- 04Version control
- Included
Written from what you do, not from a template
Most 340B policy manuals we review were adapted from a template. They are internally consistent, professionally formatted, and describe a program that does not exist at that entity. When an auditor tests practice against policy, the gap is a finding regardless of which side is better.
We build policies by observing and documenting what actually happens — then correcting the practice where it needs correcting and the document where the document is wrong. The order matters.
The policy set
- 340B program governance, oversight structure and responsibilities
- Patient definition, with tested decision rules and worked examples
- Eligibility, registration and recertification procedures
- Medicaid billing election and duplicate discount prevention, state by state
- GPO prohibition compliance and purchasing pathways where applicable
- Contract pharmacy oversight and reconciliation procedures
- Inventory management, accumulation and replenishment
- Self-audit plan, corrective action process and record retention
- Material breach and self-disclosure procedure
Different roles need different training
A single all-staff 340B session teaches nobody what they specifically need to do differently on Monday.
Pharmacy operations
Accumulation logic, exception queue handling, inventory separation, replenishment and what to escalate. The most operationally detailed session.
Revenue cycle & billing
Medicaid billing rules, modifier and identifier requirements by state, and how a billing decision creates or prevents a duplicate discount.
Compliance & internal audit
The audit criteria, self-audit method, evidence standards, corrective action documentation and self-disclosure thresholds.
Clinic & provider staff
Patient definition in practice, referral documentation requirements, and why an encounter note affects drug pricing.
Executive & board
Program value, exposure profile, regulatory environment and the questions leadership should be asking each quarter.
New hire onboarding
A reusable module so 340B knowledge does not leave with the person who had it.
Policy and training — common questions
01How often should policies be reviewed?
At minimum annually, and immediately after any material change — a new site, an acquisition, a TPA change, a state law change or a change in Medicaid billing practice. Version control and approval evidence matter as much as content, because an auditor will ask when it was last approved and by whom.
02Can you just give us a template?
We can, but we would be doing you a disservice on its own. A template that does not match your practice creates the exact gap auditors look for. We adapt from a strong base, but the adaptation to your actual workflow is the work that matters.
03Who needs to approve the policy set?
Typically the 340B oversight committee or equivalent governance body, with documented approval dates. What matters at audit is that approval is evidenced and current, not who specifically signed it.
04Do you train remotely?
Yes, and most training is delivered remotely by role. On-site delivery is available where an entity prefers it, particularly for pharmacy operations sessions where walking the actual workflow adds value.
Marked up with FAQPage schema for search and AI-answer eligibility.
Next step
When was your policy set last compared to what your team actually does?
That comparison is usually a one-day exercise, and it is the cheapest finding-prevention available.