While health care industry professionals continue to unpack the text of the finalized stage 2 meaningful use rules, experts who have read through the regulations say there are relatively few surprises.
When I look at the requirements that they have, I think it's a little bit disingenuous to say that they're not [burdensome].
managing partner, Chilmark Research
"There really were no 'gotcha's,'" said John Moore, managing partner at Chilmark Research, adding that the finalized rules make relatively few changes from the proposed regulations published in February 2012. Additionally, blog posts and other public information distributed by the Office of the National Coordinator for Health Information Technology (ONC) over the past few months sent an indication of the direction the meaningful use rules were headed.
One of the biggest things to come out of the release of the final stage 2 meaningful use rules, Moore said, is the deadline delay. The final rule, released by the Centers for Medicare and Medicaid Services (CMS), pushed back the deadline for meeting the requirements of stage 2 to 2014 -- a one-year delay. Moore said the delay will be beneficial to critical access and rural hospitals, which tend to be behind major academic institutions in adoption of electronic health records (EHRs).
Dianne Bourque, a member of the health law section at the U.S.-based firm Mintz Levin, which counsels health care clients on federal regulation compliance, agreed that the delay will be beneficial to the health care industry. She said, aside from giving providers more time to comply with the regulations, the delay makes it possible for EHR vendors to design and produce new products that meet the technical standards of the rules. Without the delay, it would have been difficult for vendors to produce systems that comply with changed technical standards and support the kind of functions doctors will need, Bourque said.
The second stage of meaningful use represents a game changer for providers and vendors alike who are trying to meet the criteria and receive incentive payments. As the final stage 2 rule officially delays the start to 2014, it also solidifies the federal government's focus on establishing interoperability and information exchange.
Toward that end, eligible hospitals and providers will be required to demonstrate meaningful use for a three-month period, instead of a full year as originally planned, in 2014. This will be true regardless of which stage is being implemented -- some adopters will still be implementing stage 1 -- because in the same year, everyone will be required to upgrade technology to 2014 standards, based on the standards and certification criteria established through the stage 2 companion ruling from ONC.
This will create a level of flexibility to help adopters and vendors install and upgrade technology to the 2014 standards, said Rob Anthony, policy analyst with the CMS Office of eHealth Standards and Services.
The changes that were made between the proposed and final meaningful use criteria focus on patient engagement and information exchange, Anthony said during a presentation that gave an overview of the final rules. There is an "emphasis on breaking down the walls."
Regulations still burdensome for adopters, vendors
Some physicians may be dissatisfied with the increased regulations of the final rules, Moore said. In announcing the regulations, National Coordinator for Health IT Farzad Mostashari, M.D., said the finalized rules show that federal authorities are committed to minimizing regulatory burden and that the new rules reflect that drive. But Moore is unconvinced.
He pointed to the final stage 2 meaningful use rules that take many of the menu options physicians could choose from in stage 1 and turn them into core requirements. Furthermore, Moore described the technical requirements for vendors as a "spec sheet," providing a complete list of required functions and service that systems must offer. To him, this does not reflect a lessening of the regulatory burden.
"When I look at the requirements that they have, I think it's a little bit disingenuous to say that they're not [burdensome]," Moore said. "From my initial scan, I don't see that to be the case."
While the specific changes made as the rules progressed from proposed to finalized may be relatively minor, experts said the regulations are likely to play a role in steering the health care industry for years to come. Now that the final rules are published, providers can begin implementing changes that are likely to influence patient care. This is particularly true of the rules governing patient engagement.
After the stage 2 rules were initially proposed, many physician groups expressed their opposition to regulations that would have required physicians to provide online records access to 50% of their patients, with doctors accountable for demonstrating that 10% of patients actually downloaded or viewed their records online. This became one of the more contentious proposals.
The finalized rules keep the patient engagement regulations in place, but they lower the threshold for patients viewing or downloading their records from 10% to 5%. Christine Bechtel, vice president of the National Partnership for Women and Families, said that even though the bar for meeting this rule was lowered from its initial height, it's still a win for patients.
"It incentivizes providers to put in place the kind of workflow changes that mean they'll actually promote the use of that kind of functionality to patients," Bechtel said.
While requiring 5% of patients to access information electronically may seem like a low threshold, Bechtel said she believes physicians will put in place systems that encourage greater numbers of patients to take advantage of this service. She said that it wouldn't make sense for doctors to promote online access to such a limited number of patients. Most will likely try to go above and beyond the minimum requirements to ensure compliance.
Regulations could have gone further in requiring data exchange
Still, despite the list of criteria providers have to meet, not everyone is satisfied that the final stage 2 meaningful use rules go far enough. Joel White, executive director of the Health IT Now Coalition, said his organization would have liked to see requirements for data exchange enhanced. By failing to put in place rules that require abundant data exchange, federal regulators may have missed an opportunity to foster care coordination, he said.
White described the requirement that physicians submit an electronic summary of care documents for 10% of patients who are being transferred to another provider, such as a specialist or a hospital, as a "stutter-step" in the direction of data transfer. It moves the industry in the right direction, but not very far.
Furthermore, the fact that certified EHR systems must include data exchange capabilities based on the standards of the Direct Project could hinder care coordination efforts, White said. Direct is good at supporting patient referrals and other simple data exchange needs. However, it is not so useful when it comes to aggregating data, as is needed in accountable care organizations (ACOs) and other coordinated care models, White said. He believes that by requiring providers to use Direct in some cases, the stage 2 meaningful use rules could actually serve as a disincentive to the development of ACOs.
White added that the inclusion of a standardized technical vocabulary for use in summary of care documents represents progress on the interoperability front.
Laura Kreofsky, a health IT consultant with Naperville, Ill.-based Impact Advisors, said the stage 2 meaningful use rules could present other interoperability challenges for certain health care providers. For example, large multi-specialty medical groups with physicians in separate offices could have providers who are at different stages of EHR adoption. While some might be ready to progress to stage 2 now that the rules have been published, other may need more time at stage 1.
Providers who are at different stages may use different versions of EHR systems that were designed for different objectives, Kreofsky said. This could result in headaches for health systems that are looking to improve coordination of care among disparate providers and increase standardization.
Kreofsky predicted physicians' reactions to the finalized stage 2 meaningful use rules will largely depend on the degree to which they have been paying attention to the rule-making process. Those who read through the proposed rules likely won't be surprised by much in the final rule. However, since stage 2 does push the bar for EHR use higher for some measures, doctors who are unfamiliar with what was previously proposed may find some regulations to be onerous.
Ultimately, said Chilmark's Moore, the final stage 2 meaningful use rules represent progress, even if the regulations were all expected. While he described the entire push to ward EHR adoption as a "grand experiment," he said it is one that is built upon a solid foundation. The evidence supporting claims that EHRs improve care quality and lower costs may be sparse, but the regulations should put doctors in a position to make improvements.
"It's a building block," Moore said. "You have to start somewhere. If you talk to any physician, if they can [access] the patient's most recent labs, medications and allergies, they can get a pretty good read on what the status of that patient is." That availability of information that the meaningful use program facilitates could be the greatest effect of the rules, Moore said.
Jean DerGurahian, editorial director, contributed to this article.