From: Paskman, AndreaDespite the fact that some people mistakenly believe that HIPAA privacy regulations REQUIRE AZ to take this action, I beg to differ (see "On Cupcakes and HIPAA").
Sent: Tuesday, May 01, 2007 4:49 PM
To: Danhoffer, Ronald E; Hardesty, Edward L: Russel, Joseph; Cioll Richard E (ONC DSM); Karcewski, Thomas M; Call, Teresa
Cc: Kelly, Shawn; Hagelbarger, Jeff A
Subject: FW: MUMs Programs
For those who have been asking about the MUMs program:
Recently, questions have been raised to both legal and compliance personnel regarding the sales force’s ability to distribute patient educational materials for the MUMs programs. During the month of May 2007, the sales force will be permitted to conduct such in-office MUMs programs, however the following provisions apply:
1. Approved patient education materials may be distributed to patients in the office on behalf of, and with the permission of , the HCPs
2. PSS may display patient education materials on a small table in the office waiting room
3. The provision of food, snacks, beverages, and/or flowers to patients is not permitted.
The future of the MUMs program and similar in-office programs is currently being evaluated. You will be notified once the evaluation is complete.
The AZ Group of Seven quoted this from internal sources:
Here is the source for our HIPAA research:To which I reply:
May a sales representative sit in on a patient's exam or treatment?
No — unless the physician has obtained a valid authorization from the patient to share the information for these purposes. A sales representative may sit in on a patient's exam or treatment only if the patient has signed a valid authorization expressly allowing the sales representative to do so. The physician should provide the patient with sufficient opportunity to read the authorization form and ask questions before the patient decides whether to provide permission.
Reps in the examination room is a completely different scenario from reps in the waiting room, which is what I was talking about and presumably where AZ put the cupcakes.
Reps often do get invited into the exam room when patients are consulting with physicians under what's called preceptorship programs. In this case, HIPAA privacy regulations DO require express patient authorization.
Note, however, that it is perfectly possible that some reps may be acting under contract with physicians to assist in the provision of care (eg, medical device reps) -- these contracts are allowed under HIPAA, which refers to them as Business Associate Contracts (BACs).
In that situation, patient authorization is NOT required under HIPAA just as HIPAA does not require patient authorization for the doc to send blood samples to outside labs.
I would note, however, that very few pharma companies would ever enter into BACs because these are very serious contracts. Most opt to make sure that the HIPAA authorization is in place.
BTW, I have written some of these HIPAA-related guidelines for sales rep training at a very large pharmaceutical company, which shall remain nameless.
But the bigger issue is THIS REALLY SUCKS FOR PATIENTS!
I cannot see how it is perfectly OK for reps to feed pizza to docs, but not give cupcakes to patients! (For more on this topic, see "Free lunch for patients! Why not?")
It’s time that we patients stood up and demanded our share of the pharma giveaway program!
Citing HIPAA as an excuse for not giving patients cupcakes is a red herring. That law was never intended to leave patients in the cold while docs feasted on gourmet deli sandwiches!
It’s all because of pharma bloggers — Ed Silverman, Peter Rost, Jack Friday — that this memo was written!
Does anyone think that a cupcake could influence me to ask my doctor for a course of Arimidex? Certainly not!