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President Obama Signs 21st Century Cures Act into Law

The 21st Century Cures Act will streamline drug approval processes at the FDA, provide medical research funding, and target better EHR and health IT use.

By Sara Heath

Earlier this week, President Barack Obama signed the 21st Century Cures Act into law.

Among its main provisions to relax drug approval procedures at the Food and Drug Administration and provide funding for various projects such as the Precision Medicine Initiative and Cancer Moonshot, the law targets better EHR use and supports health data interoperability.

In a public statement, Senator Lamar Alexander (R-Tenn.), chairperson of the Health, Education, Labor, and Pensions committee and co-sponsor to the bill, reiterated his delight at its passage.

“The real winners today are American families whose lives stand to be improved by the legislation signed into law. For the second consecutive year, President Obama has signed another Christmas miracle,” he said.

“This bipartisan law will help us take advantage of the breathtaking advances in biomedical research and bring those innovations to doctors’ offices and patients’ medicine cabinets.”

Specifically, the law calls for the Secretary of Health and Human Services to “establish a goal with respect to the reduction of regulatory or administrative burdens (such as documentation requirements) relating to the use of electronic health records,” and subsequently create a strategy to achieve such a goal.

Those strategies should include incentive programs to spur increased EHR and health IT adoption. These include meaningful use, requirements under the Quality Payment Program, and the Hospital Value-based Purchasing Program.

Additionally, the law calls on ONC to establish better requirements for health IT interoperability. Through strong health IT certification rules, the agency is expected to facilitate better data transfer between disparate systems.

ONC is also required to establish clear language surrounding information blocking.

Certification rules must ensure a health IT developer “provides assurances satisfactory to the Secretary that such developer or entity, unless for legitimate purposes specified by the Secretary, will not take any action described in clause (i) or any other action that may inhibit the appropriate exchange, access, and use of electronic health information,” the law says.

The rules should include ramifications for health IT developers who do engage in intentional information blocking.

The bill also states that no later than six months after it has been passed, the HHS Secretary must submit to ONC meaningful use attestation statistics. The Secretary must also make meaningful use hardship exemptions reasonably available to both eligible professionals and eligible hospitals.

In addition to support health IT, the 21st Century Cures Act calls for new drug development and clinical trial protocol, reportedly streamlining the process to help get potentially life-saving drugs on the market. According to FDA’s Commissioner, Robert M. Califf, MD, this fast-tracking of cures will extend to health devices, as well.

“For devices, this past year was the first full year of operation for FDA’s expedited access pathway (EAP) program, which helps speed the development and availability of certain medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly-debilitating diseases or conditions,” Califf said in a public statement.

Additionally, the law allocates greater funding for biomedical research. The law provides $4.8 billion to the National Institutes of Health to be split among four different projects: $1.8 billion will go to the Cancer Moonshot, $1.4 billion will fund the Precision Medicine Initiative, and $1.6 billion will fund the BRAIN Initiative which supports Alzheimer’s disease research.

The 21st Century Cures Act began making its way through Congress in the summer of 2015. At the end of November 2016, a group of senators, including Alexander, reintroduced a revised version of the bill reportedly with the hopes to pass it during its lame duck session.

At the start of December, the House passed the bill in a 392 to 26 vote, sending it to the Senate for approval. After a vote of cloture, which pushed the bill to a decisive vote, the Senate voted in favor 85-13.

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