SAM #75FCMC26R0050

Sole Source Contract for LOINC Code Creation and Maintenance (FY 2027-2031)

This opportunity is a sole source procurement by CMS for the continued creation and maintenance of LOINC codes, which are essential for standardized clinical data interoperability in federal health IT systems. - The contract is with the Regenstrief Institute, the sole OEM and copyright holder of LOINC codes - LOINC codes standardize health measurements, laboratory tests, clinical observations, and assessment data in electronic health records - The contract is firm-fixed price, valued at $2,130,654, covering a base period plus four option years (FY 2027-2031) - The procurement supports statutory requirements for interoperable post-acute care assessment data, as mandated by the Social Security Act and IMPACT Act - The project also supports the Quality Improvement Organizations Program by linking assessment data to standardized health IT terminologies (LOINC, SNOMED-CT) - Only the Regenstrief Institute can provide these services due to proprietary rights and copyright - Previous contracts for similar services were awarded to Regenstrief for FY 2016-2021 and 2021-2026 - No product quantities or part numbers are specified, as the work is service-based and involves ongoing code creation and maintenance

Description

This purpose of this request is for a new Sole Source contract entitled “Logical Observation Identifiers Names and Codes (LOINC) for Assessment Data Elements” to create and update standardized identifiers in the Data Element Library. Developed by the Regenstrief Institute, LOINC codes enable consistent naming and identification to primarily health measurements, laboratory tests, clinical observations, document types, and assessment data in electronic health records for interoperability. This initiative aligns with Section 1899B of Title XVIII of the Social Security Act and the IMPACT Act of 2014, which mandate standardized, interoperable PAC assessment data elements to facilitate coordinated care and improved outcomes. These codes support the standardization of data elements within electronic health records (EHRs), to support the interoperable exchange of information, including assessment information. Additionally, Section 4125(b)(1) of the Consolidated Appropriations Act, 2023 (CAA, 2023) amended section 1886(s)(4) of the Social Security Act to require Inpatient Psychiatric Facilities (IPFs) participating in the IPF Quality Reporting Program to collect and submit standardized patient assessment data, using a standardized patient assessment instrument. The IPF Patient Assessment Instrument (IPF-PAI) has been developed and intended to be implemented in a way to support interoperable exchange of data. Of additional significance, this project supports the administration of the Quality Improvement Organizations Program (QIO). The Social Security Act, outlined in Part B of Title XI - Section 1862(g), established the Utilization and Quality Control Peer Review Organization Program, now known as the Quality Improvement Organizations Program. The statutory mission of the QIO Program is to enhance the effectiveness, efficiency, economy, and quality of services provided to Medicare beneficiaries. By linking assessment data elements to standardized health IT terminologies and code sets such as LOINC and SNOMED-CT, CMS provides post-acute and other healthcare providers with critical health IT infrastructure components necessary for exchanging, sharing, and reusing assessment content and other health information. Quality Improvement Organizations (QIOs) can leverage this interoperable assessment content to support quality measurement, care coordination, and performance improvement initiatives throughout the healthcare environment.

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