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Stem cell therapy using autologous bone marrow or adipose-derived cells is regulated under Section 361 of the Public Health Service Act as minimally manipulated tissue, allowing clinics to offer it without formal FDA approval if cells are harvested and reimplanted in the same procedure
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Collaborate with your healthcare provider to ensure that all necessary documentation is complete, or seek assistance from a Medicare expert to navigate the appeal process.
Krasniak AE, Knipp GT, Svensson CK, Liu W