The Advamed guidelines set the "rules" on interacting with health care professionals and set specific rules as discussed in lecture such as being able to take a physician out for dinner if legitimate tasks or business is being conducting but not being able to pay for their spouse's dinner. Being able to pay physicians for legitimate tasks such as research, consultations, teaching classes and board time is appropriate, but is it crossing the line to take them out to dinner and pay for a modest meal. In my opinion, the rules do seem conflicting and this guideline is flawed and should be modified.
Where is the line drawn to decipher whether the interaction is a collaboration or a conflict? Do you find any flaws with the current guideline as well?
It is customary in medical device companies to allow for meals with health care professionals (HCP) where the company representative will pay for the meal. There is typically a limit to how much the meal can cost and regulations around what the purpose of taking out that particular HCP (for example if you are partnering in research or collaborating on a project). The line gets drawn when the gift or dinner to the HCP (or HCP to company rep) is excessive, as that can indicate that there is a conflict of interest between the HCP and company representative (example: patient referral). Excessive gifts include cash, theater or sports tickets, wedding/personal gifts, etc. This keeps the relationship between the HCP and company professional, while still allowing for courtesy gestures like small gifts and dinner.
In my experience in the pharmaceutical industry, I personally never had to deal with the possibility of paying for a modest meal or doing favors for doctors when talking business but as for company policy I had to do training which discussed best practices on how to deal with conflict of interest. In our training we were instructed that a modest meal between two parties, employee and health care professional HCP is allowed and can be done in a way that dosent imply impartiality. I believe a meal between a company and an HCP should be allowed when strictly discussing business. Now I agree that anything beyond a meal should be strictly prohibited, which include taking the party out to an exuberant outing, or paying for sports events or concerts, as that involves special and unnecessary sorts of compensation for talking business. This however can be considered as special treatment and would indeed violate federal laws and company laws as well.
Prior to this lecture I had never learned about the AdvaMed Code of Ethics. For those unfamiliar with the topic, the AdvaMed Code of Ethics outlines guidelines on what is considered ethical interactions and relationships between companies and health care professionals (HCPs). The guidelines reflect the prohibitions found in the U.S. Federal Anti-Kickback Statute which prevents the payment or receipt of anything of value to induce or reward referrals or the generation of business payable under federal health care programs. As per the guidelines, which I have linked below, the AdvaMed Code of Ethics identifies value through collaboration if the intent is to: [1] advance medical care and clinical science through research, product development, and product testing, [2] instruct, educate, and train HCPs on the safe and effective use of medical technology, [3] provide product service and technical support, and [4] promote charitable giving and public awareness of medical conditions. Therefore, any direct consulting arrangements, programs and meetings, as well as education/grants/donations/sponsorships between companies and HCPs where the outcome provides value, as defined earlier, would qualify as being within safe harbor regulations. The line is drawn when there is no legitimate need, benefit, or value from the interaction (i.e. entertainment or having a spouse dine/travel and lodge in) or if the cost of arrangements are not considered modest.
https://www.advamed.org/wp-content/uploads/2022/03/2022-AdvaMed-Code-of-Ethics-Digital.pdf
I think it all comes down to if this is appropriate in the context of work. Something like a dinner or excessive gift falls outside of the bounds of a typical working relationship and therefore would be a conflict. I agree that there are some instances where the guidelines are a bit strict and we are after all humans who want to bond with others.
The AdvaMed Code of Ethics guidelines are in the best interest of keeping the integrity of the health care system. Although I agree with the prior post that context plays a big role in this code of ethics, I also understand these ethics have been made to eliminate the subjectiveness of any context. However, I question how seriously these ethics are taken in the medical field. Dr. Simon described how physicians used to be accommodated with all-paid-for trips to Hawaii as an example of a kickback by medical device companies, which is highly excessive compared to a dinner. But, does a minor kickback such as dinner bought for a health care provider and their spouse get noticed as easily as all-inclusive trip to Tahiti? Can anyone provide an instance where a medical device company faced governmental action due to paying for an excessive dinner of a healthcare provider and their spouse or paying for some of the other excessive kickbacks described in prior posts?
A recent example I could find of kickback allegations is with the medical device manufacturer Biotronik Inc. This company is a privately-owned partnership that manufactures various types of cardiovascular devices including coronary stents and pacemakers. However in July of this year, they had to pay a settlement of $12.95 million due to kickback allegations. The allegations consisted of pretty much exactly what we learned not to do in lecture this week - the company reportedly "paid for physicians’ holiday parties, winery tours, lavish meals with no legitimate business purpose and international business class airfare and honoraria in exchange for making brief appearances at international conferences." They ended up in trouble because these alleged payments and gifts are excessive enough to potentially convince the physicians to choose Biotronik over a competitor. In a society lacking the ethical regulations proposed by Advamed, the company with the most money to spend on bribes will get ahead rather than the company with the most effective products, so it is important that these anti-kickback guidelines are followed, even if they may at times seem too strict.
Personally, I believe that the entire process can be made simpler if the guidelines are revised so that the healthcare professional cannot be given gifts or be taken out for meals for the duration that they are consulting with the company or while they are deciding on what company's product to use. After the consulting is over or the decision is made then a reasonably priced gift or dinner can be given. Another option is that if dinners and gifts are to be allowed, then the company should make it clear to the doctor that the gift/dinner is in good will or as a thank you, and there is no reciprocation from the doctor expected. This way the doctor's integrity can be maintained and the company is protected from accusations of influencing or bribing the doctor's decision while still allowing the company to thank the doctor for their help.
While I do agree that the inclusion of providing gifts to HCPs can be confusing and complicate situations between HCPs and companies, I do think if any transactions are done, they should be done solely electronically, so that it is easier to track down how much money may have been disclosed between the two parties and what it is being used for, should the need arise to look into it. This way, if there is a need to investigate for a conflict of interest, it can be easy to track down the source and goal of the money that is being exchanged for "gifts" etc. While this does not fully solve the issue, it can to some degree, help in damage control.
