Q: I'm uneasy about accepting meals and other free stuff from sales reps, and I want to avoid any appearance of unethical behavior. Do you have any advice?

A: You're right to be concerned about this topic. The government is becoming increasingly aggressive in prosecuting physicians who allegedly receive "inducements" to prescribe specific medications. The costs to a practice in defending itself against a government investigation can be staggering—both in terms of expense to the practice and stress on everyone. Even if you are exonerated, some people will always look at you "differently," and we've found that the public's negative perception can be devastating to a physician's future.

You can avoid a lot of trouble by using a practical, common sense approach to this issue and by following the American Medical Association's Ethical Guidelines on Gifts. For example, the AMA Guidelines say that a sales rep can provide modest meals (according to local standards) and gifts of minimal value (for example, mugs, pens, pads of paper), as well as items of minimal value (that is, less than $100) directly related to patient care if given only on an occasional basis.

You should not, however, accept anything that could be seen as influencing your medical decision-making. Here's the $64,000 question to ask yourself: Will this meal/gift/grant induce you to use this product more—or even appear to induce you in this way?

Q: What types of things are getting the government's attention?

A: One area is the practice of giving "free samples" to physicians. Free samples often serve legitimate needs. When the physician submits a bill for the "free" sample, however, the government will take great exception and the physician and drug company could find themselves facing criminal charges.

Another area under heavy scrutiny is the practice of "grant" giving. Of course, there are certainly legitimate reasons for giving a physician a grant, such as for valid clinical studies. Some types of clinical study grants can, however, be suspect. The Office of the Inspector General says that payments to physicians for clinical research purposes should be at fair market value and for legitimate, reasonable and necessary services. Research-related contracts with physicians that originate through the sales and marketing departments (or that are offered in connection with sales of drugs) are highly suspect.

Q: Where can we go for guidance on all this?

A: The best source for guidance for physicians is the AMA website. It contains two important documents, Gifts to Physicians from Industry (E-8.061), and Clarification of Gifts to Physicians from Industry (E-8.061). The latter is the most updated document, and it can be accessed at www.ama-assn.org/ama/pub/article/4001- 4388.html. Here is a brief synopsis of what the AMA guidelines say:

 • Any gifts accepted by physicians individually should primarily entail a benefit to patients and should not be of substantial value (e.g., less than $100).
 • Gifts of textbooks and modest meals may be appropriate if they serve a genuine educational function.
 • Cash payments should not be accepted.
 • Physicians should not accept subsidies for CME activities (e.g., meeting costs, travel, lodging or other personal expenses) directly from a pharmaceutical manufacturer or sales rep.
 • Gifts of expensive hardware (PDAs, handhelds, computers, etc.) or software, even if for educational purposes or pertaining to industry activities, are not appropriate.
 • The use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples. It would not be acceptable for non-retired physicians to request free pharmaceuticals for personal use or for use by family members.
You might also want to take a look at the pharmaceutical industry's guidelines for ethical behavior on the part of sales reps, available at www.phrma.org/publications/policy//2002-04-19.391.pdf.

Q: At the risk of sounding naive, how would the government ever learn of questionable gifts, grants or donations?

A: I get this question all the time. You would be surprised about the many "eyes and ears" that observe your practice. Many times, allegations surface from a whistleblower. This could be a disgruntled employee, a patient, or simply one of your colleagues who is jealous of your all-expenses-paid trip to Cancun! It could also be a colleague who is under investigation himself and rats you out in an effort to negotiate a deal with investigators. What's in it for the whistleblower? He or she can receive up to 30 percent of the money recovered by the government.

Q: Who generally will bring charges, and what are the penalties?

A: The Department of Justice, the OIG and/or the state Medicaid fraud control unit are likely to bring charges against physicians when these kinds of allegations are made. The penalties depend on what statute they elect to pursue against the physician. For example, a violation of the federal anti-kickback statute is a felony carrying a fine of $25,000 for each offense and up to five years in prison. If you are charged civilly, you can be fined $50,000 per act plus up to three times the prohibited remuneration. Also, you can be excluded from all federal health-care programs.

If you are charged under the False Claims Act, your civil liability can be up to three times the damages the government received and up to $11,000 per claim (those add up very quickly). False claims suits are typically the most common way these things surface, and they are generally easier for the prosecution to prove than a kickback charge. A host of state laws apply in a similar vein, and the states can bring charges as well.

Here's my closing thought: In general, never accept a gift if it appears to have strings attached. Remind yourself, "If somebody is giving me something, there's a reason." 

Ms. Poindexter is an attorney in the Health Law practice group at Shook, Hardy & Bacon, LLP. She frequently lectures on health-care legal issues.