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<span>Summaries of Past Public Comments</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>When specifying measures, measure developers should consider whether a similar measure exists for the same condition, process of care, outcome, or care setting. Measure developers should consider <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Harmonization&lt;/span&gt; is the standardization of specifications for related measures with the same measure focus (e.g., influenza immunization of patients in hospitals or nursing homes); related measures for the same target population (e.g., eye exam and Hemoglobin A1c for patients with diabetes); or definitions applicable to many measures (e.g., age designation for children) so they are uniform or compatible, unless the measure developer can justify differences (i.e., dictated by the evidence). The dimensions of &lt;span class=&quot;glossify-exclude&quot;&gt;harmonization&lt;/span&gt; can include numerator, denominator, exclusion, calculation, and data source, and collection instructions. The extent of &lt;span class=&quot;glossify-exclude&quot;&gt;harmonization&lt;/span&gt; depends on the relationship of the measures, the evidence for the specific measure focus, and differences in data sources. Value sets used in measures (especially eCQMs) should be harmonized when the intended meaning is the same. &lt;span class=&quot;glossify-exclude&quot;&gt;Harmonization&lt;/span&gt; of logic in eCQMs is beneficial when the data source in the EHR is the same.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">harmonization</abbr> for every measure under development or maintenance throughout the Measure Lifecycle and harmonize measures unless there is a compelling reason for not doing so (e.g., significant risk variation by age, comorbidity, race) that would justify a separate measure. Harmonization standardizes similar measures when their differences do not make them scientifically stronger or more valuable. Harmonization should not result in inferior measures, but in scientifically strong, clinically valuable, evidence-based measures, which are important to persons/families/caregivers. <abbr tabindex="0" title="&lt;p&gt;The Patient Protection and Affordable Care Act defined a &lt;span class=&quot;glossify-exclude&quot;&gt;quality measure&lt;/span&gt; as “a standard for measuring the performance and improvement of population health or of health plans, providers of services, and other clinicians in the delivery of health care services.” (&lt;a href=&quot;https://www.gpo.gov/fdsys/pkg/PLAW-111publ148/pdf/PLAW-111publ148.pdf&quot;&gt;Pub. L. 111-148, 931&lt;/a&gt;)&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Quality measures</abbr> should be based on the best way to capture and specify the measure based on the current scientific information and guidelines. Do not assume a <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)-endorsed measure is better than a new measure.</p><p>Measure harmonization is important because it reduces duplication and overlap across quality measures. Measure duplication is undesirable because it may result in unnecessary data collection burden and make the processes of measure selection and interpretation less straightforward. The CMS consensus-based entity (CBE) requires consideration of measure harmonization as part of its endorsement processes.</p><p>When developing <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>, measure developers should consider various aspects of the measure for potential harmonization. Harmonization often requires close inspection of specification details of the <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Related measures&lt;/span&gt; are measures addressing either the same topic or the same population. This term is used when considering harmonization. See also Competing Measures.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">related measures</abbr>. Harmonizing measure specifications during measure development is more efficient than harmonizing a <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> and specified measure. The earlier in the process that measure developers identify related or <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Competing measures&lt;/span&gt; address the same topic and the same population. Use this term when considering harmonization. See also Related Measures.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">competing measures</abbr>, the sooner there is resolution to problematic issues.</p><p>Harmonization may include comparison and reconciliation of</p><ul><li>Age ranges</li><li>Measurement period</li><li>Allowable values for medical conditions or procedures (e.g., codes, <abbr tabindex="0" title="&lt;p&gt;A code system is a managed collection of concepts with each concept represented by at least one internally unique code and a human-readable description (e.g., SNOMED CT).&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">code systems</abbr>, code lists, descriptions)</li><li>Allowable conditions for inclusion in the <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> (e.g., codes, code systems, code lists, descriptions)</li><li>Denominator or <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> exclusion categories, whether the exclusion is from the denominator or numerator, and whether optional or required</li><li><abbr tabindex="0" title="&lt;p&gt;A &lt;span class=&quot;glossify-exclude&quot;&gt;calculation algorithm&lt;/span&gt; is an ordered sequence of data element retrieval and aggregation through which numerator and denominator events or continuous variable values are identified by a measure. Also referred to as the performance calculation.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Calculation algorithm</abbr></li><li><abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Risk adjustment&lt;/span&gt; is a mathematical model applied to a quality measure correcting for differing characteristics within a population, such as patient health status. Its purpose is a fairer and more accurate comparison of outcomes of care across health care organizations or clinicians. Measure developers usually apply &lt;span class=&quot;glossify-exclude&quot;&gt;risk adjustment&lt;/span&gt; models to outcome and cost/resource use measures.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">Risk adjustment</abbr> and/or <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Stratification&lt;/span&gt; divides a population or resource services into distinct, independent groups of similar data, enabling analysis of the specific subgroups. This type of adjustment can show where disparities exist or where there is a need to expose differences in results.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">stratification</abbr> methods</li></ul><p><strong>Examples of when the Measure Developer Should Consider Harmonization</strong></p><ul><li>Diabetic Foot &amp; Ankle Care, Peripheral Neuropathy (CMIT Member ID 00199) Neurological Evaluation (Steward: American Podiatric Medical Association) is a <abbr tabindex="0" title="&lt;p&gt;A process measure is a measure focusing on steps that should be followed to provide good care. There should be a scientific basis for believing that the process, when executed well, will increase the probability of achieving a desired outcome.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">process measure</abbr> reporting the frequency of peripheral neuropathy evaluations by <abbr tabindex="0" title="&lt;p&gt;&lt;span class=&quot;glossify-exclude&quot;&gt;Measured entities&lt;/span&gt; are the front-line clinicians and their organizations, including health information technology, collecting quality measurement data. &lt;span class=&quot;glossify-exclude&quot;&gt;Measured entities&lt;/span&gt; are the implementers of quality measures. The effect of quality measure data collection on clinician workflow can be negative. There may be effects on their payments, positive and negative, with respect to reporting and actual performance on quality measures. Because of these potential effects, &lt;span class=&quot;glossify-exclude&quot;&gt;measured entities&lt;/span&gt; should be involved in all aspects of the Measure Lifecycle.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">measured entities</abbr>; the proposed measure addresses peripheral neuropathy outcomes.</li><li>An existing diabetes measure includes individuals aged 18 to 75. A new process of care measure is based on new <abbr tabindex="0" title="&lt;p&gt;Clinical practice guidelines are systematically developed statements to support practitioner and patient decisions about appropriate health care for specific clinical circumstances.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">clinical practice guidelines</abbr> that recommending a specific treatment only for individuals aged 65 years and older.</li><li>An existing diabetes measure includes individuals aged 18 to 75. CMS has requested measures for beneficiaries aged 75 years and older.</li><li>Influenza immunization measures exist for many care settings, but the new measure is for a new care setting.</li><li>Readmission rates exist for several conditions, but the new measure is for a different condition.</li><li>A set of new hospital measures may be able to use <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 elements</abbr> already in use for existing hospital measures.</li></ul><p>If harmonization of the measure can occur with one or more existing measures, then the measure developer should use existing definitions for those attributes. Other resources (e.g., <a href="https://cmit.cms.gov/cmit/#/MeasureInventory">CMS Measures Inventory Tool [CMIT]</a>, <a href="https://www.emeasuretool.cms.gov/madie-mvp">Measure Authoring Development Integrated Environment [MADiE]</a>, and the <a href="https://ecqi.healthit.gov/">Electronic Clinical Quality Improvement [eCQI] Resource Center</a>) contain specifications and shared libraries to help identify opportunities for further harmonization. If the measure developer decides not to harmonize measures, they must document the reasons and include any literature used to support this decision.</p><p>Some reasons not to harmonize include</p><ul><li>The science, such as clinical practice guidelines, behind the new measure does not support using the same variable(s) found in the existing measure.</li><li>The measures intentions vary across programs/payors, which requires the measures to be distinct.</li><li>The measures have differing denominator <abbr tabindex="0" title="&lt;p&gt;The &lt;span class=&quot;glossify-exclude&quot;&gt;population&lt;/span&gt; is the total group of people of interest for a quality measure, sometimes called the target/initial &lt;span class=&quot;glossify-exclude&quot;&gt;population&lt;/span&gt;. The measure &lt;span class=&quot;glossify-exclude&quot;&gt;population&lt;/span&gt; is a defined subset appropriate to the measure set not excluded from the individual measure.&lt;/p&gt; " class="glossify-tooltip-tip" lang="en">populations</abbr> at significantly different risk (i.e., the denominators are risk stratified).</li></ul></div>
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<div class="views-row"><span class="views-field views-field-changed"><strong class="views-label views-label-changed">Last Updated: </strong><span class="field-content"><time datetime="2024-05-23T15:06:05-04:00">May 2024</time>
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