Press Release - HHS Secretary Responds to the President's Executive Order on Drug Prices

Action announces new models and supports access to $2 generic drugs

Today, the Centers for Medicare & Medicaid Services (CMS) announced that the Secretary of the Department of Health and Human Services (HHS) has selected three new models for testing by the CMS Innovation Center to help lower the high cost of drugs, promote accessibility to life-changing drug therapies, and improve quality of care. The Secretary released a report describing these three models to respond to President Biden's Executive Order 14087, "Lowering Prescription Drug Costs for Americans," which complements the historic provisions in the Inflation Reduction Act of 2022 (IRA) that will lower prescription drug costs.

"HHS is using every tool available to us to lower health care costs and increase access to high-quality, affordable health care," said HHS Secretary Xavier Becerra. "We are full steam ahead in delivering the cost savings from the President's Inflation Reduction Act of 2022, and people on Medicare are already feeling the benefits. But as President Biden has made clear, we must build on the new prescription drug law with further action, which is why HHS is implementing these new projects to bring down prescription drug costs."

"Prescription drug prices in the United States are the highest in the developed world, resulting in affordability and access challenges," said CMS Administrator Chiquita Brooks-LaSure. "The prescription drug law is making lifesaving prescription drugs more affordable for millions of people who have Medicare, and through the selected models, the Innovation Center will lower prescription drug costs and improve access for people with Medicare and Medicaid, ranging from $2 access to certain generic drugs to better deals for expensive new therapies."

Tackling the high costs of prescription drugs and increasing access to novel therapies continue to be priorities of the Biden-Harris Administration. As part of the Inflation Reduction Act of 2022, for the first time in history, Medicare will be able to negotiate lower prescription drug prices for beneficiaries, and starting this year, drug companies that raise their prices faster than inflation will have to pay Medicare a rebate. But the Administration recognizes there is more work to do to lower prescription drug costs for more American families. That's why on October 14, 2022, President Biden issued an executive order directing Secretary Becerra to consider additional actions to further drive down prescription drug costs. In particular, the executive order directs the Secretary to consider whether to select for testing, by the CMS Innovation Center, new health care payment and delivery models that would lower drug costs and promote access to innovative drug therapies for beneficiaries enrolled in the Medicare and Medicaid programs, including models that may lead to lower cost-sharing for commonly used drugs and support value-based payment that promotes high-quality care.

"These selected models will test strategies to make it easier for Medicare patients to afford and access needed prescriptions at $2 or less, help expand access to cutting-edge cell and gene therapies for people with Medicaid, and help ensure drugs already on the market are safe and effective," said CMS Deputy Administrator and Director of the CMS Innovation Center Liz Fowler, PhD, JD. "We look forward to working on these models and helping to lower drug costs for Americans with Medicare and Medicaid."

The three models selected by the Secretary for testing by the CMS Innovation Center and described in the report address the themes outlined in the executive order and meet the selection criteria thresholds of affordability, accessibility, and feasibility of implementation. The models are:

• The Medicare $2 Drug List: For chronic conditions like high blood pressure and high cholesterol, there are many relatively inexpensive generic medications that have significant clinical benefits, but cost-sharing can vary widely across insurance plans based on the specific formulation a doctor prescribes. This means patients may experience unexpected changes in their cost-sharing and may pay more than they have to. Under this model (the Medicare High-Value Drug List Model), Part D plans would be encouraged to offer a low, fixed co-payment across all cost-sharing phases of the Part D drug benefit for a standardized Medicare list of generic drugs that treat chronic conditions. Patients picking plans that participate in the Model will have more certainty that their out-of-pocket costs for these generic drugs will be capped at a maximum of $2 per month per drug.

• The Cell and Gene Therapy Access Model: Cell and Gene Therapies are an emerging area of new drug development that holds significant potential, but these therapies can cost upwards of $1 million. Under this model, state Medicaid agencies would assign CMS to coordinate and administer multi-state, outcomes-based agreements with manufacturers for certain cell and gene therapies. As new therapies come to market, this will help Medicaid beneficiaries gain access to potentially life-changing, high-cost specialty drugs for illnesses like sickle cell disease and cancer.

• The Accelerating Clinical Evidence Model: Some drugs are approved before they have established evidence of improvement in a clinical endpoint, which is called accelerated approval. CMS would develop payment methods for drugs approved under accelerated approval, in consultation with the Food and Drug Administration, to encourage timely confirmatory trial completion and improve access to post-market safety and efficacy data. This would reduce Medicare spending on drugs that have no confirmed clinical benefit.

To help identify model options, the CMS Innovation Center solicited input from a variety of sources, including beneficiary advocates, health care providers, prescription drug manufacturers, and more. The CMS Innovation Center looks forward to additional input as these models are further developed.

In addition to the three selected models, the Secretary has identified additional areas for research with the potential to lower prescription drug costs. The CMS Innovation Center looks forward to feedback on these ideas and will continue research into the design and feasibility of these ideas.

For more information on the selected models and the additional areas of research that address the executive order, a Fact Sheet is available at https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report-summary.

Frequently Asked Questions are available at https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report-faqs.View the report at https://innovation.cms.gov/data-and-reports/2023/eo-rx-drug-cost-response-report.