Watch the Webinar Here: https://compliatric.com/340b-recertification-and-audit-changes/ Compliatric is excited to host the second 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 outline requirements and updates covered entities should be made aware of heading into annual recertification, as well as highlight key changes to HRSA’s audit data submission and review process.

1. 340B Recertification & Audit
Changes/Tips
Ryan DiGiovanni, PharmD, 340B ACE
ryan_digiovanni@rush.edu

2. Disclosures
• No conflict of interest
• Information provided should not be construed as legal advice.

3. 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. Agenda
+ Hot Topics
+ Audit Trends & Readiness
+ 340B Data Request Review

5. Poll
1. What entity type are you?
a. Hospital
b. Grantee
2. What do we want to spend most of our time on?
a. 340B Hot Topics & HRSA Audit Impact
b. Annual Recertification
c. HRSA Audit Data Request List

6. Hot Topics: Timeline of Events
2019
Guidances Not Legally Binding
Trump Administration issued an executive
order (Federal Register, 84 Fed. Reg.
55235-55238 Oct 15, 2019) that rendered
guidance documents published by federal
agencies as non-binding and not legally
enforceable.
Manufacturer Restrictions Begin
Effective July 1, 2020, Eli Lilly
announces it will no longer sell
Cialis at 340B ceiling prices to
covered entities through contract
pharmacy arrangements
2020
2020
HRSA Loosens Audit Findings
The Government Accountability Office (GAO)
issues report, stating HRSA began to relax its
auditing standards, only issuing findings
non-compliance that are directly related to
340B Program Statute.
2022
Genesis v. Azar Appeal
Genesis appeal argued HRSA audit findings were
based on interpretation of ‘patient’ defined in guidance,
contradicting the plain language of the law and
overextended HRSA’s enforcement capability
HRSA ultimately reinstated Genesis in the 340B
Program, voided its audit, and the district court
dismissed the lawsuit.
2023
1st Ruling in favor of Manufacturers
U.S. Court of Appeals for the 3rd Circuit rule in favor
of Sanofi-Aventis U.S. v. HHS et al. Not required to
provide 340B price at contract pharmacy. Cases
raising similar legal questions are pending in the
District of Columbia and 7th Circuits.

7. Hot Topics: Genesis V Agar & Guidance on Patient Definition
Diversion

8. Hot Topics: Op-Ed
❖ Background/Discussion
Currently, HRSA’s authority is limited only to program statutes and regulations*
- Mega-guidance and other common guidelines (i.e. Patient Definition) are not enforceable findings
during a HRSA audit*
❖ Tips/Warnings
- May drive greater attention to enforceable laws/regulations. Recommend special attention to
specific aspects of program:
- Accuracy/Eligibility information in OPAIS database
- Recertification/Registration
- Policy & Procedure
- annual review and update
- Duplicate Discount Prevention
- Medicaid Exclusion File, State Policy
- Maintained auditable records
- Compliance with HRSA Audit
-
*based on presentation date 02/21/2023. Statements outlined are opinion based and/or subject to change

9. Recertification

10. Recertification - General
❖ Background/Discussion
- Annual recertification is mandatory for 340B covered entities
- Authorizing Official & Primary Contact get email notifications
❖ Requirements
- Must ensure all information is accurate and up to date
- Must update and attest before recertification window ends
- ONLY AO can Attest (PC can update/make changes)
Entity Type Recertification Window
FQHCs & Most Grantee January 30, 2023 - February 27, 2023
Hospitals Summer 2023
Title X family planning clinics, STD,
TB clinics
No dates yet

11. Recertification - General
❖ Tips/Warnings
- Have MCR/Grant documents ready for upload
- Verify addresses match on eligibility forms to OPAIS
- Ensure each registered site is still operational/eligible
- Grantees: falls under scope of grant
- Hospitals: outpatient charges/expenses on MCR lines 50-118*
- Have you Medicaid billing numbers and/or NPI numbers ready
- Ensure contact information for AO and PC is correct
❖ Tools/References
- Get help:
- ApexusAnswers@340bpvp.com
- 888-340-2787
- Online Resources:
- Recertifying a CE
*FAQ ID: 4301. HRSA 340B FAQ Search (340bpvp.com)

12. Start Session
Go to links provided in Autorizing Official (AO) or Primary
Contact (PC) email. Sign in to HRSA 340B OPAIS database
(Office of Pharmacy Affairs 340B OPAIS (hrsa.gov)) to start.
Recertification tasks will appear in My Dashboard section
under ‘My Task’ tab’. Click on ‘Recertification’
Summary Page
The recertification summary page will outline items for
you that must be updated, and items that should be
reviewed. “Update” = required, “Review” =
Recommended. Read these then hit ‘Continue
AO Signs & Attests
After all information is updated and reviewed, the Authorizing
Official must check the attestation box, and ‘Submit’
Go Through Each Tab
- Go through each tab Qualification Info,
Attachments Info, Medicaid Billing,
Parent/Child.
- Read any ‘update’ or ‘review’ messages.
- Click the Edit link to review the details pages
and make necessary updates.

13. Recertification - Uploading Attachments
❖ Background/Discussion
- This is usually the biggest issue requiring additional follow up from HRSA
❖ Tips/Warnings
- Only Microsoft Excel (xlsx) and Adobe PDF formats are allowed.
- File size is limited to 50MB.
- Files must not be password protected.
- Number of uploaded files must not exceed 10 files per submission
❖ Tools/References
- ApexusAnswers@340bpvp.com
- 888-340-2787
- Uploading Documents

14. Recertification - Cost Report
- If you change the entity's Qualification Information during recertification or if the most recent cost report is out of date, the system will prompt
you to upload updated supporting documentation from the latest Medicare cost report.
- If you change the entity’s Filing Date, and if the Filing Date is more than 5 months and 5 days after the Cost Reporting Period end date then the
system will display a warning message and require you to upload the signed/dated Worksheet S from your latest filed Medicare Cost Report.

15. Changing AO - Recertification
The current AO or PC may submit an AO change request. Only an AO change can be requested in a Change Request when the entity is undergoing
recertification.
On the Covered Entity Details page, type the email address for the new AO and click the Search button.

16. Medicaid - Recertification
This information is used to populate the medicaid exclusion file
‘At this site, will the covered entity bill Medicaid fee-for-service for drugs purchased at
340B prices? Yes = Carve-in, No = Carve out
Duplicates cannot be created because upon the save in the Edit Medicaid and NPI
Info by State pop-up window, the duplicates will be ignored. However, if duplicates
already exist, it is up to the AO and PC to correct them either by associating each
duplicated number with a different State or removing the duplicates from the current
State.

17. Audit Overview &
Expectations

18. HRSA Audit Agenda
What to Expect:
Introductions – Consider one person to coordinate if remote
Scripted Reason for Audit
Agenda timing will vary
Auditor will review housekeeping items that may still need to be uploaded
Begin with a general overview of program and auditor questions
Sampling, Transaction Testing, Provider Review, Claim Review
Follow Up On Any Outstanding Items
Closing

19. HRSA Selection Criteria
Maximum number of random samples
selected is 56
28 samples from largest universe
If any universe is 300 or less there will never be
more than 10%
5 samples are judgmental which will always
come from the largest dataset
❖ Background/Discussion
Since 2020, HRSA has implemented consistent data sampling practices:

20. Provider Administered Drugs Sample
• Time of Dispense or Administration
• Patient Status
• Drug Order and Dose
• Provider Name - If Health Care Professional Stance utilized, show documentation to
substantiate care
• Location – If not from an eligible location, demonstrate the continuum of care via
primary care visit or referral documentation.
• Payer

21. Retail Claims Drug Sample
• Date of Visit to Substantiate Care
• Location Where Prescription Was Written
• Prescription Order
• Medication Present in Med list
• Medication Present in Provider Documentation
• Referral Origination and Care Note Back (if applicable, best practice)
• Payer – If in-House Retail and FFS Medicaid will want to see clarification codes

22. Billing Claim Form Review
❖ Background/Discussion
If carving-in Medicaid, expect auditor to review billing
- Will need to verify NPI-UB04 Box 56 & CMS 1500 Box 33
- Confirmation of any state modifiers
❖ Requirements
- Only required to upload Medicaid FFS claim

23. 340B Audit Data
Request List

24. 340B Audit Data Request List
❖ Background/Discussion
Reviewed and updated beginning of every fiscal year
❖ Requirements/New Information
1. Policy & Procedures
2. Eligibility
3. 340B Universe for Sample Period
4. Provider List
5. Purchasing
6. Contract Pharmacy
7. Entity-Owned Pharmacy
8. Self-Disclosures
9. Medicaid Billing
10. Re-audit
❖ Tips/Warnings
❖ Tools/References
- 340B Data Request List Sample pdf

25. 1. Policies & Procedures
❖ Background/Discussion
- All CE’s: loosened eligibility of providers, locations and acceptable patient records during public health
emergency
- Hospitals: Definition of eligible site when location is not on the MCR yet or for special circumstance
❖ Requirement
- Policy & Procedures must reflect the covered entities eligible location definition, provider and record-keeping
requirements to allow for this
❖ Tips/Warnings
- Ensure P&P’s updated to provide entity this wiggle room
- Auditor may ask about emergency activations of locations within sampling period
❖ Tools/References
- HRSA FAQ ID: 4301
- Public Health Emergency Considerations

26. 2.B. Eligibility - Hospitals
❖ Background/Discussion
- More transparency of site eligibility when reviewing sample data
❖ Requirement
New in FY23: Section 2B - Include all applicable Medicare Cost Reports
- Most recently filed MCR for the start of the audit period;
- MCR used at the time of the last recertification; and
- MCR filed since the start of the sample period through the date of audit
- The encrypted signature on Worksheet S must be provided with all MCRs
-

27. 2.G. Eligibility - Hospitals
❖ New Requirements
2.C - Item G Added FY21
- The 340B ID
- Name of each offsite outpatient facility as identified on OPAIS
- Address of the off-site outpatient facility
- Worksheets A & C: Line Number and Cost Center Description
- Trial balance name and department code/account
- The location code or shorthand used to identify the site in the electronic health record
(EHR)
- Indicate if 340B drugs are utilized during encounters at the site
-

28. 2.E. Eligibility - Hospitals
❖ Background/Discussion
HRSA wants hospital eligibility documents to be easier to decipher
❖ New Requirements
2.E. Hospitals Requiring Contract with State or Local Government
- New FY22: must highlight the following in the contract:
■ Provision whereby indigent care provided by Hospital
■ Name of Hospital and Government Agency
■ Signatures of Hospital and Government Agency
■ Effective Dates of the Contract
Private non-profit and hospitals granted government powers must prove non-profit status
documentation.
- IRS Form 990, Hospital Charter, Articles of incorporation, Bylaws, 501(c)(3)

29. 2. Eligibility - Grantees
❖ Background/Discussion
- Auditor will likely go through services provided at each associated clinic during an opening conference.
- Crosswalks create bridge to cipher eligible locations listed on OPAIS to EHR record locations to Billing/Shipping Locations
- Will make for seamless preparation and audit
❖ Requirements
- Notice of Grant Award and/or sub grantee documentation
- EHB Forms 5A and 5B. 5C is not on list but have available as well.
- EHB Crosswalk – Include a list of locations where health care services are provided for which the grantee deems itself responsible
❖ Tips/Warnings
Creating EHB Crosswalk:
1. Start with OPAIS extract
2. Crosswalk each associated site’s physical address, verify they match the EHB
3. Add bill to and ship to columns and populate with appropriate addresses
4. Add location code or shorthand to identify the site in the health record
5. Include additional columns to indicate if actively purchasing 340B drugs and add billing numbers if carving in Medicaid.
❖ Tools/References
- Apexus Sample Data Request
- 340B Crosswalk - Basic Template

30. 3.A. Universe & Program Narrative
❖ Requirements
3.A: Not New - Include a narrative describing the methodology and
system or software used to gather the data: note any limitations,
exclusions, and inclusions (e.g., reversals, direct purchases, etc.)
Universe Methodology/System/
Software
Report Name(s) Notes
Mixed Use Mixed Use TPA Includes Reversals and direct
purchases, explain limitations,
or any exclusions
Child Site EHR or TPA
In-House Rx TPA
Contract Rx TPA

31. 3.A. Universe & Program Narrative
❖ New Requirements
3A. - Define each area of service on the spreadsheet(s) with column
headings name and indicate which area the spreadsheet represents
❖ Tips/Warnings
Copy the column headers and add into the program narrative
Create a key for abbreviations and/or unknown terms
- For example:
- CSN = Contact Serial Number = Unique Patient ID
- MRN = Medical Record Number
- ESN = Encounter Serial Number

32. 3.A. Universe & Program Narrative
❖ Tips/Warnings
- Review ALL data prior to upload
- Remove non-covered outpatient drugs
- exclude limiting definition drugs (vaccines), orphan drugs
- pvp-value added drugs (use pvp price file for this)
- Only report data elements that have been asked for
- REMOVE PHI (just Rx number, MRN, or tracking number)
- BUT Keep copies of original records on file for better cross-walking
during audit period

33. 4. Provider List
❖ Requirements
- Name
- NPI
- Employment type (Employed, Resident, Contract)
- Start Date
- End Date
❖ Tips/Warnings
- Create ‘Type 2’ dimension- table to address any potential gaps in employment and/or change in employment type
- Be prepared to show the auditor proof of employment, contract, or credentialing for providers during the onsite/remote
audit
Provider Map ID First Name Last Name NPI Employment Type Start Date End Date isActive
1 John Doe 1234564789 Dedicated 1/1/2010 3/1/2015 N
2 John Doe 1234564789 Contracted 3/2/2015 Y

34. 5. Purchasing Docs
❖ Requirements
- List all accounts – for all universes – including if applicable (340B, GPO, WAC, CSOS) by 340B ID
- Include wholesaler name
- Include a column for bill to and ship to which will assist in OPAIS address verification
- Provide Invoice example for each account – embed or list corresponding file name
- Provide all purchases (340B ONLY) - embed or list corresponding spreadsheet name
❖ Tips/Warnings
- Update on a rolling 6-month basis to be in HRSA audit ready state
- Create ‘Type 2’ dimension- table to address any potential gaps in employment and/or
change in employment type

35. 5. Purchasing Crosswalk Example
Clinic /
Hospital /
Retail
Account
Location 340B ID
Ship To
Address
Bill To
Address
ACCOUN
T #
DESIGNATI
ON
WHOLESALE
R
Invoice Name
Reference
Purchasing
Record
Off-Site Clinic
CE
Physicians
Group
HRSA
ID
336 S.
Jefferson
113 W.
Hickory
XYZ 340B Add Name
5.B. HRSA ID
Invoice
7805XXX
5.C. HRSA ID
Wholesaler
Purchasing
Record
Off-Site Clinic
CE
Physicians
Group
HRSA
ID
336 S.
Jefferson
113 W.
Hickory
XYZ GPO Add Name
5.B. HRSA ID
Invoice
387XXXXX
NA
Hospital CE Hospital
HRSA
ID
113 W.
Hickory
Street
113 W.
Hickory
XYZ GPO Add Name
5.B. Mixed Use
GPO Invoice
995XXXXX
NA
Hospital CE Hospital
HRSA
ID
113 W.
Hickory
Street
113 W.
Hickory
XYZ 340B Add Name
5.B. HRSA ID
340B Invoice
3087XXXXXX
5.C. HRSA ID
Wholesaler
Purchasing
Record

36. 6A. Contract Pharmacy Crosswalk
❖ New Requirements
- 6.A. must disclose whether pharmacy is being used by the covered entity
- 6.C. Provide last Independent Audit of Contract Pharmacies
- 6.D. Provide supporting documentation of internal contract pharmacy audits during start of sample period through date of audit.
❖ Tips/Warnings
- Create ‘Type 2’ dimension- table
1. Can use OPAIS Extract of all contact pharmacies to get you started and minimize to the following columns:
- 340B ID, Pharmacy Name, Address 1, Address 2, City, State, Zip, Contract Approval Date
2. Then add the following additional columns:
- TPA, Pay on: Dispense or Replenishment, True Up Terms, Utilized or Not Utilized, Wholesaler, Account Number, Invoice, Contract Name

37. CONTRACT PHARMACY CROSSWALK EXAMPLE
340
B ID
Retail
Account
Location Address
Contract
Approval
Date
TPA Pay on
True
Up
Active Wholesaler Account # Invoice Name Contract Name
HRS
A ID
Contract
Pharmacy
Uptown
Drug Store
N Bus
hwy
date from
extract
Macro
Replenis
hment
180 Utilized Cardinal XYZ or 123
CAHXXXXXX-00
copy of invoice
List contract file name
when first registered or
embed copy
HRS
A ID
Contract
Pharmacy
Drug Stores
on the
Boulevard
S BLVD
Ste A
date from
extract
Macro
Replenis
hment
180 Utilized Cardinal XYZ or 124
CAHXXXXXX-00
copy of invoice
List contract file name
when first registered
HRS
A ID
Contract
Pharmacy
Walgreens
#0XYZ
S BLVD
date from
extract
Walgree
ns
Dispens
e
60 Utilized Amerisource XYZ or 126
CAHXXXXXX-00
Walgreens copy of
invoice
List contract file name
when first registered
HRS
A ID
Contract
Pharmacy
PHY
S
Jefferso
n
date from
extract
ScriptPr
o
Dispens
e
60 Utilized Amerisource XYZ or 127
CAHXXXXXX-00
Walgreens copy of
invoice
List contract file name
when first registered
HRS
A ID
Contract
Pharmacy
Walmart
001
Grand
Ave
date from
extract
Macro
Replenis
hment
180 Utilized McKesson XYZ or 128
CAHXXXXXX-00
Walmart
Invoice_AXXXXX
List contract file name
when first registered
HRS
A ID
Contract
Pharmacy
Walmart
005
Range
RD
date from
extract
Macro
Replenis
hment
180
Not
Utilized
McKesson XYZ or 130 Not Utilized
List contract file name
when first registered if in
audit window, if not list
term date or NA

38. 7. Entity-Owned Pharmacies
❖ New Requirements
Provide a list of pharmacies, other than contract pharmacies utilized during the start of the sample period through the audit start date.
- Pharmacy name and address
- Whether pharmacy is located within a registered off-site facility/grant-associated Site
Type of pharmacy (Retail/Community, Infusion, Specialty, Compounding, Mixed-Use)
- Documentation to demonstrate ownership
- Pharmacy license, Business license, Certificate of liability insurance, or Listing of pharmacy on the CEs grant or MCR and corresponding trial
balance
❖ Tips/Warnings
- Also adding in OPAIS Pharmacy ID, OPAIS Contract ID, Pharmacy NPI number would provide more efficient tracking
and reference ID columns.
- Can use these columns for Xlookup/Vlookup functions to audit pharmacy dispensing data across all
pharmacies/TPAs.
❖ Tools/References
340B Crosswalk - Basic Template

39. 9. Medicaid Documents
❖ Requirements
- Provide Medicaid FFS billing document for each covered entity site (340B ID) that carves in
- Every NPI, every Medicaid number, for EVERY 340B ID
340B ID State State Requirements NPI(s)
State assigned
Medicaid number(s)
Medicaid FFS Claim Form
CAH12345-00 MN UD 123 XYZ [Embedded document]
CAH12345-01 MN UD 1234 XYZ [Embedded document]
CAH12345-02 MN UD 12345 XYZ [Embedded document]

40. Key Takeaway - 340B DRL
- 340B Program Narrative, with data methodology table, and column header
crosswalk
- Location Crosswalk
- Purchasing Crosswalk
- Contract Pharmacy Crosswalk
- Medicaid Crosswalk

41. Appendix

42. 340B News: Genesis v Agar
Genesis Healthcare Inc. v Alex Azar:
Genesis, an FQHC, removed from 340B program after 340B audit findings of Diversion. (qualified rx’s as 340B eligible from ‘non-eligible
locations’)
Bullet Points:
• After being removed from 340B, Genesis filed suite that argued that the audit findings, which were based on adherence to HRSA’s
interpretation of ‘patient’ defined in guidance, contradict the plain language of the law and overextended HRSA’s enforcement capability
• HRSA ultimately reinstated Genesis in the 340B Program, voided its audit, and the district court dismissed the lawsuit.
• Genesis has since appealed the dismissal, pressing the court for a declaratory judgment that the 340B patient definition issued through
guidance is illegal. Oral arguments for the appellate case were heard in March 2022.
Historical perspective regarding the case:
• In 2019, the Trump Administration issued an executive order (Federal Register, 84 Fed. Reg. 55235-55238 Oct 15, 2019) that rendered
guidance documents published by federal agencies as non-binding and not legally enforceable.
• Mfg have taken advantage by restricting 340B drugs through contract pharmacy channels, as outlined in non-binding guidance
• The Government Accountability Office (GAO) issued a report in December 2020 on HRSA’s efforts to oversee CE compliance with 340B
Program requirements. The report noted that, starting in the fall of 2019, HRSA began to relax its auditing standards by which it would only
issue findings for areas of non-compliance that are directly related to requirements stipulated in the 340B Program statute.
• 340B Statute: https://www.hrsa.gov/sites/default/files/hrsa/rural-health/phs-act-section-340b.pdf

43. 340B News: Genesis v Agar
Conclusion:
Broadening the patient definition may provide CEs with significant value in terms of 340B savings optimization, and may
be permissible according to law, given the lack of specificity of “patient definition” outlined in 340B Program statute and
regulations.
Considerations:
• Elements of case are directly applied to grantee, not a hospital
• Current HRSA audit standards reflect the agency’s limited enforcement authority, HOWEVER, these standards could
evolve should they receive rule-making authority and/or the ability to enforce 340B Program guidance.
Potential Next Steps:
• Assess for scenarios where a “continuum of care” relationship may apply
• Review non-reimbursable hospital departments (e.g., Line 190 clinics) that may be integral to the CE.
• Quantify the financial impact of broadening the Patient definition
• Ensure any modifications to patient definition are clearly articulated in policies and procedures.