Letter of Intent.pdf

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Medicare & Medicaid Services

7500 Security Boulevard, Mail Stop B3-30-03

Baltimore, Maryland 21244-1850

OFFICE OF ACQUISITION AND GRANTS MANAGEMENT

DATE: June 16, 2026

FROM: Issuing Contracting Office:

Centers for Medicare & Medicaid Services (CMS)

Office of Acquisition and Grants Management (OAGM)

7500 Security Boulevard

Baltimore, Maryland 21244

Point of Contact:

Scott Filipovits

Contracting Officer

Phone: 410-786-5779

Email: Scott.Filipovits@cms.hhs.gov

SUBJECT: Solicitation No. 75FCMC26R0050 Logical Observation Identifiers Names and

Codes (LOINC) for Assessment Data Elements

NOTICE: NOTIFICATION OF INTENT PENDING AVAILABILITY OF FUNDS

This acquisition is being conducted on a sole-source, other than full and open competition basis pursuant to:

FAR 6.302-1(a)(2) - Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements

When the supplies or services required by the agency are available from only one responsible source and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for. A Justification for Other Than Full and Open Competition

(JOFOC) has been prepared and approved in accordance with applicable regulatory requirements.

Basis for Authority:

Market research has confirmed that Logical Observation Identifiers Names and Codes (LOINC) is a proprietary nomenclature developed, maintained, and copyrighted exclusively by the

Regenstrief Institute. As required by the IMPACT Act, CMS must link assessment data elements to accepted health IT standards, including LOINC. Additionally, Section 4125(b)(1) of the mailto:Scott.Filipovits@cms.hhs.gov https://calm.cms.gov/suite/sites/calm-home/page/home/record/g_1llPPZlznPVjinHOEw6TSVgEaKkyjBVMJ2RR6rOEGsDrZNWMApN0k_1qMZGJmW2mL0HMuTaGlErMotgKCcAsZIAHdWHydzCNa3PoRloi4CnbYO6k_9HJ_700dyLepvKUgBZWV71f2/view/summary

Consolidated Appropriations Act, 2023 (CAA, 2023) amended Section 1886(s)(4) of the Social

Security Act, requiring Inpatient Psychiatric Facilities (IPFs) to collect and submit standardized patient assessment data using a standardized instrument. There are no other acquisition sources or in-house alternatives. Any other solution would result in substantial duplication of costs and unacceptable delays.

Intended Sole-Source Contractor:

Regenstrief Institute, Inc.

1101 W. Tenth Street

Indianapolis, IN 46202-4800

Phone: 317-274-9000

CMS intends to award a Firm Fixed Price (FFP) Contract to Regenstrief Institute, Inc. for the continuation of services supporting the standardization and interoperability of assessment data elements as required under the IMPACT Act and related legislation.

The IMPACT Act requires that CMS make certain assessment data elements standardized and interoperable so that this data may be exchanged and used by post-acute care and other providers to support care coordination and improved beneficiary outcomes. In making data element elements interoperable, CMS must link assessment data elements to certain accepted health IT standards, including LOINC. LOINC is a proprietary nomenclature developed and maintained by

Regenstrief. Regenstrief holds the copyright for LOINC. Therefore, Regenstrief is the only organization capable of maintaining and extending LOINC in order to meet HHS and other

Federal agency requirements, including CMS requirements to link LOINC to assessment data elements. 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.

There are no other acquisition sources or in-house alternatives.

Any vendor that believes it is capable of fulfilling all requirements of this effort in their entirety is invited to submit a written capability statement or written objection to this intended sole-source award no later than:

Date: June 23, 2026

Time: 11:00 AM Eastern Standard Time (EST)

All responses must be submitted in writing to the Contracting Officer identified above. Oral communications will not be accepted. Capability statements must clearly demonstrate the vendor's ability to meet all requirements, including the maintenance and extension of LOINC as a proprietary, copyrighted health IT standard.

CMS is not committed to reimburse any costs associated with the preparation or submission of a proposal nor to procure or contract for the services described herein. In addition, the Contracting

Officer is the only individual who can legally commit the Government to the expenditures of public funds in connection with the proposed procurement.

Sincerely, Scott Filipovits

Contracting Officer