Straight answers to the questions we get on every first call.
Organized by the questions covered entities actually ask — eligibility, patient definition, contract pharmacy, audits, the rebate model, infusion, and what it's like working with us.
Every category, in one place.
Eligibility, patient definition, contract pharmacy, audits, the rebate model, infusion, and working with us — jump to the section you need below.
Eligibility
What makes a hospital or clinic a 340B covered entity?
Eligibility is defined by statute across roughly a dozen categories — DSH, critical access, rural, children's and cancer hospitals among them, plus federal grantees like FQHCs, Ryan White clinics and others. Each category has its own specific qualifying criteria.
Do all sites of a health system automatically qualify?
No. Each site (including child sites) must be separately registered in HRSA's OPAIS system and, for hospital-based sites, tied to the most recently filed Medicare cost report.
How often does eligibility need to be reconfirmed?
Annually, through the recertification process — and any material change (a new site, an acquisition, a change of ownership) should trigger a review before the next scheduled recertification.
Can eligibility be lost?
Yes — through a change in hospital classification, a failed recertification, or sustained non-compliance identified in an HRSA audit. Ongoing monitoring is the best protection against losing eligibility unexpectedly.
Patient definition
What is the 340B patient definition?
It's the set of criteria HRSA uses to determine whether a specific prescription qualifies for 340B pricing — generally requiring an established relationship with the covered entity, a qualifying encounter, and that the entity maintains responsibility for care.
Why is patient definition the most commonly cited finding area?
Because it requires an operational policy to be applied consistently across every prescriber, every site, and every encounter type — including referrals, discharge care, and telehealth — and written policies frequently lag behind how care is actually delivered.
Does telehealth change the patient definition analysis?
It can — the encounter still needs to meet the same underlying criteria, but how that's documented and evidenced for a telehealth visit is worth reviewing specifically rather than assuming parity with in-person care.
Contract pharmacy
How many contract pharmacies can a covered entity use?
There's no statutory limit, though individual manufacturer restrictions have narrowed practical access for many entities since 2020 — this is exactly what the manufacturer restriction matrix tracks.
What should be reconciled between the entity and a contract pharmacy?
Claims accuracy, ship-to/bill-to compliance, agreement currency, and manufacturer restriction impact — reconciled on a defined, recurring cadence rather than only at recertification.
Do manufacturer restrictions apply to every entity the same way?
No — restrictions vary by manufacturer, by drug, and sometimes by entity type or state, which is why a filterable, regularly updated matrix is more useful than a static list.
Audits
Can you guarantee we'll pass our HRSA audit?
No, and you should be cautious of anyone who says otherwise. What we can do is test the same areas HRSA tests and help you close gaps before a notice arrives.
How often does HRSA audit covered entities?
HRSA conducts a limited number of audits each year relative to the total number of registered entities, selected through a mix of risk-based targeting and random selection — infrequent enough that many programs go years without direct experience of one, which is itself a risk.
What happens if an audit finds something?
Findings typically require a corrective action plan with a defined timeline, and in some cases repayment to manufacturers for improperly captured discounts. Severity and required response vary by finding type.
Rebate model
Is the 340B rebate model definitely happening?
This is an active, evolving area of policy. Treat any specific date or drug list as subject to change, and confirm current status before making operational commitments based on it.
What's the biggest operational difference under a rebate model?
Cash flow — purchasing at full price and waiting for a rebate, rather than receiving the 340B discount at the point of purchase, ties up working capital that needs to be modeled in advance.
Infusion
Does 340B eligibility work differently for infusion centers?
Eligibility follows the same covered-entity rules, but site-of-care and ownership structure materially affect whether a specific infusion site qualifies — which is why we model 340B eligibility alongside chair economics rather than after the fact.
What is white bagging, and why does it matter for 340B?
White bagging is when a specialty or health-system pharmacy dispenses a drug to a provider for administration, rather than the provider buying and billing it directly — a practice that can shift the drug acquisition, and the 340B benefit, away from the covered entity.
Working with us
Where is your team based?
Client-facing consultants and clinical leads are US-based and Apexus ACE-certified. We publish a data map and hand it over during procurement without being asked.
Do you work with entities that aren't yet registered?
Yes — program implementation from a standing start is one of our core service lines.
How quickly can you start?
A discovery call within about a week, and most engagements begin within two to three weeks of a signed statement of work. If you're responding to a HRSA audit notice, say so on the first call — we prioritize those.
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