On February 14, 2023, the Centers for Medicare & Medicaid Services (CMS) announced that the Secretary of the Department of Health and Human Services (HHS) selected three models aiming to address high prescription drug costs for testing by the Center for Medicare and Medicaid Innovation (CMMI). This effort to identify ways to lower drug costs in United States comes in response to President Biden’s Executive Order, “Lowering Prescription Drug Costs for Americans,” which complements provisions in the Inflation Reduction Act (IRA).

Both chambers of the United States Congress are working on a top health care priority for the session—protecting patients from high out-of-pocket drug costs and pharmacy benefit manager (PBM) practices that could reduce access and adherence to treatments. The Association for Clinical Oncology (ASCO) will monitor the status of these bills and any future bills that address PBM practices and patient out-of-pocket costs, and it will work with Congress to ensure the oncology community is heard throughout the process.

The Association for Clinical Oncology (ASCO) submitted comments in response to the Centers for Medicare & Medicaid Services (CMS) Contract Year 2024 Policy and Technical Changes to the Medicare Advantage (MA) and Medicare Prescription Drug Benefit Programs proposed rule. ASCO’s comments focus heavily on the proposed changes to prior authorization in the MA program in addition to enhancing health equity and other updates to the Part D drug benefit program.

“ASCO applauds President Biden’s focus on ‘ending cancer as we know it’ during the State of the Union address. We continue to urge the president to keep cancer care and research as top national priorities and are pleased with his plans to advance efforts to strengthen the Cancer Moonshot, improve cancer clinical trials, and foster breakthroughs through the Advanced Research Projects Agency for Health (ARPA-H).” 

On February 3, 2023, the Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. 

The Association for Clinical Oncology (ASCO) submitted comments in response to the Centers for Medicare & Medicaid Services’ (CMS) Patient Protection and Affordable Care Act 2024 Notice of Benefit and Payment Parameters proposed rule. ASCO’s comments support proposals aimed at reducing or eliminating gaps in health care coverage, and the Association continues to advocate for beneficiary protections by opposing the use of copay accumulator programs.