Document 423347

3085 STEVENSON DRIVE, SUITE 200, SPRINGFIELD IL 62703 | 217-529-6948 |
American Society for
Pharmacy Law
Developments in Pharmacy Law
Seminar XXV
November 6 - 9, 2014
Hyatt Regency Indian Wells Resort & Spa
Indian Wells, California
We invite you to join us to attend 12 informative educational sessions
and earn 15 hours of legal and pharmacy continuing education
credits while networking with your colleagues and friends.
ACPE Continuing Education Credits
Participants may earn up to 15 contact hours (1.5 continuing education
units) of Accreditation Council for Pharmacy Education (ACPE)-accredited
continuing pharmacy education (CPE) credit. Sessions approved for CPE credit are
listed with an ACPE universal activity number and number of continuing education
units. To receive credit for successful completion for any activity, the participant must
complete an attendance form and an activity evaluation form at the conclusion of the
program. Verification of participation will be reported to the CPE tracking service, CPE
Monitor, within 4 weeks after the program, and will then be accessible to participants at
You will need your NABP e-profile ID to note on your CE form so that it may be
reported to CPE Monitor. If you have not yet obtained your NABP e-Profile ID, you may do
so by visiting, creating an e-Profile, and registering for CPE Monitor.
Be sure to register for CPE Monitor to ensure that your e-Profile ID is fully activated.
The Washington State University College of Pharmacy is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing pharmacy
CPE now requires that all pharmacy continuing education (CE) credits must be
processed and claimed no later than 60 days from the date of the live activity.
Continuing Legal Education Credits
If you intend to apply for continuing legal education credits, please
be sure to indicate the state (or states) in which you are licensed
and the corresponding license number(s) on the conference registration form. Quarles & Brady,
LLP will process the CLE credits for the Developments in Pharmacy Law Seminar.
Continuing Legal Education credit will be applied for based on attendee return of the
“Continuing Legal Education Credit Certificate of Attendance Form” at the conclusion of the
Register Today at
2014 Developments in Pharmacy Law Seminar XXV SEMINAR AGENDA
American Society for Pharmacy Law
November 6 - 9, 2014
Hyatt Regency Indian Wells Resort & Spa - Indian Wells, California
Thursday, November 6, 2014
8:30 am – 5:00 pm
ASPL Board Meeting
3:00 pm – 5:00 pm
Registration Open
5:30 pm – 7:00 pm
ASPL Opening Reception
12:00 pm– 1:00 pm
Registration Open
7:00 am – 8:00 am
8:00 am – 8:15 am
1:00 pm – 3:00 pm Case Law Update
Once again, there have been significant court decisions affecting
many areas of pharmacy and the pharmaceutical industry. This
presentation will summarize cases involving pharmacy board
decisions, pharmacists’ liability, product liability, drug product
labeling, the Federal False Claims Act, anti-kickback claims, and
Roger Morris, RPh, JD, Quarles & Brady, LLP; William Stilling, RPh, MS,
JD, Parsons Behle & Latimer (2 credit hours)
Friday, November 7, 2014
7:00 am – 5:00 pm
requirements, and increased patient-related demands.
John S. Linehan, Ober/Kaler (1 credit hour)
8:15 am – 9:45 am Legislative and Regulatory Update
Federal and state legislative and regulatory activity that impact
payment for medications, professional services, and government
initiatives that impact the quality and safety of medications
constantly evolve and legal professionals in pharmacy must
understand the impact of these changes to pharmacists and
pharmacies. This session will provide an update on the latest
developments in federal and state regulations impacting
pharmacy and pharmacists including compounding, Medicare
Part D, health care reform, controlled substances, and provider
Mary Jo Carden, RPh, JD, Academy of Managed Care Pharmacy
(1.5 credit hours)
9:45 am – 10:00 am Break
10:00 am– 11:00 am Update: Mitigating False Claims Act and
Consumer Protection Exposure for Retail Pharmacies
Retail pharmacies’ vulnerability to whistleblower cases under
federal and state False Claims Acts has grown as government
reimbursement expands and costs to government payors
increase. At the same time, state consumer protection agencies
are becoming more active in investigating pharmacies and
threatening injunctions and penalties to enforce their regulations.
This interactive session will review recent enforcement trends for
retail, mail order and specialty pharmacies.
Barbara Rowland, Principal; John Joseph, Principal, Post & Schell, PC
(1 credit hour)
11:00 am – 12:00 pm The Legal Implications of Pharmacist
Provider Status: the Past, Present, and Future of a
Transformative Movement
This presentation will explore the quest for pharmacist provider
status by outlining the history of the movement, current legislative
and lobbying efforts, and the potential industry-wide impact and
significance of provider designation. In addition to providing upto-date information on federal and state legal reforms, this session
will explore how the practice of pharmacy may be transformed
through greater regulatory scrutiny, expanded credentialing
3:00 pm – 3:15 pm
3:15 pm – 4:15 pm What’s Next?: The Ever Changing
Landscape of Pharmacy Compounding
This presentation will shed light on the expected impact on
pharmacy compounding from the Drug Quality and Security Act
on pharmacies and pharmacists. Attendees will gain insight on the
history and foundation of pharmacy compounding, highlighting
past case law and FDA guidance and focusing on recent legislative
and FDA actions. The presentation will focus on both the expected
challenges and the likely opportunities for pharmacists presented
by the DQSA as it is implemented.
Frank Palumbo, PhD, Esq, University of Maryland School of Pharmacy
Center on Drugs & Public Policy; Lee Rosebush, PharmD, RPh, JD, MBA,
MS, BakerHostetler (1 credit hour)
4:15 pm – 5:15 pm Maintaining an Effective Controlled
Substance Compliance Program
This session will provide strategies and tools for companies to
use in maintaining an effective program to comply with federal
and state requirements on the receipt, storing, distribution and
dispensing of controlled substances. It also will emphasize areas
such as where investigators/inspectors are known to focus their
inspections, how to be prepared for these inquiries, when and if
to authorize employee interviews, the importance of developing
techniques to “audit the investigator” and how to “own your data”
to ensure ongoing compliance and successful audits. John A. Gilbert, Jr, JD, Hyman, Phelps & McNamara, PC
(1 credit hour)
6:30 pm – 8:30 pm
Afternoon of Golf
Are you interested in playing a round of golf on Saturday? We
would play at the hotel golf course (if available) or at a local golf
course starting at 12:00 noon. Format (e.g., scramble) and cost will
be dependent upon the number of players, but a fair estimate is
$130. Please respond to Aaron Moore by Sept. 5, 2014 if you intend
to play and/or have any questions at [email protected] or 410783-4994.
Register Today at
Saturday, November 8, 2014
7:00 am – 12:00 pm
Registration Open
7:00 am – 8:00 am
8:00 am – 10:00 am Ethics: A Case-Based Approach
This session will study legal and pharmacy ethics as they relate
to ethical decision-making both for the pharmacist and the
lawyer. The program will explore legal and pharmacy ethics by
interacting with the lawyers and pharmacists in the audience
while examining decisions and incidents, real and hypothetical,
in both professions.
Ken Baker, BS Pharm JD, Renaud Cook Drury Mesaros, PA; Bruce D.
White, DO, JD, Alden March Bioethics Institute (2 credit hours)
10:00 am– 10:15 am
10:15 am– 11:15 am Implications of the Drug Quality and
Security Act on Track and Trace Requirements
On November 27, 2013, President Obama signed into law the
Drug Quality and Security Act (H.R. 3204). Title II of the Act, the
Drug Supply Chain Security Act, establishes a national system
for tracing pharmaceutical products through the supply chain
and sets national licensing standards for wholesale distributors
and third-party logistics providers. This Act will change the way
prescription drugs are distributed in the United States over the
next 10 years. This session will discuss these changes and their
impact on stakeholders.
Martha Russell, Cardinal Health; Susan Pilch, JD, National
Community Pharmacists Association (1 credit hour)
11:15 am – 12:15 pm What Should CIA’s Be Telling Me? Using
Recent Corporate Integrity Agreements to Inform and
Assess Your Compliance Program’s Effectiveness
Corporate integrity agreements (“CIAs”) are a common feature of
health care fraud settlements and they offer important lessons
about expectations for effective compliance programs for health
care providers. CIAs shed light on the government’s thinking on
industry best practices, and help organizations to identify risk
areas and to benchmark their own compliance practices. This
presentation will discuss trends in recent CIAs and what they
mean for pharmacies and related organizations not under a CIA
Deborah Gersh, Partner; Brett Friedman, Partner, Ropes & Gray
(1 credit hour)
2:00 pm– 4:30 pm
Pharmacy Law Educators
Join other pharmacy law educators to share information and
materials to assist with course development and student
Sunday, November 9, 2014
7:00 am – 12:00 pm Registration Open
7:00 am – 8:00 am
8:00 am – 9:00 am Pharmacy and the Continuum of Lethal
Lethal injection drug shortages in the US are disrupting the capital
punishment process. This program reviews clinical, legal, and
ethical implications of lethal injections, including: (1) scientific/
clinical origins; (2) key jurisprudential cases; (3) supply chain disruption;
and (4) fundamental ethical principles involved. Dilemmas in supply chain
disruption are an opportunity for the professions of pharmacy and law
to reflect on the objectives of lethal injection in civilized society.
James Ruble, PharmD, JD, University of Utah College of Pharmacy
(1 credit hour)
9:00 am – 10:00 am Use of Technology for Telepharmacy and
Remote Dispensing
This interactive session will provide a comprehensive overview of remote
dispensing and telepharmacy regulations from a patient, pharmacy,
physician, healthcare facility perspective as well as an overview of
technology advancements in the field of remote pharmacy services. The
session also will focus on a variety of related federal and state regulations
as well as operational issues associated with the technology. Practical
operational and regulatory considerations applicable when developing
remote dispensing/telepharmacy regulation, particularly concerning
the integration of the technology into an existing IT infrastructure will
be discussed.
Loreto Grimaldi, JD, Medavail Technologies; Michael Simko, RPh, Walgreens
(1 credit hour)
10:00 am – 10:15 am Break
10:15 am – 11:45 am Marijuana: The Evolving Issues
This program will summarize the state of state marijuana laws, legal
implications of real-life clinical and business issues that arise in all states
as a result of the conflict between federal and state laws, and ethical
considerations for attorneys who advise clients and pharmacists who
participate in a marijuana business.
Laura Carpenter, RPh, JD, LLM, Carpenter Law Firm PC; William Stilling, RPh,
MS, JD, Parsons Behle & Latimer (1 credit hour)
A block of rooms has been reserved for the ASPL Seminar at the Hyatt
Regency Indian Wells Resort & Spa, Indian Wells, California. The resort is
located at 44600 Indian Wells Lane, Indian Wells, California 92210.
Room Rate is $169 plus 11.25% tax. Call 1-888-421-1442 to make your
reservation. Be sure to identify yourself with the ASPL meeting to receive
this special rate. The hotel reservation cut-off date is October 14, 2014.
When you make your room reservation, you will need to guarantee
the room with a credit card. The cancellation of a guaranteed reservation
must be received 72 hours prior to arrival to avoid a charge of one night’s
room and tax. Space is limited so make your reservations today!
Air Transportation: The Hyatt Regency Indian Hills Resort and Spa is
conveniently located 15 miles from Palm Springs International Airport.
Ground Transportation:
Rental Car: Eight (8) National chains service the Palm Springs
International Airport: Alamo, Avis, Budget, Dollar, Enterprise, Hertz, National
and Thrifty.
Taxi: Taxis are available curbside, outside baggage claim. Approximate
cost is $60 (plus gratuity) each way.
Shuttle: Service First Transportation, 760-272-0960. Vehicles
accommodate 1-6 passengers in courteous and clean comfort. Fee from
Palm Springs International Airport is $80 (plus gratuity) each way.
2014 Developments in Pharmacy Law Seminar XXV
November 6-9, 2014
Hyatt Regency Indian Wells Resort &
Indian Wells, California
Last Day to PRE-Register for seminar - OCTOBER 24, 2014
Please print or type participant information exactly as you would like it to appear on your badge. Please use a
separate form for each registrant.
Name: _________________________________________________________________________
Credentials: (i.e. RPh, JD, PharmD, etc.) ______________________________________________
For CLE Credit, please provide:
Licensure State(s): ______________________ License #(s) _______________________________
To Register Online Now!
Please indicate:
 Pharmacist
 Attorney
 Pharmacist/Attorney
 Student
 Technician
 Paralegal
 Other _____________
Company: _____________________________________________________________________
Address: _______________________________________________________________________
City: ___________________________________ State: ____________ Zip: __________________
Phone: ____________________ E-mail: ______________________________________________
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Phone: ________________________________________________________________________
Please indicate which meals
you/guests plan to attend:
Thursday q Reception
q Breakfast
q Lunch
q Reception
Saturday q Breakfast
Sunday q Breakfast
You have a choice between receiving your conference
Registered guest(s): _____________________________________________________________
materials electronically on a thumb drive or in a conference
binder. Please select one option.
 I am a first time ASPL Conference attendee
 I plan to attend the Saturday afternoon Pharmacy Law
Educators Session
 I want my materials electronically on a Thumb Drive
 I want my materials in print via a Conference Binder
Register by October 17 For Early Bird Discount
 ASPL Member
 Nonmember
 Spouse/Guest
 Student  Tech.  Paralegal
One Day Registration:
 ASPL Member  Fri
 Sat Sun
 Nonmember  Fri
 Sat Sun
 Student  Tech.  Paralegal
 Fri
 Sat Sun
By 10/17
After 10/17
$370.00 $200.00
$175.00 $100.00 $205.00
Total Fees: _________________
Payment Method:
 Check enclosed for full payment.
Please charge my:  MasterCard  Visa
Card Number: ______________________________________
Exp. Date: _______________________ CVV#___________
Name on Card: ____________________________________
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Registration fee for Seminar includes attendance at all seminar sessions,
breakfast, refreshment breaks, Thursday and Friday receptions, Friday
lunch and all seminar materials.
Cancellation policy: Cancellations must be received in writing. You can email to
[email protected] or fax to 217-529-9120. Your cancellation is null
and void unless you receive confirmation of cancellation from the ASPL office.
Refund of registration (less a $50 administrative fee) will be granted for cancellations
received in writing on or before October 1, 2014. Refund of registration (less a
$150 administrative fee) will be granted for cancellations received in writing after
October 1, 2014 but on or before October 31, 2014. Refunds will not be granted for
no-shows or cancellations received after October, 31, 2014 regardless of cause. In
the event of a no-show or cancellation after October 31, 2014, meeting materials
will be forwarded to the address provided on your registration form.
Register on-line at
ASPL is accepting on-line registrations at
or, you can mail registration form to:
American Society for Pharmacy Law
3085 Stevenson Drive - Suite 200 - Springfield, IL 62703
or fax to: 217-529-9120.
Payment must accompany registration.
Direct registration questions to
Janet Bascom at [email protected] or 217-529-6948
ASPL is a 501(c)(3) non-profit, voluntary professional association and all contributions
are fully tax deductible. The ASPL Federal Tax ID Number is: 52-1250852.