Protecting Patient Access to Cancer and Complex Therapies Act of 2023

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, and it adjusts how Medicare payments and beneficiary coinsurance are calculated for those drugs.

Sec. 2, Rebate by manufacturers for selected drugs and biological products subject to maximum fair price negotiation: This section establishes a new rebate system for selected drugs under Medicare Part B. The Secretary of Health and Human Services must, within six months after each calendar quarter, provide manufacturers with information on the total units of the drug furnished and the difference between the standard payment amount (ASP+6) and the maximum fair price payment amount (MFP+6). Manufacturers must then pay a rebate equal to that difference multiplied by the number of units, within 30 days of receiving the information. Beneficiary coinsurance for these drugs is calculated based on 20% of the MFP+6 payment amount, instead of the standard amount. The rebates are deposited into the Medicare Supplementary Medical Insurance Trust Fund. The section also includes civil money penalties for non-compliance and makes conforming amendments to other parts of the law, including how payments are calculated for hospital outpatient departments and ambulatory surgical centers, and ensures that these rebates are excluded from the calculation of average sales prices.