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by Michael J. Shapiro | July 01, 2010
They Make the Rules

MedPharm gavel

As medical and pharmaceutical meeting planners well know, a whole host of codes and guidelines exists to keep meetings in line, dependent on the specific type of meeting as well as who's in attendance at the event. A growing number of state laws -- and now, federal health-care reform legislation -- provide additional concerns. Among the rule-makers:

• Pharmaceutical Research and Manufacturers of America (PhRMA) issues the Code on Interactions with Healthcare Professionals.

• Advanced Medical Technology Association (AdvaMed)
issues the Code of Ethics on Interactions with Health-Care Professionals.

• Council of Medical Specialty Societies
issues the Code for Interactions with Companies.

• The Office of Inspector General issues the Compliance Program Guidance for Pharmaceutical Manufacturers.

• The U.S. Food and Drug Administration issues guidance, compliance and regulation materials.

• The Foreign Corrupt Practices Act addresses, in part, potential bribery of foreign officials. The involvement of governments in foreign health-care systems makes this a concern.

• U.S. health-care reform legislation
includes provisions of the Physician Payments Sunshine Act introduced in early 2009. Provisions will require disclosure of physician payments from the industry (pharmaceutical companies, device manufacturers) and call for a public, searchable database of that information to be established by September 2013.

• State laws have introduced strict legislation, such as those passed in Massachusetts and Vermont, regarding interaction with health-care professionals. Laws apply to interactions with doctors who practice in the states in question, and fines and penalties may be levied for noncompliance. A number of these laws set limits on the payments that may be received by health-care professionals. The effect of federal legislation on these laws is yet to be determined.



Photograph: ©iStockphoto.com/aluxum

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In late March, President Obama signed into law a health-care reform bill that promises broad changes to the country's health-care system. After a contentious political battle to pass the legislation, the process of implementing the law, as spearheaded by government entities such as the Department of Health and Human Services, has only just begun. In fact, most provisions won't go into effect until September 2013. Just how the bill will influence meetings in the medical and pharmaceutical industries remains to be seen, but insiders already are anticipating change.

Disclosure and dissemination Likely the most significant effect on meetings will stem from the provisions of the Physician Payments Sunshine Act, introduced by U.S. Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) in early 2009 and eventually modified for inclusion in the overall reform bill. In short, the provisions require disclosure of physician payments by industry (pharmaceutical companies, device manufacturers) and call for a public, searchable database of that information to be established by September 2013.

"Those provisions are going to put a tremendous emphasis, for pharma companies in particular, on understanding exactly how much money they're spending on a [guest] doctor," says Kim Slocum, president of West Chester, Pa.-based KDS Consulting, which works with health-care organizations. "And that's going to have to include everything they spend on that person -- detailing expenses, speaker's honorarium, meetings that they attend, the whole deal. I don't know exactly yet who's going to be the collector of that data, or who's going to have the enforcement mechanism -- but I think it's very clear that the onus is going to be on companies to start to track this."

That means a complete and efficient means of data collection will soon be absolutely essential for medical and pharmaceutical meetings that include health-care professionals -- potentially a tall order for some corporations, given that strategic meetings management programs (SMMP) are really just beginning to be rolled out on a larger scale. (SMMP is defined as a disciplined approach to managing enterprise-wide meeting and event activities, processes, suppliers and data in order to achieve measurable business objectives aligned with their organizations' strategic goals and vision.)

Without an SMMP in place, executives tend to underestimate their general meeting spend by as much as two-thirds, according to Kari Kesler, chief strategist of KK Consulting and a principal developer of the National Business Travel Association's Strategic Meetings Management Certification. That's the big picture; Sunshine Act provisions will require that detailed data be available for meetings on a per-attendee basis when doctors are involved.

Clearly, the new legislation continues to demonstrate the importance of centralized tracking of meeting activity, points out Teresa Bria, senior vice president of projects and operations for Phase to Phase Strategy LLC, a Weston, Conn.-based consulting organization offering strategic services to pharmaceutical clients. "It also underscores the need to ensure all initiatives are strategically designed to achieve legitimate and transparent objectives," she notes.

Of course, the data-collection requirements don't come as a surprise; federal legislation requiring strict disclosure policies has been discussed for several years, and a number of states already have passed such legislation. Rx Worldwide Meetings, an independent pharmaceutical event and meeting planning company, began collecting detailed data with respect to physician attendees about three years ago. The information is incredibly specific, says Judy Benaroche Johnson, CMP, president and CEO of the Plano, Texas-based firm. "It's not just about how much you spent on Dr. Smith," she explains. "It's about what you spent on air, hotel, this meal, that meal... it's really, really detailed."

Judy Benaroche JohnsonThe resulting paper trail is immense. "In the last two years," notes Johnson, "for the bigger pharma clients that we have, it's five times the amount of reporting and forms than we've done in the past."

The pharma companies that haven't been as proactive have some catching up to do. "I think their systems are going to get better fast," says Kim Slocum. "They're going to have to. Very few pharma companies have any interest in being hauled up before the Office of the Inspector General, or any of the other potential enforcement agencies, and being accused of malfeasance."

Many companies already have been adhering to the self-regulatory guidelines set forth in the PhRMA Code for Interactions with Healthcare Professionals, but federal legislation still will likely require that they take their data collection systems -- and their audits of such systems -- up a notch. "Once there's actual money or sanctions on the table," says Slocum, "people get a lot more serious about this kind of thing. If there's any question of a violation, companies are going to have to produce records to what, generally speaking, are relatively unsympathetic audiences. In terms of the cast of characters that might be involved in the enforcement of this, basically they are not noted for having a sense of humor."