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That is, we are proposing at 410.30 to include orally and enterally administered compounded formulations with active ingredients derived only from FDA-approved drugs that have approved immunosuppressive indications or FDA-approved drugs that have been determined by a MAC to be reasonable and necessary for specific purposes in immunosuppressive treatment in the immunosuppressive drug benefit

The billing level is significant and represents billing activity that would cause significantly inaccurate and inequitable payments and repayment obligations in the Shared Savings Program if not addressed

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