agenda - 340B Coalition Winter Conference

CONFERENCE
AGENDA
PAGE 1
CONFERENCE AGENDA
Sessions indicating a badge color are limited to the respective colored entity, industry, or government groups. See pg. 5 for badge color descriptions. n n n n n n n n n n
WEDNESDAY
DATE: 02/17/2016
8:00 AM–2:00 PM
EXHIBIT SET UP
Location: Upper Grande Hall
12:00–6:00 PM
EARLY REGISTRATION
Location: Group Registration Desk
1:30–5:15 PM
PRE-CONFERENCE
WORKSHOPS (Two Options)
There is an additional cost to attend pre-conference
workshops and you must register for them.
1:30 PM
OPTION 1:
340B: THE ESSENTIALS
PART 1
Location: Crown Room
Are you brand new to the 340B program or in
need of a refresher course? This introductory
session will provide a foundation for 340B by
covering the basics in key 340B program areas,
including patient definition, contract pharmacy,
duplicate discounts, diversion and the GPO
prohibition. During Part 1, 340B program
stakeholders will describe their experiences
navigating compliance requirements in various
340B program areas and will review resources
that can help your entity achieve compliance.
You will hear from Apexus, the Prime Vendor
for the 340B program, as well as speakers who
will provide perspectives from hospital and
community health center sites. During Part 2,
participants will use the information learned
in Part 1 to engage in a series of interactive
discussion questions based on entity-type.
NICOLE CRASE
Pharmacy Manager, Five Rivers Health Centers
RUSOL KARRALLI
Manager of 340B Education and Compliance
Support, Apexus
ALEX MANSOUR
Director of Finance, 340B Compliance Officer,
Henry Ford Health System
AMANDA NAGROTSKY
Assistant Counsel, 340B Health (Moderator)
PAGE 2
1:30 PM
OPTION 2: UPDATE ON AUDIT
FINDINGS & CREATING EFFECTIVE
COMPLIANCE PLANS
Covered entities only n n n n n n
PART 1
Location: Ballroom
As HRSA enters its fourth year of conducting
audits of 340B providers, stakeholders are
beginning to observe a number of trends in
the audit results that can shed light on HRSA’s
enforcement policies and where the agency is
focusing its program oversight. The first part
of this workshop will provide participants with
an overview of HRSA’s published audit results,
including trends in audit findings. Panelists
will focus on diversion findings and how
providers can implement compliance plans to
be consistent with HRSA’s enforcement of the
prohibition against diversion.
MICHAEL GLOMB
Partner, Feldesman Tucker Leifer Fidell; Counsel,
National Association of Community Health Centers
JASON MILLS
Manager, Pharmacy Supply Chain, Medical
University of South Carolina
MAUREEN TESTONI
Senior Vice President and General Counsel,
340B Health (Moderator)
2:45 PM
Location: Upper Grande Hall
Exhibitor Forum
Refreshment Break
Networking Opportunity
3:45 PM
OPTION 1:
340B: THE ESSENTIALS
PART 2
Location: Crown Room
Workshop continues.
MICHAEL BONCK
Manager of Pharmaceutical Services, Franciscan
Health System, Catholic Health Initiatives
BURNIS BRELAND
Manager of 340B Education and Compliance
Support, Apexus
NICOLE CRASE
Pharmacy Manager, Five Rivers Health Centers
DAVID HACHEY
Professor, Idaho State University
RUSOL KARRALLI
Manager of 340B Education and Compliance
Support, Apexus
ANDREW LOWE
Clinical Director of Pharmacy, Arrowhead
Regional Medical Center
CYNTHIA MARTENS
Director of Pharmacy, Monroe County Hospital
SAM WILHELM-ROSS
Manager, Policy Development and Education,
340B Health
AMANDA NAGROTSKY
Assistant Counsel, 340B Health (Moderator)
3:45 PM
OPTION 2: UPDATE ON AUDIT
FINDINGS & CREATING EFFECTIVE
COMPLIANCE PLANS
Open to all registered workshop attendees
PART 2
Location: Ballroom
The second part of this workshop will focus
on how covered entities can implement
compliance plans that are consistent with
HRSA audit enforcement of program rules
and that adequately address the issues
that commonly arise in audit findings. The
workshop will assist covered entities and other
stakeholders in identifying key compliance
areas and the types of systems or procedures
that should be in place to monitor compliance.
Covered entities on the panel will share
their experience developing 340B policies
and procedures (P&Ps), coordinating 340B
oversight across multiple departments within
the health care organization, and conducting
self-audits and other ongoing oversight
mechanisms to verify that the organization’s
P&Ps are followed and are working.
GRETCHEN BECKHAM
Director of Pharmacy, Eau Claire Cooperative
Health Centers
CHERYL RAY
340B Analyst, Dartmouth-Hitchcock
TRENT STECHSCHULTE
Compliance Officer and Legal Counsel,
AIDS Resource Ohio
THOMAS WOODWORTH
Pharmacy Business Analyst, Avera McKennan
Hospital
JEFF DAVIS
Counsel, Legal and Policy Affairs, 340B Health
(Moderator)
#340Bconf Tweet and Win­—Enter our Twitter Contest! page 9
5:15 PM
Location: Upper Grande Hall
Exhibitor Forum
Networking Opportunity
5:30—6:00 PM
Location: Garden Room
THURSDAY
DATE: 02/18/2016
COMMENCEMENT OF CONFERENCE
7:00 AM
Location: Sun Deck (outdoor venue)
Continental Breakfast
Stakeholder Networking
Opportunity
CONFERENCE PRIMER
This session is designed for conference
attendees and exhibitors who are looking
to get the most out of their 340B Coalition
Conference experience. Attendees will hear
what is new at the conference, receive a handson tutorial of the conference app, and leave
this short program with a better understanding
of everything the conference has to offer.
Whether this is your first or fifteenth Coalition
Conference, everyone can benefit from the
conference tips in this session.
Join attendees during breakfast to discuss
topics of interest to various stakeholders.
Topics will include split billing, contract
pharmacy, in-house pharmacy, and many
others. This informal format will provide time
to network with peers. Check the schedule
in the mobile app for a list of “hot topics.”
Attendees are encouraged to stay as short
or as long as the conversation flows and
moving to different topics is all up to the
attendees.
DANIELLE MATHERS
Communications Manager, 340B Health
SAM WILHELM-ROSS
Manager, Policy Development and Education,
340B Health
OPENING REMARKS
6:00 PM
END OF PRE-CONFERENCE
SESSIONS
8:00 AM
Location: Ballroom (Overflow: Crown Room)
This session will be your official welcome
to the conference. Conference hosts will
introduce themselves and get you prepared for
the event.
8:30 AM
340B: A LOOK BACK
AND LOOK AHEAD
Location: Ballroom (Overflow: Crown Room)
2015 witnessed many significant developments
for the 340B program and its stakeholders, and
2016 is expected to be another busy year. In
2015, HRSA issued proposed regulations and
guidances on a broad range of 340B topics,
including new patient definition guidelines,
that could substantially impact providers
and manufacturers. The House Energy and
Commerce Committee held a hearing on
340B and drafted legislation that would have
added additional restrictions and requirements
to the program. In addition, the Government
Accountability Office, HHS Office of Inspector
General, and Medicare Payment Advisory
Commission all released reports on the
intersection of 340B program and Medicare Part
B spending. A federal court also ruled in favor
of PhRMA in a highly watched case regarding
340B pricing for orphan drugs. This session will
cover these highlights and will address potential
developments in the year ahead.
TED SLAFSKY
President and Chief Executive Officer, 340B Health
Editor-in-Chief, Drug Discount Monitor
9:00 AM
IMPLICATIONS OF
PROPOSED PATIENT
DEFINITION
Location: Ballroom (Overflow: Crown Room)
The Health Resources and Services
Administration (HRSA) received over 1,200
comments in response to its proposed “megaguidance” on the 340B program. Virtually
all comments focused on HRSA’s proposed
revisions to the definition of patient (i.e. to
whom covered entities may dispense 340B
drugs for). During this session, you will hear
from hospitals, grantees and other industry
stakeholders who will share their perspectives
on the proposed mega-guidance, particularly
their take on patient definition.
COLLEEN MEIMAN
Director of Regulatory Affairs, National
Association of Community Health Centers
CONSTANCE WILKINSON
Partner, Epstein Becker Green, PC
MAUREEN TESTONI
Senior Vice President and General Counsel, 340B
Health (Moderator)
DOWNLOAD THE CONFERENCE APP
Go to the App Store or Google Play and search for “340B” or scan the QR code above.
You can also access our online event guide at https://crowd.cc/wc16.
RECORDING/VIDEOTAPING POLICY AND PHOTO RELEASE: Only officially contracted 340B Coalition vendors will be permitted to photograph, video, and/or audiotape sessions. Individuals recording with personal video/audio equipment or other recording devices (e.g., cell phones, digital or film cameras or recorders) without
prior permission from the 340B Coalition may be asked to cease recording or utilizing such devices immediately. By virtue of your attendance at the 340B Coalition
Conference, the 340B Coalition reserves the right to use photographs or video/audio of conference participants in our promotional materials and products.
PAGE 3
CONFERENCE AGENDA
10:15 AM
Upper Grande Hall
Exhibitor Forum
Refreshment Break
Networking Opportunity
11:00 AM
340B UPDATE FROM HRSA
Note: Some sessions have been organized into three separate tracks to meet the varying
interests of conference attendees. Although attendees may be drawn to all of the presentations
organized under one track, they are free to attend any track that interests them.
TRACK ONE sessions are
designed for covered entities
and other parties that are
interested in learning about
how to operationalize 340B.
Location: Ballroom (Overflow: Crown Room)
Office of Pharmacy Affairs (OPA) Captain
Krista Pedley will update attendees on the
agency’s plans for 2016 including finalizing
the proposed mega-guidance. HRSA also
plans to finalize regulations establishing 340B
ceiling prices and civil monetary penalties for
manufacturers that intentionally overcharge
covered entities. HRSA is also in the process
of proposing formal regulations establishing
a mandatory and binding dispute resolution
process, and taking steps to make a database
of 340B ceiling prices publicly available. In
addition to rulemaking, Captain Pedley will
address continued oversight efforts and
initiatives including the audits of covered
entities the agency plans to complete
in FY 2016 in addition to more audits of
manufacturers.
CAPTAIN KRISTA PEDLEY
Director, Office of Pharmacy Affairs, Health
Resources and Services Administration
11:45 AM
UPDATE FROM APEXUS
Location: Ballroom (Overflow: Crown Room)
Apexus, as HRSA’s government contractor
for the 340B Prime Vendor Program (PVP),
is responsible for negotiating sub-ceiling
discounts on 340B drugs and discounts
on other pharmacy-related products and
services for participating covered entities. The
organization also plays an important role in
providing 340B technical assistance to covered
entities. Apexus will provide an update on key
initiatives.
CHRISTOPHER HATWIG
President, Apexus
12:15 PM
Location: Windsor Lawn (outdoor venue)
State Networking
Opportunity Lunch
PAGE 4
TRACK TWO sessions
will appeal to the broader
community of 340B
stakeholders, including the
pharmaceutical industry, that
might be more interested
in hearing about recent
developments involving 340B
policy and compliance.
TRACK THREE sessions are
designed for all attendees
to participate in the patient
care aspect of 340B and
how savings from this vital
program are utilized.
DISCUSSIONS/ROUNDTABLE SESSIONS are designed to facilitate small roundtable discussions
primarily focused on the other three tracks’ topics. These sessions, which are limited to 50
attendees each (first-come, first-serve basis), will allow for more dialogue and questions and
answers with our expert panelists.
BREAK INTO TRACKS
1:30 PM
TRACK 1: 340B Operations
Experiences from the Field
ESSENTIAL ELEMENTS OF
340B CONTRACT PHARMACY
ARRANGEMENTS
NICOLE CRASE
Pharmacy Manager, Five Rivers Health Centers
ALEX MANSOUR
Director of Finance, 340B Compliance Officer,
Henry Ford Health System
GREG DOGGETT
Counsel, Legal and Policy Affairs, 340B Health
(Moderator)
Location: Carousel
1:30 PM
Covered entities are responsible for ensuring
that their contract pharmacy arrangements
comply with 340B program rules such as patient
definition and the duplicate discount prohibition.
Therefore, covered entities must be mindful
of program requirements through each stage
of a contract pharmacy relationship, including
negotiation of the contract, implementation,
and ongoing oversight. Speakers will explore
what legal, business, and operational issues
covered entities and contract pharmacies should
consider when entering an agreement, specific
challenges to be aware of when implementing
an arrangement, and how entities can
continually monitor their contract pharmacies to
ensure 340B compliance. The session also will
address current hot topics in the area of contract
pharmacy, including HRSA’s proposed changes
to contract pharmacy arrangements, the
implications of the track-and-trace law for such
arrangements, and how covered entities further
their safety-net missions by using their contract
pharmacies to provide discounted drugs to lowincome uninsured patients.
TRACK 2: 340B Policy & Compliance
JASON REDDISH
Associate, Powers Pyles Sutter & Verville PC
A)MEDICAID BILLING
AND REIMBURSEMENT
Location: Crown Room
As more state Medicaid agencies continue
to implement and expand managed care
pharmacy benefits, questions persist related
to how states can identify 340B managed care
claims to prevent duplicate discounts. The drug
industry also continues to monitor whether
340B purchases have subjected manufacturers
to duplicate discounts. This session will review
recent developments in these areas and provide
perspectives from 340B providers and the
drug industry. The session will also address
the Final AMP Rule recently published by CMS,
which includes guidance to states on how to
identify 340B managed care claims and new
requirements for how states should pay for
340B drugs based on actual acquisition cost
(AAC). Panelists will discuss trends among
state Medicaid programs and managed care
organizations related to 340B claim identification
as well as strategies for manufacturers to
identify when duplicate discounts have occurred.
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JIM DONNELLY
Vice President of Pharmacy Services, Hudson
Headwaters Health Network
MARCY IMADA
Principal, Deloitte & Touche LLP
JEFF DAVIS
Counsel, Legal and Policy Affairs, 340B Health
(Moderator)
B) HRSA AUDIT EXPERIENCE
& TAKING CORRECTIVE
ACTION
Location: Ballroom
Receiving an audit notification from HRSA can
be intimidating for any covered entity. This
session will provide an overview of the audit
process, so that covered entities know what
to expect and how to proceed in the event of
a HRSA audit. The session will cover taking
corrective action, an important component
of the audit experience. Whether HRSA
identifies a compliance problem through a
formal audit or a covered entity discovers one
during an internal audit, the covered entity
must correct the problem. Taking corrective
action can be a complex undertaking with
many moving parts, including self-disclosure,
creating a comprehensive corrective action
plan, and calculating and offering refunds to
manufacturers. How will your entity know if
corrective action is needed and what it entails?
Providers with first-hand audit experience will
address these questions and others that arise
before, during, and after a 340B program audit.
KEVIN JONES
340B Program Director, Intermountain
Healthcare
TRENT STECHSCHULTE
Compliance Officer and Legal Counsel,
AIDS Resource Ohio
for patients discharged from your facility.
Providers will share unique perspectives on
their organizations’ discharge prescription
programs funded with 340B savings, including
how they have improved health outcomes by
educating patients and promoting medication
adherence. Speakers will provide both hospital
and non-hospital perspectives. The session will
also address how HRSA’s proposed megaguidance may impact your institution’s ability
to use 340B for discharge prescriptions.
JANELL CLAUDY
Pharmacy Director, Family Health Services
DAVID HACHEY
Professor, Idaho State University
DEB HAUSER
Pharmacy Director, Albert Einstein Healthcare
Network (Moderator)
ROBERT NAHOOPI
President, Turnkey Pharmacy Solutions
LEE-ANNE GABRIELLI
Project Manager, 340B Health (Moderator)
C) ADVOCATING AND
DOCUMENTING THE
340B STORY
This session is open to all health care
providers and HRSA grantees participating in
340B, including C-Suite executives. Pressure
continues to mount on the 340B program in
Washington. Learn about a new transparency
campaign to help providers quickly document
the benefits of 340B savings to underserved
patients. Get the latest pointers on how to
promote the program to your congressional
delegation from experts on the front lines.
REIMBURSEMENT
PRINCIPLES FOR 340B
HOSPITALS: MAJOR ISSUES
AND CURRENT TRENDS
Location: Windsor Complex
Two attorneys who represent 340B providers
will provide a course on Medicare cost reports
and Medicare’s provider-based rules as they
relate to 340B. Topics to be addressed include
criteria for provider-based status, how to use
the cost report to support the 340B eligibility of
facilities and patients and the impact on 340B
of new legislation eliminating the Medicare
facility fee for off-campus clinics.
TODD NOVA
Shareholder, Hall, Render, Killian, Heath & Lyman
B) 340B VENDOR
Low-income and otherwise vulnerable
individuals are at risk of experiencing adverse
health events upon discharge. This session
will explore how to improve health outcomes
MIKE COUGHLIN
President, Chief Executive Officer and Chief
Financial Officer, ScriptPro
A)MEDICARE
Group Discussions/Roundtables
1:30 PM
Location: Crystal/Continental
MADELLINE WALLACK
Founder, Rx|X Consulting
Covered entities only n n n n n n
BARBARA STRAUB WILLIAMS
Principal, Powers Pyles Sutter & Verville PC
(Moderator)
IMPROVING PATIENT
HEALTH OUTCOMES
WITH DISCHARGE
PRESCRIPTION PROGRAMS
JEFF SPENCER
Vice President, PSG
1:30 PM
BILL VON OEHSEN
Principal, Powers Pyles Sutter & Verville PC
(Moderator)
TRACK 3: Clinical Best Practices
PAM BURCH
Vice President of Sales and Marketing, Macro
Helix, Inc.
PERSPECTIVES
Location: Garden Room
Are you preparing to issue an RFP for services
to support your 340B operations and oversight?
Do you know the 340B vendor marketplace?
This session is designed for covered entities
to hear vendors’ perspectives on 340B and the
lessons they have learned from their extensive
experience with the program.
RITA BASKETT
Partner, Integrated Pharmacy Services, Inc.
Location: Hanover
KATHRYN DIBITETTO
Director, Government Relations, 340B Health
MARY EDWARDS
Vice President, Public Policy, Fairview Health
Services
THE HONORABLE GIL GUTKNECHT
Former U.S. Congressman­—1st District of Minnesota
MICHAELA KELLER
Manager of Federal Affairs, National Association
of Community Health Centers
RAJA ZEITANY
Vice President, Chief Pharmacy Officer,
Providence Health
RANDY BARRETT
Vice President, Communications, 340B Health
(Moderator)
2:45 PM
Location: Upper Grande Hall
SPONSORED BY 340B HEALTH
Exhibitor Forum
Refreshment Break
Networking Opportunity
PAGE 5
CONFERENCE AGENDA
3:45 PM—5:00 PM
BREAKOUT SESSIONS
FOR VARIOUS 340B
STAKEHOLDERS
HOSPITALS n
(DSH, Rural, Children’s and Cancer Hospitals)
Location: Ballroom
Hospitals will learn about expected 340B
program developments for 2016, the proposed
mega-guidance and other legislative changes.
We will also discuss different ways hospitals
can educate their local communities on the
importance of the 340B program.
ANNA MAGNUM
Vice President, Member and Board Relations,
340B Health
DOLORES DUNN
Vice President, Government Relations, 340B Health
340B program, Medicaid and other third-party
billing and reimbursement issues, and an
update on legislative matters impacting CHCs.
This session will be an opportunity to raise any
issues affecting your CHC.
MICHAEL GLOMB
Partner, Feldesman Tucker Leifer Fidell; Counsel,
National Association of Community Health Centers
MICHAELA KELLER
Manager of Federal Affairs, National Association
of Community Health Centers
COLLEEN MEIMAN
Director of Regulatory Affairs, National Association
of Community Health Centers (Moderator)
HIV/AIDS CLINICS, ADAPS, AND
AIDS SERVICE PROVIDERS n n
Location: Windsor Complex
JOSEPH PUGLIESE
President, Hemophilia Alliance (Moderator)
FAMILY PLANNING CLINICS,
STD CLINICS, AND OTHER
NON-HOSPITAL PROVIDERS n n
Location: Hanover
This session will focus exclusively on family
planning and STD clinics and programs,
with an emphasis on 340B issues, including
implications of the proposed mega-guidance on
clinics and programs. We will also discuss the
political landscape around the program, 340B
legislation, the status of 340B-related health
care reform provisions, including issues related
to third-party billing and reimbursement.
STEPHANIE ARNOLD PANG
Director of Policy and Communications, National
Coalition of STD Directors (Co-Facilitator)
TED SLAFSKY
President and Chief Executive Officer, 340B Health
This session will focus on 340B issues affecting
Ryan White grantees and sub-grantees, AIDS
Drug Assistance Programs (ADAPs), and other
HIV/AIDS clinics and service providers. This will
be a discussion-based session.
MAUREEN TESTONI
Senior Vice President and General Counsel,
340B Health
SEAN DICKSON
Manager, Health Care Access, National Alliance
of State & Territorial AIDS Directors
340B CONTRACT PHARMACIES AND
PHARMACY SERVICE PROVIDERS n n
PHARMACEUTICAL
MANUFACTURERS n
EMILY MCCLOSKEY
Senior Manager, Policy and Legislative Affairs,
National Alliance of State & Territorial AIDS
Directors
Location: Carousel
RANDY BARRETT
Vice President, Communications, 340B Health
Location: Crystal/Continental
Pharmaceutical manufacturers will learn the
latest developments involving the 340B program
and how they will impact the pharmaceutical
industry. Likely topics include HRSA’s
proposed mega-guidance, 340B legislation
and HRSA’s plans to increase oversight over
the pharmaceutical industry, and HRSA and
manufacturer audits of covered entities.
ED MCADAM
Vice President, Sales Administration, Pricing and
Contract Solutions, Fresenius Medical Care
CONSTANCE WILKINSON
Partner, Epstein Becker Green PC
LINDA SCHOCK
Director of Government Programs and Price
Reporting, Jazz Pharmaceuticals (Moderator)
COMMUNITY HEALTH CENTERS n n
Location: Crown Room
Join us to discuss the latest 340B issues and
developments affecting community health
centers (CHCs). Likely topics will include the
proposed mega-guidance and its implications
for health centers, continuing scrutiny of the
PAGE 6
TRENT STECHSCHULTE
Compliance Officer & Legal Counsel, AIDS
Resource Ohio
BRITTEN PUND
Associate Director, Health Care Access, National
Alliance of State & Territorial AIDS Directors
(Facilitator)
HEMOPHILIA TREATMENT CENTERS n
Location: Garden Room
This session will focus exclusively on matters
impacting hemophilia treatment centers (HTCs),
with an emphasis on 340B issues. Likely topics
include 340B legislation, implications of HRSA’s
proposed mega-guidance, HRSA’s oversight
efforts, including audits, and Medicaid billing
and reimbursement issues. This session
also will be an opportunity to discuss issues
impacting your HTC.
ELIZABETH KARAN
Associate, Feldesman Tucker Leifer Fidell;
Counsel, Hemophilia Alliance
SEAN SINGH
Senior Vice President, Hemophilia Alliance
MINDY MCGRATH
Policy Director, National Family Planning &
Reproductive Health Association (Co-Facilitator)
(Chain, Independent & Mail Order Pharmacies and
Related Vendors)
This session is designed for all 340B service
providers. Participants will share perspectives
and information and on a range of 340B hot
topics, including HRSA’s proposed megaguidance, Medicaid managed care, contract
pharmacy oversight, the track-and-trace
law’s implications for contract pharmacy
arrangements, 340B claim identification, and
the use of contract pharmacy to serve lowincome uninsured patients.
JASON REDDISH
Associate, Powers Pyles Sutter & Verville PC
MICHAEL KEEGAN
Director, Policy and Regulatory Affairs, National
Community Pharmacists Association
GREG DOGGETT
Counsel, Legal and Policy Affairs, 340B Health
(Moderator)
CONCLUSION
5:00 PM—6:00 PM
Upper Grande Hall
SPONSORED BY VERITY SOLUTIONS
Thursday Evening Reception
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5:00-6:00 PM
Sponsored by:
THURSDAY EVENING RECEPTION
Upper Grande Hall
FRIDAY
DATE: 02/19/2016
7:00 AM
CHARITY FUN RUN/WALK
(Check-in begins at 6:30 AM)
Coalition Registration/Help Desk
The Coalition will be donating proceeds to help
fund Family Health Centers of San Diego.
See pg. 19 for more details
8:00 AM
Location: Sun Deck (outdoor venue)
Continental Breakfast
Stakeholder Networking
Opportunity
Join attendees during breakfast to discuss
topics of interest to various stakeholders.
Topics will include split billing, contract
pharmacy, in-house pharmacy, orphan drugs
and many others. This informal format will
provide time to network with peers. “Check
the schedule in the mobile app for a list of
“hot topics.” Attendees are encouraged to
stay as short or as long as the conversation
flows and moving to different topics is all up
to the attendees.
WHAT DID HE SAY?
Don’t miss a beat: Access speaker
presentations through the conference
mobile app and follow along!
After the conference, select video
materials will be available through
www.340bwinterconference.org.
8:30 AM
to manufacturers’ and payers’ networks.
ASK THE EXPERTS:
BREAKFAST FOR
PHARMACEUTICAL
MANUFACTURERS
LYNNAE MAHANEY
Executive Director, Center for Pharmacy Practice
Accreditation
Manufacturers only n
Location: Pointe
Hear from experts who work on a broad range
of 340B-related issues. Consultants with
significant experience with 340B and other
federal drug pricing programs will field your
questions in this small group discussion.
ROMIT KAMDAR
Partner, Akara Group LLC
MARCY IMADA
Principal, Deloitte & Touche LLP
BREAK INTO TRACKS
9:15 AM
TRACK ONE:
340B OPERATIONS
A) THE FUTURE OF
SPECIALTY DRUGS & 340B
Location: Crown Room
Specialty drug spending has grown rapidly in
recent years, and this trend shows no sign of
slowing. As specialty drugs become an ever
bigger share of the pharmaceutical market,
many such drugs are being sold to providers
through manufacturer’s limited distribution
networks and given to patients through
payers’ limited provider networks. Providers
report challenges when purchasing specialty
drugs or simply attempting to access these
networks, including when buying or trying to
obtain specialty drugs at 340B prices. This
session will outline these challenges, as well
as relevant 340B developments and HRSA
policy. The panel also will address overall
trends in the specialty market and the potential
benefits of specialty pharmacy accreditation
for providers seeking to improve their access
REBEKAH HANSON
Clinical Liaison Pharmacist, Specialty Pharmacy
Services, University of Illinois Medical Center at
Chicago
GREG DOGGETT
Counsel, Legal and Policy Affairs, 340B Health
(Moderator)
B) INVENTORY
MANAGEMENT
Location: Carousel
340B providers face challenges managing their
drug inventories in ways that are compliant with
program rules. Covered entities must establish
inventory management systems to protect
against the risk of drug diversion and duplicate
discounts, and those entities with contract
pharmacy arrangements must find suitable IT
solutions to address inventory management
needs. Hospitals face particular challenges, with
rural and cancer hospitals needing systems
in place to manage orphan drug purchases,
and hospitals subject to the group purchasing
organization (GPO) exclusion using inventory
management systems that incorporate
wholesale acquisition cost (WAC) purchasing
accounts. HRSA grantees face their own
unique challenges when it comes to inventory
management. This session will review options
to support compliant inventory management
practices. Attendees will hear both the hospital
and community health center perspective on
strategies to manage 340B drug inventories.
ASHLEY MAINS ESPINOSA
System Pharmacy Manager, 340B Program SCL
Health
VICTOR FOURNIER
Director of Pharmacy, Harbor Health Services
ALEX MANSOUR
Director of Finance, 340B Compliance Officer,
Henry Ford Health System (Moderator)
PAGE 7
CONFERENCE AGENDA
9:15 AM
TRACK TWO:
340B POLICY & COMPLIANCE
CONTINUED
CONVERSATIONS ON
PROPOSED MEGA-GUIDANCE
Location: Ballroom
The proposed “mega guidance” published by the
Health Resources and Services Administration
(HRSA) last August has created significant
interest among all program stakeholders.
Although much of the discussion surrounding
the proposed guidance has focused on changes
to the definition of a 340B-eligible patient, the
proposed guidance addressed virtually all
areas of the 340B program. This session will
provide perspectives from 340B providers
and the drug industry on the potential impact
of the other areas addressed in the proposed
guidance, apart from patient definition. Among
the topics to be discussed are: GPO exclusion,
audits, self-disclosure, hospital and off-site clinic
eligibility, manufacturer responsibilities, contract
pharmacy, HRSA grantee-specific issues and
more. Note that the provisions in the proposed
mega guidance addressing patient definition
will be addressed during the Patient Definition
session.
JOSEPH PUGLIESE
President, Hemophilia Alliance
ROMIT KAMDAR
Partner, Akara Group
JEFF DAVIS
Counsel, Legal and Policy Affairs, 340B Health
(Moderator)
9:15 AM
TRACK THREE:
CLINICAL BEST PRACTICES
340B PROVIDER TALES
Location: Crystal/Continental
Savings from the 340B program allow
providers to do more with less every day. Hear
from the front lines about the clinical care and
patient support made possible by the program.
Learn creative ways to use 340B resources and
help underinsured and uninsured patients.
DAVID NEU
Executive Director of Pharmacy,
Saint Thomas Health
MERRILL THOMAS
Chief Executive Officer, Providence Community
Health Centers
PAGE 8
CHARLES COOPER
340B Program Manager, Fairview Health Services,
University of Minnesota Medical Center (Moderator)
10:30 AM
Upper Grande Hall
Exhibitor Forum
Refreshment Break
Networking Opportunity
9:15 AM
SMALL GROUP DISCUSSIONS
AND ROUNDTABLES
Limit 50 attendees per session
A) HOSPITAL AUDIT AND
CORRECTIVE ACTION PLAN
ROUNDTABLE
11:15 AM
LEGISLATIVE UPDATE
Location: Ballroom
MAUREEN TESTONI
Senior Vice President and General Counsel, 340B
Health (Moderator)
High drug prices have caught the eye of
lawmakers and Presidential candidates.
Congress also continues to debate various
health care matters including the 21st Century
Cures bill, the future of Obamacare, Medicaid
expansion, health exchanges and reimbursement
matters. Attendees will be briefed about the hot
topics on the legislative calendar and what issues
might have to wait until 2017. You will also learn
more about the continued debate over 340B and
where we might be headed. Get the perspectives
of the safety net provider community and a
leading watcher of the pharmaceutical industry.
B) RURAL PROVIDER
MICHAELA KELLER
Manager of Federal Affairs, National Association
of Community Health Centers
Hospitals only n
Location: Windsor Complex
This roundtable is limited to hospitals only.
Attendees will hear from hospitals that have
been through a HRSA audit and developed a
corrective action plan (CAP). The roundtable will
provide an opportunity to discuss best practices
in audit preparation and lessons learned from
the audit experience and CAP development.
ROUNDTABLE
Location: Garden Room
Rural safety-net providers participating in
340B face their own, unique challenges when
it comes to program participation. In particular,
their remote location and limited resources
can require a different approach to program
compliance and monitoring of systems than
methods used by other providers. Rural
hospitals are also subject to different program
rules than other participants and must maintain
inventory management systems to comply with
the orphan drug exclusion. Representatives
from rural providers of different types will
facilitate informal conversations at tables for
rural hospitals and community health clinics and
will discuss their experiences managing 340B
programs. There will be a particular emphasis
on the latest developments with access to 340B
pricing on orphan drugs for rural hospitals.
GRETCHEN BECKHAM
Director of Pharmacy, Eau Claire Cooperative
Health Centers
CHERYL RAY
340B Analyst, Mary Hitchcock Memorial Hospital
MICHAEL BONCK
Manager of Pharmaceutical Services, Franciscan
Health System, Catholic Health Initiatives
(Moderator)
MICHAEL MCCAUGHAN
Senior Editor, RPM Report; Founding Member,
Prevision Policy LLC
DOLORES DUNN
Vice President, Government Relations,
340B Health (Moderator)
12:15 PM
PASSPORT AND SOCIAL
MEDIA CONTEST PRIZE
DRAWINGS & CLOSING
REMARKS
Location: Ballroom
12:30 PM
CONFERENCE ADJOURNS
SEE YOU JULY 11-13, 2016 FOR
THE 340B COALITION SUMMER
CONFERENCE IN WASHINGTON, DC!
ProCE® is accredited by the
Accreditation Council for
Pharmacy Education as a
provider of continuing pharmacy
education.
ANNUAL WINTER CHARITY FUN RUN & WALK!
WHAT:
DONATE!
FUN RUN & WALK
COMMEMORATIVE T-SHIRT AND
CONFERENCE WATER BOTTLE
Help us meet our goal of
$15,000 and make a difference.
WHO
WHY
ALL FITNESS LEVELS
The Coalition will be donating
proceeds collected from
sponsorship and registration
fees to help fund Family Health
Centers of San Diego.
WHEN
FRIDAY, FEBRUARY 19—7:00 AM
(check-in begins at 6:30 AM)
MEET
At the Coalition Registration/Help Desk
(located at the Group Registration Desk)
COST
$25
(see Registration/Help Desk to register prior to
February 19)
WHERE
Participants can either go along the beach or
walk-way.
TURN-AROUND
1 MILE EACH
In 2014, Family Health Centers of San Diego
provided care to over 24,000 unduplicated
homeless individuals. Services for homeless
individuals are available at all FHCSD clinics,
including our three Mobile Medical Units.
This includes primary care, vision care, dental
care, medications assistance and mental
health counseling. They offer support groups,
case management teams, substance abuse
programs and insurance enrollment assistance.
They also support the National Health Care for
the Homeless Council’s mission to eliminate
homelessness by ensuring health care and
secure housing for everyone.
BEACH PATH
While the 340B Coalition will be donating
proceeds from the Fun Run & Walk, we
encourage attendees to make donations on
their own as well.
TO DONATE, GO TO FHCSD.ORG. Scroll
down and click on the ‘Donate Now’ button.
Choose the 340B Coalition Conference
icon and proceed as instructed.
WE ARE
AT 65%
OF OUR
GOAL.
Any check donations made on-site should be
made out to Family Health Centers of San Diego.
WALK-WAY PATH
START/END
HOTEL DEL
The 340B Coalition would like to thank the following exhibitors and vendors for their generous contributions and support for the event and FHCSD.
PREMIER SPONSORS
• Apexus
• Drug Discount Monitor
• Friends of 340B PAC
SUPPORTER SPONSORS
• Intelligent Compliance
Solutions
• PDMI
• National Association of
Community Health Centers
• R&S Northeast, LLC
• RxStrategies, Inc.
• Turnkey Pharmacy
Solutions
PAGE 9
CONFERENCE AGENDA
CONTINUING EDUCATION
INSTRUCTIONS
1. To receive CE credit for the activities at this
conference, YOU MUST COMPLETE THE
ACTIVITY EVALUATIONS ONLINE NO LATER
THAN FRIDAY, MARCH 18, 2016. The portal will
be active from 2/19/2016 to 3/18/2016.
2. Read the CPE Monitor information on the lower
right hand page.
Session Time
3. Visit www.ProCE.com/evaluation.
4. Click on the Evaluations button which is listed
with the 12th Annual 340B Coalition Winter
Conference­—February 17-19, 2016 CE activity.
5. Enter the Event Codes for all of the CE sessions
you attended. Each session has a unique event
code.
Session Title
6. Follow the online instructions to complete the
activity evaluations and to receive CE credit.
NOTE: Complete the activity evaluations and claim
CE credit only for the sessions you attended.
7. If you need assistance or have questions, please
contact ProCE at 630.540.2848 or via email at
[email protected].
ACPE UAN
CPE Hours
340B Essentials (Part 1)
0221-9999-16-036-L04-P/T
1.25
Audit Findings Update and Improving Compliance (Part 1)
0221-9999-16-037-L04-P/T
1.25
340B Essentials (Part 2)
0221-9999-16-038-L04-P/T
1.5
Audit Findings Update and Improving Compliance (Part 2)
0221-9999-16-039-L04-P/T
1.5
Event Code
PRE-CONFERENCE: FEBRUARY 17, 2016
1:30 - 2:45 PM
3:45 - 5:15 PM
MAIN CONFERENCE: FEBRUARY 18, 2016
8:30 - 9:00 AM
340B: A Look Back and Look Ahead
0221-9999-16-040-L04-P/T
9:00 - 10:15 AM
Implications of Proposed Patient Definition
0221-9999-16-041-L04-P/T
1.25
11:00 - 11:45 AM
340B Update from HRSA
0221-9999-16-042-L04-P/T
0.75
11:45 AM - 12:15 PM
Apexus Update
0221-9999-16-043-L04-P/T
0.5
Essential Elements of 340B Contract Pharmacy Arrangements
0221-9999-16-044-L04-P/T
1.25
Medicaid Billing & Reimbursement
0221-9999-16-045-L04-P/T
1.25
HRSA Audit Experience & Taking Corrective Action
0221-9999-16-046-L04-P/T
1.25
Improving Patient Health Outcomes with Discharge Prescription Programs
0221-9999-16-047-L04-P/T
1.25
Medicare Reimbursement Principles for 340B Hospitals
0221-9999-16-048-L04-P/T
1.25
340B Vendor Perspectives
0221-9999-16-049-L04-P/T
1.25
Advocating and Documenting the 340B Story
0221-9999-16-050-L04-P/T
1.25
Hospitals
0221-9999-16-051-L04-P/T
1.25
1:30 - 2:45 PM
0.5
Community Health Centers
0221-9999-16-052-L04-P/T
1.25
3:45 - 5:00 PM
Hemophilia Treatment Centers
0221-9999-16-053-L04-P/T
1.25
(Stakeholder
Breakout Sessions)
HIV/AIDS Clinics, ADAPs, and AIDS Service Providers
0221-9999-16-054-L04-P/T
1.25
Family Planning Clinics, STD Clinics and Other Non-Hospital Providers
0221-9999-16-055-L04-P/T
1.25
340B Service Providers
(Contract Pharmacies, Consultants, PBMs, and Related Vendors)
0221-9999-16-056-L04-P/T
1.25
MAIN CONFERENCE: FEBRUARY 19, 2016
9:15 - 10:30 AM
11:15 AM - 12:15 PM
The Future of Specialty Drugs and 340B
0221-9999-16-057-L04-P/T
1.25
Inventory Management
0221-9999-16-058-L04-P/T
1.25
Continued Conversations on Proposed Mega-Guidance
0221-9999-16-059-L04-P/T
1.25
340B Provider Tales
0221-9999-16-060-L04-P/T
1.25
Hospital Audit & Corrective Action Roundtable
0221-9999-16-061-L04-P/T
1.25
Rural Provider Roundtable
0221-9999-16-062-L04-P/T
1.25
Legislative Update
0221-9999-16-063-L03-P/T
1.0
These continuing education activities for pharmacists and pharmacy technicians have been developed through a joint providership of ProCE, Inc. and 340B Health. ProCE
is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education (CPE). Participants attending the Pre-Conference
Workshops and the 12th Annual 340B Coalition Winter Conference CPE activities may earn a maximum of 10.5 contact hours of CPE credit (1.05 CEUs). Note: some of the
CPE sessions are being held concurrently. The sessions offering ACPE credit are designated with a UAN (Universal Activity Number) and hours of CPE credit. The release
date for these CPE activities is February 17-19, 2016. Conference registration fees cover the cost of CPE credit. Statements of completion will be issued at www.ProCE.
com upon successful completion of the online CPE activity evaluations. All activity evaluations must be completed no later than March 18, 2016. No partial credit will be
given for any individual session. ProCE uploads completed CE activities to NABP/CPE Monitor once each week, usually on Mondays. Conflict of interest disclosures are
required of all faculty and shall be provided to all participants at the conference.
PAGE 10