Meetali Desai. 340B Compliance Specialist UMass Memorial Medical Center (UMMMC)

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Hubert Hampton
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1 Meetali Desai 340B Compliance Specialist UMass Memorial Medical Center (UMMMC)

2 Statement of Conflicts of Interest Meetali Desai has no actual or potential conflict of interest in relation to this presentation. 2

3 Today s Agenda UMass Memorial s 340B Audit Timeline Pre Audit Preparation On site Audit Post Audit Experience 3

4 CE Question Which of the following helps contribute to a successful HRSA audit A. Establishing internal controls B. Establishing a strong multi disciplinary 340B team C. Consulting with 340B Health before and after the HRSA audit D. All of the above 4

Establishing a strong multi disciplinary 340B team C.

5 UMass Memorial s 340B Audit Timeline Week 1 10/24/14 Audit Notification and Data Request Week 8 12/16/ /18/2014 On site Audit Week 21 3/19/2015 Final Audit Report Week 26 4/22/2015 UMass response to Final Audit Report Week 36 7/1/2015 Second Final Report 5

site Audit Week 21 3/19/2015 Final Audit Report Week 26 4/22/2015

6 Pre Audit UMass Memorial s preparation Data compilation Inter-departmental meeting Notification to 340B administrators and contract pharmacies Auditor Communicat ion Conference call to go over the data submitted Discuss the audit plan Audit started before the on site visit Prep work Conference call with 340B Health Audit samples 6

Conference call to go over the data submitted Discuss the audit plan Audit started

7 On site Audit Auditor asked that no more than three people be present in the conference room Auditor asked that consultants/vendors not be present in the room Audit lasted three days 7

8 On site Audit Day 1: Review of twenty eight randomly selected samples and six high drug cost samples for the mixed use and ambulatory sites Observation status patients timestamp validation Offsite clinic using WAC only 8

the mixed use and ambulatory sites Observation status

9 On site Audit Day 2: Review of twenty eight randomly selected samples for the contract pharmacies and in house retail pharmacies Few contract pharmacies registered and effective with OPA but not implemented Auditor s concern about two samples 9

retail pharmacies Few contract pharmacies registered and

10 On site Audit Day 3: Review UMass Memorial s oversight process for contract pharmacies Review of audit records On site visits two contract pharmacies and two child sites 10

11 Post Audit Pulling additional supporting documentation Conference call with the auditor UMMMC s request to share supporting documentation with HRSA Conference call with 340B Health 11

12 Post Audit Three months later Final Audit Report Conference call with 340B Health Conference call with external legal counsel Written letter of disagreement Tip: Make it concise and focus on demonstrating why the responsibility of care for the prescribed drug (or the condition associated with the drug) remained with the covered entity 12

it concise and focus on demonstrating why the responsibility of care for the

13 Post Audit Requested extension was granted by HRSA Response material was submitted on April 22, 2015 HRSA reissued the Final Report on July 1, 2015 findings were reversed. 13

14 Summary Establish a robust compliance plan : Establish internal controls, audit plan and perform regular internal audits Targeted audits if needed Document findings and Corrective Action Plans 340B Oversight Committee meetings 14

internal audits Targeted audits if needed Document

15 Summary Prep work for on site audit: Consult with 340B Health Notify all 340B vendors and partners Establish a support team that can help in the background Review the samples in advance if possible 15

16 Summary Post audit: Compile supporting documents for the potential findings If appealing the audit findings: Consult with 340B Health and legal counsel Response material should be concise and focused on the finding as stated in the Final Report 16

with 340B Health and legal counsel Response material should

17 CE Question Which of the following helps contribute to a successful HRSA audit A. Establishing internal controls B. Establishing a strong multi disciplinary 340B team C. Consulting with 340B Health before and after the HRSA audit D. All of the above 17

18 CE Question & Answer Which of the following helps contribute to a successful HRSA audit A. Establishing internal controls B. Establishing a strong multi disciplinary 340B team C. Consulting with 340B Health before and after the HRSA audit D. All of the above 18

19 Additional Questions? Meetali Desai 340B Compliance Specialist UMass Memorial Medical Center 55 Lake Ave Worcester, MA Phone:

Jason Mills, PharmD, MBA Pharmacy Supply Chain Manager Medical University of South Carolina

Jason Mills, PharmD, MBA Pharmacy Supply Chain Manager Medical University of South Carolina Statement of Conflicts of Interest I(Jason Mills) have no actual or potential conflict of interest in relation