Bill of Health

OCTOBER 27, 2023

The regulation and administration of health care in the United States suggests a list of familiar institutional names — the Department of Health and Human Services, the Food and Drug Administration, Centers for Medicare & Medicaid Services, and the National Institutes of Health, to list a few.

HIPAA 157

HIPAA FDA Informed Consent Health Insurance 157

Healthcare Law Blog

MARCH 17, 2022

22-05 , relating to subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial involving medical devices (the “Proposed Arrangement”). The Therapy is available only for clinical use under an FDA-approved, Category B Investigational Device Exemption (“IDE”) ( see 42 CFR 405.211(b)-(c) ).

US Department of Health and Human Services 52

US Department of Health and Human Services Informed Consent Medicare Medicare 52

Hall Render

FEBRUARY 10, 2023

over Claims Practices Where things stand in Central California 1 month after a community hospital’s closure California hospital names Kelly Linden CEO Upcoming California health bills to watch, including a conversation with Rep. Blue Shield of California is counting on it.

US Department of Health and Human Services 40

US Department of Health and Human Services COVID-19 Nursing Homes Nurses 40

Drug & Device Law

DECEMBER 29, 2023

2023) (rejecting any express anti-preemption presumption in Medicare case) ( here ); Baker v. Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis.

FDA 105

FDA US Department of Health and Human Services COVID-19 Informed Consent 105