With reporting requirements for the Physician Payment Sunshine Act looming, pharmaceutical companies have been busy developing physician payment tracking and reporting processes. Some companies, like Eli Lilly, are ahead of the game in instituting Sunshine Act–level systems for tracking physician spend. In a session called U.S. Compliance and Regulatory Oversight for Meeting Managers at the 8th Annual Pharma Forum, held March 26-28, 2012, in Orlando and co-organized by and The Center for Business Intelligence, Diane Hilligoss, a consultant with Eli Lilly’s physician aggregate spend team in Indianapolis, offered some tips on creating a compliance strategy.
There are not a lot of details and guidelines on how to implement the meetings provisions of the Sunshine Act, said Hilligoss, who shared the dais with Angie Duncan, director, SMM Operations North America, Carlson Wagonlit Travel; and Lisa Keilty, president, The Keilty Group. It’s largely up to the individual company to create its own process and standards.
The first thing is to determine what needs to be disclosed, and what does not. Airfare, food and beverage, and ground transportation are all physician expenses that should be disclosed, she said. Some companies don’t disclose audiovisual, meeting space, or other costs associated with the meeting, or shuttles to and from an off-site event, because those expenses are considered to be part of the meeting overhead.
“It’s about perception,” she said. Because audiovisual is just part of the overall meeting experience, the general public would not perceive it as something of value being given to the docs. However, some might perceive the cost of a flight, hotel room, or reception as something of value.
Instead of using actual numbers for expense reporting, some companies use a process called Standard Cost Methodology to average costs. It’s a reasonable approximation of the standard cost of each meetings-related activity such as ground transportation and breakfast, explained Hilligoss. If a doctor doesn’t eat breakfast, it doesn’t matter—the cost is still associated with any doc who attends the meeting. It may not equal the exact value of what was spent on a particular physician, but it usually comes within 10 percent of the actual cost.
Whatever system is used, make sure it’s documented, consistent, and defensible. The key is to be able to justify whatever reporting procedure is used. It must also be complied with, and that, quite often, falls to the meeting manager.
Hilligoss also spoke about the importance of informing physicians about the Sunshine Act and any associated procedures. While she has found that many physicians are concerned about the lack of control they have over what’s being reported and disclosed about them, others haven’t even heard of the Sunshine Act yet. Eli Lilly has created a Web site that answers frequently asked questions and explains in detail all its reporting obligations. It has also started posting physician payments on its own Web site. One audience member asked if there have been any complaints from doctors over privacy issues, but so far, Eli Lilly has had very few complaints. The company does offer opt-out and self-pay options for physicians who prefer to pay their own expenses or are uncomfortable with the reporting requirements, but to date not many doctors have used it.
Even though the information is already out there, Hilligoss said it will be more closely scrutinized in 2013 when it’s posted on government Web sites. “Once the data is out there, people are going to make assumptions about it,” she said. “We have to make sure they understand it and educate people so they don’t make the wrong assumptions.”
Getting to Terms
Understanding pharmaceutical meetings starts with knowledge of the drug development pipeline. Each phase of the drug development process spawns several clinical meetings, which Lisa Keilty, president, The Keilty Group, Mystic, Conn., outlined in a presentation at the 8th Annual Pharma Forum, March 25-28 in Orlando. Here is a rundown of the clinical meetings involved in the various phases of the drug development process. (Terms and budgets are generalizations. Some companies may have different budgets or naming conventions.)
Research Programs. Research programs are typically sponsored by the chief science officer and are held to discuss new science, trends, approaches, and unmet medical needs in a given therapeutic area. Attendees consist of 15 to 20 academics, physicians, or key opinion leaders (KOLs). These meetings last a day or two and are often held at either a company facility or an off-site venue with easy access, like an airport hotel. The budget is $15,000 to $20,000 and they are held two to four times per year.
Investigator Meetings. Investigator meetings are held to train investigators—research physicians—and study personnel on specific protocols, such as instructions on administering the drug that is being developed. Attendance is anywhere from 40 to 100. The meetings are held in a central location at a venue within 30 minutes of an airport. They typically last from one to three days. The budget for an investigator meeting is $80,000 to $150,000.
Clinical Consultant Meetings. Clinical consultant meetings occur throughout the clinical trial. A panel of 10 to 15 third-party experts and KOLs are invited to assess the progress of a clinical trial. Meetings are held in a central location and last a day or two. They convene two to four times per year and the budget is $10,000 to $20,000 per meeting.
Advisory Committee-FDA Hearing. These are meetings to seek FDA approval for a drug. The FDA chooses an advisory committee of independent consultants to evaluate the drug. The FDA may call on the pharmaceutical company to present data on the benefits and risks of the drug. The budget, number of attendees, and length of meeting are all variable, depending on the drug. Some may take up to a week.
Marketing Meetings. Once the drug is fully approved, there are a variety of marketing meetings, including speaker training, conventions, dinner meetings, and advisory board meetings. Attendees consist of healthcare professionals, so venues, menus, and budgets all have to be business-appropriate. The number of attendees and budgets vary by meeting.
Post-Marketing-Obligatory Trials. These meetings in the post-approval phase train investigators and study personnel on the protocols for administering the drug. Budgets are $80,000 to $150,000 and meetings can last one to three days. Attendance is 40 to 100 and meetings are held in a central location at venues within 30 minutes of an airport.