CMS Proposed Rule Threatens Care Quality in Rural Communities

CMS Proposed HIT Incentive Rule Threatens Care Quality in Rural Communities

Summary

Due to the fact that the proposed rule incentivizes providers to implement EHRs without allowing for time to perform the culture change, workflow redesign, and education that are prerequisites for quality improvement, the CMS HIT incentive proposed rule has the potential to erode quality in rural provider settings.

Additionally, the new quality reporting requirements are likely to create significant new reporting burdens with minimal corresponding rural provider quality gains.

Background

One of the key premises of the HIT incentive program is that quality improvement can be achieved through the use of EHRs. Most of us, including myself, believe this to be true for two reasons: (1) EHRs can guide caregivers to make better decisions by providing them with relevant information (such as comprehensive clinical data, decision support, alerts, information received from other providers, etc.), and (2) EHRs can facilitate the submission and analysis of data relating to how care has been provided in the past, in order to inform future care decisions.

However, it’s important to note that there is very little data that actually demonstrates that EHRs improve care. According to the Agency for Healthcare Research and Quality’s 2006 wave-making Costs and Benefits of Health Information Technology,[1] “Using existing published evidence, it is not possible to draw firm conclusions about which HIT functionalities are most likely to achieve certain health benefits. The assessment of costs is even more uncertain … More widespread implementation of HIT is limited by the lack of generalizable knowledge about what types of HIT and methods for its implementation will result in changes in benefits and costs for specific health organizations, especially for small practices and small hospitals.”

CMS, without providing any substantiating evidence, takes a very different position. According to the proposed rule, “any impacts that would arise from the implementation of certified EHR technology in a rural eligible hospital would be positive.”

The truth—or at least the general consensus within the provider and quality community—is that EHRs, when implemented appropriately (with intense attention paid to quality goal setting, cultural transformation, workflow redesign, and end-user education), have the potential to enable safer and more effective care. It’s also true (i.e. substantiated by many case studies) that EHRs, if implemented without such attention paid, have the potential to cause less safe and less effective care.

So does the CMS proposed rule support the type of HIT transformations required to actually achieve the stated quality goals of the program, especially in the context of small rural providers?

My belief is that CMS has designed the incentive program in a way that will likely produce negative quality impacts on many rural (and other) providers.

Why the Proposed Rule Will Negatively Impact Rural Health Quality

The fundamental reason that the CMS proposed rule is likely to erode quality in rural provider settings is due to the fact that the timeframes for achieving meaningful use are unattainable for a large portion of rural providers, especially if they are to perform the culture change and workflow redesign that are prerequisites of quality improvement. Please consider the following statements:

1. Rural and small providers are generally at early stages of EHR adoption.
2. HIT interventions that fail to devote appropriate time for culture change, workflow redesign, and education are likely to lead to reduced quality.
3. The CMS proposed rule’s timing and meaningful use requirements are such that providers at early stages of adoption cannot devote appropriate time for culture change, workflow redesign, and education, and still meet the incentive and penalty deadlines. (See chapter 4 of http://www.worh.org/hit/arra-history/)
4. Providers will nevertheless attempt to implement the CMS requirements as incented by CMS (rather than quality) timetables. They will be justified in doing so due to CMS’s statement that “the impacts … of certified EHR technology … can only be positive.”

If we agree with the above statements, the logical conclusion seems to be that the CMS proposed rule will likely lead to reduced quality in many rural and small provider settings.

The FDA would not take an experimental drug only shown to be successful in adult men, under precise protocols, and then incentivize physicians to prescribe the same drug and dosage to women and children. This is the essence of CMS’s proposed rule. Please do not draw from this the conclusion that EHRs are not important for small and rural providers.  They are critically important. But rural and small providers have distinctive EHR needs, and they require reasonable time to develop the protocols and workflows that will make EHR systems work safely and effectively in their environments.

I am very curious to understand which of the above 4 statements CMS disagrees with and/or whether they can draw any different conclusions. Thus far, CMS and ONC have been unwilling to address this issue. Rural providers and communities deserve an explanation of how the incentive program will improve (or at least not damage) the quality of care in rural America.

Additional Note:  The fact that ONC used rule-making to revise legislative intent by excluding rural and critical access hospitals from receiving technical assistance through the Regional Extension Center program exacerbates this problem. If small rural hospitals had been included in REC funding, as Congress clearly intended, they would at least have some level of access to the workflow redesign and quality improvement resources they sorely need.  (See chapter 5 of http://www.worh.org/hit/arra-history/)

Rural Issues Relating to Quality Metrics in the Proposed Rule

In addition to the fundamental problem raised above, there are numerous other problems in the CMS proposed rule relating to quality reporting requirements, including:

1. Many of the quality metrics in the proposed rule are not relevant for small rural providers, and many metrics that are relevant have not been included. The Outpatient Core Measure Set was built with rural and critical access hospitals (CAHs) specifically in mind, but is not included in the CMS proposed rule. This measure set includes AMI (Heart Attack), Chest Pain, and Surgical metrics for outpatients that come through EDs and ORs, and is data that is already being reported to CMS. The ER throughput measures that have been proposed are still being tested in terms of applicability to electronic submission and receipt by CMS.

2. Given workforce issues, rural providers simply cannot keep up with expanding reporting programs. Even if the same questions will not have to be answered under separate programs, the fact that CMS is creating a new program with distinctive rules will create significant duplicate work. Why can’t we develop one comprehensive reporting program from which all quality stakeholders (whether RHQDAPU, HIT Incentive, or State programs such as Checkpoint in Wisconsin) can access data from the CMS warehouse? Hospitals that must prioritize dedication of quality expertise hours between reporting requirements to an ever-growing list of stakeholders jeopardize patient safety and quality at the point of care.

3. CMS’s time estimates for quality reporting, whether for rural or any other providers, are based on a faulty assumption that EHRs will have all of the required data elements in discrete, machine readable fields, and that CMS’s abstraction rules will somehow be automatically applied without any need for manual abstraction. To the contrary, many of the selected measures will not be electronically abstractable even after providers achieve Stage 1 meaningful use (which most rural providers will be struggling to attain through 2014). Take for example the inpatient core measure of “Beta-blocker prescribed at discharge.” When a physician decides not to prescribe a beta-blocker for a specific clinical reason, the data identifying that clinical decision-making process will more than likely be in a transcription or a physician’s note that is not extractable without human intervention. The current specifications for abstracting that one aspect of the beta-blocker measure require complex logic as well as in-depth combing of a patient’s medical record.

The result of the above problems will be to significantly increase the reporting burden for rural providers without any significant corresponding quality gains.

What Can Be Done About These Issues

• We hope that Congress will ask CMS to lengthen the timing requirements and create flexibility (rather than an all-or-nothing standard) in order to make the meaningful use requirements reasonably achievable for early stage providers. Rural providers must have an opportunity to achieve reasonable incentive goals without jeopardizing the safety of the rural patients in their care.

• We hope that Congress will reiterate to ONC that it intended in ARRA to provide rural and critical access hospitals (not just physician clinics) with Regional Extension Center technical assistance that would have provided them with quality improvement and workflow redesign expertise.

• We hope that CMS will focus on a starter-set of metrics that are relevant to both large and small providers, as well as develop a plan to unify disparate reporting requirements into one system that will efficiently support effective quality improvement. Additionally, CMS needs to take care to design automated quality reporting measures with an understanding of what is likely to be electronically abstractable in environments that have reached Stage 1 meaningful use.

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[1] http://www.ahrq.gov/downloads/pub/evidence/pdf/hitsyscosts/hitsys.pdf