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As we receive more information about how these codes are being used and implemented in medical practice, we anticipate that these codes and future related codes will be refined over time

CMS understands it is possible that a manufacturer may not have sales or monthly units of a COD to report to the Medicaid Drug Programs system for a calendar quarter because, for example, there may be a temporary interruption in sales of the COD, or there may be no sales immediately after the drug is first approved or licensed by the FDA

If CMS determines there is a severe supply chain disruption for an NDC-11, CMS will apply any reduction of the rebate amount as described in paragraphs (b)(1) and (2) of this section to a Part D rebatable drug at the NDC-9 level

Therefore, we believe it is appropriate to propose new payment for nalmefene as it would align with existing authority under 410.67(b) that recognizes opioid antagonist medications which treat known or suspected opioid overdose as an OUD treatment service

As proposed at 428.303(c)(7), CMS would keep confidential, to the extent allowable under law, any requests for a rebate reduction, including supporting documentation