Understanding Appropriate Systems for Managing KOL Compensation Exceptions

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Products Team Leader

For most teams that engage with thought leaders and other HCPs, the emphasis is typically on documentation and consistency.  And for good reason – regulatory audits are much easier to manage when processes are clearly explained and explicitly stated. However, for every rule there are compensation exceptions, and companies should build contingencies for this into their policies.

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Funding an Investigator Sponsored Study? Use Milestone Payments.

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

Funding an investigator sponsored study (ISS) is a great opportunity for companies to expand a product’s data portfolio, strengthen relationships with HCPs and demonstrate corporate goodwill.  Despite these benefits, there are some risks to ISS’s.  Namely, the data produced will be tied to the company’s product — regardless of the scientific merit — and the funding provided to the investigator may be open to public scrutiny.  For these reasons, most investigator sponsored study teams will carefully evaluate each research proposal and fund investigators based on milestone payments.

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Moving Forward with Physician Payment Disclosure Requirements in Scotland

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Already, many countries have established physician payment disclosureregulations that require companies to publish any exchanges of value that take place between healthcare practitioners (HCPs) and themselves. In some cases—as with the Loi Bertrand in France—these regulations may also extend to other members of the healthcare community. Beyond HCPs, the Loi Bertrand also covers audiences such as pharmacists, nurses and professional medical associations.

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Building Assumptions Documents that Work for You and for CMS Sunshine Act Reporting

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Data Products Team Leader

As the Sunshine Act becomes part of standard regulatory procedures, pharmaceutical companies are looking to further develop their compliance efforts. Many of our clients are looking to streamline their reporting processes and proactively identify potential compliance pitfalls. One key way to maintain consistency and accuracy in reporting processes is through a comprehensive assumptions document.

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Fair Market Value Annual Rate Caps: A Look at How Individual Events Contribute to Life Science Teams’ Maximum Compensation Hours

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Fair market value (FMV) activities help life science teams develop consistent, defensible remuneration rates for the healthcare practitioners (HCPs) with whom they work. As part of their FMV configuration processes, companies may consider each HCP’s scope of influence and his or her specialty type. For example, life science teams may develop compensation rates based on three tiers:

• Tier 1 reflects HCPs or other industry influencers with global-level reach.
• Tier 2 indicates HCPs or other industry influencers with regional influence, and
• Tier 3 denotes HCPs or other industry influencers with a strong local-level following.

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Facilitate Consistent, Competitive FMV Practices with Strategically-Developed Rate Caps

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

From speaking engagements to advisory board leadership, healthcare practitioners (HCPs) provide an invaluable resource for pharmaceutical, biopharmaceutical and device companies alike. However, life science teams may struggle to develop fair market value (FMV) compensation rates for the important contributions that these HCPs and other medical professionals provide. Essentially, life science teams must balance competitive remuneration rates while also adhering to regulatory stipulations and avoiding the undue perception that they have bought HCPs’ support.

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Managing Thought Leader Travel Compensation With Standardized Fair Market Value Methodologies

Pharmaceutical and biotechnologies are becoming increasingly strict with their thought leader travel compensation practices.  Because more and more countries are implementing open payment legislations, life sciences firms must be prepared to develop and implement physician fair market value practices.  These standardized payment methodologies ensure that the company offers its thought leaders the best fit compensation for their level of expertise and their contributions to the company’s research or promotional efforts.

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Implementing Thought Leader Compensation Caps to Remain Compliant with New Legislation

More and more countries are implementing open payment legislation, similar to the US Physician Payment Sunshine Act.  With these laws in place, pharmaceutical, biotechnology and medical device firms must be careful of how they are working with and compensating their key opinion leaders.  These firms must standardize their key opinion leader compensation practices to avoid regulatory scrutiny and hefty fines.

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