On Wednesday, the Senate voted 94-5 to pass the long-awaited 21st Century Cures Bill. As it has backing from the current White House administration, President Barack Obama is expected to sign the legislation into law.
The law has been called the "most important bill of the year" by Senator Lamar Alexander (R-TN), as Politico Pulse reported Tuesday. The bill, while bipartisan, is not without controversy. While the House version of the legislation passed swimmingly with a vote of 392-26, the bill did have its share of opponents in the Senate– including Sen. Elizabeth Warren (D-MA) and Sen. Bernie Sanders (I-VT) – who think the bill is too favorable to pharmaceutical companies. Both Sanders and Warren were among the five Senators to vote against the measure.
And as Modern Healthcare's Merrill Goozner notes in an editorial, it's likely the true impact of the bill won't be known right away but will be realized as the years pass. "The final details of the 996-page legislation...weren't known until five days before it passed," Goozner wrote.
About three years of work and efforts from 1,400 lobbyists for 400 companies went into the making of this $6.3 billion package. It seeks to deliberately speed medical research and treatments. Because seemingly no healthcare legislation can be a reasonable length (it's about 90 pages longer than the ACA) and because nothing in healthcare is simple, we've summarized some of the notable implications of the bill in four buckets: Health IT, mental health, FDA reform and research and care funding.
Over the course of 10 years, the Cures bill authorizes the National Institutes of Health to spend $4.8 billion toward funding the Cancer Moonshot ($1.8 billion) and the precision medicine and the BRAIN Initiative efforts ($3 billion). The package allocates $1 billion to help curb the opioid epidemic in the U.S.
It should be noted while the Cures act authorizes the spending, the actual money must be appropriated by Congress. This means the NIH funds must get fresh approval every year.
While the bill is largely known for helping to fund efforts such as precision medicine, the "cancer moonshot" and potentially being a gift to the pharma industry, the bill contains some health IT-related provisions.
Low-risk medical devices
The legislation clarifies low-risk medical devices will not be regulated as a medical device under the FDA. This includes your FitBits, your smart shirts that can track your physical activity or your EHRs for that matter. This is important from a health IT developer perspective, Stephanie Zaremba, director of government and regulatory affairs at athenahealth, told Healthcare Dive, as investors won't face the uncertainty that the health app could be blocked by the FDA before gaining a return on investment.
"Giving certainty is really important for investing purposes," Zaremba says, noting she believes such a law will help get more innovative, low-risk technology in patients' hands.
It's the buzzword that just won't go away: Even after years and millions of dollars have been funneled into helping force the hand of the industry into the digital era, it's still not at a point of seamless integration as expected. With the Cures bill, Congress is trying to make the necessary changes to get health information flowing in a private sector-led way, Zaremba says.
One way the bill takes aim to drive greater interoperability is by having the Office of the National Coordinator for Health IT (ONC) assist public-private and public-public partnerships to create a "trusted exchange framework, including a common agreement among health information networks nationally." ONC would also help set up a provider directory for those that have adopted the agreement and data exchange standards.
One of the barriers to data exchange, whether real or perceived, is health data information blocking. The Cures act gives HHS' Office of the Inspector General authority to "resolve an information blocking claim." Though Zaremba notes it's important for CIOs and C-suite execs on the health IT side of the aisle to recognize their roles as purchasers and clients of health IT. "Once more health systems and CIOs demand information flowing, you'll see more of it," she says.
In addition, under the legislation, HHS will be tasked to "educate healthcare providers on ways of leveraging the capabilities of health information exchanges" and "clarify misunderstandings" on HIEs' use.
Zaremba notes time will tell if this legislative strategy gets providers to share the data. "When the market works, related parties get together and say 'here’s how we’re going to exchange information because it’s in our best interest to do so,' and we need to get that in healthcare," she says.
Dr. John P. Docherty, senior vice president and medical director from ODH, Inc., tells Healthcare Dive the passage "of this bill in the House marks the first mental health reform bill in more than 50 years. It would require providers to care for the whole person, not just the physical. This will likely transform routine physicals as well as other preventative care screenings and exams."
The bill would authorize the creation of a new HHS assistant secretary of mental health in charge of mental health and substance misuse disorders as well as authorize grants for community treatment teams and assisted outpatient treatment for non-cooperative patients.
The most important provision to Docherty are provisions that will help to strengthen laws mandating parity for mental and physical healthcare. "Additionally, the bill will work to help coordinate care for mental health services to ensure patients get the help they need and to avoid duplicating services," he says. "The bill will push states to provide early intervention for psychosis [who] will be required to use at least 10% of their mental health block grants on early intervention, which can help those suffering get the help and treatment they need as soon as possible."
The Cures act authorizes the FDA to receive $500 million to help speed up product approval processes, which some critics say weakens safety and efficacy standards. For example, when drug makers seek to expand approvals for their marketed products, they will be allowed to include "real world evidence" rather than additional placebo-controlled trials in their applications.
Sanders blasted the bill for not including any provisions addressing the rising cost of drug prices. "At a time when Americans pay, by far, the highest prices in the world for prescription drugs, this bill provides absolutely no relief for soaring drug prices," the former presidential candidate said.
Ned Pagliarulo, an associate editor for BioPharma Dive, contributed to the reporting of this article.