House votes ‘aye’ for Cures Act

House votes ‘aye’ for Cures Act

‘Of the 10,000 known diseases – 7,000 of which are rare – there are treatments for only 500.’

After 18 months in the making and vigorous bipartisan campaigning, the 21st Century Cures bill, H.R. 6, which aims to get new medical treatments to market faster, passed the U.S. House of Representatives today. Next stop: the U.S. Senate.

Work on the bill, introduced by Rep. Fred Upton, a Republican from Michigan, and chairman of the House Committee on Energy and Commerce, and Rep. Diana DeGette, a Democrat from Colorado, began with a series of roundtable discussions – fact-finding sessions – with healthcare luminaries across the industry.

The legislation originally called for an additional $10 billion for the National Institutes of Health over five years, but funding was lowered to $8.75 over that period. The legislation also calls for $110 million per year for the FDA.

Called ‘historic” by several House members speaking before the vote this morning, the bill had seemed likely to pass given the wide bipartisan support, but a few concerns did crop up in the few days prior to the vote.

The White House in a statement released July 8, raised concerns over funding, and highlighted the proposed FDA funding, noting the FDA could not handle all the tasks outlined in the bill.

“The new responsibilities for FDA outlined in H.R. 6 exceed the resources provided in the bill and the President’s FY 2016 Budget and as such, FDA will be unable to fully implement the programs established in the bill, while maintaining its current performance levels,” the administration stated in the memo.

The Administration also raised the worry that the bill could undermine regulatory standards by allowing unproven uses of therapies to be marketed to health care payers as though such uses had been proven safe and effective.

Also, it touched on health IT interoperability, stating, “The Administration appreciates the bipartisan interest in advancing the interoperability of health information technology and remains focused on the need to strengthen this critical foundation for delivery system reform and precision medicine.”

Organizations such as HIMSS, CHIME – as well as health IT experts including John Halamka, MD, CIO of Boston’s Beth Israel Deaconess Medical Center – have all weighed in on the interoperability aspect of the bill, essentially cautioning lawmakers that interoperability can be complicated. Halamka has said that some of the legislative language on standards makes no sense.
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