Additional discussions and research may provide further insight into the various IP issues addressed above. Conversations with the leadership at the NLM, the Regenstrief Institute, the interRAI consortium, UDSMR®, and the Center for Health Services Research at the University of Colorado, may prove helpful for future development and standardization of federally-required assessment instruments. It would be instructive to understand how the Regenstrief Institute was able to address interRAI’s international licensure constraints when incorporating the MDS into LOINC and whether any other IP issues remain in applying and disseminating accepted HIT standards to MDS patient assessments. Further, these conversations could shed light on issues that will likely be faced should there be an effort to apply CHI standards to the IRF-PAI. These discussions maysuggest useful steps that could be taken to minimize or eliminate IP issues in the development of future assessment instruments.
The terms of past contracts under which assessment instruments and related documentation were developed may inform how future contracts could be written so that data collection instruments developed for government use remain in the public domain. In particular, incorporating the "special works" clause of the Federal Acquisitions Regulations (FAR) into contracts would give the government the ability to limit the contractor's rights to claim ownership in content first produced through the contract. It would also allow the contracting agency to direct the contractor to establish a copyright claim and assign the copyright to the government, which would give the government unlimited rights in how the instruments are released and used.181
Preliminary conversations indicate that CMS is fully aware of many of the issues that can arise when federally-required assessment instruments are not freely available in the public domain, including concerns that IP claims may constrain the application of HIT standards to these instruments and limit the dissemination of HIT-enabled standardized assessments. Obtaining guidance from those with expertise in applying and disseminating CHI-accepted standards to current assessment instruments developed under federal contracts or grants will facilitate the application and dissemination of HIT standards to emerging assessment instruments, and support the goal of health information exchange and system interoperability.
A number of organizations have commented to CMS on the non-interoperable nature of the specifications for the electronic transmission of patient assessment data, and have recommended that code formats be consistent across the various assessment instruments, encouraging CMS, for example, to adopt the HL7 Patient Assessment Questionnaire and Clinical Document Architecture (CDA) instead of using a custom-designed data transmission tool, stating “Rather than developing a custom based data transmission process,… CMS [should] reevaluate the benefits and usage of CDA for the MDS 3.0 including the applicable content standards (LOINC and SNOMED-CT).182
Efforts are underway to create a system for all PAC assessments using consistent terminology. The instrument being developed is the CARE which aims to harmonize data elements across the three assessment tools CMS currently requires. The National Quality Forum is also calling for harmonization of assessment items in the areas they are addressing as part of their quality initiatives.
A major piece of legislation from 2009 with broad implications for health care delivery and health information exchange was the ARRA, also known as the “stimulus bill.” Provisions in the HITECH section of the Act address incentives for the adoption of HIT by health care providers. Although care assessments are not addressed specifically in the wide-ranging act, the Act is likely to significantly impact health information exchange and the use of certified EHRs. The stimulus plan provides significant funding for EHR adoption by some healthcare providers. While ARRA's definition of health care providers includes SNFs, nursing facilities, home health entities and other LTC facilities, these providers are not yet slated to receive the same incentive payments physicians and hospitals will be eligible for if they are able to demonstrate "meaningful use" of HIT. However, with the ONC investigating how to expand HIT adoption incentives to other providers and industry movement towards certification of PAC electronic records, significant opportunities exist to leverage federally mandated functional assessment tools to drive the interoperability required in the stimulus bill. Standardizing the data sets in these assessments is an important first step towards achieving that interoperability.
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