1. Pharmacy Access Office Hours
June 2019
Focus Topic:
Recent Trends in Audit Findings
This session is supported by the Health Resources and Services Administration (HRSA) of the U.S. Department of Health and Human Services (HHS) as part of an award totaling $6,375,000. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by HRSA, HHS, or the U.S. Government. For more information, please visit HRSA.gov.

2. Webinar Logistics We strongly recommend calling in on your telephone
Access Code: #
Your Attendee ID: Listed below the access code in the box under “Select Audio Connection”.
To ask/ answer a question, or share a comments, please use the Chat box on the right hand side of the screen
You can download these slides on Noddlepod, & from NACHC’s NEW 340B/ Rx webpage:
Or go to NACHC.org and search 340B

3. Operational Updates
Focus Topic – Recent Trends in Audit Findings
Q&A
And Comment Box discussions throughout…

4. Teaching and Technical Assistance
OPERATIONAL UPDATES
Tim Mallett, RPh
340B Consultant for NACHC
Teaching and Technical Assistance

5. Some small increases in transparency
Administration finalizes some new rules for Medicare that will increase price transparency
TV ads for drugs that are covered by Medicare and Medicaid will be required to list the Wholesale Acquisition Cost (WAC) starting around July.
EHRs will need to tell providers the price of drugs prescribed under Medicare Part D (1.1.21).
Medicare EOBs will provide info on price increases and lower-cost alternatives (1.1.21).
HHS did NOT finalize any changes re: rebates and copays.

6. In the News!
Washington State was successful recently in pushing back on the State Medicaid office’s efforts to take 340B savings on managed care drugs !
An insurer/PBM recently told a CHC pharmacy that NCPDP required the addition of the 20 modifier for 340B claims.
Not a NCPDP requirement.
Was one of many suggestions posed back in 2011 by an advisory panel.

7. July Site Registration Info
From the HRSA Primary Health Care Digest
Quarterly 340B Program Registration Quarterly 340B Program site registration is open from July 1 to 15. Health centers are still able to register a site that has been verified as implemented and with a site status reflected as “active” in EHBs Form 5B through Friday, August 23, after which the system will close to prepare for the October 1 start. the 340B call center or call (Monday-Friday, 9:00 a.m.-6:00 p.m. ET) to register a new site or ask questions.
You will need to provide the following information when calling:
Health center name,
Site/clinic name,
Site IDs for all sites,
HRSA/BPHC grant number,
Contact name and address, and
Authorizing official name and address.
The authorizing official will receive an message that the account is unlocked and a registration may be submitted

8. 340B University for FQHCs
In Chicago at the Hyatt Regency on 8/17/19.  Registration opens approximately 60 days ahead of time and you can use this link to got to the registration page.
Should know more about registration later this week or early next week
 Will post on Noddlepod when registration opens.

9. Additional Support for Rx Operations
Tim Mallett from 340Basics is now under contract with NACHC to provide Training and Technical Assistance (T&TA) to health centers on pharmacy operations.
Contract is funded through BPHC Cooperative Agreement, so:
Thank you BPHC!
Focus is operations, not advocacy.
To access Tim’s expertise, you can either:
Colleen at or
Tim directly at and cc Colleen (This is probably the faster route….)

10. Tips for Using “Noddlepod”
Noddlepod is an on-line platform, limited to members of the health center “family”, to discuss pharmacy and 340B-related issues.
Please categorize your posts and add “tags” (aka search terms.)
Please use the “attach” function to attach documents.
One-pagers, P&Ps, Competency Tests etc.
Not yet on Noodlepod? Sign up by ing or

11. Improvement Coming to Ceiling Price Database!
Starting this quarter, 340B providers can verify that they are not being overcharged for 340B drugs by checking the “ceiling price” section of the OPAIS database.*
Starting next quarter, info will be available based on package size.
Kris Klein-Bradham from Apexus
* Remember that the 340B CEILING price is not always the same as the 340B PURCHASE price, since the PURCHASE price may contain “sub-ceiling” discounts & distributor fees.

12. Outreach from “DecisionPoint Research?
DecisionPoint Research (DPR), an independent market research firm, has been hired by a major retail pharmacy chain to study FQHCs’ in-house pharmacies. 
If you or your colleagues are contacted by DPR, please contact Colleen Meiman at before responding.

13. Are You Overpaying for Vaccines or IUDs?
As 340B provider, you are eligible for discounts on:
Discounts on vaccines (which are outside of 340B)
$50 IUDs (similar to Mirena.)
For info on discounted vaccines, contact Apexus at BPVP or
For info on $50 IUDs, contact or go

14. Want More Info on In-House Pharmacy?
We are considering creating a full-day training on in-house pharmacy.
Please Tim Mallett at if you:
Would be interested in such a training
Have specific issues:
You’d like to see addressed
You could help speak about.

15. Miscellaneous
Recordings of most Rx Office Hours sessions are now available on the NEW NACHC Pharmacy website.
A couple months are missing due to Colleen’s IT learning curve….
GAO now conducting a study of methods to avoid duplicate discounts.
Increased focus on contract pharmacy compliance.
If you are contacted by Kalderos, we advise you to respond promptly.

16. More Learning Opportunities
1. For people new to 340B:
340B University for FQHCs – Aug 17 in Chicago (right before NACHC CHI)
Offered by Apexus with FQHC staff, free.
2. For people who work with 340B or their FQHC’s finances:
340B Coalition Conference
July in Washington DC
Three sessions focused specifically on FQHCs
Two will focus on “Three Strategies to Optimize the value of your 340B program.”

17. Upcoming Office Hours Topics
Looking Ahead
Upcoming Office Hours Topics
JULY: Pharmacy Charges - Sliding Fee Scale & Other Considerations ( Presenter TBD)
AUGUST: No Rx Office Hours (conflicts with NACHC CHI)
Please “reply’ to my post on Noddlepod with ideas for future Office Hours topics

18. Summary of Operational Updates
Tim Mallett at for support with operational issues. (Please cc
Some movement on prescription drug transparency .
Remember to use tags, categories, and the “attach” function on Noddlepod. ( or if you need to sign up.)
Package-size info is coming to the OPAIS ceiling price database.
Contact Colleen if you are contacted by DecisionPoint Research.
There are several upcoming learning opportunities around 340B, geared both to “newbies” and “old hands.”
Will posts updates on registration on Noddlepod
Tim Mallett at if you have ideas or interest in expanded training on in-house pharmacy.
Registration for new clinic sites and contract pharmacies begins July 1st

19. Please do the 1-minute evaluation

20. Recent Trends in Audit Findings
Matt Atkins
CPA, CIA, 340B ACE

21. About Matt Atkins
Matt is a manager with Draffin Tucker where he focuses exclusively in the firm’s healthcare practice
Matt is recognized as a 340B Apexus Certified Expert
Frequent speaker at national 340B conferences and other national and regional events
Routinely performs 340B compliance reviews and provides on-site HRSA audit assistance for covered entities

22. HRSA Audits Since 2012 All Entity Types – CHC Number Overlay
Created with Mapchart.net 29 3 1 2 4 7 5 6 13 1 1 1 1 1 22

23. Audit Distribution Since 201223

24. Percentage of Entities with Adverse Findings24

25. Community Health Centers Types of Audit Findings 2012-201825

26. Community Health Centers Types of Audit Findings 2017 & 201826

27. CHCs With Adverse Findings Sanctions by Type27

28. Corrective Action Plans (CAPs)
Community Health Centers 28

29. Corrective Action Plans
Required for adverse findings
HRSA will provide template form to complete
“Encouraged” to use template
Must submit within 60 days
CE must implement a CAP to ensure program compliance
HRSA staff are generally helpful and willing to work with CE’s to ensure the CAP is adequate and practical

30. Corrective Action Plans
May 2018 Update
HRSA now expects CAP’s to be implemented within six months of approval, including repayment to manufacturers
Subject to termination if unable to meet this expectation
HRSA may re-audit to assess compliance
Findings of non-compliance in two or more audits may result in removal from the Program

31. Causes of 2018 Adverse Findings
Community Health Centers 31

32. Duplicate Discount 2018 HRSA audit findings:
Inaccurate or incomplete information in the Medicaid Exclusion File
Entity did not have controls in place to prevent duplicate discounts
Medicaid billing numbers and NPI numbers were incorrect on the Medicaid Exclusion File
Entity was billing Medicaid contrary to information included in the Medicaid Exclusion File
Entity was billing Medicaid at contract pharmacies 32

33. Incorrect 340B Database Record
2018 HRSA audit findings:
Incorrect entries for offsite outpatient facility names
Failed to remove closed contract pharmacy location registration
Failed to include entity owned pharmacy as a shipping address
Failed to remove duplicate registrations for offsite outpatient facilities
Incorrect entry for entity name
Incorrect entry for Primary Contact
Registered a contract pharmacy without a contract in place 33

34. Diversion 2018 HRSA audit findings:
340B drug dispensed at a contract pharmacy for a prescription written at an ineligible site
340B drug dispensed at a contract pharmacy for a prescription written by an ineligible provider
340B drug dispensed at a contract pharmacy for prescription not supported by a medical record 34

35. Oversight of Contract Pharmacies
2018 HRSA audit findings:
No oversight by covered entity of contract pharmacy 340B operations 35

36. HRSA’s Program Integrity Analysis
Incorrect contract pharmacy registration remains a problem area
HRSA issued notification of Program Integrity Analysis (PIA) in July 2018
AO’s will receive notification of selection for PIA.
Failure to pass PIA will result in registration rejection. 36

37. Duplicate Discounts/Inaccurate MEF
Different Carve-in/Carve-out elections by associated site
Billing Medicaid inconsistent with MEF
If you carve-in, list every Medicaid provider number and NPI used to bill Medicaid 37

38. On-Site Audit Walkthroughs –associated sites & contract pharmacies
100% Virtual inventory –
Physically Separate inventories
Avoid the Gotcha! moment

39. Individual Dispense Testing – Clinic Administered Drugs
Don’t make assumptions
Often health centers assume in-house inventories need not be audited if they are Medicaid carve-in
Why?
This assumption can lead to significant difficulties under audit 39

40. The Good News It’s not difficult to add this step!
Periodically reconcile 340B inventory
Test audit trail
Drug
Beginning Inventory
Purchases
Eligible Dispenses
Waste/ Expired/ Other
Computed Ending Inventory
Actual Inventory on Hand
Variance A 10 20 25 5 6 1 B 2 C
400
2,100
1,500 50
950
900
(50) 40

41. Individual Dispense Testing
Unable to locate support in CHC medical record for 340B replenishment drugs purchased by contract pharmacy
CHC medical record did not contain a documented encounter that supported the prescription.
OPA Finding:
Diversion – 340B drugs dispensed at contract pharmacy for prescription not supported by responsibility of care. 41

42. Individual Dispense Testing
Prescriptions were generated in ineligible locations.
Prescriptions were provided to patients while in a non-registered offsite location.
Physicians were moonlighting in other locations which were not affiliated with the covered entity.
OPA Finding :
Diversion – 340B drug dispensed at contract pharmacy for prescription originating from ineligible site. 42

43. Questions? Matt Atkins, CPA, CIA 340B Apexus Certified Expert
Contact:
Matt Atkins, CPA, CIA
340B Apexus Certified Expert

44. Please do the 1-minute evaluation

45. General Q&A Reminder: Qs submitted in advance get priority.