It has been about two and one half months since the Stage 2 Final Regulations on the EHR incentive program, AKA “meaningful use,” were released in late August by ONC and CMS (including a brief correction notice). This has been a very busy time for GE Healthcare and other software developers, for our customers, and for ONC and CMS. My eyes are still tired.
At GE Healthcare, we have been heavily focused on understanding the final regulations and what we should be doing in terms of product development to best meet our customers’ needs for Meaningful Use preparation and more generally, to be able to achieve timely product certification under the new ONC process. We have also worked, along with industry partners, such as the HIMSS Electronic Health Record Association to provide feedback to ONC and CMS on aspects of the Final Rules and follow-up government materials that need clarification or refinement.
I encourage those with an interest in this program to monitor the CMS and ONC websites and to subscribe to the CMS Listserv on Meaningful Use. ONC and CMS have issued several key items critical to enabling vendors and providers to fully understand what we must do to prepare for Stage 2 and 2014.
- Certification Test Methods (out for comment)–These building blocks for certification test scripts are essential for vendors to know exactly what we must do in our products for meaningful use
- Clinical Quality Measure Specifications and “Value Sets” (issued as final)
- Updated FAQs from CMS and ONC on interoperability and data exchange and other key topics
- Specification Sheets for each meaningful use objective and measure–These have been an invaluable resource and we can expect CMS to revise and enhance these over time
- Updated grids from ONC linking meaningful use objectives and measures for both Stage 1 and Stage 2 to associate certification criteria and standards
As with Stage 1, but only more so, it has become ever more clear that each new Meaningful Use measure generates new questions and implementation challenges that must be addressed by vendors, providers and federal and state governments. The need to align the culture of laws and regulations with the realities of software code development and varied customer product and implementation needs and workflows leads to a never ending round of questions and answers, and then more questions and answers.
Our colleagues in the federal government have been highly professional and responsive. Still, it is an inescapable fact that vendor and provider actions in addressing each new set of Meaningful Use requirements are enormously complex and time consuming. These regulatory requirements mean that we, as HIT software developers, have competing priorities as we identify and meet other customer challenges and opportunities, including those that relate to emerging delivery and payment models, such as accountable care, patient centered medical homes, and bundling, as well as innovative approaches to product usability. These latter items remain priorities but, at the end of the day, there are only so many months and a finite set of engineers available for development.
The Meaningful Use program is meeting its overall goals, with increasing numbers of eligible professionals and eligible hospitals registering for the program, achieving meaningful use, and securing Medicaid payments for adopting, upgrading, or implementing certified EHR technology. As of September 2012, over 300,000 eligible professionals had registered for the Medicare or Medicaid incentive programs and just over 4,000 eligible hospitals. Just under $4 billion have been paid for Medicare incentives, all for meaningful use, and just over $3.5 billion were paid out for Medicaid incentives, mostly for “adopt, upgrade, and implement”. Overall, EHR adoption continues to grow, whether as reflected in meaningful use data or more generally, with 55% of physicians having adopted EHRs as of 2011. No doubt the incentive program has accelerated this growth in adoption of interoperable EHRs and other healthcare IT.
And yet, as we consider the fact that its nearly December and we still do not have all of the final materials that we need to prepare for product certification and for full understanding of the scope of what will be required to prepare for Stage 2 and the “2014 edition” of certified EHR technology, it is impossible not to feel some amazement (but not surprise) that the HIT Policy Committee has just released for about 60 days of review, a 37 page highly detailed request for comments on Stage 3 of meaningful use, which is to start in 2016 (October 1, 2015 for hospitals).
So, what to do? Maintaining the Meaningful Use program as an incentive and source of financial resources for adoption and meaningful use of interoperable EHRs and other HIT is essential. At the same time, we should be looking to shift implementation of the program, starting with Stage 3, to a less prescriptive model that focuses on encouraging and assisting providers to take advantage of the quite substantial capabilities established in Stages 1 and especially Stage 2, including interoperability (within and across provider organizations), rather than adding large numbers of new meaningful use requirements and product certification criteria. Any new items should be limited and highly focused on key areas like interoperability. In this regard, and considering our recent experience with the delayed availability of essential Stage 2 materials, we should also rethink the desirability of major changes every two years and consider seriously a longer period between stages, which is permitted by the enabling statute.
We also can expect that provider and patient responses to emerging delivery and payment models will generate diverse product requirements, many of which may occur outside of traditional EHRs, and we should increasingly use such provider-based demand for specific features and functions to drive the ways in which HIT is used and products are designed.
Calling for a refinement in course does not repudiate the course set by the Congress in creating this program or its implementation by ONC and CMS. Rather, it is reflects application to public policy of the agile software development principles used by GE Healthcare and other software leaders, aimed at encouraging technology adoption, with a focus on iteration and incremental approaches, and flexibility in responding to feedback and changing environmental conditions. What a wonderful idea, agile public policy!
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