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
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
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
Our newly updated FMV Benchmarking service now provides medical, scientific and regulatory staff at life sciences companies with fair-market value benchmarks for thought leaders and influential physicians in more than 100 countries. The service is built upon a decade of detailed key opinion leader management research and the Research and Consulting teams’ expertise in FMV benchmarking and developing physician fee schedules. Continue reading
Six Tips to Help Build the Ideal Thought Leader Database
As the industry awaits the release of the delayed Sunshine Act guidelines, pharmaceutical and medical device companies are benefiting from the extra time by reviewing current physician payment reporting structures and tightening their documentation procedures. “Every company, no matter how large or small, needs a tracking and reporting system capable of handling Continue reading
New study provides process for calculating compliant fair-market value payments
Although 100 percent of drug companies compensate key opinion leaders (KOLs) for their method of travel, only 60 percent do so for any preliminary work. And as mandatory public reporting of thought leader compensation approaches with the launch of the Sunshine Act, questions remain surrounding both travel and pre-work compensation. Continue reading
In about five weeks, pharmaceutical, biotechnology and medical device companies will have to start compiling and aggregating data on their physician expenditures to meet the requirements spelled out in the Physician Payments Sunshine Provision of the Patient Protection and Affordable Care Act. There’s a fairly significant problem, however – the U.S. government has yet to provide Continue reading
Physicians’ conflict of interest is once again popping up as a hot topic. A study published in the British Medical Journal has received a lot of attention lately. It highlighted the prevalence of financial conflicts of interest (COI) for researchers sitting on 14 specific guideline-setting panels in the United States and Canada between the years 2000 and 2010. Our colleague Ed Silverman of Pharmalot discussed it. And both the Wall Street Journal and Continue reading