Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more
1/31/2024
/ Advisory Opinions ,
Anti-Kickback Statute ,
Beneficiaries ,
Centers for Medicare & Medicaid Services (CMS) ,
Civil Monetary Penalty ,
Clinical Trials ,
Cost-Sharing ,
Digital Health ,
Food and Drug Administration (FDA) ,
Medical Devices ,
Medicare ,
OIG
On November 6, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released the contract year 2025 proposed rule for Medicare Advantage (“MA”) organizations and Part D sponsors (the “Proposed Rule”). The Proposed...more
This month, pharmaceutical manufacturer, Merck & Co., Inc. (“Merck”), as well as four chambers of commerce, have filed suits against the federal government, arguing that the Medicare Drug Price Negotiation Program introduced...more
6/22/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
Drug Pricing ,
Healthcare Reform ,
Inflation Reduction Act (IRA) ,
Manufacturers ,
Medicare ,
Medicare Part B ,
Medicare Part D ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Regulation
On February 9, 2023, the Centers for Medicare and Medicaid Services (“CMS”) released two highly-anticipated guidance documents (the “Guidance”) detailing the agency’s proposed implementation of the Medicare Part B (“Part B”)...more