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.

Webinar Logistics We strongly recommend calling in on your telephone Access Code: 632 274 023 # 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: http://www.nachc.org/focus-areas/policy-matters/340b/ Or go to NACHC.org and search 340B

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

Teaching and Technical Assistance OPERATIONAL UPDATES Tim Mallett, RPh 340B Consultant for NACHC Teaching and Technical Assistance tmallett@340Basics.com

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.

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.

July Site Registration Info From the HRSA Primary Health Care Digest 6.18.19 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. Email the 340B call center or call 888-340-2787 (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 email address, and Authorizing official name and email address. The authorizing official will receive an email message that the account is unlocked and a registration may be submitted

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. https://www.340bpvp.com/education/340b-university/ Should know more about registration later this week or early next week  Will post on Noddlepod when registration opens.

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: email Colleen at Cmeiman@nachc.org or email Tim directly at tmallett@340Basics.com and cc Colleen (This is probably the faster route….)

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 emailing cmeiman@nachc.org or cdevoe@nachc.org

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 kristina.klein-bradham@apexus.com * 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.

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 cmeiman@nachc.org before responding.

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 888.340.BPVP or apexusanswers@340Bpvp.com For info on $50 IUDs, contact mdiallo@medicines360.org or go www.medicines360.org

Want More Info on In-House Pharmacy? We are considering creating a full-day training on in-house pharmacy. Please email Tim Mallett at tmallett@340Basic.com if you: Would be interested in such a training Have specific issues: You’d like to see addressed You could help speak about.

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.

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 15-17 in Washington DC Three sessions focused specifically on FQHCs Two will focus on “Three Strategies to Optimize the value of your 340B program.”

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

Summary of Operational Updates Email Tim Mallett at tmallett@340Basics.com for support with operational issues. (Please cc Cmeiman@nachc.org.) Some movement on prescription drug transparency . Remember to use tags, categories, and the “attach” function on Noddlepod. (Email cmeiman@nachc.org or Cdevoe@nachc.org 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 Email Tim Mallett at tmallett@340Basics.com if you have ideas or interest in expanded training on in-house pharmacy. Registration for new clinic sites and contract pharmacies begins July 1st

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

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

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

Audit Distribution Since 2012 23

Percentage of Entities with Adverse Findings 24

Community Health Centers Types of Audit Findings 2012-2018 25

Community Health Centers Types of Audit Findings 2017 & 2018 26

CHCs With Adverse Findings Sanctions by Type 27

Corrective Action Plans (CAPs) Community Health Centers 28

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

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

Causes of 2018 Adverse Findings Community Health Centers 31

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

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

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

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

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

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

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

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

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

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

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

Questions? Matt Atkins, CPA, CIA 340B Apexus Certified Expert www.draffin-tucker.com Contact: Matt Atkins, CPA, CIA 340B Apexus Certified Expert matkins@draffin-tucker.com 229-883-7878

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