Health Resources and Services Administration Office of Pharmacy...

2/2/2016

©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


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


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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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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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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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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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


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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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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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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compliant?



How do you decide

which policies

and procedures you need?






compliant?



How do you decide

which policies


Who drafts and monitors your policies & procedures that pertain

to 340B compliance? Why is it that

person?

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compliant?



How do you decide

which policies


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


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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.


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?



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organization?



Where/how is the data

generated or housed

within your organization?






organization?




generated or housed


How does the data generation

relate to your policies and procedures?

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organization?




generated or housed


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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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.


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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


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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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


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

2/2/2016


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

• [email protected]

• 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/

2/2/2016


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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