Can my meeting presentation get me in trouble?
Editor's note: "The Higher Ground" is designed to keep ASPS members aware of the real-world ethical quandaries that plastic surgeons commonly face. The columnist, Joe Gryskiewicz, MD, Edina, Minn., has been practicing for more than 25 years, and he is a former member of the ASPS Judicial Council. Readers are encouraged to submit questions directly to Dr. Gryskiewicz at drjoe@tcplasticsurgery.com or to PSN at PSN@plasticsurgery.org. Names will be withheld, and the views expressed in this column are those of the author.
Q: I was asked to speak at Plastic Surgery 2011 in Denver, but I'm worried about getting "dinged" by the Justice Department if I say the wrong thing about my clinical study, which focuses on a product not yet cleared by the FDA. I want to avoid inadvertently promoting the product - which hasn't been approved. I also don't want to get in trouble with the manufacturer that's paying me. What can I safely tell my colleagues?
A: This is a question frequently asked by presenters at the "Hot Topics" session - designed to bring new techniques and technologies to plastic surgeons - at the annual meeting because it's like walking through a field of land mines. Although not a specific ethics violation, a "misstep" could not only put your study out of commission, it could alter your career as you know it. The roadmap to carry reads: "No Promotion - Just the Facts." Keep your presentation strictly factual. Evidence-based medicine is fact-based medicine - and the facts are not inflammatory. Stick with the facts so you can't be accused of promoting.
Here are some guidelines:
- Delineate or articulate your presentation with the manufacturer. Be sure its regulatory department is crystal clear on what you'll be presenting. Verify that you have their "seal of approval."
- Realize that what you tell your audience is just as important as what don't tell them. You need to state clearly that you're presenting an investigational device, product or drug. You can't state anything about safety and efficacy for an unapproved product or device.
- You can show your results, but you can't "spin" them.
If you follow this roadmap on the podium, you'll be absolutely fine. To take this discussion a step further, the FDA is concerned about the promotion of off-label use. This concern applies to a clinician's judgment to go off-label with products, devices or pharmaceuticals that have already been cleared for safety and efficacy, and allowed for marketing and distribution. Good luck with your study - and I'm looking forward to hearing your presentation!
Q: I performed a facelift on a patient six months ago. A hematoma developed within a day of her surgery, so I took her back to the O.R. to evacuate the blood. It turns out her hypertension was more of a problem than I thought it would be - she's on medication for it. After the surgery, the side with the hematoma was thicker and brawnier, leaving her really upset. She saw another local plastic surgeon who told her she had a bad outcome that may require more surgery. He also told her I've barely been out of training and just took my board exams - which is true. The patient now comes to see me with an entourage that includes a relative who's an attorney, and I think she's going to sue me. How do I handle this?
A: I feel your pain. A pejorative remark by another colleague to a disgruntled patient initiates more lawsuits than any other cause. Some physicians refer to this practice as "jousting." Either way, it's serious business because "loose lips sink ships." You want to keep seeing this patient and keep up your rapport with her. Always have one or more of your staff in the room when you see her. Have a trusted colleague in town examine her for a second opinion, and if necessary cover the cost of that office visit. Discuss the case with your colleague. Call your malpractice carrier to start a file on this case, and discuss the situation with the carrier at length. We don't really know what the other plastic surgeon said to your patient, but if things smooth out with her, you may want to pursue this with your county medical society. This would not rise to the level of ASPS Ethics Committee involvement (should the other surgeon be an ASPS member), but his/her behavior exhibits unprofessional conduct. That said, "barely" out of training is a put-down word and not a statement of fact. There was no reason for the other plastic surgeon to inject this comment into this patient's care, which is probably upsetting her all the more. When you completed your training per se has no material bearing on this patient's care. So stick it out, call your insurance carrier and get the patient to meet with an experienced colleague in your area.
Q: I saw a young patient in the E.R. who had lower extremity lacerations with multiple tendon injuries. I repaired these in the middle of the night. My office submitted the correct CPT codes but inadvertently inserted a modifier that inflated her bill to $69,000. This amount was paid to me in full by her automobile insurance company. Now I'm being investigated for egregious billing. I don't feel I did anything wrong. I had nothing to do with the inappropriate modifier. I didn't even know about the overpayment. What's your opinion?
A: The ASPS Code of Ethics specifically speak against "Charging exorbitant fees, particularly of a non-contractual nature (e.g., emergency care)." It goes on to state: "Fees are exorbitant when they are wholly disproportionate to the services rendered." (Code of Ethics Section 2: Specific Principles I, F (3)).
Whether you knew about this charge or not, you're responsible to some degree. You must rectify this overpayment. In addition, you're obligated to initiate safeguards to "ensure" your "insurance" carrier is not overbilled by your office or billing service again. Should you be contacted by the ASPS Ethics Committee on this matter, make it clear it was an oversight, that you have reimbursed the carrier and that you've initiated safeguards to prevent this same occurrence in the future. I would guess the matter would be dropped and you would not have to appear before the committee. If you choose to ignore an Ethics Committee call, there's a good chance you would have the opportunity to buy yourself a round-trip plane ticket for your very own live appearance before the ASPS Judicial Council.
Q: I'm a recently board-certified plastic surgeon, and it's important to me that I grow my practice in an ethical, responsible manner. Is it considered within the scope of ethical practice to offer complimentary products (such as lash-enhancement products or facial fillers) with the purchase of another product or service? It's common to be encouraged by product sales reps to offer such package deals, but I'm very interested in learning the Society's official position on this matter.
A: As long as it's above-board and clearly spelled out to the patient, it's fine to provide lash enhancers and fillers for promotions. Because neurotoxin dosage differences depend on the brand, it's easier to advertise regional treatment rather than a specific dose. I interviewed our office territory manager to discover there are many physicians' offices that offer these types of packages. I think most of them stipulate that to qualify, the patient must be a candidate for that type of procedure.
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