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By Alex Ruoff
Feb. 9 — The Senate HELP Committee Feb. 9 approved a bill that would overhaul the way the federal government regulates health IT and address some of the industry's most pressing issues.
The Improving Health IT Act would create a star rating program for federally certified electronic health record systems and direct federal regulators to address hospitals' ongoing issue with matching patients to their electronic health records and electronically exchanging patient records with other health-care providers.
Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-Tenn.) called the bill an “important and far-reaching piece of legislation.”
“Everything we’re trying to do is affected by improvements in electronic health-care record systems,” Alexander told reporters.
The bill is part of a slate of bills that make up the Senate's version of the 21st Century Cures bill (H.R. 6) that passed the House last July.
The HELP Committee expects to approve more than 30 bills by April that together will act as a companion to the House's Cures bill, Alexander said.
While the bill has garnered support from health IT industry groups, the American Hospital Association warned that the bill could unfairly blame hospitals for blocking the electronic transfer of patient records among health-care providers.
In a letter dated Feb. 8, the AHA said EHRs often can't exchange patient records due to technical issues that can be costly to fix.
The Health IT Improvement Act would empower the HHS Office of Inspector General to investigate claims of information blocking, defined in the legislation as interfering with or discouraging access, exchange or use of electronic health information. The legislation would also allow the Department of Health and Human Services to fine any organization guilty of information blocking.
Hospitals and health-care providers could be fined under this legislation simply for being unable to electronically exchange records due to technical or administrative issues, the AHA said.
“For those reasons, we have concerns that the enforcement provisions risk unfairly penalizing providers as engaging in information blocking when the core issue is technical or operational,” the AHA said.
However, there remain unanswered questions about how Congress will pay for these initiatives. Lawmakers are split along party lines over whether to establish a mandatory funding stream for the medical innovation measures or fund them during the annual budget process.
The Feb. 9 markup of the medical innovation bills set the stage for a coming battle over how the federal government will pay for what could be more than $9 billion in new funding for the National Institutes of Health, the HHS and other agencies.
Alexander said he doesn't want any new government spending to remain permanent, mandatory funding. Instead, he proposed an innovation projects fund that would support a limited number of high-priority NIH projects, such as the Precision Medicine Initiative, the recently proposed Cancer Moonshot program and the BRAIN Initiative. He did, however, say mandatory funding might acceptable for temporary projects.
“We may be able to pay for these initiatives in our normal appropriations process, but I am willing to consider using mandatory funding for these initiatives,” Alexander said. “Because of our budget deficit, I believe we would need to find that funding by reducing existing mandatory funding.”
The House-passed Cures bill would provide mandatory spending of $8.75 billion for the NIH and $550 million annually for the FDA through the Cures Innovation Fund that would sunset after five years.
The House bill also includes a number of proposals to offset those costs, such as a provision regulating the amount of oil sold from the Strategic Petroleum Reserve, which falls under the House Energy and Commerce Committee's jurisdiction.
Alexander told reporters Feb. 9 that the HELP Committee will vote on a total of 50 proposals in more than 30 bills by April and then, separately, he'll introduce a proposal to create the Senate version of a medical innovation fund.
“We have to decide what programs we want and how we will pay for them, and we will do that on the floor,” Alexander said.
The innovation projects fund could include mandatory funding but only for nonpermanent NIH projects, Alexander said.
“These areas need to be jump-started, but they also need a beginning and an end,” he said. “In other words, it's not a 40-year commitment.”
Any new funding for NIH would also come with new oversight for the NIH, Alexander said.
Sen. Bill Cassidy (R-La.) said during the HELP committee markup session that NIH should be required to improve its administrative structure as part of any new funding.
Sen. Elizabeth Warren (D-Mass.) said NIH funding and basic medical research has fallen “dangerously behind.” She said researchers need long-term funding commitments to support their work.
“We cannot punt this to some vague promise to add funding later on,” Warren said.
The HELP Committee also on Feb. 9 passed a set of bills on health research, device accountability and targeted therapies for rare diseases as part of its innovation package.
The next medical innovation markup is scheduled for March 9, and the bills to be considered in that session include bipartisan legislation to modernize the National Institutes for Health and the Food and Drug Administration.
The committee also plans to consider a bill to support the White House's Precision Medicine Initiative, which aims to transform medicine by providing more targeted treatments to patients.
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