Later this week, the House of Representatives is expected to consider the H.R. 6, the 21st Century Cures Act.  Ahead of the House vote, the House Rules Committee released a revised version of the bill with new funding offsets and other policy changes.  Notably changes in the newest version include:

  • A provision excluding authorized generics from calculation of average manufacturer price (AMP) for purposes of determining Medicaid brand name drug rebates (sponsors note that this policy would have the effect of increasing the AMP of brand drugs and in thus increasing the rebates drug manufacturers would owe to the states and federal government).
  • Modifications to National Institutes of Health and Food and Drug Administration funding levels for purposes of carrying out the bill;
  • Clarifications to the standards for development of health information technology, including revisions to the role of federal agencies.
  • Elimination of a previous provision that would have delayed certain Medicare prescription drug plan prepayments.
  • Application of the Medicare average sales price plus six percent methodology to infusion drugs furnished through durable medical equipment (instead of 95 percent of the October 2003 average wholesale price).
  • Extension of the Medicare power mobility devices prior authorization demonstration and a limitation on audits related to items approved through the advance determination process.
  • Expansion of civil monetary penalties in cases of HHS grant or contract fraud.

On July 8, the House Rules Committee is scheduled to vote on the terms for debate on H.R. 6.