The Congressional Election and What It Means for 2019

By Jim Flood, Byron Brown, Scott Douglas, Traci Vitek, Jerrica Mathis & Tim Shadyac on November 20, 2018

The Congressional election on November 6, 2018 produced a new split Congress with a House Democratic majority and a Senate Republican majority starting in January 2019. The difference between the outgoing 115th Congress, with a Republican House and Senate, and the 116th Congress starting in 2019 will be significant for U.S. businesses. While the divided Congress brings opportunities to advance bipartisan legislation involving infrastructure, energy, and pharmaceuticals, the new House Democratic majority in the 116th…

C&M Health Law

Government Affairs – The Progress of Telehealth Bills in Congress

By Traci Vitek, Jim Flood & Stephanie Willis on November 16, 2018

The Centers for Medicare & Medicaid Services (CMS) recently proposed a rule to allow Medicare Advantage plans to expand telehealth benefit coverage. (See alert for more detail) This proposed rule implements the statutory provisions in section 50323 the Bipartisan Budget Act of 2018. What you might not know, however, is that the Bipartisan Budget Act of 2018 is only one of many legislative vehicles by which advocates for telehealth expansion have been able to move…

C&M Health Law

FDA’s Medical Device Safety Action Plan

By Jodi G. Daniel, Maya Uppaluru, Traci Vitek & Payal Nanavati on May 8, 2018

On April 17, 2018, the Food and Drug Administration (FDA) released its Medical Device Safety Action Plan which outlines FDA’s intended steps to address medical device safety while preserving enough space for innovation in the market. The FDA’s plan is the latest effort by the FDA on medical device safety, including a recent budget request seeking $70 million to create a Center of Excellence on Digital Health that would, among other things, craft new regulations…

C&M Health Law

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

By Ashley N. Southerland, Payal Nanavati, Jodi G. Daniel & Traci Vitek on April 26, 2018

Despite the Trump Administration’s declaration of a state of emergency on October 26, 2017, the federal response to the opioid crisis largely languished on the back burner—much to the chagrin of states in the trenches of the opioid epidemic. However, based on the flurry of activity over the past several weeks, the federal government response now seems to be gathering substantive momentum, with various agencies and government actors launching attacks on all fronts—administrative, legislative, and…

Traci Vitek

The Congressional Election and What It Means for 2019

Government Affairs – The Progress of Telehealth Bills in Congress

FDA’s Medical Device Safety Action Plan

The Freight Train Gathers Steam: An Update on the Federal Response to the Opioid Crisis

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