FDA Law Blog

NOVEMBER 6, 2022

In June 2019, Pfizer sought an OIG advisory opinion to ensure that its proposal would not run afoul of federal law. Now, after an unfavorable HHS Office of the Inspector General (OIG) advisory opinion and two defeats in court, Pfizer has appealed the Second Circuit’s decision to the Supreme Court. Background. Borrasi, 639 F.3d

Manufacturing 83

Manufacturing Patient-Centered Healthcare Utilities 83

FDA Law Blog

SEPTEMBER 29, 2021

Department of Health and Human Services (“HHS”), which reported that discounted purchases totaled $38 billion in 2020, a 27% increase compared to 2019. Manufacturers may choose not to participate in this program, but the federal government will not reimburse for their outpatient drugs under Medicaid or Medicare Part B if they do not.

Manufacturing 52

Manufacturing Government Referral Provider 52

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. The Eliminating Kickbacks in Recovery Act (“EKRA”). 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

Lab Testing 52

Lab Testing Referral Individual Patient-Centered 52

FDA Law Blog

JANUARY 6, 2022

In general, EKRA prohibits, knowingly and willfully, soliciting, receiving, paying or offering kickbacks in exchange for referring to, inducing a referral to, or using the services of a recovery home, clinical treatment facility, or laboratory. The Eliminating Kickbacks in Recovery Act (“EKRA”). 18 U.S.C. § 18 U.S.C. § 24(b) (emphasis added).

Lab Testing 40

Lab Testing Referral Individual Patient-Centered 40