At last. Cue the Etta James music because the Centers for Medicare and Medicaid Services (CMS) released the final version of 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
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.
By Elio Evangelista,
Director of Research
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 disclosure rules outlined in the Physician Payments 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
|By Yanis Saradjian,
Director of Consulting
Our newly updated Fair-Market Value Benchmarking and Analysis 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 all of the Sunshine Act’s requirements now,” said Elio Evangelista, director of research at Cutting Edge Information. “The largest companiesare ahead of the pack. Most already have sophisticated databases in place, as well as the IT infrastructure and personnel to support the documentation requirements.”
Cutting Edge Information’s report, “KOL Fair-Market Value and Aggregate Spend,” serves as a guidebook to companies working to comply with the reporting requirements of the Physician Payment Sunshine Act while meeting the needs of physicians and internal stakeholders. Based on interviews conducted with medical affairs executives across the industry, Cutting Edge Information recommends the following fundamentals when constructing a KOL database:
- Include fields for all information required by the Sunshine Act – Each entry must have fields to enter name, company, Medicare billing number, service provided, physician compensation and other reimbursed expenses (including travel, hotel, and food).
- Design strong report-building capabilities – The more sophisticated the database’s query building and report-generating capabilities are, the less work companies will have to do on the back end.
- Establish a centralized location – Centrally located databases are more reliable for preventing duplicated efforts and data loss.
- Create multiple access points with differing levels of clearance – Some employees may need the ability to enter new information into the database, but not everyone needs to alter information.
- Create a built-in system to verify data – It is always easier to handle mistakes internally than to have external agencies point them out.
- Include links to, or archive, thought leader deliverables – An easily traceable copy of the thought leader’s deliverable provides undisputable proof that a service has been rendered.
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
|By Elio Evangelista,
Director of Research
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
|By Ryan McGuire,
Senior Research Analyst
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
As compliance and medical affairs teams prepare for the Sunshine Act, they are relying less on exact compensation limits for key opinion leaders. “KOL Fair-Market Value and Aggregate Spend: Documentation, Tracking and the Sunshine Act” found that only 35 percent of all companies surveyed have established compensation limits for individual thought leaders – down from 45 percent in 2008. When data are broken down by company size, 29 percent of large companies use compensation limits, while almost no medium-sized participating in the study have annual limits on individual key opinion leader (KOL) compensation. However, some companies did report setting compensation limits for specific KOL activities. Continue reading
Just under one-third of drug manufacturers set a compensation limit on their European key opinion leaders to help drive compliant KOL interactions. Executives interviewed for the study said that companies implement compensation limits to avoid overusing individual physicians, which can lead to a perception that a KOL is being offered high-value contracts in exchange for promoting specific products, rather than communicating scientific information. Continue reading