Health Care Law News and Insights

Shingles, Vaccines, And Rule 702

Published: Oct 09, 2023
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We've discussed our Drug and Device Law Blog elder care duties before and how it has educated us about health issues faced by the senior population. Shingles is one health risk that increases as you get older. It is often described as a painful rash, but "painful rash" doesn't really capture how bad shingles...

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Federal Court Strikes Down Copay Accumulator Programs

Published: Oct 06, 2023
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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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FDA Proposes Phased Approach To Regulating Laboratory Developed Tests

Published: Oct 02, 2023
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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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