Posted on December 9, 2016
Aboard Air Force One headed for Tennessee on a frosty day two Januarys ago, President Barack Obama gave Sen. Lamar Alexander a preview of his Precision Medicine Initiative, the plan to get genomic and other data from a million Americans to use in developing targeted drug therapies.
The Tennessean, who was about to take over the Senate HELP Committee, was a natural ally for Obama because of his own interest in biomedical innovation that grew out of years of discussions with academics from the sprawling biomedical campus of Vanderbilt University, which he has represented in the Senate since 2003.
Their work to advance Precision Medicine quickly came across a hurdle the three-term senator was familiar with: health IT. Medical information couldn’t easily flow from researcher to researcher or from hospital to hospital. It was trapped within the electronic health infrastructure that the federal government had spent nearly $35 billion to build.
Precision Medicine’s biggest problem wasn’t obtaining genomes; it was prying data out of EHRs. To realize the program’s potential, Washington policymakers needed to unlock the data and get the meaningful use incentive program “out of the ditch,” as Alexander said.
Alexander’s HELP Committee would hold a half dozen hearings on EHRs in 2015. With help from top Democrat on the committee Sen. Patty Murray and others, HELP crafted legislation to spur health information sharing that became part of the 21st Century Cures bill, which passed the House with 392 votes and the Senate with 94 yeas Wednesday. Obama is expected to sign it soon.
“I think we’ll look back and see that HELP assisted the industry in making the transition from meaningful use to value-based payment incentives for health IT adoption and use,” said David Kibbe, chief executive of DirectTrust.
The Senate was able to build upon EHR policies put forth initially in the House, leaving the final product deeply imprinted with Senate fingerprints.
HELP Committee hearings addressed clinical usability of the technology, documentation requirements, patient access to health records and “information blocking,” all issues addressed in the final bill.
Executives from major EHR vendors Epic, Cerner and Allscripts testified before lawmakers. “I certainly am pleased with the evolution of the bill and appreciate the good work and leadership of Sens. Alexander and Murray and their staffs,” said Leigh Burchell, head of government affairs at Allscripts.
Alexander’s familiarity with EHR problems predated the Air Force One trip. He was one of six senators who in April 2013 called for a “reboot” of the meaningful use program.
In 2015, as Republicans retook the Senate, new developments created an opportunity. Meaningful use penalties on doctors and hospitals were starting to hit, and providers were increasingly lobbying to get relief from the third and final stage of meaningful use.
HELP’s hearings came at “exactly the right time,” said Stephanie Zaremba of athenahealth. “Multiple senators called attention to information blocking behaviors in those hearings, and that spurred more changes in terms of vendors working together and dropping excessive fees than any mandates in legislation will,” she said.
Vanderbilt is home to one of the handful of elite biomedical informatics centers in the United States, receiving millions in grants annually from NIH. It will play a major role in the Precision Medicine Initiative, including hosting the Data and Research Support Center for the PMI Cohort Program with a $.71.6 million, five-year grant. It also will have a major role in Vice President Joe Biden’s cancer moonshot.
Alexander’s influence in the area stems from the fact that he’s an old-school senator, one willing to work with Democrats. Bipartisanship “has become a hallmark of his chairmanship on the HELP Committee,” said Jeff Smith, vice president of public policy at the American Medical Informatics Association. “He also empowered other senators to weigh in, and that's how Sens. Cassidy and Whitehouse got involved.”
Bill Cassidy and Sheldon Whitehouse sponsored the TRUST IT Act, which would have created a star-rating system for usability, interoperability and security in EHRs. The rating system was dropped but other elements of TRUST IT made it into the final Cures bill.
Problems that providers have correctly matching patients to their records — an issue dear to Sen. Elizabeth Warren’s heart — were also addressed.
In 2014, Alexander worked with Democrats on language inserted into an appropriations bill that called for ONC to create an information blocking report, and that helped kick-start industry action on the issue. Soon after its publication in April 2015, EHR giant Epic Systems announced it would drop fees for exchanging health records with non-Epic systems.
Alexander and Murray also spotlighted cybersecurity in health care, creating a government task force on the issue in last year’s broader cybersecurity bill.
Obama and Alexander met again in February, following a White House event marking the anniversary of PMI. They discussed Precision Medicine and the cancer moonshot, aides said.