6 Benefits & Challenges in CMS' Meaningful Use Stage 2 Proposed Rule

On Feb. 23, 2012, CMS released its proposed rule for Stage 2 requirements for the Medicare and Medicaid Electronic Health Record Incentive Programs. The Stage 2 rule included criteria eligible professionals, eligible hospitals and critical access hospitals must meet in order to qualify for an incentive payment for adoption and "meaningful use" of electronic medical records.

Shortly after, HHS' Office of the National Coordinator for Health Information Technology released a proposed rule for certification requirements and associated standards for electronic health record technology, effective in 2014. In a notable revision to the Stage 1 regulations, The ONC proposes that hospitals and eligible professionals be required to have certified EHR technology only for the objectives they use to demonstrate meaningful use under the Medicare or Medicaid EHR incentive program. Other major changes involve new and revised certification criteria and standards for EHRs sold by vendors or self-developed by healthcare providers, including new patient safety criteria for certification.

Both proposed rules were formally published on March 7, 2012.

Feedback from the healthcare industry on the two proposed rules has been mixed. It is clear that hospital executives, physicians, healthcare consultants and electronic health record vendors see areas that need further attention and discussion. However, the effort by CMS to offer more consistency and clarity with the Stage 2 requirements is appreciated.

According to Wendy Whittington, MD, MMM and CMO of Anthelio Healthcare Solutions, a provider of healthcare IT services, a "can-do" attitude came through in the Stage 2 rule. "There seemed to be a reaffirmation in the document that CMS is after patient-oriented, efficient and equitable healthcare and that CMS believes healthcare information technology can be a foundation for real health reform in this country," says Dr. Whittington. "That was necessary. After Stage 1, I felt it was easy for hospitals and providers to lose sight of the purpose. People were focused on checking off the requirements to receive [incentive payments] and not necessarily looking at the big picture. [Stage 2] has refocused us on the big picture."

Stage 2 follows most of the existing Stage 1 core and menu objectives while adding new objectives for patient access to health information and increasing expectations for health information exchange and data transfer, among other changes. Certain areas and elements in the Stage 2 rule may benefit hospitals and professionals aiming for, and currently on the way to, meaningful use, whereas others may represent challenges.

Here, Dr. Whittington; Mark Segal, PhD vice president of government and industry affairs for GEHealthcare IT in Barrington, IL., and Jack Wolf, vice president and CIO of Montefiore Medical Center in New York, discuss three areas in the CMS' stage 2 proposed rule they believe could provide benefits and three areas that could cause challenges.


1. Stage 1 extension

One big change in Stage 2 is CMS' proposal of an extension of Stage 1, giving providers an additional year for implementation of Stage 2 criteria. CMS originally established that any hospitals and eligible professionals who first attested to Stage 1 criteria in 2011 would have to meet Stage 2 criteria in 2013 — specifically, Oct. 1, 2012 for hospitals and Jan. 1, 2013 for eligible professionals. In addition, all providers pursuing meaningful use would need to use Stage 2 certified EHRs on that same timetable. The proposed rule delays the onset of Stage 2 for those providers by one year, until 2014, which CMS believes would allow the needed time for vendors to develop and providers to implement certified EHR technology that can meet Stage 2 requirements.

The additional time to achieve Stage 1 objectives has been perceived as critical for vendors, hospital and professionals and thus, extremely valuable. "Looking at the two regulations, you see why an additional year was essential," says Dr. Segal. "There was no way, with proposed regulations coming out now and final regulations this summer, that hospitals would have been able to start Stage 2 by Oct. 1, 2012 or professionals by Jan. 1, 2013."

The additional time for the start of Stage 2 introduces gives providers more time to achieve CMS and ONC's upgraded definition of meaningful use. Dr. Whittington believes extending the deadline gives providers the opportunity to emphasize quality over quantity in meeting meaningful use objectives. "I think it gives hospitals and providers, time to [attest for meaningful use] the right way. Had deadlines stayed the same, [many providers] may have scrambled to complete only what was necessary for [the] incentive [payments], and nothing more," says Dr. Whittington. "If providers are not rushed by a short-term deadline, providers may be more thorough in achieving the meaningful use objectives. There could be more time to weave other projects in to produce a truly meaningful outcome."

2. Clinical decision support and information exchange
The Stage 2 changes for clinical quality measures include an enhanced objective and associated measure to use clinical decision support to improve performance on high-priority conditions. This is a move from a requirement to use one decision support "rule" relevant to a specialty or a high clinical priority to the use of five clinical support "interventions" associated with a high-priority health conditions. There is also a specific requirement to link each decision support intervention to one or more of the clinical quality measures reported on by a provider. Additionally, the objective to "exchange key clinical information" from Stage 1 was enhanced to provide summary of care when a patient transitions from, or is referred to, a healthcare professional. There was also a proposal to have 10 percent of these exchanges be electronic and sent outside of the provider’s organization as well as to a different vendor’s certified EHR, using ONC-designated capabilities and standards. These changes are intended to enhance the value of the clinical decision support and data exchange objectives.

Dr. Whittington believes the Stage 2 objective of using clinical decision support to improve performance on high priority health conditions is on point. "While most clinicians are in favor of clinical decision support that is meaningful and useful, the alert fatigue and frustration that arises from attempted clinical decision support without real clinical context can be a deal breaker in the clinical world," says Dr. Whittington. "Allowing doctors to have a say in what matters most in their patient population is highly helpful. As a result, there may be more buy-in and the use of the system is going to be more beneficial, meaningful and safe."

3. Interoperability between vendors
With the EHR certification companion rule, vendors may be more compelled to collaborate, or at least communicate with each other to produce more compatible EHR products and systems. In a sense, the ONC is pushing vendors to create a better scenario for hospitals and providers to meet meaningful use objectives for EHRs and data transfer. https://www.beckershospitalreview.com/healthcare-information-technology/onc-issues-ehr-certification-companion-rule-to-stage-2-meaningful-use.html

The ONC proposed rule includes changes to certification for EHRs sold by vendors or self-developed by healthcare providers, and new patient safety criteria for certification.

"There have been comments that the interoperability in the Stage 2 rule and the companion rule did not go far enough or that they took a step backwards. We believe that the rule is a solid move in the right direction," says Dr. Segal.

According to Mr. Wolf, better vendor interoperability could increase the shareability, normalization and integration across different, disparate systems. He believes the rule requires vendors to put more focus on product integration, which could have a direct bearing on patient transition of care — physicians could look up information across systems and across vendor products. "It would give physicians a real leg up," says Mr. Wolf.

Furthermore, Mr. Wolf believes the Stage 2 objectives for interoperability are one of the immediate benefits for the healthcare industry as a whole. "You can see how CMS is looking long-term at how to improve flow and longevity," says Mr. Wolf. "As the patient transitions, their information should be able to transition with them. Additionally, interoperability could help providers capture more information in their electronic medical records. "The new information could drive quality improvement, which is what CMS envisioned in the first place," says Mr. Wolf.

Although the push for great collaboration between EHR vendors is generally perceived as beneficial for the healthcare industry, reaching the level that CMS and ONC seem to desire may be a challenge. With increased interoperability comes a higher expectation for data transfer and health information exchange. Hospitals and providers may face challenges in reaching the Stage 2 objectives focused on EHRs, data transfer and health information access.

Specifically, Dr. Segal and Mr. Wolf expect comments from vendors, providers and hospitals on the interoperability objectives in Stage 2, because sharing data between certified products and unaffiliated providers may be operationally difficult.


1. Electronic data transfer among providers and vendors

A great benefit of electronic medical records and meaningful use is the exchange of health data that occurs within a hospital or health system and across departments and specialties.

The Stage 2 proposed rule includes core and menu objectives encouraging eligible providers to increase electronic data transfer to meet specific thresholds. The requirements include a higher threshold for e-prescribing; incorporating structured laboratory results into EHRs; and the expectation that providers will electronically transmit patient care summaries to support transitions in care across unaffiliated providers, settings and EHR systems.

According to Dr. Segal, there is a perception that some vendors have proprietary or semi-proprietary exchange requirements. He believes that CMS is trying to cut across, what some may call silos, to encourage exchanges across vendors, across hospitals and across health systems. "While I expect some of the requirements to be modified, I believe the intention was to push healthcare organizations and vendors outside of their existing data exchange flows," says Dr. Segal.

While data transfer has the potential to create wider access to health information and increase integration of services, CMS and ONC are requiring a high level of vendor transparency. One area of Stage 2 requires vendors to put the prices of their products on all their marketing materials and other communications. "It is understandable why that type of transparency is asked for," says Dr. Segal. "However, the complexity of selling technology solutions is not conducive to such mandatory public provision of pricing information. It is not how the technology market typically works. I expect many vendors, including GE Healthcare, will comment on that element."

The requirement to share data among certified EHR products and different vendors may challenge hospitals as well. "For [Montefiore], we are one of two or three provider organizations in the Bronx that has attested under Stage 1 meaningful use. For Stage 2, when we want to integrate and share data with another certified provider, we may have difficulty," says Mr. Wolf. "In many parts of the country, providers will need to consider, whether they are the only provider in the area who has attested under Stage 1 and if so, how they are going to share data with another certified provider. What is expected is not clear either. These issues need to be drilled into."

2. Sustaining health information exchanges
One of the biggest problems with health information exchanges is their financial sustainability. Unfortunately, the Stage 2 proposed rule does not address the issue. "While Stage 2 has pushed for more information exchange, which is a really great thing, it did not give me a comfort level that it is actually going to happen," says Dr. Whittington. "It did not designate who is going to be responsible for making sure that health information exchanges have a financial basis. We need to see infrastructure continue to emerge that keeps the patient in the center."

The lack of direction of financially sustaining HIEs is another challenge for hospitals and healthcare professionals. Stage 2 directs hospitals and providers to engage in health information exchange as a "verb", focusing on so-called "directed exchange" from one known provider to another. Such data exchange could use both a specialized form of secure, health e-mail called "direct" or other standards-based approaches to exchange through an HIE. Notably, many are concerned that the funding sources for HIEs as organizations, which could, many believe, support more robust, two-way exchange, including data queries, remains unclear. "When you look at Stage 2 you might think that individual States, counties or local regions should fund an HIE," says Dr. Whittington. "But they are not the ones reading the Stage 2 rule. Hospitals, providers and vendors are reading the document — the onus is on them to participate and potentially fund it."

3. Patient access to electronic health information
Another theme within the Stage 2 proposed rule is providing patients with greater access to their health information electronically. According to Dr. Segal, the patient access standard is likely to be a challenge for many providers. "The argument for encouraging patients to access their health information is understandable," says Dr. Segal. "However, placing the responsibility of whether patients access health information on the providers is a new challenge."

CMS is incentivizing providers to encourage patients to use technology to access health information. The proposed rule includes core objectives to use EHR technology to identify patient specific education resources; to provide patients the ability to view, download and transmit information about their hospital admissions and their health information online; and to secure electronic messaging to communicate with patients on health information.

The CMS Stage 2 proposed rule is another step towards improving quality, safety, efficiency and reducing health disparities in the U.S. healthcare system by engaging patients in healthcare, improving care coordination and increasing the electronic access, usage and distribution of health information. Achieving meaningful use will not always be easy for hospitals and providers, especially when the standards and objects are challenging. However, CMS' Stage 2 also offers benefits to eligible providers and their patients so that they may work toward reaping the rewards of meaningful use.

CMS began accepting comments on the proposed rule March 7. The federal government's regulations.gov website provides a platform for the public to submit online comments on the proposed rule. The 60-day public comment period ends May 7.

More Articles on CMS Meaningful Use:

Meaningful Use: What You Need to Know About Release of Information Requirements
Making the Most of Electronic Health Records – It's All About Infrastructure
ONC Issues EHR Certification Companion Rule to Stage 2 Meaningful Use
39 Things to Know About CMS' Stage 2 Requirements for Meaningful Use

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