The OASIS is a data collection instrument designed to measure adult, non-maternity patient outcomes in the home health care setting. The data elements "represent core items of a comprehensive assessment for an adult home care patient; and form the basis for measuring patient outcomes for purposes of outcome-based quality improvement (OBQI)."96 While the primary objectives of creating the OASIS were to support both systematic collection of data and quality improvement initiatives to benefit HHAs and their patients, secondary objectives were to meet the needs of payers, regulators, and the government.
OASIS data must be collected on all home health patients at the initial visit and at certain other episodic and periodic time points, including time of discharge.97 The complete OASIS assessments must be electronically transmitted within 30 days of assessment completion date to the state health agency (or Medicare contractor) for storage in an electronic database, and are then forwarded to the CMS.
CMS makes available free software (HAVEN) which Medicare and Medicaid HHAs may use to electronically transmit MDS assessments.98
CMS expects to continue to collect data using OASIS for the foreseeable future, but indicates that priorities like pay for performance, standardizing assessment and quality measurement, integration of measures of process and systems, and EHRs may impact future use of OASIS.99
Regulatory Background (100)
Since mid-1999, the CMS and its predecessor agency, the HCFA have required all certified HHAs to systematically use the OASIS to measure functional status and medical conditions of Medicare beneficiaries receiving home health care and to send assessment data to a central repository. The Conditions of Participation for Home Health Agencies were revised in 1999 to reflect the regulation first published in the Federal Register (64 FR 3764) that stated each patient must receive from the HHA a "patient-specific, comprehensive assessment that accurately reflects the patient's current health status and includes information that may be used to demonstrate the patient's progress toward achievement of desired outcomes. The comprehensive assessment must identify the patient's continuing need for home care and meet the patient's medical, nursing, rehabilitative, social, and discharge planning needs." (CFR 42 §484.55). The Conditions of Participation also require that the comprehensive assessment "incorporate the use of the current version of the OASIS items, using the language and groupings of the OASIS items, as specified by the Secretary." (CFR 42 §484.55).
A second rule, published concurrently with the initial regulations requiring the use of OASIS, provided guidelines for the electronic transmission of the OASIS data set, set out the responsibilities of the state agency or HCFA Medicare contractor in collecting and transmitting the information to HCFA, and set forth rules concerning the privacy of patient identifiable data generated by OASIS, all of which were required in order to create a PPS for HHAs.
Since October 2000, OASIS data has served as the basis for the PPS for reimbursing home health services. Since 2003, data collected through the OASIS instrument have been used by CMS to support home health care quality initiatives. OASIS data are also used by CMS to assess compliance with the Pay for Reporting requirements of the DRA of 2005. CMS views the use of the same data to support both quality monitoring and payment as their way of ensuring HHAs are not maximizing reimbursement at the expense of quality outcomes. In March 2009, CMS published a request for comments in the Federal Register regarding the use of a revised OASIS, and in July 2009 received the OMB approval to use OASIS-C. In August 2009 CMS published the final rule which established January 1, 2010 as the required date for HHAs to begin using OASIS-C.
Creation and Development of OASIS
In the late 1980s, the HCFA, along with the Robert Wood Johnson Foundation and later the New York State Department of Health, provided funding to the Center for Health Services and Policy Research at the University of Colorado to assess the feasibility and usefulness of measuring the outcomes of home health care.
The OASIS data set, which allowed HHAs who were already collecting assessment data to do so in a more precise form, was developed over a period of years. The original 73-item data set was first published in a report by the Research Center in 1994. The data set has gone through several iterations of expanding and refining since then, as it was anticipated at the time of initial implementation that OASIS would evolve to reflect changes in quality measurement, health research, health policy, reimbursement, and standards of care. Shortly after the data set was first published, a task force of home care experts convened by HCFA reviewed the items and recommended additional items considered essential for patient assessment. In 1995, incorporating input from the task force, the Research Center revised and rearranged the items into a data set that was called OASIS-A. This data set was used and tested in two demonstration programs in 1995 and 1996. The demonstration programs suggested select refinements which resulted in OASIS-B. Subsequently, OASIS-B was modified slightly to take into account HCFA's needs for data management and administration. The version containing these modifications was released in 1998 and was referred to as OASIS B-1. Further revisions were made to OASIS B-1 in 2007 to support the revised PPS effective January 1, 2008.
As of December 31, 2005, the Colorado Outcome Reporting and Enhancement (CORE) Research Partnership, which appears to have been an extension of the Research Center's (now the Center for Health Services Research) work with OASIS, ceased operations.101
Development of modifications to the OASIS-B1 instrument began in 2005 following input from a variety of stakeholders that included industry feedback, recommendations from the National Quality Forum (NQF), and an expert panel who identified best practice process measures. In September 2006, CMS contracted with Abt Associates and subcontractors from the University of Colorado Health Sciences Center and Case Western University to help CMS refine the OASIS data set.102 Earlier recommendations, along with a major effort to align OASIS measures with those of other assessment instruments, including the Minimum Data Set (MDS) and the Continuity of Care Record Evalution (CARE) tool, formed the basis of the OASIS revisions. CMS viewed the revision as an opportunity to address quality of care across the health care continuum as patients moved among health care settings.
OASIS-C testing was completed in 2008 and a revised instrument revision posted in November 2008. After a comment period that ended in January 2009, a revised final version was submitted to the OMB in compliance with the Paperwork Reduction Act, and after receiving OMB approval, posted to the CMS web site August 12, 2009.103
Intellectual Property Issues
Prior to 2008, rights to the OASIS instrument were retained by the Center for Health Services and Policy Research in Denver, Colorado. The Research Center, however, granted the right to use the OASIS tool freely, as evidenced by the copyright notice on the CMS web site,104 and previous agreements that were reached with the NLM105 and LOINC.106
The OASIS implementation manual was originally developed in 1999 and has been revised several times to reflect changes to the OASIS data set. A revised manual was released in September 2009 as part of the project to upgrade the instrument to OASIS-C.
The designation for the OASIS in the UMLS is LNC221_OASIS_2002 -- the OASIS. The owner of the data set is the University of Colorado Center for Health Services Research (UCHSC) in Denver, Colorado. Contact information for the OASIS is Andrew Kramer, MD at UCHSC. Use of the OASIS through the UMLS is subject to category 3restrictions, referenced in the section on the MDS, above.
The OASIS is also represented in the LOINC database. The text of the agreement concerning third party content in the LOINC database is referenced in the section on the MDS, above.
RELMA provides the following language concerning the OASIS copyright claim:
RIGHT TO COPY, REPRINT, AND USE OASIS.
The Outcome and ASsessment Information Set (OASIS) is the intellectual property of the Center for Health Services Research, Denver, Colorado, and may not be copyrighted by any other party. It is our intent to permit the free use of OASIS by home care providers and related organizations, businesses, and individuals, to be incorporated into patient or client assessment forms or software. To this end we grant all such organizations or individuals the nonexclusive right to copy or reprint the contents of the OASIS and to incorporate OASIS items into printed forms, software, or other products. No royalty or use fee is required, but acknowledgement of authorship is expected.107
As of late 2007, Copyright information on the CMS OASIS web site indicated that OASIS B-1 was now in the public domain. Copyright information on the CMS web site reads: "The Outcome and ASsessment Data Set (OASIS) B1 (1/2008) is in the public domain and may not be copyrighted. No permission is needed to copy and use the data set." Similar text is in the OASIS Implementation Manual: Appendix B, dated January 2008.108 There is no information with regard to copyright and OASIS-C on the CMS web site, and the issue is not addressed in the OASIS-C guidance manual.
CMS requires that state health agencies transmit encoded OASIS data in a format conforming to the CMS standard electronic record layouts, edit specifications, and data dictionary. The HAVEN system, developed by CMS, supports the data transmission requirements, but other software programs conforming to CMS requirements have also incorporated OASIS into their programs for the purpose of transmitting the data to CMS. There is no indication IP issues were ever a barrier.
Samples of paper assessment forms sold by the Briggs Medical Services Company over the years claim copyright to the forms, but also note that the OASIS data set is the IP of the Center for Health Services and Policy Research, and was being used with permission.109