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.
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.
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.
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.
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.
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.
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.
Standardizing your global fair market value (FMV) methodology was the underlying theme at the 3rd Annual FMV of HCP and Investigator Payments conference in Philadelphia on May 9-10, 2016. What we at Cutting Edge Information are seeing right now is that many life science companies have different FMV methodologies for different countries. As more and more countries develop their own version of the US Open Payments Act, it is becoming increasingly important to remain consistent in your global methodology. Continue reading
Pressure on groups working with HCPs and other thought leaders has increased over the past five years with the rise of the Sunshine Act in the US and increased regulatory scrutiny around the world. CEI has conducted extensive research on how companies should compensate thought leaders and what represents fair market value in the current healthcare landscape. We are going to be leading a webinar on Thursday, May 19th at 2:00pm Eastern time to discuss a range of topics associated with KOL engagement by pharmaceutical companies. Continue reading
In light of the Sunshine Act and the restrictions that are being placed on the pharmaceutical industry, there is much more scrutiny placed on these companies for overcompensating key opinion leaders for business and travel. Some life sciences companies are starting to adopt policies that highlight exactly how KOLs may be compensated and by how much and/or to what degree. Of these policies, most pharmaceutical companies provide a very vague overview explaining that travel provided to thought leaders must be reasonable and not excessive (i.e. below first class ticket). Continue reading