Opportunities for Engaging Long-Term and Post-Acute Care Providers in Health Information Exchange Activities: Exchanging Interoperable Patient Assessment Information. Intellectual Property Issues and Mandated Assessment Instruments

12/01/2011

The primary intent of this report is to review known IP issues that may affect the ability to use assessment instrument content in an increasingly interoperable environment. Developers or contributors to portions or all of the three PAC assessment instruments under review, the MDS RAI, the OASIS, and the IRF-PAI, claim or have in the past claimed ownership to all or parts of these instruments. Typically, the developers copyrighted the instrument to maintain the quality and integrity of the instrument and the data derived there from, although as these instruments have become integral to reimbursement mechanisms, financial interests may also have played a role. Though likely not with outright intent, instrument developers have employed a two-pronged strategy in encouraging acceptance and then reliance on the instrument, first to promote the use of the instrument as being the most appropriate for the required use, and then to protect the instrument from unauthorized use, either for financial or quality control issues. This continues to hold true with the developers of the MDS/RAI 2.0 and the IRF-PAI.

Although there has been some momentum towards a single comprehensive assessment tool,23 it is unlikely one will be developed, approved, and implemented in the near term that will completely replace all of the content in the existing instruments. Therefore the need exists to apply HIT standards to the setting-specific assessment data sets currently mandated by CMS. Since third party claims of ownership to all or part of these assessment instruments will likely persist, questions have arisen about the ability and inclination of standards development organizations (SDOs) to link HIT codes to assessment content without first settling the ownership issues and reconciling the IP issues. There are further questions, if HIT codes are linked to legitimately-copyrighted assessment content, as to whether and under what conditions or restrictions the coded assessment content can be disseminated.

It is not clear to what extent simply associating HIT codes with assessment content would constitute an infringing activity under the copyright laws. The copyright owners may argue that the creation of this association in and of itself is a derivative work, which only the copyright owner would have the right to create. In addition, dissemination of HIT coded assessments by a standard setting entity may infringe upon the copyright of an assessment instrument that a third party claims to own, because it could violate the copyright owner’s exclusive right to reproduce, distribute and prepare derivative works based on the assessment instrument.

It also is not clear that claims to exclusive rights to some of the content of these instruments, or the instruments themselves, are always entirely legitimate, as IP issues are frequently complex. However, if non-government ownership of assessment instrument content is established, before undertaking the process of linking HIT codes to assessment content, standard setting entities may need to negotiate agreements and/or licenses with the owners of the assessments to lawfully distribute the HIT codes. Some of these issues have been addressed previously by the NLM in relation to the UMLS. A post on the Integrating the Healthcare Enterprise (IHE) collaborative web site (wiki) asserted that “UMLS is aware of the IP issues and challenges in general, and is exploring ways to address them.”24

It is evident that the creators or developers of all or parts of the MDS/RAI and the IRF-PAI are cognizant of the goal of having an assessment instrument that works across care settings, as both are developing additional, but compatible assessment instruments for use in settings other than that for which their assessment instrument is currently mandated. Carl Granger, representing UDSMR in comments to CMS regarding the adoption of the Continuity Assessment Record and Evaluation (CARE) tool [72FR55225, September 28, 2007], suggests CMS should consider that “using the AlphaFIM® instrument in acute care settings, the FIMTM instrument in SNF, IRF, and LTCH settings, and the OmegaFIMTM instrument (augmented with the LIFEwareSM System) in HHAs would be a more appropriate choice.”25 Brant Fries, president of interRAI, in testimony before the National Commission for Quality in Long-Term Care, promoted the use of the assessment system created by interRAI, covering most of the LTC settings, including “frail elderly in the community, home care, assisted living, nursing homes, post-acute care, (for example, rehabilitation hospitals), palliative care, acute care, and inpatient and community-based mental health; with additional systems underway for intellectual disability and younger persons with disabilities.”26

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