21st Century Cures bill set for markup

'This is a major milestone for hope and health'
By Bernie Monegain
10:45 AM
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The 21st Century Cures bill put forth by the House Energy and Commerce's Subcommittee on Health, is set for markup Thursday, a process in which subcommittee members offer amendments.

The bill aims to launch a new effort to provide cures for the more than 6,000 diseases for which there are no treatments. An updated draft will be released prior to Thursday’s markup. The draft bill calls for $10 billion in extra funding for the National Institures of Health over five years.

"Every bill we draft, every vote we cast, we're moving forward on the path to cures," said full committee Chairman Fred Upton, R-Mich., in a news release. "This is a major milestone for hope and health."

21st Century Cures is the product of a yearlong, bipartisan, nationwide listening tour spearheaded by Upton and Rep. Diana DeGette, D-Colo. DeGette, Health Subcommittee Chairman Joe Pitts, R-Penn., and full committee Ranking Member Frank Pallone Jr., D-N.J., and Health Subcommittee Ranking Member Gene Green, D-Texas, recently released a discussion draft and held a Health Subcommittee hearing to continue the public discussion on Cures.

[See also: 21st Century Cures effort gains steam and House panel drafts bill to speed cures.]

“Every step in this process has been hard fought, not for our own interests, but for those who suffer," Upton said in a statement rleased this morning. "Every policy has been scrutinized, every voice considered. We’ve pushed harder and faster than anyone thought possible, because we know patients cannot wait. They need 21st Century Cures now."
Read the updated draft online here and a section-by-section online here.

Several stakeholders have already weighed in on the bill with recent formal comments: HIMSS, CHIME and the National Law Review to name just three.

In their responses, both HIMSS and CHIME urged the panel to take into account the critical need to to be certain the right data is connected to the right patient every time.

HIMSS offered its response to the legislation in a July 22, 2014, letter to Upton and DeGette.

"Make development and adoption of a consistent nationwide patient data-matching strategy through government-private sector collaboration a top priority for the administration," they wrote. 

CHIME concurs. Before CHIME CEO Russell Branzell and Board Chair Charles Christian, who signed the May 7 letter, they pointed to the industry's failing to know for sure the right data is tied to the right patient – always.

"We must first acknowledge that the lack of a consistent patient identification strategy is the most significant challenge inhibiting the safe and secure electronic exchange of health information," Branzell stated in a May 7 letter. To the House subcommittee. "As our healthcare system begins to realize the innately transformational capabilities of health IT, moving toward nationwide health information exchange, this essential core functionality – consistency in accurately identifying patients – must be addressed."

As data exchange increases among providers, patient data matching errors and mismatches will become exponentially more dangerous and costly. We must first acknowledge that the lack of a consistent patient identification strategy is the most significant challenge inhibiting the safe and secure electronic exchange of health information. As our healthcare system begins to realize the innately transformational capabilities of health IT, moving toward nationwide health information exchange, this essential core functionality – consistency in accurately identifying patients – must be addressed. As data exchange increases among providers, patient data matching errors and mismatches will become exponentially more dangerous and costly."

CHIME recently announced it would raise a $1 million for the person or team that could come up with a feasible plan.

"CHIME calls on Congress to remove the prohibition baring federal regulators from developing standards to improve positive patient identification," Branzell and Christian wrote in their letter to the subcommittee. "CHIME members wish to highlight the enormously difficult socio-technical challenge of making technology systems interoperable; not only does it require harmonizing complex technology systems, but complex systems of policies, processes and people must also align to achieve interoperability. We stress the need for simplicity as an overarching goal of future drafts, but we also caution against any notion that interoperability will come easily or cheaply."

Both HIMSS and CHIME essentially told the house panel interoperability is complicated.

"Interoperability and standardization of data and transmission rules, leading to successful exchange and re-use of health information and efficient and safe clinical workflows, requires the regular updating of standards, implementation guides, regulations, and operating rules. The importance of “adoption and implementation” of the standards is essential to fully realize interoperability," Paul Kleeberg, MD, chair of the HIMSS board of directors, and HIMSS CEO H. Stephen Lieber wrote in the HIMSS letter to Upton and DeGette.

"CHIME members wish to highlight the enormously difficult socio-technical challenge of making technology systems interoperable; not only does it require harmonizing complex technology systems, but complex systems of policies, processes and people must also align to achieve interoperability. We stress the need for simplicity as an overarching goal of future drafts, but we also caution against any notion that interoperability will come easily or cheaply," Branzell and Christian continued.

Read the most recent draft of the bill here.