The Nevada Department of Health and Human Services (DHHS) released today its 2019 Drug Transparency Report in connection with the state law requiring transparency related to essential diabetes drugs (EDD). Notably, the Report states that 695 drug national drug codes (NDCs) were included on the February 2019 EDD list published […]
Biologic drug makers will soon have to alert the Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ) of agreements, including patent litigation settlements, they reach with biosimilar applicants. The new reporting requirement is part of the Patient Right to Know Drug Prices Act, which President Trump signed into […]
***Further update – Federal Court Vacates Rule*** Yesterday, U.S. District Court for the D.C. Circuit Judge Amit Mehta invalidated the final rule. In ruling on the merits, Judge Mehta said the Department of Health and Human Services went beyond its rulemaking authority. Specifically the ruling states, “[n]either the Act’s text, structure, […]
This week a California judge dismissed a lawsuit filed in December 2017 by the Pharmaceutical Research and Manufacturers of America (PhRMA) challenging CA S.B. 17. PhRMA had sought a declaration that Section 4 of S.B. 17 was unconstitutional and a permanent injunction preventing the state’s Governor and Director of the Office […]
Today, the Centers for Medicare & Medicaid Services (CMS) released guidance and a Fact Sheet that will provide Medicare Advantage (MA) plans the option of utilizing “step therapy” for Medicare Part B drugs. Recall, the concept of changing the way Medicare pays for Part B drugs was first discussed in the Administration’s May 2018 Blueprint.
Following on the heels of several other states, including California, Nevada and Oregon, that have enacted drug pricing transparency bills, Connecticut and Vermont are the latest states to join the fray. In Connecticut, Public Act No. 18-41 requires pharmacy benefits managers (PBM), health carriers, and drug manufacturers to report certain information […]
Tomorrow at 2 p.m., EST, the President is scheduled to deliver a long-awaited drug pricing strategy speech to put “America’s patients first.” While details of the speech have been closely held, it is anticipated that it will discuss a “comprehensive strategy” for combating the rising cost of prescription drugs and build on two previous actions which […]