Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
The Centers for Medicare & Medicaid Services (CMS) published an interim final rule implementing the Most-Favored-Nation (MFN) Model for Medicare Part B drugs and biologics in the November 27, 2020, Federal Register (the...more
On September 13, 2020, President Donald Trump issued an Executive Order, “Lowering Drug Prices by Putting America First,” to direct the Secretary of Health and Human Services (HHS) to implement new payment models under...more
The Centers for Medicare & Medicaid Services (CMS) has just released the final 60-day overpayment rule (the Rule) on February 11, 2016, in what the agency describes as a continuing move targeted at rooting out fraudulent...more
The United States Government Accountability Office (GAO) recently released a report entitled “Medicare Part B Drugs: Action Needed to Reduce Financial Incentives to Prescribe 340B Drugs at Participating Hospitals” (“the...more
7/14/2015
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Section 340B