Update: The 21st Century Cures Act

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On July 10, 2015, the House of Representatives passed the 21st Century Cures Act, which modifies Food and Drug Administration (FDA) processes, provides funding for the FDA and the National Institutes of Health (NIH), includes provisions related to the interoperability of health information technology (HIT) and modifies certain Medicare and Medicaid coverage and reimbursement requirements. It is anticipated that the Senate will consider its version of the bill, the Innovation for Healthier Americans initiative, when it reconvenes after Labor Day.

The Senate bill will be originating in the Committee on Health, Education, Labor and Pensions (HELP), and will likely be materially different than the bill that passed the House. For example, the bill that passed the House included several Medicare payment reduction provisions to offset the costs of the bill. These “pay fors” have been assessed and scored by the Congressional Budget Office (CBO). However, due to the HELP committee’s jurisdiction, it is likely that the Senate’s initial bill will not include Medicare provisions to offset the costs of the bill. Nonetheless, Congress may consider the “pay fors” passed by the House, as well as offsets for other legislation down the road. The Senate is considering FDA policies separately from interoperability. It is possible that the Senate may release multiple bills covering different topics rather than one large bill. It also is likely that the Senate bill may be narrower than the bill passed by the House.

It is anticipated that the Senate’s version of the bill will be brought to the Senate floor by the end of the year.

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Update: The 21st Century Cures Act

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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