On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Medicaid and Children’s Health Insurance Program Managed Care Access, Finance and Quality Final Rule, a final rule that updates several...more
From wholesale revisions of the merger guidelines to significant amendments to the Hart-Scott-Rodino premerger notification forms, the Federal Trade Commission (FTC) and the Department of Justice (DOJ) have proposed...more
On August 29, 2023, the Centers for Medicare & Medicaid Services (CMS) announced the ten (10) Medicare Part D drugs selected for the first round of negotiations of the Medicare Drug Price Negotiation Program (Program)—a few...more
On August 15, 2023, the U.S. Court of Appeals for the Tenth Circuit (the “Tenth Circuit”) issued its decision in Pharmaceutical Care Management Association (PCMA) v. Mulready, one of the first major opinions to further define...more
8/31/2023
/ Drug Pricing ,
Employee Retirement Income Security Act (ERISA) ,
Health Insurance ,
Pharmaceutical Industry ,
Pharmacies ,
Pharmacy Benefit Manager (PBM) ,
Preemption ,
Prescription Drug Coverage ,
Prescription Drugs ,
Rutledge v Pharmaceutical Care Management Association ,
SCOTUS
On June 8, 2023, the Centers for Medicare & Medicaid Services (CMS), Center for Medicare and Medicaid Innovation (CMMI), announced a new demonstration model under the authority of Section 1115A of the Social Security Act that...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
The Centers for Medicare & Medicaid Services (CMS) recently issued the Medicare Advantage (MA) and Part D proposed rule for contract year 2024 (the “Proposed Rule”), which represents the Biden administration’s broadest effort...more