The 21st Century Cures Act has passed the Senate by a 94 to 5 vote, marking the last stop before President Obama’s desk to become a law.
As we reported before, The Cures Act took three years to pass and was one of the most hotly-lobbied healthcare bills in the current Congress. It passed in the House last week. The bill allocates $4.8 billion to the National Institutes of Health over the next 10 years, and the funding goes towards three signature Obama administration initiatives that drive innovation in digital health: The Precision Medicine Initiative, the BRAIN Initiative, and the Cancer Moonshot. It also grants an additional $1 billion to states to address the opioid crisis as well as $500 million for the FDA. The Cures Act would also put different evidence standards on the FDA’s drug and device approval, effectively speeding up the process.
What the bill fails to specifically address is deadlines for implementation -- particularly with regards to the role of the FDA in establishing a “breakthrough device pathway” for the approval of medical devices. The bill requires the agency to build upon the existing priority review device program and improve the medical device classification review process, as well as identify five types of low-risk medical software that will not be regulated as medical devices.
In addition, yesterday, the House passed via voice vote the ECHO Act, which passed 97-0 last week in the Senate and is also on its way to the president’s desk. The bill expands a success model on New Mexico telehealth program onto the national stage. Project ECHO is a hub-and-spoke model for connecting specialists at academic medical centers with primary care physicians via teleconferencing technologies.
The bill, proposed by Senator Orrin Hatch (R-Utah), doesn't increase deployment of the ECHO model outright, but it prioritizes the study of the model, including study by the Government Accountability Office, and paves the way for HHS to expand the model in the future.“Our legislation improves medical services for all Americans by providing healthcare professionals in rural and underserved communities with access to a network of peers and specialists who can teach specialty care,” Hatch said in a statement before the bill was passed. “By connecting doctors and nurses with teams of experts, patients can receive the care they need, when they need it. And most importantly, patients won’t have to travel long distances to receive treatments; they can stay close to home and receive treatment from doctors they know and trust."
In state telemedicine news, the Michigan state Senate unanimously passed a telemedicine bill yesterday. The bill allows healthcare providers to use telehealth, so long as their patients first agree to the technology. New Jersey is close to passing a law that would regulate telemedicine. The bill has already passed in the state Senate.