On Tuesday, September 30, the Facilities for Medicare & Medicaid Companies (CMS) issued last steerage for the third cycle of negotiations underneath the Medicare Drug Value Negotiation Program (Negotiation Program). Based on the information launchthe steerage contains important coverage updates primarily based on public suggestions, with a specific deal with growing transparency, and enacts expanded protections for orphan medicine launched within the Working Households Tax Cuts Act.
The principle provisions embody:
- Enhanced Orphan Drug Protections: CMS broadens exclusions from negotiation for merchandise designated by the Meals and Drug Administration (FDA) as medicine for a number of uncommon illnesses or circumstances.
- Medicare Benefit Integration in Drug Choice: The ultimate steerage outlines a framework for incorporating each Medicare Benefit (MA) encounter knowledge for Half B objects and providers, in addition to conventional Charge-for-Service (FFS) Half B claims knowledge, into Complete Expenditure calculations underneath Half B.
- Therapy of Vaccines for Infectious Illness(s): CMS’s last steerage addresses how CMS will determine a possible qualifying single-source drug that could be a vaccine primarily based on its antigen element(s).
“CMS is working to decrease healthcare and prescription drug prices for Individuals whereas making certain the negotiation course of is open, honest, and aware of modifications available in the market and affected person wants,” mentioned CMS Administrator Dr. Mehmet Oz in an announcement. “We have listened to stakeholders, and their suggestions helped us make the Negotiation Program extra clear, extra workable for producers, and extra aware of the wants of Medicare beneficiaries.”
The third cycle of negotiations will happen in 2026, with negotiated most honest costs (MFPs) changing into efficient on January 1, 2028. CMS will announce as much as 15 extra medicine coated underneath Half D and/or payable underneath Half B for potential negotiation by February 1, 2026, together with every other medicine chosen for the primary cycle of renegotiation.
