JULY 20, 2005 — The bipartisan goodwill at Wednesday's Senate Health Education and Labor Committee markup was such that members combined their voices in chorus to unanimously approve a bill promoting health information technology.
They then all harmonized in a round of "Happy Birthday" to one of their own, Sen. Barbara A. Mikulski. "This is what I wish the Senate would be more like," the Maryland Democrat said. "It's a happy day for me."
The Wired for Health Care Quality Act (S 1418), which is expected on the Senate floor [the week of July 25], would establish the public–private American Health Information Collaborative to make recommendations for uniform standards for information technology. Federal programs would have to follow the standards to make computer systems compatible, but the standards would be voluntary for the private sector.
The legislation blends a bill developed by Sens. Bill Frist, R-Tenn., and Hillary Rodham Clinton, D-N.Y., and another by Chairman Michael B. Enzi, R-Wyo., and Edward M. Kennedy, D-Mass.
"Because we share this goal, we have worked together to combine our bills into one that will bring the government and the private sector together to build new electronic pathways for medical data, and thereby provide all Americans with health care that is better, safer and more efficient," Enzi said. "When this is implemented we are going to see huge decreases in error rates," added John Ensign, R-Nev.
Under the bill, competitive grants would be awarded to hospitals, group practices, and other providers to ease adoption of the technology. Grants also would be made available to academic health centers to teach medical students how to use health IT in practicing medicine. The bill also would establish a quality measurement system to pay more to providers who improve the quality of care.
Financing IT
A key issue confronting policymakers is where the money will come from to fund health IT.
Removed from the bill before Wednesday's markup was language that would have eased federal legislation intended to prevent financial inducements by hospitals to doctors to make referrals. The language relaxing the "Stark law," written by Rep. Pete Stark, D-Calif., would allow a hospital to donate a computer system to a physician's practice if the result was to make care safer or more efficient.
Without such a loosening of the law, hoped-for donations of IT to physician practices may be much less likely. And the sum authorized in the bill for grants—$125 million in fiscal 2006 and $155 million in fiscal 2007—is a pittance compared with the tens of billions of dollars needed to wire the entire U.S. health system.
So were high spirits at the markup misplaced? No, according to a Senate leadership aide, who said the language to relax the Stark law falls under the jurisdiction of the Senate Finance Committee and will return once that panel signs off on it.
And as for the relatively small amount of grant money, "our responsibility as the government is not to build the system," the aide said. "The private sector really needs to step up here." And it will, the aide said, because there's a big business case for it.
"The feeling is when the standards are set and the payment incentives are set, the capital will flow," the aide said.
Another issue that must be clarified is a potential conflict between quality performance measures in the bill and those in legislation offered by Sens. Charles E. Grassley, R-Iowa, and Max Baucus, D-Mont., that would tie Medicare payments to quality of care. But Enzi expressed confidence the potential conflict would be resolved.
Meanwhile, Health and Human Services Secretary Michael O. Leavitt told the Senate Budget Committee on Wednesday that the federal government's first priority should be ensuring that health care providers' computer systems are compatible with one another.
Panel Moves to Preserve User Fees
The panel also unanimously approved by voice vote a bill (S 1420) that would preserve industry-paid user fees to help fund Food and Drug Administration (FDA) reviews of medical device marketing applications.
The fees help speed approvals by allowing the FDA to hire more reviewers, but Congress fell short of its funding obligations for device reviews in fiscal 2003 and fiscal 2004. In the absence of congressional action, the shortfall triggers a provision in the Medical Device User Fee and Modernization Act causing the user fee program to sunset September 30.
The measure OK'd by the panel would preserve the user fee program but reduce the yearly fee increases industry must pay for product reviews. It would increase the number of businesses that pay smaller fees by increasing the ceiling of yearly revenues for such firms from $30 million to $100 million. The bill also addresses labeling requirements for single-use devices that are reprocessed to allow subsequent use.
The Senate is expected to vote on the bill early next week, and medical device lobbyists expressed optimism the House would approve the measure before the August recess.