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Tumor immunosuppression In the TME, metabolic reprogramming not only provides energy and biosynthetic substrates to support the accelerated growth of tumor cells, but also significantly changes the local immune ecology

of this proposed rule, beginning with new technology add-on payment applications for FY 2025, we are proposing, for technologies that are not already market authorized, to require applicants to have a complete and active FDA market authorization request at the time of new technology add-on payment application submission and to provide documentation of FDA acceptance or filing to CMS at the time of application submission

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