Compliatric is excited to host the first of a two part 340B webinar series, presented by Ryan DiGiovanni, an Apexus Certified Expert (ACE) Pharmacist, President of EPL Health, and 340B Program Manager, Rush University Medical Center. This webinar will provide evaluation tactics, operational considerations and planning required for covered entities before, and potentially after, participating in the 340B ESP platform. For the C-suite, this webinar will provide an overview of impact and implications of participation. For those involved in daily 340B program management, a more detailed breakdown of 340 ESP app usage, requirements, and resources will be discussed.

1. epl.health
340B ESP Overview from a
Participating CE
Ryan DiGiovanni, PharmD, 340B ACE
ryan_digiovanni@rush.edu
01/18/2023

2. epl.health
Disclaimer
Nothing in this presentation should be interpreted as legal advice. Materials and discussion are intended to help
organizations understand the current 340B landscape to help ask the right questions with their legal counsel and
steering committees.
Information provided in these slides is subject to change.

3. epl.health
Bio
Ryan DiGiovanni – PharmD, 340B ACE
Founder - EPL Health
• Build and support 340B compliance & operations
for covered entities (CE)
• Entities we serve: FQHC, FQHC-LA, DSH, CAH,
RW Clinics
340B Manager- Rush University Health System
• 2 Disproportionate Share Hospital (DSH)
• 1 Hemophilia Treatment Center (HTC)
• 700+ Contract Pharmacy
• 3 Third Party Administrators
340B Satellite Office
340B
Coordinator
Expansion &
Growth
All Vendor
Management
Compliance &
Audit
Consolidated
Reporting

4. epl.health
Contents
• Resource Links
• Overview
• CHC Affected Manufacturers
• Process
• Impact & Considerations
• Pros/Cons
• Useful Tips

5. epl.health
Overview
• In 2020 Eli Lilly began restricting 340B pricing, reporting a need to
monitor for ‘Duplicate Discount’
• Current Manufacturers (mfgs) restricting 340B: 19
• Mfg Pharmacy Arrangements:
• 16 require submission of contract pharmacy dispensing
• 13 allow for 1 pharmacy designation (if no entity-owned pharmacy)
• 12 allow ‘wholly owned exemption’ of designation of CE-owned pharmacies
• 6 allow for ‘Attestation’ across all participating contract pharmacies for
universal approval.

6. epl.health
Overview
• 340B ESP collects 340B claims data dispensed at contract
pharmacy
• Transmits claims data to participating mfg
• Mfg use data to identify potential Medicaid and Commercial duplicate
discounts
• Lots of litigation currently underway.
• NACHC letter

7. epl.health
Litigation
Source: 340B Health

8. epl.health
340B ESP & CHC
Full view: 340B ESP Tool
MFG Name MFG Policy
CHC Need to
Submit Claims Effective Date Lookback Limits
Bausch Mandates 340B ESP submission of claims data to access 340B pricing at Contract Pharmacies Y 8/1/2022 within 45 days of the date of dispense
Boehringer Ingelheim Hospitals must apply for limited exceptions to mfg restrictions Y 8/1/2021 within 45 days of the date of dispense
Bristol Meyers Squibb Hospitals must apply for limited exceptions to mfg restrictions N 3/1/2022
Eli Lilly Mandates 340B ESP submission of claims data to access 340B pricing at Contract Pharmacies Y 12/16/2021 within 45 days of the date of dispense
Gilead Mandates 340B ESP submission of claims data to access 340B pricing at Contract Pharmacies Y 5/2/2022 within 45 days of the date of dispense
Merck Mandates 340B ESP submission of claims data to access 340B pricing at Contract Pharmacies Y 9/1/2021 within 45 days of the date of dispense
Sanofi Mandates 340B ESP submission of claims data to access 340B pricing at Contract Pharmacies Y 10/1/2020 within 45 days of the date of dispense
United Therapeutics Mandates 340B ESP submission of claims data to access 340B pricing at Contract Pharmacies Y 12/1/2021

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Process for claim submission
• Covered entities are expected to upload data twice per month
• 9 data elements suggested, 7 elements required
• 340B Covered Entity ID*
• Rx Number*
• Date Written*
• Fill Date*
• National Drug Code (NDC)*
• Quantity*
• Pharmacy NPI*
• Prescriber NPI
• Wholesaler Invoice Number
• Most TPAs have 340B ESP specific reports now

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Data Submission
Process
https://www.loom.com/share/a9e97e83c7a847f0b4ccbe5
c75f8e92f
1. Download each TPA/contract pharmacy
report with required fields
1. Can upload all NDC’s. only participating
NDCs will be selected/submitted to ESP
2. Upload and create a column mapping
template for each unique report
3. Save submitted files with naming
conventions that have claims date
range
4. Uplaod all documents to ESP before
submitting
5. Review submission for any identified
errors. Delete, edit and reupload error
files.
1. Spaces after numbers
2. Dashes

11. epl.health
Impact
• Financial: Increased 340B
Net Savings by 43%
compared to non-ESP
submission months in CY
2022
• Med Access: Restored multi-
pharmacy charity care access
program
• Resource Commitment: <0.5
FTE additional time/resource
requirement

12. epl.health
Considerations
• CE health benefit plan will lose commercial rebates back on 340B eligible
claims
• CE charity care program established at multiple contract pharmacies
• Resources/manual work
• 2-3 weeks pre-submission/1st submission
• ~1 hour per claim submission
• ~1-3 hours per ad-hoc ESP inquiry (2 per month on average)
• HIPPA permissible. A CE may disclose PHI:
• for its own treatment, payment, or health care operations
• To another CE or health care provider for payment activities of the entity that receives
the information

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Considerations
• CE Protections in place?
• State discriminatory
reimbursement laws
• **Not a comprehensive list**
Arkansas, Georgia, Illinois,
Indiana, Kansas, Kentucky,
Minnesota, Montana, North
Dakota, Ohio, Oregon, South
Carolina, South Dakota,
Tennessee, Utah, Vermont,
and West Virginia

14. epl.health
340B ESP Pros
• FQHC’s recouping close to 75% of pre-restriction savings
• Majority of TPAs now creating 340B ESP submission
• 340B ESP custom mapping feature reduces manual work
• Latest portal update allows for CE-driven reporting

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340B ESP Cons
• Initial claim submissions can be a challenge for entities/TPAs to
produce
• The ‘Chicken and the Egg’ scenario
• The ‘45 day’ rule
• Delays in turning/maintaining 340B pricing
• Inconsistent ‘340B eligibility status’ vs loaded catalog price
• Customer support knowledge of 340B operations is lacking
• Faulty flagging

16. epl.health
340B ESP Cons: Flagging
340B ESP Flagging System algorithm:
1. Assess volume of qualified claims vs 340B purchases over 30
day period
a. IF purchases > qualified claim volume THEN pharmacy is flagged as
‘at-risk’
1. ESP may inquire for claims of affected NDCs
a. IF CE does not comply or produce satisfactory claims THEN
pharmacy may be deemed ‘Ineligible’ and pricing removed

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Tips: Designation/Exemption
Designating a pharmacy
• DO NOT NEED TO PICK THE SAME PHARMACY FOR EACH MFG
• Recoupment Analysis
• Total volume across all mfg NDC
• Contribution margin by mfg
• Include Dispense Fees
• Bargaining chip
• Self-pay/Charity Care participation
• Re-negotiation of dispensing fee terms
Wholly-owned exemption
• Ability for CE-affiliated ‘contract pharmacies’
• Apply for HIN (wholly owned exemption/CP designation)
• Cardinal/ABC – should already have one
• McKesson – will need to apply
• Hospital/grantee can also exempt contract pharmacies with proof of ownership docs*
• Johnson & Johnson stipulates that the wholly-owned pharmacies must be non-profit*
• Proof of ownership docs: Certificate of Liability, W-9 form

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Tips: Before Claim Submit
• Quantify Value
• TPA reports to predict future claims and impact
• Get 340B wholesaler purchase reports
• Gather pharmacy NPIs
• Ensure current NDC holds/exclusions still allow for
accumulation with TPA

19. epl.health
Tips: 1st Claim Submit
• Will take up to 18 business days for 340B pricing to be turned
on with wholesalers
• Inquire with TPA on ability to produce impact report that
incorporates lookback
• Pay special attention to mfg that mandate 45 days & those that don’t!
• Create mapping template for each unique report you are
submitting

20. epl.health
Tips: Maintenance Claim Submit
• Consistent submission days
(1st & 15th every month)
• Keep claim submission
records
• Write dates in naming
convention
• Track each mfg:
• At your wholesaler, for every CP
purchasing account for pricing
updates
• In your TPA, ensure qualifying
and ordering

21. epl.health
Resource Links
Overview of Mfg restrictions and effected NDCs
• 340B ESP Tool
Detailed Mfg Policies
• ESP Participating Mfg Policies
Wholly-owned Exemption or Single Contract Pharmacy Designation?
• Obtaining HIN
Recoupment Analysis
• 340B PVP Price File
• NDC List