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

UDS (later UDSMR®), a division of UBFA, was formed on October 1, 1987. UBFA, a New York not-for-profit corporation, claims exclusive ownership of the Functional Independence Measure (FIM® instrument). The Research Foundation of the State University of New York (SUNY) originally claimed ownership of the FIM, with rights being transferred to UBFA "in order to facilitate proper protection and licensing of the FIM System."140 UDSMR® provides teaching workshops and data management services through their FIM® System. Most IRFs in the United States subscribe to UDSMR® services.141

Any use of the FIM, other than for reimbursement from CMS authorized through license agreements signed between UBFA and HCFA (in 1995) and CMS (in 2002), requires a license agreement with UDSMR®. Vendors who incorporate the FIM® portions of the IRF-PAI into products may do so only with a license agreement with UDSMR®.142 UDSMR® offers a number of different kinds of licenses for use of the FIM® instrument, all of which, including use of the FIM for research purposes, require a license fee. Academics who want to use the FIM for research or educational purposes need to sign research licenses with UDSMR®, identify the FIM as required by UDSMR®, and present the results of their research to UDSMR® for review. Research letters of agreement are available for students, as well as for large-scale or collaborative research projects carried out by researchers in the field. In order to qualify for a research license to use the FIM for research or educational purposes, UDSMR® requires the individual or entity to complete and return to UDSMR® a research tracking form, including an abstract or description of the project along with the proposed use of the FIM in the project. If the request is approved by the UDSMR® research committee, the licensee:

will be asked to conform to established criteria regarding use of service marks and trademarks, as well as established standards with respect to references to materials copyrighted or registered by UDSMR. The entity will also be required to sign a written agreement that serves to protect intellectual property rights as well as formally establish responsibilities of both parties with respect to use and dissemination of UDSMR data and copyrighted materials.

A licensing fee is assessed for each research request approved. Also, licensees using the FIM are required when reporting results to indicate whether they have taken and passed the UDSMR mastery level test.143

UDSMR® offers annual licenses to health care facilities for use of the FIM® instrument and data collection software. A limited license for a defined period of time is also available to facilities not currently subscribing to UDSMR® services, with the expectation that a long-term relationship would develop. This license allows a facility to test the FIM® System to determine clinical usefulness. There are fees associated with license agreements for these pilot projects. Subscribers are required to acknowledge that UDSMR® owns the FIM.144

Geographical areas also can license the FIM® system. Territorial licenses include training and distribution agreements for marketing and distributing FIM® materials and for provision of FIM® training for UDSMR® subscribers in that region. Licensing arrangement with countries also may include a database license for the purpose of using the FIM® instrument for aggregating data and providing statistical reports within the country.145

Software companies who have licensed the FIM for use have been given permission to use the FIM as long as software screen pages properly incorporate the FIM® service and trademarks. A typical letter agreement between UDSMR® and a software company states:

You have asked for UDSMR’s permission to incorporate descriptive and definitional elements of the FIM System. UDSMR is willing to grant to you permission to use and incorporate the FIM System into your software upon the terms and conditions set forth in this letter agreement…

1. UDSMR hereby grants to you the right to incorporate some or all of the description, definitional and other terms comprising the FIM System…

2. In consideration of and as a condition to the rights granted to you pursuant to this letter agreement, you shall take all steps reasonable and necessary to acknowledge UDSMR’s ownership rights to the FIM System. Without limiting the generality of the preceding sentence, a notice substantially in the form set forth should be incorporated into and appear (a) on introductory screen displays as well as any screens which make specific reference to or which introduce any sub-routines that incorporate any elements of the FIM System and (b) in any manuals or documentation relating to said software…. “The Uniform Data Set and the Functional Independence Measure are proprietary products of UB Foundation Activities, Inc.”

3. You shall provide to UDSMR upon request, samples of proposed screen layouts and other portions of text containing elements of the FIM® System or containing the foregoing notice.146

The requirement regarding furnishing UDSMR® with screen displays of the acknowledgments of copyright, trademarks, and service marks continues to be part of the License Agreement with UDSMR® for incorporation of the FIM into software.

In a 2002 Addendum to the 1995 License Agreement with HCFA, UDSMR® agreed to develop and update on a periodic basis the IRF-PAI Training Manual. UDSMR® claims compilation rights to the manual, and also provides training and help desk support for IRF-PAI issues, presumably under contract with CMS.147

The “FIM® system,” including the data set, definitions, documentation, and software for storing and analyzing the data, is maintained by UDSMR®, which has licensed the system since 1994. The number of subscribers in 1994 was 622, which by 2009 had grown to 1400. Revenues for use of the FIM and "the FIM® System" goods and services are in the seven million dollar range.148

UDSMR® requires that in order to be called “FIM® data,” the data must be collected by trained clinicians and sent to UDSMR® for analysis.

Data management services are performed by UDSMR. To include facility data in the aggregate reports, UDSMR requires that the data be credentialed through a two-step process that requires clinicians who are reporting data to demonstrate understanding of rating with the FIM instrument by passing a mastery test and by subjecting the data to analysis of each subscribing facility for outlier variables.149

Facilities retain ownership in the data they send to UDSMR®, but there are limitations to the uses they can make of UDSMR®-analyzed data:

When facilities subscribing to UDSMRSM compare results of their own programs with those of the national aggregate, they should be aware that the aggregated regional and national data from their UDSMR reports are copyrighted and owned by the University at Buffalo Foundation Activities, Inc., State University of New York at Buffalo, and must be used according to the UDSMR service agreements and contracts.150

Unlike the MDS and OASIS, neither the FIM® data set nor the IRF-PAI assessment instrument is represented in either UMLS or LOINC.

Intellectual Property Notices Displayed by the CMS

CMS accepts the assertion by the University at Buffalo Foundation Activities, Inc. (UBFA) that they own the Functional Independence Measure (FIM). UBFA’s copyright notice appears in the final rule for the IRF PPS published in the Federal Register August 7, 2001. The copyright notice also appears on the CMS web site.151 The text of the copyright notice reads as follows:

The FIM data set, measurement scale and impairment codes incorporated or referenced in the IRF PAI are the property of UB Foundation Activities, Inc.© 1993, 2001 UB Foundation Activities, Inc. The FIM mark is owned by UBFA, Inc.

UBFA's copyright notice also appears on every page of the 244-page training manual available for download from the UDSMR web site.152 The text of the copyright notice in the training manual reads as follows:

Copyright © 2001-2004 UB Foundation Activities, Inc. (UBFA, Inc.) for compilation rights; no copyrights claimed in U.S. government works included in Section I, portions of Section IV, Appendices I and K, and portions of Appendices B, C, E, G, H and J. All other copyrights are reserved to their respective owners. Copyright © 1993-2001 UB Foundation Activities, Inc. for the FIM Data Set, Measurement Scale, Impairment Codes, and refinements thereto for the IRF-PAI, and for the Guide for the Uniform Data Set for Medical Rehabilitation, as incorporated or referenced herein. The FIM mark is owned by UBFA, Inc.

Intellectual Property Notices Displayed by UDSMR®

The UDSMR® web site displays the following copyright notice:

The Uniform Data System for Medical Rehabilitation, a division of UB Foundation Activities Inc., is the developer and sole owner of the copyrighted assessment tool known as the FIM™ Instrument. As the owner, UDSMR only grants permission to use the FIM™ instrument though a variety of licensing arrangements. The intended use of the instrument dictates the level of licensure and the associated rights and fees.153

UBFA License Agreements with HCFA and CMS

In September 1995, UBFA and HCFA entered into a agreement that allowed HCFA to study the Functional Independence Measures as a basis for the IRFs PPS. Addenda to the September agreement were signed in November 1995, and again in February 2002. The license had two distinct phases -- one was to evaluate the FIM® System as the basis for the PPS. The second phase covered the terms of the agreement should HCFA decide to use the FIM for the PPS.

The license agreement gave HCFA the right to use the FIM® instrument and related materials in the development, design, and evaluation of the PPS. As interpreted by UBFA, the agreement permitted "HCFA to sublicense hospitals to use the FIMTMinstrument and related materials 'without fee or obligation to UDSMR' as part of the Medicare-payment system."154

The agreement did not limit the use of the FIM to reimbursement, but the use had to be related to the payment system. Clause 2(b)(iv) gave HCFA the right "to use the Licensed System for other HCFA program needs related to the Payment System, including quality assurance, hospital certification and research." In the agreement, the parties also agreed "that discharge data, provider data, or other data and products derived from and specifically related to the Payment System, including but not limited to data or other products relating to quality assurance, hospital certification, or research derived from or relating to the Payment System, shall be subject to public disclosure and use for purposes of the Payment System, notwithstanding that such data or products incorporate any portion of the Licensed System."155

UDSMR® viewed the agreement as giving HCFA the "right to use the FIM instrument and related materials and to license one or more third-parties to use UDS system 'in connection with the development, design, implementation, maintenance, operation, and evaluation of the [Medicare] Payment System.' Specifically, the License Agreement permits HCFA to sublicense hospitals to use the FIMTM instrument and related materials 'without fee or obligation to UDSMR' as part of the Medicare-payment system." [emphasis theirs]156

In a 2002 clarification letter to an employee at HHS/ASPE regarding legitimate use of the FIM, the Director of UDSMR® wrote:

Under the License Agreement, the only authorized users of the portions of the Training Manual contributed by UDSMR are CMS, UDSMR and the inpatient rehabilitation facilities subject to the payment system. UDSMR has made these materials available to CMS and the facilities on a completely royalty-free basis. However, the right to use them does not extend to the 'regulatory community' in general, as AMRPA erroneously states.157

The letter continued:

As you may be aware, UDSMR worked closely with CMS’s attorneys to develop the copyright notice for the Training Manual. It has been carefully crafted to indicate that some sections and appendices of the Training Manual have been wholly developed by either UDSMR or CMS, while others reflect contributions from both and/or other parties.

The AMRPA had suggested that the copyright notice was confusing and that it was not necessary to put it on every page of the training manual.

In response, the Director of UDSMR® wrote:

AMRPA’s letter highlights the need for a brief explanation of the ownership issues relating to the Training Manual and the related Inpatient Rehabilitation Assessment Instrument on CMS’s website. We have made this suggestion to CMS on numerous occasions. We believe that many of AMRPA’s concerns would be addressed if CMS were to place a notice similar to the following on its website:

"The Inpatient Rehabilitation Facility-Patient Assessment Instrument (IRF-PAI) and the IRF-PAI Training Manual were created for use by facilities subject to CMS’s payment system for Medicare inpatient rehabilitation services. The IRF-PAI and the Training Manual contain proprietary material that was incorporated with the express permission of the owners. Anyone other than a facility subject to the payment system who wishes to use the IRF-PAI or the Training Manual should contact such owners prior to any such use."158

Portions of the license agreements between HCFA (and subsequently CMS) and UBFA, which limited how and for what purposes the FIM could be used, appear to be in direct contradiction to the Code of Federal Regulations and OMB Circular A-110 grant rules under which the FIM was developed, and rules to which UDSMR® points as justification of their copyrights.159

The 1995 license gave HCFA the right to modify the instrument. The amended license signed in 2002 limited CMS's (HCFA's successor) rights to modify the instrument without first consulting with UDSMR®, and asserted that "any such modification shall only be for the purpose of carrying out CMS’s tasks relating to the Payment System…."160

The IP rights section of the 1995 agreement outlines how HCFA must acknowledge UDSMR® ownership of the FIM:

5. Intellectual property

(a) HCFA acknowledges that all right, title and interest in and to the Licensed System, the Marks, and all copyrights shall remain the sole and exclusive property of UDSMR. To the extent permitted by federal law, HCFA's use of the Licensed System and the Marks shall inure to the benefit of UDSMR, and this Agreement shall not operate to transfer or convey to HCFA or to any Third Party any ownership interest whatsoever in the Licensed System, the Marks or any derivative works thereof created by UDSMR.

(b) HCFA shall take all steps reasonable and necessary to acknowledge UDSMR's ownership and copyright rights to the Licensed System and the Marks. Without limiting the generality of the preceding sentence, notices substantially in the forms set forth below or any successor notices shall be incorporated into and appear in any printed or published documentation or other tangible materials relating to or resulting from the exercise by HCFA of its rights and licenses under this Agreement insofar as any such materials refer to or incorporate any portion of the Licensed System.

"The FIMSM data set, measurement scale and impairment codes incorporated or referenced herein are the property of UB Foundation Activities, Inc."

"The FIMSM service mark is owned by UB Foundation Activities, Inc.

In addition, any such materials which substantially reproduce the Data Set, the Adult FIM Scale or the Impairment Codes from the Guide, or any other copyrighted UDSMR materials, shall contain the following copyright notice: "Copyright 1993 UB Foundation Activities, Inc.", or any successor notice.

(c) To the extent HCFA has the requisite right and license, and the authority to grant such right and license, HCFA agrees to grant to UDSMR an unconditional, irrevocable and nonexclusive right and license to use, to modify and to sublicense others to use and modify any modifications, enhancements, improvements or other derivative works made to, or based upon, the Licensed System by HCFA or any of its sub licensees."161

The 2002 addendum to the agreement added the following sentence to Section 5(b) of the 1995 license. "CMS shall also include the copyright notice contained in the Training Manual in any reproduction of the Training Manual in whole or in part, regardless of the medium in which such reproduction is made."162

Between the time that UDSMR® and HCFA signed the 1995 license agreement, and while awaiting the report from RAND, with whom CMS contracted to analyze the Functional Independence Measure and Function Related Groups (FRGs) for use in the PPS, UDSMR® issued a position statement, prompted by concerns expressed by the rehabilitation community that UDSMR® was standing in the way of a PPS based on the FIM and the FIM/FRGs. UDSMR® was reticent to let the RAND study be published without UDSMR® edits, based on what they saw as the unauthorized publication of proprietary information:

The present issue with HCFA over publication of the RAND reports involves the protection of UDSMR's intellectual property rights under its agreements with HCFA. The premature dissemination of the draft reports without UDSMR's consent has already led to improper commercial exploitation by third parties of the information contained in those reports, and UDSMR seeks only to avoid further breaches of its proprietary rights. UDSMR has requested deletion of certain information for purposes of general publication, and had agreed to make the full reports available subject to appropriate terms and conditions. [emphasis theirs]163

In the position statement, UDSMR® writes:

Although Dr. Granger has always believed strongly in the free flow of ideas among researchers and others, UDSMR has had no choice but to take steps to protect the FIM instrument and data so valuable to the field and to UDSMR's subscribers.

Analysis of IRF-PAI Intellectual Property Issues

Sorting out the IP issues with respect to the IRF-PAI is not easy. The IRF-PAI is a government document, based largely on the Functional Independence Measure (FIM) of which UBFA claims ownership. Whether the claim is legitimate or not is a matter of dispute. HCFA's agreement to “license” the FIM and to print UBFA’s copyright claims on their web site, in the Federal Register final rule, and on every page of the IRF-PAI user’s manual, lends legitimacy to the ownership claims. As Trosow writes, "once copyright attaches to a work, there can be significant negative consequences for downstream access to that work."164

On the coding form, UBFA claims copyrights to all parts of the IRF-PAI except for the medical needs and quality indicators sections. The copyrighted portions include Identification Information, Admission Information, Payer Information, Medical Information, Function Modifiers, FIMTM Instrument, and Discharge Information.

Ownership of the FIM has been challenged in at least two legal cases. A challenge to the trademarking of FIM was settled by the Trademark Trial and Appeal Board of the U.S. Patent and Trademark Office in UBFA’s favor, giving them the right to trademark FIM® and the FIM system®.165 A dispute before the Federal District Court in Western New York has been ongoing since 2003 and, barring an unlikely settlement between the parties, is slated to come to a jury trial in 2010. The original defendant in the case (there has been a countersuit) claims UBFA has admitted they don't own the copyright to the FIM, although it is not clear that has been stipulated by the plaintiff. The dispute now appears to be focused more on restraint of trade and monopolization issues, but ownership of the FIM is a key issue. Part of the problem in these cases appears to be an expanding definition of what is being claimed as IP, whether it was the data collected and analyzed using the FIM® instrument, the software used to collect and store the data, the user and training manuals (which at some point began adding "including the FIM® instrument" to the title), the "FIM system®," or the FIM® data set itself. Over the years, the definition appears to have grown to include all of the above.166 A 2006 study by the Division of Health Care Policy and Research at the University of Colorado at Denver and Health Sciences Center described the system as such: "The UDSMR® consists of four components: (1) a data set used to assess disability severity and medical rehabilitation outcomes; (2) computer software; (3) a data management service for subscribing facilities; and (4) a training program for users."167

From the beginning, a complicating factor was the fact that one of the co-chairs of the Task Force was the project director on the grant and also a faculty member in the Department of Rehabilitation Medicine at the State University of New York at Buffalo, the recipient of the grant from the U.S. Department of Education. Another complicating factor was the intention in the grant proposal to issue an RFP for a software company to create software designed for locating, interpreting, and reporting the data. However, the RFP was never issued because the task force decided that the University at Buffalo was equipped to carry out the task.168 As the assessment tool was accepted, data accumulated, and software developed, the analysis of which became a profitable business, ownership rights to the software and analyzed data became entangled with ownership rights to the FIM itself, since the FIM was not only integral to the software and related documentation, but also to derivative products created by UDSMR® (e.g., FIMware®, weeFIM®).169

Also confusing the issue were conflicting statements from UDSMR® concerning who owned the tool and whether it was in the public domain. Reviewing contemporary correspondence and other materials produced as evidence in the Trademarks case, it is unclear when UBFA began to assert their IP rights, but it is clear that, from the beginning, this was an issue hovering below the surface. In the grant extension proposal in 1985, under the "Inventions and Copyrights" section, the proposal states: "It was too early to consider copyrighting the National Data Set."170

An undated draft of a UDSMR brochure entitled “Why Uniform Data Now?” stated:

With the development of the Uniform Data System for Medical Rehabilitation (UDSMR) clinicians are now able to document the severity of patient disability and results of the medical rehabilitation process. The national task force which created the much-needed system is co-sponsored by the American Congress of Rehabilitation Medicine and American Academy of Physical Medicine and American Academy of Physical Medicine and Rehabilitation.171

Other statements made during this period include a 1986 letter by Carl Granger in which he wrote:

I certainly confirm that the coding sheet of the Uniform Data System (UDS) is in the public domain. We have worked very diligently to obtain national consensus regarding the assessment items and have a detailed and scientifically rigorous method for evaluating the reliability, validity, and precision of the Functional Independence Measure (FIM) component. Therefore, we have copyrighted the coding sheet to preserve its integrity while we promote its use as widely as possible.172

In correspondence with a company called Formations in Health care, Inc., UDSMR®, through their attorney wrote:

With respect to the "FIM" mark, it is neither descriptive nor generic, but rather a coined phrase which UDSMR has adopted and is using in connection with its business. This is legally protectable trademark use which UDSMR intends to enforce as its exclusive right for its business purposes. There are no barriers to its claim to ownership. …With respect to copyrightability of the Functional Independence Measure itself, it is clear under the Copyright Act that the measurement device, and the manner of its definition, including the instrument and item definitions are copyrightable subject matter under Section 102 of that Act, as original works of authorship in the category of literary works. It is equally clear that ownership of those copyrights is properly and legitimately claimed by the Research Foundation of the State University of New York and/or by the UDSMR division of the UB Foundation Activities, Inc., as their respective rights may appear.173

A document presented for exhibit in the case before the Trademark Trial and Appeal Board, stated:

All copyrights, service marks and trademarks relating to the FIM SystemSM are owned by UBFA and none of the FIM SystemSM is or has ever been in the public domain. Any unauthorized or unlicensed incorporation of portions of copyrighted works relating to the FIM SystemSM into other works, any modification of any such modified works by third parties and any unauthorized or unlicensed use of any such copyrighted works or of the UDSMR or FIM service marks or trademarks are and remain inproper and in violation of UDSMR's intellectual property rights. (Trademark dispute case, p.207 OPP-47.)

Correspondence between Kenneth Aitchinson, chair of an AMRPA PPS Task Force and Carl Granger in April 1998 included this exchange:

Aitchinson: "We are in a very critical period in the development of a PPS for rehab and AMRPA is, as you know, mounting a major campaign to influence the outcome. We need to be sure that there be no misunderstanding…." At the Task Force meeting on January 19, Jim [Phillips, of UDSMR] was asked specifically… whether [UDS] would assert proprietary rights to the FIM or portions thereof if it was used by HCFA, in whole or in part, as an element of a new MDS instrument. Jim assured us that there was no problem… and the HCFA had complete license to use the FIM or items therefrom. Based on those assurances AMRPA developed the policy position set forth in the attachment."174

Granger's response was: "We are in communication with John Morris, the HCFA contractor, for the MDS-PAC and these issues are being discussed and analyzed. He understands that no barriers exist under the license agreement between UDSMR and HCFA.175

In a 1999 letter, UDSMR® made the statement that:

…the FIMTM instrument and all other aspects of the FIM system is owned by UDSMR, and that no part of the FIM system is or ever has been in the public domain. UDSMR has entered into numerous licensing arrangements granting licensees the right to use the FIM instrument and related materials for a variety of purposes. Unfortunately, UDSMR must from time to time take action with respect to researchers and service providers who are ignorant of, or choose to ignore, UDSMR's ownership rights in the FIM System.176

E-mail correspondence between the VA and UDSMR® with the subject line "copyright question," indicates that the VA was confused about the proprietary nature of the FIM. A response from UDSMR® to an e-mail inquiry from the VA with the subject line "Copyright question" read:

I am sending this email to you in response to a question you had given to Dr. Carl Granger regarding UDSMR's ownership in the IRF-PAI. In answer to your concerns, CMS (formerly HCFA) has a license agreement with UDSMR under which CMS has UDSMR's permission to use elements of the FIM[TM] instrument in connection with the IRF-PAI. UDSMR, however, retains all ownership rights in and to the FIM[TM] instrument.177

The VA Medical System subscribes to the FIM®instrument and UDSMR®.178 However, the VA User's Manual for the FIM, developed for use with the the VA's electronic health care system, VistA, dated May 2003, makes no mention of the copyright issue, or of UDSMR® or UBFA, Inc.179

The Functional Independence Measure (FIM) is likely copyrightable, but it is unclear that UDSMR® has exclusive rights as to how the FIM can be used. If UBFA has legitimately copyrighted the FIM, based on rules published in the OMB circular (A-110) and title 34 of the Code of Federal Regulations concerning "intangible property" created through government grants (in this case, the U.S. Department of Education), it is unclear, based on the same rules, how they have justified the restrictions they have placed on HCFA's and CMS's use, unless it is simply a technical matter that the grant was through the U.S. Department of Education and not the HHS.

UBFA, Inc. has not had an easy time asserting their exclusive rights to the FIM. That being the case, it is hard to surmise whether they would be inclined to permit the creation and dissemination of HIT-coded versions of the FIM, simply because the policing of unauthorized use could prove to be burdensome. Despite the ubiquitous copyright notices, it appears that many continue to be unaware, or doubtful of the legitimacy of UBFA's claims to the FIM, even though most people in the rehabilitation field are likely familiar with UDSMR® and their data services.

While it is not possible with currently available documentary evidence to sort out the ownership claims and counterclaims to determine the IP issues that will arise if standards organization wish to apply HIT standards to the instrument and disseminate a standardized IRF-PAI, some further analysis of where we have been and how we got here as described in "Medicare Funding for Inpatient Rehabilitation: How Did We Get to This Point and What Do We Do Now?" may be informative.180 It should be noted however, that the work underway in CMS to develop a new patient assessment instrument, the CARE instrument, may eliminate the need to rely on the FIM® data elements for Medicare payment purposes if the data elements in the CARE instrument are found to support appropriate Medicare payment algorithms for IRFs.

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