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

12/01/2011

  1. Wark, Cynthia G., et al. "Government Issue: CHI Lays the Groundwork for Federal Data Exchange." Journal of AHIMA 75, no.8 (September 2004): 36-38.

  2. Consolidated Health Informatics (2006). Standards Adoption Recommendation -- Functioning and Disability. http://www.ncvhs.hhs.gov/061011p2b.pdf; NCVHS’s letter to the Secretary and Secretary Leavitt’s response are available on the NCVHS web site at http://www.ncvhs.hhs.gov/sssmemb.htm.

  3. U.S. Department of Health and Human Services. "Additional Consolidated Health Information (CHI) Health Information Technology Standards" 72 Federal Register 71413-14 (December 17, 2007) Accessed January 2008 at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-6058.htm.

  4. For purposes of this report, post-acute care services are defined as services received after patients are discharged from hospital stays to a skilled nursing facility (SNF), a home health agency (HHA), and/or a rehabilitation hospital/unit -- inpatient rehabilitation facility (IRF).

  5. Kramer, Andrew, et al. Case Studies of Electronic Health Records in Post-Acute and Long-Term Care. Washington, DC: U.S. Dept. of Health and Human Services, Office of the Assistant Secretary for Planning and Evaluation, Office of Disability and Long-Term Care Policy, 2004. http://aspe.hhs.gov/daltcp/reports/ehrpaltc.htm.

  6. Kramer. Case Studies. (2004).

  7. Gage, Barbara, and Jeremy Green. "The State of the Art: Current CMS PAC Instruments" Uniform Patient Assessment for Post-Acute Care (Aurora, CO: Division of Health Care Policy and Research, University of Colorado at Denver and Health Sciences Center, 2006), accessed at http://www.bu.edu/hdr/documents/QualityPACFullReport.pdf.

  8. Wang, 2008.

  9. 74 Federal Register 10050 (March 9, 2009) and 74 Federal Register 22208 (May 12, 2009).

  10. 74 FR 10050 (March 9, 2009).

  11. See http://www.nasl.org/files/members/IT/mds3-1-15-09.pdf.

  12. National Association for Home Care and Hospice, AAHSA, AHIMA, CAST, National Association for the Support of Long Term Care. Response re: Information Collection -- Medicare and Medicaid Programs OASIS Collection Requirements as Part of the CoPs for HHAs and Supporting Regulations in 42 CFR, Sections 484.55, 484.205, 484.245, 484.250 [74FR10050] (April 8, 2009) accessed online at http://www.ahima.org/dc/documents/AHIMArespondstoOMBreviewrequestforCMSOASISCollectionRequirements.pdf. AHIMA. Comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed changes to the Skilled Nursing Facilities Inpatient Prospective Payment Systems (SBF-PPS) as published in the May 12, 2009 Federal Register [74FR22208].

  13. AHIMA. Comments on the Centers for Medicare & Medicaid Services’ (CMS) proposed changes to the Skilled Nursing Facilities Inpatient Prospective Payment Systems (SBF-PPS) as published in the May 12, 2009 Federal Register [74FR22208].

  14. 74 Federal Register 40287 (August 11, 2009).

  15. Chan, Leighton, Thomas D. Koepsell, Richard A. Deyo, Peter C. Esselman, Jodie K. Haselkorn, Joseph K. Lowery, and Walter C. Stolov. 1997. The Effect of Medicare's Payment System for Rehabilitation Hospitals on Length of Stay, Charges, and Total Payments. N Engl J Med 337, no. 14: 978-985. http://content.nejm.org/cgi/content/abstract/337/14/978.

  16. Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999, Pub.L. 106-113.

  17. Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000, Pub.L. 106–554.

  18. Deficit Reduction Act of 2005 (DRA 2005). Pub.L. 109-171.

  19. Matherlee, Karen. "Implementing the BBA: the Challenge of Moving Medicare Post-Acute Services to PPS." National Health Policy Forum Issue Brief No.743 (Washington, DC: The George Washington University, 1999).

  20. Pub.L. 106-554. Appx F -- Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000. Section 545.

  21. DRA 2005. Accessed at http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=109_cong_public_laws&docid=f:publ171.109.

  22. U.S. Office of Management and Budget. "Data Collection for Administering the Medicare Continuity Assessment Record and Evaluation (CARE) Instrument" Clearance Package Supporting Statement Part A. (Washington, DC: Centers for Medicare and Medicaid Services, July 17, 2007).

  23. Avalere Health LLC. (2009). Post-acute and Long-term Care Reform: Estimating the Federal Budgetary Effects of the AHCA/NCAL/Alliance Proposal. Retrieved July 16, 2009, from http://post-acute.org/bundling/Avalere%20Report%20prepared%20for%20AHCA-NCAL-Alliance%20on%20Post-acute%20and%20Long-term%20Care,%20April%202009.pdf.

  24. Talk: Functional Status Assessments (FSA) Integration Profile Supplement (IHE wiki) accessed at http://wiki.ihe.net/index.php?title=Talk:Functional_Status_Assessments_(FSA)_Integration_Profile_Supplement.

  25. Granger, Carl V. “UDSMR Comment Letter re: CMS CARE tool and PAC-PRD Demonstration”. (September 17, 2007).

  26. Testimony of Brant E. Fries, Professor, Department of Health Management and Policy, University of Michigan School of Public Health, Public Hearing, Reports and Testimony, July 22, 2005. (Washington, DC: National Commission for Quality Long-Term Care) accessed at http://www.qualitylongtermcarecommission.org/meetings/722PH/pdf/txstmtRQIfries07-18-05.pdf.

  27. U.S. Office of Management and Budget Circular A-110 (revised November 19, 1993; as further amended September 30, 1999), codified at 45 CFR §74.36 and 45 CFR §92.34 for the Department of Health and Human Service and 34 CFR §74.36 and 34 CFR §80.34 for the U.S. Department of Education, applies to grants awarded to nonprofit institutions; Federal Acquisition Regulation 52.227 (Rights in Data clauses begin with 227-14), codified at 48 C.F.R. §52.227-14-18 applies to data rights in the performance of contracts with federal agencies.

  28. CENDI Copyright Task Group. Frequently Asked Questions About Copyright: Issues Affecting the U.S. Government. (Oak Ridge, TN: CENDI Secretariat, Information International Associates, Inc., 2002; updated August 2007) accessed at http://www.cendi.gov/publications/04-8copyright.html#41.

  29. OMB Circular A-110 is codified at 45 CFR §74.36 and 45 CFR §92.34 for the Department of Health and Human Service and 34 CFR §74.36 and 34 CFR §80.34 for the U.S. Department of Education.

  30. U.S. Office of Management and Budget. Circular A-110 (revised November 19, 1993; as further amended September 30, 1999) http://www.whitehouse.gov/omb/circulars/a110/a110.html#36l . Text from earlier versions of Circular A-110, in affect at the time of the contract or grant awards, is available in the relevant sections of the Code of Federal Regulations, referenced above. See also "The Federal Grant and Cooperative Agreement Act" (31 USC 6301-08), available at http://www.access.gpo.gov/uscode/title31/subtitlev_chapter63_.html for further guidance on the use of contracts, grants, and cooperative agreements.

  31. Federal Acquisition Regulation. 48 CFR §27 (Patents, Data, and Copyrights). Solicitation provisions and contract clauses are addressed at 48 CFR §52.227-14 (Rights in Data -- General); §52.227-17 (Rights in Data -- Special Works); §52.227-18 (Rights in Data -- Existing Works).

  32. FAR 52.227-17(c)(1).

  33. Trosow, Samuel E.I. Copyright Protection for Federally Funded Research: Necessary Incentive or Double Subsidy? (draft paper September 7, 2003). Accessed at http://publish.uwo.ca/~strosow/Sabo_Bill_Paper.pdf.

  34. 72 Federal Register 71413-14 (December 17, 2007).

  35. U.S. Centers for Medicare & Medicaid Services (CMS). Data Collection for Administering the Medicare Continuity Assessment Record and Evaluation (CARE) Instrument. (OMB Clearance Package Supporting Statement Part A. (October 23, 2007).

  36. U.S. Centers for Medicare & Medicaid Services (CMS). Revised Long-Term Care Facility Resident Assessment Instrument User’s Manual: version 2.0 (December 2002, revised March 2007).

  37. CMS. RAI 2.0 User's Manual.

  38. Wunderlich, G.S., & Kohler, P.O. “Information Systems for Monitoring Quality” Improving the Quality of Long-Term Care (Washington, DC: National Academies Press, 2001).

  39. Information about RAVEN software is accessible at http://www.cms.hhs.gov/MinimumDataSets20/07_RAVENSoftware.asp.

  40. Regulations are available on the Federal Register web site at http://www.gpoaccess.gov/fr/index.html. These regulations have been codified at 42 CFR 483.20 (Public Health, Requirements for States and Long Term Care Facilities, Resident Assessment). CFR 483.75 covers the confidentiality issues. Other relevant legislation affecting the MDS includes the Omnibus Budget Reconciliation Act of 1987. P.L. 100-203. Subtitle C: Nursing Home Reform. (OBRA 1987) and the Balanced Budget Act of 1997 (BBA 1997) (establishing the PPS system). Section 1819 of the Social Security Act contains the regulations for skilled nursing facilities participating in the Medicare program and section 1919 contains the regulations for nursing facilities participating in the Medicaid program. Annual updates to the prospective payment system (PPS) rates for skilled nursing facilities (SNFs) are required by section 1888(e) of the Social Security Act, added by section 4432 of the Balanced Budget Act of 1997 (BBA), and amended by the Medicare, Medicaid, and SCHIP Balanced Budget Refinement Act of 1999 (BBRA), the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA).

  41. Smith vs. O'Halloran, 55i F Supp. 289 (Denver, Colorado Circuit, in 1983.), reversed subnom. Smith vs, Heckler, i37 F2nd 583 (10th Cir 1984) see Spector, W.D., & Drugovich, M.L. (1989). "Reforming Nursing Home Quality Regulation: Impact on Cited Deficiencies and Nursing Home Outcomes." Medical Care, 27, 789-801.

  42. Morris, J.N., Hawes, C., Fries, B.E., Phillips, C.D., Mor, V., Katz, S., et al. (1990). "Designing the national resident assessment instrument for nursing homes." The Gerontologist, 30, 293-307.

  43. Institute of Medicine. Committee on Nursing Home Regulation. Improving the Quality of Care in Nursing Homes. (Washington, DC: National Academy Press, 1986).

  44. Hawes, C., Mor, V., Phillips, C.D., Fries, B.E., Morris, J.N., Steele-Friedlob, E., et al. (1997). "The OBRA-87 nursing home regulations and implementation of the Resident Assessment Instrument: effects on process quality." J Am Geriatr Soc, 45, 977-85.

  45. U.S. Centers for Medicare & Medicaid Services. "Minimum Data Set (MDS) 3.0 Timeline" accessed at http://www.cms.hhs.gov/NursingHomeQualityInits/downloads/MDS302010ImplementationTimeline.pdf.

  46. Cotterill, P.G., & Gage, B.J. (2002). "Overview: Medicare post-acute care since the Balanced Budget Act of 1997." Health Care Financ Rev, 24, 1-6.

  47. 63 FR 26252-26316 ( May 12, 1998).

  48. "Development of Resident Assessment System and Data Base for Nursing Home Residents," Health Care Financing Administration (#500-88-0055); October 1988; 4 years, $3.5 million (extended to 6 years, $4.9 million) to Research Triangle Institute, with Brown University, Hebrew Rehabilitation Center for the Aging and The University of Michigan. See Fries, Brant. "Curriculum Vitae" Accessed January 2008 at http://www.sph.umich.edu/faculty/pdf/bfries.pdf.

  49. Morris (1990).

  50. "Revision of Resident Assessment Instrument (RAI) and Development of Resident Assessment Protocols (RAPs)," Centers for Medicare and Medicaid Systems (#500-94-0058); September 30, 1994; 6 years, $465,000 to Hebrew Rehabilitation Center for Aged; Principal Investigator: J. Morris; Co-Principal Investigator [Brant Fries]. Refine Version 2 and develop Version 3 of the National Nursing Home Resident Assessment Instrument, develop the RAI-PAC assessment instrument for post-acute care, and evaluate the nursing home population under age 65." See Fries, "Curriculum Vitae".

  51. interRAI web site. "Long Term Care Facility". Accessed January 2008 at http://www.interrai.org/section/view/?fnode=17.

  52. See Fries et al. letter to the editor, Journal of the American Geriatrics Society, July 2007.

  53. The letter to the editor from Lisa Hines at the Office of Clinical Standards and Quality of the Health Care Financing Administration objected to the use by the authors, who were also investigators associated with contractors or subcontractors on the HCFA MDS contracts, of the designation "InterRAI-HCFA" in describing the work that was being done under contract to HCFA. The author of the letter wanted to make it clear that the contract was not with interRAI, and that whatever relationship the authors had with interRAI, their work on the contract had nothing to do with that relationship but due to the fact that they were experts in the field. Hines, L. (2001). Response to "Pain in U.S. nursing homes: validating a pain scale for the Minimum Data Set". The Gerontologist, 41(4), 553.

  54. U.S. Centers for Medicare & Medicaid Services. MDS 3.0 Town Hall Meeting Conference Call. Transcript (June 3, 2003) Accessed at http://www.cms.hhs.gov/NursingHomeQualityInits/25_NHQIMDS30.asp.

  55. U.S. Centers for Medicare & Medicaid Services. [MDS 3.0]: Phase 1 -- 2003 Stakeholder and Expert Review. Accessed at http://www.cms.hhs.gov/NursingHomeQualityInits/25_NHQIMDS30.asp.

  56. U.S. Centers for Medicare & Medicaid Services. Draft Minimum Data Set, Version 3.0 (MDS 3.0) For Nursing Home Resident and Care Screening. (July 31, 2006) http://www.cms.hhs.gov/NursingHomeQualityInits/Downloads/MDS30Draft.pdf.

  57. RAND Health. "The MDS 3.0: Improving Assessment." Special Open Door Forum, January 24, 2008.

  58. U.S. CMS [MDS 3.0]: Phase 1 -- 2003 Stakeholder and Expert Review.

  59. RAND Health. "Evaluating Revisions to the Minimum Data Set for Nursing Homes" Presentation at CMS Town Hall Meeting on the MDS 3.0 (June 2, 2003).

  60. U.S. Centers for Medicare & Medicaid Services. [MDS 3.0]: Phase 2 -- VA Validation Protocol Research. Accessed at http://www.cms.hhs.gov/NursingHomeQualityInits/25_NHQIMDS30.asp.

  61. RAND Corporation. (April 2008). Development & Validation of a Revised Nursing Home Assessment Tool: MDS 3.0.

  62. Dougherty, Michelle, and Sue Mitchell. "Getting Better Data from the MDS: Improving Diagnostic Data Reporting in Long-term Care Facilities." Journal of AHIMA 75, no.10 (Nov-Dec 2004): 28-33. PubMed link http://www.ncbi.nlm.nih.gov/pubmed/15559836.

  63. Letter to Barbara Paul, MD, Director, Quality Measurement and Health Assessment Group at CMS. Signees were the American Association of Homes and Services for the Aging, the American Association of Nurse Assessment Coordinators, the American Hospital Association, the American Health Care Association, the Catholic Health Association, the National Association of Directors of Nursing Administration in Long-Term Care, the National Association of Subacute and Post-Acute Care, the National Citizens Coalition for Nursing Home Reform, and the National Hospice and Palliative Care Association.

  64. Apelon Inc., Making MDS 3.0 Compliant with CHI Standards: Project Summary (August 2005). Accessed at http://aspe.hhs.gov/daltcp/reports/MDSprjsum.htm.

  65. 72 Federal Register 71413-14 (December 17, 2007).

  66. PPS Alert for Long-Term Care, May 2009, p.7.

  67. 74 Federal Register 22208 (May 12, 2009).

  68. MDS 3.0 RAI Manual (November 2009). http://www.cms.hhs.gov/NursingHomeQualityInits/Downloads/MDS30RAIManual.zip.

  69. See https://www.qtso.com/strive.html.

  70. U.S. Centers for Medicare & Medicaid Services. "Special Open Door Forum on Minimum Data Set 3.0 (MDS 3.0)." Transcript, January 24, 2008. Accessed at http://www.cms.hhs.gov/OpenDoorForums/05_ODF_SpecialODF.asp.

  71. Connolly, Robert. "MDS 3.0 Implementation Plans." Presented at the National Academy for State Health Policy's 20th Annual State Health Policy Conference in Denver, Colorado (October 2007).

  72. U.S. Centers for Medicare & Medicaid Services. "Nursing Home Quality Initiatives: MDS 2.0 for Nursing Homes" accessed January 2008 at http://www.cms.hhs.gov/NursingHomeQualityInits/20_NHQIMDS20.asp.

  73. Morris, John N., Katharine Murphy, and Sue Nonemaker. Long Term Care Facility Resident Assessment Instrument (RAI) User's Manual. (HCFA, October 1995).

  74. U.S. Centers for Medicare & Medicaid Services. Revised Long-Term Care Facility Resident Assessment Instrument User's Manual: Version 2.0. (December 2002; revised March 2007).

  75. Murphy, Katharine M., and John N. Morris. "The resident assessment instrument: Implications for quality, reimbursement and research." Generations, Winter95, Vol. 19 Issue 4, p43-46.

  76. Testimony of Brant E. Fries, Professor, Department of Health Management and Policy, University of Michigan School of Public Health, Public Hearing, Reports and Testimony, July 22, 2005. (Washington, DC: National Commission for Quality Long-Term Care) accessed at http://www.qualitylongtermcarecommission.org/meetings/722PH/pdf/txstmtRQIfries07-18-05.pdf.

  77. Implementing The Resident Assessment Instrument: Case Studies Of Policymaking For Long-Term Care In Eight Countries (New York: Milbank Memorial Fund, 2003). Accessed at http://www.milbank.org/reports/interRAI/030222interRAI.html.

  78. interRAI. "Licensing with interRAI." Accessed January 2008 at http://www.interrai.org/section/view/?fnode=32.

  79. interRAI. "Licensing".

  80. interRAI. "Licensing".

  81. Hirdes, John P. et al., “The Resident Assessment Instrument-Mental Health (RAI-MH): Inter-Rater Reliability and Convergent Validity” The Journal of Behavioral Health Services & Research 2002, 29(4), 419-432.

  82. Fries, B. E. (2005, July 22). Testimony of Brant E. Fries, Professor, Department of Health Management and Policy, University of Michigan School of Public Health. Public Hearing, Reports and Testimony, National Commission for Quality Long-Term Care. Accessed at: http://www.qualitylongtermcarecommission.org/meetings/722PH/pdf/txstmtRQIfries07-18-05.pdf.

  83. Hirdes, J. P. (2006). "Addressing the health needs of frail elderly people: Ontario's experience with an integrated health information system." Age Ageing, 35, 329-331.

  84. Canadian Institute for Health Information. (2005) Resident Assessment Instrument (RAI) -- MDS 2.0©and RAPs Canadian Version, Second Edition, March 2005. Ordering information available at http://secure.cihi.ca/cihiweb/dispPage.jsp?cw_page=bl_ccrs_29apr2005_e.

  85. See http://www.kent.ac.uk/chss/interrai/develop/what_is_interrai.htm, http://www.interrai-au.org/authorisation.htm, and http://ageing.hku.hk/interrai/index.html.

  86. Integrating the Healthcare Enterprise (IHE) wiki. "Follow-ups to 2/15 call from Tom White" http://wiki.ihe.net/index.php?title=Talk:Functional_Status_Assessments_(FSA)_Integration_Profile_Supplement#Follow-ups_to_2.2F15_call_from_Tom_White.

  87. U.S. National Library of Medicine. National Institutes of Health. (2007) "License Agreement for Use of the UMLS® Metathesaurus®." Accessed January 2008 at http://wwwcf.nlm.nih.gov/umlslicense/snomed/license.cfm.

  88. LOINC. "LOINC and RELMA Terms of Use." Accessed January 2008 at http://www.regenstrief.org/medinformatics/loinc/terms-of-use.

  89. Copyright information concerning sources in the LOINC database is available from the full RELMA download available at http://www.regenstrief.org/medinformatics/loinc/downloads/files/loinc-and-relma-complete-download/gotoCopyrightedFile. In the loinccdb MS Access database, see the Source Organization table.

  90. interRAI web site accessed at http://www.interrai.org/section/view/?fnode=32.

  91. LTCQ, Inc. ["MDS Scales"] accessed January 2008 at http://www.ltcq.com/MDS%20Scales.pdf.

  92. CMS. Open Door Forum, held December 9, 2009.

  93. See http://elderlife.med.yale.edu/pdf/The%20Confusion%20Assessment%20Method.pdf.

  94. See http://www.qualitymeasures.ahrq.gov/summary/summary.aspx?ss=1&doc_id=369.

  95. Personal communication between staff at the Regenstrief Institute and the Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services.

  96. U.S. Centers for Medicare and Medicaid Research. U.S. Department of Health and Human Services. "OASIS Background". Accessed December 2007 at http://www.cms.hhs.gov/OASIS/02_Background.asp.

  97. Shaughnessy, P.W., Crisler, K.S., Schlenker, R.E., & Arnold, A.G. (1997). "Outcomes across the Care Continuum: Home Health Care" Medical Care, 35(11), NS115-NS123.

  98. U.S. Centers for Medicare & Medicaid Services. "OASIS: HAVEN." Accessed at http://www.cms.hhs.gov/OASIS/045_HAVEN.asp.

  99. U.S. Centers for Medicare & Medicaid Services. "Home Health Quality Initiatives." Accessed December 2007 at http://www.cms.hhs.gov/HomeHealthQualityInits/.

  100. Regulations published are available at the Federal Register web site: 64 FR 3748 (January 25, 1999), 64 FR 3764 (January 25, 1999), 64 FR 32983 (June 18, 1999), 64 FR 32992 (June 18, 1999), 66 FR 66903 (December 27, 2001), 70 FR 76199 (December 23, 2005), and 72 FR 49761 (August 29, 2007). Regulations have been codified at: CFR 42 §484 Public Health. Chapter IV-Health Care Financing Administration, Department of Health and Human Services. Part 484 -- Conditions of Participation: Home Health Agencies http://www.access.gpo.gov/nara/cfr/waisidx_06/42cfr484_06.html and CFR 42 §488 Public Health. Chapter IV-Health Care Financing Administration, Department of Health and Human Services. Part 488 -- Survey, Certification, and Enforcement Procedures. Sections relevant to OASIS include: CFR 42 §484.20 - Reporting OASIS Information; CFR 42 §484.11 -- Release of patient identifiable OASIS information; CFR 42 §484.55 -- Comprehensive Assessment of Patients, and CFR 42 §488.68 -- State agency responsibilities for OASIS collection and data base requirements. Other relevant legislation includes: the Social Security Act §1861(o) which required the establishment of a Home Health Prospective Payment System (HHPPS); the Social Security Act §1891(d) which required the Secretary of HHS to designate an assessment instrument for home health agencies to use; the Balanced Budget Act of 1997, which authorized the Secretary of HHS to require that home health agencies submit information for the purpose of implementing a prospective payment system (PPS) for HHAs, and the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which temporarily suspended the requirements in CFR §484.55 requiring comprehensive assessments for non-Medicare/non-Medicaid patients.

  101. Center for Health Services Research. Division of Health Care Policy and Research. University of Colorado Health Sciences Center. Accessed December 2007 at https://www2.uchsc.edu/chsr/index.shtml.

  102. "Home Health Quality Measures and Data Analysis". Contract # HHSM 500-2005-000181 T.O. #2. (Awarded September 2006).

  103. U.S. Centers for Medicare & Medicaid Services. Outcome and ASsessment Information Set : OASIS-C Guidance Manual. September 2009. Accessed at http://www.cms.hhs.gov/homehealthqualityinits/14_hhqioasisusermanual.asp.

  104. Center for Health Services and Policy Research. "Right to Copy, Reprint, and Use Oasis". Accessed December 2007 at http://www.cms.hhs.gov/HomeHealthQualityInits/downloads/HHQIOASISDataSetPermit.pdf.

  105. Appendix to the License Agreement for Use of the UMLS®Metathesaurus LNC_OASIS_2002 (new) -- The Outcome and Assessment Information Set (OASIS), 2002, Center for Health Services Research, UCHSC, Denver, CO. Accessed at http://www.nlm.nih.gov/research/umls/metaa1.html.

  106. LOINC. "LOINC and RELMA Terms of Use." Accessed January 2008 at http://www.regenstrief.org/medinformatics/loinc/terms-of-use.

  107. Copyright information concerning sources in the LOINC database is available from the full RELMA download available at http://www.regenstrief.org/medinformatics/loinc/downloads/files/loinc-and-relma-complete-download/gotoCopyrightedFile. In the loinccdb MS Access database, see the Source Organization table.

  108. U.S. Centers for Medicare & Medicaid Services. OASIS Data Set. Accessed February 2008 at http://www.cms.hhs.gov/HomeHealthQualityInits/12_HHQIOASISDataSet.asp.

  109. "Comprehensive Adult Nursing Assessment Including SOC/ROC Elements with CMS 485 Information" (Briggs Medical Service Company, 2003). Accessed December 2007 at http://shop.briggscorp.com/pdf/3491P.pdf.

  110. Carter, G.M., & et al. (2002). Analyses for the Initial Implementation of the Inpatient Rehabilitation Facility Prospective Payment System. Retrieved from http://www.rand.org/pubs/monograph_reports/MR1500/.

  111. "Item-by-Item IRF-PAI Coding Instructions" The Inpatient Rehabilitation Facility -- Patient Assessment Instrument (IRF-PAI) Training Manual: Effective 4/01/04. (Buffalo, NY: UB Foundation Activities, Inc., 2004), p. II-1. Accessed February 2008 at http://www.udsmr.org/pdfs/irfpaimanual040104%20(1).pdf.

  112. Regulatory notices can be found at "Medicare Program; Prospective Payment System for Inpatient Rehabilitation Facilities; Proposed Rule" 65 FR 66303-66442 (November 3, 2000) and "Medicare Program; Prospective Payment System for Inpatient Rehabilitation Facilities; Final Rule" 66 FR 41316-430. Updates to the Medicare Conditions of Participation for Inpatient Rehabilitation Facilities have been codified at 42 CFR, sections 412.610, 412.614 and 412.602. In order to participate in the Medicare program, hospitals must comply with Medicare Conditions of Participation, which are found at CFR 42 482 and subparts. Before performing an assessment using the IRF-PAI, a patient must be given several documents outlining their privacy rights, based on the Privacy Act of 1974 and HIPAA (1996).

  113. 66 FR 41317 (August 7, 2001).

  114. U.S. Centers for Medicare & Medicaid Services. (2002) IRF-PAI Training Manual. "Appendix J: Relative Weights for Case-Mix Groups (CMGs)".

  115. A list of qualifying conditions is available at http://www.cms.hhs.gov/InpatientRehabFacPPS/Downloads/IRF_PPS_75_percent_Rule_060807.pdf. This requirement has been one of the most controversial aspects of the IRF PPS. Implementation of the 75 percent rule was delayed several times and is being gradually phased in. For the last extension of the phase-in period for the 75 percent rule, see 44292 FR 72 (August 7, 2001) accessable at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/07-3789.htm.

  116. 66 FR 41323 (August 7, 2001).

  117. 66 FR 41326 (August 7, 2001).

  118. 66 FR 41325 (August 7, 2001).

  119. 66 FR 56681-56687.

  120. Trela, Patricia. "IRF PPS Coding Challenges." Journal of AHIMA 78, no.5 (May 2007): 70-71.

  121. ACRM/AAPM&R Task Force, Uniform National Data System, Meeting Minutes (Las Vegas, NV, February 26, 1984).

  122. Hamilton BB, Granger CV, Sherwin FS, Zielezny M, Tashman JS. "A uniform national data system for medical rehabilitation," in Fuhrer MJ (ed): Rehabilitation Outcomes: Analysis and Measurement. Baltimore, MD: Paul H Brookes Publishers, 1987, pp 137-147.

  123. The Research Foundation of State University of New York, SUNY at Buffalo. "Proposal for Field Initiated Research Project: Development of a Uniform National Data System for Medical Rehabilitation." Submitted to the National Institute of Handicapped Research, Office of the Assistant Secretary for Special Education and Rehabilitative Services, U.S. Department of Education by the State University of New York at Buffalo, Department of Rehabilitation Medicine, Carl V. Granger, M.D., Project Director, Byron B. Hamilton, M.D., Principal Investigator. (May 21, 1984).

  124. ACRM/AAPM&R Task Force, Uniform National Data System, Meeting Minutes (Las Vega, NV, February 26, 1984).

  125. A letter from Carl Granger to the American Hospital Association Section for Rehabilitation Hospitals and Programs suggesting how to respond to developers of existing assessment instruments included the text: "Several developers of disability assessment and rehabilitation outcome instruments and/or reporting systems have recommended that the Task Force adopt their products as a national system. The Task Force has noted the recommendations and implications of these requests and as a result has developed a position statement (appended) intended for wide dissemination concerning proprietary interests and development of the National Data System for Medical Rehabilitation…. The Task Force is attempting to anticipate the needs of the marketplace by developing an unbiased, valid, and reliable minimum data set." [Letter from Forer and Granger, signed only by Granger; no copy of the position statement found.] The Task Force rejected a system in place at the University of Pittsburgh, saying "Although the HUP system is perhaps the best available patient data base for medical rehabilitation, it has some shortcomings. It is an abstracting service with the usual reports to each hospital, but many rehabilitation units do not want to subscribe to such a service even if they are willing to contribute data for the purpose of establishing national norms." (Research Foundation, SUNY-Buffalo. "Proposal," 1984.)

  126. The National Task Force on a Uniform National Data System for Medical Rehabilitation, Minutes September 28-29, 1985, Kansas City, MO.

  127. The National Task Force on a Uniform National Data System for Medical Rehabilitation, Minutes for Meeting held in Baltimore, MD, October 20, 1986.

  128. Research Foundation, SUNY-Buffalo. "Proposal," 1984.

  129. The dispute over FIM ownership is at the heart of the FIM trademark case, in which UBFA, Inc. is the claimant and AMRPA the opposer. AMRPA argues in their opposition: “Applicant is aware that others in the field contributed to the research and development of the assessment tool known as the FIM, and that the assessment tool was not developed solely by or for Applicant but was the product of an industry-wide Task Force.” ("Notice of Opposition" American Medical Rehabilitation Providers Association, Opposer v UB Foundation Activities, Inc., Applicant" In The United States Patent and Trademark Office Before the Trademark Trial and Appeal Board, November 7, 2003). The UBFA applicant-respondent's trial brief (September 21, 2007) reads: "Dr. Carl Granger, the Director of Uniform Data System for Medical Rehabilitation ("UDS" or UDSMR") and a physician with an extensive background and experience in rehabilitation medicine, began to develop a medical-rehabilitation-assessment tool in 1970. In early 1984, Dr. Granger became a member of a task force to look at rehabilitation tools. Three months later, in May 1984, the Research Foundation of the State University of New York applied for a grant to the National Institute of Handicapped Research within the U.S. Department of Education. The grant's purpose was to develop a uniform national-data system for medical rehabilitation. Dr. Granger was the grant's Project Director. Contrary to repeated statements in AMRPA's Brief, the Task Force did not apply for or receive the grant; indeed the Task Force is explicitly identified in the grant application as nothing more than a consultant. As Dr. Granger testified, the Task Force played an advisory role. In 1985, the Research Foundation of the State University of New York filed a further application to continue the grant. The FIMTM instrument was developed as part of the work under the grant; it was not completed before the grant was completed. All rights in the FIMTM instrument were owned by the Research Foundation of the State University of New York, and were assigned to University at Buffalo Foundation Activities, Inc." ("Applicant-Respondent's Trial Brief" American Medical Rehabilitation Providers Association, Opposer-Petitioner, v UB Foundation Activities, Inc., Applicant-Respondent" The United States Patent and Trademark Office Before the Trademark Trial and Appeal Board, September 21, 2007).

  130. ACRM/AAPM&R Task Force minutes (February 26, 1984).

  131. American Medical Rehabilitation Providers Association, Opposer-Petitioner, v UB Foundation Activities, Inc., Applicant-Respondent" The United States Patent and Trademark Office Before the Trademark Trial and Appeal Board.

  132. The grant extension proposal also suggested a greater role for the task force: "The AAPM&R Task Force reviewed a draft of the demographic characteristics and functional behavior items at the October 20 meeting held in conjunction with the annual meeting in Boston… Over the course of a full day's deliberations, decisions were made with respect to the items. A major decision was to measure functional behavior on a four-point rather than a five-point scale. The instrument is called the Functional Independence Measure." "Steven Forer [task force co-chair] developed the demographic items for review by the project personnel as well as a code sheet. Both were adopted with some modifications." ("Continuation of Field Initiated Research Project; Development of a Uniform National Data System for Medical Rehabilitation". Submitted to: The National Institute of Handicapped Research, Office of the Assistant Secretary for Special Education and Rehabilitation Services. Submitted by: The State University of New York at Buffalo, Department of Rehabilitation Medicine, Carl V. Granger, MD, Project Director, Byron B. Hamilton, MD, Principal Investigator, January 18, 1985).

  133. Research Foundation, SUNY-Buffalo. "Proposal," 1984.

  134. Research Foundation, SUNY-Buffalo. "Continuation of Field Initiated Research Project," 1985.

  135. Harada, N.D., G. Kominski, and S. Sofaer (1993). "Development of a Resource-Based Classification for Rehabilitation" Inquiry. 30(1): 54-63.

  136. Stineman, M.G. et al. (1994) "A Case Mix Classification System for Medical Rehabilitation." Medical Care 32 (4):366-79.

  137. Carter, G.M., D.A. Relles, B.O. Wynn, et al., (2000) Interim Report on an InpatientRehabilitation Facility Prospective Payment System, Santa Monica, CA: RAND, MR-1503-CMS. Accessed at http://www.rand.org/pubs/drafts/DRU2309/.

  138. P.L. 106-113.

  139. Medicare Payment Advisory Commission: Post-Acute Care Providers: Moving Toward Prospective Payment. Report to Congress: Medicare Payment Policy. Washington, DC. March 1999.

  140. UDSMR. "Statement of Ownership of the FIM System." (n.d.) The Statement went on to read: "Any incorporation of portions of the Guide or other copyrighted works relating to the FIM System into other works, any modification of any such modified works by third parties, and any use of any such copyrighted works of the FIM service marks owned by UDSMR, without a license from UDSMR, is and remains improper and in violation of UDSMR's intellectual property rights."

  141. Tesio L, Granger CV, Perucca L, Franchignoni FP, Battaglia MA, Russell CF: "The FIM(TM) instrument in the United States and Italy: A comparative study." Am J Phys Med Rehabil 2002;81:168-176.

  142. Letter from Kathleen Wall, Partner HodgsonRuss Attorneys LLP (counsel to UDSMR) to Mr. John Shinn, President, PPS Plus Software (December 5, 2002). [interestingly, this letter goes on to say that there is no comparison to MDS and OASIS, because those two, unlike the FIM, are not proprietary.]

  143. UDSMR. Center for Functional Assessment Research. "Research Policy: Use of Instruments" http://www.udsmr.org/instruments.php. [Note December 21, 2009: the research policy is no longer available on the UDSMR web site. A view of an archived edition of the policy is available here -- http://web.archive.org/web/20050930205127/http://www.udsmr.org/instruments.php.]

  144. "UDSMR International: General Information".

  145. UDSMR states that countries, including Italy, Sweden, Finland, Israel, and Japan have implemented parts of the FIM system under license and standards developed by UDSMR. (Tesio, "The FIM Instrument".)

  146. License Agreement Letter between UDSMR and Integrated Voice Solutions, dated July 12, 1994.

  147. The Inpatient Rehabilitation Facility -- Patient Assessment Instrument (IRF-PAI) Training Manual: Effective 4/01/04. (UB Foundation Activities, Inc. 2004). Accessed at http://www.udsmr.org/pdfs/irfpaimanual040104%20(1).pdf.

  148. UB Foundation Activities, Inc. "Briefs on Merits for Defendant" before the Trademark Trial and Appeal Board, in the U.S. Patent and Trademark Office. (September 21, 2007); KPMG LLP. University at Buffalo Foundation, Inc. and Affiliates. Consolidated Financial Statements, June 30, 2009 and 2008 (With Independent Auditor's Report Theron). (October 30, 2009). Accessed at http://www.ubfoundation.buffalo.edu/drpl/node/456.

  149. Tesio. "The FIM Instrument" (2002).

  150. Fiedler, Roger C., Granger, Carl V. and Carol F. Russell. (2000) “UDSMRSM: Follow-Up Data on Patients Discharged in 1994-1996” American Journal of Physical Medicine & Rehabilitation 79:2, March/April 2000, pp. 184-192.

  151. 66 FR 41334; U.S. Centers for Medicare & Medicaid Services. "IRF Patient Assessment Instrument" accessed at http://www.cms.hhs.gov/InpatientRehabFacPPS/04_IRFPAI.asp#TopOfPage.

  152. See http://www.cms.hhs.gov/InpatientRehabFacPPS/downloads/irfpaimanual040104.pdf.

  153. UDSMR. "UDSMR International: General Information" accessed at http://www.udsmr.com/WebModules/International/int_About.aspx.

  154. UB Foundation Activities, Inc. "Briefs on Merits for Defendant" before the Trademark Trial and Appeal Board, in the U.S. Patent and Trademark Office. (September 21, 2007) License Agreement between UBFA, Inc. and HCFA, dated September 21, 1995.

  155. License Agreement between UBFA, Inc. and HCFA, dated September 21, 1995.

  156. American Medical Rehabilitation Providers Association, Opposer-Petitioner, vs. UB Foundation Activities, Inc., Applicant-Respondent. "Applicant-Respondent's Trial Brief". Trademark Trial and Appeal Board, U.S. Patent and Trademark Office, deposited September 21, 2007. http://ttabvue.uspto.gov/ttabvue/ttabvue-91158512-OPP-70.pdf.

  157. Letter from Richard T. Linn, Director, UDSMR, to Christy Schmidt, Executive Coordinator, Regulatory Reform Initiative, ASPE, dated April 17, 2002. ASPE apparently had put out a request for input to which AMRPA had responded.

  158. Richard Linn letter, April 17, 2002.

  159. The text of the OMB circular at the time of the FIM grants was slightly different from what it is currently, but basically states the same thing. As codifed in 34 CFR 74.145 (revised as of July 1, 1984), the text read: "Copyrights. (a) Works under grants. Unless otherwise provided by the terms of the grant, when copyrightable material is developed in the course of or under a grant, the grantee is free to copyright the material or permit others to do so… (c) ED rights. If any coyrightable material is developed in the course of or under an ED grant or subgrant, ED shall have a royalty-free, nonexclusive, and irrevocable right to reproduce, publish, or otherwise use, and to authorize others to use, the work for Federal Government purposes."

  160. "Addendum to September 21, 1995 License Agreement Between Uniform Data System for Medical Rehabilitation and Department of Health and Human Services, the Centers for Medicare & Medicaid Services, dated February 1, 2002.

  161. 1995 License Agreement.

  162. 2002 License Agreement Addendum.

  163. UDSMR Position Statement Concerning HCFA/RAND Reports on the Development of a Prospective Payment System for Medical Rehabilitation (dated September 1997).

  164. Trosow, Samuel E. I. Copyright Protection for Federally Funded Research: Necessary Incentive or Double Subsidy? (draft paper September 7, 2003).

  165. U.S. Patent and Trademark Office. Trademark Trial and Appeal Board. American Medical Rehabilitation Providers Association v. UB Foundation Activities, Inc. September 23, 2008. Accessed at http://ttabvue.uspto.gov/ttabvue/ttabvue-91158512-OPP-78.pdf.

  166. For example, Herndon, in the Handbook of Neurologic Rating Scales 2nd ed.(Demos Medical Publishing, 2006) indicates that the 7-point scale is under copyright, but later writes that "The FIM has become proprietary."

  167. Holthaus, Danielle, and Andrew Kramer. "Introduction, Background, and Objectives" Uniform Patient Assessment for Post-Acute Care (Aurora, CO: Division of Health Care Policy and Research, University of Colorado at Denver and Health Sciences Center, 2006). Accessed at http://www.bu.edu/hdr/documents/QualityPACFullReport.pdf.

  168. The National Task Force on a Uniform National Data System for Medical Rehabilitation, Minutes for Meeting held in Baltimore, MD, October 20, 1986.

  169. UDSMR web site.

  170. Research Foundation, SUNY-Buffalo. "Continuation of Field Initiated Research Project," 1985.

  171. UDSMR. "Why Uniform Data Now?" (n.d.) Document appears to be a draft of a brochure.

  172. Letter marked "Draft" from Carl V. Granger, M.D. to Carolyn Zollar (dated August 8, 1986). This letter was in response to a letter from Carolyn Zollar, General Counsel to the National Association of Rehabilitation Facilities (NARF), dated June 29, 1986.

  173. Letter re: UDSMR/Formations in Health Care, Inc. dated August 16, 1994, from Tricia T. Semmelhack to Laura Dickinson Lee.

  174. Letter from Kenneth W. Aitchison, President, Kessler Rehabilitation Corporation to Carl V. Granger, M.D., UDSMR, dated April 7, 1998. (A copy of the AMRPA position statement was not located.)

  175. Letter from Carl V. Granger, Professor Rehabilitation Medicine, and Director, CFAR & UDSMR to Kenneth V. Aitchison, President, Kessler Rehabilitation Corporation, dated April 28, 1998.

  176. Letter from Marisa Smith, Paralegal, UDSMR to Robert M. Rowe, Director of Information Services, InterLink Rehab Services, dated October 22, 1999.

  177. Email response from Marisa Smith, Legal Services Supervisor at UDSMR to Dr. Michael Yoshida at the VA, dated April 08, 2002.

  178. Velozo, C.A., Byers, K.L., & Joseph, B.R. (2007). Translating measures across the continuum of care: Using Rasch analysis to create a crosswalk between the Functional Independence Measure and the Minimum Data Set. Journal of Rehabilitation Research and Development. 44(3): 467-478.

  179. The VA user's manual for the FIM is available at http://www.va.gov/vdl/documents/Clinical/Func_Indep_Meas/fim_user_manual.pdf.

  180. Braddom, Randall L. "Medicare Funding for Inpatient Rehabilitation: How Did We Get to This Point and What Do We Do Now?" Archives of Physical Medicine and Rehabilitation Volume 86, Issue 7, July 2005, Pages 1287-1292.

  181. 17 U.S.C. §105 http://www.copyright.gov/title17/92chap1.html#105.

  182. AHIMA Comments on CMS SNF PPS for Skilled Nursing Facilities (June 30, 2009). http://www.ahima.org/dc/documents/AHIMACommentsonCMSSNFPPSforSkilledNursingFacilities.pdf.

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