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

12/01/2011

The copyright notice for RAI/MDS 2.0 on the CMS web site states: “Please note that InterRAI [sic] holds the copyright to Version 2.0 of the RAI for long-term care outside of the US. Therefore, this revised Version 2.0 of the RAI/MDS manual should not be reproduced outside of the United States without permission of InterRAI [sic]. Within the US, Version 2.0 is in the public domain.”72

The RAI/MDS Version 2.0, currently in use, and related training materials were developed by the HRCA under a contract with HCFA. Lead authors on the 1995 edition of the User's Manual for Version 2.0 were John N. Morris and Katharine Murphy from HRCA and Sue Nonemaker from HCFA.73 The 2002 and 2007 revisions to the User's Manual for Version 2.0 appear 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.74

IP issues with respect to the RAI/MDS are complicated because the assessment instrument and data set have always been considered to be in the public domain, but only in the United States. Beyond United States borders, interRAI claims rights to version 2.0 of the RAI and MDS, and use of the RAI/MDS requires a license agreement with interRAI. IP issues are futher complicated by the fact that the 1995 edition of the user's manual for version 2.0, written for and with HCFA, has been copyrighted by interRAI with the U.S. Copyright Office, which is unusual for a work considered to be in the public domain.

InterRAI is an international consortium of researchers in the area of LTC systems, formed in 1992, whose aim is to use MDS data to study LTC in individual countries and to enable cross-national comparisons.75 Brant Fries, a founding member of interRAI and an investigator for the HCFA contracts, described interRAI in testimony before the National Commission for Quality Long-Term Care in 2005:

Let me say a few words about interRAI, and then about what it has developed. interRAI is a cross-national collaboration of 47 expert clinicians, researchers and policy-makers from 26 nations spanning the globe. We develop assessment systems that can accomplish the tasks I have been describing. As a non-profit corporation that holds the copyrights, interRAI gives its assessment systems for free to any government or caregiving organization around the world.76

The interRAI web site indicates that use is granted freely to government agencies worldwide. However, issues concerning use of the MDS outside of the United States, including barriers, were addressed in a 2003 Milbank Memorial Fund report, entitled Implementing The Resident Assessment Instrument: Case Studies Of Policymaking For Long-Term Care In Eight Countries. This report made it clear that "free" did not necessarily mean unhindered. Regarding Ontario, Canada, the report indicated there were a variety of factors that made introducing MDS 2.0 a challenge, including the fact that there was not a “pre-existing working relationship with interRAI, the international research group that developed and owns the rights to the MDS." Also, the government had mandated that data be submitted electronically, “but interRAIhad not licensed any software vendors to sell MDS software in Canada." About Japan, it was written: "The fact that the MDS items were protected by copyright presented another hurdle to the adoption of an MDS-based instrument. The government would have had to negotiate with interRAI if any changes had been necessary, which the government was unwilling to do." The Japan report goes on to say: "If MDS items had been used in the assessment form, they would have been embedded in the LTCI [long-term care insurance] and integrated with care planning. This might have been possible if interRAI had adopted a more flexible attitude toward the copyright issue, because the government’s concern lay in maintaining a free hand in negotiation rather than actually making substantive revisions." In Spain, Spanish translations were completed, software was created to support the data collection needs, and “the software company formalized a contract with interRAI to produce and distribute RAI-NH software commercially." In Italy, the pharmaceutical company Pfizer obtained an interRAI license for the RAI for home care, and financed its “translation, computerization, and implementation.”77

Fairly extensive copyright and licensing information for use of the set of RAI instruments is provided on the interRAI web site.78 InterRAI claims copyright to version 2.0 of the RAI/MDS outside of the United States, and a set of additional assessment instruments, presumably both within and outside United States borders. The interRAI web site lists these major clauses as part of their royalty-free license agreements:

  • the instrument is not to be changed substantially (excepting individual identifiers and demographics);
  • the license is limited to non-commercial use (i.e., the instrument will not be incorporated into products to be sold to others);
  • no royalties will be charged;
  • the organization will make appropriate efforts to inform others of the copyright status of the instrument;
  • interRAI's logo and copyright notice are to appear on the form;
  • authors, author institutions, and translators (as appropriate) are to be acknowledged in any document where authors would regularly be indicated (e.g., publication of a training manual);
  • publication of any training manual is limited to the period until a commercially-published version is available;
  • data from use of the instrument are to be shared with interRAI, subject to existing laws on confidentiality.79

Licensing for commercial use generally requires that royalties be paid to interRAI. All of the clauses that apply to royalty-free licenses apply to licenses for commercial use as well, although interRAI indicates they may omit the requirement that data collected using the instrument be shared with interRAI.

InterRAI’s policies concerning collaboration and instrument development include willingness in “contract negotiations to acknowledge the participation of individuals or organizations which have played a substantial role in getting the instrument to the point of implementation.”80 InterRAI and the Ontario Joint Policy and Planning Committee, a partnership of the Ontario Ministry of Health and Long Term Care and the Ontario Hospital Association, collaborated, beginning in 1996, on a RAI for mental health (RAI-MH). A research team based in Ontario led the effort. Those two organizations share copyright ownership with interRAI for that particular instrument, and use without additional license agreement in Canada is allowed. The copyright notice for that instrument reads: “The RAI-MH is a copyrighted instrument that is owned jointly by the Ontario Ministry of Health, the Ontario Hospital Association, and interRAI.”81

The other instruments in the suite of data collection tools for assessing across the continuum of care, for example home care, assisted living, palliative care, and acute care, appear to be solely the IP of interRAI, and their use subject to licensing agreements with interRAI. InterRAI has promoted the complete set of assessment instruments as suitable for assessing all PAC patients.82

Since publication of the Milbank report, Canada, or at least the province of Ontario, appears to have developed a close working relationship with interRAI. A number of assessments from the interRAI suite are used in Canada, and three have been adopted by the Canadian Institute for Health Information (CIHI) as national standards,83 with interRAI retaining ownership rights. On the CIHI web site, interRAI’s ownership of MDS 2.0 is prominently displayed. Manuals for RAI MDS 2.0 and RAPs Canadian Version: User’s Manual are available electronically for free downloading from the web site for LTC facilities, but must be ordered.84 Samples of other copyright notices from English-speaking countries using the RAI are available on the interRAI web sites from the United Kingdomo, Australiap, and Hong Kongq.85

IP issues with respect to the MDS are known to the NLM and the Regenstrief Institute, the owner of Clinical LOINC, an HL7-approved coding system for observation identifiers and a CHI-endorsed standard for federally-required assessment forms.86 The NLM and Regenstrief have negotiated with, presumably, interRAI, to incorporate MDS 2.0 into LOINC and the UMLS. Contact information for MDS 2.0 in the UMLS does not mention interRAI, but instead names Brant Fries at the Institute of Gerontology of the University of Michigan, who is also president of the interRAI consortium.

The designation for the MDS in the UMLS is LNC_MDS20 -- Minimum Set 2.0, Institute of Gerontology, University of Michigan, 300 North Ingalls, Ann Arbor, Michigan 48109-2007 USA. Use of the MDS 2.0 through the UMLS is subject to category 3 (for non-United States users) and category 4 (for United States users) restrictions, as outlined below:

Category 3:

LICENSEE's right to use material from the source vocabulary is restricted to internal use at the LICENSEE's site(s) for research, product development, and statistical analysis only. Internal use includes use by employees, faculty, and students of a single institution at multiple sites. Notwithstanding the foregoing, use by students is limited to doing research under the direct supervision of faculty. Internal research, product development, and statistical analysis use expressly excludes: use of material from these copyrighted sources in routine patient data creation; incorporation of material from these copyrighted sources in any publicly accessible computer-based information system or public electronic bulletin board including the Internet; publishing or translating or creating derivative works from material from these copyrighted sources; selling, leasing, licensing, or otherwise making available material from these copyrighted works to any unauthorized party; and copying for any purpose except for back up or archival purposes.

LICENSEE may be required to display special copyright, patent and/or trademark notices before displaying content from the vocabulary source. Applicable notices are included in the list of UMLS Metathesaurus Vocabulary sources, that is part of this Agreement.

Category 4:

LICENSEE is prohibited from translating the vocabulary source into another language or from altering the vocabulary source content. 12.4.2. LICENSEE's right to use the vocabulary source is restricted to use in the United States by LICENSEE's employees, contractors, faculty, students, clients, patients, or constituents within electronic systems or devices built, purchased, licensed, or used by LICENSEE for United States governmental purposes or for any health care, public health, research, educational, or statistical use in the United States. Use by students is limited to research or educational activities under the direct supervision of faculty. 12.4.3. LICENSEE has the right to distribute the vocabulary source in the United States, but only in combination with other UMLS Metathesaurus content. Further, LICENSEE's right to distribute is restricted to: 1. Electronic distribution to LICENSEE's direct United States affiliates, or to other United States entities that have signed the UMLS license, in order to facilitate use of the vocabulary for health care, public health, research, educational or statistical purposes in the United States only. 1. LICENSEE must take reasonable precautions to prevent distribution of the vocabulary source to non-US entities. 2. LICENSEE must include in its annual report a list of all United States affiliates or other United States entities to whom it has distributed content from the vocabulary source. 2. Distribution of encoded patient level data sets or knowledge encoded in the vocabulary source by LICENSEE to any United States entity for use in the United States only. 3. Inclusion of encoded records or content from the vocabulary source in: (1) free publicly accessible retrieval systems or (2) fee-based retrieval systems that are accessible within the United States only, provided that these systems do not permit users to copy or extract any significant portion of the vocabulary source. 12.4.4. DEFINITIONS 1. United States is defined as all United States states, territories, and the District of Columbia; any United States government facility or office, whether permanent or temporary, wherever located; and access to a system in any of these locations by United States government employees, designated representatives or contractors, wherever located, for United States government purposes. 2. United States entity is defined as (i) for government entities, an agency or department of the United States government, (ii) for corporations, as a corporation incorporated and operating in the United States and (iii) for other entities as an entity organized under the laws of the United States.87

The LOINC database is a public-use set of codes accessible in the United States and internationally. MDS information in LOINC, including supplemental material added to LOINC representations, cannot be reproduced without interRAI permission outside of the United States.

Generic agreement text on the LOINC web site reads:

third party content is either used with permission or under the applicable terms of use. In all such cases, we have included the copyright notice. This third party content is highlighted in the program as follows: When such copyright content appears in the RELMA [Regenstrief LOINC mapping assistant] look-up grid, RELMA will highlight the row containing that content by printing in a different background color and using italics. It will also include a link in the (EXT (C)) column. By clicking on that link, users will get to the copyright notice and to the terms of use for the content of those LOINC-mapped terms. In the case of a LOINC database (e.g., the tab delimited file and the LOINC Access database) we include the copyright notice (up to 250 characters).88

RELMA provides the following language concerning the interRAI MDS copyright claim:

As a not for profit corporation under the U.S. Tax Code, interRAI holds the copyright to a number of assessment systems, including the Resident Assessment Instrument (RAI) for long-term care facilities outside of the United States (the RAI is in the public domain within the United States), as well as the assessment systems for Home Care (HC), Assisted Living (AL), Palliative Care.89

An IP issue that may have been addressed although, if so, it is not clear how it was resolved, regards the creation of scales based on the MDS. Copyright information on the interRAI web site includes the statement: "The scales, algorithms, and case-mix measures based on these assessment instruments cannot be copyrighted and are thus available to everyone (although the individual items on which they are based are usually copyrighted).”90 Presumably, this refers to scales created by interRAI, since LTCQ, Inc. claims ownership rights to the Cognitive Performance Scale (CPS), a well-known scale based on the MDS. It is unclear whether claiming copyright to the MDS-based CPS is in direct conflict with the terms on the interRAI web site. LTCQ, a consulting company formed in 1992 by other participants in the HCFA MDS contracts, has patented or trademarked Data Integrity Audit, Performance Portfolio, RiskRx, and Q-Metrics. In addition to the CPS, LTCQ claims copyrights to the Pain Scale (PS), Pressure Ulcer RAP Items [scale], Pressure Ulcer Risk Model [scale], Depression Rating Scale (DRS), and the Social Engagement Scale, all of which are based on v.2.0 MDS data.91

A large number of organizations, government agencies, contractors, and industry experts have been involved in the creation and development of the third revision of the MDS item set along with associated pieces such as the data specifications, resident assessment instrument and user manual, care area assessments, and RUGs classification. At this point, there do not appear to be restrictions on the use of any of the parts of the version of the RAI scheduled for implementation in 2010. MDS 3.0 incorporates screening tools for depression (PHQ-9©) and delirium (CAM©), that are copyrighted, but presumably fall under the rights in general provisions of the FARs which states that a Contractor may not, without permission of the Contracting Officer, incorporate any copyrighted material unless the Contractor grants to the Government, or acquires on its behalf, a license to use the material. The CMS indicates copyright permission for the PHQ-9© and the CAM extends to any use of the instrument made in connection with reporting to CMS, as long as the copyright symbol is present.92 The CARE tool displays the statement, "Copyright©1990 Annals of Internal Medicine. All rights reserved. Adapted with permission."

Use not associated with reporting to CMS and any replication of the CAM requires this acknowledgement:

Adapted from: Inouye SK, vanDyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: The Confusion Assessment Method. A new method for detection of delirium. Ann Intern Med. 1990; 113: 941-948. Confusion Assessment Method: Training Manual and Coding Guide, Copyright 2003, Sharon K. Inouye, M.D., MPH.93

Information concerning the CAM© in the Agency for Healthcare Research and Quality's (AHRQ) National Quality Measures Clearinghouse is contradictory. According to the copyright statement on the NQMC web site, no copyright restrictions apply,94 but the measure availability statement states: "Please note that the CAM is copyright protected, therefore you must apply for permission to replicate the CAM within your facility."

While it is not know what restrictions might be placed on the use of these tools by third parties in the future, the Regenstrief Institute has made arrangements with Pfizer in the past to resolve IP issues in relation to incorporation of the PHQ tools into LOINC and has also received permission from the copyright holder of the CAM to include that tool in the worldwide LOINC distribution.95

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