1 Centers for Medicare & Medicaid Services Department of Health and Human Services Room 445 G Hubert H. Humphrey Building 200 Independence Avenue, SW. Washington, DC RE: CMS 0033 P; Comments to Meaningful Use Notice of Proposed Rulemaking Dear Administrator Frizzera: The more than 230 members of the Continua Health Alliance (Continua) commend the Centers for Medicare and Medicaid Services (CMS) for accepting comments related to the Notice of Proposed Rulemaking for the Medicare and Medicaid Incentive Program (Proposed Rule). Continua is a non-profit, open industry coalition of healthcare, technology and medical device companies joining together in collaboration to improve the quality of healthcare through the use of personal telehealth, remote patient monitoring (RPM) and other health information technologies. Continua is dedicated to establishing interoperable personal health solutions with the knowledge that extending those solutions into the home fosters independence, empowers individuals, and provides the opportunity for personalized health and wellness. More information about Continua and its members can be found at Continua appreciates CMS vision for expanding the goals of meaningful use over three different stages. While we understand that CMS Proposed Rule only addresses the Stage 1 objectives and measures in detail, we believe it is critical for the Proposed Rule to ensure that each stage of meaningful use sets the foundation for the next. Under the American Recovery and Reinvestment Act, incentive payments will be provided to
2 eligible professionals (EPs) and eligible hospitals participating in Medicare and Medicaid programs that adopt and meaningfully use certified electronic health record (EHR) technology. As stated in the Proposed Rule, meaningful use is a term defined by CMS and describes the use of health information technology (HIT) that furthers the goal of information exchange among health care professionals. This is why we strongly encourage CMS to remain consistent with its definition of meaningful use and promote, not only the systems that govern EHRs, but also the adoption and use of interoperable HIT technologies. To solely focus on EHRs and not on how EHR data will be populated will limit the proper implementation of HIT. EHR systems and technologies should not be considered the stand-alone answer to this nation s healthcare crisis. EHRs are an important foundational element in a broader health information technology ecosystem that is comprised of EHR technologies and interoperable remote monitoring devices, sensors, applications and products. To merely focus on EHR technologies and systems is to shortchange the capabilities of interoperable HIT and stifle technology innovation and its adoption. As health information technologies like remote patient monitors, personal connected healthcare devices and mobile health (mhealth) (collectively known as ecare ) continue their rapid evolution and increasingly become the focus for the provision of healthcare, it will be those wired, wireless and mobile devices, sensors, products, and applications that will derive and capture health information data for applicable facets within the HIT ecosystem. True HIT includes all of these devices, sensors and applications, not merely those which focus solely on the exchange of EHRs. Thus, we were disappointed to see that, in the HIT Policy Committee s final recommendation to CMS, the incorporation of data from home monitoring devices and medical device interoperability were not included as objectives until Stages 2 and 3
3 respectively. In the Proposed Rule, CMS states that the meaningful use Stage 1 objectives focus on electronically capturing health information in a coded format; using that information to track key clinical conditions and communicating that information for care coordination purposes (whether that information is structured or unstructured, but in structured format whenever feasible); consistent with other provisions of Medicare and Medicaid law, implementing clinical decision support tools to facilitate disease and medication management; and reporting clinical quality measures and public health information. 1 Interoperable remote patient monitoring can assist EPs in meeting the Stage 1 objectives as it can be used to (1) capture data that can be directly inserted into an EHR; (2) track clinical conditions and communicate this information for care coordination purposes; and (3) enhance data that would facilitate the use of decision support tools. In later stages of meaningful use, CMS intends to focus on the exchange of data and improvement in health outcomes from the use of HIT. RPM fits into the overarching policy structure of meaningful use, and Continua believes that the use of this technology is integral to the achievement of these national goals and priorities. We believe commercially available technologies can be used by patients, EPs and other professionals to achieve the goal of data capture that CMS has set forth for Stage 1 of meaningful use. Thus, the capture of data from RPMs should be explicitly included as a Stage 1 objective. Services provided through RPM devices extend an EP s reach and should be viewed as an extension and augmentation of their services, which are similar to those offered in the 1 Centers for Medicare and Medicaid Services, Medicare and Medicaid Programs; Electronic Health Record Incentive Program; Proposed Rule, 75 Fed. Reg. 8, 1852 (January 13, 2010).
4 professional s office. For instance, RPM devices can be used to record and chart changes in vital signs. 2 RPM devices can directly populate a patient s EHR whether the device is used in the professional s office or in the patient s home or anywhere. These technologies collapse time, space and distance to more effectively monitor patients, develop analytical trends, and ultimately save lives while maximizing efficiency and helping to avoid lengthy hospital stays and costly readmissions. More and more devices utilize broadband technologies over wired, wireless and mobile networks to seamlessly provide important patient information to healthcare professionals, clinicians and even loved ones at a low cost and in secure, real-time usable formats. Furthermore, Continua believes that data from RPM devices should be treated in a manner similar to that of laboratory data. In Stage 1, EPs and hospitals would be required to incorporate clinical lab-test results into EHR as structured data. 3 Similarly, data collected from RPM devices can be incorporated into EHRs as diagnostic data. This data is collected over time and is an important aspect of a patient s comprehensive health data, as is information gathered from laboratory tests. Ultimately, Continua believes that RPM devices can aid EPs in meeting CMS objectives for all three stages of meaningful use. RPM technology can be used to capture health information in a coded format, improve quality at the point of care and promote consistent, safe and efficient care. We believe CMS should clarify within its final rule on the EHR incentive program that RPM devices, as part of the broader effort to bolster HIT use, can be used to meet certain objectives, as applicable. While we commend CMS effort to promote the widespread adoption of HIT, we also encourage a flexible approach to meaningful use that will advance the goals of HIT use 2 Id. at Id. at 1958.
5 without seeming unachievable for certain providers. We note that approximately 20 percent of hospitals could attain the requirements of meaningful use as currently proposed. Continua believes that a more flexible approach could encourage more providers to participate in the incentive program. An approach, such as the approach proposed by the HIT Policy Committee, could be used to provide this flexibility. By allowing providers to defer certain objectives and still qualify for the incentive payments, CMS could ensure that providers adopt EHRs earlier rather than later. Lower thresholds can incentivize providers to begin using EHRs whereas higher thresholds may have the opposite effect and drive providers to forgo adoption because of the stringency of the requirements. Ultimately, Continua views this Proposed Rule as working in tandem with the Office of the National Coordinator s (ONC s) Interim Final Rule on initial standards, implementation specifications and certification criteria (Interim Final Rule). Continua plans to comment on the Interim Final Rule as well to ensure that HIT devices like remote patient monitors can be certified as EHR modules. While we understand that monitoring technologies may take on a more important role in later stages of meaningful use, Continua believes it is extremely important to ensure that the initial stage of the definition does not stifle current adoption or confuse providers currently using this technology to discontinue their use. RPM technologies can populate EHRs with certain information required for Stage 1, and the final rule should note this as an option. Ultimately, if remote devices meet the standards and implementation specifications to be considered an EHR module, then the use of these devices should be incorporated into the meaningful use final rule as the devices not only capture and collect data but also populate the EHR appropriately with patient data.
6 In conclusion, with the current shortage of physicians and the increased need for timely patient data, the use of health information technologies is a logical extension of the meaningful use of EHRs. Continua believes CMS should specify that, where devices are capable of capturing the data included in the Stage 1 definition of meaningful use, the use of those devices can qualify EP s for incentive payments. This will guarantee a strong foundation for the use of RPM devices under the definition of meaningful use as that definition evolves over the course of the next five years. Continua is appreciative of this opportunity to comment on the Proposed Rule and commends CMS development of the Medicare and Medicaid EHR incentive programs. We believe HIT enabled by powerful wired, wireless and mobile broadband networks currently exists and are available today to supplement America s healthcare delivery. HIT, when used as part of an interoperable ecosystem, will advance our nation s healthcare needs and lead to improved quality and health outcomes. We have extensive experience in the development and use of RPM devices, telehealth and mhealth, which can enhance the delivery of care and extend the oversight of patients beyond the physician s office. If we can be of any further assistance to CMS as this final rule is developed, we would be eager to share our experiences and knowledge. Sincerely, Charles Parker Executive Director Continua Health Alliance
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