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OVERVIEW

There is an ever increasing drive to ensure that Pharmaceutical and Medical Device companies avoid even the appearance of offering inducements to Healthcare Professionals (HCPs) through activities such as grants. Regulatory bodies are increasingly scrutinizing payments made by Medical Device, Pharmaceutical and Biotechnology Companies to healthcare professionals. The OIG, through its Compliance Program Guidance for Pharmaceutical Manufacturers, advised companies to separate the grant-making function from sales and marketing activities. More recently, lawmakers have been focusing on grants to HCPs and working to increase the financial transparency of companies' financial relationships with HCPs.

To effectively manage compliance risks, such as the grants process, a Company must ensure that it has a robust Compliance Framework that includes: comprehensive policies and procedures, documented processes, employee training, monitoring and auditing protocols, and periodic audits and evaluations.

In this 90 minute audio conference, we will review the following points and discuss a variety of steps companies can take to develop and implement a compliant grant process.

  • Current Trends:
    • Centers for Medicare and Medicaid Services;
    • HHS Office of Inspector General;
    • Department of Justice;
    • State Attorneys General.
    • US Senate Finance Committee
    • PhRMA Code Update

  • Key Risk Areas:
    • Are these payments potential inducements for product selection?
    • Could these payments be construed as a "kickback" or part of a "quid pro quo" arrangement?
    • Did these payments potentially initiate use of the product inappropriately?
    • Does your company have an auditable process?

  • Risk Management for Companies:
    • Demonstrate that the payments are for "bona fide purposes".
    • Demonstrate that the payments represent "fair market value"
    • Document clear and consistent criteria and process for grant approvals/denials
Sample Questions to be Answered
  • Evaluating the "Appropriateness" of Payments
  • Process to deal with risk for individuals in a position to influence a referral or formulary placement
  • Tracking the totality of your relationship with HCPs
  • Building a scalable process for future requirements
  • Using technology to assist in both streamlining and managing a compliant process
  • Recognize the risks with Sales and Marketing involvement
What Is an Audioconference?

It is a live event that includes session handouts, an interactive question and answer period, and access for an unlimited number of participants at each call-in site. However, only one site can be offered per registration. It is impermissible for an organization to purchase one registration and to operate multiple sites through an internal telephone system. During the live Audioconference participants will be able to ask questions and make comments. The Audioconference faculty has agreed to take follow-up questions via email. Audioconferences are simple, accessible, cost effective and reach a broad audience locally.

Who Should Listen:
  • Regulatory and Compliance Professionals
  • Grant and Contract Managers
  • Legal
  • Executive Management
Audioconference Materials:

All Faculty Materials will be Posted on the CME Audioconference website: www.CMEAudioconferences.com/CMEAudio20081209 in downloadable PDF Formats.





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