Quality Priorities

September 18, 2006

MINUTES 
Kidney Care Quality Alliance Steering Committee
September 18, 2006
Conference Call

Attendees:

Gail Wick, ANNA
Don Wesson, ASN
Barry Straube, CMS
Kent Thiry, DaVita
Dolph Chianchiano, NFK
Deven McGraw, National Partnership for Women & Families
Maureen Michael, NRAA
Rob Blaser for Alan Kliger, RPA
Kathy Lester/Piper Nieters, Facilitator/Administrative Arm Patton Boggs
Linda Keegan, KCP

Dr. Charlie McAllister also participated in the call to describe the work of the Clinical Measures Work Group.

Summary
The Alliance Steering Committee reviewed the “Recommendations for Finalizing Phase I Clinical Measures” and the “Recommended Consensus Development Process for the Kidney Care Quality Initiative (KCQI)/Kidney Care Quality Alliance” process documents.

The group also discussed submitting measures to the National Quality Forum.

Finalizing Phase I Adult Clinical Measures
The Alliance Steering Committee reviewed the recommendations for finalizing the Phase I Adult Clinical Measures (see attached document).  Dr. Straube indicated his support for the process, as did the other members of the Committee.

The group stressed the need to finalize Phase I as quickly as possible.  During the discussion, Dr. Wesson asked about the role of the American Society of Pediatric Nephrology (ASPN).

It was discussed and agreed that the Pediatrics Work Group has an important role to play going forward, most importantly taking the domains that have been identified and translating them into a set of measures.

It was agreed that the current Alliance Steering Committee will be focused on finalizing the adult clinical measures.

The Alliance Steering Committee unanimously approved the proposed process for finalizing the Clinical Measures and the timeline.

Alliance Process
The Alliance Steering Committee reviewed the proposed Alliance structure and process (see attached document).  Dr. Straube stressed the importance of setting out a process in the beginning.  The group agreed not to select a formal chairman in an effort to avoid any appearance of favoring a particular industry or group.

Additionally, Dr. Straube suggested including a discussion about membership in the Alliance.

The group agreed to insert wording that the approach to membership in the Alliance will be inclusive, not exclusive.  The Alliance Steering Committee unanimously agreed to take an open approach to membership in the Alliance.  They also approved the proposed process, as amended.

Submitting Measures through National Quality Forum (NQF)
In response to Dr. Straube’s question, the Alliance Steering Committee discussed the pros and cons of submitting measures to the NQF.

The primary concern related to the price associated with obtaining NQF approval.  Dr. Straube indicated that CMS may not be able to assist with funding of measure submission; however, he emphasized the importance of working with NQF.

CMS is currently working with NQF on measure development and is encouraging the organization to reduce the costs associated with measure submission.  After a discussion about the cost and process, the group asked the staff to prepare a short summary of what is required for submitting measures through NQF.

Next Steps
The Alliance Steering Committee tasked the staff to engage the Task Group and provide them with the charge outlined in  “Recommendations for Finalizing Phase I Clinical Measures.”  The staff will also determine a time for the next Steering Committee call.

Appendix 1
Recommendations for Finalizing 
Phase I Clinical Measures
The Kidney Care Quality Initiative (KCQI) Work Group on Clinical Measures submitted final Phase I recommendations to the KCP Board.  The KCP Board considered these recommendations and submitted them to the Kidney Care Quality Alliance (KCQA) with several recommendations.

The members of the KQCA have until September 18 to submit comments on these recommendations as well.

To finalize the Phase I Clinical Measures Recommendations, we suggest the following approach:

The Alliance Steering Committee selects a new Task Group to review the comments and submit recommendations to the Steering Committee.
The Task Group should be a diverse set of individuals. 

Staff recommends:  Alan Kliger (representing physicians), Charlie McAllister (representing facilities), and Gail Wick (representing nurses).
The new Task Group reviews the comments and consults as needed with kidney care community experts to submit written recommendations to the Steering Committee.  This may include consulting with members of the previous KCP Work Group members. 

If the Task Group is unable to meet the timeline outlined below, the Alliance Steering Committee must re-evaluate the composition of the Task Group and establish a new Task Group that will reach closure consistent with the requirements set forth by the Alliance Steering Committee.
The Steering Committee reviews the recommendations and forwards a final set of recommendations to the Alliance Members.
The Alliance review and vote on the recommendations via ballot.

We suggest the following timeline:

September 18 Creation of the Task Group

Week of Sept. 18 First call of Task Group to review the recommendations

Week of Sept. 25 Task Group call to discuss recommendations

Week of Oct. 2 Task Group finalizes recommendations to distribute to the Alliance

Week of Oct. 16Circulate written ballot to Alliance that will be returned within 10 days to the Administrator (Note:  Alliance members will be asked to vote on each individual measure consistent with NQF process)

Appendix 2
Consensus Development Process for the
Kidney Care Quality Initiative (KCQI)/Kidney Care Quality Alliance

The Alliance Convener/Administrator
KCP professional staff will serve as the convener and administrative arm of the Alliance and the Alliance Steering Committee.  Responsibilities will include facilitating meetings to ensure the smooth operation of the Alliance.  In that capacity, KCP professional staff will provide these services and act as the Alliance Convener/Administrator.

The Alliance and the Alliance Steering Committee will not have a chairperson to ensure a balanced process both in fact and appearance.

By not having a chairperson, we assure that each Alliance member and Steering Committee representative has equal representation.  We also assure a level playing field for each organization and interest with regard to both process and outcome.

If any sub-group created by the Alliance Steering Committee, such as a Task Group or Work Group, is unable to comply with the charge or timeline established for it by the Alliance Steering Committee, the Convener/Administrator must notify the Alliance Steering Committee.  The Alliance Steering Committee must then re-evaluate the composition of the sub-group (e.g., Task Group or Work Group) and may establish a new sub-group that will reach closure consistent with the requirements set forth by the Alliance Steering Committee.

Membership 
Alliance is open to organizations in the health care community, including patient organizations, consumers, providers, health care professionals, and manufacturers.  Interested entities should contact the Alliance administrator.  There is no cost associated with joining the Alliance. The

Approval Process
All Alliance members in good standing will have the opportunity to vote on any consensus proposal.

Upon receipt of recommendations, the representatives of Alliance will meet to review the recommendations and to discuss them.

All members of the Alliance will have opportunities to comment on the recommendations in writing.

If there are comments, the Alliance Steering Committee will meet to discuss how to address the comments, which may include creating a special task group to evaluate comments and consult kidney care experts, such as the previous KCP Work Group members, in the creation of a final recommendation.

Once it has reviewed the comments, the Alliance Steering Committee will make recommendations that will be forwarded to each member of the Alliance.

Upon receipt of final recommendations, ballots will be distributed to the member’s designated primary liaison.

Ballots will specify the components of the document or other product for which vote(s) are being sought and will also provide an option to abstain.  Ballots shall also identify the specific deadline and manner in which they should be returned to the Alliance Administrator.

Prior to the close of the voting period, the Alliance will contact non-respondents at least once.  The minimum period for voting shall be 5 calendar days.

Only ballots cast in the affirmative or negative shall be tallied to determine the outcome of a vote within the Alliance.  The affirmative or negative action receiving the highest number of votes shall prevail.

For purposes of balloting on recommendations, a quo­rum of fifty percent is not required.  For purposes of adoption recommendations, the following is required for approval:
1- a healthy majority of those voting; and
2- at least a majority of the non-kidney care community organizations.

Suggested modifi­cations to the recommendations that are pro­posed during the voting process must be sent in writing to the Alliance Administrator.  All comments must be received within 48 hours of distribution of the ballot.
The Alliance Administrator will provide the comments to the Alliance members’ designated primary liaisons prior to the close of the voting period; comments received after the designated 48 hours period will be shared as soon as possible, but might not be avail­able until after the voting deadline.

If a member wishes to change his or her vote based on comments received within the voting period, it may direct a written request to the designated Alliance Administrator.
The requested change must be forwarded by the same signatory as the initial ballot and must be filed prior to the voting deadline.

In the event a change of vote is requested within the voting period, the record shall duly note both the original and the change. The changed vote shall be incorporated into the final tally.
Requests to change a vote after the voting deadline shall be limited only to the specific ballot option(s) — i.e., no additional comments shall be considered.  Post-deadline changes will be duly noted in the record of the vote, but will not be used for purposes of reporting the decision to the Alliance.

Notice of all Alliance decisions for consensus products will be made available to the public on the KCQI website and by other vehicles (e.g., press releases and other public announcements), as appro­priate, within 30 days of Alliance action.

Appeals
Anyone may register a request for reconsideration of an endorsed voluntary consensus recommendation by notifying the Alliance Administrator in writing within 30 days of public notification that the Alliance has approved the recommendations.  For an appeal to be considered, the notification letter to the Alliance must include infor­mation clearly demonstrating that the appellant has interests that are directly and materially affected by the Alliance–endorsed recommendations, and that the Alliance decision has had (or will have) an adverse effect on those interests.

The Alliance Administrator will review appeals.  They may consult with the Alliance members, the Alliance Steering Committee, and/or other sources, as appropri­ate, before presenting a recommendation.

The Alliance Administrator shall notify the Alliance Steering Committee as soon as practicable and act on them in a timely manner.  If the Alliance Steering Committee agrees to consider the appeal, it will follow the same process used to consider comprehensive proposals outlined above.

Distribution of Information
Lists of Alliance members, Ad Hoc Work Groups, and final Alliance documents (including approved recommendations, Guiding Principles, and minutes), as well as other relevant materials will be posted on the KCQI website (www.kidneycarepartners.org) as they become available.  The distribution of some materials and information (e.g., meeting agen­das, background materials, and draft recommendations) may be limited.