C&M Health Law

JANUARY 25, 2023

Telehealth Section 4113 of the Act extends certain Medicare telehealth flexibilities that were allowed during the COVID-19 PHE for two years, through 2024. The section ensures that telehealth flexibilities under Medicare are extended for two years, regardless of the status of the PHE.

Medicaid 104

Medicaid Medicaid Medicare Medicare 104

Drug & Device Law

DECEMBER 29, 2023

2023) (rejecting any express anti-preemption presumption in Medicare case) ( here ); Baker v. 2023) ( Buckman preemption barred MDL asserting fraud on EPA), cert. Further, the plaintiffs’ arguments were based on scientific standards “not utilized by the FDA,” and thus preempted. Executive Health Resources, Inc. , 3d 239 (Cal.

FDA 105

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

Drug & Device Law

JANUARY 30, 2023

470 (1996), was decided – removing express preemption as a defense for manufacturers of §510(k) products So defendants moved on fraud on the FDA under an implied preemption theory and won. Plaintiffs Legal Committee , 531 U.S. Bartlett , 570 U.S. 472 (2013), implied preemption decisions, cited only by the dissent in Wyeth v.

FDA 72

FDA Fraud Governance Medicare 72