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Measure Implementation

Measure Selection

The path a measure takes for selection and implementation depends on the program, as not all measures go through the pre-rulemaking and rulemaking process. The requirement is that only measures for Medicare subject to Section 3014 of the Patient Protection and Affordable Care Act (ACA) go through the pre-rulemaking and rulemaking process. For a list of the programs, and information on their needs and priorities, see the annual Measures Under Consideration (MUC) List program-specific measure needs and priorities on the Pre-Rulemaking page. Other quality initiatives, like those for the Health Insurance Marketplace Quality Initiatives, do not go through pre-rulemaking and follow another path.

 

CMS Measure Selection Criteria

CMS measure selection criteria help ensure that each measure

  • Supports the CMS and national healthcare priorities, prioritizing outcome measures, patient-reported outcome measures, digital measures, and equity
  • Is responsive to specific program goals and statutory requirements
  • Addresses an important condition or topic with a performance gap and has a strong scientific evidence base to demonstrate the measure can lead to the desired outcomes and/or more affordable care 
  • Has written consent for any proprietary algorithms needed for measure production
  • Promotes alignment with CMS program attributes and across Department of Health and Human Services (HHS) programs and healthcare settings
  • Identifies opportunities for improvement (e.g., not topped out)
  • Does not result in negative unintended consequences (e.g., overuse or inappropriate use of care or treatment, limiting access to care)
  • Does not duplicate another measure currently implemented in one or more programs
  • If an electronic clinical quality measure (eCQM), it must have a Measure Authoring Tool (MAT) number (i.e., created in the MAT) and expressed in Health Quality Measure Format using the Quality Data Model and Clinical Quality Language

Fully Developed Measure

To meet these selection criteria, the measure developer must fully develop the measure. A fully developed measure means the measure developer has completed 

  • Person/encounter-level testing for each critical data element and the measure specifications do not need changes based on the results. 
  • Reliability testing at the accountable entity level and the measure specifications do not need changes based on the results. 
  • Empiric validity testing, when appropriate, at the accountable entity level and measure specifications do not need changes based on the results. 

Completion of face validity testing as the sole type of validity testing does not meet the criteria for fully developed. However, face validity is acceptable for new measures (i.e., those not currently in use in CMS programs and undergoing substantive changes) only. 

Additionally, for measures based on survey data, assessment tools, or patient-reported tools, including patient-reported outcome-based performance measures (PRO-PMs), the measure developer has tested the survey or tool and the survey or tool does not need changes based on the results. For measures based on assessment tools, the measure developer must have completed patient/encounter-level testing for each critical data element with no changes to the tool needed based on the results.

 

Pre-Rulemaking Process

Section 3014 of the ACA mandated the establishment of a federal pre‐rulemaking process for selecting quality and efficiency measures for specific programs within HHS. The pre-rulemaking process requires HHS to consider multi-stakeholder input on quality and efficiency measure selection. To meet these requirements, CMS develops a MUC List. The Measure Applications Partnership (MAP) is currently the multi-stakeholder group described in Section 3014 and it provides input to HHS on the list of measures for use in a specified program. By statute, HHS and CMS must consider MAP input and publish the rationale for selecting any measure (i.e., in proposed or final rules) not CMS consensus-based entity (CBE)-endorsed.

 

Measures Under Consideration

Over the past few years, CMS has articulated a number of measure selection criteria in its final rules for various programs. The term “measure selection” typically applies to determining whether a measure should be included in a measure set for a specific program, while “measure evaluation” applies to assessing the merits of an individual measure, not in the context of a specific program. CMS has established a set of measure selection criteria so that HHS can develop the MUC List for qualifying programs and make it available publicly by December 1 each year. These selection criteria are operationalized by CMS program staff and leadership, who decide which measures to place on the MUC List for review by the MAP.

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Pre-Rulemaking process depicted by an arrow facing right

After opening the CMS Measures Under Consideration Entry / Review Information Tool (MERIT) (login required), intended to gather specifications and supporting information on new candidate measures, CMS publishes guidance on the Pre-Rulemaking page. CMS may host educational webinars to kick off the official MUC season. Visit the Pre-Rulemaking page for more information. 

Applying the measure selection criteria, CMS develops the MUC List. CMS may ask measure developers to provide details on the measures to help CMS develop the MUC List. CMS then provides this list to the MAP.

 

MAP Recommendations

The MAP input to HHS on the annual list of quality and efficiency measures that are under consideration by one or more Medicare programs is due by February 1 of each year as a recommendation report. Each annual report can be found on the MAP pages on the CMS CBE website and on the Pre-Rulemaking page. CMS strongly encourages measure developers to attend the MAP meetings.

The MAP may also offer recommendations in other areas not subject to the rulemaking process, for example, the Medicaid Adult and Child Core sets and rural health.

 

CMS Considers MAP Input for Final Selection

After CMS receives the MAP input, a deliberation process begins. CMS determines the inclusion of the measures in the federal rulemaking processes. The measure selection criteria used during development of the MUC List are the same criteria used for rulemaking. HHS must consider MAP input and publish the rationale for selecting any measure for use in a CMS program—in proposed or final rules—not endorsed by the CMS CBE.

 

CMS Rulemaking Processes

After CMS completes the pre-rulemaking process and selects measures for potential inclusion in rulemaking, the next steps in the cycle are

  • Proposed rules: CMS writes the proposed rules and publishes them in the Federal Register. A proposed rule is generally available for public comment for 60 days.
  • Final rules: CMS considers the received comments and publishes the final rules in the Federal Register.

CMS treats existing measures that undergo substantive changes as new measures.

  • Changes to the

    • Intent of the measure
    • Numerator’s inclusion and/or denominator/numerator exclusion criteria
    • Methodology previously published in a final rule
    • Denominator exclusions/exceptions, or numerator exclusions, cohort, both a significant increase or decrease
    • Science impacting the primary medication, dosage, or medical device
    • Removal or addition of a component measure to a composite measure
       
Last Updated: Nov 2022