The role a Laboratory Information System (LIS) plays in the Meaningful Use (MU) incentive program relates to the Reportable Laboratory Results option, an objective of Stage 1 of the MU rules. These rules are stated in the American Recovery and Reinvestment Act (ARRA), commonly referred to as the “stimulus package,” of 2009 which President Obama signed into law on February 17, 2009. It included the Health Information Technology for Economic and Clinical Health (HITECH) act, which stipulates that healthcare providers will be offered financial incentives for demonstrating meaningful use.
Deadlines and Requirements for the HITECH Act
2014 was the last year a Medicare provider could initiate a program under the HITECH act, and next year will be the deadline for Medicaid providers. The last year to register for the program is 2016 for both Medicare and Medicaid providers. Payment adjustments for eligible Medicare providers and hospitals that are not meaningful users began this year. There are no payment reductions for Medicaid providers. Hospitals that are not meaningful users will receive a net reduction of ¼ applicable in 2015, ½ in 2016 and ¾ in 2017, of the market basket update. According to the Medicare and Medicaid HITECH, Title IV of the ARRA:
The Secretary of HHS may, on a case-by-case basis, exempt a hospital if requiring the hospital to be a meaningful EHR user would result in a significant hardship.
In order to receive EHR MU incentives, facilities or providers must first meet several operational and public health criteria as established by CMS. In Stage 1 of the MU rules, the requirements are divided into 15 core set objectives and 10 menu set objectives (with an option to choose five out of 10). Stage 1 states that all providers must meet its requirements for a 90-day period of the first MU year and for the full year of their second MU year.
Stage 1 has three public health objectives:
- Reportable Laboratory Results for eligible hospitals only.
- Syndromic Surveillance.
Eligible hospitals must choose one public health objective. If a provider chooses Reportable Laboratory Results, then the provider must prove the capability, “to submit electronic data on reportable (as required by state or local law) laboratory results to public health agencies.”
The Interaction of LIS and EHRs
Reportable Laboratory Results reporting for MU is a subset of the Electronic Laboratory Reporting (ELR) initiative, which includes results reporting among labs, public health agencies and providers. LIS affects MU by facilitating result reporting of tests indicative of notifiable conditions, such as E-coli, HIV and hepatitis, as specified by the Health and Safety Code. The transmittal of data will feed to the National Electronic Disease Surveillance System at the Department of State Health Services.
To better understand the relationship between an LIS and MU, it’s important to understand the relationship between the Electronic Health Record/Electronic Medical Record (EHR/EMR) and the LIS. LIS systems were introduced and developed by instrument manufacturers and predate the EHR and EMR systems. They functioned to provide greater lab productivity and functionality and provided the first automated reporting capabilities while easing regulatory compliance. However, while the LIS was positively affecting laboratory function, valuable time and resources were wasted on duplication of efforts by entering patient demographics and billing information into multiple systems. A push to have these systems communicate with one another ensued, which resulted in the creation of EHR.
Currently, many LIS systems interface successfully with EMR/EHR systems via Health Level 7 (HL7) interfaces, which allows the flow of data from the LIS to the EMR/EHR and back. HL7 submissions are a step in Stage 2 of the MU rules. In Stage 2, ELR reporting moves from a menu set objective of Stage 1 to a core objective. Two full years of requirement must be met in Stage 2 of the MU rules.
According to Markets and Markets, the global LIS market is expected to grow at a Compound Annual Growth Rate of nine percent from 2014 to 2019. That is an expected $1,806.1 million by 2019, compared to the $1,175 million for 2014. MD Buyline data shows six major LIS players in the market. Cerner (Millenium), Epic (Beaker) and Mckesson (McKesson Lab, formerly Horizon Lab) are part of larger health systems, and Soft, Orchard and Sunquest are software specific for the laboratory setting but that interface successfully with hospital systems. CAP Today lists 32 LIS vendors in the market today in the Product Guide released November 2014.
Choosing a LIS that Fits the Reportable Laboratory Results Objective
If choosing Reportable Laboratory Results as one of your public health objectives in Stage 1 of the MU rules, consider the connectivity of your systems. Choose LIS systems that interface well with your EMR/EHR, as well as with your laboratory instruments.
For lower-volume settings, or smaller providers, look for low-volume instruments that can interface directly with the EMR/EHR in the event an LIS is not in use or not an option. Vendors are making small, low-volume and POC instruments HL7 compatible. Some have a wireless feature, and others also offer optional middleware software to manage the transmission of data to your EMR/EHR system.
Visit the ELR Implementation Guidance page for a suggested framework to implement ELR.