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IPPS hospitals that elect to participate in the Bundled Payments for Care Improvement Advanced (BPCI Advanced) model, which started October 1, 2018, will continue to be paid under the IPPS and, therefore, are eligible to receive empirically justified Medicare DSH payments and uncompensated care payments

In both cases, different forms of regulatory interaction including Scientific Advice may occur in advance or in parallel to the FIH trial, to agree on the development plan, study design or specific aspects of the investigational compound