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©2016 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.
February 10, 2016 2:00-3:00 PM Eastern
340B Compliance Improvement Series: Integrated 340B Systems
We encourage you to submit
questions throughout the
presentation through the chat function of the
webinar.
340B Webinar
Q&A – for questions
Download Slides
Links
Closed Captioning
Full Screen
2/2/2016
©2016 American Pharmacists Association. All rights reserved.2
Financial Disclosure
Zandra Glenn, PharmD; Anne Marie Kondic, PharmD; Deborah Brafford; Richard Fons, RPH,AAHIVP; Amanda Eamigh, PharmD, BCPS; Kris Klein-Bradham, PharmD, BCPS, CD 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.
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 340B Compliance Improvement Series: Integrated 340B Systems, is approved for 1.0 contact hours of CPE credit (0.10 CEUs). The ACPE Universal Activity Number (UAN) assigned to this activity is 0202-0000-16-089-L04-P/T. The target audience is pharmacists and pharmacy technicians and there is no fee required for this activity.
Initial release date: February 10, 2016
http://www.pharmacist.com/education
2/2/2016
©2016 American Pharmacists Association. All rights reserved.3
P314CPE 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 Thursday 3/10/16 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
Deborah BraffordSenior Director - Business Operations & Education
Federal Contracts and Grants
APhA
Kris Klein-Bradham, PharmD, BCPS, CDDirector of Pharmacy Services
CommUnityCare***
Richard “Rick” Fons, RPh, AAHIVPVice President of Pharmacy ServicesAIDS Resource Center of Wisconsin*
Speakers
*Peer-to-Peer Recognized Site
**APhA Federal Contracts & Grants Consultant
***Former Peer-to-Peer Recognized Site
Anne Marie Kondic, PharmDEducation Specialist
Federal Contracts and Grants
APhA**
Zandra Glenn, PharmDSubject Matter Expert
Federal Contracts and Grants APhA**
Faculty & Host Peers & Subject Matter Experts
Amanda Eamigh, PharmD, BCPSClinical Pharmacy Manager
DuBois Regional Medical Center – Penn Highlands DuBois*
http://www.p2phrsa.com/webinar/webreg.aspx?cid=45367&id=107
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©2016 American Pharmacists Association. All rights reserved.4
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
Learning Objectives
At the completion of this activity, participants will be able to:
• Identify the steps needed to develop, implement, and maintain comprehensive340B policies and procedures.
• Identify the process to generate auditable records that demonstrate compliancewith 340B Program guidelines.
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©2016 American Pharmacists Association. All rights reserved.5
Compliance Improvement Webinar Series
Date Topic
November 18, 2015 Leadership Commitment
December 9, 2015 Open Office: Leadership Commitment
January 13, 2016 Education and Training
January 27, 2016 Open Office: Education and Training
February 10, 2016 Integrated 340B Systems
February 24, 2016 Open Office: Integrated 340B Systems
March 9, 2016 Measurable Improvement
March 23, 2016 Open Office: Measurable Improvement
Purpose:
• Provides guidance in establishing anorganizational infrastructure
• Discussions with Peers on how to createa culture that promotes continuousimprovements
• Sharing of demonstrated performanceimprovement concepts and action steps
Compliance Improvement Guide
• Developed by the Peer-to-Peer Program
• Helps covered entities navigate through a qualityimprovement process
• Designed to transform organizational culture andpractices
• Provides guidance on “how to” establish anorganizational structure to achieve 340Bcompliance
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©2016 American Pharmacists Association. All rights reserved.6
Compliance Improvement Guide:Proficiency Self-Assessments C - J
Also included in the Compliance Improvement Guide are self-assessments for each of the 8 proficiency areas of knowledge and competency:
• Program Background
• Audit Preparedness
• Contract Pharmacy
• Eligibility/Database
• Diversion
• Duplicate Discount
• Inventory
• Prime Vendor Program
To review the list of proficiencies for each category, refer to the self-assessment
appendices C through J in the Compliance Improvement Guide
http://p2pcomplianceguide.com/latest.aspx
Compliance Improvement Guide:Education & Tools Resources
Appendices K & L list 340B education tools and resources, see pages 40-43 of the Guide.
http://p2pcomplianceguide.com/latest.aspxhttp://p2pcomplianceguide.com/latest.aspx
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©2016 American Pharmacists Association. All rights reserved.7
Compliance Improvement Model Links
• https://www.brainshark.com/aphanet/340BComplianceIntroductory Video
• http://p2pcomplianceguide.com/latest.aspxCompliance Improvement
Guide
• http://complianceassessmentA.com/form.aspx340B Compliance Rapid Self-
Assessment – Appendix A
• http://complianceassessmentB.com/form.aspx340B Compliance Culture Self-
Assessment – Appendix B
• Pages 29-39 of Guide
• http://p2pcomplianceguide.com/latest.aspx
340B Proficiency Self-Assessments C-J
• http://www.hrsa.gov/opa/peertopeer/webinars.html Register Now!
Tell Us a Little About Yourselves
Webinar Polling Question:
Which of the Compliance Improvement Resources have you already accessed?
Select All That Apply
• Introductory Video for the Compliance Improvement Model
• Compliance Improvement Guide
• Compliance Improvement Assessment Forms
• Participated in Webinar #1 – Leadership Commitment
• Participated in Open Office #1 – Leadership Commitment
• Participated in Webinar #2 – Education & Training
• Participated in Open Office #2 – Education & Training
https://www.brainshark.com/aphanet/340BCompliancehttp://p2pcomplianceguide.com/latest.aspxhttp://complianceassessmenta.com/form.aspxhttp://complianceassessmentb.com/form.aspxhttp://p2pcomplianceguide.com/latest.aspxhttp://www.hrsa.gov/opa/peertopeer/webinars.html
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©2016 American Pharmacists Association. All rights reserved.8
Major Highlights from Previous Webinars in Series
Leadership Commitment (November 18)
• Compliance Improvement Guide andresources
• 340B is beyond “just a pharmacy program”– interdepartmental engagement required
• Full engagement of C-suite
• Engage external partners
Education and Training (January 13)
• Minimum 340B requirements for each jobdescription within a covered entity
• Role specific training/customized training
• Include education and training in policiesand procedures
• Use the content of the Guide withsoftware applications for educationtesting/assessments
Compliance Improvement Model
Leadership Commitment
Integrated 340B Systems
Measurable Improvement
Education and Training Integrated 340B Systems
Improvement Concepts
1. Policies & Procedures
2. Auditable Records
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©2016 American Pharmacists Association. All rights reserved.9
Peer/SME Panel
Kris Klein-Bradham, PharmD, BCPS, CDDirector of Pharmacy Services
CommUnityCare
Richard “Rick” Fons, RPh, AAHIVPVice President of Pharmacy ServicesAIDS Resource Center of Wisconsin
Amanda Eamigh, PharmD, BCPSClinical Pharmacy Manager
DuBois Regional Medical Center –Penn Highlands DuBois
Strategic Aim: Integrated 340B Systems
Develop, implement, and maintain comprehensive 340B policies and procedures.
Why do covered entities need policies and procedures?
How do policies and procedures
help covered entities to stay
compliant?
Improvement Concept:
Interview Question(s):
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©2016 American Pharmacists Association. All rights reserved.10
Strategic Aim: Integrated 340B Systems
Develop, implement, and maintain comprehensive 340B policies and procedures.
Why do covered entities need policies and procedures?
How do policies and procedures
help covered entities to stay
compliant?
Improvement Concept:
Interview Question(s):
How do you decide
which policies
and procedures you need?
Strategic Aim: Integrated 340B Systems
Develop, implement, and maintain comprehensive 340B policies and procedures.
Why do covered entities need policies and procedures?
How do policies and procedures
help covered entities to stay
compliant?
Improvement Concept:
Interview Question(s):
How do you decide
which policies
and procedures you need?
Who drafts and monitors your policies & procedures that pertain
to 340B compliance? Why is it that
person?
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©2016 American Pharmacists Association. All rights reserved.11
Strategic Aim: Integrated 340B Systems
Develop, implement, and maintain comprehensive 340B policies and procedures.
Why do covered entities need policies and procedures?
How do policies and procedures
help covered entities to stay
compliant?
Improvement Concept:
Interview Question(s):
How do you decide
which policies
and procedures you need?
Who drafts and monitors your policies & procedures that pertain
to 340B compliance? Why is it that
person?
How do you ensure
compliance with procedures? How do you
document staff’s understanding &
application to their position?
Action Items: Policies and Procedures
Action items for Policies and Procedures
are located on page 18 of the Compliance
Improvement Guide
http://p2pcomplianceguide.com/latest.aspx
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©2016 American Pharmacists Association. All rights reserved.12
Action Items: Policies and Procedures
H15. Establish a 340B team that meets
regularly to update policies and practices
and to review compliance.
H14. Maintain all policies and procedures in physical locations or electronic systems for convenient access and reference by staff or
compliance reviewers/auditors.
H17. Establish parameters and
methods for ongoing management of contract pharmacy performance
and compliance with contractual terms and
340B compliance.
Strategic Aim: Integrated 340B Systems
Generate auditable records that demonstrate compliance with 340B program guidelines.
How do you generate and manage 340B
auditable records within the various
departments within your
organization?
Improvement Concept:
Interview Question(s):
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©2016 American Pharmacists Association. All rights reserved.13
Strategic Aim: Integrated 340B Systems
Generate auditable records that demonstrate compliance with 340B program guidelines.
How do you generate and manage 340B
auditable records within the various
departments within your
organization?
Improvement Concept:
Interview Question(s):
Where/how is the data
generated or housed
within your organization?
Strategic Aim: Integrated 340B Systems
Generate auditable records that demonstrate compliance with 340B program guidelines.
How do you generate and manage 340B
auditable records within the various
departments within your
organization?
Improvement Concept:
Interview Question(s):
Where/how is the data
generated or housed
within your organization?
How does the data generation
relate to your policies and procedures?
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©2016 American Pharmacists Association. All rights reserved.14
Strategic Aim: Integrated 340B Systems
Generate auditable records that demonstrate compliance with 340B program guidelines.
How do you generate and manage 340B
auditable records within the various
departments within your
organization?
Improvement Concept:
Interview Question(s):
Where/how is the data
generated or housed
within your organization?
How does the data generation
relate to your policies and procedures?
How do you
maintain data
integrity?
How Do You Maintain Data Integrity?
CE Database
Policies
Procedures
Transaction Data
Inventory Tracking
Self-Audit
Several Categories of Auditable Recordsto Demonstrate Compliance with 340B Requirements
Eligibility
Duplicate Discounts
Diversion
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©2016 American Pharmacists Association. All rights reserved.15
Action Items: Auditable Records
Action items for Auditable Records
are located on page 18 of the Compliance
Improvement Guide
Action Items: Auditable Records
I12. Use electronic medical record (EMR) to maintain accurate and up-to-date 340B drug utilization records that span from prescribing to administration to billing.
I9. Develop standardized reports and data metrics
for reporting to entity leadership and management.
I19. Engage IT department to develop
automated reports within EMR and
pharmacy system.
http://p2pcomplianceguide.com/latest.aspx
2/2/2016
©2016 American Pharmacists Association. All rights reserved.16
Please respond to the following question via poll box:
What will you do next week to improve your organization’s Integrated 340B Systems?
(You may also submit questions for the presenters. Questions will be addressed during the Open Office
session on February 24th.)
Group Activity
CPE Self Assessment Question
Webinar Polling Question:
Which of the following is incorrect:
Select One
1) The Compliance Improvement Guide contains 340B education tools and resources indexed byproficiency areas.
2) Covered entities need a dedicated 340B coordinator employee to develop, implement, and maintainpolicies and procedures.
3) Data generated for compliant auditable records could come from the 340B database, transactiondata, inventory tracking and self-audits.
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©2016 American Pharmacists Association. All rights reserved.17
How to Claim CPE Credit
P314To 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 Thursday 3/10/16 at11:59 Eastern Time in order to receive credit.
Open Office
Still have questions?
Join the webinar speakers on February 24, 2016 at 2pm ET
Questions for the Open Office session will be from:
Participants must submit question(s) by February 12, 2015
Register Today to join this interactive discussion!
Open Office registration
Overflow of questions from this webinar
Webinar satisfaction survey
Questions during Q/A
http://www.pharmacist.com/live-activitieshttp://www.p2phrsa.com/webinar/openreg.aspx?cid=45369&id=108
2/2/2016
©2016 American Pharmacists Association. All rights reserved.18
Additional Events & Resources
Training
• Webinars• Prior Webinars – Listed on the OPA Website
• Upcoming – March 9, 2016 2pm ET340B Compliance Improvement WebinarSeries: Open Office: MeasurableImprovement
• 340B University™• March 3 – Baltimore, MD
• April 16 – Alexandria, VA
• 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
• Apply to become a Peer-to-PeerLeading Practice Site• Peer-to-Peer Program – HRSA OPA Website
• Peer-to-Peer Program – Apexus PVP Website
• Video about the Peer-to-Peer Program
• Apply Now!
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
http://www.hrsa.gov/opa/peertopeer/webinars.htmlhttp://www.p2phrsa.com/webinar/openreg.aspx?cid=45371&id=110https://www.apexus.com/solutions/education/340b-universityhttps://www.apexus.com/solutions/education/340b-u-ondemandmailto:[email protected]://visitor.r20.constantcontact.com/manage/optin/ea?v=0017WwahkuseW8GbAme6wJbhg==https://www.linkedin.com/groups?home=&gid=1818962&trk=anet_ug_hmhttp://hrsa.gov/opa/peertopeer/index.htmlhttps://www.apexus.com/resources/hrsa-340b-peer-to-peer-programhttps://www.brainshark.com/aphanet/vu?pi=zJXzpKifxzNwWfz0https://p2p.aphadms.com/mainP2P/Forms/P2PApplicationV5.aspxhttps://p2p.aphadms.com/mainP2P/Forms/P2PApplicationV5.aspxhttps://www.brainshark.com/aphanet/vu?pi=zJXzpKifxzNwWfz0
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©2016 American Pharmacists Association. All rights reserved.19
Compliance Improvement Model Links
• https://www.brainshark.com/aphanet/340BComplianceIntroductory Video
• http://p2pcomplianceguide.com/latest.aspxCompliance Improvement
Guide
• http://complianceassessmentA.com/form.aspx340B Compliance Rapid Self-
Assessment – Appendix A
• http://complianceassessmentB.com/form.aspx340B Compliance Culture Self-
Assessment – Appendix B
• Pages 29-39 of Guide
• http://p2pcomplianceguide.com/latest.aspx
340B Proficiency Self-Assessments C-J
• http://www.hrsa.gov/opa/peertopeer/webinars.html Register Now!
Contact Information
• www.hrsa.gov/opa340B Program
• http://www.hrsa.gov/opa/peertopeer/index.html
340B Peer-to-Peer Program
• 1-888-340-2787
• https://www.340bpvp.com
Apexus Answers 340B Technical
Assistance
https://www.brainshark.com/aphanet/340BCompliancehttp://p2pcomplianceguide.com/latest.aspxhttp://complianceassessmenta.com/form.aspxhttp://complianceassessmentb.com/form.aspxhttp://p2pcomplianceguide.com/latest.aspxhttp://www.hrsa.gov/opa/peertopeer/webinars.htmlhttp://www.hrsa.gov/opahttp://www.hrsa.gov/opa/peertopeer/index.htmlmailto:[email protected]://www.340bpvp.com/
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©2016 American Pharmacists Association. All rights reserved.20
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
www.340bPVP.com (888) 340-BPVP
ApexusAnswers@340bP
VP.com
www.340Bpvp.com/340B-
University
http://www.340bpvp.com/mailto:[email protected]?subject=340B question from P2P Webinar attendeehttp://www.340bpvp.com/340B-University
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