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<a href="/measure-lifecycle/measure-specification/develop-specification/target-initial-population">
<span>Define the Target/Initial Population</span>
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<span>Define Stratification Scheme</span>
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<a href="/measure-lifecycle/measure-specification/specify-code/code-systems-vocabularies-terminologies">
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<span>Encoding Clinical Information</span>
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<span>Define Key Terms, Data Elements, Codes, and Code Systems</span>
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<span>Determine Risk Adjustment</span>
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<span>Define Any Time Intervals</span>
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<span>Describe Scoring &amp; Calculation Algorithm</span>
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<span>Document the Measures</span>
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<span>Measure Harmonization</span>
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<span>Measure Harmonization and Alignment</span>
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<div class="views-row"><div class="views-field views-field-field-parent-title"><h1 class="field-content"><span class="glossify-exclude">Measure Implementation</span></h1></div></div>
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<h1 class="margin-0">
<span property="schema:name">Measure Selection</span>
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<div property="schema:text" class="field field--name-body field--type-text-with-summary field--label-hidden field__item"><p>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. Section 3014 of the Patient Protection and Affordable Care Act (ACA) requires those measures subjected to this section go through the pre-rulemaking and rulemaking process. For a list of the programs, and information on their needs and priorities, see the annual <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;Measures Under Consideration&lt;/span&gt; is a list of quality and efficiency measures HHS is considering adopting, through the federal rulemaking process, for use in the Medicare program. Made publicly available by December 1 each year for categories of measures that are described in section 1890(b)(7)(B)(i)(I) of the Social Security Act as amended by Section&amp;nbsp;3014 of the Patient Protection and Affordable Care Act (ACA).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Measures Under Consideration</abbr> (MUC) List program-specific measure needs and priorities on the <a href="https://mmshub.cms.gov/measure-lifecycle/measure-implementation/pre-rulemaking/overview">Pre-Rulemaking</a>&nbsp;page. Other quality initiatives, such as the Health Insurance Marketplace Quality Initiatives, do not go through pre-rulemaking and follow another path.</p>
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<div class="field field--name-field-body-cont- field--type-text-long field--label-hidden field__item"><h3>CMS Measure Selection Criteria</h3><p>CMS measure selection <abbr tabindex="0" title="&lt;p&gt;A criterion is an accepted standard, principle, or rule used to make a decision or to inform an evaluators judgment.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">criteria</abbr> help ensure that each measure</p><ul><li>Supports the CMS and national health care priorities including&nbsp;prioritizing <abbr tabindex="0" title="&lt;p&gt;An outcome measure is a measure focusing on the health status of a patient (or change in health status) resulting from health care desirable or adverse.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">outcome measures</abbr>, <abbr tabindex="0" title="&lt;p&gt;PROs are status reports on a patients health condition or health behavior that comes directly from the patient, without interpretation of the patients response by a clinician or anyone else. This definition reflects the key domains of health-related quality of life (including functional status), symptoms and symptom burden (e.g., pain, fatigue), and health behaviors (e.g., smoking, diet, exercise). (Adapted from the Food and Drug Administration &lt;a href=&quot;https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM193282.pdf&quot;&gt;Guidance for Industry PRO Measures: Use in Medical Product Development to Support Labeling Claims&lt;/a&gt;)&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">patient-reported outcome</abbr> measures, <a href="https://ecqi.healthit.gov/dqm">digital measures</a>, and <abbr tabindex="0" title="&lt;p&gt;Equity is the consistent and systematic fair, just, and impartial treatment of all individuals, including individuals who belong to underserved communities that have been denied such treatment, such as Black, Latino, and Indigenous and Native American persons, Asian Americans and Pacific Islanders and other persons of color; members of religious minorities; lesbian, gay, bisexual, transgender, and queer (LGBTQ+) persons; persons with disabilities; persons who live in rural areas; and persons otherwise adversely affected by persistent poverty or inequality. (&lt;a href=&quot;https://www.federalregister.gov/documents/2021/01/25/2021-01753/advancing-racial-equity-and-support-for-underserved-communities-through-the-federal-government&quot;&gt;Executive Order 13985, 2021&lt;/a&gt;)&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">equity</abbr></li><li>Is responsive to specific program goals and statutory requirements</li><li>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&nbsp;</li><li>Has written consent for any proprietary algorithms needed for measure production</li><li>Promotes <abbr tabindex="0" title="&lt;p&gt;Alignment, with respect to quality measures, is encouraging the use of similar, standardized quality measures across and within public and private sector efforts. Achievement of alignment is when a set of measures works well across care settings or programs to produce meaningful information without creating extra work for measured entities. Alignment includes using the same quality measures in multiple programs when possible. It can also come from consistently measuring important topics across care settings.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">alignment</abbr> with CMS program attributes and across Department of Health and Human Services (HHS) programs and health care settings</li><li>Identifies <abbr tabindex="0" title="&lt;p&gt;Opportunity for improvement is when data demonstrate considerable variation or overall, less-than-optimal performance, in the quality of care across measured entities, and/or there are disparities in care across population groups.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">opportunities for improvement</abbr> (e.g., not <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Topped-out&lt;/span&gt;, sometimes referred to as &lt;span class=&quot;glossify-exclude&quot;&gt;topped off&lt;/span&gt;, is when measures performance is so high and unvarying that measured entities can no longer make meaningful distinctions and improvements in performance.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">topped out</abbr>)</li><li>Does not result in negative unintended consequences (e.g., overuse or inappropriate use of care or treatment, limiting access to care)</li><li>Does not duplicate another measure currently implemented in one or more programs</li><li>If an <abbr tabindex="0" title="&lt;p&gt;An electronic clinical quality measure (eCQM) is a measure specified in a standard electronic format that uses data electronically extracted from electronic health records and/or health information technology systems to measure the quality of health care provided. Electronic Clinical Quality Improvement Resource Center. (n.d.) &lt;em&gt;Glossary&lt;/em&gt;. Retrieved May 22, 2024, from&amp;nbsp;https://ecqi.healthit.gov/glossary&lt;/p&gt;" class="glossify-tooltip-tip" lang="en">electronic clinical quality measure</abbr> (eCQM), it must have a CMS ID (found in MADiE) and expressed in <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;HQMF&lt;/span&gt; is a standards-based representation of quality measures as electronic documents. Refer to a quality measure expressed in this way as an eCQM.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Health Quality Measure Format</abbr> using the <abbr tabindex="0" title="&lt;p&gt;The &lt;a href=&quot;https://ecqi.healthit.gov/qdm&quot;&gt;QDM&lt;/a&gt; is an information model defining relationships between patients and clinical concepts in a standardized format to enable electronic quality performance measurement. The model is the current structure for electronically representing quality measure concepts for interested parties involved in electronic quality measurement development and reporting. The &lt;span class=&quot;glossify-exclude&quot;&gt;QDM&lt;/span&gt; provides the language defining the criteria for clinical quality measurement. It allows the electronic definition of a clinical concept via its data elements and provides the vocabulary to relate them to each other. By relating attributes between data elements and using filtering functions, the &lt;span class=&quot;glossify-exclude&quot;&gt;QDM&lt;/span&gt; provides a method to construct complex clinical representations for eCQMs.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Quality Data Model</abbr> and <abbr tabindex="0" title="&lt;p&gt;&lt;a href=&quot;https://ecqi.healthit.gov/cql&quot;&gt;CQL&lt;/a&gt; is a Health Level Seven International® mixed normative/Standard for Trial Use. It is part of the effort to harmonize standards between electronic clinical quality measures and clinical decision support. &lt;span class=&quot;glossify-exclude&quot;&gt;CQL&lt;/span&gt; provides the ability to express logic that is human-readable yet structured enough for processing a query electronically.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Clinical Quality Language</abbr></li></ul><p><strong><abbr tabindex="0" title="&lt;p&gt;To meet these selection criteria, the measure developer must complete&amp;nbsp; testing of the measure. This means the measure developer has completed&amp;nbsp;&lt;/p&gt;&lt;ul&gt;&lt;li&gt;Person/encounter-level (data element-level) reliability and validity testing, when appropriate,&amp;nbsp;for each&amp;nbsp;critical data element&amp;nbsp;and the measure&amp;nbsp;specifications&amp;nbsp;do not need changes based on the results.&amp;nbsp;Testing may be empiric or reference external or previous testing (e.g., established data element library such as the CMS&amp;nbsp;&lt;a href=&quot;https://del.cms.gov/DELWeb/pubHome&quot;&gt;Data Element Library&amp;nbsp;(DEL)&lt;/a&gt; or &lt;a href=&quot;https://ecqi.healthit.gov/mc-workspace-2/data-element-repository&quot;&gt;Data Element Repository (DERep)&lt;/a&gt; or literature).&lt;/li&gt;&lt;/ul&gt;&lt;p&gt;AND&lt;/p&gt;&lt;ul&gt;&lt;li&gt;Accountable entity-level (measure score-level) reliability and validity testing, when appropriate, and specifications do not need changes based on the results. Measure developers are encouraged to report accountable entity-level reliability results by decile (rather than just the median) to detect differences in reliability across the target population size distribution.&lt;/li&gt;&lt;li&gt;Completion of face&amp;nbsp;&lt;a href=&quot;https://mmshub.cms.gov/measure-lifecycle/measure-testing/evaluation-criteria/scientific-acceptability/validity&quot;&gt;validity testing&lt;/a&gt;&amp;nbsp;as the sole type of&amp;nbsp;validity&amp;nbsp;testing does not meet the criteria for completion of testing for a fully developed measure. However,&amp;nbsp;face validity&amp;nbsp;is acceptable for new measures (i.e., those not currently in use in CMS programs and undergoing substantive changes) that are not electronic Clinical Quality Measure (eCQM)&amp;nbsp;.&amp;nbsp;Instead of Likert-scale type assessments of face validity, measure developers are encouraged to develop a logic model consisting of inputs, activities, outputs, and outcomes to describe the associations between the health care structures and processes and the desired health outcome(s). The logic model should indicate the structure(s), process(es), and/or outcome(s) included in the measure. A detailed logic model will help the measure developer identify appropriate constructs for future empiric validity testing.&lt;/li&gt;&lt;/ul&gt;&lt;p&gt;AND&lt;/p&gt;&lt;p&gt;For measures based on survey data or patient-reported assessment tools, including&amp;nbsp;patient-reported outcome-based performance measures&amp;nbsp;(PRO-PMs), the measure developer has tested reliability and validity of 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 reliability and validity testing for each critical data element and complete testing of the assessment tool itself with no changes to the tool needed based on the results.&lt;/p&gt;" class="glossify-tooltip-tip" lang="en">Fully Developed</abbr> Measure</strong></p><p>To meet these selection criteria, the measure developer must complete&nbsp; testing of the measure. This means the measure developer has completed&nbsp;</p><ul><li>Person/<abbr tabindex="0" title="&lt;p&gt;An encounter, as defined by the ASTM International is “(1) an instance of direct provider/practitioner to patient interaction, regardless of the setting, between a patient and a practitioner vested with primary responsibility for diagnosing, evaluating or treating the patients condition, or both, or providing social worker services; and (2) a contact between a patient and a practitioner who has primary responsibility for assessing and treating the patient at a given contact, exercising independent judgment.” Encounter serves as a focal point linking clinical, administrative, and financial information. Encounters occur in many settings—ambulatory care, inpatient care, emergency care, home health care, field and virtual (telemedicine).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">encounter</abbr>-level (<abbr tabindex="0" title="&lt;p&gt;A data element is a basic unit of information with a unique meaning and subcategories (data items) of distinct value. National Institute of Standards and Technology. (n.d.). &lt;em&gt;Data element&lt;/em&gt;. Computer Security Resource Center. Retrieved November 1, 2023, from&amp;nbsp;&lt;a href=&quot;https://csrc.nist.gov/glossary/term/data_element&quot;&gt;https://csrc.nist.gov/glossary/term/data_element&lt;/a&gt;&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">data element</abbr>-level) <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Reliability&lt;/span&gt; reflects the measure is well defined and precisely specified so measured entities can implement consistently within and across organizations and that it distinguishes differences in performance.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">reliability</abbr> and <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Validity&lt;/span&gt; includes measure &lt;span class=&quot;glossify-exclude&quot;&gt;validity&lt;/span&gt; (when the measure accurately represents the evaluated concept and achieves the intended purpose, meaning to measure quality) and data element &lt;span class=&quot;glossify-exclude&quot;&gt;validity&lt;/span&gt;, which is the extent to which the information represented by the data element or code used in the measure reflects the actual concept or event intended.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">validity</abbr> testing, when appropriate,&nbsp;for each&nbsp;critical data element&nbsp;and the measure&nbsp;<abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Specifications&lt;/span&gt; are measure instructions addressing data elements, data sources, point of data collection, timing and frequency of data collection and reporting, specific instruments used (if appropriate), and implementation strategies.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">specifications</abbr>&nbsp;do not need changes based on the results.&nbsp;Testing may be empiric or reference external or previous testing (e.g., established data element library such as the CMS&nbsp;<a href="https://del.cms.gov/DELWeb/pubHome">Data Element Library&nbsp;(DEL)</a> or <a href="https://ecqi.healthit.gov/mc-workspace-2/data-element-repository">eCQM Data Element Repository (DERep)</a> or literature).</li></ul><p>AND</p><ul><li>Accountable entity-level (<abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;measure score&lt;/span&gt; is the numeric result computed by applying the measure specifications and scoring algorithm. The computed &lt;span class=&quot;glossify-exclude&quot;&gt;measure score&lt;/span&gt; represents an aggregation of all appropriate patient-level data (e.g., proportion of patients who died, average lab value attained) for the measured entity (e.g., hospital, health plan, home health agency, clinician). The measure specifications designate the measured entity and to whom the measure applies.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">measure score</abbr>-level) reliability and validity testing, when appropriate, and specifications do not need changes based on the results. Measure developers are encouraged to report accountable entity-level reliability results by decile (rather than just the median) to detect differences in reliability across the <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;target/initial population&lt;/span&gt; refers to all events for evaluation by a specific performance measure involving patients who share a common set of specified characteristics within a specific measurement set to which a given measure belongs. Measured entities should draw all patients/episodes (e.g., as numerator, as denominator) from the &lt;span class=&quot;glossify-exclude&quot;&gt;target/initial population&lt;/span&gt;.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">target population</abbr> size distribution.</li><li>Completion of face&nbsp;<a href="/measure-lifecycle/measure-testing/evaluation-criteria/scientific-acceptability/validity" data-entity-type="node" data-entity-uuid="1f8597c2-86b5-4ed3-a857-cb70f8c272be" data-entity-substitution="canonical" title="Validity">validity testing</a>&nbsp;as the sole type of&nbsp;validity&nbsp;testing does not meet the criteria for completion of testing for a fully developed measure. However,&nbsp;<abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Face validity&lt;/span&gt; is the extent to which a test appears to cover the concept it purports to measure “at face value.” It is a subjective assessment by experts of whether the measure reflects the quality of care (e.g., whether the proportion of patients with blood pressure &amp;lt; 140/90 is a marker of quality.)&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">face validity</abbr>&nbsp;is acceptable for new measures (i.e., those not currently in use in CMS programs and undergoing substantive changes) that are not eCQMs.&nbsp;Instead of Likert-scale type assessments of face validity, measure developers are encouraged to develop a <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Logic&lt;/span&gt; is the criteria used to define a quality measure and its key components.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">logic</abbr> model consisting of inputs, activities, outputs, and outcomes to describe the associations between the health care structures and processes and the desired health outcome(s). The logic model should indicate the structure(s), process(es), and/or outcome(s) included in the measure. A detailed logic model will help the measure developer identify appropriate constructs for future <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Predictive validity, also known as empirical validity,&lt;/span&gt; is the ability of measure scores to predict scores on some other related valid measure. The degree to which the operationalization can predict (or correlate) with other measures of the same measured construct at some time in the future.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">empiric validity</abbr> testing.</li></ul><p>AND</p><p>For measures based on survey data or patient-reported assessment tools, including&nbsp;<abbr tabindex="0" title="&lt;p&gt;A patient-reported outcome-based performance measure (PRO-PM) is a performance measure that is based on patient-reported outcome measure (PROM) data aggregated for an accountable health care entity. Measured entities collect the data directly from the patient using the PROM tool, which can be an instrument, scale, or single-item measure.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">patient-reported outcome-based performance measures</abbr>&nbsp;(PRO-PMs), the measure developer has tested reliability and validity of 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 reliability and validity testing for each <abbr tabindex="0" title="&lt;p&gt;A &lt;span class=&quot;glossify-exclude&quot;&gt;critical data element&lt;/span&gt; is an element contributing most to the computed measure score, meaning it accounts for identifying the greatest proportion of the target condition, event, or outcome being measured (numerator); the target population (denominator); population excluded (exclusion); and when applicable, risk factors with largest contribution to variability in outcome.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">critical data element </abbr>and complete testing of the assessment tool itself with no changes to the tool needed based on the results.</p></div>
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<div class="field field--name-field-body-cont- field--type-text-long field--label-hidden field__item"><h3>Pre-Rulemaking Process</h3><p>Section 3014 of the <a href="https://www.govinfo.gov/content/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf">ACA</a> mandated the establishment of a federal prerulemaking process for selecting quality and <abbr tabindex="0" title="&lt;p&gt;An &lt;span class=&quot;glossify-exclude&quot;&gt;efficiency measure&lt;/span&gt; is the cost of care (inputs to the health system in the form of expenditures and other resources) associated with a specified level of health outcome.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">efficiency measures</abbr> for specific programs within HHS. The pre-rulemaking process requires HHS to consider multi-interested party input on quality and efficiency measure selection. To meet these requirements, CMS develops a <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;Measures Under Consideration&lt;/span&gt; is a list of quality and efficiency measures HHS is considering adopting, through the federal rulemaking process, for use in the Medicare program. Made publicly available by December 1 each year for categories of measures that are described in section 1890(b)(7)(B)(i)(I) of the Social Security Act as amended by Section&amp;nbsp;3014 of the Patient Protection and Affordable Care Act (ACA).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">MUC</abbr> List. The <abbr tabindex="0" title="&lt;p&gt;The Medicare Improvements for Patients and Providers Act of 2008 requires the U.S. Department of Health and Human Services to contract with a consensus-based entity (CBE) regarding performance measurement. The CMS CBE endorses quality measures through a transparent, consensus-based process incorporating feedback from diverse groups of interested parties to foster health care quality improvement.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">CMS consensus-based entity</abbr> (CBE) convenes interested parties&nbsp;described in Section 3014, to provide input to HHS on the list of measures for use by CMS. By statute, HHS and CMS must consider this input.</p></div>
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<div class="field field--name-field-body-cont- field--type-text-long field--label-hidden field__item"><h3>Measures Under Consideration</h3><p>Over the past few years, CMS has articulated a number of measure selection <abbr tabindex="0" title="&lt;p&gt;A criterion is an accepted standard, principle, or rule used to make a decision or to inform an evaluators judgment.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">criteria</abbr> in its final rules for various programs. The term “measure selection” typically applies to determining whether a measure should be included in a <abbr tabindex="0" title="&lt;p&gt;A measure set is a group of measures related in some way such as measures addressing a specific condition, procedure, or specialty.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">measure set</abbr> 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 HHS can develop the <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;Measures Under Consideration&lt;/span&gt; is a list of quality and efficiency measures HHS is considering adopting, through the federal rulemaking process, for use in the Medicare program. Made publicly available by December 1 each year for categories of measures that are described in section 1890(b)(7)(B)(i)(I) of the Social Security Act as amended by Section&amp;nbsp;3014 of the Patient Protection and Affordable Care Act (ACA).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">MUC</abbr> 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.</p><p>Click here to view the <a href="/measure-lifecycle/measure-implementation/pre-rulemaking/overview" data-entity-type="node" data-entity-uuid="41fad9a9-fdf6-40b1-b22e-d1e68854bba2" data-entity-substitution="canonical" title="Pre-Rulemaking">annual pre-rulemaking timeline</a>.</p><p>After opening the&nbsp;<a href="https://cmsmerit.cms.gov/merit/#/login">CMS Measures Under Consideration Entry / Review Information Tool</a>&nbsp;(MERIT) (login required), CMS gathers&nbsp;<abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Specifications&lt;/span&gt; are measure instructions addressing data elements, data sources, point of data collection, timing and frequency of data collection and reporting, specific instruments used (if appropriate), and implementation strategies.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">specifications</abbr>&nbsp;and supporting information on new candidate measures. CMS publishes guidance on the Pre-Rulemaking page and may host educational webinars to kick off the official MUC season. Visit the&nbsp;<a href="/measure-lifecycle/measure-implementation/pre-rulemaking/overview" data-entity-type="node" data-entity-uuid="41fad9a9-fdf6-40b1-b22e-d1e68854bba2" data-entity-substitution="canonical" title="Pre-Rulemaking">Pre-Rulemaking</a>&nbsp;page&nbsp;for more information.&nbsp;</p><p>Applying the measure selection criteria, CMS develops the&nbsp;<a href="/measure-lifecycle/measure-implementation/pre-rulemaking/lists-and-reports" data-entity-type="node" data-entity-uuid="ab756b66-7379-4d00-b010-724342b44359" data-entity-substitution="canonical" title="Pre-Rulemaking MUC Lists and Recommendation Reports">MUC List</a>. 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 CBE.</p></div>
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<div class="field field--name-field-body-cont- field--type-text-long field--label-hidden field__item"><h3><strong>MUC List Recommendations</strong></h3><p>The input provided by interested parties convened by the <abbr tabindex="0" title="&lt;p&gt;The Medicare Improvements for Patients and Providers Act of 2008 requires the U.S. Department of Health and Human Services to contract with a consensus-based entity (CBE) regarding performance measurement. The CMS CBE endorses quality measures through a transparent, consensus-based process incorporating feedback from diverse groups of interested parties to foster health care quality improvement.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">CMS CBE</abbr> to HHS on the annual list of quality and&nbsp;<abbr tabindex="0" title="&lt;p&gt;An &lt;span class=&quot;glossify-exclude&quot;&gt;efficiency measure&lt;/span&gt; is the cost of care (inputs to the health system in the form of expenditures and other resources) associated with a specified level of health outcome.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">efficiency measures</abbr>&nbsp;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&nbsp;<a href="/measure-lifecycle/measure-implementation/pre-rulemaking/overview" data-entity-type="node" data-entity-uuid="41fad9a9-fdf6-40b1-b22e-d1e68854bba2" data-entity-substitution="canonical" title="Pre-Rulemaking">Pre-Rulemaking</a>&nbsp;page. CMS strongly encourages measure developers with measures on the <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;Measures Under Consideration&lt;/span&gt; is a list of quality and efficiency measures HHS is considering adopting, through the federal rulemaking process, for use in the Medicare program. Made publicly available by December 1 each year for categories of measures that are described in section 1890(b)(7)(B)(i)(I) of the Social Security Act as amended by Section&amp;nbsp;3014 of the Patient Protection and Affordable Care Act (ACA).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">MUC</abbr> List to attend these recommendation meetings.</p></div>
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<div class="field field--name-field-body-cont- field--type-text-long field--label-hidden field__item"><h3><strong>CMS Considers MUC List Recommendations for Final Selection</strong></h3><p>After CMS receives the recommendations on the <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;Measures Under Consideration&lt;/span&gt; is a list of quality and efficiency measures HHS is considering adopting, through the federal rulemaking process, for use in the Medicare program. Made publicly available by December 1 each year for categories of measures that are described in section 1890(b)(7)(B)(i)(I) of the Social Security Act as amended by Section&amp;nbsp;3014 of the Patient Protection and Affordable Care Act (ACA).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">MUC</abbr> List, a deliberation process begins. CMS determines the inclusion of the measures using the federal rulemaking processes. The measure selection&nbsp;<abbr tabindex="0" title="&lt;p&gt;A criterion is an accepted standard, principle, or rule used to make a decision or to inform an evaluators judgment.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">criteria</abbr>&nbsp;used during development of the&nbsp;MUC&nbsp;List are the same criteria used for rulemaking. HHS must consider the recommendations on the MUC List.</p></div>
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<div class="field field--name-field-body-cont- field--type-text-long field--label-hidden field__item"><h3><strong>CMS Rulemaking Processes</strong></h3><p>After CMS completes the pre-rulemaking process and selects measures for potential inclusion in rulemaking, the next steps in the cycle are</p><ul><li><strong>Proposed rules</strong>: CMS writes the proposed rules and publishes them in the Federal Register. A proposed rule is generally available for public comment for 60 days.</li><li><strong>Final rules</strong>: CMS considers the received comments and publishes the final rules in the Federal Register.</li></ul><p>CMS treats existing measures that undergo substantive changes as new measures.</p><p><strong>Examples of Substantive Changes</strong></p><p>Changes to the</p><ul><li>Intent of the measure</li><li><abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;numerator&lt;/span&gt; is the upper portion of a fraction used to calculate a rate, proportion, or ratio. Also called the measure focus, it is the target process, condition, event, or outcome. &lt;span class=&quot;glossify-exclude&quot;&gt;Numerator&lt;/span&gt; criteria are the processes or outcomes expected for each patient, procedure, or other unit of measurement defined in the denominator. A &lt;span class=&quot;glossify-exclude&quot;&gt;numerator&lt;/span&gt; statement describes the action satisfying the conditions of the performance measure.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Numerator</abbr>'s inclusion and/or <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;denominator&lt;/span&gt; is a statement describing the population evaluated by the performance measure and is the lower part of a fraction used to calculate a rate, proportion, or ratio. It can be the same as the target/initial population or a subset of the target/initial population to further constrain the population for the purpose of the measure. CV measures may refer to this as measure population.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">denominator</abbr> inclusion, denominator exclusions and exceptions, numerator exclusion <abbr tabindex="0" title="&lt;p&gt;A criterion is an accepted standard, principle, or rule used to make a decision or to inform an evaluators judgment.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">criteria</abbr></li><li>Methodology previously published in a final rule (methodology in this case refers to measure calculation/measure <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Scoring&lt;/span&gt; is the method(s) applied to data to generate results/score. Most quality measures produce rates; however, other &lt;span class=&quot;glossify-exclude&quot;&gt;scoring&lt;/span&gt; methods include categorical value, CV, count, frequency distribution, non-weighted score/composite/scale, ratio, and weighted score/composite/scales.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">scoring</abbr> methodology)</li><li>Cohort, both as significant increase or decrease</li><li>Science impacting the primary medication, dosage, or medical device</li></ul><h4>Paperwork Reduction Act Guidance for CMS Measure Developers</h4><p>There may be a requirement for CMS measure developers to prepare documentation for an Information Collection Requirement (ICR), which is part of the <abbr tabindex="0" title="&lt;p&gt;The &lt;a href=&quot;http://www.gpo.gov/fdsys/pkg/PLAW-104publ13/pdf/PLAW-104publ13.pdf&quot;&gt;PRA&lt;/a&gt; mandates that all federal government agencies must obtain approval from the Office of Management and Budget before collection of information that will impose a burden on the public. Measure developers should be familiar with the PRA before implementing any process involving the collection of new data.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Paperwork Reduction Act</abbr> (PRA). CMS measure developers can find more information about ICRs and PRA in the <em>Blueprint Contractual Guidance and Considerations</em> found on the <a href="https://cmsbox.box.com/s/77w8dlvl41nhfp40vze3gzh7bp28i1eo">Measure &amp; Instrument Development and Support (MIDS) Library</a>. The MIDS Library is a protected website restricted to CMS and CMS MIDS contractors. MIDS contractors should email <a href="mailto:MMSsupport@battelle.org">MMSsupport@battelle.org</a> to request access to the MIDS Library. Once eligibility is confirmed, the MIDS contractor will receive an invitation to the site.</p><dl class="ckeditor-accordion"><dt>Resource</dt><dd><p><a href="/sites/default/files/CMIT-Data-Elements-Substantive-Change.pdf" data-entity-type="media" data-entity-uuid="aa34aec8-68b6-4273-8c48-a54576fdcc44" data-entity-substitution="media" title="CMIT-Data-Elements-Substantive-Change.pdf">CMIT Data Elements Substantive Change</a></p></dd></dl></div>
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