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

BioPharma Advisors Network

Communication with RecipientsDecember 11, 2013

www.BioPharmaAdvisors.net©BioPharma Advisors LLC

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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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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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?

4




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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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.

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Develop a compliance

checklist that will help you

determine how you need to

let the physician know.




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?

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Yes to any of the questions

increases the regulatory risk




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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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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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.

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BioPharma Advisors Network

Thank You!

Robert Nauman

BioPharma Advisors

[email protected]

(919) 336-5026

mailto:[email protected]

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

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