COGNIZANT 20-20

Helping Pharmas
Manage Compliance
Risks for Speaker
Programs
By taking a rigorous and thoughtful approach
that pivots around key performance indicators,
pharmaceuticals companies can proactively
identify and solve noncompliance challenges
with speaker programs before they impact the
bottom line.

Cognizant 20-20 Insights | February 2017

Executive Summary

Among the many promotional and marketing strategies used by pharmaceuticals companies,
one of the most widely used and necessary components in the industry is the speaker
program event. Pharma companies typically use peer-to-peer speaker programs to promote
and educate healthcare professionals (HCPs) about their drug therapies and the diseases
their drugs treat. The interactions between HCPs through such events not only affect
prescribing patterns but also help HCPs stay up-to-date on the latest molecules, newly
approved drug indications, the latest clinical data and safety issues, among many other
things.

But over the past few years, speaker program events have become a bone of contention in
the industry as they tend to be misused. For example, some programs have provided
opportunities for pharma companies to promote off label use of their drugs, which is
illegal. In such instances, companies have been heavily penalized - and in some cases the
resultant fines are estimated to be billions of dollars. As a result, multiple rules and
regulations have been enacted by various U.S. government bodies, trade associations, and
pharmaceuticals companies themselves, to ensure program compliance.

This white paper examines key rules and regulations surrounding speaker programs and
provides an overview of how we believe pharma companies can proactively identify and
solve noncompliance challenges before they impact the bottom line.
Cognizant 20-20 Insights

Figure 1. Layers of Speaker Program Compliance

Pharma companies conduct speaker program events for which they use SMEs to present
approved educational materials to medical and associated professionals. These speaker
programs must adhere to specific rules and regulations which are set by the government,
trade organizations, and internally - as shown, respectively, below.

Office of Inspector General Code on Interactions with Office of Ethics and Compliance
Corporate Integrity Agreement Health Care Professionals Financial Compliance Team
Physician Payments Sunshine Act Legal Office
Sales & Marketing Operations

DECONSTRUCTING SPEAKER Attendees: Attendees are primarily HCPs

PROGRAMS
A speaker program event typically consists of one
or more speakers, multiple attendees and the
company representative who is responsible for
arranging the program venue, topic and speaker.
(prescribers, nurses, technicians, etc.) or
non-HCPs (office staff, patients), and their
medical specialty must correspond with the
topic of the speaker program. Attendees are
typically provided a meal at these events as a
courtesy for their time.

Speakers: Speakers at such events are
typically subject matter experts (SMEs)
approved by the companys internal review
organization who have credentials and have
undergone speaker training. They can be HCPs
(national, regional and/or local key opinion
leaders) or non-HCPs (business or best-prac-
tice experts). Speakers are paid a fee for
service based on fair market value (FMV)
determined by their credentials.
Topic: Presentation materials used must be
compliant and reviewed by the U.S. Food and
Drug Administration (FDA). Material can
consist of the benefits, safety and usage of the
product, or the diseases it treats, or it can be
completely unrelated to the product. The
speaker must present all the material provided;
any modifications made should be approved
before the material is presented.

Helping Pharmas Manage Compliance Risks for Speaker Programs | 3

Cognizant 20-20 Insights

CONSEQUENCES OF Report overpayments, reportable events and

NONCOMPLIANCE ongoing investigations/legal proceedings.

During the past nine years, 10 of the worlds major
pharmaceuticals companies have been penalized a
combined $12.9 billion by the government
(see Figure 2) and are now operating under a
corporate integrity agreement (CIA) for violating
speaker program rules enforced by the Office of
Inspector General (OIG). CIAs typically last five
years and make corporate officers personally
liable for the companys compliance with
stipulations set forth by the CIA. These agreements
usually require the following:
Hire a compliance officer/appoint a
compliance committee.
Develop written standards and policies.
Implement a comprehensive employee
training program.
Retain an independent review organization to
conduct annual reviews.
Provide an implementation report and annual
reports to U.S. OIG on the status of the
entitys compliance activities.
A part of the Affordable Care Act (ACA) known as
the Physician Payments Sunshine Act covers
physician financial transparency reports. This
legislation requires manufacturers of drugs,
medical devices and biologicals that participate in
U.S. federal health care programs to report certain
payments and items of value given to physicians
and teaching hospitals.
The Pharmaceutical Research and Manufacturers
of America (PhRMA) is a U.S. industry trade group
that represents pharmaceuticals research and
biopharmaceuticals companies and advocates for
public policies that encourage the discovery of
new medicines for patients. They have codified
rules concerning interactions with HCPs for the
trade groups members to abide by. (The

Figure 2. Financial Consequences for Noncompliance with a Blockbuster Drug

GlaxoSmithKline
$3 Bn
Johnson &
Pfizer
Johnson
$2.3 Bn
$2.2 Bn

AbbVie
Eli Lilly
$1.5 Bn
$1.4 Bn
Merck
$950 Mn Amgen
AstraZeneca
$762 Mn
$520 Mn Sanofi- Boehringer
Aventis Ingelheim
$109 Mn $95 Mn

2012 2009 2013 2012 2009 2011 2012 2010 2012 2012

Penalties levied by the Office of Inspector General on each company during recent years.

Helping Pharmas Manage Compliance Risks for Speaker Programs | 4

Cognizant 20-20 Insights

Figure 3. A Framework for Speaker Program Compliance

Vendor Data Speaker Information RSVP Data Attestation Data

Client Data Specialty Data Budget Data Topic Information
Expenses Attendee Information Contract Information Food Ordered Info
Compliance Transparency of speaker payments
Allowable Aggregate Speaker Programs with high catering
RSVP
Meal Spend Contract expenses
Requirement
Limit Analysis Confirmation
Speakers who are paid incorrect
Honoraria for Approved Annual honoraria
Attestation
Cancelled Specialty Plan Attendees attending the same
Questions
Programs Monitoring Monitoring topic multiple times
Speakers without a contract
Programs without attendees
Guideline HCPs who promote off-label usage
of drugs
Attendee Speaker Meal F&B
Frequency Attendance Consumption Management Speakers with an expiring contract
Speakers attending programs on
the same topics they spoke on
Percent of topics unutilized
Efficiency Programs where F&B ordered was
Speaker less than the number of attendees
Material Program Attendee
Bureau Percent of speakers unutilized
Management Costs Summary
Management
Planned vs. actual

peer-to-peer speaker programs are considered a
form of interaction with HCPs.)
As mentioned above, companies that have a CIA
are also required to hire a compliance officer
and/or appoint a compliance committee. These
entities must set company policies to prevent
inappropriate engagements as well as to
preempt any activity that could be perceived as
misconduct.
Our process involves, initially, defining or
identifying the various metrics or key
performance indicators (KPIs). These KPIs would
be based on the relevant laws, regulations,
policies, standards, procedures or contractual
obligations to which the organization must
conform. These include the CIA, the Sunshine
Act, the PhRMA code on interactions with HCPs,
and the pharma companys own internal
regulations and guidelines, among others.

IDENTIFYING NONCOMPLIANCE Some of the compliance areas covered are the

following:
Our solution proposed in Figure 3 not only helps
to identify cases of noncompliance but will also
help a pharma company to more efficiently
manage speaker programs, in turn making them
more effective. It will also enable the company to
identify the gaps in its compliance systems and
processes and help it define the guidelines
required to close them.
Transparency of speaker payments: All
expenses paid to speakers and other transfers
of value (i.e., meals) can be tracked for each
individual speaker in a calendar year. This can
be tied to the type of program (lunch/dinner/
teleconference), the number of times each
speaker presented, the number of attendees,
whether the program took place or not (to

Helping Pharmas Manage Compliance Risks for Speaker Programs | 5

Cognizant 20-20 Insights
According to a companys CIA, it must
submit annual plans that identify the
business needs for various publication
activities (including speaker programs) and
the estimated numbers of such activities.
monitor potential kickbacks) and brand-
related information. Excessive expenses
(hotel, airfare, etc.) can be identified and new
rules can be set to prevent further risks. This
would be in accordance with a CIA as well as
the Sunshine Act.
Excessive value of company-provided
meals: This would satisfy transparency and
PhRMA guidelines, which stipulate that each
meal should be of nominal value and is
provided as a courtesy. Importantly, it should
not be used to influence an attendee or a
speaker.
Signed contract confirmation: For every
speaker program, a statement of work (SOW)
or contract must be signed between the
speaker and the organization that details the
speakers fee-for-service, expenses, topic to
be covered, etc.
Approved specialty monitoring: To prevent
the promotion of off-label use of its drugs,
companies must ensure that attendees are
appropriate to the topic presented. The
approved specialty is usually determined by
FDA parameters covered in the speaker
program.
RSVPs: To ensure that the event has a
minimum number of attendees apart from
Helping Pharmas Manage Compliance Risks for Speaker Programs
the speakers and reps, speaker programs are
required to have a minimum number of RSVPs
a few hours prior to the event. The minimum
number may vary based on the event type.
Annual plan monitoring: According to a
companys CIA, it must submit annual plans
that identify the business needs for various
publication activities (including speaker
programs) and the estimated numbers of
such activities. The plans also identify the
budgeted amounts to be spent on such
activities. Speaker bureau size, number of
programs and amount spent on programs are
tracked.
Meal consumption: Companies are allowed
to provide a nominal meal as a courtesy to
the attendees and speakers for participating
in a speaker program. They will set limits on
frequency of meals consumed by attendees
to avoid the perception of the meal serving as
a kickback. In addition, reporting on the meals
consumed will be utilized for transparency of
payments and transfer of value to HCPs
(attendees and speakers).
Food and beverage management: When
speaker programs are held in a physicians
office, the meals provided are intended for only
those individuals who attend the speaker
program. HCPs at the physicians office not
| 6
Cognizant 20-20 Insights
attending the speaker program are not
permitted to receive food intended for
attendees (i.e., distribution of leftovers is not
permitted). So, the amount of food ordered
should not exceed the requirements for the
number of actual attendees or other parameters
set forth by the company, such as RSVPs.
Speaker bureau management: Companies
can track the frequency of speaker utilization
(national/regional/local key opinion leader
(KOL) and non-KOL), average attendance size
per speaker, attendee mix per speaker (doctor,
physicians assistant, etc.), speakers with
expiring contracts, etc.
Presentation decks management: Companies
can track the frequency of utilization, average
number of attendees per topic, average
Helping Pharmas Manage Compliance Risks for Speaker Programs
attendee mix (doctor, physicians assistant,
etc.), expiring topics, etc.
Attendee summary: Companies can track the
number of attendees by program type (in-
office, out-of-office or teleconference),
attendee category, etc.
Speaker program costs summary: Speaker
program-related expenses can be tracked for
better budget management. Expenses can be
categorized into expense types, such as
speaker expenses (honoraria, travel, meals,
etc.), pass-through costs (A/V costs, room
rentals, management fees, etc.) and catering.
These expenses can also be viewed by program
type.
| 7
Cognizant 20-20 Insights

ABOUT THE AUTHOR

Bill Restrepo Bill Restrepo is a Senior Associate within Cognizants

Analytics & Information Management Practice. He has over
Senior Associate 15 years of experience in data analysis/analytics (the past four
with Cognizant). Prior to Cognizant, Bill worked for companies
in the life sciences, medical devices and scientific equipment
industries. While at Cognizant, he has worked on projects for
multiple pharmaceuticals clients. Bill has a bachelors degree
from the University of Illinois Urbana-Champaign. He can be
reached at Guillermo.Restrepo@cognizant.com.

ACKNOWLEDGMENTS

The author would like to thank Navin Vipin for his contributions
to this white paper.

Helping Pharmas Manage Compliance Risks for Speaker Programs | 8

ABOUT COGNIZANT
Cognizant (NASDAQ-100: CTSH) is one of the worlds leading professional services companies, transforming clients business, operating and
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