National Committee on Vital & Health Statistics

July 3, 1997

Bruce Vladeck, Ph.D.
Health Care Financing Administration (HFCA)
200 Independence Ave., Rm. 314G
Washington, D.C. 20201-0001

David Garrison
Deputy Assistant Secretary
Office of Planning and Evaluation HHS
200 Independence Ave., Rm. 415F
Washington, D.C. 20201-0001

Dear Dr. Vladek and Mr. Garrison:

On June 24th the National Committee for Vital and Health Statistics (NCVHS), Subcommittee on Population-Specific Issues were briefed by two Health Care Financing Administration (HCFA) staff about the Notice of Proposed Rule Making (NPRM) to alter the conditions of participation for Home Health Agencies by mandating the use of the Outcome Assessment Information Set (OASIS) measurement data collection tool. The Committee appreciates the fact that these individuals were so responsive to the agenda and time frame of the Subcommittee which is charged with examining data issues pertaining to populations needing long term care services. We realize that the formal “comment period” specified in the NPRM has elapsed, but the Subcommittee was encouraged to submit comments for consideration by HCFA. The purpose of this letter is to raise a series of questions for your consideration that emerged from the testimony the Subcommittee heard and from subsequent discussion.

We were told that HCFA intends to review the formal comments received, to make those revisions considered necessary and then to proceed with the preparation and publication of final rules. However, we also were told that a major demonstration program is not scheduled for completion until 1999. Furthermore, we were told that discussions within HCFA regarding the viability of integrating data collection across the broad array of post- acute settings is underway. These efforts may significantly reshape the content and structure of OASIS. In light of these activities, and in the absence of a legislative mandate, the Committee does not understand the reason for the rush to issue final rules in this area.

As you know, rapid changes in the health care system are currently underway, particularly in the post-acute and long term care industry. These are already changing the structure of inter-agency relationships amongst hospitals and post-acute settings. While outcomes measurement is important within a single type of provider, the Subcommittee felt that it is increasingly important to have common information about outcomes across the spectrum of post-acute providers. Since there are a variety of different code sets currently in use in other HCFA data collection requirements, it might be best to mandate an instrument for home health only after an overall review of all data gathering in the post-acute setting which would be more consistent with the goal of administrative simplification to which the Committee has been devoting itself.

Several more detailed questions about the use of the OASIS instrument and the resulting data also were raised by Subcommittee members. First, since home based data collection must rely upon the patient and her/his family informants more than the same activity in an institutional setting, Subcommittee members were concerned that alternative language versions of the instrument were not available nor tested (e.g. Spanish). Second, Subcommittee members felt that the cultural interpretation and cross-cultural validity of items pertaining to distressed mood and behavioral problems might be biased, particularly since there are limited, or no, behavioral definitions for whether these states of being were present. Third, it appears that some data elements do not comply with established coding guidelines. The Subcommittee suggests that HCFA fully review all data elements to ensure that they follow established coding guidelines where they exist.

Fourth, use of OASIS to measure the outcomes of clinical interventions delivered by nursing staff who also make the clinical determination of improvement was questioned given the potential for “gaming”. Audits, whether performed by staff internal or external to the agency and which could only be performed sparingly due to the associated costs, may be burdensome for patients being assessed. Even if audits were possible routinely, since the OASIS measures patients’ “capacity” to perform functions, raters can readily argue that improvement in capacity occurred in the absence of no change in behavior. Given the subjectivity of nursing assessments based upon judgments of “capacity”, changes in quality “outcomes” observed in the aggregated reports may be partly attributable to this interpretive subjectivity.

We recommend that HCFA complete an internal review of all data collection initiatives having to do with post-acute care and ensure that new data collection mandates are consistent with established methods or have compelling justification for adopting different approaches. This is consistent with the goal of administrative simplification. We specifically recommend that you reconsider implementation of the OASIS until this

review is complete. Additionally, the results of the major demonstration project underway should be considered. At that point a new NPRM should be released and additional public comment solicited. The Committee would be happy to work with you in these efforts.



Don Detmer, M.D.


cc: Mary Vienna, HFCA