Tag: 21st century cures

21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for […]

FDA hits the brakes on LDT draft guidance

Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT).  First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs.  This guidance marked a significant shift in the regulation of LDT as FDA has chosen […]

Washington’s 2016 healthcare agenda remains unfinished, leaving plenty for 2017

As Washington speeds towards Election Day on November 8th, it is a good time to examine the status of the key legislative and policy issues impacting the healthcare and life sciences sectors.  Congress has few legislative working days remaining in 2016, but could make some headway on legislation to promote innovation as […]

Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter

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.

Senate opts for “Step by Step” approach for innovation legislation

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.

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 […]

Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to accelerate new medical innovations and improve the way in which these innovations are brought to market. One notable inclusion […]