FDA Law

MAY 7, 2025

The Seventh Circuit took a more lenient approach than the Fourth Circuit, focusing its rationale on whether an independent contractor had improper influence over a healthcare providers independent healthcare decisions. Sorenson follows the Fifth Circuits decision last year in United States v. Marchetti, 96 F.4th Marchetti, 96 F.4th

Referral 59

Referral Relationship Government Healthcare 59

FDA Law

NOVEMBER 6, 2022

In its petition filed earlier this month, Pfizer challenges HHS’s interpretation of the AKS as “staggeringly overbroad,” contrary to the congressional intent behind the AKS, and a threat to “almost any activity that facilitates patient access to federally funded healthcare.” Background. Borrasi, 639 F.3d 3d 774 (7th Cir.

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

Manufacturing 52

Manufacturing Government Referral Provider 52

Annals of Family Medicine

NOVEMBER 20, 2024

Context: The ExPAND Mifepristone (ExPAND) learning collaborative is a year-long program focused on growing the pool of abortion providers by integrating medication abortion into primary care. Objectives: 1) Participating clinics begin to provide mifepristone for early pregnancy loss (EPL) and/or abortion care.

Primary Care 130

Primary Care Clinic Referral Provider 130