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Demonstration Approval: November 1, 2023, through October 31, 2028 20

d. Consider the application of sensitivity analyses, as appropriate. 7. Other Additions – The state may provide any other information pertinent to the Evaluation Design for the demonstration.

Table A. Example Design Table for the Evaluation of the Demonstration Research Question Outcome measures used to address the research question Sample or population subgroups to be compared Data Sources Analytic Methods Hypothesis 1 Research -Measure 1 -Sample e.g. All -Medicaid fee- -Interrupted question 1a -Measure 2 attributed Medicaid for-service and time series -Measure 3 beneficiaries encounter claims -Beneficiaries with records diabetes diagnosis Research -Measure 1 -Sample, e.g., PPS -Patient survey Descriptive question 1b -Measure 2 patients who meet statistics -Measure 3 survey selection -Measure 4 requirements (used services within the last 6 months) Hypothesis 2 Research -Measure 1 -Sample, e.g., PPS -Key informants Qualitative question 2a -Measure 2 administrators analysis of interview material

D. Methodological Limitations – This section provides more detailed information about the limitations of the evaluation. This could include limitations about the design, the data sources or collection process, or analytic methods. The state should also identify any efforts to minimize these limitations. Additionally, this section should include any information about features of the demonstration that effectively present methodological constraints that the state would like CMS to take into consideration in its review.

CMS also recognizes that there may be certain instances where a state cannot meet the rigor of an evaluation as expected by CMS. In these instances, the state should document for CMS why it is not able to incorporate key components of a rigorous evaluation, including comparison groups and baseline data analyses. For example, if a demonstration is long- standing, it may be difficult for the state to include baseline data because any pre-test data points may not be relevant or comparable. Other examples of considerations include: 1. When the demonstration is: a. Non-complex, unchanged, or has previously been rigorously evaluated and found to be