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Other Considerations Hyperpigmentation: Minimal compared to Melanotan II due to reduced MC1R affinity and intermittent dosing Long-term safety: Data spanning up to one year has not revealed unexpected adverse events or cumulative toxicity Pregnancy: Category not established
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Specifically, one commenter suggested that CMS consider unpackaging their product, a contrast agent, and believed CMS's reasoning in the CY 2026 OPPS/ASC proposed rule for unpackaging and paying separately for diagnostic radiopharmaceuticals applies equally or even more to their product, since the cost of their product is over 500 times greater than the amount reported for the policy packaged drugs offset associated with the Level II Urology APC
Proc Natl Acad Sci USA 107(35):1564315648
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