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© 2016 by the American Pharmacists Association. All rights reserved. 1
Health Resources and Services AdministrationOffice of Pharmacy Affairs
340B Peer-to-Peer Program
*The 340B Peer-to-Peer Program operates under a Health Resources and Services Administration contract with the American Pharmacists Association Federal Contracts and Grants. The intent of this program is for 340B Leading Practice Sites and Subject Matter Experts to share
their operational best practices and not the official policies of the Office of Pharmacy Affairs. The mention of trade names, commercial practices, or organizations does not imply endorsement by the U.S. Government. Additionally, your practice setting may require differences to
ensure 340B program integrity and meet all state or federal requirements.
April 13, 2016 2:00-3:00 PM Eastern
Self-Audit Series: Defining your 340B Drug Operations Environment in Required
Policies and Procedures
We encourage you to submit
questions throughout the
presentation through the chat function of the
webinar.
340B Webinar
2
Q&A – for questions
Download Slides
Links
Closed Captioning
Full Screen
© 2016 by the American Pharmacists Association. All rights reserved. 2
Financial Disclosure
Tracey Cole, RPh; Anne Marie Kondic, PharmD; Heidi Larson, PharmD; and Casey Norris, PharmD declare no conflicts of interest or financial interests in any product or service mentioned in this activity, including grants, employment, gifts, stock holdings, and honoraria. For complete staff disclosures, please see the Accreditation information section at www.pharmacist.com/education.
The content of this session was developed by the Federal Contracts and Grants group, which is managed by the American Pharmacists Association. No commercial support was used to develop this activity.
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ACPE Information
The American Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education (CPE). This knowledge‐based activity Self-Audit Series: Defining your 340B Drug Operations Environment in Required Policies and Procedures, is approved for 1.0 contact hours of CPE credit (0.10 CEUs). The ACPE Universal Activity Number (UAN) assigned to this activity is 0202-0000-16-106-L04-P/T. The target audience is pharmacists and pharmacy technicians and there is no fee required for this activity.
Initial release date: April 13, 2016
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© 2016 by the American Pharmacists Association. All rights reserved. 3
OPW2CPE credit is only available for the live webinar. You MUST be registered through the registration page to obtain credit. The registration link will close today at 4:00pm Eastern.
To obtain CPE credit for this activity, you are required to actively participate in this activity and complete an evaluation. The attendance code above is needed to access and complete the evaluation.
Your CPE must be filed by Friday 5/13/16 at 11:59 Eastern Time in order to receive credit.The attendance code expires on this date and no CPE will be granted after this time.
ACPE Credit
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Speakers
Faculty & Host Peers & Subject Matter Experts
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Heidi Larson, PharmDPharmacy Business and Revenue Manager
Hennepin County Medical Center***(Minnesota / Urban DSH)
Casey Norris, PharmDDirector of Pharmacy
CareSouth Carolina, Inc.***(South Carolina / CHC)
Anne Marie Kondic, PharmDEducation Specialist
Federal Contracts and Grants
APhA**
Tracey Cole, RPhDirector, Pharmacy Practice
and HRSA 340B Peer Program
Federal Contracts and Grants
APhA*
*APhA Staff**APhA Federal Contracts & Grants Consultant
***Peer-to-Peer Recognized Site ****Former Peer-to-Peer Recognized Site
© 2016 by the American Pharmacists Association. All rights reserved. 4
Learning Objectives
At the completion of this activity, participants will be able to:
• Define the characteristics of a covered entity’s 340B Drug Operations Environment.
• Describe how Peer Mentors reflect their actual practice in required policies and procedures by including the details of their 340B Drug Operations Environment.
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340B Compliance Improvement Model
• Recorded webinar series November 2015 –March 2016 on the 4 strategic aims
• Compliance Improvement Guide developed as a complement to the series
• The Guide is a tool to be used to help covered entities advance through stages of improving 340B compliance
• Updated to ensure education resources are current – current date in lower left corner
• Watch the short videos on the model and the Guide
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View Recorded Webinars
© 2016 by the American Pharmacists Association. All rights reserved. 5
340B Compliance Improvement Model
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Leadership Commitment
Integrated 340B Systems
Measurable Improvement
Education and Training
Integrated 340B Systems
Improvement Concepts
1. Policies & Procedures
2. Auditable Records
340B Compliance Improvement Webinar Series: Integrated 340B Systems (2/10/2016)Open Office: 340B Compliance Improvement Webinar Series: Integrated 340B Systems (2/24/2016)
Questions We Will Address in Today’s Webinar
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What is the 340B Drug Operations
Environment?
How does a covered
entity map its 340B Drug Operations
Environment?
What policies and
procedures does OPA require?
What should OPA required policies and procedures
include?
© 2016 by the American Pharmacists Association. All rights reserved. 6
Order
ReceiveDispense/ Administer
Bill to Payor
The 340B Drug Operations Environment
Where and how a covered entity’s 340B drugs are purchased and provided to patients.
340B drugs may be dispensed for take-home use or administered/dispensed as part of a medical encounter.
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Ord
er
The 340B Drug Operations Environment
EmergencyRoom
Mixed-UsePharmacy
Inpatient Area
340B IDDSH12345
DSH12345AInfusion Center
Covered Entity’s Outpatient Retail
Pharmacy
Order
ReceiveDispense/
Administer
Bill to Payor Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
DSH12345BCancerCenter
Order
ReceiveDispense/
Administer
Bill to Payor
ContractPharmacy
X
Maintain accurate 340B Database records.Eligible locations where 340B drugs are provided to patients.
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© 2016 by the American Pharmacists Association. All rights reserved. 7
Ord
er
The 340B Drug Operations Environment
PrimaryCare
UrgentCare
Covered Entity’s Outpatient Retail Pharmacy
340B IDCHC12345
Pediatrics
Behavioral Health
Order
ReceiveDispense/
Administer
Bill to Payor Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
FP34567FamilyPlanning
Order
ReceiveDispense/
Administer
Bill to Payor
340B IDCHC12345B Contract
Pharmacy
Maintain accurate 340B Database records.Eligible locations where 340B drugs are provided to patients.
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Ord
er
The 340B Drug Operations Environment
How ? Order
ReceiveDispense/
Administer
Bill to Payor Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
Order
ReceiveDispense/
Administer
Bill to Payor
Prevent diversion and duplicate discounts.How 340B drugs are purchased, provided to patients, and billed to Medicaid.
How ?
How ?
How ?
How ? How ?
How ?
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© 2016 by the American Pharmacists Association. All rights reserved. 8
The 340B Drug Operations Environment
Physical Inventory Virtual Inventory
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How 340B drugs are provided to patients and billed to Medicaid.
Managing 340B Inventory and Associated Data Vulnerabilities in a Physical System (5/13/2015)
Managing 340B Inventory and Associated Data Vulnerabilities in a Virtual System (4/8/2015)
Peer-to-Peer Frequently Asked Questions
• Can you share your self-audit tool?
• Can you share your policy and procedure manual?
• Can you share your employee 340B training materials?
• How did you choose your independent auditor?
• Can you share your 340B coordinator job description?
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© 2016 by the American Pharmacists Association. All rights reserved. 9
Peer-to-Peer Frequently Provided Answers
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Download and customize a 340B tool or template from the Apexus website
to reflect your covered entity’s actual practice:
https://www.apexus.com/solutions/education/340b-tools
Site-specific policies and procedures must reflect a covered entity’s actual practice.
The 340B Drug Operations Environment
A covered entity’s 340B Drug Operation Environment is unique to the covered entity
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Policies and procedures and self audit systems are unique to a covered entity’s 340B drug operations environment
© 2016 by the American Pharmacists Association. All rights reserved. 10
Hennepin County Medical Center (HCMC)
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Disproportionate Share Hospital
• 32 child sites• 1 mixed-use pharmacies• 5 entity-owned outpatient pharmacies• 2 non-340B retail pharmacies
Inventory Type(s)Provided to Patients
Inventory System Used 340B Medicaid Status
Mixed-Use Pharmacy 340B and non-340B Virtual Carve-In
Entity-OwnedOutpatient Pharmacy
340B and non-340B Virtual Carve-In
Provider Administration /Dispensation
340B only Virtual Carve-In
Teen Clinics 340B only Physical Carve-Out
Outpatient Retail Pharmacy
Non-340B only Physical N/A
Care South Carolina (CSC)
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Federally Qualified Health CenterRyan White Grantee
• 12 child sites• 1 entity-owned outpatient pharmacy (total of 4 by spring 2016)• 9 contract pharmacies
Inventory Type(s)Provided to Patients
Inventory System Used 340B Medicaid Status
Entity-OwnedOutpatient Pharmacy
340B and non-340B Physical Carve-Out
Mobile Van at child site C 340B Only Physical Carve-In
Provider Administration /Dispensation
340B Only Physical Carve-In
Contract Pharmacy 340B Only Virtual Carve-Out
© 2016 by the American Pharmacists Association. All rights reserved. 11
Why Map the 340B Drug Operations Environment?
The maintenance of auditable records, including documented 340B Program compliant policies and procedures, is a 340B Program requirement. All 340B Drug Operations Environments should be reflected in policies and procedures and self-audit systems and a covered entity’s practice must align with its policies and procedures. Systems or mechanisms must be in place to ensure ongoing compliance with all 340B Program requirements, including accuracy of 340B database records and prevention of diversion and duplicate discount (both at the covered entity and a contract pharmacy).
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Tell Us a Little About Yourselves
Webinar Polling Question:
Please choose the appropriate response on your screen to indicate how many total people from your organization are participating today:
Select One• 1 Only me • 2 - 3 people • 4 - 5 people • More than 5 people
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© 2016 by the American Pharmacists Association. All rights reserved. 12
How to Map the 340B Drug Operations Environment
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Download the word and/or excel version today!
Word Version: https://docs.340bpvp.com/documents/public/resourcecenter/Mapping_340B_Drug_Operations_Environment.docxExcel Version: https://docs.340bpvp.com/documents/public/resourcecenter/Mapping_340B_Drug_Operations_Environment.xlsx
How to Map the 340B Drug Operations Environment
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© 2016 by the American Pharmacists Association. All rights reserved. 13
Table 1: Overall Drug Operations Environment
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Table 2: 340B ID Site-Specific Drug Operations Environment
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© 2016 by the American Pharmacists Association. All rights reserved. 14
Table 2: 340B ID Site-Specific Drug Operations Environment
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Table 3: Entity-Owned Pharmacy Drug Operations Environment
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© 2016 by the American Pharmacists Association. All rights reserved. 15
Table 3: Entity-Owned Pharmacy Drug Operations Environment
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Table 4: Contract Pharmacy Drug Operations Environment
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© 2016 by the American Pharmacists Association. All rights reserved. 16
Table 4: Contract Pharmacy Drug Operations Environment
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HRSA Audit Findings
Audit findings that might result when a covered entity does not accurately map its 340B Drug Operations Environment:
• Incorrect Database record
• Dispensed 340B drugs to ineligible individuals (ineligible sites)
• Dispensed 340B drugs to ineligible individuals (inpatients)
• Lack of adequate controls/mechanisms in place for prevention of diversion
• Incorrect (inaccurate)/incomplete information on the Medicaid Exclusion File
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OPA Website: FY 2016 Audit Results
© 2016 by the American Pharmacists Association. All rights reserved. 17
Mapping the 340B Drug Operations Environment
What insights did you gain
from mapping your entity’s
340B Drug Operations Environment?
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Mapping our Entity’s 340B Drug Operations Environment
Covered Entity (Table 2 and Table 3)
• Snapshot of 340B operations
Contract Pharmacy (Table 4)
• Contract Pharmacy properly listed on the OPA Database
• Compare to executed contract
• Monthly self-audit
‒ Maintain records of self-audits
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© 2016 by the American Pharmacists Association. All rights reserved. 18
Mapping our Entity’s 340B Drug Operations Environment
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Covered Entity (Table 2)
Eligibility• Document the 340B ID of each location
registered on the OPA Database
Inventory• For each location, document the inventory
method(s) used for 340B drugs that are administered/dispensed as part of outpatient encounters.
Medicaid• For each location, document the Medicaid
and/or NPI numbers used to bill 340B drugs to Medicaid
• For each location, document the Medicaid and/or NPI numbers used to bill non-340B drugs to Medicaid
What Policies & Procedures Does OPA Require?
What is the 340B Drug Operations
Environment?
36
How does a covered
entity map its 340B Drug Operations
Environment?
What policies and
procedures does OPA require?
What should OPA required policies and procedures
include?
© 2016 by the American Pharmacists Association. All rights reserved. 19
OPA Monthly Update February 2016
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http://www.hrsa.gov/opa/updates/2016/february.html
OPA Monthly Update February 2016FY16 Audit Data Request for Policies and Procedures
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Policies and procedures to describe CE’s process for: DSH PED CAN CAH RRC SCH CHC
Contract Pharmacies
Physical Inventory
Virtual Replenishment
InventoryA.B.C.D.E.F.G.H.I.J.K.L.M.N.O.P.Q.
X X X X X X X X X X
http://peertopeer340b.com/?P20=MediaFile
17 Defined Policies and Procedures
Applicability
© 2016 by the American Pharmacists Association. All rights reserved. 20
Policies and Procedures to Describe CE’s Process
A. Accuracy of 340B database information J. Prevention of diversion at CE – patient definition
B. Determination of eligible sites K. Prevention of diversion at CE – split billing software
C. Procurement L. Prevention of diversion at CP – patient definition
D. Prevention of GPO violations M. Prevention of diversion at CP – split billing software
E. Identification of covered outpatient drug exclusions
N. Complying with orphan drug exclusion
F. Oversight of contract pharmacy O. Prevention of duplicate discount at CE
G. Tracking and accounting of physical inventory P. Prevention of duplicate discount at CP
H. Tracking and accounting of virtual inventory Q. Disclosure of material breach
I. Accumulation by 11-digit NDC match39
What Policies & Procedures Does OPA Require?
How did you use the OPA February Update to review
your organization’s 340B Policies and Procedures?
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© 2016 by the American Pharmacists Association. All rights reserved. 21
How did you use the OPA February Update to review your organization’s 340B Policies and Procedures?
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A. Accuracy of 340B database information J. Prevention of diversion at CE – patient definition
B. Determination of eligible sites K. Prevention of diversion at CE – split billing
software
C. Procurement L. Prevention of diversion at CP – patient definition n/a
D. Prevention of GPO violations M. Prevention of diversion at CP – split billing
softwaren/a
E. Identification of covered outpatient drug exclusions N. Complying with orphan drug exclusion n/a
F. Oversight of contract pharmacy n/a O. Prevention of duplicate discount at CE
G. Tracking and accounting of physical inventory P. Prevention of duplicate discount at CP n/a
H. Tracking and accounting of virtual inventory Q. Disclosure of material breach
I. Accumulation by 11-digit NDC match
How did you use the OPA February Update to review your organization’s 340B Policies and Procedures?
• Review and update policies and procedures on a regular basis
• HRSA recommends 17 policies and procedures related to program requirements
• Covered Entities must be prepared to provide these policies and procedures during a HRSA audit
• Policies and procedures must be specific to your organization and reflect actual practice
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© 2016 by the American Pharmacists Association. All rights reserved. 22
What Should OPA Required Policies and Procedures Include?
What is the 340B Drug Operations
Environment?
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How does a covered
entity map its 340B Drug Operations
Environment?
What policies and
procedures does OPA require?
What should OPA required policies and procedures
include?
340B Program Policy and Procedure Self-Audit Tool
Download the tool today: Policy and Procedure Self-Audit Tool44
Purpose: The purpose of this tool is to identify and evaluate the topics within a covered entity’s
340B Program policy and procedure documents.
• Evaluate policies and procedure to ensure that key topics are addressed.
• Document a summary of results
• Share summary of results with the covered entity compliance oversight body
• Develop a corrective action plan if applicable
© 2016 by the American Pharmacists Association. All rights reserved. 23
340B Program Policy and Procedure Self-Audit Tool
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HRSA requiredpolicy and procedure
Document the policy and procedure section or page number for each key topic
area that should be addressed within thepolicy and procedure
Answer toassessment
question
Approval date
Explain
What We Include In OPA Required Policies & Procedures
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© 2016 by the American Pharmacists Association. All rights reserved. 24
What We Include In OPA Required Policies & Procedures
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Apexus Tool:Establishing Material Breach Threshold Tool
Updated 3/9/2016
What We Include In OPA Required Policies & Procedures
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© 2016 by the American Pharmacists Association. All rights reserved. 25
Which Would You Do First?
Webinar Polling Question:
Should an entity start with the Mapping the 340B Drug Operations Environment Tool or the 17 OPA Policies and Procedures Grid?
Select One• Mapping the 340B Drug Operations Environment Tool
• 17 OPA Policies and Procedures Grid
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340B Drug Operations Environment / OPA Policies & Procedures
50
Map the 340B Drug Operations
Environment
Include all 340B Drug Operations
Environment in 17 P&P’s
© 2016 by the American Pharmacists Association. All rights reserved. 26
Participant Check-in
51
Please respond to the following questions via poll box:
What insights did you gain about mapping an
entity’s 340B Drug Operations
Environment?
What insights did you gain about the February
OPA Update & the Policy and Procedure
Self-Audit tool?
340B Drug Operations Environment / OPA Policies & Procedures
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Map the DrugOperations Environment
→Self-Audit
Policies and Procedures
https://docs.340bpvp.com/documents/public/resourcecenter/Mapping_340B_Drug_Operations_Environment.docx
https://docs.340bpvp.com/documents/public/resourcecenter/Policy_and_Procedure_Self-Audit_Tool.docx
© 2016 by the American Pharmacists Association. All rights reserved. 27
CPE Self Assessment Question
Webinar Polling Question:
Which of the following is correct:
Select One
1. The 340B Drug Operations Environment defines where and how a covered entity’s 340B drugs are purchased and dispensed to inpatients.
2. To be compliant, a covered entity must have all 17 required policies and procedures listed in OPA’s February 2016 update.
3. Policies and procedures and self-audit systems include areas where 340B drugs are purchased and administered or dispensed as part of outpatient medical encounters.
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How to Claim CPE Credit
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OPW2To obtain CPE credit for this activity, go to:• http://www.pharmacist.com/live-activities• Login• Click “claim credit” or “add to cart”• “Enroll” in the activity • Complete the assessment and evaluation
Your CPE must be filed by Friday 5/13/16 at 11:59 Eastern Time in order to receive credit.
© 2016 by the American Pharmacists Association. All rights reserved. 28
Open Office
Still have questions?
Join the webinar speakers on April 27, 2016 at 2pm ET
Questions for the Open Office session will be from:
Participants must submit question(s) by April 15, 2016
Register Today to join this interactive discussion! 55
Open Office registration
Overflow of questions from this webinar
Webinar satisfaction survey
Questions during Q/A
Additional Events & Resources
56
Training
• Webinars• Prior Webinars – Listed on the OPA Website
• Upcoming – May 11, 2016 2pm ET Self-Audit Series: 340B Inventory Tracking Systems
• 340B University™• April 16 – Alexandria, VA
• June 11 – Baltimore, MD
• Register
• 340B University OnDemand™
• More Information [email protected]
Communications
• Monthly Update• Important Peer-to-Peer communications the
1st week of the month. Sign up today!
• LinkedIn• Join the discussion on the group page
340B Resource Network
• HRSA 340B Peer-to-Peer Program –Becoming a Leading Practice Site• Peer-to-Peer Program – HRSA OPA Website
• Peer-to-Peer Program – Apexus PVP Website
• Compliance Improvement Guide• Watch a short video to learn more!
• Access the Guide
© 2016 by the American Pharmacists Association. All rights reserved. 29
Interested in Becoming a HRSA Recognized 340B Leading Practice Site?
Apply Today!
The American Pharmacist's Association is currently accepting
applications from covered entities to become a
340B Peer-to-Peer Leading Practice Site.
Watch a short video for more information
57
340B Compliance Improvement Model Links
• http://www.hrsa.gov/opa/peertopeer/webinars.htmlCompliance Improvement
Guide - Webinar Recordings
• https://www.brainshark.com/aphanet/340BComplianceModel Introductory Video
• https://www.brainshark.com/aphanet/vu?pi=zHlzfC1xDzNwWfz0Guide Introductory Video
• http://p2pcomplianceguide.com/latest.aspxCompliance Improvement
Guide
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© 2016 by the American Pharmacists Association. All rights reserved. 30
Contact Information
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• www.hrsa.gov/opa340B Program
• http://www.hrsa.gov/opa/peertopeer/index.html
340B Peer-to-Peer Program
• 1-888-340-2787
• https://www.apexus.com
Apexus Answers 340B Technical
Assistance
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Solutions for 340B Entities
CO
NT
RA
CT
ING 340B Prime
Vendor Program
ED
UC
AT
ION 340B University™
& 340B OnDemand
AS
SIS
TA
NC
E Apexus Answers Call Center
https://www.apexus.com/ (888) 340-BPVP
https://www.apexus.com/soluti
ons/education/340b-university