Curbside Consult with Dr. Jayne 6/5/17

Quite a few people called or emailed this week to find out what I thought of the EClinicalWorks settlement. Two of them were ECW users asking for my advice on whether they should change EHRs and, if so, what I thought they should be looking at. For those practices potentially impacted by the alleged wrongdoing, it’s a very uncertain time. My advice was to pause and let the dust settle before making any decisions. Neither of the ECW physicians I talked to this week had concerns about how the system is actually performing based on their scope of use, and felt fairly confident that they’re not experiencing functionality issues that impact patient care.

As for those that reached out simply curious about what I thought, I’ll share what I had to say. There were several allegations addressed in the settlement. I say “allegations” deliberately because ECW hasn’t admitted guilt nor has it been proven in a court of law. Everyone can speculate on the fact that they settled, but given that I have a plaintiff’s attorney in the family, I understand how expensive litigation can be and how $155 million may be a bargain compared to having to mount a defense, deal with the side effects of having half your company (and your customers) deposed, and having ongoing distraction that impacts your ability to keep the lights on and the business running.

First, let’s look at the kickback issue. The suit alleged that it gave kickbacks to customers for promoting its products, including payments for reference site visits. Many of the vendors I’ve worked with would also fall into this category. During my days at Big Hospital System, we regularly received extra attention from our vendor in exchange for being a reference site, and at times we also received credits against our software maintenance payments. I’m sure that could be construed as a kickback, although our site visits were quite “tell it like it is” rather than pure attempts to induce anyone to switch to the vendor. We always insisted that the vendor reps stay out of the discussion and sit in the back of the room or outside the room altogether. It looks like ECW also paid a bonus when prospects actually signed, and paid individual physicians to do references, which is a little murkier.

The way it’s described in the actual filing, any “manufacturers of products paid for in whole or in part by federal healthcare programs may not offer or pay any remuneration, in cash or in kind, directly or indirectly, to induce physicians or hospitals or others to order or recommend products paid for in whole or in part by Federal healthcare programs such as Medicare and Medicaid.” If you take that at face value, then the medical device reps need to stop wooing the cardiologists and orthopedic surgeons, regardless of whether they’re reporting their meals and tchotchkes in compliance with Open Payments. The language also applies to services, so the people from hospice that bring lunch while they explain the services they offer are guilty as well, even though they’re a nonprofit.

Next, let’s look at the issue of cheating on certification. Although some of what they did (such as hard coding the RxNorm codes for the test scripts rather than having the system access the entire library) is pretty egregious, anyone who’s been part of a certification process knows that there’s a gray area between complying with the test scripts and complying with the spirit of the requirement versus the letter of the requirement. There’s plenty of functionality out there that passes the test scripts but isn’t user friendly or sometimes isn’t even usable.

Let’s also look at the allegation that ECW “released software without adequate testing and overly relied on customers to identify bugs and other problems. Some bugs and problems – even some identified as ‘critical’ or ‘urgent’ – persisted on ECW’s bug list for months and even years. ECW lacked reliable version control, so problems addressed in one version of the software or for one particular user could reappear in other versions or remain unaddressed for other customers.” I’m currently working with half a dozen vendors who could fall into that description, and can name a few more to round out the group. Nearly every vendor I’ve worked with is guilty of this to some degree.

As a customer, I’ve been part of beta testing programs that are more like alphas, and have seen code that doesn’t seem to have been tested by anyone conscious. Sure, the coded functionality may have met the technical requirement specifications, so it passed, but when deployed to the field it’s broken or simply useless. I heard from a couple of friends who work for vendors that they were taking joy in ECWs pain. I challenged them to think about their own situations, and whether they’ve ever let a regression error go out the door. It sobered them up pretty quickly. Developers who live in glass houses definitely should not throw stones, because they could be the next ones in the spotlight.

That takes me to looking at the whistleblower component. There was quite a bit of buzz around the fact that the software technician who filed the original suit will receive $30 million. I’m wondering if this is going to be an incentive for individuals to try to prove wrongdoing across the industry in exchange for a potential windfall. Hopefully, this will spur vendors to pay more attention (and devote more resources) to defect resolution as well as defect prevention, since most vendors likely have a backlog of issues needing remediation. On the other hand, it could lead to a lot of rock-turning during which plenty of creepy crawlies will come to light. If vendors have robust systems to manage their issues they’ll persevere, but if not, potential whistleblowers could create a lot of noise that will create distractions that may ultimately harm customers.

Hopefully this settlement will be a call to action for vendors to get their houses in order, and bring greater transparency to the sausage-making that is the certification process. It’s been interesting, though, to see the number of people putting the blame on the certification process itself. The bottom line is that there are rules; if we think they are unfair, we should seek to have them changed in an orderly way rather than just flout them. It will be interesting to look back on this in six months or a year and see whether it’s changed anything or whether it just goes down as another footnote on corporate wrongdoing.

What would you do with a $30 million whistleblower settlement? Email me.

Email Dr. Jayne.