View Full Agenda - 340B Coalition Summer Conference

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CONFERENCE
AGENDA
Capitol Hill
CONFERENCE AGENDA
1
PRE-CONFERENCE AGENDA
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.
SUNDAY, JULY 12, 2015
9:00 AM
7:00 AM
Location: Exhibit Hall
Location: West Registration Desk
Exhibitor Setup
3:00 PM
Early Registration
5:00 PM
Conference Primer for Attendees
Location: Palladian Room
This is session is the “decoder ring” of the
conference designed for those attendees
and exhibitors who like to be ahead of the
curve. Attendees will speak with conference
staff and learn how to make the most of
their 340B Coalition Conference experience.
Whether it is your first time or fifth time,
primer attendees will learn new facts about
the conference, receive hands on help with
the conference app, and leave this short
program with useful tips. For attendees
who wish to continue networking, the 340B
Coalition team has made reservations at
several local DC eateries. Be sure to stop
by the registration desk to check out the
restaurants and sign up for your favorite—
bring a friend or come alone and leave with
new 340B friends. Dinner is not included
with conference registration.
Lisa Scholz
Senior Vice President and Chief Operating
Officer, 340B Health (Moderator)
6:00 PM
Adjourn
BADGE COLORS:
nnnnnnnnnnn
Sessions indicating a badge color are
limited to the respective covered entity,
industry or government groups. For
example, hospitals should not attend the
pharmaceutical manufacturer’s session
and vice versa. Please visit the conference
help desk if you have questions regarding
your badge color or attendance to sessions.
2
MONDAY, JULY 13, 2015
340B COALITION SUMMER CONFERENCE I
Registration
7:00 AM–8:15 AM
Continental Breakfast & Stakeholder
Networking Opportunity
(Workshop Attendees and Exhibitors Only)
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 “hot
topic” board in the Exhibit Hall for table topic
assignments. 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.
8:15 AM–11:45 AM
Pre-Conference Workshops
(Two Options)*
Pre-Conference Workshop Option 1:
340B Essentials
8:15 AM
340B Essentials (Part 1)
Location: Ambassador Ballroom
This is not your average 340B introductory
session! We have reinvented Essentials to be
highly interactive. Part 1 will take you through
the essential elements of 340B and contract
pharmacy to provide a baseline foundation
that will cover program requirements,
prohibitions, and compliance. Attendees will
then participate in an entity-specific practical
application to test their knowledge with fellow
attendees through the “340B Simulator.”
During Part 2, participants will continue
their “simulator” experience through case
studies that will connect the dots between
policy and operations. Case studies will
be led by facilitators from practice sites
including hospitals (DSH, Children’s, Rural),
#340bconf
community health centers, Ryan White/HIV/
AIDS facilities, and contract pharmacies that
have in-house and/or contract pharmacy
operations. Attendees will select which
practice site best suits their educational
needs. This workshop requires active
participation.
Rusol Karralli
Manager, 340B Education and Compliance
Support, Apexus
Lisa Scholz
9:30 AM
Networking and Refreshment Break
10:15 AM
340B Essentials (Part 2)
Workshop Continues.
Burnis Breland
Manager, 340B Education and
Compliance Support, Apexus
Dana Darger
Director of Pharmacy, Rapid City Regional Health
Amy Gutierrez
Chief Pharmacy Officer, Los Angeles County
Department of Health Services
Maria Lopez Andrzejek
Pharmacy Director, Mission Wellness Pharmacy
Andrew Lowe
Clinical Director of Pharmacy, Arrowhead
Regional Medical Center
Mary Elizabeth Marr
Chief Executive Officer, Thrive Alabama
Joanne O’Kane
National 340B Program Director, Catholic
Health Initiatives
Rory Phillips
Director of Pharmacy Services, Southern Ohio
Medical Center
Rosanne Thurman
Director of Pharmacy, Cook Children’s Medical
Center
Lisa Scholz
*Please note there is an additional cost to attend the pre-conference workshops and you must register for them.
11:45 AM
Networking Lunch
Pre-Conference Workshop Option 2:
Audit Results, Preparing for
Mega-Guidance and Implementing
Effective Compliance Plans
8:15 AM
Part 1—Audit Results and Preparing
for Mega-Guidance
With HRSA’s mega-guidance expected to
be released in 2015, 340B stakeholders are
taking stock of their operations to prepare for
anticipated changes to the program. Since the
mega-guidance will affect each stakeholder
group differently, the first part of this workshop
will be broken into three separate sessions for
hospitals, HRSA grantees, and manufacturers.
In their respective sessions, hospitals and
grantees will discuss HRSA’s key audit findings
and what they might mean for potential program
changes in the mega-guidance. During their
session, manufacturers will discuss how the
mega-guidance could impact their participation
in 340B, as well as recently proposed HRSA
regulations regarding 340B ceiling price
regulations, civil monetary penalties, and the
forthcoming formal dispute resolution process.
A) Audit Results and Preparing for
Mega-Guidance for Hospitals
(covered entities only)
Badge Color: n
Charles Cooper
340B Program Manager, University of
Minnesota Medical Center, Fairview
Jeff Davis
Counsel, Legal and Policy Affairs, 340B Health
Maureen Testoni
Senior Vice President and General Counsel, 340B
Health (Moderator)
B) Audit Results and Preparing for
Mega-Guidance for HRSA Grantees
(covered entities only)
Location: Diplomat Room
Badge Color: nnnnn
Kathryn Watson
Associate, Feldesman Tucker Leifer Fidell;
Counsel, Hemophilia Alliance
Michael Glomb
Partner, Feldesman Tucker Leifer Fidell; Counsel,
National Association of Community Health
Centers (Moderator)
C) Audit Results and Preparing for
Mega-Guidance for Manufacturers
(manufacturers only)
Location: Congressional Room
Badge Color: n
Linda Schock
Director, Government Programs & Price
Reporting, Jazz Pharmaceuticals
Marcy Imada
Principal, Deloitte & Touche LLP (Moderator)
9:30 AM
Networking and Refreshment Break
10:15 AM
Part 2—Implementing Effective
Compliance Plans
The second part of workshop will focus on
340B compliance. For a covered entity,
running a 340B program is a complex
operation with many moving parts.
Compliance requires an understanding of
program requirements and how to apply
them to the purchasing, dispensing, billing,
and inventory management systems within
a health care facility. Covered entities should
establish not only policies and procedures
(P&Ps) to comply with 340B requirements,
but also ongoing oversight mechanisms
to verify that the organization’s P&Ps are
followed and are working. For covered
entities considering enrolling in 340B,
these safeguards should be established
before discounted drugs are ordered and
dispensed. The need to be prepared is
especially acute because HRSA continues to
audit a steadily increasing number of entities
to ensure 340B compliance.
Part 2 of the workshop will assist covered
entities and other stakeholders in identifying
key compliance areas, as well as the types
of systems or procedures that should be
in place to monitor compliance. There will
be a particular focus on how to conduct
self-audits. Part 2 will consist of two separate
sessions, one for HRSA grantees and another
for hospitals, and will cover topics specific
to each group. Both Part 2 sessions will be
open to all workshop attendees.
A) Implementing Effective Compliance
Plans for Hospitals (open to all
workshop attendees)
Kevin Jones
340B Program Director, Intermountain
Healthcare
Shaun Phillips
Vice President, Clinical and Pharmacy Services,
Bronson Battle Creek Hospital
Cynthia Williams
Vice President, Chief Pharmacy Officer, Riverside
Health System
Jeff Davis
(Moderator)
B) Implementing Effective
Compliance Plans for HRSA Grantees
(open to all workshop attendees)
Matthew Bare
Program Coordinator, Virginia Commonwealth
University Ryan White and HIV Clinical Service
Programs
Sarah Minick
Pharmacist in Charge, Carolina Health Centers
Ed Shanshala
Chief Executive Officer, Ammonoosuc
Community Health Services
Kathryn Watson
Counsel, Hemophilia Alliance (Moderator)
11:45 AM
Networking Lunch
WALK FOR A CAUSE!
Join us for our charity fun walk
Wednesday morning in Rock Creek
Park to benefit Food and Friends,
an organization delivering meals to
those in need.
CONFERENCE AGENDA
3
COMMENCEMENT OF
MAIN CONFERENCE
1:00 PM
Opening Remarks
Location: Regency Ballroom
This session will be your official welcome
to the conference. Conference hosts will
introduce themselves and get you prepared
for the rest of conference.
1:20 PM
340B Update from HRSA
Office of Pharmacy Affairs (OPA) Deputy
Director Michelle Herzog will update
attendees on various agency initiatives
including the proposed mega-guidance
and regulations pending at the Office of
Management and Budget (OMB). The
proposed guidance will address a range of
important program issues, including patient
definition, contract pharmacy, hospital
eligibility, and offsite facilities. HRSA is also in
the process of proposing formal regulations
establishing a mandatory and binding
dispute resolution process, civil monetary
penalties for manufacturers that intentionally
overcharge covered entities, and taking steps
to make a database of 340B ceiling prices
publicly available. In addition to rulemaking,
Deputy Director Herzog will address the
agency’s continued oversight efforts and
initiatives including the approximately 200
audits of covered entities the agency plans
to complete in FY 2015 in addition to more
audits of manufacturers.
Michelle Herzog
Deputy Director, Office of Pharmacy Affairs,
Health Resources and Services Administration
2:05 PM
Apexus Update
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
2:35 PM
Exhibitor Forum, Refreshment Break,
and Networking Opportunity
3:20 PM
HRSA Audit Experience
Over the past year, there have been several
significant changes to HRSA’s 340B audits.
Not only did HRSA double the number
of audits, but it changed the process for
disputing findings, preparing corrective
action plans, and notifying manufacturers of
repayment obligations. In addition, covered
entities are reporting an increasing number
of inquiries by drug companies into covered
entity purchasing practices and compliance
processes. Panelists representing the hospital
and HRSA grantee community will discuss
their experience including responding to
audit findings. Because audits impact 340B
stakeholders in different ways, there will be
two sessions, one for hospitals and one for
HRSA grantees. Manufacturers and other
340B stakeholders may attend either session.
A) Hospitals
Meetali Desai
340B Compliance Specialist, UMass Memorial
Medical Center
Marcy Imada
Principal, Deloitte & Touche LLP
Jason Mills
Pharmacy Supply Chain Manager, Medical
University of South Carolina
Maureen Testoni
Health (Moderator)
B) HRSA Grantees
4
#340bconf
Susan Dunne
Senior Principal, Managed Markets Services,
IMS Health
Brian Rasmussen
Pharmacy Director, Cares Community Health
Michael Glomb
Centers (Moderator)
3:20 PM
Contract Pharmacy Interest Group
Limited to contract pharmacies only. Whether
you are operating a contract pharmacy or
considering becoming a contract pharmacy,
this session is designed for you. Connect
with colleagues, hear from experts, and
receive the latest updates impacting 340B
contract pharmacy. Likely topics include
340B legislation, track and trace law, megaguidance, audits, contract negotiations, and
PBM developments.
Alan Arville
Member of the Firm, Epstein Becker & Green
Greg Doggett
Michael Keegan
Director, Policy and Regulatory Affairs, National
Community Pharmacists Association
Frank Messina
General Counsel, SCL 340B Care
Jason Reddish
Associate, Powers Pyles Sutter & Verville PC
Lisa Scholz
Officer, 340B Health (Facilitator)
4:35 PM
10 Minute Transition Break
4:45 PM
Breakout Sessions for
Various 340B Stakeholders
A) Hospitals (DSH, Rural, Children’s
and Cancer Hospitals)
Location: Blue Room
Badge Color: n
Hospitals will learn about expected 340B
program developments for 2015, including
proposed legislative changes and the
much-anticipated HRSA mega-guidance.
We will also discuss different ways hospitals
can educate their local communities on the
importance of the 340B program.
Randy Barrett
Vice President, Communications, 340B Health
Dolores Dunn
Vice President, Government Relations, 340B Health
Anna Mangum
Vice President, Member and Board Relations
Ted Slafsky
President and Chief Executive Officer, 340B Health
Maureen Testoni
Senior Vice President and General Counsel,
340B Health
B) Community Health Centers
Badge Color: n
Join us to discuss the latest 340B issues and
developments affecting community health
centers (CHCs). Likely topics will include the
upcoming mega-reg and its implications for
health centers, continuing scrutiny of the
340B program, Medicaid and other thirdparty 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.
Jennifer Taylor
Manager, Federal Affairs, National Association of
Community Health Centers
Michael Glomb
Centers (Co-Facilitator)
Colleen Meiman
Director of Regulatory Affairs, National
Association of Community Health Centers (CoFacilitator)
C) Family Planning Clinics
Location: Forum Room
Badge Color: n
This session will focus exclusively on
family planning clinics and programs, with
an emphasis on 340B issues, including
implications of the upcoming megaguidance on family planning clinics, audits,
recertification, and meetings with and
outreach to government agencies regarding
billing and reimbursement of 340B Medicaid
managed care drugs. 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.
Amanda Kelinson
Manager, Health Care Delivery, National
Family Planning and Reproductive Health
Association (Co-Facilitator)
Amy Yenyo
Senior Policy Counsel, Planned Parenthood
Federation of America (Co-Facilitator)
D) Hemophilia Treatment Centers
Location: Cabinet Room
Badge Color: n
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 forthcoming
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.
Sean Singh
Vice President, Hemophilia Alliance
Kathryn Watson
Counsel, Hemophilia Alliance
Joseph Pugliese
President, Hemophilia Alliance (Facilitator)
E) HIV/AIDS Clinics, ADAPs,
and AIDS Service Providers
Location: Executive Room
Badge Color: nn
This session will focus on 340B issues
affecting Ryan White grantees and subgrantees, AIDS Drug Assistance Programs
(ADAPs), and other HIV/AIDS clinics and
service providers. This will be a discussionbased session.
Kim Hood
Chief Compliance Officer, HIV/AIDS Alliance
Region Two (Louisiana)
Sean Dickson
Manager, Health Care Access, National Alliance
of State and Territorial AIDS Directors (CoFacilitator)
Emily McCloskey
Senior Manager, Policy and Legislative Affairs,
National Alliance of State and Territorial AIDS
Directors (Co-Facilitator)
F) Pharmaceutical Manufacturers
Badge Color: n
will impact the pharmaceutical industry.
Likely topics include HRSA’s forthcoming
mega-guidance, 340B legislation and
HRSA’s plans to increase oversight over the
pharmaceutical industry, and HRSA and
manufacturer audits of covered entities.
Mike Benedict
Vice President of Operations, Apexus
Linda Schock
Director, Government Programs & Price
Reporting, Jazz Pharmaceuticals
Christopher Schott
Associate, Hogan Lovells
Kathleen Black
Director Government Strategy, Pfizer
(Moderator)
G) 340B Service Providers (Contract
Pharmacies, Consultants, PBMs, and
Related Vendors)
Badge Color: nn
This session is designed for all 340B service
providers. Participants will exchange ideas
and share information on various 340B hot
topics including compliance, indigent care
programs, the upcoming mega-guidance,
and the track and trace law. An expert panel
(wholesaler, pharmacy, advocacy association,
and legal counsel) will provide insight into
the future of the 340B program and the role
service providers play.
Alan Arville
Greg Doggett
Michael Keegan
Director, Policy and Regulatory Affairs, National
Community Pharmacists Association
Frank Messina
Lisa Scholz
Officer, 340B Health (Facilitator)
5:45 PM–6:45 PM
Exhibits and Opening Reception
Sponsored by (Booth 25/30):
Pharmaceutical manufacturers will learn
about the latest developments involving the
340B program and how those developments
CONFERENCE AGENDA
5
TUESDAY, JULY 14, 2015
7:30 AM
Continental Breakfast—Stakeholder
Networking Opportunity
topic” board in the exhibit hall for table topic
to the attendees.
Sponsored by (Booth 8):
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7:30 AM
Ask the Experts Breakfast for
Pharmaceutical Manufacturers
Location: Cabinet Room
Badge Color: n
This session is an opportunity for
pharmaceutical manufacturers to 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.
Jeremy Docken
Engagement Manager, IMS Health
Marcy Imada
Principal, Deloitte & Touche LLP
8:30 AM
Patient Perspectives
Congress created the 340B program in 1992
to “reach more eligible patients and provide
more comprehensive services.” Over two
decades later, safety-net providers continue
to use their 340B savings to serve patients in
a variety of ways. This session puts a human
face on the 340B program by providing
patient perspectives on 340B, including
patients telling stories of how the program
helped them get the care they needed.
Dorian-Gray Alexander
Patient of CrescentCare Health, New Orleans, LA
Shannon Williams
Patient of Monroe County Hospital,
Monroeville, AL
Gustavo Rosales
Patient of Mile Square Health Center, Chicago, IL
Randy Barrett
(Moderator)
9:15 AM
Legislative Update
Search “340B” in the app store
or scan the QR code above!
6
Attendees will be briefed about the latest
340B developments from Washington
and hot-button pharmaceutical and
biotech industry issues. Topics include:
status of 340B legislation, congressional
oversight, GAO, OIG, MedPAC studies and
recommendations; what’s in store for 340B
for the remainder of the congressional
calendar and a preview of 2016 elections.
Michael McCaughan
Senior Editor, RPM Report; Founding Member,
Prevision Policy LLC
#340bconf
Ted Slafsky
President and Chief Executive Officer, 340B
Health; Editor-in-Chief, Drug Discount Monitor
(Moderator)
10:15 AM
Exhibits Open: Networking and
Refreshment Break
11:00 AM
Keynote Panel
Where is healthcare going in the coming
months and what does 2016 have in store?
Join us for an enlightening conversation
featuring the Hon. Henry Waxman (D-Calif.,
ret.) and Dean Rosen, moderated by veteran
journalist Susan Dentzer. Now that the
Supreme Court has made its historic decision
in King vs. Burwell, policymakers are starting
to focus on how to make the ACA work
better, rather than debating whether Obama
Care will stay in existence. You will get the
perspectives of the three of the nation’s most
respected health policy experts on Congress’s
next moves, as well as the challenges ahead
on the health reform area.
The Honorable Henry Waxman
Co-Founder, Waxman Strategies, former U.S.
Congressman—California
Dean Rosen
Partner, Mehlman Castagnetti Rosen Bingel &
Thomas Inc.
Susan Dentzer
Senior Policy Adviser, Robert Wood Johnson
Foundation (Moderator)
12:15 PM
State Networking Lunch for Attendees
and Exhibitors
Note: The following sessions have been
organized into three separate tracks to
accommodate the varying interests of
conference attendees.
TRACK ONE SESSIONS are designed for
covered entities and other parties that
are interested in learning about how to
operationalize 340B.
TRACK TWO SESSIONS will appeal
to the broader community of
340B stakeholders, including the
pharmaceutical industry, who might be
more interested in hearing about (1)
recent developments involving 340B
policy and compliance and (2) expert
analysis.
TRACK THREE SESSIONS are designed
for all attendees to discuss the patient
care aspects of 340B and how savings
from this vital program are utilized.
ROUNDTABLE SESSIONS are designed
to facilitate small group discussions
primarily focused on the other two
tracks’ topics. These sessions, which are
limited to 50 attendees each (first come,
first served) allow for more dialogue with
our expert panels.
Although attendees may be drawn to
all of the presentations organized under
one track, they are free to attend any
track that interests them.
1:30 PM
Track One—340B Operations:
Experiences from the Field
Key Elements of 340B Contract
Pharmacy Arrangements
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
the implications of the track-and-trace law
for these arrangements and how covered
entities further their safety-net missions by
using their contract pharmacies to provide
discounted drugs to low-income insured
patients.
Jason Atlas
Manager, 340B Education and Compliance
Support, Apexus
Lydia Klinger
Director, Virginia Commonwealth University
Ryan White and HIV Clinical Service Programs
Jason Reddish
Associate, Powers Pyles Sutter & Verville PC
Greg Doggett
(Moderator)
1:30 PM
Track Two—340B Policy
and Compliance
Manufacturer Oversight of Covered
Entity Compliance
Has your organization ever received a
formal letter of inquiry from a manufacturer
and wondered why it was receiving such
a letter? This session will aim to provide
answers to that question as attendees will
receive a behind the scenes view of the
internal process behind these inquiries from
manufacturer representatives. Panelists will
share methods and key indicators they look
for when determining whether to initiate
the formal inquiry process. A provider
representative will also discuss the latest
trends in this area and covered entity best
practices for responding to inquiries.
Emily Cook
Partner, McDermott Will & Emery LLP
Romit Kamdar
Partner, Akara Group
Aaron Vandervelde
Director, Berkeley Research Group
Maureen Testoni
Health (Moderator)
1:30 PM
Track Three—
Clinical Best Practices
Revolutionizing Care Post Affordable
Care Act
Health care is changing. 340B is changing.
Don’t be left behind! This session will discuss
programs that are implementing cutting-edge
practices in reducing costs to underserved
patients as we experience a revolution in
health care. See how effective sliding fee
and co-pay assistance programs paired with
patient engagement efforts can revolutionize
care for the most complicated cases. Come
to this session to learn from the “uber”
generation of health care providers in 340B.
Patrick Dunham
President and Chief Executive Officer,
Curant Health
Andrew Lowe
Clinical Director of Pharmacy, Arrowhead
Regional Medical Center
Mary Elizabeth Marr
Chief Executive Officer, Thrive Alabama
Lisa Scholz
1:30 PM
Small Group Discussions/Roundtables
A) Medicare Reimbursement
Principles for 340B Hospitals: Major
Issues and Current Trends
Two attorneys that 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 how to make a facility
provider-based and how to use the cost
report to determine and support the 340B
eligibility of facilities and patients.
Todd Nova
Shareholder, Hall, Render, Killian, Heath &
Lyman
Barbara Straub Williams
Principal, Powers Pyles Sutter & Verville PC
(Moderator)
B) ADAP Roundtable
Like other 340B covered entities, AIDS
Drug Assistance Programs (ADAPs) can
purchase drugs at 340B prices. Unlike other
CONFERENCE AGENDA
7
entities though, ADAPs can also receive
340B discounts by collecting rebates after
drugs have been dispensed. Under HRSA
guidance, ADAPs must take steps to ensure
that they do not collect a 340B rebate on a
drug that was purchased at a 340B price by
another covered entity. Panelists will address
different methodologies that ADAPs are
using to prevent this from happening and
will discuss how those methodologies have
affected other covered entities.
Eric Gutierrez
Health Policy Director, Los Angeles Gay &
Lesbian Center
Diana Jordan
Director, Division of Disease Prevention,
Virginia Department of Health
Sean Dickson
Manager, Health Care Access, National Alliance
of State and Territorial AIDS Directors (CoFacilitator)
Emily McCloskey
Senior Manager, Policy and Legislative Affairs,
National Alliance of State and Territorial AIDS
Directors (Co-Facilitator)
2:45 PM
Refreshment Break
Sponsored by (Booth 51):
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, with a particular emphasis
on ways to ensure replenishment occurs at
the 11-digit NDC level.
Jennifer Agee
Manager, Pharmacy Services Systems, Legacy
Health System
Corey Heiligmann
340B Analyst, Dartmouth-Hitchcock Medical
Center
Cindy Kehr
Director of Pharmacy Services, Keystone
Healthcare
Maureen Testoni
Health (Moderator)
3:45 PM
Track Two—340B Policy and
Compliance
A) Medicaid Billing & Reimbursement
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. Entities using virtual
inventory systems are also required to
replenish at the 11-digit national drug
code (NDC) level. Hospitals face particular
State Medicaid agencies continue to
issue 340B-specific rules on billing and
reimbursement of 340B drugs, and
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, the drug industry and a
representative of state Medicaid directors.
Panelists will discuss trends in Medicaid
billing and reimbursement for 340B drugs
as well as compliance obligations related
to duplicate discounts and strategies for
manufacturers to identify when duplicate
discounts have occurred.
George Oestreich
Medicaid Consultant, Apexus
#340bconf
3:45 PM
Inventory Management
8
Matt Salo
Executive Director, National Association of
Medicaid Directors
Jeff Davis
(Moderator)
B) Taking Corrective Action and
Making Repayments
Covered entities and manufacturers are
responsible for complying with 340B
program requirements and invest in
knowledgeable staff and sophisticated
software systems to do so. But even when
the most robust compliance efforts are
made, issues may arise, as 340B is complex
and evolving. Perhaps your organization
has chosen to validate its 340B compliance
status by conducting an internal audit or
HRSA has indicated that it will conduct
a formal audit of your organization. In
either instance, if a compliance problem is
identified, your organization will be required
to fix it and in some cases, take additional
corrective action. How will you know what
corrective action is needed and when you
need to take it? This session will address
these questions and cover: self-auditing
methods to identify compliance problems,
knowing when self-disclosure is appropriate
and how to self-disclose, creating and
implementing an effective corrective action
plan, calculating and offering refunds,
determining the appropriate look-back
period, resolving disputes, and guarding
against or minimizing potential liability. The
panel will include speakers who offer both
provider and manufacturer perspectives.
Josh O’Harra
Assistant General Counsel, Eli Lilly and
Company
Michael Ostrander
Chief Financial Officer, Nathan Littauer
Hospital and Nursing Home
Bill von Oehsen
Principal, Powers Pyles Sutter & Verville PC;
Outside Counsel, 340B Health (Moderator)
TWEET FROM YOUR SESSIONS!
Be sure to use #340bconf
3:45 PM
A) Advocating and Communicating the
340B Story
Badge Color: nnnnnn
This session is open to all health care
providers and HRSA grantees participating
in 340B, including C-Suite executives. The
battle over the 340B program is entering
a new and decisive phase in Washington.
It is imperative that healthcare providers
proactively support the program in the
media and persuasively make the case
with lawmakers. The session will cover
best practices in communications and
government relations as they relate to 340B.
Expand your toolkit with stories from experts
on the front lines.
Randy Barrett
Robert Chapman
Director, Josephine Ford Cancer Institute, Henry
Ford Health System
Melisa Lindamood
Director, Government Affairs, Johns Hopkins
Health System
Jennifer Taylor
Manager, Federal Affairs, National Association of
Community Health Centers
Kathryn DiBitetto
Director, Government Relations, 340B Health
(Moderator)
B) Third-Party Billing &
Reimbursement Roundtable
Over the last few years, a number of thirdparty payers and their pharmacy benefits
managers (PBMs) have tried to contract with
340B pharmacies on different terms than
those applied to non-340B pharmacies.
In most cases, the different terms include
paying 340B pharmacies at lower rates.
Some payers and PBMs are also requiring
pharmacies to identify 340B claims at the
point of sale. Speakers will address a range
of issues relating to 340B reimbursement
including:
• Why these trends are occurring
• How they impact covered entities and their
patients
• The payer’s perspective on the 340B
program and reimbursement of 340B
drugs
Alan Arville
Frank Messina
Greg Doggett
(Moderator)
C) 340B Vendor Perspectives
Are you preparing to issue an RFP for
consulting services to support your 340B
operations? Do you know the vendor
marketplace? This session is designed for
covered entities to hear vendor perspectives
and lessons learned from their extensive
experience with 340B.
Bruce Boelter
Vice President, National Practice Leader,
Intelligent Compliance Solutions
Ivy Espendez
Senior Manager 340B Compliance and Audits,
Sentry Data Systems, Inc.
Chad Gay
Director, Contract Compliance, Cardinal Health
Lori Grosso
Senior Vice President, PSG340B
Bryce Morsello
Chief Executive, Officer, Cirrus Pharmacy
Systems
David Sirowich
Executive Vice President, PBIRx
Lisa Scholz
5:00 PM
Adjourn
CONTINUING EDUCATION
To receive CE credit for the activities
at this conference, you must complete
the activity evaluations online no later
than Friday, August 14, 2015.
Call for
Winter
Conference
Speakers!
Do you have an interesting story to
tell? Have you considered sharing
your thoughts, ideas, experiences,
and expertise? The 340B Coalition
Conference is the nation’s most well
attended and respected venue for
stakeholders to hear the latest on
340B program developments and
implementation. We are interested in
receiving proposals on a broad range
of 340B-related topics, including
operations, policy, compliance, and
patient care. The conference will be
held February 17-19, 2016 in San
Diego, CA.
Speakers will have their conference
registration fee waived but will be
responsible for hotel and travel
costs. Please note that preference
is given to proposals from 340B
covered entities, pharmacies (retail,
independent, and specialty), and
pharmaceutical manufacturers.
We will not be able to select all
proposals.
The call for speakers is open
until Friday, September 25, and
we welcome early submissions.
Please visit www.surveymonkey.
com/s/MHLCXBK to view the
required information and application
form to learn how to submit
your proposal. Encourage your
colleagues to participate – share this
announcement!
Thank you for your interest, and we
hope to see you this winter in San
Diego. If you have any questions,
please contact Sam Wilhelm-Ross at
[email protected]
or 202-536-2280.
CONFERENCE AGENDA
9
WEDNESDAY, JULY 15, 2015
6:30 AM–7:15 AM
Charity Fun Walk in Rock Creek Park
(check-in will begin at 6:00 am)
Proceeds from the Charity Fun Walk will be
donated to Food & Friends, the only home-visiting
nutrition service in the DC Metro Region that
delivers hope by the meal to children and adults
living with critical illnesses, such as HIV/AIDS,
cancer and other life-challenging conditions.
Trevor Casey
Director of Pharmacy, Mount Desert Island
Hospital
Kevin Jones
340B Program Director, Intermountain
Healthcare
Sue Veer
President and Chief Executive Officer, Carolina
Health Centers
Jeff Davis
(Moderator)
8:00 AM
7:00 AM
Continental Breakfast and
Stakeholder Networking Opportunity
topic” board in the exhibit hall for table topic
to the attendees.
8:00 AM
8:00 AM
Track Two—340B Policy and
Compliance
Rural Provider Issues
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,
relevant 340B developments and HRSA
policy, and reasons why manufacturers and
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 track their orphan
drug purchases. This session will provide the
perspective of rural hospitals and community
health clinics and their experiences
managing 340B programs. There will
be a particular emphasis on the latest
developments with implementation of the
orphan drug exclusion and access to 340B
pricing on orphan drugs for rural hospitals.
#340bconf
The Future of Specialty Drugs
and 340B
10
payers use such networks. The panel also
will discuss how providers can try to address
these challenges, including developing their
own specialty pharmacies and entering
340B contract pharmacy arrangements with
specialty pharmacies, and the issues that
providers should consider when evaluating
potential solutions.
Michael Hess
Member, Bass, Berry & Sims PLC
Gary Johnson
Chief Pharmacy Officer, University of Kentucky
Healthcare
Greg Doggett
(Moderator)
Track Three—
Clinical Best Practices
How 340B Savings Improves Quality
While 340B becomes ever more important
in supporting hospitals, CHCs and other
covered entities in their mission to provide
care to all regardless of ability to pay, the
environment is evolving and the focus
has shifted to just how entities are serving
vulnerable populations. This clinical track
is designed for providers who wish to learn
more about connecting their 340B savings
to 340B’s purpose “to stretch scarce federal
resources and serve more patients through
comprehensive programs.” Learn how 340B
savings improve and strengthen patient
care programs, reach critically underserved
patients, and enable organizations to survive
the rising costs of pharmaceuticals and a
payor system moving from quantity to quality.
Lydia Klinger
Director, Virginia Commonwealth University
Ryan White and HIV Clinical Service Programs
Ed Shanshala
Chief Executive Officer, Ammonoosuc
Community Health Services
Mark Loafman
Chair, Family and Community Medicine,
Cook County Health and Hospitals System
(Moderator)
NEED A PLAYBACK?
Purchase materials and
select video recordings at
www.340bsummerconference.org
8:00 AM
A) Hospital Audit & Corrective Action
Plan Roundtable (hospitals only)
Badge Color: n
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.
Maureen Testoni
Health (Moderator)
B) 340B Vendor Perspectives
Are you preparing to issue an RFP for
consulting services to support your 340B
operations? Do you know the vendor
marketplace? This session is designed for
covered entities to hear vendor perspectives
and lessons learned from their extensive
experience with 340B.
Rita Baskett
Partner, Integrated Pharmacy Services, LLC
Gabrielle Scheer
Vice President, Strategic Initiatives, Macro Helix
Shafi Shilad
Vice President, Business Development, ScriptPro
Brian Ward
Vice President, Regulatory Affairs & Compliance,
SUNRx
Lisa Scholz
8:45 AM
10:45 AM
Refreshment Break & Prize Drawing
9:30 AM
HRSA Audit Update
As HRSA continues to enhance its oversight
of the program, audits of covered entities
remain a major point of interest for all 340B
stakeholders. This is a unique opportunity to
hear directly from HRSA on the latest audit
developments and the agency’s audit plans
for the near future.
Brad Lang
Public Health Analyst, Office of Pharmacy
Affairs, Health Resources and Services
Administration
Jane McLaughlin-Middlekauff
Pharmacist, Office of Pharmacy Affairs, Health
Resources and Services Administration
Jelani Murrain
Public Health Analyst, Office of Pharmacy
Affairs, Health Resources and Services
Administration
Sherry Pontell
Branch Chief, Program Performance and
Quality, Office of Pharmacy Affairs, Health
Resources and Services Administration
ProCE® is accredited by
the Accreditation Council
for Pharmacy Education
as a provider of continuing
pharmacy education.
Perspectives on 340B from
Government Watchdogs and Health
Care Researchers
The HHS Office of Inspector General (OIG)
and Government Accountability Office
(GAO) have become increasingly active
in their work on 340B in 2015. In March
2015, OIG and GAO representatives testified
before Congress on its oversight of program.
Both agencies are expected to release
additional reports in 2015 about the 340B
program, including 340B’s relationship to
Medicare Part B and Part D and duplicate
discounts, all of which could impact 340B
moving forward. Representatives from the
OIG and GAO will be joined by a prominent
Washington health care policy researcher
Joan DaVanzo. Ms. DaVanzo, of Dobson
& DaVanzo Associates, will discuss the
findings of a recent report her firm released
on the extent to which disproportionate
share hospitals that participate in the 340B
program focus their services on vulnerable
patient populations.
Geri Brennan
Assistant Director, Healthcare, U.S. Government
Accountability Office
Joan DaVanzo
Chief Executive Officer, Dobson & DaVanzo
Associates LLC
Ann Maxwell
Assistant Inspector General, Office of the Inspector
General
Maureen Testoni
Senior Vice President and General Counsel,
340B Health (Moderator)
12:00 PM
Conference Adjourns
MARK YOUR CALENDARS:
FEBRUARY 17–19, 2016
JULY 11–13, 2016
Hotel del Coronado,
San Diego, CA
Omni Shoreham Hotel,
Washington, D.C.
Winter 2016 Conference
www.340bwinterconference.org
Summer 2016 Conference
www.340bsummerconference.org
CONFERENCE AGENDA
11

View Full Agenda - 340B Coalition Summer Conference

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