There are many key elements to running a successful investigator sponsored trails (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
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
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
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
After the Sunshine Act was released and a Final Rule was issued in early 2013, pharmaceutical companies geared up to make sure that their reporting and disclosure systems were in good working order. Determining fair-market value (FMV) for services provided is an ongoing effort. Continue reading
Having just completed a new benchmarking study on fair-market value (FMV) rates in the Middle East, Cutting Edge Information uncovered a few important trends that may also affect country-level teams in many other regions. Primarily, how can country-level managers set FMV rates when there are few to no consistent benchmarks available? Continue reading
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
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
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
The United States is still waiting for the Centers for Medicare and Medicaid Services (CMS) to issue its final ruling on how it will implement the physician payment disclosures rules outlined in the Sunshine Act. However, this has not deterred companies from continuing to make public disclosures or caused them to lose focus on determining fair-market value (FMV) physician fee schedules.
Initially, CMS was scheduled to give a ruling to drug and device manufacturers in October 2011. But the agency Continue reading