March 31, 2014, ushered in a new era for medical meetings. On that date, all pharmaceutical and medical device companies were required to submit reports to the federal government detailing virtually every dollar spent on American healthcare professionals at meetings and conferences of any kind. That means everything from a training session over dinner for a dozen local doctors and an educational conference attracting hundreds, to a major medical association conference drawing tens of thousands. A C-level executive at each of those companies is required to attest to the accuracy of the report. And the penalties for non-compliance are stiff: up to $1 million a year in fines and, in extreme circumstances, jail time.
The details of that spending — including the cost of flying each physician to meetings, putting them up in hotels, feeding them, paying for speakers, even printing materials such as dosing cards — must be tallied for every doctor at every meeting and reported to the government. After physicians are given a brief time to review the details of that spending and dispute anything they feel is incorrect, the government will display it on a public website that is searchable by physician name.
The main concern of pharmaceutical and medical-device companies is that the press, the public, opponents of pharmaceutical companies, and, ultimately, doctors, will see this list as public shaming rather than disclosure, and that this will make it harder to attract doctors to educational meetings or to participate in the clinical trials needed to bring new medicines and medical devices to market.
There is a simple reason for this, says Steve O’Malley, division president of Maritz Meetings & Incentives. It will be easy to search that database to find the doctors who accepted the most money from pharmaceutical companies in a city, state, or region and turn it into a news story about drug manufacturers bribing doctors.
Some doctor “is going to be in the top 10,” he says. Even if that doctor’s patients aren’t bothered by the publicity, the doctor “will not want the grief he will get,” O’Malley adds. And every other doctor will see it, not want to be that person, and at least consider not attending educational meetings or participating in drug trials.
The secondary but more immediate concern is that tracking and compiling all of that data is an enormous task. At a panel on the new reporting requirements for physician-attended meetings at the Third Annual Global Pharmaceutical and Medical Meetings Summit in Philadelphia on Feb. 4, Gus Papandrikos, director of aggregate spend and transparency reporting compliance for Daiichi Sankyo, a global pharmaceutical firm based in Japan, said his company expected to report 5 million lines of data to the federal Centers for Medicaid & Medicare Services (CMS), the agency responsible. And that covers only the last five months of 2013, the first reporting period mandated by the Physician Payments Sunshine Act’s Open Payments regulations.
As is the case with all pharmaceutical and medical-device makers, many of those 5 million lines of data were gathered at meetings and conventions large enough to require the services of a professional meeting planner, in many cases that of a third-party meeting planner. Papandrikos’ firm uses about 30 separate suppliers, he said.
“A meeting planner’s job used to be providing good planning and good service,” said Gavin Houston, a fellow panelist and CEO Americas, of Ashfield Meetings & Events, a division of international healthcare industry services provider Ashfield Medical and Commercial Services. “It still is, but now that job also includes data capture.”
O’Malley agrees. “At the meeting level, the burden will fall to the planning companies,” he says. “This is kind of like taking strategic meetings management (SMM) to the next level. It is another set of data we need to figure out how to capture and report.”The Stakes Are High
For the past year, since the Open Payments regulations were released on Feb. 1, 2013, medical meeting planners have been working to figure out exactly what data clients need them to collect and how to collect it. This is not a simple task.
For one thing, all covered healthcare professionals (HCPs) — primarily physicians — in attendance have to be properly identified, including by name with middle initial, business address, medical license number, and a National Provider Identifier (NPI) number issued by the CMS. Beyond that, any “transfer of value” from the pharmaceutical or medical-device company to the HCP must be tracked and reported correctly for each attendee. This means the cost of transportation to the meeting or conference, hotel rooms, and food and beverage, as well as anything like training materials, the cost of speakers hired, and fees for participating in drug research trials.
The good news is that “meeting planners will never be liable for jail or fines,” says Pat Schaumann, newly appointed director of healthcare meeting compliance for Meeting Professionals International, and an adjunct professor at St. Louis University, where she helped create the healthcare meeting compliance certificate course. The bad news, she adds, is “they could be fired.”
Beyond that, Schaumann notes, some pharmaceutical and medical-device companies are putting clauses in their contracts saying that if an error by a third-party planner causes a fine, the planning company will pay the client back. “A million-dollar fine could put your company out of business,” she notes.
The planners to whom she has spoken, Schaumann adds, say they are signing contracts with those clauses because they don’t want to lose the client. “I’d advise [third-party planners] to say, ‘Okay, but you must train us.’”
Besides, she adds, “planners have always been responsible for budgets, logistics, and per-person costs. This is nothing new to planners.”The Guessing Game
What is new to meeting planners, aside from the legal consequences of reporting errors, is that every pharmaceutical client needs all that data reported to them in a very specific way, and none of these clients want it the same.
“All clients have different reporting modules,” says Houston. “That means there is a big training component, especially if you are working with multiple clients.”
One of the reasons why pharmaceutical and medical device clients don’t all collect data in the same way is that there is very little clarity from the CMS on the details of how it wants the data collected, or even what must be collected.
What many pharmaceutical companies are doing, therefore, is creating “assumption documents,” says John Oroho, executive vice president and chief strategy officer for Porzio Life Sciences, which provides regulatory compliance software and services to life sciences firms. These simply state why the company made the decisions it did about what information to report and how to report it. “This is a very tortured set of regulations,” says Oroho. “The question we get from a lot of clients is, ‘Can we benchmark?’ No one wants to be the outlier.”
Speaking at the Global Pharmaceutical and Medical Meetings Summit, Oroho gave the example of the reporting requirements for buffet meals at educational sessions that pharmaceutical and medical-device companies host at conventions. When these attract large numbers of HCPs, it can be especially difficult to track attendees. So, CMS clarified the rules to say that companies do not have to report value transfers of buffets or snacks at “large-scale” events. What it didn’t do was define “large scale.” So, Oroho says, different companies are defining it different ways, from 100 to 250 to 500 attendees.
Oroho points to the question of how to handle no-shows at a meal as another issue that assumption documents can help with. “If a meal is in a meeting room with a $4,000 minimum, and only 10 HCPs show up, is it fair to assign a value of $400 each to them?” he asked. From a third-party planner’s perspective, he says, the answer is to report costs based on what the client tells you.
In this particular case, Schaumann says, most of the pharmaceutical and medical-device manufacturers to whom she has spoken are just reporting what the planned, per-person cost of the meal would have been.
That is the reason why assumption documents are so vital, says Lisa Keilty, vice president of healthcare compliance consulting firm PMC2. “It shows a consistent system and effort to comply,” she says. So, if the company does guess wrong, “it seems likely the CMS will treat it more lightly.” Indeed, the Sunshine Act’s terms put the maximum annual penalty for a non-deliberate failure to report a transfer of value at $150,000, compared to $1 million for deliberate failures.
“We have to make clear [to third-party planners] how we want to see the data,” said Kathryn Chellgren, another panelist at the medical meetings summit in February, and a compliance consultant for pharmaceutical giant Eli Lilly and Company’s global travel and meeting services division. “We have to tell them: Meet these specific criteria, and here are the financial penalties for failing to do so. Planners appreciate that.”
At the same time, Keilty says, the onus is on planners to know the Open Payments regulations well enough to ask the right questions. “One client will be clear and another will be all over the map,” she says. “So, planners must push hard. But that is difficult, because you have to handle clients with kid gloves.”Policing the Attendees
The day-to-day tracking at a meeting itself is fairly straightforward, if not necessarily easy, once the correct information about each attendee has been gathered. Many pharmaceutical and medical-device companies are letting attendees know from the get-go how much they will report spending on each attendee.
“When we send out the invitation, it includes the amount that will be charged to them, plus or minus 5 percent,” says Chellgren. “Very few physicians have opted out.” Houston says his firm has seen about 5 percent of attendees opt out.
“We have had physicians bring brown bags,” to meetings over meals, Papandrikos adds. “[But] that is infrequent at the moment.”
Chellgren says Eli Lilly has taken the position that any HCP who attends one of its meetings will have the entire per-person cost reported to CMS, whether or not they eat a specific meal, and makes that clear on the invitation. So far, she says, there has been very little pushback.
“It is beneficial to have sign-in sheets every day,” says Papandrikos. “This reminds the physician that this data will be recorded.” He notes that studies still show that about half of American HCPs do not even know about the Open Payments reporting requirements.
When it comes to the actual tracking of HCPs, planners still need to know three things: what an HCP is, if there will be any at the meeting, and where the HCPs are from.
Defining an HCP is something the Open Payments regulations are clear on. An HCP is a doctor of medicine or of osteopathy, a dentist, podiatrist, optometrist, or chiropractor. Transfer of value to teaching hospitals must also be reported. That says, some pharmaceutical and medical-device companies choose to use broader definitions, such as including any healthcare professional who can prescribe medicine, which includes nurse practitioners and physicians’ assistants.
Determining if any HCPs will be at a meeting is something third-party planners have to rely on their clients to inform them of.
Knowing where the HCPs are from is vital, because certain states have reporting requirements and transfer-of-value limitations that go beyond the federal Open Payments regulations. And other countries in Europe and Asia — notably the U.K., France, and Japan — have similar but different reporting requirements.
In Massachusetts, Oroho says, state requirements mandate tracking value transfers to registered nurses as well as HCPs, a much larger pool. Minnesota, Vermont, West Virginia, and Washington, D.C., also have separate regulations about value transfers. Some, like Vermont, even have hard spending caps, which can put planners in the awkward position of telling a meeting attendee that he or she is not allowed into the lunch room.
That is one reason HCPs themselves often present a tracking challenge, Chellgren says. “A physician who went to Harvard often gets a license in Massachusetts,” she notes. If that physician moved out of state after graduation, “they may forget the Massachusetts license and not mention it. And some have licenses in several countries. You need to ask probing questions.”
Planners also need to check that the person in charge of ensuring the tracking is doing it correctly. “Someone has to own the spaghetti, the complex series of rules about who has to report what to whom,” says Kimberly Meyer, founder of Meetings Analytics, which specializes in data management, reporting, and analysis.
One way pharmaceutical and medical device companies are dealing with this, Houston says, is by bringing in somebody specifically to handle data tracking. “The planner sees that the food is up to par, and is augmented with a person responsible for reporting the data,” Papandrikos says.
But by and large, adds O’Malley, “at the meeting level, the burden will fall to the planning companies.”
That is why every meeting planner and supplier who wants to work on pharmaceutical and medical meetings business would be wise to learn the ins and outs of Open Payments, says Taya Paige, vice president of sales at Access Destination Services’ Orange County, CA office, who recently completed a healthcare meeting compliance certificate course.
“If you plan to work in the pharmaceutical meetings industry, you don’t know what you don’t know,” Paige says. The regulations “are not as daunting as you might think, but they are very detailed. You learn to ask the right questions. Now we need to work with third-party planners on reporting, mainly in the areas of transportation and meals.”
That knowledge is also a selling point with planners who might decide to turn to a transportation company instead of going through a DMC, she adds.Back to What Matters
All of the concern over Open Payments comes back to an issue meeting planners have become very aware of in the past five years: the power of public perception to overshadow the value of face-to-face meetings.
Like much of the meeting planning industry that works with pharmaceutical and medical device companies, Maritz has been spending a lot of time and energy in the past few years preparing for Open Payments by learning the regulations and preparing to meet its requirements, says O’Malley.
“We as an industry tend to get lost in the ‘how’ and the ‘what,’” he says. “What’s missing is the focus on ‘why.’ “We should not focus on ‘How do I get the data I need to give to CMS?’ We really need to think about these meetings from the viewpoint of the guest: ‘What is the unifying theme of the meeting? What are the goals?’”