Health Care Law News and Insights

On September 29, 2023, the U.S. District Court for the District of Columbia vacated a Trump-era rule from 2021 that allowed insurers to exclude drug manufacturer co-pay support coupons and assistance from a patient's annual cost-sharing caps. This practice, commonly referred to as a copay accumulator program, is typically used by insurance...

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On September 29, 2023, the U.S. Food and Drug Administration (FDA) posted and scheduled for publication its long-awaited proposed rule concerning FDA regulation of laboratory developed tests (LDTs). If enacted, the proposed rule would amend the Agency's regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal...

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On December 27, 2020, the Centers for Medicare & Medicaid ("CMS") of the Department of Health and Human Services created a new provider type for embattled rural1 and critical access hospitals ("CAHs")2—the Rural Emergency Hospital ("REH").3 Designation as an REH allows for a suspension of a hospital's inpatient operations while maintaining emergency...

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