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avoidance of certain foods known to be common bladder irritants for IC/BPS patients such as coffee or citrus products

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During our CY 2026 OPPS/ASC proposed rule assessment of CPT code X432T, we determined that the enhanced lithotripsy service involved a non-FDA approved device not excepted by any IDE status and therefore not payable under the OPPS/ASC because non-FDA approved devices are considered not reasonable and necessary under Section 1862(a)(1)(A) of the Act

The positive votes came despite highly critical reviews from FDA staff scientists, who said there was little data that BPC-157, TB-500 and the other chemicals can be safely used for medical purposes