Ethics guidelines need risk manager input
Health care providers are taking a hard look at how to restrict the free gifts, meals, and travel from pharmaceutical companies and device manufacturers that have become a standard part of the health care business, and risk managers have a major role to play.
The trend clearly is for health care providers to restrict freebies, and some are going so far as to ban them outright. One of the most comprehensive and restrictive policies was enacted recently by the University of Pittsburgh Medical Center, where the policy bans gifts such as pens, notepads, and food provided by industry representatives. It applies to about 50,000 faculty, staff, and students of the university's Schools of the Health Sciences and other professionals and staff employed or contracted by UPMC's U.S. operations.
Risk managers should be deeply involved in the development and monitoring of industry relations guidelines, says Edgar Bueno, JD, an attorney with the Pillsbury Winthrop in McLean, VA. Bueno focuses on fraud and abuse and compliance counseling, and he previously worked at the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services in Washington, DC.
"The line as to what is appropriate or legal can get pretty murky, but the ramifications are potentially quite large," he explains. "The risk manager has to step in and protect the organization."
Bueno says these are the primary laws that providers need to worry about with industry relations guidelines:
- The anti-kickback statute, which is a criminal law;
- The federal False Claims Act, which allows the government to recover huge penalties and treble damages for fraudulent claims submitted as a result of an impermissible kickback relationship;
- An OIG program exclusion which would prevent an individual or entity from doing business with any of the federal health care programs. "If freebies are being offered or provided to patients, then certain patient inducement laws may also be implicated," Bueno says.
He notes that there is no requirement to have industry relations guidelines in place, and up to this point, many providers have had none or only a loosely worded, rarely enforced policy. But not having a policy means you must depend entirely on your employees knowing what is and is not acceptable, trusting that they won't get you in a load of trouble by accepting a free dinner or a trip to the Bahamas. (An academic group has proposed a total ban on such gifts.
"When it comes to whether you need a policy, a lot depends on how much of the perception issue the institution is willing to manage. Put another way, how much is the institution willing to defend its conduct or its physicians if ever questioned by regulators?" Bueno contends. "Is there reasonable justification for an entire department to be accepting free pens, lunches, or gift certificates from a drug sales rep?"
The first step for a risk manager should be to determine what is going on in your institution, he says. If you work at a large academic medical center, you probably know already that industry representatives are offering gifts at every opportunity. That type of facility is most in need of a comprehensive and strict policy such as that recently put in place at UPMC, he says. But if you are a risk manager at a smaller institution with no teaching affiliation, the gifts in question might just concern the ink pens, writing tablets, drug samples, and an occasional lunch. A policy on those gifts still might be appropriate, Bueno says, but a UPMC-style policy that addresses every possible scenario might be overkill.
"The scale of the gift has a lot to do with it. I don't think anybody's going to argue that something nefarious is happening because your doctor took a free pen," Bueno says. "But if your entire surgery department is taking free vacations and going to lavish dinners provided by a device manufacturer, and your risk management department doesn't even know about it, then obviously there is a compliance risk there."
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UPMC policy covers gifts, meals, consulting The University of Pittsburgh Medical Center (UPMC) is the latest large academic medical center to implement a comprehensive set of industry relations guidelines. The policies are far-reaching and restrictive. Because of sharply differing opinions on the value of drug samples that can be passed on to patients, doctors were given the option of whether to continue offering samples. UPMC reports that some doctors have chosen instead to provide patients with information about other ways to obtain their medicine, such as manufacturers' assistance programs. The university is putting together a centralized process for UPMC to accept samples from companies, and then provide them to doctors' offices. Here are some of the other provisions of the UPMC policy:
Penalties for UPMC employees can include mandatory counseling, written reprimands, revocation of hospital privileges, fines, or termination. Companies repeatedly violating the policy could have their sales and marketing personnel suspended from UPMC and the Health Sciences schools for a year or more. The complete policy and related information is available online at www.coi.pitt.edu/IndustryRelationships. |
Gabriela Cora, MD, MBA, president of the Executive Health & Wealth Institute, a consulting practice in Miami, and managing partner of Florida Neuroscience Center in Fort Lauderdale, has seen the whole range of practices throughout her career. Working at hospitals she has seen extensive interaction with industry representatives, but then when she worked at the National Institutes of Health in Bethesda, MD, there was virtually no exchange of gifts. Cora says risk managers can expect considerable resistance from physicians if you try to restrict gifts.
"Some physicians will tell you that it is not an ethical issue because they can spot the bias and know when they are being manipulated," she says. "That is not really true. It can be difficult for a doctor to know when a free gift is influencing a decision. I know of cases in which patients were treated with certain drugs just because the free samples were available."
Cora says risk managers should combine education with awareness about regulatory issues. That tactic will be more productive than simply declaring that certain practices are prohibited and threatening disciplinary action, she adds.
"Enlist some people from their field to discuss how bias works, that it is a psychological process that can be very subtle. Show them how it occurs," Cora says. "Combine showing them the data on this with explaining the procedures you expect them to follow. You will make much more headway if you can first convince them that there is a real risk of bias from these gifts that seem so harmless."
Cherie Fieri, MHSA, a health care specialist with LECG, a consulting firm in Chicago, says she has seen a trend toward a more conservative approach to industry relations guidelines. That is generally good advice for risk managers, she says.
"The pharmaceutical companies are responding in the same way, by minimizing the logos on the small gifts they hand out, by trying not to be so blatant about getting their names out there," she says. "My advice to clients is to be very conservative with this topic and formulate guidelines that make it clear you expect people to err on the side of caution. Make clear the intent of your organization, that you don't want to give the perception of any improper influence."
Everyone needs guidelines
It is not just large academic centers that need industry relations guidelines, Bueno says. Regula-tors tend to look at the biggest, most obvious targets first and then move on to smaller institutions where they know the same problems exist, he says. (The problem doesn't just concern pharmaceuticals and device manufacturers either. )
Developing a policy should not require re-creating the wheel; many institutions have made their industry relations guidelines public, and a risk manager can start there to establish the basic components of a policy, Bueno says. However, he warns risk managers against rushing to a complete ban on gifts and policies so strict that employees can't have any meaningful contact with industry representatives. Such a complete ban is easier to enact sometimes because you don't have to argue over the details of what should and should not be allowed. The downside, he says, is that you can deny your employees important contact with others in the health care business.
"The other possible risk is that you have made the policy so restrictive and ironclad that you're setting yourself up for failure," he says. "Either your employees try to comply but just can't because the policy is not realistic, or they just forget it altogether and do what they need to do."
Sources
For more information, contact:
- Edgar Bueno, JD, Attorney, Pillsbury, Winthrop, Shaw, Pittman LLC, McLean, VA. Telephone: (703) 770-7709. E-mail: [email protected].
- Gabriela Cora, MD, MBA, President, Executive Health & Wealth Institute, Miami. Telephone: (305) 762-7632. Web site: www.executivehealthwealth.com.
- Cherie Fieri, MHSA, LECG, Health Care Specialist, Chicago. Telephone: (312) 267-8206. E-mail: [email protected].
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