Get Your Compliance Ducks in a Row By Evaluating IIT Research Grants for FMV

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

Like any medical affairs subfunction, compliance is a major concern for investigator initiated trial (IIT) teams.  Companies have no say in an IIT’s protocol, patient recruitment practices or final publication, so teams need to get all their compliance ducks in a row before giving out an IIT research grant.  One of the most crucial compliance concerns is that the IIT’s proposed budget is fair-market value (FMV). Continue reading

Investigator Sponsored Trials: Structuring Evaluation and Approval Committees

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

There are many key elements to running a successful investigator sponsored trials (ISTs) program, such as:

  • Evaluating IST proposals efficiently
  • Only approving ISTs that have high scientific merit and align with corporate research objectives
  • Maintaining compliance with fair market value (FMV) and milestone payments

The investigator sponsored trials evaluation committee is at the heart of many of these processes.  A company’s IST team runs the program, but the IST committee is responsible for evaluating the submissions. Continue reading

Three Steps for Calculating FMV Investigator Compensation

Natalie DeMasi, FMV investigator compensation researcher
By Natalie DeMasi,
Research Analyst

In recent years, regulatory policies dictate that life sciences companies must pay physicians fair-market value (FMV) payments.  But, regulatory guidelines offer no rule book for how to calculate FMV.  This situation — however dire it may seem — actually offers companies a tabula rasa for establishing the best methods for FMV calculations.  While pharma continues to build its own guidelines for FMV, there are three broad steps for determining FMV investigator compensation: Continue reading

Basing Fair-Market Value on Physician Salary Data Isn’t Enough Anymore

Elio Evangelista, physician fair-market value expert
By Elio Evangelista,
Senior Director

Medical Marketing and Media published an article recently stating that 46% of the highest-paid physicians (orthopedists at $413,000 annually) are unsatisfied with their pay. This is a telling metric given the discussions that compliance executives throughout the pharmaceutical industry are having around determining fair-market value (FMV) for the physicians their companies work with.  Continue reading

Using Cost Per-Patient-Visit for Investigator Compensation

Ryan McGuire, costs per-patient-visit for investigator compensation expert
By Ryan McGuire,
Research Team Leader

There is a strong push from regulators worldwide for pharmaceutical companies to first report and then justify physician payments. This push includes all compensation for activities such as scientific speaking, journal publications and clinical trial operations. Authorities are looking for greater transparency, and that starts with fair-market value reporting. But for the most part, life science companies have been left without concrete guidance on how to calculate fair-market value for investigator compensation. Continue reading

Transparency for FMV Rates: Finding a Balance Abroad

When France first released its 2011 draft of the Bertrand Act — which included a provision similar to the Sunshine Act here in the US – the legislation promised to be more stringent than US guidelines.  The draft required companies to post its payments on its website within 15 days of the activity — complete with the recipient’s name and the amount he or she received.  It also required companies to deliver a report detailing their outside spending to six professional organizations — even if payments were under the US equivalent of $95.  Continue reading

Is Pharma Ready for the Sunshine Act?

At last.  Cue the Etta James music because the Centers for Medicare and Medicaid Services (CMS) released the final version of the Sunshine Act.  Is pharma ready for the Sunshine Act? As of February 8, the Sunshine Act will be included in the Federal Register and will go into effect shortly thereafter.  Finally, pharma and the rest of the healthcare industry can breathe a little easier as they shift away from eagerly — or perhaps reluctantly— awaiting further legislative updates to focusing on adhering to these now-finalized guidelines. Continue reading

Four Guideposts to Improve Investigator-Initiated Trials Payment Processes for FMV Compliance

By David Richardson,
Research Team Leader

The Office of the Inspector General at Health and Human Services (OIG) has been highly focused recently on tracking and publicizing pharmaceutical companies’ payments to thought leader physicians and clinical investigators. A number of companies have found themselves under investigation, and some have had to enter into Corporate Integrity Agreements to ensure their practices are up to the scrutiny.

Teams that run investigator-initiated trials (IITs) can play a major part in avoiding (or passing) OIG scrutiny by focusing on improvements in three major areas: Continue reading