Evaluate information collected during environmental scan and empirical data analysis

Evaluate existing or related measures for applicability

If there are related measures, evaluate the measures using the measure evaluation criteria to assess if they meet the needs of the measure development contract. If the measure cannot be adapted or adopted to meet the needs of the contract, consider harmonization issues related to similar data elements (e.g., age ranges, time of performance, allowable values for medical conditions or procedures, allowable conditions for inclusion in the denominator, reasons for exclusion from the denominator, risk adjustment methods, etc.). Refer to the Harmonization section for issues related to harmonization considerations.

Regarding adapted measures, if the measure contractor changes an existing measure to fit the current purpose or use, the measure is considered adapted. This may mean changing the numerator or

denominator, or changing a measure to meet the needs of a different care setting, data source, or population. Or, it may mean adding additional specifications to fit the current use.

Examples:

 A diabetes measure exists that uses medical claims information; however, the new measure, which is based on the existing measure, uses pharmacy data only.

 A measure for a particular process of care exists for hospitals; however, the new measure is for physician-level use.

The first step in evaluating whether or not to adapt a measure is to assess the applicability of the measure focus to the measure topic or setting of interest. Is the measure focus of the existing measure applicable to the quality goal of the new measure topic or setting? Does it meet the importance

criterion for the new setting or population?

If the population changes or if the type of data is different, new measure specifications would have to be developed and properly evaluated for soundness and feasibility before a determination regarding use in a different setting can be made. (Refer to the Technical Specifications section for the

standardized process.)

Measures that are being adapted for use in a different setting, the unit of measurement usually do not need to undergo the same level of development as a new measure. However, aspects of the measure need to be evaluated and possibly re-specified for the new setting in order to show the importance of the measure to each setting the measures may be used for. Additional testing of the measure in the new setting may also be required for the measure to get NQF endorsement. For further details, please refer to the Measure Testing section.

Empirical analysis may need to be conducted to evaluate the appropriateness of the measure for the new purpose. The analysis may include, but is not limited to, evaluation of the following:

 Changes in the relative frequency of critical conditions used in the original measure specifications when applied to a new setting/population (i.e., dramatic increase in the occurrence of exclusionary conditions).

 Change in the importance of the original measure in a new setting (i.e., an original measure addressing a highly prevalent condition may not show the same prevalence in a new setting; or, evidence that large disparities or suboptimal care found using the original measure do not exist in the new setting/population).

 Changes in the applicability of the original measure (i.e., the original measure composite contains preventative care components that are not appropriate in a new setting such as hospice care).

If an existing measure is found with a measure focus appropriate to the needs of the contract, but the population is not identical, it may be possible for CMS to collaborate with the owner of the original measures to discuss issues related to ownership, maintenance and testing.

Example:

 A measure for screening adult patients for depression is found. The current contract requires mental health screening measures for adolescents. The owner of the adult depression

screening measure may be willing to expand the population in the measure to the adolescent population. If the owner is not willing to expand the population, it may be necessary to develop a new measure specific to the adolescent population which will be harmonized with the existing measure.

 Regarding adopted measures, if the proposed measure has the same numerator, denominator, data source, and care setting as its parent measure, and the only additional information to be provided pertains to the measure’s implementation, such as data submission instructions, the measure is considered adopted.

Examples:

 Measures developed and endorsed for physician- or group-level use are specified for

submission to a physician group practice demonstration project and are proposed for a new physician incentive program.

 An existing Joint Commission hospital measure not developed by CMS is now added to the CMS measure set.

If a measure is copyright protected, there may be issues relating to its ownership or to proper

referencing of the parent measure. In either case, the measure owner will need to be contacted. Upon receiving approval from the original developer to use the existing measures, the detailed specifications will be included for the measure.

Conduct a measurement gap analysis to identify areas for new measure development

Develop a framework to organize the measures gathered. The purpose of this gap analysis is to identify measure types or concepts that may be missing for the measure topic or focus. Refer to Appendix 6a for an example of a framework for assessing needed outcome measures. Through this framework and analysis, the measure contractor may identify existing measures that can be adopted or adapted, or identify the need for new measures that need to be developed.

Determine the appropriate basis for creation of new measures

If there are no existing measures suitable for adoption or adaption and new measures must be developed, the measure contractor will determine the appropriate basis for the new measures based on the material gathered. The appropriate basis will vary by type of measure. It is important to note that the goal is to develop measures most proximal to the outcome desired. Contractors should avoid selecting or constructing measures that can be met primarily through documentation without

evaluating the quality of the activity—often satisfied with a checkbox, date, or code—for example a completed assessment, care plan, or delivered instruction.

If applicable to the contract, and as directed by the COR/GTL, the contractor may choose to solicit TEP input to identify the appropriate basis for new measures.

 For process measures, the appropriate basis consists of relevant clinical leverage points. A clinical leverage point is defined as follows:

A key state of health, clinical process, or event that has demonstrable effect on the health outcome. “…Three considerations arise when evaluating leverage points: (1) the area being measured is an important contributing factor to the clinical or contextual process for the goal, (2) the area is one in which measurement and reporting is likely to stimulate improvement (through either selection or change), and (3) the purpose is to be selective rather than comprehensive.” 3

 For outcome measures, the appropriate basis is the evidence that the specific outcomes of interest are linked to an important CMS goal and may be impacted by clinical interventions. Measures of intermediate outcomes may rely on clinical leverage points as defined above. (Refer to the Special Topics section for more information).

 For structural measures, the appropriate basis is the evidence that the specific structural elements are linked to improved health outcomes or improved care.

 Cost & Resource Use measures should be linked with measures of quality care for the same topic. (Refer to the Special Topics section for more information).

 For all measures, it is important to assess the relationship between the unit of analysis and the decision maker involved. Consider the extent to which processes are under the control of the entity being measured. The measure topic should be attributed to an appropriate provider or setting. This is not an absolute criterion. In some cases there is “shared accountability.” For

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example, for measures of health functioning and care coordination, no one provider controls the performance results.

Examples:

 It is probably not reasonable to hold a physician, who practices in an emergency department (ED), accountable for long-term medication adherence because an ED physician does not provide ongoing management for chronic conditions.

 It may be reasonable to hold an emergency department accountable for timeliness of

reperfusion therapy for acute myocardial infarction (AMI) even when the patient is transferred to another hospital. Timeliness relies on the shared accountability of transferring and receiving facilities, as well as the transport team.

 The timely receipt of aspirin when a patient presents with AMI is a shared responsibility of the hospital and emergency department physician and represents an appropriate leverage point for the basis of a measure for both hospitals and emergency department physicians.