Preparing for Compliance with the New MA Pharmaceutical and Medical Device Code of Conduct Law

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Preparing for Compliance with the New MA
Pharmaceutical and Medical Device Code of Conduct
Law

• January 23, 2008

Rupa M. Cornell Director, SEC Compliance and
Corporate Counsel
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Agenda

• Overview of Boston Scientific Corporation
• Compliance Challenges
• Approaches to Compliance
• Key Tactics for Compliance
• Summary

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Boston Scientific Corporation Profile

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Boston Scientifics Mission
Boston Scientifics Mission Statement
Boston Scientifics mission is to improve the
quality of patient care and the productivity of
health care delivery through the development and
advocacy of less-invasive medical devices and
procedures.
This is accomplished through the continuing
refinement of existing products and procedures
and the investigation and development of new
technologies that can reduce risk, trauma, cost,
procedure time and the need for aftercare.
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Broad and Deep Portfolio of Over 13,000 Products
Sampling of Boston Scientifics Product Portfolio
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Boston Scientific is Organized into Five
Businesses
International
Cardiovascular
Neuromodulation
Cardiac Rhythm Management
Endosurgery
Americas
Europe/ Middle East/Africa
InterventionalCardiology
Endoscopy

Asia / Pacific
Electrophysiology
PeripheralInterventions
Japan
Urology Gynecology
Neurovascular

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MA Statute Compliance Challenges

• Broad statutory language
• Bona Fide Services, Covered Recipients and
• Health Care Practitioners
• Clinical trials and RD included as part of
  Sales and Marketing activities?
• Vague language
• Fifty dollar threshold in aggregate or per
  transaction?
• Discounts and rebates
• Incomplete regulations

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Possible Approaches

• Broad approach to overall Health Care
  Practitioner (HCP) compliance taking Federal,
  state, local level laws into account
• Focused MA-only approach

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BSC Approach HCP Project

• Boston Scientific is approaching HCP compliance
  broadly
• HCP Project Team
• Focused on our policies, systems and processes
  involved in planning, approving, monitoring,
  controlling, compiling and reporting HCP
  payments/relationships
• To ensure compliance with legal requirements, as
  well as with desired standards of conduct
• Key to staff project with leadership and team,
  and identify and budget sufficient resources

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BSC Approach- HCP Project

• Comprehensive workplan that addresses near term
  HCP program requirements, and anticipates long
  term requirements
• Closely align required HCP project workflows
  with project teams, with defined
  objectives/deliverables
• Develop cross- functional teams, with subject
  matter experts, as well as those who use the
  systems, processes and policies on a day-to-day
  basis
• Develop a program that is compliant and works
• Smooth implementation for company and HCPs

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Key Tactics - MA

• Since regulations are not yet final and statute
  remains broad and vague, gather all possibly
  relevant data and refine once regulations are
  final
• Continue vigilant lobbying efforts until
  regulations are finalized

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Key Tactics - MA

• Information Technology is INTEGRAL CRITICAL
• Information Technology Considerations
• Identification of MA HCPs who fall within
  statutory requirements consider outside vendor
  for databases
• Working across multiple business unit/payment
  systems, for consolidation or common data
  warehouse possibilities
• Systems to track travel and expenses and other
  spending sufficient detail captured to comply
  with MA statute
• System controls and tools to ensure compliance
  with requirements
• Online training for various groups across your
  organization

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Key Tactics MA

• Define scope and elements of compliance,
  considering
• US vs. Global application
• Identification of applicable ethical codes,
  Federal, state, local laws
• Anticipate future requirements to identify long
  term requirements/functionality that may be
  required
• Plan project and workflows
• Understand companys current state
• Define expected end state
• Identify steps required to bridge from current
  state to expected end state
• Consider use of outside resources/advisors to
  assess current policies and procedures and
  recommended changes

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Key Tactics - MA

• Tee up key people and resources now
• Leadership
• Staffing
• Budget
• Develop appropriate cross-functional teams
• Legal
• Compliance
• Marketing
• Sales
• Communication
• Executive Management
• Clinical

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Key Tactics - MA

• Rolling Communication Plan
• Timing is critical
• Communicate on a high level now (e.g., National
  Sales Meetings)
• Be prepared to provide more specific
  communication as soon as the regulations are
  final
• Training
• Break-out sessions

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HCP Project Workflow

• Example of HCP Project Workflow Teams to address
  MA law or broader HCP initiative

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Summary

• Be proactive the time to act is NOW, even
  though regulations arent final
• Consider an approach that allows
  expansion/modification of MA compliance measures
  to meet other states, and likely Federal, law
• Communication and training are key

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Thank You

• Questions