October 2015

A Life Without Meaningful Use
By Mike Bassett
For The Record
Vol. 27 No. 10 P. 18

With the road to stage 3 filled with potholes and lined with critics hungry for blood, the federal incentive program has seen better days. It's unlikely to go kaput, but stranger things have happened.

It seems no one is very happy with meaningful use these days.

For example, a recent report from the AmericanEHR Partnership and the American Medical Association (AMA) found that, compared with five years ago, more physicians are either dissatisfied or very dissatisfied with their EHRs. In fact, approximately one-half of the physicians surveyed responded negatively to questions about whether their EHR systems improved costs, efficiency, or productivity.

At the same time, there continues to be a fair amount of evidence that hospitals and physicians are becoming increasingly frustrated with the meaningful use program, particularly as the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) took seemingly forever to release the rules for stage 3. For example, the AMA has long criticized the program's ambitious timetable and what it considers to be meaningful use's "one-size-fits-all" approach.

Good Start Gone Awry
Despite the current level of dissatisfaction, there seems to be broad agreement that the meaningful use program helped accomplish one primary goal: accelerate EHR adoption. "Back when the HITECH Act was passed in 2009, that market wasn't really working," says Mark Savage, the director of HIT policy and programs for the National Partnership for Women & Families. "Today, we are a whole lot further along than we otherwise would have been and this is the direction that patients and families needed health care to go so that they can become more involved in their health care and have better electronic access to their information and better partnerships with their doctors."

"Meaningful use stage 1 was a huge success," says Niam Yaraghi, a fellow in the Brookings Institution's Center for Technology Innovation. "And that's because its main goal was to push hospital physicians to adopt EMRs, and most of them did."

That said, Yaraghi believes stage 2 of the program has "failed," as demonstrated by the extremely low attestation rates. "It hasn't been able to achieve the goals the program set for itself," he says. "The program is so meaningless that not only are physicians not adopting it, but they also believe it makes more sense to incur the penalties rather than meet the incentives by doing what the government wants them to do."

Consequently, Yaraghi believes more information needs to be obtained about why stage 2 has struggled before there can be any thought to implementing even more complicated rules and regulations.

Nevertheless, on October 6, the CMS and the ONC released the final rules for stage 3, combining it with modifications to the incentive program for 2015 through 2017. The CMS also announced a 60-day public comment period to address lingering concerns from stakeholders.

While the rule does not postpone stage 3, as many industry stakeholders had hoped, it does give providers and state Medicaid agencies until January 1, 2018, to comply and prepare for the next set of system improvements, and makes stage 3 optional in 2017.

The idea of delaying the program had been gaining traction. For a number of reasons, organizations such as the AMA, the American Hospital Association, the College of Healthcare Information Management Executives, and the Medical Group Management Association called for a delay in stage 3.

Washington took notice. In late July, Rep. Renee Ellmers (R-NC) introduced the Further Flexibility in HIT Reporting and Advancing Interoperability Act. In remarks accompanying the bill's introduction, Ellmers pointed out that only 19% of providers have met stage 2 attestation requirements, which is "a clear sign that physicians, hospitals, and health care providers are challenged in meeting CMS' onerous requirements.

"From my conversations with doctors back home, it is clear they are eager for relief," she added.

Other observers urged CMS to go further. For example, in comments related to stage 3, the Texas Medical Association called on CMS to "sunset" the meaningful use program and "use the foundation set by the meaningful use program to focus on value-based initiatives."

Savage says one problem with discontinuing meaningful use is that the program is related to other health care initiatives on Washington's agenda. For example, there is substantial support for "21st Century Cures," proposed legislation that would streamline the FDA's regulatory process, modernize clinical trials and medical product regulation, and support the development of innovative cures.

"That support for 21st Century Cures has to be support as well for the meaningful use of electronic health information because those approaches are integrally related," says Savage, who points out that stage 3 also intersects with President Obama's Precision Medicine Initiative, which the White House describes "as an innovative approach to disease prevention and treatment that takes into account individual differences in people's genes, environment, and lifestyles."

Over the long term, the initiative's goal includes a national cohort study of at least one million Americans to expand the nation's understanding of health and disease. In the short term, precision medicine is focused on expanding cancer genomics with the goal of developing better treatments and preventive measures.

On that front, EHR vendor Allscripts has entered into a partnership with NantHealth, a precision medicine software vendor, with the idea of introducing clinical decision support software that uses complex genomic and proteomic analysis that can be integrated into EHR systems. Allscripts President, CEO, and Director Paul Black has gone on record arguing that meeting the goals of precision medicine depends on achieving the requirements of meaningful use stage 3.

Savage says dropping the final stage of meaningful use would have negatively impacted the concept of patient-generated health data, which is a significant part of stage 3. "When I sat on the Consumer Empowerment Workgroup of the HIT Policy Committee in 2013, we developed a recommendation to build that in a structural way, so that instead of just having one-directional communication between provider and patient, you actually could have bidirectional and even multidirectional communication," he says.

Patients can use this functionality to not only access electronic records but also perform functions such as correcting records when they spot mistakes and sharing data outside of office visits. However, the final stage 3 rule may have eliminated many of these benefits, according to Yaraghi.

"The proposed rule, under the—justified and rational—pressure from medical providers, specifically AMA, has relaxed many criteria to the extent that they have now become meaningless. Consider the criteria for patients' access to their records," he says. "Since medical providers were arguing that the 5% threshold is too much—because patients are not engaged enough to go and see their records on a patient portal—the new rule now says that 'At least one patient seen by the EP (or his or her authorized representatives) during the EHR reporting period views, downloads, or transmits his or her health information to a third party.' Just one patient! I can understand why HHS [Health and Human Services] has lowered the bar so much, but on the other hand, we should think about the expected benefits of such regulations. Why would you pay incentives to hospitals so that just one patient can view his or her records?

"I think HHS has to throw in the towel and let the medical industry find its way out," Yaraghi continues. "[Meaningful use] stage 1 could be justified, maybe we needed to buy everyone an EHR to get them going, but now we should let the industry figure out if there is any meaningful benefit in health IT. Those technologies that prove beneficial will naturally be used by providers and those that don't will be forgotten. That is the only way which technology diffuses in every other business sector and health care is no longer an exception."

Better Off Without Meaningful Use?
Some industry experts question whether meaningful use hurt more than helped the electronic record environment. "I don't think [meaningful use has] really advanced the ball that far," says Jeffery Daigrepont, senior vice president at the Coker Group, a national health care advisory firm, "[The program] resulted in a large sum of money being thrown into the market and that created a scenario where a lot of vendors rushed in, and anytime that happens you are going to have quality issues."

This resulted in a lot of providers buying products that "just didn't sustain themselves," Daigrepont says. "A lot of people thought they were buying the right solution or the right vision, and I think all of these vendors had every intention of becoming big vendors, but once the [government] money began to run out, it became hard to sustain themselves. And that's why we're seeing a lot of [EHR] replacements today."

While there is general agreement that meaningful use helped raise EHR adoption rates, there also is some evidence that that would have occurred without the introduction of meaningful use. "I think most doctors would have—and should have—justified the spending [on EHRs] on their own, even without the help of the government," Daigrepont says. "I think most, even before meaningful use, were looking into it or planning to adopt it, and would have done so without the intervention of the government."

That view is supported by a recent study in the Journal of the American Medical Informatics Association that found "weak evidence" that the meaningful use program and its incentive payments had any impact on the rate at which physicians would have adopted EHRs.

"[T]he external stimulus on physicians of the [meaningful use program] had ambiguous effects on their overall adoption rates," the authors wrote. "Somewhat like the 'cash for clunkers' subsidies in the automobile industry, the HITECH subsidies may have only contributed to inevitable adoptions."

The authors also suggest that meaningful use has had unintended negative consequences. For example, they posit that the meaningful use requirement for certified EHRs may have stunted technological innovation by encouraging vendors to invest in compliance rather than research and development.

One of the authors, Eric Ford, PhD, a professor in the department of health policy in the Bloomberg School of Public Health at Johns Hopkins University, points out that while meaningful use was an "infrastructure" program designed to introduce computers into clinical settings, the idea was that clinical innovation and health information exchange would naturally follow.

"However, the results have as yet to materialize," he says. "For hospitals, the program and the certified systems requirement have reduced the number of EHR vendors to a relatively small group, with two or three players dominating. Therefore, it has reduced competition. In addition, giving so much market power to a few large companies has given them a lot of influence over the meaningful use program's later stages. Using that influence, they have resisted innovations and open exchange."

And had the program never existed?

"Fewer hospitals would have implemented full-blown systems and would have adopted the specific applications they needed to address organizational challenges," Ford says. "More technology companies would be developing software solutions. Having a more fragmented market would have required the companies to make their systems interoperable.

"The good news is that there is still a large and active health IT sector," he adds. "But it is not as diverse, competitive, or innovative as it might have been absent meaningful use."

A Modest Proposal
Yaraghi believes that while the federal government has succeeded in helping create a basic HIT infrastructure, it's time to let the private sector take over. "Now that the providers have invested so much in HIT, we should rely on entrepreneurs to come up with new solutions, approaches, and innovations to take advantage of this infrastructure," he says. "The government built the roads, so it has to let the people decide where to go on the roads."

The problem, according to Yaraghi, is that meaningful use is a solution that requires dictating how physicians and hospitals should use these "roads." "And it's an impossible task to come up with a solution that's optimal for everyone," he says. "How can you come up with a set of criteria to measure the level of technology savviness that are exactly the same for a superspecialist working at MD Anderson in Houston and a family care physician working in rural upstate New York? You can't."

Yaraghi says one solution is to simply stop the meaningful use program. "But I don't think that's politically feasible," he adds. "There's about $7 billion or $8 billion remaining in the program, most of which is basically being pushed to the EHR vendors and other players in the HIT market. They have a powerful lobby in Washington, D.C., and it would be difficult to slash that spending."

A better policy would have been to integrate meaningful use with capitated payment models that pay providers a fixed amount per patient and encourage them to provide better health care at lower costs, Yaraghi says. This, in turn, would have incentivized providers to come up with IT solutions that address their specific needs.

Yaraghi suggests that some of the money still left in the meaningful use coffers be used to fund a pilot program to test this idea. Under such a plan, providers could submit grant proposals for specific types of IT projects to an institution such as the ONC.

"So maybe that family health care provider in New York comes up with a proposal that doesn't involve an EHR at all," he says. "Instead, maybe it's just an IT solution that creates a better reminder system for his patients to get them to remember their scheduled visits."

It's similar to how the National Science Foundation (NSF) and the National Institutes of Health (NIH) operate, Yaraghi says. "We ask our researchers and scientists to design their own research programs and if they make sense, the NSF and NIH will support them," he points out. "And it's been shown that this approach is very successful."

— Mike Bassett is a freelance writer based in Holliston, Massachusetts.