Ask for the Fees Back: Real Vendor Accountability in Multi-State 340B | Dr. Maria Campanella

Episode Summary

In this episode of 340B Pulse, host Muhammad Atif speaks with Dr. Maria Campanella, who leads 340B operations and compliance across a multi-state nonprofit health system running hospitals and clinics in markets throughout the U.S. Dr. Maria studied pre-pharmacy at Xavier University in New Orleans, moved into specialty pharmacy in Atlanta managing a large Ryan White clinic for infectious disease patients, then served as a 340B program director for operations and compliance before taking on enterprise-scale responsibility. The conversation is about the point where informal, site-by-site management stops being reliable, and what has to replace it. Her clearest operational answer: when a vendor misses accumulations it was contractually paid to capture, request that the vendor credit back the administration fees — because those are things you are paying the vendor to do.

1. Every state carries its own regulatory and compliance requirements, so a multi-state program needs a centralized team to standardize alongside internal compliance, regulatory, and government affairs functions.
2. TPAs, compliance, policies and procedures, and SOPs should be standardized enterprise-wide; vendor selection and legal contracting often cannot be, because state law dictates local contracting processes.
3. The core compliance objectives — avoiding diversion, duplicate discounts, and high WAC spend — are the "core heartbeat" of the program and must be identical at every site regardless of local complexity.
4. Local variation is managed through a named local leader in each market who reports into a national oversight committee, which is what bridges enterprise policy and site-level reality.
5. Internal audits stay with each entity and are shared upward; external audits should be run by the contracted vendor across all entities, with per-market findings reported to the national corporate group.
6. Exception-based management requires one centralized dashboard, built in-house or on Tableau or Power BI, that every local market feeds into and that can be filtered by market, entity, issue, or data feed.
7. Consolidating support tickets across markets is how a health system detects that a fix is not working and that the same root cause is repeating in more than one location.
8. Vendor governance means weekly or bi-weekly cadence calls with the account manager, monitoring EDI feed turnaround so eligible claims are not missed, and independently validating duplicate discounts, medication exclusion files, split billing, crosswalk, and high WAC exposure rather than trusting vendor-generated reports.
9. When a vendor meets its SLA but the outcome does not follow, the escalation path is to go above the account manager, convene focus groups with internal leaders and technical staff, and request a credit of administration fees for contracted work that was not delivered.
10. Facing the HRSA rebate model, 340B ESP, and Truzo at once, Dr. Maria's team built a tracker covering every change, the states affected, and the financial impact per market, and monitors DSH percentage as an early indicator of Medicaid patient loss.
11. Her position on the rebate model is that covered entities are being made to clear a hurdle to reach a discounted price promised over 30 years ago, while savings fund medical missions, free copay assistance, and cash cards for patients who are largely uninsured or underinsured.
12. On technology, she draws a specific line: AI is genuinely useful for reporting and analytics — tracking which manufacturer paid a rebate and which did not, or what happens after an appeal goes unanswered — but she does not expect it to replace the person doing the hands-on submission, monitoring, and appeal work.

Show Notes

• The true definition of an enterprise 340B operating model is a centralized team that standardizes, not a head office that approves everything.
• Why most operators falsely assume a local variation is justified when it is really a control weakness that has become normalized over time.
• The critical difference between administering a vendor contract and actively governing a vendor relationship.
• Why a vendor can meet every service level in its contract and still leave a covered entity without visibility into its own program.
• The overlooked right most covered entities never exercise: requesting a credit of administration fees when the vendor misses accumulations it was paid to capture.
• Why more reports do not produce more control, and what exception-based management looks like when every market feeds one dashboard.
• The specific data points a covered entity should validate independently rather than accepting the vendor's own report.
• How a multi-state system absorbs the HRSA rebate model, 340B ESP, and Truzo simultaneously without each site interpreting the requirements differently.
• Key Insights and Takeaways
• Dr. Maria Campanella studied pre-pharmacy at Xavier University in New Orleans before moving into specialty pharmacy in Atlanta.
• She managed a large Ryan White clinic for infectious disease patients, then became a 340B program director for operations and compliance at a nonprofit health system.
• She now leads 340B across a multi-state nonprofit health system with hospitals and clinics in markets throughout the U.S.
• Every state carries different regulatory and compliance requirements, so the program has to be adjusted for each territory or market.
• TPAs, compliance, policies and procedures, and SOPs should be standardized across the enterprise.
• Legal contracting usually cannot be standardized, because local states require their own contracting processes.
• Avoiding diversion, duplicate discounts, and high WAC spend is the core heartbeat of the program and stays standardized regardless of site complexity.
• Each market should have a local leader who acts as the point of contact and meets with a national oversight committee.
• Internal audits are kept by each entity and shared with the corporate oversight group.
• External audits should be performed by the contracted vendor across all entities, with a report of findings per market delivered to the national group.
• Local market data feeds should run into one centralized dashboard, built internally or on a tool like Tableau or Power BI.
• That dashboard should be filterable by market, by entity, by issue or case report, and by data feed.
• Consolidating support tickets across markets reveals repeating patterns and shows when a vendor's fix is not actually working.
• Documentation lives on one shared drive with subfolders for compliance, legal, finance, TPAs, project management, and technology.
• Contract pharmacy agreements get their own subfolder, and each state the system operates in gets its own subfolder as well.
• Each covered entity should hold a weekly or bi-weekly cadence call with its vendor account manager.
• EDI feed turnaround time should be monitored so eligible claims are not missed.
• Duplicate discounts, medication exclusion files, split billing, crosswalk, and high WAC exposure should be validated independently by market analysts on a weekly or bi-weekly basis.
• When a vendor meets its SLA but outcomes do not follow, escalate above the account manager and convene focus groups with internal leaders and technical staff.
• If a vendor misses accumulations covered in the contract, request that the vendor credit back the administration fees paid for that work.
• Her team built a tracker covering every policy and manufacturer change, which states are affected, and the financial impact per market.
• The team monitors DSH percentage as an early signal of Medicaid patient loss.
• 340B Health free webinars, the 340B Report newsletter, and the HRSA website are the sources her compliance and regulatory team monitors for legislative updates.
• The organization advocated in Washington DC and spoke with members of Congress about the rebate model.
• Savings are returned to the community through medical missions at home, free copay assistance, and cash cards to help patients afford medications.
• Most of the patients served are uninsured or underinsured, so reimbursement does not offset the cost of paying up front for high-cost drugs.
• Patient health information requested under the rebate model raises an unresolved data protection question for covered entities.
• AI is useful for reporting and analytics, including tracking which manufacturer paid a rebate and which did not, but not for the hands-on submission, monitoring, and appeal work.
• A high volume of compliance findings in audits, particularly diversion or duplicate discounts, is the clearest sign a program has outgrown site-by-site management.
• A monthly report comparing WAC spend to 340B spend tells a leader more about program health than total savings or claim volume.
• Referral capture is the vendor scorecard metric she believes more health systems should be using.
• Having far more vendors than necessary for work that could be done in-house is a warning sign a team is relying too heavily on vendor logic.
• Training internal staff to run auditing and crosswalk management can replace a higher outsourced contract fee.
• The single discipline that keeps a large program scalable is a centralized oversight committee that ties every market together and meets constantly.
• Her closing principle is to stay present and visible with third-party vendors, align internal and external audits across states, and pull finance and legal into the program rather than leaving it to the 340B department alone.