[Ed. Note: We are pleased to welcome Ana Liggio, Esq., to HRW. She is a health care and technology lawyer, in practice over 15 years. Prior to pursuing her LL.M. in Health Law here at Seton Hall Law, she was Director, Law Department, for Sony Electronics.]
The CMS website explains that meaningful use “means providers need to show they’re using certified EHR technology in ways that can be measured significantly in quality and in quantity. As CMS moves into finalizing meaningful use, Stage 2 requirements, I would like to introduce the concept of “meaningful experience” as an essential corollary to that of “meaningful use.”
Meaningful experience takes the idea a step further, representing ways to evaluate and encourage the merits of both proposed and existing criteria as seen from the value they bring to the provider and healthcare consumer stakeholders. While “meaningful use” focuses on ensuring that the financial beneficiaries of the Medicare and Medicaid EHR Incentive Program (the “Program”), the Certified Electronic Health Record Technology (“CEHRT”) industry, and the eligible healthcare providers (insofar as meaningful use bonus payments are at stake), continue to operate their EHR in a purposeful manner, there are additional, important stakeholders to consider. With billions of federal and state dollars earmarked for the Program and a strong interest in seeing EHR enjoy long-term success, taking a broader view of stakeholders and inserting more transparency into their experiences will better help the Program thrive. Meaningful Use, Stage 2, is the perfect time to look towards ensuring meaningful experience.
The Program is in full swing, with the Centers for Medicare and Medicaid Services (“CMS”) having released the NPRM on Meaningful Use, Stage 2, in the Federal Register on March 7, 2012.
The CMS blog explains: “Today’s proposed rules focus on using EHRs to improve health and health care while reducing the burden on physicians and hospitals where possible.” With early participation rates appearing strong, CMS continues to be cautious about keeping industry groups engaged and seeking out robust commentary through the NPRM. CMS clearly wants the healthcare industry to continue up the “EHR Escalator” without having anyone jump off for being frustrated or overwhelmed. To date, the strategy is working, as the CEHRT industry and healthcare providers appear to be embracing the Program. However, as Nicolas Terry points out in his article “Anticipating Stage Two: Assessing the Development of Meaningful Use and EMR Deployment,” ultimately, growth will have to be endogenous, fueled by innovation and consumer demand.
The comprehensive NPRM for Meaningful Use, Stage 2 demonstrates CMS’s commitment to considering the experiences and opinions of the interested industries. The ONC also asks data holders and non-data holders to take a pledge “to empower individuals to be partners in their health through health IT.” There is no doubt that the Program is making huge strides and continuing to chip away at the difficult issues of interoperability, access, privacy and security- and pushing the United States slowly but surely closer to a much higher healthcare IT standard similar to that enjoyed by many other developed nations. Moving into Stage 2, CMS seeks to enhance interoperability among different entities and further patient involvement by requiring increased access to their health information. That being said, the ONC’s National Coordinator for Health Information Technology, Farzeed Mostashari, explains that Stage 2 is meant to be more “evolutionary than revolutionary.” Importantly, Stage 2 also begins an initiative to align the requirements of the Program with other complementary, ongoing healthcare reform initiatives involving national quality and the development of ACOs.
Reading through the NPRM, I saw a few areas that CMS could focus on to help build a self-sustaining system. First, the initial iteration of the Program was clearly written with an eye toward maximizing meaningful use for family care and general practitioners and not towards other types of practices like pediatrics, various specialists, and physicians whose practices do not entail much face-to-face patient interaction (e.g., radiologists); they should be given further attention. Second, while CMS provides somewhat of a return on investment analysis in the NPRM, it apologetically declares it too early in the Program to be able to provide meaningful data; CMS could use the attestation process to collect the necessary data. Finally, healthcare consumers – those taxpayers who fund this program — should be actively considered and made aware of the enhancements and improvements that comprise the Program, which will be offering them a more efficient, accessible, safe and evidence-based healthcare experience; a “meaningful user” designation for CEHRT users who meet certain criteria could be developed to help providers publicize their investment in the Program and the attendant benefits it will bring to their patients. Meaningful Use, Stage 2, is the perfect time to address these issues and move the Program forward in such a way that will make it self-sustaining for the long-term, not because of incentive funding, but because meaningful use is providing a meaningful experience to the various EHR stakeholders.
As with early versions of the Medicare Shared Savings Plan and healthcare reform generally, the focus of the Program’s meaningful use objectives and criteria, initially at least, is on general practitioners and how they can use EHR to advance the overall wellbeing of the population. This goal is laudable, of course, but the population of eligible providers extends well beyond PCPs. Certain objectives and measures allow providers to claim an exclusion if they do not apply to their practice, thereby not penalizing those types of practitioners for whom compliance would be unnecessary and inefficient. However, focus on these different categories of practices could allow for alternative objectives and measures to be found. If one were to consider meaningful experience in addition to meaningful use, the attestation would ask EPs who are claiming exemptions to use and, possibly attest to, alternative meaningful use standards that are applicable to their practices. For instance, there is a proposed measure for recording 80% of an EP’s patients’ height, weight and blood pressure as structured data. There is an available exclusion, however, for EPs who do not believe that recording such vital signs is “relevant to their scope of practice.” An EP who claims the exclusion simply gets a pass on this field during the attestation process. Alternatively, a required (or even optional) free-form response area could be provided in the attestation each time an EP claims exclusions. As time goes on, data would be collected that would allow CMS to customize attestations, and CEHRT requirements as well, to different specialties so that meaningful use translates into meaningful experience for those whose practices do not fit the general practitioner mold on which the first versions of Meaningful Use were based. Certainly the technology will allow, rather easily, for modifications where appropriate if the effort is set forth to ask those in the field what would be meaningful to their practices and to encourage them to use the EHR tools available to them in such ways.
Because the proposed rule is anticipated to have an annual effect of over $100 million on the economy, a Regulatory Impact Analysis (RIA) that measures costs and benefits must be performed. While CMS does a fair job of estimating costs to providers of implementing EHR and costs to taxpayers of funding the Program, it has not done much to quantify benefits gleaned. The NPRM qualifies its analysis by pointing to various unknowns and a lack of “new data regarding rates of adoption or costs of implementation.” Without specific data, it estimates various “high and low” scenarios for different practice settings and ultimately concludes, “there are many positive effects of adopting EHR” as well as various benefits for society. While I tend to agree with this conclusion as general matter of conjecture, why not collect the actual data during the attestation process? Ask the EHR attesters how much their systems cost initially and to maintain. Ask the EHR attesters where the systems are adding value to their practices and for their patients. Yes, it’s a leap of faith to ask these questions because the answers may not offer a perfect picture, but they will offer an honest representation of the current state that can be addressed going forward. It is only fair to give the stakeholders an honest assessment and it would not be difficult to collect the data. While EHR is all about collecting healthcare data and crunching numbers to see trends and identify areas where improvements can be made, let’s use those same principals here to perform the same analysis with regard to the EHR technology.
Finally, to assist providers who have made the investment and will continue to feed important data to the various government health databases, CMS could offer some type of certification that the providers could use in marketing their practices. For all the good that EHR is meant to do in terms of patient safety, efficiency of care and meaningful communication between patients and their providers, let’s devise a way to inform patients about which providers are running state-of-the-art practices. Providers who attest to meeting the meaningful use requirements could be offered the option of using a certified meaningful user designation and displaying a certain logo, all of which would indicate to the public that such providers are using the latest healthcare technology. For healthcare consumers who consider it important to have the ability to access their records or have their prescriptions transmitted electronically, for example, this designation would help lead them to the types of practices they desire. Assuming this is the future of healthcare and what the American public desires or will come to desire of its healthcare providers, such a tool would be useful to the providers and healthcare consumers alike.
At the end of the day, the success of the EHR program, and the value it will have brought to the US healthcare system, will be measured by the experience of the healthcare providers and consumers. In the best-case scenario, there will be data showing that the EHR Program has achieved the desired results with a minimum burden placed upon providers. But what will actually entice providers to continue to make “meaningful use” of the systems will be when meaningful use results in an experience they deem worthwhile for themselves and their healthcare consumers and when their patients agree. As such, CMS should use the attestation process and resultant data to continuously measure the actual costs and benefits and make adjustments as needed. During the attestation process, it could ask providers to suggest alternative meaningful uses for EHR when the existing measures do not apply and to volunteer cost data and their impressions of meaningfulness. Finally, CMS could give providers a way to publicize their commitment to using technology to enhance patient care. Some time and effort devoted to meaningful experience will allow meaningful use to translate into a self-sustaining, successful program.
[Ed. note: this piece originally ran on April 17, 2012, but was lost in the vagaries of cyberspace to a blog mishap. It's just too good to lose and so here enjoys a repeat performance]