OK SPA 22-0021 Clinical Trials Patient Costs

OK SPA 22-0021 Clinical Trials Patient Costs

Beginning January 1, 2022, a new mandatory benefit is added to the Social Security Act for routine patient costs for items and services furnished in connection with participation by Medicaid beneficiaries in qualifying clinical trials. These services include any item or service provided to a member under the qualifying clinical trial, including any item or service provided to prevent, diagnose, monitor, or treat complications resulting from participation in the qualifying clinical trial. Routine patient costs associated with qualified clinical trials will be covered to the extent that the provision of such items or services to the member would otherwise be covered outside the course of participation in the qualifying clinical trial under the state plan, home and community-based services (HCBS) waiver, and the 1115 SoonerCare demonstration project. The coverage determination shall be completed within 72 hours and shall be based on attestation from the qualified clinical trial provider. Reimbursement for routine patient costs associated with qualified clinical trials will follow the Agency’s existing rate methodology within the Oklahoma State Plan for the individual service/item provided. The Agency currently covers the aforementioned services; however, a state plan amendment (SPA) is required to assure coverage and participation requirements.

Please view the draft SPA pages here: OK SPA 22-0021 and submit feedback via the comment box below.

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