Protecting Patient Access to Cancer and Complex Therapies Act

This bill amends the Social Security Act to require manufacturers of certain drugs and biological products that are subject to maximum fair price negotiation to pay rebates to Medicare Part B. The rebate is based on the difference between the current payment amount (ASP+6) and the payment amount based on the maximum fair price (MFP+6). The bill also adjusts beneficiary coinsurance to be based on the MFP+6 amount and makes related changes to other payment systems.

Sec. 2, Rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation: This section establishes a new rebate requirement for manufacturers of selected drugs that have a maximum fair price agreement. The Secretary must provide manufacturers with quarterly information on units furnished and the rebate amount. Manufacturers must pay the rebate within 30 days of receiving this information. The rebate is calculated as the difference between the ASP+6 payment amount and the MFP+6 payment amount, multiplied by the number of units. Beneficiary coinsurance for these drugs is set at 20% of the MFP+6 payment amount. The rebates are deposited into the Federal Supplementary Medical Insurance Trust Fund. Civil money penalties apply for non-compliance. The section also includes conforming amendments to ensure that the rebate is not included in the calculation of average sales price, and that the rebate requirement is incorporated into manufacturer agreements under the drug price negotiation program.