In 2007, the Office of the Assistant Secretary for Planning and Evaluation (ASPE) of the U.S. Department of Health and Human Services (HHS) contracted with the AHIMA Foundation to perform several activities related to standardizing federally-required post-acute care (PAC) assessments to support interoperable health information exchange. A primary goal of the project was the application of health information technology (HIT) standards adopted by the Consolidated Health Informatics (CHI) Initiative to two of the assessment tools currently mandated by the Centers for Medicare and Medicaid Services (CMS) for reimbursing PAC. These instruments are:
- the Resident Assessment Instrument (RAI), including the Minimum Data Set (MDS), used in nursing facilities, and
- the Outcome and ASsessment Information Set (OASIS), used by home health agencies (HHAs).
These two instruments, along with the Inpatient Rehabilitation Facility Patient Assessment Instrument (IRF-PAI), used by CMS for payment in inpatient rehabilitation facilities (IRFs), are standard data collection tools for particular care settings, designed to collect and submit information to CMS according to the agency's electronic submission requirements. The data collected, however, are not comparable across settings, are not standardized using interoperable vocabularies in support of health information exchange, require different and sometimes proprietary formats for reporting based on care setting, and frequently do not interface with a patient’s electronic health record (EHR).
The CHI Initiative, which was transferred to the Federal Health Architecture (FHA) within the Office of the National Coordinator for Health Information Technology (ONC) in 2006, was an effort to establish messaging and vocabulary standards allowing federal agencies to exchange information efficiently and effectively in order to provide better care and lower administrative costs. CHI standards were considered for use through the public/private processes of the Healthcare Information Technology Standards Panel (HITSP), convened by the American National Standards Institute (ANSI) in 2005 under contract to HHS to administer ONC's standards harmonization initiative.
In 2006, the CHI recommended for adoption, across the federal health enterprise, HIT standards defining requirements for exchanging and reusing standardized, federally-required patient/client assessments for functioning and disability. These recommended standards were subsequently approved by the National Committee on Vital and Health Statistics (NCVHS) and the Secretary of the HHS, and forwarded to ONC. The adoption of the CHI-endorsed standards for disability and patient assessment (along with ones for allergy and multi-media) in federal HIT systems was announced in a Federal Register notice published in late 2007.a
The purpose of the specific project task addressed in this report was to explore the intellectual property (IP) issues associated with the three assessment tools mandated by CMS for PAC reimbursement, investigate the implications of disseminating CHI-standardized MDS, OASIS and IRF-PAI assessment data sets, and develop recommendations for the future dissemination of HIT-encoded instruments.
IP issues with respect to these three assessment instruments vary as to the degree of restriction placed on the use of the data sets and tools within them. All three data sets were initially created with the aid of grant or contract money from the U.S. government. The developers of these data sets claim, or have in the past claimed, some ownership in the assessment instruments. Although work created under grant from or contract with the U.S. government can be copyrighted by the award recipient, government agencies generally reserve the right to use the work for government business, and to authorize others to do so.b
The RAI/MDS is in the public domain, but only in the United States. Version 2.0 of the RAI/MDS, currently in use, was developed by the Hebrew Rehabilitation Center for Aged (HRCA) under a contract with the Health Care Financing Administration (HCFA), predecessor to the CMS. Lead authors on the 1995 edition of the User's Manual for the RAI version 2.0 were from HRCA and HCFA.c The 2002 update to the User's Manual for 2.0 appears to have originated within CMS. A number of individuals are acknowledged, many of whom appear to have been members of the MDS Coordinating Team within CMS.d Outside of the United States, the interRAI Association, a group of researchers in the field of long-term health care, claim the copyrights to version 2.0 of the RAI/MDS. InterRAI registered the copyright to the 1995 edition of the user manual for version 2.0, although they allow it to be used and copied freely within the United States. Version 3.0 of the MDS, currently scheduled for implementation in October 2010, represents a major revision to the assessment tool. This version appears to have originated within CMS, with considerable input from outside experts in long-term care (LTC) issues. The tool was evaluated and validated through a contract with the RAND Corporation, with principal investigators from RAND and the Harvard Medical School Department of Health Care Policy. The final version of the MDS 3.0 item set and data specifications were published by CMS in October 2009. Parts of the RAI manual for version 3.0 were published in November 2009 with the complete manual expected to be available in early 2010.e While CMS has reported there will be no restrictions on the use of the MDS 3.0 and accompanying tools for the purpose of reporting to assessment data to CMS, it is unclear whether other IP issues might arise. Two screening tools that are integrated into MDS 3.0 are copyrighted. The Regenstrief Institute has received permission from the copyright holder of the Confusion Assessment Method (CAM) tool to incorporate that tool into the Logical Observation Identifiers Names and Codes (LOINC) database, and has previously worked with Pfizer in order to incorporate the Patient Health Questionnaire (PHQ) depression scales into LOINC.f
Early versions of the OASIS (OASIS A, B, B-1) were developed by the Center for Health Services and Policy Research at the University of Colorado with funding from HCFA, the Robert Wood Johnson Foundation, and later the New York State Department of Health. Prior to 2008, rights to the OASIS instrument were retained by the Center for Health Services and Policy Research. As of late 2007, the OASIS data set had moved into the public domain, and permission to copy or use was no longer required. CMS contracted with Abt Associates and subcontractors at the University of Colorado Health Sciences Center and Case Western Reserve University in 2006 to revise the OASIS data set, resulting in OASIS-C, which HHAs began using in January 2010.g While it appears there are no longer any IP issues attached to the OASIS data set itself, some of the tools available, but not required, for use with OASIS-C are copyrighted, in particular the Pfizer PHQ depression scales.h As mentioned in relation to the MDS, Regenstrief Institute has worked with Pfizer in the past to secure permission to use the PHQ screening tools in LOINC.
MDS and OASIS data sets currently in use are available through the Unified Medical Language System (UMLS) of the National Library of Medicine (NLM) and Regenstrief Institute's LOINC database. There are slight differences in the license agreements for using these two instruments through the UMLS, primarily related to the additional restrictions placed on the use of the RAI/MDS outside of the United States. The copyright claims to the MDS and OASIS data sets as represented in LOINC are spelled out in the RELMA (Regenstrief LOINC mapping assistant). The versions of MDS and OASIS in the UMLS Metathesaurus are extracted from LOINC and not necessarily an exact representation of the original source. Since MDS and OASIS are updated in each Metathesaurus release along with LOINC, it is expected that MDS 3.0 and OASIS-C will be available when the version of LOINC containing the new versions of OASIS and MDS is available.i
The IRF-PAI was developed and validated through a combination of government grants, contracts, and license agreements with the University of Buffalo Foundation Activities, Inc. (UBFA) and the RAND Corporation. HCFA contracted with RAND to evaluate the feasibility of using the Functional Independence Measure (FIMj) as the foundation piece for the prospective payment system (PPS) for IRFs. UDSMR®, a division of UBFA, claims exclusive ownership of the Functional Independence Measure (FIM), the core of the IRF-PAI, trademark rights to FIM®, and compilation rights to the IRF-PAI training manual.k Due to UDSMR®ownership claims, anyone other than a facility subject to the Medicare payment system who wishes to use the IRF-PAI can only do so through a license agreement with UDSMR®. The FIM has not been incorporated into either the UMLS or LOINC.
Both interRAI and UDSMR® have created assessment instruments for additional PAC settings, and are clearly aware of government mandates to utilize instruments that can work across multiple settings. Also, the recent revision of the OASIS data set was undertaken in part so that the data collected are more in alignment with the assessment data collected in other PAC settings. Given additional mandates arising out of the CHI Initiative, particularly the one requiring future federalhealth information acquisitions be based on CHI standards, instrument developers may be interested in participating in HIT standardization activities in order to remain relevant as the movement toward interoperability and standardization continues to gather steam.
CENDI Copyright Task Group. (2002). Frequently Asked Questions About Copyright: Issues Affecting the U.S. Government. Oak Ridge, TN: CENDI Secretariat, Information International Associates, Inc. Retrieved from http://www.cendi.gov/publications/04-8copyright.html#41.
CHI (2006). Standards Adoption Recommendation -- Functioning and Disability. Accessed January 2008 at http://www.ncvhs.hhs.gov/061011p2b.pdf.
HHS. "Additional Consolidated Health Information (CHI) Health Information Technology Standards" 72 Federal Register71413-14 (December 17, 2007). Accessed January 2008 at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-6058.htm.
Kramer, Andrew, et al. Case Studies of Electronic Health Records in Post-Acute and Long-Term Care. (Washington, DC: HHS, ASPE, Office of Disability, Aging and Long-Term Care Policy, 2004. Accessed January 2008 at http://aspe.hhs.gov/daltcp/reports/ehrpaltc.htm.
Wark, Cynthia G., et al. "Government Issue: CHI Lays the Groundwork for Federal Data Exchange." Journal of AHIMA75, No.8 (September 2004): 36-38. PubMed link http://www.ncbi.nlm.nih.gov/pubmed/15455567.
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