Final definition of “meaningful use”?

On December 30, 2009, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) at the Department of Health and Human Services issued proposed regulations on the definition of “meaningful use” and the initial set of standards, implementation specifications, and certification criteria for EHR technology.

This announcement was made in conjunction with the publishing of two separate documents and a request for public comments:

• Health Information Technology Initial Set of Standards, Implementation
• Medicare and Medicaid Programs; Electronic Health Record Incentive Program

Beginning on page 32 of the “Medicare and Medicaid Programs: Electronic Health Record Incentive Program” document, a definition of “meaningful use” is provided along with associated discussions such as definition background and definition considerations.

Both documents discuss the proposed stages of “meaningful use”:

Stage 1 (beginning in 2011): The proposed Stage 1 meaningful use criteria “focuses 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.”

Stage 2 (beginning in 2013): CMS has proposed that its goals for the Stage 2 meaningful use criteria, “consistent with other provisions of Medicare and Medicaid law, expand upon the Stage 1 criteria to encourage the use of health IT for continuous quality improvement at the point of care and the exchange of information in the most structured format possible, such as the electronic transmission of orders entered using computerized provider order entry (CPOE) and the electronic transmission of diagnostic test results (such as blood tests, microbiology, urinalysis, pathology tests, radiology, cardiac imaging, nuclear medicine tests, pulmonary function tests and other such data needed to diagnose and treat disease). Additionally we may consider applying the criteria more broadly to both the inpatient and outpatient hospital settings.”

Stage 3 (beginning in 2015): CMS has proposed that its goals for the Stage 3 meaningful use criteria are, “consistent with other provisions of Medicare and Medicaid law, to focus on promoting improvements in quality, safety and efficiency, focusing on decision support for national high priority conditions, patient access to self management tools, access to comprehensive patient data and improving population health.”

Pages 51 through 61 of the “Health Information Technology Initial Set of Standards, Implementation” document provide Stage 1 “meaningful use” objectives in a table alongside corresponding certification criteria to support the achievement of “meaningful use” Stage 1 by eligible professionals and eligible hospitals. In reading this table, keep in mind the provided definition of “EHR module”:

EHR Module: any service, component, or combination thereof that can meet the requirements of at least one certification criterion adopted by the Secretary

The following note is provided alongside examples of EHR modules:

While the use of EHR Modules may enable an eligible professional or eligible hospital to create a combination of products and services that, taken together, meets the definition of Certified EHR Technology, this approach carries with it a responsibility on the part of the eligible professional or eligible hospital to perform additional diligence to ensure that the certified EHR Modules selected are capable of working together to support the achievement of meaningful use. In other words, two certified EHR Modules may provide the additional capabilities necessary to meet the definition of Certified EHR Technology, but may not integrate well with each other or with the other EHR technology they were added to. As a result, eligible professionals and eligible hospitals that elect to adopt and implement certified EHR Modules should take care to ensure that the certified EHR Modules they select are interoperable and can properly perform in their expected operational environment.

Pages 79 through 81of the “Health Information Technology Initial Set of Standards, Implementation” document elaborate on this interoperability requirement for patient summary records, drug formulary checks, electronic prescribing, administrative transactions, quality reporting, submission of lab results to public health agencies, submission to public health agencies for surveillance or reporting, and submission to immunization registries. Page 85 outlines adopted privacy and security standards for Certified EHR Technology, and the document distinguishes these standards from those associated with HIPAA.

With a combined total of nearly-700 pages, the two documents discussed here necessitate a thorough review that will take some time to digest. This post simply provides an initial level of awareness that these documents have been published.