Today the House Energy and Commerce Committee is marking up H.R. 6, the 21st Century Cures Act, a high-profile, bipartisan bill that seeks to accelerate the pace of medical cures in the United States through a variety of reforms addressing drug and device development and approval, clinical trial design, research funding, interoperability of health technology, and other issues. The amendments to be considered during markup have been posted, including Chairman Upton's amendment with offsets/"pay-fors" for the bill, including provisions:

  • Limiting Medicaid durable medical equipment reimbursement rates to Medicare fee-for-service rates applicable in the state, effective January 1, 2020;
  • Making various changes to Medicare imaging policy; and
  • Implementing OIG recommendation to delay certain Medicare prescription drug plan prepayments, beginning with 2020.

Other amendments address other drug policy issues, including a Welch amendment that would direct the Secretary to negotiate with drug manufacturers regarding Part D prices and a Schakowsky amendment requiring manufacturers to submit drug R&D cost information as part of the drug approval/biological licensing process.

The full text of the version of HR 6 to be considered today and the various amendments are available here.

UPDATE: The bill was just approved, with adoption of Chairman Upton's amendment and no others, by a unanimous, 51-0 vote.

This article is presented for informational purposes only and is not intended to constitute legal advice.