Under the 21st Century Cures Act (Cures Act), the Health and Human Services (HHS) Secretary is mandated to have promulgated regulations by Dec. 13, 2017 that, among other requirements, prohibit “information blocking” as a...more
As stories and statistics of the opioid crisis become increasingly prevalent in our national discourse, we are seeing a stronger, more innovative, and more aligned push for interventions across communities, government...more
In a health policy landscape fraught with partisan rancor, congressional members from both sides of the aisle came together to pass the 21st Century Cures Act. Championed over the past three years by bill sponsor and House...more
The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more
President Obama has signed into law the 21st Century Cures Act (Cures Act), that expands funding for medical research. Hidden within the Cures Act is a provision entitled “Exception from Group Health Plan Requirements for...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
The 21st Century Cures Act signed into law on December 13, 2016 is gaining significant attention as landmark legislation promoting medical innovation. But the massive Cures Act goes much further and includes some relief...more
The December 8, 2016 passage of the 21st Century Cures Act by Congress is expected to lead to sweeping changes to the biotech, medical device and health industries and streamline the regulatory system for approval of both...more
The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more
President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...more
Last week the Senate passed, nearly unanimously, the 21st Century Cures Act, which President Obama signed on December 13, 2016. The Act is divided into three divisions: 21st Century Cures, Helping Families in Mental Health...more
On December 13, 2016, President Obama signed the 21st Century Cures Act ("Cures Act"), H.R. 34, into law. It enjoyed bipartisan support and was overwhelmingly approved by the House and Senate in recent weeks. The expansive...more
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,...more
Even with the federal legislators poised to head home at the end of the week, two significant telehealth measures continue to work their way through the House and Senate, further evidence that telehealth services have become...more
On November 30, 2016, the House overwhelmingly passed (392-26) the 21st Century Cures Act (“Bill”). The Bill moves on to the Senate next week and it is projected to pass in the Senate as well. Notably, the Bill seeks to...more
Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
House Leadership Elections: Republican House leadership changes remain in flux in the wake of Speaker John Boehner's (R-OH) decision to retire and the unexpected delay of the vote to select his successor. House Majority...more
This Week: Senate Reauthorizes Older Americans Act; Bill Heads to the House... White House Holds 2015 Conference on Aging and Launches Several New Administration Healthy Aging Initiatives Enveloping Alzheimer’s, Dementia,...more
The bill known as the “21st Century Cures,” H.R.6, would extend Civil Monetary Penalties (CMPs) to cover false claims and false statements relating to grants, contracts, and other agreements funded by the Department of Health...more
A consortium of hospitals from across the country has delivered a letter to Congressional leaders, urging them to preserve the federal 340B program in its present form. Neither the content nor the timing of the letter was...more
In This Issue: - 21st Century Cures Markup; Full Committee to Take Up this Week - Senate Finance Committee Solicits Health Bills for Upcoming Markup - Implementation of the Affordable Care Act - Federal...more