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Managing Change: Regulatory and Compliance

Managing Change: Regulatory and Compliance. Diane Benson, CTSM Global Events Manager GE Healthcare, Medical Diagnostics Kathy Clarke Managing Partner SageRock Advisors, LLC. Disclaimers and Disclosures.

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Managing Change: Regulatory and Compliance

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  1. Managing Change: Regulatory and Compliance Diane Benson, CTSM Global Events Manager GE Healthcare, Medical Diagnostics Kathy Clarke Managing Partner SageRock Advisors, LLC

  2. 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 company’s 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.

  3. 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?

  4. 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?

  5. 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 HCP’s? 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?

  7. Resources: Corporate Integrity Agreements: https://oig.hhs.gov/compliance/corporate-integrity-agreements/index.asp Physician Payment Sunshine Act: http://www.policymed.com/physician-payment-sunshine-act/ http://www.policymed.com/2012/11/physician-payment-sunshine-act-american-medical-association-voices-concerns-over-potential-implement.html http://www.policymed.com/2012/03/physician-payment-sunshine-links-to-comments-to-cms.html Transparency Initiatives (FDA): http://www.fda.gov/AboutFDA/Transparency/TransparencyInitiative/default.htm Related Articles: Pens Vs. Payments: http://www.forbes.com/sites/matthewherper/2011/09/27/pens-vs-payments-in-pharmaceutical-marketing Dollars for Docs- http://thoughtbroadcast.com/2011/09/25/dollars-for-docs-what-it-really-means/

  8. Thank you! See you in Austin at the HCEA Annual Meeting, June 22-25

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