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MISSISSIPPI DIVISION OF MEDICAID Eligibility Policy and Procedures Manual CHAPTER 200A – Income: ABD Categories Page |93 Effective Month: July 2025 o An informed consent form is proof an IRB reviewed and approved the trial. In the absence of the informed consent form, assume IRB approval if the clinical trial appears in the Clinical Trials.gov website. • Must involve research and testing of medical treatments, e.g., experimental treatments, new combinations of drugs, new approaches to surgery or radiation therapy, etc.; and • Must target an “orphan” or rare disease or condition. o Some commonly known rare disease are Lou Gehrig’s disease, Crohn’s disease, cystic fibrosis, cystinosis, Duchenne muscular dystrophy, Huntington’s disease, and Tourette syndrome. o If the disease associated with the clinical trial is not one of the above or the documentation provided does not state the condition is a rare disease or condition, search for it in the Office of Rare Disease Research’s rare disease database at www.rarediseases.info.nih.gov under Rare Diseases and Related Terms. Verify date, frequency and payment amount using check stubs, payment receipts, informed consent form, etc. Apply the exclusion, if applicable. Otherwise, use regular income counting rules. The Act specifies this exclusion will expire on October 5, 2015, but this provision was renewed by the Ensuring Access to Clinical Trials Act of 2015 and continues.