CME Collaboration

 Operations
Administration

• Medical Education Department

  • Where it resides within the corporate organizational structure

    • Independent

    • Medical Affairs

    • Other

• Organizational structure of unit (Director, Assistant, Manager)Designated individual at a senior level position, or an executive committee accountable for overseeing Med Ed unit’s compliance with guidelines

  o Numbers of medical education personnel in unit and educational background

  o Responsibilities assigned by product/therapeutic category

  o Primary point of contact to enhance efficiencies

Financial

• Identification of where Med Ed funding originates and where grants are sourced
   

• Person(s) responsible for budget allocation and grant review and disbursement

Compliance Program

• Med Ed relationship to other departments/units in company
   

• Corporate CME guidelines and processes communicated to other internal units
   

• Role of regulatory or legal in overseeing CME activities and who is responsible for the ultimate approval, ie, “sign-off”
   

• Compliance officer that oversees CME compliance
   

• Historical perspective re: regulatory breaches/warnings
   

• Published procedures to address warnings
   

• SOPs established for commercial support
   

• Utilization of a referral list for CME providers versus a preferred vendor list

Professionalism

• Service to the CME community
   

• Active participation in relevant organizations (ACME/PACME, PhRMA, others)
   

• Employees holding leadership positions in service organizations

Educational Framework

Knowledge Base & Core Competencies

• Preparation of strategic educational plans and participation in long-range plans for respective franchises
   

• Documented understanding of adult learning principles and application to CME
   

• Ongoing training programs for med ed personnel
   

• Med ed personnel clearly make the distinction between education and promotion and demonstrate that understanding
   

• Company-specific SOPs regarding interaction with providers; evidence of transparent collaboration
   

• Types and numbers of programs supported
   

• SOPs in place re: grantor review to accommodate timelines

CME Process

• CME provider: collaborator vs. vendor relationship

  • Patient care focused

  • Learner focused

  • Grant process

    • Grant process review done electronically, via phone, hard copy, etc.

    • If electronic, a grant process liaison is assigned to address inquiries

  • Procedures and guidelines for med-ed unit input into CME

  • Procedures that govern interface between marketing, med-ed unit and CME provider: published SOPs

  • Procedures result in complete internal and external transparency

Assessment of learning and behavioral change

• Appreciation that the support of an outcomes strategy creates regulatory transparency
   

• Demonstrated ability to support programs that generate outcomes data
   

• Interest in support of educational interventions that

  • Utilization of proven methods to measure knowledge gained, application of knowledge to practice and behavioral change

  • Differentiation of change in physician behavior and patient outcomes (patient component beyond provider and/or physician control)

  • Differentiation of intent to change and resulting barriers to change

• Support of practical and cost-effective means to assess outcomes

  • Support of an integrated educational strategy that includes measurement of outcomes

Selection Criteria for Grantors in Assessing Potential Providers

Operations
Administration

• Corporate, staffing, and organizational structure (parent organization; marketing/advertising separate from education)
   

• Number, credentials, and specialty of personnel (ie, editorial capabilities, project management skills, CME expertise, etc.)
   

• Demonstrated expertise in therapeutic area(s) of interest
   

• Demonstrated ability to collaborate with multiple stakeholders
   

• Demonstrated ability to meet or beat established deadlines

Financial

• Operational capabilities including the level of documentation and support the company deems necessary to evaluate and substantiate expenses associated with an educational activity (therapeutic/clinical issues, etc.)

Compliance Program

• Appropriate written policies and procedures concerning specific risk areas including:

  • Firewall structure and integrity

  • Policies to ensure that industry directs personnel to CME provider for the provision of the following: fees, travel reimbursement policy, conflicts of interest, etc.

  • Appropriate communication and responsiveness

  • A means of handling incoming communications including appropriate channels of communication for employee and customer complaints

  • A system to monitor and periodically assess the CME provider’s systems for compliance

• Appropriate procedures to manage corrective action
   

• Appropriate policies describing disciplinary actions that can arise from breach of the CME provider’s compliance requirements
   

• Mechanism for resolving conflict of interest issues

Professionalism

• Service to the CME community
   

• Active participation in relevant organizations (ACME/MECCA, NAMEC, others)
   

• Employees holding leadership positions in service organizations; ACCME site surveyors, etc.

Educational Framework

Adult Learning Principles

• Application of adult learning principles throughout the educational design process based on education and/or training
   

• Examples of application: small group discussion, audience response systems, learning over time methods, reinforced learning; question and answer

Accreditation

• Current accreditation status; number and type of accreditations held from various agencies
   

• The results of recent assessments and a review of past and pending complaints received by the CME provider (provider could submit last letter of ACCME accreditation as evidence)
   

• If not accredited, can provide a list of which providers are partners
   

• Demonstrated ability to partner with other providers; track record of collaboration

Educational Design

• Input into planning should reflect a shared function of inter-divisional stakeholders who address the following questions from their individual perspectives:

  • Procedures result in complete internal and external transparency

  • Identification of unmet medical needs

  • Existence of clinical data to satisfy those needs

  • Identification of learning objectives required for understanding and to improve delivery of care

  • Identification of target audiences: clinical, patient, etc.

  • Methods to communicate the educational learning objectives by type of audience

  • Definition of success

  • Identification of remaining educational gaps post activity

Assessment of learning and behavioral change

• Appreciation that the inclusion of an outcomes strategy creates regulatory transparency
   

• Demonstrated ability to generate outcomes data
   

• Proven methods to measure knowledge gained, application of knowledge to practice and behavioral change

  • Differentiation of change in physician behavior and patient outcomes (patient component beyond provider and/or physician control)

  • Differentiation of intent to change and resulting barriers to change
     

• Practical and cost-effective means to measure outcomes

  • Integrated educational strategy that includes measurement of outcomes