PM –3 PM Easternelearning.pharmacist.com/portal/Files/LearningProducts/0...July 31, 2013 2 PM –3 PM Eastern Corporate Leadership ‘C‐suite’ Perspectives and Experiences with

1© 2013 by the American Pharmacists Association. All rights reserved.

Health Resources and Services AdministrationOffice of Pharmacy Affairs

340B Peer‐to‐Peer Resource Network

*The 340B Peer‐to‐Peer Resource Network 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 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.

July 31, 2013 2 PM – 3 PM Eastern

Corporate Leadership ‘C‐suite’ Perspectives and Experiences with the 340B Program

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340B Webinar

We encourage you to submit questions throughout the presentationthrough the phone or chat function of the webinar.

HandraisingX

Chat Q&A – for questions

Download Slides

Links

Closed Captioning

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340B Community of Practicewww.HealthcareCommunities.org


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Financial Disclosure

Patrick Barnes, Jay Breines, Tracy Cole, Tre Dixon, Gina Flanagan, and Anne Marie Kondic, Janis Sunderhaus, Lauri Schall, and Donavan Smith declare no conflicts of interest, real or apparent, and no financial interests in any company, product, or service mentioned in this program, including grants, employment, gifts, stock holdings, and honoraria.Jenny Clark declares that she has had financial relationship with commercial interest (Patient Safety and Clinical Pharmacy Services Collaborative) during the past 12 months.

The content of this session was developed by the (Federal Contracts and Grants) which is managed by the American Pharmacists Association. No commercial support was used to develop this activity.

Anne Marie Kondic

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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 Corporate Leadership ‘C‐suite’ Perspectives and Experiences with the 340B Program, is approved for 1 contact hour of CPE credit (0.1 CEUs). The ACPE Universal Activity Number (UAN) assigned to this activity is 0202‐0000‐13‐159‐L04‐P/T. The target audience is pharmacists and pharmacy technicians and there is no fee is required for this activity.

Initial release date: July 31, 2013

Anne Marie Kondic

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Learning Objectives

At the completion of this activity, participants will be able to: • Describe organizational approaches to address the 340B

program intent.• Discuss corporate leadership (C‐suite) and their management

techniques to ensure compliant programs.• List C‐suite key points or observations regarding the 340B

program.

Anne Marie Kondic


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LWQTCPE credit is only available for the live webinar. You MUST be registered through the healthcarecommunities.org registration page to obtain credit. The registration link will close today at 3:30pm Eastern.

To obtain CPE credit for this activity, you are required to actively participate in this activity and complete an evaluation. The voucher code above is needed to access and complete the evaluation. Please view the CPE Activity Form for the process to obtain credit.

Your CPE must be filed by Wednesday, 8/07/13 at 11:59 Pacific Time in order to receive credit. The voucher code expires on this date and no CPE will be granted after this time.

ACPE Credit

Anne Marie Kondic

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Assessment Questions

1. Approaches by Peer organizations to address the 340B program intent include which of the following:

A. Stretch scarce federal resources: greater access to reduced cost prescriptionsB. Reach more eligible patients: savings used to support free clinics and expanded accessC. Provide more comprehensive services: savings used for expanded pharmacist and clinical careD. All of the above

1. Corporate leadership (C‐suite) 340B management techniques for program compliance include all of the following except:

A. Delegation and empowerment with oversightB. Regular meetings with financial reportsC. Limited training supportD. Self‐audit practices

1. The C‐suite perspectives for a compliant and efficient 340B program include:A. Integrate pharmacy as a key member of the 340B teamB. Regular monitoring of programmatic changes and requirementsC. Scheduled review of P&P practices and OPA database informationD. Ability to track a 340B product from purchase to dispensingE. All of the above

Anne Marie Kondic

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Speakers – C‐suite & Facilitator

Jay Breines, MA,MSExecutive Director

Holyoke Health Center, MA*

Tre Dixon, JDVice President & Senior Counsel

UF Health Jacksonville, FL*

Janis Sunderhaus, MSN, RNCChief Executive Officer (CEO)Health Partners of Western Ohio,

OH*

*HRSA Peer‐to‐Peer Recognized Site **American Pharmacists Association (APhA) – HRSA Contractor

Gina FlanaganExecutive Director

Wayne Community Health Center, UT*

Anne Marie Kondic

Anne Marie Kondic, PharmDP2P/PSPC Specialist

Federal Contracts and GrantsAPhA**


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Speakers – Peers

Tracey Cole, RPhPharmacy Director

Holyoke Health Center, MA*

Patrick Barnes, RPhPharmacy Manager

UF Health Jacksonville, FL*

Jenny Clark, RPhPharmacy Director

Health Partners of Western Ohio, OH*

*HRSA Peer‐to‐Peer Recognized Site

Donavan Smith, RPhDirector of Pharmacy ServicesWayne Community Health

Center, UT*

Anne Marie Kondic

Lauri Schall, LPN, CPhT340B Pharmacy Coordinator

DuBois Regional Medical Center, PA*

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Topic Health Partners of Western Ohio (OH)

Holyoke Health Center (MA)

Wayne Community Health Center (UT)

DuBoisRegional Medical Center (PA)

UF Health Jacksonville (FL)

Entity Type* FQHC FQHC FQHC DSH DSH

340B Enrollment/Operational

January2005

January2007 (operational)

December1992

June 2004

December1992

Number of Sites (Entity/Child)

5 2 2 62 1

Annual Volume ‐ Patients

20,000+ 15,000 3,800 443,000 606,000

Annual Volume ‐ Prescriptions

40,000+ 240,000 40,000+ 65,527 (with contract pharmacy prescriptions)

425,600

PharmacyModel

In‐House In‐House In‐house ‐ 3 In‐house‐ 10 Contract pharmacies

Inpatient Mixed Use Setting, Outpatient

Medicaid Carve‐in Carve‐in with enhanced dispensing fee

Carve‐out Carve‐out Carve‐in with enhanced dispensing fee

Entity Overview

*FQHC ‐ Federally Qualified Health Center; DSH – Disproportionate Share Hospital

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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

Anne Marie Kondic


13Current Session:

C‐suite Webinar ‐ Framing

• Era of 340B enhanced compliance and integrity emphasis

• Entity recertification in 2012– Authorizing official’s certification statement

• OPA database accuracy• GPO prohibition• Duplicate discount / Medicaid• Patient eligibility• Contract pharmacy

Anne Marie Kondic

14Current Session:

C‐suite Webinar ‐ Framing

• Resources– OPA FAQs http://www.hrsa.gov/opa/faqs/index.html#6– PVP FAQs

• https://docs.340bpvp.com/documents/public/resourcecenter/faq/FAQs_EligibilityRegistrationRecertification_Recertification.pdf

– PVP 340B University – 340B Compliance for the C‐suite• https://docs.340bpvp.com/documents/public/resourcecenter/340BCompliance_CSuite.pdf

– Consequences and situations of non‐compliance; entity responsibilities; patient eligibility; self‐audit best practices; pharmacy scenarios: contract, in‐house, and hospital

• C‐suite Peer‐to‐Peer (P2P) webinar– 340B program intent, C‐suite compliance approaches, Peers operational

tactics, C‐suite general comments

Anne Marie Kondic

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Holyoke Health Center

Jay Breines | Executive Director

Jay BreinesExecutive Director

Holyoke Health CenterHolyoke, Massachusetts


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In‐House Pharmacy Model with Clinical Pharmacy Services

• All patients have access to medications they need• 340B savings helps fund un‐funded programs• Clinical Pharmacy Services improves patient health and medication safety

• Pharmacist is part of the provider team• Providers have access to medication information

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• C‐Suite commitment• Pharmacy Director part of leadership team • Control costs and manage savings to support greater access and services

• Control of program integrity and quality• Rapid cycle change and response



Why Pharmacy Works at Holyoke

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• Patient Safety and Clinical Pharmacy Services Collaborative (PSPC)• Approaching 6th year of collaborative experience (6.0)• Upcoming learning sessions

– Session 1 – Live – Sept. 17‐18th (Tues & Wed)» Advanced Team Learning – transitioning to a payer model» Registration & Details:» http://www.medsmatter.org/index.cfm/upcoming‐pspc‐learning‐session‐no3‐ls3/

– Session 2 – Virtual – Sept. 26 (Thurs)» Launching and spreading your services» Leadership / C‐suite 15 minute pre‐conference segment» Registration & Details:

http://www.healthcarecommunities.org/FAQs.aspx?id=4294983301

– For more information, email [email protected]


Tracey Cole| Pharmacy Director | Holyoke Health Center

Why Pharmacy Works at Holyoke


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Panel Question 1

How has your organization addressed the 340B Program intent?• INTENT‐ The 340B Program enables covered entities to

– stretch scarce Federal resources as far as possible – reaching more eligible patients– provide more comprehensive services

• Viewpoints – DSH & FQHC [Tre / Janis]

Anne Marie Kondic

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UF Health Jacksonville Formerly Shands Jacksonville

• Closed ambulatory pharmacy• 1.2 million dollars in savings• Charity write off 4.7 million dollars• Total Care Clinic• Pharmacist involvement in ambulatory clinics• Decreased cost per prescription

How has your organization addressed the 340B Program intent?

Tre Dixon | VP/General Council | UF Health Jacksonville




‐

5,000

10,000

15,000

20,000

25,000

30,000

$0

$50,000

$100,000

$150,000

$200,000

$250,000

RX COUNT

Ambulatory Pharmacy - Full Charity & Part PayShands Jacksonvil le Medical Center, Inc.

Acquisition Cost City Contract Rx Count ‐ Full and Part Pay



Health Partners of Western Ohio

Janis Sunderhaus | CEO | Health Partners of Western Ohio

Maximize federal resources to serve more people with comprehensive care to achieve better health outcomes:

• Access low‐cost medications for uninsured patients

• Use 340B in‐house dispensing pharmacy as an avenue to participate in additional programs that benefit patients including other drug inventory programs







Maximize federal resources to serve more people with comprehensive care to achieve better health outcomes:


Improvement in HbA1c(Full PoF = 30 patients)

updated 6/3/2011

77.5

88.5

99.510

10.511

11.512

Baseline Follow-up

Initial Ave.HbA1cMost RecentAve. HbA1c

• Utilize savings from 340B drug discount program that can be used elsewhere in the health center system to expand access to care.

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Panel Question 2

At the C‐suite level, how do you manage the 340B Program to ensure you are compliant and prepared for recertification or audits?• Viewpoints – DSH & FQHC [Tre / Gina]

Anne Marie Kondic

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• Responsibility of 340B Program delegated• Monthly meetings with Chief Operating Officer (COO)• C‐Suite involves Pharmacy in 340B decisions

• Definition of Patient• Oncology Practice

• Supports travel

At the C‐suite level, how do you manage the 340B Program to ensure you are compliant and prepared for recertification or audits?



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At the C‐suite level, how do you manage the 340B Program to ensure you are compliant and prepared for recertification or audits?

WCHC corporate leadership role in the 340B program is:- Put in place the policies and procedures that are needed to meet the

program guidelines. Management of the 340B program is very detailed

- Having an individual or group of individual that owns the program is important.

- Allow for training to those individuals that will be running your 340B program

- Understand that you may not have all of the answers and allow for those that are trained to make decisions with oversight

- Self audits are a necessity and should be done on a regular basis- Keep all of your information correct and UP TO DATE on OPA database and

in the HRSA Electronic Handbook (EHB)

Wayne Community Health Center

Gina Flanagan | Executive Director | Wayne Community Health

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Audience Q & A

What thoughts or questions (similar or different) do you have related to C‐suite and the 340B program intent and methods to ensure compliance?

The phone lines are open for discussion and questions. – Press *1 to be placed in the phone Q&A queue– Press *2 to cancel your request

Anne Marie Kondic

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Panel Question 3

At the operational level, how do you as a Peer Mentor keep your C‐suite educated on the following compliance issues?• Patient Eligibility / Diversion • Duplicate Discount / Medicaid• GPO Prohibition• Contract Pharmacy

Anne Marie Kondic


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• Keep the “Boss” in the loop• Educate, educate, educate

- Advocate the importance of your program• K.I.S.

- Keep it simple- Do not burden them will all of the operational intricacies

o Give them what they need to know and move on o Remember they are running the whole operation and their time is

valuableo Charts are great teachers

• Computerized or even Crayon work! • Open door policy for both parties


Donavan Smith| Director of Pharmacy | Wayne Community Health Center

At the operational level, how do you as a Peer Mentor keep your C‐suite educated on the following compliance issues?

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• Incorporate your 340B owner into your “C” team– Realize that they are able to help instead of hinder the process

• Focus together on a goal of success and integrity with your 340B program

• Think outside of the box– Open minded to new ways of thinking– 340B is truly evolving

• Example: Patient Definition / Eligibility- Starts with a good definition of a patient- Then build upon that

Donavan Smith| Director of Pharmacy | Wayne Community Health Center



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Jennifer Clark| Pharmacy Director | Health Partners of Western Ohio

Audits• Internal / External• Reported to QI Committee / Administration

Monthly Financial Reports



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Example may be found at www.healthcarecommunitites.orgPeer to Peer Community

Sample Audit Tool

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Example: Duplicate Discount Prohibition• Medicaid Exclusion File• 340B Recertification


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Patrick Barnes| Pharmacy Director | UF Health Jacksonville


• Monthly meetings• Kept C‐suite informed• 340B University• Involve C‐suite in monthly audits• Recertification

• Example: GPO Prohibition

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DuBois Regional Medical Center


Lauri Schall| DuBois Regional Medical Center | PA | DSH

Monthly reports • Financial for CFO / Clinical for CMO

Emails ‐ New Guidelines

Meetings when necessary• Independent Pharmacies do request meetings with CEO/CFO. During these

meetings we go over all of our compliance regulations and guidelines. We review our procedures and policies for both the C Suite benefit and the new pharmacy benefit.

With education it has now become a way of life to include 340B when making executive decisions since they have become aware that new clinics will have an impact on 340B and must meet regulations and follow 340B policies.

Example: Contract Pharmacy

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Question 4

What 340B corporate leadership words of wisdom or key points would you like to share with the participants?

Anne Marie Kondic


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• 340B University• Compliance tools• Policy and Procedures• Be involved with the Pharmacy• Support Pharmacy Department


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• Patient Eligibility Audit‐ Is the patient allowed 340B purchased product?

• Clinic Injection Audit‐ Can we track the medication from purchase to dispensing and identify the patient that received it?

• It is a process but it can be done

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Wayne Community Health CenterPatient Eligibility Audit



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Wayne Community Health CenterPhysician Administered Audit


Branded Product Names

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• 340B University and Peer to Peer trainings are invaluable.– Training can be costly but worth it in the end.

• Look at every type of medication usage within your facility. If you are using a 340B product, make sure you have the ability to track it.

Wayne Community Health CenterWords of Wisdom and Lessons Learned


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• Management of 340B program requires adequate time, dedication, and attention to detail.

• Rules surrounding the 340B Program are ever changing and organizations need to be flexible and stay attentive to maximize benefits to your overall organization.

• Pharmacy Team has the ability to impact an organization’s overall quality significantly if they are given a larger role in organization’s clinical quality.



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Health Partners of Western OhioPartnering with CMS – Ohio KePro

Janis Sunderhaus | CEO | Health Partners of Western OhioCPS Interventions Began Nov 2011

PoF n=24

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Audience Q & A

What thoughts or questions (similar or different) do you have related to C‐suite communications and experiences for the 340B program.

The phone lines are open for discussion and questions. – Press *1 to be placed in the phone Q&A queue– Press *2 to cancel your request

Anne Marie Kondic


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Assessment Questions

Anne Marie Kondic

1. Approaches by Peer organizations to address the 340B program intent include which of the following:

A. Stretch scarce federal resources: greater access to reduced cost prescriptionsB. Reach more eligible patients: savings used to support free clinics and expanded accessC. Provide more comprehensive services: savings used for expanded pharmacist and clinical careD. All of the above

1. Corporate leadership (C‐suite) 340B management techniques for program compliance include all of the following except:

A. Delegation and empowerment with oversightB. Regular meetings with financial reportsC. Limited training supportD. Self‐audit practices

1. The C‐suite perspectives for a compliant and efficient 340B program include:A. Integrate pharmacy as a key member of the 340B teamB. Regular monitoring of programmatic changes and requirementsC. Scheduled review of P&P practices and OPA database informationD. Ability to track a 340B product from purchase to dispensingE. All of the above

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Webinar Information

All slides and audio from today’s call are available in the 340B Peer‐to‐Peer community at: http://www.healthcarecommunities.org/FAQs.aspx?id=11162

Upcoming Webinars• Wednesday, August 14, 2013 from 2 – 3pm Eastern

– Patient Eligibility: A Systems Approach– http://www.healthcarecommunities.org/form.aspx?ekfrm=4294983396

• Wednesday, August 28, 2013 from 2 – 3pm Eastern– 340B Inventory Management Fundamentals– Registration opening soon

http://www.healthcarecommunities.org/FAQs.aspx?id=11162

• Survey reminder

Anne Marie Kondic

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Peer‐to‐Peer Leading Practice Site Applications

Are you a high performing site that may be interested in becoming a HRSA recognized 340B Leading Practice Site? Funding available for those entities selected for this recognition!

• APhA ‐ accepting applications (Limited spots are available).• Initial qualified sites will be selected.• All 340B entity types are encouraged to apply as soon as possible. • Selected sites that will receive a stipend as well as other benefits such as:

– Off–site training– APhA association membership and – Access to other 340B events

To apply visit the HC website, click on the "340B/P2P" tab at the bottom of the screen and select "340B Peer to Peer Application.“

Contact the Peer‐to‐Peer inbox at [email protected] to schedule an application completion consultation call.

Anne Marie Kondic


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Contact Information

www.hrsa.gov/patientsafety

[email protected]://www.340bpvp.com/controller.html

1‐888‐340‐2787 or

www.hrsa.gov/opa

340B Drug Pricing Program & Pharmacy Affairs

For Technical Assistance on the 340B Program Contact Apexus Answers at

To sign up for the 340B Peer‐to‐Peer Community and access 340B Community Information and Resources go to : www.healthcarecommuities.org

To learn more about the 340B Program and the Patient Safety and Clinical Pharmacy Services Collaborative go to:

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How to Claim CPE Credit

LWQTCPE credit is only available for the live webinar. You MUST be registered through the healthcarecommunities.org registration page to obtain credit. The registration link will close today at 3:30pm Eastern. To obtain CPE credit for this activity, you are required to actively participate in this activity and complete an evaluation. The voucher code above is needed to access and complete the evaluation. In order to complete the online activity evaluation form, participants will need to have a valid pharmacist.com user name and password.

1. Use http://www.pharmacist.com/live‐activities and log in with your http://www.pharmacist.comusername and password or create one as directed. 2. On the right side “Claim Credit” locate the June 26th Peer‐to‐Peer webinar, select the Claim Credit link to proceed.3. Enter the attendance code given during the webinar. 4. Follow the on‐screen instructions to the complete activity evaluation.5. Upon successful completion of the evaluation, your Statement of Credit will be available to print.6. Print the Statement of Credit and save for your records. You may also print your Statement of Credit from your pharmacist.com account.

Your CPE must be filed by Wednesday, 8/7/13 at 11:59 Pacific Time in order to receive credit.The voucher code expires on this date and no CPE will be granted after this time.

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APPENDIX A

• http://www.healthcarecommunities.org• Overview & Site Navigation


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gRegister & Joinwww.HealthcareCommunities.org

• Register with healthcarecommunities.org– http://www.healthcarecommunities.org/Registration.aspx

• Join the 340B Peer‐to‐Peer Community– http://www.healthcarecommunities.org/MyCommunities.aspx

• Select the Health Resources & Services Administration Tab• Select ‘Join 340B Peer to Peer’• Select ‘Join Selected Communities’ at the bottom of the page• You will be notified via email when your membership is approved

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340B Community of Practice

• 340B Community ‘Home’ Page– Login to access this link– http://www.healthcarecommunities.org/community.aspx?groupid=10

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www.HealthcareCommunities.org

Login required to access links on the Community pagehttp://www.healthcarecommunities.org/community.aspx?groupid=10

• Planning [left side of 340B Peer‐to‐Peer page]– Upcoming Events– Announcements

• Reference Materials [notice the parent and sub‐folders]– Webinars Audio files & narrative summary in the Knowledge‐base Document

• 2011 http://www.healthcarecommunities.org/Comm_Docs.aspx?groupid=10&id=0&fid=4294973234&tnid=TREE1_2_4294971372_4294973234

• 2012http://www.healthcarecommunities.org/Comm_Docs.aspx?groupid=10&id=0&fid=4294978549&tnid=TREE1_2_4294971372_4294978549

– Policies & Procedures Parent Folder (several subfolders available)• http://www.healthcarecommunities.org/Comm_Docs.aspx?groupid=10&id=0&fid=4294981057&tnid=TREE1_1_46785_42949

81057– Tools & Resources

• http://www.healthcarecommunities.org/Comm_Docs.aspx?groupid=10&id=0&fid=4294987279&tnid=TREE1_1_46785_4294987279

– Resource Links• http://www.healthcarecommunities.org/Comm_Links.aspx?groupid=10

• Communications– Community Forums

• http://www.healthcarecommunities.org/Comm_Forum.aspx?groupid=10&g=topics&f=46790– Listserv

• http://www.healthcarecommunities.org/CommunitySubscribeListserv.aspx?groupid=10


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www.HealthcareCommunities.org

Publically available links

• Webinar Registration & Audio Recording– http://www.healthcarecommunities.org/FAQs.aspx?id=11162

• Continuing Pharmacy Education (CPE) Activity Form– ACPE credit for pharmacists and pharmacy technicians is

available for the select live webinars.– Webinar Activity Preview and Accreditation Information for

specific webinars found at this link:• http://www.healthcarecommunities.org/ResourceCenter.aspx?pid=80872&tid=4294976643

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APPENDIX B

• http://www.340BPVP.com• Prime Vendor Program (PVP)

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www.340BPVP.comTo register as a 340B Prime Vendor Program participant, click on the “Register” tab on the home page of the www.340BPVP.com website. Next, select “Become a PVP Participant” from the drop down menu to begin the online registration process.

Rotate left and right in this section for quick links, such as 340B flash tutorial and 340B University Tools!

Click on the “Resource Center” tab to go to 340B University information, visit the FAQs section and other valuable resources.

Quick links to the most recent 340B News updates and upcoming events, including 340B University sessions.


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Click on the “Resource Center’ from the main navigation tab and select 340B University.

Scroll down the page to find links to all 340B University tools!

Documents

PM –3 PM Easternelearning.pharmacist.com/portal/Files/LearningProducts/0...July 31, 2013 2 PM –3 PM Eastern Corporate Leadership ‘C‐suite’ Perspectives and Experiences with