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 Value What 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 Compliance Program Policy & Procedures Training Communication Monitor & Audit Owner Discipline Process Corrective Actions

Policies and Procedures Develop policies and procedures for Sales and Marketing personnel and corresponding Medical department policies Grant requests ­ Educational ­ Research Medical information Interactions between Medical personnel and Sales and Marketing personnel

Training and Communication Explain the importance of the “firewall” between Medical and Sales / Marketing Clearly outline roles and responsibilities Train on Anti-Kickback law and the OIG guidance Cover how to handle “real world” situations in the proper manner – Use scenarios – Give verbatims – Model the appropriate behavior

Monitoring and Auditing Review district expenses Attend sales meetings Ride with reps Review call notes Audit grants

Corrective actions Provide a hotline for reporting violations Investigate any findings or reports Implement corrective actions –Discipline –Preventive measures

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