Vendors say Stage 2 is 'doable.' But test scripts, and guidance on quality measures, would be appreciated to really get going.
For the most part, health IT vendors have hit the ground running - having begun the process of tinkering and retooling their technologies to meet the certification criteria of the Stage 2 meaningful use final rules soon after their publication on August 23.
Makers of EHR and HIE technology all seemed relieved that the final rules came out earlier, rather than later. And most seemed satisfied, more or less, that the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) took their input to heart during the comment period this spring.
But many are frustrated that some lingering uncertainties - especially with regard to quality measures specifications and the test scripts needed for development - have prevented them from having the "final package" to truly move forward with their plans to meet the new mandates.
"We're happy they're here," said Mickey McGlynn, senior director of strategy and operations at Siemens Healthcare, and chair of the HIMSS Electronic Health Record Association (EHRA)d-ehr" target="_blank" class="directory-item-link">Electronic Health Record Association (EHRA). "They're the first step in letting us do our job."
McGlynn said EHRA "provided a ton of input based on our own perspective," and its member companies "definitely see a lot of places where our input was taken." There's "certainly some that was not taken," she adds.
One victory for vendors and their clients was CMS allowing a reporting period of 90 days for 2014 program participants, rather than requiring providers to report on a full year of meaningful use activity.
EHRA members were at great pains to convince policymakers that it takes a good six to 12 months for developers to properly test and certify their technologies, and even more time for their clients to implement the software and train its users.
"Hands down," says McGlynn, the shortened reporting period "increases the likelihood for success. There was an overwhelming level of feedback" that a yearlong reporting period, "regardless of the scope, wasn't doable. It just was not likely to succeed."
Still, McGlynn notes that there's "a lot of angst" about the specifications for quality measures, and about the missing software test scripts.
Stage 2 rules call for a "significant change in the way quality measures have been done in the past, a transformation in the way quality measurement, data capture and reporting have been done," she says. With more specific guidelines from the feds still forthcoming about this "new territory," some vendors are nervous about not having "all the information to truly assess that."
Is there enough there to at least get going? "Certainly there are things that can be done," says McGlynn. "But the quality measure specs really define a lot of that. And the test scripts really define the workflow you have to follow.
Vendors have gotten to work in earnest in the past month or so, but still, "There will be places we have to stop; we can't do anymore until we get this information - and then you go back [later]," says McGlynn. "The ideal situation is it all comes out together. We can get started, but we don't have it all."
Leigh Burchell, vice president of government affairs at Allscripts, says her company, beyond being, "unquestionably, really pleased with the 90-day reporting period," also appreciated that ONC and CMS "continue to push provider use of technology at the point where it can add the most clinical value."
For example, computerized provider order entry and clinical decision support, places "where the technology comes into play with the patient, when the provider is with the patient and can give an intervention or reminder or actually have an impact on the care that's provided," is a crucial area for improvement, says Burchell.
Even though there "were a lot of comments that went into CMS that asked for them to back off some of those measures a little bit," she says, "those are some of the places where you can get the most value out of the program - where the technology can help the clinician make a more informed decision."
There were other areas, such as "calls for increased standards around data exchange, clarification on transport mechanisms for interoperability, things like that, where we could see in the rule that they heard us and reflected on that," says Burchell.
Data exchange
Other areas offered less satisfaction, however.
"Something we discussed internally was the requirement to have a certain percentage of clinical information exchange occur between providers using products from a different vendor," she says. "There was a lot of reaction to that in the proposed rule. And we were kind of back and forth on that internally. The concept is something that we support wholeheartedly."
Burchell notes "there are challenges in the industry right now with people who are intentionally obstructing data exchange. Whether it's vendors or providers - and for a variety of reasons - they are not looking for information to flow freely."
Still, the reality of implementing what the feds were proposing "was not going to be doable, technically," she says. "Where they net it out, I think, they were trying to walk a tightrope a little bit, of continuing to push that policy but reflect that challenge. I'm not 100 percent sure yet whether they landed on the right thing. I'm not sure the industry will move forward fast enough with data exchange and interoperability if ONC and CMS aren't the ones to kind of force it to happen."
Usability rules worry some
Nonetheless, with Stage 2, ONC and CMS "raised their own bar in terms of the extent to which they really considered comments," said Mark Segal, vice president of government and industry affairs at GE Healthcare IT. "They reviewed them very substantively and they responded in detail to the comments they received."
He said GE was also "quite pleased the regs came out when they did, around the middle of August, instead of in September like many of us were anticipating. Every week, every month matters."
For that reason, "We really would have liked the certification test methods closer to when the rule was out," said Segal. "We really need those as a guide for development. I was more than a little surprised to hear the test methods would be out in waves, through December. That's much later than we would have anticipated."
"We also wanted the quality specifications out sooner," he added.
Also of concern was that the agencies "really stuck to their original proposal around usability testing," said Segal. "We're very strong supporters of good user design and user interface, but there's a concern that, for the short time available, having to go back and basically make sure that formal user-centered design principles were applied to the specified functionality is a challenge in a short time period, and for software that's been already developed and out in the market for some time."
The time challenge can't be understated, said Segal. "We are just a little over a year away from when hospitals, for example, will need to be using the certified product."
Turning the ship
The combined 1,100 pages of the CMS and ONC final rules had both vendors and provider CIOs poring over the dense documents for days following their release. But Dave Riley, chief of informatics at Harris Health Care Solutions, said that stands to reason.
"Given that reimbursement is dependent on compliance, the fact that it is more than 1,000 pages is not surprising to me," says Riley. "There is a tendency to try to cover all the angles, so as to reduce misunderstanding. Hence the lengthy discourse in the regulation."
Of course, that necessarily means that "everything moves so slowly," he says. "Most of the large organizations that are impacted by these changes have a lot of inertia, and it's hard to 'turn the ship' when these kinds of changes are enacted. Even though I'd like to go faster, I understand that rate of change healthcare organizations are capable of tolerating."
Still, he says, the change called for in the Stage 2 final rules should ultimately be worth the angst and agita.
"I think as the market shifts from a volume-based, fee for service approach to a value-based purchasing approach, things like health information exchange, patient engagement and image access" - all areas where Stage 2 puts a special focus, and where Harris happens to focus its technology offerings - "become critical to being able to assess whether or not organizations are getting value for the money being spent."
For Harris Healthcare's part, Riley says he'd been waiting for CMS and ONC to finalize the rules, "so we could have a stable set of targets to aim for in terms of product features and capabilities. Obviously we didn't want to miss something. Now that this is a known quantity, we can ensure compliance and move quickly into addressing our customer's needs. I'm not seeing any hurdles that are insurmountable at this time."
