On 30 June 2023, Centers for Medicare and Medicaid Services (CMS) released revised guidance instructions related to the Medicare Price Negotiation Program.
Some of the more significant elements include:
1. Selected products will appear on Medicare Part D formularies but may not receive favorable placement.
Significance: Even when the price is reduced, the change does not ensure that the product will have favored placement or usage in any way. Products not selected by CMS will be free to negotiate with Part D plans and Medicare Advantage plans to exchange preferred formulary status for price concessions.
2. Two events were added following the 2 October 2023 data submission deadline: CMS /manufacturer meeting and patient-focused listening sessions.
Significance: CMS is responding to the widespread pushback from drug companies to provide additional opportunities for feedback from multiple parties.
3. Manufacturers will be free to disclose information about the negotiation process.
Significance: additional transparency added for the negotiation process from CMS and from the drug manufacturers at their discretion.
4. Only specified Medicare Part D patients will be maximum fair price (MFP)-eligible in 2026. In 2026, the MFP will be in effect for patients covered by Part D only. The MFP will not apply when a selected product is reimbursed under Part B.
5. The Medicare Transaction Facilitator will ensure data exchange to see that all eligible patients have access to the selected products at the MFP.
Significance: The Medicare Transaction Facilitator will ensure that all eligible patients have access to the MFP. No mention of ensuring that ineligible patients will be denied access to the MFP.
Preparation is the key. Even if your drug isn’t selected, same-class drugs are likely to be significantly impacted as the market adjusts to new, lower drug prices for your competition.
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