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Pennsylvania Keystones of Health Section 1115 Demonstration Approval Period: December 26, 2024 through December 31, 2029 Page 69 of 90 b. Explain how the state will isolate the effects of the demonstration from other initiatives occurring in the state at the same time (e.g., through the use of comparison groups). c. Include a discussion of how propensity score matching and difference–in– differences designs may be used to adjust for differences in comparison populations over time, if applicable. 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 question 1a –Measure 1 –Measure 2 –Measure 3 –Sample e.g. All attributed Medicaid beneficiaries –Beneficiaries with diabetes diagnosis –Medicaid fee– for–service and encounter claims records –Interrupted time series Research question 1b –Measure 1 –Measure 2 –Measure 3 –Measure 4 –Sample, e.g., PPS patients who meet survey selection requirements (used services within the last 6 months) –Patient survey Descriptive statistics Hypothesis 2 Research question 2a –Measure 1 –Measure 2 –Sample, e.g., PPS administrators –Key informants Qualitative 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–