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21st Century Cures Act

21st Century Cures ActAfter the House and Senate passed the 21st Century Cures Act, it went to President Obama who signed it earlier this week. The long-awaited legislation covers the following 5 major points, along with other changes in research, funding, and new drug approval.

Focus on health information technology (HIT)

The bill means to encourage interoperability of electronic health records by incentivizing a process for standards development and prohibiting practices that discourage the sharing of patient health information, known as “information blocking”.

Cancer Moonshot funding

The bill will provide the National Institutes of Health (NIH) $4.8 billion over the next ten years to fund cancer research as well as other medical research. This funding will help continue the efforts of the Cancer Moonshot Initiative led by Vice President Joe Biden.

Impact on medical devices

Part of this legislation will impact the FDA approval of medical devices. The Act will establish a program for priority review of breakthrough medical devices, as well as improve the regulatory process and streamline clinical trials.

Opioid abuse prevention

The bill includes $500 million a year to go towards opioid abuse prevention and better treatment programs for addicts. The legislation provides a significant increase in funding for opioid treatment, as well as other smaller provisions related to substance abuse and suicide prevention.

Small-group HRA provision

The provision will allow eligible small employers to offer health reimbursement arrangements (HRAs) funded solely by the employer to reimburse employees for qualified medical expenses. The maximum reimbursement is up to $4,950 per year for the employee only, or up to $10,000 if the employee has family coverage.