prosthethics (part 2)


In last week’s post, I shared with you the first half of my presentation at the recent American Orthotic and Prosthetic Association’s Annual Convention. In that talk, I discussed key ethical issues facing prosthetists. My presentation had several parts: (1) a prologue, which focused on why ideologies (i.e., worldviews) are resistant to change, (2) Chapter 1, which set the stage for our main characters, and involved reviewing the government’s increased scrutiny of the prosthetic profession at a time when health care spending is on the rise, and (3) Chapter 2, which introduced us to the main characters, the federal Anti-Kickback Law and False Claims Act, two laws that the government is increasingly using to crack down on certain practices between manufacturers and providers of medical devices.

I ended part 1 of this discussion last week asking the following question: where should a prosthetist look for guidance when it comes to the kinds of issues that the Anti-Kickback Law and False Claims address?

* * *

I want to present two different reference points for you. And I’m focusing on them because they are in some ways substantively similar but in others quite different. The first is AOPA’s Code for Interactions with Healthcare Professionals.

If you go to AOPA’s redesigned website and look under “Resources”, and then click on “Resources” again, you can (and should) review this Code.

AOPA’s Code – which is well written and focuses on the right issues – is also incredibly focused. I don’t know if this was intentional or not, but it’s written from the perspective of what a prosthetist or orthotist can do when interacting with a physician, and that’s it. [AOPA’s President, Tom DiBello, who was sitting next to me on stage, confirmed that the Code was directed at that narrow set of interactions.] So you should review it and understand it, but it doesn’t say anything about what your ethical obligations are when a manufacturer comes to you and offers you something. So for that, I want to turn to the AdvaMed Code of Ethics.

Before looking at AdvaMed’s code in detail, I want to emphasize something: AdvaMed’s code and AOPA’s are largely identical in terms of what they permit and prohibit. The primary difference is their respective area of focus: AOPA looks only at what a prosthetist/orthotist can offer a doctor, while AdvaMed’s addresses what a manufacturer can offer a health care provider, including prosthetists. My company follows the AdvaMed code because we believe it represents the current “state of the art” approach to manufacturer compliance. So let’s walk through how that Code answers each of the ethical questions I asked before.

Can a manufacturer offer and a prosthetist accept gifts? Assume there’s a “life event” – the birth or death of a prosthetist’s family member. Can a manufacturer send something to that customer to express congratulations or condolences? AdvaMed says, “No, you can’t” – the gift will unduly influence the recipient to make product choices based on something other than independent clinical judgment.

Old favorites in this category also used to include iPods and digital picture frames. The rationale on the manufacturer’s end was that these devices served a business purpose – an iPod could be used to keep video of patients, and a digital picture frame could show images you deem relevant in your facility. However, these items can also be used by the health care provider at home for personal use. So AdvaMed prohibits them as well.

How about entertainment? Sporting events or concerts? Advamed says no – giving your customer tickets to this kind of event will skew clinical decision-making.

AdvaMed does permit you buy a customer meals, BUT. There’s a big “but” here. There must be a legitimate business purpose for the meal. You can’t go out with a manufacturer to discuss your golf clubs and personal life. You can if you’re going to discuss your opinion about the manufacturer’s products, treatment protocols, or other business-related issues. And you better make sure that the legitimate business purpose gets documented someplace in case you’re ever asked.

In addition, Advamed says the meal must be modest. The basic test that I recommend to comply with this standard is as follows: would you be comfortable with your restaurant bill appearing on the front page of the New York Times? If two people go out and the bill includes three expensive bottles of wine, four appetizers, and entrees totaling $750, it would be hard to argue that’s a modest meal.

Finally, Advamed says the meals should be occasional. Once a month isn’t occasional – it’s regular. Once a quarter is arguably a regular event as well. My read of the Advamed requirement is that 2-3 times per year, at most, meets the “occasional” standard.

That then brings us to the world of branded items. Advamed has adopted a bright-line test: nothing branded. No polo shirts or tee shirts. No post-it pads or pens. No mugs. Nothing.

[While I did not discuss it explicitly when I gave my talk, there’s one other area that merits mention. Advamed does permit charitable donations. However, the donations must be made to a legitimate not-for-profit organization, and not to a customer directly or in a customer’s name for him/her. At my company, charitable donation requests are closely scrutinized in order to ensure compliance with every aspect of AdvaMed’s requirements.]

That covers the Anti-Kickback Law. So now we turn to what I earlier called the psychotic and highly unpredictable younger brother of the AKL: the False Claims Act.

The FCA, as its name implies, prohibits the filing of any false claim that results in a payment from the government. Federal prosecutors typically use the FCA in conjunction with the Anti-Kickback Law. In other words, if they believe they have an anti-kickback claim against you, they will typically also add a FCA claim also. And given the fact that the FCA provides for three times the actual damages established plus costs, the financial risk associated with such an allegation is considerable.

Perhaps more relevant, however, is that the FCA incentivizes your employees to sue you. This is the overlooked aspect of the FCA, and it poses significant risks to your business. When you think about things that could take your company down, you’ll immediately think of reductions in reimbursement and increased competition in the O&P space. But you’ll probably fail to mention the FCA.

The law treats your employees like a plaintiff’s attorney, giving them between 20% and 30% of whatever amount gets recovered. Employees have the power under the FCA to commence litigation against you on their own. That is called a “qui tam” lawsuit. The government then has the authority to decide whether it wishes to join in the litigation. So every time an employee of yours brings a qui tam action, you face the risk of an Assistant U.S. Attorney investigating your billing practices.

So how do you manage this kind of risk? You can’t prevent current or former employees from filing a whistleblower action against you. The only thing you can do is make sure that whenever there’s an ethical issue related to the AKL or to coding, you err on the conservative side.

The final point to make about the FCA: Tony West, an Assistant U.S. Attorney General who speaks regularly about health care fraud and abuse, has been quoted saying that the government is looking for both “traditional and new” ways to use the FCA. Any time an attorney for the U.S. uses the word “creative” in conjunction with a Federal law, that translates as “we will increase the number of claims we choose to prosecute.” And the data bear that out.

According to USA Today, health care prosecutions have risen 85% in 2011 versus 2010. The total number of cases filed through August of this year nearly matches the total for all of 2010. Under the current administration, the willingness to prosecute and the number of U.S. attorneys available to file these actions have both increased. So this is a trend that is likely to continue for the foreseeable future.

And that, finally, brings us to Chapter 3, which I call “Sybil“. If I can now date myself, “Sybil” was the name of a bad late 70’s movie starring Sally Field as a woman with multiple personality disorder. If you went to a liberal arts college and considered minoring in psychology, you got to see this movie. And this is the “twist at the end” of our story that I mentioned back at the beginning of my talk: our profession’s split personality.

On the one hand, we want to take the P&O out of “DMEPOS”. We emphasize how different P&O is from the storefronts and online retailers that sell DME and supplies. We want and try to elevate our profession so that it’s seen as closer to the medical treatment given by physicians than the “small/medium/large/left/right” treatment given by the rest of the individuals in the world of DMEPOS.

We push for and implement new educational requirements. The move in the future towards a Master’s level education for all O&P providers again highlights the profession’s efforts to elevate itself.

We talk about the custom work that only a certified and/or licensed O&P professional can provide. We emphasize that much of what we do fits in that custom world, and that no one else in the DMEPOS alphabet soup can do that.

Finally, if you’ve walked around the meeting this week, you’ve heard everyone talking about outcomes, outcomes, outcomes. The push to capture meaningful data about how the treatment you provide affects your patients is one of the central themes of this year’s conference. And again, this serves to elevate the profession, to raise your standing so that it’s closer to that of a physician and less like that of a DME shop or a supplies supplier.

And these are all good things. This is exactly what we should be doing. We do need to hammer home the unique and powerful way that we transform the lives of our patients through a skill set that only a few thousand people in the United States possess. Not anyone can do what it is that you do.

But that’s why it makes it so painful for me to hear some version of the following, and I have heard this repeatedly over the years in my current position: “Why can’t I have an [insert name of manufacturer] polo shirt? Everyone else is giving me one and the rules you’re talking about don’t apply to me. I’m not a doctor.”

[Long pause]

Folks, you can’t have it both ways.

We can’t be trying to say, “look at us, we provide unique and transformative care like a physician” on the one hand, and “don’t treat me like a doctor when it comes to getting branded items from manufacturers” on the other. We can’t send Peter Thomas, representative for the O&P Alliance up to Capitol Hill to discuss the finer points of regulations defining what a “qualified supplier” is and arguing for your unique position in the health care industry and then undercut that by saying that the rules that apply to other medical professionals don’t apply to us. It doesn’t work.

Sometimes, doing the right thing is the hard thing, but I think there’s an opportunity for the O&P profession here. Instead of Sybil, we need to take an aggressive, public stance on this issue. We should be adopting the highest ethical standards as a profession and proudly trumpeting and proclaiming them to anyone who will listen.

The way you elevate the profession is by holding yourself to a different standard than people expect you to, to go farther than people expect you to go. In light of everything I’ve discussed here today, in light of the current environment of increased healthcare costs and with it, increased scrutiny, in light of increasingly aggressive prosecution by the government of claims under the Anti-Kickback Law and False Claims Act, do you want to collect lots of golf shirts today and deal with that risk, or do you want to let all that stuff go in the short run in an attempt to help secure the long-term standing of your business the profession as a whole?

I believe this is an important issue facing the O&P profession and I thank you for giving me the time to talk about it with you today.

*   *   *

I spoke about this from my perspective as a person who works for a medical device manufacturer and who previously owned an O&P facility. However, undoubtedly, my viewpoint as a patient who receives treatment from a prosthetist also informed my opinions.

But I’m interested in what the average patient thinks (i.e., those of you who aren’t as enmeshed in the O&P “industry” as I am). This is your chance – let yourselves be heard.

4 thoughts on “prosthethics (part 2)

  1. I’m a traumatic BKA of six years and I suspect the average patient doesn’t think about this much at all. The purpose of the regulations is to lower the cost of healthcare, so suppliers and providers are interested, as is the government. But unless the patient is paying out-of-pocket (or a significant percentage), what things cost doesn’t really matter to most. We all just want the best care possible.

    That said, this kind of regulation strengthens the integrity of the prosthetic industry. And that’s a good thing.

    • Tom – thanks for your thoughtful reply. I agree that the average patient doesn’t think about this much. But where I think I may disagree with you a little is in your conclusion that the purpose of the regulations is to lower the cost of health care. The Anti-Kickback Law, at least, is designed to prevent clinical decisions being made based on something other than what’s best for the patient.

      So, let’s assume for the sake of argument that Manufacturer A wines and dines your prosthetist, gives him lots of free stuff (polo shirts, digital picture frames, tee shirts), and sends him an expensive holiday gift at the end of the year.

      Let’s further assume that Manufacturer B does none of that.

      And finally, let’s assume that both companies sell prosthetic feet with different characteristics, and that a device from Manufacturer B, given your unique clinical situation, will make you more able than the equivalent device from Manufacturer A.

      Should you be interested in Manufacturer A’s pattern of behavior and its potential impact on your prosthetist? Do you think that you’re going to get the device from Manufacturer B?

      You’re right – we all want the best care possible. My question is, do you think the interactions between manufacturers and your prosthetist that I highlighted in my posts are consistent with that goal?

      Thanks so much for reading less is more! I appreciate your taking the time to comment.

  2. The reason I focus on the cost aspect is that I was intimately involved in government contracting, where this kind of influence was eliminated many years ago. Buying the best product should involve weighing cost and function among the competing vendors, not because one of them took you on a golf outing recently.

    So yes, I’d like to see suppliers and practitioners in the prosthetic industry operate at arms-length. The result will be both better function and lower cost.

    [BTW, I just discovered your blog a couple of days ago and have spent a few very enjoyable hours reading your thoughts. You’re an inspiration to us all ;-)]

  3. Where I live (Switzerland) a prosthetic technician will add about +30% to all units sold, regardless of work which is billed separately. With that, any EXPENSIVE unit is a good unit, any CHEAP unit is a bad unit, not very hard to understand. Usually, the orthopedic technician buys the units, assembles prosthesis, and the customer then gets the finished result, or, one of a series of refined results – with components also getting re-used. As not all units end up working for any given customer, technicians will end up with a number of used or tested units sitting around that they paid for but did not get insurance reimbursement – and new customers may have to start out wearing up a technician’s old unit collection that they then can get rid off. – – This being the deal, soft bribes may be offered by companies offering units for customer testing without forcing a technician to pay for them at first. Another soft bribe here is that companies increase (!!!) unit pricing so technician’s +30% share increases as well.

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