Articles on Compliance Strategies

Featured Health Business Daily Story March 5, 2009

Pressure Mounts to Manage Medical Device Vendor Reps in Operating Room

Reprinted from REPORT ON MEDICARE COMPLIANCE, the nation's leading source of news and strategic information on false claims, overpayments, compliance programs, billing errors and other Medicare compliance issues.

By Nina Youngstrom, Managing Editor (nyoungstrom@aispub.com)

It seems to be viewed almost as a necessary evil: Medical-device vendor representatives sometimes must be in the operating room (OR) to provide surgeons with technical support when the vendor's product or service is being used (e.g., knee or hip implant). But the presence of vendor reps raises all kinds of concerns, and hospitals are struggling to manage vendor reps' access, thoroughly screen them, ensure patient safety and privacy, and prevent conflicts of interest and kickbacks. It's a formidable task against the backdrop of the larger challenge of crowd control in the OR, a popular place for everyone from residents and med students to the surgeon's children.

"There's increasing concern among regulators about the role these vendor representatives play and making sure the role is appropriate," says Heidi Sorensen, former chief of the HHS Office of Inspector General's (OIG) civil and administrative remedies branch. "It creates compliance issues, and hospitals need to have policies [addressing vendor reps]. Hospitals don't want to rely on whatever the individual surgeons decide to do in their own practice. Hospitals want control over access to the OR, access to patient information and access to procedures," says Sorensen, now with Foley & Lardner LLP in Washington, D.C.

CCO Vetoed Payments for Training

The most basic compliance issue is triggered if money changes hands. One compliance officer tells RMC that he recently had to fend off a proposal by surgeons at his hospital that was clearly a conflict of interest and could have violated the anti-kickback law. The surgeons had been approached by a vendor that wanted to create a training program for the OR. The vendor would pay the surgeons to teach new vendor reps so they would be more effective in the OR. The compliance officer, who asked not to be identified, turned the surgeons down. "If they stopped buying products from the vendor, their teaching money would evaporate," he says. It would have been fine if the surgeons had taught the vendor reps for free.

Instead, the hospital is setting up a "vendor representative training program." The training will focus on what vendor reps need to know when certain surgeries are performed (e.g., stent implantation). Vendors will pay tuition to the program for each rep who attends training. But the money will go into the training program's general pot, not to the surgeons. The compliance officer hopes it will improve quality. If the vendor reps' presence is inevitable, they should be as knowledgeable as possible, he says. It's not clear yet who will teach the classes.

Questionable financial relations were described by Gregory Demske, assistant HHS Inspector General for Legal Affairs, at a Senate hearing last year. He spoke of the misconduct that let to a landmark fraud settlement with five medical device makers. One example: Consulting surgeons "billed for training sessions that involved sales representatives observing the surgeon while in the [OR]. Some of these training sessions were held for experienced sales representatives who, as part of their jobs, had been servicing the surgeons in their sales regions for some time. These sales representatives were already required to be present in the [OR] with the surgeons to assist them with the procedures. These training sessions lasted for one to two hours, but the consultants billed for an eight-to-10-hour workday."

Some Vendors Wear Black Scrubs

Even when there are no overt deals, hospitals need to restrict the reps' movements. If they are onsite to provide technical support for their device, they shouldn't be milling around other areas of the hospital. "Vendor reps must understand they are here for a limited purpose — to facilitate a surgical procedure" — not to pass out trinkets and schmooze people and hang out in the break room, says Julie Chicoine, compliance director for Ohio State University Medical Center.

"There are merits to having vendors in the OR guiding physician in terms of a device the physician might not be that familiar with," Chicoine says. "For example, a device may need some kind of baseline assessment and initial checking, so it can be beneficial to have the vendor rep there. But you need safeguards to show the public you are really vetting the vendor rep - that there is some kind of process to control access and ensure patient safety."

Hospitals should designate an area where vendor reps wait until it's time for surgery, and the area should not be the physicians' lounge, compliance officers say. The vendors should wear badges and, perhaps, different color scrubs so they're not mistaken for hospital employees. Some hospitals require vendor reps to wear black scrubs so everyone is clear about their role. Vendor reps should scrub in (wash hands and arms very thoroughly), and stay out of the OR until the patient has been properly draped, compliance officers say. And vendor reps must have proof of negative TB and hepatitis tests. Some hospitals require them to complete questionnaires about their health (e.g., that they have no infectious diseases).

"This is a patient safety issue, and more people are interested in it," says Robert Michalski, compliance officer for West Penn Allegheny Health System in Pittsburgh. "Only the appropriate people should have access to those patients." From a privacy perspective, "you don't want [vendor reps] knowing who's in the hospital." In fact, the vendor rep doesn't need to know the name of the patient on the operating table, or at least there should be a provision to prevent the vendor rep from writing down that patient's name.

Patient rights and informed consent is another important issue. Under HIPAA, patients have to give their consent to the presence of the vendor rep. But one compliance officer questions how meaningful this is. When patients are anxious because they are about to have surgery, how likely are they to say no to the people who control their fate? "I don't think patients are going to argue with the clinical people," even if they have privacy concerns about the vendor rep's inclusion in the surgery, says the compliance officer, who asked not to be identified. So some hospitals require vendors to sign a statement in advance agreeing to comply with the hospitals' privacy and security policy.

It's also critical to make sure that vendor reps have adequate credentials. Hospitals struggle to ensure the vendor reps have the biomedical expertise to support the surgeons with the relevant device. Michalski's health system is now evaluating a vendor-credentialing process to screen vendor reps. "All vendors would have to go through [the credentialing process]" before setting foot in the hospital, he says. The credentialing includes verifying licensure (if relevant), conducting criminal background checks, ensuring that vendor reps have read the hospital's relevant policies and procedures (infection control, HIPAA, code of ethics), and confirming annual TB testing. "This is an operational decision by our health system to try to bring more control to the process," he says. Outside firms can conduct vendor credentialing, he notes.

Despite efforts to manage vendor reps' access, people are uneasy. "There are no standards for their clinical training except what is created by the vendors," one of the compliance officers says.

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