Insights

On Monday, July 15, New Jersey Attorney General Matthew J. Platkin and the New Jersey Division of Consumer Affairs released proposed rules (the “Proposed Rules”) which require certain New Jersey healthcare providers (i.e., physician assistants, physicians, nurses, and midwives) who provide perinatal treatment and care to pregnant persons to undergo bias training. The training is designed to root out prejudices and stereotypes that may negatively impact the quality of care delivered by these providers to patients during pregnancy, labor, delivery, postpartum, and neonatal periods.  The Proposed Rules were promulgated in an effort “to address pronounced racial disparities in maternal and infant health outcomes in New Jersey.”

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On October 21st, the U.S. Food and Drug Administration (FDA) released a draft guidance that, if finalized, will update the agency’s 2018 guidance on its Breakthrough Devices Program (the “Program”). In the draft guidance, the FDA announced that when reviewing the eligibility of medical devices for the Program, the agency will also consider whether a device will help address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.