Saturday, September 1, 2012

Influencing the ONC - Collusion or just reasonable lobbying?

Summary: The EHR vendors amongst themselves and/or through their EHR Association appear to have colluded to ensure that imaging download and transmit was excluded, and Epic in particular lobbied their customers to comment; this was presumably obvious to the ONC; regardless of the merits of the argument, is it fair?

Long Version.

This post is not going to discuss the merits of including Download and Transmission of images, which I will save for another post, but rather the appropriateness of the comments and the manner in which they are submitted.

I wasn't going to bother addressing this issue further, but the topic of the commonality of certain aspects of the comments was picked up from my summary on the Healthcare Renewal blog in "Health IT Vendor EPIC Caught Red-Handed Using Customers as Stealth Lobbyists; Did ONC Ignore This?", so I suppose I should.

Also, an anonymous commenter on my blog entry responded last night:

"But that doesn't mean that there is a conspiracy - or that one organization (as you blogged earlier in the week) has deeper influence than any other .. and if you think that Epic's redundant comments parroted by their many customers counted as anything more than one opinion - you underestimate the aptitude of our friends at ONC and CMS. They weren't born yesterday, ya know."

I do agree that it is likely that similarity of the comments was completely obvious to the government folks, who no doubt did a very thorough analysis, and that they took this into account. It seems likely that they were sensitive to the intensity of the strident opposition of the entire EHR industry, and considered the merits of the arguments independent of the manner in which they were submitted.

I can't say that I agree, however, that there might not have been a "conspiracy", although I don't think there was anything particularly clandestine about it (particularly since many of the comments from the customer sites were prefaced in their covering material with "I agree with Epic", etc.).

I took a look with Google and on the HIMSS EHR Association web site to see if I could find minutes or other records of EHRA meetings, where perhaps they might have discussed a consistent response in order to discourage the inclusion of View, Download and Transmit images, but I couldn't find anything.

I don't know what anti-trust protection procedures these EHR vendors follow when they meet in their association, and there was no mention of that on the association's site or on the parent organization HIMSS web site either (in their bylaws or any where else). I found this a bit surprising, since in my experience, NEMA (the DICOM parent organization), as one example, is obsessive about this issue, and has all minutes both reviewed by counsel and posted publicly to assure transparency and appropriate conduct.

Since the public comment process for a proposed rule-making is not a procurement or grant award, I dare say that the "Red Flags of Collusion" described on the DOJ web site are not directly relevant here, even though the Final Rule specifies certification criteria that products will have to meet to be viable in the marketplace, and hence the conduct of the public comment process directly shapes that market. Certainly if they were applicable, the "similarities between vendor applications or proposals" criterion would be met! I am not sure to what extent this does or does not fit within the concept of conduct to "encourage uniform action" (as distinct from "voluntary parallel action").

I guess there is a fine line between trying to develop or adopt standards to promote interoperability, a goal that is clearly in the public interest, and trying to manipulate the market to satisfy the shared objectives of a group of vendors. Others have expressed general concerns (in a context that has nothing to do with imaging) about the MU certification process distorting the marketplace and leading to increased prices for certain functions (e.g., see the comments by the Kansas Hospital Association).

Likewise, making public comments may or may not constitute "lobbying". I couldn't easily find online any documentation of whether the EHRA or HIMSS does or does not formally engage in lobbying or have a separate PAC, or how this is related to their non-profit status (insubstantial portion), or whether they report this. By contrast, in NEMA, as I understand it, the standards development and other activities are separated from lobbying activities, and there is a separate NEMA PAC, and it makes the required reports to the Senate about how much it spends, etc. I mention NEMA only because I have some familiarity with them, not to imply that they are pure as the driven snow.

What about the distinction between comments from vendors and customers? Why, for instance are so many Epic customers apparently willing to relay the EHRA's message that single sign-on is not wanted? Why on earth would a user want to log in separately to the PACS every time they wanted to look at an image, even though they were already logged in to the EHR application (and the operating system for that matter)?

I suspect the answer is the obvious one, the responses aren't from actual "users" at all, but rather from the IS folks who deploy the systems, and who are on the hook for providing the service and paying for the infrastructure, which in many cases may not be supported by their existing software choices (and in some cases obsolete versions). It is clear from the Epic template, as well as explicit comments from other vendors, that customers were left in little doubt that the single sign on feature was going to either cost them money or divert resources from other developments that they might perceive to be a higher priority, as well as require engagement from other vendors. This almost suggests "intimidation" but I suppose can be construed as simply laying the facts on the table (resources are limited; choose what to focus on).

Amongst those other vendors making similar comments were the PACS vendors, some of whom may be equally lame when it comes to infrastructure friendliness features like single sign on, and may well be equally opposed to being forced to deal with this, as would their "customers" (as opposed to "users") too; in theory the PACS vendors might be happy to have the infrastructure manage security and access control, but in practice, how many customers want to be forced to upgrade their PACS just to support meaningful use, and how much would it cost them? Bottom line is that many folks may well want to do this, but in their own time, with as little extra cost as possible, and not be regulated into doing it.

And, with respect to the single sign on feature in particular, it may simply be that the technology and the standards are not ready for prime time; the fact that ONC has a Challenge to study this currently in progress would seem to substantiate that. But I am digressing into the "merits" rather than the "appropriateness", so I will defer that for another occasion.

The same goes for downloading and transmitting images on the network, which is largely a security integration question too, since the EHR "portal" would likely just be acting as a proxy to the PACS where the images reside; this is perhaps not as technically difficult as some have construed (a later discussion), but it is one more thing that involves two vendors talking, and that, as we all know, despite standards, costs money. Contrast the position of the vendors and the customers, with that expressed by the "real" users, the physicians in this case, as expressed by the support, for example, by the American College of Physicians.

So, as the line from the movie goes, "follow the money", not in the sense that any bribery or corruption is involved, of course, but rather in terms of commenters' motivation. The cynical view is that everyone wants to receive the incentives (or benefit from the market created by them) yet spend the least in the process.

The lesson for me, of course, is that those of us who wanted this done "right" should have worked harder to assure that ONC was swamped with supportive comments (and sufficient technical detail to clarify feasibility) and then they might have felt more comfortable sticking to their guns; in failing to do so, "we" were outmaneuvered by the naysayers.

Presuming it is indeed legal and ethical to engage in such conduct, next time "we" need to call in the super-PACs (and not in the imaging sense of the word).

By "we" in this context, I mean those of us who believe that ready access to a full set of diagnostic quality images encoded in DICOM is a critically important and entirely feasible part of any comprehensive electronic healthcare "system", and hence equally deserving of incentives, lack of penalties and certification criteria.


PS. My Anonymous commenter also made the point that "doesn't mean ... that one organization (as you blogged earlier in the week) has deeper influence than any other", presumably referring to my initially singling out as GE Healthcare as the prime evildoer in this respect. And he/she is probably right to some extent, since, as it turns out, GE's comments parrot those of their other EHR "fellow travelers"; I would though, be very interested to know how much influence GE individual contributors had in terms of developing the EHRA position in the first place (I have no inside knowledge in that respect). That said, comments that come from companies like GE, which have a reputation as both imaging and EHR vendors, might well, in my opinion, have held greater sway, given their presumed experience in both fields. Hence I suggest that GE and their ilk deserve extra vilification as a consequence of their disloyalty to the imaging cause.


InformaticsMD said...

That ONC did not reprimand the stealth lobbying/lobbyists, or direct its findings of the obvious to OIG, is a problem.

In other words, they tolerated this behavior.

Whether it affected their decisions is something I addressed at a followup post:

Was EPIC successful in watering down the Meaningful Use Stage 2 Final Rule?

-- SS

Unknown said...

I suspect there was lot of collusion HIMSS which represents mostly the big EHR vendors, had lots of HIMSS representative infiltrate ONC, NIST etc....Policy proved to be the brutus in assailing Interoperability.

There are at-least 75 on LinkedIn who have worked both at HIMSS and ONC.