Gaining access to hospital purchasing decision makers is becoming increasingly difficult for medical device manufacturers. Over the past year, medical device sales reps have seen a proliferation of requirements that providers are demanding vendors meet in order to call on them.

As vendor representative credentialing has become an increasingly hot-button topic among medical device manufacturers, industry has begun exploring possible paths toward standardizing such requirements. For example, the vendor access work group of industry association AdvaMed (Washington, DC) is communicating with the Joint Commission on Accreditation of Healthcare Organizations (JCAHO)—an entity that has regulatory and credentialing authority over hospitals—to work for reasonable hospital vendor access policies and address the increasing amounts of hospital vendor access fees, as well as the associated potential fraud and abuse issues.

John Tara, leader of AdvaMed's vendor access work group and director of corporate strategic marketing for Boston Scientific Corp. (Natick, MA), was on hand at the annual AdvaMed meeting earlier this month to discuss the issue of vendor credentialing with members. Also presenting during the session was Robert A. Wise, MD, JCAHO vice president for standards and survey methods, and David Donahower, president of Chesapeake Surgical Ltd., a distributor of orthopedic implants for DePuy Orthopaedics Inc. (Warsaw, IN), a Johnson & Johnson company.

Although lines of communication are open, implementation of a standardized nationwide vendor credentialing policy is likely still on the distant horizon. At press time, JCAHO had not yet decided whether it would go forward with posting requirements for healthcare industry representatives. “Currently, more research is being conducted,” said Ken Powers, media relations manager for the commission. “A decision will be made in the next month or so as to whether or not more research is needed before going forward with a field review.”

In September 2007, AdvaMed proposed its own set of healthcare industry representative credentialing requirements for adoption as national standards. The proposal can be viewed here. AdvaMed reports that the vendor access work group is also preparing a best practices document, based on advocacy positions developed earlier, for endorsement by other industry stakeholders.

In the meantime, many medical device sales executives continue to express frustration with the growth of hospital-based vendor access restrictions. Hospitals' policies vary widely in scope, imposing an increasing burden and cost on device companies.

“On the East Coast, Philadelphia and Boston seem to be the cities that are jumping on vendor credentialing requirements faster than anybody else,” says Mark Adams, vice president of sales and marketing for CryoCor Inc. (San Diego). “Hospitals are telling vendor reps that after a certain time they will not be allowed in the hospital unless they have paid a fee. But the fee is expensive, and it's becoming restrictive.”

Although vendor credentialing applies to manufacturers of all sizes, Mark Miller,vice president of sales and marketing for Zonare Medical Systems Inc. (Mountain View, CA), says that larger companies are at an advantage because they can negotiate for their entire company across a large number of hospitals. “And since those hospitals would obviously have more than a single rep calling on them from that company, it makes sense for them to set up an agreement on a companywide basis,” he says.

“Smaller companies often find themselves in more of a hit-or-miss situation,” Miller adds. “Each time we go into an institution, we don't know what's going to happen. Sometimes we get tripped up by unexpected requirements, and our rep has to retreat. And a lot of times the reps don't even go into the hospital, they just go somewhere else. And that's not good for us.”

Mark Leahey, executive director of the Medical Device Manufacturers Association (MDMA; Washington, DC), says that hospitals seem to be approaching vendor credentialing from one of two perspectives. While some institutions are rightly focused on liability and privacy issues associated with granting vendor representatives access to their physicians and patients, others are implementing credentialing programs as a means of cutting off communication between physicians and supplier reps, he says.

“What started as a decent idea is now erecting barriers for companies looking to have access to physicians in the hospital setting,” says Leahey. “Such programs do a disservice by not allowing the free flow of information between physicians and supplier reps.”

Leahey also notes that it's not just manufacturers' sales and marketing personnel being barricaded by vendor credentialing—he's also heard of instances in which companies conducting clinical trials have been unable to gain needed access to clinicians for lack of the proper credentials.

Leahey agrees that a national system for vendor credentialing needs to be established and administered by reputable body. Ideally, he says, the system would operate like a driver's license for vendor reps, certifying that they've met certain established criteria for training, background checks, immunizations, and other relevant areas. Leahey also agrees that JCAHO would be well-suited to develop and administer such a system.

For more information on the increasing array of vendor credentialing requirements and tougher legal scrutiny facing device manufacturers' sales forces, MX called upon a panel of experts—including Adams and Miller—to provide their views about the current state of medtech company sales efforts. The roundtable, appearing in the March/April issue of MX magazine, is available at www.devicelink.com/mx/archive/08/03/roundtable.html.

© 2008 Canon Communications LLC

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