With the patient at the true center of next generation care, it is critical to stay on the cutting edge of what is required for compliance monitoring, particularly for specialty products. With a focus on patient interactions and associated programs, this Helio presentation highlights how the automation of a company's compliance monitoring and implementation of an analytics engine can produce real-time results and identify best practices to be applied to business intelligence for future activities.

1. Automating Compliance Monitoring
of Patient Programs in Light of Recent
Government Scrutiny
February 28, 2018

2. Disclaimer
PROPRIETARY & CONFIDENTIAL | 2
The views expressed and ideas presented in this session are those of the
speakers and are not necessarily shared by the presenters’ employers.
Any examples provided are hypotheticals and should not be attributed to
any individual company.

3. Introductions
Manny Tzavlakis
Managing Partner
Helio Health Group
Chapman Richardson
Global Head of Data
Consumerization
Sanofi
SPEAKERS
PROPRIETARY & CONFIDENTIAL | 3

4. Agenda
PROPRIETARY & CONFIDENTIAL | 4
 Patient Services Compliance Landscape
 Patient Services Monitoring – Automation
 Potential Use Cases / Scenarios

5. Patient Services
Compliance Landscape

6. Industry Landscape
INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS
PROPRIETARY & CONFIDENTIAL | 6
Patient Services
Program
Financial
Support
Benefits
Education
Pharmaceutical companies have created patient
services programs to aid patients in the use of
their products by providing support and
reimbursement services.
Pharmaceutical and biopharmaceutical
manufacturers have begun receiving more
attention, legal scrutiny and activity from
government and other entities regarding various
components of their patient support services
programs.
Due to the changing landscape in the healthcare
reform act as well as the increased number of
specialty pharmaceuticals, this new attention
and focus on compliance is becoming an
increasing risk that companies are beginning to
address.

7. Industry Landscape
INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS
PROPRIETARY & CONFIDENTIAL | 7
While there are many business and process considerations in creating and executing patient services
programs, if not managed or executed correctly, these programs can increase companies’ risk in
various areas for litigation and investigations. Various government investigations have caused
companies to examine aspects of their patient services programs for compliance and risk mitigation
Warner Chilcott Agrees to Plead Guilty to Felony Health Care Fraud Scheme and Pay
$125 Million to Resolve Criminal Liability and False Claims Act Allegations
Aegerion Agrees to Plead Guilty to Submission of False Claims to Federal Health Care
Programs and Pay more than $35 Million to Resolve Criminal and Civil Liabilities.
Office of Inspector General 2014 Supplemental Special Advisory Bulletin: Independent
Charity Patient Assistance Programs Addressed Trend of PAPs Establishing Specific
Disease Funds Limited to Subset of Available Products
Government Accountability Office Report States that Coupon Programs for Privately
Insured Patients Could Impact Medicare Part B Drug Spending
DOJ Led by the US Attorney’s Office of Massachusetts Has Issued At Least Ten
Subpoenas Related to Charitable PAPs
Founder and Owner of Insys Therapeutics Inc., Arrested and Charged with Conspiracy
to Profit by Using Bribes and Fraud for Illegal Distribution of Cancer Pain Medication

8. Industry Landscape
INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS
PROPRIETARY & CONFIDENTIAL | 8
Recent settlements with the OIG, which saw
United Therapeutics pay $210 million to
resolve kickback claims for contributions to
copay assistance charities, have resulted in
companies entering into Corporate Integrity
Agreements (“CIAs”) providing the industry
with a first glimpse on how federal agencies
plan to monitor companies on their Patient
Services programs.
The agreements shine light and guidance
into a key area of focus - Patient Assistance
Programs (”PAPs”) - where companies can
potentially influence charities on who or
where to allocate support for patients in
need of drug funding.
Patient
Assistance
Programs
StandardizingCriteria
andControlsfor
Donations
EmphasisonPolicies&
Procedures(Budget,
Communications,etc.)
Establish Clear
Roles &
Responsibilities
Live & Automated
Monitoring of
Interactions
“Specifically, OIG seems focused on patient charities with
narrowly defined diseases that allow companies with
relevant products to sidestep the independence required to
avoid anti-kickback violations”

9. Industry Landscape
INCREASED SCRUTINY OF PATIENT SERVICES PROGRAMS
“Sales staff passed around intricate
spreadsheets, with thousands of
rows each, on potential patients,
including details such as birthdates
and information about symptoms,
doctor, and hospital.”
“Nurses reported directly to sales,
and the pressure to lock in and
keep customers was often heaped
on them because they had the
most access.”
PROPERTY OF HELIO HEALTH GROUP. ALL RIGHTS RESERVED | PROPRIETARY & CONFIDENTIAL | 9

10. Potential Risk Areas
PROPRIETARY & CONFIDENTIAL | 10
ALONG THE PATIENT JOURNEY – EXAMPLE
Example Patient
Experience: Each
company provides
different patient support
services based on the
specific product. Some
companies internally
manage various
components of patient
support services while
other outsource all
services or portions to
HUBs or Specialty
Pharmacies.

11. Patient Services Monitoring –
Automation

12. Compliance Monitoring: Patient Services
MITIGATING RISK WHILE SUPPORTING EXECUTION
PROPRIETARY & CONFIDENTIAL | 12
Increasing scrutiny of the relationship between industry and patients highlight the
importance of ensuring patient service programs are not only compliant with existing
regulations but also mitigating any perceived risks. The following are examples of
compliance initiatives that support patient service activities:
Establish compliance
controls to mitigate
risk through
processes and
documentation of
activities
Institute field
monitoring:
in-person and digital
Implement firewalls
between sales
activities and case
management
Create advanced
compliance programs
utilizing analytics and
automated digital
audits

13. Compliance Monitoring: Patient Services
The implementation of an analytics engine
can produce real-time results when
monitoring your patient services program.
Discovered outcomes are addressed and
identified best practices identified will be
applied to business intelligence for future
activities.
ARCHITECTURE & METHODOLOGY
IDENTIFY &
PREPARE DATA SETS
• Gather relevant data
• Normalize, aggregate
and bridge data to
obtain insights from
full range of
information
• Identify key
measures to utilize in
analysis
DATA ANALYSIS
• Establish comparative
criteria and measures
for analysis
• Develop algorithms to
evaluate data
• Score risk areas and
organize risks by
priority
• Anticipate future risk
from historical
contexts and trends
CREATE
VISUALIZATIONS
• Develop supporting
visualizations to
provide valuable
insights
• Develop full view to
understand scale of
identified risks
REMEDIATION
• Develop strategic plan
to mitigate identified
and potential risks
• Determine gaps,
weigh key attributes
and identify areas of
improvement to
prevent future
occurrences
PROPRIETARY & CONFIDENTIAL | 13
ENGINE

14. Compliance Monitoring: Patient Services
IDENTIFY & PREPARE DATASETS
CRM Patient
Consent
Data
Patient
Support
Territory
Alignment
CRM Call
Notes Data
CRM
Materials
Provided
Attachments
from Call
Notes
Approved
Materials for
Product ListPatientID
Patient
SupportID
ProductID
ProductNDC
The key to gathering insightful information is to
prepare accurate data. By gathering relevant
datasets and normalizing the information, a
biopharma can optimize analytic capabilities.
The key to this model is to bridge datasets to extract
the full range of intelligence for patient services and
compliance teams to evaluate.
50
55
60
65
70
75
80
85
65 75 85 95 105 115
HCPRx's
Details (Field Nurse)
Normalize datasets to
define risk constraints
PROPRIETARY & CONFIDENTIAL | 14

15. $-
$5
$10
$15
$20
$25
$30
2012 2013 2014 2015 2016
PAPPaymentAmounts
x100,000
0
2
4
6
8
10
12
14
2012 2013 2014 2015 2016
PAPPayments
Compliance Monitoring: Patient Services
DATA ANALYSIS
Next step is to establish risk criteria and measures
to analyze the datasets against. Based on these
measures, algorithms can be developed to dissect
the data and provide the required compliance
monitoring metrics. Algorithms can be run as often
as the data is updated to provide up-to-date, real-
time results.
A data engine will also weigh these attributes with
historical context to measure how likely future
violations will occur. Key stakeholders can then
decide next best actions and allocate the proper
resources to minimize those prospects.
The goal is to continuously refine the engine to
consistently provide value to each company’s
Compliance program.
Data Sets
Create & Apply
Algorithms &
Perform
Analysis
Summary
PROPRIETARY & CONFIDENTIAL | 15
y = 36667x + 90000
R² = 0.222
$-
$1
$2
$3
$4
$5
2012 2013 2014 2015 2016
AveragePAPPaymentAmount
x100,000

16. Compliance Monitoring: Patient Services
VISUALIZATIONS
Visual dashboards will provide the supporting
details to help our clients understand where
areas of risk are occurring and the story behind
these areas. Helio strives to give our clients the
full view of the landscape before assessing next
steps.
PROPRIETARY & CONFIDENTIAL | 16

17. Compliance Monitoring: Patient Services
LIVE MONITORING AND ADDITIONAL AUDIT FUNCTIONALITY
A Patient Services team or its delegates (vendors) should create and document live monitoring or other
assessments and audits of its various groups and employees.
This functionality allows all qualitative and quantitative analyses to be completed and compiled in the same
tool. Additionally, and engine will summarize the data and create visualizations of the outcomes of these
audits / monitoring activities for additional usage or presentations.
The inputs of these audits / monitors or reviews can be updated and changed at any time by managers of
the tool. Examples of usage of these can be patient advocate speaker program monitors, patient support
services team ride-a-longs, hub audits, etc.
PROPRIETARY & CONFIDENTIAL | 17

18. Compliance Monitoring: Patient Services
REMEDIATION
Based on the results of the data analysis, a biopharma should look for summaries of
identified risk areas and group them by category. Risk summary will indicate issues with
high priority and suggest actionable recommendations for remediating identified risks as
next steps.
The key is to develop strategic plans to mitigate risks and to prevent them from happening
in the future.
PROPRIETARY & CONFIDENTIAL | 18

19. Patient Use Cases / Scenarios

20. Compliance Monitoring: Patient Services
Patient Consent
Patient & HCP Interactions
Patient Communication
Patient Materials
POTENTIAL COMPONENTS & DATA SOURCES
PROPRIETARY & CONFIDENTIAL | 20
The following are some high level areas that has various components that can be
monitored to address various risks. Additionally, from a Patient Services standpoint,
this may include monitory services provided by HUB providers or internal services,
based upon who is conducting the activity.
Prior Authorizations / Appeals
Patient Adherence
Patient Data Usage & Sharing
Patient Assistance Programs (PAPs)

21. Use Cases / Scenarios
PATIENT CONSENT
PROPRIETARY & CONFIDENTIAL | 21
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
Were any patients contacted by Patient Services
Support Team (Internal / HUB / SP)
1. without consent?
2. prior to receiving patient consent?
3. or during lapse in consent (when restarting a
drug or expired consent form)?
Are inactive patients at risk of patient consent
lapse (data violations)?
• HUB or Internal CRM Patient Consent Dates
• CRM Call Notes & Details
• CRM Patient IDs
• Comparison of patients enrolled in patient services
program to list of patients agreeing to consent
• Comparison of patient enrollment dates to patient
consent dates
• Comparison of CRM call note dates for Patient
Services team members to patient consent dates
• Comparison of consent end and restart dates
within CRM call note details
• Comparison of patient consent end dates to
product shipment dates
• Potential HIPAA Violations

22. Use Cases / Scenarios
PATIENT & HCP INTERACTIONS – ANALYSES ON CALL LOGS
PROPRIETARY & CONFIDENTIAL | 22
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
Are there any patients or HCP activity outliers in
the Patient Support Services call activity logs?
Examples:
1. Are injection education nurses conducting
more than one training per patient?
2. Are there any reimbursement specialists
spending too much time on a specific territory
/ HCP?
3. Are patients responding to field nurse follow-
up calls?
• Patient Support Services Territory Information
• CRM Call Notes
• HUB Call Notes
• SP Call Notes
• HCP information (CRM) including patient scripts
• Total number of patient injections vs number
of patients; highlight instances totaling more
than allowable per patient (by product)
• Total calls by reimbursement specialist vs total
number of prescriptions; Highlight outliers for
total calls vs prescriptions
• Total calls for field nurses (answered calls vs
messages left and returned by patient);
compare percentages of answered
• Effectiveness of Patient Services Team activities
and interactions with HCPs and Patients
• Potential ANTI-KICKBACK issues

23. Use Cases / Scenarios
PATIENT & HCP INTERACTIONS – ANALYSES ON POST-INTERACTION SURVEYS
PROPRIETARY & CONFIDENTIAL | 23
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
Did the patient or HCP indicate any negative
behaviors/interactions with Patient Support
Services in follow-up surveys:
Examples:
1. Did the field nurse provide fair and balanced
medical advice?
2. Did the reimbursement specialist provide
information on diagnostic/medical codes for
prior authorizations?
• Post-Interaction Survey Results
• Number of instances where patient or HCP
indicated a field nurse mentioned competitor
products
• Number of instances where patient support
services provided diagnostic codes to an HCP
while filling out diagnostic codes
• Potential instances where a rep or patient
support team member mentioned off-label
indications to a patient or HCP
• Direct feedback from HCPs and patients on the
quality of interactions with Patient Support
Services
• Effectiveness of Patient Services Team activities
and interactions with HCPs and Patients
• Potential ANTI-KICKBACK issues
• Potential Off-Label interactions

24. Use Cases / Scenarios
PATIENT COMMUNICATION
PROPRIETARY & CONFIDENTIAL | 24
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
Are Patient Support Services / HUBs communicating
the following when working with patients or HCPS:
1. Providing safety vs. efficacy in fair and
balanced statements
2. Utilizing approved "scripts"
3. Answering questions utilizing approved FAQs
verbiage
Confirming that they are not:
1. Providing medical advice to patient
2. Discussion off-label indications or answering
off-label questions
• Call Notes & Details
• Voice Recordings of Patient Calls
• ICD-9 / 10 Codes
• Call Script Language
• FAQ Language
• Voice monitoring of calls with Support
Services for off-label, medical advice, script
adherence, fair & balanced utilizing key
terms based on product, scripts, label, etc.
• Patient support services call note monitoring
for support services for off-label, medical
advice, script adherence, fair & balanced
utilizing key terms based on product,
scripts, label, etc.
• Off-label messaging
• Compliance with company policies / procedures
• Provision of medical advice

25. Use Cases / Scenarios
ADVERSE EVENTS
PROPRIETARY & CONFIDENTIAL | 25
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
• Are adverse events mentioned on calls
properly documented, addressed and
reported by HUB, Patient Services
support or Specialty Pharmacies?
• Voice recordings
• CRM Call Notes
• AE Reports
• Voice Analytics and call note monitoring
for key adverse events terms
• Comparison identified adverse events to
adverse events reporting system
• Potential identification of adverse events that
have not been reported or have not been
reported accurately
• Compliance with company policies / procedures

26. Use Cases / Scenarios
PRIOR AUTHORIZATIONS / APPEALS
PROPRIETARY & CONFIDENTIAL | 26
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
• Are company employees / delegates
(reimbursement specialists, sales reps, etc.)
aiding in filling out, completing, or submitting
prior authorization forms or appeals
• Are those individuals coaching HCPs and / or
the HCP staff on language for prior
authorizations or appeals (diagnoses)?
• Call Notes
• ICD 9 / 10 Codes
• Voice Recordings
• Pas / Appeals
• Hand-writing analysis via machine learning
(if prior authorization / appeals are
available)
• Monitoring ICD 9 / 10 code data
• Reviewing sales reps and reimbursement
specialist call notes
• Voice analytics and call monitoring for key
terms
• Potential for False Claims

27. Use Cases / Scenarios
OFF-LABEL
PROPRIETARY & CONFIDENTIAL | 27
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
• Is the Patient Services support
team providing support to off-
label patients?
• ICD-9 / 10 Codes
• HUB Data
• Free Product / Copayment Data
• Review co-payment & free
product information for
prescribed for off-label
indications
• Potential for Off Label mentions

28. Use Cases / Scenarios
PATIENT ASSISTANCE PROGRAMS (PAPS)
PROPRIETARY & CONFIDENTIAL | 28
Potential Insights
Questions to Answer
Key Data Sources
Example Metrics
1. Are government insured patients
receiving product from PAPs (i.e. Co-
Pay Support and Free Product)?
2. Are ineligible patients receiving
access to co-payment or free drug
program support from PAPs?
• HUB
• CRM (Insurance Information, Co-
payment information, free product
information)
• Comparison of patient insurance
information against patients currently
enrolled in PAPs
• Comparison of patient insurance
information, tax return, income,
diagnosis info, etc. against approved
eligibility criteria for PAPs (specific to
company and product)
• Anti-kickback government insured
employees receiving PAPs
• Ineligible patients receiving PAPs

29. Contact Us
Manny Tzavlakis
Managing Partner
(201) 966-9656
mtzavlakis@heliohealthgroup.com
PROPERTY OF HELIO HEALTH GROUP. ALL RIGHTS RESERVED | PROPRIETARY & CONFIDENTIAL | 29
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