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Department of Health and Human Services

NATIONAL COMMITTEE ON VITAL AND HEALTH STATISTICS

Workgroup on Quality

September 14, 2004

Hubert H. Humphrey Building
Washington, D.C.

Meeting Minutes

The National Committee on Vital and Health Statistics Workgroup on Quality was convened on September 14, 2004 at the Hubert H. Humphrey Building in Washington, D.C.  The meeting was open to the public.  Present:

Committee members

  • Justine M. Carr, M.D.
  • Peggy B. Handrich
  • Robert W. Hungate, Chair, Workgroup on Quality

Absent

  • John R. Lumpkin, M.D., M.P.H.
  • Donald M. Steinwachs, Ph.D.

Staff and Liaisons

  • Stan Edinger, Ph.D., AHRQ
  • Marjorie Greenberg, NCHS/CDC
  • Vickie M. Mays, Ph.D., Chair, Committee on Populations  (conference call)
  • Steve Steindel, Ph.D., CDC liaison
  • Julia Holmes, Ph.D., NCHS (for Ed Sondik, Ph.D., NCHS liaison)
  • Gail R. Janes, Ph.D., CDC
  • Anna Poker, AHRQ, Lead Staff

Others

  • Bill Alfano, BlueCross BlueShield Assn.
  • George Arges, AHA
  • Donald Asmonga, AHIMA
  • Michael Beebe, CBT
  • Teresa Chapa, HHS
  • Robert Davis, Health Care Services Data Reporting Guide
  • Louis Diamond, MEDSTAT
  • Alexandra Goss, ANSI X12
  • Henry Heffernan
  • Debbie Jackson, NCHS
  • Katherine Jones, NCHS
  • Ken Kizer, National Quality Forum
  • Ted Klein, HL7
  • Jean Narcisi, NUCC
  • Dan Rode, AHIMA
  • Barbara Siegel, Hilcrest Health Service System, Inc.
  • Gracie White, NCHS
  • Michelle Williamson, NCHS

EXECUTIVE SUMMARY

ACTIONS

1.  A motion was made, seconded, and then tabled for lack of a quorum for the Workgroup on Quality to move from candidate recommendation three to full recommendation.  This would facilitate reporting on all patient claims of a diagnosis indicator to flag diagnoses present on admission on secondary diagnosis fields. An open conference call will be scheduled before the November 5, 2004 NCVHS Committee meeting.

Other Suggested Actions

Ms. Greenberg suggested sending an electronic version of all presentations of this September 14, 2004 hearing to all full Committee members.

Mr. Hungate recommended raising concerns about the timing of the implementation of UB-04 with the full Committee. Ms. Greenberg suggested composing a letter to the Committee that supports the increased functionality of the UB-04 but that also identifies a problem with a likely delay in implementation.

Ms. Greenberg recommended that the Workgroup on Quality move the recommendations agreed upon at the November 2004 meeting from candidate to actual recommendations.

Purpose of Hearing

The purpose of today’s hearing, as expressed by Ms. Greenberg, was to get more input from those who maintain administrative data. Mr. Hungate delineated the role of the Workgroup on Quality as that of talking about a process that moves the work from agreement to implementation rather than that of decision-maker about the specifics of the process.

INFORMATION NEEDS FOR QUALITY MEASUREMENT PRESENTATION

Ken Kizer, National Quality Forum

The specifics of NQF’s consensus development process were described. NQF is increasingly involved in measure development, primarily in partnership with other entities.

The National Quality Forum (NQF) is supportive of the Committee’s candidate recommendations, especially the focus on functional status. Standardized instruments that measure functional status are needed.  It is important to pursue the business case for measures and the eight candidate recommendations concomitantly. Dr. Kizer expressed concern about putting specific data elements into regulation or statute.

PANEL DISCUSSIONS

George Arges – NUBC 

A UB-04 dataset has been developed with an attempt to closely match the 837i components that pertain to the development of a claim. Among other revisions described, the most significant change to the UB-04 design is the accommodation of the ICD-10-CM diagnosis coding structure, which is intended to provide a better understanding of services rendered.

In responding to questions about the Workgroup’s eight recommendations, Mr. Arges stressed the need to better understand the business case for requested items before they are adopted as part of a routine process for claims submission.

 Jean Narcisi, NUCC

Ms. Narcisi believes that candidate recommendations #1 (Selected Laboratory Results); #2 (Selected Vital Signs and Objective Data); #6 (State and End Dates for Global Procedures), and #8 (Reporting Functional Status Codes) of the eight candidate recommendations apply to a professional claim but recommends pilot testing (including vendors) in each of the above areas.

In response to questions about race and ethnicity, Ms. Narcisi said that neither are typical data elements collected by providers of health care and neither is collected on the paper claim form or the electronic 837 transaction. If race and ethnicity data are available in enrollment databases, administrative claims data would need to be linked to appropriate data in a health plan’s reenrollment databases to identify comparisons among racial and ethnic groups.

 Mr. Michael Beebe, CPT

The AMA and CPT Editorial Panel view CPT Category II codes as an essential part of clinical quality data collection strategy whose use is expected to increase despite the lack of payment incentive for reporting. However, while CPT codes can be used to report lab results, there is a disconnect between a reported lab test and results that often surface at a later date.

Mr. Beebe thought that candidate recommendations #1, 2, 6, & 8 apply to professional claims for which CPT codes would apply. However, there may be a timing issue for reporting laboratory test results since they may not be available to coders when claims data are reported to the payer.

Mr. Dan Rode, AHIMA and Ms. Barbara Siegel, AHIMA

Ms. Siegel supported the adoption of ICD-10-CM and advocated for a classification system that provides better data related to quality and patient safety. Mr. Rode specifically addressed questions raised about the eight candidate recommendations, noting that the candidate recommendations should serve as a core group of data elements for consensus and standards, as additional recommendations from other groups are anticipated.

Mr. Rode was unable to gather feedback from his group about race and ethnicity in time for the meeting though he noted that providers typically do not collect this data outside of the inpatient environment, and even then, it is not standardized. There is also no way to collect data on people who do not have health coverage.

Candidate recommendation #10 (standardization of current inconsistent data) should accompany the first eight recommendations. Mr. Rode also suggested further consideration of recommendations #14 (adoption of standard clinical terminologies) and recommendation #16 (adoption of ICD-10-CM).

Ms. Greenberg explained that the adoption of ICD-10-CM and ICD-10-PCS (for inpatient use) would not affect the use of CPT codes. Mr. Arges clarified that the redesign of the UB-04 is primarily to accommodate ICD-10-CM. Mr. Rodes believes it will be useful for the Workgroup on Quality to point out the potential uses of a more detailed and updated classification system.

Alexandra Goss, ANSI X12

Ms. Goss noted that the underlying system supporting the exchange of administrative and financial health care information is not standard. The industry has focused on collecting data to justify reimbursement rather than on improving the state of health.  Thus, a learning curve is needed.

X12 supports changes defined by industry consensus. Ms. Goss noted that candidate recommendations #1-8 can be supported using existing transactions. A two-tiered approach using a short- and long-term structure is recommended. Ms. Goss requested that X12 be invited to testify at future hearings on recommendations #11, 12, 13, 16, 19, 20, 21, and 22.  She provided specific input about the eight recommendations.  X12 supports bundling the eight recommendations if quality outcomes will improve. X12 recommends that NCVHS finalize their policy and submit change requests through the DSMO process.

With regard to race and ethnicity, some reporting can be supported but the specific data element for reporting an individual’s race or ethnicity (known as DMGO5) is not currently used in most implementation guides. There are also operational concerns with collecting and the accuracy of this data.

Mr. Ted Klein, HL7

HL7 version 3 standards are a form for information intended to achieve interoperability that is based upon the reference information model. At present, nearly all US hospitals use HL7.

Mr. Klein commented on the eight recommendations, stating that most items identified in the recommendations are currently covered in HL7 transactions. In cases where the data exists, billing systems rarely accept HL7 data, which is correctable. He supported the use of business or regulatory incentives and suggested modification of current claims transaction forms. Mr. Hungate concluded that HL7 is rich source of clinical information that, however, does not translate into what purchasers ask for. Mr. Hungate suggested that this is where a business case must be made.

All HL7 transactions carry patient demographic data including race and ethnicity codes but these codes are rarely captured, due mostly to “people” issues.

Mr. Robert Davis, Health Care Services: Data Reporting Guide

The Health Care Service Data Reporting Guide utilizes existing health care data to help answer basic questions about quality and cost of health care. Mr. Davis recommends a data centric approach to integrating diverse health service delivery systems that denotes what and how data is collected.

In response to the eight recommendations, Mr. Davis noted that certain data elements are already supported using the Health Care Service Data Reporting Guide 837 document. He also noted what concepts would not apply to data elements in the Reporting Guide.

Regarding benefits to NCVHS constituencies, 45 states collect and use hospital administrative data for market, policy, and quality purposes. With regard to pay-for-performance, NAHDO and the Consumer-Purchase Disclosure Group believe that enhancing UB data elements by adding specific target data elements would increase the power of existing administrative data.

Ms. Goss reiterated that X12 and HL7 have different objectives, systems, and standards but noted that X12 and HL7 have begun to develop more of a working relationship, which is much needed for terminology harmonization.

MEDSTAT PRESENTATION:  Louis Diamond, VP and Medical Director

The presentation focused on a global approach to access and use of clinical data to support quality measurement sets. Interim strategies are needed until an electronic health record is fully operational and even then, a consistent approach will be necessary. Questions were posed about the scope and amount of clinical data, the identification and criteria used to determine data elements, and approaches to obtaining data. Definitions of data were presented. Also noted was the distinction between use measures and robust quality measures (and concomitant levels of evidence), laid out on a continuum from use measures to quality indicators to quality measures.

Dr. Diamond described the need for a systematic approach to developing priority conditions and steps needed to make sequential decisions about what clinical and administrative data and criteria to focus on.  In the interim, linking financial and claims data to patient level laboratory results is important.

Responding to the candidate recommendations, Dr. Diamond said that he did not understand the context of the chosen data elements. Although all the data elements were “important,” he might not have listed them in a first go-around for collecting or linking clinical data to the UB-92 or UB-04. He asked about the uses of the chosen data elements and said that he was not fully comfortable with those data elements.

Discussion – NEXT STEPS

Central to the discussion was a plea for standardization of data elements as well as consideration of what vehicle should collect the data.  The development of a matrix to facilitate analysis of categories of key characteristics of this hearing’s comments was suggested.

Highlights:

Need to work on data sets while developing electronic health records was emphasized along with the need to understand the goal of the inquiry. Other considerations included the definition and intrinsic value of data elements; how data is collected; where data is stored; and how data is transmitted.

Need for consensus: Standards do not stand in the way of collecting information but consensus is needed for what is to be accomplished and how. The bottom line is about whether a real business case exists rather than whether the data could be valuable.

Conversion of candidate recommendation to a definite recommendation:

In the November 2004 Committee meeting, recommendations will be made to the Department  about adopting the 5010 as the next version of the HIPAA standards for the claim implementation guide. A suggestion was made that the Workgroup bring any of the eight candidate recommendations ready for conversion into actual recommendations to the November 2004 Committee meeting.

Support of ICD-10-CM includes the possible submission of another letter of support by the Workgroup to the Department. It was noted that UB-04’s increased functionality goes beyond accommodating ICM-10-CM and ICM-10-PCS in that it can be used with 9-CM volumes one, two, and three. With no signal from the Department that ICM-10-CM and ICM-10-PCS will be implemented, it would be difficult to make the case to the provider community.

Follow-up for UB-04 and ICD-10-CM relationship was discussed. An 837R with the 275 claims attachment would meet more needs and address many concerns raised (it was suggested that the latter be called the 275 clinical attachment). The appropriateness of the Workgroup identifying the mechanics but not the researchable business case of the data collection process was clarified.

Race and ethnicity:  The business case for race and ethnicity data is now generally accepted but how to collect this data poses a different challenge. At issue on the business side is the question of why and for what purpose the data is being collected. It would be useful to talk about criteria for a business case, which the Workgroup on Quality has not yet done. A question was raised about how to check for data reliability on race and ethnicity. Some thought it important to report race and ethnicity in sites other than inpatient hospitalization.

Removal of quality data collection from regulatory process:  Some felt that the collection of quality data should be taken out of the regulatory process for greater flexibility although this removal would need to be re-examined if the adjudication process were to move toward pay-for- performance.

DETAILED SUMMARY

CALL TO ORDER, WELCOME, INTRODUCTIONS, REVIEW OF AGENDA

Information Needs for Quality Measurement
Ken Kizer, National Quality Forum

The National Quality Forum (NQF) is supportive of the Committee’s recommendations, especially the focus on functional status.  The NQF cannot comment about the business case but thinks that the recommendations help build the business case for other entities more directly involved.  NQF is supportive of standardization and public reporting of information to make health care more transparent but strongly believes that the metrics used must be standardized.

Discussion

Responding to a question from Mr. Hungate about NQF’s process of moving the “art” of the measurement system, Dr. Kizer provided background information.  NQF is a voluntary consensus standard setting membership group of approximately 250 organizations, which operates under the guidance of the National Technology and Transfer Advancement Act to endorse national performance measurements. It serves as the convener of consumers, purchasers, providers, researchers, and industry but is increasingly being asked to become involved in implementing various recommendations.

NQF’s consensus development process is formal and specific. They convene an expert group or steering committee and issue a call for consensus standard, which, as defined by OMB, includes performance measures, quality indicators, and preferred or safe practices, among others.  A candidate set of performance measures is selected for widespread review to member organizations and the public. Once revised, the document is voted on by member organizations and some measures may be returned to members for further review.  Measures are then forwarded for an action vote by the board of directors.  The board may request further work on documents or it may vote on the measures. An obligatory appeals period follows a board endorsement of measures. With no further challenges, measures are accepted as national NQF endorsed performance measures. Despite its complexity, the process moves along quickly, using 30-day timelines. A formal consensus process typically takes four to six months after developing a candidate set of measures.

While NQF endorses existing measures based on needs, priorities, validity of measures, etc., they are increasingly involved in measure development, primarily in partnership with other entities.  NQF shows how a consensus process and development of standards cuts down on time and expense while capitalizing on the expertise of partnering organizations.  NQF’s involvement ensures an appropriate balance of interest (a requirement by law) as well as clear documentation of the decision-making process.

Dr. Carr asked Dr. Kizer if he had a preference for measures over outcomes and also about whether there is value in trying to achieve quality on the basis of a specific outcome versus a measure.  Dr. Kizer noted the complexities of looking at outcomes, especially as related to performance measures and risk adjustment. NQF, which “likes” outcomes, also recognizes that there will never be enough to satisfy the need for quality measurement. Dr. Kizer predicts a panoply of measures, the majority of which would be process measures subject to influence by the caregiver.  Structural measures may also exist, as illustrated by the nursing care measures endorsed earlier in 2004. Achievement of valid and reliable measures is probable in the future.

Noting that some candidate recommendations ask for results (such as lab or blood pressure results), Dr. Carr wondered whether quality will move ahead with such results. That something was measured is more important than what was measured. Dr. Kizer added that this depends upon the intended use of a specific measure. With hypertension control, for example, one must look at blood pressure levels as well as at medication, dietary counseling, weight control, and other considerations.

Dr. Carr asked how NQF recommendations might be operationalized.  Was there a systematic strategy for gathering and reporting on NQF recommendations in the field? She noted that since Leapfrog put forward safety measures, hospitals have been scoring themselves and self-reporting, which is a good start. Dr. Kizer noted that operationalizing the process would vary.  For example, nursing care performance measures endorsed in early 2004 will be part of the Joint Commission accreditation process in 2005. In California, NQF’s work involves getting health plans, hospitals, consumers and others to agree on what goes into a statewide report card on hospitals. He reiterated that NFQ’s involvement in implementation is relatively new but definitely moving forward, largely in partnership with others.

Referring to the example of hypertension control, Dr. Steindel asked why measurement was important for a patient with hypertension. Dr. Kizer said measurement was important in determining the effectiveness and cost of treatment.  Dr. Steindel noted many reasons for ineffective treatment and Dr. Kizer agreed that it is important to look at an array of factors. Dr. Steindel thought it important to understand why a desired outcome does not happen.

Relative to performance measures, Dr. Steindel also wondered what process steps to develop guidelines would look like, particularly if other organizations were also working on the same guidelines. He wondered how to standardize decision support dissemination and the use of guidelines. Dr. Kizer differentiated between guidelines and performance measures, noting that performance measures are one way of looking and guidelines are one way of getting to a desired outcome that can be assessed with a performance measurement. Ms. Greenberg referred to a summary of the June 24-25, 2004 Workgroup on Quality hearings on data gaps impeding the ability to adequately assess health care quality, with a principal focus on care delivered in hospital and office or clinic settings. (note Quality report “Measuring Health Care Quality: Obstacles and Opportunities”)

Ms. Greenberg noted frustration in the provider community due to “everyone asking for the same thing a little differently.”  She asked what NCVHS and specifically what the Workgroup on Quality could do to support further standardization, noting that both organizations have the goal of promoting the use of standards. Dr. Kizer said that while consolidation has begun, there is still much to do, with lots of turf, proprietary, economic, and other interests at play.  NQF believes that anything they endorse must be an open source, but this can conflict with the business model of some measure developers. He will think about what the Workgroup on Quality can contribute.

The purpose of today’s hearing, as expressed by Ms. Greenberg, was to get more input from those who maintain administrative data. Ms. Greenberg identified conflict between those making the business case for measures and the eight candidate recommendations from the June 24th Hearing. Dr. Kizer noted that we are many years from achieving electronic health records as the norm in this country. Yet, the quality agenda continues to move forward such that we need to make our administrative data better as we pursue the acquisition of electronic health records.

Dr. Holmes inquired about the extent to which NQF’s members think about whether data exists on which to build performance standards and measures. Dr. Kizer described an uneven playing field but said that the Forum has mostly worked with existing measures. As they move into the development arena, the availability of data will be one of the criteria used in making recommendations for measures.

Dr. Steindel stated that the development of administrative data and electronic health records were on relatively convergent tracks. He asked Dr. Kizer if it made sense to divert energy from the electronic health record to administrative data.  Dr. Kizer believes it important to pursue both tracks concomitantly. Ms. Greenberg added that administrative data could move forward within a year or two for specific candidate recommendations, but that the process would slow down significantly in a rulemaking phase. Dr. Kizer expressed concern about putting specific data elements into regulation or statute. He thinks it makes much more sense to refer to consensus standards or a body with a process because the science base changes so quickly that we don’t need to put these measures into law, whether administrative or statutory.

Dr. Mays asked for clarification about Dr. Kizer’s earlier comment about the need for more traction for functional status. Dr. Kizer said that at the end of the day, what is important is that patients are more functional and their lives are improved. He added that we can have all kinds of process and outcome measures that don’t give us this information. Therefore, we need standardized instruments that measure functional status. Dr. Kizer expressed disappointment that the VA remains the only system that tracks functional status. He expressed hope that Medicare would again consider assessing functional status with encouragement from the Workgroup on Quality. He further stated that the VA system’s use of objective measures costs half to two-thirds of what Medicare pays.

PANEL DISCUSSIONS
1.  George Arges – NUBC 

A voluntary committee working to establish data reporting requirements for institutional providers since 1975, NUBC approved its first dataset in 1982, the UB-82, also called HCFA 1450, which was replaced in 1992 with the UB-92 dataset. In 1992, the committee approved a 10-year moratorium on changes to the dataset to allow the health care community to focus on the HIPAA implementation. Since late 2002, the NUBC has reviewed UB-92 for a redesign in response to a 2003 request by NCVHS to align the UB paper form with the HIPAA electronic 837 standard. Other review considerations include public health concerns; the need for a national approach to research data; new reimbursement models; increased administrative efficiency of existing standards, recognizing the importance of clinical coding and the eventual implementation of ICD-10-CM; the eventual release and adoption of other HIPAA identifiers such as provider and health plan identifiers and improvement of the handling of liability claims; and a mix of state variations in handling local health care data needs.

A UB-04 dataset has been developed with an attempt to closely match the 837i components that pertain to the development of a claim. “Pay-to” provider instructions have been added while employer address and marital and employment status codes have been removed. Distinct areas within the form have been created to handle city, state, zip code, last and first names, and accident information. The UB-04 dataset is likely to meet challenges from federal and state legislation and new reimbursement models.

The most significant change to the UB-04 design is the accommodation of the ICD-10-CM diagnosis coding structure for diagnosis reporting in all patient services. The field size has been expanded along with the number of diagnosis codes reported on the paper from nine to 16. An ability to report whether a particular diagnosis code was present at the time of admission was added within each diagnosis field. These changes are intended to provide a better understanding of services rendered to the patient.

Other revisions include: an expanded field size for procedure code reporting at the line and claim levels. For example, the procedure code for inpatient services can now accommodate the new ICD-10-PCS field size. For outpatient claims, the field size at the individual service line can be 14 characters in length, which allows reporting of the HCPCS with up to four modifiers (up from two modifiers). This shift allows for the reporting of some of the new cancer drug codes that are also covered under the MMA, using a national drug code.

A new feature of the UB-04 dataset is the introduction of a code-code field, which allows reporting of data from external, non-NUBC code lists. The purpose is to reduce the frequency of reliance on costly claim attachments when unusual events require reporting of a particular clinical value or measure. The design of this field can also accommodate overflow reporting of internal NUBC code fields such as condition, value, and occurrence codes. Another new feature establishes a distinct field for handling report accidents. A state identifier is part of the field, which will help health plans and workers compensation organizations review the claim.

Mr. Arges responded to questions about the Workgroup’s eight recommendations:

Recommendation 1:  The UB dataset accommodates the reporting of laboratory results by using a value code or a code-code field. For example, a new value code reports a patient’s weight and height, allowing CMS to determine body mass index for additional payment to the ESRD provider.

Recommendation 2:  Value codes and code-code fields also accommodate reporting for select vital signs such as heart rate, blood pressure, temperature, respiratory rate, and others. It is important to understand their use during a claims review and to know when to take these vital signs for reporting purposes. As new treatments and technologies arise, these data measures are likely to change or influence how data components are viewed in their application of quality-based performance. Providers are concerned about the frequency and the implications of such changes.

Recommendation 3:  UB-04 design allows reporting of a diagnosis modifier with each ICD-10-CM diagnosis. One of the main reasons for the UB-04 is to accommodate the clinical code enhancements.

Recommendation 4:  The UB-04 will have a distinct field for reporting “operating” physician responsible for the principal surgical procedure. The NUBC is working with the X12 Claim Workgroup to better define attending, operating, referring, and other provider types for reporting in a claim transaction.

Recommendation 5:  The new UB database allows reporting of Admission Date and Time (hourly code range) along with corresponding dates. There is no reporting field for the procedure hour.

Recommendation 6:  Global procedure code reporting is not part of the institutional billing process but is more common on physician claims. NUBC encourages health plans to come to agreement about provisions of global procedure code reporting and to present those recommendations to them.

Recommendation 7:  The UB dataset accommodates the reporting of functional status but requests additional guidance about the implications for collecting functional status and clinical reporting. NUBC has the right data element design to accommodate such reporting but acknowledges that there is more work to be done in understanding how health plans routinely utilize and apply data. There is a need to standardize practices among health plans for data items within the dataset.  (See transcript for examples and a more detailed description of the need for consistent use of data items within datasets and health plan differences)

Recommendation 8:  The UB-04 accommodates the recommendation to facilitate the reporting of a diagnosis modifier to flag diagnoses present on admission on secondary diagnosis fields in inpatient claim transactions. The adoption of UB-04 is predicated on whether ICD-10-CM is adopted for diagnosis reporting.

Summary:   Mr. Arges stressed the need to better understand the business case for requested items before they are adopted as part of a routine process for claims submission. This includes having sufficient information about proposed performance adjustment factors.  He added that other questions can only be answered when NUBC receives specific requests.

2.  Jean Narcisi, NUCC

The National Uniform Claim Committee (NUCC) was created to develop a standardized dataset to transmit claim and encounter information to and from all third party payers. Replacing the Uniform Claim Form Task Force co-chaired by the AMA and CMS, the organization’s work has paralleled that of the NUBC for the non-institutional health care community since 1995.  NUCC maintains the CMS 1500, a single paper claim used by all third party payers.

NUBC is formally named in the administrative simplification section of HIPAA as one of the organizations to be consulted by the American National Standards Institute and the Secretary of HHS. The NUCC was also asked to maintain HIPAA transaction standards. The updated version of the NUCC dataset serves as a supplementary document to the 837 professional implementation guide and includes a mapping and cross reference to the 1500 paper claim form.

Ms. Narcisi believes that recommendations #1 (Selected Laboratory Results); 2 (Selected Vital Signs and Objective Data); 6 (State and End Dates for Global Procedures), and 8 (Reporting Functional Status Codes) of the eight candidate recommendations apply to a professional claim but recommends pilot testing (including vendors) in each of the above areas.

Note:  CPT Category II codes for Performance Measurement are new codes intended to facilitate data collection by coding services and/or test results that contribute to positive health outcomes and quality patient care. These optional tracking codes for performance measurement decrease the need for record abstraction and chart.

Candidate Recommendations #1, 2, and 6 could currently be reported using CPT Category II codes on a 1500 paper claim form or an electronic 837 transaction without modifying the NUCC dataset, 1500 form, or electronic transaction. However, lab results and vital signs may not be available to coders when claims data are collected and reported to payers. Category II codes are not currently used to collect this kind of data and data collection is not yet standardized.  Relative to #6, billing instructions are not yet standardized for procedure start and end dates. While NUCC could develop standardized billing instructions as well as codes and guidelines for global procedures, they would need to be adopted by CMS, Medicaid agencies, and private payers.  Recommendation #8 could possibly be reported in the current 1500 paper claim form or electronic 837. (see transcript for further explanation of allowing functional status to be reported using current reporting mechanisms)

Standards for exchange of patient data are necessary and must be consistent with already mandated standards. Quality measurement data standards must support dual use of privacy, security, identifiers, messaging formats and data content of HIPAA standards. Cost of implementation must be considered.

In response to questions about race and ethnicity, Ms. Narcisi said that neither are typical data elements collected by providers of health care and neither is collected on the paper claim form or the electronic 837 transaction.  Adding these elements to the HIPAA implementation guides would take a very long time to implement and collection of these data would be burdensome to the provider. Currently, the following is listed in the enrollment guide: “this data should only be transmitted when such transmission is required under the insurance contract between the sponsor and payer and allowed by federal and state regulations.” (see transcript for detailed discussion of DSMO change request in this arena)

Ms. Narcisi stated that the focus of data collection must remain on the needs of patients, their physicians, health care professionals, and the institutions in which patients receive care. Therefore, if race and ethnicity data are available in enrollment databases, administrative claims data would need to be linked to appropriate data in a health plan’s reenrollment databases to identify comparisons among racial and ethnic groups.

3.  Mr. Michael Beebe, CPT

Mr. Beebe opened discourse on a relatively new effort by the AMA and the CPT Editorial Panel to develop codes for performance measurement. Stating that the new CPT Category II codes are a significant step towards a simplified and standardized reporting mechanism for agreed upon performance measures, Mr. Beebe described the history of CPT as a standard.

Category II codes, which facilitate data collection by coding certain services and/or test results that contribute to positive health outcomes and quality patient care, are published twice/year (January and July 1st) in the CPT book and are distributed on the AMA CPT Internet site. AMA has developed a standard clinical documentation format known as the SOAP form (subjective, objective, assessment, and plan) as an outline structure in the CPT book that contains categories such as patient history; physical examination; diagnostic screening; therapeutic, preventive, and other interventions; follow-up; and patient safety. Appendix H in the CPT book connects CPT codes to descriptions of performance measures and other pertinent information.

Category II codes are developed by the Performance Measures Advisory Group (PMAG) appointed by the Editorial Panel (membership is described in the transcript). PMAG considers code proposals from a variety of regulatory, accrediting, and professional organizations when the purpose or definition of the measure reflects quality improvement or accountability measures (note examples in transcript). Recently, some Category II codes have been based on measures developed by the NCQA. AMA has asked NCQA to include information about the availability of Category II codes in their upcoming publication of “NCQA Criteria and Measurement Rules.”

Mr. Beebe thought that the same four of the first eight candidate recommendations as described in the previous panel presentation apply to professional claims for which CPT codes would apply (recommendations #1, 2, 6, & 8).  However, there may be a timing issue for reporting laboratory test results since they may not be available to coders when claims data are reported to the payer.  CMS has also stated that no additional payment would be made for the use of these codes though practitioners may report them on Medicare bills to track the services.

Summary: The AMA and CPT Editorial Panel view CPT Category II codes as an essential part of clinical quality data collection strategy whose use is expected to increase despite the lack of payment incentive for reporting.

Discussion

Mr. Beebe said yes to Ms. Greenberg’s question about whether CPT codes could be used to report laboratory results but noted a disconnect between a reported lab test and results that often surface at a later date. Using the example of a diabetic foot exam, Mr. Beebe emphasized a provider’s ability to say that a foot exam had met a process measure within the CPT Category II codes during an office visit on a diabetic patient although s/he would not be able to report that a foot exam was actually done.

Dr. Steindel asked if a provider was using the codes to report a result utilizing the 1500 form, would s/he report a Category II code in the code field or the result in the charge field?  Mr. Beebe said that both would be reported but that a provider might report the test result at a later  encounter. Reporting of a range of results (rather than exact results) would go in the CPT code field.

4.  Mr. Dan Rode, AHIMA and Ms. Barbara Siegel, AHIMA

AHIMA is a professional association representing more than 48,000 members certified to manage patient medical and clinical information in the form of health records and databases.  AHIMA members work for the supplier of data, taking quality of care and patient safety into consideration.. Mr. Rode stated that many health care organizations are facing implementation of standardized electronic health record at different rates.

Ms. Barbara Siegel (immediate past president of AHIMA and director of Health Information at Hackensack University Medical Center), described the environment facing many healthcare providers, and especially hospitals. Recognizing that “perfectly provided care does not always equal perfectly documented care, perfectly coded or abstracted care.” Troubled by data that does not fit into current classification and coding systems, Ms. Siegel supports the adoption of ICD-10-CM and advocates for a classification system that provides better data related to quality and patient safety. She described the use of costly health information clinical data analysts (CDAs) hired to meet reporting requirements and a significant amount of time devoted to supporting staff needs.

Ms. Siegel spoke of an “urgent need to achieve census and support for standardized data, data definitions, and reporting for the benefit of the health care industry and our consumers…”

She described varying indicator definitions and incomparable outcomes between data reporting projects. Examples of the issues she described (in particular the lack of integration of projects, outcomes, process measures, and data definitions) can be found in the transcript. If healthcare professionals are struggling to make sense of the incongruities, she asked how they expect the public to use such conflicting data to make informed decisions. Another question she posed was how the health care industry and employer-purchasers would know that data is consistent, uniform, and proven. She wondered how gaps would be resolved in our current population information and what would have to happen for data collection, reporting, and analysis to work efficiently and effectively. She challenged the Workgroup on Quality to consider dilemmas such as one she has encountered in which her hospital’s physicians disagree with the CMS guidelines. She suggested that providers and HIM professionals be included in the establishment of data standards.

Mr. Rode concluded the panel presentation by stating that accurate health care data will improve public health, the reimbursement process, health care policy making, health care research, and quality of services, all of which lead to population health improvement. Standards must ensure that data is comparable and consistent, including within the many registries that exist or are in development. Data must keep pace with the changes in medicine as well as public and private needs for information.  The standards setting group must also connect to current efforts by public bodies such as AHRQ and HRSA to establish data standards.

Mr. Rode also specifically addressed questions raised about the eight candidate recommendations in today’s hearing:

  1. AHIMA would be opposed to including data with population health improvement on the healthcare claim form used for reimbursement for the sake of confidentiality.  AHIMA believes that it would be better to develop a separate transaction for sending such information but one that conforms to the standard EHR.
  2. There must be professional involvement and agreement on the data to be collected and the reporting standards.
  3. Standard HER and data standards for reporting would significantly reduce the cost of data acquisition, analysis, and dissemination.
  4. Unless there are standards and buy-in from those producing the original documentation, there will be considerable disagreement about equity of such pay-for-performance processes. Also, a pay-for-performance process should be preceded by an effort to ensure that all healthcare entities can economically purchase the software and hardware needed to meet reporting requirements.
  5. The candidate recommendations should be considered as a group, serving as a core group of data elements for consensus and standards, in anticipation of additional recommendations from other groups. Inclusion of time and dates seems to be the most difficult for organizations to report consistently.

Mr. Rode was unable to gather feedback from his group about race and ethnicity in time for the meeting. He thought that candidate recommendation #10, relating to standardization of current inconsistent data, should accompany the first eight recommendations.  He suggested further consideration of recommendations #14 (adoption of standard clinical terminologies) and recommendation #16 (adoption of ICD-10-CM).  He stated that it is important to get the industry moving forward now.

Discussion

Mr. Beebe explained that CPT Category II are intended to be licensed like the regular CPT Category I codes.  As of September 2004, there are no specific licensing rates for Category II codes. In response to Mr. Steindel’s question about the overlap between LOINC and CPT II codes, Mr. Beebe agreed that there is potentially an overlap, although the LOINC codes are much more specific. CPT-II codes only record what are agreed upon as national performance measurement standards (see transcript for example). Since the CPT II code is already out in the public domain, what needs to happen is a broader awareness of this resource.

There was also discussion about the elements and timetable needed for adoption of ICD-10-CM. Ms. Greenberg explained that the adoption of ICD-10-CM and ICD-10-PCS (for inpatient use) would not affect the use of CPT codes. A recommendation by the national committee to move ahead is still under consideration, relative to a Notice of Proposed Rule Making. Even after a final rule, this shift would be a two-year process that could impact almost every health care organization in the country.

Mr. Arges clarified that the redesign of the UB-04 is primarily to accommodate ICD-10-CM. He hopes that ICD-10-CM can move forward as part of the recommendations implementation phase. He emphasized that data collection, as it stands, is disjointed and that the ICD-10-CM is a “critical lynchpin” relative to what information is gathered, reported and addressed. It is a tool that benefits the electronic health record, which can be used for payment of administrative claims and even, in some states, for mortality reporting. The limitations, as Mr. Hungate perceives, are not with the coding sets but rather with the ability of people who use it to agree on what they want to do. Mr. Rodes believes it will be useful for the Workgroup on Quality to point out the potential uses of a more detailed and updated classification system. Mr. Siegel added that his staff has found the ICD-10 provided better information, was more logical, and easy to use.  Cause for concern is the pinch on current dollars that creates a lack of willingness and fear about change and how to spend existing dollars. Another complication lies with the Patient Safety Bill, S-720, which specifies the gathering of data to “some sort of centralized or networked warehouse.” Data collection here is for a different purpose and it may not work to use HIPAA codes.  Mr. Rode believes that understanding the different needs and the move toward standardization is a role of the Workgroup on Quality. He also stressed the importance of consistent data collected from a variety of sources such as CDC, public health groups, and the Department of Homeland Security. He believes that the best way to proceed is to establish a consensus process that works on an overall strategy for effective data collection.

The next topic of discussion involved disparities related to race and ethnicity in the collection of data and the difficulty of gathering this data. Providers typically do not collect this data outside of the inpatient environment, and even then, it is not standardized. In addition, there is no way to collect data on people who do not have health coverage.

5. Alexandra Goss, ANSI X12

Ms. Goss represents ASC X12, an ANSI accredited standards development organization.   Operating since 1979, ASC X12 is a membership non-profit organization mandated to develop uniform data standards and specifications for cross industry electronic exchange of business transactions, which brings together business and technical professionals and works in industries such as finance, transportation, materials management, and insurance.

Background:  There are two core product types of the X12 committee, the base X12 standard (superset of structure and data definition) and the technical report type 3 or implementation guides (subset of the base standard). The approach to standards development is to ensure broad industry consensus on an issue before incorporating changes into an implementation guide specification. Ms. Goss noted that while the exchange of administrative and financial health care information is supported by the current health care system, the underlying system supporting that exchange is not standard. The industry has focused on collecting data to justify reimbursement rather than on improving the state of health.  Thus, a learning curve is needed.

X12 can meet the needs defined by the eight recommendations.  A two-tiered approach using a short- and long-term structure is recommended. Short-term would include the 837 institutional claim transaction and the 275 claims attachment transaction. Long-term is designed to achieve industry-wide agreement on the model for data exchange and reporting.

Ms. Goss requested that X12 be invited to testify at future hearings on recommendations #11, 12, 13, 16, 19, 20, 21, and 22.  She then went into specifics about the eight recommendations:

  • Recommendations 1 & 2:  recommend using claim attachment solution, the 275 implementation guide containing an HL7 message to meet these needs.
  • Recommendation 3:   The current x12 base standard, version 5010 supports this functionality.  Ms. Goss suggests referring to this recommendation as an indicator rather than a modifier.
  • Recommendation 4:  A clarification on current requirements in the 837I was described (see transcript for details).  Efforts by X12 and NUBC to agree on provider definitions might achieve this objective by defining the operating provider as the provider with overall responsibility for the procedure.
  • Recommendation 5:  Instructions in the current implementation guide do not indicate date and time as required elements but admission date and time are required for inpatient claims. A modification to the implementation guide to include a date/time qualifier to the existing procedure date element was suggested.
  • Recommendation 6:  The implementation guide can support modification of payer billing requirements but Ms. Goss noted practical and financial issues relevant to implementing this change (see transcript).
  • Recommendations 7 & 8:  More information is needed but functional status is best suited for the claims attachment implementation guide.

Response to questions posed:  X12 is currently developing the next health care implementation guides in version 5010 but the time to integrate these industry-supported recommendations is now (see transcript for suggestions on how to proceed). It is the job of ANSI to meet the defined business need of its end users. Ms. Goss noted the financial and human resource costs of developing and implementing processes to encompass new data. X12, which has seen little or no activity related to pay-for-performance requests, recommends that NCVHS testimony be given to X12 and other DSMOs to determine follow-up action. X12 supports bundling the eight recommendations if quality outcomes will improve, especially since a piecemeal approach is expensive and confusing.  X12 recommends that NCVHS finalize their policy and submit change requests through the DSMO process (described in transcript). With regard to race and ethnicity, some reporting can be supported (see transcript) but the specific data element for reporting an individual’s race or ethnicity (known as DMGO5) is not currently used in most implementation guides. There are also operational concerns with collecting and the accuracy of this data.

Summary:  X12 supports changes defined by industry consensus. Technical modifications are easier than achieving industry support. Recommendations 1-8 can be supported using existing transactions.

6.  Mr. Ted Klein, HL7

Background (overview of HL7):  Founded in 1987, HL7 is an ANSI standards development consensus-based organization that produces messaging transaction and a wide variety of other standards, including those covering Arden syntax, clinical document architecture, clinical context object workgroup, and the reference integration model. HL7 handles clinical and demographic data as well as logistics, supplies, guidelines, nursing information, medication administration, and more. Version 2.6 should be released early in 2005. HL7 version 3 standards are a form for information intended to achieve interoperability that is based upon the reference information model. At present, nearly all US hospitals use HL7 and other nations such as Great Britain, Canada, Australia and the Netherlands also use HL7 messaging (see transcript fordetails).

Comments about the eight recommendations:  (see transcript and PowerPoint presentation for detailed technical descriptions) (WILL POWERPOINT PRESENTATION BE ON-LINE? THIS SECTION IS VERY TECHNICAL AND THERE WAS MUCH IN THE POWERPOINT THAT WAS NOT SPECIFICALLY MENTIONED IN THE TRANSCRIPT)

  • Recommendation 1:   Current laboratory reporting was described. Most institutional provider billing systems are able to receive HL7 transactions with Lab data to generate claims but a very small number of physician offices receive these HL7 messages.
  • Recommendation 2:  HL7 tightly integrates LOINC and SNOMED to support clinical information. Most systems do not currently encode these data despite their usefulness.
  • Recommendation 3:   In HL7 v2.5, a diagnosis may repeat with each instance having a ‘type.’ Requirements for types of secondary diagnoses already exist in HL7 but such codes are not currently standard or widely used.
  • Recommendation 4:   The details of an HL7 transaction differ from those on the 837 transaction sets. It is unclear what modification is necessary to extend uses of the data.
  • Recommendation 5:  HL7 transactions with admissions data have date/time fields that are optional. HL7 transactions with procedure data requires date/time fields. All time stamps are “machine processable” but processing these transactions is variable.
  • Recommendation 6:  aligning dates, procedures and codes in billing transactions is more of a workflow and definition issue that is not in HL7’s domain. However, all HL7 transaction dates are associated with specific procedure codes.  
  • Recommendation 7:  LOINC has encountered copyright issues with SF-36 items when trying to incorporate functional status. Few commercial systems collect coded functional status information.
  • Recommendation 8:  HL7 observation reporting transactions are designed to carry lab results and functional status. If coding uses CHI vocabularies (LOINC, SNOMED), no changes are necessary to existing observation transaction definitions, which are identical in structure to lab results transactions.

All HL7 transactions carry patient demographic data including race and ethnicity codes but these codes are rarely captured, due mostly to “people” issues. Currently, the race field contains OMB race codes and ethnic group contains codes for Hispanic/Latino and Not Hispanic/Latino, as requested by HHS. Work is underway to change the race code structure.

Summary and Recommendations:  Most items identified in the recommendations are currently covered in HL7 transactions. In cases where the data exists, billing systems rarely accept HL7 data, which is correctable.  Adoption of standards that support multiple groups require business or regulatory incentives. Finally, Mr. Klein suggested the modification of current claims transaction forms, using a more direct model that defines an auxiliary transaction specifically for quality data that flows through existing EDI networks. Some agencies could accept these transactions directly over the Internet, using facilities that already exist. The benefits are that changes would focus on standards, systems, and communities whose concern is for improvement of quality and patient safety. Competition for agenda time and priorities would be eliminated with this focus.

Discussion

Mr. Klein clarified the use of standards and techniques of the CDC secure data network rather than use of the network itself. Ms. Greenberg clarified that LOINC is not a functional status classification although it has the capacity to classify questions about functional status assessments. Mr. Klein said that by standardizing responses in LOINC and having a set of codes to support questionnaires, the process can be standardized.

7. Mr. Robert Davis, Health Care Services: Data Reporting Guide

The concept of data centricity was introduced, having to do with decisions about what data is collected and how data is collected, as driven by operational realities of the current data infrastructures of the health care industry.

Background:  Mr. Davis is the principal author of Health Care Service Data Reporting Guide, an implementation guide based on industry standards and written for hospital public reporting purposes, using the ANSI X12 837 standard. Core data for state discharge is UB-92 (soon to be UB-04) for mandated and voluntary discharge data systems. Mr. Davis stressed that the relationship between data sources and data collection is key to getting accurate and complete data from the existing health services data infrastructure.

In response to the eight recommendations, Mr. Davis noted that certain data elements are already supported using the Health Care Service Data Reporting Guide 837 document, to include: discharge diagnosis modifier/flag for “present at admission;” data on patient race and ethnicity; operating physician identifier code, both dates and times for admissions; episode start and end dates for services billed using Global Procedure Codes; standard provider identifier; and voluntary standard patient identifier/identifier logic.  The following data elements will be supported in the next ANSI ASC X12 version (5010): expanded diagnosis coding standard; selected vital signs and objective data; primary language of all enrollees; and functional status.

The following concepts would not apply to the data elements maintained in the Health Care Service Data Reporting Guide: adequate benchmarking data for states and metropolitan areas and racial and ethnic sub-populations; standard survey items; data on race and ethnicity of all enrollees; standard clinical terminologies; common vocabulary for patients; crosswalk of standard procedure codes across care settings; clinical decision support functionality in EHRs, standards for data content and reporting functionality in EHRs; interoperability of EHRs and standard formats for selected record extracts from EHRs; and impediments to record access and linkage for coordination of care and QA/QI. (see transcript from detailed description of the preceding two paragraphs)

Regarding benefits to NCVHS constituencies, 45 states collect and use hospital administrative data for market, policy, and quality purposes. The challenge is how to enhance the data without adding burden to the health data infrastructure.  The burden of collecting these data is reduced because state reporting systems are aligned with industry systems. Integration of data systems would solve interoperability questions. A goal of EHR is to promote interoperability across health service clinical and administrative data systems and to find a balance between these systems (see transcript for example).

With regard to pay-for-performance, Mr. Davis said that NAHDO and the Consumer-Purchase Disclosure Group believe that enhancing UB data elements by adding specific target data elements would increase the power of existing administrative data. Further, NAHDO membership believes that severity adjustment algorithms become more predictive with the addition of specific clinical variables, thus benefiting pay-for-performance initiatives, hospital quality comparisons, and consumer choice activities. Collecting lab values should be the most accessible for immediate payback at minimal burden to the provider community.

Believing in the consensus process, Mr. Davis believes that the burden of proof for changing existing standards or creating new standards lies with the requestor of the change. The cost must be less than the benefit.

Summary:  Health care costs, the biggest expense for many states and businesses, are rising and yet little is known about how the money is spent. The Health Care Service Data Reporting Guide is a vehicle for utilizing existing health care data to help answer basic questions about quality and cost of health care.   A data centric approach to integrating diverse health service delivery systems is recommended.

Discussion

Dr. Steindel wondered what happens after the change to 5010. Ms. Goss clarified that the 5010 is complete but that the 5010 implementation guides or technical report threes are still in development. The review process (by DSMOs, NCVHS, HHS, and the public) could take four to eight years. Mr. Davis stated that, because the Health Care Data Reporting Guide is not a HIPAA guide, it is not subject to any rulemaking.  Therefore, it would be ready for use when the industry decides that it meets business needs defined for a particular implementation. Ms. Goss added that X12 has a short- and long-term approach because of the need for use in the field as well as the need to build models. Dr. Steindel agreed that the process to implementation is a long road but that one valid approach would be to use the material in a voluntary manner and in a trading partner agreement. Mr. Davis pointed out that many states mandate the collection of this data so that while collection would not be entirely voluntary, it could remain at the state rather than at a national level. Mr. Klein told of an effort underway at HL7 to update transactions with the UB-04.

Asked about what is taking place to remedy the fact that billing systems rarely accept HL7, Mr. Klein said that the reasons for this are varied, from lack of interest, a “home”, or money to address comprehensibility issues (see transcript for example). Ms. Goss reiterated that X12 and HL7 have different objectives, systems, and standards but said that X12 and HL7 have begun to develop more of a working relationship, which is much needed for terminology harmonization.

MEDSTAT PRESENTATION:  Louis Diamond, VP and Medical Director

MEDSTAT is a health information company that builds databases and works to facilitate measurement of cost, use and quality. Clients come from all markets. MEDSTAT is exploring how to obtain better clinical data for commercial and federal clients.

The focus of the presentation was on accessing and using clinical data to support quality measurement sets for various purposes, using a global approach. Interim strategies are needed until an electronic health record is fully operational and even then, a consistent approach will be necessary. Questions were posed about the scope and amount of clinical data, the identification and criteria used to determine data elements, and approaches to obtaining data. Definitions of data were presented with ‘administrative’ referring to support payment and some limited clinical detail and ‘clinical’ data referring to all information about a patient’s history, treatment, and outcome. Uses of clinical data are for diagnosis and treatment; evidence-based practice; quality measurement and improvement; management of health care facilities; public reporting on performance; provider accountability; payment for performance; management of populations (e.g., disease management and predictive modeling); public health surveillance; research and development; and cross-cutting risk stratification and risk adjustment. Despite some overlap in these areas, there are also differences relative to depth of reporting and accountability. Also noted was the distinction between use measures and robust quality measures (and concomitant levels of evidence), laid out on a continuum from use measures to quality indicators to quality measures.  Quality measures, which are more accountable, access more data and enable more outcomes. The core of the approaches is a series of mapping exercises for the uses of clinical data, to include quality measures developed and adopted by organizations; disease and conditions to support CPMs and disease management; and quality measures and measurement set supported by clinical data. (NOTE DETAILS AND EXAMPLES IN THOMSON MEDSTATE NCVHS POWERPOINT PRESENTATION OF 9-14-04 – WHERE CAN THIS BE FOUND?)

One could take the IOM list of priority conditions list and the NQF list, rerun some data about cost and frequency and come up with priority conditions. Then, it would be possible to figure out what data sources are needed to support which diseases and which measurement sets within each disease. Further refining administrative data from risk adjustment and stratification with clinical data is an important next step. These patient stratification and risk adjustment algorithms become important as decisions are sequentially made about what clinical data to access. The next step in the process is to focus on the criteria for the most valuable set of clinical data. Valuable and useable clinical data have known and valued uses; reside in known locations and databases; are available in digital formats with classification systems; are not prohibitively costly; and produce value for the end user.

A systematic approach is called for to obtain and identify clinical data. In the interim, linking financial and claims data to patient level laboratory results will be important. Research on the uses of the electronic medical record will move forward the probability of extracting key data elements uniformly and efficiently.

Discussion

Ms. Handrich asked Dr. Diamond for his reactions to the candidate recommendations. Dr. Diamond said that he did not understand the context of the chosen data elements.  Although all the data elements were “important”, he might not have listed them in a first go-around for collecting or linking clinical data to the UB-92 or UB-04.  He asked about the uses of the chosen data elements and said that he was not fully comfortable with those data elements.  Ms. Handrich gave a short history of gathering testimony of experts over several years, producing a report that summarized the testimony in 2002.

Discussion – NEXT STEPS

Participant Comments

Dr. Holmes identified the primary issue as a plea for standardization relative to specifications for the data elements.  The second issue asks what kind of vehicle should collect the data.

Ms. Handrich heard a dramatic variation in reaction to the report and about the utility of expanding data requirements.  Her suggestion was to compose a matrix of the major categories of today’s comments’ key characteristics to facilitate analysis of the input. She also wanted members of the Workgroup and others who participated in the last hearing to comment on this input, including the Standards Committee.

Dr. Carr was struck by the importance of developing the electronic health record while continuing to work with data sets. She emphasized the importance of understanding the goal of the inquiry.  She stressed consideration of definition of data elements, how data is collected; its intrinsic value; where data is stored; and how data is transmitted.  Relative to administrative data sets, Dr. Carr was intrigued by a further exploration of ICD-10 and especially of the CPT II.  If these codes have the increased granularity described today, then it might be possible to join clusters of codes to represent best practice that could be promoted in ambulatory settings. Dr. Carr wondered if ICD-10 would enable the elimination of some data collection (e.g., in hospitals) because it would unify a myriad of activities currently being done.

Ms. Greenberg suggested sending an electronic version of all this hearing’s presentations to all full Committee members (Dr. Steindel thought that the Standards and Security Committee would especially benefit from these presentations). She stressed that the standards do not stand in the way of collecting information but that rather, there needs to be consensus about what is to be accomplished and how. She talked about adding some information to the claim (using a claims attachment or separate transaction). She reiterated the concept of data centricity and stated that the bottom line was still about whether there was a real business case rather than whether the data could be valuable.  She also restated what Dr. Kizer and others had said about not being able to wait for an electronic health record but that work is needed on both fronts simultaneously.  Consensus on priorities and how they should be configured must be in place with or without an electronic record. She stated that in the next Committee meeting in November 2004, there would be recommendations to the Department about adopting the 5010 as the next version of the HIPAA standards for the claim implementation guide.  She wondered whether inclusion of the 837 should be brought to the full Committee in order to convert this Candidate Recommendation into a definite recommendation to be made to the Secretary (which could then be shared with X12 and put on the NCVHS Website). Also for discussion at the November meeting would be the Workgroup on Quality’s consideration of submission of another letter to the Department on ICD-10-CM.

Dr. Janes commented that the Workgroup was looking backwards and forwards. She reiterated Ms. Greenberg’s comments about the fact that nothing technical is standing in the way of implementing many of the eight recommendations but that there is still a question about making the business case. She thought that the raw material might be in place to create a business case from the current and last Workgroup meeting.

Dr. Mays felt that the business case was being made for race and ethnicity but she wondered what the presenters thought and especially relative to the people for whom this data is collected.

Dr. Steindel thought that the business case for race and ethnicity data is now generally accepted.  How to collect this data is a different question. He stated that there are multiple means to mechanically collect the data, that the standards exist in various forms and stages of completeness; and that there are various regulatory “acceptabilities.” In short, these are resolvable issues. On the business side, at issue is the question of why and for what purpose is the data being collected. Dr. Steindel thinks a business case must be made for the validity of process-oriented data. He believes that even with implementation of the electronic record, there would still be questions about what to do with that mass amount of data needed to answer questions about quality.

As a follow-up, Dr. Janes believes that the Workgroup is still struggling with whether the data is worth collecting. The answer is still “it depends.”

According to Ms. Handrich, it would be useful to talk about criteria for a business case, which the Workgroup on Quality has not yet done. It might be useful to review the testimony to look for key features others have suggested in order to set up a standard of what is usable.

Mr. Hungate observed that race and ethnicity are currently reported although not on the enrollment form. Dr. Holmes said that the quality of state-level discharge data is variable. Ms. Greenberg said that the new head of the Division of Health Care Statistics wondered if this data collection was getting worse because of the use of UB (with no required element for race ethnicity). Concerns and conjectures about the variability and reliability of race, ethnicity, and other (e.g., education and socioeconomic) reporting ensued. Mr. Hungate thought that the business case on race and ethnicity had been established. A question was raised about how to check for data reliability on race and ethnicity. Dr. Steindel pointed out that variability is associated with individually reported data. Mr. Davis said that hospital data provides control numbers and data within discharge, pointing out that linkage could be done within identifiers in hospitals, which in turn can provide some idea of how good the data is over time within itself.

Dr. Steindel wondered whether the question to ask about race and ethnicity data was about its consistency rather than its reliability. Taking consistency into consideration, Mr. Davis thought that the reliability question should be asked.  Dr. Steindel also wondered about the new way OMB is asking for this data to be collected. Dr. Davis maintained a problem with reliable reporting. Dr. Holmes clarified that OMB requirements are incumbent on government institutions but not on private institutions and stipulated that one must consider the source of data on race and ethnicity by self-report or by observation. Mr. Davis maintained that some states are adopting these requirements and described NAHDO’s movement to OMB’s five major categories. Mr. Hungate suggested that the Population Subcommittee should write a letter about race and ethnicity that recommends action and present it to the Chair of NCVHS.  Dr. Mays suggested the inclusion of issues such as cost and training (an email defining this suggestion was requested by Mr. Hungate).

Dr. Steindel reiterated the assumption that the data would be collected but what was at issue was how to collect that type of data in a reproducible and reliable way. Mr. Hungate felt the approach to this issue needed more discussion with Dr. Mays. He thought that the Workgroup now had a better understanding of the importance of collecting this data (than the last presentation about this topic several years ago). He suggested a joint meeting with the Workgroup on Populations as an ongoing action step.  Mr. Davis spoke of the importance of understanding why patients find race and ethnicity data a problem to report.  Hospitals are afraid of a backlash.  He recommended the inclusion of consumer groups to address trust concerns about how and for what purpose the data will be used. Dr. Holmes thought it important to also discuss reporting of race ethnicity in sites other than inpatient hospitalization to include, for example, ambulatory care, nursing homes or home health care. Mr. Klein thought that a clear unambiguous publication of what the data would be used for would reassure people. Dr. Holmes mentioned a study by the Commonwealth Fund about the attitudes of employers about collecting data on race and ethnicity.

The discussion moved to the need for follow-up about the UB-04 and ICD-10-CM relationship.  Mr. Hungate thought the UB-04 was very encouraging in content but was concerned about  timing. He recommended raising this concern with the full Committee. His conclusion is that the rich source of clinical information is HL7 but this does not translate to what the purchasers ask for.  Implementation issues are therefore “stuck.”  Mr. Hungate pointed out that this is where the business case must be made.  He wondered if selecting researchable topics and picking a set of measures for business case development would be a role for AHRQ, along the lines that MEDSTAT outlined.  Ms. Greenberg suggested some pilot studies prior to implementation. Mr. Hungate delineated the role of the Workgroup on Quality as that of talking about a process that moved things from agreement to implementation rather than the group that would decide the specifics of the process. Mr. Hungate delineated the claims attachment as the proper vehicle to use because it implies provider/purchaser dialogue that focuses on the form.  Ms. Goss thought that an 837R with the 275 claims attachment would meet more needs and address many of the concerns raised (it was suggested that the latter be called the 275 clinical attachment). There was clarification about the appropriateness of the Workgroup identifying the mechanics but not the researchable business case of the data collection process.

Ms. Greenberg recommended that the Workgroup move from candidate to actual recommendations those of the recommended eight they agree upon at the November 2004 meeting. She asked if there was anything that the Committee would recommend for inclusion into the mandated guide. She would like data elements within 837i that would be potentially recommended as the next iteration for HIPAA included.  From a state perspective, Mr. Davis thought that putting the data elements as part of UB-04 would minimize the need to change a lot of state legislation.

Mr. Arges stated the importance of having a clear direction of where data is going from a national perspective. From a hospital perspective, the database has to be built with the right elements as part of the data structure, to include much of UB-04, which builds on functionality, some of which is the anticipation of performance-based reimbursement. A decision must be made about whether UB-04 is used.  Ms. Greenberg said the Committee supports the ICD-10-CM but that it is the Department that decides. Mr. Arges said that it may be difficult to sell system changes to the provider community.  Mr. Hungate expressed enthusiasm for UB-04 and concern about the uncertainty of the ICD-10-CM since, in Dr. Steindel’s words, “UB-04 can’t go anyplace until ICD-10-CM.”  Mr. Arges clarified that the UB-04 has added health plan identifiers and the NPI, which will require a transition period. Ms. Greenberg added that the UB-04 has increased functionality that goes beyond accommodating ICM-10-CM and ICM-10-PCS.  The UB-04 can be used with 9-CM Volumes one, two, and three.  She stipulated that it would be difficult to make the case to the provider community if there is no signal from the Department that ICM-10-CM and ICM-10-PCS will be implemented. Mr. Arges said that it would be better to lay out all the variables that providers must work with by a certain date to allow them to program around it. Ms. Greenberg suggested composing a letter to the Committee that supports the increased functionality of the UB-04 but has identified a problem with its likely delay in being implemented.

Dr. Steindel suggested that the collection of quality data be taken out of the regulatory process for greater flexibility. However, if the adjudication process moves towards pay-for-performance, this removal should be re-examined. Mr. Hungate and Ms. Greenberg agreed and Ms. Greenberg added that if the 837R is used along with a clinical attachment, the capacity and functionality would exist to do some pilot tests at the state or payer level. This might bring providers and payers together to determine top priority data and to then build a case.  In response to a question about volume and accuracy of data without regulatory backing, Ms. Greenberg said that a willing trading partner would be necessary. Dr. Janes said that if the regulatory process is removed, the approach becomes “if we build it, they will come”, which can be fraught with problems. Mr. Davis, who believes that the best solution is a regulatory solution, clarified that the R guide is the same as the institutional guide except in the places that are different (i.e., no absolute business case in the claim guide). Mr. Hungate did not think a regulatory approach is the ultimate objective because without cooperation from providers, who don’t like to be told what to do, such a system will not work. He advocated for a voluntary approach.

The business case for collecting quality data can be made in light of 14% increases in health care premiums and more questions from enterprises paying for this health care about what they are paying for. According to Dr. Steindel, this can be a voluntary process because there are now drivers that did not exist several years ago. He believes that hearings should be held to investigate building the business case to collect quality data.

Dr. Carr proposed that the Workgroup move from candidate recommendation three to full recommendation, to facilitate reporting of a diagnosis indicator to flag diagnoses that were present on admission on secondary diagnosis fields on all patient claims.  Mr. Hungate seconded the motion and the motion was then tabled for an open conference call (requiring a quorum) to be scheduled before the November 5, 2004 Committee meeting.

Relative to race and ethnicity, Ms. Greenberg stated the need for training on costs as well as advice on what to do about mixed race and dealing with the hierarchy. Dr. Mays suggested that the Workgroup knows enough to have a hearing rather than a research subject.