Clinical Compliance Programs:Investigator Payments, GCPs, and More….

Teri Crouse, J.D.Director of Compliance for Healthcare & Marketing

High Level Overview

…And More• OIG Guidance and Medical departments• CME / ACCME• Field-Based Medical Personnel

Transparency and Firewalls OR

How to achieve separation between commercialization and medical/scientific areas

Counseling Medical on OIG Compliance

What is your client’s current perspective on compliance?

• Medical generally: GCP mentality, process/SOP focused

• OIG focus is INTENT: Not just what, but also why

“Intent” and “One Purpose”

Question is intent: not impact, not amount, not whether legitimate service was rendered,…

Kickback if any one purpose of offer is to induce …

Grant ($)

Pharma Company

Healthcare Provider

Purchase ($)

The standard of scrutiny

“There is no true intent, only perception of intent”

Opportunities to establish perceptions of improper intent are numerous

Example: Investigator-initiated grant program• At initiation of request• Prior to consideration• During consideration• When communicating decision• During conduct of research

“Intent” and Investigator Payments

Difficult to get Medical/Scientific areas to understand the “follow the money” mentality

Fair Market ValueWhat work is being performed?

What is the value of the researcher’s time “on the market”?• Are you hiring a world thought leader? • A regional thought leader?

Can this site / investigator speed up your trial? • He / she has a large pool of potential patients • He / she has a proven track record in conducting clinical research and following GCPs

“Intent” and off-label promotion

Question of intent in medical research:

Conduct and publish off-label studies to answer important scientific questions and disclose those answers to the medical community

vs.

Conduct and publish off-label studies to promote off-label use through investigators’ study experience and physicians hearing study results

Question of intent in Medical Science Liaison role:MSLs provide special medical expertise in addressing HCP questions regarding company products

vs.MSLs discuss company products with HCPs to promote off-label uses of company products

“Intent” and the For-Profit Pharma Company

“But ultimately, isn’t everything we do designed to sell our products?”

• Intent vs. consequence

• General intent vs. specific intent

Ensuring Behaviors Align with a Valid Intent

Exercise: – Clearly define the purpose of your activity,

– Vigorously align your actions with that purpose

– Challenge anything that creates contrary perceptions

Ensuring Behaviors Align with a Valid Intent Example: Investigator-initiated Grant Program Roles of Medical and Marketing

– Funding source– Communications with requester– Consideration of request– Monitoring progress of research

Valid decision-making– Criteria for decision-making– Application of criteria– Source of request– Amount of request

Follow through– Structure of grant support– Monitoring progress

ACCME and CME

Increasing concern over “control” by sponsors• Reaction: increased stringency on conflict of interest

rules• Increased stringency toward role of sponsor in CME

What is the future of Pharma-sponsored CME?

ACCME and CME

Increasing concern over “control” by sponsors• Reaction: increased stringency on conflict of interest

rules• Increased stringency toward role of sponsor in CME

What is the future of Pharma-sponsored CME?

Confusion over Field-Based Personnel

Sales reps vs. Medical Science Liaisons

Promotional or not?

Where to draw the line

Role of the Sales Representative

To detail customers on your products

To provide samples

To provide customer service

They are the face of your company to your customers- Being Responsive, but not always the

Responder

Role of the Medical Science Liaison

To interact with Thought Leader physicians

To develop relationships with potential research physicians

To help evaluate potential research physicians

To answer questions (not to prompt questions!)

To provide customer service

They are also the face of your company to your customers- Being Responsive, but not always the Responder

A hypothetical situation A customer asks a sales rep if the company could provide

funding for an upcoming regional medical society conference.

Does the rep respond:

A)Can you tell me how many other doctors on my call list will be there and will there be a presentation about my product?

B)No problem doc, since you are such a big writer.

C) You will have to submit a grant request to the appropriate department at my company. Here’s the information on how to submit your request.

A customer tells a sales rep she is considering doing a small study with your product and wants to know if she could get a research grant.

A hypothetical situation

Does the rep respond:

A) I’ll check with my district manager. I think he has some extra money right now.

B) Only if you’re going to purchase the product.

C) Our medical department evaluates all research funding requests based on the scientific merit of the proposal. I can only provide you with the contact information for that department.

A customer asks your rep to do a literature search for information about one of the known side effects of your product.

A hypothetical situation

How does the rep respond:

A)Runs to the university medical library and copies all the articles he can find.

B)Tells the doctor not to worry about that side effect, it’s really not a big deal.

C)Tells the doctor he will submit a request for your medical department to send the information they have related to the side effect.

While your rep is making a sales call on a customer who is being considered for participation as a clinical investigator, the customer complains that they have contacted the medical person at your company with a question, but haven’t received back a reply.

A hypothetical situation

How does the rep respond:

A) Tell me your question, and I’ll contact the medical person again for you.

B) Tell me your question, I can probably answer it for you.

C) I will contact the medical person or their supervisor and ask them to get back with you as soon as possible.

How can you be certain that your sales reps would know that only answer C is appropriate in each of these hypothetical situations?

And the answer is….

Implement a complete Compliance Program

ComplianceProgram

Policy &

Procedures

Training

CommunicationMonitor &Audit

Owner

Discipline Process

CorrectiveActions

Summary

In order to maintain the “firewall” between Sales & Marketing and Medical Personnel

• Develop clear policies and procedures• Provide training on ”real world” scenarios• Monitor to assure compliance• Take corrective action, if necessary