An early maintenance review is a focused examination of the measure’s methodology or data collection process based on new information from clinical evidence or feedback from the field. If there is new evidence that a measure may have significant, adverse effects on patients or its implementation, the measure developer must undertake an early maintenance review. The measure developer should complete early maintenance reviews as quickly as possible regardless of annual or 3-year scheduled comprehensive reviews because of the nature of the triggering information. The early maintenance review process ensures the measure remains balanced between the need for measure stability and the reality of a constantly shifting measure environment. For example, the evidence can be evolving, or other items may affect the measure environment, e.g., changes in measurement science best practices or public health emergencies. To preserve measure stability, the measure developer should reserve early maintenance review for instances when new evidence indicates the need for a very significant revision.

Early maintenance review specifically does not include the process of adapting or harmonizing a measure for use with a broader or otherwise different population. 

Trigger for an Early Maintenance Review

The early maintenance review process begins when the measure developer becomes aware of evidence – either through ongoing surveillance or other interested parties – that may have a significant, adverse effect on the measure or its implementation. If it is a CMS consensus-based entity (CBE)-endorsed measure, the CMS CBE may have received a request for an early maintenance review.

Deferring an Early Maintenance Review 

The measure developer should postpone an early maintenance review to the next scheduled review, if reasonable. The presence of any accompanying patient safety concerns associated with the changes to the endorsed measure will influence the timing of the early maintenance review. If the measure developer will be updating or reevaluating the measure in the near future, they should incorporate the information received into that update or reevaluation. For example, if the measure is due for a comprehensive reevaluation or an annual update within the next 120 days, the measure developer should refer the information to the team conducting the review and that team should incorporate the early maintenance review process into its work.

Early Maintenance Review Procedure 

The early maintenance review process typically includes six steps, comprising three primary subparts:

• Determining whether to conduct an early maintenance review 
• Conducting the review and recommending an outcome
• Approving and implementing the approved outcome

Determine Whether the Concern Is Significant

If the clinical practice underlying the measure is causing harm to patients (directly or as a function of unintended consequences), the measure developer should revise, suspend, remove, or retire the measure. If measure revision is not feasible in the time frame necessary, the measure developer should discuss suspending with program implementers (e.g., CMS) or retire the measure.

If there are no projections of patient harms, only the strongest concerns will result in an early maintenance review. The measure developer monitoring the measure should consider first whether the issue is significant and then may engage the technical expert panel (TEP) most recently involved with the measure. If the measure developer does not have access to the TEP, they may contact a professional association closely associated with the measure for input regarding the significance of the issue raised. The CMS CBE may also be the source of the request for urgent early maintenance review, depending on the nature and source of the concerns.
If experts determine the issue is not significant, the measure developer should document the issue for consideration at the next scheduled review.

Conduct Focused Information Gathering

The measure developer conducts a literature review to determine the extent of the issue(s) triggering the early maintenance review and identify significant areas of controversy if they exist. Unlike environmental scans conducted during measure development, ongoing surveillance, or comprehensive reevaluation, the measure developer should limit the scan performed for an early maintenance review to new information directly related to the issue(s) triggering the review. Investigation of all aspects of the measure is not necessary—only the aspect generating the concern.

Detailed guidance for conducting and documenting the environmental scan (including the literature review) is in Conduct an Environmental Scan and the Environmental Scans for Quality Measurement supplemental material.

Consult with the Experts, Especially the TEP

If feasible, the measure developer should consult with the original TEP contributing to the most recent comprehensive reevaluation or measure development.
If the issue of concern relates to clinical guidelines, the measure developer should ask the organization responsible for the guidelines about its plans for updating the guidelines or issuing interim guidelines. The measure developer may also consult professional organization(s) closely related to the measure.

The measure developer should ask the experts (e.g., TEP, guideline writers, professional organizations) about the

• Significance of the issue, to confirm they consider it important
• Risk of possible patient harm if the measure remains in use, including harm from unintended consequences
• Feasibility of implementing measure revisions, including cost and time

Determine Whether It Is Feasible to Change the Measure

Assessing the feasibility of changing a measure should include consideration of the cost of resources associated with data collection, measure calculation, and reporting systems, and those requiring updates to vendor systems. Depending on the resources available and the time involved in making the necessary changes, the measure may be either revised immediately or suspended until updates to the systems occur with the measure’s updated specifications.

Recommend a Course of Action

Based on the findings of these steps, the measure developer will recommend a course of action. A discussion of the criteria forming the basis for the disposition decision for each measure and description of the possible outcomes is in Measure Maintenance.

Depending on the findings from the previous steps, the recommendation may be

• Retain
• Revise
• Remove
• Retire
• Suspend

Implement the Disposition Action

When proposing measures for revision, suspension, removal, or retirement, the measure developer should evaluate the impact of the decision on the program using the measure when developing the implementation plan. If there are relevant regulatory or rulemaking schedules, the measure developer should include them in the implementation plan. For more information, see Measure Use, Continuing Evaluation, & Maintenance.

CMS CBE Early Maintenance Review

The CMS CBE has its own early maintenance review process, either an Emergency Review or Off-Cycle Review. Check their website for the most up-to-date information.

More Information for CMS Measure Developers

Please note, the MMS Hub and Blueprint content are not CMS-specific, and the guidance is not prescriptive. CMS measure developers can find more information about measure maintenance reviews in the Blueprint Contractual Guidance and Considerations found on the Measure & Instrument Development and Support (MIDS) Library. The MIDS library is a protected website restricted to CMS and CMS MIDS contractors. MIDS developers should email MMSsupport@battelle.org to request access to the MIDS Library. Once eligibility is confirmed, the MIDS developer will receive an email with instructions on accessing the site.