BioPharma Advisors Network

Communication with Recipients
December 11, 2013
Agenda
 What’s at issue?
 What is the best way to let a physician know
that a reprint or educational item may have a
rep...
Who is BioPharma Advisors



Started firm in 2002
Focus on 3 areas of life
science commercial and
clinical activity
•

K...
Polling Question
 How many believe you need to let HCP’s
know about this issue?

 How many of you currently have work
on...
How should applicable manufacturers
determine the value of journal reprints
provided to covered recipients?




The valu...
What’s at issue here,
how do you communicate this value?


Provision of reprints as a
service TO the HCP
• Several ways t...
Compliance Questions Checklist






Does the HCP have a existing contractual relationship with
the company?
Did the ...
Benefits To This Approach




Regulatory authorities will see management has begun to
establish an infrastructure for co...
What are some of the channels?
 Cover Letter with the reprint
• Attached to hard copy
• In security protected PDF

 Sign...
What are the implications for the
future?






This issue is an example of more regulation that can
strangle a company...
BioPharma Advisors Network

Thank You!
Robert Nauman
BioPharma Advisors
rnauman@mybpa.net
(919) 336-5026
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Ways to let a physician know that a reprint or educational item may have a reportable value

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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

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Ways to let a physician know that a reprint or educational item may have a reportable value

  1. 1. BioPharma Advisors Network Communication with Recipients December 11, 2013
  2. 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? ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 2
  3. 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 ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 3
  4. 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? ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 4
  5. 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. ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 5
  6. 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. ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 6
  7. 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 ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 7
  8. 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. ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 8
  9. 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. ©BioPharma Advisors LLC www.BioPharmaAdvisors.net 9
  10. 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 10
  11. 11. BioPharma Advisors Network Thank You! Robert Nauman BioPharma Advisors rnauman@mybpa.net (919) 336-5026

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