Managing Change: Regulatory and Compliance

1
Managing Change Regulatory and Compliance

• Diane Benson, CTSM
• Global Events Manager
• GE Healthcare, Medical Diagnostics
• Kathy Clarke
• Managing Partner
• SageRock Advisors, LLC

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Disclaimers and Disclosures

• Independence - The contents and opinions within
  this presentation are the opinions of Diane
  Benson and Kathy Clarke and do not necessarily
  reflect the opinions of HCEA, GE Healthcare, any
  GE entity, or SageRock Advisors LLC.
• Sole Merit The material in this presentation is
  for general informational/discussion purposes
  only. It is not legal opinion or binding advice
  and is not intended to deal with or disclose
  particulars of any specific pharmaceutical,
  medical device, or other healthcare companys
  practices. For specific advice, it is
  recommended that you consult with your own
  corporate legal counsel and compliance officials.
• Neither Diane nor Kathy has any active paid
  relationships to HCEA, the sponsors of this
  program.

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Change Management
 

• In what ways has the preparation for the
  Affordable Care Act /PPSA created unexpected
  opportunities (positive or negative) either
  individually or company-wide?
• Are there examples to be shared?
• What criteria were used to define strategies
  needed to prepare for the impending new laws?
• Development of cross-functional teams
• Timelines
• Key stakeholder identification
• Trigger points to re-evaluate and re-establish
  outcomes/timelines
•  
• Of these areas, which have presented the most
  challenge and what was done to de-escalate or
  remove the challenge and get back on track?
• Example, setting thresholds or developing
  guidelines
• Understanding the desired outcome
•  
• Did understanding one challenge create
  new challenges?

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Corporate Integrity Agreements

• How can your company lessen the likelihood of
  being placed under a CIA? (or lessen the pain, if
  already under one?)
• Rigor, transparency, self-reporting
• How do you promote your investigational drugs at
  trade shows (medical pipeline)? Any co-mingling
  w/commercial? How are you managing staffing for
  your booths?

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Transparency Initiatives

• Fully vetting your consultants speakers
• Investigate any possible conflicts of interest
  i.e. serving on safety review board, boards of
  directors, participating in active clinical
  trials (perception of undue influence)
• Are you using them too frequently? Paying them
  too much? Where can you find guidance?
• What are your corporate guidelines for payment of
  honoraria? Do you have a threshold of aggregate
  spend?

6
Physician Payment Sunshine Act

• What processes does your company have in place
  for the collection of data for reporting
  transfers of value and aggregate spend to HCPs?
• How has this impacted you? Do you feel prepared?
• Are the show organizers with whom you exhibit
  collecting NPI numbers as part of the
  registration process?

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Resources Corporate Integrity Agreements https/
/oig.hhs.gov/compliance/corporate-integrity-agreem
ents/index.asp Physician Payment Sunshine
Act http//www.policymed.com/physician-payment-su
nshine-act/ http//www.policymed.com/2012/11/phys
ician-payment-sunshine-act-american-medical-associ
ation-voices-concerns-over-potential-implement.htm
l http//www.policymed.com/2012/03/physician-paym
ent-sunshine-links-to-comments-to-cms.html Transp
arency Initiatives (FDA) http//www.fda.gov/About
FDA/Transparency/TransparencyInitiative/default.ht
m Related Articles Pens Vs. Payments
http//www.forbes.com/sites/matthewherper/2011/09/
27/pens-vs-payments-in-pharmaceutical-marketing D
ollars for Docs- http//thoughtbroadcast.com/2011/
09/25/dollars-for-docs-what-it-really-means/
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Thank you!

• See you in Austin at the
• HCEA Annual Meeting, June 22-25