221 pages. "This draft guidance [1] describes how CMS will implement the Negotiation Program for initial price applicability year 2028 (January 1, 2028 to December 31, 2028) ... [2] sets forth additional policies regarding manufacturer effectuation of the MFP in 2026, 2027, and 2028 ... [3] specifies the requirements that will be applicable to manufacturers of drugs that are selected for negotiation or renegotiation ... [4] includes information on the successor regulation exception to the IRA's formulary inclusion requirement for 2027 and 2028 ... [and] [5] describes the procedures that may be applicable to drug manufacturers, Medicare Part D plan sponsors, pharmacies, mail order services, and other dispensing entities that dispense drugs covered under Medicare Part D, in addition to ... providers of services and suppliers that furnish or administer drugs to individuals enrolled under Medicare Part B."  MORE >>