Last week, Vermont adopted the first state law that requires drug companies registering the highest hike in prices to justify the rationale for the increase. Vermont policymakers are not alone pursuing laws that address rising drug prices. California and Ohio are eyeing pricing-related bills and ballot initiatives. This begs the question: If […]
Health care policy issues continue to stream out of Congress and the Administration. The Senate held a markup of various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates.
Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office. While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates. Moreover, proposals directed at addressing the […]
Late last week, Senator Barbara Boxer (D-CA) wrote to the leaders of Johnson & Johnson, GE Healthcare, Siemens USA, Medtronic and Philips USA, to “express serious concerns” about potential cybersecurity vulnerabilities in their medical devices. From the letter, the rationale for selecting these companies is that together they “control more […]
Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced that he will pursue a “step by step” approach to crafting major biomedical innovation legislation. This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan.
Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”). This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion in tax breaks. The Omnibus includes several health care related provisions, both on the funding and tax sides. This post highlights some of the more significant items.
In the wake of Amarin Pharma’s victory in securing a preliminary injunction against the Food and Drug Administration’s (FDA) prohibition of off-label communication of Vacepa , Pacira Pharmaceuticals has filed a First Amendment challenge to the FDA’s attempt to restrict communications about its postsurgical pain drug, Exparel. Pacira’ s lawsuit, […]
As we discussed here, the government continues to improve its use of data analytics to identify and prevent fraud, waste, and abuse in the health care industry. This week, the Centers for Medicare & Medicaid Services (CMS) announced that its Fraud Prevention System (FPS) has identified and prevented $820 million in improper […]
21st Century Cures Passes House of Representatives; Ups the Ante for HHS Grant and Contracting Fraud
Earlier today H.R. 6, “21st Century Cures”, passed the House of Representatives by an overwhelming vote of 344-77. Among the myriad provisions, the bill contains language creating civil money penalties (CMPs) for fraudulent grants and contracting with the Department of Health of Human Services (HHS). According to a summary of the bill […]
Yesterday, the House of Representatives voted 280-140 to pass H.R. 160, a bill that eliminates the 2.3 percent medical device tax. The vote was strongly bipartisan with 46 Democrats joining all Republicans voting in favor of scrapping the tax. The vote came amid the threat of a veto from the […]