Required Medical Disclosures For Physicians

When it comes to working with industry, keep your karma clean.

Working with industry comes with strings. The Patient Protection and Affordable Care Act, signed into law on March 23, 2010,  includes a number of provisions including a requirement that all pharmaceutical and medical device manufacturers publicly post on a website all payments or transfers of value from the manufacturer to a health care professional or institute. Some companies, like Allergan, have taken it a step further and entered into a Corporate Integrity Agreement with the feds. (http://www.allergan.com)

The present oversight environment demands that you disclose and make transparent your interactions with industry and any financial interests that result from that interaction. Here are some things to do to be sure you don't get caught with your stock options down.

Keep score

Be sure to keep an updated inventory of your consulting engagments, contracts and activities and  how you were compensated in cash, stock or some other financial instrument

Disclose

If you are an employee of an organization, like a univeristy of hospital chain, it is likely that you will get  a friendly (hopefully) reminder from your compliance officer to submit your conflict of interest statement. They will review it and get back to you if they see problems.

Don't study or use what you own

Big ticket conflicts make headlines. If you are being paid as a consultant to an orthopedic company and use lots of their products, beware. If you give lectures on depression to docs who like to eat expensive steaks and drink top shelf wines for free, and, you are the biggest prescriber of antidressants in your galaxy, that will raise a red flag.

Disclose your activity to peers and others

When you publish something or give a talk, disclose your interests. If you participate in medical legal activities, like expert witness participation, understand that your commercial interests will come under the magnifying glass of opposing counsel. Likewise, if you agree to work with one company, you will usually be asked to sign something saying that you will not work with another company where there might be a conflict.

When working with industry, it's best be safe than sorry. Doctors hate to flunk tests. The worst one to flunk is the New York Times test.

Comments

[Dallas Doc]

Should I have my lawyer review a very standard looking NDA when consulting for a client?

[Arlen D Meyers, MD,MBA]

When I was asked to sign my first NDA (or CDA, confidential disclosure agreement), I freaked and had a lawyer look it over. He added or subtracted a few things around the edges, adding nothing very substantive, but I felt better. Since, then I've become experienced with the language and generally don't consult a lawyer unless I see a glaring red flag. I compare it to surgery...see one, do one, teach one.

As long as we are talking about not showing yours if you don't show mine, here are a few other tips:

1. NDA's can be unilateral or bilateral. Take for example executing an NDA between myself, an inventor who wants to work with a medical device company to further develop my product and the company, that wants to disuss my product. In that case, we signed a biliateral NDA.

2. I've been presented with NDA's that vary in length from a single page to 17 pages. The basic disussion points have to do with the definition of "confidential information", due diligence and retained rights, term and termination (when and how the agreement ends), and other CYA legalese topics like severance and assignability.

3. All contracts are negotiable. You might feel powerless or insecure about negotiating terms because of your inexperience, but be sure to make your concerns known. For example, being asked to keep something secret for 10 years is unreasonable. Most of the time, contracts stipulate 3-4 years as the time window.

4. If there is a breach of contract, your medical professional liability insurance in unlikely to cover the costs of any legal proceedings. Get an umbrella liability policy that will cover you.

5. If you have ideas or intellectual property you want to protect , and you want to share your idea with others,I'd have a lawyer draft the agreement and have clients sign it before you give away the recipe for the secret sauce.

6. In general, without an NDA in force, talk about the "what" not the "how"

7. Be sure you have the authority to sign an NDA. For example, if you are a faculty member at a major research university, you generally don't have the authority to represent the university when it comes to agreements concerning intellectual property that the university might own or potentially own. I get the signature of the Associate VP for Technology Transfer to sign it. The Supreme Court has recently agreed to hear a case concerning a faculty assignment of IP to Stanford, so stay tuned.

8. If you are in doubt, spend a few bucks to get someone to hold your hand.

I'd be interested in hearing about the experience of others.

[Arlen D Meyers, MD, MBA]

http://www.propublica.org/article/medical-schools-policies-on-faculty-and-drug-company-speaking-circuit
More about conflict of interest

[Dr D]

While I agree with this in principle, docs should be a bit perturbed by the fact that they are required to do what many in other areas of endeavor are not. At what point does disclosure become unreasonable? Does getting a pen from a pharmaceutical rep constitute anything untoward? Lawyers have standing commission agreements with other lawyers which are rarely if ever disclosed. We are held to a higher standard and are not appropriately compensated. We are easy prey.

[Arlen D Meyers, MD, MBA]

Dr D,
Thanks for your comment.

Your bring up several good points.
Q: Where do you draw the line? A: Where you'd be emabarrassed to read about it in the newspaper.
Q: Why do we have different standard? A: Not sure we do. Anyone in a fiduciary capacity, let alone those who deal with people'd lives, has a duty to disclose.