Wild, Wild West: HCIR Credentialing

FROM THE EDITORS

These are tough times for the medical device industry. And just when you thought there couldn't possibly be another hurdle to overcome, along comes requirements for healthcare industry representative (HCIR) credentialing. Barely heard of just 18–24 months ago, HCIR credentialing is gaining traction, with many of the nation's hospitals seeking some sort of credential from your sales reps.

But it is far from organized and efficient. Requirements run the gamut—from simply seeking a letter certifying training to demanding proof of background checks and drug tests. Some are attempting to put industry reps through the same process used to credential clinicians. And, in some cases, the requirements are simply inappropriate. In Dade County, FL, for example, healthcare representatives must register as lobbyists. Worst of all, the requirements are inconsistent. Hospitals, indeed, must protect themselves and their patients. But this well-meaning goal could spell disaster for medical device manufacturers, especially ones such as implant makers, whose reps sometimes understand the product better than the physicians do. These reps need direct access to patients and doctors during the procedure.

Some of the initial credentialing programs focused primarily on sales representatives who needed to be in the operating room during device implantation procedures. However, these programs are expanding to cover all reps—even those who don't need patient access. Magnify this scenario times each hospital that decides one day to implement new requirements. Because every hospital seems to have its own standard, John Tara, leader of AdvaMed's vendor access work group and director of corporate strategic marketing for Boston Scientific Corp. (Natick, MA), described what is happening as “the Wild West of credentialing.”

The solution seems to be a national standard. But, the onus is on you to make it happen or you might get something that is unrealistic. Without input from industry, you may very well end up with scenarios like this one: Your rep calls on a hospital and is told that in order to gain access, he or she must first pay a $600 fee to have a third party do a criminal background check, a drug test, and training verification. The first time you might hear of it is when it shows up on the rep's expense report. Currently, fees range from $85 to $695, depending on which third-party firm a particular hospital uses. For small companies, such fees could even be a prohibitive barrier to market entry.

In September 2007, AdvaMed proposed its own set of credentialing requirements for adoption as national standards, and the AdvaMed work group is also preparing a best practices document. Tara says that document speaks to four key areas: it focuses on credentialing reps in a way that promotes patient safety and patient care; it reduces redundancy, duplication, and cost; it creates reciprocal arrangements; and, ultimately, it creates a sort of credentialing passport. He says the passport idea means that if industry has the right set of national standards with the right type of oversight, companies would understand what they need to attest to that documentation being completed appropriately.

It won't necessarily be easy. Robert Wise, MD, vice president for standards and survey methods for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), made these suggestions at the AdvaMed meeting in March:

So, if there is a universal industry standard, who is going to develop it and, moreover, who is going to enforce it? The best answer, of course, is you.

Sherrie Conroy for the Editors