January 22, 2016

Senate Committee Adjusts Strategy to Advance Innovations Bill

Sen. Lamar Alexander (R-TN), chair of the Health, Education, Labor and Pensions (HELP) Committee, announced a limited bipartisan agreement Jan. 19 to begin consideration of a series of stand-alone bills to promote greater innovation and flexibility for the regulatory review of investigational pharmaceuticals and medical devices. The HELP Committee will hold a bipartisan mark-up of seven pieces of legislation on Feb. 9, including a forthcoming bill designed to improve the electronic health record (EHR) “meaningful use” program.

The health information technology legislation was expected to be released at some point during the week of Jan. 18. It will focus on three goals, specifically decreasing unnecessary physician documentation, enabling patients to have easier access to their own health records and making EHRs more accessible to the entire health team. HELP Committee Republicans have also announced additional legislative markups for March 9 and April 6, though Democrats serving on the committee have not agreed to this tentative schedule.

HELP Committee Chair Alexander adopted this piecemeal approach after extended negotiations with Ranking Member/Sen. Patty Murray (D-WA) failed to yield an agreement on a plan for consideration of H.R. 6, the 21st Century Cures Act, a comprehensive bill that is also designed to modernize and streamline the federal government’s approval process for pharmaceuticals and medical devices.

H.R. 6 previously passed the House of Representatives with overwhelming bipartisan support in July 2015, but the HELP Committee announcement clouds the possibility that this more extensive legislation will be passed in its entirety. Senate Republican opposition to the creation of a mandatory funding stream for the National Institutes of Health (NIH) and a strong sense among Senate Democrats that H.R. 6 relaxes needed government regulation at the behest of lobbying from the drug and device industries has, thus far, prevented the HELP Committee from considering the 21st Century Cures Act.

Congress’ decision to use many of the financial offsets previously reserved for 21st Century Cures Act to pay for other major initiatives, such as the October 2015 budget agreement and H.R. 2029, the Consolidated Appropriations Act of 2016, further complicate the effort to pass this more comprehensive House bill. Nevertheless, Sen. Alexander has promised to continue negotiations with Senate Democrats in hopes of finalizing a bipartisan strategy to consider and pass H.R. 6 while also holding a series of legislative markups.

In the House, Rep. Fred Upton (R-MI), chair of the House Energy and Commerce Committee, welcomed the news that the HELP Committee will consider various drug and device bills next month.

While the American College of Radiology (ACR) is closely following the HELP Committee’s efforts to reform and streamline the pharmaceutical and medical device approval process, the Government Relations office is particularly intrigued by the forthcoming EHR bill. ACR members are encouraged to monitor the Advocacy in Action newsletter for the latest information surrounding the HELP Committee mark-ups and the forthcoming EHR legislation.