Healthcare Law Blog

JANUARY 26, 2023

BACKGROUND The Proposed Rule is the latest in a long line of federal legislation and rulemakings governing the conscience rights of healthcare providers and entities. The Church Amendments In the 1970s, the federal government enacted the Church Amendments, 42 U.S.C.

ACA 105

ACA Medicaid Medicaid Compliance 105

SQA

FEBRUARY 15, 2023

” The reason: The existing document of the EU GMP Guideline dates back to 2011 and no longer corresponds to the state of the art in various areas or does not consider increasingly important new technologies for the GMP field, according to the EMA. ” The requirements for providers (e.g.,

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Verisys

JULY 13, 2023

Verisys’ former VP of Pharma and Pharmacy Solutions, Joe Thompson, shared a prime example of how speaker programs introduce risk to the pharmaceutical company: “In 2011, one of the most prominent endocrinologists in my sales region was an active speaker for my previous company. He led multiple programs for us each year.

Compliance 52

Compliance Due Diligence Pharmaceutical Industry Fraud 52

Healthcare Law Blog

JANUARY 10, 2022

Enrollee Participation in Plan Governance (§ 422.107). CMS believes its proposals would improve Federal and State oversight of certain D-SNPs (and their affiliated MCOs) through greater information-sharing among government regulators. Key provisions of the Proposed Rule are summarized below. Comments are due by March 7, 2022.

Medicare 98

Medicare Medicare COVID-19 Medicaid 98

Health Law Advisor

AUGUST 10, 2023

5] But that Interstate Commerce Clause needs to be viewed also in balance with the 10th Amendment of the Constitution, which reserves to the states any powers not delegated to the federal government. Implementing a Constitutional limit, FDA does not regulate a licensed practitioner who makes devices for use in his or her own practice.

FDA 98

FDA Licensing Hospitals Medicaid 98

Drug & Device Law

MAY 19, 2023

at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. Sorsaia , 2023 WL 3211847, at *7 (citations omitted). See also GenBioPro, Inc. Sorsaia , C.A. 2023 WL 3451688, at *1 (S.D.W.

FDA 111

FDA Medical Personnel Telemedicine Licensing 111

Drug & Device Law

JULY 31, 2023

Since digital files were not “articles” under the statute, the government could not rely on this statute to prevent their importation. 2011 WL 13186258, at *2 (C.D. May 17, 2011) (flight simulator and associated training materials were not products subject to strict liability); Heindl v. Wells Fargo Bank , 2011 WL 1833020 (D.

Governance 52

Governance Payment Systems Hospitals Licensing 52