CMMI Issues Report on Status of Pending Drug Models

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Editor’s Note: The article below, sharing the status of CMS’ three models in development to address prescription drug costs, was first published on Manatt on Health, Manatt’s premium legal and health policy subscription service covering topics and trends transforming health care. Additional insights are available on Manatt on Health. For more information on becoming a Manatt on Health subscriber or scheduling a demonstration, please contact Barret Jefferds at 

The Center for Medicare and Medicaid Innovation (CMMI) has provided new updates on CMS’ planned initiatives to address prescription drug costs in a blog post from Director Liz Fowler. One test, the Accelerating Clinical Evidence Model, appears to have stalled, while progress continues on other projects.

The post came on the one-year anniversary of Executive Order 14087 in which President Joe Biden ordered Secretary Xavier Becerra to consider selecting Innovation Center models for testing focused on lowering drug costs and increasing access. That order in turn led to a January 2023 report by the Department of Health and Human Services (HHS) selecting three models for testing and announcing next steps for their development and design. The blog post describes the state of the three models, each of which remains in development with no fixed start date.

The most controversial of the three models from the HHS report is the Accelerating Clinical Evidence Model. As proposed, in that model CMS would decrease Medicare Part B payments for some drugs approved through the Food and Drug Administration’s (FDA) Accelerated Approval Program (AAP) when manufacturers fail to timely complete their post-approval clinical studies. That proposal garnered criticism from congressional Republicans who worried the model could undermine the FDA’s prerogative in approving medicines as safe and effective. In the blog post, CMS describes little progress on this model. Instead, much of the post’s attention is directed at lauding the FDA’s current success at encouraging manufacturers to complete trials. The post identifies no next steps for the model, other than the Innovation Center’s desire to “continue to monitor” the AAP pathway, suggesting plans for this test are on the back burner, if still under consideration at all.

The Cell and Gene Therapy Access Model is a proposed test in which CMS would make and implement voluntary multistate value-based payment arrangements with life sciences companies for their cell and gene therapies that state Medicaid programs could join. The blog post describes a series of stakeholder sessions held by CMMI in the past few months and projects the Center is now targeting a “rolling” launch in 2025, with states joining the model throughout the year.

Finally, the blog post discusses the Medicare $2 Drug List Model, under which Part D plans would offer a standardized slate of low-cost generics as part of their basic benefit package. The blog post details efforts by CMS to examine how Prescription Drug Plan sponsors are covering generics to date and to find a slate of approximately 150 drugs that would offer a treatment option in over 90% of instances when a drug might be prescribed. The blog does not give a date for launch, stating only that “CMS will release additional details about this model as soon as is feasible.” It may be that CMS intends to include model information in this fall’s upcoming Medicare Advantage (MA) prescription drug plan rule for a 2025 launch. However, this might complicate the 2025 implementation of the Inflation Reduction Act’s (IRA’s) changes to the Part D benefit, and CMS might prefer to wait until 2026 for the launch of this project.



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