the bpllc advantatage: case study, msl management and cia impact

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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. 1

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Case Study: Medical Science LiaisonsWith 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

Your Problem Our Research Your Solutions 2

The Challenge: explore MSL management options and potential impact of a CIA

Improve MSL management and create value for

various customer segments

Gather data and establish best practices from benchmarking

class

What do Medical Science Liaisons (MSLs) Services look like? What methods do they employ?

What do MSLs provide to Key Opinion Leaders (KOLs)? How do they do so, and how often?

How do MSLs develop and manage internal and external relationships?

What MSL management changes and risks have arisen? How do Corporate Integrity Agreements impact companies?

Your Problem Our Research Your Solutions

• General Observations• 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

3

Case Study Focus: MSL management trends and mitigating CIA-inducing risks

Rese

arch

Foc

us A

reas

Your Problem Our Research Your Solutions 4

Our initial assumption that those companies with CIAs would be much less restrictive turned out to be untrue.

More Restrictive No Change Less Restrictive0%

20%

40%

60%

80%

42%

54%

4%

38%

58%

4%

Total Benchmark Class

More Restrictive No Change Less Restrictive

38%

50%

13%

25%

63%

13%

CIA CompaniesCompared to 12-24 Months ago

Next 12-24 Months

(n=8)(n=32)

“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?”

Your Problem Our Research Your Solutions 5

Using statistical analyses, we discovered that the correlation lay instead with risk perceptionA 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.

Perceived Risk Level

High Risk Medium Risk Low Risk0%

20%

40%

60%

80%

100%

46% 48%

25%

40%

52%

75%

15%

High Risk Medium Risk Low Risk

67%

39%

10%

26%

61%

77%

7%13%

Less Restric-tionNo Change

More Restric-tion

Last 12 Months Next 2-3 Years

Your Problem Our Research Your Solutions 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

“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 7

Therefore, we recommended that the Client must decide room for risk aversion in the future to set restrictions for MSL/KOL interactions

21%

-10%

-14%

High Risk

Medium Risk Low Risk

S.D. = 16%

S.D. = 9%S.D. = 13%

Likelihood respondents will become more restrictive with MSL activities over next two years, by risk group:

Risk aversion and regulatory intention metrics reveal that those forecasting an unfavorable environment will mitigate these risks by further restricting MSL activities.

As a high-risk company, client should consider further policies to mitigate risk over the next

few years.

Your Problem Our Research Your Solutions 8

Our research allowed us to establish the client’s positioning and make a recommendation

• Company sees potential CIA on horizon

• Stricter regulations anticipated for industry

Now

• CIA companies seem to be minimally impacted

• Risk perception dominant in companies’ MSL restriction decisions

However,• Rather than make

decisions based on potential CIA, client should act as do industry leaders: in reaction to anticipated risks

Future

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, LLC6350 Quadrangle Drive, Suite 200, Chapel Hill, NC 27517

[email protected]

About Us: Best Practices, LLC