Protecting Patient Access to Cancer and Complex Therapies Act

The Protecting Patient Access to Cancer and Complex Therapies Act would create a new rebate program within Medicare Part B for a subset of drugs and biological products that are subject to maximum fair price (MFP) negotiation. For those “selected drugs,” manufacturers would owe quarterly rebates to the Secretary, calculated by comparing the current ASP+6 payment amount with an MFP+6 payment amount, and then applying the resulting reconciliation to beneficiary cost-sharing. The rebates would be deposited into the Federal Supplementary Medical Insurance Trust Fund. The bill also tightens compliance with penalties for noncompliance and makes a series of conforming amendments to ensure the rebate system works alongside existing Part B and Medicaid rebate provisions. In short, the bill is designed to lower patient out-of-pocket costs for certain high-need cancer and complex therapies by requiring manufacturers to rebate part of the payments when those drugs are priced under MFP, with the rebates funding the Medicare Part B program.