CMS Pulls Back from Denying Claims Related to Birth Tissues

The Centers for Medicare & Medicaid Services have rescinded their February 23, 2022 mandate to broadly deny claims for “manipulated amniotic and/or placental tissue biologics for injections to treat illness.” This action follows information provided by AATB and FDA clarifying that not all birth tissue for transplant requires pre-marketing authorization via the IND/BLA pathway, i.e., some birth tissues are “361 HCT/Ps.”