Given the impact of some of the sunshine regulations, this presentation was delivered in response to letting healthcare professionals know that the value of the reprints they receive from industry may be reported to various state and federal agencies as part of the companies obligations under the Accountable Care Act

1. BioPharma Advisors Network
Communication with Recipients
December 11, 2013

2. Agenda
 What’s at issue?
 What is the best way to let a physician know
that a reprint or educational item may have a
reportable value?
• Especially if it is coming through medical
information.
 What are the implications for the future?
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3. Who is BioPharma Advisors


Started firm in 2002
Focus on 3 areas of life
science commercial and
clinical activity
•
Key Opinion Leader
management & contracting
 Development of FMV
survey methodology
•
•

Patient Adherence and
Behavior Change
Digital Marketing
Expert at Product launch
planning and execution
•
Launched over 25
pharmaceutical brands over
20+ years in the industry
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4. Polling Question
 How many believe you need to let HCP’s
know about this issue?
 How many of you currently have work
ongoing or have launched a project looking
at this issue?
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5. How should applicable manufacturers
determine the value of journal reprints
provided to covered recipients?


The value of a journal reprint should reflect the cost that an
applicable manufacturer or applicable group purchasing
organization paid to acquire the reprint from the publisher or other
distributor.
• CMS has developed a uniform reporting system for journal
reprints which is the cost of the acquisition of the reprints from
the publisher by the manufacturer or GPO divided amongst the
individual recipients.
Applicable manufacturers and applicable group purchasing
organizations may submit an assumptions document clarifying
any assumptions made to determine the value of journal
reprints.
Note: Washington Legal Foundation has raised constitutional questions about including education items
such as books and reprints in reporting.
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6. What’s at issue here,
how do you communicate this value?

Provision of reprints as a
service TO the HCP
• Several ways to
communicate
• Discuss the Fair Market
Value

Provision of reprints as a
component of a consulting
contract.
• Cover the cost inside the
context of the consulting
contract.
Develop a compliance
checklist that will help you
determine how you need to
let the physician know.
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7. Compliance Questions Checklist





Does the HCP have a existing contractual relationship with
the company?
Did the sales or marketing organization offer up this
information without the HCP request?
Are there an excessive amount of reprint requests for this
individual HCP?
Is there documentation that tracks how much this service
was actually provided to this individual HCP?
Is the HCP receiving additional benefits tied to the
company’s product or service?
Yes to any of the questions
increases the regulatory risk
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8. Benefits To This Approach


Regulatory authorities will see management has begun to
establish an infrastructure for compliance to be essential
• Will provide compliance guidance & policies to reprint
distribution
• Employees will be trained on compliance policies
• The company will begin to monitor & update HCP policies
• Allows management the ability to take action when
necessary
Setting Valuation
• Will demonstrate a consistent and logical methodology is
applied when reporting this as physician compensation
• Will establish internal thresholds for reporting
• Will provide defensible documentation as to why the reprints
where provided.
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9. What are some of the channels?
 Cover Letter with the reprint
• Attached to hard copy
• In security protected PDF
 Signature reply that HCP received the reprint
 A quarterly report provided to the HCP as
part of their overall disclosure process.
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10. What are the implications for the
future?



This issue is an example of more regulation that can
strangle a company’s ability to provide relevant scientific
information
Questions still remain with accredited CME including further
clarification on the other accreditation bodies that meet the
accreditation standards of one of the five listed accrediting
bodies including the ACPE (Pharmacists), COPE
(Optometrists) and the AANC (Nurses).
With less than 30 day to recording payments, companies
have limited time to prepare for some of the changes
coming from the Q&A.
©BioPharma Advisors LLC
www.BioPharmaAdvisors.net
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11. BioPharma Advisors Network
Thank You!
Robert Nauman
BioPharma Advisors
rnauman@mybpa.net
(919) 336-5026