Drug manufacturer Eli Lilly has filed suit against four companies involved in making, prescribing, and/or selling compounded versions of its weight loss and diabetes drugs ZEPBOUND® and MOUNJARO®....more
4/30/2025
/ Business Litigation ,
California ,
Corporate Practice of Medicine ,
Enforcement Actions ,
Life Sciences ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation ,
State Legislatures ,
Telehealth ,
Unfair Competition
Important changes are unfolding in the vaccine space.
How have vaccine exemptions posed a significant risk to populations across the country? What are the long-lasting effects of the new administration's federal health...more
A federal appeals court panel in New Orleans is poised to uphold a lower court ruling enjoining the enforcement of the Affordable Care Act's (ACA) requirement that most private health insurance cover recommendations of the...more
Braidwood v. Becerra represents a significant legal challenge to the Affordable Care Act’s (ACA’s) preventive services coverage provision, which requires private health insurance to cover various clinical preventive services,...more
On March 30, 2023, the U.S. District Court for the Northern District of Texas issued a final judgment in Braidwood Management Inc. v. Becerra, invalidating a requirement in the Patient Protection and Affordable Care Act (ACA)...more
On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more
4/4/2023
/ Acquisitions ,
Biologics ,
Biopharmaceutical ,
Centers for Medicare & Medicaid Services (CMS) ,
Clinical Trials ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Healthcare ,
Inflation Reduction Act (IRA) ,
Investment ,
Life Sciences ,
R&D ,
Research and Development
For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19...more
The Novavax COVID-19 vaccine recently received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for individuals 18 and older, making Novavax the fourth COVID-19 vaccine to receive either...more
The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Physician Fee Schedule (PFS) proposed rule for calendar year (CY) 2023, which clarified the timeline for increased COVID-19 vaccine...more
Questions Remain for Pharmacy Test-to-Treat Programs Last week, the U.S. Food and Drug Administration (FDA) revised the Emergency Use Authorization (EUA) for Paxlovid to authorize state-licensed pharmacists to prescribe the...more
On June 7, 2022, the Federal Trade Commission (FTC) unanimously voted to initiate a study into how business practices employed by some pharmacy benefit managers (PBMs) may impact prescription drug pricing and patient access...more
On May 9, 2016, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule addressing the implementation of physician payment reforms included in the Medicare Access and CHIP Reauthorization Act of 2015...more
On March 8, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule titled “Patient Protection and Affordable Care Act; CMS Notice of Benefit and Payment Parameters for 2017” (“Final Rule”)[1] setting...more
The Advance Notice (“Advance Notice”) of Methodological Changes for Calendar Year (“CY”) 2017 for Medicare Advantage (“MA”) Capitation Rates, Part C and Part D Payment Policies and 2017 Call Letter was released by the Centers...more
On January 21, 2016, the Centers for Medicare & Medicaid Services (“CMS”) released a final rule (“Final Rule”) addressing key areas of Medicaid reimbursement for outpatient drugs and changes made to the Medicaid Drug Rebate...more
On December 2, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule titled “Patient Protection and Affordable Care Act; CMS Notice of Benefit and Payment Parameters for 2017” (“Proposed...more