The Centers for Medicare & Medicaid Services (CMS) released the 2024 Medicare Advantage and Part D Final Rule, which will revise regulations governing Medicare Advantage (MA), the Medicare Prescription Drug Benefit (Part D), Medicare cost plans, and Programs of All-Inclusive Care for the Elderly (PACE). The rule makes changes related to prior authorization, health equity, marketing and communications, and other areas on which Association for Clinical Oncology (ASCO) commented during the rulemaking process.

On January 1, a provision of the Inflation Reduction Act (IRA) went into effect requiring drug companies to pay rebates to Medicare when prescription drug prices increase faster than the rate of inflation for certain drugs given to people enrolled in the program. The provision also provides for lower Medicare Part B beneficiary cost sharing on such drugs beginning April 1, 2023.

Cisplatin has been in shortage since February 2023 (per FDA data), and the shortage has grown particularly acute in the last week or two. Accord/Intas released a cisplatin lot this week and subsequent releases are expected. 

The following is a message from the Director of the FDA Oncology Center of Excellence, Dr. Richard Pazdur:

On April 3, 2023, the Food and Drug Administration granted accelerated approval to enfortumab vedotin-ejfv (Padcev, Astellas Pharma) with pembrolizumab (Keytruda, Merck) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

The Association for Clinical Oncology (ASCO) submitted a statement to the U.S. Senate Committee on Homeland Security and Government Affairs for a hearing titled, “Drug Shortage Health and National Security Risks: Underlying Causes and Needed Reforms.” ASCO’s statement highlighted the current drug shortages facing the oncology community and offered specific recommendations to help mitigate them. 

The Association for Clinical Oncology (ASCO) recently submitted a response to an RFI from the Senate HELP Committee, focusing on current oncology workforce demographics, drivers of oncology shortages across the care team, lack of workforce diversity, and the distribution of oncology professionals across rural America.

The Association for Clinical Oncology (ASCO) submitted comments in response to a Centers for Medicare & Medicaid Services' (CMS) proposal is to streamline prior authorization by requiring Medicare Advantage plans, Medicaid plans, and Qualified Health Plans (QHP) on Federally Facilitated Exchanges (FFEs) to establish an electronic prior authorization process that would be integrated into a provider’s workflow.