21st Century Cures Act - Not Just an FDA Reform Bill



21st Century Cures Act - Not Just an FDA Reform Bill

Fresh off the passage of the Medicare Access and CHIP Reauthorization Act, The House Energy and Commerce Committee is now considering another significant piece of healthcare legislation. The 21st Century Cures Act (21CCA) has generated considerable momentum behind its two major provisions, increasing NIH funding and making targeted reforms to the FDA approval process.  These concepts are popular and have Congress uniting in bipartisan fashion around the 21CCA, creating a vehicle for smaller, but nevertheless significant, policy changes. 

For example, the 21CCA would increase transparency for local coverage determinations (LCD) made by Medicare Administrative Contractors (MAC). The bill would require MACs to post LCDs in their entirety online with explanations for their rationale, the evidence considered and responses to comments regarding their LCDs

The bill would also seek to foster greater transparency for Medicare site-of-service payments. Beginning in 2017, the bill requires HHS to create and annually update a public website that displays estimates for the appropriate number of items and services, anticipated costs to the Federal government and estimated costs to the beneficiary for services provided in hospital outpatient departments and ambulatory surgical centers.

The bill also contains language that would exempt Continuing Medical Education (CME) and tuition reimbursement for CME as a transfer of value which needs to be disclosed online under the CMS open payment program.

The 21CCA also seeks to significantly boost interoperability among electronic health records (EHR). The bill would require EHRs to be able to securely transfer the entirety of a patient’s data between all qualified EHRs, grant providers and authorized users complete access to EHR health data and ban information blocking practices. The 21CCA also requires EHRs certified after January 1, 2018 to both be interoperable as well as to be able to support third party software programs via an application programing interface (API). Providers and hospitals would be able to qualify for a hardship exemption from penalties under the EHR meaningful use incentive program if their EHR is decertified as a result of this provision.

The House Energy and Commerce Committee will consider debate and vote on the bill with the goal of bringing the package for a vote on the House floor this summer. The Senate has indicated its intent to pass its own similar bill but the chamber is not expected to meaningfully act until after the summer.