Pharmaceutical, biotech, and medical device company meeting planners and third parties who provide meeting planning services to the life sciences industry have a lot of questions about how to comply with the ever-growing compendium of rules and regulations governing their meetings for healthcare professionals. Two meeting experts tackled their questions head-on after an August webinar detailing the requirements of the PhRMA and AdvaMed Codes, state reporting authorities, and the federal Sunshine Act. The new act requires industry to track what companies spend per physician annually—including at meetings. (An archive of the webinar, which was hosted by , can be accessed for free here.)
Here’s a rundown of some of the questions—and answers from the presenters, James Vachon, associate director, Millennium: The Takeda Oncology Co.; and Angie Duncan, CMP, CMM, vice president, client operations, VMS Inc., a meeting management agency that specializes infor the medical industry.
What’s an HCP?
The voluntary codes, state reporting requirements, and now federal law place the burden on the pharma company to track meeting-related spending on healthcare professionals, or HCPs. So it’s important to define what your organization considers to be an HCP. While the rules and regulations don’t spell it out in detail, planners should ensure that their company has a definition, and that it be fairly broad. It’s better to collect the HCPs’ names, specialties, payment amounts and forms, and the other data you need to track now, rather than to have to go back and recreate the records in the future.
How do you track which states require what, and how do you keep updated?
Most companies have someone in their compliance and/or legal departments who monitors state regs. Planners—whether in-house or third-party—should partner with the company’s legal and compliance teams to develop an update plan. If your company doesn’t have an in-house department, find out who the company’s main legal person is, and consult with him or her on the company’s overall compliance policy.
To which states do you need to report data? The state where you’re meeting? The state where you’re incorporated? Where your HCPs are coming from?
You have to report the relevant data to whichever state the HCP is licensed in. And be forewarned that many physicians are licensed in more than one state, so be sure to ask for all states in which they are licensed, not just their home state, when they register for a meeting, or include it in your .
If an HCP is licensed in a strict state and a less strict state, do you have to report to both?
Will planners be held accountable for data reporting errors?
Either the planner, meeting sponsor, or owner will be held accountable for errors, so make sure that the information you report is accurate.
Is there a technology system that you use to capture specific HCP information?
There are several tools that are commercially available, though many companies have created their own technology to capture this information, and others just use an Excel spreadsheet.
Where does all this data you capture ultimately go?
Some of the data is reported to the states in which the HCP is licensed, and once the Sunshine Act is implemented, data also will have to be reported to that system.
Now that food-and-beverage spending needs to be kept to a “reasonable” cost, how do you define what is reasonable?
Limits for dinners often are in the $100-$125 per-personrange, though each company has to define reasonable for itself. The figure could take into account taxes, gratuities and service charges. Some companies include other costs, such as venue rentals and transportation. Planners should work with their compliance departments to set F&B benchmarks, and include the figures and inclusions in the addendum.
Do these regs make it easier or harder to outsource site selection to third parties?
They shouldn’t make it harder. In fact, outstanding suppliers are those who understand the regs and are able to use their expertise for their clients’ meetings.
Are there any specific rules around international meetings?
It used to be that, at some very large events with attendees from countries that didn’t have strict guidelines, affiliates from that country could take their attendees off and do their own thing, but most companies no longer allow that. Now that most countries have their own compliance guidelines, you should follow whichever country has the strictest rules.
We’re now having some HCPs asking to opt out of meals at meetings altogether. How would you handle this?
We wouldn’t object to it, but we would want to know about it in advance so we could ensure that we could meet the F&B guarantee.
And remember that HCPs may not be spending less money by eating on their own. If they expense the dinner back to your company, it could be a wash, or even more than the original meal at the food function. You need to have expense guidelines and be meticulous about tracking them. You must audit this information and it too must be reported if it is being reimbursed.
How do you set pricing limits when the cost of things is not equal around the country?
You have to set limits in your hotel or venue addenda, and be ready to walk away if the facility can’t meet them. You also have to be willing to say you’re not going to do meetings in cities that don’t have venues that can accommodate your limits.
How long do you need to retain the data you’re tracking? Is it ever safe to destroy the records?
You never know when you’ll be asked to go back and pull data on specific physicians. For third parties, your clients usually will tell you how long to keep the data. In-house planners should ask their internal legal/compliance departments what the record-retention policy should be.
Do these rules and regs apply to biomedical and device industries, or just to pharma?
While the PhRMA Code is specific to the pharmaceutical industry, the AdvaMed Code sets the guidelines for biomedical and device companies. The main difference between the PhRMA and AdvaMed codes is that the AdvaMed Code has a broader definition of HCP.
While some companies may think they’re too small, too new, or somehow don’t fall under the rules, Vachon and Duncan strongly advised that all companies get ahead of the game by establishing processes and procedures now. You’re better off assuming the rules will apply to you at some point and be proactive, instead of trying to backpedal if you get called on the carpet years from now. While only 12 states have rules governing HCP meetings, Vachon tracks meeting spend for HCPs across the board.
Also, much more on the rules and regulations around medical meetings can be found in our Rules and Regulations Special Report