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Case Study: Medical Science Liaisons
            With the advent of Corporate
           Integrity Agreements, our client
          came to Best Practices, LLC with
                  several questions.


           Our team of experts explored
          ways to deliver exceptional MSL
            Services to various customer
           groups and stakeholders in an
              increasingly challenging
               business environment.


              Here’s what they found.
                                              1
The Challenge: explore MSL management options
and potential impact of a CIA

                         What do MSLs          What MSL management
 What do Medical                                                        How do MSLs develop
                         provide to Key        changes and risks have
 Science Liaisons
                         Opinion Leaders       arisen? How do           and manage internal
 (MSLs) Services look
                         (KOLs)? How do they   Corporate Integrity      and external
 like? What methods
                         do so, and how        Agreements impact        relationships?
 do they employ?
                         often?                companies?




                                                 Gather data and             Improve MSL
                                                  establish best           management and
                                                  practices from            create value for
                                                  benchmarking             various customer
                                                       class                   segments



          Your Problem               Our Research               Your Solutions         2
Case Study Focus: MSL management
trends and mitigating CIA-inducing risks

                                •     General Observations
Research Focus Areas


                                •     KOL management
                                •     Internal services and activities
                                •     Payer group support and education
                                •     Hospital and health care access
                                •     Emerging trends and mitigating risks
                                •     MSL group structure and oversight

                       Your Problem          Our Research   Your Solutions   3
Our initial assumption that those companies with CIAs would
be much less restrictive turned out to be untrue.
  “How restrictive is your company now compared to 12-24 months ago and how will it be in the next 12-24 months in
                                regards to MSL interaction with healthcare providers?”
                     Total Benchmark Class                                           CIA Companies
80%                                                                                                  Compared to 12-24
                          (n=32)                                                         (n=8)       Months ago
                                                                                                     Next 12-24 Months

                                                                                             63%
60%                              58%
                           54%
                                                                                       50%

        42%
40%           38%                                                  38%



                                                                          25%

20%
                                                                                                       13%    13%

                                             4%    4%

 0%
      More Restrictive     No Change     Less Restrictive        More Restrictive      No Change     Less Restrictive


            Your Problem                          Our Research                      Your Solutions            4
Using statistical analyses, we discovered that the correlation lay
instead with risk perception
A perception of low risk correlates with a much lower likelihood of increased restrictions on MSL
activities, and vice versa, suggesting that those who fear a changing environment are more
likely to react with more stringent measures.

                    Last 12 Months                                      Next 2-3 Years
    100%                    0%
                                                                7%
              15%                                                                          13%

     80%                                                        26%
                           52%                                                                      Less
                                                                            61%                     Restriction
              40%
     60%                                75%
                                                                                                    No
                                                                                                    Change
                                                                                           77%
     40%                                                                                            More
                                                                67%
                                                                                                    Restriction

              46%          48%
     20%
                                                                            39%
                                        25%

      0%                                                                                   10%
            High Risk   Medium Risk   Low Risk
                                                            High Risk    Medium Risk     Low Risk

                                         Perceived Risk Level


           Your Problem                  Our Research                       Your Solutions                 5
Best Practices Key Industry Insight: “Corporation’s
response” has greater impact than the CIA itself

                        “Even the parts of the organization that had no role
                      in the malfeasance that caused the CIA to be put in
                      place reacted in a way that neutered the organization.

                         “It comes down to the corporation’s response to
                      what is going on. If you get down to it the rules
                      we play by are just suggestions by OIG, but if you
                      cross the line and can document that money changed
                      hands or something was done that was wrong or
                      illegal.

                        “Organizations get to that point, get slapped on the
                      wrist that causes the pendulum to swing so far back
                      the other way that the companies become
                      ineffective.”
                                                – Director, Medical Affairs



      Your Problem   Our Research                Your Solutions           6
Therefore, we recommended that the Client must decide room for risk
aversion in the future to set restrictions for MSL/KOL interactions
Risk aversion and regulatory intention metrics reveal that those forecasting an unfavorable
environment will mitigate these risks by further restricting MSL activities.
                   Likelihood respondents will become more restrictive with MSL activities over next two years, by risk
                                                               group:




                                                    S.D. = 16%


 As a high-risk               21%
company, client
                                                                 Medium Risk                          Low Risk
should consider
further policies
to mitigate risk                High Risk                         -10%
                                                                                                       -14%
 over the next                                                                        S.D. = 9%
                                                                                                                          S.D. = 13%
   few years.




            Your Problem                       Our Research                            Your Solutions                     7
Our research allowed us to establish the client’s
positioning and make a recommendation


                                   However,
• Company sees potential                                  • Rather than make
  CIA on horizon                                            decisions based on
• Stricter regulations       • CIA companies seem to be     potential CIA, client should
  anticipated for industry     minimally impacted           act as do industry leaders:
                             • Risk perception dominant     in reaction to anticipated
                               in companies’ MSL            risks
                               restriction decisions



             Now                                                     Future

           Your Problem           Our Research            Your Solutions                   8
About Us: Best Practices, LLC


  We are a research and consulting firm that conducts work based on the
  simple yet profound principle that organizations can chart a course to
 superior economic performance by studying the best business practices,
    operating tactics and winning strategies of world-class companies.




                   Best Practices, LLC
         6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517
                             919-403-0251
                       best@best-in-class.com
                       www.best-in-class.com

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The BPLLC Advantatage: Case Study, MSL Management and CIA Impact

  • 1. Case Study: Medical Science Liaisons With the advent of Corporate Integrity Agreements, our client came to Best Practices, LLC with several questions. Our team of experts explored ways to deliver exceptional MSL Services to various customer groups and stakeholders in an increasingly challenging business environment. Here’s what they found. 1
  • 2. The Challenge: explore MSL management options and potential impact of a CIA What do MSLs What MSL management What do Medical How do MSLs develop provide to Key changes and risks have Science Liaisons Opinion Leaders arisen? How do and manage internal (MSLs) Services look (KOLs)? How do they Corporate Integrity and external like? What methods do so, and how Agreements impact relationships? do they employ? often? companies? Gather data and Improve MSL establish best management and practices from create value for benchmarking various customer class segments Your Problem Our Research Your Solutions 2
  • 3. Case Study Focus: MSL management trends and mitigating CIA-inducing risks • General Observations Research Focus Areas • KOL management • Internal services and activities • Payer group support and education • Hospital and health care access • Emerging trends and mitigating risks • MSL group structure and oversight Your Problem Our Research Your Solutions 3
  • 4. Our initial assumption that those companies with CIAs would be much less restrictive turned out to be untrue. “How restrictive is your company now compared to 12-24 months ago and how will it be in the next 12-24 months in regards to MSL interaction with healthcare providers?” Total Benchmark Class CIA Companies 80% Compared to 12-24 (n=32) (n=8) Months ago Next 12-24 Months 63% 60% 58% 54% 50% 42% 40% 38% 38% 25% 20% 13% 13% 4% 4% 0% More Restrictive No Change Less Restrictive More Restrictive No Change Less Restrictive Your Problem Our Research Your Solutions 4
  • 5. Using statistical analyses, we discovered that the correlation lay instead with risk perception A perception of low risk correlates with a much lower likelihood of increased restrictions on MSL activities, and vice versa, suggesting that those who fear a changing environment are more likely to react with more stringent measures. Last 12 Months Next 2-3 Years 100% 0% 7% 15% 13% 80% 26% 52% Less 61% Restriction 40% 60% 75% No Change 77% 40% More 67% Restriction 46% 48% 20% 39% 25% 0% 10% High Risk Medium Risk Low Risk High Risk Medium Risk Low Risk Perceived Risk Level Your Problem Our Research Your Solutions 5
  • 6. Best Practices Key Industry Insight: “Corporation’s response” has greater impact than the CIA itself “Even the parts of the organization that had no role in the malfeasance that caused the CIA to be put in place reacted in a way that neutered the organization. “It comes down to the corporation’s response to what is going on. If you get down to it the rules we play by are just suggestions by OIG, but if you cross the line and can document that money changed hands or something was done that was wrong or illegal. “Organizations get to that point, get slapped on the wrist that causes the pendulum to swing so far back the other way that the companies become ineffective.” – Director, Medical Affairs Your Problem Our Research Your Solutions 6
  • 7. Therefore, we recommended that the Client must decide room for risk aversion in the future to set restrictions for MSL/KOL interactions Risk aversion and regulatory intention metrics reveal that those forecasting an unfavorable environment will mitigate these risks by further restricting MSL activities. Likelihood respondents will become more restrictive with MSL activities over next two years, by risk group: S.D. = 16% As a high-risk 21% company, client Medium Risk Low Risk should consider further policies to mitigate risk High Risk -10% -14% over the next S.D. = 9% S.D. = 13% few years. Your Problem Our Research Your Solutions 7
  • 8. Our research allowed us to establish the client’s positioning and make a recommendation However, • Company sees potential • Rather than make CIA on horizon decisions based on • Stricter regulations • CIA companies seem to be potential CIA, client should anticipated for industry minimally impacted act as do industry leaders: • Risk perception dominant in reaction to anticipated in companies’ MSL risks restriction decisions Now Future Your Problem Our Research Your Solutions 8
  • 9. About Us: Best Practices, LLC We are a research and consulting firm that conducts work based on the simple yet profound principle that organizations can chart a course to superior economic performance by studying the best business practices, operating tactics and winning strategies of world-class companies. Best Practices, LLC 6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517 919-403-0251 best@best-in-class.com www.best-in-class.com