Insights

On October 14, 2022, President Biden signed an Executive Order (EO) directing the Secretary of the Department of Health and Human Services (HHS) to consider new healthcare payment and delivery models the Center for Medicare & Medicaid Innovation (CMMI)—part of the Centers for Medicare & Medicaid Services (CMS) and created by the Affordable Care Act—can test to lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. The EO specifies the HHS Secretary should include models that may lead to lower cost-sharing for commonly used drugs and support value-based payment initiatives that promote high-quality care. The Secretary’s report, describing any models selected, must be submitted within 90 days of the EO’s issuance.  

On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address health care disparities and promote health equity. In other words, FDA intends to specifically consider whether a device may provide for more effective treatment or diagnosis in populations impacted by health and/or health care disparities when determining eligibility for breakthrough status.