June 16, 2008
MINUTES
Kidney Care Quality Alliance Steering Committee
June 16, 2008
Conference Call
Attendees
Gail Wick, ANNA
Barbara Fivush, ASPN
Barry Straube, CMS
LeAnne Zumwalt, DaVita
Dolph Chianchiano, NKF
Maureen Michael, NRAA
Allen Nissenson, RPA
Linda Keegan, Robyn Nishimi, Lisa McGonigal, KCP
Summary
Dr. McGonigal opened by taking a roll call and advising the Steering Committee that the conference call would be used to review and discuss the various Kidney Care Quality Alliance (KCQA) measure testing options that had been identified and to reach agreement on a recommendation to the Kidney Care Partners (KCP) Operations Committee on how best to proceed.
Dr. Nishimi led the ensuing discussion during which the Steering Committee deliberated on the pros and cons of each option and ultimately made the unanimous recommendation to proceed with plans to test all five KCQA measures that have received time-limited endorsement from the National Quality Forum (NQF).
KCQA PERFORMANCE MEASURE BACKGROUND AND HISTORY
Dr. Nishimi began by reminding the Steering Committee that in 2005, the KCP launched its Kidney Care Quality Initiative/Phase I KCQA efforts, and between 2005 and 2007 convened several Workgroups to develop performance measures intended for use by the industry and the Centers for Medicare and Medicaid Services (CMS). The initiative yielded 12 measures that were ultimately submitted to NQF for endorsement consideration; five of these were granted two-year time-limited endorsement from NQF, set to expire in November 2009:
- Vascular Access, Assessment for Functional A-V Fistula (clinician-level);
- Vascular Access, Assessment by Vacular Surgeon (clinician-level);
- Influenza Vaccination in the ESRD Population (facility-level);
- Patient Education Awareness (clinician-level); and
- Patient Education Awareness (facility-level).
Dr. Nishimi noted that time-limited endorsement is a designation bestowed to measures that meet all NQF endorsement criteria with the exception of having been adequately field-tested; these measures must be tested for reliability, feasibility, and validity within two years to maintain NQF endorsement. Dr. Nishimi also reminded the Steering Committee that based on the most recent Conditions for Coverage, all five of these measures are poised to be included in CMS’ new set of 26 ESRD Clinical Performance Measures (CPMs).
TIME-SENSITIVITY OF MEASURE TESTING
Dr. Nishimi next informed the Steering Committee that a decision on whether to proceed with KCQA measure testing has reached a point of urgency for the following reasons:
- Testing cycle and expiration of the time-limited NQF endorsement. Dr. Nishimi reminded the Steering Committee that a measure-testing plan was prepared for KCQA by an outside contractor and was filed with NQF in early 2008. The plan envisioned testing planning, recruitment, and education commencing in early 2008, with data collection during 2008-2009, and auditing and analysis occurring in Summer 2009. Under this protocol, a report would have been delivered to NQF well before the November 2009 deadline. However, at this late date, the earliest that data collection could begin is September 1, 2008, with a conclusion of August 31, 2009, leaving barely enough time to “audit” the final quarter of data, analyze data, and prepare a report for delivery to NQF by November 1, 2009.
- CROWNWeb 1.0 implementation and collection of data on the new CMS Clinical Performance Measures (CPMs). Dr. Nishimi then informed the Steering Committee that CMS intends to begin data collection via the CROWNWeb data repository for 22 of its 26 new ESRD CPMs—including the two KCQA clinician-level Vascular Access measures—in February 2009. CMS has already coded the basic data elements for the two KCQA measures into CROWNWeb 1.0, but has expressed its willingness to work with KCQA to revise these data elements prior to the release of CROWNWeb 2.0 in July 2009, should they not satisfactorily meet KCQA’s expectations or perform as anticipated during pilot testing. Dr. Nishimi noted that it is essential for KCQA to begin its review of the CMS data elements and make any plans for changes that facilities want pilot tested so they can be incorporated into CROWNWeb 2.0.
- Business requirements for CROWNWeb 2.0 implementation. Dr. Nishimi next reported that while KCQA’s Influenza Immunization and Patient Education Awareness measures have not been included in the initial release of CROWNWeb, CMS has expressed interest in incorporating the data elements for these measures—as defined and ultimately tested by KCQA—into CROWNWeb 2.0. As CMS is currently preparing to issue its request for proposals for a contract to develop CROWNWeb 2.0 and must include the business requirements that will serve as the basis for potential contractors’ bids, the KCQA measure data elements must be provided to CMS no later than August 2008.
- Influenza Immunization testing collaboration with PCPI. Finally, given that CMS has indicated that CROWNWeb will be only for facilities at this point, even for the clinician-level measures, Dr. Nishimi informed the Steering Committee that the RPA/PCPI has expressed willingness to work with KCQA as we test the analogous, facility-level measure. As PCPI has indicated it hopes to enter its field-testing phase in June 2008, a decision by KCP not to pursue testing should be conveyed as soon as possible to PCPI. Additionally, Dr. Nishimi reminded the Steering Committee that because the measurement period is vaccination during the “flu season” of October-March, it is especially important that facilities know the data elements for these measures as soon as possible so that they can incorporate them into their workflow and software.
OPTIONS FOR CONSIDERATION
Taking this background information into account, Dr. Nishimi informed the Steering Committee that four options have been identified for consideration:
- No testing
- Data element/microspecification development only
- Test only the Vascular Access measures
- Test all five measures
Option 1: No Testing
Dr. Nishimi informed the Steering Committee that the first option would be for KCP/KCQA to proceed no further with defining data elements or pilot testing of any of its NQF-endorsed ESRD measures. While none of the costs associated with data element specification and field-testing would be accrued with this option, she explained that a failure to test would result in NQF endorsement being rescinded at the conclusion of the allotted two-year testing period (i.e., November 2009), and KCQA would ultimately forfeit a unique opportunity to help shape the future of ESRD quality measurement, reporting, and pay-for-performance. Moreover, all funds and time invested in measure development to date would, in effect, be lost, as would KCQA’s intellectual property rights to the measures; negative perceptions of KCP’s commitment to quality may well result if the central accomplishment of its quality initiative is abandoned. Finally, KCQA’s Patient Education measures are the only such measures in the ESRD set and were strongly advocated for by patient groups. These measures, as well as the Influenza Immunization measure—the only “public health” facility measure in the ESRD set—are central to several elements, including inclusion in the CPMs, that were published in the Final Rule for the Conditions of Coverage.
Option 2: Data Element Definition Only
Dr. Nishimi next reported that the second option would be for KCQA to define the data elements for the Influenza Immunization and Patient Education Awareness measures and to review and supplement CMS’ data elements, as deemed necessary and appropriate, for the two Vascular Access measures. KCQA would not, however, proceed with field-testing any of the measures. She noted that while this option would provide the data elements for all five NQF-endorsed KCQA measures, which potentially could be used in CROWNWeb Version 2.0, costs associated with field-testing would not be incurred. However, as with Option 1, NQF endorsement would be rescinded, and while the timeframe for inclusion in CMS’ Request for Proposal for CROWNWeb 2.0 would technically be met, the measures’ future without testing or NQF endorsement is unclear. Again, KCP/KCQA would lose its opportunity to help shape the future of ESRD performance measurement, time and money already invested in the process would be wasted, intellectual property rights to the measures would be lost, and negative perceptions about KCP/KCQA might occur.
Option 3: Test Only the Vascular Access Measures
Dr. Nishimi informed the Steering Committee that the third option would be to limit data element definition and field-testing to the Vascular Access measures, as there are the only two measures that we know with certainty will be used in CROWNWeb 1.0. Because CMS defined the data elements without KCQA input, it is unknown at this time whether facilities will consider the microspecifications adequate to permit standardized results and “apples-to-apples” comparisons. If KCQA’s pilot testing does indeed indicate that changes to the data elements should be made, CMS has indicated its willingness to incorporate these in future CROWNWeb releases. Dr. Nishimi noted that the strengths of this option would be that the two measures would meet NQF’s endorsement requirements and would allow KCQA to supplement or recommend changes to CMS, as necessary, to make the measures accurately reflect performance. While additional costs would be accrued with this option, expenditures related to testing the Influenza Immunization and Patient Education measures would be avoided. Again, however, NQF-endorsement would be lost for these measures, and all associated negative consequences as described in Options 1 and 2 might occur.
Option 4: Test All Measures
Finally, Dr. Nishimi described Option 4—to proceed with data element definition and complete feasibility, reliability, and validity testing for all KCQA measures. She noted that, given existing circumstances, this option would require three concurrent approaches:
- Vascular Access measures: KCQA would work with CMS to ensure its current data elements for these two measures will produce standardized measurement and reporting. If not, KCQA would recommend changes for incorporation in a future release of CROWNWeb. Any necessary fieldwork would occur concurrently with the other measures.
- Influenza Vaccination measure: KCQA would work with RPA/AMA/PCPI to test the Influenza Immunization measures (facility- and physician-level, respectively). The PCPI has indicated its willingness to provide KCQA with its microspecifications, which would save KCQA costs.
- Patient Education measures: KCQA would define the data elements and do the fieldwork for pilot testing concurrently with Influenza Immunization testing, thereby creating efficiencies in fieldwork costs.
Dr. Nishimi noted that the strengths of this option outweigh the weaknesses. Specifically, completion of testing of its measures allows the KCP to realize the goals that spurred the creation of the KCQI and KCQA: “to develop a well-designed continuous quality improvement program that meets the needs of patients, other members of the kidney care community, and federal policymakers.” Moreover, perseverance in this endeavor will bolster the credibility of the KCP/KCQA, both in perception and in reality, as it utilizes the knowledge and experience of its members to actively shape and drive ESRD quality measurement, reporting, and pay-for-performance by likely ensuring all of its measures will be incorporated into the CPMs and CROWNWeb. The cons associated with this option are that additional monies will be required to complete measure specification and testing over the next two years; commitments from facilities to participate in the pilot testing also will be required.
Dr. Nishimi noted that while Options 1, 2, and 3 are fiscally conservative, all fail to effectively achieve the defined purposes of the KCP/KCQA. She thus opined that abandoning the Phase I output is both tactically and strategically inadvisable, and recommended that the Steering Committee recommend that KCP pursue Option 4 and proceed with data element definition and testing of all NQF-endorsed KCQA measures. She remarked that this option would both fulfill the goals and substantiate the credibility of the KCQA as it enters the next phase of its quality work, but does not lock the KCQA into the measure development business going forward.
STEERING COMMITTEE DISCUSSION AND RECOMMENDATIONDr. Wick, Steering Committee Co-Chair, remarked that the KCQA has been admirably proactive in establishing measures for the care provided to its target patient population. She noted that Dr. Nishimi had carefully and thoughtfully outlined all viable options for overseeing/driving the quality initiative for the renal care, and urged the Steering Committee to endorse and support Option 4 to carry this initiative to its completion.
Ms. Michaels then requested verification that the responsibility for data entry for all of the CPMs, including the five clinician-level measures, will fall to the facilities. Dr. Nishimi confirmed that all discussions with CMS to date indicate that CROWNWeb is to be available only to facilities.
Dr. Chianchiano noted that NKF is eager to see the Patient Education measures tested, but questioned how likely it is for CMS to include these two measures should the KCQA proceed with testing. Dr. Nishimi responded that based on conversations with CMS, CMS has indicated that it currently plans to incorporate the Patient Education, as well as the Influenza Immunization, measures into CROWNWeb 2.0. She and Ms. Zumwalt noted that there are Patient Education conditions in the Conditions for Coverage that CMS must meet. However, Dr. Chianchiano expressed concern that if the Patient Education measures were indeed dropped by KCQA, the topic might nonetheless fall by the wayside.
Dr. Fivush then asked whether the Steering Committee members had any concerns regarding the imminent implementation of the CROWNWeb data repository. Ms. Zumwalt responded that while CMS’ path is reasonable, there are always concerns about the ability to aggregate this much data—more over, CMS will be asking facilities to input data that has always been a paperwork function between networks and so facilities will thus need to get an education process in place. She questioned, however, how CMS will handle incorrectly entered demographic data and whether such data will be discarded. She concluded that this is indeed a daunting undertaking and that the challenge ahead should not be minimized, but ultimately, she sees no reason not to move forward.
Dr. Wick next remarked that the biggest issue in her opinion is what and whose measures will be included in the CPMs and CROWNWeb. She stressed that, given the expertise of its members, the KCQA should be contributing measures to this initiative and expressed concern that a less qualified entity would “take up the slack” if KCQA does not follow through. Ms. Zumwalt concurred and noted that if KCQA wants to be a player in quality and bring all interested constituents together, this is a unique opportunity to do so. She noted that this is a long-term and arduous goal, but she sees definite value in KCP and others coming together to shape quality.
Dr. Nissenson then noted that Options 1-3 are, in his opinion, not viable and that the KCQA must follow through to ascertain that the integrity of these measures is retained. He concluded that it would be both impractical and unacceptable to stop now. Ms. Michaels opined that if Options 1 or 2 were selected and the KCQA later decided to follow through with testing the remaining measures, this would likely be even more expensive. Dr. Nishimi added that, more importantly, NQF’s endorsement requirements would not permit this approach.
Dr. Fivush queried whether KCQA would be able to come up with the necessary money to support Option 4. However, Dr. Nissenson remarked that he felt the role of the Steering Committee is only to make a technical recommendation to the KCP Operations Committee, which would then be charged with considering funding issues, based on the Steering Committee recommendation; Dr. Fivush concurred. Dr. Wick also agreed and suggested that a vote be taken. The Steering Committee voiced its unanimous support for Option 4, testing of all five KCQA measures.
The Steering Committee’s recommendation in support of Option 4, testing of all KCQA measures, will be conveyed to the KCP Operations Committee during its June 19 meeting in Washington, DC.
FACILITY RESPONSIBILITY FOR CLINICIAN-LEVEL MEASURES VIA CROWNWeb
Lastly, Dr. Nishimi returned the conversation to the issue of CROWNWeb being used solely by facilities for the clinician-level measures. Dr. Nissenson remarked that this is an unacceptable onus on the facilities, and that doctors will likely be unhappy with this arrangement as well. He noted that he will present this information to the RPA Board and questioned why CMS could not make CROWNWeb accessible to nephrologists’ offices to circumvent this issue. Dr. Nishimi noted that she and Dr. McGonigal had specifically asked whether CMS would be making CROWNWeb available to physicians and the response was that it’s intended only for facilities. Dr. Fivush noted that while ASPN physicians have never entered data, reporting by the clinicians might indeed be more complete and accurate. Dr. Nissenson reported that he will take this issue back to the RPA Board for consideration. The Steering Committee was in agreement that this issue merited further discussion within KCQA and with CMS, as it is problematic for both physicians and facilities.
